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.

AMA vows united voice in battle for tort reform

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).

Go over and read Rangel's take. He has been on a roll recently, and this particular rant is great. Howard Dean: compromising on tort reform? I like this line particularly:

But the rest of this statement seems as if Dr. Dean had two henchmen from the DNC looking over his shoulder making sure that he didn't stray too far from the party line. First he evokes the trial lawyer's favorite "scientific" study of all time that appeared to show that as many as 98,000 people die in US hospitals every year due to medical "errors". The problem is that the study is deeply flawed and total bullshit and most physicians know this. Or does Howard really believe that our hospitals "mass murder" almost 100,000 patients a year?

State legislatures have taken heed. They are passing positive laws to attack the obesity epidemic. Worried about obesity, states mulling laws for restaurants, schools and public employees

Under the laws that have passed, states will:

* Test the BMI -- body-mass index, a ratio of height to weight -- of students in six Arkansas schools, and send results home. Pediatricians say regular tests like this should be performed nationwide to track children at risk of becoming obese.

* Ban junk food from vending machines in California. New York City, in an administrative decision, banned hard candy, doughnuts, soda and salty chips from its vending machines.

* Require physical education programs in Louisiana schools, and encourage it in Arkansas and Mississippi. Though once a staple, such daily classes are now only required by state law in Illinois; other states let local officials decide or require exercise less often.

For even more information on obesity - here is the Surgeon General's web page on the subject - The Surgeon General's Call To Action To Prevent and Decrease Overweight and Obesity

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.

Making Malpractice Harder to Prove

Slowly and quietly, the rules regarding expert witness testimony in medical malpractice cases have been changing: a handful of states have passed legislation in the last two years that generally requires physician experts to work in the same field as a defendant doctor, while professional doctors' groups are setting up committees to review the testimony of their members.

A medical expert is indispensable to a medical malpractice case. To show negligence, the plaintiff must demonstrate that the "standard of care" has been breached by the doctor in question. And who knows more about that standard than another doctor? Without a medical expert, there is no case.

As I say repeatedly, we need a new system. The current one does not work. Comments on the article??

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

I harp on fitness often. Personally I work out approximately 5 days a week, some resistance training, some cardiovascular work. This article speaks to young adults, but I suspect it is rarely too late. Treadmill Tests Gauge Future Fitness

The study involved about 4,400 men and women who were given a treadmill test when they were 18 to 30. Most of them were followed for 15 years after that.

Those who did not do well on the treadmill test faced double the risk of developing high blood pressure, diabetes or a condition called metabolic syndrome, compared with highly fit participants. Metabolic syndrome is a cluster of symptoms that includes high blood sugar, poor cholesterol levels, elevated blood pressure and a fat belly.

Some of the participants underwent a second treadmill test, seven years after the first one. Those who became more fit during those intervening years reduced by 50 percent their risk of diabetes and metabolic syndrome.

The study is published in Wednesday's Journal of the American Medical Association.

The findings ``confirm what common sense has always told us -- lack of fitness in youth is not a good thing for later life,'' said Dr. Teri Manolio, director of epidemiology at the National Heart, Lung and Blood Institute, which funded the research. ``It doesn't take that long for risk factors to develop and disease to develop.''

Fitness levels were determined by how long participants could walk on a treadmill without becoming fatigued and short of breath.

We should spend public health dollars on middle school and high school fitness programs. "Phys Ed" is not a luxury for students, but rather a most important class. It should provide life long exercise habits. This is important.

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)

Robert Prather writes:

I have a question. I don't know if you read this post: Regulation Through Litigation but a friend went to a surgeon's office and the doctor won't provide service to plaintiff's attorneys or their employs. In a political / philosophical sense I agree with it since you could make a good argument that these guys have been enemies of the healthcare industry.

However, I'm wondering if it's ethical. Any thoughts?

What a great ethical dilemma! I will cheat on this one and give two answers.

For elective care, i.e., normal office consultation, physicians have no obligation to accept any patient. The physician can elect to see only private insurance, only indigent patients, or only patients who live in their town. If one assumes that the potential patient pool is large enough, then these are legitimate decisions.

Physicians can even fire patients for any variety of reasons.

Physicians should not abandon patients. Thus, if a patient has an ongoing relationship with this physician and then goes to work for the lawyer, he/she should continue the doctor patient relationship.

All discretion ends when emergencies arise. If the surgeon is on call for the emergency room, and the lawyer comes in with an emergency, then the only ethical standard that I know would require the surgeon to provide the emergency care.

There are probably more intelligent ethicists who could expand on this quick and dirty analysis.

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.

For reasons that I cannot entirely explicate I am interested in identifying particularly moving and relevant lyrics. If you have some favorites, please comment. I will give a few from time to time. Today's favorite:

This ain't no party
This ain't no disco
This ain't no fooling around

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!