How To Minimize Conflicts Of Interest In Medical Research

Steven E. Nissen, M.D., chief cardiologist at the Cleveland Clinic, discusses his findings of a study of the drug Torcetrapib, during the American College of Cardiology Conference in New Orleans, Louisiana, Monday, March 26, 2007. The drug Pfizer Inc. stopped developing in December because of a link to excessive deaths failed to reduce artery-clogging plaque in studies presented today. Torcetrapib was supposed to work by raising levels of good cholesterol, or HDL, which scientists believe helps sweep bad cholesterol from arteries. Research presented at a scientific meeting used sophisticated imaging technology that peered inside patients' arteries to determine the drug has no effect on the build up of fatty plaque and raises blood pressure. Photographer: Scott Saltzman/Bloomberg News.

With so much medical research funded by pharmaceutical companies and others with a financial interest in the outcome, it can be hard to avoid conflicts of interest. Years ago, Harvard Medical School revamped its policy on professors reporting potential conflicts of interest after critics, including many students, claimed the old rules were too lax and hid the financial ties many professors had to the manufacturers of the drugs they researched and discussed in class. In an article about a new study published in JAMA on how statins do in fact lead to muscle pain in some patients, the Washington Post gives recognition to Dr. Steven E. Nissen’s approach to minimizing such conflicts.

One can see the potential for conflict in how JAMA describes the role of one of the drugs’ manufacturers:

This study was funded by Amgen Inc.[, which] was involved in the design and conduct of the study, selected the investigators, monitored the trial, and collected and managed the trial data. The sponsor participated in the decision to publish the study and committed to publication of the results prior to unblinding the trial. The sponsor maintained the trial database and transferred a complete copy to the Cleveland Clinic Center for Clinical Research and the sponsor to facilitate independent analyses. The sponsor had the right to comment on the manuscript, but final decisions on content rested with the academic authors.

It’s nice that the the Cleveland Clinic’s researchers had the final say, but one can still see the potential for Amgen to influence the study.

The study’s lead author, Dr. Nissen, voluntarily imposed on himself an additional safeguard. Nissen is chair of the department of cardiovascular medicine at the Cleveland Clinic. According to the Post:

Nissen has worked with many pharmaceutical companies to determine the efficacy of heart therapies but requires the companies to donate any payments to charity so that he receives no compensation or tax breaks, according to a bio accompanying the study.

Nissen’s bio at the Cleveland Clinic’s web site clarifies that this is his personal policy, not one imposed on him by his employer:

As a physician/scientist, Dr. Nissen is often called on by pharmaceutical companies to consult on the development of new therapies for cardiovascular disease. He maintains a long-standing personal policy that requires these companies to donate all related honoraria directly to charity.

There is probably no sure-fire way to eliminate conflicts of interest in medical research. Nissen’s rule could still allow for conflicts if, for example, researchers ask that funders direct their honoraria to a charity in which the researcher has a strong financial or personal stake. Conflicts can arise when government funds medical research, too. The best we can hope for is to minimize the potential for conflicts that impede the growth of medical knowledge.

Kudos to Nissen for taking a confidence-inspiring step in that direction.