By Jeffrey Young - 06/22/05 12:00 AM EDT
The National Institutes of Health (NIH) continues to receive increased scrutiny of its activities by the House Energy and Commerce Committee, which wrote NIH Director Elias Zerhouni on Monday charging that the agency does not adequately account for human tissue samples it collects during its research activities.
Acting on a tip from an NIH employee who remains anonymous, committee investigators have determined that “NIH has no uniform, centralized, and mandatory authority regulating the handling of human tissue samples,” Committee Chairman Joe Barton (R-Texas), ranking member John Dingell (D-Mich.), Oversight and Investigations Subcommittee Chairman Ed Whitfield (R-Ky.) and subcommittee ranking member Bart Stupak (D-Mich.) assert in the letter. “In addition, there is no formal inventory control or tracking system,” the letters says.
When he took over as chairman of the committee last year, Barton made it clear that Congress’s oversight of the NIH had been inadequate and that the agency’s management would be subject to renewed attention by the panel. Barton also indicated that the Energy and Commerce Committee would undertake a thorough effort to reauthorize the massive agency, which has a $28.5 billion budget for the current fiscal year. The NIH’s budget more than doubled between fiscal years 1998 and 2003, but the agency has not been reauthorized since 1993.
The NIH became the target of several investigations by the Energy and Commerce Committee under then-Chairman Billy Tauzin (R-La.) and then-Oversight and Investigations Subcommittee Chairman Jim Greenwood (R-Pa.) in 2003 and 2004. Greenwood and Tauzin focused on potential conflicts of interest arising from NIH researchers’ taking on outside work with drug companies and others, compensation for senior agency employees, and the public availability of the results of NIH-funded research.
The underlying problem is that the director’s office lacks sufficient authority to implement its management objectives, said Kevin Schweers, the Energy and Commerce Committee’s spokesman. Barton has made similar statements in the past and intends to address the power of the director in the reauthorization legislation. Zerhouni was named director in May 2002.
The implications of NIH policies — or lack thereof — regarding the collection and storage of human tissue samples are wide-ranging, according to the Energy and Commerce Committee letter. In addition to complicating the efforts of NIH researchers to identify and use samples that should already be available, “the lack of accountability leaves NIH wholly vulnerable to theft and diversion of valuable human tissue samples,” the letter states.
“We are extremely concerned over what was described to committee staff by NIH officials of a fairly loose, ad hoc approach to controlling human tissue samples,” the committee leaders wrote.
An NIH spokesman yesterday offered a defense of the agency’s policies but emphasized it will cooperate with the committee. “There are complex rules that govern obtaining, storing, using and destroying human tissue samples. These involve important considerations of safety, protection of human subjects, research integrity and clinical use. NIH will be responding to the committee’s request for information,” the spokesman said.
The committee was approached in April by an NIH researcher who raised concerns about the shortcomings of the agency’s rules governing human tissue samples. Last year, the researcher tried to obtain spinal-fluid samples she had collected in the 1990s during a stint at the National Institute of Mental Health (NIMH), part of the NIH. (She left NIMH in 1997 and joined another part of the NIH in 2001). In January of this year, her former superior at NIMH told her that most of the samples could not be located.
The Energy and Commerce Committee requests that the NIH provide detailed information on its human tissue samples, including the “current total number” in the agency’s position. The committee also wants a variety of other information, including whether any investigations have been conducted about missing samples. The NIH is instructed to produce that information by July 5.
The NIH spokesman said the agency would reply “as quickly as possible.”
In response to a question about whether the agency would be able to comply with these directions if it, in fact, currently does not comprehensively track its human tissue samples, Schweers said the agency’s answers to the requests would indicate the quality of its internal oversight. “We don’t know for sure [whether the NIH can provide the information requested], but that’s really the point,” Schweers said. “Either they will be able to, indicating there are some safeguards in place, or they won’t be able to, and that’ll be telling as well,” he said.
The Energy and Commerce Committee letter does not name the NIH employee who tipped off the panel but provides a high level of detail about her, including her sex, the NIH institute and office where she was employed until 1997, when she rejoined the NIH, and the area of research on which she works.
Nevertheless, the NIH spokesman maintained that “the individual is completely anonymous” and that the agency enforces strict policies to protect whistleblowers and others from retaliation by superiors.
“There [was] no significant fear of retribution expressed” by the NIH employee who approached the committee, Schweers said.