December 30, 2004

AIDS Fatigue: Celia Farber on "the AIDS Spin Machine"

From New York Press, a lengthy and thorough argument, right or wrong, from Celia Farber, with particular attention to Uganda and to Jonathan Fishbein:
After 20 years of hysteria, alarmism, misplaced recrimination and guilt, AIDS fatigue has beaten the newspaper-reading mind into a kind of blank. Citizens can't be faulted for not knowing how exactly to respond to last week's eruption of scandal from an NIH whistle-blower named Jonathan Fishbein, an AIDS researcher charged with overseeing clinical trials here and abroad. A reverberating language of bureaucracy and euphemism surrounds AIDS stories, making it impossible to know what has actually transpired. When people die from AIDS drugs, for instance, the word "death" is studiously avoided. I have seen medical articles documenting the fact that more people now die of toxicities from AIDS drugs than from the vanishingly opaque syndrome we once called AIDS. Death was referred to as a "grade four event," thus placing it eerily within the acceptable parameters of predictable phenomena in AIDS research—not as a failure, a crisis or even something to lament.

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December 27, 2004

Well, NIH Doesn't Pay a Lot

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NIH Department of Transfusion Medicine Director Harvey G. Klein

This is the LA Times major story about what, if it is true, constitutes a significant conflict of interest for an NIH administrator, namely Harvey Klein:
Confidential income disclosure documents that the NIH recently surrendered to the House Energy and Commerce Committee and other records examined by the Los Angeles Times show that from 1999 to this year Klein received $240,200 in consulting fees and 76,000 stock options from five blood products companies. Klein acknowledged in written responses for this article that several other firms also had paid him fees; he said that he properly reported the compensation to the NIH.

While taking industry's money and also working for the government, Klein helped shape policies and practices that directly affected his industry clients and patients. He participated as an expert at dozens of federal meetings that focused on uses of new blood- related products but did not publicly acknowledge his role as a paid consultant to any company, records show. Other experts did so voluntarily.

Klein also wrote an article for a major medical journal whose editors now say they would not have published if they had known about his company ties.

Editorial ethics groups including the Council of Science Editors' and the World Association of Medical Editors (on both of which I serve) have just ramped up deliberations on this sort of conflicts of interest, but never did any of us imagine that the disclosure of information regarding conflict of interest within the NIH would reach this far or go this high. It seems likely an audit of publications by NIH scientists will be forthcoming. - GM

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December 14, 2004

NIH's Jonathan Fishbein Takes Whistleblower Protection

MSNBC:
Dr. Jonathan Fishbein, a 10-year expert on safe drug research practices in the private sector before joining NIH in summer 2003, has met with congressional investigators and provided extensive information about problems in NIH research.

NIH officials declined to discuss Fishbein, citing personnel privacy, except to say the move to fire him is based on his performance. Fishbein, who is represented by the National Whistleblower Center, was told earlier this year he is being fired before he completes his two-year employment probation after a series of disputes with NIH managers over safety concerns in various AIDS research projects, according to his lawyer.

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November 08, 2004

Harvard Bioethics

Harvard held off on bioethics for a very, very long time. Ezekiel Emanuel worked hard to build something there before he moved to NIH. Then Harvard's Department of Social Medicine advanced the notion that bioethics needs to be framed as something other than "bioethics," and created its own, small division of medical ethics to keep that faith. Like several other top schools, Harvard has kept a low profile on the bioethics scene. Beginning in 2002, though, Harvard has been grabbing up senior scholars in bioethics, spread out across several schools and departments. Norman Daniels now chairs an amazing graduate education steering committee that is offering a PhD level degree in bioethics. Faculty include Dan Brock, Allan Brandt, Nicholas Christakis, Norm, Frances Kamm, Thomas Scanlon and Dan Wikler.

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October 13, 2004

DeCode Funded by NIH to Study Genetics of Infectious Disease

Jon Merz pointed us to this amazing piece on the funding of Iceland's for-profit genomics company, DeCode, which has official authorization to conduct population-based genomics research using the health histories and gene samples from Icelanders. NIH is funding a study of the genetics of infectious disease and vaccine response, which would access genome-wide scans of Icelanders. But does funding from NIH, though, imply the Fed's assent - or might anyway - to DeCode's "presumed consent" model?

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September 25, 2004

NIH Employee Payment Policy (COI)

The Los Angeles Times story about the NIH response to conflict of interest includes an Institutes-wide ban on outside payments to employees. Bob Koepp brought this to the attention of MCW readers.

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