December 7

NIH Expert on Safe Drug Research Seeks Whistleblower Protection

NIH Expert on Safe Drug Research Seeks Whistleblower Protection

Tue, 14 Dec 2004

In the wake of the Associated Press investigative report about unethical NIH-sponsored AIDS research involving infants and pregranant women Africa, and charges of misconduct by high officials at the National Institutes of Health (NIH), Senate Finance Committee Chairman Charles E. Grassley has asked the Justice Department to investigate. In a letter released yesterday, Grassley said he was compelled to do so by “the serious nature of these allegations and the grave implications if the allegations have merit.”

That the leadership at NIH continues to defy rules of conduct and ethical research standards is once again demonstrated by NIH’s highest officials who accused of covering-up research misconduct and research-related deaths. AP reports that NIH officials seek to oust the very scientist who was hired last year to change the conduct of research at NIH following documented revelations of research misconduct and financial conflicts of interest. Congressional hearings brought NIH director, Dr. Elias Zirhouni to acknowledge

See: Stealth Merger: Drug Companies and Government Medical Research By David Willman. Los Angeles Times series beginning

December 7, 2003:,1,7108097.story?coll=la-home-headlines

The public is getting an illuminating dose of reality about the misconduct of the nation’s elite research institution. NIH officials have demonstrated utter disregard for the health and safety of humans outside their tightly controlled circle of Œpeers.’ Taxpayers have awarded NIH billions of dollars in the hope of finding cures for disease. Instead of cures NIH has been the seat of unethical, harmful research here and abroad. The researchers and administrators involved have harmed babies, have embarrassed the President, and have blackened America’s reputation internationally.

Stringent laws and strict government enforcement mechanisms are needed to protect the world community from unscrupulous medical researchers. AHRP believes that strict public oversight and criminal penalties are the essential means for changing the culture of arrogance and the pattern of corruption in medicine – both within the research enterprise and clinical practice.

In his recent book, On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health, Dr. Jerome Kassirer, Editor in Chief of The New England Journal of Medicine (1991-1999), documents the varied and ingenious ways in which physicians have managed to accept money and gifts from pharmaceutical companies without calling the practice “bribery.” In fact, medical researchers in academia and NIH are living high on industry hog.

Dr. Kassirer notes that in the process physicians have abandoned the standard laid down by the Hippocratic Oath – "First, do no harm" – operating with no rules whatever. This is in sharp contrast to other professionals who are guided by rules of conduct. For example, the wine writers of The Wall Street Journal do not accept free wine, free trips, or free meals; the editorial policy of The New York Times prohibits staff members from having any financial interest in the topics or industries they cover; the publishers of the Lonely Planet travel books have a policy of not merely refusing gifts and payment from potential beneficiaries of their recommendations, but also refusing their advertising. Kassirer asks, quite reasonably, why should doctors set their own ethical bar so much lower?

"That physicians are not held to the standards of journalists, attorneys, and other professionals is one of the greatest scandals of our time."

See:On The Take: How Medicine’s Complicity with Big Business Can Endanger Your Health by Jerome Kassirer. Oxford University Press, 2004.

Contact: Vera Hassner Sharav

NIH researcher seeks whistleblower protection
Fishbein reported concerns about AIDS research
The Associated Press
Updated: 3:39 p.m. ET Dec. 13, 2004

WASHINGTON – The expert hired by the National Institutes of Health last year to improve its research practices after problems in an AIDS drug study surfaced is seeking whistleblower protection after disagreements with management have left him on the verge of being fired.

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.

In one instance, Fishbein refused to discipline an employee for reporting safety concerns to the Food and Drug Administration, and another time he was overruled when he objected to restarting problematic research, documents show.

Attorney Stephen M. Kohn, who represents Fishbein, said NIH officials have a built-in conflict because they both fund the research and monitor safety.

"He found a system that was broken," Kohn said. "There’s a tension at NIH. A tension between those doctors who want to push the clinical results, that want to publish, that want to take credit for major breakthroughs, and other doctors and professionals who want to adhere to the quality standards."

© 2004 The Associated Press. All rights reserved.
AIDS Drug Whistleblower (Resending)
Man hired to fix N-I-H now seeking protection for pointing out problems

WASHINGTON (AP) _ A researcher who was supposed to clean things up at the National Institutes of Health is seeking whistleblower protection after disagreements with top officials there.

Doctor Jonathan Fishbein is now on the verge of being fired. He was hired last year to revamp research at the agency, after problems surfaced in the agency’s study of an AIDS drug.

Documents show that Fishbein wouldn’t punish a worker for reporting safety concerns — and another time he objected to a problematic research project.

But N-I-H says the move to fire Fishbein is based on his performance.

Fishbein now is taking his concerns to another body. He’s meeting with congressional investigators to talk about problems at N-I-H.

Copyright 2004 Associated Press. All rights reserved.
Research Flawed on Key AIDS Medicine
Bush Had Planned Its Use in Africa
By John Solomon
Associated Press
Tuesday, December 14, 2004; Page A14

Weeks before President Bush announced a plan to protect African babies from AIDS, top U.S. health officials were warned that research on the key drug was flawed and may have underreported thousands of severe reactions, including deaths, government documents show.

The 2002 warnings about the drug, nevirapine, were serious enough to suspend testing for more than a year, let Uganda’s government know of the dangers and prompt the drug’s maker to pull its request for permission to use the medicine to protect newborns in the United States.

But the National Institutes of Health, the government’s premier health research agency, chose not to inform the White House as it scrambled to keep its experts’ concerns from scuttling the use of nevirapine in Africa as a cheap solution, according to documents obtained by the Associated Press.

“Everyone recognized the enormity that this decision could have on the worldwide use of nevirapine to interrupt mother-baby transmission,” NIH’s chief of AIDS research, Edmund C. Tramont, reported March 14, 2002, to his boss, Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases.

The documents show that Tramont and other NIH officials dismissed problems with the nevirapine research in Uganda as overblown and were slow to report concerns to the Food and Drug Administration.

NIH’s nevirapine research in Uganda was so riddled with sloppy record-keeping that NIH investigators could not be sure from patient records which mothers got the drug. Instead, they had to use blood samples to confirm doses, the documents show.

Less than a month after Bush announced a $500 million plan to push nevirapine across Africa to slow the AIDS epidemic, the Department of Health and Human Services sent a nine-page letter to Ugandan officials identifying violations of federal patient-protection rules by NIH’s research.

Nevertheless, NIH officials said they remain confident after re-reviewing the Uganda study and other research that nevirapine can be used safely in single doses by African mothers and children to prevent HIV transmissions during birth. But they acknowledged their Uganda research failed to meet required U.S. standards.

As a result, NIH recently asked the National Academy of Sciences to investigate its science in the case and has spent millions in the past two years improving its safety monitoring and record-keeping.

One lesson derived from a closer review of the Uganda research is that even single doses of nevirapine can create instant resistance, meaning patients may not be able to use the drug or others in its class again when their AIDS worsens, Lane said.

Lane said NIH officials were aware in spring 2002 about the impending White House announcement on nevirapine but did not tell presidential aides of the problems because they were confident, even before reviewing the Uganda research, that the underlying science was solid.

The White House — though unaware of the NIH concerns — also remains confident in Bush’s $500 million plan in 2002 to send nevirapine to Africa. Bush approved $2.9 billion for global AIDS fighting next year.

Senate Finance Committee Chairman Charles E. Grassley (R-Iowa) has asked the Justice Department to investigate NIH’s conduct. In a letter released yesterday, Grassley said he was compelled to do so by “the serious nature of these allegations and the grave implications if the allegations have merit.”

© 2004 The Washington Post Company

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