By Dr. Geoffrey Modest
Two issues on conflict of interest in medicine just came out in 1 online blog HMS-in the News on 9/30/15 (a regular email highlighting whenever Harvard Medical School people make it into the news, even apparently when the news isn’t so great).
- The BMJ just printed an article on the prevalence and compensation of academic leaders, professors and trustees on US healthcare company boards. As we know (and as has been mentioned several times in prior blogs), we are getting more and more clinical guidelines, and these guidelines increasingly come from specialty societies (vs the good ol’ days, when the NIH did them). And, with the increasing role of the private sector (drug companies, etc.) in academia and in funding academic research, more of the specialty society leaders are financially tied into the private sector. There has been great general concern about conflicts-of-interest (COIs), and many of the larger specialty societies (e.g. Am Acad of Cardiology) are increasingly explicit about exploring and revealing COIs. Coincidentally, the Annals of Internal Medicine just published the Guidelines International Network position paper on disclosures of conflicts of interest and their management, citing 9 principles (see Ann Intern Med. 2015;163:548-553). Although many of us are deeply concerned that COIs in clinical guidelines could seriously distort the quality and integrity of these guidelines (as we should be), it turns out that there is a much more profound COI in academia, assessing data from 2013 (see BMJ 2015;351:h4826).
Details:
- 442 healthcare companies had publicly accessible disclosures on their boards of directors
- 180 (41%) had one or more academically affiliated directors (166 drug companies, 107 biotech companies, 94 medical equipment and supply companies, and 75 healthcare provider companies)
- These directors were affiliated with 85 geographically diverse non-profit academic institutions, including 19 of the 20 NIH funded medical schools and all of the 17 US News and World Report “honor roll hospitals”
- These 279 academically affiliated directors include: 73 leaders (17 CEOs, 11 vice presidents, 15 university presidents/provosts/chancellors, and 8 medical school deans/presidents), 121 professors including 16 department chairs, and 85 trustees
- The total compensation to them was $54,995,786, with median individual compensation of $193,000
- In addition, these directors owned 59,831,477 shares of company stocks, with median individual share being 50,699 shares (stock shares, of course, are tied to company performance)
So, this brings up some pretty big issues:
- Although guideline writers and higher-ups in specialty societies are under more scrutiny about COI’s, it is clear that the involvement of these highly-respected individuals could still distort the integrity of the recommendations
- However, the stakes are much higher/the issue is more profound for leaders in academic institutions being on company boards: as noted in the BMJ article: “unlike consultants who are compensated to provide expertise on a specific issue, directors are subject to fiduciary responsibility to company shareholders to advance the general interests of the company and increase profits”: i.e., by being on the board of a for-profit company, their explicit role is to increase the profits of the company. This is a whole level of COI above the scientist who may feel forced to accept drug company money in order to do their research. The issue with the researchers is that in the climate of public-sector cuts and the ideological and financial shift to increasing private sector support, they actually may not have so much choice (that is not to say this is a good thing, just that this is the current perverse reality for the ongoing array of political changes since 1980/Reagan presidency, with defunding public research support and shifting research to the private sector). Of course several of the leading researchers have done quite well financially as a result of this relationship (project funding, speaking engagements, ownership of small companies, etc.). But, it is really a much more significant infiltration of some of the most highly regarded academic hospitals and medical schools to have their leaders contractually (by being on the for-profit board) have an obligation to make the company profitable (of course, this COI really manifests itself when the “for profit mission of industry competes with the non-profit taxpayer funded clinical and research missions of academic medical and research institutions”, per the BMJ article. All of this is compounded by the fact that the company-based compensation is so high for these directors that it might well dwarf their academic compensation.
- The Washington Post interviewed Wallid Gellad, one of the study leaders, who noted “Part of the impetus for [doing this study] is it’s remarkable that my $15 lunch with a pharmaceutical company is on a public Web site, but this {board of directors] information is not. It is publicly available, but you have to do a lot of searching and connecting”. As a local Boston example, “Elizabeth Nabel, the president of Brigham and Women’s Hospital, and a professor of medicine at Harvard Medical School, for example, accepted a role on the board of the medical device company Medtronic last year. According to the company’s proxy statement, she received $71,800, a prorated amount since she started midway through the fiscal year.” Despite Harvard’s own policy on faculty members serving on a company’s board of directors, which comments that as an individual’s authority within Harvard increases, “the scrutiny applied by HMS (and the affiliated institution) will similarly increase in view of the individual’s scope of authority”. She does not exactly serve as a great role model, or seem to be in line with the HMS stated policy …. Especially since >50% of Medtronics business is in cardiac devices, $8.8 billion per year per their website, in a hospital which is remarkably cardiology-focused.
(For full article, see http://www.washingtonpost.com/news/wonkblog/wp/2015/09/29/academics-received-55-million-to-serve-on-health-care-company-boards-in-2013/ )
- As a somewhat related issue, the Boston Globe had an article on Harvard Medical School noting that 5 years ago they strengthened their COI rules in response to a US Senate investigation into MD payments from drug and medical-device companies. There is currently a backlash at Harvard, with some researchers claiming that the stricter regulations have “hurt innovation”. The rules that they are looking at are the “research support rule, which bars faculty who own equity in a company from receiving research grants or contributions from that company” and the clinical research rule, which prohibits “faculty from conducting clinical trials on a company’s product if they have equity in or earn at least $10,000 in income from that company”. As above, there have been shifts in the research climate and public funding which have pushed this, and one researcher commented that “professors like him didn’t set out to be entrepreneurs but have felt compelled to launch companies to test their discoveries because the pharmaceutical industry has moved away from basic research, shifting the risk to academic scientists and their institutions. Federal grant money has also become harder to get, prompting academics to launch startups that can collect funds from investors.” The reality is that the cleanest way to avoid COIs would be to re-establish a robust public sector system of funding and monitoring the research, with clearcut COI boundaries. As commented by Marcia Angell, the proposed posed changes in COI at Harvard will “be going along with the times — and the times are that everything is for sale.”
(For full article, see https://www.bostonglobe.com/metro/2015/09/26/harvard-medical-school-puts-strict-ethics-rules-under-microscope/bH9zzpcpQS9sElIhPPOzfO/story.html )
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