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Treatment guidelines and conflict of interest

Posted by medconsumers on April 13, 2011

More than half of the cardiologists, cardiovascular surgeons and other experts who produce treatment guidelines have financial ties to companies that make heart drugs or surgically implanted devices. A new study takes a hard look at the conflicts of interest among experts who serve on panels that set the treatment standards for prestigious organizations like the American College of Cardiology and the American Heart Association. While many of us would like to think our physicians and surgeons keep up by reading medical journals. In fact, many physicians rely on these guidelines panels to guide their practice decisions.

I used to think that the main task of these influential panels was to distill the best scientific evidence for practicing physicians who do not have the time or skills to do it themselves. But then I learned from an in-depth review presented at a 2004 Cochrane Collaboration conference that treatment guidelines are largely based on opinion rather than scientific evidence. That’s the first problem, and one not confined to cardiovascular medicine. The second problem is that the panels are supposed to be independent, but in fact, the individuals chosen to join them often have major conflicts of interest.

The new study appears to be the first to determine the scope of the second problem by taking a broad look at the experts who served on heart treatment panels from 2002 to 2008. It found that 56% of them have major conflicts of interest, most commonly a paid consultant to a drug or device company or a member of a company advisory board. Even more troubling was the finding that the physicians who chair the panels are most likely to have conflicts of interest (80%).

The study was led by Todd B. Mendelson, MD, University of Pennsylvania’s Center for Bioethics and Cardiovascular Medicine, and published last month in Archives of Internal Medicine.

In stating their conclusion, Mendelson and colleagues went the glass-is-half-full route, pointing out the bright side of their results. “Conflicts of interest are prevalent in cardiology guidelines, but there seems to be a significant number of experienced experts without conflicts of interest [44%].” In other words, the 44% refute the standard argument that almost all knowledgeable heart specialists take industry money and setting stringent rules about conflicts of interest would leave no one to serve on panels.

There has been a fair amount of media attention given to conflicts of interest over the last decade, and the solution always seems to be disclosure. But in a related commentary entitled, “Can we trust cardiovascular practice guidelines?,” Steven E. Nissan, MD, chairman of cardiovascular medicine at the Cleveland Clinic, dismisses disclosure as a solution and called for banning anyone with conflicts of interest from serving on these panels. “While sunlight is a good disinfectant, there is nothing about disclosure that inherently guarantees scientific independence.” (At the end of his commentary, Dr. Nissen writes that he has consulted for a number of pharmaceutical companies without financial compensation. “All honoraria, consulting fees, or any other payments from any for-profit entity are paid directly to charity, so he receives neither income or tax deduction.”)

These panels are extremely influential, writes Nissan, citing their influence on government and insurance company decisions about which procedures and drugs should receive reimbursement. “Hospitals and clinics use [the guidelines] to decide when innovative, but expensive, therapies are sufficiently mature to warrant a major investment.”

Dr. Nissan comes down hard on professional medical association, stating that any proposed reforms must include them because many receive extensive funding from pharmaceutical and device companies for continuing education for physicians and for advocacy. Although they went unnamed, Dr. Nissan was referring to organizations like the American College of Cardiology. For more on this from ProPublica, click here.

What can you trust? I wish I had an answer. Last February, as I stood outside the cardiac care unit waiting for my husband who just had an emergency angioplasty, I was handed a folder about the drug-emitting stents inserted during the procedure. Not until the surgeon was halfway down the hall did I notice that all the information he gave me came from the company that makes the stents. I’m still looking for independent, long-term safety not only about drug-emitting stents but also the multiple drugs my husband will stay on for the rest of his life.

Maryann Napoli, Center for Medical Consumers©

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