a bad reputation…

Posted on Tuesday 10 April 2012

The verdicts in South Carolina, Louisiana, Texas, and now Arkansas against JNJ/Janssen are beginning to mount and may reach the magnitude that begins to have a preventive effect. I expect the KOL set will see these verdicts as driving Pharma away from what they call "CNS," though that’s unlikely the cause. They’ve milked the market and are moving on. It’s pretty simple. I expect the inertia of motion will continue the medication focus of many of the set of psychiatrists who’ve known little else in their careers, but the evaporation of huge sums of pharmaceutical money should at least take some of the fire out of the movement.

But that’s not the only money to account for. I was reading a perfectly abysmal paper this afternoon by Dr. Nemeroff et al published this month in the Journal of Psychiatric Research:
The effects of child abuse and neglect on cognitive functioning in adulthood
by Felicia Goulda, Jennifer Clarke a,b, Christine Heim c, Philip D. Harvey a, Matthias Majer c, and Charles B. Nemeroff a
a Department of Psychiatry and Behavioral Sciences, University of Miami Leonard M. Miller School of Medicine, Miami, FL, USA
b Department of Epidemiology and Public Health, University of Miami Leonard M. Miller School of Medicine, Miami, FL, USA
c Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA
Journal of Psychiatric Research 2012 46:500-506.

AIMS: Recent research has revealed that early life trauma (ELS), including abuse (sexual and/or physical) and neglect, produce lasting changes in the CNS. We posited that cognitive deficits, often observed in psychiatric patients, result, in part, due to the neurobiological consequences of ELS. Additionally, we hypothesized that the nature and magnitude of cognitive deficits would differ according to the subtype of ELS experienced.
METHOD: The Cambridge Neuropsychological Test Automated Battery (CANTAB) was used to assess neurocognitive functioning in 93 subjects (60 with ELS and 33 without). In the patients with a history of ELS, 35% and 16.7%, respectively, met criteria for current major depression and PTSD.
RESULTS
: Significant associations between ELS status and CANTAB measures of memory and executive and emotional functioning were found.
CONCLUSIONS: These data suggest that exposure to ELS results in a cascade of neurobiological changes associated with cognitive deficits in adulthood that vary according to the type of trauma experienced.

Funding body:
Support for this research was provided by a National Institute of Mental Health grant, MH-58922, which was awarded to Dr. Nemeroff.

Contributors:
All contributors are listed as authors. Drs. Nemeroff and Heim designed the study and wrote the protocol. Dr. Heim conducted the study. Dr. Majer collected data for the study. Dr. Gould managed the literature searches and analyses. Dr. Clark performed the data analyses. Dr. Gould wrote the first draft of the manuscript with Drs. Nemeroff and Harvey. All authors provided editorial contributions to the paper.
The study is immaterial. It’s another on of those where they recruit paid subjects with ads on MARTA buses and give them lots of tests to conclude that ELS [early life stress] changes your brain. He’s done a ton of them throughout his career, all equally immaterial. What’s material is that this study was funded by an NIMH Grant to the Conte Center at Emory – a grant that seems to have ended 3 years ago. The study was done in Atlanta but all but one author is in Miami. How is this study supported by the NIMH? Was it done before Nemeroff went to Miami? If so, why are the authors in Miami? My trust level is low here.

YEAR AMOUNT
2000 $6,219,622.00
2001 $6,263,166.00
2002 $6,413,344.00
2003 $7,234,250.00
2004 $2,972,156.00
2005 $3,709,165.00
2006 $7,904,831.00
2007 $6,816,202.00
TOTAL $47,532,736.00

I looked up Nemeroff in the NIH RePORTER database and tallied the net grant amount from 2000 when they started posting amounts to his last listing in 2007. I knew it was a lot, but the actual figure caused me to gasp. I’m sure that there’s some kind of creative accounting that explains how an expired NIMH Grant was involved in this study of people who read the ads in the Atlanta Journal Constitution and ride MARTA buses, but whatever the method – it doesn’t change the fact that what we got for our $47 M was not useful science. And I expect the pharmaceutical grant contributions to Emory in those years would also illicit a gasp response.

With all of this money floating about and damages being paid, there are a few questions that hang in the air about damage that never really get addressed.  What about the damage to patients. I don’t mean the things like diabetes or Tardive Dyskinesia. We at least know about those. What about the patients who were not faring very well in their lives and couldn’t figure out how to get back on track and needed to talk to somebody who might’ve been able to help them figure out the parts they couldn’t see for themselves. Or maybe people in need of a careful diagnostic evaluation and a multidisciplinary treatment plan. Back when I came to Emory, that was a lot of what we talked about, and taught. But that was a generation ago – a generation when the money we didn’t have in the past began to flow like a river into Atlanta Georgia. We don’t have much to show for it. Just a bad reputation. And does anyone remember any scientific advances from Atlanta in those years? None come to mind…
  1.  
    Steve Lucas
    April 11, 2012 | 7:55 AM
     

    Troubling has been the popular press’s coverage of the concept that early age depression leads to latter life health problems. The take away from pharma will be that we should all be on antidepressants for our general health.

    This may seem like a reach until, from my perspective, you look at the push to diagnose two year olds as bi-polar and statins have been associated with curing all types of diseases, including dementia.

    In the recent past many doctors gave statins as a matter of course to all of their patients, because they were “good” for you. As these drugs have gone off patient the push has lessened as drug money has stopped flowing to promote their use.

    Can we now expect any less of a promotion of anti-depressant from pharma?

    Steve Lucas

  2.  
    jamzo
    April 11, 2012 | 1:17 PM
     

    http://psychnews.psychiatryonline.org/newsArticle.aspx?articleid=1096598

    APF Convenes Unique Pipeline Summit

    “Leaders from academia, government, the pharmaceutical industry, venture-capital firms, and clinicians met at APA headquarters March 8 to discuss the shrinking investment in new drug development for psychiatric disorders.”

    “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.”

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