Strict & Stricter
Campaigns to strengthen medical conflict-of-interest regulations are gaining ground in academia
PhRMA's recently introduced bans on items including drug-company-supplied pens, mugs, and other gifts are just a fraction of what's needed to clean up the relationship between the pharmaceutical industry's marketing efforts and the medical profession. So say a number of groups focused on ridding medicine of alleged conflicts of interest - and their campaigns calling for stricter guidelines are being heard now as never before.
"In our view, [the PhRMA revisions] are just the tip of the iceberg," said Nitin Roper, a third-year medical student at the University of Connecticut and a national coordinator of the American Medical Student Association's (AMSA) PharmFree campaign (www.pharmfree.org). He added: "There are a host of issues that they have not addressed, including speakers bureaus and funding of continuing medical education."
The PharmFree campaign, which was launched in 2002, urges medical students to pledge not to accept industry-sponsored gifts of any kind and to eschew medical education funded by drug-industry marketing efforts, including sponsored lectures by paid physicians. Recent victories include a campaign at Harvard Medical School, where AMSA student activists successfully pressed for the school's conflict-of-interest policies to be rewritten.
The problem with the new PhRMA code, according to Susan Chimonas, Ph.D., an associate research scholar at Columbia University's Center on Medicine as a Profession (CMAP), is that it takes away "little-ticket items" like pens while leaving big-ticket items like consultancy fees - paid to physicians by drug companies - virtually untouched. "And those need to be really tightened up, in a lot of important ways," said Chimonas, who is co-director of research for The Prescription Project, which promotes policy changes in academic medical centers and professional medical societies.
About 60 percent of the budget for continuing medical education comes from pharmaceutical industry sources, Chimonas said. "That starts to give you a sense of how dependent the medical profession has become on the industry for maintaining technical competence," she said. "I think that CME is a complicated thing and I don't want to oversimplify it, but ultimately it comes down to, are you going to bite the hand that feeds you?"
Among Chimonas' worries is that medical organizations that depend on drug-company money to carry out their educational missions won't have the freedom to create programs that have potentially negative effects on drug-company sales. If a doctor has a personal or financial relationship with a drug company, Chimonas said, "Are they going to talk about prevention? Are they going to put on presentations that say [a given drug] is not a good product and use this product instead?" A speaker may hesitate, she said, because of potential payback from the drug companies.
Roper, like other critics of the ties between drug companies and physicians, acknowledges the critical role the pharmaceutical industry plays in the profession. "Companies create medicines that save lives," he said. But "we want to separate the research and marketing of drug companies. The point is that physicians should be prescribing medicine based on the evidence that's there, not on the marketing that we receive from [drug] companies."
Medical Schools Leading Change
One place where policy change is occurring rapidly is at the nation's academic medical centers. In 2008, the Association of American Medical Colleges (AAMC) released policy recommendations as part of a study on industry funding of medical education. "Unlike the amendments to the PhRMA code, our gift language has no exceptions," said Susan Ehringhaus, senior director and regulatory counsel in AAMC's Biomedical and Health Sciences Research division, who worked with the panel responsible for developing the organization's guidelines for industry and medical education. "That doesn't take away from what PhRMA wants to do," she said, "but our recommendations are much more stringent."
In the last four years, Ehringhaus said, the rate of adoption of conflict-of-interest policies at medical centers has picked up substantially. Since 2005, "you could plot it on a curve going up - and going up more with each successive year." One catalyst for change, Roper noted, has been the "AMSA Scorecard" (www.amsascorecard.org), an online, searchable database that assigns letter grades to conflict-of-interest policies at 151 U.S. medical schools. The ratings are based on a range of factors, including policies on gifts and physician-consulting relationships. The letter grades, which are posted online, provide not just a means for medical center administrators to compare their policies with other schools, but guidance on creating model policies, said Kim Cunningham, AMSA's director of public relations. The public nature of the forum creates a powerful incentive for change, Roper said. "You're seeing an academic medical center creating a strong conflict-of-interest policy almost every month."
The Turning Tide
Pressure for greater transparency in drug-industry interactions with physicians also is coming from the general public, which, Roper said, has become accustomed to reading about scandals and multimillion-dollar settlements involving the illegal marketing of drugs. Surveys have shown, he added, that 70 percent of the public supports the Physician Payment Sunshine Act, proposed federal legislation that would require physicians who receive Medicare and Medicaid payments to report drug-industry payments of more than $100.
The tide is turning toward improving the relationship between physicians and patients and "clarifying our ethical standards and what really defines a conflict of interest," Roper said. "Physicians are starting to see that the drug industry has a significant influence on our prescribing practice and, in turn, that's really damaged our relationships with patients."
Not all doctors agree. "By and large, physicians in private practice are kind of in denial," Chimonas said. "They are very reluctantly going along with the changes forced upon them, but are not exerting leadership." She added: "I'm not 100 percent convinced that industry has no role in CME. I'm not there yet, primarily because there is not enough outcome data. We need more research. Meanwhile, I feel like we should err on the side of caution - we should already be exploring and preparing for the possibility of going without industry funding."
Funding for CME that now comes from the drug industry could come from the National Institutes of Health and other government or nonprofit organizations interested in medical education, Chimonas said. "Raising tuition is not an unreasonable approach," she said. "Medicine may be one of the only professions where the learners are not expected to pay for their own courses. Lawyers get continuing legal education. Engineers, architects - a lot of professions need to stay current. [In those professions,] the individual pays or their company pays."
"Everybody is very critical of the CME enterprise," Chimonas said. "People in medical education are taking a lot of hits and are feeling very criticized from all sides. But if you go to these events, you realize that these are people who are trying very hard to follow the rules. The problem is that the rules are not necessarily helping to address the fundamental problems that people are complaining about."

