From The New England Journal of Medicine
Armed with support from the Robert Wood Johnson Foundation, Deyo and Patrick make a well-documented -- if depressing -- argument that doctors, scientists, and laypersons alike are far too easily seduced by industry hype for merely new (as opposed to truly better) drugs and medical devices. Deyo and Patrick are appropriately tough on the Food and Drug Administration's (FDA's) drug approval process, in part because the agency's mission does not include weighing one drug against another but, rather, merely approving a new drug if it works at all, even if it has no advantages over cheaper drugs already on the market. The authors are even tougher on the FDA's process for approving medical devices, deftly hanging the agency by its own quotes, such as this gem: "New devices are less likely than drugs to have their safety established clinically before they are marketed." And, of course, they note that it is not part of the FDA's mission to regulate surgical procedures. But the basic message from Deyo and Patrick, both professors at the University of Washington, is that we are all too ready to believe that new, expensive, or aggressive care must be better than older, cheaper, or milder treatments. It is a cultural thing, they argue, citing one study that showed that whereas 34 percent of Americans believe that modern medicine can cure almost anything, only 27 percent of Canadians and 11 percent of Germans do. There is little that is new in this book for anyone who has followed the medical journals and the mainstream press over the past decade. But it is an excellent reference for the reader who wants details of the horror stories that have grabbed headlines: the rise and fall of the fenfluramine-phentermine diet pill (sometimes referred to as "fen-phen"); the high failure rate associated with some cardiac pacemakers; the widespread use of bone marrow transplantation for advanced breast cancer before studies finally showed that it was no more effective, and could be more dangerous, than standard chemotherapy; the appalling suppression or delayed publication of "negative" results in studies funded by drug makers. Citing example after example, Deyo and Patrick are at their most successful when they detail the degree to which the pharmaceutical industry, the most profitable industry in the United States, sometimes abuses its enormous power. Happily, just when you are about to move on to something, anything, else, Deyo and Patrick come up with a comparatively upbeat ending, exploring some remedies for America's ills. They like the idea of having insurers pay provisionally for some new treatments so that the insurers could easily stop payment if a treatment proved worthless or dangerous. They like the idea, endorsed last September by a coalition of editors of medical journals, including this one, of a national registry for clinical trials in order to make it harder for the manufacturers of drugs and devices to suppress negative findings. They want to stop drug companies from claiming marketing expenses as tax deductions -- a no-brainer, in my mind. And they want a better post-marketing surveillance system for drugs and devices. None of this will be easy. Fixing the mess, the authors conclude, will "require action by doctors, hospitals, the media, and the government." Judy Foreman, Ed.M.
Copyright © 2005 Massachusetts Medical Society. All rights reserved. The New England Journal of Medicine is a registered trademark of the MMS.
The authors, medical research academics, present their analysis of a phenomenon in American culture, which seeks state-of-the-art medicine regardless of the price. Avoiding controversial issues such as stem-cell research and abortion, theirs is an indictment of our health-care players, including the drug industry, device manufacturers, the media, the government, advocacy groups, hospitals, doctors, and patients. Deyo and Patrick recommend all parties change their behavior. Their concerns include aggressive marketing of new and costly products that contain only modest or no advantage over older alternatives, and doctors performing unnecessary operations. They focus upon whether and how new treatments sometimes become popular. They conclude that while fewer people in the U.S. can get insurance, people with insurance are getting a richer package of treatments although some of the technology they are buying is worthless. This is an important topic, and although many may argue with the authors' views, they present an excellent framework for debate and discussion. Mary WhaleyCopyright © American Library Association. All rights reserved