NIH Implements Royalty Disclosure Policy Five Years After Promised
NIH officials last week implemented a policy requiring government researchers to disclose personal royalties they receive for developing medical treatments -- almost five years after HHS officials pledged to disclose such arrangements to patients, the AP/Hartford Courant reports. NIH issued the order after the Associated Press filed a Freedom of Information Act request. Almost 1,000 current and former NIH researchers receive royalties for medical innovations they developed while federally employed, according to data obtained by the Associated Press.
Those recipients affected by the new policy include 51 NIH employees who currently are helping to conduct clinical trials of the medical treatments they developed. In 2004, researchers affected by the new policy were paid $8.9 million in royalties. Personal royalties up to $150,000 annually are legal, and 12 NIH researchers received the maximum legal allotment in 2004.
Former HHS Secretary Donna Shalala in May 2000 promised members of Congress that the agency would develop policies to require "that any researchers' financial interest in a clinical trial be disclosed to potential participants." Officials in January 2001 published guidance for such a policy. HHS Secretary Tommy Thompson in May 2004 also issued guidance, referring to "compensation that may be affected by the study outcome" and "proprietary interests in the products, including patents, trademarks, copyrights or licensing arrangements."
Before the new policy, NIH officials discouraged doctors from reporting royalties on federal financial disclosure forms because "NIH considers the money federal compensation, not outside income," the AP/Courant reports. In addition, NIH did not require researchers to disclose royalty information on patient consent forms. According to the AP/Courant, "The nearly five-year delay means hundreds, perhaps thousands, of patients in NIH experiments decided to participate in experiments that often carry risks without full knowledge about the researchers' financial interests." Before the policy, patients relied on patent records and scientific journals for information about researchers' royalty payments.
National Institute of Allergy and Infectious Diseases Director Anthony Fauci and NIAID Deputy Director H. Clifford Lane since 1997 received royalties of $45,072.82 each for the development of interleukin-2, an AIDS treatment they invented with NIH physician Joseph Kovacs.
Fauci said he initially refused to accept the royalties but eventually donated the money to charities when he "was told he legally had to accept them," the AP/Courant reports. Lane accepted the royalties but noted that he sometimes provided patients with articles from medical journals that list him as a patent holder. Lane said, "I believe patients should know everything that might influence their desire to be participants in research"
Bill Allison of the Center for Public Integrity said, "It's hard for patients to make an informed decision when they don't have all the information," adding, "When a doctor says, 'Here, try this experiment, it is safe, or it will help,' and the patient isn't aware he has a financial interest in the outcome of that treatment, it in essence is taking advantage of someone by not letting them have all the information."
NIH spokesperson John Burklow said, "Quite frankly, we should have done it more quickly. But as soon as [NIH] Director (Elias) Zerhouni found out about it, he ordered it done immediately" (Solomon, AP/Hartford Courant, 1/11).