Jonathan Fishbein
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Dr. Jonathan Fishbein is one of the highest-ranking drug whistleblowers in American history. He was Director of the National Institutes of Health (NIH) Office for Policy in Clinical Research Operations when he exposed a series of unethical and improper medical problems within the NIH's drug safety clinical trials program, specifically their AIDS Prevention Program. He was soon terminated for making this disclosure[citation needed]; after his discharge, Fishbein sought protection as a whistleblower.
The clinical trial in question was the HIVNET 012 study, which tested the AIDS drug nevirapine, which has been used in some developing countries as a cost-effective method to prevent HIV transmission from mother to unborn child.[1] Irregularities in the trial prompted Fishbein to testify about the failure of the NIH to comply with mandatory health and safety requirements in its AIDS research program.[2][3] An Administrative Judge with the Merit Systems Protection Board (MSPB) ruled that Dr. Fishbein is not protected under the Whistleblower Protection Act.[citation needed]
An independent review of that study by the Institute of Medicine determined "...the Ugandan drug trial's findings that the AIDS medication nevirapine is effective and safe in preventing HIV transmission from mother to unborn child during birth were well-supported." [4] Fishbein has called the value of that review into question, however, alleging that the authors of the review refused to consider certain testimony and evidence that would have vitiated the drug trial, and also that six of the nine authors were, at the time of the review, receiving grants from DAIDS, the very body whose conduct they were reviewing. Fishbein has argued that this conflict of interest must also undermine confidence in the review.[5]
[edit] References
- ^ Guay LA, Musoke P, Fleming T, et al. (1999) Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet 354: 795-802 PMID:10485720
- ^ Allegations Of Waste, Fraud and Abuse at Jonathan Fishbein's website
- ^ Associated Press (2006-01-04). Whistleblower says government bungled AIDS study. USA Today. Retrieved on 2006-01-16.
- ^ IOM Review of Ugandan HIVNET 012 Clinical Trial. Retrieved on 2007-29-07.
- ^ Press release on Fishbein's response to Institute of Medicine Report. Retrieved on 2007-13-11.

