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A dangerous dose

Page 2 of 2 -- Through a series of legislative blunders, Americans have managed to create a drug industry that combines outrageously high profits with a disappointing lack of scientific originality. For many years the drug industry has reaped the highest profit margins of any industry in America. In 2002, the top 10 American drug companies had profit margins of 17 percent; Pfizer, the largest, had profit margins of 26 percent. So staggeringly profitable is the drug industry that in 2002 the combined profits for the top 10 drug companies in the Fortune 500 were greater than those of all the other 490 companies combined.

Why do we put up with this? According to official drug industry propaganda, these high profits are necessary to sustain a risky, financially punitive research agenda. Angell strongly disagrees. She argues that the industry research agenda is anything but a model of medical innovation. Of the 78 drugs approved by the Food and Drug Administration in 2002, only seven were classified as improvements over existing drugs. The most profitable drugs on the market today are ''me-too" drugs, such as Pfizer's Lipitor, the fourth of six chemically similar, cholesterol-lowering drugs. What the massive industry profits are really there to sustain, she argues, is an equally massive marketing budget. By the industry's own accounting, the largest drug companies spend over twice as much on marketing and administration as they do on research.

Angell proposes a number of sensible policy changes. The FDA should require that new drugs be tested against currently available standard treatments (and not just placebos) so that clinicians know how newly approved treatments compare with what they are currently prescribing. (This would also help discourage the development of ''me-too" drugs.) The Prescription User Fee, which drug companies pay the FDA to expedite approval of drugs, should be repealed and the FDA should be made financially independent of the pharmaceutical industry (which currently provides a hefty proportion of its funding). Exclusive marketing rights should be rolled back to open up competition from generic drugs. Drug prices should be transparent and as uniform as possible to all purchasers. The pharmaceutical industry should have no place at all in medical education -- no matter how much money it puts up. And the federal government should set up an institute to oversee the design and analysis of clinical trials, so that the industry cannot manipulate and withhold scientific data to suit its own marketing needs.

Will Angell's excellent book help fix the system? We can always hope so. Maybe a corner has been turned. It's possible that the ongoing debate over drug pricing, the suppression of research data, the push for a clinical trials database, and congressional hearings about conflict of interest at the National Institutes of Health will come together into some kind of backlash against the industry. But it seems unlikely. News of industry wrongdoing has become so routine that it hardly makes a ripple anymore. There are headlines for a day or so, some hand-wringing in the universities, the usual signs of public regret without any admission of wrongdoing, perhaps a blue-ribbon panel or two. But when all the fuss dies down, it's back to business as usual.

Carl Elliott is the author of ''Better Than Well: American Medicine Meets the American Dream" and co-editor of ''Prozac As a Way of Life." 

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