Saturday, October 3, 2009

Speakers' Bureaus Unethical? Ask the Boston Globe

Further evidence that sunshine is a good cleansing agent comes from this editorial in the Boston Globe:

The editorial referred to the previous Globe news article--
--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:

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.


Medical Spa Position said...

I think that there is too much involvement by others in the work of many doctors. The pharmaceutical companies have too much say and not enough restrictions. They should not be worried about the ethics of the doctor, they need to worry about the ethics of the pharmaceutical companies. My question is for them. If the only ingredient in rat poison is Sodium Fluoride (and we all know Hitler used in concentration camps), then why is it being used in different anti-depressants?

Marilyn Mann said...

Thanks for this post. I also liked this one by Danny Carlat:

Howard Brody said...

Marilyn, many thanks for adding the link to Danny's blog; it was an oversight on my part to have omitted it (sorry, Danny!) best, Howard

JS said...

This assessment is simplistic, misleading and the situation presented at the end--doctors choosing to be a shill or criminal--is a blatant false dichotomy.
First, doctors working with pharma companies are often incorporated into the development of the slides and presentation content. After the development, they also review the content for accuracy from their research or experience.
Moreover, presentations on disease states are not about just one drug or treatment, and the bent is educational. This leaves much room for physicians to expand upon a presentation they helped prepare based on medical experiences, contingencies of situation, or in a comparison of treatment options--one of them being the sponsor's drug, to be sure--without talking about off-label indications.
Also, familiarity with the clinical profile and belief in the efficacy of the product are prerequisites for a company to work with a physician. Often the doctor was involved in the clinical development. So, why would he or she not speak on it?
Furthermore, most physicians in speaker bureaus are apprised of the ramifications of speaking off-label, which is not often immediate federal prosecution. Abuses have and will take place, indubitably, but there's a big difference between reform and reactionary overkill.