Map of life expectancy at birth from Global Education Project.

Wednesday, September 03, 2008

Oh yeah, public policy

Marcia Angell has a most excellent rant in the new JAMA, but to their shame, the editors won't let you read it. As you know, the New England Journal of Medicine has adopted a policy of making policy research and commentary of importance to the general public open access, but JAMA has not followed suit. This is greatly to their discredit and shame. At least I can summarize some of the high points for you.

No doubt you have heard about the reports and commentary in NEJM regarding ezetimibe, which they have made available to you here, even though you are just common trash. This is a drug which was heavily advertised on television (although the manufacturers have recently backed off the advertising due to growing controversy) and very widely prescribed, bringing in $5.2 billion to its manufacturers last year, although it has never been shown to be of any benefit whatsoever, to anybody. It was approved on the basis of a surrogate end point - reduction in serum cholesterol - after a very short follow-up period, but subsequent trials have so far failed to show any health benefit. (In case you might be taking it, the brand name is Zetia, and it is most commonly sold in a combination pill called Vytorin. Schering-Plough makes ezetimibe, and jointly markets Vytorin with Merck.)

Now there is an unexpected observation that it may be associated with an increased risk of cancer. As Jeffrey Drazen explains in the editorial, other ongoing trials have not found an association with cancer, but the follow-up period in those trials is still short, so we need to keep watching. Meanwhile, it will be years before we know whether this drug actually does anybody any good -- a question which Merck and Schering-Plough didn't even set out to answer until three years after the drug was approved. It's much more expensive than generic statins, it might be dangerous, nobody knows if it actually does any good -- so why do doctors continue to prescibe it?

Marcia Angell has the answer. The drug companies control clinical trials from beginning to end, including setting up the questions in a way that tends to make their products look good -- e.g. testing them against placebo instead of the established treatments they will compete with, using too little of the competing drug so it seems ineffective, or using too much so their product seems to have fewer side effects, or, as in the case of ezetimibe, looking only at surrogate end points with very short follow-up periods; suppressing unfavorable results by not publishing them at all, or writing articles in a way that puts a positive spin on them; exaggerating favorable results in publications; building financial relationships with researchers so they stand to get rich if the results are favorable, and will promote the use of the drugs in lectures and presentations; and influencing practice guidelines. She concludes:

[I}t would be naive to conclude that bias is only a matter of a few isolated instances. It permeates the entire system. Physicians can no longer rely on the medical literature for valid and reliable information. . . .Clinicians just do no know any more how safe and effective prescription drugs really are, but these products are probably nowhere near as good as the published literature indicates.

Physicians who would be quite skeptical about drug company advertisements and the pitch of sales representatives ten do trust the peer-reviewed medical literature. One result of the bias in this literature is that physicians learn to practice a very drug-intensive style of medicine. Even when lifestyle changes would be more effective, physicians and their patients often believe that for every ailment and discontent there is a drug. Physicians are also led to believe that the news, most expensive, brand-name drugs are superior to older drugs or generics, even though there is seldom any evidence to that effect . . .

Now, our libertarian friends are going to have to admit two things:

1) The "free market" is not giving us safe and effective treatments, or evidence-based medicine;
2) Making patients pay more for their medical care is not going to do anything at all to solve this problem.

This requires major structural reform which confronts the reality that it is market fundamentalist ideology and the subversion of democracy by corporate power which has brought us to this point. So far I haven't heard Obama really take this on, but at least he wants to take small steps in the right direction instead of heading off 180 degrees in the wrong direction as John McCain wants to do. I'll have more to say on the kind of reforms we really need in a bit, but the core remains the same:

We need universal, comprehensive, single payer national health care.

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