Saturday, December 25, 2004

More on a key case relating to human subject protection in biomedical research done in Afica.

The New York Times > Washington > Judge Limits Protections Allowed to Federal Whistle-Blowers (Registration required.)

Dr. Jonathan Fishbein is among several employees of the U.S. National Institutes of Health (NIH) who raised concerns about treatment of participants in a study in Africa involving the AIDS drug nevirapine. He was hired by the institutes in 2003 to help improve AIDS research practices.

Dr. Fishbein was hired under Title 42 of the federal code, which allows the government to give competitive salaries to research and medical experts. The law is intended to help the government compete against high-paying private industries. Dr. Fishbein was paid $178,000 a year, slightly more than the $175,700 that members of President Bush's cabinet receive.

Dr. Fishbein told the wistle-blower protection board that he was being fired because he had raised concerns about sloppy practices that might endanger patient safety. NIH said that he was being fired for poor performance and that he had failed to complete his two-year probationary period successfully.

The court ruled that Dr. Fishbein was not covered by the law, because he was a Title 42 employee and therefore enjoyed "no appeal rights" during his probationary period. The ruling is being appealed.

Kris Kolesnik, executive director of the National Whistleblower Center, an advocacy group in Washington, said: "This is a major setback for drug safety. Many of these employees, such as Dr. Fishbein, hold sensitive health- and safety-related positions. Without protections, these employees will not blow the whistle."

More than 3,900 Title 42 employees work for the national institutes, according to the Department of Health and Human Services, the agency's parent.

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