Issues and Challenges in Marketing to Physicians

Disclosure...An Ethical Concept for Physicians, Businessmen and Politicians

Two recent articles in the New York Times grabbed my attention. Both addressed the importance of fully disclosing the financial arrangements, both direct and indirect, between scientists, including research physicians, and industry. Both articles were spawned by conflicts of interest in the publication of research results. These conflicts range from failure to reveal that an author or reviewer was a paid consultant on a medication being reviewed; to an instance where a chest implant device was under review by a physician with an undisclosed partial ownership in the device manufacturer; to other cases where the authors involved failed to reveal that they were paid consultants to a distributor, although the particular medication being reviewed in their article was not the direct product for which they were being compensated.

Yet another topic of debate is the issue of whether participants in drug trials or other tests of efficacy are fully informed as to the financial interests of the scientists conducting the research. Obviously, such research criteria as selection bias, the effect size or power of the study, and the robustness of the findings are all subject to doubt if the folks running the tests have undisclosed economic interests in the given study findings.

The media highlights those cases where businessmen and politicans fail to honor their obligation to their constituents to disclose their actual and potential conflicts of interest. If Ken Lay, Jeff Skilling [both Enron] and Richard Scrushy [Healthsouth] had been forthcoming about the real financial status of their corporations, they might each have been fired for incompetency, but at least their character, if not their legal status, would not likely have been in question. If Tom DeLay had publicly disclosed his relatonship with Jack Abrahamoff and his efforts to salt the redistricting procedures for seats in Texas, he might have been subject to political criticism, but he would not be facing jail or huge legal bills now. In fact, the issue is a far larger one for politicians, since at least the formal part of business education exposes young business men and women to a theory of ethics. I find it perplexing, but perhaps revealing, that politicians as a group seem to lack any sense of ethics, although the vast majority of them are lawyers. That is food for another commentary, on another day.

Industry, that is, the drug and device companies, have an obligation to their shareholders to optimize the revenues they receive from marketing their products. The effectiveness of those products are subject to verification by formal means of testing which require participation, supervision and interpretation by experts in the relevant science, applicable fields of medicine, and the tools of advanced statistics. Unfortunately, how these expert skills are applied is beyond the capability of even the informed public to easily evaluate. For example, I doubt that more than a handful of even the well-educated realize that, with the normal p<.05 criterion for attributing effectiveness to a tested treatment, at least one time out of twenty a test or trial will generate what appears to be a valid effect purely by chance!!!! That is, even if the drug or device actually fails to be useful, there is a one in twenty chance that the results will incorrectly indicate that it is effective. For that reason, more than one or two tests and an adequate test subject pool size are both fundamental standards for truly valid conclusions from the testing process.

We rely upon and trust the judgments and endorsements provided by what amounts to a class of "high priests" in science and medicine to monitor and oversee these eccentricities of the testing process. The very least we can expect of the physicians and scientists we trust with our health and well-being is to let us know up front where their actual and POTENTIAL conflicts lie. It is not enough for an individual physician to assert personal integrity or to claim that he or she would never let money stand in the way of their impartial judgments. Plenty of evidence from experimental psychology shows us that time and again, and especially with respect to professionals imbued with expert knowledge, we are completey unaware of our biases and how easily they can be influenced or manipulated. In fact, industry capitalizes on the ignorance and hubris of the physician with the very materials they design and props they employ to promote their wares to them. Come with me to any medical assembly and you will see how easily this agenda is fulfilled.

The best antidote to all these real and potential conflicts of interest is "fresh air"--that is, disclosure. When the expert physician reveals his or her financial interests, he or she makes it possible for the "buyer"--that is, the patient or his agent--to decide for themself if they want to bear the risk that the expert is biased. That is a fair tradeoff for the prestige, compensation and social clout we accord the physician and the scientist in our society. It is a missing ingredient throughout the marketing side of the pharmaceutical and device industry, and it is our duty as an education company to support disclosure wherever and whenever possible.

posted by Robert E. Sweeney, DA, MS @ 3:51 PM