good riddance…

Posted on Sunday 18 December 2011

I was looking around for some recent Tom Insel writing that was fully available on-line, and ended up at his Director’s Blog on the NIMH website. These are his December offerings with a plug for what’s coming next:

  1. Antidepressants: A complicated picture [December 06, 2011]
  2. Treatment Development: The Past 50 Years [December 14, 2011]
  3. "In the next blog, I will suggest that what many are calling a ‘crisis in medication development’ may be an opportunity for NIMH innovation"
The offering on antidepressants was a response to the October CDC Report on antidepressant use in America reporting that 10+% are taking antidepressants.
Insel says,
    "We know that depression is a very heterogeneous syndrome." "A true understanding of the nature of these different forms of depression and the ability to predict who will benefit from the various treatments available depends on a better understanding of the biology of depression, either directly or indirectly through the use of ‘biomarkers.’"
ending with,
    "As we engage ourselves in efforts to gain a deeper understanding of the biology of depression, it is important to remember that optimal treatment for depression does not begin or end with medication. Treating depression is an art that requires many tools. We will not save lives by dismissing any of the tools we currently have available, even as we endeavor to develop better ones. A quality treatment plan for depression includes a thorough assessment, a comprehensive treatment plan that includes choices tailored to and guided by the individual — whether that be medication, psychotherapy or both — and careful, frequent follow-up."
That last part was unexpected – "art"? "many tools"? "choices tailored to and guided by the individual"? "whether it be medication, psychotherapy, or both"? This from Dr. Clinical Neuroscience? Hmm… Well, on to his second December blog [Treatment Development: The Past 50 Years]:
This is the traditional picture of treatment development: public sector support of scientific discovery, and private sector investment in specific compounds and early phase clinical trials, followed mostly by private and some public funding of clinical trials. This traditional picture is about to change. NIH has announced plans to create a new institute—the National Center for Advancing Translational Science [NCATS]. Pending Congressional approval, NCATS should enable the development of innovative methods and technologies to enhance the development, testing, and implementation of diagnostics and therapeutics important for a wide range of human diseases and conditions, including mental disorders. NCATS would also support studies of the process of R&D, including a collaboration with the Food and Drug Administration to help identify barriers to progress and provide science-based solutions to reduce costs and the time required to develop new drugs and diagnostics. This should help reduce the “bottleneck” that occurs in the treatment development pipeline.

But change is coming from another direction as well, especially for psychiatric medications. Over the past year, several companies, including Astra Zeneca, Glaxo-Smith-Kline, Sanofi Aventis, and recently Novartis, have announced either a reduction or a re-direction of their programs in psychiatric medication R&D. Some of these companies [such as Novartis] are shifting from clinical trials to focus more on the early phases of medication development where they feel they can identify better targets for treating mental disorders. Others are shifting from psychiatry to oncology and immunology, which are viewed by some as lower risk.

There are multiple explanations for these changes. For instance, many of the blockbuster psychiatric medications are now available in inexpensive generic form. In addition, there are few validated new molecular targets [like the dopamine receptor] for mental disorders. Moreover, new compounds have been more likely to fail in psychiatry compared to other areas of medicine. Studying the brain and the mind has proven to be much more difficult than the liver and the heart. Most experts feel the science of mental disorders lags behind other areas of medicine. The absence of biomarkers, the lack of valid diagnostic categories, and our limited understanding of the biology of these illnesses make targeted medication development especially difficult for mental disorders.

Given the industry’s lack of innovation over the past three decades and the history of aggressive marketing of psychiatric medications, some might understandably say, “good riddance.” But by almost any measure we need better treatments, both medications and psychotherapies, for the entire range of mental disorders. It is never a positive sign for those with mental illness when thousands of scientists and millions of dollars are shifted away from research on these disorders.

What can NIMH do about this? Without the large budget and the scientific expertise for medication development, how can NIMH compensate for the pharmaceutical industry’s shift in focus? Is it appropriate for NIMH to invest public dollars in an area that many pharmaceutical companies have deemed too risky for investment? In the next blog, I will suggest that what many are calling a “crisis in medication development” may be an opportunity for NIMH innovation…

Tom Insel has had a non-clinical career. There’s nothing wrong with that, except that it gives him a skewed view. After finishing his residency in 1979, he went to the NIMH where he notably worked on the psychopharmacology of Obsessive Compulsive Disorder. When he lost his position there in 1994, he took a position as Director at Yerkes Primate Center in Atlanta working on the hormonal influences in social behavior of Voles. In 1999, his contract was not renewed at Yerkes and he became Director of a "a new $40 million National Science Foundation Science and Technology Center, the Center for Behavioral Neuroscience. This new program used behavioral neuroscience to develop a cross-institutional training and research effort for 7 colleges and universities in Atlanta." In 2002, he was unexpectedly selected to head the NIMH. I need hardly to remind anyone that was in Atlanta that this was the heyday at Emory and beyond of Emory’s chairman, Dr. Charlie Nemeroff, "Boss of Bosses" [1991-2008] who surely was involved in Insel’s moving from place to place, including his move to the NIMH [many see Nemeroff’s recovery job at Miami as the favor repaid by Insel]. It was also the heyday of the brave new world of "Clinical Neuroscience" [1980-2008]. And Tom Insel didn’t originate the idea of Translational Science, but he has been one of its ardent Apostles:
    Translational science is a cross disciplinary scientific research that is motivated by the need for practical applications that help people. The term is used mostly in the health sciences and refers to things like the discovery of new drugs that directly help improve human health. Thus, translating bench science to bedside clinical practice or dissemination to population-based community interventions. In the United States, the National Institutes of Health have implemented a major national initiative to leverage existing academic health center infrastructure through the Clinical and Translational Science Awards.
My own biases are as obvious as Insel’s. After the recent past, my reflexes say "Good Riddance" with the emphasis on "Riddance." And Translational Science seems to me to be "pushing a rope." It’s not my idea of how science works [since the days when Alchemy ended]. The Manhattan Project wasn’t science. The science was already there and the Manhattan Project just made it happen. Same thing with DARPA [and our Sputnik] or NASA. You can push implementation, but I’m not convinced "pushing science" is a good idea.

I’m sure that Tom Insel is not the right person to answer the question, "Is it appropriate for NIMH to invest public dollars in an area that many pharmaceutical companies have deemed too risky for investment?," or say "It is never a positive sign for those with mental illness when thousands of scientists and millions of dollars are shifted away from research on these disorders." Like the situation with Drs. David Kupfer and Darrel Regier and their DSM-5 revision, these are people who have spent their lives cheerleading the "up-side" of the DSM-III "Clinical Neuroscience" Psychopharmacology revolution while overlooking [or not seeing] its very tawdry under-belly. And they’re still riding the bus…

We await Dr. Insel’s proposals ["an opportunity for NIMH innovation"] with a very wary eye…

  1.  
    December 18, 2011 | 12:11 PM
     

    Mickey,

    Insel writes –

    “We will not save lives by dismissing any of the tools we currently have available, even as we endeavor to develop better ones.”

    The assumption with all of this is that antidepressants save lives.
    Really?

    In the literal sense, with a reduction in suicide rates?
    If so, show me the numbers.

    In the figurative sense, by improving the quality of life?
    Sure, if becoming fat and asexual is an improvement.

    Take away the placebo effect and the spellbinding nature of antidepressants, and there’s not anything left to “show” that they work.

    Antidepressants do NOT “save lives.”

    Duane

  2.  
    December 18, 2011 | 2:16 PM
     

    Mickey,

    Actually there are 3 reasons antidepepressants “work” –

    Placebo effect.
    Spellbinding.

    And natural recovery (which is falsely attributed to the drug).

    We have 1 in 10 people in this country on these drugs….
    More people on antidepressants than people who are depressed.

    Wake up, America.
    We are becoming a drug-addicted nation… on drugs that are clinically no better than placebo, and with “side effects” that have no end.

    If psychiatry wants to help, it would develop a protocol to help people get OFF (slowly and safely) the very drugs it has prescribed.

    That would be good “medicine!”

    Duane

  3.  
    Peggi
    December 18, 2011 | 9:16 PM
     

    Actually, Duane, regarding the numbers on suicide rates, I think the current numbers posted by AFSP which are for 2008 are the worst in more than a decade. So, even if 10% of us are taking these meds, then why are more of us ending our lives??

  4.  
    December 19, 2011 | 12:16 AM
     

    Peggi,
    More people are ending their lives because more people are taking the drugs…SSRIs the most used “antidepressants” list suicidal ideation as a “side effect.” If that isn’t depressing I don’t know what is.

  5.  
    Peggi
    December 19, 2011 | 8:16 AM
     

    My goodness, Mickey, now you have me reading the director’s blog on the NIMH site!This excerpt causes me great concern: Perhaps the best evidence for efficacy comes from patients who have been treated successfully with antidepressants and are switched in a blinded fashion to placebo. In a meta-analysis of 31 withdrawal studies among more than 4,000 patients, Geddes and colleagues found that 41 percent of patients who were switched to placebo relapsed, compared to 18 percent who remained on an antidepressant. These studies provide compelling evidence that antidepressants are effective for some people. The head of NIMH doesn’t even mention that perhaps there is a withdrawal effect from switching to placebo? He thinks that the presence of withdrawal symptoms mean the drugs are effective???

  6.  
    December 19, 2011 | 12:11 PM
     

    Peggi,
    Excellent point! I missed that one…

  7.  
    Peggi
    December 19, 2011 | 12:38 PM
     

    REALLY scary that he thinks this is “the best evidence for efficacy”! If that’s the case, I’m back to believing there is zero efficacy.

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