Nemeroff’s Effexor Love-Fest: It’s CME-Like!

According to the Wall Street Journal Health Blog, in 2000 Dr. Charles Nemeroff organized a Wyeth-funded supplement of a journal which he also edits, Depression and Anxiety, paying himself and 13 other academics $3000 each. This money was disbursed from an “unrestricted educational grant” given to Emory by Wyeth. The fact that the supplement was paid for by Wyeth was, unfortunately, not disclosed to the readers.

Also from the Wall Street Journal, we learn here that Emory’s defense of Nemeroff’s undisclosed hundreds of thousands from GSK is that some of the payments were not for promotional talks, but for “CME-like” talks.

Nobody seems to have an inkling what "CME-like" means. But after reading through Nemeroff's Effexor Love-fest supplement, I'm getting an idea.

Here is how Dr. Nemeroff introduces the supplement:

“There is little doubt that the introduction of venlafaxine has had a remarkable impact on clinical practice. I have had more than 25 patients who have failed multiple trials with virtually all of the antidepressants available who have responded to venlafaxine often with complete remission.”

And here are some random phrases culled from the abstracts of the 13 other CME-like articles, done up in Wyeth's green and purple Effexor color scheme:

Venlafaxine is a unique antidepressant medication with well documented efficacy and safety in the acute treatment of major depressive disorder

easy to monitor and dose

may also be effective in the treatment of dysthymic disorder and bipolar II depression

facilitate successful treatment of patients.

low potential for drug interactions

appropriate first-line medication for GAD

may be particularly effective for the severely ill

good tolerability

may be effective for conditions such as stroke, anxiety, and neuropathic pain

may be useful in children and adolescents with a variety of psychiatric disorders

effective in reducing anxiety in patients with depression

efficacy...in several other conditions including panic disorder, social anxiety disorder, obsessive compulsive disorder, trichotillomania, ADHD, chronic pain, and fibromyalgia

an attractive choice for geriatric patients

So here is a working definition of CME-like:

--Too academic-sounding to be an advertisement

--Too commercially biased to be CME

--Ergo...it's CME-like!

Psychiatrist Recounts a Wyeth Snow Job

In 2004, Dr. Steven Reidbord, who was at that time the medical director of the mental health clinic at California Pacific Medical Center, had a Wyeth coming-of-age experience (read about my own adventures here). As he details in his interesting new blog, Dr. Reidbord was approached by his own hospital's Community Health Resource Center to give a talk to the public about depression. This was part of an event called "GOAL" (Go on and Live!), and would feature Delta Burke, an actress best known for a role on the TV show "Designing Women."

Dr. Reidbord, assuming that this was a community initiative and not a drug company-sponsored event, initially agreed to give the talk, but when he received the flyer advertising the program, he noticed a phrase that sounded suspiciously Wyeth-crafted: "... it is possible to virtually eliminate the emotional and physical symptoms of depression and go on and live." Recall that the Effexor XR campaign emphasized remission as the goal of treatment, because their studies found that the drug slightly outperformed SSRIs only when remission was used as the outcome statistic.

Dr. Reidbord investigated the event further, and found that it had been organized by a public relations firm, Porter Novelli, and that the website created to promote the event was copyrighted (surpise, surprise) by Wyeth.

I won't steal anymore of Dr. Reidbord's thunder, but I will give you the sneak preview that this story also involves that Zelig of industry-funded research, Charles Nemeroff.

Congratulations on a great new blog, Dr. Reidbord, and welcome to the Wyeth Refugee Club!

Spinning and Spinning for Cymbalta

I was browsing the January issue of the Journal of Clinical Psychiatry in order to get ideas for the "Research Updates" section of The Carlat Psychiatry Report, and I happened upon two articles, one for those intrepid counter-detailers out there, and the other for Lilly drug reps.

The first one, "Time to Rehospitalization in Patients with Major Depressive Disorder Taking Venlafaxine or Fluoxetine," is an article important for evaluating the long term usefulness of Effexor, but one which, I can guarantee you, will not show up in the hands of your Effexor rep. In this study, depressed patients in a Taiwan psychiatric hospital were discharged with instructions to continue either Effexor or Prozac, depending on which medicine made them better in the hospital. The two groups were compared to see whether Effexor would better protect patients from rehospitalization than Prozac. The results? About 45% of patients in both group were eventually reshospitalized. For patients on Effexor, the average time to rehospitalization ("survival time") was 223 days, and for patients on Prozac, it was 222 days. What does this prove? Not much, since patients were not randomly assigned to treatments. However, it's certainly no endorsement of Effexor's vaunted superiority over SSRIs. As the authors (who have no pharma relationships) state: "Our findings do not support the notion that venlafaxine, a dual reuptake inhibitor, is associated with less relapse/tachyphylaxis."

The next article, on the other hand, will be parlayed into a "teaching point" by your Eli Lilly rep, although there's precious little to teach. Entitled "Switching to Duloxetine from Selective Serotonin Reuptake Inhibitor Antidepressants: A Multicenter Trial Comparing 2 Switching Techniques," this Lilly-funded study identified 368 depressed patients who had not responded to at least 6 weeks of SSRI treatment. These patients were then randomly assigned to either abruptly switching to Cymbalta, or gradually switching to Cymbalta. They were then maintained on Cymbalta for 10 more weeks to see if they would respond. Before we get to the results, think carefully about the design of this study, and what questions one might reasonably be able to answer, or to not answer.

This was not a double-blind study: in fact, both patients and doctors knew that the participants were being switched to Cymbalta. Furthermore, there was neither a placebo arm, nor an SSRI continuation arm. This is crucial, because patients who don't respond to a medication after 6 weeks may well respond if continued on the same medication for an additional 10 weeks. Thus, if these patients improve after a switch to Cymbalta, we have no idea how to interpret this. It might mean that Cymbalta is better. But it might also mean that the 10 extra weeks of being in treatment worked its nonspecific placebo-related magic. After all, with enough time, many people become less depressed, no matter what treatment they receive. Thus, the design of the study allows no meaningful evaluation of Cymbalta's effectiveness. The only potentially useful information here relates to the technical issue of how to conduct a switch from an SSRI to Cymbalta. As it turns out, an abrupt switch works fine and is well-tolerated. And that's all you can conclude from the study.

However, if you read only the abstract (which is as far as most readers will venture) you'll get the uncanny sensation of having been teleported to Eli Lilly's website:

"Conclusion: Switch to duloxetine was associated with significant improvements in both emotional and painful physical symptoms of depression and was well tolerated and safe, regardless of which of the switch methods was used."

If it reads like copy written by a Lilly employee, it's because it was: Dr. Perahia, the first author, works for Lilly in England. One might have hoped that the editors of the Journal of Clinical Psychiatry would have caught this bit of blatant promotionalism before it went to press. Because of this awful oversight, now Lilly will likely end up paying the journal thousands of dollars to purchase article reprints for its drug reps--someone's head will roll!

"Return the 30K, You Cheap Thief"

Or so opines one of the commenters on the WSJ Health Blog, where you will find many angry folks calling me a "hypocrite," a "pathetic liar," etc....

I'd be curious to hear opinions about: A. Whether I should return the dirty money; and B. Where it should go if I can bear to part with it?

Other comments that I've received about Dr. Drug Rep:

--"Don't blame Wyeth, blame yourself. Nobody was holding a gun to your head--you chose to take the money." Can't argue with this. The article was, in fact, a long confessional about a series of unethical choices I made every step of the way. I don't blame Wyeth, nor do I blame the pharmaceutical industry in general. I blame the doctors who allow themselves to be complicit and corrupted by the allure of money. And yes, I was there with the worst of them!

--At his excellent blog, Hooked, Howard Brody raises the interesting possibility that Wyeth paid me the 30K as a bribe to get me to prescribe more Effexor in my practice. I'm sure that was one of the motivations, and I received letters from some drug reps indicating that this is standard operating procedure in the industry.

--I've received many letters from people who either are taking Effexor now or had difficulties coming off the drug in the past. While my article may have seemed an indictment of Effexor, it was not meant that way. Effexor is a very effective antidepressant, and I continue to prescribe it in my practice, usually as a second-tier agent. But the hypertension and drug withdrawal risks are real. For a very interesting article profiling one man's struggle with Effexor withdrawal, see Bruce Stutz's article, "Self Nonmedication," also published in the New York Times Magazine.

--Many physicians wrote their own mini-confessionals about giving drug talks. One doctor, also a reformed Effexor speaker, described a teleconference in which Norm Sussman minimized withdrawal problems with Effexor. In response, the doctor had an "ethical lapse" and couldn't help mentioning to the audience that Lexapro might be an easier drug for primary care doctors to prescribe, much to Sussman's annoyance. The writer eventually quit speaking for Wyeth.

--I've also received some shocking marketing stories from drug reps and former drug reps, some of which I'll be sharing in the future as I get permission to do so from the parties involved.