We first met Shawn Collins, chair of the Collins Law Firm, Naperville, Ill., when he represented the North American Spine Society, one of the four societies named as defendants in the pedicle screw litigation.
In the landmark case--the first mass tort suit to hit CME--the societies were accused of putting on sales events under the guise of CME seminars. Three years and $10 million later, the societies were exonerated--but, as Collins warns, the court's ruling that speech at seminars may well be commercial rather than academic speech, and thus not entitled to full First Amendment protection, still stands, and societies are still vulnerable to lawsuits. A passionate advocate for CME, Collins spoke with us because he is now seeing more danger signs in the CME world.
Q: You have expressed great concern about the growing tide of ethics violations in the CME community. What is driving this trend?
A: There is a party going on. This is a very exciting time in America, with lots of medical developments. There is a rush to bring products to market to benefit people--which is all very good, but when the amounts of money to be made are as huge as they are, it creates incentives to move the process along as fast as possible. I get concerned when I read and hear about reactions to the Washington Legal Foundation decision; for example, when people make statements like "This is the elimination of the final barrier to promotion." No, it's not. (See news story, page 18.)
The law on the books from the pedicle screw case is still there. It still says that if you engage in false and misleading speech even a not-for-profit CME provider can be held liable in a court of law. That law has not changed and we all have to live with it. When you take that law and combine it with an environment where there is so much money to be made, and where the perception is that the regulations are being significantly relaxed--you've got a recipe for danger.
Q: You have mentioned physicians' ethical violations as another land mine in the current environment. Would you elaborate?
A: One of the things that especially concerns me is the January 19th JAMA [Journal of the American Medical Association] article--it's explosive. (See news story, page 18.) It synthesizes 29 studies that explored whether there is a connection between gifts to physicians and prescribing practices. The bottom line is that the article determines yes, there is. One of the consequences of these apparently cozy relationships is that patients are now paying more for nongeneric drugs. That's what lawsuits are made of. The land mines are strewn all over the field here.
It's just a matter of time until somebody steps on one, unless industry starts to take care of itself, and it may be too late for that. You can wait for the almost inevitable class action lawsuits or the almost inevitable regulatory and perhaps congressional scrutiny, or you can begin to clean your own house. Unfortunately, in many instances, it takes an atom bomb to change behavior--namely, a huge lawsuit or a congressional hearing.
Q: What do you think organizations, such as the American Medical Association, should do to address this problem?
A: First of all, the AMA and other prominent medical organizations have to acknowledge the seriousness of the problem. Apart from the important fact that some of this is clearly unethical, it is now evidently affecting the lives of patients. That's what's unacceptable. The ethical constraints that are currently on the books need to be enforced. If they are not sufficient--and they may not be--then new ones should be created.
Q: CME providers are in a difficult situation. Increasingly, when supporting CME, industry wants proof of--which includes increased script writing.
A: There's a real tension there. I can understand why manufacturers need to think in terms of ROI. I can understand why a CME provider wants to keep the focus on education. I don't see how you can easily reconcile those two things. I see CME providers as a bulwark against the too rapid movement of those who would profit in this area. CME providers occupy a very delicate position, one that is easily abused if we are not careful. A lot of people put their faith and trust in the integrity of CME events. We cannot allow them to be turned into promotional events.