Why Grassley Is Investigating Emory’s Nemeroff
3 CommentsBy Ed Silverman // October 3rd, 2008 // 2:41 pm
The reason - the psychiatry department chair at Emory University earned more than $2.8 million in consulting arrangements with various drugmakers between 2000 and 2007, but failed to report at least $1.2 million of this income to his university. This oversight violated federal research rules, a point that is central to a widening probe of some 30 academic researchers by the Senate Finance Committee.
Since yesterday, we have twice posted items indicating Charles Nemeroff and Emory were caught up in the investigation (look here and here). Now, The New York Times has revealed a detailed account.
For instance, the paper writes that Nemeroff signed a letter dated July 15, 2004, promising Emory administrators that he would earn less than $10,000 a year from Glaxo to comply with federal rules. But on the same day, he was at the Four Seasons Resort in Jackson Hole, Wyoming, earning $3,000 of what would become $170,000 in income that year from Glaxo - 17 times what he agreed.
“It looks like problems with transparency are everywhere,” Chuck Grassley, the ranking Republican on the committee who has spearheaded the investigation, tells the paper. “The current system for tracking financial relationships isn’t working.”
So far, the committee has singled out Stanford University’s Alan Schatzberg, Harvard University’s Joe Biederman, Brown University’s Martin Keller, University of Texas’ Karen Wagner and John Rush, and Melissa DelBello at the University of Cincinnati.
As for Nemeroff, he was the principal investigator for a five-year, $3.9 million grant from the National Institute of Mental Health for which Glaxo provided drugs. Income from Glaxo of $10,000 or more in any year of the grant - a threshold Nemeroff crossed in 2003, 2004, 2005 and 2006 - required Emory to inform the NIMH and manage the conflict or remove Nemeroff as the investigator. Repeatedly assured by Nemeroff that he had not crossed the threshold, Emory did nothing, the Times writes.
An Emory spokesman writes the Times that the university was “working diligently to determine whether our policies have been observed consistently with regard to the matters cited by Senator Grassley. Dr. Nemeroff has assured us that: ‘To the best of my knowledge, I have followed the appropriate university regulations concerning financial disclosures. I have dedicated my career to translating research findings into improvements in clinical practice in patients with severe mental illness.’ ”
“Results from NIH-funded research must not be biased by any conflicting financial interests,” John Burklow, an NIH spokesman, wrote the Times. “Officials at Emory are investigating the concerns. Failure to follow NIH standards on (conflicts of interest) is very serious and NIH will take all appropriate action to ensure compliance.” Under pressure from Grassley, the NIH prompted Stanford to remove Schatzberg as principal investigator on a grant, but such moves are still very rare.
Emory investigated Nemeroff’s outside consulting arrangements four years ago and, in a 14-page report, the university’s conflict of interest committee detailed multiple “serious” and “significant” violations of university procedures intended to protect patients, the paper writes. But besides insisting that he mend his ways Emory took little apparent action and made no attempt to independently audit Nemeroff’s consulting income, and his violations continued. Look here, here and here.
In 2003, Nemeroff failed to state in a review of experimental treatments for depression that he had significant financial ties to three therapies that he mentioned favorably. He blamed the journal. Three years later, he blamed a clerical mix-up for failing to disclose in an article that he co-wrote, published in a journal he edited, that he and his co-authors had financial ties to Cyberonics, the maker of a controversial device that they reviewed favorably, the Times writes. Nemeroff stepped down as editor.
The Cyberonics paper led to a bitter e-mail exchange between Nemeroff and Claudia Adkison, an associate dean at Emory, the Times writes. Adkison noted Cyberonics had paid not only Nemeroff and his co-authors but also given an unrestricted educational grant to Nemeroff’s department. “I can’t believe that anyone in the public or in academia would believe anything except that this paper was a piece of paid marketing,” she wrote on July 20, 2006.
Her exasperation may have resulted because, unknown to the public, Emory’s conflict of interest committee in June 2004 discovered Nemeroff had made more serious blunders, including failures to disclose conflicts of interest in trials of drugs from Merck, Lilly and Johnson & Johnson. His continuing oversight of a federally financed trial using Glaxo drugs led Adkison to write Nemeroff on July 15, 2004, that “you must clearly certify on your annual disclosure form that you do not receive more than $10,000 from GSK.”
In a reply dated Aug. 4, Dr. Nemeroff wrote that he had already done so but promised again that “my consulting fees from GSK will be less than $10,000 per year throughout the period of this N.I.H. grant.” But when he sent that letter, the Time writes, Nemeroff had already earned more than $98,000 that year from Glaxo. Three weeks later, he got another $3,844.56 for giving a marketing talk at the Passion Fish Restaurant in Woodbury, New York. Look here and here.
From 2000 through 2006, Nemeroff earned more than $960,000 from GlaxoSmithKline but listed earnings of less than $35,000 for the period on his university disclosure forms, according to Congressional documents the Times revieed.
A Glaxo spokeswoman tells the Times that “Nemeroff is a recognized world leader in the field of psychiatry,” and that the drugmakers requires its paid speakers to “proactively disclose their financial relationship with GSK, and we believe that healthcare professionals are responsible for making those disclosures.”
Robin Green
these physicians should be immediately fired from their respective universities. They have permanently sullied their reputation. It’s disgraceful. I hope Emory and the other schools are sitting up and taking note of this horrid publicity for their institutions.
Justice in MI
As an academic, I think full sunlight - in blinding detail - is much better than firing particular individuals. Of course, there are spectacular offenders. But we are also talking about a far more general phenomenon which leaves virtually no major research university untouched. And it is not only in the relationship with the pharm industry and ‘academic medicine’, but in a range of other industry-university partnerships.
I am not against the latter. But it is time to open the window and see what’s going on, what makes sense, and what does not.
Ditching Nemeroff will not solve Emory’s problem, nor that of many other institutions.
Terryeo
Ditching Nemeroff would be a good first step. The man has flaunted the many regulations put in place that insure psychiatric research is valid. He has used his academic position to create academic support toward marketing Pharm industries production. That puts us and our children at risk because then Pharma can sell us any drug they stir up. Then that causes negative results like school shootings, drug recalls, and finally, the court system is activated to do Nemeroff’s job which is PROTECTING THE PUBLIC. When psychiatric research becomes scribbled notes, Psychiatry’s reputation is hurt, academic reputation is hurt and the public is effected.