The National Institutes of Health (NIH) has suspended a $9 million grant for a depression study led by a psychiatrist at Emory University in Atlanta. The punishment, imposed in August but only made public today, is apparently the most severe reaction by NIH so far to a Senate investigation of NIH-funded researchers who may have failed to report all of their income from drug companies.
Since last spring, Senator Charles Grassley (R-IA) has accused at least nine academic psychiatrists of failing to follow federal rules that require NIH grantees to report industry consulting income to their institutions. One investigator at Stanford University has been removed from an NIH grant. The most recent revelations involve Emory's Charles Nemeroff, who allegedly reported only $1.2 million of at least $2.4 million that drug and device companies told Grassley they paid him between 2000 and 2007.
Nemeroff is "voluntarily stepping aside" from all NIH grants on which he was the leader or co-investigator, according to an Emory statement, after having stepped down as chair of the psychiatry department. NIH recently asked that Nemeroff be removed from the three research grants and some training grants "until there's resolution" of the concerns, says David Wynes, vice president for research administration at Emory, which has launched its own investigation. In addition, NIH has halted funding for one grant--a $9.3 million, 5-year clinical study of depression that began in 2006. (The suspended grant was first reported today by the Atlanta Journal-Constitution.)
The depression study aims to enroll 600 patients in a 12-week study testing two psychoactive drugs and cognitive behavioral therapy. Co-investigators are using genetic testing, personality assessments, and brain imaging to find out which of these treatments work best. Wynes says fewer than a dozen patients have been enrolled, although anyone still in treatment will continue to receive it. NIH suspended payment in mid-August.
It is not clear exactly why NIH suspended this particular grant. Nemeroff has consulted for Eli Lilly, which makes one of the drugs being tested, duloxetine, but his recent income has fallen below a $10,000 annual reporting threshold. The other drug, escitalopram, is manufactured by Forest Laboratories; this company does not appear on Grassley's tally of at least $2.4 million in payments to Nemeroff.
Emory also informed faculty members last week that NIH is imposing "special award conditions" on all grants. The university says it must verify that all investigators of any new grant have filed disclosures and describe any conflicts, as well as the actions Emory took to manage them. Normally, universities do not have to give NIH these details.
An NIH spokesperson declined to comment on the suspended grant. The agency is expected to issue a notice soon seeking comments on ways to strengthen conflicts-of-interest regulations that apply to NIH grantees.
NIH had previously resisted pressure from Grassley to suspend grants for conflicts violations. NIH director Elias Zerhouni told reporters last month that "you have to be careful" because halting a clinical trial can affect the treatment of patients with serious illnesses. "This is not a light decision," said Zerhouni, who is retiring later this month.