Congressional Investigation of NIH: Cash Gifts From Grantees

Congressional Investigation of NIH: Cash Gifts From Grantees

Tue, 8 Jul 2003

The Scientist reports that a Congressional committee is investigating the for “possible violations of federal criminal and ethics laws” involving Richard Klausner (former director of the National Cancer Institute) and other officials who accepted “lecture awards” and other cash gifts from universities and research institutions that receive NCI and NIH research grants.

In a June 26 letter, NIH director, Elias Zirhouni, was ordered to turn over numerous documents relating to “management and ethical concerns at the agency” by July 11. “The committee noted possible “systemic issues” in the award approval process at NIH, including “self-certification of ethical requirements” as opposed to an independent assessment by a federal ethics officer.”

Another ethically questionable practice (at least at one other NIH institute) involves public officials who serve as paid expert witnesses for academic institutions that are funded by NIH. A controversial case involves a much criticized, controversial research project funded by National Institute of Mental Health (NIMH) in which patients suffered schizophrenia relapses. One NIMH official received more than $13,000 payment for testimony favorable to the University of California which receives grants from NIMH.

A complaint filed in December 2002 with the Office of the General Counsel on Ethics (DHHS) questioned whether NIMH officials who serve as paid witnesses on behalf of the institutions they fund violated the NIH Code of Ethics?

A Congressional investigation into conflict of interest by public officials at the nation’s medical research institutes is welcome as such conflicts of interest have affected the safety of research subjects and integrity of the entire medical research enterprise. Self-regulation by the research community has resulted in corruption at all levels.

~~~~~~~~~~~~~~~~~~~~~~~

http://www.biomedcentral.com/news/20030630/06

June 30, 2003Previous

NIH ethics investigation
Cash gifts from grantees prompt congressional investigation of NIH officials | By Ted Agres

Richard D. Klausner, former director of the National Cancer Institute (NCI), and other current and former senior officials of the National Institutes of Health (NIH) are being investigated by a congressional committee for possible violations of federal criminal and ethics laws. The investigation centers on the acceptance by Klausner and other officials of “lecture awards” and other cash gifts from universities and research institutions that receive NCI and NIH research grants.

In a June 26 letter, Rep. Billy Tauzin (R-La.), chairman of the House Energy and Commerce Committee, and Rep. James Greenwood (R-Penn.), chairman of the Subcommittee on Oversight and Investigations, ordered NIH Director Elias Zerhouni to turn over numerous documents relating to “management and ethical concerns at the agency” by July 11.

John Burklow, associate director for communications at NIH, said in a statement: “We just received the letter. We are not aware of any ethics rules violations; however, we will review the questions raised by the committee and respond in a timely manner.”

Of particular interest to the committee is Klausner’s receipt in 2000 of a $3000 cash award plus transportation and lodging expenses from the Arizona Cancer Center, an NCI-designated comprehensive cancer facility at the University of Arizona Health Sciences Center in Tucson. Klausner was NCI director from 1995 to 2001.

In December 1999, the Arizona Cancer Center invited Klausner to give its annual Waddell Award Lecture. Klausner accepted, and on January 13, 2000 he delivered a lecture in Tucson on the future of cancer research. At the time of the award, the Arizona Cancer Center received NCI grants in excess of $25 million and had $486,000 in federal contracts, the committee stated. Klausner signed a recusal statement disqualifying himself from participating in matters involving the Arizona Cancer Center from December 15, 1999 until at least January 15, 2000. He also certified that the “award is not being offered by an entity that has interests… that may be substantially affected by the performance or non-performance of the employee’s official duties.”

The committee asked an attorney with the American Law Division of the Congressional Research Service (CRS) to analyze the legal issues surrounding the award, Tauzin and Greenwood wrote. The attorney concluded that the NCI director is a presidential appointee and is prohibited by executive order from receiving any outside earned income from the course of his appointment. “Thus, the NCI director could not accept private payment as compensation or consideration for giving a speech or lecture,” the CRS attorney concluded.

Furthermore, the NCI director and other high-ranking NCI officials are prohibited under federal ethics regulations from receiving an honorarium from a private source for a lecture that focused on cancer research funded by the NCI, the attorney said.

Klausner’s 1-year recusal also does not resolve conflict of interest problems since it was for a limited, short period of time and did not prevent him from making decisions in the future, “immediately after accepting the large cash award, which may affect new grant applications [and] the renewal of existing grants.”

Klausner is currently director of the global health program at the Bill & Melinda Gates Foundation in Seattle. A spokesman for the foundation did not respond to a request for comment. Rob Raine, media relations coordinator for the Arizona Cancer Center, said the Waddell Award is granted to acknowledge expertise in cancer research. “There was no intention to influence any kind of grants,” Raine told The Scientist. “In fact, it’s impossible. The grant process is a peer-reviewed process.”

Klausner’s award from the Arizona Cancer Center is not the only such incident, Tauzin and Greenwood stated. The following year, another senior NCI official also received a Waddell Award and delivered a lecture on cancer research.

In 2000, Klausner also received the Daniel Nathans Memorial Award, a $4000 cash prize from the Van Andel Research Institute in Michigan, the committee letter stated in a footnote. In 1999, Klausner “apparently accepted” a $15,000 Block Leadership Award from Ohio State University. That award was not included in Klausner’s public financial disclosure report for 1999, the letter stated.

The committee noted possible “systemic issues” in the award approval process at NIH, including “self-certification of ethical requirements” as opposed to an independent assessment by a federal ethics officer.

In launching a “broad examination of ‘lecture awards’ from NIH grantees received by NIH officials,” the committee has instructed NIH to provide a list of all lecture awards and prizes given to NIH employees by institutions since January 1, 1998 and specific information on the amounts and dates of all NIH grants awarded to those institutions.

The lecture awards and cash gifts given to Klausner and other NCI officials raise “precisely the ethics and conflict of interest concerns at which the regulations and statutes on gifts and compensation from interested parties are focused,” the CRS attorney concluded.

Links for this article
National Cancer Institute
http://www.nci.nih.gov/

National Institutes of Health
http://www.nih.gov/

“Tauzin, Greenwood Launch Ethics Investigation at NIH, The House Committee on Energy and Commerce Correspondence,” June 26, 2003.
http://energycommerce.house.gov/108/Letters/06262003_991.htm

Arizona Cancer Center
http://www.azcc.arizona.edu/

©2003, The Scientist Inc. in association with BioMed Central

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available to advance understanding of ecological, political, human rights, economic, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a ‘fair use’ of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior general interest in receiving similar information for research and educational purposes. For more information go to: http://www.law.cornell.edu/uscode/17/107.shtml If you wish to use copyrighted material for purposes of your own that go beyond ‘fair use’, you must obtain permission from the copyright owner.