NIH Whistle-Blower Speaks Out
Dec. 14, 2004 — -- The National Institutes of Health never told the White House about problems it found with its research on the AIDS drug nevirapine before President Bush unveiled a $500 million plan to distribute the medicine across Africa, The Associated Press reported.
Dr. Jonathan Fishbein, associate director of the AIDS division at the National Institute of Allergy and Infectious Diseases, was one of several NIH officials who came to believe the nevirapine experimental trials taking place in Uganda were seriously flawed.
He talked to ABC News' Brian Ross about why he decided to speak out, what happened when he came forward and why he thinks "Africans are treated to a different standard than Americans." Following is a partial transcript of that interview.
ABC NEWS' BRIAN ROSS:Why did you decide to come forward?
DR. JONATHAN FISHBEIN: I decided to come forward because there was evidence of professional misconduct that I felt I attributed to the deputy director of the division and I felt it was obstructing my ability to do my job. I reported this to the division director and, all of a sudden, after six or seven months after he's been expressing tremendous satisfaction for my duties and my job, all of a sudden my performance was deemed poor. I was demoted and I was told I would be terminated. It was that time that I began to bring this to the attention of people over his head, and because I felt there were a number of things that indicated that this represented criminal activity, I took this to the HHS [Health and Human Services] inspector general. They declined to investigate. Then I took it to the office of manage assessment at the NIH. They, too, refused to investigate. And then I took this to the U.S. House of Representatives, to the Committee of Energy and Commerce Subcommittee on Oversight and Investigations, and they were interested.
ROSS: Where do things stand now?
FISHBEIN: Where does it stand now? I have taken these allegations, not only to this committee, but to a number of committees of the U.S. Senate, and my understanding is that there was a lot of interest in the way that the NIH has handled the HIV NET 012 study. And I am hopeful that they will launch an investigation and that they will launch a hearing.
ROSS:You're still at NIH?
FISHBEIN: I still work there, correct. Well, I have in effect been asked to work at home, and my duties have been taken away from me and I was given a make-work project. I was asked to asses the training needs of the division without being allowed to speak with anyone in the divisions.
ROSS: So it's been difficult to continue on with your work?
FISHBEIN: Absolutely. How would I? It's devastating. It's destroyed my career and have to learn that I've been humiliated in the office. I found that word of my demotion has been out in the pharmaceutical industry, which is where my career is, and I am quite concerned about my future.
ROSS: Tell me about when you first became concerned.
FISHBEIN: Well, in the audit [that] was conducted by the Westat Corp. in February, where they noted that thousands of adverse effects were probably missing, where they noted that the investigators did not make assessments of the adverse effects that were reported, and they didn't make those assessments based on their own observations. I found those to be particularly puzzling, and also the fact that there, a lot of sloppiness in terms of consenting patients, and maintaining proper records that would assure that patients rights were protected.
ROSS: And this concerned you?
FISHBEIN: Correct, it bothers me. It bothers me to no ends that Africans are treated to a different standard than Americans.That really, it really, it really hurts me to see, let me put it this way. It really bothers me -- what it says about the integrity of the NIH and the United States government.
ROSS: They were treated as test subjects?
FISHBEIN: I think these people are used as guinea pigs. I feel that they're being used in a clinical research, and that's not being held to the same stringent standards as clinical research is here in the United States.
ROSS: Why would the NIH cover this up?
FISHBEIN: I think the reason the NIH has covered this up is twofold, and the investigators. OK, there are reputations at stake, and I think there's a dire need to justify the billions of dollars that are appropriated to the division of AIDS for the research it sponsors, and we desperately need, we need results. I don't think we are talking about a bunch of people who have bad intentions. I think it's a situation where good people do bad things. I don't think that there's anyone I have met, anyone who gets funding from the division of AIDS, whose intentions are bad. Everybody desperately wants a win in this epidemic. They want to destroy this epidemic, to end this epidemic, but unfortunately people get a little carried away, a little careless.
ROSS: What are the effects of this cover-up?
FISHBEIN: The effect of that is that, well, the immediate effect is that many people in resource-poor countries, many women and their newborns got this drug. This is not a safe drug, necessarily. It's a drug that has serious side effects, and one of the serious side effects is that, in over half the women that get this drug -- and remember, these are women that have AIDS -- they become resistant to that drug with one dose. Now, this is one of the very few inexpensive AIDS drugs that's available to people in Africa, so in effect if you give this as a dose you may save the child, but you in a sense sentenced the mother to death, because there are no other AIDS drugs that are probably affordable that what women will be able get. So you have created an orphan.