The free pens and mugs adorned with the names of commonly prescribed drugs are soon to be a thing of the past, thanks to a new set of voluntary guidelines from the Pharmaceutical Research and Manufacturers of America.
But the real impact of the guidelines is still up for debate.
The voluntary guidelines, which will go into effect in January, were released this summer as pressure mounted from Congress and the academic medical community for industry to rein in its marketing practices. The new guidelines update the 2002 PhRMA Code on Interactions with Healthcare Professionals.
“Although our member companies have long been committed to responsible marketing of the life-enhancing and life-saving medicines they develop, we have heard the voices of policymakers, health care professionals, and others telling us we can do better,” Billy Tauzin, PhRMA president and CEO, said in a statement.
Among the changes outlined in the new guidelines is a prohibition on even “modest” gifts to physicians if they lack educational value. For example, the ubiquitous pens and mugs given out by pharmaceutical representatives are no longer acceptable under PhRMA's new code of conduct. However, gifts valued at $100 or less that are used primarily for patient or health care professional education, such as an anatomical model, are still allowed on an occasional basis.
The guidelines also prohibit sales representatives and their immediate managers from taking physicians out for dinner, even if they have an educational presentation to make. However, they can still provide “modest” meals, such as pizza, in the office or at the hospital if they stay to provide their educational session there. The voluntary guidelines also prohibit companies from providing any type of entertainment or recreational items such as tickets, sports equipment, or trips, even if the item is inexpensive.
In terms of continuing medical education (CME), the guidelines call on pharmaceutical companies to separate their CME grant-making functions from their sales and marketing activities. Subsidies to attend CME meetings should not be given directly to physicians, according to the guidelines. Instead, any funds should be given directly to the CME provider, who can use the money to reduce fees for all attendees. Companies are also not allowed to provide meals directly at CME events.
The guidelines continue to allow pharmaceutical companies to provide scholarships to medical students and others in training so they can attend educational conferences, as long as the recipients are chosen by the academic or training institution.
The guidelines also call for greater transparency among physicians who work as industry consultants. Physicians who serve as company consultants or speakers and also serve on committees that set formularies or clinical practice guidelines should disclose their industry relationships, according to the PhRMA guidelines.
The changes were praised by some in the medical community as progress on the part of the pharmaceutical industry to respond to criticisms and police itself.
“It's a big step forward,” said Dr. David Korn, chief scientific officer for the Association of American Medical Colleges, which recently released its own report on industry funding of medical education.
The PhRMA guidelines don't go as far as some academic medical institution policies, but they are significant because they appear to have the full backing of the industry, Dr. Korn said. It shows that the pharmaceutical industry has heard the concerns of the public and has deemed some interactions to be unacceptable. “What we're talking about really is a culture change,” he said.
The AAMC report calls on medical schools and teaching hospitals to prohibit any gifts from industry. The AAMC also instructs academic institutions to set up a central CME office to distribute industry funds, and strongly discourages participation by faculty in industry-sponsored speakers bureaus.
But other physicians criticized PhRMA for leaving open loopholes that allow for much of their marketing activities to continue.
The changes are primarily cosmetic, said Dr. Daniel Carlat, of the psychiatry department at Tufts University, Boston. PhRMA appears to be decreasing marketing activities, he said, but in fact they are keeping the tactics that are most successful.
The visible items like mugs, clocks, and pens don't tend to influence physicians, he said. However, the voluntary guidelines still give pharmaceutical sales representatives plenty of chances to get valuable face-time with physicians.
For example, the guidelines still allow sales representatives to provide free lunches in the physician's office or the hospital. And the code does not place any restrictions on dinners with pharmaceutical company consultants, Dr. Carlat said.
Time will tell whether the guidelines will result in any real changes, said Dr. Howard Brody, director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston.