on the wrong side of the equation…

Posted on Saturday 15 March 2014

“… clinicians have to decide on treatments and therefore the best goal, interim goal at least, we may want to understand the pathophysiology better and I’m not against that, but I think we have to help clinicians decide on one versus the other treatment."
Dr. Madhukar Trivedi, Mayflower Conference, October 2009

More needs to be done now if we are to have new treatments in the next decade for patients with psychiatric disorders.
Dr. Alan Schatzberg, Pipeline Summit, March 2012.

Watching the celebrities parade up and down the red carpet at the Oscars, I kept wondering what that was about, how it got started. And who were those dress designers that they kept mentioning? Who wears those dresses anywhere else? Certainly no one I know, or have ever known. And the awards and acceptance speeches – epics, giants, "I couldn’t have done it without …", a gathering with rules, an etiquette, a place in our culture. The Superbowl of something. But throughout the program [which I also watched like many of the rest of us], I kept having snippets of thoughts about two meetings of psychiatrists that struck me as similar. The first was the Mayflower Conference [video] in 2009. It was a gathering of US KOLs from far and wide assembled by Evian Gordon, an Australian guru, to roll out his entrance into the Personalized Medicine market. Personalized Medicine is the notion that by some technology [any technology will do], doctors will be able to pick the antidepressant that’s "right for you," just like in the commercials. The quote above from Dr. Trivedi was my take-home. He, and the assembled guests, thought that they had been called to tell us how to practice medicine [a position that I thought was right arrogant] – treatment guidelines, algorithms, lab tests. In my mind, that meeting marked the expansion of commercialism in psychiatry – from alliances with the PHARMA medications to other lucrative products used to practice psychiatry.

The second celebrity gathering was a meeting at the APA Headquarters sponsored by the American Psychiatric Foundation and the NIMH two years ago. It was after the summer of 2011 when the KOLs realized that the pharmaceutical pipeline was indeed, empty, and that no one was at the other end even trying to fill it anymore. The cast of characters at that meeting was similar to the Mayflower gathering, but with more industrial representatives. Some comments from that Pipeline Summit:

  • Jeffrey Lieberman, M.D.: “There are huge unmet clinical needs in mental disorders and addiction. There should be tremendous interest in this area, but there is not.”
  • Steven Paul, M.D. [Eli Lilly], pointed out that the industry as a whole is challenged with “less innovation, longer development cycles, shrinking margins, and less investment in R&D.”
  • Armin Szegedi, M.D. [Merck]: “[a] lot of drug targets [that were] validated in the lab have not panned out in clinical trials.” The reason? Psychiatric disorders are not single-pathway diseases. For example, what is known as major depressive disorder may be a heterogeneous group of diseases with different etiologies and genetic factors, he said. Targeting one pathway may not help patients with other pathologies, and no one yet knows how to differentiate patients by their biology.
  • Joseph Belanoff, M.D. [Corcept Therapeutics], said that based on his experience, the attitude toward industry-sponsored drug research seems very different between endocrinologists and psychiatrists… Pharma-sponsored research is considered not prestigious and “a bit dirty” among top-notch academic researchers in psychiatry, a sentiment that is absent in endocrinology. He urged APA to take a strong stand to support industry research. Others also commented that some academic psychiatry departments are reluctant to collaborate with industry.
  • Herbert Pardes, M.D., president of the Scientific Council of the Brain and Behavior Research Foundation commented that if there is an innovative treatment with convincing effectiveness coming out of industry, “the vast majority of psychiatrists will embrace it.”
  • Amir Kalali, MD. [Quintiles CRO]… urged APA to “help normalize academia’s relationship with industry” and encourage psychiatrists to take up industry-supported research.
  • Mudhukar Trivedi, M.D. [Pharma anywhere]… observed that “we are creating a virtual world in which [psychiatric] trials are conducted in the [least-severely ill] patients by the least-qualified people, and then [we] are surprised by the placebo effect.” Consequently, the general public and part of the medical community believe that antidepressants are no better than placebo.
  • … It was suggested that the proposed dimensional approach in DSM-5, along with NIMH’s ongoing development in Research Domain Criteria, could provide more precise clinical and biochemical targets for new and rational drug design.
  • One of APF and APA’s roles, Schatzberg said, is to continue to fight the stigma against psychiatry and psychiatric drugs. In addition to facilitating more collaboration between the government and the private sector, he proposed that APF and APA work with other stakeholders to create incentives for industry to reinvest in psychiatry. Philip Skolnick, D.Sc., Ph.D., of NIDA raised the issue of whether extending market exclusivity for compounds that are first in class and/or first in indication as is done abroad could promote investment.
  • Thomas Laughren, M.D., director of the Division of Psychiatric Products at the FDA, suggested that APA could help the agency by organizing public discussions and publishing consensus on clinical endpoints, biomarkers, and standardized clinical definitions such as response and partial response.
I understood why the Academy Awards made me think of the Mayflower Conference – festive, celebratory, celebrity, all designed to  sell  movies and dresses  Personalized Medicine. But why did I think of the Pipeline Summit? I think I figured it out. It was the dresses after all. It was Dr. Schatzberg’s comment at the end, "More needs to be done now if we are to have new treatments in the next decade..." It sounded to me like those dress designers thinking about what new innovations they could muster for the coming year. It has to be something new – novel, innovative, a new look, a new material, a new something to drape the pretty ladies with on the red carpet next year. Or a producer thinking about what he/she could come up with new for next year’s movie themes.

The psychopharmacology era from 1987 to the recent past has been like that. The next wonderful new antidepressant has to be more desirable than the last one. The novel way of accessorizing [sequencing, combining, augmenting] has to be value added. Without a pipeline producing something new periodically, the shine wears off of the old drugs and their foibles begin to show. So we need a new design, a new line [as they say in the garment industry], something to keep the momentum flowing. But our KOLs haven’t been like the dress designers, they’ve been more like the Red Carpet commentators who talk about other peoples’ designs – giving talks like recent advances in …, or neurobiology of ..., or writing review articles, or signing on to the industrial clinical trials – more groupies than stars. That must be why they’re so frantic. Commentators with nothing to comment about.

So they are trying to find a way to lure PHARMA back into CNS drug development. How to make sure academic psychiatry stays connected with industry. How to keep the bonanza of the 1990s and 2000s alive. This is the American Psychiatric Foundation [Pharma funded APA auxilliary], the NIMH, NIDA, the FDA, all meeting in APA headquarters, moderated by the then APA president elect and an APA past president, with suggestions for incentives to sweeten the pot for PHARMA. In the words of Dune author, Frank Herbert, "The spice must flow."

I wish this were exaggerated satire [the part about dress designers and runway commentators]. Or that it mattered as little as the Academy Award ceremonies. We could send around some silly selfies and carry on. But that’s not the case. It’s a visible reality. While lots of people, patients, healthcare professionals, scientists, some psychiatrists, are spending a lot of time and effort trying to counter the gross commercialization and overmedication of patients, organized psychiatry regularly ends up on the wrong side of the equation, and continues with an inertia that transcends its origins…
    Bernard Carroll
    March 16, 2014 | 12:21 AM

    That’s an excellent metaphor, Dr. Mickey – KOLs as groupies. Whining groupies at that. And when I look over the names up there, well, I see that they have done squat to refill the lamented empty pipeline. As for the American Psychiatric Association, they seem to have bailed on holding the DSM-5 Task Force chairman to account for repeated nondisclosures of his competing financial interests. Goodbye, APA, you have forfeited your ethical standing.

    berit bryn jensen
    March 16, 2014 | 3:29 AM

    Thank you, dr Nardo, for another exquisite exposition of the corruption, hypocricy and absolute foolishness of the maledominated, mainstream, academic machopsychiatry. May your satire sting egomanical males, out to make big bucks on the backs of vulnerable humans. The ugliness of this systematic, institutionalized abuse, brushed over with glitter and shine, is surely much more sophisticated, but as oppressive, damaging and evil as slavery.
    Three women saved us from total failure in the court case after 22. july, when dominant males in Norwegian psychiatry fought to have the massmurderer diagnosed and sentenced to psychiatric treatment. One female psychiatrist observing him in prison saw no sign of psychosis and said so. Then the court, led by a young female judge, found him sane and responsible for his evil crime. Later a young female lawyer delivered the governmentordered, damning report on systematic failures in public services contributing to the magnitude of the massacre.
    The groupthink of greedy groupies in psychiatry has to go. I just read Tina Minkowitz’s report in MiA. Our ladies have been in Geneve, doing their level best to shatter statesanctioned cruelty in psychiatry. Respect for human rights shall again set slaves free.

    berit bryn jensen
    March 16, 2014 | 5:47 AM

    A pertinent saying by scrupulously honest scientist Richard Feynman:

    “For a successful technology reality must take precedence over public relations, for Nature cannot be fooled.”

    Steve Lucas
    March 16, 2014 | 7:31 AM

    When we look at medicine, all of medicine, we see there are no limits to what even a well respected drug/device company will do to sell product:


    Additionally it become obvious how a drug company will spin the numbers to gain any, any, advantage or result from a drug trial:


    Much like the designer of those impossible dresses they claim everyone will be using their product by the end of the year.

    The reality is the average person cannot afford the dress or treatment, and the side effects of massive weight loss, or in the case of drugs weight gain, creates unintended side effects.

    Lost in all of this is the impact on the public at large. The award shows put forth an unattainable body image. The doctors put forth an impossible state of mental bliss and the public is left feeling inadequate in both instances. The desire in both cases is to sell product, with no concern as to the practicality of that product.

    Steve Lucas

    Steve Lucas
    March 16, 2014 | 7:33 AM
    March 16, 2014 | 7:59 AM

    I read Brody’s post last night. It’s a good one with a powerful point about almost significant science…

    deena hoblit
    March 16, 2014 | 10:58 AM

    I may sound defensive, but it bothers me when they talk about psychiatry and the stigma around it. This is not a united front. These are the people who make money from my suffering. They create stigma to boost their overall profit margin. Worst of all, they all seem so smug and morally superior as they do it. People who live with stigma, they don’t have the benefit of being so cavalier about acknowledging it. As to the stigma about psych drugs… that isn’t stigma… stigma is prejudice and assumption and propaganda. Worse, what people suspect about those drugs is nothing compared to the reality. Ignoring that, at it’s most basic, psych drugs perpetuate the problem. They don’t actually fix anything. They just push it aside for a while where it can fester, and a person who is already ill equipped to cope anyway, forgets. It’s not that the patients relapse. They stop taking those meds because they don’t feel like active participants in their own lives anymore, and the original problem is waiting for them, and it’s built momentum. How can that many IVY league educated people not grasp that?

    Arby (Not a Doctor)
    March 16, 2014 | 11:41 AM

    How can that many IVY league educated people not grasp that?

    Because while it may be taught in school, it is not learned there. It is learned in life and I often think that their lives are significantly different from those of the rest of us..

    March 16, 2014 | 11:45 AM

    I hear ya’, deena. That so many Ivy league, educated people cannot grasp what they’re doing is privilege writ large.

    March 16, 2014 | 12:24 PM

    Having come from that league, these are my thoughts. When one has been successful in schooling, a certain kind of superiority and entitlement gets reinforced over and over again. Make no mistake, these KOLs work hard and they tend to be highly competitive But the entitlement and superiority is reinforced. It does not have the same impact on everyone – Marcia Angel hails from Harvard and the Safra Center is there – but it does on some.
    I may have mentioned this book before because I found it so helpful but I highly recommend Daniel Kahnemann’s, “Thinking, fast and slow”. He talks about how intuition (in his lexicon, fast thinking) is pretty remarkable but can lead us astray. All of us. Even those who are considered highly intelligent.

    March 16, 2014 | 3:38 PM

    I should have been more specific— sorry about that Sandra— I was referring to the “it” psychiatrists who like these KOLs who are so cocksure they know someone before they listen to them that they might as well prescribe over the telephone.

    You’re a people person who doesn’t objectify patients.

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