Physician group pushes back on strict conflict-of-interest policies
The newspapers are full of news about medical conflicts of interest. We read about articles in peer-reviewed journals that have been subsidized or ghost-written by industry. We read about payments to the government by big companies to settle allegations that they used trips, gifts, “consulting” arrangements, etc., to influence physicians to use (or prescribe) their products.
There really are two questions to ask. First, how susceptible are physicians to being influenced to purchase products or equipment, or prescribe certain drugs, based on their relationship with a vendor and the freebies or consulting/speakers’ fees they receive? Second, do physicians, in fact, make purchasing or prescribing decisions based on relationships rather than on the merit of the product or drug?
Most of the big vendor associations – including the Advanced Medical Technology Association (AdvaMed) and Pharmaceutical Research and Manufacturers of America (PhRMA) – have spelled out model codes of conduct for their members, proscribing certain practices, placing limits on gifts, etc. Many professional societies and associations, including the American Medical Association, also have codes of conduct or ethics in place.
Some states have attacked the issue through legislation. Minnesota has a long-standing ban on gifts, and Massachusetts and Vermont this summer put into place some fairly strict limitations on vendor/physician relationships. Other states are looking at doing the same thing.
For many JHC readers, such measures seem logical and proper. But not all doctors see it the same way. This past July, an organization called the Association of Clinical Researchers and Educators, or ACRE, held its charter meeting in Boston. ACRE (www.acreonline.org) is an organization of medical professionals “who recognize that appropriate physician-industry collaborations and relationships benefit patients and advance science.” The theme of its conference was “Optimizing Value to Patient Care of Industry-Physician Collaboration.”
Not everyone greeted ACRE’s meeting with open arms. Indeed, in a press release issued immediately afterward, American Medical Student Association President Lauren Hughes, M.D., said, “ACRE is truly behind the times.” And no doubt many JHC readers are asking themselves, “How could anyone of sound mind advocate relaxed conflict-of-interest policies?”
With that in mind, we spoke with ACRE steering committee member Carey Kimmelstiel, M.D., director of cardiac catheterization laboratory and interventional cardiology, and director of clinical cardiology at Tufts Medical Center in Boston. He is also an associate professor of medicine at the Tufts University School of Medicine.
According to Kimmelstiel and the ACRE organization, today’s efforts to eliminate conflicts of interest have gone too far. The primary reason, he says, is that the practices about which people are concerned – such as gift-giving, nice trips, etc. – have pretty much been eliminated.
Interpretation of rules about reimbursing physician practices for CME talks are tight – probably too tight, he adds. “Recently I looked at a slide deck for a very interesting, novel, approved drug. I [asked] the chief legal counsel of the company, ‘What if we’re going to give a talk and we want to put in a couple of slides that are illustrative of the way our practices use this drug for an approved indication?’ He said, ‘You can’t do that.’” The reason: The company had had the slide deck reviewed by the Food and Drug Administration, and no changes could be made. The answer surprised Kimmelstiel. “I’m a physician with a lot of experience.” Yet he was prohibited from sharing his clinical experience with others.
Yes, physicians can be influenced by gifts, trips, etc., he says. “Anybody can be influenced.” But, he adds, “I think there are individuals in any field who can be influenced inappropriately. That said, most physicians are savvy enough to be able to ferret out those who are giving a talk of value vs. those who are prostituting themselves.
“A lot of these regulations [including the recently passed legislation in his home state, Massachusetts] come from the idea that physicians are either inherently corruptible or ignorant, or in fact, easily coerced,” he continues. “This whole idea that our practice patterns are going to be changed by a pad of Post-It notes is kind of insulting. I have a little bit of a problem with the idea that if I use a pen with a company’s logo on it, it will influence what I buy.”
Overly strict conflict-of-interest policies can stand in the way of the education of students, physician trainees and practicing physicians, adds Kimmelstiel. For example, it’s not uncommon for groups of fellows and physicians to gather on a regular basis, perhaps quarterly, to listen to cases and share knowledge on particular medical topics. These dinner sessions, held at local restaurants and the like, are often subsidized by industry. Under new, strict conflict-of-interest guidelines, however, industry has most likely bowed out. “Who will fund them?” asks Kimmelstiel. “Hospitals? No. State government? That’s laughable.”
Worse, such policies could potentially spell an end to clinical research being carried out at hospitals. One pharmaceutical firm has already said it is ending its clinical research in the state of Massachusetts. “When you ask them why, they say, ‘There are 49 other states that don’t have these laws, where we don’t have to spend our time worrying about compliance and exposure.’ It’s an enormous problem for the medical investigative complex.”
Physicians need ongoing education on new technologies and pharmaceuticals, says Kimmelstiel. And the best people to provide that training are other physicians. “I don’t like this term ‘promotional speaking,’” he says. “The only thing I promote is my patients’ health. I call it ‘industry-funded speaking.’ Do I feel guilty about getting paid [for giving talks and seminars]? No. I would rather spend time with my family. Why should I do it for free?” But physicians need to be trained about new technologies, clinical guidelines and clinical trials. “How is that going to happen? Only if you go out and conduct an educational session.”
Kimmelstiel quotes a mentor, who once told him, “If you want to understand a topic, give a talk on it.” Speaking to groups of physicians – regardless of who funds it – is healthy for the profession and for patient care, he says.
What do Kimmelstiel and ACRE want? “To begin to level the playing field, to begin to have a discussion so we don’t throw out the baby with the bath water, so we don’t stop doing clinical research, so we don’t stop educating our peers and others,” he says. “There is no way we can survive without industry.”
Is there truth to what he says? We’d like to hear from you.