SEE ALSOResearch disputed: Professor's study may have hid drug's suicide link
Investigators from the U.S. Senate Finance Committee are scrutinizing Brown over disclosure of conflicts of interest in clinical research, Provost David Kertzer '69 P'95 P'98 confirmed Thursday.
Though University spokespeople would not comment on the details of a letter of inquiry from ranking committee member Sen. Charles Grassley, R-Iowa, a source familiar with the investigation has confirmed that the letter names Professor of Psychiatry and Human Behavior Martin Keller, the chairman of the psychiatry department at the Alpert Medical School.
Grassley has sent letters to more than 20 academic institutions asking that specific researchers disclose all financial ties to drug companies.
The letter from Grassley is the latest in a years-long string of questions that have been raised over Keller's clinical research and his relationships with the drug companies who sponsor it. The research and relationships have been lambasted in medical journals, the popular press and, more recently, an inflammatory book.
The Herald contacted Keller several times starting Sept. 10, but he said he was unavailable for comment before press time.
Keller has gained notoriety for authoring a controversial clinical study of the antidepressant drug paroxetine - marketed as Paxil in the United States - which concluded that the drug was safe and effective in adolescents. Keller and some of the study's co-authors have been accused by doctors, lawyers and journalists of having the 2001 study ghostwritten, earning large sums of money from Paxil's maker, GlaxoSmithKline. In addition, some say the researchers manipulated and suppressed data - including those showing increased suicidal tendencies in children taking the drug.
Study 329, as it is referred to by GSK, went on to become one of the most-cited articles in medical literature supporting the use of antidepressants for adolescent depression. At the time, GSK jumped on the favorable results, seeking to promote the use of its product among children, a largely untapped market for antidepressants.
In recent years, new studies and secondary research using old data have demonstrated that Paxil can lead to increased suicidal tendencies in children.
Keller would later acknowledge in a 2006 deposition that he had been accepting tens of thousands of dollars in consulting fees from GSK and Scientific Therapeutics Information - a company acting on GSK's behalf - during and after the years he was conducting crucial research on the efficacy and safety of Paxil in children.
The University encourages its researchers to collaborate with outside companies, said Regina White, associate vice president for research administration, though it requires full disclosure of all payment involved.
But Alison Bass, a former reporter for the Boston Globe, said Keller may have earned more than he acknowledged in tax returns. In a 1999 article for the Globe, Bass reported that Keller had earned a total of $1 million in consulting fees from various drug companies over the fiscal years 1997 and 1998, according to his tax returns from those years.
According to Bass, the tax returns show that Keller received $218,000 from Pfizer and $77,400 from Bristol-Myers Squibb during the same year he was praising Pfizer's Zoloft and publishing positive conclusions on BMS's Serzone.
Missing from his tax returns, Bass told The Herald, was the money Keller acknowledged earning from GSK.
To root out conflicts of interests in research, the National Institutes of Health requires all of its grant applicants to disclose "significant financial interest" involving at least $10,000 in earnings. But the same restrictions do not extend to research funded fully by the private sector, of which GSK is part. However, some of Keller's other research on antidepressants like Prozac, Celexa, Zoloft and Paxil is funded by the NIH, which may be how he landed on Grassley's list.
Grassley's office has recently made public a small number of the letters requesting information, including one this month to Karen Wagner, a clinical professor at the University of Texas Medical Branch at Galveston and a co-author with Keller of Study 329. The letter claims that GSK paid Wagner $160,404 over six years, of which Wagner reported $600.
The Iowa senator has also targeted physicians at some of Brown's peer institutions over similar charges, including Alan Schatzberg of Stanford - who recently resigned his position as principal investigator on a federal research grant in response to the committee's scrutiny, the Stanford Daily reported Monday.
GSK's Director of U.S. Media Relations Sarah Alspach wrote in an e-mail to The Herald that the company has given Grassley full information on Keller's financial compensation. She added that GSK requires full disclosure from its employees and imposes "rigorous guidelines" over researchers who are compensated by the company.
In an e-mail to The Herald, Kertzer wrote that the University has complied with Grassley's requests and has supplied the appropriate information. No University spokesperson would comment on the specifics of Keller's case, citing the privacy of its employees, but Kertzer wrote that the University is diligent in monitoring conflicts of interests among its researchers.
"The University promulgates and enforces policies that require disclosure of significant financial interests related to their University responsibilities," Kertzer wrote. He referred to the University's policy for responding to allegations of research misconduct, which defines conflicts of interest as any case where "bias may occur due to prior or existing personal or professional relationships. White added that it is common practice for researchers to have financial relationships with outside companies, but these only become problematic when they interfere with a researcher's objectivity.
Policies like Brown's are "very common in most universities," she said. "Conflict of interest is not inherently wrong." But White drew the line at misconduct. "Scientific misconduct is inherently wrong. It's unethical, and it actually is harmful to the research environment."
