Map of life expectancy at birth from Global Education Project.

Thursday, October 19, 2006

Doctor Evil

Unfortunately, despite my vast influence, the editors of the New England Journal of Medicine have yet to heed my entreaties that they make material of general public interest available to the little people. So you can only read the first 100 words of this rather important exposé by Peter Q. Eichacker (yeah, he must have had a rough childhood), Charles Natanson, and Robert Danner. This has gotten some coverage in the corporate press but I haven't found it very clear or edifying so I figured I'd offer my own.

The rising calls for evidence based medicine, and measures of quality in health care, have been accompanied by the increasing popularity of "consensus guidelines" or cookbook recipes for how people with particular diagnoses and symptoms are to be treated. For example, there are guidelines for when to initiate antiretroviral therapy in people with HIV that have to do with CD4+ cell counts and symptoms of immunodeficiency. This is a good thing in that it gives physicians an accessible, practical summary of what a panel of experts thinks the available evidence tells us about the best approach to a situation.

There is some controversy about holding physicians strictly accountable to such guidelines in quality assurance efforts, because people aren't cakes or casseroles and the same recipe isn't necessarily right for all of us. For example, a physician might choose not to prescribe a drug because it is clear the patient won't adhere to the regimen. Nevertheless such guidelines do represent one method of helping to assure that people get the most appropriate, effective and cost-effective care.

Well, sure enough, they are also just one more target for drug company manipulation. I wrote a while back* about the Texas Medication Algorithm Project, which was funded by drug companies and touted in the President's New Freedom Commission report on mental health (a lot of "compassionate conservative" BS from early in the Chimpoleon administration that went nowhere, of course). It's a "decision tree" that by an amazing coincidence, leads to drugs manufactured by the project's sponsors -- and it was based on the expert opinions of drug company consulants, not evidence. (See also here for a perspective from a chapter of the National Alliance for the Mentally Ill, with some additional links.)

In the latest outrage, Eli Lilly got a drug called Xigris approved for treatment of sepsis in 2001, even though half of the advisory committee members who reviewed the drug voted against it. (Sepsis is essentially a bacterial infection that overwhelms the immune system. Adverse consequences of the immune response cause as much trouble as the infection itself -- these include fluid in the lungs, and shock, which is essentially a catastrophic fall in blood pressure.) Later trials established that Xigris increases the risk of bleeding and did not save lives compared with older, cheaper drugs. Oh yeah -- a treatment with Xigris costs $8,000.

Obviously, under the circumstances, Xigris was not selling well. So what did Lilly do? Invest its profits in coming up with a better drug, as John Stossel assures us is their only reason for making a profit in the first place? Sadly, no. Among other ploys, they hired a group of experts to create practice guidelines for treatment of sepsis -- including many who had other, existing financial relationships with Lilly -- that included use of Xigris. They also hired a public relations firm to tout the results. Their justification for endorsing Xigris was that it had been tested in randomized controlled trials, whereas the alternatives -- antibiotics -- had not. But you can't test antibiotics in controlled trials because it would be unethical -- we already know they work, so you can't compare them to placebo. And the clinical trials of Xigris showed it to be dangerous.

There are more details and complexities to all this, which I won't go into. But here's my bottom line: experts who sell their opinions are far worse than prostitutes. They are, in this case, quite possibly murderers. Yet they occupy prestigious positions in universities, enjoy huge incomes, and presumably the esteem of their colleagues. They should be outed, and disgraced.

*Or at least I thought I did, but the post appears to be saved as a draft only. Somehow I never put it up. Oh well.

No comments: