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Wednesday, January 12, 2005

Yet More Conflicts of Interest at the NIH

Another story, reported by the Associated Press here and in more detail here, about conflict of interest at the NIH has surfaced. NIH full-time staff are now legally able to collect royalties on inventions they developed while working for the government, including drugs and medical devices. By 2000, The NIH was supposed to develop a process to assure that NIH researchers would disclose such financial interests to patients in clinical studies. The Secretary of the Department of Health and Human Services at the time, Donna Shalala, promised "that any researchers' finanacial interest in a clinical trial be disclosed to potential participants." But the NIH only got around to actually doing so last week, prompted by an enquiry by an Associated Press reporter about royalty payments and the policy for their disclosure under the Freedom of Information Act.
For example, Dr. Anthony Fauci and Dr. H. Clifford Lane, who helped develop Interleukin-2, have each received more than $45,000 since 1997 in royalties. Meanwhile, they continued to have influence over continuing trials of the drug. Independently concerned about the appearance of conflict of interest, they asked for outside reviews of their work. But when Fauci tried to return his royalties, and to disclose them on a standard government form, agency managers told him he could do neither. Furthermore, in the absence of any NIH policy about disclosing the royalties, neither Fauci nor Lane informed study patients about them.
Again, the NIH is one of the most important biomedical research organizations in the world. It used to have a reputation for impeccable integrity. So I will simply repeat what I said in another post : "In my humble opinion, it is a tragedy and disgrace for the country's and perhaps the world's premier biomedical research organization to be tainted by leaders with the gross sorts of conflicts of interest reported in yesterday's articles. It will take drastic measures to cleanse it. But until it is cleansed, can anyone fully trust its actions?"

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