University of Michigan Bans Industry Funded CME

As originally reported in a New York Times article last week, with more coverage today in Med Page Today, the University of Michigan School of Medicine has decided to end all industry support of CME as of January 1, 2011. According to the dean of the medical school, "the decision was based on a review of literature about the influence on clinical faculty of industry-funded CME." Apparently the decision was made after a series of "town hall meetings" at the university and after the Chairs of the academic departments voted to end commercial CME.

We are witnessing a very gradual falling of the dominos, since U Michigan is now the fourth major medical institution in the U.S. to end commercial support of CME. In February of 2008, the Sloan Kettering Memorial Cancer Center in New York gave commercial CME the heave-ho (see my coverage here); East Carolina University's Brody School of Medicine is rapidly weaning its CME programs of industry support, to the point where currently only 0.75% of their CME budget is from industry; and Kaiser Permanente's mid-Atlantic region (which covers about 500,000 patients in Maryland, Virginia, and Washington DC) does not accept industry funding of CME. The new information on Brody School of Medicine and Kaiser was shared this past Friday at Pharmed Out's Prescription for Conflict conference at Georgetown University

Meanwhile, Stanford University is trying to distance itself from industry influence on CME, but is having a hard time giving up its addiction to the cash. While the dean had announced in August of 2008 that Stanford would no longer allow companies to sponsor specific courses, recently the University accepted a $3 million block grant from Pfizer for CME initiatives that would focus in certain specific areas of medicine, areas in which Pfizer markets pharmaceuticals. Presumably, Pfizer will have no influence on the content of the courses, but this is a line we have heard many time before, generally from for-profit Medical Education Communication Companies. Unfortunately, the firewall between the drug companies' promotional agendas and the educators' offerings inevitably thins out, especially when it dawns on the grantees that if the sponsors doesn't like the content of the courses, they'll find someone else to fund the next time granting decisions are made. As if to emphasize this economic reality, the Pfizer grant is actually structured as sequential one million dollar grants to be spread out over three years, presumably with the option of reassessment before the next payment is made. You can read details of the Stanford grant in their proposal to Pfizer here.

Carlat cynicism aside, it is commendable that Michigan has taken this courageous and principled step, and let us hope that other universities take note.

Latest Issue of Bioethics Journal Spotlights Ghostwriting

The current issue of the journal Bioethics focuses on the problem of ghostwriting in the medical literature and is well worth a read. At this point, the main three articles on the topic appear to be free (at least I was able to gain full text access today, and I have no subscription to the journal.)

The first article, by Tobenna D. Anekwe at Harvard School of Public Health, argues that ghostwriting is in fact a form of plagiarism. While ghostwriting is sometimes called "honorary authorship" in order to make it seem acceptable, Anekwe makes the following interesting point:

"Yet honorary authorship is a form of plagiarism
because it entails claiming authorship for work that
was done by others. The twist is that, here, the corporation
(the willing ‘victim’ of plagiarism) actually wants the
scientist to ‘steal’ its work and publish it as his or her
own. But surely this one difference makes industry ghostwriting
no more acceptable. Honorary authorship should
be frowned upon by the research community in the same
way that other types of plagiarism are frowned upon. Yet
it remains unclear from their policies whether universities
view this practice as being as serious as other forms of
plagiarism."

The second article, by Sismondo and Doucet at Queens University in Ontario, describes the insidious process known as "ghost management:"

"In this article, we present evidence that pharmaceutical companies engage in the ghost management of the scientific literature, by controlling or shaping several crucial steps in the research, writing, and publication of scientific articles. Ghost management allows the pharmaceutical industry to shape the literature in ways that serve its interests."

This fascinating trifecta is rounded out by a commentary penned by Carl Elliot and Amy Snow Landa at the University of Minnesota. The authors conclude that both ghostwriting and ghost management are unethical practices and will be difficult to regulate until the medical education companies and physicians who collude with the process feel the sting of litigation:

"Given the amount of litigation against the pharmaceutical industry in recent years, some of which has resulted in record-breaking penalties, it is surprising that no litigation has been directed towards medical writers, medical communications agencies, or the physicians who sign their names to ghosted articles. Maybe this is because these players are seen as mere instruments in a much larger marketing enterprise, or maybe it is simply that their pockets are not as deep. But if a few high-profile lawsuits were successfully aimed in their direction, it is a good bet that the practice of ghostwriting would come to a sudden halt."

Well said.

Uh Oh! Thomas Insel gets pulled into Nemeroff's World

One truism of professional life is that some favors, no matter how alluring, should be politely turned down. The trick is predicting which bestowers of favors spell D-A-N-G-E-R, and which do not. Unfortunately, it looks like Dr. Tom Insel, the director of the National Institute of Mental Health, made the mistake of accepting multiple favors from Charles Nemeroff, and he is now paying the price.

Several media outlets have covered this developing saga, or scandal, or Greek tragedy (following the analogy of the Trojan horse, the most famous examples of bad judgment in gift-accepting). The best and most thorough coverage is in this article in The Chronicle of Higher Education, which broke the story. Also, see today's coverage in the Washington Post, and ongoing coverage in Health Care Renewal.

Here's the digest of key events. Charles Nemeroff is a psychiatrist and researcher who makes friends easily, gives great talks, and exudes charisma and power. He's probably a genius and has an encyclopedic knowledge of neuroscience. Unfortunately, he has shown repeatedly that he is willing to bend institutional rules and play loose with the truth in order to accomplish his various financial and professional objectives. His self-imposed trials and tribulations are well known to readers of this blog.

The Low Points:

--2002: Nemeroff co-authored a review article saying wonderful things about an investigational antidepressant, mifepristone, without disclosing that he had a significant financial stake in the product. Nemeroff said that he would have disclosed the conflict of interest if the journal had only asked him to: "If there is a fault here, it is with the journal's policy." (see this coverage in the New York Times).

--2006: Nemeroff co-authored a positive review article about vagus nerve stimulation. The Wall Street Journal soon reported that Nemeroff neglected to disclose his significant financial relationships with Cyberonics (the maker of VNS), and that the article itself was possibly ghost-written by a medical writer hired by Cyberonics. This time, Nemeroff could not convincingly blame the journal, because he was the journal's editor-in-chief! He was soon forced to quit the post. (See my article covering the debacle here).

--2007: Nemeroff co-authored an industry-funded CME supplement to the journal CNS Spectrums which his "co-author" Linsey Devane called "ridiculous" and "inaccurate," and he claimed that Nemeroff had encouraged him to be involved "for the sake of selling CME time." (See my coverage here). Eventually, the ACCME determined that the article violated its Standards for Commercial Support because it was biased in favor of the Bristol-Myers Squibb's drug EMSAM.

--2008: Both the New York Times and the Wall Street Journal simultaneously broke the story that Nemeroff had consistently failed to disclose payments from GlaxoSmithKline for promotional talks, even while he was in charge of an NIH grant studying the company's drugs. This led to Nemeroff's resigning his chairmanship of the Emory University Department of Psychiatry.

Given Nemeroff's track record, I am surprised that Tom Insel agreed to endorse his standing with the NIH to Dr. Goldschmidt, the dean of University of Miami's medical school. The proper thing would have been for Insel to politely decline to discuss Nemeroff at all. In today's Washington Post, Insel is backtracking, saying that "I didn't recommend him" for the Florida job. But Goldschmidt's recollection of the phone conversation was that Dr. Insel "confirmed to me that Charlie was absolutely in fine standing" with the NIH, according to the Chronicle for Higher Education.

What a mess for Insel, for the University of Miami, for the NIH, and once again, for Charles Nemeroff. Now Senator Grassley is involved and is requesting all relevant information concerning the relationship between Insel and Nemeroff. Presumably, Insel's lapse of judgment in this matter was a result of his long-time friend "Charley" calling in favors--but exactly what those favors are will be determined once the documents are released.

File this under: "To be continued...."

Mass General Hospital Provides Great Therapy Training, But....

This is a brief note to respond to some understandable misinterpretations of both my New York Times Magazine article and my book, Unhinged.

My psychotherapy training at Mass General Hospital was excellent. As two young faculty members wrote in a recent letter to the Times in response to my article, MGH's psychiatry residency includes "three years of intensive, individual supervision in psychotherapy." That was true in the early 1990s as well. I saw a lot of therapy patients and received great supervision from such skilled psychiatrists/psychotherapists as Robert Abernathy, Paul Hamburg, Chris Gordon, and many others. Not to mention superlative psychopharmacology supervision from such consummate clinicians as Andrew Nierenberg and Carey Gross.

I also agree with Drs. Roffman and Levy (the authors of the Times letter) that psychiatry residencies throughout the country are doing a great job of ensuring that psychotherapy training remains a central part of the programs. For many years, the American Board of Psychiatry and Neurology has published a list of "core competencies" required of psychiatrists. These have always included psychotherapy. According to the latest version, all psychiatrists should be able to "conduct a range of individual, group, and family therapies using standard, accepted models, and to integrate these psychotherapies in multi-modal treatment, including biological and sociocultural interventions." Furthermore, in 2001, the Council in charge of all graduate medical education (the ACGME) instituted a specific requirement that all psychiatric residencies teach cognitive behavioral therapy, and by 2006, 90% of residencies had complied.

And yet, notwithstanding these laudable intentions and curricular changes, psychotherapy by psychiatrists declined sharply from 1997 (when 44% of all psychiatry visits included psychotherapy) to 2005 (when only 29% of such visits included therapy.) This is because great training during residency is necessary but not sufficient to bring therapy back to psychiatry. Once residents graduate, they have loans to pay off and they follow the money, and the money is found in short medication visits. And as with any complex skill, becoming an excellent therapist requires years and years of practice, most of it after residency.

One can always blame insurance companies for this state of affairs, but insurance companies reimburse more highly for med visits not because they are out to degrade mental health treatment, but because they believe they get more bang for the buck with meds. Based on the typical 6 to 8 week clinical trials, medications work as well as therapy for most conditions, and better for some. But studies are increasingly showing that--at least for non-psychotic disorders-- specific therapies work better than medication at preventing relapse over one or two years of follow up (see this study, for example). Good studies of therapy are hard to find, because drug companies are rarely willing to fund them. But I predict that as the evidence base for the long term efficacy of therapy expands, insurance reimbursement rates will improve as well.

In the meantime, however, my crystal ball reveals no impending great shift among psychiatry graduates toward therapy, no matter how many therapy supervisors residents are exposed to.

Bottom line: Psychiatry residencies do what they can to teach therapy skills, but the dominant culture among practicing psychiatrists remains medication-based, for a number of interwoven reasons including pharmaceutical marketing, insurance reimbursements, and the desire to be as "biomedical" as other doctors.

Rosenberg Covers the APA Meeting

I enjoyed Chicago journalist Martha Rosenberg's take on the APA meeting in New Orleans, which you can read at Scoop Independent News. Although Rosenberg is obviously a partisan, her coverage is entertaining and brimming with telling little details.

For example, she found it ironic that after all of the damning press on Charles Nemeroff's undisclosed conflicts of interests with pharmaceutical companies (which led him to resign his chairmanship at Emory), where should he show up? In the same hallowed location where Mina Dulcan became apoplectic toward me--namely, the book-signing dias at the American Psychiatric Press.

To quote Rosenberg: "Nemeroff was signing the Textbook of Psychopharmacology which he co-edited with Schatzberg, also investigated by Congress. Schatzberg, psychiatry chairman at Stanford, consults to seven drug companies, owns stock and patents with others and is on Sanofi-Aventis' Speakers Bureau according to the meeting's Daily Bulletin."

By the way, there is an interesting back story on Dr. Schatzberg. The official meeting's program book begins with a fat disclosure section, listing all of the speakers who have financial relationships with industry. The next, far thinner section, lists speakers who have no such relationships. Inexplicably, Dr. Schatzberg's name is listed in the weight watcher's section. An anonymous tipster emailed me this glaring error, and I immediately called the press office for an explanation. The friendly staff member only had to hear me introduce myself before she interjected, "Hi Dr. Carlat. Are you calling about Dr. Schatzberg?" "Uhh, yes I am." "The correction is printed in today's meeting bulletin." Apparently several other Schatzberg-watchers beat me to the punch. Or maybe the doctor himself noted the error and corrected it?

I'm going out on a limb and saying that I imagine that the APA's beleaguered press staff is not unhappy that Dr. Schatzberg is the OUTgoing APA president. But that's just a guess.

A Hot City, an Empty Exhibit Hall, and a Stern Mina Dulcan

The annual meeting of the American Psychiatric Association was held in New Orleans this past week. The weather was hot (in the mid-90s) though the meeting was somewhat tepid and under-attended.

The exhibition hall in particular had an empty and echoey feel that I had not seen in years past. I talked to one exhibitor, my friend Dr. David Robinson, the prolific author of several books and the owner of Rapid Cycler Press, who told me that ever since the drug companies had stopped giving out free gifts, the attendance at exhibit halls was down. “In the past, they used to line up before the hall opened in the morning. No more.” This is not terribly good news for the publishers, but on the other hand publishing is undergoing unrelated and much more far-reaching changes with the advent of e-books, and the ritual of carting tons of paper to exhibit halls will eventually end.

Another attendee, a noted researcher in mood disorders, told me that he noticed fewer psychiatrists from other countries this year. Most such psychiatrists typically receive travel funding from drug companies. But this year, because of the APA's decision last March to phase out industry-funded symposia, fewer companies were willing to pay the travel expenses of our foreign colleagues. What's the connection, you might ask? In the past, companies justified these travel expenses because they knew that the sponsored psychiatrists would be attending their CME symposia, which are infomercials in support of their latest drugs. There were only two such symposia this year. So the ROI (return on investment) of funding foreign attendees is no longer robust enough to justify the marketing expense.

Nonetheless, there were still plenty of exhibitors, including mega displays by Merck to push their antipsychotic Saphris (ALL the effectiveness, plus a numb mouth and a metallic taste!), Shire for Vyvanse (proud sponsors of drug diversion for college students since the 1990s), Lilly for Cymbalta (depression is painful, depression is painful, depression is....), and several others. And they were still giving away things, but not the disposable cameras, personalized business cards, or emblazoned clocks of old. Now, the only things they can offer are "educational" items such as textbooks, and here Stephen Stahl was the superstar, doing book signings for various drug companies (you can see one of the announcements here) who have found that his faith in molecular psychopharmacology dovetails nicely with their marketing messages. The man's a great writer, I'll give him that, and he works the pharma angle with the energy and creativity of a Barnum and Bailey circus hawker. He's obviously making some serious cash from industry, but frankly, I'm a little embarrassed for him.

However, I'm the one who should really be embarrassed. Sauntering through the APA's official book publishing area, I came across Dr. Mina Dulcan, Chair of Child Psychiatry at Northwestern Medical School. She was signing copies of her various textbooks. She's a bigwig in the field, having been the editor in chief of the major journal in child psychiatry (the Journal of the American Acacemy of Child and Adolescent Psychiatry) until recently. (The photo above was apparently taken after the events outlined below. It was published in the APA's daily meeting bulletin--and yes, they spelled her name wrong).

Anyway, I went up to her to introduce myself in order to show her a copy of my new newsletter, The Carlat Child Psychiatry Report, edited by Dr. Caroline Fisher from UMass Worcester.

"Hi Dr. Dulcan," I said, "I'm Danny Carlat, nice to meet you."

She took a look at my name tag, and said, "Oh, I've heard about you."

Since her expression was somewhere between stern and outright hostile, I queried, "In a good way or a bad way?"

"In a bad way, to tell you the truth." And then she was off on a high volume rant that went something (if memory serves) like this:

"How DARE you write an article in the New York Times saying that your therapy training at Mass General was terrible, and then later having this GREAT AWAKENING that"--she made a religious hand waving gesture--"'Oh, it's important to understand my patients,' and then you write an article in order to sell your new book and your newsletter. How are you any different from the drug companies? I was outraged by your article and showed it to my colleagues. What a disservice you have done to psychiatry." And it went on from there.

Her argument was not new to me, certainly has its merits, and I am generally happy to engage in constructive debate. But this was not debate, it was simply a very angry person yelling at a colleague with dozens of other psychiatrists looking on in jaw-dropped amazement. I decided not to prolong this awkward encounter (to the relief, I'm sure, of the leaders of American Psychiatric Press who were nearby), and slunk out of the booth, passing along the way a psychiatrist who smiled at me and whispered, "I subscribe to your newsletter and love it!"

Psychiatry--truly, a House Divided.

Adriane Fugh-Berman's Article and Upcoming Conference

In the same issue of the Boston Review as Marcia Angell's great article (profiled in my last post) you can read a fantastic article about commercially-funded CME called "Selling Diseases," written by the irrepressible Adriane Fugh-Berman of Georgetown Medical School.

For those who understand the inherently corrupt process of industry-funded CME, the article covers familiar ground, but is nonetheless great reading. For those who are not aware of how self-deluding many of our top physicians have become, the article is an eye-opener and a call to action.

My favorite quote is:

"Industry-paid speakers frequently deny espousing marketing messages. I’ve heard many physicians justify their pharma-funded speaking gigs by saying, “I never emphasize their product” or, triumphantly, “I don’t even mention their drug!” But these comments only highlight their sales skills. Pharma doesn’t hire doctors to sell drugs; that’s a drug rep’s job. Pharma hires physicians to sell diseases."

I have always been amazed at my colleagues' capacity for rationalizing behavior when it suits their pocketbooks, and Dr. Fugh-Berman nails the issue here perfectly.

By the way, Dr. Fugh-Berman's non-profit organization, PharmedOut, has organized a CME conference called "Prescription for Conflict: Should Industry Fund Continuing Medical Education? It wil be held on June 25 of this year in Washington DC, and includes a start-studded line-up of speakers, including Deputy FDA Commissioner Joshua Sharfstein, the author and bioethicist Carl Elliott, senior investigator for Senator Grassley Paul Thacker, the director of Pfizer's CME programs Maureen Doyle-Scharff, among others. (There are also a few almost famous wannabees on the program, like me!) Here is a link to the agenda and the speakers, along with registration information. I hope to see you there!