A guest editorial by Ghislaine Mathieu, commenting on the story The Seroquel Scandal: A Minnesota Psychiatrist’s Ethical Lapses Are Suspected.
Back in 2003, a 26-year-old, Dan Markingson was enrolled in a trial at the University of Minnesota to compare AstraZeneca’s Seroquel antipsychotic with rival brands supervised by a Minnesota psychiatric professor, Stephen Olson – who had previously indicated in a court petition that Dan was dangerous and mentally incapable of consenting to taking antipsychotics. In fact, he was then exhibiting troubling schizophrenic behaviour, even threatening his mother, and briefly committed to a mental institution. Yet, although schizophrenic patients experiencing psychotic episodes are at a higher risks of killing themselves or other people during a study, Dan was recruited by his own psychiatrist, Stephen Olson, in the AstraZeneca’s study, against Dan’s mother, Mary Weiss’ concerns, who accused Olson of having coerced Dan to sign up. Apparently, each recruited subject was worth $15,000 to the university. Mary Weiss made numerous calls to the study’s investigators, complaining that during Dan’s first six months in the study, he was not getting better and that he should be withdrawn from the study. Yet, Olson recommended to extend Dan’s participation in the study for another six months. Tragically, Dan killed himself on May 2004. Mary Weiss filed a lawsuit against Olson, AstraZeneca and the University of Minnesota, claiming that Dan had been coerced to participate in the study, and that the university kept him enrolled to preserve its research, and to keep payments coming for his participation. The judge presiding the lawsuit ruled that the university had statutory immunity from such lawsuit and that AstraZeneca shouldn’t stand trial because there was no convincing proof that its drug caused Dan’s death! Being the only defendant left, Olson settled with Mary Weiss for $75,000 – which went entirely towards her legal bills. Sadly, the university decided to countersue May Weiss to collect $57,535 to cover its own legal fees in defending itself against her suit. She was forced to reach a settlement with the university, provided that she promised not to appeal the original ruling. That proves that you may have strong institutional conflict of interest policy — Minnesota ranked B in the 2010 AMSA scorecard — and still very badly manage a COI situation.
The following article in the Boston Globe (Deeply conflicted) gives a wonderful overview of the fascinating psychological and economic research being conducted by Daylian Cain, Don Moore and George Loewenstein on the limits of disclosure as an effective mechanism for managing COI (see also their excellent 2005 book: Conflicts of Interest: Challenges and Solutions in Business, Law, Medicine, and Public Policy).
The take home message is that in many situations, disclosure not only does not eliminate the COI, but it can make the conflict even worse because 1) the party receiving the disclosure of COI (a patient, members of a committee) may be even less inclined to be critical of the person disclosing, and 2) by disclosing their COI, people may feel (unconsciously) that they’ve dealt with the issue and can even behave less ethically. The result is that in some circumstances, disclosure might simply not work in managing COI and reducing the associate harms or risks.
Furthermore, as Moore admits, in some cases the high costs of eliminating conflicts of interest may not be worth the effort. But in circumstances where conflicts cause harm, changing the system could be worthwhile. Regulators, Moore says, need to look for ways to structure systems so that experts’ personal interests are matched with the interests of those they are helping. “Restructuring to align interests is difficult,” he says, “but when you do it, it can be beautiful.”
The issue about COI and policy recommendations in favour of stockpiling Tamiflu to protect against a potential flu pandemic has been in the news in Canada recently, following an investigative report by the CBC (CBC Tamiflu probe sparks drug policy review) and French language RDI (Le Tamiflu au coeur d’une polémique). In April I did a presentation on this case (online video) at the Institut de recherche en santé publique de l’Université de Montréal; the following write-up (Les conflits d’intérêts exigent la transparence, in French) summarises the key points of my presentation. My main message was that in a situation where public health agencies are making policy decisions that impact the general public, they need to work towards the highest levels of transparency and accountability, and should avoid even the perception of COI. This is a situation that, like the judiciary, cannot permit even a hint of COI, because the risk for undermining public trust and confidence (and the serious negative consequences of this, i.e., refusal to participate in public health prevention campaigns) is simply too great.
Nancy Walton at the Research Ethics Blog has a nice analysis of the issues of COI in research and the implications for public health policy making (Disclosing Conflicts of Interest: The Case of Tamifl).
It looks like the WHO is again (after the H1N1 situation) facing COI allegations with regards to industry involvement in its expert advisory panels. This time, there is Concern as Novartis exec approved to WHO group. Paul Herrling, the Swiss head of corporate research at Novartis, has been named to a WHO expert group that will evaluate funding applications for projects into neglected tropical diseases. Not only is “the only expert in the group who is also an executive in the drugs industry“, but he is also “the author of a proposal to the same working group for a new funding model that would allocate $10 billion (SFr9.42 billion) in grants to fund research by pharmaceutical firms as well as public research institutes and public private partnerships”. Even if the WHO can put in place effective mechanisms to manage these COI, the optics are still terrible!
With disclosure becoming the key mechanism promoted to manage COI in academic — and especially biomedical — conferences and other educational events, its interesting to see that there is still enormous work to do so that academics and clinicians even understand what and when to disclose. As the following story reports “Conflict of Interest Reporting Varies Among Spine Meetings”
There is a lack of uniformity among disclosure policies of various medical associations, and confusion regarding what relationships need acknowledgement results in variability in the reporting of financial conflicts of interest in clinical research, according to research published in the January issue of The Spine Journal [full text of the study]