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 voluntary guidelines is still up for debate.
The 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. They 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 policy makers, 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 the 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 (AAMC), which recently released its own report on industry funding of medical education. Although the guidelines don't go as far as some academic medical institution policies, they are significant because they appear to have the full backing of the industry, he said.
In the AAMC report, released in June, the organization calls on medical schools and teaching hospitals to prohibit the acceptance of any gifts from industry. It also instructs academic medical institutions to set up a central CME office to coordinate the distribution of industry funds and strongly discourages participation by faculty in industry-sponsored speakers bureaus.
But others criticized PhRMA for leaving loopholes that allow for much of their marketing activities to continue.
The first major loophole is that the policy is voluntary, said Dr. Carey Chisholm, residency program director for emergency medicine and professor of emergency medicine at Indiana University, Indianapolis. It also continues to allow for a significant amount of marketing through the “modest” on-campus meals and through off-campus meals with industry consultants, he said.
Dr. Daniel Carlat of the psychiatry department at Tufts University, Boston, labeled the changes “primarily cosmetic.” PhRMA appears to be decreasing marketing activities, he said, but they are keeping the tactics that are most successful. In addition, although the code prohibits sales representatives and their immediate supervisors from taking physicians out for dinner, there are no restrictions on dinners with pharmaceutical company consultants, said Dr. Carlat.
Dr. Howard Brody, director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston, said ultimately, the medical profession needs to make these changes. Physicians should think about how they can learn about new treatments without meeting with sales representatives, forego samples, and say no to free lunches provided by pharmaceutical companies, he said.