Speakers' Bureaus Unethical? Ask the Boston Globe

Further evidence that sunshine is a good cleansing agent comes from this editorial in the Boston Globe: http://www.boston.com/bostonglobe/editorial_opinion/editorials/articles/2009/10/01/keep_doctors_independent_ban_fees_from_drug_makers/

The editorial referred to the previous Globe news article--
http://www.boston.com/news/health/articles/2009/09/29/60_doctors_took_speaker_fees_from_drug_giant/?page=full
--in which Liz Kowalczyk reported, "At least 60 Massachusetts doctors collectively have earned more than a half-million dollars this year as speakers paid by pharmaceutical giant Eli Lilly & Co. - including two Boston Medical Center physicians whose participation is being reviewed for possible violation of a hospital policy against marketing activities by its doctors." She further explained that Lilly is out ahead of other drug companies in releasing these data, but that as of next July, all drug companies will be required to reveal this information under the new sunshine law in effect in Massachusetts.

Boston Medical Center has a policy that their faculty physicians should give talks only if they determine the content. Kowalczyk added, "In e-mailed statements, the doctors defended their talks. [Dr. Elliot] 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.’"

Dr. Sternthal's insistence that he's a good guy because even though he receives his slides and talking points from the drug firm, he decides all by himself how to tweak the talk, reminded me of a sad spectacle at my own medical center a few years ago. We held a panel on the ethics of taking stuff from the drug companies, and the majority of the panelists spoke in favor of a laissez-faire relationship with industry. (That was before our medical school adopted a strict policy banning most gifts.) Several of the panelists admitted to being on speakers' bureaus and "tweaking" talks much the way Dr. Sternthal claimed. "Yes, I use their slides," said one, "but I always throw in some of my own observations."

Unfortunately I was slow out of the starting block at that panel, or else I could have asked the panelists who were preening themselves on their editorial independence if they had talked with their lawyers about possible Federal prosecution.

That's what happened to a Maryland psychiatrist, Dr. Peter Gleason, back in 2006, as reported by the New York Time's Alex Berenson and reprinted at: http://www.ahrp.org/cms/index2.php?option=com_content&do_pdf=1&id=299

Dr. Gleason took money for speaking for Jazz Pharmaceuticals and adding his own medical opinions to the scripted talks he was provided. Like my colleagues on the panel, he assumed that was what scientifically trained physicians are supposed to do--supplement any canned talk with their own clinical observations and knowledge. Unfortunately some of his so-called "knowledge" included using the drug for off label purposes.

The drug company is legally prohibited from marketing a drug for off label use. Dr. Gleason figured that as he was a physician, and could legally prescribe the drug for anything he wanted, he could also talk about off label uses.

Not so, said the federal agents in suits who surrounded and handcuffed him at a train station. So far as they were concerned, he took the drug company's money, and so he was a drug company employee. Jazz Pharmaceuticals pointed out to him that they gave him a script to follow, and he refused to follow the script, so as far as his legal hassle was concerned, he was on his own.

The Gleason case puts the dilemma of the speakers-bureau physician neatly in a nutshell. If you exactly follow the script, you're clearly nothing but a shill for the company, and ought not to be able to hold your head up in polite medical society. If you insist on giving your own spiel, and don't follow the script--but take the company money anyway--the Feds may be after you with handcuffs.

And so, concluded the Globe editorial very reasonably, "When doctors promote drugs in exchange for pay from pharmaceutical companies, they cease to be independent evaluators of the risks posed by those drugs, and they cease to be unbiased caregivers for their patients. Hospitals should prohibit doctors from taking part in so-called speakers bureaus, whereby companies compensate them for giving talks to colleagues about new drugs. Legislators should go beyond requiring disclosure of the relationships, and ban the practice."

My only question is why we doctors should have to have hospitals and legislators tell us what's ethical.