I have been doing some speaking on behalf of several pharmaceutical companies in the course of the launch of their new products. I found this article compelling, it made me assess my own behavior during these talks. It can’t be denied that there is some pressure to put the best light on the sponsor’s drug, but the pressure varies. Fortunately for me, I feel I’ve been honest in my interaction with my audience, and have never gotten any sort of flak from the sponsor, except for one company, which is well known for its aggressive marketing. I subsequently quit speaking for that company and refuse to do any more talks for them.
By DANIEL CARLAT
Daniel Carlat is an assistant clinical professor of psychiatry at Tufts University School of Medicine and the publisher of The Carlat Psychiatry Report.
Published: November 25, 2007, The New York Times
I. Faculty Development
On a blustery fall New England day in 2001, a friendly representative from Wyeth Pharmaceuticals came into my office in Newburyport, Mass., and made me an offer I found hard to refuse. He asked me if I’d like to give talks to other doctors about using Effexor XR for treating depression. He told me that I would go around to doctors’ offices during lunchtime and talk about some of the features of Effexor. It would be pretty easy. Wyeth would provide a set of slides and even pay for me to attend a speaker’s training session, and he quickly floated some numbers. I would be paid $500 for one-hour “Lunch and Learn” talks at local doctors’ offices, or $750 if I had to drive an hour. I would be flown to New York for a “faculty-development program,” where I would be pampered in a Midtown hotel for two nights and would be paid an additional “honorarium.”
I thought about his proposition. I had a busy private practice in psychiatry, specializing in psychopharmacology. I was quite familiar with Effexor, since I had read recent studies showing that it might be slightly more effective than S.S.R.I.’s, the most commonly prescribed antidepressants: the Prozacs, Paxils and Zolofts of the world. S.S.R.I. stands for selective serotonin reuptake inhibitor, referring to the fact that these drugs increase levels of the neurotransmitter serotonin, a chemical in the brain involved in regulating moods. Effexor, on the other hand, was being marketed as a dual reuptake inhibitor, meaning that it increases both serotonin and norepinephrine, another neurotransmitter. The theory promoted by Wyeth was that two neurotransmitters are better than one, and that Effexor was more powerful and effective than S.S.R.I.’s.
I had already prescribed Effexor to several patients, and it seemed to work as well as the S.S.R.I.’s. If I gave talks to primary-care doctors about Effexor, I reasoned, I would be doing nothing unethical. It was a perfectly effective treatment option, with some data to suggest advantages over its competitors. The Wyeth rep was simply suggesting that I discuss some of the data with other doctors. Sure, Wyeth would benefit, but so would other doctors, who would become more educated about a good medication.
A few weeks later, my wife and I walked through the luxurious lobby of the Millennium Hotel in Midtown Manhattan. At the reception desk, when I gave my name, the attendant keyed it into the computer and said, with a dazzling smile: “Hello, Dr. Carlat, I see that you are with the Wyeth conference. Here are your materials.”
She handed me a folder containing the schedule of talks, an invitation to various dinners and receptions and two tickets to a Broadway musical. “Enjoy your stay, doctor.” I had no doubt that I would, though I felt a gnawing at the edge of my conscience. This seemed like a lot of money to lavish on me just so that I could provide some education to primary-care doctors in a small town north of Boston.
The next morning, the conference began. There were a hundred or so other psychiatrists from different parts of the U.S. I recognized a couple of the attendees, including an acquaintance I hadn’t seen in a while. I’d heard that he moved to another state and was making a bundle of money, but nobody seemed to know exactly how.
I joined him at his table and asked him what he had been up to. He said he had a busy private practice and had given a lot of talks for Warner-Lambert, a company that had since been acquired by Pfizer. His talks were on Neurontin, a drug that was approved for epilepsy but that my friend had found helpful for bipolar disorder in his practice. (In 2004, Warner-Lambert pleaded guilty to illegally marketing Neurontin for unapproved uses. It is illegal for companies to pay doctors to promote so-called off-label uses.)
I knew about Neurontin and had prescribed it occasionally for bipolar disorder in my practice, though I had never found it very helpful. A recent study found that it worked no better than a placebo for this condition. I asked him if he really thought Neurontin worked for bipolar, and he said that he felt it was “great for some patients” and that he used it “all the time.” Given my clinical experiences with the drug, I wondered whether his positive opinion had been influenced by the money he was paid to give talks.
But I put those questions aside as we gulped down our coffees and took seats in a large lecture room. On the agenda were talks from some of the most esteemed academics in the field, authors of hundreds of articles in the major psychiatric journals. They included Michael Thase, of the University of Pittsburgh and the researcher who single-handedly put Effexor on the map with a meta-analysis, and Norman Sussman, a professor of psychiatry at New York University, who was master of ceremonies.
Thase strode to the lectern first in order to describe his groundbreaking work synthesizing data from more than 2,000 patients who had been enrolled in studies comparing Effexor with S.S.R.I.’s. At this time, with his Effexor study a topic of conversation in the mental-health world, Thase was one of the most well known and well respected psychiatrists in the United States. He cut a captivating figure onstage: tall and slim, dynamic, incredibly articulate and a master of the research craft.
He began by reviewing the results of the meta-analysis that had the psychiatric world abuzz. After carefully pooling and processing data from eight separate clinical trials, Thase published a truly significant finding: Effexor caused a 45 percent remission rate in patients in contrast to the S.S.R.I. rate of 35 percent and the placebo rate of 25 percent. It was the first time one antidepressant was shown to be more effective than any other. Previously, psychiatrists chose antidepressants based on a combination of guesswork, gut feeling and tailoring a drug’s side effects to a patient’s symptom profile. If Effexor was truly more effective than S.S.R.I.’s, it would amount to a revolution in psychiatric practice and a potential windfall for Wyeth.
One impressive aspect of Thase’s presentation was that he was not content to rest on his laurels; rather he raised a series of potential criticisms of his results and then rebutted them convincingly. For example, skeptics had pointed out that Thase was a paid consultant to Wyeth and that both of his co-authors were employees of the company. Thase responded that he had requested and had received all of the company’s data and had not cherry-picked from those studies most favorable for Effexor. This was a significant point, because companies sometimes withhold negative data from publication in medical journals. For example, in 2004, GlaxoSmithKline was sued by Eliot Spitzer, who was then the New York attorney general, for suppressing data hinting that Paxil causes suicidal thoughts in children. The company settled the case and agreed to make clinical-trial results public.
Story continued at NY Times.com