The Institute of Medicine (IOM) has finally released its report “Conflict of Interest in Medical Research, Education, and Practice”. One of the biggest reasons for rising healthcare costs is related to pharmaceutical and medical device costs. Some of the techniques used to increase demands for these products have been well publicized. Ghost writing (where the company basically writes the paper and gets someone else to agree to be the primary “author”), no matter how unethical, is a well-known phenomenon. Paying well-respected physicians or “opinion leaders” to speak at meetings and luncheons or dinners about the benefits of a drug or device (often for an “off-label” indication) is a tactic that often results in increased product sales or use. Negative studies (clinical trials that failed to show a beneficial effect of the drug or device compared to the control group) almost never get published. Until recently, the data from such negative studies was never available to any parties other than the industry sponsor (now clinical trial data is supposed to be posted publicly, though there is not yet full compliance with that). And in many cases, the researcher or the university has a financial interest in a study producing a positive outcome (eg. they may hold a patent on the drug, test, or device). Device manufacturers have paid large “consulting fees” to physicians who are in a position to get hospitals to purchase their devices. National standards and clinical guidelines are often written by panels on which there are individuals receiving considerable funding from industry. Industry also provides physicians a variety of “freebies” either directly or indirectly by sponsoring CME courses. And those of us who claim “those things don’t influence my practice” are in a state of denial. And the conflicts of interest do not just involve the physician community. Some organizations established to advocate for patients with a particular disease or conditon are often heavily subsidized by the companies who have the most to gain by promotion of their products. The conflicts go on and on. The result is that many of our patients receive treatments that ultimately are found to be either no more beneficial than a current treatment or in some cases actually harmful to them.
All these are examples noted in the IOM report. The report calls for substantial reform in how these conflicts of interest are both declared and managed. Our own feeling is that the only real way to avoid such conflicts of interest is to return research to financially disinterested parties. Whereas in the past most medical research was performed by academic medical centers and sponsored by NIH or other non-industry sponsors, now most research is sponsored and funded by the industry itself. So the government’s failure over the years to provide adequate research funding and oversight has really allowed medical research to be hijacked by the very parties likely to have conflicts of interest. Failure to adequately fund the national research endeavor thus has actually been one of the root causes of our rising healthcare costs.
Institute of Medicine. Conflict of Interest in Medical Research, Education, and
Practice. Report Brief • April 2009