A loyal reader and fellow blogger - Alex Chernavsky - suggests this link - Drug firms profit from 'murky' link with journals, study shows. He is right to make the suggestion.

The "murky" relationships between the world's leading pharmaceutical companies, supposedly independent medical journals and family doctors are exposed in the British Medical Journal today.

A landmark edition of the BMJ is devoted entirely to claims that patients and governments are being systematically misled over the benefits of new treatments and therapies by drugs giants. It is the most comprehensive and damaging dissection to date on the tactics used to promote new drug products, despite supposedly strict guidelines safeguarding the independence of research and a ban on advertising medicines in Britain.

One of the BMJ studies exposes the first weak link in the chain from a company developing a drug to it becoming an international "bestseller". It outlines how pharmaceutical companies increasingly sponsor research into therapies and treatments previously funded by governments. Scientists from York University in Canada found that published clinical studies sponsored by pharmaceutical companies were four times more likely to favour products made by that company. The drugs in question ranged from contraceptives to treatments for depression, osteoarthritis and Alzheimer's disease. In some supposedly independent academic studies, the drug produced by the sponsoring company was compared with an "inappropriate" alternative, or was given at a higher dose, meaning it was bound to be more effective, the BMJ claims.

The next step for the drugs giants is to get their new products approved by govern-ments. Experts for the BMJ analysed the way in which five antidepressant drugs were submitted to the Swedish authorities for marketing approval. As well as submitting "favourable" trials sponsored by the drugs companies themselves, the journal found that some studies were being submitted twice, or even three times, but in different publications so that the pile of evidence looked weightier. "Selective" submissions meant trials that did not strongly support the drugs were left out.

Richard Smith, the editor of the BMJ, analysed the influence drug giants had on the medical newspapers - their shop window for prescribing doctors. Many publications rely heavily on revenue from advertisements placed by the very drugs companies they should be scrutinising - adverts Mr Smith says are often "misleading". Moreover, some companies may offer to buy advertising space on the basis that the paper runs articles favourable to their products.

"Health care, doctors, journals and, I believe, the pharmaceutical industry, would all benefit from relationships being less grubby and kept more at arm's length," Mr Smith concludes.

Yet another study cited by the BMJ found that GPs who regularly spoke to sales representatives from drug companies were more likely to prescribe medicines unnecessarily and in contravention of guidelines. Mr Smith said: "The [drug] industry dominates health care, and most doctors have been wined and dined by it."

But perhaps most worrying is the way that drug companies in Britain now give money to patients' groups - or even set up their own ones - in an effort to promote products directly to the public. Unlike in the US, there is a strict ban in Britain on marketing prescription medicines directly to the public. But patient groups are now relying on drug companies for up to 20 per cent of their funding, says a BMJ article.

Lest any readers have forgotten, I personally use the $10 rule. I will accept lunch at a conference, or a pen, or a pad of paper - as long as the value is $10 or less. I will not attend any dinner meetings, go to any plays or even play golf on pharmaceutical industry money. Our division will not allow any pharmaceutical sponsored talks at our weekly noon conference - even if it would help us financially.

CMS Draws Heat as Coverage of MADIT II ICD Decision Draws Near

With the clock ticking toward the Centers for Medicare and Medicaid (CMS) self-imposed deadline of May 31 to give a thumbs up or thumbs down on instituting coverage of implantable cardioverter defibrillators (ICDs) based on MADIT II criteria,[1] economics--not evidence--may be the deciding factor, according to Sean Tunis, MD, Medical Director of CMS

At a free-wheeling CMS issues session at the North American Society of Pacing and Electrophysiology (NASPE) 24th Annual Scientific Sessions,[2] Tunis bluntly told attendees that "it is about the money." There is no wiggle room in the Medicare budget, he said, so CMS has drawn a clear line in the sand. Before CMS can give the go ahead for payment, each technology must: (1) clearly work and (2) not be simply more expensive (yet no more effective) than other treatments. Tunis noted that drug-eluting stents met the first criterion, which is why CMS approved payment before the United States Food and Drug Administration (FDA) approved the devices for marketing.

"As money goes to higher tech services and newer benefits, we are led in [the] direction of under compensating for primary care, home health care, [and] skilled nursing care," Tunis said. "Medicare must avoid this tendency so that these worthwhile services don't "get starved as more and more resources are applied to newer, high tech services, especially those that are very expensive and have [only] modest benefits." Tunis added that Medicare dollars will continue to go to "fairly compensate for beneficial basic services.

...

In the meantime, the outcome was still in doubt during the run-up to the NASPE session. The day before Tunis addressed NASPE, Health and Human Services Secretary Tommy Thompson held a closed-door session with representatives from Guidant, Medtronic, and St. Jude Medical, Inc. (St. Paul, Minnesota), but no one would comment on the results of that private meeting. Tunis did, however, say that CMS is not getting public pressure to extend coverage.

"AARP has really been neutral. There's been no patient advocacy organization pressuring us. ACC has not been pressuring us. The pressure has been mainly from NASPE and the industry -- Guidant, Medtronic, and St. Jude Medical. Not that I attribute anything inappropriate to that," he said.
Acronym Glossary

AARP: American Association of Retried Persons

ACC: American College of Cardiology

AHA: American Heart Association

CMS: Centers for Medicare and Medicaid Services

EPS: Electrophysiological study

FDA: United States Food and Drug Administration

ICD: implantable cardioverter defibrillator

MADIT II: Multicenter Automatic Defibrillation Implantation Trial II

MCAC: Medicare Coverage Advisory Committee

NASPE: North American Society of Pacing and Electrophysiology

SCD-HeFT: Sudden Cardiac Death in Heart Failure Trial

It is about the money. And it probably must be about the money.

False Positive (Can This Marriage Be Saved?) - tells a poignant story. I will make the case that overtesting can lead to problems because of the false positive problem.

Over the years I have taught many students and physicians about diagnostic tests. Several principles concerning diagnostic tests are very important. First, each test has a sensitivity and specificity. Sensitivity defines the probability that a patient with the disease has a positive test. Specificity defines the probability that a patient without the disease has a negative test. The false positive rate equals 1 minus the specificity.

Now that I have demonstrated my nerdiness once again, let us understand the problems that these definitions cause. The problem we are discussing today is the false positive problem. Patients and physicians often worry about false negative tests - missing a diagnosis. However, as this case demonstrates a false positive diagnosis carries important costs. I usually use the example of a colleague's patient (who happened to be a 45 year old lawyer). This lawyer went to give blood. The initial screening test for HIV read positive. The patient had no known risk factors for HIV. It took my colleague 3 months to prove to everyone's satisfaction that the patient was HIV negative. What was the cost to the patient? This occured early in the HIV epidemic, prior to any antiretrovirals. Our testing was rudimentary. Prognosis for AIDS was less than 1 year.

Multiply this example by the extensive testing that many patients get. Even with a specificity of 99% (pretty damn good), 1 of 100 healthy patients will receive a false positive diagnosis. And they will have anxiety and doubt.

Now read the story - especially these quotes:

"Buenos dias," I say. "Soy Doctor Eshleman. Cómo se siente hoy?" and reflexively brace myself for the torrent of Spanish that usually follows my feeble attempts at bilingualism. Instead, the nurse speaks to me in English, telling me that Mr. Guerrero is here for treatment for syphilis and that he really doesn't understand how this could be. He is very sad because last month, when he first learned of the diagnosis from a blood test, he was advised to have his wife tested. His wife was shocked when she was told that she needed to be checked for a venereal disease. She accused her husband of being unfaithful and moved out of their home and flew back to El Salvador. That's why he had been crying.

I knew there was a problem before I entered the exam room.

In reviewing Mr. Guerrero's medical record, I noted that he had had two recent blood tests for syphilis. One was the VDRL test -- VDRL stands for "Venereal Disease Research Laboratory," the U.S. Public Health Service (PHS) facility where the test was developed -- while the other was an FTA test. (Those initials stand for "fluorescent treponema antigen," another PHS test. Treponema pallidum is the bacterial species that causes syphilis.) I also noted that he had received two injections of penicillin.

The VDRL is a screening test. A positive VDRL does not necessarily mean one has been exposed to syphilis. If the VDRL is positive, clinical laboratories will routinely perform the confirmatory FTA test. If that's positive, it clinches the diagnosis. In Mr. Guerrero's case, his VDRL was weakly positive and the FTA was negative.

I found all this confusing, because my interpretation of his test results was that he did not have -- and has never had -- syphilis. Instead, his test result was almost certainly a biological false positive. Lots of other diseases, including lupus, rheumatoid arthritis, mononucleosis, malaria, HIV, mycoplasma pneumonia, leprosy and Lyme disease can give a biological false-positive VDRL. In parts of the tropics and of Latin America, the diseases yaws and pinta, which are caused by a bacterium that is a close cousin of T. pallidum, will also give a false-positive VDRL. And sometimes there's just no explanation for a biological false positive. But false-positive VDRL tests for syphilis are common, which is why the confirmatory FTA test -- the one that actually shows the presence of the bacterium -- is so important.

This case (and the one I recalled) put faces and feelings into those numbers. We should never forget the faces and the feelings.

This case, like most whistle blower cases, will become nasty. Court Papers Suggest Scale of Drug's Use

Documents released yesterday in the case of a drug company whistle-blower shed light on how extensively doctors were involved in promoting unapproved uses of a Warner-Lambert drug, Neurontin.

Warner-Lambert paid dozens of doctors tens of thousands of dollars each to speak to other physicians about how Neurontin, an epilepsy drug, could be prescribed for more than a dozen other medical uses that had not been approved by the Food and Drug Administration. The top speaker for Neurontin, Dr. B. J. Wilder, a former professor of neurology at the University of Florida, received more than $300,000 for speeches given from 1994 to 1997, according to a court filing. Six other doctors, including some from top medical schools, received more than $100,000 each.

Other doctors were paid to write reports on how Neurontin worked for a handful of their patients, the court papers said. Still others were paid to prescribe Neurontin in doses far exceeding the approved levels as part of a clinical trial that Warner-Lambert created to market the medicine, according to the court papers, which are new documents filed in the lawsuit by the whistle-blower. The papers are backed up by hundreds of pages of corporate documents and memos recently filed with the court.

The whistle-blower, Dr. David P. Franklin, a former Warner-Lambert employee, contends that the company's marketing tactics, which have helped make Neurontin a top-selling medicine, with more than $2 billion in revenue, were illegal. He says that federal and state governments paid hundreds of millions of dollars for Neurontin as doctors prescribed the drug to Medicaid patients for various conditions including pain, bipolar disorder and restless-leg syndrome.

It is illegal for a drug company to market a medicine for uses the F.D.A. has not approved, but doctors can prescribe a drug in any manner that they think is best for their patients.

Lawyers for Dr. Franklin argued that the company relied on the doctors to market Neurontin for unapproved uses because it was illegal for the company to do so. The speaking program, which also included paying doctors to listen to the speeches at hotels and resorts, was called peer selling, according to the documents.

I have several comments on this story. First, these allegations do not surprise me. I know many academic physicians (and practicing physicians) who markedly supplement their income speaking for pharmaceutical companies. I have personally been approaced and made the decision to forgo that lucrative income stream. This was a personal ethical decision. Many physicians rationalize that the company does not control their content. I do understand that rationalization, but do find it a rationalization.

Second, I do favor off label use of Neurontin. I never go to drug company sponsored dinners or meetings (I went to a few 15 years ago, prior to considering my personal ethical framework for interacting with the pharmaceutical industry). I assume that the information that colleagues have given me on off label Neurontin use came from these apparently illegal practices. Thus, I have a quandry. I do believe that off label Neurontin works - especially for certain types of pain syndromes. However, I am concerned about how we obtained that knowledge.

This case leaves me with shades of grey. The company seems to have broken laws and profitted greatly. However, they may have given physicians a valuable tool for treating some patients.

They could have, and should have, sponsored formal research into these areas, with a goal of obtaining FDA indications. They did not, and if found guilty should receive an appropriate penalty.

I am obsessed! I see social injustice and I cannot control my fingers. I must type incessantly. Malpractice lawyers are hazardous to patient care. They hide behind hyperbole and obfuscation, yet they are slowly depriving Americans of adequate health care. In Insurance Cost, Woes for Doctors and Women

Shannon Minor went to the drugstore last year to buy a home pregnancy test, picked up the local newspaper and read some bad news: her obstetrician, Barbara Pringle, was planning to stop delivering babies.

But not only was Dr. Pringle giving up obstetrics, so were four other doctors in Mount Vernon, including Dr. Pringle's husband, Robert, and the Pringles' longtime partner. Within a year only four obstetricians would be practicing in Mount Vernon, a small city in an agricultural valley of the Cascade Mountains, halfway between Seattle and the Canadian border.

"I was so upset about it," said Ms. Minor, 35, who found a doctor at a hospital in Everett, Wash., 34 miles north of here. "There were hardly any doctors available. When I got pregnant a second time, I just felt lost."

Ms. Minor's obstetrician is one of hundreds around the country giving up delivering babies. They cite the soaring cost of malpractice insurance. Here in Washington, rates have more than tripled since 1975, even after accounting for inflation, according to figures from Physicians Insurance, the state's largest insurer of doctors.

The Pringles calculated that the annual cost of policies that would cover them for claims of up to $2 million ? the median jury award in lawsuits related to childbirth ? was about the same as the income they would lose by giving up obstetrics.

The Pringles are not suffering as much as their patients. Apparently malpractice lawyers have no concern for social justice.

An opinion piece on CBS Marketwatch (free registration required) adds these interesting points. Why we need malpractice reform

Overall, malpractice insurance rates are increasing 25 percent annually and quadrupling in states with particularly high damage awards. It's no wonder that premiums are so high when juries bring back damage awards in the $20 million range.

Can it be that doctors are getting that much worse? Or is it that our approach to conflict resolution is in complete chaos? Statistics show that only 28 percent of every dollar paid for malpractice insurance actually goes back to the victim. The other 72 percent disappears in legal, administrative and "related" costs.

Meanwhile, physicians are fighting back by practicing "defensive medicine" that adds some $50 billion annually to the nation's medical bill in the form of unnecessary tests and treatments.

From my perspective as CEO of a hospital company that owns 100 facilities in 23 states, as well as the District of Columbia, Puerto Rico and France, I see the need for change.

To put it plainly, I can't run a hospital and provide quality care without a stable, professional staff. I fear what might happen to our patients if doctors decide the price for practicing medicine is too great.

If anyone had evidence that malpractice suits lead to better care, then I could understand. I believe that malpractice suits lead to worse and more expensive care. They negatively impact the doctor patient relationship. I assume that malpractice lawyers either do not, or do not want to understand the unintended consequences of their actions. I cannot accept that they really understand.

During my medical career, we generally have moved from a paternalistic attitude towards medical decision making to a patient centered approach. Some physicians find the patient centered style uncomfortable. This case from the NY Times helps explain the conflict - Seeing Risk and Reward Through a Patient's Eyes

But more important, many doctors weigh risks and potential benefits of treatments in ways different from their patients without realizing that wide contrasts exist.

Risks, after all, are relative: what one person considers too dangerous, another might not. The way risks are presented and framed shapes our perceptions of them.

A patient once told me: "The night before my open heart operation, my surgeon told me I had a 5 percent chance I may die. I couldn't sleep all night." This patient, if instead told that he had a 95 percent chance of thriving after the surgery, would have slept much better.

In research, too, investigators are supposed to warn participants of possible dangers. Yet at times, they minimize such hazards and promote only the benefits.

According to research, humans do not always think rationally about risks, but instead rely on stereotypes, overestimate the likelihood of bad outcomes, underestimate the possibility of good results and think they see patterns where none exist.

But this psychiatrist was telling me something else, too: that doctors and patients view risks and benefits in drastically different manners.

This story, about a psychiatrist who gained 45 pounds on Lithium, should reframe how we as physicians consider side effects. One of our greatest challenges is understanding the patient's perspective. But, I would argue, we must do that to provide the care the patient desires.

Another loyal reader wrote this comment yesterday:

Is that how capitation works? The HMO pays a fixed fee for each patient treated by the doctor? A couple of years ago that form of reimbursment was getting some attention and I thought both the doctors and patients hated it. And it it's easy to understand why. It's a nice deal for the HMO because it transfers the risk to the doctor and gives the HMO a guaranteed profit. And it puts the doctor in the ethical bind that each additional treatment for the patient comes out of the doctor's income creating an incentive to treat patients as cheaply as possible.

I will explain my understanding of capitation versus a retainer or administrative fee. When dealing with a managed care company, they would provide several pools of moneys. One pool representative an administrative fee - several dollars per patient per month. We still receive this from our Medicaid managed care program.

This fee (in many ways comparable to a retainer fee of small proportions) is not controversial. What was controversial were the at risk capitation fees. These pools were "set asides" for expenses. If physicians underspent, they profitted. If they overspent, it cost them money. Many have argued that the incentives here were malaligned. The physician might value protecting these money pools over the patient's best health interest.

Having such a plan at best gives the appearance of a conflict between our income and your health. Many physicians and patient advocates have questioned the ethics of such schemes, making them no longer in vogue.

Readers know that I favor testing and treating for h pylori in dyspeptic patients (below the age of 45). A loyal reader - Razzberry - asked yesterday

Very interesting articles on h. pylori -- especially the one discussing the potential protective effect of h. pylori on esophageal cancer. As a person who has been treated for h. pylori, I can attest to the fact, albeit with anecdotal evidence, that this treatment has improved my quality of life mmensely.

My question for you is, do you know why the authors of the British Medical Journal study choose to look at patients 45 years and younger? Do you know of a reason that the results would differ in younger vs. older patients? (Point of note: I am 26 years old)

All experts believe that endoscopy is indicated for patients with alarm symptoms (weight loss especially) or those over 45 years. These groups have a high enough risk of gastric cancer to make endoscopy indicated. Thus, the test and treat strategy (which avoids endoscopy in many patients) is only recommended in otherwise healthy young patients.

While I still favor the test and treat approach, I must caution physicians and patients about this new evidence - H. pylori Eradication Can Result in Significant Weight Gain

Of the total number of individuals involved, 1,634 subjects tested positive for H. pylori on 13C-urea breath testing. These individuals were then randomized to receive either ranitidine bismuth citrate 400 mg twice daily plus clarithromycin 500 mg twice daily for two weeks or placebo. Height and weight were measured at baseline and then at a six-month follow-up visit. All subjects also answered a questionnaire about dyspepsia symptoms before and after treatment.

Average body mass was 77.2 kg at baseline and 75.9 kg at the six-month mark, with subjects on active treatment gaining an average of 0.6 kg more than subjects randomized to placebo, Dr. Lane reported.

In total, 19% of patients receiving active treatment gained 3 kg or more compared with 13% of patients receiving placebo. Dr. Lane told Medscape that subjects who reported the greatest symptom relief after eradication therapy were those most likely to gain weight. "Weight gain was presumably the result of symptom relief," she said.

"General practitioners may want to warn their patients about what they eat [after treatment for H. pylori infection]," Dr. Lane continued. "They may want to caution them...because this was a significant amount of weight gain in many patients."

Hormone Use Found to Raise Dementia Risk

Hormone therapy doubled the risk of Alzheimer's disease and other types of dementia in women who began the treatment at age 65 or older, a large study has found.

The finding disappointed many researchers and doctors, who had hoped for the opposite result: that hormone therapy would prevent Alzheimer's disease.

"No one anticipated this outcome," said Dr. Marilyn Albert, a professor of neurology at Johns Hopkins, in a statement issued by the Alzheimer's Association.

The new report on dementia, being published today in The Journal of the American Medical Association, is one more piece of bad news about hormone therapy. Indeed, it is the latest in a string of studies showing that purported benefits do not exist and that the hormones actually raise the risk of several serious diseases, including some they were thought to prevent.

The latest finding is based on a four-year experiment involving 4,532 women at 39 medical centers. Half took placebos, and half took Prempro, a combination of estrogen and progestin, the most widely prescribed type of hormone therapy.

In four years, there were 40 cases of dementia in the hormone group, and 21 in the placebo group. Translated to an annual rate for a larger population, the results mean that for every 10,000 women 65 and older who take hormones, there will be 45 cases of dementia a year, with 23 of them attributable to the hormones.

With each study, we learn more about hormones. Our previous conventional wisdom was wrong. I see these studies as victories for scientific inquiry!

Sometimes Canada understands issues better than we do. Canada May Allow Small Amounts of Marijuana

Justice Minister Martin Cauchon, who introduced the bill in Parliament, said at a news conference in Ottawa, the capital, that most Canadians prefer that possession of small amounts of the drug become a "ticketing offense."

"We are not legalizing marijuana. We have no plans to do so. We are changing the way we prosecute certain offenses," Cauchon said.

"Cannabis consumption is first and foremost a health matter," he continued. "It should not result in criminal penalties. We have to ask ourselves as a society: Does it make sense that a person who makes a bad choice can receive the lasting burden of a criminal record? . . . The legislation I introduced today will make sure the punishment fits the crime."

Decriminalization, officials said, would be accompanied by a national campaign to alert Canadians to the dangers of drug use.

The bill would also increase penalties for people who grow marijuana illegally. Small amounts may be grown legally by Canadians who need marijuana for medical reasons.

Common sense from above the border will probably not translate to common sense in D.C. Many states would make these changes. When will we view recreational drug use as a medical issue? I include alcohol and tobacco in this category. We need medically directed management of these chemicals. We do not need further prohibition.

I have blogged about this previously. This commentary says it well. Lawyers who make you sick

The American medical system may be the world's best, but don't let that get you down. Our trial lawyers have the answer. They plan on suing the blankety-blank out of the pharmaceutical companies, relieving them of billions of dollars and forcing them, if all goes well, to concentrate on flavored aspirins and fingernail clippers.

Our legal eagles ? "(e)nriched and emboldened," as the New York Times puts it, "after successful fights against asbestos and tobacco companies" ? charge that the drug makers have been concealing dangers they know to exist with medicines like the antidepressant Paxil. These dangers exist because of the makers' affection for profit ? a disgraceful consideration that would never enter a trial lawyer's mind. Naturally.

Reading the commentary is worth your time. When will the madness end?

And this from the NY Times - Pressure Increases for Tighter Limits on Injury Lawsuits

Legislative battles in the states have also become intense as doctors protest what they call the effects of costly malpractice insurance and lawsuits. Hospitals in some states have closed their obstetrics departments because the risk of lawsuits and the price of liability insurance are both too high, an issue that resonates with the public. Measures drafted to reduce doctors' liability often contain language that will also limit other kinds of liability.

"This is a year where we had seen considerable opportunity at the state level, and the major reason is the health care issue has been driving the agenda," said Sherman Joyce, president of the American Tort Reform Association.

Just last week, doctors held a poorly attended rally in Manhattan in favor of changing state laws on tort litigation ? civil lawsuits arising from claims of injury, including injury as a result of malpractice. Doctors and insurers blame jury verdicts for the high premiums.

"That's where you see these losses," said Loretta Worters, a spokeswoman for the Insurance Information Institute in New York. The average medical malpractice award rose to $3.9 million in 2001, from $3.41 million in 2000 and $3.29 million in 1999, according to the institute.

I rant so often on tort reform, that I may have to take some law courses. Seriously (that was a joke) we have too much evidence of the cost to society of our current tort system. Unfortunately, most reform has to occur on a state by state basis. Thus, some states will win and some will lose in the business and medical marketplace.

I believe that much unhealthy drinking comes from our approach to adolescent drinking. Read this piece to understand my viewpoint (if I could only write this eloquently) - Let My Teenager Drink

As a wandering Post correspondent, I have raised teenagers in three places: Tokyo, London and Colorado. No parent will be surprised to read that high school and college students had easy access to alcohol in all three places. In all three countries, kids sometimes got drunk. But overseas, they did their drinking at a bar, a concert or a party. There were adults -- and, often, police -- around to supervise. As a result, most teenagers learned to use alcohol socially and responsibly. And they didn't have to hide it from their parents.

In the United States, our kids learn that drinking is something to be done in the dark, and quickly. Is that the lesson we want to teach them about alcohol use? It makes me glad my teenagers had the legal right to go down the street to that pub.

Two of my favorite medical writers have addressed the Atkin's diet articles published last week. Pounds Lost on Atkins Diet May Quickly Return from the NY Times.

The studies, reported in The New England Journal of Medicine, compared the effects on weight loss and cardiovascular risk factors of the Atkins plan with the conventional low-fat, low-calorie diet recommended by most health experts. Both diets resulted in weight loss, but participants on the Atkins diet lost more weight, faster.

But it is too soon to jump on the Atkins bandwagon in hopes of achieving bathing-suit slimness by the Fourth of July. Yes, the diet does help obese people lose weight quickly, and those wanting to shed 10 pounds in the next four weeks could achieve that goal. But the research suggested that by Labor Day many, if not most, are likely to be back to their starting weight.

The first five to seven pounds lost on Atkins are not fat but water, released by the body when it gets little or no starch or sugar from food. So as soon as you are unable to resist that bun with your burger or summer's succulent sweet corn, a cooling ice cream cone, thirst-quenching watermelon or a bag of fries, those lost pounds are likely to come bounding back.

And Miracle Cure? Fat Chance from the Washington Post.

Losing weight takes commitment. About 40 percent of participants in both groups quit the studies before they ended, a fact that some scientists said could bias the results. What the findings meant to Gary Foster, clinical director of the University of Pennsylvania's Weight and Eating Disorders Program and lead author of one of the studies, is this: "No matter what diet you're on, doing it alone is tough work."

Calories count. The Atkins philosophy is that total calories consumed don't matter, provided carbohydrates are severely restricted. But in one of the studies published last week, participants in the Atkins group ate fewer calories than those in the low-fat group, although the differences were not statistically significant. "The law of thermodynamics still holds here," says Frederick Samaha, chief of cardiology at the Philadelphia Veterans Administration Hospital and lead author of the study. "Weight loss is still entirely an effect of total calories in and total calories out."

And read RangelMD for a further discussion of this tautology - The Atkins diet: A case in calorie restriction.

Today's Wall Street Journal (subscription required) has an editorial on the need for tort reform - The Tort Temptation

Somehow in recent years the American tort system changed from one designed for justice to one bent on redistributing income. Now we are beginning to see the temptation to corruption that usually accompanies such political abuse.

...

The solution here is for state legislatures to return tort law to the business of promoting justice instead of making instant billionaires. Plaintiffs can still get their day in court, without putting the entire tort system in the dock.

These thoughts are very important.

Regular readers know my position on the financing of outpatient practice. Our current model does not work. We live under reimbursement controls, yet have no expense controls. We receive the same reimbursement for most visits, almost regardless of the necessary time needed for the visit. We have not received any income for other time consuming tasks (directly related to our physician roles). Many physicians are changing that - That's Going to Cost You: Pinched Between Rising Costs and Lower Revenues, Some Doctors Are Charging Patients for Phone Time, Paperwork and Other Services

While I prefer a modified retainer approach (patients would pay a set fee for a year of medical care), until we adopt such a system, these charges are ethical and necessary, for our only commodity is our time.

"Here's my philosophy," said Joseph A. Leming, the practice's managing partner. "Whenever physicians incur a cost or extend liability, they should be able to capture revenue to offset that cost or liability. The fact is, the cost of doing business is just going nuts."

Pincered by rising overhead and declining reimbursement -- and beset by burgeoning mounds of required paperwork -- a small but growing number of medical practices are quietly charging for services they have long provided for free.

Among the new billable items: talking on the telephone with or e-mailing patients or their relatives; providing copies of records to patients or sending files to another doctor; calling a pharmacy with a prescription refill; and completing forms for school, disability, medical leave, life insurance or summer camp. Some practices, including Capitol Medical Group, are charging patients for missed appointments or those canceled without at least 24 hours notice.

"Across the board, doctors are looking at ways to improve their bottom line," said Regina Regembal, a medical practice consultant in Winchester, Va., who noted that her clients in Virginia and North Carolina are actively considering whether to impose such fees. "The groups I work with don't want to do these things, but they want to able to pay their bills."

While the nascent trend is impossible to quantify, officials of medical organizations and practice consultants say the new surcharges are more likely to be found in the trio of primary care specialties that are the least lucrative and most patient-intensive: internal medicine, pediatrics and family practice.

"Over the last 10 years there has been pressure on physician fees," noted John DuMoulin, director of practice advocacy for the American College of Physicians, a group that represents the nation's internists. Prompted by members' inquiries, the College has drafted new guidelines for the reimbursement of telephone and e-mail communications.

The costs of running a medical practice have risen about 60 percent during the past decade, DuMoulin estimates, while reimbursements by the federal government and private insurers have remained static. "Patients are coming into doctors' offices less and demanding more services when they get there," he added. And primary care physicians complain that they routinely spend about two hours per day doing paperwork or returning phone calls -- services for which they are rarely reimbursed.

But then regular readers know about these factors. I keep saying that we must change our reimbursement system. I will keep saying this, as it does represent a major impediment to providing outpatient care for our population.

Medicare Must Take Cost Into Account

Ronald Berger's argument that Medicare should pay for expensive implantable cardiac defibrillators (ICDs) ["Life-and-Death Federal Meddling," op-ed, May 15] implied that Food and Drug Administration approval of ICDs is a reason for the government to pay for their use. FDA approval of a device does not mean the agency endorses insurance coverage of it.

Although the cost of expanded ICD use might account for less than 1 percent of health care expenditures, in a trillion-dollar-plus health care system, 1 percent is more than $10 billion.

That's a lot of prescription drugs. Further, the research cited in the article found that the $30,000 devices help only about one patient in every 17 during 20 months of follow-up. This means that the cost per life saved is many times the per-unit cost.

I agree that the Centers for Medicare and Medicaid Services should not manipulate scientific data to support policy positions. Officially or not, however, the agency ought to consider cost when determining what therapy Medicare will cover.

SARS vaccine booster - this article explains why developing a vaccine will take time.

Back in 1984, Health and Human Services Secretary Margaret Heckler announced a vaccine for AIDS "will be ready for testing within two years." Today there's no AIDS vaccine approval in sight. Now with severe acute respiratory syndrome (SARS) it's the same silliness. But the new tools of biotechnology do bring hope of much faster vaccine development.

"Vaccine [for SARS] Could Be Ready in 1 to 3 Years, Scientists Say," blared the sub-headline of an article in The Washington Post. Worse was CBS "Morning Show" host Harry Smith asking guest Dr. Anthony Fauci, "Is there a chance there'll be a vaccine by, say, next winter?" Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), politely replied, "I doubt [that] very seriously." A better response would have been to fall out of his chair.

On average it takes 10 to 15 years to bring a drug to market, according to a 1995 Tufts University study. (Not to mention about $800 million, according to more recent research.) But biotech has already sped up the SARS vaccine effort.

Developing and testing a vaccine represents a major project. You cannot skip steps. A bad vaccine (either one which does not work, or worse yet causes significant side effects) would represent a major problem. We cannot afford to release any vaccine which does not protect against SARS and which has minimal side effects. Thus, we need to work on quarantine procedures until our scientists can proceed properly with their jobs.

Illinois has done the right thing. I discussed this issue in my Q&A column yesterday. Illinois creates nation's first statewide ephedra ban

Ephedra, blamed for nearly 120 deaths, drew national attention after officials investigating the February heat stroke death of Baltimore Orioles pitching prospect Steve Bechler linked it to a diet pill containing ephedrine, ephedra's active ingredient.

The herbal supplement is sometimes marketed as an athletic performance enhancer.

The drive for a ban in Illinois began last September with the death of 16-year-old Sean Riggins of Lincoln, whose father said he was taking the supplement to help make the first-string football team.

"We have to make sure that (young athletes) can no longer go to the store and buy ephedra as easily as they can chewing gum,'' Blagojevich said Sunday. The ban took effect immediately.

Earlier this month, nutritional supplement retailer General Nutrition Centers said it would stop selling products containing ephedra. Florida Gov. Jeb Bush signed a law last week banning the sale of all diet supplements to children under 18.

The American Heart Association has urged a ban on ephedra sales, and the NFL, NCAA and International Olympic Committee have banned its use by athletes. Chicago Bears linebacker Brian Urlacher stood with Blagojevich on Sunday to support the ban.

Late Sunday, time to clean out my comments and emails. Sorry for the delay.

I feel that ephedra is not forced upon the general public, by the companies that produce it. It is forced upon us by the media. I never knew what in the world ephedra was until the news took all of the dirt it could dig up on the herb and force fed it to me. Ephedra is no more dangerous than alchol. I have never heard of an ephedra user killing any innocent victims, I want the FDA to pretend like the people that are of age, to decide the future of our country, are capable of watching there weight or increasing energy what ever LEGAL way they want!

This comment on ephedra misses the point. Ephedra is a drug, not a food. I have several problems with the current way supplements are sold in general. Ephedra makes the point well.

We have no quality assurance mandated for supplements. Thus, the dose you take has much more randomness than the dose of any prescription (or even non-prescription) drug. When you think you are taking a specific dose of ephedra, you may or may not be taking that dose.

My other major problem with ephedra is the lack of appropriate warnings and caveats. It is possible that one could use ephedra responsibly with little danger (note that I say it is possible - that hypothesis would require testing). However, as currently marketed people take this drug without sufficient medical supervision. It can cause sudden death. Ephedra is dangerous, and therefore it should have the same regulations as any drug you might buy.

"If we had no efficacy requirement, drug companies would have the ability to assert claims without supporting data. The evidence based physician would not have the data necessary to make good decisions about drugs."

There is a difference between an unelected bureaucracy requiring some particular standard for an efficacy claim, and longstanding law forbidding fraud. You seem to have no faith in the latter.

If a pharm supplier made false claims of efficacy, they would be criminally liable for fraud, just as is anyone distributing anything that is not subject to FDA's particular requirements for efficacy.

I'd trust my physician's opinion on efficacy over a bureaucracy's any day. If I find my physician's opinions inaccurate, I can change physicians. If I find the FDA's pronouncements inaccurate, I can't change government bureaucracies.

I find this an interesting argument. As I consider it, I have two problems (and hope the writer will respond). First, proving liability for fraud would require that we engage our legal system. I do not believe that our legal system can answer these questions as well as scientists answer these questions. Second, as a physician, I do not trust my opinions on efficacy as much as I trust the FDA. I do not have the data, nor the time to analyze the data if I had it.

I believe that you do misunderstand the FDA. Their analyses include physicians and statisticians. These are not bureaucratic decisions, rather scientific decision (in my opinion). Thus, while I share your distrust of bureaucracy, in this specific case I believe we do have the right bureaucracy.

Would the patient have preferred the physician have not talked to him? Is the value of the visit only in the hands-on component? I agree that the case has to be made that the physician's time has value, whether it is spent listening, examining, performing procedures or talking. Lawyers, who do lots of talking, never seem to have to make this argument. Why is that? And for some reason--which does not seem to apply to our lawyer brethern--only the doctor's time spent with the patient is deemed to be compensable. Try telling a lawyer that you will only pay for the time spent is his presence. The patient needs to understand that listening and giving professional advice is a service. I think that retainer-based practice, which you have argued for here in the past, would help to fix this problem.

As usual C. Henry has made the point very well. This comment reinforces everything that I have stated about our current reimbursement system.

I agree in the importance of case taking and case taking skills. But good case taking isn't talking to the patient, it's listening to the patient. When people tell me that the doctor they saw was "no good", I ask why. The number one reason is, "He doesn't listen to what I have to say. The minute I give my complaint, out comes the prescription pad and he's writing the prescription."

Point well made!! If all we do is talk, then shame on us. We must listen and respond to the patient. Perhaps the key here is conversation rather than lecture.

Does anyone suffer from cancer of the stomach as a result of taking Proton Pump Inhibitors ?? I read that this is a known side effect to occur on trials of the drug on mice!

This theoretical consideration has no data to support it. We have many years of PPI use now, with no epidemiological evidence of a stomach cancer - PPI association.

I'm aware of the problem that lawyers sometimes make settlments in class action suits that enrich themeselves but provide little reward to the defendants. I would like to see the problem fixed as much as you do. However, to ignore the problem of adverse drug reactions, which is a leading cause of death and injury in America, and criticize lawyers pursing the issue on behalf of their clients is a perverse set of priorities. Why doesn't this issue get the attention it deserves from the medical profession?

Physicians worry about adverse drug reactions constantly. We are faced with a difficult situation. We must balance potential benefit against potential risk. Often patients can help with the decision making, however, many patients will not participate in the decision making process.

So we are damned if we do, and damned if we do not prescribe a specific medicine. Side effects occur. We do our best to minimize their impact, but sometimes we have an unavoidable risk.

How should we give this issue more attention? Who are you blaming - physicians, insurers, or the pharmaceutical industry?

...

...

Thanks again for the comments and questions. I still have much to answer and comment. Hopefully I can find some time again tomorrow. Keep the comments coming, it certainly makes this blog a lot more interesting!!!

Pass the Butter, Please

Though the Atkins diet has been reviled by the medical establishment for decades as a bit wacky and even potentially dangerous, the two new studies and a third published last month suggest that the diet actually works better than standard low-fat diets in the short term, without any detectable signs of harm. It was a startling reminder of how little the experts know, in this obesity-plagued nation, about the best way to lose weight and keep it off.

I would argue with the last point. We do know how to lose weight and keep if off. The successful keys are portion control and exercise. What we do not know is how to succesfully get patients to follow the formula! Weight loss is achievable, but requires lifestyle changes. And lifestyle changes are not easy to induce.

Many patients want to blame someone or something for their health problems (or even their perceived health problems). We see this often with drug side-effects. Readers of this blog can turn to any new drug discussion, then read the comments section. Any perceived side effect automatically is blamed on the drug. However, studies which include placebos generally show sizeable side effects from placebos. This makes the data driven physician wary of attributing symptoms to drugs, until we collect appropriate data.

Most physicians that I know have remained skeptical about "Gulf War Syndrom". The British Medical Research Council has concluded that this syndrome does not exist. Gulf War Syndrome 'does not exist'

The MRC report, which reviewed all scientific research into the veterans' illnesses, is quoted as concluding: "There is no unique Gulf War Syndrome."

It said symptoms suffered by veterans were similar, despite varying exposures to vaccination, nerve agents, oil fire smoke and other potential hazards.

"In short there is no evidence from UK orientational research for a single syndrome related specifically to service in the Gulf," the report states.

The symptoms - which include tiredness, headaches, lack of concentration, memory loss and numbness or weakness - were shared by non-Gulf veterans, the scientists said.

They accepted that Gulf veterans were at increased risk of suffering from post-traumatic stress disorder, but since this affected about 3% of them it could not have caused the illnesses of all those claiming to have Gulf War Syndrome - a much larger group.

Depression and alcohol are much more important health risk factors," the report is quoted as saying. 'No case'

Patients and veterans groups do not want to hear this message. They are not interested in the data and scientific inquiry.

The study was dismissed by the Gulf Veterans and Families Association, which said: "How can the MRC say that Gulf War Syndrome does not exist when it appears in the Royal College of Medicine encyclopaedia?"

Having a "Gulf War Syndrome" to blame ones symptoms on makes life simpler. We all would rather blame than accept responsibility for our own health behaviors. Belief trumps data for many in our society. As a physician I must favor the data approach. Only through careful investigation of data can we discover medical truth. Anecdotes are interesting, but not scientific proof.

The new Annals of Internal Medicine has an important article on the utility of a new second generation rapid-turnaround quantitative latex d-dimer test for ruling out deep vein thrombosis (DVT). A Diagnostic Strategy Involving a Quantitative Latex D-Dimer Assay Reliably Excludes Deep Venous Thrombosis . This study first stratified patients using a standardized model for estimating pretest probability in patients with suspected DVT. The article includes the model. For those who cannot access the full text article, you can view the model here - Deep Venous Thrombosis and Thrombophlebitis.

The article has a simple, yet important message. They found that the combination of a low or moderate pre-test probability of DVT and a negative d-dimer test safely rules out DVT. This can help us avoid doppler testing or more invasive testing in many outpatients and inpatients. This strategy can also decrease costs.

I have ranted about this subject several times. Today I want to share two new observations, and try to place these observations into perspective.

Recently, I debated this subject at Grand Rounds. I concluded:

• H pylori infection can cause important disease (gastric cancer, atrophic gastritis and duodenal ulcer) and symptoms
• Treating h pylori decreases the probability of both the diseases and the symptoms
• While some dyspeptic h pylori + patients will receive no benefit from treatment
• A significant number will benefit ? thus we should treat!

Today's British Medical Journal addresses the evaluation of dyspepsia in patients 45 years or younger who have no alarm systems.

A "test for Helicobacter pylori and treat" strategy is more effective than treatment with a proton pump inhibitor for managing dyspepsia in young patients. In a randomised controlled trial in patients aged under 45 with uninvestigated symptoms of dyspepsia, Manes and colleagues (p 1118) compared empirical treatment with omeprazole with test and treat (urea breath test for H pylori followed by eradication treatment if necessary or by omeprazole alone). With the test and treat strategy, symptoms resolved in many patients and the need for endoscopy was reduced, whereas symptoms usually recurred after a trial of omeprazole. The authors conclude that test and treat should be the preferred option if empirical treatment of dyspepsia is to be performed.

The article - Empirical prescribing for dyspepsia: randomised controlled trial of test and treat versus omeprazole treatment - supports previous studies suggesting that this strategy is both cost-effective and better for decreasing future symptoms. This article certainly supports the position I took in the debate.

However, we may have another consideration for the future. H. pylori Infection May Protect Against Esophageal Cancer

Individuals carrying H. pylori "were significantly less likely than uninfected subjects to get esophageal adenocarcinoma," lead author Dr. Catherine de Martel, from Stanford University in California, told reporters.

In the study, the researchers reviewed the medical records of nearly 130,000 subjects who were followed since the 1960s. Fifty-two of the patients went on to develop esophageal cancer.

The researchers looked for signs of H. pylori in past blood samples from the patients and compared the results to those of 551 controls who never developed cancer.

According to Dr. de Martel, individuals infected with H. pylori had a 72% lower risk of developing esophageal cancer than uninfected individuals. This finding held even after researchers adjusted for other cancer risk factors such as age, gender, obesity, and history of smoking.

I find these results bothersome. While I still favor treating h. pylori in dyspeptic patients, we must investigate this hypothesis further. We may have a difficult decision in the future. If treating h. pylori decreases the risk of gastric cancer and increases the risk of esophageal cancer, what are we to do? If we confirm this dilemma, then our decision making will remain very difficult for years. Unfortunately, we may be damned if we do and damned if we do not treat h. pylori. I can only imagine how this could translate to the courtroom (db transforms into Stephen King, writing a medical horror story).

Robert Prather is a great blogger! There, I have typed it. Now read his rant on health care costs. I need not expand on his outstanding rant - Health Insurance Abuse

Tort reform, R.I.P. While this article refers to more general tort reform, the inability to pass this legislation seems chilling to those who champion malpractice reform.

Tort reform is a popular issue for Republicans on the stump. At a March speech to the American Medical Association, President Bush said, "Without fair and reasonable limits, the legal system looks more and more like a lottery. And with trial lawyers getting as much as 40 percent of the awards and settlements, it's pretty clear who is holding the winning ticket." Tort reform is a major plank of the president's plan to reform health care. Unfortunately, Senate Republicans blew an opportunity to make progress on limiting excessive lawyers' fees.

By a vote of 61-37, the Senate last Thursday rejected an amendment authored by Jon Kyl to the tax-cut bill that would have capped the amount lawyers could receive when working on major tort cases for the government, such as in the anti-tobacco litigation. Republicans voting against the amendment were George Voinovich, George Allen, Norm Coleman, Lindsey Graham, Lincoln Chafee, Saxby Chambliss, Thad Cochran, Mike Crapo, Mike DeWine, Richard Shelby, Gordon Smith and Arlen Specter. Trent Lott voted "present," and Orrin Hatch voted against it twice ? once in the Finance Committee two days earlier, signaling to conservative colleagues that it was acceptable to vote against it on the floor. Every single Democrat voted nay, except for Daniel Inouye, who didn't vote.

Despite the 14 Republican defections,Mr. Kyl's legislation was not radical or restrictive to the suing profession. It merely would have confined the lawyers' cut of awards of more than $100 million to 500 percent of "reasonable hourly rates." Poor chaps, the law would have pared their pay down to $2,500 per hour, from the $100,000 an hour some currently are making on the tobacco settlement.

For once I think that I am speechless.

We have followed this story closely for several months. This link summarizes the final bill - $15 Billion AIDS Plan Wins Final Approval in Congress

So the NEJM published two articles today on low carbohydrate diets. If you read the popular press you will see various spins on the results. The AP reports - Atkins Diet Bolstered by Two New Studies

The research, in Thursday's New England Journal of Medicine, found that people on the high-protein, high-fat, low-carbohydrate Atkins diet lose twice as much weight over six months as those on the standard low-fat diet recommended by most major health organizations.

However, one of the studies found that the Atkins dieters regain much of the weight by the end of one year.

The Washington Post reports Atkins Similar to Low-Fat Diets Study: Long-Term Results Differ Little

"The findings say that no matter what diet you're on, doing it alone is tough work," said the study's lead author, Gary Foster, clinical director of the University of Pennsylvania's Weight and Eating Disorders Program.

Because the Atkins diet encourages consumption of foods high in saturated fat, including butter, cream and steak, there has been great concern that it may increase the risk of heart disease. But three months into the study, there were no differences in the two groups in either total cholesterol or low density lipoprotein (LDL), the "bad cholesterol."

"The weight loss may override the effect of the high-fat, high-cholesterol" Atkins approach, said the University of Cincinnati's Bonnie J. Brehm, who has been studying the Atkins diet in women. "These findings are similar to ours."

And this report from Medscape - Benefits of Low-Carbohydrate Diet Still Uncertain

The controversy over the benefits of low-carbohydrate diet continues, according to two reports and an editorial in the May 22 issue of the New England Journal of Medicine. A randomized trial showed no difference in weight loss at 12 months for a low-carbohydrate diet compared with a conventional weight-loss diet. Another study in severely obese patients did show a benefit, but the duration of the trial was six months. The editorialist helps to clarify the message.

"Despite the popularity of the low-carbohydrate, high-protein, high-fat (Atkins) diet, no randomized, controlled trials have evaluated its efficacy," write Gary D. Foster, PhD, from the University of Pennsylvania School of Medicine in Philadelphia, and colleagues.

...

"Severely obese subjects with a high prevalence of diabetes or the metabolic syndrome lost more weight during six months on a carbohydrate-restricted diet than on a calorie- and fat-restricted diet, with a relative improvement in insulin sensitivity and triglyceride levels, even after adjustment for the amount of weight lost. This finding should be interpreted with caution, given the small magnitude of overall and between-group differences in weight loss in these markedly obese subjects and the short duration of the study," the authors write. "Future studies evaluating long-term cardiovascular outcomes are needed before a carbohydrate-restricted diet can be endorsed."

So what does DB think? First, these studies do vindicate the concept that weight loss trumps fat intake. The most important factor in maintaining or decreasing lipid levels comes from weight. Second, one can lose weight on a low carbohydrate diet. But finally, weight loss remains difficult. Diets can start the ball rolling, but true sustained weight loss depends on lifestyle changes. No gimmicks need apply. We must all figure out how to control portion sizes indefinitely and increase our calorie expenditure (through both resistance and cardiovascular exercises).

They have released the study results, and I remain confused. Results of Costly Emphysema Operation Are Mixed, Study Finds

An expensive and widely promoted lung operation for severe emphysema can make many patients feel better but on average does not prolong their lives, researchers said yesterday, reporting on the first large study of the procedure.

Two million Americans have emphysema, and the study is expected to help clarify who can safely have the surgery and who should avoid it. The researchers found that the operation either did not help or was too risky for 30 percent of the patients in the study, who had widespread lung damage. But in 25 percent, who had a different pattern of disease, the operation improved both quality of life and length of survival.

"The effects of the surgery vary widely among patients," said Dr. Gail Weinmann, a project officer at the National Heart, Lung and Blood Institute, a sponsor of the study. "It is not a procedure for everyone. This is information that doctors and patients need."

The government will use the results in deciding whether Medicare will cover the operation for those age 65 and over. Medicare does not now pay for the operation, which costs about $60,000, though it did pay for patients in the study.

Dr. Sean Tunis, chief medical officer of the Centers for Medicare and Medicaid services, estimated that a few thousand of the lung operations were done each year. He said Medicare would probably decide on coverage in 30 to 90 days and would probably decide in favor of the operation. Private insurers generally follow Medicare's example.

But, Dr. Tunis said, it was not clear whether Medicare would cover the operation for all patients with severe emphysema or only for those who met certain medical criteria. The government may also consider whether coverage should be limited to hospitals that have good track records with the operation, he said.

The surgery discussed here paradoxically is lung reduction surgery. Patients with areas of great destruction (and large blebs) theoretically would benefit when the worst areas are removed, allowing the remaining lung to function better.

About a quarter of the patients in the study were most likely to benefit from the surgery. They had two traits: emphysema predominantly in the upper lobes of their lungs, and a poor capacity to exercise. After 36 months, the death rate was 20 percent in those who had surgery, but 40 percent in those who did not. The surgery group was also functioning better and able to exercise more.

This information could help us decide to recommend surgery for a small, but definable, subgroup of patients.

An extremely important finding, the researchers said, was identifying very sick patients who should avoid lung reduction surgery, because it is unlikely to help them and runs too high a risk of killing them. Those patients, one in eight in the study, had damage throughout their lungs, and their ability to force air out of their lungs was no more than 20 percent of normal.

One hundred forty patients in the study fell into that category. In 2001, researchers found that 69 had no improvement in their quality of life after the surgery, and 16 percent died in the month after the operation, as compared with no deaths among patients in the same condition who did not have surgery.

Another group who did not benefit from the surgery were patients who had emphysema in parts of their lungs other than the upper lobes, and who had a somewhat higher exercise capacity. In that group, people who had surgery were twice as likely to die as those who did not.

The problem with these subgroup analyses relates to the general problem of subgroup analyses. The investigators designed the study to look at the overall patient group. Re-analyzing data in subgroups increases the chance of statistical error.

A statistics expert writing in the medical journal cautioned that findings based on subgroups of patients identified after the study was finished are not the strongest kind of proof. But Dr. Douglas E. Wood, a surgeon from the University of Washington in Seattle who participated in the study, said that it was statistically rigorous and that it would be unfair to patients to ignore information from the subgroups that could provide important information about who should and should not have the surgery.

We have a technique which may improve quality of life in selected patients. It is very expensive. The surgery probably harms patients who do not have the favorable profile. We need excellent pulmonologists to guide us in deciding about this surgery for individual patients.

For those who are interested, the original articles are prereleased on the NEJM web site.

Congress and the President are now focusing on a Medicare drug benefit. We should all view this debate cautiously. Pharmaceutical costs have a major impact on the sick. Without a drug benefit, only the wealthy can afford our many medication advances. We all agree that we would like to provide a benefit to all Medicare beneficiaries, however, we also must consider the fiscal viability of any such plan. Herein lies the debate, which the NY Times outlines well - Bush Drug Proposal in Medicare Plan Faces a Stiff Battle.

As Congress begins drafting Medicare legislation, one of the most contentious and politically explosive issues is whether the same drug benefits should be available to all.

The Bush administration and many of its allies on Capitol Hill say they want to use prescription drug benefits as an incentive to encourage older Americans to enroll in private health plans. People who stay with the traditional, government-run Medicare program would receive only modest drug benefits, while those who join private plans would be rewarded with much more extensive coverage.

White House officials and Republicans in Congress say the private plans would be more efficient than Medicare's lumbering bureaucracy. But the idea of using drug benefits to entice elderly people into those plans is in trouble on Capitol Hill.

Democrats are almost universally opposed to the effort, which they deride as a move to privatize Medicare. More ominous for the administration is the opposition of many Republicans, including several moderates who bucked the White House on tax cuts and several powerful lawmakers from rural states.

The debate is gaining urgency as Congress begins an intensive six-week drive to pass Medicare legislation, potentially one of the most significant domestic policy bills of the legislative session and one that is already behind schedule because of the struggle over tax cuts.

I personally am conflicted over this issue. Sorting out the pros and cons is, at least for me, dizzying. I do understand both sides of this issue, and can make a strong case either way. I could also attack each position.

The cost of prescription benefits will become staggering. How we pay for that benefit will, unfortunately, impact how we pay for the rest of health care. We should follow this debate and watch how the politics unfold. The process makes me uneasy.

The government says you're fat

Nor are Americans aware that the newly proclaimed federal policy comes right out of the United Nations. The World Health Organization and the Food and Agricultural Organization issued a draft "Report of the Joint WHO/FAO Expert Consultation on Diet, Nutrition" that made the case that various restrictions must be imposed on everything from soda to snack foods in order to save the world from fat people. The U.N. report manages to ignore the estimated 815 million undernourished people in the world.

This is a plan to create an Orwellian world in which everyone is compelled to do what Big Brother tells them to do. The U.S. campaign, though couched in terms of obesity's financial costs, is a subterfuge for yet greater control over our personal lives.

Health and Human Services Secretary Tommy G. Thompson was on television recently pointing the figure at the fast-food industry, urging it to "do what is right for Americans."

What is right is the right of all Americans to determine what and how much they eat, and to be responsible for whatever consequences they encounter.This is not a public issue. It is a private one.

It is one in which the government should have no role nor say.

Here is the problem. I do not mind people making a conscious decision to ignore their future health, whether by smoking, drinking excessively, or eating enough to become obese. What I do mind is the economic consequences that effect me!

If one chooses a lifestyle that increases health care costs, then one should pay those increased costs. Why should I pay the same health insurance rates as those who make unhealthy lifestyle choices?

We need a health insurance surcharge plan. That plan would include Medicare! If we cannot get such a plan, then your lifestyle choices (a great euphemism for smoking, drinking excessively and eating excessively) cost me money. And that is intrusive.

I get ongoing comments from readers who have taken Zetia and complain of side effects. Whenever I read of individual side effects, I wonder about causation. Thus, large placebo controlled studies generally provide more reliable data on side effects.

An article in yesterday's Circulation (subscription required) indirectly addresses this issue - Effect of Ezetimibe Coadministered With Atorvastatin in 628 Patients With Primary Hypercholesterolemia . They have patients who received placebo, ezetimibe, atorvastatin or both. One table summarizes the safety data. For this rant, I will report only the ezetimibe (Zetia) versus placebo data.

10% of patients taking placebo and 6% of patients taking Zetia had GI side effects. Thus, we cannot blame GI side effects on Zetia. 5% of each group had muscle complaints. Again we cannot blame muscle complaints on Zetia.

Analyzing these data makes an important point. The onset of symptoms which coincide with starting a new drug does not necessarily mean that the drug caused the symptoms. Placebos cause a lot of symptoms.

Most patients believe their own anecdotes. They know that they can blame the drug. However, careful scientific inquiry may call that belief into question.

Drugs can cause side effects. Many such side effects are well described and well known. However, prior to accepting that a drug causes a side effect, we should determine scientifically the incidence and severity of the effect. We should also prove that the claim cannot be explained by coincidence. In the case of Zetia, I suspect that most of the claims I receive in my comments section are in fact coincidence.

While it seems as if I write about malpractice incessantly, I omit many stories. Overlawyered.com does a great job keeping up with this crisis. Go read (but maybe take a Valium first) - Malpractice studies

Congress's Joint Economic Committee publishes a new study finding that the medical malpractice litigation system performs poorly in both its major social roles: deterring medical negligence and fairly compensating the negligently injured. Reform including liability limits would offer substantial benefits that could include billions in annual budgetary savings to the federal fisc and improvements in medical care affordability that could permit millions of Americans to be priced back into the health insurance market.

A great way to improve health care access is to solve the malpractice crisis. But I guess the Democrats will deny that message.

Sometimes I start to think that I am a broken record. I keep harping on this theme. I try to break my addiction, but I just cannot. This issue is so important that I cannot avoid it.

Tort crisis limits hospital services

A majority -- 53.1% to be exact -- of the more than 1,000 hospitals surveyed in the 18 states the American Medical Association has determined are in the middle of a medical liability crisis say it's more difficult for them to recruit physicians.

About 45% of the hospitals in those states say high medical liability insurance premiums have forced them to cut emergency department coverage.

Nearly 35% of hospitals say insurance woes have caused a negative impact on their ability to provide services, particularly trauma care and obstetrics.

And nearly 19% of hospitals say professional liability premiums have had a "significant" impact on their community's access to care.

But when will our society and our legislators listen to the physicians and the hospitals. The problems are so obvious, and yet they garner little attention. If I were just a bit more cynically, I would roll my eyes, and pontificate. It will get worse. People will die, or suffer. And it will not be the medical professions fault. Maybe trial lawyers can learn neurosurgery.

As I wrote last week, we have a new label - pre-hypertension. The committee chose to label patients with the hope that they would take action to prevent higher blood pressures. Some patients have hypertension regardless of lifestyle. They should not feel guilty, and we should not make them feel guilty. Others, however, develop hypertension as part of the "metabolic syndrome". They could, and should, prevent hypertension during the pre-hypertension phase. Lean Plate Club: Evading Hypertension

Are you one of the 45 million people who learned last week that their previously normal blood pressure is now considered unhealthy?

Before your blood pressure rises any higher with worry, know this: Federal health officials also underscored that one of the best ways to help bring blood pressure under control is by -- drumroll, please -- achieving a healthy weight, eating better and getting more physical activity. (This advice should be familiar to Lean Plate Club members.)

There are no surprises here. There are no magic bullets. Your probability for greater quality and quantity of life increases as you take care of yourself - especially with prudent diet, maintaining a good weight, and exercise. This message comes through in many forms and many studies. Now all we need is a way to stimulate self-discipline.

As an internal medicine attending, I often stress the importance of making the correct diagnosis. This link, from the NY Times, makes that point well. First, read the presentation. Think of the probable diagnosis, then go read the article to check yourself.

But ultimately, Tom did not die because of the technical limitations of medical hardware. Rather, he died because two decades ago, when his first symptoms appeared, no one thought to search for their underlying cause.

Tom was in his early 30's when he lost interest in sex and was bothered by achy joints. He saw his doctor, who found Tom's testosterone level to be extremely low. Tom was started on testosterone treatment, as well as over-the-counter anti-inflammatory medication for the arthritis. Tom's libido returned, and his joints improved; the medications seemed to work.

Gradually, Tom's skin became darker. He attributed this to a tan, though he spent little time in the sun. A year ago, he noticed difficulty exercising. His abdomen began to swell, and when he could take only a few steps before becoming short of breath, he came to the hospital.

Today is Medrants birthday. When I started a year ago, I had not thought carefully about what daily blogging would mean. Why was I doing this? What did I hope to achieve?

Two months after starting, I ranted a bit about blogging. Rereading those words puts today into perspective - About my blog .

A year of blogging has helped me grow as a writer and as a thinker. I spend more time each day considering the latest medical literature and how it might impact practice. Prior to ranting, I mean to consider each finding carefully, providing my interpretation and trying to support my reasoning.

These exercises have formalized a process that I did sporadically. I read more articles now. I stay more up to date.

Blogging has made me more aware of the economic pressures on medicine. I try to include these issues in Medrants because I believe the readers care. Perhaps we (db and the readers) can influence the debate. While that idea seems grandiose, I do believe we can influence how people consider these issues whenever we engage in the debate.

Personally, I find writing this blog a great pleasure. I believe that my writing has improved and I find myself writing more willingly and more often (even when not blogging).

As I have said in the past, I mostly write Medrants for myself, however, I confess that my ego loves the attention that it receives from others. The daily comments that I receive and read tell me that my words mean something to others. The thank you notes that I receive are very special.

Blogging is a joy. Daily I can express myself, be outrageous if I like, educate occasionally, and consider the medical world carefully. Blogging time allows me to think, consider, and grow intellectually. What a great decision I made a year ago! What a wonderful experience!

Thanks for reading Medrants.

As I have reflected on this year of blogging, I have considered my hot topics. They have changed over the year. I suspect that they will change several times over the coming year.

Last year resident work hours started as one of my major topics. Over the year, the ACGME made their decision (mostly correct, although I do disagree with a few details) and we (housestaff programs) are all preparing for July. I will be ward attending in both June and July, thus I will personally experience a new system in transition.

How programs adapt to these new rules will be a story interesting mostly to insiders. I will however comment on the changes periodically.

Over the past 6 months the malpractice crisis has attracted much attention on these pages. I suspect that I will continue to rant about malpractice suits, and the unintended consequences of those suits. This subject has helped me understand the economics of medical care. I now understand clearly that we do not work in a free market system.

We need (as I have said, and will say incessantly) better methods of valuing and charging for medical care. Physician reimbursement methods are unsuited to current expectations and needs. Our system makes it difficult to increase collections, however there are few constrainsts on increasing expenses. The system is broken, and must be fixed for patients to receive the high quality care they deserve.

Medical advances continually amaze me. Most weeks I can rant about an important new study which helps us understand disease, or even changes how we provide care. The study of medicine has fascinated me for 30 years and will continue to fascinate me for many more.

Considering each day the myriad topics about which I could rant adds intellectual rigor to my day and my life. I hope that these topics interest you. I believe them important to physicians, other health care professionals and to all who may become patients.

Check my pulse, this rant defends the pharmaceutical industry! Seriously, the pharmaceutical industry has contributed greatly to our improved health - both quality and quantity of life. But the trial lawyers see more deep pockets. Watch out for some costly suits. Trial Lawyers Now Take Aim at Drug Makers

Enriched and emboldened after successful fights against asbestos and tobacco companies, some of the nation's top plaintiffs' lawyers have trained their sights on drug makers, claiming that many giant pharmaceutical companies have hidden the dangers of medicines the lawyers say have harmed thousands of people.

In some cases the drugs at issue have already been pulled off the market, like Rezulin, a diabetes treatment from Pfizer that the Food and Drug Administration has linked to liver damage and is the target of almost 9,000 suits. Other suits name some of the industry's current best sellers, including Paxil, an antidepressant that plaintiffs contend is addictive — a claim denied by the drug's maker, GlaxoSmithKline.

In some instances, teams of plaintiffs' lawyers are spending several million dollars preparing cases for trial, in the hopes of winning billions of dollars in settlements and jury verdicts from the drug companies, which have some of the deepest pockets among American corporations.

The lawyers pursuing the suits say that the Food and Drug Administration has systemically failed to protect patients from dangerous drugs, and that the companies have tried to hide side effects. But the agency says medicines are safer now than they have ever been.

Depressed? Go see a trial lawyer. Pregnant? Call a trial lawyer.

The trial lawyers have no controls. They never seem to consider the public welfare. They see dollars, deep pockets, and potential victimization.

Why do I rail against the trial lawyers? They bother me for several reasons. First, they always appear sanctimonius. They are only suing to protect the "little people".

Second, I understand the contingency fees for which they work. They want large settlements, partly because they keep a large percentage.

Third, their suits undermine the fabric of our society. That seems a bit harsh on first reading, however, I believe that their accumulated suits (and incessant advertizing) have contributed towards our become a society of victims. Their attitude, and more important their actions, make us believe that we should never have adverse outcomes, else we can blame someone and sue them .

If they succeed with these law suits, then future patients will suffer. But they do not seem to care. They see targets for suits. They vision money trees. They never seem to understand the consequences of their "victories". And our society is damaged with each verdict.

The NY Times gets it! Diagnosing SARS in China

Unfortunately, China's leaders have not fully grasped that Beijing's catastrophic mishandling of the health crisis is as much a political failure as a medical calamity. The country's new president, Hu Jintao, has won praise for firing incompetent officials and ordering the release of more timely statistics tracking SARS, but far more ambitious reforms are needed.

China still isn't being open enough about SARS to satisfy the World Health Organization and scarcely open at all about other subjects vital to its citizens' lives. Mr. Hu appears to have little interest in modernizing China's political system.

In response to the SARS crisis, Mr. Hu has turned to depressingly familiar Communist methods of exhortation and regimentation. These include a Mao-style order to build a new SARS hospital from scratch in barely a week. Public health policies have been highly punitive, like last week's decree threatening people who knowingly spread the SARS virus with possible execution.

These words ring true. When political considerations threaten the public health, then the political system should change. The Times understands.

Nonprofit Health Care Takes a Hit. I will quote this entire letter to the Washington Post.

Yes, private-practice doctors are having difficulty obtaining malpractice insurance [Business, May 10], but nonprofit health care organizations are taking just as big a hit.

Premiums for physician malpractice insurance at Whitman-Walker Clinic jumped last year from $50,000 to $150,000. And because the number of insurers in the Washington market fell from 11 to two, at one point we were one day away from suspending medical services because we couldn't find coverage. The extra $100,000 we now have to pay could go a long way toward providing our 7,000 clients with health care they desperately need.

Their only sin is trying to provide health care in DC. Malpractice causes problems for all of society. This is the health care crisis.

No trial lawyer means to decrease health care access. Nonetheless, their actions have that effect. No jury rewards a huge settlement with the understanding of the down stream implications. They hit the deep pockets of the insurance companies. Everyone forgets where the money comes from, and the unintended consequences of each settlement.

Most readers know that I generally dislike herbal supplements. I want the same data on supplements that I expect on pharmaceuticals. Going to a pharmacy has become a nightmare to me. They sell stuff over the counter which can harm patients.

Larry King's testimonial spooks me. Why would anyone take medical advice from him? He has touted Ginseng but never discusses data - because there are no data for its benefit. Ginseng fails to increase energy, immunity in tired people, study finds

Ginseng is touted as an energy and immunity booster, but the popular herb didn't do much for healthy volunteers who took it for eight weeks.

Actually, ginseng did nothing for those volunteers. It only helped the unscrupulous supplement industry who sells this stuff.

I did not know this. I had not considered this. The information in this op-ed piece does disturb me. Do You Know Where That Cartilage Came From?

Human tissue transplants are being used with increasing frequency to reconstruct injured or aging body parts. In the coming year, cartilage, tendon, bone and other tissues will be used in nearly one million procedures. They will be implanted in arthritic knees and inserted between vertebrae to stabilize the spine in cases of chronic low back pain.

Despite the growth in these procedures, the Food and Drug Administration has failed to regulate human tissue transplants. Moreover, it shows no signs of taking action any time soon. The agency's apathy, highlighted in a Senate hearing this week, is particularly vexing because in 1997 it announced plans to draw up human tissue regulations, and later floated proposals to test donors for infectious diseases and to require standards for the processing of products that contain tissue.

At first glance, this is difficult to fathom. But the lapse in federal oversight can be explained when the potential consequences of F.D.A. regulation are explored. Once questions about the safety of tissue transplants are asked, it is not long before other questions come along — questions about whether such transplants actually work. This is an area where some in the medical community would prefer not to venture.

These introduce a troubling question. Surgeons are tranplanting tissues, and have no trials showing efficacy. These tissues can carry infection. The author poses some excellent questions. Maybe this article will bother you too.

Found this link thanks to Jane Galt - Asymmetrical Information. Premium Blend: Why is it so difficult to provide universal health care?

...the core economic issue: It's the rising cost of health care that has left some 41 million Americans without health insurance today. For the last 30 years, health-care costs have been rising 6 percent to 8 percent a year—more than double the inflation rate in the rest of the economy—because demand keeps outstripping supply. Moreover, the forces behind this exploding demand cannot easily be changed or affected. As people's real income rises, they expect more medical care; our society is aging, so people need more care; and with new technologies treating formerly intractable conditions, people want more care.

In practice, almost everyone, insured or not, has access to health care, especially in emergencies. Insurance affects how much people actually use health services: The access of the uninsured involves inconveniences and costs that encourage them to underconsume medical services, sometimes with grim results. By contrast, people with insurance often have such broad access that many overconsume those services. These consumption patterns drive the price increases that ultimately shrink insurance coverage. Still, it's hard to blame Gephardt or Dean for skipping past the cost issues, since every effort in the last 30 years to stem those costs—creating Medicare and Medicaid, wage and price controls, government threats of strict cost containment regulation, and the rapid spread of managed care—has failed. Anyway, who gets elected president by telling people that their health-care costs will soar so long as everybody has access to the most expensive forms of care?

The problem lies not in people's natural desire for the best (and most expensive) care, but in the way our health-care market operates—especially the weakness of the market forces that normally slow high inflation. That makes health care a prime example of what economists call "path dependency," where pivotal events from long ago shape a sector's development more than normal competitive forces. Health care's path began when employers in World War II, desperate to attract workers without breaching wage controls, first offered health insurance as an untaxed fringe benefit. This approach took strong root, because tax law requires that firms providing any tax-free form of compensation have to offer it to all their employees.

Over time, these beginnings brought most people into an insurance system that insulated them from the full cost of each treatment; they also left government as the insurer for everyone outside the work force, notably retirees and the poor. All insurance markets are subject to "moral hazard," where the small personal cost of using the insurance—a co-payment in this case—encourages people to overuse it for minor complaints. The hazard is intensified in the case of health care, because people don't pay for the insurance directly. To be sure, working people ultimately pay for their coverage in lower and slower-rising wages, but the cost of premiums is still subsidized by its tax-free treatment; and since employers write the checks for us, we don't even feel the pinch directly when premiums go up. (Imagine how much less coverage many would accept if we all had to write annual premium checks for $4,000 or $5,000.) These hazards are even greater in public-sector health care, where the retirees and poor people consuming most of the services don't bear most of the taxes financing them.

Individual costs are rising, but other forces continue to undercut greater price discipline. In most markets, for example, this discipline also depends on people having the information required to judge the value of goods or services before they buy them. In health-care markets, how many people have the information to say no to a more expensive test for diabetes or a treatment for a heart murmur? The norms of the medical profession are supposed to reduce this "agency" problem by aligning a doctor's incentives with a patient's medical interests (especially when the prospect of a malpractice suit reinforces these incentives). But there's no mechanism to align the financial interests of doctors and their patients. So doctors can deliver sound health services in ways that maximize their billings.

When prices rise unusually fast in other markets, people can usually find and substitute cheaper products: Beef prices rise and people eat more chicken, or a real-estate bubble drives up housing prices and people downsize their residential ambitions. That doesn't work nearly as well in health care, when patients are told that the alternative to a costly test or procedure is poor health or even premature death.

Finally, health-care inflation suffers from a classic "free rider" problem. Everyone has a common interest in moderating demand if it will ensure continuing coverage. But no one has an incentive to take the step alone, so no one does.

I hope you read those paragraphs carefully. Shapiro has summarized the dilemma of health care costs beautifully!!

He offers a modest solution, but admits that it is unlikely to work. As long as we have no connection between health care costs and personal expenditures, we likely will have no major health care reform.

Economists cannot tell us how much health care we need . Rather, as a society we determine how much health care we want . Unfortunately, our desires have no relation to what we would spend. The current system has no balances. Universal health care would not improve that problem, it would only shift the locus of control. One need only look to Canada and Great Britain (amongst many) to understand the types of health care cost decisions made in a single payor system.

Our health care insurance system is broken. Perhaps we could look at ways to improve that system, and in some way link behaviors with costs (e.g., smokers and the obese would pay higher insurance) and expenditures with graduated co-pays. Only when each individual starts to understand costs will market forces apply. Without the power of market forces, I suspect that we will be continuing this debate for many years.

First Biotech Drug to Treat Asthma Clears Key Panel

An advisory panel of the Food and Drug Administration yesterday endorsed Genentech's new asthma drug, the first biotechnology product for the disease.

The advisory panel, meeting in Gaithersburg, Md., voted 11 to 0 that the benefits of the drug, known as Xolair, outweigh its risks. The vote is expected to pave the way for the F.D.A. to approve the drug next month. Genentech, which is based in South San Francisco, Calif., developed Xolair with Novartis, the Swiss pharmaceuticals company, and Tanox Inc., a biotechnology company in Houston.

"I think that's as good as the company can hope for," Joel Sendek, an analyst at Lazard, said of the panel's vote.

Still, the panel members, who are mainly medical professors and practicing physicians, had some concerns about the safety of the drug and its effectiveness in certain patients, including those over 65. The agency's staff, in its own review of the data, said that the drug's effect was modest.

The biggest safety concern is that the drug might increase the risk of cancer. The rate of cancer in the group treated with Xolair in clinical trials was 0.5 percent, more than twice the 0.2 percent in the group that received a placebo.

Panel members said this evidence was inconclusive because of the small number of patients who developed cancer. Also, some members said, cancers usually take years to develop, making it unlikely that the drug caused the cases that arose during the yearlong clinical trials.

My quick summary - we have a new asthma drug which should receive approval. Now we need to understand its mechanism, and likely use.

Xolair is a monoclonal antibody, a type of genetically engineered protein, which would make it the first protein drug to be approved for asthma. It is taken by injection once or twice a month. The antibody blocks the action of immunoglobulin E, a substance in the body that helps set off allergy and asthma attacks. While many drugs try to blunt an attack once it begins, Xolair is designed to prevent such attacks from starting at all.

In clinical trials, those who took the drug had a lower number of asthma attacks than those who received a placebo. More of the treated patients were also able to reduce or eliminate their use of inhaled corticosteriods, which can have long-term side effects. One person who took the drug in clinical trials told the panel that he was able to join a softball team for the first time.

Genentech, Novartis and Tanox originally applied in 2000 for permission to sell Xolair to treat both asthma and hay fever in both adults and children. But the next year, the F.D.A. requested more safety data. The companies then decided to apply only for asthma use and only in adults and adolescents.

This drug does not represent a panacea. However, it will add another option for some patients. As usual it will take some time to understand how it works in routine practice. I am somewhat wary, but do find this an interesting possibility.

Robert Goldberg certainly makes you think. Read this opinion piece on the lack of sound epidemiologic practice and the spread of HIV. Disease control

A person suspected of having SARS refuses to be tested for the disease and, instead, files a lawsuit claiming that government-mandated screening is a violation of his constitutional right to privacy and the Fourth Amendment's prohibition against unreasonable search and seizures. Then SARS activists ? afraid of being "treated like lepers" ? hold up Food and Drug Administration approval of a private home SARS testing kit on the same grounds and because of objections that home tests didn't have face-to-face counseling. They also threaten to seize the patent of any company that develops a SARS drug or vaccine and give it to any generic company to ensure "access." Guess how far SARS would spread in the face of such obstacles?

Now, replace SARS with HIV, and you get an idea of why we may have a chance to control the spread of SARS and HIV will never be contained. Chalk it up to post-September 11 thinking about terrorism, bioweapons and the vulnerability of borders perhaps, but SARS is regarded as a clear public health crisis ? and nothing else. But our approach to fighting SARS could be the exception, not the rule. This is why the incidence continues to climb here and ? with greater speed ? in Africa, and parts of Asia.

SARS and HIV are the same in one respect: You can test positive but not show symptoms. That means the only way to control it is through testing, screening and education. But for years, the AIDS community fought implementation of such simple public health measures or what one epidemiologist in Beijing calls Disease Control 101.

That is because then and now, the HIV crisis is defined as a political and legal battle, a civil rights movement instead of a public health crisis. Twenty years ago, HIV activists had good reason to worry that an effort to contain HIV would also be used to discriminate against gay men. Fortunately, America responded aggressively to outright discrimination by disease.

He asks why we can not treat HIV like another other communicable disease. What costs have we paid as a society by treating this poltically?

The reports first hit the net yesterday morning. Yesterday evening I heard commentary on talk radio, then saw news stories about the new guidelines. Rather than quickly linking to this story, I decided to read the guidelines carefully so that I would understand the key points - The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (published online in JAMA - hard copy comes out next Wednesday). It behooves us to carefully go through the key messages.

The following are the key messages: (1) In persons older than 50 years, systolic blood pressure (BP) of more than 140 mm Hg is a much more important cardiovascular disease (CVD) risk factor than diastolic BP; (2) The risk of CVD, beginning at 115/75 mm Hg, doubles with each increment of 20/10 mm Hg; individuals who are normotensive at 55 years of age have a 90% lifetime risk for developing hypertension; (3) Individuals with a systolic BP of 120 to 139 mm Hg or a diastolic BP of 80 to 89 mm Hg should be considered as prehypertensive and require health-promoting lifestyle modifications to prevent CVD; (4) Thiazide-type diuretics should be used in drug treatment for most patients with uncomplicated hypertension, either alone or combined with drugs from other classes. Certain high-risk conditions are compelling indications for the initial use of other antihypertensive drug classes (angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, -blockers, calcium channel blockers); (5) Most patients with hypertension will require 2 or more antihypertensive medications to achieve goal BP (<140/90 mm Hg, or <130/80 mm Hg for patients with diabetes or chronic kidney disease); (6) If BP is more than 20/10 mm Hg above goal BP, consideration should be given to initiating therapy with 2 agents, 1 of which usually should be a thiazide-type diuretic; and (7) The most effective therapy prescribed by the most careful clinician will control hypertension only if patients are motivated.

They are not making explicit a finding that we have known over the past several years. Systolic hypertension probably does more damage than diastolic hypertension. Thus, we should strive to get the "top number" within acceptable limits (especially for those of us > 50).

They now define prehypertension because of message #2. Studies have shown that risk starts increasing once the BP exceeds 115/75. Thus, the prehypertension group (see message #3) does have some increased risk.

Unfortunately, he third message has gotten the most press. For example, U.S. Lowers 'Normal' Levels for Blood Pressure Readings appears in the New York Times. The text reads better than the headline -

"The prehypertension area is important," Dr. Edward J. Roccella, coordinator of the program, said. "We want people to act long before the disease is established, to prevent the progressive blood pressure rise."

In addition to weight loss and diet changes, he said, the program was recommending 30 minutes of exercise most days, which could be broken into two 15-minute walks.

"If you don't have time for physical activity, you will have time for illness," Dr. Roccella said. "Illness doesn't make an appointment."

Blood pressure tends to increase steadily with age, and the new report says that even people whose readings are normal at the age of 55 have a 90 percent chance of eventually developing high blood pressure, although changes in diet and exercise can ward it off.

So this new category of pre-hypertension is meant as a "wake up call". Once your BP starts to increase, we (generalist physicians) should us this new label - prehypertension - to further motivate diet, weight loss and exercise. We should also carefully evaluate these patients for other cardiovascular risk factors.

Is this really a big change? Perhaps, for some physicians it is, however, these guidelines merely codify current desirable preventive practices.

The statement on thiazides is well balanced and therefore admirable. They recognize "compelling indications" for other anti-hypertensives as first-line therapy. In the absence of those indications they recommend thiazides first. With those indications, they recommend that we use thiazides as the second drug in combination therapy. They list the compelling indications in Table 6. This table appears accurate and worthwhile.

They recognize that most hypertensive patients will need combination therapy to achieve the BP target of < 140/90 or < 130/80 if the patient has either chronic kidney disease or diabetes mellitus.

In an interesting and logical new recommendation, they recommend starting 2 drug therapy for patients with BP for 160/100 or higher. They list the combination drug possibilities, stressing that combinations which include a thiazide are highly preferred.

They finish their key messages stating that patient motivation keys our success. Physicians cannot treat hypertension, they can only provide the tools for patients to treat their own hypertension successfully.

You can also read more about the guidelines on the NIH web page devoted to JNC 7 - The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7). Overall, this is a well considered, logical and balanced report. It does not change dramatically my current practice, but does refine some details.

Now I still need to understand how to get patients to diet and exercise. These lifestyle changes can improve our longetivity, and more important our ongoing quality of life. It seems so simple on paper, yet it is so difficult in reality.

Several weeks ago in clinic I made this point. Another attending challenged me, questioning whether I had data for this claim.

In COPD, patients have more larger airway bronchoconstriction (as opposed to asthmatic patients who have more smaller airway bronchoconstriction). Since anti-cholinergics provide more relaxation of larger airway bronchoconstriction, it seems logical that they would work better in chronic bronchitis (with some reversible obstruction). However, I did not know a specific article (although I thought that I had read something to that effect). Here comes a study to my rescue! Tiotropium More Effective Than Salmeterol in COPD

Tiotropium is more effective than salmeterol for treating chronic obstructive pulmonary disease (COPD), according to the results of a study published in the May issue of Thorax. This long-acting, inhaled anticholinergic has not yet been approved.

"Exacerbations of COPD and health resource usage were positively affected by daily treatment with tiotropium," write V. Brusasco, from Universita di Genova in Italy, and colleagues. "With the exception of the number of hospital days associated with all causes, salmeterol twice daily resulted in no significant changes compared with placebo."

The investigators enrolled 1,207 COPD patients in two six-month randomized, placebo-controlled, double-blind, double-dummy studies of 18 µg tiotropium once daily via HandiHaler or salmeterol 50 µg twice daily via a metered dose inhaler.

Combined analysis of both trials revealed that compared with placebo, tiotropium but not salmeterol was associated with a significant delay in time to onset of the first exacerbation. Compared with placebo, there were significantly fewer COPD exacerbations per patient-year in the tiotropium group (1.07 vs. 1.49; P < .05), but not in the salmeterol group (1.23; P value was not significant).

Hospital admissions for COPD exacerbations were 0.10 per patient-year in the tiotropium group, 0.17 for salmeterol, and 0.15 for placebo. Hospital admissions for all causes were also reduced in the tiotropium group. Both the tiotropium group and the salmeterol groups had fewer days in hospital than did the placebo group.

We always use ipratropium bromide (Atrovent) in our hospitalized COPD patients. I look forward to the FDA approval of this longer acting anticholinergic option.

Prescription drugs can greatly improved our quality and quantity of life. Advances during my medical career (I graduated from medical school in 1975) have occurred in the treatment of almost every important disease. However, all substances that we ingest can have side effects. Some drugs have the potetential to do good, but the risk of causing problems. Apparently the media generally emphasizes the good - Media May Mislead on Drug Study Stories

News reports about newly available prescription drugs are often incomplete and unbalanced, according an analysis of Canadian newspapers. The findings suggest that consumers need to be more skeptical about what they read as a consequence, the researchers said.

Researchers, led by Alan Cassels of the School of Health Information Sciences at the University of Victoria in British Columbia, found that newspaper stories often overemphasized the benefits of drugs, and many articles did not adequately address the risks associated with taking the drug.

Furthermore, according to the study released this week by the Canadian Center for Policy Alternatives, when information was provided regarding benefits and harms, it was quantified in only one in four articles, and in 26 percent of these it was 'misleading.'

'Misinformation and biased information leads to overuse and inappropriate use of drugs,' said Cassels in an interview with Reuters Health. He explained that the situation is 'worse' in the US, where direct-to-consumer advertising of prescription drugs is legal.

Just over two-thirds of stories did not mention any side effects, and in those that did discuss harms, they were often in the bottom half of the article. Contraindications were mentioned in only 4 percent of cases, and the financial ties to drug manufacturers of individuals giving testimonials about the drug were often not disclosed.

We would hope as physicians that we could give excellent advice about each drug we prescribe. However, we must first gain the appropriate knowledge, and then have the time to educate the patient. As I write incessantly, time is our only commodity, and we do not have enough of that commodity. Thus, physicians often are not up to date on the side effect profile of every new drug. Moreover, they rarely take the time to educate the patient.

Drug side effects are important, and should receive more attention. Perhaps if the media emphasized the side effects more often, patients would ask questions about side effects and prompt their physician to engage that discussion. Perhaps not.

Like Jane Galt, I am working through my thoughts on the Democratic health care proposals. In the meantime, read these two posts from her site - HillaryCare, Part II. In this post, she challenges readers

But here's the thing: I'm unaware of any situation in which sick children go without seeing a doctor simply because their parents can't afford it. Poor people have Medicare. Less poor, uninsured people have free clinics, out-of-pocket payments, or the emergency room. The only situation in which I can see this occurring -- that a child goes without a doctor simply for lack of health insurance, rather than because of other parental dysfunction -- is one in which a lower-middle-class family cares more about their credit rating than their child. In other words, it seems vanishingly unlikely.

But perhaps I'm wrong. Can anyone produce evidence -- not anecdotal, "my cousin says. . . ", but real data consisting either of peer-reviewed studies not funded by single-payer advocates, or of personal experience in which you, or a member of your immediate family, did not take a sick child in need of medical attention to the doctor because of the expense? Children with the flu, or other non-fatal maladies for which the only treatment is rest and liquids, do not count. Perhaps in some theoretical medical textbook world, they should see a doctor to ensure that it's nothing serious -- but my mother didn't take us to the doctor for those things, and we had perfectly good health insurance. The pain-in-the-ass factor is too difficult to separate from the expense factor in mild illnesses, so please -- only serious cases.

So Jane instead gets an email example which proves her point. Wow. I just got this amazing response to my post on Dean's health care rhetoric: The response is heartwrenching and finishes with this quote

I don't know if anything I've written above might be of use to you in your coming "pungent words". I have to admit, writing this was at least 20% therapy for me (I've wanted to say these things for some time now - your post just opened the door). But I have a very compelling reason for opposing anything resembling HillaryCare.

I've been through the worst case scenario most HillaryCare advocates like to use as a rhetorical bludgeoning tool - and it convinced me just how wrong they are.

Research on SARS continues to move at a rapid pace. This article suggests a possible treatment based on the biology of the virus - SARS drugs may already exist

German scientists announced Tuesday that they have isolated a key protein that the SARS virus needs to attack the body, and that drugs designed to inhibit the protein may already exist. Meanwhile, China eased some SARS quarantine orders in the hard-hit capital of Beijing, and Greece and Nigeria said they may have their first cases of the virus.

IN A STUDY appearing this week in the journal Science, the researchers say their study suggests an experimental common cold drug called AG7088 may be able to keep the SARS virus from replicating.

AG7088 was developed by Pfizer Inc. and is currently in clinical trials for the treatment of rhinovirus, a pathogen that can cause the common cold.

...

The protein in the SARS virus, called protease, snips up parts of the cells the virus attacks. Protease inhibitors are the most effective drugs used against the AIDS virus and may work in the same way against SARS.

As scientists learn more about the virus, they are more likely to find specific targetted treatments. The investments in HIV and hepatitis C research over the past 2 decades have given us great insights into viral workings. Hopefully, scientists will build on that knowledge to more quickly find specific treatments for SARS.

I think we know this. Somehow exercising improves our mood - Scientists have a good feeling about exercise

Physical activity is known to exert a powerful "feel-good" effect, brightening mood and enhancing mental health ? in fact, regular exercise may be as effective as medication for some people with depression.

A growing body of evidence supports this boost to psychological well-being, but the exact mechanisms are not completely understood.

"We know exercise makes people feel better, but we're not exactly sure how," says Patricia Dubbert, associate chief of mental health at the VA Medical Center in Jackson, Miss. Dubbert is one of a growing number of mental health professionals who are prescribing exercise as a way to relieve stress and lift spirits.

This makes sense to me. I work out 2 mornings a week, and get to work in a great mood!

Today's theheart.org features an article on the COMET (Carvedilol or Metoprolol European Trial) study - "COMET: Carvedilol improves survival more than metoprolol in CHF".

Results of the Carvedilol or Metoprolol European Trial (COMET)the first-ever head-to-head mortality study comparing two beta-blockers in patients with chronic heart failurehave shown a significant improvement in survival for carvedilol when compared with metoprolol.

COMET was designed to investigate whether differences in pharmacology between the two drugs would translate into differences in outcome in heart failure patients.

"COMET is the longest and largest study ever conducted in chronic heart failure, with more than 10 000 patient-years of follow-up," commented Prof Philip Poole-Wilson (Imperial College, London, UK), chair of the COMET steering committee. "The significant survival benefits of carvedilol demonstrate a clear difference between the agents," he added.

This report is apparently preliminary and does not include the percentages. I will follow this important story, as choosing the correct beta blocker for CHF has important patient implications, as well as cost implications (metoprolol is generic, carvedilol is only available as the trade drug Coreg).

This story is important, and I will revisit it with the data as they are released.

Men and women have different athletic abilities and different injury susceptibilities. Muscle Groups: Women and the Susceptible Knee

Women who play sports like basketball that involve extensive jumping and pivoting are known to be much more susceptible to knee ligament injuries than men. A new report suggests some reasons and what women can do about the problem.

Writing in The Journal of Bone and Joint Surgery this month, researchers from the University of Michigan said men appeared better able to contract the muscles that support the knee and protect its ligaments.

Women involved in some sports are up to eight times as likely as men to rupture the ligament toward the front of the knee, the anterior cruciate ligament, the study said. But they should not feel discouraged from participating in the sports, the researchers said.

The researchers have nicely identified the problem. We always hope that identifying a problem allows us to design a positive intervention.

To test whether women are as able as men to stiffen the knee intentionally, the researchers used machines that assessed the knees of 12 men and 12 women, all college athletes, to see how they reacted to stress. The results showed significant differences in muscle responses.

Dr. Wojtys said women involved in sports like basketball should pay extra attention to strengthening the muscle groups that protect the knee ligaments, including the quadriceps, hamstrings and calves.

Sports medicine experts, he added, are close to devising training programs to reduce the injuries.

"For years," he said, "we've been training female athletes just like men. Women have their own needs."

These data could help many women athletes in the future.

Many readers know that I am a big fan of Jane Brody. Her weekly column often has a wonderful summary of a complex issue. This week is no exception - Pap Test: Champion Against Cervical Cancer

Cervical cancer has been perhaps the biggest success story in the long-running war against cancer.

Once the leading cause of cancer deaths in women, cervical cancer will this year account for 4,100 deaths, not even 1 percent of cancer deaths among American women. Credit for the progress goes almost entirely to the Pap smear, a test now administered to 50 million Americans a year.

Despite the excellent results we have achieved with routine Pap smears, we now can probably achieve even better results. The improvements take advantage of our growing knowledge of the cause of cervical cancer.

For many years before the discovery that viruses could play a major role in causing human cancers, it was obvious that cervical cancer was a sexually transmitted disease, little different in its pattern of transmission from syphilis and gonorrhea. The earlier a woman became sexually active and the more sexual partners she or her partner had, the more likely she was to develop this cancer.

This pattern clearly implied that something transmitted in sexual intercourse increased a woman's risk of developing cervical cancer. That something, it is now known, is a very common virus called human papillomavirus, or HPV, the same virus that causes warts, including genital warts.

Scientists have also learned that HPV exists in more than 100 forms, but only 13 are considered likely to cause cancer. It is now possible to screen women for the presence of an infection with one of the high-risk strains.

This screening adds important information to the routine Pap smear. In fact, most practices now have adopted the new guidelines for cervical cancer screening.

Rather than having every woman tested every year, the new schedule has been changed to take into account age, medical and sexual history, presence of HPV infection, results of past Pap tests and even the type of Pap test used.

The new guidelines should greatly reduce the number of women who are told that their test is abnormal and thus requires further evaluation. (Most of these abnormalities cure themselves.)

Under the previous guidelines, 2.5 million to 5 million women a year were called in for more testing to find about 5,000 cancers, according to Dr. Carmel Cohen, the director of gynecologic oncology at the Mount Sinai Medical Center in Manhattan, who headed the committee that produced the revised guidelines for the American Cancer Society.

About half the 13,000 cases of cervical cancer that occur each year are found in women who have never been screened, Dr. Cohen said.

...

Rather than having every woman start screening at 18, the groups now recommend starting three years after the onset of sexual activity or by 21, whichever comes first. After that, screening should be done every year with the regular Pap test or every two years using the liquid Pap until age 30.

If a woman 30 or older has had three normal test results in a row, the interval can increase to every two to three years.

But there are important exceptions. Annual screening may still be recommended for women with certain conditions that increase their cancer risk like smoking; infection with a cancer-causing form of HPV; infection with the AIDS virus; chlamydia infection; poor diet; exposure to DES, a synthetic estrogenlike drug, in utero; treatment with immune-suppressing medication or a weakened immune system; and a personal or family history of cervical cancer.

Women 30 and older can have a Pap test and an HPV test at the same time. The double test is not advised for younger women because they are much more likely to be infected with HPV and also to eliminate the virus in a few months or a year. In older women, the virus infection is much less common but is more likely to be persistent.

This year, the Food and Drug Administration approved using the HPV test in conjunction with the Pap test for women over 30. Previously, it was used only when the Pap test showed abnormalities. If a woman over 30 has a normal Pap test and no viral infection, she may safely wait three years to repeat her exams, according to the new guidelines.

Woman 70 and older who have had three or more normal Pap tests in a row and no abnormal test in the last 10 years can stop cervical cancer screening. Also, screening is not needed for women who have had total hysterectomies, unless cervical cancer was the reason for the surgery.

These guidelines do represent a significant change which responds to our newer better data. Some physicians might want to make copies of this article to hand out to patients!

Occasionally I get caught up in my own hyperbole. Like all commentators, I should be careful in my choice of wordings. In this piece - A contrary view on Scully , I was wrong to use this language: "Well, Mr. Goldberg (the editorialist) knows a lot about politics and perhaps even economics, but he does not know medicine. He continues this harangue with a spirited defense of Nexium and Aranesp. I admire his hyperbole and obfuscation, but he clearly is writing as a shill for the pharmaceutical industry. "

I should not have called Mr. Goldberg a shill. I still disagree with him strongly in how he defends Nexium and Aranesp. Nonetheless, I believe that he believes his arguments. Thus, I apologize for calling him a shill.

I do stand by my support of Scully. If we are to have a free market medical economy (which we do not), then each new drug requires debate and decision making based on benefit and price. I teach residents not to use Nexium for the same reasons that Scully argues against the high price of Nexium. This drug does not add to our therpeutic armamentarium. No reasonable cost-effectiveness analysis would argue for its use. The drug really is not different from omeprazole.

In a free market economy, we (physicians) should speak out against unnecessary costs for our patients. The newest drug is not necessarily better.

I do not want to destroy the pharmaceutical industry, rather I want to hold them to reasonable standards. I disagree with their marketing tactics, and believe it my right and duty to point out their deficiencies. I hope that Mr. Goldberg understands that point, and the medical judgement behind my beliefs.

Today's fight for tort reform will ensure care in future

A study in JAMA last September found medical school applications are down 30% since 1996. This decline in interest persists even in the face of an economic downturn, when graduate medical programs usually flourish.

Medical research and medical education are also inspiring less interest. Between 1980 and 2000, the percentage of physicians serving on medical school faculties or research staffs fell from 6% to 2%.

The reasons for these declines are clear to anyone in medicine: government red tape; Medicare payment problems; an average medical school debt of more than $100,000; eroding physician independence under managed care; and most of all, a medical liability system that is sending insurance premiums skyrocketing.

This oppressive system fails to identify negligence and impedes efforts to improve medical safety. It creates inappropriate standards of care and abuses innocent defendants.

The crisis isn't just making it difficult to practice medicine today. It is also poisoning the well for the physicians of the future. This is especially true in crisis states such as Nevada.

I write often about unintended consequences . I hope that congress will understand how the malpractice crisis impacts the health of the nation. This crisis is snowballing, and causing widespread angst.

On this issue, medicine must speak as one. We must demand reform of our medical liability system. For physicians, medical students, our patients and the public.

Let's ensure that our destiny is a matter of choice, not chance. Through our unity, enthusiasm and optimism, we can attract the best and brightest to carry on the traditions of ethics, caring and science.

At stake isn't only access to care for the people we treat now. The future of our profession is also on the line. If medicine is to survive -- and thrive -- it must continue to push the boundaries of science and technology. In so doing, we make longer, better lives available to all Americans -- and all humankind. That is something worth fighting for.

Well said!!!

Resident work hours change July 1. I have ranted extensively on this issue previously (just search on ACGME). At least one Senator is not satisfied. Resident work-hour bill lives on in Senate

The medical education community may have thought federal lawmakers would cut it some slack while it adapted to self-imposed limits on resident work hours, but no such luck.

Sen. Jon Corzine (D, N.J.) reintroduced legislation April 30 to limit the hours medical residents may work. The move keeps the hammer of federal regulation over physicians' heads as they count down to July 1 -- the day when the Accreditation Council for Graduate Medical Education officially restricts all residents to an 80-hour workweek.

Congress should not enter this fray. The ACGME has aggresively worked on this issue.

The ACGME plan does not have uniform support from trainees. We have major changes in training, without any data on the effect on patient care. This issue is complicated. Meeting work hour requirements can effect continuity of care. We all worry about patient "hand offs". What happens when one doctor leaves and another takes over? Figuring out how to provide good continuity under these guidelines is a major challenge.

Hopefully, with Dr. Frist as Senate majority leader, the Senate will wait a year or two to see how the ACGME guidelines work. Senator Corzine should focus on more important health care issues - malpractice reform, Medicare and Medicaid reform.

Back finally for a shortened version of Q&A. I have had too many trips recently, and Q&A needs quiet time at home. I will certainly get back to serious Q&A in 2 weeks.

How can I know in advance when a drug will be available as a generic? I saw a note at drugstore.com saying that Wellbutrin SR will be available as a generic soon but no date was given. I asked my pharmacist and she didn't know.

I have a love / hate relationship with the drug companies. I know they have a lot of costs to cover but if you look at the actual prices there's no way they're priced to market; they're priced to be sold to insurance companies. And the games they play with the patent system. It irritates me to no end.

The pharmacists are not much better. A couple of years ago I found out by chance -- in Time magazine of all places -- that an anxiety drug I was taking, Buspar, finally went generic after a bitter court battle. When I went for the refill she handed me the brand name and I asked for the generic. She was puzzled. There's only an $8 difference. I insisted she put the generic in and she gave in.

Several interesting concepts here. The first questions refers to how you know when a drug goes generic. I do not know a specific source for this information. Perhaps an astute reader does. I learn 'through the grapevine'.

Second, the reader comments on patent system games. He is correct. A down side of capitalism and government is that companies will always look for loopholes. They should from a pure financial viewpoint. But I can and should dislike their patent games.

What you don't mention is that pharmaceutical companies systematically manipulate how physicians practice medicine by:

1) not doing the studies that doctors would like performed.

2) publication bias - they don't report trials that are not favourable to selling their products.

3) many, many other ways.

The pharmaceutical companies have a goal - profits. Physicians generally (I will admit to some exceptions) have the joint goals of making money and helping their patients. Once one understands and accepts the pharmaceutical companies goals as a given, then one understands that they need not do studies unless they think those studies will result in a marketing edge. That is why I want a pharmaceutical tax which would fund the important studies.

Ok, I agree there are people in the drug industry who just want to do good.

But then there is.

The Journal of the American Medical Association on April 23 published the results of an incomplete clinical trial for a hypertension treatment developed by Pharmacia accompanied by a "scathing" editorial that criticizes the decision by the company to end the trial before its scheduled completion, the Los Angeles Times reports. In 1996, Pharmacia began to enroll participants in a clinical trial to compare the effectiveness of the hypertension treatment verapamil, marketed as Covera, to less-expensive diuretics and other treatments. About half the participants received Covera, and the other half received a diuretic or a short-term beta-blocker called atenolol. Pharmacia, which had spent about $50 million on the trial, decided to end the trial in 2000, two years early. Dr. Henry Black, dean of research at Rush-Presbyterian-St. Luke's Medical Center in Chicago and the lead researcher of the trial, said that Pharmacia officials decided to end the trial for "commercial reasons." Black said that Pharmacia ended the trial early because researchers could not determine the effectiveness of Covera compared to a diuretic (Maugh, Los Angeles Times, 4/23). According to the incomplete results of the trial, Covera proved no more effective than a diuretic in the prevention of heart attacks or stroke MacPherson, Newark Star-Ledger, 4/23).

This excellent comment needs no response. The sad thing about this episode is that no one is surprised.

I am schizophrenic with regards to the pharmaceutical industry as well. You're right, every rep tries to 'spin' the evidence so that their drug is the best, and your ACE inhibitor example is apt as every rep I talk to is now trying to echo the ALLHAT study (or whatever it was) that said that drug X prevented stroke better than other ACEs.

My favorite example pro-pharmaceutical companies is the vagotomy. As in, 'that surgery we used to do before H2 blockers and PPI's came along.' But when reps start pushing me to say their PPI is the best, I tell them, "You know, I like your drug, but I have to say I like all PPI's. I remember what it was like before we had these drugs and they're all miracle workers."

And I can't really play the outraged innocent, because I have been wined, dined and entertained at the expense of the industry many a time. That would actually make for a great rant. Do you accept such invitations, and what is your opinion of doctors who do?

Great comment, and I will respond to the last paragraph only. I have a $10 rule. I have decided that you cannot buy me for $10. Thus, I do eat drug company sponsored lunch at noon conference. I will not go to dinner a the drug companies expense. Nor will a play golf, or be a "consultant". I have done a few of these in the remote past, but as I thought through my peronal ethics I have decided on this personal costs. The pharmaceutical industry understands influence. They try to influence me, and I try very hard to use less biased sources of information.

Define healthy food.

Here's my problem, lowfat food almost always equal higher sugar food. If I switch my diet to a "healthy" diet I'll be taking more insulin and thus gain weight.

I'm a teacher and our cafeteria provides food that is very high in both fat and carbohydrate. Certainly not very healthy for the middle-aged adult.

We need to do some changes in food labeling. We need to call a serving of server. Look at your average sport bottle of Gatorade. (unhealthy drink for me) the nutrition label is misleading the serving size is in small case and is usually around 2 1/2 servings. Who drinks 2 1/2 servings of the sport bottle of Gatorade. They drink the sport bottle has one serving. Bet people would stay away from it if true servings were on the label.

Same thing goes for any other packaged food. Very few label's show true servings. And also would not hurt if restaurants started serving reasonable servings. Why is McDonald's selling two of things? And try to get them to give you one during those promotions.

I'll leave you with a funny... one of our assistant principals was eating candy, one of those large bags of cherry twists that are labeled a "no fat" food. It certainly wasn't a "no sugar" food.

Excellent comment! I will ask my daughter (who wrote the post referred to herein) for her response. I would say that the challenge of a food tax is arbitrating which foods deserve the tax, and which foods deserve the subsidy. Should we regulate taxes based on Atkins, or Walter Willett, or Dean Ornish? Each expert would probably stress a different list. While I like the proposal's concept, this comment does make us think about the potential problems.

That is it for this abbreviated Q&A. I hope everyone has a great week. Keep those comments coming - they certainly help focus my thinking and make this blog much better!!!

I want to compare and contrast the current truth and the truth as proposed by my daughter. The current truth - Gov't Won't Force Cos. on Healthier Food

The Bush administration says the government can't force food companies to produce and promote more nutritious products in an effort to reduce obesity, although it is trying to encourage them.

Health and Human Services Secretary Tommy Thompson said Thursday that the industry has the resources to help Americans make healthier eating choices.

But he argued that lawsuits against restaurant chains or requirements that product labels include health information will prove less effective.

Food companies "have got the advertising dollars to do it," Thompson said at a conference on obesity sponsored by the Consumer Federation of America. "That's much better than passing legislation."

He promised that manufacturers that invest in promoting healthy eating and fitness will get recognition for their efforts. "I'm going to start giving more awards and singling out those that have done it."

At least Thompson is using the bully pulpit. This represents a good start. Perhaps he should read this paper that my daughter wrote for a public publicy course. This assignment is written in the form of a memo to a senator. She advances an interesting proposal.

The problem of obesity in the United States has grown to epidemic proportions, making it impossible to ignore. As you may know, the National Health and Nutrition Examination Survey (NHANES) recently reported the results of their 1999-2000 study which investigated the prevalence of overweight and obesity in our country. Since 1994, the prevalence of overweight, that is, persons who have a Body Mass Index (BMI) greater than 25, has increased from 55.9% to 64.5%.1 Simply put, two-thirds of the population can be classified as overweight based on their BMI. In addition, since 1994, the prevalence of obesity, defined as persons who have a BMI over 30, has increased from 22.9% to 30.5%.1 Nearly one-third of the United States population can be classified as obese. These statistics, especially when viewed in light of the negative health effects associated with overweight and obesity such as heart disease, diabetes, and cancer, are startling. Not only is the health of our country at risk, the amount of money that will need to be spent on healthcare must be considered now as this problem continues to worsen.

Interestingly, the prevalence of overweight and obesity has increased dramatically over the past ten years despite the growth of the commercial diet industry. For this reason, we can no longer afford to wait for the private sector to find a reasonable solution to fix this ever-growing problem. The government must protect the common welfare of its citizens as it has become apparent that the mixed messages coming from the diet industry are not working. To that end, I would like for you to consider drafting legislation aimed at correcting this problem. This legislation would implement a tax on foods that compose the main sources of saturated fat in one?s diet, such as whole milk, butter, cheese, and high fat meats.2 The other part of this legislation would include language for a subsidy for some foods that are low in saturated fat and/or high in fiber, such as fruits, vegetables, whole grains, and lean meats.

The problem of overweight and obesity is unequally distributed among socioeconomic groups. Less wealthy individuals are disproportionately overweight and obese as compared to the population as a whole.3 One main contributor to this is that higher fat foods offer a large amount of energy (calories) for a low price. "Super-sizing" food has become appealing because it is quick and cheap. When a family's food budget accounts for a high percentage of their total living budget, buying cheap, high-calorie foods appears to be a logical and economically sound choice. Unfortunately, these seemingly logical choices are being made at the expense of one?s health and the health of their family. Since poor people spend proportionally more of their income on food than rich people,2 it is easy to see how the prevalence of overweight and obesity differs between socioeconomic groups.

Before you consider drafting this legislation, I imagine you need a few questions answered. Namely, would a tax on these high fat foods make a difference in consumption patterns? Would lowering the prices of healthy foods increase the likelihood that they would be consumed? A group of researchers at the University of Minnesota investigated these questions.4 In their experiment, they used vending machine purchasing patterns as a means of looking at consumption patterns. During the intervention period of the study, the researchers lowered the prices of low-fat items in the vending machines by 50%. Sales of low-fat snacks increased 150%. Once the prices were returned to pre-intervention amounts, the sales of low-fat snacks resumed to baseline levels. This study suggests that with an economic incentive, it is possible that consumers will change their consumption patterns by purchasing low-fat foods as opposed to high-fat foods. The taste of the high-fat foods may not be the only motivator when it comes to consumption.

Currently, 18 states have special taxes on soft drinks, candy, chewing gum, and snack foods.5 These special taxes equal an extra $1 billion per year in revenue. This money could be used to subsidize healthier, lower fat, more nutritious foods. These "snack taxes" have been more politically amenable because they are aimed at foods with virtually no nutritional value. Although these taxes are useful, it would be more meaningful to impose taxes on foods that contain large amounts of saturated fat in an effort to decrease the rates of heart disease, our nation's #1 killer.6 Like the "snack tax," this "fat tax" would still bring in revenue to be used for healthy food subsidies. Additionally, this tax could potentially detract people from consuming foods that have been linked to heart disease. I recommend the Department of Agriculture, specifically the Food and Drug Administration, work to implement this tax by determining which foods should be taxed and which foods should be subsidized.

A "selling point" for this legislation is that the taxes would only be levied on those people who choose to buy the high-fat foods that are taxed. If people do not wish to pay these taxes, they need not buy these foods that have been found to be major contributors to the obesity epidemic. Hopefully, the high-fat foods may seem less appealing when their costs are raised. Another advantage to this legislation is that the revenues gained from these taxes would subsidize the prices of lower-fat, higher-fiber foods, allowing more individuals and families to purchase these traditionally more expensive foods. This legislation could help to lessen the divide between the rich and the poor when it comes to eating a healthy diet and assist in closing in on the gap in overweight and obesity between socioeconomic groups.

As mentioned above, the rate of overweight and obesity has grown to epidemic proportions. The costs to society, both in terms of dollars and shortened-lives, are immense. Therefore, I recommend you introduce legislation now to implement a "fat tax" that will discourage people from eating unhealthy foods and subsidize foods that contribute to a healthy diet. This tax is a small step towards addressing obesity in the United States, but it is an important step we must take now.

References

1. Flegal et al. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002; 288: 1723-1727.

2. Marshall. Exploring a fiscal food policy: the case of diet and ischaemic heart disease. 2000; 320: 301-304.

3. Philip et al. Socioeconomic determinants of health: The contribution of nutrition to inequalities in health. British Medical Journal. 1997; 314: 1545-1549.

4. French et al. A pricing strategy to promote low-fat snack choices through vending machines. American Journal of Public Health. 1997; 87: 849-851.

5. Jacobson et al. Small taxes on soft drinks and snack foods to promote health. American Journal of Public Health. 2000; 90: 854-857.

6. Anderson. Deaths: Leading Causes for 1999. National Vital Statistics Report. 2001; 49 (11).

Congress has often used taxes as a policy tool. While I have not thought carefully through the policy implications of this concept, her reasoning looks sound. If I am missing unintended consequences please let us know. Needless to affirm, I am very proud of my daughter's reasoning and scholarship. Having this blog allows me to share her work with the blogosphere! (Disclaimer: she has given explicit permission for me to share this paper with you the reader)

Doctors' Insurance Soars, Then Disappears: Physicians Blame Lawsuits, Awards . This article provides mostly data. It is not an opinion piece.

Insurance costs are causing physicians to reconsider their current practice. I have ranted on this subject so often, that I can only link this article for your perusal. I do not have the energy to repeat my arguments today. This malpractice crisis is frustrating for its lack of logic and common sense.

I write this rant with some trepidation. I am a subject in this investigation. I work part-time at the VA. However, I believe in truth and common sense - so here goes. Some VA Doctors Not Doing Scheduled Work

Some part-time physicians employed by Veterans Affairs medical centers are absent for much of their scheduled work time and managers are not keeping track of them, the VA's inspector general said Thursday.

Richard J. Griffin told the House Veterans' Affairs Committee that part-time surgeons at six VA medical centers his office reviewed were performing surgery at affiliated medical schools at times they were scheduled to be on duty at VA facilities.

VA Deputy Secretary Dr. Leo S. Mackay Jr., in an interview with The Associated Press, said the department regards the absenteeism as ``a very serious issue.''

Griffin, speaking at a hearing on efforts to curtail waste, fraud and abuse in the Veterans Affairs Department, said an audit requested by the VA secretary found that neither Veterans Health Administration officials nor medical center managers were enforcing attendance policies.

He said part-time physicians did not complete a minimal amount of patient care time -- at least an hour in surgery or two patient encounters per hour worked -- on 53 percent of days they were scheduled to work at least four hours.

Let me try to put this report into perspective. Part-time VA work is divvied into eighths. If one receives 2/8ths VA, then one has 10 hours of responsibility to the VA each week. However, physicians really do not work in eighths. We do what is necessary, sometimes overworking, sometimes underworking. What is important is whether our average work meets the criteria.

When I am on service (ward attending at the VA) I work many more hours than during the months that I am off service. How should we account those hours? On average I perform the expected work. Some weeks I do much more, other weeks I do much less. I submit that I am not defrauding anyone.

Perhaps we should develop a group mentality. The VA could contract with general surgery for a 4/8ths general surgeon. Regardless of the individual assigned, the important question is whether patient care is appropriately provided.

What this article omits is a discussion of WOC (VA jargon for WithOut Compensation)? At most academic centers, physicians do provide care WOC (generally covering for a paid physician). How do we appropriately account those contributions?

Having talked with an OIG investigator, I would submit that they are asking the wrong questions. The real question depends on whether appropriate surgery is delayed. The VA must either pay surgeons fee for service, or contract surplus capacity so that they can handle those time periods when more surgery is necessary.

This VA news piece greatly oversimplifies a complex relationship of care.

Thomas Sowell has thus far published 3 essays on universal health care. This link gets you to his column. If the column has changed from universal health care (or you want to read his first 2 essays) scroll to the bottom and click on archives to read the articles. Thomas Sowell columns

Those of us who are getting on in years can remember a time when most people had no health insurance, when we simply paid the doctors or the pharmacies and went on our way, without giving it a second thought. I have especially painful memories of having a hospital bill of $50 for the treatment of a baseball injury back in 1949.

You have no idea how big $50 was for me at that time. It was the most money that I had ever paid for anything. But the bill got paid off, a few dollars at a time, over a period of months.

When and why did health insurance, paid by third parties, become widespread in the American economy? Like so many things that the government does, third-party health insurance grew out of problems created by previous government policies.

During World War II, the government imposed wage and price controls. This meant that employers who wanted to hire more workers were forbidden to offer higher wages to attract them. So employers started offering various benefits instead. One of these benefits was employer-paid health insurance.

Since these benefits were not taxed as income, and could be treated as a business expense by the employer, everybody seemed to be better off. But, long after the war was over and wage and price controls were gone, the idea that third parties ought to pay for health insurance continued on. Eventually the government itself got into the business of providing health insurance and now some politicians depict it as a scandal that not everyone has health insurance paid for by third-parties.

Thus, we have a brief history of health insurance per Sowell. Actually, health insurance started prior to WWII to pay for surgery. Nonetheless, health insurance is a relatively recent phenomenon.

China, Britain and other countries have been surprised to discover that the costs of government-provided health care greatly exceeded the costs initially projected. But they should not have been surprised. It is one of the oldest and simplest principles of economics that people demand more when they pay a lower price, especially when that price is zero.

There is no fixed amount of medical "need." There are some minor ailments that you may either ignore or treat with some over-the-counter medication, perhaps with the advice of a pharmacist. There are some other ailments that might cause you to phone your doctor for advice but which neither you nor he considers serious enough for an office visit. And of course there are other things that require immediate and perhaps extensive medical attention.

When you are paying your own money, you sort these things out accordingly. But when someone else is paying, then the trivial and the urgent are both likely to find their way to the doctor's office. This means that both are likely to get less time and that patients with serious problems are the biggest losers.

Countries with government-provided health care have been known for shorter office visits, whether in the Soviet Union, Canada, Japan or elsewhere.

Robert Prather has made this point repeatedly. I often make this point in a different way. Our current health system generally disconnects financial considerations from patient decision making. Some would argue that patients should not have to worry about cost in health matters. However, how else can we prioritize health care?

Many years ago, while I was doing sore throat studies, we observed a much lower rate of group A beta hemolytic streptococcal pharyngitis in student health than in the emergency room. We reasoned (although never proved) that ERs represented a barrier to health care. The patients were generally sicker. Student health provides minimal barriers to health care. The location was convenient, and the price was minimal (if any). Thus, students checked out every sore throat. How large a difference did we find? ER patients had >20% strep throats and student health <10% strep throats.

Our society does ration health care by access and ability to pay. Most essential care is provided regardless. Discretionary care depends on financial considerations (most plastic surgery for example).

So we must consider the positives and negatives of any single payor system. Prior to supporting such a system, one must consider the unintended consequences .

If health care is a right (and why should our system treat health care different from legal advice, food, shelter, etc) then we should strive to provide care to all. But should we provide the same care to all.

If we try to do that, we will probably develop into a system much like Canada or Great Britain. There are clear advantages to these systems. However, there are undesirable consequences.

Who will be the physicians of the future? What incentive will drive students into medicine? We want our physicians to be the best and the brightest. Would that happen with socialized medicine?

How do we pay for increasingly expensive technology and pharmaceuticals? Who would invest in their development? Would this new system slow down medical advances?

If we must ration care, (and I submit that we would have to ration care) who makes those decisions. Would we develop an age limit for dialysis (as many countries have done)? Would surgery waiting lists become a major problem (like in Canada and Great Britain)?

Would the system ask primary care physicians to spend even less time with patients? What effect would this have on our quality of care?

I worry about unintended consequences. I agree that our current system has major problems. However, prior to considering radical surgey, I want to review our options. Perhaps we can fix the system, without taking such a drastic step.

What features would I tackle first? I have written occasionally about Medical Savings Accounts. This method could handle routine care and medications. Such accounts force one to make financial decisions about care.

I would consider a standard interface between insurers and providers and patients. We need simple, standard forms. The proliferation of forms and rules add unnecessary costs to health care. We could solve this problem without a single payor system.

I would develop a system that allows physicians to charge for time spent. Thus, if you need a 10 minute appointment, you would have a clearly different fee than if you need a 30 minute appointment. If you want to discuss an issue on the phone, then we would charge you. Emails would have charges, as would telephone calls to subspecialists. For those who find this too complicated, we could develop some modification of a retainer model.

We must think creatively about providing health care. Universal health care has some surface appeal. I fear that the unintended consequences are greater than most advocates have considered.

Physicians: So Much to Do, So Little Time: Despite More Time Spent on Patient Care, More Doctors Bemoan Lack of Time with Patients

The proportion of time physicians spent in direct patient care activities increased from 81 percent in 1997 to 86 percent in 2001. Nonetheless, the proportion of physicians reporting inadequate time with patients grew from 28 percent in 1997 to 34 percent in 2001.

Possible explanations for the growing number of physicians who feel pressed for time with patients include increased diagnostic and treatment options, managed care plans' easing of tight restrictions on care, people living longer with chronic illnesses that may require more complex coordination among caregivers and a growing list of recommended preventive services, the study noted.

"As the practice of medicine grows more complex, physicians may be frustrated because they have too much to discuss with their patients in too little time," said Paul B. Ginsburg, Ph.D., president of HSC, a nonpartisan policy research organization funded exclusively by The Robert Wood Johnson Foundation.

An additional problem causing the sense of insufficient time is the fee for service reimbursement system. If I take 25 minutes with a patient, I get paid the same as if I spend 20 minutes. Thus, we feel a time pressure and this can lead to not satisfactorily addressing all necessary issues.

I blogged on this issue on Tuesday. I will keep addressing this issue, as it remains a central one in our understanding of the current health care crisis.

I run an academic division of approximately 20 general internists. On Tuesday I was discussing our budget with my administrator. She told me that our malpractice bill was increasing 15% this coming year. This will cost us around $25,000 as a group. That increase must come from expenses, as clinical income is unlikely to cover the increase. We pay full insurance, even though we practice part time.

This increase seems minor compared to the increases seen by other specialties. Yet looking at the numbers, and understanding the implications of that money personalizes my constant ranting about malpractice insurance.

I am not alone in this persistent ranting. Medpundit stresses this problem frequently. Her Wednesday rant clued me to this link - Diagnosis: Premium Shock Rx Strike. I recommend reading the entire article (which is balanced and from a business perspective). Like Medpundit, I found this section particularly revealing.

If there aren't a huge number of lawsuits or multimillion-dollar verdicts in New Jersey, why are malpractice premiums going up? The answer, says Peter Leone, vice president of claims at Princeton Insurance, is that plaintiffs don't have to win big very often to push up insurers' costs. "Verdicts," he explains, "drive the settlements."

The bulk of the dollars the insurers pay out in malpractice cases is in the form of settlements, not verdicts. In 2002, the year insurance carriers in New Jersey lost only 54 cases, they settled 732. Jury awards, Leone explains, put floors under the amounts for which suits can be settled. If juries have tended to award plaintiffs $1 million for a certain injury, the insurer knows it can't expect to settle a similar case for much less.

And the direction of verdicts and settlements, Leone claims, is up. In 1998, he says, Princeton's average payment to plaintiffs in malpractice cases against doctors was $235,000; in 2002 it was $343,000. The company's total payout to physician malpractice plaintiffs rose from $88 million in 1998 to $115 million in 2002.

What the doctors and insurers in New Jersey want is a law to limit verdicts and thus settlements. When a jury awards a plaintiff money in a malpractice case, the award has two parts: a sum for economic damages, like lost wages and future medical costs, and a sum for pain and suffering. In any malpractice trial, there will be testimony from both sides about economic damages and the jury will be instructed to be guided by that testimony in setting an award. Pain and suffering, it goes without saying, is less tangible. If you lost a leg due to a doctor's screwup, the cost of a prosthesis, physical therapy, lost income and so on could be estimated with some precision. But what's the dollar value of your suffering? A hundred million dollars? Zero? New Jersey jurors can give you whatever they think fair (although judges and appellate courts can and do reduce awards they consider wildly excessive).

Are juries in the state giving away the store when it comes to pain and suffering? You can't tell by looking at the public records. The limited data collected by the courts doesn't break verdicts down into economic and pain and suffering damages. The insurance companies certainly know--they write the checks--but they're not required to disclose their numbers on damages to regulators or anybody else.

Princeton's Peter Leone did provide MONEY with verdict breakdowns for the largest cases the company has lost for 2001 and 2002. According to his figures--which we'll have to take on faith because they can't be checked against public records--pain and suffering accounts for roughly 70% of those verdicts. In the past two years, Leone says, the company lost 16 cases with verdicts of more than $500,000, 13 of them for $1 million or more. Usually the awards for pain and suffering were larger, often substantially, than those for economic losses. One case yielded $90,000 in economic damages but $1,910,000 in pain and suffering; another, zero economic damages and $3,580,000 in pain and suffering.

This article makes sense out of the lawyer hyperbole and obfuscation. The problem does stem from verdicts because verdicts drive settlements. Patient care is suffering. When will patient advocates understand that our broken tort system (and the trial lawyers who benefit from that system) has major unintended consequences. Each successful verdict and settlement takes money out of the health care system. Who should fund these costs? Apparently, the trial lawyers (and their political buddies) do not care, or delude themselves by not working through the consequences. This blogger will continue to rant, hoping that by ranting I will educate a few more people with each rant. As we educate more, they in turn educate more people. Eventually, I believe that a majority of the country will understand our outrage over a broken system.

Claritin's Price Falls, but Drug Costs More. What a dilemma! For those with drug benefits, the switch from prescription status to lower cost over the counter access for Claritin means that those patients pay more out of pocket for the same drug.

This is the first spring in which Claritin, the most popular allergy drug, is available without a prescription. A major health insurer pushed for the change, arguing that it would benefit consumers. But instead, insurers ? and the employers that pay for health insurance themselves ? have so far been the biggest beneficiaries, paying for allergy drugs a fraction of the $1 billion or more that Claritin used to cost them each year.

As an over-the-counter drug, the price of Claritin has fallen by one-half or more, to about $1 a pill. But because consumers now pay the full price themselves, a month's supply costs them roughly $30, instead of the $15 to $20 co-payments that people with health insurance used to pay.

This example highlights the paradoxes of both the health insurance and pharmaceutical industries. Health insurers desperately are working to control health care costs. Thus, getting a drug class to go generic saves them significant moneys. The pharmaceutical industry wants prescription drugs, as they can then charge (and receive) more money.

Each industry is entitled to some profit. However, patient welfare rarely enters their decision making. While I do understand capitalism, and the benefits therein, one can argue that these industries should take some social responsibility also.

The cost shifts may ultimately prove to be temporary, particularly if many new nonprescription drugs face the kind of generic competition now surfacing for Claritin and drug makers adjust prices to reflect the medicines' mass market status. Already, Claritin's over-the-counter status and lower price is benefiting consumers without prescription drug coverage. But even so, the overall current cost to consumers is substantial, since Claritin and the other drugs in question are among the top-selling prescription medicines.

Dr. Mark McClellan, the F.D.A. commissioner, said in an interview that there were legal and practical complications to iron out and he intended "no imminent action" on the status of any more major drugs. He noted, however, that an agency advisory panel of experts had recommended the switch for all three top allergy medicines. They are considered far safer than some allergy drugs already sold without prescriptions, which have been blamed in road accidents involving drivers who fell asleep.

"When the science and cost issues match up, it's definitely something the agency should consider very seriously," he said.

This has made the pharmaceutical industry very nervous.

The drug makers and insurers have many billions of dollars at stake in the debate over switching the status of prescription drugs. Thanks in part to aggressive marketing, Claritin, Allegra and Zyrtec have been some of the top-selling prescription medicines, generating at least $7 billion in sales for their manufacturers in 2002.

Even more important for the makers, if the F.D.A. forces Aventis and Pfizer to change the availability of Allegra and Zyrtec, it could set a precedent for other drugs.

A nonprescription version of Prilosec, a $4 billion ulcer treatment made by AstraZeneca, is expected to be approved by the F.D.A. this summer after preliminary endorsements by an agency advisory panel. Prilosec has already lost its patent protection, so its contribution to AstraZeneca's profits is declining. But if the agency were to force AstraZeneca's patented successor drug, Nexium, to be available over the counter, the company's profit ? and perhaps stock prices of the industry as a whole ? could be affected.

This switch to a potentially activist FDA certainly provides an interesting possibility for investors to consider.

As a long time member of the Society for Medical Decision Making, I have done, and read cost-effectiveness studies for over 20 years. In the early 80s we discussed the problem of limited resources. How do we prioritize medical spending? What price is unacceptable?

At the absurd one would argue that we could not spend a billion dollars to save a patient. If one accepts that statement, then the only question becomes agreeing on the magic amount to provide a year of life.

A story is told about Bernard Shaw that he was sitting next to a woman at a dinner party and asked her: ?Madam, if I gave you a million pounds, would you have sexual intercourse with me?? After some thought, the woman said yes, she thought she would.  ?Would you do it for a fiver??, Shaw then asked.  ?Sir!? she exclaimed, ?what kind of woman do you think I am??  ?I thought we had established that,? said Shaw, ?and we were merely haggling over the price.?

Thus, the debate over cost effectiveness studies is really a debate about relative value. This essay from the NY Times personalizes the question that many have wrestled with over the past 2-3 decades - Buying Time: Doctors Debate the Ethics of Care and Cost. While this article does a nice job of summarizing and personalizing the problem, it really does not cover new ground. A rational society would use cost effectiveness to ration health care expenditures. However, we do not live in such a rational society. We have many political considerations involved in our decision making.

Read the article and consider the philosophical nature of the questions the author raises.

Sudden arrhythmias are common in patients like Mr. Cheney who have suffered moderate or severe heart attacks, and the irregularities can cause sudden death. Defibrillators can clearly reduce these deaths, and it is estimated that millions of Americans could potentially qualify for the $30,000 devices.

But the cardiology fellow who presented the case wondered how hard he should push for his patient to get one, given his age and mental state.

It makes sense to implant a device in the chest of a 50-year-old with a good life who is providing to society, the fellow said, but what about a 70-year-old debilitated by heart failure and living in a nursing home? That patient might benefit the most, he added, but would also have the least to offer society in terms of productive years.

Should society invest its limited resources in such patients?

Someone else wondered whether a defibrillator was even appropriate for those patients. After all, wasn't sudden death a better way to die than struggling for breath as congestive heart failure filled lungs with fluid?

The discussion went on, back and forth, for more than an hour. It distilled some of the ethical questions that cardiologists are beginning to face as more and more expensive devices become available to treat very sick patients. Unfortunately, most of these patients will not live very long, with or without devices.

I submit that we should consider these issues. However, many patients and potential patients would then brand us (the medical community) as concerned with cost rather than their health. Thus, we have a true conundrum.

The SARS phenomenon started only months ago. Clinical researchers continue to refine their observations of this disease. The latest information suggests an even more deadly disease than previously thought - Study in Hong Kong Suggests a Higher Rate of SARS Death

The death rate from SARS may be significantly higher than health officials had thought, up to 55 percent in people 60 and older, and up to 13.2 percent in younger people, the first major epidemiological study of the disease suggests.

Mortality rates are bound to change somewhat as an epidemic continues. But unless the numbers fall drastically, SARS would be among infectious diseases with the highest death rates. Until now, fatality rates reported by the World Health Organization had ranged from 2 percent, when the epidemic was first detected in March, to 7.2 percent.

The new findings come from a statistical analysis of 1,425 patients suspected of having SARS who were admitted to Hong Kong hospitals from Feb. 20 to April 15. Over all, their mortality rate was estimated to be as high as 19.9 percent. By contrast, the influenza pandemic of 1918, which killed tens of millions of people worldwide, had an estimated mortality rate, over all, of 1 percent or less.

But calculating mortality rates for newly emerging diseases is a notoriously difficult challenge for epidemiologists, especially if there is no definitive diagnostic test, as is the case with severe acute respiratory syndrome.

It is possible, for example, that some people infected with the virus believed to cause the disease never fall ill, or develop symptoms so mild that they do not seek medical assistance. If that is the case, mortality rates could be much lower.

This article reports on a new Lancet article - Epidemiological determinants of spread of causal agent of severe acute respiratory syndrome in Hong Kong. While we do not know precisely the severity of this infection, it does appear to cause severe disease - with a high fatality.

I have been planning to rant about universal health care. As I have been thinking through this issue, I am attracted to this piece by Thomas Sowell. I will quote liberally, because the link is not permanent! "Universal health care"

If there was one defining moment in the debates among an already crowded field of Democrats seeking their party's presidential nomination in 2004, it may well have been when Congressman Dennis Kucinich, pushing for government-provided health care, spoke with obvious disgust of the "profits" of the insurance companies and provoked a burst of spontaneous applause from like-minded members of the audience.

Insurance companies, like every other kind of institution, have to earn money in order to keep functioning. So does every individual who was not born rich. But some people react to the word "profit" with automatic responses, like Pavlov's dog.

While I often have problems with the insurance companies, I do not resent them making a profit. Rather I resent the tactics they use to make those profits.

But, just as there are still pockets of resistance in Iraq and Afghanistan, so there are still holdouts like Congressman Kucinich and like-minded Democrats. Socialism has been discredited as an explicitly avowed belief but it still lives on in a thousand disguises, of which "universal health care" is just one.

Like so many pretty words used in politics, "universal health care" is seldom examined in terms of what its actual track record has been in the countries where it has been tried.

Probably the first country to have universal health care provided by the government was the Soviet Union. After decades of socialized medicine, what was the end result? In its last years, the Soviet Union was one of the few countries in the world with a declining life span and a rising rate of infant mortality.

But that terrible word "profit" had been banished and apparently that is what matters to the true believers.

Not all countries that tried socialized medicine went as far as the Soviet Union. But there has been a whole pattern of problems common to government-controlled medical care systems, whether in China, Britain, Canada or elsewhere. And none of the anti-profit zealots want to talk about any of those problems.

None of those who wants us to move in the direction of Canada on health care ever faces the question: Why do so many Canadians come to the United States for medical treatment and so few Americans go to Canada?

Could it be that we should look at what actually works, rather than what sounds good? Nor should we be overly impressed by words that sound bad, like "uninsured Americans." The bottom line is medical care, not insurance. People without insurance are treated at hospitals all across America every day.

Before we even consider throwing away what works in favor of something that has failed repeatedly, we need to stop reacting to words and start looking at facts. Socialism by any other name is still socialism -- whether it is advocated by shrill zealots like Kucinich or by other Democrats whose words are smoother.

While I will take issue with some of Sowell's arguments, he generally does understand. Our current system is flawed - a problem which I plan to address later this week. Meanwhile, please share your thoughts on this piece.

Saturday morning I ranted about a new complaint from patients - all we did was talk. The comments have added great texture to the ideas that I put forth. Over the past few days I have considered my rant and the comments. I hope that I can expand on my first rant, and use the comments appropriately.

We must try to understand what these patients meant when they accused the physician of 'just talking'. If the physician just lectured the patient, then the patient has a point. I doubt that was the problem. However, as one comment suggests, the key quality to consider here is listening. If the physician talks too much, and listens too little, then he/she deserves some criticism. Many patients are looking for a physician who will listen to their complaints and respond to those complaints . Since we do not know the context of the comments, we must consider lack of listening as a possibility.

However, even when the physician does listen and respond, some patients (and most payors) will devalue the physician's time in comparison to procedures or even radiologic interpretation. This could probably represent the CSI phenomenon. For those who have not watched either of the two Crime Scene Investigation series, these shows trumpets the scientific analysis of crime scene data. The investigators in these shows base their investigations on hard science, not on interrogation.

One can contrast these shows with an Agatha Christie novel, or Lt. Columbo. In that mystery genre, the investigator would ask questions, and reason out the sequence of events.

The excellent generalist combines both genres. We must combine the clues from a careful history (which must include listening more than talking), a directed physical examination, and then a decision to order the appropriate tests (either laboratory or imaging). Sometimes we decide to refer the patient to a subspecialist for further evaluation, and even sometimes further history.

What rankles me (and others) is the devaluation of our process? If I spend 20 minutes with you in the office, I then will spend an additional 5-10 minutes reviewing your record, my notes and any testing. Sometimes, I will go to my computer and read more information on your complaints (I personally use UpToDate). You may email me. Either I or my staff will probably call you about your laboratory results.

We all know that time is money. And as a generalist, time is our only commodity. Lawyers have understood this concept and bill appropriately. While we joke about lawyers, when we need them, we pay those bills. We have a system which does not reimburse me for the time I spend talking, listening, examining, reflecting and communicating. I get paid a flat rate for seeing you, almost regardless of complexity and the need for time. (In fact there are slight adjustments for more complex patients, but in fact time is not a factor in reimbursement.)

As the SGIM position paper (THE FUTURE OF GENERAL INTERNAL MEDICINE says

Current financing of physician services, especially fee-for-service, must be abandoned, reformed, or restructured to include reimbursement for services provided outside of traditional face-to-face visits. Physicians should be reimbursed for time spent supervising long-term care, managing teams, and providing services by phone and email. Alternatively, physicians could be paid a patient-management fee plus reimbursement for specific services or a salary with incentives for productivity, quality, and improved outcomes. We endorse the development of reimbursement based on quality and outcomes.

All generalists should aggressively support this recommendation. I believe that all patient advocacy groups should join in supporting this recommendation. Excellent medical care requires time. If we can spend the appropriate time with each patient, then we can provide better prevention, better education, and better take the time to analyze all the patient's complaints. Our current system creates perverse incentives - incentives to limit the time with each patient. Such incentives encourage inappropriate use of diagnostic tests and referrals.

I do not argue against diagnostic tests and referrals, but rather we should use those aids appropriately. Physician time is the health care crisis. Lack of time translates to less satisfied physicians and patients. This phenomenon discourages students and residents from careers as generalists. And I still believe that each patient needs a conductor, someone who understands the entirety of the patient.

Hyponatremia can kill runners. New recommendations tell runners not to drink too much water when running long distances. New Advice to Runners: Don't Drink the Water

Every athlete, every fitness enthusiast has heard the advice to drink plenty of water. Drink as much as you can. Don't wait until you are thirsty. By then it may be too late. You may be seriously dehydrated, risking dizziness, collapse, even death. "Stay ahead of your thirst," athletes and would-be athletes are told.

But now USA Track & Field, the national governing body for track and field, long-distance running and race walking, says that advice is wrong. In what it calls a major revision of its guidelines, the organization says endurance athletes, who may be consuming huge amounts of water over the course of a long event, may risk seizures, respiratory failure and even death from drinking too much.

Instead of drinking as much as they can, the new guidelines say, runners should drink when they are thirsty. People in long races like marathons may want to weigh themselves before and after long practice runs to see how much they lose from sweating and drink that amount when they race, and no more. The guidelines are at www.usatf.org.

The International Marathon Medical Directors Association (IMMDA) proposed this advisory 2 years ago. IMMDA ADVISORY STATEMENT ON GUIDELINES FOR FLUID REPLACEMENT DURING MARATHON RUNNING

So what is the problem here. Over time, in a long slow race (this is not a problem for elite runners) some runners can drink enouhg water to become hyponatremic. The actual physiology is unclear, although, probably some people get volume contracted during the run, increase ADH, and then drink back excessive amounts of pure water. This combination can cause hyponatremia, and hyponatremia can cause seizures and even death.

I wrote about his problem last June - The dangers of exercise and too much water . Many patients running marathons will tell their physicians. We should explain the water situation to our patients. I tell patients and friends to choose the gatorade! Because of the solutes in gatorade, they will not develop hyponatremia.

Regular readers of Medrants know that I strongly promote (and practice fitness). I believe that attention to fitness has many positive outcomes - including better health outcomes. Given that background, I love this idea - Tax plan to subsidize worker fitness: Health club membership would be in company health plan

Membership in a health club or an aerobic dance class could be a common part of company health plans if a tax proposal in the House becomes law.

The bill would encourage businesses to subsidize workers' workouts by letting the companies claim the contributions as income tax deductions.

The Workforce Health Improvement Program, WHIP, was drafted by a health club industry association, which sees the plan as a way to foster fitness - and, not incidentally, to get more members in the doors.

'What we are really trying to do is to extend the health benefits of exercise to as many Americans as we can,' said John McCarthy, executive director of the International Health, Racquet and Sportsclub Association.

The tax code currently lets companies deduct the costs of exercise facilities only if the facilities are at the work site, so generally only bigger businesses, with 500 workers or more, have them, McCarthy said. The proposed change would open the deduction to smaller businesses, he said.

PLAN WOULD ALLOW EMPLOYEE CHOICE

The plan would let employees choose how and where they want to work out, McCarthy said. "This bill supports all fitness suppliers - YMCAs, Jewish community centers, Jazzercise," he said.

However, WHIP specifically excludes private clubs owned and operated by their members, and facilities that "offer golf, hunting, sailing or riding."

While many could argue with the precise incentives here, the concept is a strong one. Giving tax incentives would work to encourage more use of fitness activities - clearly a desirable goal.

Medicaid crisis socks doctors

As financially squeezed state governments look for further Medicaid cuts, physicians across the country are warning of grave consequences for patient care.

"Proposed cuts are causing a great deal of anxiety among physicians," said Helen Kent Davis, director of governmental affairs for the Texas Medical Assn.

Texas' House of Representatives has proposed slashing $3 billion from the Medicaid program, including eliminating coverage for a half-million Texans and reducing payment rates to physicians and others by 5%.

Currently about 89% of Texas family physicians accept Medicaid patients, but that number would drop to 59% if the cuts go into effect, according to a survey by the Texas Academy of Family Physicians.

A recent study conducted for the TMA showed that every dollar trimmed from the state's Medicaid program means an additional 53 cents in uncompensated care provided by physicians and others. A dollar less in Medicaid money also equals $1.34 more in health insurance premiums and $2.81 less in federal funds.

This is a major problem. I do not know a solution.

Very interesting article in the NY Times - Aggressive Steps Help U.S. Avoid SARS Brunt

Public health officials from coast to coast have cited good planning and timely communication between federal and local officials as part of the reason the disease has not hit harder in the United States.

On March 15, the day the World Health Organization issued a global alert warning of a new and as-yet-unnamed virus spreading through Asia, Jonathan E. Fielding, director of the Los Angeles County Health Department, convened a conference call of his top deputies.

The health department immediately issued a notice to 81 receiving hospitals in the county, detailing the symptoms of the new virus and asking for immediate notification of suspect cases. The first report came in that same day. Ultimately the county found five probable SARS cases and four suspected cases, all of whom had recently traveled to infected areas.

"We're back where we were a century ago in dealing with an emerging infectious disease," Dr. Fielding said in an interview last week. "We don't have a definitive diagnostic test, we don't have a vaccine and we don't have a specific treatment. We're left with good public health measures as a bulwark against the spread of this disease."

He said that planning and new federal domestic security funds had helped the county prepare for the outbreak of the disease. He acknowledged that given the risk of infection ? roughly one in a million in a county of 10 million residents ? officials might have overreacted. But he said he would respond the same way if another health scare struck.

It is certainly very nice to read about some successes.

For the past 4 days I have participated in the SGIM annual meeting. Yesterday, I went to a session on worklife balance. One of the speakers was a practicing internist in Connecticut. He told a story of a patient complaining about the charges, because, he said, 'All you did is talk to me.'

Putting this into context, we must think about what patients think about their generalist, and how society values different aspects of medical care. This comment (which a colleague confirmed he had also heard from a patient) has lead to much reflection of generalism and what we provide patients.

I read mystery novels. I view generalism as analagous to being a detective. Patients come to us with complaints, which we must decipher. Our clues come from questionning the suspect, examining the suspect (collecting the physical evidence), and ordering laboratory and imaging studies.

We are taught early in medical school that most diagnoses come from the history (occasionally with laboratory confirmation). Thus, the outstanding clinician becomes a skilled questionner, using each response to trigger the next question, leading to an understanding of the problem (and once one makes the diagnosis, the answer often becomes apparent).

Even when we shift to the treatment mode (seeing the patient on anti-hypertensives; performing a periodic visit with a diabetic patient; checking the patient with congestive heart failure), most of our clues about success, or drug side effects, or new problems comes from questions and answers.

I love reading mysteries in which the detective works through inquiry. Such stories relate well to my daily life as a physician.

For reasons unknown to me, some patients now apparently only see value in procedures (either therapeutic or diagnostic). Perhaps that explains much of the attraction of the whole body scan. Yet, for most patients that I see, the story tells all.

We (generalist physicians) do a poor job of explaining our jobs. While we undertake the most complex task - sorting through patient complaints on the front lines, we rarely have our skills translated into a form understandable to the average citizen.

I am still pondering this dilemma. We should be the heroes of health care, and yet we are treated as grunts. Help me explain this better. I need help here - as does the field. For if we lose our excellence in generalism, we will lose much of our health care excellence. Remember, if the only tool that a carpenter has is a hammer, then everything looks like a nail. Only the generalist carries the full toolbox, figuring out the appropriate way to diagnose, treat, and prevent disease. We are needed; we are value; yet we are not telling our story well!

House Adopts Global Plan of $15 Billion Against AIDS

The House adopted a $15 billion initiative to combat AIDS worldwide today. The vote was taken after conservatives won a requirement that at least one-third of the money promote sexual abstinence before marriage.

The concession helped solidify support for a measure for AIDS treatment, research and education that is a priority of the Bush administration, and it resulted in a strong bipartisan vote in support of a social measure in the usually polarized House. The vote was 375 to 41.

...

Advocates welcomed the vote and said the abstinence language would not pose a serious problem. One advocate said the important development was that Republicans were voting for a measure to endorse condom distribution while Democrats backed abstinence programs.

"That is a pretty good start," he said.

Indeed it is!!!

Back in 1991 I spent one glorious month learning about medical teaching from Dr. Kelley Skeff at Stanford. A recent article about his courses appeared in the Stanford Medical Magazine (I am quoted extensively in the article). Demystifying Teaching

Kelley taught me many things over the years (we remain friends and colleagues). One of the most important lessons occurred the day he helped me understand the chasm between lecturing and learning. His point (and I take credit for the interpretation here) is that the goal of teaching is to induce learning. Everytime we teach, we should think carefully about the learner, and therefore work to make certain that the learner actually learns. Otherwise we become a lecturer rather than a teacher!

While I first learned these lessons with regard to teaching students, interns and residents, the same lessons apply to teaching patients. This study report tells me that we (most physicians) have a long way to go in this regard! Patients 'don't listen to their doctors' I like this article, but disagree with the title. It is not the patient's responsibility to listen, rather our responsibility to communicatge.

Dr Roy Kessels, from the University of Utrecht in the Netherlands found that between half and four-fifths all all medical information delivered during an average consultation was forgotten instantly by the patient.

In addition, half of the information that managed to gain a foothold in the memory of the patient was later recalled incorrectly.

The problem was particularly acute in older patients, he found, or in those who were anxious about bad news.

We can improve here. Repetition works. Taking more time works. Having the patient restate the point helps. Of course, no one reimburses us to take time and make certain that patient's understand. Some things we must do because they are the right thing to do.

Now it become official. We (the medical blogger community) have been discussing the health care crisis for many months. Today the NY Times declares it so! Health Care Limps Up Political Ladder

They (and the Democrats) rarely look at the true underpinnings of this crisis. We need solutions which diagnose the disease, not those which try to treat the symptoms.

Now it become official. We (the medical blogger community) have been discussing the health care crisis for many months. Today the NY Times declares it so! Health Care Limps Up Political Ladder

They (and the Democrats) rarely look at the true underpinnings of this crisis. We need solutions which diagnose the disease, not those which try to treat the symptoms.