miércoles, 9 de enero de 2013

John LaMattina Vs Marcia Angell


Dr. Marcia Angell, the former editor of The New England Journal of Medicine, was recently interviewed by Russ Roberts, the host of EconTalk

Some years ago Angell wrote: The Truth About Drug Companies: How They Deceive Us and What To Do About It. Her book attacked the industry essentially saying that it produces little innovation and that its primary mission is to exploit consumers. That’s a pretty serious accusation. The problem with Angell’s arguments is that they are rife with inaccuracies and fallacies. Furthermore, she makes no accounting for changes in the industry that have occurred over the last decade.

In her interview with Roberts, she continued to hammer away at the same themes that she has harped on for years, as if saying them repeatedly will make them true. But it is time to call her out on some of her most egregious positions. Here are a few.

 “The drug companies do almost no innovation nowadays….. All they have to do is the late development. And that’s the clinical trials. Now that is an expensive part of the process. But it is not an innovative part of the process.
When the drug companies sponsor trials of their new drugs….they will design the study, and the studies are designed in such a way that the new drug is compared with a placebo – that is, with a sugar pill. It’s not compared with an older drug.
.../...
Angell’s critique of clinical trial design is just not true any longer. First of all, the FDA reviews all clinical programs and if a company doesn’t follow the guidance, it risks spending hundreds of millions of dollars for results that the FDA will deem “unapprovable”. But the biggest impact that has occurred in the last few years has been that of payers. Why should a new drug be reimbursed by health plans or governments if it hasn’t been shown that the new agent is superior to existing therapies, particularly if generic drugs already exist for that disease indication? 
But the attack that I find to be particularly offensive is that on health standards. Angell implies that medical experts are being paid off by pharmaceutical companies to influence national health guidelines to favor the greater use of drugs. This is a very dangerous accusation, because it suggests that unnecessary drugs are being prescribed. Thirty years ago, it was thought that total cholesterol levels of 280 were “normal”. However, decades of clinical studies, studies that have cost literally BILLIONS of dollars have shown that lowering cholesterol to under 200 does, in fact, reduce heart attacks and strokes. That is medical science. For Angell to imply otherwise is irresponsible.

Dr. Angell was profiled by the New York Times earlier this year. Interestingly, the article pointed out that not everyone at Harvard Medical School subscribes to Dr. Angell’s views. (Más)

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