Feds Probe Researcher's Drug Industry TiesMar 5, 2009 | Parker Waichman LLP
Late last year, we wrote about prominent Emory University professor Charles Nemeroff who lost his chairmanship following controversy over payments he received from drug companies. In December, following an internal investigation, Nemeroff stepped down as head of the school's Department of Psychiatry and Behavioral Sciences, a position he held since 1991. Now, the Atlanta Journal-Constitution reports that federal officials are investigating both the university and Nemeroff and are looking into Nemeroff’s highly compensated activities with the pharmaceutical industry.
Although it is understood that industry hires scientists and physicians to test drug safety and efficacy for later use by the U.S. Food and Drug Administration (FDA) when drug approval is sought, strict procedures—including those surrounding financial information—are in place, but are clearly not always followed. Nemeroff, said the Atlanta Journal-Constitution, a renowned, international expert on depression, has been mentioned a number of times in Grassely’s Congressional investigation.
Because of this growing problem, U.S. Republican Senator and ranking member of the Senate Finance Committee, Charles Grassley, urged the investigation and sent a letter this week to the inspector general of the U.S. Department of Health and Human Services (HHS), detailing his concerns and explaining that Nemeroff might be in violation of conflict-of-interest rules with regard to a number of grants Emory University received from the National Institutes of Health (NIH); Emory is required to report such conflicts to the NIH, Grassley said, according to the Atlanta Journal-Constitution. Conflicts of interests can result in fines, fund freezes, and future grant loss, said the Atlanta journal-Constitution, which noted that the NIH awarded Emory in excess of $251 million in 2008, about 61 percent of its total research grants.
To help ensure no conflict-of-interest opportunities present themselves, the government mandates all such conflicts be reported by clinical researchers responsible for reviewing medications in advance of drug companies applying for FDA approval. But, earlier this year, the Inspector General’s Office said the FDA is not reliable when it comes to finding drug research conflicts of interest, a huge issue these days between medical professionals and industry.
In January, the Canadian Press reported that poor and late information and loopholes are to blame and that the FDA is integral to the problem, noting that the HHS said the FDA’s screening system is wanting and that it “found a number of limitations in FDA’s oversight, leaving FDA unable to determine whether (drug companies) submit financial information for all clinical investigators,” saying that such issues “could result in FDA being unaware of a clinical investigator’s financial interest, and thus unable to gauge its potential bias on clinical trial results.” As matter-of-fact, the report found that only 206 of the nearly 30,000 clinical investigators disclosed potential financial conflicts.
According to an earlier Wall Street Journal piece, Nemeroff failed to report to Emory over $800,000 he received from Glaxo for more than 250 speaking engagements from January 2000 to January 2006. According to a prior Atlanta Journal-Constitution, Emory's investigation also found that Nemeroff received income from other drug makers, but Glaxo was, by far, his biggest patron.
In October, we reported that documents released by Emory to Grassley’s investigators indicated that Nemeroff was paid more than $2 million by pharmaceutical companies, but failed to report over $1 million of that income to Emory while working on government-funded drug research. The documents include a letter from Nemeroff dated July 15, 2004 in which he promises Emory administrators he would under $10,000 annually from GlaxoSmithKline in order to maintain federal compliance; however, Nemeroff actually earned $170,000 from Glaxo that very year.