The news release suggests that this is a well-intentioned attempt to address conflicts of interest in medical specialty societies, with a special focus on their role in writing clinical practice guidelines. The Preamble states: "Members and patients count on Societies to be authoritative, independent voices in the world of science and medicine. Public confidence in our objectivity is critical... We know the public relies on is to minimize actual and perceived conflicts of interest. ... [E]very society must be sure its interactions with Companies meet high ethical standards."
I read through the complete Code to try to form an opinion as to how much teeth the Code actually possesses. Based on the most recent flap regarding my own medical specialty society to come to my attention--the AAFP-Coca-Cola deal-- I paid special attention to whether that deal would have been prohibited by this Code. (AAFP is one of the members of CMSS). (For the most recent post here on AAFP, see http://brodyhooked.blogspot.com/2009/12/aafp-coca-cola-deal-letter-to-member.html.) As everyone with whom I have consulted, except for the AAFP leadership, seems to believe that the Coke deal was a clear no-no and a serious conflict of interest, I figured it was a reasonable test case.
As best as I can read the Code, AAFP would have a green light on Coca-Cola. There seems no doubt that the general spirit of this Code runs contrary to the AAFP-Coke deal. But at each critical juncture, the Code seems to leave enough wiggle room for the deal to be justified. For example, so long as AAFP claims to have done all the following:
- decide that writing educational materials for consumers on healthy eating is part of its mission
- decide to include guidance on beverages and soft drinks, independent of the Coke deal
- reveal funding from Coca-Cola
- assure everyone that the content of the materials will not be determined or dictated by Coca-Cola
- Have an internal set of conflict-of-interest policies which it follows in dealing with Coca-Cola
A good deal of space is devoted (appropriately) to CME programs. Here I would criticize the Code for being too quick to rely on having funding from multiple firms to make sure everything is above-board. As we have discussed numerous times, getting funding from many drug companies does not eliminate bias in CME; rather, it tends to assure that all the presentations at the CME program will be about drug therapy, with nothing said about exercise, diet, etc. The Code does call for presenters at CME "to give a balanced view of therapeutic options."
We next come to the critical section on practice guidelines-- critical because it has been generally held by guideline critics that of all practice guidelines, those published by medical specialty societies are most likely to be riddled with commercial biases and conflicts. Here I was hoping for a strong statement that guideline panels would be made up of individuals without conflicts of interest, period. The Code instead insists on disclosing conflicts and requires then only that a majority of panelists are free from conflicts of interest relevant to the subject matter of the guidelines. There also seems to be a major loophole in that commercial firms cannot fund guideline development; but they can give funds to a society for later distribution and "repurposing" (whatever that is). To me this suggests a likely route for a sweetheart deal. A firm might let it be known that if a society comes up with a practice guideline that strongly endorses a treatment strategy using a drug that the firm sells, it will later on be willing to pay millions of bucks for "further distribution" of those guidelines. The society might well decide it's worth it to front its own funds to write the guideline, knowing that the firm's later largesse will effectively reimburse it for all expenses and then some. Finally the Code states, "Societies will recommend that Guideline development panel members decline offers from affected Companies to speak about the Guidelines on behalf of the Company for a reasonable period after publication" (emphasis added). Why be mealy mouthed about it? Why not just say flat out that if you agree to serve on a guideline panel, you also agree not to also serve on a company speaker's bureau for X number of years--period?
CMSS proposes to post a list on its website of Societies that sign onto this Code (including societies that are not CMSS members). Societies will be encouraged to certify annually to CMSS that they continue to adhere to the Code." Again-- why not demand annual cerification as a condition of being listed?
Great first draft, guys. When you next revise it, stiffen it up a bit. The Code emphasizes that individual Societies are welcome to adopt stricter provisions than what is in this Code--and I hope they do so.
Note added 4/24: Our esteemed colleage Dr. Danny Carlat had a very amusing and rather more cynical take on this Code-- see his post: http://carlatpsychiatry.blogspot.com/2010/04/medical-societies-new-ethics-code.html
In short he depicts the Code as pure PR fluff with no substance at all.