Excerpts from Chapter 14
This is the mother of all sleights of hand: the transformation of medical science from a public good whose purpose is to improve health into a commodity whose primary function is to maximize financial returns. As a result of this sleight of hand, the gap is widening between the scientific evidence that impartial experts (not paid or threatened by the medical industry, not biased by other personal concerns, and granted unrestricted access to all of the evidence) would agree upon and the perceptions that actually drive American health care. This growing gap is at the core of the crisis in American medicine. And why are we surprised? The drug companies have no more responsibility to oversee the public's health than the fast-food industry has to oversee the public's diet.
The substitution of narrow corporate interests for medical progress has produced some dramatic excesses. When the manufacturer of Paxil performs nine clinical studies on the treatment of adolescents for depression and finds that Paxil is no more effective than placebos and, in fact, significantly increases the frequency of "emotional lability� (including suicidal thoughts and attempts), it's no problem. The company publishes one study that shows a benefit, fails to publish the other eight, and markets away. When British drug authorities spill the beans? No problem. A task force of the American College of Neuropsychopharmacolgy is convened, and concludes that the new antidepressants are safe for adolescents after all. Too bad the task force didn't have access to some of the information that was available to the British drug authorities. But perhaps that didn't seem like so much of a problem, because, according to the New York Times, "Critics of the medicines noted that 9 of the 10 task force members had significant financial ties to the pharmaceutical industry. . . .� (However, the task force insisted that no industry money financed their report.) What to do when the FDA epidemiologist in charge of analyzing all the antidepressant studies involving children concludes, just like the British drug authorities, that twice as many children treated with the new drugs (except Prozac, which is available as an inexpensive generic) became suicidal, and that the FDA should therefore discourage doctors from treating children with these drugs? Just bar the expert from testifying at the FDA's public hearing. Then don't make him available for an interview with the New York Times, which reported the story on April 16, 2004
You don't like the way the study of an expensive drug for blood pressure is going? A nonissue -- just stop the study before the results reach statistical significance.
Endovascular Technologies (a wholly owned subsidiary of Guidant, the company that manufactures implantable defibrillators) manufactured a $10,000 device to repair aortic aneurysms that dangerously malfunctioned in a third of the 7600 patients in whom it had been used. Did this frequency of malfunction stop Endovascular Technologies? No. The company reported 7 percent of these events to the FDA and sold on. According to a plea agreement entered into with the United States government in 2003, the company belatedly disclosed another 2628 serious malfunctions and 12 deaths. No problem. It agreed to pay $92 million to cover criminal and civil penalties and then picked up with business as usual on other products.
Your drug company just received an official warning letter from the FDA for the "false and misleading� marketing of Celebrex, Vioxx, Pravachol, or OxyContin? No problem. The FDA's corrective action is unlikely to displace the false information already firmly planted in the public's mind.
And the list goes on. Controlling medical costs in this near free-for all commercial grab is not just impossible, it is a contradiction in terms. Does it make sense to talk about reducing national expenditures for cars or clothes or beer? Medical care, by far the largest consumer commodity in the United States, is now no different.