US National Institutes of Health investigated for Conflicts of Interest with Drug Companies

As Reported in the British Medical Journal

The US National Institutes of Health (NIH) has been criticised by members of Congress for letting employees accept lucrative consultancy assignments from drug and biotechnology companies. On 22 June the director of the NIH, Dr Elias Zerhouni, told the House Energy and Commerce Oversight and Investigations Subcommittee, "In retrospect, there was not a sufficient safeguard against the perception of conflict of interest." He said the NIH would tighten rules about employees' consultancy work.

The NIH's troubles began on 7 December 2003. In a front page article the Los Angeles Times described how a small number of the institutes' 17 000 employees had received millions of dollars of income from outside sources since 1995 ( 2003 December 7;sect A: 1). That in itself was not illegal, although the public and even many senators and representatives were probably unaware of the practice.

Restrictions on outside work by NIH employees were loosened in 1995 by Dr Harold Varmus, the Nobel prize winner who headed the organisation at the time, in an effort to recruit leading scientists who could earn much more at universities. In his testimony on 22 June Dr Zerhouni outlined what he described as "a major reform" since then.

"We are severely restricting the ability of NIH employees to consult with industry," he said. He suggested prohibiting holding stock in biotechnology or drug companies, consulting by senior staff and staff who award research grants, and receiving stock as payment or holding stock in drug or biotechnology companies, limiting outside work to 400 hours a year, and limiting payment to 25% of salary—as well as random audits to detect unreported outside work. He also called for more public financial disclosures by employees.

However, the Washington Post (2004 June 23;sect A: 19) reported that one researcher at the National Cancer Institute continued to receive consultancy fees, although he testified that he had suspended the agreement. It also reported that the blue ribbon committee had turned up about 100 consultancy arrangements that NIH officials didn't know about. A neurologist at the National Institute of Mental Health, Dr Trey Sunderland, had received more than $500000 (£273250; {euro}410340) over the past five years in fees, honorariums, and expense repayments from Pfizer, but the amounts had not been reported. Dr Elias Zerhouni admitted that safeguards were inadequate

The Wall Street Journal (2004 June 22;sect A: 4) reported that the investigation into conflicts of interest is being expanded to 15 other federal agencies.