GlaxoSmithKline (GSK) has become embroiled in an investigation into conflict of interest in government-funded drug research that has seen a prominent US psychiatrist step down as chairman of Emory University’s department of psychiatry and behavioural sciences until his relationships with pharmaceutical companies have been clarified.
The allegations by Charles Grassley, the ranking Republican member of the US Senate Finance Committee who has been looking into reports that a number of leading psychiatrists have failed to disclose payments from pharmaceutical companies, centre on speaking fees paid by GSK to Emery University’s Dr Charles Nemeroff.
The payments were made during a five-year period in which Nemeroff was serving as the principal investigator in a collaborative research programme between the university, GlaxoSmithKline and the National Institute of Mental Health (NIMH).
In a letter sent to the university’s president, Dr James Wagner, Grassley said it “seems [Nemeroff] failed to report approximately half a million dollars in fees and expenses from GSK” during this time, earned from “dozens of talks given to promote drugs sold by the company”.
This was despite repeated assurances from Nemeroff to Emory’s Conflicts of Interests (COI) Committee and university officials that he would comply with Emory’s COI ceiling of US$10,000 per year in consulting fees, in line with National Institutes of Health (NIH) requirements on the disclosure of any “significant financial interest” that may have a bearing on the outcomes of publicly funded research.
According to a report in the New York Times, documents provided to congressional investigators showed that Nemeroff – who has attracted attention before over his relationships with pharmaceutical and medical device companies – earned more than US$2.8 million in total from consulting arrangements with pharmaceutical manufacturers between 2000 and 2007, at least US$1.2 million of which he failed to disclose.
Grassley’s letter also includes an inventory of payments by GSK to Nemeroff between 2000 and 2006, as well as details of whether the psychiatrist filed disclosures on this income. The fees received amount to US$960,488 and only US$34,998 of that total was reported to Emory University.
Collaborative initiative
The main bone of contention is Nemeroff’s participation in the Emory-GSK-NIMH Collaborative Mood Disorders Initiative, which studied “five novel GSK antidepressant candidates”, Grassley noted. The NIH budgeted around US$3.95 million for the five-year programme, with about US$1.35 million paid directly to Emory to cover overheads.
Among the Senate Finance Committee’s allegations are that, in July 2004, Nemeroff wrote in response to concerns raised by Emory’s COI Committee about the psychiatrist’s outside activities that he would “follow the [university] management plans for my conflicts of interest”. In view of the NIMH/Emory/GSK grant, Nemeroff told the university’s executive associate dean, “I shall limit my consulting to GSK to under US$10,000/year and I have informed GSK of this policy”.
“Barely a week after this promise, on July 12, 2004”, Grassley reported, “GSK paid Dr Nemeroff US$3,500 in fees and US$505.40 in expenses for a talk he gave regarding [the antidepressant] Paxil at the Larkspur Restaurant and Grill in Las Vegas, Nevada. The following day, Dr Nemeroff gave two more talks in exchange for US$7,000 from GSK (US$3,500 per talk).”
Emory University officials say they have voiced concerns about Nemeroff’s behaviour several times in the past. While acknowledging the psychiatrist’s “fundamental contributions to the field over many years”, the university is also at pains to demonstrate that it is putting its house in order.
“Emory is committed to maintaining strong conflict of interest policies and procedures and will conduct a fair, thorough, and even-handed investigation of these claims,” the university stated. “In view of the ongoing internal and external investigations into these allegations, Dr Nemeroff will voluntarily step down as chairman of the department, effective immediately, pending resolution of these issues,” it noted.
The university also quoted Nemeroff as saying: “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. I will co-operate fully and work with Emory to respond to the alleged conflict of interest issues raised by Senator Grassley and his staff.”
GSK has sought to distance itself from the revelations, telling The Wall Street Journal it has “rigorous guidelines governing our interaction with healthcare professionals” who speak at the company’s events. These guidelines require healthcare professionals to “proactively disclose” any such relationships, the company added.
A number of leading pharmaceutical industry players in the US have endorsed the Physician Payments Sunshine Act sponsored by Senators Grassley (Republican-Iowa) and Herbert Kohl (Democrat-Wisconsin), which will oblige companies to declare gifts to doctors of more than U$500 a year.
