As the lines between corporate sponsorship and ethical practice grow fuzzier, it can be difficult to discern what constitutes a conflict of interest in scientific research and practice. With the recent storm still brewing over the apparent lack of transparency with the process of creating the next version of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM) and the Senate Finance Committee taking a closer look at the links between panel members and the pharmaceutical industry, the issue of ethical practice takes center stage.
New England Psychologist’s Catherine Robertson Souter spoke with one of the leaders in the battle for more transparency and accountability in both research and in the decision making process for professional guidelines.
Lisa Cosgrove, Ph.D., is a clinical psychologist and associate professor and graduate program director at University of Massachusetts Boston. One of the authors of a paper released in 2006 looking at the links between DSM-IV panel members and the pharmaceutical industry, Cosgrove spoke about the need for transparency, balance and further regulation in some of the decisions made by the profession and by individual professionals.
Q: You found some strong ties between the DSM-IV panel members and the pharmaceutical industry. How did you become aware of a concern in this area?
A: I was actually doing menstrual cycle research in late 2000 and coincidentally that was when Prozac’s patent [for Sarafem, an FDA-approved treatment for premenstrual dysphoric disorder (PMDD)] was about to expire. We discovered by chance that a number of the members of the PMDD committee of the DSM provided testimony to the FDA and were being paid by Eli Lilly. To me, it’s pretty clear that without this testimony, Sarafem would not have been given approval by the FDA for the treatment of PMDD.
I wondered if this was just an anomaly that some panel members of the DSM were also being either paid by industry or had significant financial associations with industry. So, I set about to do an investigation, along with Sheldon Krimsky, PhD, of Tufts. With his expertise in conflict of interest methodology and my background, it was a wonderful combination and so together, along with two graduate students, we investigated the financial ties between DSM members and the pharmaceutical industry.
Q: What were the findings?
A: We discovered that indeed there were significant ties. Over half had some financial associations and some panels had 100 percent of their members with financial ties – the Mood Disorders and Schizophrenia and Other Psychotic Disorders Panels, which is particularly problematic because medications are the standard treatment in those two disorders.
Q: You point out in your report that you are not calling this a conflict of interest, but calling attention to the fact that these ties exist. Are there levels of financial links that would or would not be considered a conflict of interest?
A: That’s where it is a slippery slope. We have a wealth of data that demonstrates that even small gifts or amounts of money can have a profound influence on behavior. It is possible to prioritize conflicts but we must do it within the context that even small financial associations can have an effect.
That said, I would agree that holding stock in a company, having equity, having a patent, should be reason for recusing oneself.
And those connections were also found.
Q: Is it getting more difficult to find people who don’t have some kind of ties to industry? Soon there won’t be anyone left to do these projects.
A: That’s the argument that is often made – and I think it is a rather spurious argument. There are certainly individuals who either no longer have industry ties or who have become critical of industry and could give a balanced and helpful perspective.
I’ve never said, nor have my colleagues or coauthors said, that there should be no industry funding. I am in no way anti-medication or anti-industry funding. For me, the issue is about informed consent and transparency of associations so that the consumers have the information that they need.
What I would advocate would be, for example on the DSM panels, that you would have both critics of industry as well as industry-funded individuals. It’s more about balance than it is about prohibition of people with industry associations.
Q: You also released a study looking at the links between the authors of the American Psychiatric Association’s practice guidelines and the pharmaceutical industry.
A: In 2009, I published a study looking at main clinical practice guidelines that the Association produces – major depressive disorder, bipolar and schizophrenia, and looked at the financial associations between the authors of those guidelines and did find that indeed there were significant ties between the authors of the clinical practice guidelines and industry.
Q: What happened with that as a result of the study?
A: Well, it might be a coincidence but at least now the Association is posting the authors’ disclosure statements. So, that is positive. It increased transparency.
Transparency is a necessary but insufficient first step in managing potential conflicts of interest. We need management of those conflicts. If you hold stock or have patent on a medication, that deserves more than just disclosure. The other issue has to do with informed consent so the public is fully privy to all the information that they would need to make an informed decision.
Q: What is next for you?
A: One of my future projects will include a content analysis of the Association guidelines. A quick perusing suggests that little attention is paid to when to discontinue medication or alternative treatments or informed consent. So, for balance, we need to pay attention to those issues as well.
I’m also interested in randomized clinical control trials. They are seen as the gold standard but I don’t think people are aware of how frequently this gold standard is compromised because of methodological designs.
I just completed a study that is under review now where I reviewed the epidemiological and biological literature on anti depressants in breast and ovarian cancer and the connection between researchers’ conclusions and their industry associations.
By Catherine Robertson Souter