I just finished a book that should be required reading for all physicians, and maybe for all medical scientists as well. It does not paint a pretty picture of how outside organizations, particularly the pharmaceutical industry, can influence the behavior of doctors and medical researchers.
On the Take, written by academic physician Jerome Kassirer, former editor of The New England Journal of Medicine, outlines the many forms of conflict of interest that confront and confound doctors, medical scientists and medical organizations ranging from hospitals to specialty groups like the American Heart Association.
In response to the defensive cries of “I can’t be bought,” Kassirer presents considerable evidence to the contrary. Despite their protestations, many in our profession have placed themselves in positions where their judgment is questionable. Even if there is no explicit or implicit bias in their behavior, the mere presence of significant financial incentives casts a pall over their work. And numerous studies have, indeed, documented that outside influence in the form of financial compensation does (in many cases) bias the outcome of medical treatment, clinical research and even basic science studies. Psychological research studies document this “rule of reciprocation.”
After reading Kassirer’s book, I reviewed some investigative reporting from the Los Angeles Times about the consulting activities of NIH senior scientists. I was truly ashamed of the behavior of key people in our profession. Granted, as paid consultants for medical companies, they may have acted in perfectly good faith. Lack of sufficient disclosure and other safeguards, however, failed to protect the integrity of their work. At best, there was the appearance of bias in their actions. At worst, the financial compensation significantly swayed their opinions. This constitutes serious negligence by these investigators.
Even perfectly ethical and totally forthright behavior can create the appearance of conflict. A senior cardiologist from UCSF wrote an opinion piece endorsing a product made by a startup company, Vasomedical. His article was published in promotional material paid for and distributed by the company. Kassirer not surprisingly concluded that the doctor had been paid to write this opinion and contacted him inquiring as to why a senior academic leader would allow a company to use him in this way. Much to his surprise, he learned that the doctor had refused any compensation and had no financial interest in the company or the outcome of the research done at UCSF. He was simply so impressed with the improved clinical outcomes of patients using the device that he felt it was important to help support a startup company with a device that he felt should become available for patients with ischemic heart disease.
There are many important lessons to learn from Kassirer’s book. I cite only a couple here. First is that opinions can be influenced by many things, and financial incentives are clearly one of those drivers. Fame, promotion, getting the next NIH grant, winning the Nobel can also contribute to biased results. But in the case of financial incentives, the conflict is both readily identifiable and quantifiable. Most importantly, the conflict of financial incentives is often avoidable. One can simply proceed without taking outside compensation.
The second lesson is that conflict-of-interest situations should always require disclosure. Disclosure is a necessary—but not sufficient—condition for supervising conflicts of interest. Additional checks, balances or prohibitions may be required to reach an appropriate risk profile for the behavior, but full disclosure is always the vital first step.
Long gone are the days when academicians, especially those involved in clinical research, can remain in the ivory tower. We want to help assure that the best drugs and devices get tested properly, and those that pass muster become widely available for routine patient use. By necessity, this objective involves the assumption of conflicts of interest, and with them, a higher degree of risk than if we maintained a completely cloistered environment. Innovation through discovery (and testing) is part of our mission.
Johns Hopkins Medicine is a revered and honored name—we are what I call a trusted agent of medical science and clinical care. The public looks upon us differently than other health care organizations and in many respects holds us to a higher standard than other hospitals and academic medical centers. In order to carry out our mission of discovery through innovation, we need to be sure that we comport ourselves to the absolute highest ethical standards possible.
