Monday, September 24, 2007

DeVane Mounts Defense of his CNS Spectrums Article

Lindsay DeVane, the Medical University of South Carolina professor who had described this article in CNS Spectrums as "commercial crap," is now defending said crap from its detractors.

Possibly responding to this
letter just published in Psychiatric News, in which Harvard psychiatrist Alan Stone advocates officially "shaming" unethical colleagues who participate in ghost-writing, Dr. DeVane sent me the following e-mail:

"Dear Dr. Carlat, I am writing to say there should be no doubt about the integrity of the CNS Spectrums publication as an i3 CME certified activity. In particular, my unflattering characterizations of the CNS Spectrums article reflect the inherent limitations in providing practicing clinicians with fundamental descriptions of complicated issues. The initial draft of the article that was eventually published was written directly from the transcripts of the live CME televised broadcast last December and was not ghost-written. All three co-authors were heavily involved in multiple edits before agreement was reached on a final manuscript. Although my opinion is that antidepressant drug-drug interactions of major clinical significance are rare events, we all know that interactions can occur and the need for such awareness was a theme in the broadcast and article. My Neuropsychopharmacology commentary allowed a more complete discussion of some scientific issues, but there should be no question about the integrity of the CNS Spectrums publication as a CME activity. Lindsay DeVane."

I can only assume that Dr. DeVane must have been severely pressured by multiple parties to change his tune. You can read his earlier, and very different take, on the article in my prior posting
here. At that time, Dr. DeVane called the first draft of the article a “ridicuous text… parts of it were inaccurate, simplistic, and [contained] over-generalizations.” The fact that he is now saying that this article was "written directly from transcripts of the live CME televised broadcast" is not exactly an endorsement of that Hawaiian event, which was funded by Bristol-Myers Squibb.

And although he is now saying that "all three co-authors were heavily involved in multiple edits before agreement was reached on a final manuscript," in his earlier letter, he stated,
"I haven't even read the CNS piece, but from what you say, I probably shouldn't as it's likely embarassing. Please ignore it for purposes of interpreting my researchand views."

By the way, the founder of CNS Spectrums, James LaRossa, who knows all the players involved in this scandal quite well (in fact, he now publishes a different journal with both Nemeroff and DeVane on the masthead), said of the CNS Spectrums piece,
"I am willing to bet dollars to doughnuts that Nemeroff never saw proofs of the article either."

As La Rossa commented further, "In truth, the CME business has become rotten to the core." I couldn't agree more.

Monday, September 17, 2007

Prescription Data Mining: A Transparent (-ly absurd) Defense by Verispan

The arguments in favor of that latest manipulative marketing technique, prescription data-mining, come in many different hues of speciousness. I recommend you visit this excellent page on the National Physician's Alliance website to learn more.

Today, however (on a tip from PharmaGossip), I read the most absurd argument in its defense yet, reported in yesterday's Philadelphia Inquirer. The reporter, Karl Stark, quoted Jody Fisher, Verispan's vice president of product management, as saying: "Doctors are trying to create a special right of privacy. I can certainly appreciate where they're coming from. But the way the world is going is toward increased transparency of information."

"Transparency of information"! What a wonderful Web 2.0 buzz phrase!

Here's what, Jody: Let's hold hands and use that argument together on the pharmaceutical companies who are refusing to reveal their payments to doctors. And while were at it, let's extend your cutting edge concept into other areas of commerce as well. For example, groceries stores can combine customer's credit card information with their bar-coded food item data to create a goldmine of "transparent" marketing information for Kraft and Proctor & Gamble. I can't wait for the smiling cereal reps to detail me. "Mr. Carlat, I was wondering if you would consider purchasing more Great Grains Selects? We have new head-to-head data comparing it to Smart Start...."

If you haven't heard about prescription data-mining yet, here's a short course. When I was a hired gun speaker for Wyeth back in 2002, drug reps would book me speaking gigs at primary care doctor's offices. My job was simple: say whatever I possibly could to get doctors to prescribe more Effexor XR.

Before each of these "Lunch 'n Learns," as they are called, the rep would fax me a little cheat sheet about the doctor we'd be visiting. This sheet spelled out exactly how many prescriptions for which antidepressants this doctor was writing. Doctors who wrote too much Celexa and Zoloft, and not enough Effexor, were crucial "targets," and I was implicitly encouraged to give these misguided doctors a particularly hard sell.

How did the reps get such detailed information? Since the 1990s, drug companies, pharmacy information companies (such as Verispan and IMS) and the AMA have been collaborating in packaging doctor's prescription information and using it to help companies more efficiently sell their drugs. Companies like Verispan buy prescription info from local pharmacies, then they purchase identifying data on all us doctors from the AMA (which makes over $40 million a year by leasing out its physician Masterfile), and finally they turn around and sell the whole package to the highest-bidding drug companies.

Most readers of this blog have probably already heard about this latest piece slime-marketing, but doesn't it make you slightly nauseous to contemplate it again? It does for me.

Well, the word about this practice has finally hit the media, and many doctors, particularly members of the vibrant new physician's organization, National Physician's Alliance , are outraged (I know, this is the second plug I've given them in this posting; here's the subliminal message: JOIN THEM INSTEAD OF THE AMA). So far, three states, New Hampshire, Maine, and Vermont, have passed legislation curtailing the practice. However, the well-funded pharmacy information companies are planning to sue each and every state that limits prescripion data-mining. They've already succeeded in persuading a New Hampshire judge to strike down the law.

Don't worry, people. The good guys are gonna win on this one--I guarantee it!

Tuesday, September 11, 2007

Publisher of Psychopharmacology Bulletin Weighs in on CME issues

James M. La Rossa Jr. built a medical publishing empire and knows a thing or two about industry-funded CME. He founded CNS Spectrums and Primary Psychiatry in 1997, and sold them to its current publisher in 2003. Aside from publishing the journals T.E.N. and Mental Fitness, he recently rescued the journal Psychopharmacology Bulletin from oblivion by buying it from NIMH, which wanted to get out of the medical journal business. He got out of the commercial CME business in 2001 because he couldn't stand what it was becoming.
I spoke with La Rossa, who had commented on a recent posting on unsavory CME manipulation.

Dr. Carlat: As publisher of various psychiatric journals, you could have made a ton of money publishing commercial CME articles. Why didn't you?

La Rossa: First of all, I am in media, which I love. I did not want to be in the CME business. Going from venue to venue to put on the exact same CME programs -what I refer to as the dog-and-pony show-had no attraction for me. I gave up a potential law career to be a journalist and publisher. The most important job of any publisher is to influence a field of interest, make your publications an indispensible part of that field, and, most importantly, play the game while keeping your third party credibility. Once you lose that independence, it is next to impossible to regain it.

Dr. Carlat: Do you think it’s possible for publishers take industry money for CME material in an ethical way?

La Rossa: I don’t think so. In my experience, the publisher inevitably becomes nothing more than an agent of the sponsoring pharmaceutical company. Rather than producing true medical education content, they are customizing intellectual material for pharmaceutical companies. While there is nothing inherently wrong with this, where it gets sticky is when the publication runs the customized project as a CME activity in the journal, which automatically implies that the project is sanctioned by the journal's editors, board of advisors, etc.

Dr. Carlat: The scale of the CME enterprise has certainly mushroomed over the past several years. Why?

La Rossa: Several reasons. First, of course, is that people began to see how much money there was to be made, and that has attracted many companies in itself. But another driver of this enormous CME problem can be traced back to about 5 years ago when the APA began to get very aggressive about retaining exclusive rights to any and all symposia. What they were doing was trying to prevent sponsors and/or outside CME companies from profiting off of these symposia. These companies responded by inviting the APA speakers to a hotel near the meeting, for example, to give the same talk. They changed the title, said it was in "conjunction with the APA meeting," or language like that. In other words, as the APA tightened controls to the dissemination of CME materials to psychiatrists, a CME free-for-all started as private content providers started coming out of the woodwork. It sounds like I am putting most of the blame at the APA's door, which is unfair. Universities-who view CME as a profit center-are getting in on the action as well. But I do think that the APA should stick to what they do best: Make excellent journals and books. Isn't that the very heart and soul of psychiatry?

Tuesday, September 4, 2007

Author Calls his own CNS Spectrums Article “Ridiculous, Inaccurate, Simplistic”

C. Lindsay DeVane, a Professor of Psychiatry and an author of an ACCME-accredited article published in the journal CNS Spectrums has termed his article a “piece of commercial crap,” and said he had not read the final version before it was published, according to an e-mail he sent to this writer (read his e-mail here).

DeVane, who is Professor of Psychiatry and Behavioral Sciences and Vice Chair for Research at the Medical University of South Carolina, is one of three authors listed for an “Expert Roundtable Supplement” published with the May 2007 issue of CNS Spectrums. The supplement was accredited and produced by i3 CME, a medical education company owned by Ingenix, and was funded by Bristol-Myers Squibb.

Responding in an e-mail to questions I had about the accuracy of the article (read this e-mail here), Dr. DeVane said that he had originally been approached by Dr. Charles Nemeroff to participate in a videotaped discussion to be held at a psychiatric meeting in Hawaii. The discussion was to be funded by Bristol-Myers Squibb, which recently released the antidepressant patch, EMSAM. DeVane initially declined Dr. Nemeroff’s invitation, saying that he did not want to participate in a “circus debate for the sake of selling CME time.” However, he eventually changed his mind and participated in a discussion of antidepressant drug-drug interactions with Nemeroff and Sheldon Preskorn, another high-profile academician who often consults and speaks for drug companies.

After the broadcast, the CME company, i3 CME, presented DeVane with an article based on the discussion, apparently ghost-written by a medical writer hired by the company. DeVane called this a “ridicuous text… parts of it were inaccurate, simplistic, and [contained] over-generalizations.” It is not clear whether DeVane insisted that editorial changes be made. He had not read the final version, and advised that the article be ignored “for purposes of interpreting my research and views.”

The controversy involves a seemingly arcane topic in psychopharmacology, the issue of how drugs interact with other drugs in the bloodstream. In an earlier article in a different journal, published without pharmaceutical funding, Dr. DeVane had argued that these drug-drug interactions were rarely significant when prescribing antidepressants. According to DeVane’s e-mail, that article “represents my summary of the field and opinions.”

The CNS Spectrums article, however, claims that these interactions are often significant when certain antidepressants are used. The article also points out that EMSAM, the drug made by the article’s sponsor, has the advantage of not sharing these drug interaction liabilities. If DeVane’s earlier statements had been used as the basis for the article, then EMSAM could not have been claimed to have this competitive advantage.

In response to inquiries about the discrepancies in DeVane’s earlier article and the newer article, CNS Spectrums and i3 CME did not comment on specifics, but denied any irregularities regarding the planning or writing of the article. According to their written statement, “the faculty [referring to Nemeroff, Preskorn, and DeVane] remains comfortable with the positions they have taken in this CME activity….”

File article under: Corruption in High Places