By Ceci Connolly
Washington Post Staff Writer
Wednesday, January 25, 2006
Declaring that the pervasive influence of drug industry money is distorting doctors' treatment decisions and scientific findings, a prestigious panel of medical experts called on their colleagues yesterday to adopt far-reaching new conflict-of-interest policies.
In an article in the Journal of the American Medical Association, the group said that voluntary efforts to limit corporate inducements have failed, resulting in the overprescribing of some medications and the withholding of negative discoveries about others. Highly publicized cases involving the anti-inflammatory drug Vioxx, antidepressants for children and spinal implants made by Medtronic -- all occurring while voluntary guidelines were in place -- highlight the need for stricter measures, they said.
"My mother told me never to accept gifts from strangers. If a stranger wants to give you a gift, it's very likely they want something in return," said Jordan J. Cohen, president of the Association of American Medical Colleges and a co-author of the new proposal. "We've become overly dependent on these kinds of blandishments to support our core activities, and that is jeopardizing public trust and scientific integrity."
The panel -- which includes Cohen, officials from several medical schools and members of the Institute on Medicine as a Profession -- urged the nation's 400 teaching hospitals to impose stringent measures, including a ban on accepting gifts, meals and drug samples and tight restrictions on outside income. A series of articles published today in the journal Academic Medicine reach similar conclusions, noting that strict, standardized policies are needed to ensure patients receive unbiased, evidence-based treatments.
Spokesmen for the pharmaceutical industry said the extra steps are unnecessary and could deprive physicians of valuable information.
From their first rounds as residents, doctors travel in a world increasingly dominated by drug company salespeople proffering meals, office supplies, entertainment and even cash to speak at conferences or sit on advisory boards.
Some physicians have been paid lucrative consulting retainers for no specific work; others are paid to put their names on articles ghostwritten by industry employees. One congressional inquiry cited in the report found that pharmaceutical executives steer research grants to doctors and schools that promote their firms' drugs.
"The problem has gotten worse and worse and worse," Cohen said. The relationships can prompt doctors to order unnecessary tests, prescribe more expensive medicines or advocate adding certain medications to a hospital's list of preferred drugs, he said.
Although most doctors say their relationships with drugmakers do not affect medical decisions, numerous studies suggest otherwise.
"There is solid evidence it isn't the size of the gift, it's the gifting itself that creates a sense of loyalty and indebtedness," said Sharon Levine, associate executive director of Kaiser Permanente's Northern California group practice. The 6,000-doctor practice and the Yale University School of Medicine are among the only institutions in the nation to implement policies similar to those outlined in JAMA.
"The industry is spending $13 billion per year on direct-to-physician promotion," she continued. "That wouldn't be happening if it weren't resulting in changing patterns of utilization. It doesn't necessarily mean patients are getting bad care, but it does mean their influence is out there."
Judging from the "grumbling" he has heard from physicians, Scott Lassman, assistant general counsel at the Pharmaceutical Research and Manufacturers of America, the industry's lobbying group, said voluntary guidelines issued by industry, government and the profession in recent years seem to be working. Modest gifts such as lunch or pens may persuade a doctor "to listen to the presentation of information, not necessarily to prescribe that product." And having those discussions over a "working meal" is merely a timesaver for busy doctors, he said.
But the JAMA authors said it is a costly mistake to confuse marketing with scientific data.
"Drug companies spend $13,000 per physician annually," said co-author David J. Rothman, a professor of social medicine at Columbia University Medical Center. "Those marketing tactics are very, very effective at getting physicians to do what each drug company wants -- to prescribe their product."
The team conducted focus groups with doctors who "came right out and said if one drug rep is nicer than another, I'm going to prescribe that person's drug, all else being equal," said co-author David Blumenthal, director of the Institute for Health Policy at Massachusetts General Hospital. In a second article, Blumenthal found that conflicts of interest have contributed to growing secrecy in research, with some scientists intentionally omitting negative findings about a drug or device.
Rather than severing all ties to the pharmaceutical industry, the panel suggested creating financial firewalls. Instead of paying a physician directly for continuing medical education, it would be more appropriate for drug companies to contribute to a central account that supported educational programs, they wrote. In addition, payments for outside work such as speeches or consulting should be explicitly defined and posted on the Internet.
Finally, the group urged the nation's 125 medical schools and affiliated hospitals to refuse drug samples and instead create a voucher system or central distribution bank for poor patients.
"The availability of free samples is a powerful inducement for physicians and patients to rely on medications that are expensive but not more effective," the JAMA article said. In most cases, once patients begin the expensive drug regimen, they are inclined to stick with it.
Some industry experts said the recommendations underestimated the ability of physicians and patients to think on their own.
"I subscribe to the crazy view that more information is better," said Daniel Troy, former chief counsel of the Food and Drug Administration. "This very sweeping proposed ban would really choke off an important flow of information to physicians."
A drug sample handed out in a doctor's office is a good way to begin treatment immediately, he said, rather than waiting to have a prescription filled.
Cohen predicted the industry and many medical institutions would blanch at the recommendations. But both could stand to improve their reputations, he said. He added: "We need a strong, ethical, effective partnership with industry."