Dr. Jonathan Fishbein, a scientist and former department head at the National Institute of Health's AIDS division, who was sacked for exposing sloppy research done in Africa on the AIDS drug Nevirapine, has been reinstated to employment, but the AIDS drug he fingered as dangerous is still in use, and the NIH AIDS division has so far refused to clean up its act and take steps to restrict the drug's use on newborns.
Liam Scheff, the investigative reporter who broke the story on forced drug trials in New York's Incarnation Children's Center has interviewed Dr. Fishbein.
Vera Hassner Sharav of the Alliance for Human Research Protection summarizes and comments the interview:
“Science has become so severely politicized that one has to be skeptical of nearly every research result that is reported.”
An interview in with Dr. Jonathan Fishbein, the former Director of the Office for Policy in Clinical Research Operations, NIH-AIDS Division, whose (official) job was “to create, implement, and enforce research policy in the Division of AIDS,” to ensure studies were being conducted according to ethical research standards.
But when Dr. Fishbein, a 20-year veteran in drug safety research, found gross research irregularities in an NIH-AIDS study testing Nevirapine (HIVNET 012) in Uganda, he was confronted with a hostile AIDS Division whose entrenched management was “guided more by politics than sound science.” He describes “an atmosphere of intimidation” that made it impossible to properly address and correct the institutional flaws that led to scientifically flawed, unethical AIDS studies.
The AIDS drug, Nevirapine, had been around since the early 1990s; it had a bad reputation for toxicity, and by 1998 it had earned the FDA’s black-box label, announcing its known toxic potential, including the ability to cause organ failure and bloody skin loss – both of which had resulted in death in patients taking the drug.
The Nevirapine study in Africa is a case example of bad faith, bad science, misplaced trust in those who have a financial stake in salvaging the drug, and the seductive power of money. The study focused on finding a use for this toxic drug among poor, rural Africans.
Here is what the NIH-AIDS Division administrators tried to hide, and when that failed, they fired Dr. Fishbein.
“In 1998 in Kampala, Uganda, the Nevirapine study to prevent transmission of HIV from mother to child was underway. The study put 645 expectant mothers on the drug. The problems started immediately. First, the study was carried on without a control group – everyone received one drug or another – AZT or Nevirapine.
A 20 percent rate of “serious adverse events” was reported in newborns in both the Nevirapine and AZT groups, including blood and tissue infection, pneumonia and severe rash. Eighty percent of mothers exhibited laboratory and clinical abnormalities. Twenty-two babies had grade 3 anemia.”
Thirty-eight babies died. Sixteen on Nevirapine, twenty-two on AZT.
According to Dr. Fishbein, the major flaw in the Nevirapine study, was the scientists’ failure to report all “serious adverse events” in the trial population.
That fatal “flaw” is pervasive in clinical research because those who control clinical trials have a financial conflict of interest: disclosure of all the risks may undermine marketability of the drug.
For those who thought The Constant Gardener was fiction, think again. Think about the efforts to cover-up the deaths of those 38 babies ... until Dr. Fishbein blew the whistle.
Dr. Fishbein was successful in his two year battle with NIH. He has been reinstated, though not to his former position in the AIDS Division. Like Dr. David Graham at the FDA, he won’t be assigned to the work he is most suited for because there are too many other cover-ups that the administrators are intent on keeping under the lid.
- end of Vera Hassner Sharav comment -
Here is the article by Liam Scheff: