Conflicts of interest among US NIH employees may go unresolved
This article was originally published in Scrip
The many institutes within the US National Institutes of Healthmust handle allegations concerning conflict of interests and ethics violations for about 18,000 employees, and an investigative agency found that one third of allegations received between January 2006 and June 2007 did not have documented resolutions – which left up in the air whether and how the allegations were resolved.
The new report, from the health and human services department's office of inspector general (OIG), also stated that the majority of institutes do not have uniform, written procedures regarding how to handle allegations uniformly – and it recommended the development of a formal, written policy to be followed by the institutes' ethics offices.
It was reported that the NIH resolved 60% of substantiated allegations internally and forwarded another 7% to OIG for possible investigation. The majority of allegations were resolved by having the employees complete the required ethics training or forms. But notably, the report cited the fact that the NIH did not provide documentation regarding its final resolutions for 33% of substantiated allegations. "The absence of documentation does not necessarily mean that the allegation was not resolved," the report concluded. "However, without complete documentation, it is impossible to determine whether and how these allegations were resolved, including whether they were handled appropriately and consistently." The OIG recommended that NIH ensures that documentation detailing how allegations are ultimately resolved is maintained.
The 7% of allegations that involved potential criminal violations (a total of 39 cases referred to the OIG) involved potential violations of conflict of interest statutes, as well as violations of other ethics regulations.
According to the report, examples of the potential criminal allegations include NIH employee(s) who:
- served as a director of a company that submitted an application for an exclusive licence to develop and commercialise a drug privately while participating as an NIH employee in research and data collection for the same drug;
- influenced the award of a contract to a university from which the employee is on a leave of absence;
- improperly acted as a consultant for pharmaceutical companies;
- used position and influence to encourage an NIH board of scientific directors to deny funding to an intramural research programme investigating a drug because of the employee's financial ties with a pharmaceutical company developing a competing drug;
- conducted prohibited outside activities; and
- accepted compensation from prohibited outside entities.
The NIH agreed with the OIG's recommendations, and stated that, as of August 2008, they were implemented as a new chapter in the NIH Policy Manual.
The NIH put in place stringent new ethics rules in 2005 to combat complaints from Congress and watchdog groups that some NIH scientists had lucrative outside activities that might be conflicts of interest. The rules ban all 18,000 NIH staffers from paid outside consulting with the pharma/biotech industry, as well as with healthcare providers or insurers.
In addition, senior NIH employees and their immediate family members can only own $15,000 worth of stock in "substantially affected organisations" (those that they or their subordinates can substantially affect by their decisions). Many senior NIH employees had to divest tens of thousands of dollars in stock in individual biomedical companies.
NIH officials had already looked into 103 cases of possible conflict of interest in 2004 – after the House energy and commerce oversight subcommittee had referred cases that suggested that scores of researchers may have taken drug industry money without seeking permission or reporting the income to the NIH (as required at the time). It was after that investigation that the strict ban on outside consulting was put in place. Only a handful of those cases were eventually referred to the HHS inspector general.
In March 2007, in a letter to the House committee, the inspector general said it was re-opening the 103 cases. At the time, the subcommittee chairman Bart Stupak said the reopening was warranted and noted: "The subcommittee discovered the violations through documents provided from pharmaceutical and biotech companies which detailed more than $1 million in payments from the companies to NIH employees. Under NIH guidelines, the employees were required to disclose the payments, but failed to do so."
In 2005, when the new ethics rules were being rolled out, the Wall Street Journal suggested that there were many undercurrents to what was happening, as the rules "have angered NIH lifers on a deeper level: their pride is hurt. Internal NIH scientists – who have included five Nobel laureates – tend to want to be treated more like academic rock stars, not as functionaries of the federal work force. To many of them, the rules reek of diminished status." Many had also suggested that the then-NIH director Dr Elias Zerhouni had to deal with a whole new attitude on transparency and ethical concerns, and had inherited a culture of special privilege put in place by former NIH director Dr Harold Varmus.