Publicizing a move that School of Medicine officials say will put the school ahead of its peers on ethical grounds, Yale Medical Group’s recently developed guidelines on interactions between physicians and the pharmaceutical industry have been published in the February issue of Academic Medicine.
More than a year in the making, the guidelines were formally accepted with a vote of the YMG Board of Governors last May. Though they are nonbinding, the guidelines demand that doctors refrain from accepting gifts, meals or free medications of any value from drug companies, and they include new measures aimed at resolving conflicts of interest due to physicians’ educational activities off campus. But while Medical School officials said Yale’s guidelines make the school ethically cleaner than nearly any comparable institution, some in the pharmaceutical industry questioned the necessity and validity of such a comprehensive ban on gifts or incentives.
Dr. David Coleman, interim chairman of the Department of Internal Medicine at the School of Medicine, said the new guidelines go above and beyond traditional ethical regulations. They were not created in response to any specific event, Coleman said, but rather reflect the faculty’s desire to be national leaders on this issue.
The problem of physicians accepting gifts from drug companies is a pervasive one, said Dr. David Blumenthal, a professor of medicine and health care policy at Harvard Medical School. Blumenthal is a co-author of a study on relationships between pharmaceutical companies and physicians, which was published in the latest issue of the Journal of the American Medical Association.
“After wrestling with this for a while, we decided that innocuous-appearing relationships had the potential to influence physician prescribing,” Blumenthal said. “Even some of the modest gift-giving and appeals that drug companies do creates a biased information environment.”
Blumenthal said he saw the Yale rules for the first time on Monday and therefore could not comment on them specifically, but he said he supported any increase in the strictness of guidelines. Coleman said the Yale rules compare favorably to the JAMA study’s recommendations.
But pharmaceutical industry representatives said the guidelines are overly broad and restrict both doctors and industry, ultimately hurting patients. Scott Lassman ’85, assistant general counsel for the Pharmaceutical Research and Manufacturers of America — the lobbying group for pharmaceutical companies such as Pfizer and Merck — said PhRMA’s own guidelines limit gifts to those that fairly reimburse physicians for their time while preventing undue influence on prescribing decisions.
Under the industry code, only gifts valued at up to $100 are permitted and then only if they support the doctor’s practice. While pens, notepads, medical dictionaries and stethoscopes are allowed, Lassman said, golf balls and sports tickets would not be. He said broader guidelines such as Yale’s only hurt doctors and their patients.
“Blanket restrictions can be dangerous if the intent is to stop interactions between physicians and the sales representatives,” Lassman said. “Our view is they have very valuable information that directly affects patient care. Anything that would stop that flow of information is inimical to the practice of medicine.”
But Coleman said pharmaceutical companies, mainly those based in Connecticut, were sent draft versions of the guidelines before they were accepted and were generally supportive of them.
Reservations about the guidelines are not restricted to pharmaceutical companies. Dr. Jon Morrow MED ’76, chairman of pathology at the Medical School, said a few parts of the guidelines met with some internal resistance. Some physicians, Morrow said, wanted the guidelines to be less restrictive and permit small gifts or working meals.
“In trying to sort out those boundaries, the egregious things are easy,” he said.
But Morrow said deciding where to set a limit on what would constitute an “inexpensive” or “small” gift was a challenge when crafting the guidelines.
The final Yale guidelines draw no distinction between expensive and inexpensive gifts, deeming both unacceptable. Coleman said both small and large gifts, as well as meals paid for by companies, have similar effects on physicians. Free samples of medications given to doctors for their own use are also prohibited for the same reason. But Coleman said medications are a special case since free samples raise drug prices for all users and because physicians could easily pay for the medications since nearly all have health insurance.
Gifts from pharmaceutical companies are not illegal, and often are not unethical, Blumenthal said. Despite the new guidelines, he said there is still an important role for the companies at medical schools in supporting clinical and other research.
Coleman said Yale’s specific guidelines do not prevent research funding at the institutional level. The guidelines are more focused on the marketing side of the pharmaceutical industry, which he said can be separated from the research side.