TCR: Dr. Kassirer, thanks for agreeing to share some of your thoughts with our readers. I have to say that your book, On The Take, was one of the most powerful books I’ve read. I want to thank you for writing it!
Dr. Kassirer: I can’t tell you how pleased I am to hear that.
TCR: I think the readers might be interested in knowing about your background first. You are well known as having been the editor-in-chief of the New England Journal of Medicine (NEJM) for several years. There was some controversy when you left there. What happened, exactly?
Dr. Kassirer: Well, in essence, the owners of NEJM, the Mass Medical Society, were eager to use the NEJM name to promote other products, and I thought that was inappropriate, and I fought them tooth and nail on doing it. For example, they had a notion of publishing a “New England Journal of Primary Care,” a “New England Journal of Cardiology,” and a “New England Journal of Oncology,” with papers rejected from the New England Journal. I disagreed with that as well as a number of other issues, and I kept saying, no, no, no, and they got tired of it and they arranged to let me go.
TCR: And I assume that you had experiences as editor-in-chief that led to your decision to write your book?
Dr. Kassirer: Yes, I wrote about conflict of interest because I saw the problem becoming increasingly severe and the profession doing nothing about it. I also got personally stung by it once when I was editor-in-chief. At one point we invited two well-known researchers to write an editorial on the diet pill Redux (dexfenfluramine) in response to a paper we had published on a series of patients who had developed pulmonary hypertension while taking it. They concluded that the risk of taking diet pills was less than the risk of remaining obese.
TCR: So how did you get “stung”?
Dr. Kassirer: It turned that one of the authors was an ongoing consultant to the company that made Redux, which we didn’t know about, and the press got after us and said all kinds of nasty things, including an editorial in the Boston Globe entitled, “Malpractice at a Medical Journal.”
TCR: But did you believe that the piece in NEJM was biased?
Dr. Kassirer: When I first looked at it I thought to myself, “Gee this is really an interesting piece of work because it not only describes the benefits and dangers of the drugs, but it also talks about the risk of obesity.” I thought that it was a balanced approach, so I signed off on it, published it, and then found later that one of them had a financial conflict of interest. Then I went back and read the editorial again, and this time I wasn’t so sure it was evenhanded. It isn’t that I knew that it was biased; it was just that now that I knew about the relationship to the drug company, I didn’t know how to interpret it.
TCR: And it’s an interesting point you make about how difficult it is for practitioners to determine what is biased and what isn’t.
Dr. Kassirer: That is the fundamental problem with conflict of interest. When you are reading something or listening to a talk, even if you know somebody has a financial conflict of interest, you don’t know how to interpret it. You don’t know whether, A, they are being completely and totally objective, B, they are in some subliminal way biased by their financial connection, or, C, they are consciously and intentionally biasing their presentation so that they will be in better favor with the company. The reader or the listener just has tremendous difficulty in interpreting the information when you know somebody has a financial conflict. It is even worse when you don’t know!
TCR: Are there any other examples of this problem that come to mind?
Dr. Kassirer: I will give you an example of a very recent issue, related to the new cholesterol guidelines. In August 2004, the National Cholesterol Education Program released guidelines for the lowering of LDL (the so-called “bad cholesterol”) and they recommended more exercise, eating less, and more statin drugs. It turned out that seven of the nine people who were on the panel that made these recommendations had a financial relationship with statin companies – and not just one statin company but three to five statin companies. So you have to ask yourself, what exactly was the relationship between the financial gains for these individuals and their recommendations? I can’t tell how the recommendations were affected by this, but I can tell you that shortly after that report came out, two of the nine members went to work for the pharmaceutical industry.
TCR: Now when you looked at those guidelines yourself, did you feel that they were on target, or did you feel they were biased?
Dr. Kassirer: Since I am not an expert in that particular area of research, I can’t adequately judge them, although I know that cholesterol experts who were not on the panel questioned the validity of the guidelines.
TCR: And since practice guidelines are so complicated and refer to so many studies, unless you are an expert and up on reading the research on a daily basis, it could be very difficult to understand whether guidelines are biased.
Dr. Kassirer: Precisely.
TCR: But what about the issue of being sponsored by multiple companies, as many of the statin experts were. Do you feel that this at least “balances out” the bias of a presentation?
Dr. Kassirer: I’ve heard that theory, and I really don’t believe it. Let’s face it, if you have five uncles and one of them gives you a little more money than the other, you are going to like that uncle a little bit more!
TCR: Were there any examples particular to psychiatry that you describe in your book?
Dr. Kassirer: One of the more blatant examples was related to a supplement published by the Journal of Clinical Psychiatry. (ed. note: J Clin Psychiatry 2003; 64; suppl 14). The entire issue was paid for by Cephalon, the makers of Provigil (modafinil), and all eight of the authors were paid consultants or were getting honoraria from Cephalon. If you looked closely at the articles, it appeared to me that each one of them was an advertisement for Provigil, even for uses that were not FDA-approved, although each article contained a disclaimer that Provigil was not approved for those conditions. It struck me as a shameful marketing tool.
TCR: Well, a lot of doctors will say, “Look, companies want to make money. This is clearly marketing. When I go to a CME presentation and I see it is sponsored by Pfizer, I know it is going to be tilted a little bit towards Geodon or towards Zoloft or whatever, but you know, give me a break, I am a grown-up. I am not going to be influenced by them and I am not going to actually change my prescribing patterns because of a talk that I already know is being sponsored.”
Dr. Kassirer: My rejoinder is that you hear this primarily from people who want to continue the status quo. The fact is that industry spends $20 billion on marketing and $16 billion of that is directed at doctors. They wouldn’t be spending $16 billion on marketing to doctors unless they knew that they were influencing their prescribing habits. And on top of that there are an enormous number of psychological studies that show that people are influenced by even the smallest kinds of gifts. We see this at the large medical meetings, in which industry pays large sums to the organizers, and provides plenty of give-aways.
TCR: Psychiatrists know all about that from our APA annual meeting. But to play the devil’s advocate, some argue that professional organizations need to have pharmaceutical funding in order to make the meetings affordable.
Dr. Kassirer: Sure, there is no question about that. Without industry involvement, the meetings would never be quite as lavish. You wouldn’t have a kiosk for free email, you wouldn’t have free phones, free food, free coffee. On the other hand, you might have a meeting that is more intellectual, more scientific, more tuned to the real practice of medicine than to this commercialism.
TCR: So what are some solutions to the conflict of interest problem in medicine?
Dr. Kassirer: In the last chapter of the book, I recommend pretty stringent guidelines. There should be no gifts of food, or trips, or anything else from industry. We should prohibit physicians from serving on speakers’ bureaus of companies that produce drugs or devices used in clinical care. There should be no company-sponsored “symposia” at professional meetings. Editors of journals should be working hard to find people to write articles who are knowledgeable about drugs and do not have financial relationships with industry. While financial disclosure is a start for journal articles, I believe disclosures must include the amounts of money physicians receive for their services and must name the specific products that might come under question because of the financial ties. We should do these things because the nobility of our profession is under siege by industry, and we need to do something to rescue it.