June 21

NIH Needs Sunshine Law Enforcement


This is a follow-up to our Infomail about the revelations in an investigative report by the Chronicle of Higher Education , showing that Thomas Insell, MD, director of the National Institute of Mental Health, who gave his unconditional support "quietly" for Charles Nemeroff, MD despite the fact that Emory University had barred him from participating in NIH grants for two years as punishment for his failure to disclose copious conflicts of interest. 

Dr. Nemeroff’s copious financial ties to industry, and a string of corrupt practices have been well documented: they includd ghostwritten articles bearing his name, promotion of dubious treatments–including the promotion of vagus nerve stimulation and Paxil during preganancy–despite its risk of causing birth defects.  Dr. Nemeroff has fully earned the epitaph, poster child for a culture of greed whose unrestrained conflicts of interest have undermined the integrity of medical research.

Dr. Insell is the director of the National Instute of Health, the nation’s foremost psychiatric research institution which not only conducts research on site, but more importantly, sets the research agenda in psychiatry by having control over billions of dollars awarded in research grants to academic researchers nationwide.

On June 16, Dr. Insell posted a disingenous response to the Chronicle report, calling himself "one of the most outspoken proponents for developing tougher conflict of interest policies at NIH," calling the dust-up over Nemeroff’s ongoing relationship with the agency "surreal."

Dr. Insell claims he was uninvolved: "I have had no contact with Dr. Nemeroff for many months."  However, his trail of email correspondence belies that claim:

Furthermore, he failed to address the damaging evidence uncovered by the Chronicle showing that while he was ostensibly a proponent of reform aimed at cleansing the NIH of its researchers’ conflicts of interest, Dr. Insell played an instrumental behind-the-scenes role in helping the discredited, long-time friend to whom he was said to be indebted.

He gave unconditional assurance to the dean of the medical school of the University of Miami that "Charlie was absolutely in fine standing" with the NIMH; in email communications with Dr. Helen Mayerberg, who collaborated with Dr. Nemeroff in promoting a dubious treatment for depression– vagus nerve stimulation–while they both received money from the device manufacturer. Those revelations made headline news in The Wall Street Journal and The New York Times.

After landing the chairmanship of psychiatry at the University of Miami, Dr. Nemeroff wrote an email to Dr. Insell, thanking him:
"Thank you for your friendship and support. Needless to say, I am already discussing potential grant applications with Linda Brady and others.    look forward to catching up with you at ACNP.  Charlie"

The Chronicle‘s most damaging revelation shows that–despite Congressional criticism of industry’s undue influence on recipients of NIH grants, the NIH has done nothing to rein in either Dr. Nemeroff or others like him: according to NIH administrators, NIH rules allow Dr. Nemeroff to continue to serve on NIMH grant review committees–despite the fact that he had been barred for cause from receiving NIH grants for two years by Emory University.

Dr. Insell disingenuously claims, "I must comply with the current policy which permits someone to apply for NIH funding unless they have been de-barred."
This raises the interesting question about what constitutes cause for debarment?

The dust-up involving Dr. Nemeroff and Dr. Insell shines a light on NIH leaders whose excuses for their failure to enforce federal disclosure requirements have the ring of theater of the absurd.

Dr. Insell would have us believe that he / NIH lack authority to deny Dr. Nemeroff an appoinatment to NIH grant awarding committees. He made the disingenuous claim that NIH lacks authority to prevent taxpayer dollars from being awarded to researchers with gross conflicts of interest; researchers who violate federal disclosure rules with impunity; researchers who violate research standards of honest science–by penning their names to ghostwritten articles, and promoting dubious treatments in which they have an undisclosed financial interest. 

Having made that claim, Dr. Insell has opened up a tightly contained can of worms: 
If, by NIH standards, Dr. Nemeroff–who was barred by Emory University from NIH-funded research for two years–is fit to serve on NIH grant awarding committees, it stands to reason that such committees are made up of equally disreputable researchers.  It would also explain why NIH maintains tightly held secrecy about who are the members of its advisory committees.

An investigation by the Senate Finance Committee is warranted to examine NIH’s entrenched secret process for making committee appointments:

As the case involving Dr. Nemeroff (dubbed the poster child for conflicts of interest run amok)  and Dr. Insell (who shirked his public responsibility) demonstrates, NIH leaders fail to enforce –or even to take seriously–the most aggregious violations of federal conflict of interest rules.

Therefore, sweeping changes are necessary to ensure that conflicts of interest do not taint the NIH grant approval process, and that the integrity of research funded by taxpayers is not tainted by conflicts of interest, or ghostwritten .
Academics who pen their name to ghostwritten promotional reports are are participants in fraud. They should, therefore, not be eligible for government grants.

Vera Hassner Sharav

Read more…

Dr. Daniel Carlat :
Dr. Bernard Carroll: Healthcare Renewal
Merrill Goozner:GoozNews
Ed Silverman, Pharmalot
1 boring old man:  


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