Limit Interface With Industry, Say Academic Leaders

Academic medical centers should take the lead in regulating relationships between physicians and manufacturers of drugs and medical devices, says an article in the Jan. 25 Journal of the American Medical Association.

The authors of "Health Industry Practices That Create Conflicts of Interest" (abstract is free; article is available for $12) cite threats to patient welfare and propose changes to the current system. "Recent congressional investigations, federal prosecutions and class action lawsuits have brought to light documents demonstrating how company practices frequently cross the line between patient welfare and profit-seeking behavior," say the authors, who are affiliated with institutions such as Harvard University, Boston; Columbia University, New York; Association of American Medical Colleges; Tufts University, Boston; University of Washington, Seattle; University of California, San Francisco; and University of California, Berkeley.

The authors call for prohibiting all gifts -- regardless of their value -- from drug and medical device manufacturers to physicians, as well as free meals and payment for time to travel to meetings or time spent at meetings.

Replace the direct provision of pharmaceutical samples with a system of vouchers for low-income patients or other arrangements, say the authors. "The availability of free samples is a powerful inducement for physicians and patients to rely on medications that are expensive but not more effective," they write in the article.

Drug and device manufacturers interested in supporting educational activities should contribute to a central repository (e.g., an office at an academic medical center) that would disperse funds to educational programs for medical students, residents or practicing physicians, say the authors. In addition, manufacturers should provide grants to a central office at an academic medical center for funds to cover physicians' travel to industry meetings.

"Faculty at AMCs (academic medical centers) should not serve as members of speakers bureaus for pharmaceutical or device manufacturers," say the authors. Academic leaders who abide by that recommendation "will be upholding the principle that faculty opinion should be data driven and not for hire," the authors add.

Consulting or receiving honoraria for speaking about drugs or devices "should take place with an explicit contract with specific deliverables, and the deliverables should be restricted to scientific issues, not marketing efforts," say the authors. "To promote scientific progress, AMCs should be able to accept grants for general support of research (no specific deliverable products) from pharmaceutical companies, provided that the grants are not designated for use by specific individuals."

"What, then, might the world of medicine look like if these proposals are widely adopted?" the authors ask. "First, decisions by physicians on which prescription to write and which device to use might become more evidence-based; medical societies' practice guidelines might become less subject to bias. … Second, total expenditures on prescription drugs might decline. … Third, although AMCs and professional societies would have to find alternative sources for funding programs, the absence of industry representatives at AMC meetings and lunches and in corridors would increase the sensitivity among medical students and house staff to the values of medical professionalism and scientific integrity."

Commenting on the JAMA article, Mark Belfer, D.O., of Akron, Ohio, said in an interview, "Our residencies need to teach residents how to dissect marketing presentations." Belfer directs the Akron General Medical Center Family Medicine Residency Program and chairs the AAFP Commission on Education.

"In a program one of our pharmacists developed, our residency has residents and faculty hear a pharmaceutical rep's presentation," said Belfer. "Then the residents and faculty evaluate it -- to help the residents learn that the reps are not pharmacists but marketing people."

Belfer also said current guidelines make unnecessary some of the proposals in the JAMA article. "Everybody's policing themselves right now," he said. "PhRMA (Pharmaceutical Research and Manufacturers of America) has stringent guidelines."

The Academy supports the guidelines developed by the AMA Council on Ethical and Judicial Affairs concerning gifts to physicians from industry and the standards on commercial support of CME developed by the Accreditation Council for Continuing Medical Education.