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Doctors say they know the score. “Everyone knows what the evening is and takes it with grain of salt,” says the surgeon. But knowing that you’re the target of a sales job doesn’t immunize you from its effect. Consumers know the purpose of TV commercials, too, and yet still go right out and buy the advertised products. Even such innocuous tactics as the ubiquitous pens and pads emblazoned with drug logos can have an impact. Studies have shown that a wide variety of interactions between pharmaceutical companies and doctors–from consulting fees to free pens–do in fact influence physicians’ prescribing patterns. In a 2003 commentary published in the Journal of the American Medical Association, Carnegie Mellon economist George Loewenstein concluded that “by subtly affecting the way the receiver evaluates claims made by the gift giver, small gifts may be surprisingly influential.”

And of these “gifts” contribute to the increase in expenditures on prescription drugs. Multiple studies have found a correlation between the cost of physicians’ treatment choices and the amount of contact with drug company representatives. An extensive review of the literature published in JAMA in 2000 found that doctor interactions with pharmaceutical companies led to increased prescription costs and “nonrational” prescribing, such as prescribing drugs that provide only incremental benefits to patients. Consider the heartburn drug Nexium, essentially a slightly improved version of Prilosec, which recently lost patent protection and became available generically and over the counter. The majority of “new” drugs now fall into this category; from 1989 to 2000, the U.S. Food and Drug Administration judged 76 percent of approved new drugs were, at best, moderate improvements over existing treatments. Many were like Nexium: a modification to an older product with the same ingredient. In 2000, according to a 2002 report by the National Institutes for Health Care Management Research and Educational Foundation, the average price of these new drugs was nearly twice that of existing drugs for the same symptoms.

A flurry of renewed, stricter self-regulation followed the Lupron case in 2002 and 2003. Both the pharmaceutical industry and physician’s organizations targeted actions that the settlement identified as violations of anti-kickback law, such as bogus consulting arrangements and control over program content at medical meetings. But drug dinners and other marketing practices–ghostwritten papers, entertainment, travel, and larger gifts, many of which are still permitted in some form or another under the new guidelines–might also constitute violation of anti-kickback laws, according to guidance published by the Justice Department’s Office of the Inspector General in April 2003.

Outright fraud, such as charging Medicare for unnecessary procedures or accepting consulting fees without performing a service, must be dealt-with. U.S. attorneys are taking action, using the criminal anti-kickback statute and the False Claims Act, both separately and in tandem. In 2003, for example, AstraZeneca settled criminal fraud charges related to the prostate-cancer drug Zoladex, a $355 million lawsuit that involved marketing inducements similar to those in the Lupron case. And in July, Schering-Plough pled guilty to charges under the anti-kickback statute and paid a $350 million fine–in part for providing grants to private physicians to conduct educational programs.

But more subtle ethical quagmires raise issues as well. Few dispute the benefits of researchers’ hiring writers to polish style and properly format papers. But medicine commands a level of public trust that other areas of science do not–and therefore it is all the more unsettling when it is revealed that medical papers are ghostwritten by drug company PR firms, with little input from the doctor whose name appears at the top. As much as prescription fraud, such practices are a betrayal of public trust.

Aggressive (and highly publicized) prosecution of the most egregious cases could help expose practices that are neither ethical nor legal, and might lead to even more aggressive self-regulation, to the benefit of patients and their trust in the doctors who treat them. A few good physician perp walks could help clean out the bad apples and help reform doctor-drug company interactions–a relationship that has gone badly astray.

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Tagged: Biomedicine

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