Gene is linked to heart attacks

They found that a particular mutation of the gene occurs more frequently in people who have had a heart attack.

It is thought the gene controls inflammation in the arteries supplying blood to the heart. A blockage here can trigger a heart attack.

The research, by Toyko's Institute of Physical and Chemical Research, is published in Nature.

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The heart attack patients were significantly more likely to carry a specific mutation in a gene that produces a protein called galectin-2.

Galectin-2 is known to bind to a molecule that assists inflammation - lymphtoxin-alpha (LTA) - and which is released when a coronary artery ruptures.

The gene mutation appears to change galectin-2, and in turn to affect the amount of LTA that is secreted - possibly boosting inflammation and increasing the risk of a heart attack.

Professor Jeremy Pearson, of the British Heart Foundation, said: "Over the last decade or so, scientists have realised that the fatty deposits (atherosclerosis) which accumulate in blood vessels are in fact due to a chronic inflammatory disease.

"The current paper strengthens this view, with the novel implication that genes which can control the release of inflammatory proteins from cells may also be related to heart disease risk."

While preliminary data, this research suggests that our thoughts about a cardiac inflammatory response make sense. As we better understand this response, and associated factors, so might we better screen and prevent coronary artery disease manifestations.

Surgery carries many risks. One is the risk of inducing a cardiac event (probable stimulated by stress). We know that beta blockers decrease the risk of post-surgical mortality (especially in patients at high risk for coronary artery disease). Now we have epidemiologic data suggesting that statins may also offer some protection.

Lipid-Lowering Therapy May Reduce Mortality After Major Surgery

"Statins have been shown to have a number of effects that may help stabilize atherosclerotic plaques," Dr. Lindenauer noted. "Since rupture of such plaques is thought to be responsible for most postoperative myocardial infarctions and other adverse events," it seemed logical to look at the effect of lipid-lowering therapy on mortality after surgery, he added.

The results are based on a study of more than 780,000 patients who underwent major noncardiac surgery in the US during 2000 and 2001. The operations included a variety of general, gynecologic, and specialist procedures. Patients who used lipid-lowering agents on the first or second hospital day were classified as users.

Overall, 2.96% of patients died during hospitalization, the authors report. The mortality rate for patients treated with lipid-lowering agents was 2.18%, significantly lower than the 3.15% rate seen for nonusers (p < 0.001). The reduction in mortality was more pronounced with statins than with other lipid-lowering agents.

Based on the risk reduction seen with lipid-lowering therapy, 85 patients would need to be treated with such drugs to prevent one postoperative death. For lower risk patients, the number needed to treat increased to 186, whereas for higher risk patients only 30 were needed to prevent one death.

So, should every patient undergoing major surgery now receive lipid-lowering therapy? Dr. Lindenauer believes that it is too early to make this conclusion. "Our study was observational and I think the findings really need to be confirmed in a randomized clinical trial."

Thus, we have interesting data founded in solid theory. But, as the investigator cautions, we still need a prospective study prior to widespread adoption of this new strategy.

I always wondered where this quote originated.

"If the only tool you have is a hammer, you tend to see every problem as a nail." -- Abraham Maslow (1908-70), American psychologist, founder humanistic psychology

We generalists often use this quotation to describe subspecialty behavior. Sometimes we are right!

Many patients who develop coronary artery disease have well known major risk factors. These include smoking, family history, high LDL cholesterol, diabetes mellitus, low HDL and hypertension. However, these risk factors do not explain all coronary artery disease. Recent research has expanded our ideas about etiology and risk.

This Washington Post article does a nice job summarizing our emerging understanding of risk factors. Not Your Father's Heart Attack

• As many as one of every five heart attacks occurs among apparently healthy individuals who have none of the major risk factors: smoking, high blood pressure, high cholesterol and diabetes.

• Half of all heart attacks happen to men who don't have high cholesterol, the most anxiously tracked risk factor.

• Most confounding: While the vast majority of men diagnosed with heart disease are known to have at least one risk factor, it's also true that the vast majority of men with one risk factor don't have heart disease.

"What we don't yet understand is, of those patients who do have the traditional risk factors, which [patients] are the ones who are going to have an event," said John Canto, a cardiologist at the Watson Clinic in Lakeland, Fla., and author of a Journal of the American Medical Association (JAMA) editorial about heart disease risk factors.

Researchers are turning their attention to new markers -- novel risk factors, as they are known -- to fine-tune predictions of who is headed for that first, or second, heart attack. They are also refining their understanding of some traditional risk factors. Following is a summary of the latest research into risk factors over which men have some control. None can yet predict with certainty whether you're a heart attack waiting to happen. But each can contribute to a portrait of your overall risk.

I recommend this article as a nice summary of an important topic.

With all the furor over anabolic steroids and ephedrine, creatine remains the leading supplement for weight training. I hesitate to label creatine a supplement, but it actually fits the title very well. We all make creatine naturally. Extra creatine (whether dietary or in supplementation) seems to allow weight lifters to lift heavier weights. This leads to increased muscle growth, because the creatine allows the athlete to handle increased loads - leading to more growth.

Numerous studies show creatine safe and effective. This article summarizes the data well - The creatine edge

I have chosen to not take creatine myself, because I do not see a reason to supplement my muscle growth. I cannot criticize those who use it, as this supplement does have good safety data. However, like all supplements, bioavailability and consistent dosing are problematic - because the industry is not well regulated.

Demonizing Fat in the War on Weight

But a growing group of historians and cultural critics who study fat say this obsession is based less on science than on morality. Insidious attitudes about politics, sex, race or class are at the heart of the frenzy over obesity, these scholars say, a frenzy they see as comparable to the Salem witch trials, McCarthyism and even the eugenics movement.

"We are in a moral panic about obesity," said Sander L. Gilman, distinguished professor of liberal arts, sciences and medicine at the University of Illinois in Chicago and the author of "Fat Boys: A Slim Book," published last month by the University of Nebraska Press. "People are saying, `Fat is the doom of Western civilization.' "

Now, says Peter Stearns, a leading historian in the field, the rising concern with obesity "is triggering a new burst of scholarship." These researchers don't condone morbid obesity, but they do focus on the ways the definition of obesity and its meaning have shifted, often arbitrarily, throughout history.

Mr. Stearns, provost and professor of history at George Mason University, has written that plumpness was once associated with "good health in a time when many of the most troubling diseases were wasting diseases like tuberculosis." He traces the equation of obesity and moral deficiency to the late-19th and early-20th centuries. In 1914, an article in the magazine Living Age, for example, stated, "Fat is now regarded as an indiscretion and almost a crime." Mr. Stearns cites it in an essay he wrote for the aptly named "Cultures of the Abdomen," a collection to be published by Palgrave Macmillan next November, edited by Christopher E. Forth, a senior lecturer at Australian National University, and Ana Carden-Coyne, a lecturer at the University of Manchester, in England. During World War I, Mr. Stearns writes, some popular magazines actually said that eating too much and gaining weight were unpatriotic, presumably because of concerns about food shortages.

A great example of this "movement" - The big fat con story

Size really doesn't matter. You can be just as healthy if you're fat as you can if you're slender. And don't let the obesity 'experts' persuade you otherwise, argues Paul Campos

His book - The Obesity Myth - represents his treatise on this issue. The article summarizes his argument.

Several important points need addressing. We can ignore the argument about BMI. Yes, many healthy athletes have elevated BMI. We should focus our definition more on fat percentage or waist circumference. Second, when we do that, we find that as fat increases, so does the risk of type II diabetes mellitus (and therefore atherosclerotic complications) and obstructive sleep apnea. Anyone you makes rounds with me for a month would see the devastation that those disease cause.

Physicians are not making a moral argument, rather we are focusing on prevention. When we have patients exercise and lose fat, their outcomes improve. Admittedly, we need a new method to achieve that goal.

Recently, a reader wrote to ask if I allowed "guest rants". The reader wanted to rant against vaccinations.

I do not allow guest rants, this page is my ranting place. You can comment, but I chose the rants.

I had not thought much about the request until I came across this article - Anti-Vaccination Fever. The author relates the story of pertussis (whooping cough) and how the anti-vaccination lobby has allowed this disease to make a comeback.

Distorted numbers, confusion of correlation with causation, and statistical innumeracy certainly played roles in this sad story. Sensationalist media campaigns fanned the glowing embers. But in each of the countries that experienced the raging fires of epidemics there were other forces at work. Most prominent in passive anti-vaccination movements were religious groups whose opposition was based on religious or moral grounds. Prominent in both passive and active anti-vaccination movements are followers and practitioners of homeopathy, chiropractic, and natural and alternative medicine (Gangarosa et al. 1998).

Despite the compelling case for vaccination that the anti-pertussis vaccination movement has inadvertently made, the Ström, Kuhlenkampff, and Stewart papers are still frequently cited in anti-vaccination literature. Speaking to Science News, Eugene Gangarosa, of Emory University, had this to say of anti-vaccine movements: "There's no question these movements undermine, collectively and individually, the benefits of vaccination" (Christensen 2001).

When anti-vaccination alarm takes hold-characterized by sudden attacks of the media, mistaken researchers, fervent religious groups, and alternative medicine quacks-the infected society begins to make horrid, whoppingly bad decisions. There is, as yet, no Latin name for this peculiar social disease.

Read this fascinating, albeit technical, exposition.

Too often, new surgical techniques do not receive a careful analysis. The VA came through to answer an important question - what is the best approach to hernia repair - Open Mesh Better Than Laparoscopic Mesh Inguinal Herniorrhaphy

Of 2,164 men with inguinal hernias enrolled from one of 14 VA medical centers and randomized to open or laparoscopic repair, 1,983 had surgery, and 1,696 (85.5%) completed two-year follow-up.

There were recurrences in 87 (10.1%) of 862 patients in the laparoscopic repair group and in 41 (4.9%) of 834 patients in the open repair group (odds ratio [OR], 2.2; 95% confidence interval [CI], 1.5 - 3.2). Complications occurred in 39.0% of the laparoscopic repair group and in 33.4% of the open repair group (adjusted OR, 1.3; 95% CI, 1.1 - 1.6).

However, the laparoscopic repair group fared better than the open repair group in terms of pain on a visual analog scale on the day of surgery (difference in mean score, 10.2 mm; 95% CI, 4.8 - 15.6) and at two weeks (6.1 mm; 95% CI, 1.7 - 10.5), and they returned to normal activities one day earlier (adjusted OR, 1.2; 95% CI, 1.1 - 1.3).

Rates of recurrence after repair of recurrent hernias were similar in both groups (10.0% vs. 14.1%). In prespecified analyses, the surgical approach (open or laparoscopic) was associated with the type of hernia (primary or recurrent) (P = .012).

For laparoscopic repair, the recurrence rate was less than 5% for 20 surgeons in the study who reported having done more than 250 of these procedures, but it was consistently above 10% for 58 laparoscopic surgeons who reported less experience with this type of repair. Outcomes of open surgery were far less dependent on the surgeon's experience.

Study limitations include a nonrepresentative sample of high average age and low health-related quality of life; self-reporting of surgeons' experience; and exclusion of patients who had previously undergone a hernia repair using mesh.

Surgical studies are always difficult. This study does remind us that we can not randomize surgical skill. Some surgeons obtain better results than others. The wise generalist figures out which surgeons to whom he/she should refer.

If patients need major surgery, they should try to find outcomes if at all possible. At least use a surgeon with significant experience doing that procedure.

Answer, but No Cure, for a Social Disorder That Isolates Many

Task Force Redefines the Domain of General Internal Medicine

The Society of General Internal Medicine (SGIM) asked a task force to redefine the domain of general internal medicine. The recommendations of the Task Force on the Domain of General Internal Medicine (DGIM) are published in the April 20 issue of the Annals of Internal Medicine, along with editorials providing additional opinions.

"The [SGIM] believes that the chaos and dysfunction that characterize today's medical care and the challenges facing general internal medicine should spur innovation," write Eric B. Larson, MD, MPH, from the Group Health Cooperative, Center for Health Studies in Seattle, Washington, and colleagues from the SGIM Task Force on the DGIM. "Remaining true to its core values and competencies, general internal medicine should stay both broad and deep, ranging from uncomplicated primary care to continuous care of patients with multiple, complex, chronic diseases."

Specific recommendations are that postgraduate and continuing education should develop mastery, enabling general internists wherever they may practice to lead teams and be responsible for team care, to embrace changes in information systems, and to provide most of the care required by their patients.

Fee-for-service and other physician reimbursements should be changed to recognize the value of services performed outside the traditional face-to-face visit, and to offer incentives to improve quality and efficiency and to provide comprehensive, ongoing care. Options could include giving physicians a patient management fee plus reimbursement for specific services, or a salary with incentives for productivity, quality, and improved outcomes.

Residency training in general internal medicine should provide both broad and deep medical knowledge, including mastery of informatics, management, and team leadership. The final one to two years of residency training should be flexible and based on practice goals, leading to a certificate of added qualification in generalist fields.

Research initiatives should include practice and operations management, focused on more effective shared decision-making, transparent medical records, and closer personal connection between physicians and patients.

"The task force believes that these changes will benefit patients and the public and reenergize general internal medicine," the authors write. "Our field must adapt to a new world of consumerism, rising public expectations, widespread information dissemination, and contradictory pressures to hold down costs at a time when the demand for services is increasing because more people survive to old age with chronic disease."

I had the opportunity to read and comment on this report during its construction. Like any such report I can find areas which I dislike. On balance though, SGIM has taken an important initiative to address the important question of how to reinvigorate general internal medicine.

A careful reading will reveal many issues that we discuss in this blog. I always try to take such reports in context of the old Southern saying: "If it ain't broke, don't fix it!"

Well, generalist care is broken, and thus requires remedies. I certainly hope that this report focuses the debate. We need a healthy discussion to develop more functional solutions to generalism.

I like this case a great deal. Read it carefully, and see how quickly you can make the diagnosis. Tunnel Vision, Cramped Hands, Nausea

As we discuss type II diabetic patients, we generally assume that they have coronary artery disease unless we have proven that they do not. Atherosclerotic complications occur very frequently in patients having type II diabetes. Current guidelines also make this assumption. Now we have a strong recommendation concerning statins in these patients.

Treatments: Statins and Diabetes: New Advice

Most patients with Type 2 diabetes should start taking statins, the cholesterol-fighting drugs, as a preventive measure against heart disease, whether or not they have high cholesterol levels, according to new guidelines released yesterday.

The recommendations, from the American College of Physicians, call for moderate doses of statins by people with diabetes who are older than 55, and for younger patients who have any other risk factor for heart disease, like high blood pressure or a history of smoking.

The new guidelines are outlined in April 20 issue of The Annals of Internal Medicine, in an article that noted that about 16 million Americans have Type 2 diabetes and that 800,000 new cases are diagnosed every year.

The lead author of an article accompanying the guidelines, Dr. Sandeep Vijan of the University of Michigan, said that "almost everyone with Type 2 diabetes should be on a statin."

The average age at diagnosis is 48, and even many patients under 55 have high blood pressure as well as diabetes, he said.

Traditionally, diabetes treatment has focused on regulating blood sugar levels by careful control of diet or through insulin injections. But researchers have come to understand that controlling sugar really protects only against the destruction of small blood vessels, which can lead to blindness or loss of fingers, toes or limbs.

Heart disease is, in fact, the more serious threat. Up to 80 percent of diabetes patients will develop heart problems or die of them, the article said. And Dr. Vijan emphasized that controlling hypertension remained the highest priority. He ranked control of lipids, the fats in the blood stream that can affect coronary health, second, ahead of glucose regulation.

I believe that this guideline makes sense in lieu of the mounting data.

Amazing! I just ranted about this issue yesterday. This article bemoans our expenditures on hypertension management - Following Evidence-Based Hypertension Guidelines Could Save Billions. Great! We can do a better job!

As they say on the Guiness commercial (I only wish that I could get some royalties here) - BRILLIANT! .

Quit bemoaning, and develop strategies to fix the problem. Identifying the problem is not enough. These researchers (who are excellent and well regarded) must address solutions.

If they do that, then it really will be BRILLIANT! .

I love General Internal Medicine - both outpatient and inpatient. The intellectual and patient interaction challenges never diminish.

We must maintain broad knowledge and develop the skills to apply that knowledge to our patients. Unfortunately, most physicians can improve their performance.

However, I am often frustrated by the repeated complaints about generalist performance. Here are the two most recent examples:

CDC: Fewer doctors urge weight loss and Statins Underused in High-Risk Elderly Patients

These two examples represent an entire class of such articles. What do these articles tell us? How should we interpret the articles? What should we (the medical community) do with this information?

Using the medical paradigm, one should seek more than making a diagnosis. One should consider the possibilities of treatment. Moreover, we should not stop at making a diagnosis. We must understand what causes the problem.

Consider outpatient medical practice. Each day we see multiple patients with multiple medical problems. Each patient requires attention to a variety of medical problems, including the interaction of those problems. In addition to those problems, we must consider a variety of preventive measures. Careful consideration of all issues might take as long as 30-40 minutes for some patients. But our current reimbursement system dictates shorter visits. Our current reimbursement system dictates seeing too many patients.

Any interest group (and yes the CDC report on obesity represents an interest group) can seek and find deficiencies. However, I do not see much work on helping diagnose and treat the problem. We focus on symptoms, but do not understand the disease.

Thus, I decry these articles. They are no longer constructive, rather they are destructive.

We need a new attitude amongst the health services research community. Quit looking for deficiencies, rather focus on diagnosing and improving health care provision. We need constructive approaches to outpatient and inpatient care. We need to improve.

If I am slicing my drives, I go to my golf pro to diagnose why, and then work on techniques to improve my drives. If the pro just tells my that I have a lousy swing, but does not teach me how to improve, I would likely look for another pro (I say likely, because some golfers are not willing to really try to improve).

Our research group has a committment to understanding medical practice and the barriers to meeting guidelines. We hope to find solutions. I believe that rather than moan about errors and deficiencies, we should champion successes. We can learn more from the positives than the negatives. Physicians will strive towards excellence. Show us how!

Physicians are damned if we underprescribe narcotics to pain patients, and damned if we prescribe to those who abuse drugs. Some pharmaceutical companies are trying to make oral narcotics effective, yet not abusable. Drug Makers Hope to Kill the Kick in Pain Relief

Cooperating closely with government officials and pain specialists, the companies are educating doctors, rewriting warning labels and tracking pills as they move from pharmacy to patient.

They are also reformulating pills with added ingredients. One combination blocks euphoria. Another produces a nasty burning sensation.

So we may soon see effective oral pain control without the option of using the pills in alternate ways. This is good news for pain control. We need the ability to prescribe without worrying about the possibility that we are contributing to drug abuse. These pills will help those patients who really need pain relief.

The End of Primary Care

The very quality of primary care that made it so attractive is what led to its downfall. Legislators, insurance companies, even physicians themselves began to look for ways to harness the expertise of primary care doctors to expand care and limit cost. But no one seemed to recognize that the basis for these economies was the bond between patient and doctor. And without that trust, the economies of primary care were lost.

The initial and most serious blow came when H.M.O.'s persuaded primary care doctors that they should take on the role of gatekeeper. Research indicated that care provided by primary care physicians was more cost-effective than that delivered by specialists. From the insurance companies' perspective, if these doctors were already curtailing costs by getting rid of unnecessary referrals and testing, then providing them with incentives to cut costs would make the savings even greater. What could be better?

The appeal of this system for doctors was more complicated, said Dr. Steve Schroeder, a self-proclaimed card-carrying generalist and the former head of the Robert Wood Johnson Foundation. It flattered primary care physicians by placing them right where they felt they should be: deciding the best, most cost-effective options for their patients. And directing them to a specialist, if need be. That was the theory.

So one can certainly lay some blame on the insurance companies for perverting the primary care concept. However, we must take blame ourselves. We did not think through the "unintended consequences" of the gatekeeper model.

Can we save primary care? Should we save primary care?

I believe that the answer to both questions is yes. Patients need generalist physicians. We need physicians who care for the entire patient. I suspect that most of our patients understand this.

Several movements bode well. Retainer medicine speaks to the concept loudly. While some argue that retainer medicine is just a money ploy, I would argue that some patients are willing to pay to have one intelligent caring physician available, knowledgeable and capable. Similarly, the cash only practice movement shows that patients will pay for good service.

Thus, I expect primary care to transform (albeit slowly and begrudgingly). The change will take time, because few adults embrace change. But the change will help our health care.

Ephedra ban takes effect nationwide after judge rejects supplement makers' request.

The supplement makers' lawyers tried!

Unlike medications, which must be proven safe and effective before they are allowed to be sold, federal law allows dietary supplements to be marketed without any such proof. To curb a supplement, the FDA must show it poses a significant health threat.

NVE maintains that the FDA failed to prove such a threat if the supplement is taken correctly, and was swayed by the outcry over ephedra deaths.

"The FDA chose to ignore valid science that showed that there wasn't a problem," said Walter Timpone, a lawyer for NVE. "In 1999, (there were) 104 deaths as a result of aspirin ingestion. Are we going to ban aspirin now?"

I guess this judge is not impressed with sophistry.

Ordering Treatments à la Carte

Many patients reject the idea of deciding on their own treatments. Overwhelmed by a confusing array of alternatives, they do not want the added stress of being forced to make hard decisions. They turn to their physicians for guidance.

Many doctors are also uncomfortable ceding decision making authority to their patients. The BMJ, a medical journal in Britain, recently published a study showing that men differ significantly in the importance they place on trying to cure prostate cancer versus avoiding the side effects of treatment. In response to this article, angry doctors wrote into Internet sites complaining that the researchers were taking decision making authority away from physicians.

Taken to an extreme, the new way of doing things clearly goes beyond what most patients and physicians want. Still, that does not justify a return to old-fashioned paternalism. Instead, a model of shared decision making gives physicians an opportunity to practice the art of medicine in ways that help patients make choices, often by exploring patients' values enough to make individualized recommendations.

As I have struggled to communicate better with patients (dropping my television analogy, for starters), I have learned that the distinction between letting patients make decisions and making decisions for them is often very subtle.

Paternalism is not dead. Nor should we kill it. Perhaps we should develop a new category, patient directed paternalism!

Medicare Web Site to Provide Comparative Data on Prescription Medicines

Residencies pinpoint work-hour hurdles

According to an Internet survey of resident program administrators, the specialty facing the biggest compliance hurdles was surgery, with 67.7% of 105 surgical programs represented in the survey saying they were greatly challenged by the new work hours. This was followed by neurological surgery, internal medicine, ob-gyn and thoracic surgery.

The survey was conducted Jan. 28 through Feb. 17 and 117 responses were collected.

Respondents said the most difficult rule to implement was the 24-hour call period, which also allows for six additional hours for patient transfers and educational activities.

Common obstacles were adjusting residents' schedules (reported by 56% of respondents), followed by uncooperative residents (31%), lack of funding to hire more staff (29%), difficulties managing transitions from one rotation to the next (27%) and uncooperative faculty (25%).

Respondents noted other barriers, such as getting residents to accurately record their hours in a timely fashion and collecting the data necessary to verify compliance.

Acceptance by faculty and program directors was an ongoing battle for some, who found they had to continually remind all involved of the rules.

Some programs noted positive effects, such as better organization of their residency programs overall, more streamlined patient care and improved resident morale.

Those who have not gone through residencies (non-physicians) have a difficult time understanding the difficulties that these new regulations bring. The regulations conflict with long traditions. I still do not understand how and why new, seemingly arbitrary regulations were adopted without testing.

Perhaps residencies will improve. Perhaps our trainees will become better doctors. But we do not know what the long term effect of these rules.

We continue to work to improve our residency while meeting the regulations. We hope for positive results.

Alert warns of Medicare conflict for concierge practices

Those who start concierge practices (I prefer the term retainer practice) must carefully examine Medicare billing rules. One can still bill Medicare, however, one must be very careful not to claim that the retainer fee covers any service for which the provider also bills Medicare.

Our buddy Trent McBride has stirred up a great controversy. So When Are We Going To Get That Free-Market Health Care Everyone's Complaining About? . If you find that interesting, he has 2 follow-up posts.

His rant explains (and I agree here) that we do not have a free market health care system. We have an almost nationalized health care system. Government payments and regulations prevent any free market influence (in general).

He has created quite a stir in the blogosphere. I believe that this stir shows a general misunderstanding of medical practice.

The biggest influence on medical reimbursement is Medicare (unless you do pediatrics). When they develop reimbursement, the insurers quickly follow. When they develop regulations, physicians pay.

He rightly comments on various governmental regulations which increase overhead without allowing a way to recoup those costs. Government (i.e., Congress) influences physicians and hospitals in ways which negate any free market forces.

Medicine has some exceptions - cash payments for some plastic surgeries, cosmetic dermatology, etc. However, generally, we work in a highly regulated environment. Kudos to the Proximal Tubule for starting the debate. We here at the Countercurrent Mechanism applaud his efforts.

Test Drug Said to Increase Good Cholesterol and Torcetrapib Significantly Increases HDL Cholesterol Levels. Epidemiologic data indicate that low HDL cholesterol levels put patients at a significant risk for atherosclerotic complications - coronary artery disease, stroke, peripheral vascular disease. We assume that raising the HDL would therefore decrease the risk of these conditions.

Until now, the only drug which consistently raised HDL was niacin. A new study shows that (at least under experimental conditions) one can increase HDL with a new drug.

According to the authors, another HDL-raising strategy involves the use of torcetrapib, a novel cholesteryl ester transfer protein (CETP) inhibitor. CETP is a plasma glycoprotein that facilitates the transfer of cholesteryl esters from HDL cholesterol to apolipoprotein B?containing lipoproteins.

Remember that this drug is still experimental. We must wait to learn two major things. First, how safe is this drug when taken over time. Second, does this drug improve patient outcomes.

One must always take these preliminary articles as just that - preliminary. The concept has promise. Now we must wait a few years until the appropriate studies are done.

I have received a few important comments about the match. The wife of an incoming intern wrote:

I wouldn't say most students would ask for the match. They probably keep quiet because they don't want to be branded a troublemaker and jeopardize a career they've worked so hard to make possible.

My husband just went through match 3/02 for a competitive specialty and we cursed every moment of it. Since then, it's become increasingly clear that residents often give a lot more than they get and that residency, as it exists now, works primarily to the hospital's benefit. Just a few of my complaints:

First, please read very carefully Save the Match. Second, imagine the world without a match. Who would suffer?

I proposed this question to some residents while supervising in clinic a couple of days ago. To paraphrase one, "obviously the critics have not participated in a non-match fellowship search". She shared with me her initial concerns about the match as a 4th year student. However, having just finished the interviews and acceptance of a non-match fellowship, she lamented the lack of a match in her fellowship!

The match uses the game theory which John Nash (he of a Beautiful Mind) developed. The current algorithm helps students get the highest choice which has an opening for them. It is student biased rather than hospital biased (go to the web site for links to the studies).

The match does not drive wages, or working conditions. Medicare reimbursement drives wages. ACGME and residency review committees drive working conditions.

Working conditions have improved dramatically since I graduated in 1975. I see excellent progress regularly.

I could develop a thought experiment in which working conditions might worsen at some highly desirable residencies! However, the working conditions depend more on regulatory bodies, and how the students "vote" during their match. Programs which treat their residents better tend to have better matches.

The anarchy of life without a match would (according to the web site) disadvantage couples (over 500 couples matched last year) and minorities. This protest and lawsuit are (in my opinion) poorly considered. Few would benefit from the unintended but predictable consequences of the lawsuit's success.

A Job or More School? Young Doctors Take On 'The Match'

In the suit, filed in 2002 by three former residents, the plaintiffs say graduating medical students should be able to negotiate wages and work hours. The medical associations and hospitals named as defendants in the suit contend that the match system compensates residents fairly.

The Federal District Court in Washington ruled on Feb. 11 that the residents who sued had an adequate basis to argue the existence of "a purported scheme of restraints that has the purpose and effect of fixing, artificially depressing, standardizing and stabilizing resident physician compensation."

Graduates of medical schools now sign binding work agreements with residency programs the minute they file their applications, before most hospitals have announced the wages. A new policy, to take effect next year, will require that residents be shown copies of their contracts before committing to programs.

The concern over salaries is heightened by the fact that medical students often carry enormous debts. In 2003, the average debt of a medical student was nearly $110,000, double the figure in 1993.

So why have a match? Why not have a free market for residencies?

We believe (the great majority of attendings and residents) that the match protects both applicants and programs. It allows us to go through a careful process of evaluating the many applicants to our programs and choose interns/residents in a standard way. What would happen if we had no match? (my speculation follows)

• Popular residencies could (and therefore probably would) decrease their financial stipends. To get a dermatology slot you might work for much less than today.
• Less popular residencies (either specialty or location) might increase their stipends to try to attract residents. This could lead to bidding wars - financially helping some residents in the short run.
• It follows that considerations other than the quality of training would have a greater influence on residency training
• Timing would become a greater issue. Students would start seeking positions in their 3rd year rather than their 4th year. Programs would encourage this trend to insure that they "fill" their positions. However, 3rd year students often change their minds about specialties. Thus, students might reneg on their committments, leaving programs scrambling to find replacements.
• The above comment seems absurd - until one examines subspecialty fellowships in internal medicine, which have exactly that problem.
• The stresses on applicants would increase without the current standarization

If the courts rule against the current situation, we will have increased chaos. I would suspect that most students would then ask for a match. I am certain that most programs would.

This suit might sound good to some who are not part of residency training. The destructiveness of this suit's possible success scares me greatly.

Most outpatient physicians hate insurance companies (including Medicare). Their pay scales are insulting, and the necessary overhead makes seeing patients minimally profitable. Some physicians have decided to go "old school" and eliminate the insurance companies. Some Doctors Choosing Cash Over Insurance

When Chuck O'Brien visits his doctor, they talk about his aches and pains, his heart problems and his diet, but never about his health insurance. That's because Dr. Vern Cherewatenko is one of a small but growing number of physicians across the country who are dumping complicated insurance contracts in favor of cash.

Is this the health care wave of the future? Probably not, experts say. Most people are content with monthly premiums and $10 copays; nine out of 10 doctors contract with managed-care companies. But cash-only medicine is becoming an increasingly attractive option for doctors frustrated by red tape and for the 43 million Americans who lack health insurance.

``It's a terrible indictment of the collapsing health care system,'' said Arthur Caplan, chairman of the medical ethics department at the University of Pennsylvania Medical School. ``Insurance and managed care were supposed to streamline -- instead what they've done is add so much paperwork and bureaucracy they're driving some doctors out.''

When O'Brien leaves the exam room, he writes a check for $50 and he's done -- no forms, no ID numbers, no copayments.

``This is traditional medicine. This is what America was like 30 years ago,'' said O'Brien, 55 and self-employed, who believes he has saved thousands of dollars by dropping his expensive insurance policy and paying cash. ``It's a whole world of difference.''

Health insurers downplay the trend, while emphasizing recent efforts to mend tattered relationships between doctors and managed care companies.

Cash visits make great sense for patients and physicians.

Cherewatenko, a broad-shouldered 45-year-old who wears black jackets and red stethoscopes at work, switched to cash out of desperation six years ago. His suburban Seattle practice was hemorrhaging money, and he and his partners realized they were spending hundreds of thousands of dollars just to process insurance paperwork.

``We said, 'Let's cut out this administrative waste,''' Cherewatenko said. Before, he charged $79 for an office visit and got $43 from an insurance company months later, minus the $20 in staff time it took to collect the payment. Now he charges $50 -- and he never worries about collection costs, because patients pay in full after every visit.

Cherewatenko sees fewer patients now. His whole office would probably fit inside his old waiting room. But he says the freedom is worth it.

``Accounts receivable is zero. It's a great feeling,'' Cherewatenko said. ``I feel like I'm a real doctor again.''

He started a group called SimpleCare to spread the gospel of cash-only medicine. The organization steers patients to doctors who offer cash discounts, and gives technical and moral support to doctors who want to start cutting their ties to insurance. Membership has grown to 22,000 patient members and 1,500 doctors. Some reject all insurance and take only cash, while others continue to accept insurance while offering discounts of 15 percent to 50 percent for cash-paying patients.

Independent of SimpleCare, doctors in California, Colorado, Minnesota, Texas, Mississippi and other states have also quit the insurance game. Some tired of the paperwork and administrative expenses. Some wanted to spend more time with patients without managed care bean-counters peering over their shoulders. The patients who pay cash range from poor to wealthy, with most in the blue-collar middle.

I love ideas that make sense. Read more about this movement - SimpleCare. This movement runs parallel to the retainer medicine movement. Both movements are suceeding due to patient and physician dissatisfaction with insurance and outpatient medicine. I would still advocate for "big ticket item" insurance. But perhaps this simple concept should become the norm.

Double surgery for obese 'safer'

Doctors first removed part of the stomach and then, in a separate operation, inserted a bypass in the intestines.

The first stage allowed significant weight loss so the second stage could go ahead.

A study of 75 patients was presented to the Society of American Gastrointestinal Endoscopic Surgeons.

The morbidly obese patients, aged from 23 to 72, first had a laparoscopic sleeve gastrectomy. This removes a large part of the stomach.

By performing this less drastic surgery first, mortality was greatly reduced

They were later given a gastric bypass, which involves constructing a pouch and bypassing a small segment of the intestines.

University of Pittsburgh researchers found this reduced the average body mass index (BMI) of patients by 19 points to 49 points after six months.

Interesting, but one must wonder about the side effects of the intestinal bypass. But then drastic situations sometimes require drastic solutions.

Animal research is starting to suggest some clues as to why weight loss is so difficult. Studies on a Mouse Hormone Bear on Fatness in Humans

New studies in mice suggest that the hormone leptin can fundamentally change the brain's circuitry in areas that control appetite. Leptin acts during a critical period early in life, possibly influencing how much animals eat as adults. And later in life, responding to how much fat is on an animal's body, it can again alter brain circuitry that controls how much is eaten.

Researchers say the findings, published today in the journal Science, are a surprise and add new clues to why weight control is so difficult in some humans.

Scientists knew that leptin is released by fat cells and tells the brain how much fat is on the body. They knew that animals lacking leptin become incredibly obese, as do a few humans who because of genetic mutations did not make the hormone. Leptin injections immediately made animals, and the patients with leptin deficiencies, lose their appetites. Their weight returned to normal.

But it was thought that leptin acted like most other hormones, attaching itself to brain cells and directly altering their activities.

Investigators did not anticipate that leptin could actually change connections in the brain, strengthening circuits that inhibit eating and weakening ones that spur appetite. And few considered the possibility that there might be a critical period early in life when the hormone shaped the brain's circuitry, possibly affecting appetite and obesity in adulthood.

Very interesting stuff, which may eventually help us better understand weight control.

I have read the comments. I have reconsidered the radical libertarian stand. As I absorb the hyperbole, sophistry and especially obfuscation which my debating opponents utilize, I will try to return to first principles. Primum, non nocere. - First, do no harm.

In this context, I believe that many medications, if sold over the counter, could do great harm. I am also certain that improper dosing and improper combinations of medications can do great harm.

Of course, we have pharmacists to help us prevent dangerous drug interactions - but would the libertarian position end the licensing of pharmacists. Why not sell HIV meds at the grocery store?

As I read the arguments for ending FDA controls and required physician prescribing, I see many straw men. I do not believe that one can extrapolate from many of the examples. But I will use this retort?

Should the government require a licensed engineering firm to design a bridge? Why not just let the construction company build the bridge from their experience?

Many drugs can reasonably make the transition to OTC. Many do. We better make those decisions once we have enough experience to know the safety profile of the drug. Many prescription drugs do cause problems, and are removed from the market.

We certainly can (and should) loosen restrictions on some drug classes. Other drug classes and diseases should require medical care and decision making. I do not worry about the compulsive intelligent consumer who might research his/her problem extensively and do self-dosing (although I have seen physicians cause harm to themselves with self prescribing). Those patients will at least think through the pros and cons of treating themselves (perhaps). I worry about the many patients who get advice from friends - oh, you must have CHF - try an ACE inhibitor - it worked for me.

Remember Primum non nocere should guide us. Following the radical libertarian approach would do harm to many, some of whom cannot understand the risks.

We all really know this. Talk to any smoker, and he/she will tell you that they always drink more in a bar. The physiology makes sense. Habits: A Smoke Much Sweeter

A new study has found that alcohol, even in very small amounts, appears to enhance the pleasurable effects of nicotine.

At the same time, the researchers say, nicotine may counteract some of the effects of alcohol, like drowsiness.

"It may be kind of a balancing act in the brain ? that you're taking one substance to balance the effects of another substance," said Dr. Jed E. Rose of the Nicotine Research Program at Duke University and the lead author of the study, which appears in the current issue of Nicotine & Tobacco Research.

The link between alcohol and tobacco is strong and complex. According to the researchers, as many as 90 percent of alcoholics smoke. And alcoholism is much more likely to occur among smokers than among nonsmokers, they said.

But while there has been a longstanding cultural marriage between drinking and smoking, scientists have had trouble explaining the physiological relationship. Some have theorized that alcohol lowers the ability of nicotine receptors in the brain to respond to the drug, creating a desire for more cigarettes.

While this may, in fact, occur in some receptors, the new study reports, over all, alcohol makes nicotine more pleasurable.

If researchers can better decipher this interaction, we might gain some treatment ideas. It does explain an interesting phenomenon, and provide some useful information for counseling patients.

As one commenter suggested, I have really enjoyed the comments on my paternalism rants. They have help inform my conceptualization about this subject.

If one takes a libertarian viewpoint in our society one must still understand that the limits of ones freedom end when another is harmed. The common shorthand expression - The freedom of your fist ends just short of my nose.

So the first test for restricting a medication must involve potential costs to society of improper use. Certainly all antimicrobials fit into that paradigm. The huge problem of MDR-TB (multidrug resistant tuberculosis) stems from unrestricted access and distribution of TB drugs. You may want to take your medications as you choose (or even think you have researched). However, your knowledge lack can lead to my worse illness. In fact, we take a very paternalistic view of TB in this country requiring DOT (directly observed therapy) give through public health departments.

One can certainly extend this concept to all antimicrobials - the good of many others should outweigh your desire to buy antibiotics without seeing a physician.

Admittedly, the philosophical position gets more complex when discussing cardiac medications. However, your illness improperly treated (because you chose your meds rather than having a trained physician choose those meds) costs society significant dollars - from hospitalizations, lost productivity, etc. That decision also has a significant impact on your loved ones.

Critics argue against licensing physicians and requiring proper training. I have a difficult time understanding that position. Medical care has advanced dramatically over the past 50 years. This care advances because of our training and research. We do need standards for the public good.

You can choose care from a non-physician - e.g. chiropractic care. That certainly gives you freedom. You can go to a health food store and self treat with supplements and herbs. That gives you freedom. In my opinion that also gives you substandard care.

Like many such arguments, one can take a highly controversial position and incite everyone. However, as I read the comments, that highly controversial position does not withstand careful scrutiny for our society.

Our current medical system is not perfect, but it is very good. We do improve the quality of lives. We do lengthen life spans. We cure many infections. I cannot believe that a call for anarchy will help society. Thus, your freedom to buy any medication that you desire without medical consultation could lead to societal harm. And that should be the main concern.

EKR at Educated Guesswork writes about my paternalism rant - When is paternalism justified?

I think DB is missing something important here. Sure, if you want high quality medical care and you're not medically sophisticated you want to be under the supervision of a doctor. The problem is that it's legally mandated. There's no law against me working on my own car, but when I have a transmission problem, I don't drop the tranny in my garage--I take it to a mechanic. (To tell the truth, I take it to a mechanic to have the wiper blades changed). So, I think if you want to have mandatory paternalism, you really have to explain why people aren't able to decide for themselves whether they want close monitoring. In my view, DB doesn't do that satisfactorily.

Let me try again. Many patients make their own decisions regardless of our recommendations (and remember, we prescribe we do not force feed medications). I guess a well educated patient might be able to figure out a complex medication regimen. But it really is unlikely. I guess I could treat myself - but we do have a saying about that - "The doctor who treats himself has a fool for patient".

So I must endorse this form of paternalism. Physicians have the training and experience to juggle the multiple conditions and disease manifestations. We should include the patient in our decision making - but we should recommend and recommend strongly a treatment course that best fits the available evidence. For that I do not apologize!

Paternalism In Medicine - Part II: Gatekeepers

Trent McBride writes a long rant about the influence of prescription drugs on the doctor patient relationship. First, I love the blog's title - I love renal physiology. Maybe I should rename my blog the Countercurrent Mechanism. Or that could be a great name for an alternative band!

Trent hypothesizes that making patients come to the doctor for prescriptions represents the ultimate form of paternalism. I will disagree to some extent on his proposed solutions.

Yes, prescribing medications is paternalistic. But then I do not assume that all medical paternalism is bad.

If you have congestive heart failure, I have a complex drug regimen to prescribe. Adjusting these medications requires repeated visits. I must understand the side-effects of each medicine, alone and in combination. I must consider your renal function, and your electrolytes. Finally, I must prescribe the medications with an understanding of your other medical problems (and few patients have CHF alone).

So to provide the highest quality care, I believe that I must be paternalistic. In that sense paternalism is not a bad attribute.

Narcotics might be the exception. I do not really know how much pain a patient suffers. How can I judge the best method for treating that pain? Should I worry about narcotic abuse? Wouldn't we be better off if we just let patients buy their own pain meds and suffer their own consequences?

Trent does mention antibiotics - and he is correct. But I will gladly argue that many conditions which I treat require complex decision making and adjusting of multiple medications. I accept that paternalism and I believe the great majority (>90%) of patients want that paternalism.

Caveat ahead - even when one must take a paternalistic stance, one should still discuss the rationale for each medication with the interested patient. When choices are available for treatment, we can and should discuss those choices with the patient.

So as usual, I am a bit wishy washy. I agree with some of the Tubule's argument. But I believe he goes overboard. But after all, that is what blogs are for - to stimulate our thinking and challenge accepted thinking. And therefore he succeeds.

A New Era in Treating Imaginary Ills

They make frequent doctors' appointments, demand unnecessary tests and can drive their friends and relatives — not to mention their physicians — to distraction with a seemingly endless search for reassurance. By some estimates, they may be responsible for 10 to 20 percent of the nation's staggering annual health care costs.

Yet how to deal with hypochondria, a disorder that afflicts one of every 20 Americans who visit doctors, has been one of the most stubborn puzzles in medicine. Where the patient sees physical illness, the doctor sees a psychological problem, and frustration rules on both sides of the examining room.

Recently, however, there has been a break in the impasse. New treatment strategies are offering the first hope since the ancient Greeks recognized hypochondria 24 centuries ago. Cognitive therapy, researchers reported last week, helps hypochondriacal patients evaluate and change their distorted thoughts about illness. After six 90-minute therapy sessions, the study found, 55 percent of the 102 participants were better able to do errands, drive and engage in social activities. Antidepressant medications, other studies indicate, are also proving effective.

"The hope is that with effective treatments, a diagnosis of hypochondriasis will become a more acceptable diagnosis and less a laughing matter or a cause for embarrassment," said Dr. Arthur J. Barsky, director of psychiatric research at Brigham and Women's Hospital in Boston and the lead author of the study on cognitive therapy, which appeared in the March 24 issue of The Journal of the American Medical Association.

If these patients do not induce "heart sink" then you are a different physician than me. These patient's name on your daily list causes anxiety, depression and thoughts of illness.

The biggest challenge is sorting out their hypochondriacal complaints from real disease, because even a hypochondriac can get sick.

I once had a patient who came to me after having 17 negative HIV tests. He had not had any sexual relations in over 6 months, yet thought he needed another test.

I saw this patient for around 9 months. My greatest feat was getting him back to see his psychiatrist, as he also had major depression. Over time with reassurance, calm, scheduled appoints and medication he was able to regain a productive life.

As I read the article this morning, I saw most of his personality and problems. We (physicians) would all like a consultant who wanted to see these patients, as most physicians and psychiatrists shun them. I certainly hope that these initial positive reports are confirmed.

The Limits of Opening Arteries

Experts agree that artery-opening methods ? like bypass surgery, or insertion of a balloon to mash down plaque and a wire-cage stent to keep the channel open ? can alleviate crushing chest pain and save some lives. But patients should not assume that their cardiovascular problems are "fixed" by such procedures, and patients without symptoms whose arteries are narrowing should be wary about undergoing these procedures to ward off a potential heart attack. They may have hundreds of vulnerable plaques elsewhere that are more apt to burst and trigger a heart attack than are the more stable plaques in the narrow section. Most such patients might better be treated with drugs to lower their cholesterol levels, control their blood pressure and prevent blood clots, or should adopt a healthier life style by giving up smoking, eating heart-healthy foods and exercising.

What follows represents the implications of this essay and the accumulated data that I teach on rounds. I have tried to interpret the original data and read about the theories.

Procedures - CABG and stenting - are still very important in 2 scenarios. First, patients who have just had an acute coronary syndrome, especially a small heart attack (which we call either NSTEMI or non-Q wave MI), clearly benefit from immediate intervention. Second, patients who have extensive disease (usually 2 or 3 vessels with severe narrowing) and problematic symptoms have their symptoms improved with interventions. Choosing an intervention must take into account the lesions, their location and availability of good artery past the obstruction. One must also consider current cardiac function (e.g., 3 vessel disease with a decreased ejection fraction has better results from surgery).

One should not go looking for disease to "repair" in asymptomatic patients. One might want to diagnose disease in patients with mild or equivocal symptoms - but not to "repair" the disease.

Regardless of whether patients do need a procedure, they need good medical management. I have written often about this issue. To reiterate:

We clearly know that coronary artery disease patients benefit from 4 drug classes

• Platelet inhibitors - aspirin, clopidogrel (in certain circumstances)
• Beta blockers
• ACE inhibitors or ARBs
• Statins

So the article and this editorial describe the current thinking of coronary artery plaques as fragile changing lesions. Understanding the dynamic nature of plaques gives us a broader understanding. This concept explains much current clinical trial and epidemiologic data. It drives current therapy.

Most important it should give hope to patients. As patients we can take some responsibility for our hearts. Exercise, weight control, and - when indicated - medications can modify coronary artery plaques, leading to regression and stabilization. Patients can often prevent coronary artery disease, but when they cannot (bad genetics especially), physicians can help greatly by prescribing the right drugs. Of course, the responsibility quickly reverts to the patient who then must take those medications.

Listening to philosophy tapes certainly gives me a different perspective on medicine. Currently I am listening to Will to Power: The Philosophy of Friedrich Nietzsche. This morning on the way to working out and then to work I was lietening in particular to: Lecture 11: Nietzsche on Truth and Interpretation. This lecture expands on the quote you see on the right of this blog: There are no facts, only interpretations. - Nietzsche .

As the lecturer expands on this discussion, I started to understand why yesterday's rant created such interest (8 comments by this morning). As I personally rate my rants, the number of comments provides me a good indicator of their effectiveness in stimulating thinking and interest.

Reading the comments, and then rereading Sydney's column, I realize that I am working from a different context. Nietzsche would argue (or at least the lecturer is arguing for him) that we only have interpretation in our attempts at truth. All interpretations depend on the context in which one views the data.

Our friend and frequent poster Bernie lives in a different contextual framework than I do. Thus, he views the same data but interprets it differently.

Now unlike many politically correctness advocates today, Nietzsche does not assume that all viewpoints have equal value (of course, he is judging from his own context). I believe that the bio-medical model is the superior model for judging medical data. (Bernie might disagree - but then I should not speak for Bernie).

As I read Sydney's column, she alludes to an important point. We must take all new data and put those data into our underlying context. What do we already know? Can we reconcile these new data with previous data?

I believe that the best way to interpret new data uses the principles of evidence based medicine. One should not discount previous knowledge or expert opinion (I am a Bayesian, and therefore adjust my probabilities based on prior information).

However, we should not ignore new data just because it does not fit current expert opinion. When the major study examining anti-arrhythmic therapy after MI came out - we all changed our context and practice - FINAL REPORT FROM THE CAST STUDY . The study results were unexpected and counter to expert opinion. The study had such compelling results that it overcame previous expert opinion and changed expert opinion.

As one studies the precepts of evidence based medicine, one first learns the hierarchy of research designs. The randomized double blind controlled clinical trial is the epitome of research. Epidemiologic studies represent an excellent method for generating hypotheses.

Perhaps my disagreement over Sydney's column involve shades of interpretation. I know many physicians who teach and practice evidence based medicine. They strive to interpret data in the context of previous knowledge and the quality of the new data.

I agree that often the popular press does not hold the same high standard. Autism and MMR attracts headlines, and headlines sell papers. Even if most medical reporters understand the evidence and avoid the article, some other reporter will see this as a quick easy controversial piece to publish.

So I would probably have written a similar article, but shaded it differently. In my mind we must remain skeptical of all new data and wait for the accumulation of supporting data prior to changing our contextual model. As a physician and scientist this seems natural. Perhaps Sydney's underlying message is that patients should remain just as skeptical.

Medpundit (Sydney Smith) and I often disagree on issues. We have communicated and agree that our public disagreements (on our respective blogs) advance thinking. Only when we have polite yet spirited debate can our readers be stimulated to think carefully about issues.

In this spirit I wish to disagree with her latest Tech Central column - Medical "Truths"

And medical science has continued to march on, or so we like to think. Discriminating doctors of the early twenty-first century, unlike the doctors of the early twentieth, pride themselves on practicing "evidence based medicine." Unless there's a paper and statistics to back up a theory, we don't put it into practice. We like to think of medicine as a hard science, as dependent on the observable and quantifiable as chemistry, or some branches of physics. But, the truth is, in many respects medical science has devolved into a science as soft as economics or sociology.

Sydney does a nice job in this article of creating a straw man argument. She reasons that when she can show examples of incorrect analyses, that we can discard all analyses. She argues (I believe) that evidence-based medicine is futile because the studies are so often flawed.

There's nothing wrong with putting forth a hypothesis. That's what science is about, coming up with and disproving hypotheses. But not all hypotheses are created equal, and this one was based on particularly shoddy science -- a very small study, and the confusion of association with causation. Yet, for some reason The Lancet found it worthy of publication, well aware of the potentially devastating effects its poorly thought out conclusions could have on public health. At the time of publication, the article was accompanied by a prescient guest editorial from an official at the CDC that warned that "passion would conquer reason and the facts" if the study's conclusions were taken at face value by the media and the public. And that is just what happened. Blessed with the imprimatur of a world renowned medical journal, and a subject enticing to the media, the lead researcher was treated to a press conference at which he suggested that parents should avoid the MMR vaccine. MMR vaccine rates in Great Britain, where the story got much play, plummeted, and the incidence of measles rose. Within two years of the study's publication, there was a measles outbreak in Dublin that killed two children and hospitalized hundreds more.

She makes an interesting point about the article which supposedly linked MMR and autism. However, I believe that she targets the wrong group with her criticism. Certainly the Lancet editors made a mistake here. However, I am not aware of physician groups who endorsed this study as "evidence based medicine". Rather, "advocacy" groups of parents made this study a reason to avoid MMR. Most experts disagreed with the study at the time of publication.

Sydney finishes with:

These are but two of the most recent and glaring examples of just how soft medical science has become, or perhaps remained. There's no shortage of marginal hypotheses that appear in the medical literature and are passed on to the lay press as solid fact. That's why one day hormone replacement therapy is good for you and the next it's bad. Why one day fish is a health food, and the next it's a toxin. We may have better technology, better drugs, and a better understanding of many disease processes than our forefathers did a hundred years ago, but we're no more sophisticated than they were in sifting the bad science from the good.

Wow! This sentence insults the entire field of evidence based medicine and medical research. What a powerful sentence! But the sentence is incorrect and an example of hyperbole.

Those of us who try to practice evidence based medicine (and we freely admit when the evidence is not satisfactory to use) work hard to carefully evaluate the data. We rarely change our practice on a single study, unless it is a large, carefully done randomized controlled trial. One great web site for evidenced based medicine: Bandolier. The Cochrance collaboration provides outstanding reviews (requires a subscription).

The advances in medical treatment over the past 25 years are incredible. 25 years ago we had no way to modify lifespan in CHF. Now we can greatly increase life expectancy for those patients. Similar stories exist in diabetes mellitus, coronary artery disease and many cancers.

One should never regard a single study as the answer to our questions. However, as data accumulate we often can provide better care to our patients. We need more critical inquiry concerning published articles. We must put each new piece of information into context. If we do not do that, then we resemble ostriches.

We have made much progress both in scientific inquiry and the careful criticism of published articles. Medicine progresses not in a straight line, but rather through fits and starts, in a jagged line. But it does progress, and our patients benefit regularly from that progress.

The data continue to support moderate alcohol as cardioprotective. Study: Drinking May Help Heart Patients

In the study, men with high blood pressure who reported having about one or two drinks a day were 44 percent less likely to die of cardiovascular causes such as heart attacks than men with hypertension who rarely or never drank.

Alcohol is known to increase levels of good cholesterol and can thin the blood, warding off artery-clogging clots that can cause heart attacks.

A drink or two a day has been linked with reduced cardiovascular risks in healthy men and women. But many doctors are wary about alcohol use among people with hypertension because heavy drinking can increase blood pressure. For that reason, the American Heart Association generally advises patients with high blood pressure to avoid alcohol.

The latest findings suggest that moderate alcohol consumption offers the same benefits to hypertensive patients as it does to healthy people. But the researchers said the findings need to be confirmed in other large-scale studies.

They and other experts advised people with high blood pressure to remain wary about drinking.

"In light of major clinical and public health problems associated with heavy drinking, recommendations regarding alcohol use must be made on an individual basis," said the authors, led by Dr. J. Michael Gaziano, a researcher at Brigham and Women's Hospital and the Veterans Affairs hospital in Boston.

The findings appear in Monday's Archives of Internal Medicine.

Each study continues the general support for a drink or two each day. Clearly alcohol has a dose response curve. No alcohol or too much alcohol can harm us in different ways.

I continue to favor moderate alcohol unless the patient has a known alcohol problem.

Congress to look at Medicare pay formula

Physicians pushing for Medicare payment reform are hoping that Congress makes good on its intentions.

As lawmakers worked to finalize legislation laying out a fiscal year 2005 budget blueprint, the Senate Budget Committee attached a provision expressing the Senate's intent for Congress and the administration to correct "major flaws" in the formula used to determine Medicare payments for physician services. At press time, the Senate had not yet voted on the budget measure.

This intention is a "no brainer". Everyone knows that the current formula has major flaws. We need to fix the formula, not the payments.

Under the current payment formula, when spending for physician services exceeds an annual target, called the sustainable growth rate, future payments must be reduced to make up for the excess spending.

Physician groups, including the American Medical Association, argue that doctors have been held responsible for increases stemming from higher drug costs and new coverage mandates, despite having no control over this spending.

I certainly hope that Congress can pass a small bill to address this problem. But knowing Congress, they cannot think about one seemingly small problem at a time. Their effectiveness would increase if they did.

New Studies Cast Doubt on Artery-Opening Operations.

This important article does a very nice job of explaining our evolving understanding of CAD. Let me try to summarize the concepts - then go read the article.

CAD has two components, first the deposition of lipid laden atherosclerotic plaques. We used to think that these plaques were static, and grew over time. As they grew into the lumen, they eventually obstructed arteries leading to symptoms. However, several observations over the past 10-20 years have changed that thinking.

We now believe that plaques exist in a dynamic endothelium. Acute coronary syndromes occur when plaques rupture and release platelet aggregating factors. These PAFs attract first platelets - leading to the eventual development of clots - which cause acute vessel obstruction presenting as acute coronary syndromes.

This current theory (with much convincing data) stresses inflammation leading to plaque instability and the coagulation system.

We know that in acute coronary syndromes, opening the vessel helps in the short run. We also know that medication treatment remains very important. "Fixing the obstruction" does not cure the underlying disease.

We now have increasing evidence that patients with stable CAD need not have obstructions "fixed" with surgery or stents. Rather we should stress aggressive medical management with platelet inhibitors (esp aspirin), beta blockers, ACE inhibitors and statins.

This theory, which follows from available data, treats CAD as a dynamic disease which we can modify at the endothelial level.

Now for a few quotes from this well researched article:

But the new model of heart disease shows that the vast majority of heart attacks do not originate with obstructions that narrow arteries.

Instead, recent and continuing studies show that a more powerful way to prevent heart attacks in patients at high risk is to adhere rigorously to what can seem like boring old advice — giving up smoking, for example, and taking drugs to get blood pressure under control, drive cholesterol levels down and prevent blood clotting.

Researchers estimate that just one of those tactics, lowering cholesterol to what guidelines suggest, can reduce the risk of heart attack by a third but is followed by only 20 percent of heart patients.

"It's amazing and it's completely backwards in terms of prioritization," said Dr. David Brown, an interventional cardiologist at Beth Israel Medical Center in New York.

Heart experts say they understand why the disconnect occurred: they, too, at first found it hard to believe what research was telling them. For years, they were wedded to the wrong model of heart disease.

"There has been a culture in cardiology that the narrowings were the problem and that if you fix them the patient does better," said Dr. David Waters, a cardiologist at the University of California at San Francisco.

The old idea was this: Coronary disease is akin to sludge building up in a pipe. Plaque accumulates slowly, over decades, and once it is there it is pretty much there for good. Every year, the narrowing grows more severe until one day no blood can get through and the patient has a heart attack. Bypass surgery or angioplasty — opening arteries by pushing plaque back with a tiny balloon and then, often, holding it there with a stent — can open up a narrowed artery before it closes completely. And so, it was assumed, heart attacks could be averted.

But, researchers say, most heart attacks do not occur because an artery is narrowed by plaque. Instead, they say, heart attacks occur when an area of plaque bursts, a clot forms over the area and blood flow is abruptly blocked. In 75 to 80 percent of cases, the plaque that erupts was not obstructing an artery and would not be stented or bypassed. The dangerous plaque is soft and fragile, produces no symptoms and would not be seen as an obstruction to blood flow.

So for all those at risk for CAD and heart attack, we should follow a fundamental health prescription. Do not smoke. Keep our weight reasonable and exercise. Address hypercholesterolemia, especially with either a family history or diabetes mellitus. Treat hypertension.

Many experts worry about chronic mercury poisoning. An advisory panel has published new recommendations, with specific reference to albacore tuna. U.S. Issues Guidelines on Eating of Some Tuna

The Food and Drug Administration and the Environmental Protection Agency will recommend Friday that pregnant women, nursing mothers and young children eat no more than six ounces of albacore tuna or about one meal's worth each week, administration officials said.

As the article states, the recommendations differ according to the type of tuna, with light tuna having less mercury.

The new guidelines will say that young children and women who are pregnant, nursing or planning to become pregnant can eat up to 12 ounces per week of light tuna, which has less mercury and accounts for about 13 percent of the nation's seafood consumption.

The agencies will continue recommending that those groups limit their intake of shark, swordfish, king mackerel and tilefish, which can also have high levels of mercury.

Colon cancer screening works, but many patients reject current screening tests for a variety of reasons. "Virtual" colonoscopy sounds like a nice alternative. The prep is just as unpleasant, but the risks are significantly less.

Gastroenterologists will support this technology, as it will increase their interventional colonoscopy business. Moreover, we do not have enough gastroenterologists to perform all the needed screening colonoscopies. Here is another study reporting on the diagnostic test performance of CT colonoscopy. CT Colonography Helpful in Cancer Screening

CT colonography compares well with conventional colonoscopy in detecting polyps with a diameter of at least 10 mm, New York-based researchers report in the March issue of Radiology. They concede that performance is lower with smaller lesions but point out that if patients undergo 5-year screening, "missing small lesions is likely to be clinically insignificant."

"The examination is well tolerated, does not require sedation and can be certainly used in patients who are unwilling to undergo conventional colonoscopy or in patients with underlying medical conditions that make conventional colonoscopy risky," lead investigator Dr. Michael Macari told Reuters Health.

Dr. Macari of Tisch Hospital, NYU Medical Center and colleagues also note that use of the evolving CT technique may increase public acceptance and thus increase the number of patients who undergo colon cancer screening.

To compare the results of the two screening approaches, the researchers studied 68 asymptomatic men who were deemed to be of average risk and were aged more than 50 years. They underwent CT colonography followed by colonoscopy on the same day.

A total of 98 polyps were found in 38 patients by colonoscopy. Of these, 21 (21.4%) were detected by CT. All 3 polyps of 10 mm or larger were uncovered by CT. However, this was true of only 11.5% (9 of 78) of those of 1 to 5 mm and 52.9% (9 of 17) of those of 6 to 9 mm in diameter.

Not an overwhelming study, but another piece of data in the continuing story.

There are no facts, only interpretations.
from Nietzsche's Nachlass, A. Danto translation.

I rarely rant about osteoporosis, yet I probably should. Osteoporosis remains a major cause of morbidity and mortality, especially in post-menopausal women, but also in older men and especially those men and women who take corticosteroids.

Thus, this report is very encouraging. Osteoporosis Drug Found Safe to Take for 10 Years

For millions of women who have the bone-thinning disease osteoporosis, researchers are reporting that Fosamax, the drug most commonly used worldwide to improve bone density and prevent fractures, can be taken safely and effectively for 10 years.

About three million Americans now take the drug, most of them postmenopausal women with osteoporosis, according to its maker, Merck.

The new study, the longest clinical trial ever conducted in osteoporosis, found that Fosamax enabled postmenopausal women to maintain or increase their bone density through 10 years of treatment, with no apparent ill effects. The improved bone density persisted even after the drug was stopped and diminished only gradually.

The study is being published today in The New England Journal of Medicine.

Yes this is important good news. One always worries about long term effectiveness. This study documents the answer to an important clinical question.

Home BP Measurement More Useful Than Office Measurement

Home blood pressure (BP) measurement has better prognostic accuracy than office-based measurement, according to the results of a cohort study published in the March 17 issue of The Journal of the American Medical Association.

"BP measurement in clinicians' offices with a mercury sphygmomanometer has numerous drawbacks," write Guillaume Bobrie, MD, from the Hôpital Europeen Georges Pompidou in Paris, France, and colleagues from the SHEAF (Self-Measurement of Blood Pressure at Home in the Elderly: Assessment and Follow-up) study. "In contrast, the use of home BP measurement improves measurement precision and reproducibility."

In a European cohort of 4,939 elderly patients (48.9% men) being treated by general practitioners for hypertension, mean age was 70 ± 6.5 years, and mean follow-up was 3.2 ± 0.5 years. Uncontrolled hypertension was defined as at least 140/90 mm Hg for office BP and 135/85 mm Hg for home BP.

At the end of follow-up, at least one cardiovascular event (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, transient ischemic attack, hospitalization for angina or heart failure, angioplasty, or coronary artery bypass graft surgery) had occurred in 324 patients.

For BP self-measurement at home, the risk of a cardiovascular event increased by 17.2% (95% confidence interval [CI], 11.0% - 23.8%) for each 10-mm Hg increase in systolic BP, and by 11.7% (95% CI, 5.7% - 18.1%) for each 5-mm Hg increase in diastolic BP. However, the same magnitude of increase in BP observed using office measurement was not associated with any significant increase in the risk of a cardiovascular event.

This study does make sense. We all know about white coat hypertension.

When I was seeing private outpatients, I generally involved them in their hypertensive management by having them check their BP several times each week. We would use those measurements (taken at home, at a pharmacy or at the fire station) as the data that we used to adjust their BP meds.

I always believed that this method had two positive outcomes. First, it helped the patient understand that BP control was their job, not my job. I can only help patients; I cannot take their medications, do their exercise or modify their diet. Second, the measured BP gave more and accurate data on their BP average (which isolated office BP did not do).

This article reinforces my belief that the office BP can be spurious.

"Home BP measurement has a better prognostic accuracy than office BP measurement," the authors write. "BP should systematically be measured at home in patients receiving treatment for hypertension."

The Flip-Flop Files

When the National Academy of Sciences (NAS) recently concluded that one's sense of thirst -- not a set number of glasses of water -- should determine the amount of liquid to drink each day, this respected scientific group overturned yet another widely held piece of health advice.

Add that to a growing list of recommendations that recently have been tweaked, changed or outright discarded. In addition to ensuring full employment for health journalists, this trend has left many consumers baffled, annoyed and discouraged.

From the finding that hormone replacement therapy doesn't help prevent heart disease in post-menopausal women to the news that we need more of certain kinds of fat in our diets, new and contrary findings are reported regularly. And consumers who thought the conclusions of medical research were ironclad often have their confidence shaken.

"We just have to accept the fact that something that is considered correct now, in a year or two there may be findings that show up to say this really isn't necessary," said Munsey Wheby, president of the American College of Physicians and professor of medicine at the University of Virginia School of Medicine. "I'm sure the public feels, 'Can't scientists just get a set of information and stick to it?' But I don't know of any way around it."

Blame can be assigned many places. Researchers and institutions often over-promote the importance of their work. Journalists, suspecting that editors and audiences don't like shades of gray, tweak findings into black or white. Consumers baffled by all the hype in the health care marketplace demand simple, unambivalent advice to act on.

Even physicians can be frustrated by the flip-flops. After giving a lecture on new guidelines for vitamin supplements during pregnancy a number of years ago, Wheby fielded a question from a physician in the audience. "Why do they keep changing these things?" the doctor asked.

As experts note, medical research and practice have never been static.

"People want science to be definitive, but anyone who has explored science knows that it is an evolving process," said Neal Kohatsu, president-elect of the American College of Preventive Medicine and an associate professor of epidemiology at the University of Iowa's College of Public Health. "Rarely is there a single definitive study. It's a matter of looking at patterns over time and seeing the results come up by different investigators."

I have ranted concerning this general issue in the past. Science demands that we test and revise hypotheses. As a physician we must search for the best data and make decisions based on those data, understanding that we may change as new data appear.

Read the long article for an update on a wide variety of interesting dietary, exercise, and even some medication issues.

Around the Globe, Drug-Resistant TB Is Rampant. TB was once known as the white plague or consumption. Literature abounds with characters who died of this scourge.

During my medical career, we have had great drugs to treat TB. Most patients have a quick and successful cure. However, due to a variety of factors, we now must once again worry about TB.

"The true burden is unknown," said Dr. Mohamed Abdel Aziz, the organization's tuberculosis expert and leader of the study. "The more we survey, the more multi-drug-resistant TB we find."

Despite 10 years of effort, the organization has examined only about one-fifth of the world's cases. Some countries have been reluctant to participate, and setting up regional laboratories, a worldwide effort led by the Prince Leopold Institute of Tropical Medicine in Belgium, is expensive and time-consuming.

In South Africa, only 1.6 percent of the cases are drug-resistant, said Abigail B. Wright, another author of the study, but the country's overall tuberculosis rate is so high that that translates into 6,000 cases. In India, which has a major TB problem, a survey limited to Tamil Nadu state found a 3 percent resistance rate.

The report highlights the need for new tuberculosis drugs, said a spokeswoman for the Global Alliance for TB Drug Development.

"The last new drug was introduced in 1963," said the spokeswoman, Gwynne Oosterbaan. Because tuberculosis is a bacterium, virtually all antibiotics attack it. But drug companies rarely test their new antibiotics against it because they might be pressured to limit the drugs' use to that disease, costing them billions.

Tuberculosis is common in very poor countries with many AIDS cases, because weakened immune systems allow the bacteria to grow. But drug-resistant cases are more common in moderately poor countries where patients receive inadequate treatment.

Many cases were found in Kazakhstan, Uzbekistan, Estonia, Latvia, Lithuania and parts of Russia, as well as in two Chinese provinces, South Africa and Ecuador. On a smaller scale, a high rate of cases per capita was also found in Israel, presumably through immigration from countries of the former Soviet bloc, the report said.

The situation in former Soviet Union countries is particularly bad because of the abrupt collapse of the bloc's economy in the 1990's, said Dr. Peter Cegielski, leader of the international multi-drug-resistant TB team at the Centers for Disease Control and Prevention in Atlanta who conducts studies in Russia.

Shortages forced many patients to cut back to one or two drugs "and that's what leads to resistance," Dr. Cegielski said. Also, a number of prisoners with TB were released in amnesties, spreading the disease. In addition, said Dr. John Jereb, a C.D.C. epidemiologist, Soviet bloc countries used unusual treatments.

In the West and in poor countries following World Health Organization recommendations, all patients are supposed to get a cocktail of four "first-line" drugs: streptomycin, isoniazid, rifampicin and ethambutol. The standard therapy, "directly observed treatment, short-course," or D.O.T.S., requires that a family member, a nurse, or even a traditional healer watch each pill swallowed every day for six months.

The first-line drugs are cheap and have few side effects. Resistance develops when patients skip pills. But researchers also suspect resistance is high anywhere that the same drugs are sold over the counter, as they are in Southeast Asia.

One of my colleagues studies this problem. Most strains are susceptible to more expensive medications. Someone must find the money to treat these patients properly. We in the US do a particularly good job at treating TB through our public health departments. For this disease we have model programs.

As this epidemic spreads, it may well once again become a major health problem. Some would argue that it already is.

Congress is trying to take preemptive action against obesity-food lawsuits (like the poorly conceived McDonald's lawsuits. The trial lawyers are screaming foul! Fast food and fat lawsuits

But now that Congress is considering a ban on lawsuits blaming food manufacturers or sellers for making people fat, Mr. Banzhaf is eager to contradict himself. In a press release issued the day before the House approved the Personal Responsibility in Food Consumption Act by a 2-to-1 margin, he said the bill "is surely premature, because there has been only one obesity lawsuit, and it was dismissed by a federal judge."

Before Congress passes legislation like this, Mr. Banzhaf said, "there should be a real history of abuse which must be corrected, not orchestrated panic based upon one failed lawsuit and some quoted-out-of-context rhetoric." Having orchestrated the panic and provided the rhetoric, he knows whereof he speaks.

Huh?

This proposed law is necessary to prevent a series of lawsuits, spending the courts money unnessarily. But then the trial lawyers would like to argue about everything.

Perhaps this law, and the movement behind it will start to help us develop a real sense of personal responsibility. Our country needs more personal responsibility and less blame. But perhaps the existentialism speaking. But probably that is me speaking!

Is a high HDL really protective? This article discusses the controversy about HDL - Scientists Begin to Question Benefit of 'Good' Cholesterol

But now, some scientists say, new and continuing studies have called into question whether high levels of the good cholesterol are always good and, when they are beneficial, how much.

While some heart experts are not ready to change their treatment advice, others have concluded that H.D.L. should play at most a minor role in deciding whether to prescribe cholesterol-lowering drugs. In the meantime, doctors are calling researchers and asking what to do about patients with high H.D.L. levels, or what to do when their own H.D.L. levels are high, and patients are left with conflicting advice.

"There is so much confusion about this that it is unbelievable," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic.

Medical advances occur because we (physicians and scientists) willingly challenge current dogma. We never assume that we know truth, but just that we function on our current best approximation.

Fortunately, we generally make most decisions based on LDL levels anyway. HDL has functioned as a minor issue for most physicians. It may decrease from mino.

One of my loyal readers writes:

The one my school district offers doesn't work that way it all.
It's completely independent of the insurance plan.
At the end of the year, you forfeit anything you didn't claim.
We also can only take out 2500.00 a year.
The good news, is that it is pretax dollars.

And that is the same plan that I currently have.

The article is referring to the new law. This creates an entirely new option. I suspect that more companies and even the public sector will start to offer these new plans. The rollover benefit makes them a wonderful choice.

They do require insurance with larger deductibles - thus you are expected to pay for the initial costs from your HSAs. I like the idea. Reread the money management article about them to pick up the nuances.

A Follow-Up on Health Savings Accounts

Thanks for the compliment! Health Savings Accounts are brand-new high-deductible health insurance accounts. Essentially, the insurance doesn't kick in until you've paid $1,000 worth of medical expenses out of your own pocket if you're single, or a total of $2,000 if you have family coverage. But you get to set aside the money to cover these out-of-pocket expenses via tax-deductible contributions. If you have individual coverage you can set aside as much as $2,600; the maximum contribution for a family is $5,150. These amounts will be adjusted every year for inflation.

Now here's where some folks get pretty jazzed about an HSA: If you don't spend all of the money you've set aside in your account, it remains there, growing on a tax-sheltered basis. In other words, as you clearly understand, Peter, these accounts can be a substitute retirement savings vehicle, similar to a nondeductible IRA.

Martha Priddy-Patterson, a director with Deloitte & Touche, says you're "absolutely right" to consider not dipping into your HSA to cover medical bills if you don't have to. "You're under no obligation to pay your medical bill out if the HSA account. If you can afford not to, it's smart." If nothing else, leaving the money in the account allows you to build up a kitty in the event you do have a major medical expense, whether planned (braces for your two kids) or unplanned (you're in a car accident).

Keep in mind that withdrawals before age 59 1/2 for expenses that are not health-related will result in a 10-percent penalty, plus ordinary income tax on the gains. However, provided the money is used for medical bills ? at any age ? your withdrawal is tax-free. And once you're past the 59 1/2 milestone, you can even take withdrawals for non-health expenses without a penalty (you'll still owe income tax on the gains, though). If you're planning to use your HSA for retirement purposes, stay abreast of current IRS regulations ? it is not inconceivable that the rules for these accounts could change once they come into widespread use.

Hopefully, this explanation will help clear some misconceptions about these accounts. I love the control that these accounts provide. They make sense financially.

They should also make many people think carefully about their health care expenditures. As I have said repeatedly, this thought process should lead to less demand for high cost procedures and medications. If that is true, we might actually get physicians and patients to become more cost effective.

Implementation of Guidelines Sharply Reduces Post-MI Mortality

A formal system designed to ensure implementation of standards of care can reduce 1-year mortality in Medicare patients admitted with myocardial infarction by 23%, researchers announced here Wednesday during late-breaking clinical trial sessions at the American College of Cardiology Annual Scientific Session 2004.

The results, from the ACC's Guidelines Applied in Practice (GAP) Project in southeast Michigan, were reported by Dr. Kim A. Eagle of the University of Michigan Health System in Ann Arbor.

The project findings included approximately 2800 Medicare patients admitted with acute MI and followed until discharge. The objective was to determine if the ACC's GAP guidelines were being implemented and how effective implementation would be. Average patient age was 76. The study group was roughly half men and half women. Between one third and one half had comorbidities on admission.

GAP tools included visible standard orders for the AMI patient, the use of pocket guidelines, patient information sheets and patient discharge contracts, among other tools to trigger GAP use.

During the study, use of the discharge tool increased from about 2% to more than 30%. As a result, a significantly greater number of patients were discharged on what Dr. Eagle called the "Fab Four," beta blockers, ACE inhibitors, lipid lowering agents and aspirin, all proven to improve survival after MI.

Changes in discharge practices as a result of GAP implementation resulted in a 26% reduction in mortality at 30 days and a 23% reduction in mortality at 1 year compared with pre-study rates.

Just another piece to the implementation puzzle. We know what to do for many conditions and many patients. Now we need to continue to study how to make certain that we give the most appropriate care to the most patients.

This study suggests a strongly positive result - good news for postmenopausal breast cancer patients. Research: Breast cancer drug switch cuts recurrence

A drug for advanced breast cancer prevents localized tumors from returning after surgery better than the current mainstay drug, according to a large, international study that promises new hope and treatment strategies for many patients.

Recurrence of such early cancer was reduced by one-third in women who started on the gold standard treatment, tamoxifen, then switched after 21/2 years to the newer drug, exemestane, compared to those who took tamoxifen the whole time.

The women switching to exemestane, a hormonal drug sold under the brand Aromasin, also had less serious side effects, were 56 percent less likely to get cancer in the other breast and were half as likely to develop unrelated cancer in other body areas.

Dr. Jeff Abrams, the National Cancer Institute's associate chief of clinical research, said a recent study on exemestane "cousin" letrozole showed important advantages over tamoxifen for their class of drugs, called aromatase inhibitors. Abrams was not involved in the new study.

Lead researcher Dr. R.C. Coombes, professor of cancer medicine at Imperial College School of Medicine in London, predicted doctors will give exemestane to many women at high risk for recurrence, such as those whose breast cancer spreads to multiple lymph nodes.

"More work needs to be done to understand what's going on" at the molecular level, he said.

The study, which included 4,742 postmenopausal women in 37 countries, focused on women with breast cancer in which the hormone estrogen fuels tumor growth -- the type causing about 70 percent of breast cancer. The results do not apply to premenopausal women or those with tough-to-treat breast cancer not driven by estrogen.

This study does give great promise to the majority of breast cancer patients. As scientists learn more about the biology of breast cancer, we may see even more advances. Great news!

Yes I continue to listen to my tapes on existentialism. Currently, the lecturer is focusing on Sartre. Sartre's philosophy is quite complicated, but does include the concept of no excuses. I found this quotation particularly interesting.

"Freedom is what you do with what's been done to you."

Extra-Low Cholesterol

A cholesterol-lowering study whose results were announced this week has a wealth of important implications. The findings could certainly presage a significant change in the way heart disease patients are treated. It should also start a careful evaluation of whether normally healthy people could benefit from a sharp drug-induced reduction in their cholesterol levels. There may also be major side effects for the economy: the potential health benefits could drive up the use of high-cost drugs in a nation that is already struggling to pay its medical bills. Finally, the study should send a message to Congress and federal regulators about the value of comparative testing of prescription drugs.

The NY Times has a few issues right, and one or two that may not be right. Clearly, this study does make us reconsider how we treat coronary artery disease patients. The study does show that. My blogging colleague, Sydney Smith, disagrees - The Love Affair Continues. She and I have previously agreed that we can and should disagree on issues. I believe she is wrong on this one.

She minimizes the benefit

The results are more notable for what they don't tell us than what they tell us. Rather than following patients over a given period of time and tallying the number of events each group had, they stopped the study when they had 925 events, then relied on statistics to estimate the rates. As a result, the paper deals not with actual event rates but with Kaplan-Meier event rates. A far better study would have been to look at the actual rates. But then, the significance of the findings might not have been as impressive. That is, it would have been harder to present their statistically significant findings as equally clinically significant.

Sorry Sydney, but Kaplan-Meier event rates are actual event rates. Kaplan-Meier curves allow one to evaluate the entire curve over time, rather than just comparing rates at one arbitrary endpoint. Therefore they are much more informative. If anyone wants to read the nitty-gritty on this subject - Survival Curves: Accrual and The Kaplan-Meier Estimate. As I read this study, the results are dramatic (and just in the first 2.5 years). As I wrote yesterday, the curves suggest that the results would become even more dramatic over longer time frames.

The NY Times has no reason to suggest using higher doses as primary prevention. Primary prevention really is a different problem than secondary prevention. Extrapolating these data to the primary prevention problem does not make sense in 2004.

The NY Times suggests that the cost of the higher dose (a difference of ~$600/year) would "drive up the use of high-cost drugs in a nation that is already struggling to pay its medical bills". They should consider the possibility that the decrease in mortality and hospitalizations could overcome the medication costs. We err when we look at medication costs without analyzing the benefits of decreased hospitalizations, decreased development of congestive heart failure, decreased bypass surgery, and decreased mortality. These costs are all important.

Finally the NY Times is correct to point out the importance of head-to-head drug trials (a process which I have championed here over the past 2 years). Interestingly, and supportive of the results:

Bristol-Myers sponsored the study and expected it to prove that its drug was just as effective as Lipitor when it came to reducing disease and preventing deaths. Bristol-Myers was disappointed. But the effort did underline the great benefit in comparing the performance of two prescription drugs. Traditionally, drugs are only tested against placebos. From now on, the value of head-to-head competitions should be obvious to everyone.

Yes, Bristol-Myers makes Pravachol - not Lipitor. Kudos to Bristol-Myers for sponsoring this important study!!

Since posting last night, I have had a couple of interesting questions concerning this article. I would also like to link on today's news stories concerning this article. Finally, I would like to more explicitly give my own interpretation.

Who should receive the high dose strategy? Why not just use pravastatin (Pravachol) at a higher dose?

We must always remember that the patients in this study already had known, active coronary artery disease. This is a secondary prevention study. That being said, if one carefully reads the NCEP guidelines - Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) you will note that patients with adult onset diabetes mellitus are treated as if they already have coronary artery disease. One can (in my opinion) extrapolate the data to diabetic patients, but not patients with pure primary prevention (and no other major risk factors).

Reading the study carefully, they used the highest dosage of each medicine which currently has FDA approval. Certainly, pravastatin at 80 mg might work, but we have no data, either on efficacy or safety.

Today's news stories: New Conclusions on Cholesterol from the NY Times and Striking Benefits Found In Ultra-Low Cholesterol from the Washington Post.

My interpretation of the data at this time:

• This study, and its results are only definitely important for secondary prevention
• The results are, to me, striking at 2.5 years. Since atherosclerosis progresses over time, it seems logical that the benefits will increase over time (although that is theory).
• The costs for Lipitor 80mg ($3-4 per day) are significant, but given the benefits not unreasonable.
• I am converted, and plan to work on giving post ACS patients the new dose
• We have no data on Crestor at high doses. I would not use a new statin until I better know the risk profile

Study: Lower Cholesterol Helps Save Lives

Lowering heart attack victims' cholesterol to levels dramatically below current standards appears to be an important strategy for saving lives and preventing new heart problems, a major new study shows.

Drugs called statins are already standard medicine for people recovering from heart attacks. But the study suggests newer, more potent varieties work best for these high-risk patients.

``The message for these people going home from the hospital is they should be on a high-intensity regimen,'' said Dr. Christopher Cannon of Boston's Brigham and Women's Hospital. ``For everyone else, treating cholesterol and getting it down is very important.''

The much-anticipated study helps answer one of the most discussed questions in cardiology: How low should cholesterol go? For those getting over recent heart attacks, at least, the answer appears to be very low indeed.

Those who did best in this study saw their levels of LDL, the bad cholesterol, plunge in half to an average of just 62. The goal in current federal guidelines is to get LDL below 100.

The study was to be presented Monday in New Orleans at the annual scientific meeting of the American College of Cardiology. It also will be published in the Apr. 8 issue of the New England Journal of Medicine.

The latest work reinforces the conclusion of another head-to-head comparison of statin drugs released last November. In that study, doctors found the more intensive treatment resulted in less artery clogging. The new report is considered even more persuasive because it looks for differences in the risk of death and other clearly measurable misfortunes of heart patients.

Both studies compared 40 milligrams daily of Pravachol to 80 milligrams of Lipitor, the highest approved doses of both drugs when the research started. Pravachol is an older statin made by Bristol-Myers Squibb, while the newer and more potent Lipitor is made by Pfizer. Last fall's study was financed by Pfizer, and this one was paid for by Bristol-Myers Squibb. Lipitor came out on top in both comparisons.

For those who want to read the article from the NEJM - Comparison of Intensive and Moderate Lipid Lowering with Statins after Acute Coronary Syndromes and the editorial - Intensive Statin Therapy -- A Sea Change in Cardiovascular Prevention

Several caveats for everyone. First, they did use a higher dose in the Lipitor group - the group that we call intensive (rather than standard) therapy. Second, all patients had acute coronary syndrome. We should not extrapolate the use of intensive therapy to primary prevention. Third, we must understand cost (sentence quoted from the Wall Street Journal) -

Dr. Topol noted that the dose of Pravachol used in the study costs about $900 a year, while the dose of Lipitor costs $1,400.

Given all these caveats, I would take the higher Lipitor dose (@$4/day) if I had an acute coronary syndrome.

Whoever fights monsters should see to it that in the process he doesn't become a monster.

Friedrich Nietzsche

While most watchers have not picked this up on their radar, I have been ranting about this issue for months. We do not have enough physicians going into primary care - because primary care physicians are treated poorly, both financially and with relationship to worklife balance. Apparently DO students are figuring that out also. Fewer new DOs picking primary care

My colleague, Stef, wrote this important comment concerning my post on autopsies:

I would fault the NY Times article for failing to reference the autopsy review literature that supports the continued value of autopsies.

At least one or two papers a decade document the surprising effectiveness of autopsies at identifying clinically important (but unsuspected) diagnoses, despite our vaunted diagnostic technology. The most recent was published in JAMA (June, 2003) with Lee Goldman as senior author, reviewing 53 autopsy series articles published since 1966. Despite clearly documented improvements in premortem diagnoses over the decades, their data suggest that a contemporary US institution "could observe a major error rate from 8.4% to 24.4% and a class 1 error rate from 4.1% to 6.7%", where major errors involve the cause of death, and class 1 errors are such that the patient outcome would have been altered. Maybe some doctors prefer not to know about those missed diagnoses. I don't know for sure.

As a medical student pathology fellow at the original home of the "Black Crow Award," (an apocryphal legend about a contest in which a resident won a prize for obtaining the greatest number of autopsies, cf. House of Gods), I conducted about 17 autopsies. I scanned my notes from those cases this evening. Brief summary, of 15 adult autopsied, we found a fair number of unsuspected diagnoses and at least 1 or 2 that appeared materially related to the cause of death but were unsuspected by the physicians caring for the patient, a rate of Type 1 error which appears consistent with the findings of Goldman et al. At that particular hospital, housestaff came to a 20 minute autopsy conference once a week, and we reviewed the findings for them.

Beyond the turning up the occasional unexpected cause of death, the post-mortem examination does help physicians develop a clearer mental picture of the diseases we are called upon to diagnose indirectly, by hints and rumors.

These comments, while true, imply that we can extrapolate from these studies to all hospital deaths. That implicit assumption (which some may make explicitly) does not work.

We must remember that those patients who have autopsies are not representative of all hospital deaths. Most physicians push harder for autopsies when they do not really understand what happened to the patient. Thus, the probability of finding new information is enriched in the autopsied patients.

I favor autopsies in many patients. Usually I do not push for an autopsy in a patient who was terminal (i.e., receiving comfort care, managed by the hospice service). As this represents a large percentage of deaths on our services these days, we will have a lower autopsy rate than 50 years ago. I believe that many patients who had autopsies in the past do not receive them because we make more pre-mortem diagnoses, and thus treat patients appropriately, obviating the need for an autopsy. But then, I cannot prove that.

We have had excellent information on the pneumonia severity index in the past. This report re-emphasizes its usefulness. Tool Accurately Assesses Pneumonia Severity. If you want to use the index online, go here - Pneumonia Severity Index Calculator

Go read our favorite surgeon (Bard Parker) - No Black Crow Award Here. I like his rant - of course we agree!

Interesting and well done study in today's NEJM. This report from Medscape describes the findings of a new COPD mortality risk index - Simple Grading System Predicts Mortality Risk in COPD

What the Body Knows

The NY Times has, in my opinion, used their editorial page irresponsibly (once again).

But autopsies have not declined because they're useless. In fact, most studies confirm that autopsies regularly turn up surprises, including mistaken diagnoses, undiscovered conditions and, in a small but steady number of cases, diagnosis and treatment errors that may have led to death. The numbers are not trivial. One study examined 1,000 autopsies between 1983 and 1988 and found that there were " `major discrepancies' between the autopsy findings and the clinical diagnosis" in 317 cases.

Autopsies have dwindled for a number of reasons. Hospitals were once required to perform them to be accredited, but that requirement ended in 1971. Insurance companies do not pay for autopsies. But the problem really lies in our attitude toward them. In recent years, families have become increasingly reluctant to authorize autopsies, and doctors too often believe that modern diagnostic tools like CAT scans and M.R.I.'s have made them obsolete. Yet underlying these reasons is another, more pervasive one: the risk of malpractice suits. An autopsy that uncovers an error in treatment also uncovers the potential for litigation. Never mind that it may improve subsequent diagnoses.

When our patients die, we frequently request autopsies, but rarely will the patient's family approve. I am probably naive or just not smart enough to consider that I could avoid malpractice through the deceit of not asking for an autopsy.

Most hospital deaths in 2004 are expected. Most dying patients are terminally ill.

Autopsies can give valuable information, but they are not as important an information source as they were in the 70s when I started training (nor as important then as they were in the 30s). I suspect that the NY Times editor has watched one too many episodes of CSI. Most autopsies show a few surprises, but rarely many that would change outcomes.

I favor getting more autopsies. They are instructive and help us understand medicine. They offer new important information less frequently than in the past.

The NY Times editors have, as I said before, overhyped this issue. But I must give them credit, they have taken a bold stance. Perhaps they understand our motivations better than we do. Thus I will finish this rant with an existential thought (yes I am still listening to the tapes) - does anyone really know our motivations for our actions - even ourselves? The NY Times editors have attacked the medical community because they believe that they can attribute motivation to us. I find that assumption arrogant.

Given the number of comments related to the MRSA article, I thought that I would provide a few thoughts.

MRSA refers to methicillin resistant staphylococcus aureus. For the non-physicians, that means that the old penicillin variants that we once use for staph infections (oxacillin, dicloxacillin, nafcillin) do no work to kill these staph. Staph infections commonly cause skin infections, like boils, but may cause even more serious infections.

Where did MRSA come from? Bacteria develop resistance by natural selection and mutation (the purest form of evolution). Bacteria naturally mutate. When we use antibiotics, we always have a probability that a mutant strain (starting with only 1 bacteria) will occur. If that mutant has resistance to the antibiotic, then it will multiply and become the prodominant infecting bacterial strain.

This process fits our understanding of natural selection perfectly. Unfortunately, staph infections spread easily between patients. Thus, once a mutant is selected and grows, it becomes capable of infecting other patients.

Some bacteria more often develop resistant strains (i.e., they mutate more often). Staph does mutate often.

Even with appropriate antibiotic use, the biology almost insures that resistance will develop. Over the past decade MRSA first became a problem in intensive care units, then hospital wards, and now the general community.

The cow is out of the barn. We now assume that staph are resistant (unless we prove otherwise with cultures and sensitivity testing).

Understanding how staph became methicillin resistant reemphasizes our need to use antibiotics prudently. They are great and powerful aids to treating serious infections. Whenever possible we need to use the most specific antibiotics possible. However, even with perfect antibiotic usage, we will still develop resistance organisms - genetics and evolution drive the development.

Continued research into the mechanisms of resistance will enable us to "defeat" the resistance - at least for a period of time. We can blame the emergence of resistance on many people and antibiotic uses. Our obligation though is to use antibiotics intelligently for clear indications. This will slow the emergence (not stop the emergence) of resistance and give research the opportunity to develop the next generations of antibiotics. We have an ongoing struggle against bacterial, viral and fungal infections. We can win battles, but will always lose some battles also.

This comment is placed with the wrong rant. Therefore I will quote the entire comment and respond.

Well there you go.

The "experts" believe the average citizen is too dumb to make healthcare decisions.

Let Daddy Government do it for you.

Or we will let the government delegate to self-appointed "experts" to decide for the people.

With government and agencies like AHRQ, heck with Hillary and her crowd...this is not about providing the most medical care, most appropriately, to the most people. People like Hillary don't care about the "little people". This is about their raw political power. They want to take your money and tell you how THEY will spend it on your behalf. The LAST thing they want is to let people decide for themselves, especially when so much money is at stake.

As has been said before, their fear is not that MSA's will not work.

The fear in government and their dependent private organizations like AHRQ......is that MSA's WILL work.

First I must defend AHRQ. AHRQ (Agency for Healthcare Research and Quality) is an important research agency. They have a meager budget (relatively) and deserve a larger budget since they fund studies which actually help us understand what works and what does not work in health care.

The article quoted an individual from AHRQ. He has an opinion with which I disagree. That does not invalidate the agency.

However, the commentor makes a very insightful point. We have advanced in medicine to patient focused decision making. Back in the 70s when I trained we generally functioned paternalistically. We rarely sought patient input into our decision making. Rather we told patients what to do.

Sharing decision making represents a major advance in health care. If we follow that logic, then HSAs extend that concept. We who favor HSAs see them as a way for patients to more actively participate in their medical care.

These plans increase patient's responsibility for their health care. As a physician I expect that patients will expect me to understand costs and explain advantages and disadvantages of differing strategies. As a patient, I should make medication decisions based upon knowledge of alternatives - especially generic alternatives.

Economically these plans should do much to control health care costs. They do require a belief in patients. That is a very libertarian concept.

Methicillin resistant staph will soon be the only staph that we see. Routine antibiotics just will not work against many minor abscesses anymore. Bacteria Run Wild, Defying Antibiotics

"Staph infections are such a common problem that the emergence of infections resistant to common antibiotics has important public health implications," said Dr. Daniel B. Jernigan, an epidemiologist at the federal Centers for Disease Control and Prevention.

But the infections are so common that they are not reportable to the local or federal public health authorities. Because of this, detective work to explain the appearance of the new resistant staph in this country and track its progress is just beginning.

The resistant staph was first recognized in the United States among children in Chicago in the mid-1990's. In 1999, the disease control centers reported that four children in the Midwest had died of infections with the new staph. Three of them had initially been treated with the wrong antibiotics.

In the last several years, clusters of infections with the resistant staph have been reported in jails and prisons in states around the country, including California, Texas, Pennsylvania and Georgia. Clusters of skin infections have also been reported among athletic team members and military recruits.

Clearly, we treat all suspected staph infections as MRSA until culture results prove otherwise. This has become the most prevalent and therefore the most important resistance problem.

Hospitals hang on to money-losing medical practices

A major problem in medicine stems from who gets paid and how much. Currently, the front line physicians (family docs, general internists) are struggling financially. They make significant money for everyone else in the health system. Some hospitals understand economics enough to support these groups.

Medical practices owned by hospitals or integrated delivery systems reported a median net loss of more than $82,000 per full-time physician in 2002, according to a survey published by the Medical Group Management Assn.

The report says the loss was 9.5% more than in 2001, when groups posted a median loss of just more than $75,000 per physician. The report highlights a trend that has been apparent to health systems for several years. Hospitals were selling practices back to physicians or anyone else that would take them more than four years ago because they already had been deemed a drain on finances.

Still, some hospitals have managed to mold thriving medical practices, while others have decided the losses are worth it to have a physician network.

"The philosophy is, 'We will make money off their referrals, even if we don't make money off their practice,' " said Janet Houser, PhD, associate professor of health services administration at Regis University in Denver.

Would it not make more sense for our system to reward these important physicians financially? We all know the answer to that rhetorical question. So why do we pretend that we cannot afford to pay these physicians?

Beat the clock: The new challenges to residents

Resident programs are taking the limits seriously, said David Leach, MD, executive director of the Accreditation Council for Graduate Medical Education, which accredits all residencies. But, he said, it is how they approach the task that makes the difference in the kind of education residents receive.

"There are early adopters and innovators who have shown you can improve patient care and [meet duty-hour limits]," he said. "The majority have shown you can do this, but in making do they've not redesigned clinical care as much as reacted to the requirements. In a few of our citations, programs have met the requirements but have weakened patient care and resident education."

The ACGME has reviewed 500 to 600 programs since July 2003 and has issued 79 citations related to duty-hour violations, Dr. Leach said.

Residents aren't completely happy with the new constraints either.

"You have to realize that the larger health care system is broken," Dr. Leach said. "Residents have lived in the cracks of that broken system for a long time, and they've been told that the system can and will kill your patient, and you need to make sure that doesn't happen. Residents have depended on vigilance, knowing that the system can't be trusted. Now we've reduced the availability of the residents, and they're worried. They want to stay [at the hospital] because they can't trust the system."

Here in our program, we are doing quite well. I have had to insist that interns leave a few times. They have a difficult dilemma. After admitting for 24 hours, then rounding for 3 hours, they only have 3 more allowed hours. If a patient has an interesting study scheduled, they really hate leaving until they know the results. They rarely want to stay for patient care (our system manages that quite nicely) but rather for their own education. So we have to say, sorry you must go home.

In talking with attendings at other institutions, they express the opposite problem. They have told me that their residents do not seem to take as much responsibility for their patients as residents formerly did.

The 24 + 6 rule is so arbitrary and without supporting data as to engender scorn from almost all of our residents and interns. How can we teach evidence based practice when our accredition body makes decisions without evidence?

But these are the rules and we do the best we can. I am proud of our residents who remain committed to outstanding patient care. They have developed a system which adheres to the most important principle - outstanding patient care - yet allows reasonable work hours. They are not always happy about the rules (and some will ignore the rules regardless of what the attendings say). Most important, our residents worry about the patients first, and the rules second. I think that should be the focus of ACGME evaluations.

HSAs (Health Savings Accounts) immediately push observers into one of two camps. Libertarians and free market economists believe that they will lead to better rationing of care - patient directed rationing. Others argue that patient care will suffer because patients do not understand enough to ration logically. Consumer-driven health care: Bush, GOP back HSA expansion

Businesses large and small are looking for ways to preserve employee health benefits without breaking the bank. Many have latched onto the concept of consumer-driven health care, which shifts more of the responsibility for health-spending choices onto the patient.

"We see a 15% reduction in drug spending right out of the chute within five to six months and a 6% reduction in physician visits," said Mike Parkinson, MD, chief medical officer for Lumenos, an Alexandria, Va.-based health insurance company offering consumer-driven plans across the country.

"You know that 20% to 25% of doctor visits are unneeded; 30% to 35% of all health care is ineffective or inefficient. How better to get at [that waste] than front-loading the consumer who says I want to get the care I want when I want it and from whom I want it," he said.

Consumer awareness of price and quality information will drive competition among physicians seeking to offer the highest value services, Dr. Parkinson said. Many physicians like consumer-driven plans because they emphasize preventive and behavioral services that support doctor-prescribed treatments and make for healthier patients, he said.

That is the argument in favor of HSAs. Others remain skeptical.

"What these plans are asking [patients] to do is to ration their own care," said Dwight McNeill, an expert in quality measurement and improvement at the Agency for Healthcare Research and Quality.

"The question now is, do consumers, as rationers or deciders of their own health care, have better or more useful information to make these decisions than doctors did" in managed care, he said. "The answer has to be, no, ... consumers just aren't ready for it, and they don't have appropriate information."

Gathering information on the efficiency, quality and value of health care services and procedures will take more time and money, McNeill said.

Republican lawmakers remain unconvinced by arguments that patients cannot make their own health decisions. Many want to move forward with legislation designed to encourage the trend.

People make bad economic decisions daily. This occurs through our economy. Those who favor HSAs (including this ranter) believe that patients will change their focus when asking for health care options. Most patients will listen to recommendations and be more likely to accept less expensive medications, rather than the newest medication advertised on television.

Our current system clearly does not work. We should collect data to understand the impact of HSAs. I have had them for several years - and am a major proponent.

Common knowledge asserts that physicians often do not let patients tell their story prior to interruption. Many physicians apparently feel that patients will just talk forever, and that they (the physician) will not have time to ask their important questions. This research shows that we can let patients have their say. Length of patient's monologue, rate of completion, and relation to other components of the clinical encounter: observational intervention study in primary care

Just go read the article - it is short and makes an important point.

For those who have access to Circulation - this perspective on the effectiveness article that I cited last week hits the mark - We Must Use the Knowledge That We Have to Treat Patients With Acute Coronary Syndromes I will quote a couple of relevant paragraphs.

Audit is an important component of quality improvement, but little is known about the effectiveness of quality improvement and audit programs. A recent pilot initiative by the Guidelines Applied in Practice (GAP) Committee of the American College of Cardiology,14 conducted in 10 acute-care hospitals in Michigan, tested strategies such as dissemination of guidelines, grand round presentations, and use of physician and nurse opinion leaders. Reassessment 3 to 11 months later showed that the usage of aspirin increased from 84% to 92% (P=0.002) in patients with acute MI, and the proportion of patients receiving counseling for smoking cessation increased from 53% to 65% (P=0.02) at discharge. The usage of ß-blockers and ACE inhibitors in "ideal" patients also increased (from 89% to 93% and from 80% to 86%, respectively), but these increases were not significant.

Some recent registries have documented relatively high usage rates of therapies. In the Global Registry of Acute Coronary Events (GRACE),15 92% of patients with ACS were prescribed aspirin at discharge, 77% were prescribed ß-blockers, 56% were prescribed ACE inhibitors, and 47% were prescribed statins. It should be noted, however, that the GRACE investigators were aware that their practice was being audited, and findings from previous audits were reported back to the investigators and compared with findings from other local and international centers.

National data sets from the United States1 show that aspirin usage in patients with coronary disease increased from 18% in 1990 to 38% in 2001, while ß-blocker usage increased from 19% to 40%, and ACE inhibitor use in patients with congestive heart failure increased from 24% to 39%. However, although the usage of these therapies has increased, it remains suboptimal, and the rate of increase in usage has slowed.1 At 1.4 years after an acute coronary event in the European Action on Secondary and Primary Prevention Through Intervention to Reduce Events (EUROASPIRE) study, 21% of patients smoked, 31% were obese, 58% had total cholesterol levels of 192 mg/dL (4.9 mmol/L), and >70% of diabetics had inadequate glucose control (fasting blood sugar 126 mg/dL [7.0 mmol/L]).16 Furthermore, too many patients were not taking aspirin (14%) or ß-blockers (37%).

=======================

Surprisingly little is known as to why doctors do not prescribe evidence-based therapies, but it has been shown that the factors most likely to encourage usage are dissemination of strong evidence, supportive opinion leaders, and integration of clinical practice within an organization that is committed to evidence-based practice.

Institution of the knowledge we already have could reduce mortality after an ACS by perhaps 80%. It is not sufficient to simply add 1 therapy at a time in patients at high risk of future ischemic events. Instead, whenever clinically possible, patients should be started simultaneously on as many as 4 evidence-based therapies while they are still in hospital, combined with nonpharmacological approaches to risk prevention such as smoking cessation, achievement of ideal weight, and graded exercise programs. There should also be insistence on long-term patient and physician commitment to these programs, with periodic testing of biomarkers and reassessment of the target variables for which the various therapies have been prescribed, in association with regular clinical examinations, stress testing, and selected imaging assessments.

Our research group spends much energy trying to understand the best ways to help physicians do this. While it does seem simple to non-phyisician observers, the problem really has great complexity. We can easily write about acute coronary syndrome care, but physicians care for patients with many problems. How can we help physicians keep up with knowledge and practice changes for all the problems that their patients have?

This commentary reemphasizes what our research group knows. Knowledge and efficacy studies are not enough. We must continue to study the problem of translating our knowledge into better practice.

I have a hobby - I listen to books and courses as I drive. Currently I am listening to a college course on existentialism - No Excuses: Existentialism and the Meaning of Life . Several comments follow from this.

First, if you are interested in lifelong learning about various topics, you should explore the Teaching Company. Second, as I listen to this course, I am finding much in existentialism that reflects my own personal philosophy.

This interesting web page - Existentialism: A Primer - has this interesting quote as the author discusses existentialism.

Despite encompassing a staggering range of philosophical, religious, and political ideologies, the underlying concepts of existentialism are simple:

• Mankind has free will.
• Life is a series of choices, creating stress.
• Few decisions are without any negative consequences.
• Some things are irrational or absurd, without explanation.
• If one makes a decision, he or she must follow through.

Existentialism, broadly defined, is a set of philosophical systems concerned with free will, choice, and personal responsibility. Because we make choices based on our experiences, beliefs, and biases, those choices are unique to us — and made without an objective form of truth. There are no “universal” guidelines for most decisions, existentialists believe. Instead, even trusting science is often a “leap of faith.”

While this philosophy (at least this abridgement) does not describe the philosophical underpinnings of this blog completely, it does come close. I particular respond to the free will, choice and personal responsibility concept. Since I will be listening to these tapes for the next few weeks, you may see several more rants on existentialism. I believe that philosophy has great relevance to medicine and the politics of health care. Having strong philosophic underpinnings allows one to develop a more consistent decision making process. As I learn more about existentialism, I will try to share my thoughts on this subject.

On a light note, you might find this excerpt from one of Woody Allen's early movies thought provoking (or even funny) - Existentialism

WOODY ALLEN: That's quite a lovely Jackson Pollock, isn't it?

GIRL IN MUSEUM: Yes it is.

WOODY ALLEN: What does it say to you?

GIRL IN MUSEUM: It restates the negativeness of the universe, the hideous lonely emptiness of existence, nothingness, the predicament of man forced to live in a barren, godless eternity, like a tiny flame flickering in an immense void, with nothing but waste, horror, and degradation, forming a useless bleak straightjacket in a black absurd cosmos.

WOODY ALLEN: What are you doing Saturday night?

GIRL IN MUSEUM: Committing suicide.

WOODY ALLEN: What about Friday night?

GIRL IN MUSEUM: [leaves silently]

"Play It Again, Sam", Paramount Pictures, 1972

Many critics assert that we (the medical profession) should work harder on quality. This concept now carries great political weight. Here is what several critics say - The quality challenge: How best to raise the bar for medical care

Dr. Schoenbaum suggested establishing a new federal agency with the sole purpose of overseeing health care quality improvement. The same recommendation was made by a presidential advisory commission in 1988, but neither the Clinton nor Bush administrations have pursued it. That commission also recommended the creation of the National Quality Forum to promote the use of standardized quality measures and public reporting of results. The forum began collecting and endorsing those measures in 2000, but it relies on health care practitioners to voluntarily adopt their use.

NQF President and CEO Kenneth Kizer, MD, said there needs to be at least a point of focus within the federal government to help coordinate efforts. "If we're going to see the improvements in patient safety and health care quality overall that have been so well defined by the Institute of Medicine in recent years, then the U.S. government has to play a central and an active role in that regard," Dr. Kizer said.

The NQF could expand its role, if asked by the federal government, to include such activities as endorsing national quality improvement priorities, establishing a national medical error reporting system, and creating a uniform medical licensure process, he said.

But practicing physicians point out that measuring quality is much more complex than just examining a scorecard -

Doctors also remain skeptical about whether measures provide an accurate picture of their quality of care. Although large group practices might have the patient volume to accurately measure quality, small or solo practices often don't see enough patients for a meaningful assessment.

"The scale of a physician's office, combined with the variety of patients and procedures that are performed, make it virtually impossible to measure quality accurately and fairly in a physician office," said Robert Reischauer, PhD, president of the Urban Institute, a Washington, D.C., think tank, and a member of the Medicare Payment Advisory Commission.

But that doesn't mean Medicare and other public programs can't begin to experiment with quality incentives for physicians, Dr. Reischauer said.

"I don't think we have to wait in the sense that we can apply qualitative measures and reward those with high quality," he said. "And those who choose to organize their practices as solo practitioners will just be out of that income stream."

Measuring quality in physician offices remains beyond the government's reach for now, said Tom Scully, former administrator for the Centers for Medicare & Medicaid Services.

"It's just too complicated. You've got how many hundreds of thousands of physicians, and appropriately measuring them is years off," he said. "My view is they all work in institutions, and what you're really trying to do is not necessarily rate the individual physicians, you're trying to drive change. If you can rate the institutions, it drives that."

So we have tension. Should we measure and score quality? Should we ignore this movement because we believe it too philosophically difficulty to find good measures of quality?

I sit on the side of starting to measure quality - as long as the quality measures predict outcomes. One would have a difficult time arguing that the quality measures used in this study (that I ranted about last week) were unimportant - Proper care of Acute Coronary Syndrome - effectiveness data.

With this (and other studies) as landmarks, I believe that we can develop measurable quality indicators which lead to observably better outcomes. As long as we stick to that standard, then I favor the quality movement.

A Healthy Sense Of Urgency. (registration required)

This article should help everyone reevaluate their priorities.

Several readers have written asking for my opinion on the antibiotic breast cancer link. Here is the Washington Post article about the study - Antibiotics May Raise Risk for Breast Cancer

The first-of-its-kind study of more than 10,000 women in Washington state concluded that those who used the most antibiotics had double the chances of developing breast cancer, that the association was consistent for all forms of antibiotics and that the risk went up with the number of prescriptions, a powerful indication that the link was real.

A variety of experts quickly cautioned, however, that the findings should not stop women from taking the often lifesaving drugs when needed to treat infections. There could be other explanations for the association, and much more research is needed before scientists understand what the surprising results mean, they said.

"This is not saying that women should stop taking antibiotics. Women should take antibiotics for infections," said Stephen H. Taplin, a senior scientist at the National Cancer Institute who helped conduct the study. "We need to follow up and find out if this is a real association."

Nevertheless, the consistency of the findings in a study with such careful methodology could indicate that antibiotic use is an important, previously unrecognized risk factor for breast cancer, experts said.

Antibiotics could increase the risk for breast cancer by, for example, affecting bacteria in the digestive system in ways that interfere with the way the body uses foods that protect against cancer, experts said. Another possibility is that antibiotics increase the risk by affecting the immune system.

Even if it turns out that antibiotics do not increase the risk for breast cancer, the finding is likely to be important because it could lead to the discovery of whatever it is about women who use the drugs that appears to make them prone to the disease, researchers said. "This has opened up a picture that people had not been thinking about," Taplin said. "The important thing is more research and asking more questions about what it could be."

My thoughts:

• This study reports an epidemiologic association. Associations are statistical findings which suggest, but do not prove linkage.
• We should classify this article are hypothesis generating. We now require more studies to examine this new hypothesis.
• The hypothesis may persist in follow up studies. If so, then we need further investigations to understand why there is an association.
• The positive side of this article is that it should remind everyone that antibiotics have clear indications. We should use them for bacterial infections and not use them for viral infections.
• This article should not change how we treat patients, but it may make women more receptive to not having an antibiotic prescription. It may decrease the demand for antibiotics for viral upper respiratory infections.

Overall, this article is interesting, but should not be over interpreted. We do not know that antibiotics cause breast cancer. We only know that one epidemiologic study found an association.

Antibiotic resistance represents a significant threat now, and in the future. Giving antibiotics for non-bacterial infections causes much of the problem. Physicians have a dilemma when patients have bronchitis. We just do not know whether whether we should prescribe antibiotics.

A new study suggests that we may be able to use a blood test to help with that decision. New test shows promise at reducing unnecessary antibiotic use

After the blood test results were revealed, the researchers then advised the doctors to prescribe antibiotics only if the blood level of the chemical marker, called procalcitonin, was above a certain level.

The rate of antibiotic prescriptions foreseen by the doctor was similar in both groups before the blood test results were disclosed.

But once test results were known, antibiotic prescriptions dropped almost in half. A total of 99 patients in the comparison group got antibiotics, compared with 55 in the blood test group.

Antibiotics were given to 22 patients with a blood test showing low levels of the chemical marker. Doctors often prescribe antibiotics to people with severe viral infections because viruses can damage the airways enough to encourage a subsequent life-threatening bacterial infection.

"Importantly, withholding antibiotic treatment was safe and did not compromise clinical and laboratory outcome," said the study, led by Dr. Beat Muller at the University of Basel.

Dr. Marc Siegel, a professor of medicine at New York University School of Medicine, said the study convinced him the procalcitonin marker may help doctors, but larger studies are needed to determine if it is safe to withhold antibiotics from high-risk patients.

The danger of missing a severe or progressing bacterial infection is too great to rely solely on the blood test, Siegel said. "You worry about antibiotic resistance, but you also worry about patients dying," he said.

Interesting! I hope we do see more studies on this test.

Prognosis: Index for Heart Risk Shows Merit

Many commentors (and this author) wave the flag of evidence based medicine to marshall arguments. Often we wave this flag without really understanding what the phrase means. We have 2 levels of evidence - efficacy and effectiveness.

Efficacy and effectiveness reflect the success of an intervention when implemented according to intervention guidelines under optimal conditions or in real-world situations, respectively.

- RE-AIM Framework: Efficacy/Effectiveness of Health Behavior Interventionsl

In that context, investigators performed an important effectiveness study on the importance of following guidelines in ACS which derive from efficacy studies. Combined Medical Therapy Improves Survival After Acute Coronary Syndromes. This study is very important because sometimes efficacy does not translate to effectiveness. In this study it does!

Use of all evidence-based therapeutic agents, when indicated, greatly reduces 6-month mortality in patients with acute coronary syndromes, according to a report in the February 17th rapid access issue of Circulation: Journal of the American Heart Association.

Several pharmacological agents have been shown to reduce mortality in patients with acute coronary syndromes, the authors explain, but the impact of their combined administration on clinical outcomes has not been studied previously.

Dr. Debabrata Mukherjee and colleagues from the University of Michigan in Ann Arbor examined the impact on 6-month survival of combined antiplatelet drugs, beta-blockers, ACE inhibitors, and lipid-lowering agents in 1358 consecutive patients with acute coronary syndromes.

Patients who received all indicated medications had only 10% of the mortality risk of patients who received none of the indicated medications, the investigators report.

The mortality risk was reduced by 83% among patients who used 3 of 4 medications indicated, by 82% among patients who used 1 of 2 medications indicated (or 2 of 3 or 4 indicated medications), and by 64% among patients who used 1 of the 3 or 4 medications indicated, the results show.

"Patients presenting with ACS represent an important high-risk cohort, where secondary vascular disease prevention is likely to be particularly effective and cost-effective," Dr. Mukherjee told Reuters Health.

This is certainly an important study. As I have written previously, our research group is focusing on methods to help physicians adhere to well accepted guidelines. This article reinforces the importance of our research. When we see such dramatic effectiveness results, it emphasizes the importance of helping physicians follow rational guidelines.

Must I Have Another Glass of Water? Maybe Not, a New Report Says

We have previously discussed this issue, but this report does a nice job of putting the recommendations into perspective.

Pricing Drugs

WITH THE MEDICARE prescription drug program projected to cost $134 billion more than originally planned, it's hardly surprising that Congress is talking price controls. Rep. Nancy Pelosi (D-Calif.), the House minority leader, and Thomas A. Daschle (D-S.D.), her Senate counterpart, have already called for the government to negotiate prices on behalf of the private companies that will be buying drugs for Medicare recipients. Others have revived the idea of reimporting drugs from Canada. Pharmaceutical executives are braced for a price-control movement that may take off -- and succeed -- at any time.

Drug pricing remains an easy target for politicians. I agree that many drugs carry prices that I consider outrageous. When we prescribe drugs for patients in our clinics, I generally consider price as part of the decision making. Several examples are relevant here:

• I almost never allow Nexium, because other cheaper PPIs work just as well - at much lower cost
• We use captopril bid for hypertension rather than a more expensive ACE inhibitor
• We use ACE inhibitors rather than ARBs for price considerations

We are handicapped often by inadequate information. The Washington Post understands!

Finally, markets don't work well without correct information. If Congress really cares about making sure drugs are used in the most effective and most economical ways possible, it should put more effort into ensuring that doctors and patients know enough about the drugs they are taking. Recent studies have shown that some older drugs may be just as effective as newer, more expensive drugs -- drugs for high blood pressure, most famously, but also some antibiotics and antidepressants. Indeed, the vast majority of new and more expensive drugs -- two-thirds, according to the FDA -- use active ingredients already on the market. Yet there is no systematic testing to measure their comparative effectiveness. Although Congress, in the Medicare legislation, authorized $50 million for the tiny Agency for Healthcare Research and Quality to do exactly that, the figure has disappeared from the budget. Before Congress starts setting prices, more should be done to ensure that the public and medical professions have access to good information and that older and generic drugs are used whenever possible.

This is a great quote. The reference is tangential - I was just reading a review of a book on greatness. But I love this quote, and will add it to my quote section.

One of Murray’s favorite ideas is contained in a quip he credits to his late colleague Richard J. Herrnstein: “It is easy to lie with statistics, but it’s a lot easier to lie without them.”

I rant so often about this topic. But it is important, and a great dilemma. U.S. Is Working to Make Painkillers Harder to Obtain

Top DEA officials confirm that the agency is eager to change the official listing of the narcotic hydrocodone -- which was prescribed more than 100 million times last year -- to the highly restricted Schedule II category of the Controlled Substances Act. A painkiller and cough suppressant sold as Lortab, Vicodin and 200 generic brands, hydrocodone combined with other medications has long been available under the less stringent rules of Schedule II

The DEA effort is part of a broad campaign to address the problem of prescription drug abuse, which the agency says is growing quickly around the nation. But the initiative has repeatedly pitted the agency against doctors, pharmacists and pain sufferers, and it is doing so again with the hydrocodone proposal.

Pain specialists and pharmacy representatives say that the new restrictions would be a burden on the millions of Americans who need the drug to treat serious pain from arthritis, AIDS, cancer and chronic injuries, and that many sufferers are likely to be prescribed other, less effective drugs as a result.

If the change is made, millions of patients, doctors and pharmacists will be affected, some substantially. Patients, for instance, would have to visit their doctors more often for hydrocodone prescriptions, because they could not be refilled; doctors could no longer phone in prescriptions; and pharmacists would have to fill out significantly more paperwork and keep the drugs in a safe. Improper prescribing would carry potentially greater penalties.

This issue has no easy solution. Patients will suffer under the new rules. Abusers will figure out ways to obtain drugs. Physicians will get caught in the middle. But you know the story.

The entire article is well done, and describes both sides of the issue. I particularly like this quote:

Susan Winkler of the American Pharmacists Association said her organization is concerned that the "ripple effects" would be substantial and negative.

"Our members and doctors would have increased liability if [hydrocodones] are rescheduled, and that will inevitably reduce prescribing," she said. "We urge the DEA to make sure their decision is based on science and will make the situation better, not worse."

And rarely are these decisions based solely on science.

Eat Your Salmon

Staying out of the sun and quitting smoking are both good ideas. But now some scaremongers want to add salmon to the list of things we all should avoid to reduce our risk of cancer.

Yes, salmon. The heart-healthy fish that's also supposed to make you smarter stands accused of causing cancer. A study published in Science magazine last month says that salmon raised on farms in the U.S. and Europe has higher levels of pollutants than salmon caught in the wild. It recommends eating farmed salmon just once a month.

There are a number of fishy things about this study, starting with the fact that the proven health benefits of eating salmon far outweigh the risk of cancer. In response to the report, the Food and Drug Administration says that "consumers need not alter consumption of farmed or wild salmon at this point in time." Britain's food watchdog agency also rose to salmon's defense, saying the levels of pollutants reported in the study are within internationally recognized safety limits.

Sometimes scientists perform solid studies but have unreasonable extrapolations of the data. From this report, we can surmise that to be the case here. I will not stop eating salmon!

Peptide May Help Predict Heart Diseases. Two articles appear in today's NEJM which further our knowledge of B-natriuretic peptide as a diagnostic and prognostic blood test. My experience thus far (our VA starting doing them a few months ago) agrees with these articles. BNP is now part of my diagnostic and prognostic toolbox.

One of the studies, conducted at University Hospital in Basel, Switzerland, found that measuring the peptide's levels in ER patients with shortness of breath helped doctors more quickly decide whether patients had heart failure.

That, in turn, reduced treatment costs and hospital stays by about one-fourth and lowered the percentage of patients hospitalized. The peptide test costs about $35.

The other study found that people with high levels of the peptide are three times as likely to develop heart failure within five years.

That study, funded mostly by the National Heart, Lung, and Blood Institute, examined 3,346 people. All of them are part of the Framingham Heart Study, which since 1948 has followed three generations and thousands of residents of the Boston suburb with regular physicals and tests.

``It's a continuing success story for the biomarkers, and I believe they hold real promise for the future, both for the management of patients with urgent symptoms and for preventive strategies,'' said former American Heart Association President Dr. Sidney Smith.

Smith said the findings should be considered when U.S. guidelines for diagnosing heart failure in ER patients are updated over the next year; European guidelines already call for the use of the test.

However, Smith said is too early to advocate widespread use of the test to predict heart trouble and plan preventive treatment.

Doctors believe a gradually failing heart tries to protect itself by secreting more and more of the peptide, which dilates blood vessels and lowers blood pressure.

Very interesting report - Institute of Medicine Advises on Water, Salt, Potassium Intake. The short summary: drink fluids moderately, water is no better than other fluids, eat less salt, eat more potassium containing foods.

New H.I.V. Test Identifies Cases in College Students

This is a sad and tragic story. The new HIV test, which diagnoses infection soon after exposure is very interesting.

WHO Issues Guidelines on Herbal Medicines

The U.N. health agency on Tuesday issued advice to governments around the world on how to ensure that the $60 billion herbal medicine business is safe and sustainable.

``There is a huge increase in this market. Many people are paying a lot for traditional medicines, and some insurance systems have started to reimburse (for) traditional remedies,'' said Dr. Hans Hogerzeil, acting direction of essential drugs and medicine for the World Health Organization.

``At the same time, this is an area where it is sometimes difficult to regulate properly and get safety assurance for patients.''

Medicines derived from plants, such as ginseng and echinacea, are becoming increasingly popular in rich countries and continue to be widely used in the developing world.

But the increase in popularity has been accompanied by an increase in the number of reported cases of damage to health from use of herbal medicines.

One cause is incorrect identification of plants. In the United States in 1997, people suffered serious heart problems after digitalis was accidentally substituted for plantain in dietary supplements. Fourteen cases of poisoning also have been reported in Hong Kong where the wrong root was used to produce an antiviral medicine.

Other problems include the use of poor quality plants, poor collection practices and the adding of other medications -- such as steroids -- to herbal remedies.

This is a huge problem. When will our Congress step up to the plate?

Our frequent commentor, Bernie, often causes controversy. I am delighted with controversy. Often I just ignore his arguments, but today I will share some of comments and give me interpretation.

I'm trying as hard as I can to empathize with your depiction of the current malpractice crisis. Certainly there are undesirable consequences that flow from the current litigious atmosphere. But I can't see how extra and possibly unneccesary medical tests or higher insurance bills for a well renumerated profession constitutes a crisis.

If you asked me what the health care crisis is, it's how the cost of medical care rises year after year faster than the cost of living and how little effort goes into fighting iatrogenic illness, which now constitutes our worst public health problem.

Bernie - please show some consistency. The malpractice crisis helps cause the financial crisis. It contributes to the increasing cost of health care. Those unnecessary tests cost money. And their results often lead to more tests - and yes iatrogenic illness.

Sometimes doing an extra test leads to more testing and those tests can cause complications.

Physicians are generally scared to discuss errors as they worry about liability. Everyone tries to avoid being sued.

The malpractice crisis paralyzes change. Until we modify our tort system, we will not have the resources or energy to address iatrogenic disease.

You also overhype this problem. It pales next to self-inflicted disease.

And another great non sequitor from Bernie:

I'm looking forward to seeing Tagamet ads that proclaim it causes impotence.

An for as the dangers of supplements: perhaps you can enlighten me and name a supplement that kills more people annually than aspirin or acetaminophen. I think I'll go make myself a cup of herbal tea -- I like to live dangerously.

What a wonderful lack of connection! We have no idea what the danger of supplements is - because we have no required testing in the USA. That is the problem! We know the risks of prescribed drugs. We have reporting mechanisms, and physicians are alert to new dangers. With the supplement industry we have 2 problems: inadequate testing prior to selling supplements and inadequate standardization of ingredients. Without these two necessities, why would someone ingest these so-called remedies.

I drink herbal tea - for the taste. I do not take supplements from health food stores, because they just might hurt me. I want data that they help and do not hurt. I want to know that if a patient is taking a supplement - I can look up the ingredients and understand what he/she is taking. I want to understand how the supplements might interact with medications that I prescribe. I do not think that my desires to help the patient should be trumped by a dangerous law. Patients need to know what they are taking. Is that such an unreasonable request?

Perhaps this is a stretch, but one can argue that we should provide safety advice. If that argument does not convince you, then just read the article anyway. I admire Malcolm Gladwell and wait eagerly for his New Yorker pieces, which I consider the best medical/science reporting that I read. Big and Bad: How the S.U.V. ran over automotive safety. That SUV is more dangerous than your smaller cars!

I recently blogged about academic medicine - stimulated by our favorite surgeon blogger, Bard Parker. He has pointed out this important article concerning academic teaching hospitals - Multiple Missions Put Teaching Hospitals at Risk

For more than a century, Americans have expressed confidence that an ever-increasing, well-trained cadre of physicians and medical scientists will protect and enhance their health. So for much of this period, the steady expansion of medical schools, research laboratories and teaching hospitals has been justified as an agent of public good.

More recently, however, with the fiscal crisis in health care, experts are beginning to question whether the nation's academic medical centers are financially sustainable in these times when Americans tend to worship the free market.

It has become increasingly difficult in recent years simultaneously to educate and train young doctors, treat patients, advance medical research, and hew to the bottom line. All these endeavors require more and more costly technology. Salaries and health care delivery expenses continue to rise. And the competition among all medical centers, whether affiliated with universities or independent, is ferocious.

The academic medical center is big business. Because it is big business, we often have mission confusion. At times the medical school and the hospital administrations are at war.

So what should the priorities be? Are academic medical centers chiefly about education, or research, or patient care? Given current finances how many academic medical centers will remain "triple threats"?

What has changed most over the past century is that today's academic medical centers are almost or completely financially independent from their parent universities. To make matters more precarious, when economic times are good, many university presidents look to their hospitals' profits to support other growth plans in the less lucrative schools or colleges. But when these revenues are threatened or reduced, they often seek ways to minimize the university's financial responsibility to its academic medical center.

"This places an enormous premium on the entrepreneurial skills of administrators and faculty and seriously threatens the older notions of humanitarianism and scholarship that guided these institutions," Dr. Risse said.

Dr. Ruth Macklin, a bioethicist at the Albert Einstein College of Medicine in the Bronx, observed, "Academic medical centers are caught in a squeeze to bring in more and more dollars, leading to the common doctors' complaint: `I just don't have time to talk to patients because I am not reimbursed for it.' "

Dr. Arthur L. Caplan, a professor of medical ethics at Penn, believes this tension may be largely generational in nature. "Older physicians and medical scientists who came of age before the end of the 1980's tend to be more concerned about the public service mission of academic medical centers than their students, who are very much the product of the concept of medicine as a business," Dr. Caplan said.

So we have these large businesses that care for complex patients, perform major research projects and, oh by the way, train our future physicians (both students and residents). With these multiple missions, few centers do all well. And too often the education piece suffers.

Oh, but this reminds me of the famous tale - The Emperor’s New Suit. There is nothing there (speaking of the industry) and yet many Americans spend large amounts of money on supplements.

At the risk of offending a reader, I will quote from his diatribe concerning Sunday's rant:

As a chiropractor, I'm a part of the alternative trend. I realize some reigns need to be put on herbs and other so-called alternative therapies, but I don't think we need to dismiss the right of the patient to make their own educated decision. After all, a patient is not going to keep up with something that is harmful to them, unless their doctor tells them to. If millions, thousands, heck hundreds within a year were suffering problems from these herbal supplements, the word of mouth of their failure would kill the sales.

So he uses sophistry (see yesterday's rant) to argue for alternative therapies. I am a simple minded physician. I need data. I want to see what happens to patients who receive a therapy - do they improve or do they get worse or does nothing happen. Clearly, I try not to prescribe medications that have no effect.

The commentor urges us to allow patients to make their own educated decision. Unfortunately, many patients cannot make an educated decision about their medical care.

This argument stems from the general argument between science and belief. As a scientist, I want evidence that a therapy both will increase the probability of helping me and have a limited probability of hurting me. I certainly do not want to spend large amounts of money on placebos.

The commentor argues that patients know. Of course, in the land of believers the anecdote is king.

I'm sure we all know how statistics can be used to get results we need, or at least point our direction. Everybody knows that if you flip a "roll-over" prone SUV that it was probably your fault. If the plane craches, well that was out of your hands. Personally I like to have control of the reigns, like most Americans.

This is a simply classic diatribe against medical statistics. We should not trust statistics - because they define outcomes precisely .

With no apologies, this reasoning leads to many patients down the wrong roads.

Many patients are not smart about their health. If they were they would not smoke, drink to excess, have multiple sexual partners, use IV drugs, or become obese. But they do!!! People often do not know what is best for them.

Ephedra "helped" many patients - but at the risk of death! Patients died because of a bad law. Perhaps they should sue Congress (oops - you cannot really do that).

We need a better law. We need to advance evidence as the determinant of medical decision making. When we have no evidence and someone wants to try either an off-label drug or a dietary approach - I have no objection, if, and only if, the patient fully understands the lack of data and the potential risks.

The dietary and supplement industry presents themselves as authoritative. They are not, and they hurt many patients. Fortunately, they mostly just bilk naive believers out of their money. That is bad enough.

I will probably go buy this issue to have a better, more readable copy of this article. The author has done outstanding research and puts the entire industry into both historical and current perspective. I hope this link lasts (not sure about the New Yorker's links) - MIRACLE IN A BOTTLE

I will quote a few key paragraphs to make some points and highlight the issue:

The diet-pill business may be the most visible segment of the vitamin-, mineral-, and herbal-supplement industry, but it is by no means the largest. Thousands of different tablets, elixirs, potions, and pills are sold in the United States, and remarkably little is known about most of them. That doesn't deter consumers. Since 1994, when Congress passed a law that deregulated the supplement industry and opened it to a flood of new products, the use of largely unproved herbal remedies - from blueberry extract for impaired vision to saw palmetto for the treatment of enlarged prostates and echinacea to prevent colds - has increased as rapidly as the use of any commonly prescribed drug.

Since that legislation, the Dietary Supplement Health and Education Act, became law, companies have been able to say nearly anything they want about the potential health benefits of what they sell. As long as they don't blatantly lie or claim to have a cure for a specific disease, such as cancer, diabetes, or aids, they can assert, without providing evidence, that a product is designed to support a healthy heart (CardiAll, for example), protect cells from damage (Liverite), or improve the function of a compromised immune system (Resist). There are almost no standards that regulate how the pills are made, and they receive almost no scrutiny once they are, so consumers never truly know what they are getting. Companies are not required to prove that products are effective, or even safe, before they are put on the market.

Those two paragraphs nicely summarize the effects of the DSHEA.

Since then, the English language has been stretched to its limits in the attempt to link products to health benefits. Even claims that are true may be irrelevant. Vitamin A, for example, is important for good vision - as supplements for sale in any health-food store will tell you. Insufficient consumption of Vitamin A causes hundreds of thousands of cases of blindness around the world each year, but not in the United States; here people don't have vision problems arising from a lack of Vitamin A. Although statements advertising Vitamin A for good vision may, like many others, be legally permissible, they are meaningless. "The laws allow manufacturers to make fine legalistic claims," Paul M. Coates, the director of the Office of Dietary Supplements at the National Institutes of Health, told me. "What we now have is an entire cottage industry of creative linguistics dedicated solely to selling these products." Instead of mentioning a disease (which in most cases would be illegal without F.D.A. approval), companies make claims that a food can affect the structure or function of the body. Such claims can appear on any food, no matter how unhealthy it is. You cannot assert that a product "reduces" cholesterol, but you can certainly say that it "maintains healthy cholesterol levels." You cannot state that the herb echinacea cures anything, since it has never been shown to do that. But there is no prohibition on stating that it "has natural antibiotic actions" and is considered "an excellent herb for infections of all kinds." Gingko biloba has been recommended to Alzheimer's patients because it "supports memory function." Does it? Since research is not required before a supplement is released, there are not nearly enough data to know.

Obviously the key here is the advertising. You can obviously sell almost anything to some people with good enough advertising. Data are irrelevant.

One recent Harris poll found that most people believe that if a supplement is on the market it must have been approved by some government agency (not true); that manufacturers are prohibited from making claims for their products unless they have provided data to back those claims up (no such laws exist); and that companies are required to include warnings about potential risks and side effects (they aren?t). "When something goes wrong, though, most people expect government health officials to find a solution," David A. Kessler told me. Kessler, who is the dean of the School of Medicine at the University of California at San Francisco, was the F.D.A. commissioner when Congress passed the Dietary Supplement Act, which he adamantly opposed. "This is really the classic American ambivalence, and it has always been part of our nature," he said. "The view of most people is simple: I want access to everything and I want it now." The Federal Trade Commission - not the F.D.A. - regulates supplement advertising. But the F.T.C. is principally concerned with commerce, not science: it focusses on the content of the labels, not the content of the pills. Although since 1994 the agency has sued more than a hundred diet-pill companies, in 2002 it found that at least half of all weight-loss ads contained false or misleading statements. Despite its vigilance, the agency has an impossible job; for each success, ten new companies seem to appear.

When people get sick, Dr. Kessler pointed out, the refrain is always "'Where the hell is the F.D.A. to protect me'? The supplement industry doesn't have to report adverse events, so the F.D.A. doesn't have the data it needs to protect people. You cannot prove something is unsafe if you don't have the data. It's the ultimate Catch-22. It is also a colossal failure to protect the public health of this country."

I hope that these excerpts have whet your appetite to read the best single overview of the dietary and supplement industry that I have yet read. DSHEA respresents the worst of our political process. The government has put the citizenry at both health and financial disadvantage. I hope that common sense and good science can prevail. Unfortunately, I am skeptical.

I often rant about the dilemma of pain control. We (physicians) often receive criticism for inadequate pain control. We clearly have risk for overprescribing narcotics. This article discusses hospitalized patients and pain control - Pain Common and Often Undertreated in Hospitalized Patients

Altogether, 18% of patients with pain reported inadequate pain control while in the hospital, even though the hospital's pain management program met JCAHO criteria for accreditation, Dr. Whelan said. "All patients need to be thought of as high risk for pain," because caregivers may be more likely to miss pain "when they're not suspecting it as much."

"Pretty consistently, age, race gender seem to play role in how perceive and report pain," he added. "Patient characteristics that seem to be consistently associated with differential reports of pain probably are important to think about as we go forward in treating and researching pain."

I find this difficult research to interpret. As an inpatient attending, I often ask patients about pain on rounds. The problem that we have is interpreting their answers and deciding how to treat. Treating pain requires some art. One never really knows how much pain a patient is suffering.

This survey methodology obtains subjective data. Patient's recall of their hospital stay gives us some clues, however, we really need prospective data.

Nonetheless, the message the we who care for hospitalized patients should attend to pain issues is an important one. Even more difficult is deciding on discharge pain meds.

Our favorite surgeon - Bard Parker (A chance to cut is a chance to cure) - blogs on this subject (unfortunately his links do not take you right to the story - therefore, scroll down to Thursday, Jan 29 and read - Those that can, do). Here is the question - Do academicians get paid for sitting around and contemplating their navels? Ok, that was sarcastic, let's quote Bard Parker's original post from January 24 (actually talking about Dr. Dean and his wife)

... The difference between Dr. Steinburg and the academic is that the academic's salary is paid by the university. If he chooses to practice part time, he doesn't have to worry about covering the cost of over-head, the university will. A doctor in private practice has to keep earning the money to pay for her rent, malpractice, staff, utilities, etc. The profit margin in medicine is very small. Cutting down by one or two days a week can erase a doctor's income. It also means two days when you're not available to your patients. And that means that a certain percentage of patients will leave and go to someone who is more accessible.

Sorry Bard you obviously do not understand how academic medical centers work. As a division chief, I am responsible for the budget for approximately 20 physicians. One can imagine the division as a medium sized business. Like any business, the moneys in must equal the moneys out.

We have multiple sources of income, only one of which is "the university". According to a formula developed in our department, we receive a sum of money calculated from our teaching activities (fortunately we are paid for teaching - not true at all medical schools). We get moneys for clinical activites (after paying an exorbitant overhead). We pay our own malpractice (just like all physicians) and get no allowance for practicing less than full time. We get moneys from research grants - some of which pay faculty salaries. Some of faculty have paid administrative positions; some work part-time at the VA (which lowers their university and practice plan salaries).

When you add up all of our sources of income they must equal or exceed the expenses. We pay the secretaries salaries. All the supplies, copy machines and computers come from our budget.

Academic salaries are competitive only if the moneys are earned (and our faculty certainly earn their salaries).

I find it interesting that you would publish some surgeon's salaries. Faculty salaries are (unfortunately) public record - regardless of how the money is earned. I have never seen private physician's salaries published.

The university does not pay the salaries. The salaries are earned. Often academic physicians (especially surgeons) can operate more for two reasons - specialty referrals and housestaff who help care for the increased patient load.

So I find the common perception of academic salaries from many practicing physicians inaccurate. We are paid just like all others. We earn money, pay overhead, and then distribute the "profits" as salary. We are not very different from private practice, except we have more diverse income sources. We still must meet a bottom line.

Long time readers know that I favor legalizing drugs, especially marijuana. As penalties for marijuana decrease in GB, they are having a heated debate about the wisdom of that policy. Is cannabis a risk to health?

Professor John Henry, a toxicologist at St Mary's Hospital in Paddington, grabbed headlines last year when he warned about the risks of smoking cannabis.

Addressing a conference in London, he said he was convinced the drug can cause mental illness.

"Regular cannabis smokers develop mental illness. There's a four-fold increase in schizophrenia and a four-fold increase in major depression," he said.

However, others have yet to be convinced. Frank Warburton, acting chief executive of DrugScope, supports the decision to downgrade cannabis.

"Cannabis is not as harmful as other Class B drugs," he says.

"While we agree that there may be link between cannabis and mental illness, we would argue against the simple assumption that cannabis causes mental illness.

"If someone had a pre-existing condition, then cannabis may exacerbate it. That is not the same as saying cannabis causes mental illness."

Mark, who first used cannabis when he was 12, said he backed the decision to downgrade cannabis.

"Cannabis is nothing. It doesn't cause any problems. It doesn't cause any violence.

Cannabis is not benign. Nor is alcohol, nor are cigarettes.

We must change the tenor of this debate. The question which I believe should drive our decision making is: Do our current laws benefit society and individuals?

I believe that they do not. They criminalize a drug which many enjoy. By making marijuana illegal with (at times) several penalties, we might well cause a disrepect for the law. Many students develop a cognitive dissonance between what the see and what the law says.

It would be difficult to make the argument that alcohol is less dangerous than marijuana - in fact I could easily make the counter argument.

By having marijuana illegal, we make its use part of a "drug culture" that may well lead many to try other drugs.

I feel strongly that we must rethink our approach. We must understand the risks and benefits of making marijuana illegal. Primum non nocere.

About 15 years ago, I first heard that we would focus CHF treatment on the neurohormonal response. The first time I heard this concept, I had a paradigm shift which has continued to this day. We improve quantity and quality of life now that we understand how decreased ejection fractions lead to progressive heart failure (it is not simply hemodynamics).

A similar paradigm shift is occurring in coronary artery disease. Multiple studies point to the inflammatory response as a major risk factor in which patients with strutural disease have the dynamic problem of intimal rupture, release of platelet activation, and clots leading to myocardial infarctions.

While we have focused primarily on C reactive protein, several studies have pointed to other inflammatory proteins as potential markers. Today's JAMA has an important study concerning another such protein. Here are two links about that article - Study Links Heart Attacks, Protein and Placental Growth Factor Helps Determine Prognosis in Acute Coronary Syndromes. This article adds to a growing literature which focuses on both predicting the risk of MI and on understanding the pathophysiology involved.

How do we put this article into perspective?

The study ``is an important step forward'' but also raises questions, including whether the protein would be useful in assessing risk in the general population, said Dr. Robert Bonow, a Northwestern University cardiologist and former president of the American Heart Association.

The German research will probably help lead to a whole new minimally invasive way of testing patients with chest pain, said Dr. Eric Topol, the Cleveland Clinic's cardiology chief.

``No one would ever have thought that through a few proteins you could know what's going on in the artery walls,'' Topol said.

He predicted that in the next few years chest-pain patients will routinely be given blood tests for an array of inflammatory proteins.

``This is where we're headed,'' Topol said.

The article's authors speculate further:

"Measuring PlGF levels may extend the predictive and prognostic information gained from traditional inflammatory markers in patients with ACS," the authors write. "Since the proinflammatory effects of PlGF can be specifically inhibited by blocking its receptor,... these findings may also provide a rationale for a novel anti-inflammatory therapeutic target in patients with coronary artery disease."

This study adds to a growing body of knowledge. While these studies do not yet effect therapy (and some of our current therapies probably work to decrease the inflammatory triggers), I suspect that we will have new exciting treatment avenues over the next 5-10 years. We should watch this story unfold.

True panic attacks are hard for us to understand. I found this description on a web site:

A panic attack is a sudden surge of overwhelming fear that that comes without warning and without any obvious reason. It is far more intense than the feeling of being 'stressed out' that most people experience. One out of every 75 people will experience a panic attack at one time in their lives.

Having made this diagnosis several times - with excellent treatment success each time - I have taken an interest in learning more about the disorder. Today's NY Times has an interesting article about panic attacks - Panic Spells Are Traced to Chemical in the Brain

People with panic disorder, according to scientists at the National Institutes of Health, have drastic reductions of a type of serotonin receptor, called 5-HT1A, in three areas of the brain. The findings, reported last week in The Journal of Neuroscience, lend credence to the suspicion that serotonin dysfunction plays a role in the disorder.

"This provides evidence for what we've been telling patients all along," said Dr. Dennis S. Charney, chief of the mood and anxiety disorders research program at the institutes and an author of the paper. "Panic disorder is due to a specific abnormality in the brain, not a weakness in character."

About 2.4 million Americans have the disease, which can leave its victims living in constant fear of attacks that might plunge them into outbursts of worry and thoughts of impending death. Experts have compared it to being stalked by a lion. The episodes, often resembling a heart attack and known to strike at any time, can be so terrifying that some associate them with the place that they occurred — the subway or the grocery store, for example — and will refuse to go there again.

Rangel wrote about panic attacks recently, with reference to another blogger who criticized Dean for having a history of panic attacks. Read Rangel's assessment - Howard Dean has suffered from anxiety attacks and remember that we are considering a disease not a human frailty.

I preach this, but until this review I did not have a great reference. Now I do - The Differences Between ACE Inhibitor-Treated and Calcium Channel Blocker-Treated Hypertensive Patients

Abstract

Large-scale outcome trials have demonstrated that blood pressure reduction with angiotensin-converting enzyme (ACE) inhibitors or calcium channel blockers (CCBs) is associated with reduced cardiovascular complications in hypertension. Comparative trials against conventional drugs and between ACE inhibitors and CCBs have failed to reveal conclusive differences in cause-specific outcomes. Studies in high-risk patients suggest that ACE inhibitors are superior to CCBs and other drugs in protection against cardiovascular events and renal disease. Very long-term prospectively collected observational data from the Glasgow Blood Pressure Clinic and the UK General Practice Research Database strongly support an advantage of ACE inhibitors over CCBs for cardiovascular morbidity and mortality. Considering all the available information, it can be concluded that the use of CCBs in the routine therapy of hypertension cannot be recommended while wider use of ACE inhibitors, along with low-dose diuretics and ß blockers, appears justified.

Tennessee doctors to get paid for "doing the right thing"

Health care quality improvement advocates believe that following evidenced-based guidelines, spending more time with patients and making better use of electronic medical databases will lead to better patient outcomes and lower costs.

A new study led by Vanderbilt University in Nashville, Tenn., and BlueCross BlueShield of Tennessee will put this theory to the test.

According to Tennessee Blues' Chief Medical Officer Steve Coulter, MD, doctors will be paid "for doing the right thing" and researchers will measure whether this improves outcomes without significantly adding to costs.

Physicians will be measured and compensated based on how well they adhere to evidence-based guidelines for treating congestive heart failure, diabetes and hypertension and for follow-up calls and e-mails to patients.

"The current system contains some perverse incentives: It rewards volume and procedural complexity; it doesn't reward low-intensity activities like phone calls and e-mails and following evidence-based guidelines," Dr. Coulter said.

What a great project! I certainly hope that they can do the study properly, and that the results fit our preconceived notions of what we should do. Hopefully more groups will take this challenge. Positive results could fundamentally change how we practice. And that would help everyone.

Generation gripe: Young doctors less dedicated, hardworking?

In a survey of physicians ages 50 to 65, 64% said doctors trained today are "less dedicated and hardworking" than physicians who entered medicine 20 to 30 years ago.

But younger doctors say that's not true. They say lifestyle considerations are shaping how they approach their practices and creating a healthier profession that strives to balance professional and personal lives.

One thing is sure: Older norms of practicing medicine are giving way to newer approaches, but not without some friction.

"There's kind of a loss of what it means to be part of the profession. Being a family physician has responsibility that sometimes extends beyond 9-to-5 and we have to be accountable to patients at other times," said San Antonio family physician James Martin, MD, board chair of the American Academy of Family Physicians.

Can we have our cake and eat it too? Can we function as excellent physicians and yet still have time for a full and rich personal life?

The younger generation has, in my opinion, a more complete perspective. Too many physicians have worked so hard, that their personal life and personal growth have suffered. Medicine is a great profession, but it need not devour ones entire life.

Being a physician did and does require great dedication. However, if one functions in that role 24/7 then he/she will likely burn out at some point. The burn out is evident in broken marriages, drug addiction and depression. Most physicians my age have doubts about their career choice.

The survey of physicians ages 50 to 65 also asked:

If you were starting out today,
would you choose medicine
as your career?
No 52%
Yes 48%

Would you encourage your children
or other young people to choose
medicine as a career today?
No 64%
Yes 36%

These answers tell me that the old ways no longer make sense. We can take great care of our patients and balance that with a full and rich personal life. Our patient care will benefit. Our families will benefit. And we will benefit.

My frequent commentor, Fakeo Nameo, writes:

Seems like HSAs are trying to get around the inflation caused by third party payers,
which is a good thing. But who actually comparison shops for medical care? "Hey Doc, how much for a liver transplant at your hospital? Do I get a discount if I talk my brother-in-law into getting one too?" Ok, some folks might shop around for checkups, and routine care but if the condition is serious they usually buy whatever the clinician recommends. The agency problem, of clinicians benefiting from advising more expensive care also drives up cost, and HSAs won't really help that.

Fakeo develops a strawman which stands tangential to the main issue. HSAs would encourage you to consider Prilosec OTC rather than insist on Nexium. They would encourage you to ask your physician to develop a lower cost regimen for your antihypertensives. They may even discourage your insistence on having a CT scan when none is indicated. They will not effect big ticket expenses - nor should they.

Rangel has continued his discussion - A small example of how HSAs might work with a nice relevant discussion.

Robert Goldberg in the Washington Times pens this heartfelt opinion - When family matters most

It is painfully apparent to me as well that the more we move toward greater government involvement in health care financing and cost containment, the more intense is the desire to both control and ultimately attack the very source of hope and better health that is at the heart of modern medicine. The insurance companies and government programs with their formularies, technology review committees and prior authorizations would have summarily delayed and denied my daughter access to the medicines that are making her well. They are drugs being used in a novel fashion, they are new and they are expensive. They are, therefore, hated and hunted by the bureaucrats, the politicians and the candidates. And they and their proposals for universal care that would control costs by limiting access or imposing price controls have nothing but dire news for Sara and others in the Princeton eating disorders program.

But President Bush has a better and more compassionate way. If his bill passes, low-income people will have the opportunity and choice to buy insurance, save for health care and deduct the full cost of insurance premiums. I will be able to invest directly in keeping my daughter alive, and millions of other families will be able to accumulate billions that will ultimately force insurers to deal directly with our doctors and us in providing more compassionate and cost-effective care for people with eating disorders.

HSAs will increase patient autonomy and make the costs involved in quality health care more explicit. I do not understand how that can be anything but a major improvement.

Bush's Health Proposals

The chief new proposal in the president's speech was a tax benefit to encourage people to set up health savings accounts, as authorized in the recent Medicare legislation. Under that measure, individuals who take out a high-deductible insurance policy to cover very large medical bills can invest money in a tax-free savings account to pay for routine medical expenses. The accounts will get unusually generous tax treatment. Now Mr. Bush proposes to allow participants to deduct the full cost of the premiums for the high-deductible coverage as well. The accounts are intended to make people more cost-conscious in deciding what care is really necessary, a worthy goal, but they have the potential to interest mostly those who are healthy and relatively well off.

I believe that this benefit will help the middle class a great deal. Higher deductible insurance should save money. Putting money into a tax-free savings account makes sense to prudent people of many economic strata. Their accusations sound like economic class warfare to me. This editorial takes a cheap shot at Bush. I would expect more from the Times. Time out. Maybe I should not expect more.

Study: Taxes Pay for Most Obesity Costs

Taxpayers foot the doctor's bill for more than half of obesity-related medical costs, which reached a total of $75 billion in 2003, according to a new study.

The public pays about $39 billion a year - or about $175 per person - for obesity through Medicare and Medicaid programs, which cover sicknesses caused by obesity including type 2 diabetes, cardiovascular disease, several types of cancer and gallbladder disease.

The study, to be published Friday in the journal Obesity Research, evaluates state-by-state expenditures related to weight problems. The research was done by the nonprofit group RTI International and the Centers for Disease Control and Prevention.

"Obesity has become a crucial health problem for our nation, and these findings show that the medical costs alone reflect the significance of the challenge," said Tommy Thompson, secretary for the Department of Health and Human Services. "Of course, the ultimate cost to Americans is measured in chronic disease and early death."

States spend about one-twentieth of their medical costs on obesity - from a low of 4 percent in Arizona to a high of 6.7 percent in Alaska.

Obesity is everyones problem. Obese patients cause health care costs to increase (in a disproportionate fashion). Therefore the increasing obesity burden raises my insurance costs. And the obese raise our Medicare expenditures.

That we must as a society address obesity is not a new thought. Placing this battle into an economic perspective makes sense. I still believe that the obese should have to pay higher insurance premiums. You should be rewarded for a healthy lifestyle. A move to HSAs would place the burden of obesity on the obese. Maybe that would change behaviors.

Medpundit has a different take on this issue - Wages of Sin:

As usual, Rangel is all over this issue with a long, well considered post - Democratic candidate John Edwards and how he got rich

Rangel is doing a great job! He started discussing HSAs recently and continues with this outstanding piece - Health Savings Accounts (HSAs); The most important legislation of 2003!

Please read his entire rant, but if you would rather just read my excerpts, here goes:

Having such high cost insurance for healthy individuals or families in order to cover every possible medical expense does not make a lot of sense from an insurance standpoint. People get insurance to protect themselves, their assets, and their property from sudden loss, accidental damage, or unexpected massive expenses. We do not purchase auto insurance so that it will pay most of the costs of gas, cleaning, and routine maintenance from normal use. We don't get home owners insurance so that most of the relatively low expenses for routine cleaning, maintenance, and repairs will be covered! If we did, then home and auto insurance rates would be massive . . just like health insurance. Yet we expect most expensive health insurance to pay for everything from routine office visits and low cost tests to prescription medications.

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The reason why health insurance costs are so high is because health care itself is so expensive. And the reason why health care is so expensive is that most consumers of health care treat it as an entitlement rather then as a consumer product or service like any other product or service in a free market system. I have commented on this before.

When you have a situation where health care consumers blindly purchase health care products and use health care services without any idea of the actual costs involved then there are no incentives to control spending or usage or to treat the health care system in any way like the free market system that it is. When we spend perverse amounts of money on health care we can only expect ever increasing costs. This is basic economics. The more money you put into a system the higher the costs are going to be.

The economic underpinnings of HSAs makes so much sense that I cannot understand why the Democrats oppose them so much. I have had an old fashioned Medical Savings Account for several years. The tax savings has made this worthwhile. I no longer buy dental insurance, because I figured out that I saved money using MSA moneys for all my dental care.

Rangel has nailed the insurance industry. We should always understand our expected gain (or loss) prior to choosing a plan. If you are healthy, the gamble (albeit a relatively small one) on high deductible health insurance is a smart one. But then you will not hear this in New Hampshire this week.

Read Rangel and his link to the NY Times article - More ideas on HSAs

His article and the NY Times article lays out the debate over whether HSAs will decrease health care costs. This interesting perspective from the NEJM (subscription required) - "Me-Too" Products — Friend or Foe? - addresses this issue, albeit indirectly.

The reason that this strategy of maintaining high prices for first-in-class products works is that we have not actually had a true market in health care — at least so far. The physicians who write the prescriptions or choose the devices and the patients who receive them have not been saddled with much or any of the cost. As a result, some me-too products have made money for their manufacturers mostly because of clever marketing, without improving outcomes or lowering costs. The lesson: for market forces to really work, physicians have to choose products as if costs matter. As patients bear more of their health care costs, we can expect that they will pressure their physicians to do so.

While the article discusses much more, that one paragraph cogently summarizes one of the major financial problems of our health care system. HSAs could address this issue.

I have no comment as I have commented excessively on this issue. But read it anyway - The Widening of America, or How Size 4 Became a Size 0

I appreciate the many comments on my two previous posts. One struck me

The outward display of emotion is not a reliable guage of one's compassion. This is because doctors must compartmentalize intellect and emotion in order to be competent. Some physycians, stone cold on the surface, are the ones who go the extra mile for the patient. I've seen others, outwardly compassionate and "touchy feely" who never seem to be around when needed. Some doctors put on a better show than others, but such appearances can be deceiving.

This is a very interesting and cogent point, however, this is tangential to the point of the rant.

My concern is in how we as physicians talk to each other. If my words are accurate then as a teaching attending I convey important meanings to my trainees. We strive to teach professionalism in training (it is actually explicit in Internal Medicine training these days). One method for teaching professionalism is role modeling professionalism. To me that was the point of the resident's post which started the entire discussion. When we forget to respect patients such as the one which started this discussion, then we have lost part of our professionalism (in my opinion). How we act at the bedside is an entirely different discussion which we may have another time.

Well that post got some attention. I wrote the post from the perspective of a teaching attending. Words are important. I pride myself in semantics. We should say exactly what we mean. Our words in medicine should convey our meaning explicitly.

As a teaching attending, I have a responsibility to be a role model (Unlike Charles Barkley). My words must convey meanings and feelings.

Thus I disagree with a couple of commenters. I should remind the students and houseofficers that we are taking care of people, not diseases. Each time I uttered the words sad case, I reemphasize that point. Each time we use the term great case in a matter other than I proposed, we are forgetting the patients.

We need some emotional detachment - just not too much. We need to learn to compartmentalize our feelings and not take our work home too often. Nonetheless, if we lose our empathy than we start to lose our humanity.

Medicine is based on science, but it requires art. When we focus excessively on the science, our patients eventually suffer. And, I believe, we do also.

So I will stick with my strict definition of great case. Students, interns and residents have complemented me when I make that explicit distinction on rounds. And I feel better about myself.

Rangel has blogged eloquently about this subject - The humanistic paradox of the study of medicine. In this rant he cites A Great Case.

I will not repeat these excellent posts, but will offer my personal definition of how I encourage the use of these phrases.

• Great case - an interesting diagnosis (either an unusual disease or an unusual presentation of a common disease) and making the diagnosis leads to a cure. For example, we had a patient several years ago who had cryptococcus growing from his blood and bone marrow. This infection was secondary to hairy cell leukemia. We successfully treated his fungal infection and then hematology/oncology cured his leukemia. That is a great case .
• Interesting case - the diagnosis makes one think. The presentation is dramatic. An interesting case can become a great case, if the patient is cured.
• A sad case occurs when a patient has major morbidity or mortality and he/she has done nothing wrong. I rarely classify alcoholic cirrhosis as a sad case. The case that Dr. Van Hee cites is both an interesting case and a sad case.

I submit that all medical educators, housestaff and students should adopt this classification system. The meanings are clear and convey the right messages.

As physicians we can find a patient's illness intellectually stimulating and yet unfortunate. That circumstand is not a contradiction. However, we should reserve great case for those patients who stimulate our intellectual needs and that we help dramatically. I (and all physicians) long for the truly great cases!

One of the problems that I have with our current malpractice system is the artificiality of the process. Malpractice lawyers use a bag of tricks to make a complex decision seem like a straightforward one. One cannot easily convey the context of the decision either on paper or in testimony.

This essay from the LA Times does convey many features of the complexity and number of decisions that one physician is making with just one patient. A doctor's daily round of judgment calls

All of medicine is probability. If 80% of people with ordinary pneumonia get better on erythromycin and Mr. Miah turns out not to be one of them, does it mean that my decision was wrong? If I call Mr. Miah and he feels fine, would my decision, then, have been the right thing?

I wonder, though, if the outcome is truly relevant. Obviously in cases of utter negligence or gross error it is important, but what about in the gray areas of everyday medicine? Could a decision about whether I made good or bad judgments in this case be rendered in the absence of knowing the outcome? Can a judgment call stand on its own legs, irrespective of the consequences?

I recommend the entire article. It reminds us the medicine is practiced much more easily through the retrospectoscope than in real time.

We all second guess our decisions at times. All bad outcomes lead to introspection. What could we have done differently? What clue did we miss? Should I have gotten a different consultant?

Medicine is a challenging and wonderful profession. I love the intellectual stimulation. I thrive on the complexity.

If my patient has a bad outcome, when is it inevitable, and when is it my fault? And who should judge?

Vaccine Is Said to Fail to Protect Against Flu Strain

Medpundit addressed this issue yesterday - Defending Dean. Today Maureen Dowd attacks Dean's wife because she continues to practice rather than campaign with her husband. The Doctor Is Out

The NY Times (who ran an article yesterday and the op-ed today) and their ilk apparently do not understand. Medicine is an important profession. Many who choose medicine feel that what we do transends politics. Dean's wife - Dr. Judith Steinberg Dean - practices medicine. She is apparently dedicated to her chosen profession.

Why would anyone expect her to sublimate her career for her husband's? Working with many medical couples in training, I see separate physicians, each working on their chosen avocation.

Why should his aspirations impact her career? What do I not understand?

Bravo to Dr. Judith Steinberg Dean! She likes seeing patients - so that is what she will continue to do. The heck with this political stuff.

BTW, this does not change my opinion of Dean. Nor should it.

I try to write clear paragraphs. Please read this one carefully.

So I was conflicted prior to adoption, and I remain conflicted. On the whole we have a better training program. I am greatly in favor of the 4 days off each month (and sometimes have been able to give housestaff an extra day during the month). The 80 hour rule is important. The 24 + 6 rule still gives my angst.

Note that I have not attacked the 80 hour rule. In fact, we try to get our residents at 70 hours or less. My only angst is the 24 + 6 rule.

Let me reiterate the problem. An intern comes to work at 7 a.m. to preround. She admits all day (maximum of 5 patients). She likely gets a few hours sleep. This next morning we make rounds from 7-10 a.m. Under the rules she has 3 hours left to get all her work done.

Several patients have diagnostic studies done. She would like to see the imaging studies and discuss them with the radiologist. She would like to go to noon conference (it is on a topic that she is very interested in).

But the ACGME insists that she leaves by 1 p.m. She hardly has time to check out her patients. Perhaps she has the next day off. By the time she returns in 2 days, her chance to review the imaging studies loses its urgency. She looks at the films, but the educational impact is decreased.

I am not saying that she should . Rather I am saying that she should have the option of staying.

I ranted on this subject in November 2002 - Screening for h.pylori. A recent study adds more support to empirically treating patients who are h pylori positive - Antibiotics May Help Stop Stomach Cancer

This study is not definitive. Given the lower rate of h pylori positivity in the US, we will not yet advocate general screening. However, the data and concept should continue to receive attention.

Our favorite surgeon - Bard Parker - first alerted me to this story. His post - More 80 hour work week stuff - does a nice job of outlining the problem.

Rangel has a relevant post also - Apparently some residency programs are still overworking their residents.

Long time readers will remember that I have ranted often about this issue (just use the handy dandy search function to find my previous rantings). I will start with my conclusion, then share my angst. Generally the new rules are working. They have improved the quality of life of many houseofficers. I still worry about patient care. I still worry about education.

Most programs have made significant modifications to meet the ACGME requirements. I have written in the past about our adjustments. These adjustments give us houseofficers who are better rested. When they are available they are easier to teach (because they are awake!).

You do have to work harder to insure continuity of care. Pass offs are difficult. In our system care becomes a team phenomenon - we (the attending, resident and both interns) must really know all the patients. Someone (other than the attending) is gone most days, thus we are consistently picking up "the slack".

My angst relates to the interns. Internship is an important stressful year. During that year you learn the fundamentals of patient care. Hopefully you learn the difference between sick and very sick. You hone your clinical instincts.

The great majority of interns with whom I work are very dedicated to their patients. They do not want to leave the hospital because it is time to punch their time card (we do not yet have a time card system - but I believe other programs do). Sometimes in medicine you should stay.

This is why the main objection that I have to the new regulations is the 24+6 rule. Interns have the most angst post call. They want to get everything done right. Sometimes that takes 8 hours rather than 6 hours.

Many residents have concerns about patient care related to the new system. Residency is a time to develop an ethic about patient care. Do these new rules send the right message?

So I was conflicted prior to adoption, and I remain conflicted. On the whole we have a better training program. I am greatly in favor of the 4 days off each month (and sometimes have been able to give housestaff an extra day during the month). The 80 hour rule is important. The 24 + 6 rule still gives my angst.

Rangel has a link to the book - House of God. Hopefully all medical students and residents do read this book. Then I hope that they put the book into perspective.

Students and houseofficers, unlike their age matched education match peers, deal daily with death, self-induced morbidity and the horrors of illness. We all need some humor to deal with these stresses. The House of God uses exaggeration to make those points. Unfortunately, I disagree with the protagonist's final decision. Many of us lived that book, and matured into caring dedicated physicians.

I wish the ACGME was less draconian in their regulations. Since I resent all bureaucracies, I find this particular one no better than others. We need some common sense in interpreting these rules. Else, our next generation of physicians just may not learn the "right stuff".

This story explains the problem of choosing the right strains of influenza to develop a vaccine against. For Health Officials, Flu Shot Is an Annual Gamble

A scary story - The Beast in the Bathhouse

For now, researchers say, crystal meth use in the city is largely confined to gay white men in Manhattan, although they fear its eventual spread to the wider gay population and beyond.

There are no numbers, however, to show what health care workers say is the growing role that crystal meth is playing in transmitting H.I.V. Although the evidence is anecdotal, health officials say that crystal, which erases inhibitions and spurs sex marathons with multiple partners, is helping to spread the virus.

According to the city's largest private clinic for lesbians and gay men, Callen-Lorde Community Health Center, two-thirds of those testing positive for H.I.V. since June acknowledged that crystal meth was a factor in their infection.

Dr. Howard Grossman, one of the city's best-known AIDS specialists, said more than half the men who test positive in his private practice blamed methamphetamine. "This drug is destroying our community," he said. "It just seems to be getting worse and worse, and no one is doing anything about it."

This really has nothing to do with medicine, but I found it drop dead funny. But then, I guess I am a geek. When the universe is expanding it can make you late for work - By Woody Allen And it is great to see that Woody Allen still is capable of creating funny pieces.

Patient-centered model offered as road to reform

From Seattle, the call went out for proposals: Come up with an idea to fix the U.S. health care system and win $10,000. Contest judges cast their votes, selecting Vaughan Glover, DDS, a dentist in Arnprior, Ontario, as the winner.

Judges didn't think it strange that they picked a Canadian's idea to cure what's plaguing America's health system. They liked his patient-centered model, believing it uses the best of the American and Canadian systems.

So what did the winner propose:

Across the border came Dr. Glover's idea, which he has been working on for years and is the focus of a book he wants to publish. His patient-centered model promotes giving the patient information to foster good health over a lifetime.

The patient would have a primary coach, such as a doctor or nurse, to help guide care. Personal savings accounts for health would provide a financial support system.

Hmm, we would pay for a primary care physician (I have reinterpreted coach to physician). We would have a personal savings account (sounds a lot like a health savings account).

I wish the article had more details on the winning plan. I am glad to see it was not universal health!

If you do not read Rangel regularly then you should start. He absolutely nails this topic - Health care costs continue to increase (and I think I know why)

But the real reasons for such continuing increases in health care costs are simple enough. Americans have become very used to such expensive health care. The problem with these expensive expectations is that most Americans do not pay out of pocket for their care hence they are not aware of the actual costs of their care. This is unlike almost any other economic system where prices are controlled by supply and demand but this is not to say that the same economic forces are not at work here. What we are seeing with health care costs is what happens to any economic free market system when you add huge amounts of money combined with an ever increasing demand that is not responsive to the actual costs of the product or service.

Rangel bolded that last sentence. He is correct.

medmusings gets most of this right - The Online Doctor Visit Will Become Common When Patients Insist on it

I would only suggest that some reasonable modification of retainer medicine will speed up acceptance of online medicine. Our billing systems, i.e., having to bill for each separate portion of care, really make no sense. We could either bill for time spent (but this would be a record keeping nightmare) or go to a flat monthly (yearly) fee. This would cover telephone access, internet access, filling out forms, office visits and hospital visits. The idea is really not that outrageous once you consider it carefully. Afterall, surgeons get paid for the operation and not the visits before and after - they get one all inclusive fee.

You could make this more complex by charging different fees for different diseases (or more for several diseases).

My main point - our reimbursement system is the biggest problem we have in providing the proper care for our patients. The incentives are malaligned for the physician to provide the most reasonable and complete care for patients. Patients should complain about our insurance system. It is the reason they have a difficult time finding a good doctor - one who will spend adequate time with them; one who will answer their telephone calls; and one who will gladly communicate with them by email. And patients would benefit!!!

I rant incessantly on this topic - on December 31st I ranked time as the number 1 story of 2003 (for this blog). I said:

1. The time pressures on outpatient generalist practice - this is my number one story because I consider myself an advocate for generalist physicians. We ask our generalists to do more each year, and then structure a reimbursement system that pays them a fixed amount for a visit - regardless of the time necessary. It takes time to follow guidelines for prevention. It takes time to explain disease and management to patients. We must fix this problem to provide better quality care.

Many non-physicians think we can fix this with midlevel providers. To that I say "balderdash"! As we learn better how to care for patients the complexities of patient care increase exponentially. It does take a physician to do it right - and a physician with enough time. Not solving this problem will continue to have a major impact on overall patient care. This is our true health care crisis.

Family Medicine Notes says it better - Rectal Exams

My nurse complained to my wife yesterday that I take too much time with my patients. She's right that I do. But shouldn't I explain things? She asks "what in the world are you doing in there for so long?"

I'm mostly listening - but sometimes I'm explaining.

And patients appreciate it. And patients expect it. Yet no one really pays for it.

This trend started when I was in medical school. It has increased as the percentage of female medical students has increased. Young Doctors and Wish Lists: No Weekend Calls, No Beepers

For me the shame here is that the best and brightest no longer clamor for internal medicine slots. This rant comes from my heart as an academic internist. I apologize if I insult anyone.

Internal medicine is the cornerstone of adult medicine. We encompass a wide variety of complaints, and excel as diagnosticians. More recently, we have acquired the expertise to juggle the many medications that our sickest patients take.

Internal medicine is the common ground for all patients. We care for the complex with the aid of other specialists.

In medical schools, internal medicine generally represents the key rotation of the 3rd year. We win the teaching awards. We use physiology, pharmacology, biochemistry and anatomy daily.

In the old days, the best and brightest aspired to become internists. We all wanted to be Sir William Osler. But times have changed.

This notion of a "brain drain" to subspecialties from the bread and butter fields of medicine is not new. But in recent years it has come to be associated with a flight to more lucrative fields. What is new, say medical educators, is an emphasis on way of life. In some cases, it even means doctors are willing to take lower-paying jobs — say, in emergency room medicine — or work part time. In other fields, like dermatology and radiology, doctors can enjoy both more control over their time and a relatively hefty paycheck.

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What young doctors say they want is that "when they finish their shift, they don't carry a beeper; they're done," said Dr. Gregory W. Rutecki, chairman of medical education at Evanston Northwestern Healthcare, a community hospital affiliated with the Feinberg School of Medicine at Northwestern University.

Lifestyle considerations accounted for 55 percent of a doctor's choice of specialty in 2002, according to a paper in the Journal of the American Medical Association in September by Dr. Rutecki and two co-authors. That factor far outweighs income, which accounted for only 9 percent of the weight prospective residents gave in selecting a specialty.

For me internal medicine represents the pinnacle of science and human interactions. I see too many students who like internal medicine but elect other specialties for "lifestyle" reasons.

I guess we need to fix the internal medicine lifestyle. But then I rant about that incessantly. Our payment system influences lifestyle.

As usual follow the money if you want to know the real issues. Lifestyle is chic to blame. But it requires excellent reimbursement to adequately control lifestyle.

Prescribing Patterns Respond to "Bad News" Findings of Clinical Trials

Physicians alter their prescribing patterns when clinical trial results suggest detrimental effects of the drug in question, two new reports in the Journal of the American Medical Association for January 7 suggest.

The intensity of media coverage appears to be a key feature in influencing physician and lay responses.

Now we just need to control the media!!!!! We can get our message out to all physicians if we just controlled the media. What a thought!

The above paragraph is meant to be sarcastic. I hope readers understand this meager attempt at humor.

While cardiac prevention gets most of the publicity, increasingly we should become aware of preventing heart disease in chronic kidney disease patients. Nontraditional Cardiac Risk Factors Prevalent in Kidney Disease Patients

Print out this article as a handout for patients who have questions about CRP. Hunt for Heart Disease Tracks a New Suspect

Among patients known to have atherosclerotic heart disease, those with the highest levels of CRP were about four times more likely to experience symptoms of impaired blood flow to the heart during a treadmill test, indicating a direct relationship between inflammation and a heart attack, researchers at the University of California at San Francisco reported in Circulation last January.

"Our study supports the idea that heart disease is more of a systemic disease rather than just a plumbing problem," said Dr. Mary S. Beattie, the study's lead author. Based on such findings, some experts believe that levels of C-reactive protein are better than cholesterol levels at predicting future cardiac events. Patients can lower their CRP levels if they lose weight, quit smoking, change their diets and exercise more. Many drugs may also help, especially the cholesterol-lowering statins and the antidiabetic thiazolidinediones.

Should CRP Be Measured?

C-reactive protein can be measured by a simple, inexpensive blood test. The best results are obtained through two tests that are done at least two weeks apart with their results averaged.

In March 2002, experts from the Centers for Disease Control and Prevention and the American Heart Association concluded that patients deemed to be at "intermediate risk" of a heart attack, stroke or other cardiovascular event should be tested for C-reactive protein.

Intermediate risk is defined as those with a 10 percent to 20 percent chance of developing coronary heart disease within 10 years, based on age, total cholesterol level, smoking status, systolic blood pressure (the upper number) and blood level of protective H.D.L. cholesterol.

The experts recommended that those with C-reactive protein levels of 1 milligram per liter or more take aggressive action to reduce the level.

Certainly food for thought!

Rangel weighs in - What's Dean’s problem? . . He's a doctor!

Let me respond a bit to Rangel. I dislike Dean as a presidential candidate. He changes positions too often, and has too many misstatements for my comfort. I disagree with him strongly on foreign policy.

However, none of those criticisms has (or should have) anything to do with his medical training. My objections to his candidacy are based on his platform and his campaigning. But medicine has nothing to do with it.

I suspect that if Medpundit reconsiders her original post on this topic, she will withdraw some of the hyperbole she employed.

Medicare reform helps doctors and patients

Physicians will have a much happier new year thanks to the Medicare reform legislation signed into law last month. Instead of a 4.5% Medicare payment cut, doctors will get at least a 1.5% increase this year and next.

Not only that, but many physicians in rural and underserved areas will be eligible for 5% Medicare bonus payments. Lawmakers also took a step toward making payments in rural areas more equitable by eliminating for three years cuts that result from geographic adjustments to a portion of the payment formula.

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The physician payment formula responsible for the now-averted cuts is still largely intact. The law makes some changes to the system in an attempt to prevent the seesaw increases and decreases that marked physician payment updates during the past several years. But those changes don't go far enough.

If Congress doesn't repair the flawed formula in the next two years, physicians will face steep payment reductions in 2006.

The root of the problem is the sustainable growth rate. The rate is actually a spending target, computed using a complex formula. If overall physician spending misses the target in any given year, payment is adjusted upward or downward in following years to compensate. The formula's goal is for physician payment updates to reflect the change in the gross domestic product.

Not surprisingly, the estimates on which the rate depends are often wrong, leaving physicians vulnerable to sharp payment hits. In addition, the formula doesn't account for factors that increase physician spending but are beyond their control, such as technological innovation and government coverage decisions that increase demand for services.

Punishing physicians for changes that benefit patients is unfair. And tying physician payment to the gross domestic product also makes no sense. As AMA President Donald J. Palmisano, MD, said recently, "The medical needs of our Medicare patients do not wane when the economy slows."

So the short run news is good. Could Congress possibly have the common sense to treat the disease rather than the symptoms? Even this Pollyanna remains a skeptic.

I must differ with Sydney Smith on this one - The Doctor Factor

Someone once described medical education as being akin to living the life of an abused child. And that's not too far from the truth. When we're medical students and residents, we get lambasted and yelled at for the simplest of mistakes or errors or lack of knowledge. We're ridiculed in front of our peers and our superiors at morning presentations, after sleepless nights spent doing work no one else wanted to do. Sometimes we're ridiculed in front of patients during morning rounds. At least, that's the way it was twenty years ago, and it's a good bet that's the way it was thirty years ago when Dr. Dean went through his training.

I either grew up in a time warp or my medical school and residency were just much more humane. I have no recollection of such treatment.

As a teaching attending I hope (and believe) that I have never treated students or residents like that.

Now I must admit that some doctors fit the description.

The man is a doctor. This is the least-examined chapter of his career. But suddenly it all makes sense: Where else but in medicine do you find men and women who never admit a mistake? Who talk more than they listen, and feel entitled to withhold crucial information? Whose lack of tact in matters of life and death might disqualify them for any other field?

I see less of this all the time. Such personality flaws are certainly not limited to medicine. Many lawyers fit this profile. Many businessmen (and businesswomen) fit this profile. Famous sports figures fit this profile.

While the original author backtracks a bit and admits using sarcasm, still I find the writing of this opinion piece, even if meant to be humor, as a personal insult. We should not attribute characteristics of a group to an individual, whether race, gender, location (Southerners), vocation or avocation.

I write in defense of physicians, who happen to span the breadth of human frailities and goodness. I see no truth in the essay, and cannot do anything but condemn such writing.

db steps gingerly off of his soapbox, somewhat angry but feeling better after venting!

My frequent commenter - Bernie - believes so strongly in "natural" remedies that he ignores the data. He uses a variety of strategies to make his points. A recent comment:

Why is it so unreasonable to place the burden of proof on the FDA? Historically the courts have been very deferential to the FDA when it has filed suit.

Today's exercise for the reader. Go to the corner drug store and head for the cold and allergy relief section. Read the list of ingredients and see how many products include ephedrine or pseudephedrine. Then write a letter to the editor of your local paper thanking the FDA for removing that "dangerous" ephedra from the market.

Another commenter responds accurately:

Bernie: The dangers of ephedra are that (1) the marketing material and packaging do not disclose the risks, and (2) many (most?) of the formulations are uncalibrated. Would you take ground foxglove leaves to "Improve cardiac output!"?

One of my greatest objections to the dietary and supplement law is the lack of information on what you are ingesting. These products do not have dosage standards. Ephedrine and pseudoephedrine (two of the active ingredients in ephedra) come in known precise dosing. We have carefully designed studies to define safe dosing.

We (the concerned medical community) are asking for the same standards on the dietary and supplement market. Patients (and their physicians) should know what they are taking. Supplements should pass safety standards (at least). We need precise information on risks.

And who can really argue that those desires are unreasonable?

A Doctor's Toxic Shock

After taking bupropion, I describe potential side effects to my patients in much greater detail. Even though I continue to prescribe it, I'm hypervigilant about any signs of distress. If a patient complains of symptoms similar to mine, I switch meds immediately. In the past, I would have encouraged the patient to stick it out, anticipating that most side effects would eventually pass. I wonder where I'd be now if I had followed my own advice.

This article tells an important story. As physicians we must understand side effects, explain them to patients, elicit them from patients, and document our discussions.

Hospitals sue over nurse law

California's hospitals sued Tuesday to challenge the state's strict interpretation of a first-in-the-nation law to establish nurse staffing levels, arguing that it will burden hospitals and threaten health care.

The California Healthcare Association, which filed the lawsuit in Sacramento County Superior Court, does not challenge the new law's overall rules, but said rules for covering nurses on breaks would be virtually impossible to satisfy and could backfire.

The law, which takes effect Thursday, requires one nurse for every six patients in general wards, and a 1-to-5 ratio a year later.

The rules require a hospital to provide a nurse to fill in whenever another nurse takes a break from patient care, so that the nurse-to-patient ratio is maintained at all times.

This is a good law and a good interpretation. As often seems to happen, the hospitals worry more about the cost than the outcome. Nursing staff ratios are important for patient care.

Researcher Links Obesity, Food Portions

The University of Illinois researcher has set up several food experiments that show the more people are given, the more they will eat -- regardless of whether they are full or think the food tastes good.

Hmm. I have ranted about this concept in the past. How many of you complain about small portion sizes at restaurants? How many of you choose a restaurant because they have "generous" portions?

I blogged on this story a few days ago. Our favorite blogging surgeon provides a more complete rant today - Practice Makes Perfect III

New Renin Inhibitor Curbs Essential Hypertension

A very interesting development that we need to follow.

Aliskiren, a new nonpeptide orally active renin inhibitor, appears safe and effective in treating essential hypertension, European researchers report. However, they also note that it remains to be seen whether this approach yields "protection against heart attack, stroke and nephropathy" comparable to "angiotensin-converting enzyme inhibition and angiotensin receptor blockade."

What Took So Long?

The answer to both those questions involves a truly terrible federal law, the 1994 Dietary Supplement Health and Education Act (DSHEA). The administration can be legitimately criticized for the unduly long time it took to get to yesterday's announcement, given the FDA's years-long effort to restrict ephedra. Even now, it will be months before the FDA's action takes effect. Mr. Thompson said he wanted to get the word out before dieters turned to ephedra to help fulfill their New Year's resolutions, but the new regulation won't be published for some weeks, and after that won't take effect for another 60 days -- and that's before the expected lawsuits from ephedra manufacturers.

But the fundamental fault lies with DSHEA. The law simultaneously makes it too easy to get dietary supplements on the market, and too hard to get them off. While manufacturers must show that ordinary drugs are safe and effective before they are allowed to sell them, dietary supplement makers face no such requirement before peddling their goods. If manufacturers develop information that calls into question their product's safety, they don't have to tell the FDA. And when there is an indication, as in the case of ephedra, that the product is dangerous, the law imposes a steep hurdle before the government can intervene: authorities must prove that the product presents a significant or unreasonable risk of injury.

I rant about this issue incessantly. I will continue to rant about this law. This is a huge public health issue.

Friends often ask me about the risk of mercury from eating certain fish. This commentary gives one answer - Fishy warning about mercury

My family will love this article, as these are foods we all love. And they seem healthy! Simple choices can boost nutrition in 2004

Less than 10% of the students in my entering class were women (1971). Even that was considered a major step forward. The profession is changing. For first time, more women apply to med school

Kirsten Mewaldt's sense of idealism prodded her to apply to medical school. She sees practicing medicine as a way to serve humanity.

But Mewaldt, like many other women, also sees a big practical benefit to becoming a physician: With the changes in the profession in recent years, it has increasingly become an attractive career for someone who wants to balance work with raising children.

"One of the things that's great about medicine is the flexibility," said Mewaldt, a second-year medical student at the University of Southern California, offering an opinion that defies the traditional reputation of a profession with little time for family life.

"I'm considering going into emergency medicine, and that has a wonderful lifestyle if you're considering having a family," she said. "You can do three 12-hour shifts a week, and then you're not on call. You're done. You can be home with your kids, pick them up from school, and actually be around."

This is great, but ...

We must reconsider all our projections on numbers of physicians needed in this country. Women (in general) have a better sense of balance and just will not work the ridiculous hours that many men worked in the past. This means that we will need more physicians for the same number of patients.

This list represents my arbitrary ranking of the top ten stories covered which I covered this year. Factors which I used to develop the ranking concern the health of patients and the medical community. Limiting and ranking the list proved much more difficult than I first thought. Readers will disagree with my list, and I invite you to submit your own. I ranked stories higher that I thought had "legs", i.e., we would continue to rant about this story in 2004.

Honorable mention

Increasing HIV in young gay males in the US - this story should scare all

The pharmaceutical industry - it was very difficult to leave this issue of the list, however, many stories on the list relate to the pharmaceutical industry

The COMET trial - very important, but also fairly specialized information

Quality assessment - I had some interesting rants on this issue and it may emerge as even more important over the next few years

Alternate payment structures for outpatient practice - these include a return to fee for service with no insurance billings and retainer medicine

And now for my list:

10. The influenza epidemic - this story shows the challenge of prevention. The CDC had to guess on the strains to include in the influenza vaccine. They guessed wrong, but seemingly made the best guess possible given the data they had.

9. SARS - this story reminds us once again how vulnerable we are to infectious diseases. We are unlikely to consistently defeat infections. The potential infecting agents are too numerous, and therefore we become susceptible to mutations that naturally occur - some of which are deadly.

8. ALLHAT - I ranted extensively on this subject. This study asked a the wrong question. The principle investigators overhyped the results. The study certainly reminds us to include a diuretic as the first or second line drug. It also reminds us that the most important variable is hypertensive control. Finally, it demonstrates that we should not take results at face value.

7. Preventing type II diabetes mellitus - this should rapidly become a major focus for preventive health. We have three major avenues - weight loss, exercise and medications. Future studies will help us learn how to approach "prediabetics" and how aggressively to screen for "prediabetes". This story gain improtance due to the epidemic numbers of affected patients.

6. Obesity - this is a curse of Western civilization. We must develop positive programs to decrease obesity. Obesity puts patients at great risk for many problems, including type II diabetes mellitus. This story will not shrink anytime soon.

5. Medical marijuana - one could argue that I ranked this story too high. However, I believe that the intrusion of government into palliation represents a serious dilemma. The story about pain control that I ranted about yesterday represents the corollary issue. We must be able to better study and understand the benefits of marijuana in patients. Many citizens agree, and have voted in favor of these laws.

4. Dietary supplements - we have an illogical law pertaining to supplements. The ephedra fiasco represents the tip of the iceberg. Too many patients take too many supplements without any understanding of how they may effect their bodies, interact with pharmaceuticals, and even interact with each other.

3. The Medicare Bill - we are just starting to understand this bill, its strengths and weaknesses. Regardless of ones opinion, we all recognize this bill as a sea change. Future Congresses will likely modify features of the bill. I expect to rant often in 2004 on the bill's effects

2. Medical Malpractice - we need true tort reform. We need a totally different system for insuring high quality care. We need a system which does not resemble a lottery. We need a system that protects patients and physicians alike. Our current system is broke - therefore we must fix it.

1. The time pressures on outpatient generalist practice - this is my number one story because I consider myself an advocate for generalist physicians. We ask our generalists to do more each year, and then structure a reimbursement system that pays them a fixed amount for a visit - regardless of the time necessary. It takes time to follow guidelines for prevention. It takes time to explain disease and management to patients. We must fix this problem to provide better quality care.

Many non-physicians think we can fix this with midlevel providers. To that I say "balderdash"! As we learn better how to care for patients the complexities of patient care increase exponentially. It does take a physician to do it right - and a physician with enough time. Not solving this problem will continue to have a major impact on overall patient care. This is our true health care crisis.

================================

Thank you for reading my blog. The readers continually stimulate me. I hope that I give you food for thought. I hope that medical blogging will eventually provide the grassroots for improving the medical care system. But then I am eternally optimistic.

Happy New Year's to all. May the coming year bring you health and happiness.

The surgery your doctor shouldn't perform

A growing body of medical literature suggests that only highly trained vascular surgeons should, in the majority of cases, be allowed to perform the surgery. Because it requires the surgeon to close down a section of the aorta -- akin to replacing a fuel hose in a plane at 30,000 feet -- it has a relatively high mortality rate.

But despite a growing cry by vascular specialists to limit general surgeons' ability to perform the abdominal aortic aneurysm surgeries, no such potentially life-saving restrictions are planned in the short-term.

...

The overall mortality rate from abdominal aortic aneurysm surgeries averages about 5 percent. But when general surgeons perform the surgery, the mortality rate is 76 percent higher than when vascular surgeons do it, according to a recent University of Michigan/Johns Hopkins study of 3,912 cases. Other studies have reached similar findings.

This article makes some very important points. As a generalist, I know that one of my obligations to patients is to understand the limits of my expertise. If I rarely take care of a problem, then I need a consultant (SLE, interstitial lung disease, inflammatory bowel disease are but a few examples). General surgeons should understand their limitations. As I read the article, apparently many surgeons do not understand.

Caveat emptor!!

Worried Pain Doctors Decry Prosecutions

In recent years, similar charges of illegally prescribing prescription narcotics, criminal conspiracy, racketeering and even murder have been brought in dozens of states against scores of doctors who treat chronic pain with prescription narcotics. At least two have been imprisoned, one committed suicide, several are awaiting sentencing, many are preparing for trial, and more have lost their licenses to practice medicine and accumulated huge legal bills.

Top DEA officials say only a relative handful of doctors have gotten into trouble with the law and that all were prescribing drugs outside medical norms in a manner that amounted to trafficking. The prosecutions, they say, have had a positive effect.

"There have been a number of very high-profile cases, and they have been a learning lesson to other physicians," said Elizabeth Willis, chief of drug operations for the DEA Office of Diversion Control. "We think doctors are much more aware of appropriate guidelines for prescribing OxyContin now."

But increasingly worried pain specialists say that although some doctors may be running narcotic "pill mills" and even selling prescriptions for narcotics, many others who have been arrested appear to be responsible physicians.

Their crime, it seems, is that they were supplying their chronic pain patients with sometimes large numbers of prescriptions for controlled but legal medications to treat their pain. The result, the doctors say, is that the established medical use of opium-based drugs for pain is becoming criminalized by aggressive drug agents and zealous prosecutors.

On the one hand we (physicians) are urged to attend to pain. To not address a patient's pain issue leaves us open to intense criticism. This guideline addresses the issue - MODEL GUIDELINES FOR THE USE OF CONTROLLED SUBSTANCES FOR THE TREATMENT OF PAIN

Inadequate pain control may result from physicians' lack of knowledge about pain management or an inadequate understanding of addiction. Fears of investigation or sanction by federal, state, and local regulatory agencies may also result in inappropriate or inadequate treatment of chronic pain patients. Accordingly, these guidelines have been developed to clarify the Board's position on pain control, specifically as related to the use of controlled substances, to alleviate physician uncertainty and to encourage better pain management.

The Board recognizes that controlled substances, including opioid analgesics, may be essential in the treatment of acute pain due to trauma or surgery and chronic pain, whether due to cancer or non-cancer origins. Physicians are referred to the U.S. Agency for Health Care and Research Clinical Practice Guidelines for a sound approach to the management of acute1 and cancer-related pain.

The medical management of pain should be based upon current knowledge and research and includes the use of both pharmacologic and non-pharmacologic modalities. Pain should be assessed and treated promptly and the quantity and frequency of doses should be adjusted according to the intensity and duration of the pain. Physicians should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not synonymous with addiction.

We have adopted pain as the 5th vital sign. This VA document discusses the importance of attending to pain - Pain as the 5th Vital Sign: Take 5.

Pain control challenges us daily. We have no great objective quantification of pain. Patients can fool us. Thus we are damned if we ignore and damned if we treat too aggressively.

This story is scary. We need a better method for controlling physicians who overprescribe pain medications. DEA arrests are not the answer. Back to our article -

"Fifteen years of progress in treating patients in chronic pain could really be wiped away if these prosecutions continue," said Russell K. Portenoy, a pain specialist at Beth Israel Medical Center in New York who is considered one of the fathers of modern pain management. Since the mid-1980s, Portenoy has been advocating the use of morphine-based drugs to address what he considers to be the widespread, unnecessary and even cruel undertreatment of chronic pain.

"Treating people in pain isn't easy, and there aren't black-and-white answers," he said, agreeing that some doctors have not been sufficiently careful about potential problems with addiction and diversion of drugs. "But what's happening now is that the medical ambiguity is being turned into allegations of criminal behavior. We have to draw a line in the sand here, or else the treatment will be lost, and millions of patients will suffer."

Amen!

Bush Administration to Ban Ephedra I have ranted extensively about ephedra - just go and search for multiple rants (22).

Ephedra, also known as Ma huang, Chinese Ephedra and epitonin, poses health hazards ranging from high blood pressure, irregular heartbeat, nerve damage, injury, insomnia, tremors and headaches to seizures, heart attack, stroke and death, the FDA says.

Ephedra has been linked to as many as 100 deaths, officials have said.

The ban is likely to be met with litigation from manufacturers who dispute the agency's assertion that ephedra is a health risk.

Ephedra, which has also been used by many athletes to enhance performance, is believed to have killed 23-year-old Baltimore Orioles pitcher Steve Bechler (search) last February.

Bechler died during spring training while trying to lose weight. Toxicology tests showed ephedra was in his system.

The government ban, one of the first involving a dietary supplement, comes after Thompson urged Congress this summer to require manufacturers to acknowledge potential side effects and to rewrite a law that rolled back dietary-supplement regulations.

And if ever a law needed rewriting - this law does!!!!!!

Just go read it. You will be amazed. Or you might not be. The Milky Way of Doing Business by Katie Allison Granju

Sometimes I feel like a broken record. I rant about the working conditions for physicians. I rail about the bureaucracy which now increasingly surrounds medicine. Mostly I complain about a reimbursement system which makes no sense.

The outcome of this and other problems is a growing physician shortage. Physician shortage predicted to spread

The AMA is the latest organization to shift official policy from recognizing a surplus of physicians to realizing that numerous factors may be contributing to an imminent physician shortfall.

Several specialty societies are considering the issue, and the government-appointed Council on Graduate Medical Education reversed its position in November 2003 and called for an expansion of medical school spaces and residency slots. U.S. medical schools have been churning out 15,000 to 16,000 doctors a year since 1980, according to the Dept. of Health and Human Services, but census data show the population has increased 24%, from more than 226 million to more than 281 million people.

Experts say a growing population that is older and needs more medical care is one of many factors converging to create a potential crisis. Also, a greater desire to balance work and family life means that many doctors are opting to work part-time or on a temporary basis.

"It's not limited to our physicians who are female," said Gibbe Parsons, MD, an American Thoracic Society delegate. "We're seeing a real shift toward physicians wanting to work very controlled hours."

...

The liability crisis that many states are experiencing may also be influencing where some doctors choose to set up shop, creating shortages in some areas.

In addition, there are suggestions that staggering medical student debt may influence which specialties students are choosing to enter. The AMA intends to look for ways to alleviate this burden.

"As student debt continues to climb, students are driven from the lower-paying specialties and practice situations, endangering access to care for minorities, indigent and the underserved," said Adam Levine, a medical student and California delegate.

If we had a reimbursement system that reflected supply and demand, then we would have less problems. When bureaucratic decisions determine fees, then we have the consequence of winners and losers - independent of needs. When malpractice awards run amuck in some states, then those states will have some physicians leave and less enter. It only makes economic sense.

So as I rant repeatedly, we have a growing health care crisis, only it is not the one that the politicians yet understand. But if we do not correct current trends it will worsen. And as usual the patients will suffer with less adequate care.

Does bureaucracy drive you crazy? Most physicians rail against bureaucracy. I found this page with great quotes about bureaucracy. First a couple of gems:

Bureaucracy is the art of making the possible impossible. He who has trusted where he ought not will surely mistrust where he ought not.
--Marie von Ebner-Eschenbach

The only thing that saves us from bureaucracy is inefficiency An efficient bureaucracy is the greatest threat to liberty.
--Eugene McCarthy

Government employees (Bureaucrats) like to solve problems. If there are no problems handily available, they will create their own problems.
--George Van Valkenburg

Man creates problems. Government and bureaucrats magnify them 100 times.
--George Van Valkenburg

Now the link - Bureaucracy Quotes

I also found this great page - Quotations on Bureaucracy and Public Administration A few more gems:

"We may not imagine how our lives could be more frustrating and complex -- but Congress can." Cullen Hightower

"How come there's only one Monopolies Commission?" Nigel Rees

"The only thing which saves us from the bureaucracy is its inefficiency." Eugene McCarthy

"What I have noticed about bureaucratic programs is that for all their rules and red tape, they keep very little track of what actually happens to the people they are serving." Tom Fulton

Both pages have many more chuckles (albeit bittersweet chuckles).

The Science of Naming Drugs (Sorry, 'Z' Is Already Taken)

It has often been noted that drug makers have favorite letters, and that they run the gamut from X to Z. Think Nexium, Clarinex, Celebrex, Xanax, Zyban and Zithromax. But why are these letters so popular?

"Some letters look better in print, make sounds people like saying and are associated with innovation," said Steve Manning, the managing director of Igor, a San Francisco branding company. "X is associated with science fiction, high tech, computers, automobiles and drugs." As in "The X Files" and "The Matrix," Xerox, the Lexus and the Microsoft X-box.

James L. Dettore, president of the Brand Institute, a branding company based in Miami that has tested 8,400 drug names in the last seven years (its successes include Lipitor, Clarinex, Sarafem and Allegra), said the letters X, Z, C and D, according to what he called "phonologics," subliminally indicate that a drug is powerful. "The harder the tonality of the name, the more efficacious the product in the mind of the physician and the end user," he said.

And I just hate that he is correct. But he is correct. And that says something about marketing to physicians and patients. And it just should not matter. But it does.

I started thinking recently about the major impact medical stories of 2003. This is a work in progress, and I need your help. This rant will just list (in no particular order) stories which captivated me and the commenters this year. I plan to consider them all week, and elicit your opinions. On New Year's I will put them in order with some comments.

The Malpractice Crisis
The Medicare Bill
The safety and efficacy of dietary supplements
The pharmaceutical industry in general
Importing drugs from Canada
Medical marijuana
The time pressures on generalist practice
Providing and measuring quality of care
Alternate payment structures - retainer medicine, cash only practices
SARS
The influenza epidemic
The increase in new HIV cases in the US
Obesity
Preventing type II diabetes mellitus
The COMET study (carvedilol vs. metoprolol for CHF)

Which stories do you find most interesting and important? Thanks in advance for your opinions!

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As we start to digest the monstrous Medicare bill, we find the good, bad and the ugly. HSAa are in the good category. Robert Prather has championed this idea on his excellent blog for the past year at least. He addresses the issue once again with reference to the bill - Maybe I (Mis)Underestimated The Reforms In The Medicare Bill

I have nothing substantial to add. He has nailed it.

A surgeon on lap versus open appendectomy

They work better than traditional appendectomy. Less invasive appendix surgery means faster recovery

Stampede of Diabetes as U.S. Races to Obesity

Many people seem to think they don't have to worry about a preventable disease that does not, at the outset at least, have serious consequences and that can be treated.

One such disease was long called adult-onset diabetes. There are two things wrong here: first, this disease does indeed have very serious consequences despite the availability of numerous drug therapies, and second, it is no longer an ailment that occurs almost exclusively in adults.

And so the name has been changed to Type 2 diabetes to distinguish it from the far less common kind of diabetes (Type 1) that nearly always starts in childhood or adolescence and has a different origin. Because so many Americans eat too much and move too little, the nation is now in the throes of an epidemic of Type 2 diabetes that has spilled over into the childhood years.

Diabetes is a disorder of blood sugar regulation. In both types glucose builds up in the blood to damaging levels and spills into the urine. You may hear people with diabetes say they "have sugar" or "sugar disease." Specialized cells in the pancreas produce the hormone insulin that has the job of moving the blood glucose into cells where it can be used for energy or stored to meet future energy needs.

In Type 1 diabetes, a form of autoimmune disease, these cells fail to produce adequate amounts of insulin. But in Type 2 diabetes, although the body typically produces enough insulin at first, body cells are resistant to its action. As blood glucose levels rise, the pancreas is forced to work overtime to produce even more insulin. Eventually the pancreatic cells may wear out, causing an insufficiency of insulin that resembles Type 1 diabetes.

We as a society need to aggressively address this epidemic. We need to make exercise easy, safe and inexpensive. We need to all learn how to eat less and better. We must make personal committments to care for our bodies. And it will not be easy!

I posted 3 rants on Neurontin in May and July - The whistle blower and Warner-Lambert, The Neurontin story, and More on Neurontin. These rants received many comments from angry users (who blame many side effects on these drugs.

One of my guiding principles is to carefully look at the data rather than anecdotes. Thus, this article caught my eye - Gabapentin Safe, Effective for Chronic Daily Headache. CDH patients challenge the best physicians. You know something is wrong, but you do not know what, nor how to help. You would like to avoid chronic narcotics, but does anything else help?

The primary efficacy measure, percentage of headache-free days per treatment period, was 9.1% less with gabapentin treatment than with placebo (P = .0005). Gabapentin was also superior to placebo in headache-free days per month (P = .0005), severity (P = .05), Visual Analogue Scale score (P = .0006), nausea (P = .03), photophobia/sonophobia (P = .04), disability affecting normal activities (P = .02), attacks requiring bed rest (P = .001); and quality of life related to bodily function (P = .01), health/vitality (P = .0001), social function (P = .006), and health transition (P = .0002).

"Consequent to these benefits there was a reduction in analgesic usage," the authors write. "Whereas gabapentin appeared to have a greater efficacy in those with lower prerandomization headache frequency, the benefit was seen across the frequency spectrum including those with headaches occurring every day."

Parke Davis supported this study.

In an accompanying commentary, Stephen D. Silberstein, MD, FACP, notes that patients with CDH are difficult to treat. He identifies study limitations including lack of defined criteria for CDH subtypes and failure to account for analgesic use. "Although their results were significant, they were modest and may not be clinically important," he writes. "Future CDH studies require subset analysis and control for acute medication overuse."

So do these results make trying this high dose of gabapentin worthwhile? I guess I will consider offering the option (with a full disclosure of known side effects) and let the patient decide. These results do not appear outstanding and as the editorialist points out, they are modest. But sometimes modest is all we can hope for.

There's a Blurry Line Between Rx and O.T.C.

The decision to sell a drug by prescription, experts say, may involve factors that have nothing to do with science or patient safety. Marketing and financial considerations, politics, doctors' concerns and consumer psychology all may play a role.

"Unequivocally, there is no bright line," said Peter Barton Hutt, a former chief counsel at the F.D.A. who now teaches at Harvard and represents drug companies. "It's a judgment issue."

This article focuses on the "morning after" pill, but we could write similar pieces on Prilosec or Claritin.

Each of these decisions brings mixed feelings. On the one hand, many drugs are safe enough and beneficial enough that patients should not need my permission to take them. However, self medication does carry dangers. Patients do not always understand warning signs. We see patients who self medicate for longer than is prudent.

I suspect we will continue to have angst over each of these decisions.

Just to complicate matters, patient insurance muddies the waters. Many patients only have prescription drugs covered. Thus, rather than take Prilosec OTC (for 70 cents a day) they want the little purple abomination (at over $4 a day). But then they do not pay.

In other cases, straightforward commercial considerations can determine how a company wants a drug classified. For example, drug manufacturers know that patients with drug coverage often prefer prescriptions to paying the full cost of over-the-counter drugs.

Doctors say they see this insurance effect all the time. Dr. James Osborne, an internist in Greensboro, N.C., says when patients with occasional heartburn ask for a prescription for Nexium, he often suggests they buy Pepsid, which costs 24 cents a day for the four pills needed to equal prescription strength, or about 17 times less than Nexium. "They say, 'It doesn't matter, doc. I have a drug card,' " Dr. Osborne said.

Maybe we need to restructure how we think about OTC and prescription drugs. Maybe we need less dichotomy here. But I cannot figure out how to modify the current structure.

Most influenza does not need a physician visit. This article makes clear the signs that should lead to physician care. U.S. Offers Advice on When to Seek Flu Care

But for some, influenza can be life-threatening. Among warning signs that should bring immediate notification to a doctor are rapid or difficult breathing and a fever that remains high for more than four days; prolonged fever can signal a serious complication like bacterial pneumonia.

Other symptoms suggesting a need for urgency are a blue tinge in the color of the skin, an inability to drink enough fluids, lethargy or irritableness, altered mental status and seizure. Flu symptoms that disappear and then return in more severe form could be a clue to a complicating bacterial infection or other problem, and should lead to a call to the doctor.

Further, people with an underlying medical problem that grows worse with the flu should also seek care. Any kind of pain or other discomfort in the chest, or a feeling of faintness, requires immediate attention.

Dr. Gerberding said people at special risk of flu complications should seek care early. These, she said, include pregnant women and people who are over 65 or have an underlying medical problem.

Often I have seen David Sackett introduce himself at medical meetings. He generally uses the pseudonym - Kilgore Trout. Of all my heroes (and yes he is clearly one of my heroes) he has the best sense of humor. This piece from the BMJ uses humor in hopes of making us think about the insidious relationship of academic researchers and the pharmaceutical industry. HARLOT plc: an amalgamation of the world's two oldest professions

Hopefully a couple of excerpts will whet your appetite to read the entire piece.

It has finally dawned on us that being good and being poor are causally related: being good doesn't pay. Accordingly, we have decided that it's time for us to find out whether being bad pays better. We're combining the world's oldest and second oldest professions, cashing in on our reputations, and distributing this confidential prospectus for our new company, HARLOT plc.

HARLOT services

HARLOT plc will provide a comprehensive package of services to discriminating trial sponsors who don't want to risk the acceptance and application of their products and policies amid the uncertainties of dispassionate science. Through a series of blind, wholly owned subsidiaries, we can guarantee positive results for the manufacturers of dodgy drugs and devices who are seeking to increase their market shares, for health professional guilds who want to increase the demand for their unnecessary diagnostic and therapeutic services, and for local and national health departments who are seeking to implement irrational and self serving health policies. The tables summarise our services: table 1 shows the ways we can cook the data in an individual randomised controlled trial; table 2 displays an array of aftercare services for keeping the truth from interfering with sales and implementation; and table 3 lists the services that we offer to our non-elite (that is, shallow pockets) customers. Limited space permits the individual description of only a few of our services. References for all of them can be obtained by subpoena from our legal department.

And

Our FPSU (Find the Pony Statistical Unit) services include back-stepwise sample size calculation software (just tell us how many patients you can get, and we'll instantly tell you the relative risk reduction claims you'll need to fabricate to justify your trial). We can provide unblinded analyses after every event, so that you will learn of impressive but irrelevant trends in the data long before your Data Safety and Monitoring Board does.

Our speciality is data dependent subgroup analysis through the use of the "Munchausen statistical grid." This strategy exploits the happy fact that the number of potential ponies in a muck of trial data is 2n where n = the number of dichotomised subgroups. Even if your intervention is totally worthless, we'll keep doubling the number of subgroups until we can emerge from the muck with at least one pony subgroup in which it seems to work. What is more, we'll then turn that phoney result over to our BS (Biology and Sociology) brain trust, which will supply a minimum of three highly plausible theories to support our otherwise patently unbelievable subgroup result. We reconcile statistical significance in the face of multiple analyses by simply ignoring this meddlesome issue.

The entire piece represents much too much effort for these intellects. However, I suspect that this farce is and was a labor of love. So enough of my ranting, read the article and enjoy a good laugh. Then remember the serious issues that stimulated this piece. Then laugh again.

Richard Smith, editor at the BMJ, recently spoke to a group of new medical students. He asked many physicians for advice. His remarks appear in today's BMJ - Thoughts for new medical students at a new medical school

While these thoughts are originally meant for new medical students, I would argue that all physicians should read this article regularly. The article contains much wisdom.

Many non-physicians will want to read this article, and I hope they will comment here. The author does a nice job of capturing the tensions of being a physician. Enough of my ranting - go clickity click and read and consider.

I ranted earlier this week on the new atrial fibrillation guidelines. Medscape does an excellent job of developing selected articles for in depth coverage. Here is the link for those who want to learn more about this issue - ACP/AAFP Issues Guidelines for Management of Atrial Fibrillation

Virtually all men eventually develop benign prostatic hypertrophy (BPH). Our goals of therapy are twofold, improve quality of life and prevent surgery. Today's NEJM has an important article - summarized in this story - Drug Combo Can Fight Enlarged Prostate

The two drugs in the study, doxazosin and finasteride, are now widely used, but not normally combined, to treat an enlarged prostate. The study was designed to decide if they can be teamed up for a stronger effect. Often, such a drug combination fails to greatly boost effectiveness.

This time, though, it succeeded. On its own, each drug reduced the risk of worsening symptoms by about a third. Together, they worked twice as well, cutting the risk by two-thirds.

Over five years, the condition worsened in about 10 percent of patients on only one drug, but in only 5 percent of those who took the combination. Without either drug, the condition deteriorated in 17 percent.

``Although we had predicted that combination therapy would be more effective than either drug alone, the magnitude of risk reduction was surprising,'' said chief researcher Dr. John McConnell, also at Southwestern Medical Center.

Doxazosin relaxes muscles that tend to choke off the flow of urine. It is usually the first drug given for an enlarged prostate. Finasteride, which also goes by the brand name Proscar, slowly shrinks the prostate gland itself. It is contained in smaller amounts in the baldness drug Propecia.

The two-drug combination can cost about $3 a day.

Half of men ages 51 to 60 and up to 90 percent of those over 80 have enlarged prostates, according to the American Urological Association.

For those who subscribe to NEJM - The Long-Term Effect of Doxazosin, Finasteride, and Combination Therapy on the Clinical Progression of Benign Prostatic Hyperplasia. The accompanying editorial puts the issue into proper perspective.

McConnell et al., concentrating on the risk of disease progression, confirmed that combination therapy was no better than monotherapy at one year. But whereas there was disease progression in the placebo group over a four-year period, combination therapy reduced the risk of symptom progression by 66 percent, the risk of acute urinary retention by 81 percent, and the need for invasive therapy by 67 percent. The authors concluded that combination therapy with an alpha-blocker and a 5-reductase inhibitor reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone. Thus, two drugs are better than one.

This study should change practice. If (or rather when) I develop symptomatic BPH I have a study to guide my treatment.

If any readers are wondering whether they have clinical significant BPH, the AUA symptom score can help. All patients in the study had a score of at least 8. CHECK YOUR AUA SYMPTOM SCORE

The American College of Physicians and the American Academy of Family Physicians have jointly released new guidelines for atrial fibrillation management. I am providing the link for those who have access to the Annals of Internal Medicine and for my own future use - Management of Newly Detected Atrial Fibrillation: A Clinical Practice Guideline from the American Academy of Family Physicians and the American College of Physicians

The guideline has 6 recommendations.

Recommendation 1: Rate control with chronic anticoagulation is the recommended strategy for the majority of patients with atrial fibrillation. Rhythm control has not been shown to be superior to rate control (with chronic anticoagulation) in reducing morbidity and mortality and may be inferior in some patient subgroups to rate control. Rhythm control is appropriate when based on other special considerations, such as patient symptoms, exercise tolerance, and patient preference. Grade: 2A

Recommendation 2: Patients with atrial fibrillation should receive chronic anticoagulation with adjusted-dose warfarin, unless they are at low risk of stroke or have a specific contraindication to the use of warfarin (thrombocytopenia, recent trauma or surgery, alcoholism). Grade: 1A

Recommendation 3: For patients with atrial fibrillation, the following drugs are recommended for their demonstrated efficacy in rate control during exercise and while at rest: atenolol, metoprolol, diltiazem, and verapamil (drugs listed alphabetically by class). Digoxin is only effective for rate control at rest and therefore should only be used as a second-line agent for rate control in atrial fibrillation. Grade: 1B

Recommendation 4: For those patients who elect to undergo acute cardioversion to achieve sinus rhythm in atrial fibrillation, both direct-current cardioversion (Grade: 1C+) and pharmacological conversion (Grade: 2A) are appropriate options.

Recommendation 5: Both transesophageal echocardiography with short-term prior anticoagulation followed by early acute cardioversion (in the absence of intracardiac thrombus) with postcardioversion anticoagulation versus delayed cardioversion with pre- and postanticoagulation are appropriate management strategies for those patients who elect to undergo cardioversion. Grade: 2A

Recommendation 6: Most patients converted to sinus rhythm from atrial fibrillation should not be placed on rhythm maintenance therapy since the risks outweigh the benefits. In a selected group of patients whose quality of life is compromised by atrial fibrillation, the recommended pharmacologic agents for rhythm maintenance are amiodarone, disopyramide, propafenone, and sotalol (drugs listed in alphabetical order). The choice of agent predominantly depends on specific risk of side effects based on patient characteristics. Grade: 2A

I agree wholeheartedly with these new guidelines. Interestingly, we just discussed this issue on rounds over the past 2 days. Time to make copies of this guideline for the students, interns and resident!

My previous rants on medical marijuana are just a search away. This particular story deserves wider coverage. Federal appeals court OKs medical marijuana in some cases

A federal appeals court ruled Tuesday that a congressional act outlawing marijuana may not apply to sick people with a doctor's recommendation in states that have approved medical marijuana laws.

The 9th U.S. Circuit Court of Appeals ruled 2-1 that prosecuting these medical marijuana users under a 1970 federal law is unconstitutional if the marijuana isn't sold, transported across state lines or used for non-medicinal purposes.

"The intrastate, noncommercial cultivation, possession and use of marijuana for personal medical purposes on the advice of a physician is, in fact, different in kind from drug trafficking," Judge Harry Pregerson wrote for the majority.

The court added that "this limited use is clearly distinct from the broader illicit drug market, as well as any broader commercial market for medical marijuana, insofar as the medical marijuana at issue in this case is not intended for, nor does it enter, the stream of commerce."

The decision was a blow to the Justice Department, which argued that medical marijuana laws in nine states were trumped by the Controlled Substances Act, which outlawed marijuana, heroin and a host of other drugs nationwide.

The Justice Department was not immediately available to comment on the ruling from a court some call the nation's most liberal appeals court.

An excellent, albeit too technical for me, blog summation from a Boston University professor is here - VICTORY IN 9th CIRCUIT MEDICAL CANNABIS CASE!

It will be interesting to see how this ruling is handled. I suspect that the Justice Department will appeal to the Supreme Court. Doesn't the Justice Department have much more important issues to worry about? Why do we spend so much money to prevent marijuana use in this country? (especially medical marijuana use)

Infectious disease experts worry about antibiotic resistance. Generally they err on the side of underusing antibiotics. The National Health Service in Great Britain now wonders whether this movement leads to difficulties. UK considers antibiotic policy

A big rise in pneumonia deaths may be linked to a clampdown on the use of antibiotics for coughs and sore throats, say researchers.

University of Aberdeen scientists found pneumonia deaths rose by 50% during a five-year period in the late 1990s.

Doctors were told in 1998 to curb antibiotic use amid concern about growing bacterial resistance.

An expert government advisory panel is now considering whether to revamp its guidance on the use of the drugs.

This study raises the interesting question of errors of comission versus errors of omission. Have we become so worried about antibiotic overuse that patient care is suffering? These findings are worrisome and deserve careful validation. We have been quick to criticize primary care physicians for dispensing antibiotics too quickly. Maybe they were smarter than we thought!!!

We were sitting in clinic yesterday afternoon with some residents. One had a documented exposure to influenza. He had taken the vaccine last month but was trying to decide whether or not to take Tamiflu as prophylaxis. Our opinion was that given the imperfect coverage of this vaccine this year, we would take 75 mg daily for 7 days. This article answers a number of questions about this flu epidemic. What to Do About The Flu?

Our colleague, Robert Prather at Insults Unpunished, has long championed health savings accounts. The new Medicare bill encourages them - Medicare reform opens up health savings accounts to all

Regardless of HSAs' ultimate popularity, the important thing is a new market option has been added, said Loussedes.

The American Medical Association shares that view. "Health savings accounts, which empower patients to have greater control over their health care decisions, will become a more attractive option for all Americans," said AMA President, Donald J. Palmisano, MD.

Republican lawmakers inserted the HSA language into the Medicare reform bill in the hopes that the accounts will help drastically reduce the future costs of the Medicare program, which will see an extra $400 billion in spending over the next 10 years because of the prescription drug benefit and other elements in the package.

By allowing people to sock away savings toward their future medical expenses, some of the burden may be taken off Medicare to cover high-cost items, such as prescription drugs and long-term care, they said.

But Democrats charged that the accounts are just another attempt to transfer Medicare responsibilities to the private marketplace. Democrats on the Senate Joint Economic Committee said the accounts would be of little use to low-income families.

"A married couple with two young children contributing to an HSA next year, for example, would not receive any tax benefit unless their income was at least $26,425," stated the committee Democrats' analysis. "Families with incomes moderately above that level would see minimal tax savings. Most of the tax benefits from HSAs go to higher-income families."

HSAs remove all the restrictions of medical savings accounts that were designed to keep usage down and limit the attraction of using the accounts as a tax shelter by high-income workers, officials from the independent Center on Budget and Policy Priorities said.

Clearly the Democrats abhor free market solutions to our health care crisis. I believe that free market solutions can work well. HSAs would encourage patients to participate in economic decision making. And as I and Robert Prather say repeatedly, the lack of participation may well be a driving force in overutilization of health care.

New Medicare Law Boosts to Chronic Care

The goal of this heightened monitoring is to prevent a medical crisis that could send the patient to the hospital. Such coordinated care for people with chronic illnesses such as diabetes, heart disease and high blood pressure is the focus of disease management programs, which got a big boost in the Medicare law signed by President Bush last week. It is these patients who consume most health care dollars.

The government hopes to enroll as many as 400,000 older people with chronic conditions in these programs. By involving the patient, physicians, pharmacists and other providers in commonsense steps to improve patient health, the government seeks to limit costly hospital stays.

``We want to prevent diabetics from becoming dialysis patients,'' said Rep. Nancy Johnson, R-Conn., a leading supporter of including disease management in Medicare.

The chronic care effort, plus a new Medicare physical and other preventive screenings, are a marked change in the 38-year-old government health care program for 40 million older and disabled Americans. Traditionally, Medicare has paid for treating illnesses, not preventing them.

But the number of Medicare beneficiaries with chronic conditions is large and growing, said Mark Miller, executive director of the federal Medicare Payment Advisory Commission.

Three-fourths of Medicare beneficiaries have at least one chronic condition, and close to one-third have four or more, Miller told a recent congressional forum. These people account for 80 percent of Medicare spending.

Such numbers make the benefit of early intervention indisputable, said Health and Human Services Secretary Tommy Thompson. ``It is better for us to start managing diabetes, hypertension, asthma and other conditions before they get exacerbated,'' Thompson said. ``It will save us money in the long run.''

While as always, the devil is in the details, this benefit seems quite promising. I have used disease management with CHF and believe that it provides an outstanding addition to care.

I love the intellectual interchange between blogs. Matthew Holt has stimulated my thinking, and hopefully I have reciprocated. As he has updated his entry (with reference to yesterday's rant), I will respond specifically to a couple of his points. His permalink is working now - QUALITY: Why doesn't evidence-based medicine happen in practice? Now with UPDATE

... The "data" we do not have and the data that I was (obtusely) referring to earlier in this post was the data directly gathered about how physicians actually practice from their records. It's the lack of accessible electronic records which stops us accurately understanding (and then managing) how practice works in real life/real time. Several medical directors of leading medical groups have been telling me for years that they don't have an accurate picture of what their MDs are doing because they can only get statistical glimpses of their practice patterns at the end of each month. ...

Oh but that we could fit medicine into databases with such immediate feedback. Unfortunately, we have two problems - cost and the extent of the task. The cost problem has two parts - the program and data entry. Having physicians enter data on their patients is not an intelligent use of their skills and time. In order to understand quality we would need such a large and broad database that data entry would take longer than patient encounters.

The extent of the task seems even more daunting. We can measure (and expect quality on multiple issues). Each quality measure has provisos which require additional information.

I understand the desire for real time feedback, but fear that the task remains beyond any reasonable solution.

... Part of the reason behind the UK's investment in electronic records is the desire to get at the information source that is the everyday recording of clinical activity. If it's achieved that huge data set will be used to both monitor medical care and assess what is the best evidence-based practice from huge data sets, rather than from chart abstracted studies done later. And eventually the one (practice) will be monitored against the other (evidence based guidelines)--something not all doctors will welcome.

Many physicians (and non-physicians) throw out the term evidence based guidelines as if one can develop a clear solution to medical issues. Oh but that it was that easy. Let me give an example that is close to my own interest - the management of adult sore throats.

Two organizations - the Infectious Disease Society of America and the American College of Physicians - have published "evidence based guidelines" on the diagnosis and management of adult sore throats over the past 3 years. These guidelines disagree in major ways. Unfortunately, many issues in medicine depend on one's perspective. In the sore throat example, the answer depends on how one values symptom resolution as opposed to minimizing overuse of antibiotics. These viewpoints and their resulting guidelines both have merit. But which would we choose for our computer program?

While it is easy to criticize anecdotal information and experience, many medical situations do require judgements for which the data are either unclear or absent. We (physicians) must have the experience and skills to make reasonable decisions with patients. This requires more than formulaic care.

Medicare and many managed care companies do have programs which are encouraging physicians to provide higher quality medical care. Our research group studies different techniques for influencing care.

Fixing a single deficiency will remain easier than remedying broad practice. We can (over time) teach physicians to prescribe beta blockers after all MIs (although we do not know how to insure that patients take their medications). But most patients are complex and many have multiple problems. How do we influence physicians to care for those complex patients and address all the indicated quality issues? And remember time is limited both in the US and in Great Britain. Maybe we could make generalist care financially stable, encouraging physicians to spend enough time with patients to address the broad scope of issues.

But then I digress and start dreaming. But a man can dream!

Many physicians still clamor for universal health care in the US. We must look at international models to better guess what such a system would do to our health care. Perhaps we would still have an active private medical care system. Great Britain does. Private health: bigger than NHS!

This week, BBC Radio 4 asked me to do an interview on the origins and growth of the non-state healthcare market. Boning up for it, I was reminded just how significant the independent sector is. It provides 85 percent of the UK's residential care beds, for example, and 20% of all acute elective surgery - that's the stuff like hip replacements that isn't exactly life-threatening, but which you want to get done fast anyway.

Indeed, the independent sector has more beds than the NHS and local-authority care homes put together!

It employs almost as many people - roughly 750,000 of them - and it accounts for a quarter of UK health and social care spending. In addition to the 15,000 nursing and residential care homes that the sector provides, private agencies care for more than 200,000 people in their own homes.

Another thing which people don't realize is the huge contribution of the private sector in mental health and dealing with drug abuse. Indeed, around half of Britain's medium-secure mental healthcare places are provided privately, in more than 200 private hospitals and units. The sector accounts for 80 percent of all rehabilitative brain-injury beds. Nearly all (96 percent) of NHS-funded in-patient child and adolescent mental health services are provided privately.

On the funding side, almost 7 million people have private medical insurance, while 6 million are members of health cash benefit plans - schemes which pay you cash when you are in hospital. Around 3.5 million trade union members (that's more than half the total membership) have some kind of private health cover.

Thanks to the blog author for the "heads up".

Matthew Holt of The Health Care Blog fame partially nails this issue - QUALITY: Why doesn't evidence-based medicine happen in practice? (permalinks do not work, so scroll to Thursday, Dec. 11).

My conclusion is that no evidence-based guideline will be perfectly applied. Some don't take into account the human situation of the patient. Meanwhile physicians will find it very hard to do something that their experience tells them is wrong--no matter what the data says.

But of course in the US this is more or less moot, as we don't have the data.

So he gets right the parts about the difficulty in applying evidence-based guidelines to individual patients. As we (and I am part of a research group that studies such issues) study these issues, one of our greatest challenges comes in defining "ideal" candidates for a drug. For example, we all know that ACE inhibitors decrease mortality in CHF caused by systolic dysfunction. However, ACE inhibitors do have side effects and contraindications to use. Our challenge (and the challenge of any report card study) is to accurately define the denominator which we use to calculate the percentage of patients who achieve the guideline.

Now Matthew is mistaken in thinking that we do not study this in the US. Medicare sponsors many such studies, giving feedback to physicians. We have learned several things about quality.

Quality (as measured by percent compliance with a guideline) varies across indicators. Quality changes across time. More post myocardial infarction patients take a beta blocker now than 5 years ago. Physicians do learn and do adopt changes in practice.

However, changing ones practice occurs for physicians at different speeds. As we get older, we become wary of the latest and greatest. We have seen too many new drugs have major side effects discovered within 2 years after release. We need excellent data to change from therapy that has worked.

I have written about this several times in the past - these two rants are a good start -
On knowledge translation in which I discuss the problem of translating knowledge into practice and Part 3 in which I answer a question about why physicians do not adopt change quickly. This link may help also - The Technology Adoption Life-cycle . Quoting from my Part 3 rant -

As one studies adoption of new practice, one finds an interesting curve of adoption.

At what point on this curve would you find someone guilty of malpractice. How do we decide when everyone should have adopted an innovation (and I would argue from my example that many still consider NAC an innovation in protecting against dye induced renal failure)?

We should look at the flip side of this curve. What if I am an early innovator of a drug which causes a serious side effect? Am I guilty of malpractice then? Where should I lie on the technology adoption curve?

My point remains that these issues are more complex than simple sound bites make them appear. We are striving to teach physicians to optimize their practice, however they know that optimal practice in 2003 may change in 2005 (e.g.,hormone replacement therapy for preventing coronary artery disease).

Health 'blogs' are multiplying - thanks to Matthew Holt at the Health Care Blog for the link. And yes I am included, along with one of my more erudite comparisons!

I received this question today:

I'm the Living with Diabetes blogger...

and something has come up on the insulin pumpers list, that needs to be commented on by a medical doctor, especially one like you who teaches other medical doctors.

Several people on the list are amazed, dumbfounded, etc. that both family care physicians and endo's tend to treat diabetes fairly cavalierly.

For example, many endos won't prescribe the pump, saying that shots are good enough. Of course the HMO's LOVE that attitude, I'm covered by one of those HMO's myself. However, those of us who have been on both shots and the pump can tell you that we feel better, have better control, and have better lives as a result.

We're also dumbfounded by the doctors who treat Type 2's by giving them pills, suggesting a life style change, and suggesting that they test once a day. In fact, I've had two sets of CDE's that thought testing twice a day was good enough. Lots of us know people who are treated that way and who are also suffering a great deal with diabetes complications, that could be avoided if they were treated right.

Why do doctor's have their attitudes? How can this be changed? It seems we're only covering the tip of the iceberg with the so-called diabetes epidemic.

Well I cannot speak for all physicians. Therefore my rant will only provide opinions and controversy. Nonetheless, that has never slowed me down in the past, so here goes!

Diabetes (especially type II) provides a special challenge for physicians. The disease is extremely common, yet very difficult to treat well. Excellent treatment requires a motivated patient and a motivated physician.

Many physicians find few motivated patients. We plead with patients to achieve excellent control. We would like them to test their sugar regularly.

As I have blogged previously, quality diabetes care requires that one touch all the FLECKS. (Feet, Lipids, Eyes, Control, Kidneys and Shots). Diabetic patients have many issues to address. Our reimbursement system penalizes us for spending adequate time with patients. Let me repeat that sentence (it is not a mistake). Our reimbursement system penalizes us for spending adequate time with patients. Doing the right thing takes time. And time is money.

Many physicians try hard. They encourage patients to develop tight control. Yet most patients show little interest.

One would hope that patients could find a physician who matches their desires. We must accept the blame, even when we can explain why. Providing quality care is difficult. Yet it should always be our goal.

I apologize for talking around the question. However, I do not think the question is directly answerable. Most physicians just have no pump experience, therefore, they use the tools with which they are experienced. But again that represents and insufficient excuse. We should refer motivated patients to the appropriate experts.

Studies confirm risks of 'economy class syndrome'

This report refers to 3 studies. Those studies show the following risk factors - longer than 6 hour flights, increased age, being overweight, birth control pills. The risk is very low, however, I would recommend (and when I fly I do this) getting out of your seat every couple of hours to walk and stretch.

While many conservatives have criticized the Medicare bill as being too costly, others have supported it. This columnist does a nice job of emphasizing his positive opinion. Making Medicare Reform Work

Conservatives like to point out that only a small percentage of seniors have a problem paying for prescription drugs. In fact, I was one of the first researchers to report that information. But let me also be the first to share some other relevant information: The percentage of seniors with extremely high drug costs is rising rapidly.

According to a study in the journal Health Affairs, the percentage of seniors with the highest share of drug costs increased nearly 600 percent from 1997 till 2000 — and their percentage of the total senior population continues to grow by about 60 percent a year now.

That is the reality that our nation is facing, and the reality that this bill is meant to address. As medical progress continues, more and more seniors are going to be taking an increasing number of new drugs that will increase drug spending and make more seniors consumers of high-cost medicines.

And that is the reality that physicians understand. We all know that we really do have major financial problems with drugs that could benefit patients significantly.

Critics of the bill fail to note that most of the $400 billion will go to cover the costs of low-income seniors with no coverage and the growing portion of seniors that are in the high cost category. And for the first time in history, Medicare costs are shared by seniors according to their income. And that is true whether the money goes to sustaining existing private drug coverage or providing it through the more dubious stand-alone programs the bill seeks to create.

As I have blogged previously, one feature of this bill that I like is that those with greater need get the greater benefit. Many seniors will not like these adjustments. However, given the huge cost of Medicare, it seems only fair that those with get less help than those without.

As we continue to digest this huge bill (knowing that it will require tweaking each year), we should read various supporters and critics to better understand our positions.

I blogged on this story last week. This article adds important information to the discussion. I was at a birthday party over the weekend (for a 50 year old), and had several people ask me about virtual colonoscopy. I suspect most physicians are getting these questions. Not quite in a comfort zone

Patient excitement at the prospect of a more convenient and comfortable exam would be understandable but, doctors say, premature until the findings can be corroborated. There are other reasons too.

For starters, the preparation for both types of screenings is the same. As those who have had the conventional exam can attest, fasting and cleansing the intestines the night before is by far the worst part of the screening. That process is still required with a CT scan.

The virtual exam also comes with its own discomfort, because the intestine must be inflated with either air or carbon dioxide for an accurate and precise picture of the intestinal lining.

Furthermore, if a patient is found to have polyps, a conventional procedure must then be scheduled to have them removed.

All things considered, patients who need to be screened should have a conventional exam because it's still the gold standard, with a three-decade track record, and allows polyps to be removed at the same time, most doctors say. For now.

This assessment seems quite similar to my interpretation last week.

Very few medical centers or radiologists now offer the optimal techniques used in the new study. (Although virtual colonoscopy surpassed standard colonoscopy in picking up polyps greater than 10 millimeters in size ? 98.3% versus 87.5%, it was not nearly as good in detecting those smaller than 5 millimeters, which are generally considered insignificant but could enlarge over many years.)

"All virtual colonoscopies are not created equal," said lead study author Dr. Perry J. Pickhardt, an associate professor of radiology at the University of Wisconsin in Madison. He led the trial of more than 1,200 asymptomatic patients who underwent both procedures. "Most free-standing centers doing whole-body scans offer something called virtual colonoscopy, but in reality, what they offer is clearly inferior to our technique."

Most radiologists who interpret virtual colonoscopy first scroll through cross-sectional images of the colon before studying the 3-D images produced from the scans. But Pickhardt's study, published in last week's New England Journal of Medicine and presented to the Radiological Society of North America, used computer software that allowed radiologists to do a 3-D virtual fly-through of the patient's colon, then use the conventional, 2-D images to confirm any suspected abnormalities. That approach nearly doubled the detection rate.

Pickhardt's study also used state-of-the-art CT scanners, plus computer filtering to electronically cleanse the images of any fecal particles that might be mistaken for polyps.

Radiologists who do virtual colonoscopies and gastroenterologists who probe colons with small, lighted cameras agree that the virtual examination is best suited to patients at average to low risk, whose colons are unlikely to have polyps. Those with symptoms such as rectal bleeding, anemia or unexpected weight loss, which can be symptoms of colon cancer, are "better suited to undergo conventional colonoscopy as the initial test," Pickhardt said.

So as I said last week, we have promising results, but not definitive results. I would not "settle" for virtual colonoscopy yet. I will follow the literature for further developments.

Apparently, many 50 year olds want a colonoscopy. 50 and Ready for a Colonoscopy? Doctors Say Wait Is Often Long

"It's fine to say everyone should have a colonoscopy," Dr. Bond said. "But we are talking about 70 million people. It is unclear whether that is even feasible in the United States."

While healthy people are unlikely to be harmed by waiting, doctors say many just do not show up when the long-scheduled day finally arrives.

"If you're urging people to be screened and then you say, O.K., the colonoscopy will be a year from now, you shoot yourself in the foot," said Dr. Robert H. Fletcher, a professor of ambulatory care and prevention at Harvard Medical School. "The meta-message from the health care community is, well, it's not that important after all."

Medicare data illustrate the trend, with the number of colonoscopies among Medicare recipients increasing by 42 percent from 2000 until 2002, the most recent year for which data are available. In 2000, Medicare paid for 2,211,925 colonoscopies; by 2002 the figure had risen to 3,150,738. The data combine colonoscopies for screening with those for people with symptoms; before 2001, some doctors say, doctors encouraged patients to find symptoms like blood in the stool that would allow them to have a colonoscopy paid for by Medicare. Yet, doctors say, 2002 was just the start of the demand.

Given the numbers crunch (and the cost) we need very careful analyses to understand the cost benefit relationship. Hopefully more studies of virtual colonoscopy will confirm that it would make an adequate screening test. Perhaps we would combine flexible sigmoidoscopy with virtual colonoscopy (on the same day) and have a superior test to colonoscopy.

This is a good problem. Having patients interested in screening shows progress. Now we must develop creative solutions.

A reader provided this link. Here is a public thanks! Stealth Merger: Drug Companies and Government Medical Research

Increasingly, outside payments to NIH scientists are being hidden from public view. Relying in part on a 1998 legal opinion, NIH officials now allow more than 94% of the agency's top-paid employees to keep their consulting income confidential.

As a result, the NIH is one of the most secretive agencies in the federal government when it comes to financial disclosures. A survey by The Times of 34 other federal agencies found that all had higher percentages of eligible employees filing reports on outside income. In several agencies, every top-paid official submitted public reports.

The trend toward secrecy among NIH scientists goes beyond their failure to report outside income. Many of them also routinely sign confidentiality agreements with their corporate employers, putting their outside work under tight wraps.

Gallin, Germain, Katz, Schlom and Trent each said that their consulting deals were authorized beforehand by NIH officials and had no adverse effect on their government work. Eastman declined to comment for this article.

Dr. Arnold S. Relman, the former editor of the New England Journal of Medicine, said that private consulting by government scientists posed "legitimate cause for concern."

"If I am a scientist working in an NIH lab and I get a lot of money in consulting fees, then I'm going to want to make sure that the company does very well," Relman said.

Relman and others in the field of medical ethics said company payments raised important questions about public health decisions made throughout the NIH:

Now I believe Relman guilty of hyperbole. Most scientists do not think that explicitly about these relationships. Rather I believe the influence more subtle.

What the pharmaceutical industry buys is influence. They do not often get an explicit quid pro quo . Rather they work to influence ones perception of the company and by extension the products that they produce.

I have referenced Cialdini's work on influence in the past, but will provide a link once again - INFLUENCE by Robert B. Cialdini I have chosen this link (from amongst many candidates) because it gives a nice overview of the conceptual framework which Cialdini has developed. If this seems intriguing, I can highly recommend the book.

Considering his work, and this story, I would reinterpret the trap that the investigators have accepted. Medical researchers (not unlike most humans) like the ability to make extra money. Being a paid consultant has the veneer of appropriateness and respectability. The researchers easily delude themselves that as scientists they are immune from influence. Unfortunately, this naivety allows them to unknowingly make mistakes.

They justify their actions as necessary to support their overall research. They truly mean well. However, much like Dr. Faustus they are selling their souls. This is the dirty secret of much medical research.

We need a new ethical standard. We need to understand why we engage in this dance. We need to stop.

Study Questions Some PSA Prostate Tests

Remember this important principle. Preventive medicine works best for those with longer life spans. At some point (difficult to assess admittedly), the potential for gain from prevention may no longer exist.

Obviously, it depends on the type of prevention. Flu vaccines are likely to help almost anyone and especially the older elderly. Cancer screening diminishes in value above a certain age.

As you read this article, remember that it refers only to screening - not evaluation. The article argues against random screening of those older than 75 for prostate cancer. However, PSA testing may have indications as a diagnostic and prognostic test rather than a screening test in these patients.

The results make sense when you consider the limited potential value of pure screening in this group of men.

Today's NEJM has a nice summary of the Canadian drug issue (for subscribers) - Canadian Drugs

Evidence of harm from these transactions is sparse. A single case of potentially serious harm has been made public: in January, an Oregon woman filed suit against Medicine Shoppe Canada, alleging that a bottle meant to contain tamoxifen actually contained an antihypertensive drug that made her ill. This suit was settled out of court. Minor problems reported with Canadian imports have included the shipment of unchilled insulin and the filling of prescriptions with more than the prescribed quantities of a drug.

However, the possibility of harm may escalate in the future. Several large pharmaceutical manufacturers have recently moved to limit supplies to their Canadian outlets to the approximate quantity required for domestic Canadian use alone. Some have stated that they are, in particular, cutting supplies to Internet drugstores that convey Canadian drugs to U.S. consumers, forcing these operations to turn elsewhere for their inventory — to such countries as Bulgaria and Pakistan, for instance. Especially in the murky marketplace of the Internet, U.S. consumers have no way of knowing with certainty the true origin of drugs ordered from Canadian sites.

How, then, are physicians to counsel their patients regarding the safety of Canadian drugs? The facts suggest that purchasing Canadian drugs entails no legal jeopardy for the individual consumer and that Canadian products themselves pose no excess health risks for patients in the United States. However, whether market pressures will create a cargo of pseudo-Canadian drugs whose actual countries of origin do not aspire to Canada's standards of quality remains to be seen. In many instances, FDA-approved generic drugs may offer savings almost as great as those of Canadian brand-name drugs, and physicians may choose to emphasize this avenue of compromise to their patients. When generic equivalents are not an option, however, physicians and their patients are left to construct risk–benefit analyses together and proceed accordingly. They do so in every other aspect of medicine, and now, apparently, they must do so in the pharmacy as well.

That Ounce of Prevention Grew Too Big

Nowadays, I think the practice of medicine is hard for different reasons. Not long ago I saw a new patient in my cardiology clinic. He was an elderly man who spoke only French, so I had to call for an interpreter. When I finally got someone on the phone, my patient told me that he had been having palpitations. Since his EKG was abnormal, I decided to order some tests.

Midway through the visit, the man asked me if I would serve as his primary care doctor. Though I am a cardiologist, I enjoy general internal medicine, so I said yes. But frankly, I was a bit ambivalent.

He was 66, which meant arranging a colonoscopy to screen for colon cancer and checking a prostate-specific antigen level. The P.S.A. is an imperfect test, but I did not have time to discuss the pros and cons of it, so I made a mental note to do so later.

The man also was going to need counseling about stopping smoking and coronary risk reduction; pneumonia and tetanus vaccinations; forms filled out for his social worker; and (based on his history) screening tests for alcoholism and major depression. There was more to do, of course, but this was more than enough to keep me busy.

However, I wasn't about to bring any of this up. Even if my patient had spoken English, each topic would have taken too much time out of my busy clinic day.

Primary care, particularly preventive medicine, is becoming untenable in the era of 15-minute office visits. A study published this year in The American Journal of Public Health estimated that it would take over four hours a day for a general internist to provide the preventive care that is recommended for an average-size panel of adult patients. "The amount of time required is overwhelming," the authors wrote.

Primary care doctors already are overstretched. Urgent issues have to take precedence during office visits. Increasingly, this means preventive care gets the short shrift.

He makes my point better than I make it! As I wrote earlier this week, our current reimbursement system does not reward excellence in primary care. It penalizes you for spending more time. Until we develop a better reimbursement system, patients will suffer. As an example:

In a recent study of family practice patients in Michigan, only 3 percent of the women and 5 percent of the men over 50 had completed age-appropriate cancer screening tests. Nationwide, less than a third of older adults have had their stool tested within the past two years for occult blood, one of the first signs of colon cancer. Only 33 percent have ever had a sigmoidoscopy, even though recent research suggests that performing this test more frequently could detect more intestinal cancers.

This is our health care crisis!!!

On the road at a retreat, so I have not had a chance to read the NEJM article. The NY Times review makes sense and puts the issue into perspective - A Gentler Type of Colonoscopy Proves Effective

The study included 1,233 people ages 50 to 79 who agreed to have a virtual colonoscopy and then, immediately afterward, a traditional one for comparison. The doctors doing the traditional colonoscopies did not know what the virtual ones had found.

Each method, the investigators report, found more than 90 percent of polyps at least 8 millimeters in diameter and about 88 percent of those at least 6 millimeters across.

The study, which will be published in Thursday's issue of the New England Journal of Medicine, was released yesterday because it is being presented at a meeting of the Radiological Society of North America.

Medical experts praised the results.

"It puts virtual colonoscopy right up there with the gold standard, optical colonoscopy," said Dr. J. Thomas Lamont, who is chief of gastroenterology at Beth Israel Medical School. Dr. Lamont wrote an editorial accompanying the paper.

Virtual colonoscopy has been around for nearly a decade, but it has never been on the recommended list of screening tests. In previous studies it missed as many as half of even the large polyps that are most worrisome. The difference this time, said Dr. Pickhardt, is in the method.

The study researchers used a computer program that revealed the colon in three dimensions. Most other virtual colonoscopy has involved two-dimensional slices created from C.T. scan images. The patients in the new study also drank a fluid that labeled fecal material so doctors did not confuse it with polyps.

"It really matters what method you're using and how you prepare the colon," Dr. Pickhardt said.

But, he cautioned, virtual colonoscopy patients still must undergo the onerous process of cleansing their colons of fecal material before the test and they must insert a small tube into their rectums and pump air into their colons during the scan, a procedure that can be uncomfortable. And if the scan finds polyps, they may need a traditional colonoscopy to cut them out.

Most health insurers also do not pay for the procedure. "What is being charged varies from $500 to over $2,000," Dr. Pickhardt said. "Patients are paying out of pocket. It's what the market allows."

While the results are very encouraging, we need more validation of the technique. It looks promising, but I wonder how radiologist dependent the reading is. Sometimes with newer radiologic procedures, those on the cutting edge who develop the procedure get better results than those who follow.

I am not ready to have virtual colonoscopy rather than the standard at this time (and yes I have already had a colonoscopy). We should follow this literature closely. This is a great first step.

Primary care troubled by coding errors: Medicare officials suggest doctors may have trouble deciphering evaluation and management guidelines in billing. Doctors may have trouble deciphering - Medicare officials use understatement to negligible effect.

The American College of Physicians said, given the difficulty even experienced professionals have with E&M coding, CMS should not include in the improper payment rate E&M coding errors if there is only a one-level discrepancy in the code. In a letter to CMS, the college cited a 1995 study in which the OIG asked eight Medicare carriers to code five hypothetical patient office visits. None of the five examples were coded the same way by all eight carriers.

ACP also questioned whether the contractor reviewing the claims had sufficient expertise to accurately review E&M service claims.

For those who do not have to deal with E&M coding, recall Kafka's book, the Trial

"There can be no doubt—"said K., quite softly, for he was elated by the breathless attention of the meeting; in that stillness a subdued hum was audible which was more exciting than the wildest applause—"there can be no doubt that behind all the actions of this court of justice, that is to say in my case, behind my arrest and today's interrogation, there is a great organization at work. An organization which not only employs corrupt warders, oafish Inspectors, and Examining Magistrates of whom the best that can be said is that they recognize their own limitations, but also has at its disposal a judicial hierarchy of high, indeed of the highest rank, with an indispensable and numerous retinue of servants, clerks, police, and other assistants, perhaps even hangmen, I do not shrink from that word. And the significance of this great organization, gentlemen? It consists in this, that innocent persons are accused of guilt, and senseless proceedings are put in motion against them..."

The Trial

Franz Kafka

Quote link - The Trial

Doctors get a 1.5% pay hike as Congress passes Medicare reform

I will use this summary to provide my opinions on several provisions. My comments in italics.

Sweeping overhaul of Medicare

The almost 700-page Medicare legislation represents the broadest reform of the program since its inception. Provisions affecting physician practices and patients include those that:

Establish an 18-month moratorium for new specialty hospitals. This provision makes some sense. Specialty hospitals usually develop to skin the cream from Medicare. We need further study to understand the pros and cons of the hospitals.

Provide $1 billion in spending for care provided to illegal immigrants under Emergency Medical Treatment and Active Labor Act obligations. No comment

Freeze rates for durable medical equipment through 2006 before phasing in competitive bidding. Reasonable

Improve mammography payments. Appropriate and desirable.

Allow for reimportation of drugs from Canada if deemed safe by the Dept. of Health and Human Services. This provision depends on implementation. If HHS does its job well, this provision could help with costs.

Retain the current CPT coding system. Boo!!! I will rant on this elsewhere today

Promote voluntary use of electronic prescribing. This makes sense. We need low cost systems and standardization.

Reform laws governing drug patents and generic competition. This provision is a step in the right direction. Now we (the academic community) must do a better job in educating our residents and practicing physicians on the options (i.e., forms of counterdetailing.

Provide subsidies for employers to maintain retiree drug coverage. I hope this works. Hopefully subsidies will cost less than the Medicare drug benefit. This provision's implementation remains unclear.

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One provision of the Medicare bill that excites me is the adjustment for rural hospitals and physician payments. Apparently New Yorkers disagree. City Hospitals Reap Little in Medicare Bill

Here in Alabama (and similar states) we have a huge problem providing adequate care in our rural areas. Finances play a major role. This bill corrects previous inequities. Bravo!

Europeans mull costs, benefits of free medical care

A $400 Billion Purchase, All on Credit

But although some economists on the left and right might wring their hands, younger workers don't seem to be complaining. According to polls, members of the post-boomer generation are actually more enthusiastic than their elders about this new legislation. Their feeling is partly due to a desire to see their parents and grandparents save money on drugs, which ultimately redounds to their own benefit. And a lot of these younger adults ? like members of Congress who voted for the bill ? probably haven't quite focused on who will pay for the program or how.

Over the past 2 years I figured out that Medicare was overpaying for cancer chemotherapy. We had a big jump in residents choosing oncology for fellowship. (I know this is a cynical jump in logic, but it does make sense). It appears that congress has adjusted. Doctors fear lower Medicare drug payments will hurt cancer clinics: Scandal prompted bill's writers to cut reimbursements

Congressional targeting of cancer clinics goes back about two years to investigations on Capitol Hill that revealed doctors obtained cancer-fighting drugs at bargain-basement prices but then received Medicare reimbursements for five times the amount they paid.

For instance, the House Energy and Commerce Committee in 2001 found that doctors paid $1.25 for 50 milligrams of Leucovorin, used in combination with chemotherapy to treat various forms of cancer. But Medicare reimburses the physicians $35.47 for that amount of Leucovorin.

Cancer doctors say the excess money goes to offset the cost of staffing and maintaining their clinics.

Medicare reimbursements for clinic expenses are insufficient, so doctors have come to rely on generous payments for drugs to keep their practices afloat, they say.

The overall effect remains opaque, but as usual, time will tell.

These links are provided for those who want a broad view of the new Medicare legislation. The breadth offered reflects our uncertainty concerning many provisions of the bill.

• Medicare Plan for Competition Faces Hurdles - which suggests that we may never have the competitive options available - and explains why
• Holding Down Drug Prices
• Beyond Medicare reform

from The Arc of the Pulmonary Artery Catheter (paid subscription required)

In the 1980s, observational studies of patients with acute coronary syndromes distinctly challenged the utility and safety of this intervention, suggesting higher mortality for patients receiving a PAC. In 1996, a retrospective observational study of 5735 critically ill patients suggested that the PAC was associated with increased mortality and increased costs of care, even after adjusting for the propensity to receive catheterization. In 2000, a large retrospective observational study of 10 217 patients showed that use of the PAC was independently associated with admission to a surgical ICU, care delivered by a nonintensivist, patient race, and private insurance coverage. In 2001, a prospective observational study of 4059 patients undergoing major elective noncardiac surgery reported that those patients treated with a PAC had a 3-fold increase in major postoperative cardiac events.

Together, these publications had important consequences. They generated debate about whether patients should be managed with a PAC and why. They raised awareness about how in nonexperimental studies potentially inadequately adjusted confounders could lead to spurious associations between the PAC and poor clinical outcomes. They challenged us to step back and critically evaluate the PAC in terms of patient populations mostly likely to benefit. It became better understood that a diagnostic and monitoring device cannot improve clinical end points unless the therapy based on data from that device is itself effective. It was no longer just about the information obtained from the PAC?what was done with the data matters. An editorial accompanying the provocative study by Connors et al called (again) for a moratorium on the PAC or more randomized trials to test its effect on patient outcomes.

This quote comes from an editorial about the following article. Early Use of Pulmonary Artery Catheter Offers Neither Harm Nor Benefit

From Jan. 30, 1999, to June 29, 2001, 676 patients aged 18 years or older meeting standard criteria for shock, ARDS, or both were enrolled from 36 intensive care units in France and randomized to receive a PAC or not to receive it. Other management treatment was left to the discretion of the treating physician. Both groups were similar at baseline.

There were no significant differences between groups in the primary end point of mortality at 28 days (59.4% vs. 61.0%), nor in the secondary end points including mortality at day 14 (49.9% vs. 51.3%) and day 90 (70.7% vs. 72.0%). At day 14, the groups did not differ in number of days free of organ system failures, renal support, and use of vasoactive agents. At day 28, there were no significant differences between groups in days in hospital, days in the intensive care unit, or days of mechanical ventilation use.

"Clinical management involving the early use of a PAC in patients with shock, ARDS, or both did not significantly affect mortality and morbidity," the authors write. "An influence on prognosis without goal-oriented therapy could only be suggested when the presence of a PAC results in significant changes in treatment with fluid loading and vasoactive agents.... Our results, which do not preclude the potential impact of a goal-oriented therapy with a PAC, strengthen the suggestion of the consensus statement made by the National Heart, Lung, and Blood Institute and the Food and Drug Administration that a randomized clinical trial with this design can be ethically performed in this population of critically ill patients."

So back to the editorial -

Some questions about the safety of the PAC remain. Richard et al reported 17 arterial punctures, 1 hemothorax, 60 patients with arrhythmias, 6 patients with catheter knots, 8 patients with signs of exit site infection and sepsis, and 2 with positive catheter cultures. However, it does not appear that systematic screening for complications was undertaken in both groups. Complications possible in both groups such as arterial punctures may not have been recorded as well in the control group vs the PAC group; therefore, reported complications may be underestimated overall and inflated in terms of their difference between the 2 groups. For all devices like the PAC, harm associated with catheter insertion and management may vary among physicians, underscoring how operator-dependent complications in device trials are the study outcomes least generalizable to other settings.

I became a skeptic concerning pulmonary artery catheters from reading Dr. Connors work, and discussing his study with him. This article while not revealing any major harm, also does not give me a reason to request pulmonary artery catheterization. We must look further to understand whether this technology has any benefit.

The results of this multicenter randomized controlled clinical trial of the PAC in patients with shock, ARDS, or both may lead to more than one interpretation. The PAC was not associated with increased mortality or morbidity; however, neither was it associated with improved clinical outcomes. This trial and other studies provide reassurance that further investigation into the role of the PAC is feasible, likely safe, and should proceed forthwith. Even larger trials may be needed to more definitively evaluate this technology. A complementary approach is selection of specific patient populations to test protocolized treatment schedules based on data obtained from the PAC. Intensivists eagerly await the completion of 2 ongoing studies that champion these different designs: the UK National Health Service sponsored study Pulmonary Artery Catheters in Patient Management in Intensive Care (PAC-Man) and the recently resumed National Heart, Lung, and Blood Institute?sponsored Fluids and Catheters Treatment Trial (FACTT) of the ARDSNet.

Critical care medicine is well poised to build on its solid foundation of pathophysiological research and technology development with collaborative multicenter clinical investigations. These complementary approaches to inquiry are needed to help physicians better understand the risk:benefit, effort:yield, and cost:benefit of the PAC, as well as other old and new interventions used to care for the most seriously ill hospitalized patients in the ICU.