Life Science Compliance Update

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October 05, 2015

Conflict of Interest Rules in Medical School Might be Changing

Rules

Harvard Medical School has been known to have some of the most stringent conflict of interest rules in the nation. Several faculty members, however, have not been shy about questioning whether stricter rules could be damaging innovation, one professor noting, “If there were conflict-of-interest policies so that Thomas Edison couldn’t be involved in the company he formed to create the electric light, we’d still have gas lamps.”

In light of faculty discontent, changes in the medical field, and additional research on conflicts of interest and how they affect physicians, Harvard Medical School is starting to take some steps back from the strict conflict of interest rules they set out five years ago. The school has started to discuss with faculty some changes that can be made to protect the integrity of the medical field while also promoting new innovation and creativity. One of the policies they are reviewing is the “research support rule,” which bars faculty from receiving research grants or contributions from a company they hold equity in. Another strict rule under review, which is believed to be unique to Harvard, is the “clinical research rule,” which prohibits faculty from conducting clinical trials on products if the faculty has equity or earns at least $10,000 in income from the company who produces the product.

The viewpoint Harvard has held for the last several years gives credence to the thought that if you have a financial stake in a particular product, it is hard for you to accurately evaluate it. They believe that these rules protect patients against self-serving doctors who are solely focused on making as much money as they can with disregard for patient health and safety.

However, it has been found that while small gifts may influence the activity of physicians, it does not necessarily follow that greater financial stakes have a large impact on the activity and decisions physicians make. Dr. Lisa Rosenbaum has done some research on the topic and believes that conflict of interest rules have been so entrenched in the medical field that at this point, keeping them is a matter of indignation, not a matter based in reality. She believes that a shift toward a conversation that “better accounts for the diversity of interactions, the attendant trade-offs, and our dependence on industry in advancing patient care“ will be a more beneficial way of looking at things for all parties involved.

Dr. Rosenbaum also has concerns about the accuracy, reliability, and relevance of the data that has been considered to be the impetus behind the strict conflict of interest rules around the country. She does believe that while patient health should never be compromised by a physician’s desire for financial gain, “the extent to which physicians’ primary and secondary interests actually conflict, under what circumstances, and at what cost are unknown.” She also highlights the fact that neither the benefits, nor the harms, of these regulations attempting to expose or mitigate these conflicts are clear.

In her research, Dr. Rosenbaum poses several questions about the suggestive data that has been relied upon to create these conflict of interest rules. Some of these studies have been somewhat self-serving, in that they specifically go out to find instances of potentially negative industry influence and wind up successful. However, just because industry influence exists, that does not mean it is harmful to the patient. Just because a doctor attends a symposium funded by a drug manufacturer and ends up prescribing that drug to a patient does not mean the patient is harmed. Just because a doctor receives drug samples or a lunch from a drug representative and then goes on to prescribe that medicine does not mean the patients who receive that medicine are harmed by those interactions between the physician and the pharmaceutical industry.

In all, while there have been many studies done on the relationships between physicians and the pharmaceutical industry, there have not been many studies done on the effects of those connections to patient health. There are two sides to this coin, but if conflict of interest rules prevent physicians and others from creating the next “big thing” in medicine, that could very well be doing more harm to patients than a doctor who has contacts with a pharmaceutical company.

It will be interesting to keep up with the progress of this Harvard Medical School review and see if any changes are made to their policies, and consequently, to any other medical schools who may have similar rules. 

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