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Clin psych just dropped me a note requesting that I scan in the documents that I described yesterday. These were the industry-funded CME activities that poor Primary Psychiatry has to schlep around like the abused but well-paid mule that it is.
I tried scanning them right into this blog but Blogger gave me too much technical grief. So I have posted them all at Google Docs. Just click on the relevant links to go directly to the artwork.
1. Here's the DVD funded by i3CME and Bristol-Myers Squibb in which they paid three of the foremost experts in schizophrenia to say nothing about Abilify's propensity to cause akathisia/activation.
2. Here is Stephen Stahl's Cephalon-sponsored newsletter, "Wake up!", which awards 1.25 hours of CME credit to encourage you to detect more patients with "excessive sleepiness" and to prescribe Provigil.
3. Here is a larger version of the actual journal (also pictured above) with its Eli Lilly overwrap advertising a nonsense telesession about bipolar disorder.
4. Finally, here is the first page of the Michael Clark "Cymbalta Synergy" article including the erroneous financial disclosure.
Good old show and tell. I haven't had this much fun since kindergarten!
Granted, everyone’s entitled to make a buck, medical publishers included. This almost always involves doing some advertising for drug companies. There’s nothing inherently wrong with this, as long as the advertising doesn’t infiltrate the content of the articles. This firewall between marketing and editorial content is crucial, and some journals are very good at maintaining this separation—journals such as Lancet and New England Journal of Medicine come to mind.
And then, on the other hand, there is Primary Psychiatry.
The September issue of Primary Psychiatry is the encapsulation of the worst of the worst of what might be called "greed journalism." Rather than serving as a medical journal, Primary Psychiatry has become a mule for various sponsoring pharmaceutical companies, heaving promotional CME programs into our offices. An almost exquisite example of journal as marketing vehicle, the September issue is the very Mona Lisa of CME corruption.
It arrived in my office “polybagged” with three industry-funded educational activities. Polybagging entails wrapping the journal in plastic wrap and throwing in stuff that drug companies want you to see. The September issue contains:
1. A DVD funded by Bristol-Myers Squibb, coyly entitled, Akathisia: Problem of History and Concern of Today. BMS markets Abilify, widely acknowledged as the atypical most likely to cause akathisia—an inconvenient truth for BMS, because this drives down Abilify’s market share. Thus, BMS paid i3CME (you remember them--the producers of the great Lindsey DeVane fiasco) to find speakers who would play down this liability, and they got exactly what they paid for in these Three CME-usketeers: Prakash Masand, Naveed Iqbal, and Tim Lambert. Abilfy’s association with akathisia is conveniently not mentioned by any of these key opinion leaders. Instead, we hear that Risperidal, Zyprexa, Clozapine, and even Seroquel (!) can cause it. If you can stomach watching this biased presentation, you'll quickly discover that its promotional message is: (1) Akathisia is more common with first generation antipsychotics; (2) There’s no real difference between the atypicals; (3) It’s often caused by SSRIs rather than atypicals; (4) Don't worry, prescribe Abilify.
2. The second prize is a newsletter called “Wake up!”, produced by Steven Stahl and funded by Cephalon. An 8-page advertisement for Provigil, it contains articles written by a Who’s Who panel of industry-funded psychiatrists, including Wallace Mendelson, famous for his ghost-written trazodone-bashing article in the Journal of Clinical Psychiatry (2005;66:469-476; see my New York Times op-ed on his work for Sepracor here). For those who don’t know, Stephen Stahl, founder of the company Neuroscience Education Institute, is one of the more industry-conflicted psychiatrists in the profession, right up there with Charles Nemeroff. The “wake up!” newsletter oozes Cephalon and Provigil, with exhortations to diagnose more people with "excessive sleepiness" and to treat them with Provigil and other meds. Cephalon pays Stahl tens of thousands to say good things about Provigil, and then pays Primary Psychiatry even more to mule the newsletter to 60,000 physicians.
3. Finally, the actual journal is covered with an overwrap advertisement for an Eli Lilly-sponsored educational event on bipolar disorder. No, I didn't spend any more of my precious time enduring that telesession. I'm assuming it will argue that patients with bipolar disorder are at a higher risk for diabetes regardless of which medication they use, so don't worry about slamming them with Zyprexa.
The "Pharmatorial" content doesn’t end with the plastic goody bag. Inside the journal, synergizing nicely with a three-page ad for Lilly’s Cymbalta, is an entire section on pain in psychiatry, including an article on "Psychopharmacology of Chronic Pain." The author, Michael R. Clark of Johns Hopkins, is listed as having “no affiliation with or financial interest in any organization that may pose a conflict of interest.” This fib can be checked out by going to Google and typing in “Michael Clark, M.D. and disclosures.” The first page of results shows that Dr. Clark has been the course director of two CME conferences on pain management this year, supported by educational grants from Lilly, King Pharmaceuticals, and Cephalon.
It isn't easy being a mule. But the money helps.
This Thursday I will be joining several colleagues in testifying at the Massachusetts State House in support of a bill to tame the cost of medical care in the state (read a fact sheet from Health Care For All here). One portion of the bill will ban most drug company gifts to doctors. The thinking here is that when we receive gifts from reps, such as textbooks or free dinners or lunches, we inevitably feel that we owe the rep something in return. That's just human nature.
What we give the rep in return varies widely. Sometimes, it's just increased access--more frequent visits with us, an extra few minutes of shmoozing, etc.... This works for the rep, since more access equals more time to sell their product.
More insidiously, the pay-back is choosing to prescribe their product over an alternative drug that may be much cheaper. This happens to us all, even to an industry skeptic such as myself. For example, not too long ago, my Ambien CR rep gave me a pamphlet with a selection of free books, and against my better judgment I took her up on it. It was a book on the brain by John Ratey.
Several days after her visit, one of my patients came in complaining of insomnia which had not responded to several hypnotics. He had tried Ambien, Sonata, and Benadryl, but was unable to sleep through the night. Usually, in these situations, I would offer trazodone, which has a long enough half life to last most patients all night long. But something in me made me think about my Ambien CR rep, who had left the office saying, "I hope you'll give Ambien CR a try." I prescribed Ambien CR. As it turned out, this worked no better than regular Ambien, and he ended up on trazodone.
The fact is that pharmaceutical gifting is an effective marketing technique, as much as physicians deny that their medical opinions can be swayed by such small dispensations.
Our increasingly embarrassing American Medical Association (AMA) touts its policy on the ethics of accepting pharmaceutical gifts. Recently, they accepted over $600,000 in pharmaceutical money in order to help advertise their guidelines to doctors. In a nutshell, the policy is: no gift over $100 in value, and any gift must be related to medical care or medical education. Here, as in most of AMA's policies, the emphasis is on making no waves and maintaining the status quo, since this allows docs to get their textbooks, stethoscopes, and nice dinner programs, as long as the dinners are modest. (By the way, the AMA defines "modest" dinners as those meals that physicians would ordinarily pay for themselves, which leaves plenty of room for largesse).
The AMA guidelines become farcical at times. For example, not only is it acceptable to accept a nice dinner out by industry, but it is also acceptable to be offered an array of $100 gifts as an inducement to attend the dinner. But here's where AMA draws the line: physicians can be offered no more than eight different gifts to choose from. Here, verbatim, is the relevant section:
"(i) May companies invite physicians to a dinner with a speaker and offer them a large number of gifts from which to choose one?
In general, the greater the freedom of choice given to the physician, the more the offer seems like cash. A large number of gifts presented to physicians who attend a dinner would therefore be inappropriate.
There is no precise way of deciding an appropriate upper limit on the amount of choice that is acceptable. However, it is important that a specific limit be chosen to ensure clarity in the guidelines. A limit of eight has been chosen because it permits flexibility but prevents undue freedom of choice. Each of the choices must have a value to the physicians of no more than $100."
We don't need gifts from drug reps, nor do we need the biased "education" they provide during their visits. Let's stop pretending that gifts are anything other than influence-peddling.
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.
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!
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?
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
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