In writing yesterday about the most recent investigative reporting from ProPublica, I missed a sidebar story:
This story describes the steps drug companies are taking to restrict what physicians who are part of their paid speakers' bureaus say during their talks. According to the companies, these speakers ("shills" is the term that seems more to get to the heart of the matter) are now told not only that they must use exactly and nothing but the slides that the company provides, but that they must even show the slides in the same order as specified by the company. With the company pulling all the strings, one wonders why they even need the physicians to give the talk at all; any robot apparently could do it.
The ProPublica reporters (Charles Ornstein and Tracy Weber) note that this puts the company policies on a collision course with the typical conflict of interest policies enacted by academic medical centers. While some of these policies simply ban speakers' bureau participation, others try to find a middle ground by saying that speaking is OK so long as the speaker retains some control of the content of the lecture--exactly what it seems the company wants to avoid.
There's no mystery as to why all this concern--of the huge settlements recently paid out by Pharma firms in federal cases, the biggest single category has been off-label marketing. Any hint from a paid physician-speaker that a drug might be used for something that is not on the officially approved label, and the company could be looking at a huge federal legal liability.
The degree to which companies are now exercising this control seems to put a lie to most of the rationalizations that my academic colleagues trot forth when asked about their accepting speakers' fees. "The slides may say one thing, but I can say whatever I want to" and "They send me the slides, but I always throw in a few of my own slides" are common responses I've heard in the past.
On the other hand, just who can be believed? A key comment in the ProPublica story is from Julie Gottlieb, an associate dean at Johns Hopkins: “Many companies may overstate the extent of their involvement in such activities to avoid the potential of running afoul of FDA regulations.” After all, it is not exactly as if the industry has set the highest bar in the world for believability... So maybe the docs who claim to exert control over their own presentations are not spinning us a tale. That, on the other hand, hardly justifies their taking drug company cash and shilling for them. It also suggests that those medical centers that have a policy of "it's OK to be a paid speaker so long as you retain some control of the content" might best consider scrapping that part of the policy, realizing that it's simply an unrealistic fig leaf in light of company goals.