Tuesday, September 29, 2009

The Ethics of Speakers Bureaus under the Spotlight

Eli Lilly's publication of a registry revealing all payments to doctors has opened up an overdue conversation. Is it ethical for a doctor to become a member of a drug company speaker's bureau? Or is it inherently deceptive for a doctor to pose as being an independent source of information while at the same time being under contract to speak for specific drugs?

In today's Boston Globe, Liz Kowalczyk does some investigative reporting based on information gleaned from the Lilly Registry. She found that two physicians at Boston Medical Center (BMC), neurologist Brian McGeeney, and endocrinologist Elliot Sternthal, were each paid thousands of dollars by Lilly during the first three months of 2009 to give education talks to other physicians. But according to Kowalczyk, for the past two years BMC has officially barred doctors from giving industry-sponsored talks unless the “lecture’s content, including slides and written materials, are determined by the clinician.’’


In fact, drug companies never allow doctors to determine their own content for promotional talks. As I described in a prior post, for example, Schering Plough's contract (view it
here) for its asenapine speaker's bureau was explict in this regard: "You will used only the Schering approved materials for all presentations performed under this Agreement." While I have not seen Eli Lilly's speakers' contracts, on their website they describe their "healthcare professional education" in the following way: "The information presented in these programs is provided by Lilly alone, is closely regulated, and must conform to U.S. Food and Drug Administration (FDA) requirements."

I think this is pretty clear. The content is produced by Lilly, and not by the doctor giving the talk.

Given all this, it sounds very much like Drs.
McGeeney and Sternthal did, indeed, break their employer's rules regarding allowable industry activities. Unfortunately, rather than admitting this, they defended themselves in e-mails to Kowalczyk in the most unconvincing terms:

Sternthal said he determines “the structure of the presentation by my choice of disease state and clinical trial slides, order of presentation and emphasis of teaching points. This is in compliance with BU/BMC policy.’’

Whaaaat? We know what disease state Dr. Sternthal chooses for his talks--it is diabetes, for which Lilly markets a plethora of products, including Byetta. We also know what "clinical trial slides" he chooses--those slides showing research conducted by Lilly to show that its diabetes products are effective. The fact that he chooses the order of his Lilly-boosting slides hardly constitutes compliance with BMC's policy that the "lecture’s content, including slides and written materials, are determined by the clinician.’’ Sternthal might argue that he follows the letter of the rules because he, in fact, determines which among a menu of Lilly slides he uses in his presentation. But this is a hollow argument, because he didn't write the menu.

Here's an analogy. If my son comes home and says that for lunch he ate a cheeseburger and french fries, I might express my dispeasure and ask him to make healthier choices in the future. "But there was nothing else on the menu," he might respond. "Where did you go for lunch?" "McDonalds!" If you choose to go to McDonald's for lunch, your "choice" of food is severely limited. Similarly, if Dr. Sternthal chooses to go to Lilly for his medical information, every slide on the menu will be Lilly-friendly, meaning that his defense that he "chooses" what to teach is meaningless. His only choice was to become a promotional speaker, and he checked his academic independence at the door.

This behavior is inherently unethical, because it demeans the reputation of all doctors. How can patients have faith that doctors are making independent medical decisions when they hear about the Dr. Sternthal's and Dr. McGeeney's of the world defending themselves in such ways? Such doctors are gradually undermining the public's trust in all physicians.

5 comments:

Bernard Carroll said...

Even the claim that he determined the order of the slides rings hollow. Like you, Danny, I used to give talks for Wyeth. I stopped when they gave me a tamper-proof CD ROM containing 6 canned lectures. They insisted that I use only their slides, that I not omit any of their slides, and that I not insert any of my own material. I imagine the other corporations do the same.

Miranda said...

I'd like to see a day when psychiatrists and other MD's must divulge their industry funding to their PATIENTS upon first appointment. Caveat emptor.

Ronald Pies MD said...

Good points, Danny...this really seems like a slam-dunk, doesn't it? Any physician giving a professional lecture should be the person who decides the nature, scope, and content of the talk, including, of course, the particular studies presented.
By the way, Psychiatric Times has developed a revised set of guidelines that tightens our control and editorial review of supplements that are sometimes enclosed with the print issue. We will be posting these soon on our website. The new guidelines are not perfect or "fail-safe", but I believe they represent a real
advance in our commitment to objective and balanced information. ---Best regards, Ron Pies MD

[Dr. Pies is Editor-in-Chief of Psychiatric Times].

Larry Husten said...

I actually disagree with you on this issue-- not that I'm a big fan of speakers bureaus! I think another, equally important reason the companies control the content is to avoid the problem of speakers indulging in off label talk, thereby getting them in all sorts of potential trouble down the road. I actually had an interesting talk about this with a well known supporter of CME. He's absolutely furious about this restriction, though of course not furious enough to turn down speaking engagements.

Again, I hardly want to defend speakers bureaus, but I do think the issue is a bit more nuanced in this case. In order to preserve this important sphere the companies are willing to accept many significant limitations and restrictions on the content, as long as it doesn't prevent them from carefully choosing and influencing the subjects, venues, speakers, etc.

BTW, there are actually a few healthy choices these days at Mickey Ds. Not that I'm defending them either!

Larry Husten
cardiobrief.org

Daniel Carlat, M.D. said...

Larry,

I'm not clear on how we disagree. We both see speakers bureaus as marketing tools for companies. New regulations from academic medical centers are efforts to strongly discourage, if not ban, academics from serving on these bureaus. Language such as BMC's is too vague and allows too much wiggle room for doctors to skirt the intent of these regulations. I believe that even in the old days (ie., 2002 when I gave talks for Wyeth) when companies did not explicitly require speakers to use only their slides, there was plenty of pressure exerted to make sure speakers were "on message." The rules from medical schools should be crystal clear: faculty should not participate on speakers bureaus, period.

BTW--I agree with you on McD's, just trying to make a point!