AIDS Study Showed U.S. Disregard for Rules – Doctor

A study aimed at showing whether a single dose of an AIDS drug could prevent mothers from passing the virus to their newborns was so sloppily run that it should be disregarded, a fired oversight expert said on Tuesday.

Dr. Jonathan Fishbein, who is disputing his dismissal by the National Institutes of Health, says he is a whistle-blower being victimized because he shed light on careless practices by doctors testing drugs in Africa.The NIH says his allegations are false and endanger the lives of babies because people will be afraid to use a valuable drug.The trial of more than 1,000 mothers and newborns in Uganda was the main basis for using a single dose of the drug, Boehringer Ingelheim’s nevirapine, to prevent mother-to-child transmission of the AIDS virus.Nevirapine is also widely used in cocktails of HIV drugs that keep patients with the incurable infection healthy.A committee of experts at the Institute of Medicine has been asked to determine if the trial was so flawed as to make the data useless, and thus force a reassessment of the practice of giving HIV-infected mothers a dose of the drug to protect their babies.On Tuesday Fishbein told them that he did not trust any of the findings from the 1997 to 1999 trial, called HIVNET 012.”HIVNET 012 is a study so poorly conducted that its data must be rendered invalid as a matter of law, policy and human health,” Fishbein told the committee.Under questioning, Fishbein said even laboratory tests done to show whether infants had become infected with the AIDS virus should be disregarded. “(Data) was generated, often by individuals that didn’t have the training,” he said.Fishbein said investigators focused only on showing nevirapine works overlooked its often dangerous side-effects. “African life, it would appear, is not to be regarded as highly as American life,” Fishbein said.ALLEGING A COVER UPFishbein, hired to standardize policies and procedures, alleges that the NIH has covered up mistakes made during the trial and submitted incomplete paperwork to the Institute committee. He has hired a lawyer and a group called the National Whistle-blower Center to back him in his dispute.His allegations have made headlines in South Africa, where the use of nevirapine was debated bitterly before being approved.South Africa’s ruling African National Congress has accused U.S. health officials of conspiring with German-owned Boehringer Ingelheim to hide adverse effects of nevirapine.”Nevirapine is not the optimal solution, but it is working and there is no better help in very poor countries to prevent HIV-positive mothers passing the virus on to their children,” a Boehringer spokesman said last month.The AIDS virus killed 2.3 million people in Africa in 2004. Using drugs just before delivery can protect a baby, which otherwise has about a 25 percent chance of being infected at birth by an infected mother.The National Institute of Allergy and Infectious Diseases, the NIH branch than oversees much AIDS research, denies Fishbein’s allegations.”Single-dose nevirapine is a safe and effective drug for preventing mother-to-infant transmission of HIV,” it says in a statement on its Web site, http://www.niaid.nih.gov.The NIAID said it had rechecked the HIVNET 012 data and found no evidence that serious adverse reactions related to nevirapine had gone unreported.”The allegations of misconduct have been assessed by the NIH Office of the Director using standard NIH protocols for handling this type of allegation and have been found to have no merit,” the NIAID added, noting that it will wait for the Institute of Medicine report on the matter, due in March. (Source: Reuters Health, January 2005)