The Honorable Elias Zerhouni, M.D.
Director, National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892

Dear Dr. Zerhouni:

The Committee is continuing its investigation of management and ethics concerns at the National Institutes of Health (NIH). We note that the Los Angeles Times in its December 7, 2003 article reported that several high-level NIH scientists have received secret consulting fees and stock options from drug companies for consulting outside their government work. In addition to the payments detailed in the Los Angeles Times, the Committee is examining additional information on the subject of outside consulting agreements and other activities of NIH scientists that have arisen from the investigation the Committee initiated on June 26, 2003 concerning the receipt of cash by NIH scientists in the form of lecture awards from outside entities that do business with the NIH. The receipt of outside payments, even though approved, raises concerns about whether the integrity of NIH clinical research has been affected and whether the honor system used by NIH to enforce recusals signed by NIH scientists and other conflict-of-interest rules has been violated.

We note also that on November 20, 2003, you initiated administrative changes to strengthen the NIH ethics program by your written statement discouraging the receipt of awards or other compensation from outside entities that do business with the NIH. We think you have taken a positive first step for the NIH and we appreciate your leadership. However, to ensure the success of your initiatives, further information is needed to ensure that the ethical concerns have been fully and accurately identified, and whether there are other legal or public policy considerations outside the control of the NIH that need to be addressed.

Therefore, in light of the ethical concerns revealed in the Los Angeles Times article and in support of the leadership you have exerted on behalf of the NIH ethics program, we are requesting further information and records. Pursuant to Rules X and XI of the U.S. House of Representatives, please provide the following by January 8, 2004:

1. A list of all consulting arrangements with drug companies for NIH employees since January 1, 1999, including the starting and ending date of the consulting arrangement, the name and position of the NIH employee, the amount of the payment and stock options paid to the NIH employee, and the amount of any expenses paid by the drug company.

2. For each drug company engaged in a consulting arrangement with a NIH employee, please provide a list of all NIH grants, contracts and agreements to that company, the institute and the specific office approving the grant, and the dates that the funds were made available.

3. A copy of the November 1995 memorandum by the then-NIH Director Harold Varmus described in the Los Angeles Times article as rescinding a policy that barred NIH scientists from accepting consulting fees and payments of stock from companies, and all records relating to this 1995 memorandum.

4. A copy of the 1999 letter that Dr. Varmus sent to the NIH institute directors that cautioned them to "avoid even the appearance of a conflict of interest," and all records relating to the 1999 letter.

5. A copy of the May 2000 speech delivered by Dr. Ruth Kirschstein to medical researchers that conflicts of interest posed a "major concern."

6. All records of outside activities disapproved since January 1, 1998 by Dr. Ruth Kirschstein.

7. A copy of the 1998 legal opinion that the Los Angeles Times reported that NIH officials relied in part to allow more than 94% of the agency's top-paid employees to keep their consulting income confidential.

8. All records since January 1, 1999 relating to communications to and from any ethics advisors at NIH, including Deputy Ethics Counselors about outside consulting arrangements with drug companies.

9. All records since January 1, 1999 relating to financial disclosure reports submitted by the NIH employees identified in Request Item #1.

Please note that, for the purpose of responding to these requests, the terms "records" and "relating" should be interpreted in accordance with the attachment to this letter. In addition, we are requesting that following production of the records to the Committee, you make available NIH employees for Committee staff interviews as requested by Committee staff.pressofficerules

Thank you for your assistance. If you have any questions, please contact Alan Slobodin of the Majority Committee staff at (202) 225-2927.

Sincerely,