Conflicts of Interest: Experts
The recent post on the Dengvaxia vaccine raised several interesting questions. A prominent local professor of medicine pointed out that the Association of South East Asian Nations (ASEAN) Member States Dengue Vaccination Advocacy Steering Committee (ADVASC) is actually supported by an unrestricted educational grant from Sanofi-Pasteur, the pharmaceutical company that manufactures and sells Dengvaxia. In a similar light, the majority of prominent clinicians and professors I know have – at some point or other in their lives (some more than others, myself included) – interacted with commercial enterprises. These interactions vary from receiving paid sponsorships to conferences, receiving honorariums to give talks to other clinicians/stakeholders, getting sponsored to be part of local/regional/international advisory panels for new products, or receiving funding for research in areas that the companies are interested in.
In one sense, such interactions are virtually unavoidable. As a clinician/scientist becomes more recognised and competent in his field, particularly if he/she has performed groundbreaking research, it is natural for pharmaceutical or biomedical companies to seek his/her expertise with regards to their products. Such companies may also provide crucial funding without which the research the clinician is interested in would be hard to accomplish – government and supranational funding bodies are not able to fund the full spectrum of research topics for obvious reasons. Governments and even the World Health Organization’s regional offices might have been slower off the block to support an advocacy group such as ADVASC, for example, unlike Sanofi Pasteur, which had developed a dengue vaccine (the company did take a very small gamble, in that in 2011 when they funded ADVASC, Dengvaxia’s Phase III trials had just begun recruitment).
It is also natural for the commercial company to seek to influence, and to make use of the influence of said clinician/scientist. The term “key opinion leader” or KOL appears to have arisen from the pharmaceutical marketing industry (although the concept is older and extends beyond the biomedical realm), and describes someone who is able to influence his/her peers’ medical practices (a full description is given here, or in this paper which is unfortunately behind a paywall). There appears to be an entire industry centered around identifying and marketing these KOLs, sometimes without the apparent knowledge of said KOL.
Frequently, such interactions and alliances result in public good. Many groundbreaking medical practices and drugs/devices would not have otherwise benefited such a large number of people across the world. A significant contribution to our adoption of the pneumococcal vaccination into our National Childhood Immunization Schedule was advocacy by Wyeth (the company that developed and sold the pneumococcal conjugate vaccines PCV-7 and PCV-13, bought over by Pfizer in 2009) and the clinicians whose studies they had supported.
Just as frequently, such interactions have proven detrimental. Many clinicians like to believe they are neutral and unsusceptible to pharmaceutical industry blandishments, but they are almost always wrong in this regard. On a grander scale, pharmaceutical companies have been known to suppress the results of clinical trials that do not favour their products – in such cases, KOLs can become their unwitting accomplices. The huge brouhaha over the influenza drug oseltamivir (tamiflu), which is probably worth a separate piece, continues to this day.
Is there a solution to this human conundrum? Full disclosures of such conflicts of interest are now the norm for both academic research and experts consulted by regulatory agencies. This is hopefully becoming the norm in medical school teaching as well, after an uproar at the Harvard Medical School made it to the New York Times. However, such disclosures are not required in medical practice (understandably too onerous and creates more complications than benefits), and they do not really detail whether any bias – or the extent of such bias – is present. They function more like “caveat emptor” warnings, and to a lesser extent exert a social pressure on the expert/KOL to be more objective. They also create and enhance the current situation in some sectors of the global population where experts are mistrusted.