Too many in our society believe that if a little is good, then more is better. That is clearly not true for many drugs. As we discussed yesterday, warfarin needs the proper dosing - not too much, not too little. For warfarin, the complications of incorrect dosing are dramatic. For vitamins, the complications are less dramatic, but also real. Vitamins: More May Be Too Many

A growing number of medical experts are concerned that Americans are overdoing their vitamin consumption. As many as 70 percent of the population is taking supplements, mostly vitamins, convinced that the pills will make them healthier.

But researchers say that vitamin supplements cannot correct for a poor diet, that multivitamins have not been shown to prevent any disease and that it is easy to reach high enough doses of certain vitamins and minerals to actually increase the risk of disease.

No longer, the experts say, are they concerned about vitamin deficits. Those are almost unheard of today, even with the population eating less than ideal diets and skimping on fruits and vegetables. Instead, the concern is with the dangers of vitamin excess.

You will not hear about these concerns at your local health food store. They will throw vitamins and other supplements at you indiscriminately.

Dr. Kava, of the American Council on Science and Health, said she abstained. "People ask me what vitamins I take," she said. "I say I don't take any. They look at me askance. They can't believe I'm a nutritionist."

Dr. Caballero also does not take vitamins. "There is no disease I know of that is prevented by multivitamins," he said.

In fact, Dr. Caballero said, typical pills, which contain a variety of minerals as well as vitamins, have ingredients that actually cancel out one another. "Minerals antagonize each other for absorption," he said. "Zinc competes with iron which competes with calcium."

Medpundit has a longer, more complete entry on this article today. I do not take a multivitamin, assuming that I eat a well balanced diet. This story is important, and worth your time to read the entire NY Times article.

The global fight against AIDS will require a variety of strategies. The President made that clear 3 months ago. Unfortunately, members of his own party do not "get it". AIDS Won't Wait

FOR THE MEMBERS of Congress who have delayed funding President Bush's global AIDS initiative, his speech yesterday should have stung: "In the three months since I announced the emergency plan, an estimated 760,000 people have died from AIDS, 1.2 million people have been infected, and more than 175,000 babies have been born with the virus," he said. "Time is not on our side."

The president could have been more explicit in chastising conservatives for their insistence on emphasizing abstinence to the exclusion of other approaches in the AIDS program. He might have cautioned Rep. Joseph R. Pitts (R-Pa.) and others not to offer amendments this week that would upend a delicate compromise that Rep. Henry J. Hyde (R-Ill.) took great pains to negotiate. In fact, the president seemingly encouraged those putting obstacles in the way of a sensible AIDS plan when he cited the famous Ugandan model of "ABC": "A" for abstinence, "B" for be faithful and "C" for using condoms. While much to be admired, Uganda's relative success neither offers a magic formula for every situation nor depends as much as conservatives suggest on abstinence alone.

But Mr. Bush's message was clear and correct: By calling AIDS prevention in Africa a "right to life" issue, he was warning conservatives not to be myopic or stubborn about their beliefs. This week the House will consider the bill with a new set of amendments. One adds a "conscience clause" allowing faith-based groups to opt out of condom prevention if they wish; this seems harmless. Another sets rigid numerical percentages for how much of the money should go to abstinence, which could bog everything down. The Senate will then have to haggle over how much money will go to U.S. organizations and how much to the Global Fund to Fight AIDS, Tuberculosis and Malaria, an international umbrella group that President Bush helped found but that he now seems to have cooled on.

Damn politics!!!

Recently I praised Thomas Scully for his courage in standing up to the pharmaceutical industry. This editorial in the Washington Times disagrees - Medicare reform, French style

 The biggest obstacle to President Bush's plan to improve Medicare is the guy who runs the program right now. In his State of the Union address, the president said that no bureaucrat, trial attorney or HMO should make medical decision, that only doctors and patients should do so. Yet, Tom Scully, the director of the Center for Medicare and Medicaid Services (CMS) can't wait to extend the rationing and price controls, which now apply to doctors, hospitals, medical devices and some medicines, to every prescription drug.

Mr. Scully said in a recent New York Times article: "We fix prices for every physician procedure and hospital visit. It would be much better to have private health plans make these decisions, but I try to be the best price fixer I can be."

Maybe Mr. Scully should work for the Chirac administration. For, rather than finding important ways to move Medicare into the marketplace, he is adopting the French method of cost containment called reference pricing. Mr. Scully calls it "functional equivalence." The government first haggles over the cost of every new drug and then either pegs the price at the generic or lowest-priced version of a product that treats the same disease, whether they are similar or not in terms of how they work, their effectiveness or impact on total cost or well-being. Patients or hospitals have to pay the difference between the price of the new drug and the government-set reference price. Drugs without an approved price receive no reimbursement at all.

Indeed, Mr. Scully claims that these drugs are mirror images of each other, so why pay more, particularly when you can spend the money on other services. But as Columbia University Business School economist Frank Lichtenberg has shown, the more money you spend on new drugs, ?$4 for every $1 of new drug spending to be exact ? the more you save on those physician procedures and hospital visits Mr. Scully loves to price-fix.

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 include this link in the spirit of balance. This blog always tries to present both sides of the issue. I do get the last word - afterall it is my blog!

The battle rages. This war will not end quickly. The combatants are obvious. In this war, too often the innocent suffer. In Pa., Doctors Rally For Malpractice Limits

This past Saturday, I spoke to 1st, 2nd & 3rd year medical students from the University of Nebraska, Creighton University and the University of South Dakota. My talk focused on how one picks a medical specialty. The symposium demystifies applying for residency training.

The first question from the audience was about malpractice. The malpractice crisis soon will impact on students' specialty choices.

Two thousand doctors, stethoscopes at the ready, gathered outside a convention center here to chant and jeer and demand that the governor and state legislature enact a $250,000 limit on malpractice awards.

Unlikely revolutionaries, the white-coated medical men and women depicted a profession besieged by lawsuits and perched on the edge of ruin. Surgeons and obstetricians around Philadelphia say they have seen their payments for malpractice insurance increase from $25,000 to $125,000 in the past five or six years.

"We are in danger of losing our best and brightest physicians," said Anthony V. Coletta, a Main Line surgeon. "Doctors may land on their feet, but it won't be in Pennsylvania. They'll move."

We do have a crisis. Which politicians will respond? How can we address this issue rationally? Who can really define malpractice? How much should the aggrieved party receive? How much should his/her lawyer receive?

We must resolve these issues. Physicians cannot "pass on the costs". Each malpractice dollar directly impacts their income. And malpractice insurance increases even if the physician has no suits filed. From a societal perspective, our current tort process makes no sense for medical care.

We need a revolution, but I wonder where it will arise.

I have a quiet morning today in beautiful Vancouver, so today I will do some serious blogging. As a travel commentary, if you have not visited Vancouver, and get a chance, definitely come here. It is drop dead gorgeous. We drove north the Whistler yesterday, and were just amazed at the scenery.

The NY Times editorial page applauds Vietnam's success in halting SARS in that country. The endorse (appropriately in my opinion) harsh epidemiologic measures to halt the epidemic. Sometimes the benefit of the many requires restrictions on the few. Finally, Good News About SARS

Warfarin is a wonderful and dangerous drug. We use it for atrial fibrillation, cardiac thrombi, deep vein thrombi, and pulmonary emboli. I always have a difficult time explaining warfarin (aka Coumadin) to patients. Perhaps this article will help - Patients on Anticlotting Drug Face a Tricky Balancing Act

As with all NY Times links, this link converts to an opportunity to pay for the article eventually (I think a month). Many physicians may want to print out this article to distribute to patients. Let me include this quotation:

But warfarin, as well as its generic mimics, is a tricky lifesaver, with a narrow margin of safety and effectiveness. Too little and it cannot do the job of preventing life-threatening blood clots. Too much and it can cause very serious and even fatal bleeding. Everyone on warfarin must be faithful about taking the right dose at the right time and having clotting times monitored at predetermined intervals.

"Patients who take warfarin (Coumadin) walk a tightrope between bleeding and clotting ? and a hundred things can tip the balance," Dr. Amir Jaffer, a hematologist, and Dr. Lee Bragg, a pharmacologist, wrote in the April issue of The Cleveland Clinic Journal of Medicine. "It's a difficult drug to use, with a narrow therapeutic index, but 60 years after it was introduced, it is still the mainstay of oral anticoagulation treatment."

Dr. Jaffer is medical director and Dr. Bragg is coordinator of the Anticoagulation Clinic at the Cleveland Clinic. They pointed out that only a minority of patients taking warfarin were managed by anticoagulation clinics, where the risk of excessive bleeding or unwanted clots is significantly lower.

Warfarin began its life at the University of Wisconsin as a highly effective rat poison. It works to inhibit clotting of the blood by interfering with the production of clotting factors that depend on vitamin K.

It was named warfarin for the Wisconsin Alumni Research Foundation (WARF), which supported its development.

In neighborhoods where warfarin is used to control rats, warnings are posted to protect pets and children from exposure, along with the recommended antidote, the coagulation promoter vitamin K, in case a nontarget animal is affected.

If I needed warfarin, I would become extremely compulsive about checking my blood work. We follow the INR as the following quote explains:

The goal is a measurement called the international normalized ratio, or I.N.R., a measure of how fast the patient's blood clots, or prothrombin time, is in relation to the average clotting time for people who are not taking anticoagulants. For most patients, the desired I.N.R. range is from 2 to 3.

The key here as that a higher INR increases the probability of bleeding, and a lower INR increases the probability of clotting. Thus we do have a tightrope analogy.

I love Jane Galt. Her blog always makes me think, and her economic sensibility adds flair to all her commentary. Today I disagree with a comment she posted yesterday.

So what you're saying is that introducing a strict third-party regulatory scheme for doctor payment has impaired quality of care by introducing perverse incentives into the system, and therefore we should analyze ways that we can do something similar with the pharmaceutical companies? Or is it just that it's moral for y'all to look for ways to maximize your profits, rather than looking selflessly to the benefit of the patients regardless of personal costs, but not for pharma executives, who aren't special like doctors?

Analyze the difference between physicians and the pharmaceutical industry. Because of the financing of medical care in this country, most physicians receive a fixed rate for an office visit, or procedure, or hospital visit. We have no ability to adjust rates based on time spent with the patient. If I have a highly desirable practice, I cannot increase my rates. This method of fixing our rates does provide a perverse incentive. It encourages us to spend less time with each patient. While many resist this incentive, I suspect most physicians do their best to see as many patients as feasible during the work day.

I am not calling for such restrictions on the pharmaceutical industry. Actually, I would like to see increased competition. The industry has a great advantage of patent protection. As the patent time expires, they engage in legalistic tricks to extend that patent protection. I am against those tricks.

We need to better publicize the equivalence of many drugs in the same class. Nexium has every right to advertize. I have the right and responsibility to argue that using Nexium is a waste of money, and that the drug should not even exist as a patented drug.

If we all used MSAs (see next post and Robert Prather's ranting) to buy our own drugs, perhaps more patients would be interested in knowing that Aciphex is cheaper and just as effective as Nexium (the both are proton pump inhibitors). Patients would more often choose drugs based on price, providing a balanced marketplace.

I would not mind having the same incentive system for office visits. The separation of cost from decision making in medicine does have a significant perversity.
 

Medicine in this country does not have free market principles. For a free market to exist, the consumer must have incentive to really care about prices. Given the insurance system in the US, patients really do not participate in financial decisions, unless they have to buy medications without coverage. Robert Prather (one of my favorite bloggers) rants eloquently on this issue today - Medical Care And Why We Need A Functioning Marketplace.

He currently is trying to exist in a free market, but I would submit that we need large numbers for the free market to influence the pharmaceutical industry and the pharmacies. Ideally, we would influence physician billing and hospital billing also. His idea of medical savings accounts has great appeal. They transform patients into consumers, who ideally will make good financial decisions, since they are spending their own moneys.

My earlier rant continued -

The Bush administration told drug companies today that many of the techniques they use to sell their drugs run a high risk of violating federal fraud and abuse laws.

The warning came as the government issued a compliance guide for the drug industry, telling manufacturers that they must not offer any financial incentives to doctors, hospitals, insurers or pharmacists to encourage or reward the prescribing of particular drugs.

Such payments have "a high potential for fraud and abuse," said the guide, issued by Janet Rehnquist, inspector general of the Department of Health and Human Services.

Federal law prohibits payments intended to generate business under Medicare or Medicaid, the federal health programs for 80 million older, disabled or poor people.

The law, known as the antikickback statute, forbids some practices that are common in other industries, Ms. Rehnquist said.

She said she was particularly concerned about marketing practices that drive up federal costs, interfere with clinical decision making and lead to overuse or inappropriate use of drugs.

These practices do not surprise physicians. This article just adds fuel to my fire over the marketing prescription drugs.

Ms. Rehnquist also warned drug companies that their research and education grants must be divorced from their marketing, or they risk violating the law.

If a drug company has any influence over the content of a professional education program or the choice of speakers, "there is a risk that the program may be used for inappropriate marketing purposes," the compliance guide says.

It also says that when drug companies pay doctors to conduct research, they must make sure the research is legitimate, "not simply a pretext to generate prescriptions of a drug."

Research and education grants are suspect if they are "based in any way, expressly or implicitly," on a doctor's ability to generate business for a drug maker, the guide says.

These represent two practices that we see too often. First, drug companies enroll physicians in "research" studies. These studies are not legitimate, but rather marketing tools. They allow the companies to invite physicians to "research meetings" - generally at fancy resorts. They also get physicians "used" to using their product - with the intent of a carryover phenomenon to "non-study" patients.

The educational programs are similar. They invite physicians to fancy dinners, or golf outings, or shows, for the ostensible purpose of an educational program. These programs always concern a disease for which they have a drug, or about to have a drug. Thus, they "educate" us in a way that is advantageous to their product (sometimes blatantly, sometimes insidiously).

These practices represent another factor in my disgust over their marketing techniques. Apparently, this pro-business administration agrees with me!

Off site seeing this morning - read this article, then come back later - I will have a long commentary on this article (and probably some additional blogging). U.S. Warns Drug Makers on Illegal Sales Practices

Still on the road - now in Vancouver for the week, first vacation then the SGIM meeting. Later this week I will comment on the SGIM report on the domain of general internal medicine. Fortunately, this wonderful hotel has high speed internet access, so that I can browse and blog daily. My blogging will be a bit limited secondary to the small keyboard on my laptop, and my schedule.

Earlier this week I started focusing on the pharmaceutical industry. Today, I will share an excellent NY Times article, and use it to expand on points I have previously made. The expansion is necessary because of questions and comments from readers.

Talking Up a Drug for This (and That) discusses "off-label" drug use. For those who are unfamiliar with off-label drug use:

Actimmune's sales represent an extreme case of what is known as off-label use. Doctors are allowed to prescribe a drug for unapproved uses, but drug companies cannot promote such uses, though in some cases they can provide educational material to doctors.

But drawing the line is tricky, and regulations are in flux. The Food and Drug Administration says restrictions on off-label marketing may conflict with the right to free speech, and it is considering relaxing the rules.

Some other drugs are sold mainly for nonapproved uses. Provigil, a drug from Cephalon that increases alertness, is approved only for narcolepsy, but most of its nearly $200 million in sales last year were for sleepiness linked to other conditions. More than 90 percent of the $119 million in sales of thalidomide, from Celgene, were for cancer, not for its approved use, leprosy. Most of the $2.3 billion in sales of Neurontin, from Pfizer, are for uses other than epilepsy, for which it is approved.

THROUGH off-label use, doctors can start treatment without waiting years for a new approval. Patients, particularly those with life-threatening diseases, often clamor for such drugs. But critics say the system allows companies to circumvent scientifically valid but costly trials.

Cephalon and Celgene have received reprimands from the F.D.A., and Pfizer has been sued over the issue. InterMune has never been warned by the F.D.A.; the company's backers say this shows that it is playing by the rules. Executives of the company say it is only responding to demand.

"We don't market it" for pulmonary fibrosis, said W. Scott Harkonen, InterMune's chief executive, in an interview. "There's been a lot of interest in the medical community, and we've responded to those requests."

But there is evidence that the company has actively stirred interest. At an investors' conference in September, it said its sales force included 60 pulmonary specialists to call on every lung doctor in the country ? "all in the context of our education and awareness program," a company executive said. Its annual report for 2002 said profits on Actimmune were low because of royalties and "direct costs of marketing."

InterMune has sponsored dinners at which doctors hear speeches by pulmonary fibrosis experts, who mention Actimmune. It has set up booths at pulmonology medical meetings. It financed the creation of a nonprofit patient advocacy group called the Coalition for Pulmonary Fibrosis.

"They are using the education loophole in a way that becomes advertising and promotion," said Michael Rosenzweig, president of the Pulmonary Fibrosis Foundation, an advocacy group based in Chicago.

As I read Robert Prather's argument (see yesterday's rant, and read his rant also), we should have no such thing as "off-label". Pharmaceutical companies need only prove that a drug is safe. Once safety is assured, then we physicians could sort out efficacy. But how can we sort out efficacy, if we have no requirement for companies to fund efficacy trials?

I am not alone in wanting an efficacy agency, funded by a special tax on pharmaceutical sales. Such an agency could supply the data that I need to better care for patients. One could argue that the studies required for FDA approval do not adequately explore efficacy and additional indications.

So we are stuck in a quandry. How much information do I need to make medication decisions? Certainly, I do not want to prescribe unsafe drugs, but most drugs are unsafe at some dose or in some people. Prior to spending health care dollars on medications, I hope to believe that there is a return on that investment. I should not prescribe a $4/day drug unless I have good evidence that I will be helping you.

So the real question focuses on how physicians can have the data that they need to work with patients to make good treatment decisions. The corollary question relates to how do we insure good data. Which studies contain data which help us?

This article discusses the "off-label" use of a drug for a progressive and fatal lung disease.

The big trial, involving 330 patients, ended last year and was intended to see whether the drug improved lung function. But the lungs of those who took Actimmune were not significantly better than the lungs of patients who received a placebo.

Somewhat unexpectedly, however, patients who took Actimmune often lived longer. That result was not statistically significant over all. But in a subset of patients with milder disease, there was a large and statistically significant difference: only six who got the drug died, compared with 21 who got a placebo.

Are these data adequate to spend $50,000/year. And who should spend the money - insurance companies (including Medicare) or patients themselves? We have a challenging problem here. I still believe that a properly funded FDA could and would help us with the decision making process. They would solve the unbiased scientist problem.

I worry about the chaos of a no efficacy rule. I worry about the impact on our medical knowledge. Having a no efficacy rule would further muddy pharmaceutical claims. The pharmaceutical industries best interest probably will not align with my patient's best interest.

Many patients will swear by a drug - based on anecdotal evidence. Others will swear at a drug - based on anecdotal evidence (for a great example of this, read my rant on generic omeprazole and the many comments). We need unbiased, composite data. Patients deserve the results of well done trials to inform their medical care. Our current system, while not perfect, does insure that we do get data, at least on the initial indication for the drug.

The development of diagnostic tests is a subject of much study. I have taught courses in medical school and CME courses on test characteristics. I always stress that it takes time and validation to assess test characteristics.

What do I mean by the phrase test characteristics ? This phrase refers to the sensitivity and specificity of any diagnostic test. Sensitivity tells us the probability that someone with disease will have a positive test. Specificity tells us the probability that someone without the disease will have a negative test.

We were hopeful as the developed a new diagnostic rapid test for SARS that the test would have excellent test characteristics. Unfortunately, it may lack in sensitivity. SARS Diagnostic Test Could Be Yielding False Negatives

The Centers for Disease Control and Prevention revealed that about seven of the 13 probable cases of SARS (search) that were tested came up negative.

The CDC also said that 32 cases considered "suspected" rather than "probable" were tested, all of them coming up negative.

"The fact that some of our probable SARS cases are not virologically positive is not surprising," said CDC director Dr. Julie Gerberding.

The World Health Organization also advised against putting too much trust in diagnostic exams, noting on its Web site that national authorities and medical staff should "understand the limitations of currently available tests."

This article should not surprise anyone. Our knowledge of SARS in still minimal. These test results should help us continue our investigation of truth. The results are a minor setback, but learning about the "false negatives" might greatly increase our understanding. Researchers should interpret these data as interesting, informative and full of clues for further advances!

Knowledge can work as an antidote for fear. The fear associated with SARS extends beyond rationality. New Yorkers avoiding Chinatown represents the best such example of this irrational fear. I have found several interesting articles today which you should read. These articles add to my understanding of the epidemic, and thus decrease my fear (I do remain concerned).

Can SARS Be Stopped? This article does a very nice job of explaining the challenges of preventing the spread of this virus.

Variety of Strains May Account for SARS Hot Spots

Different strains of the virus that causes severe acute respiratory syndrome may be circulating around the world, which could explain why the disease seems more dangerous in some places than others, scientists say.

Researchers have deciphered the entire genetic make-ups of more than a dozen samples of SARS virus, and preliminary analyses indicate there is a spectrum of genetic variation.

Although it is too early to draw conclusions from those variations, whether any affect how easily the virus spreads, how sick it makes people or how easily the immune system recognizes it, that spectrum could explain why SARS has appeared to be more transmissible and deadly in places such as Hong Kong and Toronto.

"Scientifically, it would not be at all surprising," said Robert G. Webster, a virologist from St. Jude Children's Research Hospital in Memphis, who just returned from Hong Kong. "The chances are very good that the virus that got carried into Toronto and Hong Kong were different."

This article nicely discusses our expanding knowledge of the virus and its genetics. We remain in the growth phase of knowledge of this virus. As research continues, we can develop new understandings of the observed data. I believe that we are making incredible progress in our ability to contain SARS. Only time will tell.

Some remain highly worried. Laws Not Up to SARS Epidemic

The underlying principle behind isolating infectious patients and quarantining those exposed to the virus is that "the needs of the many outweigh the needs of the individual," said Howard Markel, a physician and author of the upcoming "When Germs Travel."

The problem, said legal scholar James G. Hodge Jr., is a patchwork of 50 different state laws, many antiquated, contradictory or too disease-specific to work today. Some might not withstand a constitutional challenge because they do not provide for due process.

Other legal analysts said that the government has enough statutory authority to act in an emergency.

"The idea that a judge is going to step in and tell a health director he can't do something, when that health director says we need it to save thousands of lives, is absurd," said Edward Richards, director of the Program in Law, Science and Public Health at Louisiana State University.

Public health experts are in wide agreement that U.S. officials would always attempt voluntary isolation and quarantine at the first hint of a potential epidemic.

I would like to think that logic would prevail. However, I have seen government in action and judges on the loose. I only hope for a logical outcome.

Robert Prather has a very interesting piece today - Even More Radical Change Needed At The FDA

In addition to moving more drugs to the over-the-counter market the FDA's mandate should be limited to safety only, rather than efficacy. Let the doctor decide which drug is most effective and most appropriate. That's what they are paid for. The FDA should focus on safety only.

We have two interesting concepts here. The first refers to an article in today's Washington Post. FDA Says It Can Take Away Drugs' Prescription Status

The Food and Drug Administration has concluded that it can force drugmakers to switch some of their prescription drugs to over-the-counter medications as a way to make them cheaper and more easily available to consumers, senior FDA officials said yesterday.

The prospect of forced switches is strongly opposed by drugmakers, who say that the policy could result in the unsafe use of some drugs. But the momentum toward requiring drug companies to make certain products available over the counter appears to be growing, and two popular prescription allergy medications -- Allegra and Zyrtec -- will likely be the test cases if the FDA decides to go forward.

Now this is an interesting concept. I believe that for many drugs, physicians will support this concept strongly. I certainly would expect that the FDA would get input from physicians concerning the potential risks of OTC status. Some drugs should remain prescription only. We will have to follow this story to see what decisions the FDA makes. I would give this concept a tentative thumbs up.

On the other issue though I disagree with Prather's suggestion. I do believe that medical care benefits from the FDA's requirement of efficacy prior to approval. Let me lay out my reasoning.

The argument against proof of efficacy is that physicians can review the data and make their own decisions. I have spent 3 days now ranting about how physicians are often incompletely influenced concerning prescription drugs.

If we had no proof of efficacy requirement, then we probably would have fewer good studies of efficacy. The FDA requirement forces the pharmaceutical industry to perform important efficacy studies . 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.

Thus, Prather proposes a theoretically sound alternative (the safety only plan), which would harm medical care indirectly. I assert that the unintended consequences of such a rule would hamper overall medical care.

I am sitting in a hotel room (fortunately the have hi-speed internet access). On Wednesday I started down a road and have not yet reached the end. Therefore, I will continue discussing this issue at least today. I encourage readers to read through the thoughtful comments on yesterday's rant. I will excerpt some comments and address some comments.

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?

I personally have the $10 rule. I do eat drug company sponsored lunch at conferences that I am attending anyway. I will eat a brownie, cookie or banana. I will accept a pen or a paper pad.

I will not go to dinner, play golf, or go on a trip sponsored by a pharmaceutical company. Should physicians do those things? Many physicians delude themselves, thinking that accepting such gifts does not influence them. I have previously ranted about this issue - Gifts . Each physician should consider his/her ethical framework concerning this issue.

I would find this a more compelling argument if doctors thought that people outside the medical field ought to decide what is and is not a legitimate means for increasing their income. For example, it's very clear to me that my doctors, trying to maintain their income in this era of low-HMO payments, are interested in moving me in and out of their office in the absolute bare minimum of time. To that end, they treated my asthma by shoving some inhalers at me and telling me to call in in six weeks. They were visibly irritated when I phoned them about non-threatening bouts of asthma -- you would think a doctor might appreciate that not being able to breathe even a little bit is kind of frightening. Did this risk my life? Nope. But it certainly reduced the quality of care I got, as they had neither the time nor, apparently, the knowlege of the advances in asthma treatment, to improve my outcomes. I'm not talking about one doctor, either -- I'm talking about a succession of GP's who have bequeathed to me permanent scarring in my bronchia due to their perfunctory treatment. I have a pulmonologist now, but for the rest of my life I'm going to have to struggle to breathe because no one took ten minutes to explain the long term progress of the disease, and the need for steroid treatment, to me when it counted.

This is a poignant comment. I do like the debating technique, when one cannot really defend the pharmaceutical industry, one can reply by attacking physicians. I will try to break this comment down and respond directly.

As I (and other medical bloggers) have pointed out repeatedly, current physician reimbursement methods have negative implications for patient care. Physicians respond to financial considerations. We work under a bizarre reimbursement scheme - one which financially penalizes us when we take more time to see a patient. We work on a flat rate per case reimbursement. No lawyer, accountant, plumber, car repair mechanic, etc would consider such a bizarre system.

So what's the point? To resolve the above comment, we need to reconsider how physicians are reimbursed. Our current system is economically unsound. The incentives are malaligned. I hope to blog more on this issue over the next week.

What you don?t seem to like is that their best case for their drug is seldom the whole truth. That?s marketing for you. And a messy, sordid business it is, compared to science. Yet the information alternative to marketing in the practice world is likely to be ignorance rather than science?except for the few docs in fulltime practice who read their journals regularly. Pharmaceutical marketing, for all its one-sidedness, may even be socially useful if it leads to patients getting drugs that they need and would not otherwise get, provided that the benefits of the drugs are worth the cost. That outcome, of course, depends on we physicians acting as informed consumers and evaluating what drug reps tell us critically?as, I believe, most of us do. That?s how a marketplace is supposed to work. What would you suggest instead?

I love hyperbole! The lack of drug reps would not lead to ignorance. The reader does point out an important point. The best defense against the pharmaceutical industry's incomplete truths is stronger continuing education. Continuing education is very problematic. As the Associate Dean of CME, we are investigating methods for delivering information to physicians. The standard lecture method is not very satisfactory. We must learn how to provide useful information - both "fair and balanced".

I hope this discussion will continue for a few days. Send email, make comments, let me know your thoughts - both positive and negative.

My post yesterday on the pharmaceutical industry struck a nerve in at least one reader. You can read his comments, my response to his first comment, and then another reader's response. I expect more comments on that post.

Last night, and this morning I have considered the original comment, my post, and my response. Rather than my usual browsing the web today, I will just reflect on the pharmaceutical industry. I expect and hope for vigorous commentary on this rant.

Why should we admire the pharmaceutical industry? This industry has done much to improve medical care, decrease mortality and improve quality of life. As I reflect over the past 30 years of medicine (I was a 3rd year student in 1973), the number of new drug classes is astonishing. This list is likely incomplete - beta blockers, calcium channel antagonists, ACE inhibitors, ARBs, statins, fluoroquinolones, H2 blockers, PPIs, SSRIs, glitazones, antivirals (working against influenza, HIV, hepatitis C, the herpes family), interferons, many cancer drugs, TNF alpha antagonists, etc. Stop reading for a few seconds and reflect on that list. When I was a medical student, we treated hypertension with alphamethyldopa and a thiazide. We had very few other options. We had no known treatment to decrease CHF mortality. The treatment for ulcer disease was surgery. We knew cholesterol was a risk factor, but had no good agents to decrease cholesterol. We had no antiviral therapies.

I could ramble on for some time. The pharmaceutical industry has delivered wonderful advances which do make a major difference in our medical care. We have an expanding therapeutic armamentarium to choose from. These advances come, in part, because capitalism rewards helpful innovation. I salute the pharmaceutical industry.

For every yin there is a yang. Good is often balanced by evil. Darth Vader started out pure - then he surrendered to the dark side.

The pharmaceutical industry has heroes. The basic research provides wonderful advances. The industry invests heavily in research.

The problem begins when the marketing and promotion departments get involved. This is the face of the pharmaceutical industry to physicians. This face often looks evil to many physicians.

Let me try a few examples. Every drug company makes an ACE inhibitor (allow me some hyperbole here). Each ACE inhibitor is better than the rest (just ask the pharmaceutical rep for that particular ACE inhibitor). This story is easily repeated for many drug classes.

Now I took Logic in college. I understand that the reps are using sophistry and obfuscation. They only do this, because their superiors teach them. No political campaign has as well considered "talking points" and "spin doctors" as does a new drug campaign.

I accept that they are trying to put their drug in a positive light. But they lie! And their lies cost patients money.

Read about Nexium. Why I've lost respect for the pharmaceutical industry .

The federal official in charge of Medicare and Medicaid told doctors last month that they should not prescribe Nexium, a new heartburn drug, saying it was identical to an older drug, Prilosec, which became available in a cheaper generic form in December. The admonition infuriated executives of AstraZeneca, the maker of Nexium and Prilosec, who contend the new drug is superior.

That quote comes from another recent rant - Money talks .

So my problem with the pharmaceutical industry is not with the back rooms. The research and the product are commendable. The business tactics are often reprehensible.

So I will continue to have a love/hate view of this industry. We need a strong industry; we need their continued investment in research; but we would like higher ethical principles in marketing and promotion. I remain schizophrenic on this subject.

Viruses cause pesky infections. They have a major problem - they mutate. While all living species have mutations, viruses particularly mutate rapidly and in ways that change their infectivity and our immune response. This high mutation rate makes both treatment and vaccination strategies difficult.

When we think carefully, we should have known that the SARS coronavirus would mutate rapidly. Coronaviruses cause colds, and the cold viruses mutate often. We know that the influenza viruses mutates often - that is the reason for newly formulated flu vaccinations each year.

Sars virus 'mutating rapidly'.

The Beijing Genomics Institute reported that the virus is "expected to mutate very fast and very easily".

Other experts have warned that, once established, it could be particularly hard to stop the Sars virus causing problems.

Sars appears to be caused by a new strain of a coronavirus which may have "jumped" from animals to humans in the southern Chinese province of Guangdong.

...

Every virus is capable of mutating. Although the virus contains a large amount of genetic information, every time it is "replicated" inside a cell, tiny genetic "mistakes" are made.

Some of these may harm the success of a virus, leave it unchanged - or make it better at infecting and replicating in humans.

Natural selection means that "mistakes" that end up benefiting the virus will lead to the creation of strains that are more virulent, or more easily transmitted from human to human.

Dr Adrian Mockett, who has helped developed coronavirus vaccines for use in veterinary medicine, told BBC News Online the virus had particular characteristics that could prove a problem in humans.

"The ability of the virus to mutate has been a real problem in poultry vaccines.

"The virus has the ability to change quite quickly - a vaccine might be suitable for a while, but not forever." Every virus is capable of mutating. Although the virus Every virus is capable of mutating. Although the virus

We can only hope for containment during this first wave of infection. If SARS becomes endemic, we might have a significant long term public health problem.

As Oliver Hardy (of Laurel and Hardy) often said, "Here's another nice mess you've got me into". While I rant often about the evil pharmaceutical companies, could they actually be agents for good? Drug Makers Expand Their Medicaid Role

A growing number of pharmaceutical companies are offering to take on prominent public health roles in helping to care for the sickest poor patients in some states.

Under the agreements, the drug companies create guidelines for treating Medicaid patients with chronic conditions like asthma and diabetes. The companies then pay for case workers to help patients follow the guidelines ? for example, by phoning them to remind them of the importance of taking their medicine regularly and eating properly. The case workers also talk to the patients' doctors so that care focuses on managing disease rather than treating an acute event like an asthma attack.

The drug companies say the programs save taxpayers millions of dollars by keeping Medicaid patients out of the hospital. But critics of the programs say the drug companies are sponsoring them to persuade state governments to drop efforts to demand lower drug prices. The critics say there is no proof that the programs save money, and that states could save far more by demanding lower prices from the pharmaceutical companies.

We have an interesting conundrum. If a drug company provides a worthwhile service to patients, and also benefits (in terms of market share), how do we reconcile our ethical position.

By offering the disease management programs, Pfizer got all its products included on Florida's list, which has quickly paid off. Since the program started in June 2001, Pfizer has been getting a greater share of the more than $1.5 billion that Florida spends on Medicaid drugs each year. Last year, the state's Medicaid program bought $122.4 million of Pfizer products ? a 22.6 percent increase, according to state figures, versus a 14.5 percent increase in Florida's Medicaid drug spending over all.

There, your honor, is the evidence of Pfizer's nefarious plan. Their plan is working, they are evil.

Bob Sharpe, director of Florida's Medicaid program, said he was already negotiating with the drug makers to extend the programs for another year. Mr. Sharpe said he believed that Pfizer would be able to show that it saved the state $15 million in the first year as the company promised to do. Pfizer and state officials plan to release a report on those savings in coming weeks.

"These programs not only yield savings but they are an investment in people," Mr. Sharpe said. "This is something that will save us money year after year."

Many patients have lost weight, begun exercising or changed their diets, he said, since Pfizer's program began. The programs are not designed as drug marketing programs, he said, and do not recommend specific brands of medicine.

Oops, this does not sound so bad. They, Pfizer, have a disease management program that does not just rely on medications. The disease management program has a $15 million guarantee for the state - money saved primarily through decreased hospitalizations.

About 13,000 Florida Medicaid patients who suffer from asthma, diabetes, hypertension or heart failure are participating in Pfizer's program. The company reviewed past Medicaid claims to identify patients who were at the highest risk of being hospitalized. A network of 60 case workers, who are attached to local hospitals, contacted those patients, urging them to join the program. The case workers then regularly talk to participants about how to better manage their condition.

Larry J. Brown, a 44-year-old Gainesville resident who suffers from diabetes, said he had lost about 80 pounds since beginning Pfizer's program last year. "They'll make sure you get your medicine on time and everything," he said. "I feel a thousand times better."

Now I am really confused. Could the drug company program really help patients?

But some who have studied the programs are skeptical.

In a review of Florida's program by the Henry J. Kaiser Family Foundation, analysts noted that the drug company programs created a potential conflict of interest.

"If a competitor's product is proven to be more effective than that of the manufacturer running the disease management program, will patients receive the most effective product if it drives market share away from the disease management sponsor's product?" the report asked.

And Dr. Thomas Bodenheimer, a professor at the University of California at San Francisco, said the drug makers had so far not been able to prove that their programs saved money. The companies have been offering the programs, mostly to health insurers, since the mid-1990's.

Dr. Bodenheimer said that some well-designed disease management programs offered by other sponsors had been shown to save money, especially for patients with congestive heart failure or asthma. But so far, he said, the drug companies have not been able to prove their savings by doing a statistically valid analysis.

"It is like money down a rat hole," he said.

Wow! How do we judge these programs? Many of us tend to attribute only evil intentions to pharmaceutical companies. Our first instinct is to look for their edge.

All business situations do have the possibility of Win-Win solutions. Could these disease management programs provide such solutions? Should I trust the pharmaceutical industry? Should I trust state government assessments (especially when the pharmaceutical industry contributes to the governor's election campaign)? Should I trust the critics, many of whom criticize almost by reflex (assuming the the pharmaceutical industry cannot do good)?

I need more information here. This report makes me think. I may need to reconsider my paradigm. Are you reconsidering yours?

I was planning to address this issue once again today because of the NY Times article - Hormone Studies: What Went Wrong? I couldn limit my ranting, because Medpundit has already provided an excellent rant.

However, I cannot resist adding my own reflections. I present a paradigm for medical knowledge. I hope this discussion adds texture to our understanding.

Medical research has not failed here. Nor have physicians failed in their actions. Nor has the public health system failed.

At any time in medical history, we (physicians) must make health care recommendations base upon the best available evidence at the time. Researchers, and most practicing physicians, know that randomized controlled trials trump epidemiologic studies. The physicians who designed the Women's Health Initiative understood the importance of a prospective randomized study. Until we have such data, we cannot know the results of any intervention.

However, while we await randomized controlled trials, we must make decisions. Some have described medicine as the art and science of making decisions under conditions of uncertainty. The more general ones practice, the more uncertainty one must accept.

When a patient enters your office, or you enter the patient's hospital room, the physician must make many decisions. What questions should I ask? Which physical exam maneuvers should I perform? What tests should I order? What prevention should I recommend?

While these decisions are somewhat data driven, the data are often not definitive. We (physicians) must play the odds. We must take the available data, using those data to make the best possible decision for our patient.

I have found that physicians generally act with the patient's best interest as the first and only concern. (I do admit that it pains me to have to add the adverb generally to that statement.) Given the uncertainty in the data, we (the medical community) will make mistakes. For many years, we prescribed antiarrhhthmics to post-MI patients with more that 6 PVCs per minute. Then a well done randomized controlled trial demonstrated that the anti-arrhythmic drugs were really proarrhythmic and lead to an increased death rate. The common practice prior to the study release made sense. Almost all cardiologists had embraced that approach. It took a randomized controlled trial to provide common practice wrong.

This situation is similar. The evidence for post-menopausal estrogens was strong. Several analyses of the epidemiologic data (and not just the Nurses' Health Study) supported the role of post-menopausal estrogens.

I view this story as a positive one. This story demonstrates the importance of scientific inquiry. We can only approximate the truth, but we can always strive to get close to that elusive golden ring.

We now know more than we did prior to the Women's Health Initiative. As usual, each study raises as many questions as it answers. Researchers will continue to provide information that will help us understand the varied effects of post-menopausal estrogens. In the meantime, we will continue to make decisions based upon the best available data. Some of those decisions will actually be helping patients; some of those decisions may be hurting patients. We can only hope that the helping outweighs the hurting.

The Carbo War, Cont'd This article summarizes the controversy over low carb diets. It includes a common sense approach to dieting. I recommend this article strongly.

As our knowledge of coronary artery disease evolves, so do we change our thoughts on both primary and secondary prevention. Highly sensitive C reactive protein (hsCRP) has received much attention over the past few years (including several rants here). New Test for Hearts at Risk: What It Can and Can't Do

A panel of experts has recommended that tens of thousands of people be tested for a new indicator of heart disease. The indicator, C-reactive protein, is produced in the liver in response to injury or inflammation, and it can help identify people at higher risk for heart attack and stroke, including those with normal cholesterol.

But the panel, convened by the Centers for Disease Control and Prevention and the American Heart Association, stopped short of recommending the test for every adult and said that the test should not replace assessments of other risk factors, like cholesterol, high blood pressure and diabetes.

People with a low risk of heart disease and those with a high risk will most likely not benefit from the test, called high sensitivity C-reactive protein, or hs-CRP, the panel says.

In an interview, Dr. Thomas A. Pearson of the University of Rochester School of Medicine and Dentistry, co-chairman of the panel, helped clarify the recommendations.

I recommend this question and answer session. Some physicians may want to print this to hand out to inquiring patients (caution NY Times links "disappear" in ~ one month). Therefore I will include this snippet.

Q. According to your panel, who should be tested for hs-CRP?

A. Typically it's people who are borderline high risk. First, a doctor would measure a patient's major risk factors, like cholesterol, high blood pressure, smoking, diabetes, sex and age. Then he'd calculate the patient's 10-year risk of developing a heart attack or dying of heart disease. We have simple formulas we use for that. If the risk falls between 10 percent and 20 percent, you're in a situation in which you don't know whether to treat this person or not, so doing this test would help inform your decision.

Q. Can people figure out their own 10-year risk?

A. They can go to the American Heart Association's Web site, americanheart .com, which has a risk assessment tool.

Q. Can you give a sense of someone who has a 10 percent to 20 percent chance of developing a heart attack or dying of heart disease in the next 10 years?

A. Smoking gets you there very fast; or having two or three elevated risk factors, like high bad cholesterol, high blood pressure and being an older male, which is a substantial number of Americans. If you're obese, you probably have several risk factors, and that will get you into that category.

Q. Why do you suggest not testing people for the heart disease indictor if their risk of having a heart attack in the next 10 years is less than 10 percent? Or those whose risk is greater than 20 percent?

A. We feel very strongly you shouldn't test someone in whom you wouldn't do anything different on the basis of the test. You wouldn't do it in someone who has coronary disease, a previous heart attack or stroke or diabetes, as we're going to treat these people aggressively no matter what the results of hs-CRP are.

Similarly if you have a young person with few risk factors, you wouldn't test him either, because you're not going to do anything about it. If a young person had a 2 percent risk factor, and had a high hs-CRP, it would only bring his risk up to 4 percent, which is a level we still wouldn't treat.

I believe the panel has acted cautiously in their recommendations. We are starting to order hsCRP for consideration of secondary prevention - i.e., known atherosclerotic disease and normal cholesterol levels. If hsCRP comes back high, we will use that as an excuse to prescribe statins.

A reader - Peter Obels (see his blog just added to the blogroll on the left) - has pointed out the old Dutch origin of the word "rant". He provided two references - Online Etymology Dictionary which has the following definition:

rant - 1598, from Du. randten "talk foolishly, rave," of unknown origin. Ranters "antinomian sect which arose in England c.1645" is from 1651; applied 1823 to early Methodists.

Main Entry: 1rant
Pronunciation: 'rant
Function: verb
Etymology: obsolete Dutch ranten, randen
Date: 1602
intransitive senses
1 : to talk in a noisy, excited, or declamatory manner
2 : to scold vehemently
transitive senses : to utter in a bombastic declamatory fashion
- rant·er noun
- rant·ing·ly /'ran-ti[ng]-lE/ adverb

Well I guess that describes this blogger quite well!

A colleague at another university clued me to this quotation. It will go over on the right column - because I love the quotation.

There are in fact, four very significant stumbling-blocks in the way of grasping the truth, which every man however learned, can scarcely allow anyone to win a clear title to wisdom, namely, the example of weak and unworthy authority, long standing custom, the unfeeling of the ignorant crowd, and the hiding of our own ignorance while making a display of our apparent knowledge.

Roger Bacon

Read those words carefully, and try to live by them!

Doomsday Scenario for Doctors

In early March the House passed a much-needed tort reform bill, and the Senate now is debating the issue. Unfortunately, even if the Senate passed the bill tomorrow, more than 300 high-risk specialists in the District, mostly obstetricians and gynecologists, still would face a painful decision: Pay an outrageous amount for liability insurance or drop out of the District health care system. If they opt out, the result could be disastrous.

The annual liability insurance premium for these 300 specialists is coming due soon. Last year it was $89,000. This year it is $108,000, which equals about four months' worth of gross income for these doctors.

Rather than pay this huge sum, some of the 300 doctors may retire early. Others may take their practices elsewhere. Still others may decide to take a chance on going without insurance, which would mean that they would have no admitting privileges at hospitals and could not be preferred providers for health plans.

Any of these alternatives to ponying up $108,000 would mean that D.C. hospitals might lose thousands of patients, which would make it difficult for them to keep their delivery suites open, their trauma centers operational and their operating rooms functional. Hospital beds would go empty, and capacities that once were assets would turn into liabilities.

This story sounds very similar to Rangel's rant that I cited on Saturday. Increasing malpractice insurance rates do not just impact physicians. Rather the entire health care system is at risk in this crisis.

If enough doctors opt out of the District, health insurance plans might be unable to ensure access to necessary medical services in provider networks as required, and they, too, might not be able to remain in business in the District. Employer health benefit plans also would feel the pinch.

Ironically, doctors who choose to continue practicing in the District might see their premiums go up still more if some of their colleagues give up their D.C. practices. The National Capital Reciprocal Insurance Co. (NCRIC) is the liability insurance company for 90 percent of D.C. doctors. An exodus from the physician ranks could mean an increase in premiums for those remaining, because risk would be spread over the smaller group. Internists, whose $16,000-a-year premiums are recoverable in about two weeks, might find themselves working for several months to pay for insurance.

Further, if NCRIC went bankrupt, as similar companies have in some states, not only would all physicians be uninsured but they also would need to buy insurance to cover risks that had been covered by NCRIC before they could get other liability insurance. "Prior acts coverage" generally costs 150 percent of the annual premium for regular liability insurance; that would translate to $162,000 for obstetricians and gynecologists.

This worst-case scenario may seem extreme, but it is the logical endpoint of a long-emerging crisis. Even if a tort reform bill is passed that covers the District, it almost certainly will not reduce malpractice premiums.

Everyone must understand the unintended consequences of out-of-control malpractice suits. We need real tort reform. I remain pessimistic that we will get that reform in the near future. And the Democrats continue to accept money from the trial lawyers. And the Democrats use the tort lawyer talking points. They are talking us into a health care crisis!!!!!!!!

I have to link to this article. The AMA News interviewed me (and several other medical bloggers) by phone a few weeks ago. The author has done a nice job of understanding the blogosphere and its potential. Welcome to the blogosphere: A brave new world of Web dialogue: A growing number of physicians are sharing their thoughts and opinions on online diaries known as Web logs, or blogs. This article gives some positive publicity to our small (but apparently growing) club of medical bloggers. As I near my first blogging anniversary (May 19th), it seems that we bloggers are impacting both the blogosphere as well as medical thought in general. I hope we do make an impact. Blogging allows us to express our uncensored opinions. We often disagree, and readers often disagree with us. These rants and counter-rants allow readers (and writers) to consider these issues carefully. If we achieve that goal - inducing thinking - then we are a huge success!

State Medicaid programs have the same financial difficulties discussed below in the Medicare rant. A federal court has agreed that Michigan can work to limit drug expenditures. Federal court upholds Michigan Medicaid drug formulary plan

More than a year after Michigan implemented a Medicaid drug formulary in an effort to save money, physicians are still working through kinks in the program, and courts are still reviewing the law to decide whether it's appropriate.

In the latest court round, the state's statute came out on top. The U.S. District Court for the District of Columbia in late March upheld the law, which requires physicians to get prior authorization before prescribing Medicaid patients medications that aren't on the formulary.

But the Pharmaceutical Research and Manufacturers of America and two patient groups in Michigan already have vowed to appeal the decision because they fear that the law will hurt patient care, particularly for Medicaid recipients who are being treated for mental illnesses.

These decisions are necessary. We have limited resources. The states cannot spend moneys that they do not have. Some of these decisions seem painful. Nonetheless, they do seem necessary.

I have blogged this one silly. This article does summarize the current situation. Hypertensive studies: 2 results Are ACE inhibitors or diuretics more effective? The answer may come soon.

In December, a study of more than 42,000 white and black Americans found that old-fashioned, cheap diuretics -- "water pills" -- work at least as well and sometimes better than more expensive drugs to treat high blood pressure and certain heart problems. In February, a study of more than 6,000 mostly white Australians came to a different conclusion -- that drugs called ACE inhibitors were better than diuretics, although only for men (for unclear reasons).

Now it falls to a committee of experts picked by the National Heart, Lung and Blood Institute in Bethesda, Md., to reconcile the studies and tell America's 50 million hypertensives what to do. The conclusions are crucial: Hypertension doubles the risk of heart attack and is the leading risk factor for stroke and heart failure. One in four adult Americans has hypertension, which is defined as a reading of 140/90 or higher.

I will not repeat my previous rants on this subject. New readers who are interested can search on ALLHAT and find many rants on this subject.

Common sense lives in the Bush Administration. I know that that sentence will give some pause. Others might stop reading. However, after reading this article, you may agree - U.S. Limiting Costs of Drugs for Medicare

In a fundamental change, the Bush administration has begun to weigh cost as a factor in deciding whether Medicare should pay for new drugs and medical procedures.

Most notably, in recent weeks, federal officials have adopted policies to limit what Medicare pays for prescription drugs. These actions, they said, set a significant precedent, illustrating how Medicare will try to control spending if President Bush and Congress agree on a plan to provide more extensive drug benefits to the elderly and the disabled.

The officials said they were not imposing explicit price controls, but stretching federal dollars to ensure that the government would be a prudent purchaser, a goal endorsed by health policy experts.

But drug industry executives have strenuously protested the administration's actions. The government, they say, lacks the legal authority, the expertise and the clinical data to make such decisions.

"Medicare officials are increasingly injecting questions about cost and cost-effectiveness into decisions about coverage," said Gordon B. Schatz, a Washington lawyer who specializes in health care issues.

Almost anyone who closely examines potential Medicare expenses would come to the conclusion that Medicare cannot pay indiscriminately. Thus, an intelligent manager would make some decisions based on financial considerations. Examples:

¶The federal official in charge of Medicare and Medicaid told doctors last month that they should not prescribe Nexium, a new heartburn drug, saying it was identical to an older drug, Prilosec, which became available in a cheaper generic form in December. The admonition infuriated executives of AstraZeneca, the maker of Nexium and Prilosec, who contend the new drug is superior.

¶Medicare refused to pay the full price for a new drug to treat anemia in cancer patients, saying it was "functionally equivalent" to an older drug with a lower price. Amgen, the maker of the new drug, Aranesp, contends that it is more effective than the older drug, Procrit, sold by Johnson & Johnson.

¶In deciding whether Medicare should cover a new test for colon cancer, the government said last month that it would analyze the cost-effectiveness of the procedure in detecting cancer among people with no symptoms. The government has rarely been so explicit about considering cost.

Political watchers understand that President Bush comes from a business administration background. He delegates authority, and expects sound decision making. He and his administration do understand the cost implications of political decisions (something the Congress rarely considers). Readers of this blog know my disgust with the entire Nexium promotion in this country - My personal crusade against AstraZeneca - just say no to Nexium . Having this administration convinces me that they will not allow Medicare destroyed unnecessarily.

The Bush administration surprised doctors last month when it bluntly stated its preference for Prilosec over Nexium as a treatment for heartburn.

At a convention of the American Medical Association, Mr. Scully told doctors, "You should be embarrassed if you prescribe Nexium," because it increases costs with no medical benefits.

"The fact is, Nexium is Prilosec," Mr. Scully said. "It is the same drug. It is a mirror compound."

Mr. Scully said he had no problem paying thousands of dollars a year for an innovative drug that saves lives, like Gleevec, for certain types of leukemia and gastrointestinal tumors. But he said, "Nexium is a game that is being played on the people who pay for drugs."

Will common sense receive its just rewards? I am not certain that common sense will work in political campaigns - the sound bites might not be there. But they have convinced me - actually the New York Times has convinced me - of the administration's common sense.

Here I am, back at the Q&A desk - sorting through the comments and questions. As always, the readers provide more material than I can use. Thanks to all who comment and question. Here are my highlights.

I enjoy your site, and noticed that you maintain a listing of "other medical blogs." I thought I'd point you towards my own site, the Ectopic Brain (http://pbrain.hypermart.net ), where I maintain a "What's New" page (http://pbrain.hypermart.net/blogger.html ) featuring news and information about the medical uses of Palm OS handhelds. Just FYI.

I had forgotten this email - but found it this morning. I have added the Ectopic Brain blog to the list on the left. For those who use Palm OS, this will be a valuable resource.

There is a reason why the real stuff will cost more and be more effective, there has been deep and serious research into it, using the best components to achieve the best possible results, generic medication may come from anywhere and the least expensive components will definetely be used. The molecules used in generic may vary just a little bit from the original, but the results will prove the difference between the two. Why pay less for your health? I'd rather buy something less this month and get what makes me feel great and healthy than saving a couple of dollars -or nothing at all -for something that makes me feel cheated and terrible. -Save in shoes, houses, etc, not in health.

This comment is wrong. Generic drugs have the same regulations from the FDA as trade drugs. The FDA maintains a site which provides information on generics - "http://www.fda.gov/cder/ob/default.htm">Electronic Orange Book. As one researches this issue one finds that often the same manufacturer makes both the generic and tradename preparation. I do not understand the disinformation concerning generics. They do work and they do save money.

Regarding your euthanasia position. Amen. But here's another place physicians should absolutely NOT be involved. Execution of the death penalty. How could any physician participate?

I do not think I could participate as a physician. The point is well made, and I believe that most physicians share this view.

I have read through the response from readers on omeprazole.  I find them interesting and strangely one-sided.  About 70% of omeprazole is being is dispensed as the generic, manufactured by Kremers Urban.  Given the millions of people switched to the generic (and many having been programmed to believe generics are of poor quality) I guess I shouldn't be surprised there are many who complain.

Having said that, I have two thoughts:

1) I have no respect for tactics used by the drug industry and wouldn't put it past them to have orchestrated some of these responses.  I worked for a state Medicaid agencies and frequently saw letters orchestrated by drug representatives (standard letter with different doc or patient name) opposing policy changes, and physician and patient letters complaining about generic failure.  Medicaid programs spend millions more for Clozaril (money desperately needed elsewhere), because prescribers demand the brand - all evidence to the contrary. This may sound paranoid, but with the $10+ billion involved in PPI sales, even those companies who hold patents will eventually see their market disappear to generic omeprazole.  PPIs represent a large share of many companies revenue.  Falling sales mean layoffs.  The drug industry is a master at controlling the message.  I have looked in chat rooms used by people with depression and seen drug industry reps pumping Lexapro as a wonder drug.  There must be a law against such action by a drug salesperson.

2) An aside, one of my colleagues complained when she switched to generic omeprazole, it didn't work as well as the Prilosec.  When I questioned her pattern of use, I discovered she took it with the breakfast meal.  When I told her to start taking the omeprazole 30 minutes before the morning meal, the problem resolved.  Many people don't know PPIs should be take 30 minutes or so before a meal.

3) If these are legitimate drug failures, prescribers should be encouraged to report them to the FDA.

Thanks for your rants on drugs like Nexium, Clarinex etc.  Many low income folks are duped by the drug industry and believe they must spend their limited discretionary income on these bogus drugs.   It appears all the ethics have gone out of the ethical drug industry.  Sad.

Often readers say things more elegantly than this ranter. This is such a case.

Well, I'd been dropping hints on my site for a week or so, and this week I made it official. I'm now one of Corante's tech bloggers - they needed someone to cover drug discovery and the like, and asked me if I'd like to come over. My site's been renamed from Lagniappe to "In the Pipeline," which at least gives folks some idea of what it's about.

The new URL is http://www.corante.com/pipeline. It looks a bit different from my old Blogspot site, but that's not necessarily a bad thing. Otherwise, nothing's changing - same topics and style as before. Same weird digressions, same lack of income, etc.

This commentary presented as a public service. I have changed the blogroll appropriately.

I have been switched to omeprazole 10 mg, but apart from slight mouth dryness I have had no other symptoms. On the contrary I am happy with the product; it has completely changed my life after the surgeon botched two hiatus hernia ops (and during the second one, accidentally tore my spleen!)

Anyway all my best wishes to fellow suffers - I know what its like!

By far the omeprazole rant has attracted the most attention of any single rant in this year of blogging. I included this positive comment, since it is in the minority.

I read your artical about patient autonomy. It was an excellent example of a physcian supporting the patient autonomy in the end stage of his life. Your approach to patient autonomy should be implemented as a routine practice.

We (medical school educators) generally are doing a much better job of teaching end of life issues. This education does include an understanding that our goal is to improve the patient's quality of life - as they define quality of life. I am personally impressed with how our students, interns and residents understand these concepts and apply them daily at the bedside.

Consider this: as these figures reflect declining compensation, our youngest graduates are entering the profession with the highest levels of educational debt in history, facing the highest prices for housing in many markets in a generation and have the greatest need to provide for their own retirements at a time of profound weakness in the investment markets. Practice costs have never been higher and the Medicare system is planning to cut reimbursements again next year, after a 5.4% gross cut last year. That 4.2% cut proposed cut will register against many doctors own incomes as double that amount given that other overhead will not be going down. Americans have blithely counted on the energy and durability of the private practice medical delivery system to see to the needs of our citizens. We don't have any real alternatives. Most patients really don't think of the effects of payment cuts except as it affects their copayments and deductibles. That luxury of ignorance may end abruptly and painfully.

This kind of information will travel quickly. College students trying to make decisions about going to medical school (vs. something else) won't ignore these reports, either. How can they? Finishing school with $200K of debt and without adequate compensation to repay the debt and to recover the opportunity costs of lengthy education and training isn't an option for anyone but the reckless and foolish. We want the best but don't want to pay for it, and will sue with abandon when we aren't satisfied. We are playing with fire with this. And we will very likely get burned.

I love C. Henry's rants. They are on target. We (society) are in trouble.

Hi, I was reading your Dec. 14, 2002 post about "Start Jogging" and you mentioned how you got shoes from a specialty shoe store. I haven't heard of any such stores around where I live, but how would you suggest I go about finding some? I've seen ads for a specialty shoe store that made custom inserts for shoes, but I'm looking for actual running shoes. Were your shoes custom made or did you just buy some popular brand like Adidas or Reebok?

We happen to have a specialty running store here in Birmingham. I friend at work suggested I go there. They sell regular brands, but helped me understand which type of shoe I needed. You might be able to figure that out yourself. This article from Runner's World should provide some valuable information - The Best Shoe for YOU! Let Runner's World help you find the right shoe for your running needs

What advice would you give to obese or overweight kids that try to diet or exercise but it never works?

Unfortunately, I am much better at identifying this problem than solving it. Exercise regimens do require self discipline. So does changing ones eating habits. Behavior changes challenge physicians so much that we start to avoid trying - because we get such a low success rate. The only advice that I can really give is to keep trying. Sometimes it takes multiple attempts until a change can really occur.

Was just switched over from Prilosec to the Generic Omeprazole and have been taking for 12 days now. I have had diarrhea and nausea for 10 of those days. Will be seeing the doctor about it soon! Does anyone know if the doctor has to say that the patient must have the Brand or the Generic version? This has been a bad experience!

While I doubt that the generic is the problem, I can answer your question about brand versus generic. Prescription pads give physicians the right to insist on brand name or allow substitution. If you want to pay for the brand name, it is your right to ask either the physician or the pharmacist.

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This ends todays session. Try as I might, I just cannot avoid the Prilosec/omeprazole controversy. Without this blog I would not even know there was such a controversy!

Thanks again for the comments and questions. It is nice to know that my ranting induces comments and emails. That is wonderful confirmation that this blog has some worth. Thanks!!!
 

Stop reading this blog for a few minutes. Go to read Rangel's rant on malpractice. Then read it again. The medical malpractice crisis has yet to reach its apex!

Physicians face a shrinking pool of alternative companies that they can go to find cheaper rates and they have very little ability to pass their own increased costs on to their patients. So they have to suck it up. Guess what? This is a huge factor in determining how many physicians we will have, how many specialists there will be, and where they will be in the future. I wonder what current and future medical students are thinking when they find out that if they want to become an OBGYN or Neurosurgeon that their malpractice premiums will be as much as $100-200 thousand a year or more? My guess is that they will choose another specialty or another profession altogether.

This crisis has the potential to critically affect our health care system in the next few years. Those areas (such as the Rio Grande Valley of south Texas) that have become goldmines for malpractice lawyers because of their high jury awards will be loosing doctors by the bushel. These areas tend to be more rural and poor and they are the last areas that will be able to afford a physician exodus without substantial effects to their health delivery systems.

Nay sayers claim that the concern over this issue is overblown and except for a few highly publicized incidents that we have not seen the hail and brimstone effects on the health care system that have been forecast. Of course not! The crisis is only a few years old. It has not started to affect most physicians yet. The problem is that it shows no signs of stopping. High profile cases such as the one in North Carolina where organs from a donor with the wrong blood type were accidentally transplanted into a teenage girl will leave the public clamoring for ever higher awards without any concept as to how this will affect the over all health care system. As tragic as these cases are, they are rare and should not be literally used as "poster-child" examples for the need for unlimited malpractice awards.

The crisis has not yet reached it's maturity. Right now most affected physicians are in the middle of their careers and they have to essentially "bend over" and accept these massive increases in their malpractice rates. When you have a family, a mortgage, a well established practice, and no training in an alternate career just what the hell are you going to do but try and manage as best as you can. The near term effects of this crisis are likely to be on those at the opposite ends of their careers. Older physicians such as my father are more likely to retire much earlier then they would have done otherwise and those currently in training or considering a career in medicine are more likely to alter their plans. In the near term this will have little impact on the system but within a few years the general public will begin to notice the difference as the numbers of physicians dwindles and docs begin to move out of "high risk areas".

The Democrats and the lawyers have this one wrong. This is actually a libertarian issue, since your large suit impacts my health care. Patients must lead this fight. Enough of my ranting - if you have not already read Rangel - you must!!!!

Severe Lung Disease, Pneumonia, a Highly Destructive Bacteria

Unlike the cases I usually write about here, this one had a clear diagnosis. A chest X-ray confirmed that this man had significant lung disease and pneumonia. He was treated with antibiotics and sent to the telemetry unit, where his oxygen concentration could be closely monitored. The next day, cultures showed that the pneumonia was caused by Staphylococcus aureus, a vicious and destructive bacteria.

2. Treatment

We knew the diagnosis, yet there were questions about his treatment that were troubling. I needed to talk to him. When I went to his room, he was too weak to sit up. I pulled up a chair. ''Mr. O'Connor, you have a very bad pneumonia,'' I told him.

He smiled. ''You went to medical school to learn that?''

Staph aureus is so dangerous because it can destroy the tissues it infects, and this man had very little lung tissue to spare -- too much had already been destroyed by his smoking.

''You are very out of breath now. If this pneumonia gets any worse, your breathing could get even harder.'' When patients have difficulty breathing, we have a machine, a ventilator, which will breathe for them. But in this man's case, I worried that if his pneumonia got to be so bad that he needed a ventilator, it was unlikely that he'd ever be able to breathe on his own again.

''What's that machine like?'' he asked. ''Can I take it home?'' I explained that it has a tube that goes in through the mouth and delivers oxygen directly to the lungs. The machine requires close monitoring, but even more important, most people cannot tolerate the sensation of having a machine breathe for them and need to be sedated. ''So I'd end up sleeping my last days away?'' he asked. I nodded. ''No, I guess that's not for me,'' he said.

Now those of us who work in hospitals understand that the conversation was really a bit more complicated than written here. We do a much better job of working with patients to make intubation decisions. These discussions do take time and require patience. Often the discussion occurs over a few days. Often the patient has already considered the options prior to the discussion.

This snippet introduces a story worth reading. The patient has an incurable infection. He finishes his life with dignity. We can offer dignity, even when we cannot offer cure.

Viral Terrors

''Quarantine'' is a loaded word with metaphorical implications that many of us in America have fortunately forgotten. As the medical historian Howard Markel has noted, it derives from the Italian words quarantina and quaranta giorni, referring to the 40 days ships suspected of carrying plague were made to wait in the port of Venice before discharging their cargo. In America, the Federal Quarantine Legislation was passed in 1878, prompted by outbreaks of yellow fever. The power of quarantine was used vigorously, cruelly and arbitrarily during the New York City epidemics of typhus and cholera in 1892. (About 1,150 healthy people, mostly Russian Jews, were quarantined on North Brother Island, for example.) Fear of catching disease from immigrants (as well as fears of losing scarce jobs to them) caused citizens to rally against immigrants and immigration. Indeed, it is not far-fetched to think of race-based immigration bans as the ultimate form of quarantine.

In America, as of April 11, the Centers for Disease Control and Prevention recommended isolation for those who are ill with SARS but not quarantine; that idea does not sit well with our country's values. Given the lightninglike spread of SARS within a hospital, and given the way SARS has caused deaths in physicians and nurses caring for patients, I think we will regret our unwillingness to quarantine those who have been exposed. Singapore's authoritarian government had no such qualms. Cosmopolitan Hong Kong, on the other hand, a more enlightened, democratic society, did not quarantine at first. SARS spread more rapidly in Hong Kong.

...

Recently, we in America have sensed our right to privacy eroding, along with our rights to due process. The justification that such loss of liberty directly improves homeland security is not readily apparent, and it seems quite self-serving. But the virus that causes SARS has no political agenda, no jingoist banner to wave, and it has not read John Stuart Mill's ''On Liberty.'' The virus is democratic to its core, affecting rich and poor, doctor and patient, crossing borders with impunity and thus freezing commerce, threatening a global recession. The temporary loss of liberty that might come with quarantine for SARS, while painful, is a pill that I would find easier to swallow.

You should read the entire commentary. Freedom must have limits. The SARS epidemic may test those limits. Not testing the limits could have major implications.

New test for Sars virus

The firm Artus is confident the test can confirm the presence of the lethal respiratory disease in two hours, whereas traditional tests for antibodies take more than 10 days.

The test can detect the strain of the Corona virus which has been found in patients suffering from Sars, and is now widely thought to cause the disease.

Samples of the test will be shipped out for further evaluation by specialist labs around the world.

A spokesman for the World Health Organization (WHO) told the BBC the prospect of a standardised test was good news.

It would make it possible to test a lot of samples in a short period of time.

He also welcomed the fact that commercial companies were joining the fight against Sars.

There have been more than 3,000 cases of Severe Acute Respiratory Syndrome - most in south-east Asia - and more than 140 people have died.

News of the test kits - being distributed free of charge - came as Chinese President Hu Jintao admitted he was "very worried" by the disease, which has killed dozens in China.

This test will greatly help efforts to understand the epidemiology of this new coronavirus. Soon we will learn the complete spectrum of disease. Perhaps many are infected without significant symptoms. We just do not yet know.

Yesterday I ranted about a study which showed that magnesium supplementation could improve diabetic control - Can magnesium supplementation help diabetes control? After much searching, I found the article this story came from and offer these additional cautionary remarks.

First, the study required hypomagnesemia for entry. The investigators excluded patients with chronic diarrhea, excess alcohol intake (greater than 30 g daily), diuretics or calcium channel blockers, and reduced renal function.

The study, in this markedly restricted population, did have impressive results. We clearly need more studies of the relationship of magnesium depletion and diabetes control. This represents a very interesting focus for knowledge growth. I will try to search for more information.

Unprepared For a Plague

Smallpox has been on the minds of public health officials for the past year, as Americans worry about a bioterrorist attack. But the disease that has struck isn't smallpox, nor is it somebody's deliberate attempt to spread germs. Rather, it is nature's newest surprise: severe acute respiratory syndrome (SARS). SARS has gone from a few cases of pneumonia in southern China to a worldwide infection in just four months, with more than 150 deaths so far. This should remind us about the basics of disease control.

...

Besides chasing the chimera of the unforeseeable, biopreparedness systems are based on an erroneous premise. Our public health authorities presume that bioterrorism is a serious threat to public health. They're wrong. The number of deaths attributable to willfully produced epidemics, ever, pales by comparison with the toll taken by natural ones. In 1918-19 an influenza pandemic killed more people in just 16 months than World War I had killed in six years. Smallpox killed 10 times as many people in the first half of the 20th century as did both world wars combined. Even today malaria kills 2 million people each year; so does tuberculosis. By contrast, deliberate epidemics in the past 100 years, mostly through the actions of armies at war, have been responsible for only a few thousand deaths.

So what is to be done? Public health officials should stop tinkering with electronics and get down to basics. What America needs is not more people mining more data, but better public health. We already know how to do this: Provide good primary care, track disease outbreaks by counting cases, run effective preventive programs, vaccinate, and keep the food safe, the air breathable and the water drinkable. We can make people healthier and save more lives if we resist the lure of databases. And if we succeed at maintaining good public health, we can protect ourselves against most eventualities better than if we waste time and resources looking for "aberrant clusters."

This commentary has even more wisdom. The writer is an infectious disease epidemiologist. He speaks with a great knowledge of epidemics. Read his words, reflect and reconsider our preparedness.

Eplenerenone (Inspra) is an aldosterone blocking agent. I have ranted concerning its use for heart failure. The FDA also gave the drug an antihypertension indication. Some physicians may already have used this drug - I have not. This article provides information on efficacy for hypertension - Eplerenone Effective in Hypertensive Blacks and Whites

The aldosterone inhibitor eplerenone is equally effective in hypertensive blacks and whites and is superior to losartan in blacks, according to the results of a randomized, double-blind trial published in the April 2 issue of the Journal of the American College of Cardiology.

The editorialist comments on the importance of the study but takes issue with the use of race as a determinant of management. He suggests that in the future we will be better able to use individual genomic information, and he also adds that for patients with low renin (salt sensitivity), the addition of a low-dose diuretic can be very beneficial.

"Essential hypertension and cardiovascular-renal-target organ damage is more prevalent in black than white adults in the U.S.," write investigators John M. Flack, MD, MPH, from Wayne State University in Detroit, Michigan, and colleagues. "For reduction of systolic blood pressure (SBP), eplerenone was superior to placebo and losartan in all patients combined and in black patients, and was superior to placebo in white patients."

I cannot find any cost information yet on this drug. While the mechanism of action is similar to spironalactone, it seems to have less side effects due to a lack of androgenic blocking effects. This mechanism of action (aldosterone blocking) is intriguing. I expect much research on this drug over the next few years as we learn how it might fight into our therapeutic armamentarium.

New Drugs Block Hepatitis C

two drug companies - Schering-Plough and privately owned German company Boehringer Ingelheim - have developed compounds they hope will work against hepatitis C.

Gale's team tested the Schering product, called by its experimental name SCH-6, and found it could protect the cell's defenses.

< We found that the new protease inhibitors could actually prevent the virus from blocking this immune response and basically restore the innate antiviral response in human cells,? Gale said.

The work reported in Science was all done in the laboratory and Gale said the drugs will be difficult to test because no animals are naturally infected with hepatitis C the way humans are.

But Boehringer has reported on Phase I clinical trials, designed to test the safety of a drug in people, that suggest its protease inhibitor is both safe and may at least greatly reduce levels of the virus in the body.

In expectation of the emails I might receive, these are preliminary results . The pharmaceutical companies will move as fast as the FDA will allow. They have a strong profit motive here, and will do nothing to delay development and release. I would guess a 3-5 year time window for complete testing.

As I sat at the Seder last night, I wondered how to make this wonderful holiday relevant to Medrants!. Well, the morning browsing has found this article - the dangers of Passover food! Fish bones and matza pose Pessah dangers to the unwary

After dealing with children and infants accidentally poisoned by cleaning products left unsupervised by parents doing their spring cleaning, MDA continues to be on the alert during the festival. Small children can choke on even small pieces of matza, while others who eat too much of it suffer from stomach aches. Experts advise eating matza in moderation and drinking water or other beverages at the same meal to prevent indigestion. MDA also warns the public to remove all bones from fish before or after preparing it as gefilte fish. Unseen bones have been known to cause both adults and children to choke when they get stuck in the trachea.

So that is my Passover message - limit your matza eating, and drink plenty of fluids! And have a Happy Passover! For those who do not celebrate Passover - Have a Happy Easter!

No commentary - just read - Dictatorships and Disease

This is fascinating. I plan to get the article later today and review it. Magnesium Supplement Helpful in Diabetes Control

Drs. Martha Rodriguez-Moran and Fernando Guerrero-Romero of the Mexican Social Security Institute, Durango, note that hypomagnesemia is frequently found in diabetes and "could be involved in the development of poor metabolic control and chronic complications." However, randomized, controlled studies on this subject, they add, are "scare and controversial."

Overall, Dr. Rodriguez-Moran, told Reuters Health, it is unfortunate that the "magnesium ion is a typically overlooked electrolyte."

To further investigate whether oral magnesium supplementation might be helpful in type 2 diabetics with decreased serum magnesium levels, the researchers conducted a double-blind trial involving 63 such subjects.

They were randomized to receive a daily treatment with a solution containing 2.5 g of magnesium chloride or to placebo.

At the end of the 16-week treatment period, compared to the placebo group, those who received the supplement had significantly higher serum magnesium concentration (0.74 versus 0.65 nmol/L) and lower values (3.8 versus 5.0) for the homeostasis model assessment for insulin resistance index (HOMA-IR). There was also a reduction in glycosylated hemoglobin (HbA1c) levels (8.0 versus 10.1%).

Fascinating, but as always, I provide the cautionary note - we must view this study as hypothesis generating. I like the idea, and might even start checking magnesium levels in clinic. One caution, this treatment will endanger those with significant renal insufficiency. Perhaps more later today when I read the article, rather than just a summary.

Science works methodically - step by step towards new knowledge. As we follow the SARS story, we refresh our memories of that process.

Infectious agents must satisfy Koch's postulates before we assert that they cause the disease in question.

• The specific organism should be shown to be present in all cases of animals suffering from a specific disease but shold not be found in healthy animals.
• The specific microorganism should be isolated from the diseased animal and grown in pure culture on artificial laboratory media.
• This freshly isolated microorganism, when inoculated into a healthy laboratory animal, should cause the same disease seen in the original animal.
• The microorganism should be reisolated in pure culture from the experimental infection.

Scientists have now fulfilled the postulates for the coronavirus - Experiments on Monkeys Zero in on SARS Cause

Dr. David L. Heymann, executive director in charge of communicable diseases for W.H.O., said the agency "is 99 percent sure" that SARS is caused by the new coronavirus based on the monkey experiments in the Netherlands. Experiments on animals are necessary because the lack of an effective treatment for SARS and the relatively high death rate make it unethical to conduct such experiments on humans.

Preliminary findings show that the monkeys developed an illness resembling SARS after the coronavirus was put in their nostrils. Some monkeys developed pneumonia, and examination of their lungs under a microscope showed that the coronavirus caused a pattern of lung damage similar to what affected humans have suffered.

Scientists from the W.H.O.'s network of 12 international laboratories who have been seeking the cause of SARS will meet Wednesday in Geneva and by teleconference to review the evidence concerning the new coronavirus.

The monkey experiments are essential in fulfilling the steps known as Koch's postulates that are needed to establish proof that a virus or other microbe causes a disease. Applying the postulates to SARS, scientists must determine whether injecting the coronavirus into animals causes similar symptoms to those that humans experience. A formal announcement that the likely cause of SARS has been found could come as early as Wednesday.

In my opinion, the scientific response to this infection continues to amaze. They are obviously working full time to understand the infection. Understanding should help us prevent, and perhaps eventually treat this virus. Kudos!

Recently, our nephrologists have started advocating dual renin-angiotensin blockade for diabetic patients with proteinuria. I have read data showing that dual blockade does synergistically decrease proteinuria.

Research has shown that the protein (which enters the glomerulus as the earliest manifestation of diabetic nephropathy) damages the tubules. Various evidence shows that when one decreases proteinuria, one delays end stage renal disease.

These studies use an interesting outcome measure - the slope of 1/creatinine against time. Research over 20 years ago showed that most patients with renal disease lost renal function at a steady rate - best plotted as a straight line using 1/Cr against time. The research studies which have shown that we can delay ESRD both show less ESRD over a period of time and also a less severe slope for 1/Cr against time.

Dual Renin-Angiotensin System Blockade Best in Diabetic Nephropathy

Combining angiotensin II receptor blockade with angiotensin-converting enzyme (ACE) inhibition improved albuminuria and lipid profile compared with either therapy alone in patients with diabetic nephropathy, according to the results of a study published in the April issue of the Journal of the American Society of Nephrology.

"Albuminuria and hypertension are predictors of poor renal and cardiovascular outcome in diabetic patients," write Peter Jacobsen and colleagues from the University of Aarhus in Denmark. "A superior effect on blood pressure and a tendency toward a more pronounced drop in urinary albumin excretion of dual blockade of the renin-angiotensin system compared with single blockade has been reported in [type 2] patients with microalbuminuria."

In this double-blind, crossover trial, 20 type 1 diabetic patients with diabetic nephropathy were randomized to eight weeks of treatment with placebo, 20 mg of benazepril once daily, 80 mg of valsartan once daily, or the combination of 20 mg of benazepril and 80 mg of valsartan. Eighteen patients completed the study.

Compared with placebo, benazepril and valsartan were equally effective in reducing albuminuria and blood pressure. Compared with either monotherapy, dual blockade reduced albuminuria by 43% (range, 29% - 54%) and reduced both systolic and diastolic blood pressure by 6 to 7 mm Hg. Dual blockade reversibly reduced glomerular filtration rate compared with monotherapy and placebo. All treatments were safe and well tolerated.

We have treated patients in this manor recently. My strategy has been to start with an ACE inhibitor. If I cannot control the proteinuria I add an ARB.

I do know that the makers of the new aldosterone antagonist (Inspra - eplerenone) are funding studies to test blockade at this additional site.

So what take home message do I see here? We should always be aggressive in diagnosing and treating early diabetic nephropathy. The keys are excellent BP control, and minimizing the proteinuria. If the patient does not yet have proteinuria, yet is hypertensive, I start ACE inhibitors as my first line antihypertensive choice.

How do you get enough fiber? The Lean Plate Club: Testing One's Fiber .

Current recommendations call for women to eat about 25 grams of various sources of dietary fiber daily and for men to consume 38 grams per day. No one argues about fiber's ability to keep things, um, regular. But the recommended daily intake for fiber is aimed at lowering the risk of heart disease -- a measure of fiber's ability to reduce blood cholesterol and other blood fats significantly. There's also growing evidence that high-fiber foods may help create satiety, increase the ability to maintain a healthy weight, improve blood sugar levels and possibly reduce the risk of colon cancer and other digestive diseases.

It's not hard to meet the daily requirements without pills and potions, but to do so you need to make wise food choices. Start the day with high-fiber cereal (eight to 14 grams per half-cup); top with raspberries (eight grams per cup); order your sandwich on whole-wheat bread (three or more grams per slice); choose a bean salad, vegetarian chili, bean soup or a bean burrito (up to 17 grams per cup) to meet or even exceed the daily recommendations.

Consistent readers understand that I approach most issues from a libertarian viewpoint. You are entitled to great freedom, but the freedom of your fist ends at my nose. I argue, often without much success, that our war on drugs creates many more problems than it possibly prevents. While I understand the ravages of drugs on our youth and also many adults, the costs of the drug war (not monetary costs, but criminalization of large sectors of society, murders, robbery, etc.) far exceed the costs that would associate with decriminalization. As always, one must choose which costs are worse, costs of omission or costs of commission. We know the costs of the drug war.

This commentary does an elegant job of summarizing the problem. The war on drugs

Prominent drug legalizers or decriminalizers read like a who's who of conservatives: William F. Buckley Jr., Milton Friedman, New Mexico Governor Gary Johnson, Ronald Reagan's Secretary of State George Shultz.

Mr. Shultz, now at the Hoover Institution with Mr. Friedman, is but a recent convert. In 1984, he sang a different tune, declaring: "Drug abuse is not only a top priority for this Administration's domestic policy, it is a top priority in our foreign policy as well."

The background for the Shultz conversion is well-demonstrated in "Bad Neighbor Policy" by Cato Vice President for Defense and Foreign Policy Studies Ted Galen Carpenter, who dwells here on the more than 30 years since President Nixon declared a War on Drugs. Mr. Carpenter tweaks the title of his timely and instructive book in a play on Franklin D. Roosevelt's Good Neighbor Policy for Latin America in the 1930s, as he documents multiple U.S. sins south of the border and comments on our stepped-up war on drugs:

"U.S. officials have bribed, cajoled, and coerced Latin American governments to try to stem the outflow of illegal drugs. The result has been a rising tide of corruption and violence in those countries and a growing dissatisfaction on the part of affected populations with their own governments ? and with the United States. Washington's hemispheric war on drugs is the epitome of Bad Neighbor Policy."

We need rationale in this discussion, but I fear we will only get emotion. Some drugs are deadly, but the drug trade itself is - I believe - more deadly. We need enlightenment here. I doubt that we will get that enlightenment.

This rant does not qualify as news. The ideas are a rehash of many previous rants. Still I have not used this rant recently and I found an interesting new article related to it. A human time bomb

Worrall Thompson is the face of a new campaign to ?measure your mate?, which aims to raise awareness about the condition, known as insulin resistance syndrome (IRS). If your mate ? or any male who lets you wrap a tape measure around them ? measures more than 40in, they are at risk of IRS. The red-light figure for women is 35in.

IRS, which is also known as metabolic syndrome, glucose intolerance and Syndrome X, has been dubbed a ?medical time bomb? because it could lead to an explosion of disease in years to come. And not only among those facing midlife spread. Derriford Hospital in Plymouth last month reported that 30 per cent of 300 children between the ages of 5 and 16 were showing signs of it. Diabetes now affects about 4 per cent of the population.

The key to all this is the way that your body handles glucose. Until recently this was considered a specialised medical problem reserved for diabetics. But this comforting division is an illusion; our sedentary lifestyle, coupled with a taste for sugar and refined carbohydrates, is playing havoc with the subtle balance between glucose and insulin in our bloodstreams.

Refined carbohydrates are dangerous in the long term because they are too easily digested. The body turns all carbohydrates into glucose, which is then released into the blood. But while wholefoods, such as pulses, fruit and most vegetables, are broken down over several hours, providing a steady trickle of glucose, a sugar-laden fizzy drink, for instance, produces a glucose spike ? a sudden rise, followed by an equally dramatic fall. An occasional sugar spike is no big deal; but day after day, over many years, it can be deadly. As glucose levels rise, your body releases insulin to mop it up. After years of glucose peaks, the extra amounts of insulin have a diminishing effect. IRS then develops ? a pre-diabetic state with high levels of both insulin and glucose circulating in your blood. The result, among other things, is that hard-to-shift spare tyre around the middle and damage to blood vessels and the heart. In America the syndrome has been recognised as a medical condition, officially defined as having three or more of five conditions: abdominal obesity, high triglycerides (damaging fats) in the bloodstream, low levels of the good LDL cholesterol, high blood pressure and high glucose.

I rant about the metabolic syndrome frequently. We need to focus more energy on preventing the consequences of this syndrome. One can argue fairly persuasively that we should add waist circumference to our vital information on patients.

As I have discussed previously, waist circumference provides more information than body mass index (BMI). Athletes often have increased BMI, but excellent waist circumference. Waist circumference does a better job of predicting body fat percentage - which is the real risk factor.

Now we need to understand how we get patients (and sometimes ourselves) to prevent or treat this syndrome. The solutions will involve diet and exercise. Many believe that better understanding the glycemic index will provide great benefit.

We recommend exercise for many reasons. Exercise helps us control weight. It decreases the probability of diabetes. It decreases the probability of coronary artery disease.

We have assumed that walking worked as well as jogging or other vigorous exercise. That hypothesis is now in question. Study: Only Vigorous Exercise Helps Heart

A study published this week in Heart, a British medical journal, found that only vigorous exercise -- such as jogging, hiking, climbing stairs, racket sports and swimming -- seems to help lower the risk of early death from heart disease. Other research has shown moderate exercise helps.

Official government recommendations in the United States and elsewhere say 30 minutes of moderate activity every day, such as brisk walking, is sufficient for heart health. A major World Health Organization consensus report published last month reached the same conclusion.

However, the latest study, conducted by scientists at Queen's University in Belfast, Northern Ireland, found that activities considered to provide mild exercise -- such as walking, bowling and sailing -- as well as pursuits of moderate intensity -- such as golfing, dancing and brisk walking -- did not lower the risk of early death among 2,000 British men followed for a decade.

While this represents only one study, it does raise important questions. Science proceeds from discovering data which challenges existing hypotheses. Now we need to reassess other data sources to either confirm or refute this new hypothesis.

One fascinating phenomenon in the SARS epidemic relates to understanding how it spreads. Similar to many other infections, SARS apparently increases because of superspreaders. How One Person Can Fuel an Epidemic

A child in China so infectious that he is nicknamed "the poison emperor." A Chinese doctor who infects 12 fellow guests in his Hong Kong hotel, who then fly to Singapore, Vietnam and Canada. An elderly Canadian woman who infects three generations of her family.

Watching as the mysterious illness called severe acute respiratory syndrome hopped around the world and exploded in new outbreaks, epidemiologists began to ask themselves an unsettling question: is it carried by "superspreaders"?

The notion that some people are hyperinfective, spewing germs out like teakettles while others simmer quietly like stew pots, has been around for at least a century, ever since Typhoid Mary became notorious in 1907.

For some diseases, including tuberculosis, smallpox and staphylococcus infections, superspreaders definitely exist. They have been variously called "superinfectors," "supershedders" and even "cloud cases" for the mist of invisible droplets trailing them.

But while there are anecdotal case studies of individuals behind some outbreaks, there is little concentrated research in the field. "There hasn't been enough time, thinking and probing" to hazard more than a guess as to why superspreaders are responsible for so much of the spread of SARS, said Dr. Donald A. Henderson, the epidemiologist who led the global eradication of smallpox.

This article discusses theories of superspreaders for SARS and other infections. The SARS epidemic will focus attention on this interesting and important epidemiologic phenomenon.

Solving the health care crisis will require compromise and innovation. We must understand the costs and benefits associated with any suggested innovation. While this editorial talks about politics, I submit that we have some lessons for health care. Wow, Who Are the Smart Guys?

Mr. Sowell labels the competing visions "constrained" and "unconstrained." The constrained vision argues that perfection is impossible, that social policy consists of structuring incentives for self-centered men, that life is a series of trade-offs. This vision is represented by the likes of Adam Smith, Edmund Burke and Alexander Hamilton (and of course, Dick Cheney and the Bush administration mindset).

The unconstrained version argues that man's imperfections are the result of bad institutions, that pure intentions matter more than actual effects, that rationality can solve problems once and for all. In the time of Smith and Burke, this tradition was epitomized by William Godwin, whose "Enquiry Concerning Political Justice" was popular in Great Britain until the public started to witness the excesses of the French Revolution.

For the path of the unconstrained vision ran through Rosseau, Voltaire and Thomas Paine (a defender of the French Revolution as well as a hero of the American one). Today's academy is in thrall of descendants of these French ideas. The academically popular "deconstructionism" promoted by Jacques Derrida argues that the conception of meaning or truth is another corrupting institution, merely expressing power relationships.

Students and journalists who have never heard of Derrida reflect his influence in preoccupation with issues of gender, class and race. As Mr. Sowell writes, the "vision of the anointed" has become impervious to evidence. Rather, it's "a badge of honor and a proclamation of identity: To affirm it is to be one of us and to oppose it is to be one of them."

Earlier in my career I worked with a very bright physician who had wonderful ideas. Unfortunately, he could never accept that the world did not work the way it should. He could never separate the ideal from the real.

Solutions to health care will require the same sensibility. We cannot wish or hope that suddenly all individuals in society will act for the common good. We must assume that most individuals will approach problems hoping for solutions which maximize their own situation. Great solutions occur when incentives align for the most participants. We must strive for win-win solutions rather than idealistic solutions.

So how do we solve health care problems? This opinion piece has some very interesting ideas - To Solve America's Health Care Crisis, Think Small

Health care expert Brian Klepper introduces a three-fold strategy to respond to these concerns by marrying the best of both parties' proposals. First, Klepper advises that we need to ensure that our safety-net institutions do not collapse under the weight of an increased uninsured population. This protects the patient base while we address the pressing cost and sustainability issues.

Second, we need to rebalance the healthcare liability system. One such model is being advocated by University of Virginia law professor Dr. Jeffrey O'Connell, who calls for a no-fault system patterned after the workers' compensation program. Third, Klepper argues that we need to standardize the management capabilities of health systems. The near double-digit increases in premiums cannot become perennial entries in company balance sheets, of course. Without addressing the issue of exploding costs, it hardly matters what other reforms we pursue. Desired new management practices should include finding agreement on how to measure our progress and ensuring better information sharing, which combine to stimulate the transfer of innovation and installation of accountability.

We need creative solutions. The best solutions will not come from government. One need only look at HIPAA to understand how unnecessarily complex government solutions become.

I very much like the proposal for a no fault malpractice replacement. Corporate Law Concept May Provide Cure To Medicine's Malpractice Woes

As O'Connell and Boutros explain, the "early offers" plan is essentially an improved adaptation of the business judgment rule. It would allow a health care provider, including an HMO, facing a patient lawsuit, to offer the patient within a timeframe set by law (say 120 days after a claim is filed), periodic payments of all net economic losses not covered by other insurance, namely, lost wages, medical expenses, rehabilitation costs and attorney fees. Importantly, nothing would be paid for noneconomic damages such as pain and suffering. An early offer accepted by a patient would end the dispute.

A patient who rejects an early offer, however, would have to establish two things: First, that the defendant acted with gross negligence, and second, such gross negligence would have to be proved by clear and convincing evidence or preferably beyond a reasonable doubt. An early offer results in a much more difficult case for a plaintiff to prove, the theory being that once an early offer has been made, courts should not substitute their judgment for that of a defendant unless there is bad faith in the decision-making process or in the execution of the decision.

In an extensive discussion, O'Connell and Boutros show that the policies and rationales behind the business judgment rule apply with equal force in the area of medical malpractice claims. Moreover, they write, the majority of claims against health care providers, including HMOs, would lend themselves to resolution under the early offers plan, which offers benefits to both sides of a lawsuit.

Perhaps solutions to the malpractice crisis can come from such innovative thinking. The trial lawyers will dislike this possibility. It would greatly decrease their income possibilities.

Medpundit clued me to this site - SARS Watch Org. I will continue to rant on SARS issues. Those who want even more detail - this site seems worthwhile.

Youth and Fitness Offer Little Defense Against Disease.

The new respiratory disease known as SARS is beginning to kill younger and healthier adults as well as older people here, as medical treatments are proving somewhat less effective than originally hoped, health officials announced here today.

Until this weekend, those who died from SARS ? severe acute respiratory syndrome ? had been largely people over 60, and often were those suffering from other health problems as well. But eight people with the disease died here this weekend, and five of them were ages 35 to 52 and did not have previous medical conditions that might have been contributing factors, said Dr. Liu Shao-haei, a senior manager of the Hong Kong Hospital Authority.

As usual, prevention works much better than treatment. We need to better understand the epidemiology to decrease the spread of this virus. We should get a vaccine relatively soon (see the next rant). Perhaps with the genome defined we can also develop specific antivirals.

The next piece of detective work in the SARS saga was released yesterday. Lab Decodes Genes of Virus Tied to SARS.

Scientists in Canada announced over the weekend that they had broken the genetic code of the virus suspected of causing severe acute respiratory syndrome.

Sequencing the genome ? which computers at the British Columbia Cancer Agency in Vancouver completed at 4 a.m. Saturday after a team slaved over the problem 24 hours a day for a mere six days ? is the first step toward developing a diagnostic test for the virus and possibly a vaccine.

The genome appears to be that of a "completely new" coronavirus unrelated to any known human or animal viruses, a scientist at the Canadian agency said.

A competing United States team at the Centers for Disease Control and Prevention in Atlanta is reaching the same conclusion, and scientists from both teams said the virus's startling novelty could make it harder to trace what animal or bird it came from, if it did jump from another species.

Having the genome mapped allows virologists and epidemiologists to take many important steps. A rapid test would greatly improve epidemiologic understanding for this virus.

First, back from vacation. I will get to another Q&A later this week. For 3 days I had absolutely no internet access! After getting through withdrawal symptoms, I did really well. On the plane home though, I started lusting for my computer and cable modem. So here I am, browing the web and finding this fascinating article - Study Faults VA on Heart Care: Agency Vows Bid To Improve System . This article is sobering and I will use it to make some philosophical points about health care.

The Department of Veterans Affairs said yesterday that it's not as good at taking care of heart attack patients as it thinks it is -- or as it should be.

Heart patients treated at VA hospitals have consistently higher mortality rates than patients of similar age and in roughly similar health who are treated at non-VA institutions. A larger proportion of the veterans die in the first month after suffering a heart attack, and a larger proportion of the survivors die over the next three years.

Those were two key findings of a new study, which also found that VA patients undergo cardiac catheterization -- a key step in assessing the seriousness of a person's heart disease -- less often than patients treated in non-VA hospitals. And they have only about half the likelihood of undergoing angioplasty or bypass surgery, two procedures that can often extend life.

The department, which provides medical care for nearly 5 million veterans a year, commissioned the study and announced its findings yesterday at a news conference hosted by Veterans Affairs Secretary Anthony J. Principi. "The results of this study are valuable as well as troubling," Principi said. "The findings . . . are unacceptable, and immediate action is required and will be taken."

Principi outlined a number of changes he is ordering for the department's 162 hospitals. These include a better system for quickly moving VA heart attack patients to hospitals offering a full menu of cardiac services should they be at a VA hospital that lacks them.

You really should read the rest of this article for a good discussion of the study, and some possible explanations. I will speculate, because I can!

Americans expect the highest quality health care possible. The VA cares for American veterans - and thus the patients should get the highest quality health care possible. Many times, the highest quality health care costs significant dollars. The VA system does not always have the necessary dollars to provide such care.

Often in the VA system, health care dollars are rationed implicitly. No one tells the cardiologists to do less catheterizations or PCI or CABG - however, the resources constrain these procedures .

Additionally, VA physicians have no incentive to do another procedure on any given day. They are salaried and work hard, but work within a constrained system. The support staff have no incentive to support extra procedures.

The VA, as a model for socialized medicine (or even universal health care), has some major advantages. However, once you limit resources, you must limit health care quality . As I have ranted often, health care costs (real costs, real percentage of GNP) should increase. We can do more, but doing more costs more.

We clearly understand the benefits of spending more money on advanced technology for our armed forces. We have not yet made the case that improving health care will often cost more money.

Our society cannot have it both ways. If we want the most advanced health care in the world (and I believe we truly do have the best health care), then we will have to accept the payments. True costs are rising, and attempts to limit expenses will have an adverse effect - assuming we accept best possible care as our goal.

We must focus the debate. Physicians need to make this case. Currently, we are trying to minimize expenses by decreasing physician payments. This strategy will not work towards society's benefit over the long haul. I welcome all comments on this issue. I hope those who examine this article truly understand the ramifications of these data.

Going on vacation. Not sure of computer access and time availability. I will try to post a bit. Be back Sunday evening.

Today's NEJM contains two imporant articles about deep vein thromboses (DVT). Those who read my post earlier this week about David Bloom, now know much more about DVT and pulmonary emboli.

Warning Signs Of Pulmonary Embolisms.

For the first time, researchers have linked the hardening of arteries to blood clots in veins, a finding that could trigger new research in the effort to prevent the blockages that kill thousands of people each year.

Italian researchers found patients hospitalized with unexplained deep-vein clots were nearly 2 1/2 times more likely to also have hardening of the arteries, or atherosclerosis, than patients with deep-vein clots attributed to other health problems.

The doctors concluded either hardening of the arteries can induce blood clots in veins or the two conditions share common risk factors.

This report, while certainly not conclusive, certainly suggests that we should consider evaluating patients with unexplained DVT for the possibility of atherosclerotic disease. We do need more studies to evaluate this hypothesis.

In the same issue, we learn that patients benefit from anticoagulation beyond the 6 month time frame. The study - Long-Term, Low-Intensity Warfarin Therapy for the Prevention of Recurrent Venous Thromboembolism - gave conventional anticoagulation for 6 months, then randomized patients to low-intensity warfarin (INR 1.5-2.0) or placebo.

Results

The trial was terminated early after 508 patients had undergone randomization and had been followed for up to 4.3 years (mean, 2.1). Of 253 patients assigned to placebo, 37 had recurrent venous thromboembolism (7.2 per 100 person-years), as compared with 14 of 255 patients assigned to low-intensity warfarin (2.6 per 100 person-years), a risk reduction of 64 percent (hazard ratio, 0.36 [95 percent confidence interval, 0.19 to 0.67]; P<0.001). Risk reductions were similar for all subgroups, including those with and those without inherited thrombophilia. Major hemorrhage occurred in two patients assigned to placebo and five assigned to low-intensity warfarin (P=0.25). Eight patients in the placebo group and four in the group assigned to low-intensity warfarin died (P=0.26). Low-intensity warfarin was thus associated with a 48 percent reduction in the composite end point of recurrent venous thromboembolism, major hemorrhage, or death. According to per-protocol and as-treated analyses, the reduction in the risk of recurrent venous thromboembolism was between 76 and 81 percent.

These results are dramatic. Keeping the INR between 1.5 and 2.0 requires frequent prothrombin time checks and many office visits. All this trouble seems worthwhile for the patient. I suspect that this will (and should) become standard of care very quickly.

Old news - physicians are making less. This report from an unbiased group - the Center for Health System Change - makes the point clearly.

Behind the Times: Physician Income, 1995-99. Note the title - I will bet that the numbers are even worse over the past 2 years. The numbers are worst for primary care physicians, and some wonder why students do not choose primary care!

Coronavirus Confirmed as SARS Agent

The Hong Kong University SARS Study Group reviewed records and microbiological findings for 50 patients with SARS, representing more than five separate epidemiologically linked transmission clusters, and ranging in age from 23 to 74 years. Evaluation included chest radiography and double-blinded laboratory testing of nasopharyngeal aspirates and serum samples.

The most frequent symptoms were fever, chills, myalgia, and cough. Fewer than 25% of patients had upper respiratory tract symptoms, but 10% had gastrointestinal symptoms. Respiratory symptoms and auscultatory findings were milder than would be expected from chest x-ray findings.

Predictors of severity were household contact with other infected individuals, older age, lymphopenia, and liver dysfunction. In two patients, a virus belonging to the family Coronaviridae was isolated. Serological and reverse-transcriptase PCR specific for this virus was positive in 45 of 50 patients with SARS, but in no controls. Of 32 patients from whom acute and convalescent sera were available, all had rising antibody titers to this coronavirus.

Because this virus is not one of the two known human coronaviruses, nor is it exactly like any of the known animal coronaviruses, the investigators believe that it may be a new virus which may have originated from animals. Additional genetic analysis may confirm this hypothesis.

"The high incidence of altered liver function, leukopenia, severe lymphopenia, thrombocytopenia, and subsequent evolution into adult respiratory distress syndrome suggests a severe systemic inflammatory damage induced by this human pneumonia-associated coronavirus," they write. "Thus immunomodulation by steroid treatment may be important to complement the empirical antiviral treatment with ribavirin."

The CDC does not believe that ribavirin helps. We clearly need more research here.

The article is available on line and free from the Lancet - Coronavirus as a possible cause of severe acute respiratory syndrome

Some officials believe SARS is here to stay. Asian Officials Say SARS May Be Here to Stay. Reading the article, I find their pronouncement a bit premature.

Researchers are working diligently to better understand key factors like transmission, rates of infection, and other important epidemiologic issues. I would bet on a vaccine within the year.

The CDC speaks out on SARS - CDC: SARS 'the beginning of a problem'

"This is the beginning of a problem," Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention, said as she testified before the Senate Health, Education, Labor and Pensions Committee.

"We may see further spread of the disease in this country," Gerberding added.

This is in part because of so-called "superspreaders," or people who appear to be especially contagious after contracting the illness and could infect several other people, she said.

The future course of SARS is uncertain, Gerberding said. It could turn out to be a seasonal illness similar to West Nile virus or there could be a leveling off after the initial cases of infection.
"We don't know where this is going to go," she said.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases -- a component of the National Institutes of Health -- agreed the future of the disease was unpredictable.

"For that reason, we have to take this very, very seriously," Fauci said.

His agency already has begun initial work on developing vaccines and other treatments against SARS, which is believed to be caused by a new form of coronavirus. Known members of this family of viruses cause conditions such as the common cold and generally mild respiratory illnesses.

Researchers plan to have finished sequencing the entire genome of the new virus by this weekend, Gerberding said. That could aid attempts at finding drugs effective against it.

They also are developing diagnostic tests that will detect the presence of the virus and help identify those who have contracted it.

SARS, malpractice concerns and too much traveling have decreased my diet and fitness posts. Today I will provide a very nice link on modifying our diets. Pecking at the Pyramid

Not a pyramid, but an hourglass.

That's the shape of the American diet, according to a recent report from the U.S. Department of Agriculture (USDA). Written by Judy Putnam, Jane Allshouse and Linda Scott Kantor of the USDA's Economic Research Service, the report finds that consumers eat mostly from the tip and the foundation of the pyramid, gobbling lots of food high in fat and added sugars (the tip) along with refined grain products, such as pasta, crackers and white bread.

At the same time, they skimp on vegetables, fruit, low-fat dairy products, beans, lean meat, poultry and fish.

Read the entire article. Please.

So how extensive will this epidemic become. So far, so bad. Concerns Grow About Controlling Lung Disease Over 2,600 SARS Cases Suspected Worldwide

The World Health Organization reported the number of cases of severe acute respiratory syndrome, or SARS, under investigation hit 2,601 in 17 countries, an increase of 85 cases since Saturday. The WHO reported 98 deaths, with two new deaths in Canada, four in mainland China and three in Hong Kong. In addition, Singapore reported two more deaths.

The number of suspected U.S. cases climbed to 148 in 30 states, including two in Virginia, according to the federal Centers for Disease Control and Prevention in Atlanta. All but a handful have been among people who recently traveled in Asia. No deaths have been reported in the United States.

As the numbers continued their steady rise, health officials in the United States and elsewhere expressed uncertainty about whether the epidemic was coming under control or would continue to spread.

Thus, we must remain vigilent. Once we have a diagnostic test for SARS, then we will have a much better understanding. To Contain Ailment, a Test Heads the Wish List

I really did not want to know this - but I am not surprised.

Tragically, it may have been the long hours he spent cramped in the Army vehicle that caused his death. Three days ago, Bloom had complained of cramps behind his knee. Like most of us journalists "embedded" in the Army, he had endured days and nights of working, eating, and sleeping in our vehicles as convoys snaked their way toward Baghdad.

He consulted military doctors and described his symptoms over the phone to overseas physicians. They suspected DVT, or deep veinous thrombosis, and advised him to seek proper medical attention. He ignored their advice, swallowed some aspirins, and kept on working. On Sunday he died of a pulmonary embolism.

David Bloom's Last Ride

The public health research and epidemiologic experts are working diligently. We learn more about this new disease daily. I refuse to call it a mystery disease, because we do know a great deal. It represents a new and dangerous variety of a well known old virus. Scientists Gear Up for Fight Against a Deadly Lung Disease Identifying Virus Is First Step in Slowing Spread of SARS

The international scientific blitz has produced results in a remarkably short time. Scientists are now fairly certain SARS is caused by an entirely new coronavirus, and geneticists in labs scattered around the world are quickly decoding its entire genetic makeup. That will help them determine whether it's been hiding in nature for years, was spawned when an animal or human coronavirus mutated, or exchanged genetic material with a second virus when both infected a chicken, pig or some other animal. That's what many scientists suspect occurred somewhere in southern China last fall. It then was carried around the world by air travelers.

The pathogen transmits primarily through tiny droplets expelled by infected people when they sneeze or cough. The first symptoms, which usually show up a few days after being infected, are a sudden fever of 100.4 or above, a dry cough and other flu-like symptoms. At least 80 percent of those infected recover in about a week. But the rest get much worse, often developing pneumonia and sometimes needing a machine to help them breathe as the virus ravages their lungs. A combination of the antiviral drug ribavirin and steroids may help some of the sickest. But about 3.5 percent die, mostly the old and frail, an apparent death rate that makes it more deadly than the typical flu bug, including the devastating Spanish flu of 1918-19.

But some of the most important questions remain unanswered: Can it spread in other ways, such as through air, water or sewage? How many people who get infected get sick? How many of those who get sick recover? Are people infectious before they have symptoms? Do any existing drugs work against the virus? Does the virus get stronger or weaker as it gets passed from one person to another, and as the seasons change?

"We're in the third line of a three-act play," said Michael T. Osterholm, an infectious disease expert at the University of Minnesota. "We have a lot to go yet."

Scientists react to fearful situations by striving for understanding. We all fear the unknown. Hopefully as we learn more about the epidemiology we can replace fear with respect and caution. We need to respect this infection, learn about it, and hopefully learn to contain it. Fortunately, we have invested greatly in the medical scientists who will quickly learn the relevant details about this virus. In the meantime, we must all remain vigilent.

Many times yesterday, friends asked me why David Bloom died. What is a pulmonary embolism, and why did he have one? Without knowing any of his medical details, one can only speculate. Nonetheless, we can explore pulmonary embolism and perhaps understand why he might have died. NBC?s David Bloom dies in Iraq.

We start by understanding what a pulmonary embolus is and what are the risk factors. We need some definitions - let's go to Stedman's Medical Dictionary.

thrombus , pl. thrombi (thrombs, -b) A clot in the cardiovascular systems formed during life from constituents of blood; it may be occlusive or attached to the vessel or heart wall without obstructing the lumen (mural thrombus).

embolus , pl. emboli (emb-ls, -l) A plug, composed of a detached thrombus or vegetation, mass of bacteria, or other foreign body, occluding a vessel.

Restated, a thrombus represents a clot in a blood vessel. When a thrombus "breaks loose" and travels in the blood stream, it land somewhere, plugging that vessel. At that time we call it an embolus.

A pulmonary embolus generally comes from a thrombus which originates in a leg vein. The clot "breaks loose" and travels up the venous system, through the right side of the heart and into the pulmonary artery. The clot plugs there, and if it is a large enough clot, prevents blood flow from the right side of the heart to the left side of the heart. It also causes a lack of blood flow to the lungs, preventing oxygenation of the blood. These events combine to cause death in some patients.

When considering pulmonary embolism, one must always first consider deep vein thrombosis (DVT) of the legs. So what we really want to understand is why an apparently healthy 39 year old man would develop a major blood clot in his leg.

DVT can occur when the blood is hypercoagulable (more likely to clot). Reasons for hypercoagulability include inherited disorders of blood clotting, dehyration, and a variety of cancers.

DVT also can occur when the blood flow in the legs decreases for periods of time. This occurs frequently during surgery (especially knee and hip surgery). It also occurs on long flights (especially when the flier does not move his or her legs for long periods of time).

So now my speculation. I suspect that David Bloom probably had a hypercoagulable state, brought on by dehydration in the desert. He then was sleeping in a position that prevented normal leg movement. Quoting from the MSNBC article:

"Given the fact that we're filing at all hours of the day and night, you try to pace yourself and get a little sleep," Bloom told the Post. "You're sleeping with your knees propped up around you."

That may have been a risk factor: blood clots frequently form in legs when they've been immobilized and travel through the body, said Dr. Harold Palevsky, chief of pulmonary critical care with the University of Pennsylvania health system.

While he may have had other risk factors, these risks (dehydration and his sleeping position) were probably enough to cause the DVT and subsequent pulmonary embolism. This story remains tragic, but I hope that this rant has helped you understand why it happened. Understanding represents just a little solace. Bad things do happen to good people.

Thanks for the many comments and questions. I pick for Sunday based on my assessment of reader interest, or my own interest.

I am troubled by your answer to one of yesterday's Q&A questions and further troubled given your rant today regarding "When doctors sell out."

Yesterday you indicated the current medical system is flawed in that doctors who make correct diagnoses are not rewarded, but rather are punished when something might go wrong (punished perhaps by being dragged into court). I assume you mean the satisfaction of a healthy patient is not a reward in and of itself, but rather there should be some financial incentive for physicians who make the right diagnosis. That is, because doctors might be "punished" by a malpractice claim, they should be equally rewarded for doing their job correctly. Should the same system be in place for a police officer who stops a crime, an air traffic controller who succesffuly allows planes to land without an accident, for the same pilot landing the plane, or countless other professionals whose only reward is a job well-done and the satisfaction of knowing they did their job well?

Compounding my frustration, is your comment in today's rant about doctors selling supplements when you said "While money is not necessarily the root of all evil, it certainly can cloud one's judgement." Is this the same "cloud" that you propose as a financial incentive for doctor's who perform their job correctly???

I have thought carefully about how to answer this question from a long time reader. He raises some very interesting points, which I will do my best to answer.

I probably did not make my first point clearly enough. In medicine, even when we do everything properly, patients can still have bad outcomes. Unfortunately, sometimes patients (or families if the patient has died) view the bad outcome as the physician's fault. This tendency increases in our "blame someone" culture. Thus, we may have penalties for bad outcomes, regardless of our actions.

In most professions, and indeed in most jobs one receives rewards for a job well done. Promotions occur in law enforcement; higher fees result in law; more business results for a restaurant. Physicians have no such "upside". All generalists that I know already have too many patients. Fees are fixed by the insurance companies. Overhead keeps increasing.

I hope that I have explained the frustration and imbalance here. A job well done does give great satifaction - but only when the outcome is a positive one. We do not need great rewards, but we do need a better system to avoid penalties - and being named in a malpractice suit, regardless of the outcome of the suit - is a huge penalty.

The second question really compares apples and oranges. Supplement selling probably clouds physician judgment. Once once has a financial interest in something one sells, one will tend to sell that thing. Rewards for good work represent a different financial incentive. Here the incentives are aligned with the patient and physician's best interest - the health of the patient. Perhaps my wording was a bit imprecise. The problem I see is when physicians receive a financial reward not for providing medical care, but rather for something which the sell (using their MD as a sales advantage).

While I agree that advertising can have its pitfalls, as a psychiatrist I am pleased that patients come in for
treatment-with me or with anyone else. It has been my experience that very few patients request medications that they have heard about on TV. What they do request is treatment for the condition that they learned they were suffering from when educated by the advertisement.

Currently, only 50% if depressives in this country receive a diagnosis, half of those receive treatment and only 8 per 100 patients with depression are currently treated to remission (the currently accepted standard of treatment).

If residency programs do not train physicians adequately in the recognition of mental illness, and as long as some doctors still refuse to diagnose or treat it, then the most effective way to assure treatment will be consumer-driven. I applaud those companies that continue to advertise antidepressants on TV and would also like to note that these companies are amazingly philanthropic in their willingness to provide free medication for the indigent. We also rely heavily on them to continue to put money back into research to further decrease the mental illness burden for future generations.

I posted this comment just for the alternate viewpoint! Psychiatry may represent the main area of benefit for these ads! As a generalist, I do not want to argue about Nexium or Celexa. I do understand this psychiatrists point - and it is well stated - but I do not find it generalizable to most medical conditions.

"it is our right and who is to decide you have to live in pain "

This comment refers to a post on euthanasia from last May! I personally cannot accept active euthanasia as an option. Passive euthanasia is perfectly acceptable. Let me try to clarify.

I care for terminally ill patients regularly in the VA hosptial. When we have such a patient, we make a complete assessment of their quality of life issues. We can do a good job of treating pain and other symptoms.

I would never give a patient a narcotic dose with the purpose of ending his/her life. However, I will give a patient enough narcotics so that they do not have pain, even if that dose could possible stop respirations. This line, in my mind, is very clear. It has to do with intent. I will allow a patient to die in peace; I will not purposely cause a patient to die.

I find the latter a slippery slope. Once we (physicians) cross the point so that we help patients die, we will always have difficulty defining acceptable criteria. How does one develop criteria to prevent physicians from using euthanasia too "loosely"?

Thus, I remain on the side of aggressive palliation - for those interested read this rant from last October - More on palliation .

Re: Statins and muscle pain

Should endurance athletes ( say a triathlete anticipating a 6-6.5 hour maximal effort in a half ironman race ) stop their statin prior to the race? If so, then for how long? Incidently, races of this length and longer can cause elevated CPKs and in some cases mild elevations in cardiac CPK levels. This data makes no mention about pre-race statin ingestion.

I wish I knew the answer to this question. Someone should perform a study, perhaps at first during a 10K. I suspect (having no data, just hypotheses) that most patients would have no problems. But I really do not know the answer.

Well, anecdotally (is there such a word?) speaking, I probably still won't volunteer. I get one mild cold once a year, and "walking pneumonia" about every fourth, but the worst was the last time I took the vaccine. I prefer the pneumonia.

Probably idiosyncratic, I do not discourage others from taking it.

This comment represents the problem physicians have in promoting prevention. Patients (and sometimes physicians) rely on anecdotes rather than data. This process is known as the availability heuristic . You can read more about the heuristic - Availability heuristic

Definition: A heuristic or "rule of thumb" strategy biased for estimating probabilities (of past or future events), based on how easily the related instances of that event come to mind.

Example: Although diseases kill many more people than accidents, it has been shown that people will judge accidents and diseases to be equally fatal. This is because accidents are more dramatic and are often written up in the paper or seen on the news on t.v., and are more available in memory than diseases.

Background: People use heuristics to solve problems or reduce the range of possible answers to questions. Although at times it can result in the correct solution, the availability heuristic can also result in erroneous solutions to problems/questions. In using this rule of thumb, people judge frequency based on a quick count of examples. The use of this strategy is very widespread, and is used in making both trivial and important judgements. People tend to overestimate the frequency of certain rare events if they are dramatic and sensational and underestimate those that are more frequent but occur in private, ordinary situations. This appears to be because the rare, dramatic and sensational events are more easily available in memory.

The reader is wrong. We have many studies which show clearly that flu vaccines do not cause illness. But I doubt that I can convince him.

SARS is a respiratory ailment. If a person is very fit, doing a lot of cardio to strengthen the heart and lungs, are they less likely to succumb to such a virus?

First, we really do not know enough epidemiology to fully answer this question. In general, with any viral infection, host factors have great importance. I suspect that being fit improves ones odds, but this virus does act very aggressively in a small percentage of patients.

As an RN who just recently recieved her MSN in nursing education and would like to go into teaching other nurses the profession, it is really hard to leave the bedside knowing that I will make less money. THere needs to be more incentive to get that higher degree. As far as replacing the number of nurses we need through enrollment, that will be a long process, but the problem took a long time to evolve, it may take a long time to solve also. The problem is going to get worse, and the more qualified nurses we do produce, the better care for patients and the society we live in. 

AMEN!!!

I am a Human Resources Staffing Specialist who also happens to be a college student. I'm doing a research project on the 80-hour workweek and I'm trying to get some additional information. Do you happen to know where I might find how hospitals are going to comply with this rule? At my hospital, a large academic medical center in Philadelphia, we are planning on utilizing nurse practitioners and physician's assistants to make up the difference. My project is going to focus on how hospitals are planning to make up the hours lost by the residents as well as a cost analysis. Obviously, this rule will have a major financial impact on hospitals, large and small.

Tip O'Neill (from Speaker of the House) once said - "All politics is local". I suspect that you will find a wide variety of solutions to the 80 hour workweek problem. You will find variations within the same hospital. Let me try to clarify a bit.

Most medicine and pediatric programs will make minor modifications, being fairly close to the 80 hour work week already. Radiology, anesthesiology and pathology should have no problems. Surgery programs will have the greatest problem, as they are currently the most frequent offender. I suspect that many programs have not really determined how they will address the new rules. And some will try to ignore these rules (see last week's Q&A for example). Good luck in your project!

Final comments

Thanks again for the many comments and questions this week. You, the readers, make me think, keep me honest, and make this blog much better. As usual I apologize for not answering all questions or highlighting all comments. I have decided to avoid the omeprazole controversy as I have nothing else to add at this time.

Now it looks like a beautful morning in Alabama - off to the golf course (I know that is a cliche for a physician - but I really do love golf)!

The CDC did another update on SARS yesterday. CDC Update on Severe Acute Respiratory Syndrome (SARS)

Let me update you now on the U.S. case counts as of today. The current case count is 115. That is an increase of 15 from yesterday. These are reported from 29 states. There are no deaths among these suspect cases of SARS in the United States.

Forty-three of these 115 are or at some point were hospitalized. There are 27 that are currently hospitalized. Twenty-seven have had evidence of pneumonia in the course of their illness. Among the 115, 109 have traveled to SARS-affected areas and had direct exposure to this infection, four individuals are close contacts of patients ill with SARS who have traveled to affected areas, and two are health care workers who were exposed to one patient with SARS.

We are very encouraged that most people are recovering from this illness in the United States, and we are working very hard to understand this better so that we can keep everyone provided with the most current information.

On the international front, if you set aside the U.S. experience, today's report from WHO indicates that there are 2,222 cases. These are reported from 16 countries. There have been a total of 81 deaths, and the mortality rate is approximately 3.5 percent.

Among the many things that CDC is doing is working to alert outgoing travelers to SARS-affected areas, and we are continuing to meet planes returning from SARS-affected areas in providing disembarking passengers with health alert notices.

We have distributed now over 250,000 of these health alert notices and our quarantine officials and their colleagues have met over 1,000 flights today. We are distributing these health alert notices to travelers who are arriving directly or indirectly from Mainland China, including Hong Kong, from Vietnam and from Singapore.

Closer to home, we have about 18 multidisciplinary teams formed that are working very hard on this problem. It involves very much a multidisciplinary approach. We have approximately 20 people currently deployed to overseas locations to assist in this investigation. Some are returning and some additional ones are going. So this number is a bit of a moving target. We have a number of epidemiologic and laboratory surveys underway.

Let me provide you with a bit more of an update on the ongoing laboratory investigation. CDC is part of an international collaborating network of laboratories led by WHO. There are 12 laboratories and 10 companies participating in this network.

Evidence for this previously unrecognized Coronavirus has been found now in at least 10 laboratories, including the laboratories here at CDC. The preponderance of the evidence continues to mount and continues to favor an etiologic role or this previously unrecognized Coronavirus in the cause of SARS.

So far, in looking at specimens from the suspect cases in the United States, we now have evidence of infection with this agent in a total of four people, and we are working with the state health departments in the states where these people reside, so that they are provided with the information and they, in turn, will provide the clinicians and the patients with the information.

Now, let me give a little more detail on the extent of the laboratory evidence. We have cultured this Coronavirus from a total of four patients. We have electron microscopic evidence from two patients of this virus. We have PCR results--that is the Polymerase Chain Reaction, the amplification technique--where we find evidence of Coronaviral nucleic acid in 11 patients.

Looking at the antibody tests, of which we have two--an IFA test and Allose test--there is evidence for infection in a total of five patients. And from the standpoint of histopathology, looking through the microscope at tissue from deceased patients, we have seen evidence of an entity that the pathologist call diffuse alveolar damage, which is the pathologic correlate for the clinical syndrome of Acute Respiratory Distress Syndrome, which has appeared in patients with severe forms of SARS.

We have seen that evidence in a total of four specimens. Don't try to add those numbers up and get a grand total because some patients, in some cases, have more than one positive result.

Let me summarize my observations thus far. First, we have a putative organism - probably a new more virulent coronavirus. Still, some investigators are considering the possibility of either Chlamydia or a paramyxomvirus working together with the coronavirus in some patients. Second, the CDC is developing diagnostic testing, which will help better define the epidemiology. Third, work has started on developing a vaccine.

We all fear the unknown. I have ranted several times on my respect for this new infection. But we must put this respect into perspective. How does this infection compare to influenza?

It's a surprise often to people to hear that every year on average there are about 20,000 deaths that occur in the United States that are attributable to influenza. We don't report a case fatality rate for influenza infections, and the reason that we don't in part reflects the fact that there are well recognized risk groups for severe outcome from influenza, the elderly, especially people in nursing homes, people with severe underlying disease. They will have a relatively high case fatality rate for influenza, certainly higher than 3.5 percent in severe outbreaks. But the average healthy person is not likely to die from influenza, so the mortality rate in that group would be much lower.

We must remain vigilant concerning this infection. The CDC has done an excellent job (in my opinion) of analyzing data and communicating with physicians and the media.

I enthusiastically support email communications between physicians and patients. When I was seeing private outpatients (I stopped 2 years ago), I used email regularly with many patients.

Email has many advantages, but some disadvantages. I certainly answer email more easily than I return phone calls. Often patients had a very simple question which I could answer easily - saving us both time and aggravation.

However, keeping good records of these email discussions was a challenge. I would like a special system for storing the questions and answers. Ideally, all communications would go through a secure web site with storage of questions and answers. This web site would have the appropriate cautions about email usage. If the physician was going on vacation and out of email access for a period of time, then the patient would not be able to use the web based site.

The problems are solvable and the advantages clearly outweigh the disadvantages. Physicians should have a fee for email communication - because it takes time, and our time is the only way we earn money.

The Washington Post has an article concerning email this week - uncertainty@dr-mail.com: Some Doctors Use Patient E-mail in Their Practices, but Most Aren't Ready to Log On

The two doctors say responding to e-mail relieves them of the hassle of tracking a patient down by phone -- it may surprise some patients to learn their doctors complain about phone tag almost as much as they do. E-mail lets them leave a direct response to a patient's message instead.

"I don't like to leave a detailed medical message on an answering machine, because I don't know who's [listening to] it," says Robinson. "Unless a patient tells me otherwise, I assume they're the only ones reading their e-mail and I leave detailed messages." The exception -- "If I need to be talking about sensitive issues" -- say, lab tests that indicate a serious medical concern -- he says, "I won't do that by e-mail." Most physicans asked about their e-mail habits say they follow similar etiquette.

Email is important enough to have created a business opportunity.

Several business startups such as RelayHealth, based in Emeryville, Calif., and HealthyEmail, based in Dallas, are aggressively marketing "secure" -- or hacker-resistant -- messaging services to Washington area doctors. RelayHealth hopes to sign with a local insurer later this year for a pilot program in which the carrier would reimburse physicians for some comprehensive e-mail consults.

The article does a nice job of laying out the pros and cons. I suspect readers of this blog (and almost any other blog) are more web savvy and email savvy than the average person. Thus, I suspect you the readers would embrace email communication more easily than many others.

Now this is an interesting epidemiological finding. Brittle bones link to heart disease

A study by US researchers shows women who have early signs of osteoporosis are up to five times more likely to have damaged arteries than those with healthy bones.

The association was so strong that low bone density was a stronger predictor of heart disease than major risk factors such as high blood pressure, diabetes or a family history of heart disease.

This is believed to be the first time the bone-wasting illness has been linked with cardiac disease.

But the findings do fit with earlier research suggesting women taking vitamin D supplements to protect against thinning bones also see a decline in heart attacks.

Dr Hillary Tran, from the William Beaumont Hospital in Royal Oak, Michigan, said: "Our study is the first to report an increase in documented coronary artery disease in patients with osteoporosis.
"The presence of osteoporosis predicts significant coronary stenosis, narrowing of the arteries, with higher odds ratio than traditional risk factors."

These data come from an abstract presentation at the American College of Cardiology meetings this week. While the authors did not speculate on the reason for this finding, one can make an educated guess. I can think of at least 2 shared risk factors for both osteoporosis and coronary artery disease - cigarette smoking and lack of weight bearing exercise. I suspect diet also can contribute.

This finding is fascinating - but like all new findings we must apply the finding cautiously. The study needs confirmation from other studies. We have an interesting new hypothesis!

I have had a chance to read the article I referenced on Tuesday. This study had two very interesting findings. First, we (physicians) are prescribing less antibiotics for minor problems now than then. But, when we prescribe antibiotics, we more often use broad spectrum antibiotics.

As some readers may remember, I have ranted about treating suspected strep throat - More on sore throats . I still believe that there are significant benefits to treating adults with probable strep throat. However, I do strongly agree that antibiotic selection should focus on older, more narrow spectrum antibiotics. Perhaps we spend too much time just focusing on unnecessary antibiotic use. We (the medical education community) should spend as much time discussing which antibiotic provides the most parsimonious choice!

While everyone was assuming the Iraqi War would have a huge effect on the economy, along comes a virus ... Gun, Germs and Stall?

Meanwhile, there's a new concern: macroeconomic recovery may fall victim to microbe economics.

Serious people know that germs pose a far greater threat to mankind than terrorism, and readers of books like William McNeill's "Plagues and Peoples" and Jared Diamond's "Guns, Germs and Steel" know microbes have been the downfall of many a civilization. SARS ? severe acute respiratory syndrome, a new virus from Guangdong Province in China ? doesn't look like a civilization-killer, and probably isn't nearly as bad as the 1918-19 influenza virus. But experts fear it may be too late to prevent a global SARS pandemic ? that is, it may be too late to stop the virus from spreading throughout the world. And the bug is already having major economic consequences: fear of the disease has paralyzed much business in Hong Kong and has led to a drop in air travel worldwide.

Even if SARS doesn't become widespread here ? and that's not a safe bet ? it can do a lot of damage to our own economy because the world has grown so interdependent. Consider this: the most likely engine of a vigorous U.S. recovery would be a renewed surge in technology spending, and Guangdong is now the workshop of the information technology world, the place where a lot of the equipment that we would expect businesses to buy if there was an investment boom ? for example, components for wireless computer networks ? is assembled. The virus is already hampering production, not so much because workers have become sick as because

Taiwan-based managers and engineers are afraid to visit their plants. The result may be to stall an investment recovery before it starts.

Hopefully, we can control this epidemic and let the world economy improve (not to mention prevent a few deaths). I am impressed with the WHO and CDC response to this viral threat.

On another note, if you have not read Guns, Germs and Steel, you should. This is a fascinating book!

U.S. heart group urges ephedra ban

School debt helps drive medical students into specialty matches

James C. Martin, MD, believes family physicians are the backbone of the health care system. But the San Antonio, Texas, doctor sees the spine weakening.

For the sixth year in a row, the number of graduating medical school seniors and other match applicants who chose residency programs in family medicine has dropped, according to the National Resident Matching Program.

This year's Match Day figures show that seniors are increasingly choosing residencies in specialties. Many are driven by better-paying job opportunities for specialists, income that will take a bigger bite out of their student debts.

Some primary care organizations are worried that the students' choices will translate to fewer family doctors and internists. Dr. Martin, president of the American Academy of Family Physicians, said the decline of family medicine residency matches eventually would devastate health care, and the trend needs to be reversed. "My concern is what is this going to mean for the health care system in this country."

Readers of this blog are not surprised. When you treat generalists poorly, pay them poorly (relative to specialists) and then tell them they need to work harder - what do you expect? In Alabama, the family physicians try to blame the medical schools. As a faculty member, who talks to many medical students, those family physicians are wrong. The students see the life of a family physician, and then choose to do something else. The internal medicine rotation wins awards each year, but our recruitment is decreasing.

The AAFP has conducted studies to determine the cause of declining interest. Results show students take issue with long work hours and inadequate reimbursement. They said family physicians are not as highly valued as subspecialists.

Dr. Martin said the AAFP is exploring ways to make family medicine more attractive to medical students.

Students look for a reasonable lifestyle, and enough reimbursement. When they look at the future for generalists, they see bleakness. While I do believe that the pendulum will swing, I have the advantage of a much longer telescope (and history).

The real battle for generalists should occur with insurance companies, Medicare, and the public. Too many do not really understand the worth of the generalist. Somehow we need to promote ourselves. We need make some hard choices about insurance companies. Perhaps we even need to force a Medicare crisis - a crisis of new physician availability. (I believe this will occur naturally - and that crisis will start the pendulum swing back towards a more even playing field).

This is getting serious. Cancer Association Calls Off Meeting Because of SARS

This report from the American College of Cardiology meeting: All Patients With Positive Troponin T Tests Require Aggressive Treatment

Dr. Matthew T. Roe and colleagues at Duke Clinical Research Center in Durham, North Carolina, analyzed data from CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC and AHA Guidelines) on 21,694 patients. CRUSADE is a national quality improvement initiative, a project which regularly gathers data from 342 hospitals in the US on patients with non-ST-segment elevation MI and acute coronary syndromes and provides the hospitals with feedback on their adherence to ACC/AHA treatment guidelines.

Patients were divided into four groups: those with mild, intermediate and major troponin T elevations and those with negative test results. The researchers then analyzed treatment strategies and outcomes in each of the groups.

Dr. Roe told attendees of the 52nd annual scientific session of the American Heart Association on Tuesday that death occurred in 6.1% of patients with major elevations in troponin T levels, 4.6% of those with moderate elevations, 4.3% of those with mild elevations and 2.8% of those with negative troponin T test results.

"These findings demonstrate then even patients with mild troponin T elevations have a two-fold increase in risk of early, in-hospital mortality," Dr. Roe said in a Duke press release.

This represents a very important finding. Patients should not have elevated troponin levels. We (inpatient physicians) should assume these patients have serious disease and treat them aggressively.

We work at convincing patients to take the flu vaccine. I personally take the vaccine each October. We always assumed that we helped patients, since decreasing influenza certainly saves lives, especially in older patients. Perhaps the vaccination has even more benefit than we realized. Flu Shot Cuts Hospital Stay in Heart Cases and Strokes. This article reports on an article in today's NEJM. The study is not a randomized controlled trial, nonentheless, the data are impressive. This study may provide additional ammunition to convince patients to accept the vaccine.

Finally, we have the data. WHO has convinced China to cooperate in the SARS investigation. China Admission Raises Number of Reported Cases of Mystery Illness

The number of reported cases of a mysterious respiratory illness jumped yesterday as China bowed to international pressure and admitted that it had more of them, in more provinces, than it had said before.

It also agreed, for the first time, to let international health investigators visit southern Guangdong Province, where the illness ? severe acute respiratory syndrome, or SARS ? is believed to have sprung up late last year.

Also, for the first time in its 55-year history, the World Health Organization recommended that travelers avoid part of the world because of an infectious disease: in this case, Hong Kong and adjoining Guangdong Province.
There have also been serious outbreaks in Singapore, Vietnam and Canada.
In the United States, the Centers for Disease Control and Prevention said there were 85 suspect cases in 27 states, the highest number being in California, with 19. Only one was life-threatening, with a patient on a ventilator. Many other patients had already gone home.

"Right now, we aren't planning any quarantining for any categories of individuals," said Dr. Julie L. Gerberding, director of the disease control agency. She also said she saw no need for routinely wearing surgical masks on the street or at work, as has become common in Hong Kong.

China admitted yesterday that it had 1,190 suspect cases, not 806, and 46 deaths instead of the 34 it had previously acknowledged. Cases were reported in Guangxi, Hunan, Sichuan and Shanghai Provinces for the first time.

Thus, far we do not have a major public health problem in US. This may continue. Will SARS wreak havoc here? So here is the theory:

Health officials say that quick public health response to the news last month of the disease in Asia allowed for rapid implementation of prevention measures, such as dissemination of information on symptoms, vigorous surveillance of community illnesses at acute care and medical facilities, and alerting passengers at airports arriving from hot spot countries ? actions which may have stemmed the tide of the disease in the United States.

...

Once news spread, U.S. hospitals put in place strict infection control procedures for suspected cases and placed people in isolation. As no scientific test exists to identify cases, doctors determine SARS by seeing if patients have a 100.4-degree temperature, respiratory symptoms, such as shortness of breath, and recently traveled to Asia or have come in contact with someone who has.

Healthcare workers caring for suspected SARS cases also employ safety measures, such as wearing special masks and gloves, and monitoring their own possible symptoms after exposure to the patients. The CDC also recommends family members caring for SARS patients wear gloves and masks, if possible, if in close contact; frequently wash their hands; and avoid sharing beds, towels, linens, and utensils.

This describes one major advantage. We have become used to universal precautions in hospitals, and likely have stocked enough preventive measures (gloves and masks). Putting these precautions into place is not very difficult.

The United States is not seeing the case numbers reported in Asia said Dr. Susan Lance-Parker, epidemiologist for the Georgia Division of Public Health, because Asia has more dense populations and some places may have less sophisticated infection control practices than the United States. The United States also had the benefit of watching the news unfold in Asia, allowing officials here to characterize potential cases of the disease.

I believe this is a major factor. Our housing arrangements (especially for those who travel abroad) have less density. Thus, spread becomes much less likely. The CDC has done an excellent job. They have acted quickly and decisively. We must hope that these measures work well.
       

Medicare Drug Benefit Plan Is Proposed by 2 Democrats. I have previously ranted that we really cannot afford to provide a complete drug benefit for all Medicare aged patients. Finally, some Democrats agree.

In a break with party leaders, centrist Democrats proposed today that Medicare provide drug benefits immediately to people who have low incomes or high prescription drug expenses.

Members of both parties said Congress could eventually embrace such a plan if lawmakers could not agree on more ambitious proposals to pay drug costs for all Medicare beneficiaries, regardless of income.

The new proposal was offered by Representatives Cal Dooley of California and Rahm Emanuel of Illinois, with support from 16 other House members who call themselves New Democrats.

"Our proposal is fiscally and politically realistic," said Mr. Dooley, a House member for 12 years. It would, he said, provide drug benefits to people with the greatest financial needs.

Mr. Emanuel, a freshman who worked in the Clinton White House, said the proposal provided "a solid foundation on which Congress can build."

Howard J. Bedlin, vice president of the National Council on the Aging, a research and advocacy group, said, "This is not the ultimate solution, but it would be a good start, a potential compromise, that could attract bipartisan support if we find there's not enough money to provide more comprehensive drug benefits."

Under the proposal, Medicare would pay 80 percent of the cost of each prescription after a beneficiary had incurred $4,000 of drug costs in a year.

The $4,000 deductible would not apply to elderly people with incomes less than twice the poverty level. For the poorest among these, the federal government would pay at least 80 percent of their drug costs, and the federal share would decline as a person's income rose toward 200 percent of poverty. The poverty level for a couple is $12,120 this year.

This proposal has the advantage of making sense. We should strive to help those who clearly need governmental help. A $4,000 deductible makes more sense for those with adequate incomes.

Interesting story - Study: Doctors Overprescribing Superdrugs

``The good news is antibiotics are being used less often in situations where they are not needed, such as to treat the common cold and mild bronchitis,'' said Dr. Michael Steinman of the University of California at San Francisco, lead author of the study. ``The troubling news is that when doctors do turn to an antibiotic they are increasingly turning to broad-spectrum agents.''

Antibiotics only fight bacteria and have no effect on viruses. Doctors, however, often prescribe them for children with viral earaches or for adults with colds -- because patients demand them or because there's not a clear diagnosis and antibiotics kill many different bugs.

This article refers to a new study published in the Annals of Internal Medicine. I like the message - pick the right antibiotic. More on this later this week.

I have previously ranted on eplerenone - the new aldosterone antagonist. Investigators reported the results of the post-MI and left ventricular function trial at the American College of Cardiology meetings yesterday (you can find a summary at theheart.org). Simulataneously, the NEJM prereleased the article which they will publish this Thursday - Eplerenone, a Selective Aldosterone Blocker, in Patients with Left Ventricular Dysfunction after Myocardial Infarction. Quoting from the abstract:

Patients were randomly assigned to eplerenone (25 mg per day initially, titrated to a maximum of 50 mg per day; 3313 patients) or placebo (3319 patients) in addition to optimal medical therapy. The study continued until 1012 deaths occurred. The primary end points were death from any cause and death from cardiovascular causes or hospitalization for heart failure, acute myocardial infarction, stroke, or ventricular arrhythmia.

The patients had MI and left ventricular dysfunction and received all other appropriate medications.

Conclusions The addition of eplerenone to optimal medical therapy reduces morbidity and mortality among patients with acute myocardial infarction complicated by left ventricular dysfunction and heart failure.

I will study this article later this week (when I return to my home computer).

Here I am at Kinko's in San Diego. I will not have enough time to read these information sources carefully today, but let me provide some important links. First, the NY Times has a very good summary of our current knowledge, and what questions need answering. Step by Step, Scientists Track Mystery Ailment

Scientists have gained a significant, though rudimentary, knowledge of SARS in a short time. For example, they know the hallmarks of the disease, which are a fever of 100.4 degrees or higher, chills, muscle aches and dry cough. They also know the average incubation period — the time it takes from exposure to symptoms — is about 4 days, ranging from 2 to 10. Scientists also know that no drug is effective against SARS. Its spread can be prevented by having health workers wear masks, gowns, gloves and goggles, and by isolating patients.

But many answers are needed to determine the most effective measures to control SARS. These are among the questions:

The article lists the important questions. This summary is thorough enough for most of us. For those who want or need more details - the NEJM has these early release articles - Severe Acute Respiratory Syndrome (SARS) . I plan to read these later this week and report my thoughts.