I’m written previously about the controversy surrounding the diabetes mellitus drug Avandia (rosiglitazone), and I found interest in the recent news story that reviewer for the New England Journal of Medicine had leaked an early copy of a meta-analysis on rosiglitazone to the pharmaceutical company that makes the drug, GlaxoSmithKline. The physician-scientist, Steven Haffner at the University of Texas Health Center in San Antonio, was a peer reviewer for the Nisset and Wolski (2007) study that suggested that rosiglitazone had a small increase in risk for acute myocardial infarctions (heart attacks) over placebos (later, it was shown that it had an increased risk over older treatments for diabetes mellitus such as metformin and sulfonylurea). According to a Nature article, he explained his behavior in this fashion:
“Why I sent it is a mystery. I don’t really understand it. I wasn’t feeling well. It was a bad judgment.”
Although this story broke several days ago, I didn’t want to write about it until I had time to reflect and have a better understanding about why it bothered me so much. I personally have great admiration and respect for the NEJM editors with whom I worked for some time, but this is not what perturbed me as much as the greater implications of Haffner’s actions.
First, Haffner’s actions are on the border between legality and criminality. Disclosing information to stockholders (executives at GSK) that may affect the company’s stock price (e.g. a study reporting that a company’s blockbuster drug is not safe) may be seen as inappropriate insider trading; however, a representative for the GSK executives denied selling their stock, though this matter has not been investigated for lack of readily available evidence.
Secondly, Haffner used a very common excuse in a questionable way: “I was sick.” This has multiple implications. It may support a misguided impression that people who are sick (to any degree) are also typically impaired in judgment (I previously wrote about the role of pain and suffering in impairing judgment, but this is not always a predominant factor in every patient). If Haffner was sick, how sick was he? He claims he “wasn’t feeling well,” but there are plenty of people in our society who don’t feel well on a particular day but have perfectly intact judgment. If he was so sick that his judgment was impaired to the point of commiting a crime, he needs to see a doctor! Alternatively, Haffner may have recently been suffering emotionally from a close personal tragedy or difficulty that would not be appropriate to disclose to the public, but again, impaired judgment of this magnitude is not a key feature of normal bereavement (mourning) and is still highly questionable with regards to situations of emotional distress.
It’s possible that Haffner didn’t have a clear understanding of his role as a peer reviewer and the importance of confidentiality in medical science’s peer review process. Much of science and medicine functions on a system of honorable action and gentlemanly conduct, a system that can be much abused by those who care only for success and gain for themselves and their allies. Haffner had worked on previous clinical trials for rosiglitazone, had served on a steering committee for the drug, and had received “considerable” amounts of speaking fees from GSK for prmoting rosiglitazone. Upon publication of the Nissen and Wolski meta-analysis, Haffner was famously quoted in a newsletter as saying, “The three major medical journals are becoming more like British tabloid newspapers. All they lack is a bare-chested woman on Page 3.” It seems mind-boggling that a physician-scientist of his standing would make such a callous comment while making a serious and obvious breach of medical professional ethics.
Does Haffner truly lack an understanding of his actions? I do not think this is the case. Rather, I suspect that the physician-scientist is deficient in the mechanisms that would keep improper actions in check. It seems highly unlikely that he would not know prior to the public reporting of his actions that his faxing of the manuscript to a GSK employee was a breach of professional conduct: confidentiality is one of the most basic, simplest, and obvious rules made clear to reviewers when they are invited. Confidentiality is a key principle in both ancient and modern medicine. The Hippocratic Oath itself clearly binds physicians to confidentiality (within reason): “What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep to myself, holding such things shameful to be spoken about.” I think that it is more likely that Haffner understood his actions but was willing to break the rules for the benefit of himself and his friends. Rule-breaking, to some degree, is often celebrated in our society: we celebrate the James Deans (”Rebel Without A Cause”), the O.J. Simpsons, and Jack Sparrows. However, while many or most people in their lives engage in some degree of rule-breaking, most do not break rules so egregiously or in ways that may have profound negative effects on other people. The rules normal people break (outside the context of clear injustice, such as during the Civil Rights movement) tend to be rules that are perceived as arbitrary, and so there is almost a sense of justice (or at least ambivalence) in breaking them. This physician-scientist, on the other hand, demonstrated the breaking of a rule not for perceived arbitrariness or injustice, but rather, for personal gain. This is akin to the premed student that cheats on a test, plagiarizes a paper, or modifies an article on Wikipedia so that other students who might call up that page for answers will be misinformed. Normal people, even under duress, still have scruples and principles guiding their actions. There is something wrong in the minds of people who choose to do otherwise, something that would impair this physician-scientist’s ability to function within the broader context of his profession.