The SRA Symposium - College of Medicine

After A Day Of Infamy, December 7, 2003—What Regulatory Ethics
Have Become at the National Institutes of Health by August 31, 2005
John J. Gillon, Jr., J.D., M.P.H.
Senior Attorney
Office of Petitions, U.S. Patent and Trademark Office,U.S. Department of Commerce
Visiting Fellow, Center for Biomedical Ethics/University of Virginia Health System
Serves pro bono on the Institutional Review Boards of Walter Reed Army Institute of Research,
Walter Reed Army Medical Center, and the American Red Cross Biomedical Services
2921 Stanton Avenue
Silver Spring, MD 20910-1218
Phone/FAX (301) 589-6527
john.gillon@starpower.net
Authors’ Note
The views presented are those of the author and do not represent the policy or opinion of the
Government of the United States or any of its agencies.
Comments from Society members are welcomed.
Papers
Abstract
For the 17,500 employees of the National Institutes of Health there may have been a sense of
unprovoked attack when they awoke to find that Los Angeles Times reporter David Willman
had targeted their institution with allegations that conflicts of interest and their corrupting influences
were standard operating procedure at the NIH. The Congressional and Inspector General
investigations of these allegations demonstrated that fewer than 70 scientists—maybe fewer than
50—had violated ethics rules then in place. Yet, the newspaper’s indictment of the NIH staff was
carried as a top story by news operations throughout the nation, even The Washington Post buried
on page the vindication of the many thousands of dedicated women and men at the NIH. Why
and how the staff and institutes of NIH came under—in the last half of the 20th Century—an
unmeasured and almost wholly undefended attack is lucidly and elegantly discussed by Evan G.
DeRenzo, Ph.D., in a recent article for the Kennedy Institute of Ethics Journal, and need and will
not be re-examined here. Better now to reflect upon the substance of some of the changes that
have taken place over the last decade—that is, to look at the regulations in the wake of legislation
and the administration of former NIH Director, and Nobel Prize winner, Harold Varmus, M.D.,
and how those regulations have been changed twice in 2005 following the December 2003 L.A.
Times allegations. Whether any of the feared mass exodus of scientific talent from the NIH occurs
likely will have more to do with whether the monies and the freedoms to engage in challenging
and state-of-the-art scientific research continue to be made available to NIH staff than what stocks
NIH staffers can own and for whom they can consult.
Introduction
Flooded with 1,300 comments by employees and threats of high-level defections, the head of the
National Institutes of Health agreed [on August 25, 2005,] to loosen some of the ethics rules he
unveiled in February.
* * *
Congress prompted the new regulations after lawmakers discovered that dozens of scientists had
not revealed income and other perks they received from for-profit companies, as required.
(Emphasis supplied)
-- The Washington Post, Friday, August 26, 2005 (Connolly 2005)
2005 Symposium Proceedings Book 77