Medical Ethics Reform Urged

Issuing a sweeping call for ethical reform in medicine, a group of leading physicians and scholars said doctors shouldn’t accept drug samples, junkets or even ballpoint pens from drug or medical-device companies.

In today’s Journal of the American Medical Assn., or JAMA, 11 experts warned that the financial ties between physicians and drug and device vendors are undermining scientific integrity and patient care.

The authors said existing guidelines were ineffective and called on university-affiliated hospitals to take the lead in establishing stricter policies that would bar gifts, restrict corporate financial ties and require transparency in medical research contracts.

The recommendations mark the first high-profile effort from within the medical profession to broadly limit financial entanglements between doctors and companies.

Concerns about the influence of marketing on medical decisions have been on the rise, fueled recently by courtroom revelations about Merck & Co.’s lobbying of physicians for its now-banned blockbuster pain reliever Vioxx.

In February 2004, the National Institutes of Health announced strict ethics rules barring agency scientists from taking consulting fees from drug companies. For years the agency allowed its scientists to consult for biomedical firms despite the researchers’ roles in overseeing clinical studies and making recommendations to doctors.

The authors of the JAMA article said doctors must embark on reforms or face increased government regulation.

“If you don’t do it, it’s going to be done to you,” warned David J. Rothman, the group’s co-chairman and president of the Institute on Medicine as a Profession at Columbia University.

The pharmaceutical industry spends about 90% of its $21-billion marketing budget on efforts aimed at physicians, the authors said. That is an average of $13,000 a year per doctor -- an outlay that the authors contend drives up the cost of medications and influences what gets prescribed.

“It’s clear that voluntary disclosure is not working and even small gifts can influence behavior,” said group co-chairman Dr. Troyen Brennan, a Harvard professor of medicine.

The work of the group, which spent two years preparing today’s report, was sponsored by the institute at Columbia University and the ABIM Foundation, a nonprofit organization affiliated with the American Board of Internal Medicine.

JAMA editor Catherine DeAngelis said she expected the new recommendations to stir controversy but viewed the debate as important to patients.

“There’s some recommendations in there that I think are excellent,” she said. “Whether all or some of them will be enacted

The journal is owned by the American Medical Assn. but makes independent editorial decisions. Under AMA guidelines, doctors may accept gifts that benefit patients and are “of modest value.”

Drug industry executives say doctors should be careful not to go too far. Pharmaceutical sales representatives, many of whom also are pharmacists and nurses, provide information that ensures medications are used correctly and answer questions about how the drugs work and their side effects, the executives say.

A voluntary code adopted by the Pharmaceutical Research and Manufacturers of America three years ago has been effective, said Ken Johnson, a senior vice president.

“The code states that entertainment, expensive meals and gifts that are for personal use by the physician are not appropriate,” he said in a statement. “Only practices that do not compromise independent judgments of health providers, such as modest working meals, gifts of minimal value that support medical practice and distribution of free samples, are permitted.”

A medical-device industry representative, however, cautioned against any rules that treat device and drug makers alike.

Many devices are developed through collaborations between practicing physicians and biomedical engineers, said Mark Leahey, executive director of the Medical Device Manufacturers Assn. The complexity of many devices requires vendors to train doctors who use them, he said.

“In the device industry, the technologies are advanced and the therapy being delivered has a tremendous amount to do with the physicians’ technique,” Leahey said.

But Rothman of Columbia University said efforts to prevent undue influence on doctors -- including industry, professional and institutional guidelines -- weren’t working.

“The guidelines that now exist are very weak and operate mostly at the margin,” he said. “They lack monitoring and, for the most part, they lack teeth.”

Among other recommendations, the authors said teaching hospitals should:

* Bar doctors from serving on manufacturers’ speakers bureaus or participating in articles ghostwritten by industry-paid authors.

* Exclude physicians who have ties to manufacturers from committees that decide what drugs and devices will be allowed at a hospital.

* Prohibit open-ended grants and gifts to physician researchers and post all consulting and research contracts on a public website.

Jordan J. Cohen, president of the Assn. of American Medical Colleges, signed the JAMA article and said he planned to ask the association’s board to endorse its recommendations. He said he believed that they would appeal to many physician faculty members.

Cohen said he also believed that most teaching hospitals would be open to the group’s proposal that an arrangement be found for funding continuing-education programs for doctors.

Instead of allowing drug and device companies to directly pay doctors to teach or attend these courses, the medical profession should set up a centrally administered fund to which companies could contribute, the JAMA authors suggest. The companies could be acknowledged as general sponsors, but would not exercise financial influence over individual physicians.

Cohen said adoption of a new code of ethics could be hampered by the extent of the financial ties between physicians and manufacturers and their value to the hospitals where they practice and teach.

“There is a lot of money flowing from industry to these institutions,” Cohen said. “It’s regrettable that we’ve allowed the system to evolve to the point where it is dependent on the largesse of drug companies.”