key opinion leaders: the new millennium…

Posted on Monday 30 May 2016

Having become preoccupied with the newer antidepressant, Vortioxetine, I was going to talk some about the KOL’s [Key Opinion Leader] place in psychiatry using Michael Thase, one of the main such figures in the Vortioxetine story, as an example. But then I received a copy of an older article I’ve heard about but never seen. It’s as good an introduction to the topic as one might wish for…
hat tip to the librarians   
Boss of Bosses: Charles B. Nemeroff, MD, PhD
by James La Rossa Jr. and Genevieve Romano
TEN: The Economics of Neuroscience. 2000 2[9]:8.

Charlie Nemeroff is sitting quietly at the speaker’s table, ignoring the bustle going on around him. His face betrays nothing — neither boredom* nor interest, or apprehension. Only the blinking of his eyes distinguish him from a statue. When he hears his name he rises very slowly, and begins to move to the lectern with deliberate strides, gathering speed as he goes, brightening now. He breaks into a grin and begins speaking the minute he approaches the microphone and, before the hush of the room takes hold, he has won the crowd with a disarming and deliberate manner that cuts simply to the heart of the most complex issues in neuropsychiatry.

Charles B. Nemeroff, MD, PhD, chairman of the Department of Psychiatry and Behavioral Sciences at Emory University School of Medicine in Atlanta, finds himself addressing a room of crowded colleagues hundreds of times each year. Even in the ultra-competitive world of medicine and academia, Nemeroff is admittedly the most coveted academic speaker in psychiatry in the United States. His prolific authorship [he has published 600 research reports and reviews] along with a sheer enormity of research grants, awards, and scientific board appointments, has afforded him unprecedented celebrity within the psychiatric community. Nemeroff’s academic and intellectual largess translates to a small and influential group of close friends, including fellow department chairmen Alan Schatzberg [Stanford], Marty Keller [Brown], Dwight Evans [U-Penn], Bob Hirschfeld [U. of Texas, Galveston] and NIMH heavyweight Dennis Charney, all of whom spend a great deal of professional and personal time together. Psychiatry is a highly charged topic these days, and these six thought leaders walk a fine line between controversy and political correctness, often made possible by their strong allegiances both to topics and to one another.

The ethics surrounding the implementation of placebo-control trials is one of psychiatry’s most super-charged political issues, as is addressed in more detail in this issue of TEN. "From a scientific point of view, the best data on efficacy of any treatment is best derived from placebo-controlled trials," Nemeroff says. But with diseases like cancer and stroke, placebo trials become unethical. Thus, "the FDA in most cases has allowed for comparison between novel treatments for devastating disorders with traditional already-approved treatments." If a novel agent proves efficacious against en existing agent, it gets approved. But "that has not been the case in psychiatry. And we have to raise questions about the use of placebo in conditions like mania, where patients are terribly ill. [In these cases] one wonders why it isn’t sufficient to have evaluation based on ‘just-as-good-as’ or ‘better-than’ currently available treatments and better side effect profile."

Nemeroff is among the most coveted advisors to the pharmaceutical industry. Predictably, rumors about his alliances, or lack thereof, abound. It is safe to say that his views are expressed in a forceful manner — he is a passionate person — and he fully expects to lead the corporate strategy of those he advises. Those who do not heed his advice are often recipients of his wrath. Consequently, Nemeroff is often in favor with the most successful drug makers, since those firms are doing the lion’s share of research, which he often directs.

Privately, Nemeroff is circumspect about the role between private and public funding. Working with industry can "he a win-win. There is a shared vision but also separate mission – The university mission is a troika: research, teaching, clinical service; whereas the pharmaceutical industry [mission is to] discover new drugs and to market them effectively. Sometimes those goals are simpatico and sometimes they’re not." As an example of a situation where industry funding works to the benefit of the scientific community, Nemeroff recounts a new teaching council that he started recently with a grant from Janssen called The Young Faculty Development Program, where young professors get the opportunity to learn about clinical issues and academic life. And he talks also about the differences he sees between today’s young clinicians and those of his generation, "in the past, there was a clear schism between psychoanalytically oriented psychiatrists and so-called biological psychiatrists. Today, this mind-brain dualism seems silly … Patients of course have both minds and brains." The fact of the matter is that psychosocial factors … can certainly affect how the brain functions and we also know that the brain itself changes. The nature/nurture controversy is really no controversy, as we’ve improved our understanding of the brain."

The Bronx-NY-born Nemeroff is most content being both a researcher and a physician. As an example, he recounts a part of the very day of this phone interview. "[Earlier today] I saw four patients, one on emergency consult; at the same time, I was dealing with a number of issues related to an NIMH grant of the psychobiology of early trauma. What can be better than being a teacher and a researcher and a physician?"
When I left academic and mainstream psychiatry in the mid-1980s, we had experts – people who were known and knowledgeable about some particular topic in the field. When I returned several decades later, we had a different breed – Key Opinion Leaders [KOLs]. They too were well known and knowledgeable, but they were something else as well. The term comes from the PHARMA marketing lingo and was well chosen – they can lead the opinions of others. So they are in high demand by industry as advisors, authors, speakers, grantees, etc. And the pay, though sometimes indirect, has been excellent, both to them and their institutions. Some did actual research, but most referred to themselves as researchers by defining Clinical Trials as research. And they published like crazy – authoring and co-authoring hundreds of articles.

By the turn of the century when this piece was written, Charlie Nemeroff was at at the top of the heap and the top of his game – the quintessential KOL. This article mentions some of the other major KOLs of the time, a core group of his friends and fellow chairmen. So as the new drugs flowed from industry at a steady rate, there was plenty to talk about, and the promise of future breakthroughs was always fertile ground for their stream of presentations and review articles. But that’s just the very public part. There were the advisory positions [left below] and those paid pharma speaker engagements to small groups all over the country [right below] generating personal income.

While this article was not written as an exposé, it offered a candid look behind the scenes at how Dr. Nemeroff and his colleagues occupied a formidable power-base in psychiatry in 2000, and hinted at how the boundary between academia and industry was disappearing. In the same year, responding to an article in the NEJM where Nemeroff and three other authors came from the group mentioned above [of the 29], editor Marcia Angell wrote an editorial, Is Academic Medicine for Sale? [after looking at the voluminous COI declarations]. Perhaps she could’ve even substituted bought and sold for for Sale, at least in the psychiatric literature on RCTs.

We all know how this story finally came to something of a close, though Nemeroff’s reign didn’t exactly end because of his industry connections – it was personal greed. In 2002, he published a review article recommending three different treatments all of which he had a personal financial stake in without disclosing that interest – easily seen by watchdogs Bernard Carroll and Bob Rubin. In spite of being publicly exposed and censured by Emory, in 2006 he did it again with a review of a treatment he and his coauthors all had financial interests in, again with no COI declarations [and in a journal he edited to boot], again seen by Drs. Carroll and Rubin. He was forced to step down as editor of the prestigious journal, Neuropsychopharmacology, and was put on a tight rein by Emory. But in 2008, when he was investigated by Senator Grassley for unreported pharma income, he lost his chairmanship [as did two of his cohorts on Senator Grassley’s list, Drs. Schatzberg and Keller].

So at the turn of the century, the academic·industrial complex was going strong in psychiatry, but largely out of sight. Clinical Trials were conducted by Contract Research Organizations [CROs]. The data was analysed by the sponsors and written up by contracted medical firms [ghostwriters]. The publication authors were editors and window dressing for the industry·dominated process. Inside academic psychiatry, there was a powerful coalition of KOLs and a boss·of·bosses running the show with pharma allies [or vice versa].
    May 31, 2016 | 1:50 PM

    What is inherently the antisocial triad found in at least 90% of people legitimately diagnosed as such, irregardless of legal matters?

    repetitive lying, lack of remorse, and no respect for boundaries. Not the 3 “R’s” one would want in basic education, eh? Gee, traits not only applicable to our current two leading candidates for President, but, much of what pretends to be both past and present KOLs for much of psychiatry, if not much of medical interventions by in large these days, eh?

    Where there is money and power to be had, there is addiction and corruption dancing along. Just one question to any interested to entertain in rebuttal: what do you call those who admit there are people in positions of power, influence, and leadership who are flawed and impaired to a point of being detrimental to society at large, yet those aware do nothing to even try to remedy the problem?

    Clueless? Complicit? Cohorts?

    I’ll stick with the easiest assessment: compromised!

    Do you like associating with people who are compromised? I don’t!

    Bernard Carroll
    May 31, 2016 | 2:09 PM

    The New England Journal of Medicine received a number of responses to Marcia Angell’s editorial “Is Academic Medicine for Sale?” I give the prize to this one: “No, the present owners are very happy with it.” I applaud you for revisiting that era, lest we all forget the lessons.

    May 31, 2016 | 3:13 PM

    No, the present owners are very happy with it.
    Isn’t there the additional problem that when superpowers warp local politics and poor leaders are installed, then even when those superpowers withdraw the poor leaders remain? Having built careers on what to most appearances was a selling of academic imprimatur, the KOL mindset persists even if the previous owners have moved on.
    “Unfortunately, the specialties are left to deal with the wreckage left behind. And that pressure is still there to make it in the for-profit world we continue to live in.”
    In response to
    “What we know for sure is “not this”…”
    No, the great majority of our colleagues do not view it as “not this.”
    What to me is unprecedented in AACAP’s selection of Wagner is that this selection and election is status post all the revelations. It says that what we know is “yes this.”

    May 31, 2016 | 3:40 PM

    AACAP “Nominating Committee chaired by Marty Drell, MD and members that include: Carl Feinstein, MD, Rich Martini, MD, Rachel Ritvo, MD, and Marianne Wamboldt, MD” Do we have a culture of academic psychiatrists who have come to see no issues with the culture of academic psychiatrists?
    To paraphrase Dr. Carroll: Thus does our academic and professional society culture become corrupted in a self sustaining manner.
    Wagner will in her turn become chair of the nominating committee for AACAP’s next presidential slate.

    May 31, 2016 | 4:35 PM

    “says expert”
    “When parents express anxiety about using SSRIs and ask for psychotherapy, Wagner explains that cognitive-behavioral therapy (CBT) takes time to work and that a faster response can be obtained by combining an antidepressant with CBT.”

    James OBrien, M.D.
    May 31, 2016 | 5:06 PM

    It may be time to create a competing institution since guild interests are so ossified.

    The other APA has competition since late eighties, no reason this APA shouldn’t have it too.

    NBPAS is now competing with ABMS since the latter became so corrupt.

    Virtual monopolies don’t respond to criticism, they respond to competition. Any remember Adelphia cable or your local phone company when they had you captive?

    May 31, 2016 | 8:57 PM

    “he fully expects to lead the corporate strategy of those he advises.”
    I wonder what to make of that line…

    June 1, 2016 | 1:31 AM

    “The more pessimistic answer is, what can you expect now that the post-Bayh-Dole university has declared its allegiance to making money over academic values? On this view, the conflict of interest train left the station a long time ago–some say, all the way back in 1980 when the Bayh-Dole act was passed (see HOOKED). If the university must make its research money from industry to stay afloat, then the unversity’s conflict of interest is much bigger than any individual faculty member’s conflict of interest, even Nemeroff’s. And that assures that the university dare not bite the hand that feeds it, whether the hand is Nemeroff’s or Eli Lilly’s or GlaxoSmithKline’s.”

    “The University of California system relied on state funding for almost a quarter of its budget as recently as 2002, according to the American Academy of Arts and Sciences. Now, that figure is 9 percent, after $1 billion in cuts.”
    What are the key distinctions between pharmaceutical companies and universities? What is the hand that feeds? Who is tail, who is dog?

    Is “academic” medicine in this context an anacronism?

    June 1, 2016 | 1:42 AM

    “The outcomes have been positive on nearly all counts,”

    “But by retaining the rights to federally funded discoveries, taxpayers got no return on their investment because government is not in the business of turning discoveries into products that benefit people. That’s up to private industry, but private industry couldn’t commercialize discoveries to which they had no rights. As a result, discoveries languished as pieces of paper — i.e., patents — in government offices.
    The Bayh-Dole Act unlocked those discoveries that were made with taxpayer money. It allowed businesses and nonprofits, such as universities, to retain title to their inventions that were made with federal funds and to license them to private companies for commercialization.”
    “Prior to the enactment of Bayh-Dole there were a grand total of 0… that is ZERO… drugs commercialized from underlying university research. Whether we like it or not, pharmaceutical companies are for-profit entities”

    James OBrien, M.D.
    June 1, 2016 | 9:48 AM

    Thanks for posting both sides of the issue, 1BYM.

    Cutting off private funds is no more the solution to bad movies than bad research.

    At some point, people got fed up and stopped letting Pauly Shore make comedies.

    June 1, 2016 | 10:50 AM

    Why aren’t more people outspoken about profit mongering by those who are allegedly clinicians? Sorry, you can’t “profit” and be a provider at the same time, they are inherently incongruent goals. To care for someone at some point will have to accept costs will be made, both literal and figurative.

    I guess the problem is, most academicians aren’t really providers at some point, they just are intrinsically politicians in their academic systems, and they are about the bottom line. Which makes one wonder, what is really taught in residency programs these last what, 15 years or so, has it really degraded from standards of care to “why should I care”?

    From “making a living” to “living to make” money, wow, maybe that should be a trick question on the MCAT exams these days…

    Again, the antisocial not only expects silence and passive complicity at least, but, depends on it as well. Am I really the only one reading here who sees how almost sociopathic Nemeroff has become?!

    James OBrien, M.D.
    June 1, 2016 | 11:20 AM

    Stop going to the lectures, stop fawning all over them and the problem goes away.

    We have met the enemy and he is us.

    Doctors seeking CME are sheep.

    June 1, 2016 | 5:09 PM
    A group of us who were stationed together as doctors in the UK in the early 70s have remained friends since, and vacation together for a week every summer for the last 40+ years. We’re sort of family now. At one point, we were talking about hating those CME courses we had to attend and decided to form a medical group [all different specialties]. It was surprisingly easy. And we played it straight.

    Each morning we’d gather at the pool/beach/mountain·stream and someone would give a presentation. Sometimes we all rode in the same van going to see a site. Who could forget my famous Borderline Personality Disorder talk on the way from Santa Fe to Los Alamos? Approprtiate! They still bring it up. One year, we took a course in alternative and Native American Medicine in Sedona which was surprisingly interesting.

    We did it for a few years then got close to retiring and stopped. But we still occasionally do it informally if someone has something to tell. It has to be sponsored, but universities or hospitals are glad to do it. And yes, you can write off some of your travel expenses. It was, in retrospect, the most helpful CME I can ever recall attending.

    Post Script: We’re getting old enough now where we’re presenting ourselves as interesting cases…

    James OBrien, M.D.
    June 1, 2016 | 6:19 PM

    That’s a great plan.

    I love it how the typical conference offers the early registration discount special of 230 per night at the hotel.

    Of course, the next week for the CPA convention the rate will be 85 per night.

    We are such collective saps. Is that Stockholm Syndrome from internship?

    I’ve become a big fan of on-line CME.

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