Reporter Lauritsen concluded: "It should be clear that Burroughs Wellcome is a thoroughly unscrupulous company, and the collusion between the FDA and Burroughs Wellcome is as strong as ever." The text of John Lauritsen's address to the FDA Committee meeting on 14 February 1991 was as follows:

"I'm John Lauritsen. I'm here as a working journalist, and also as an AIDS Dissident, so my comments will be against the grain. In the United States, AIDS dissidents are not sent to Siberia, the way that dissidents were in the Soviet Union when they disagreed with the tenets of Lysenkoism. However, we are punished. Two physicians who questioned the HIV-AIDS hypothesis had their practices destroyed, and were driven to the edge of bankruptcy. Molecular biologist Peter Duesberg, an outstanding scientist, had a grant cancelled. And I've taken my share of abuse. All this was for questioning what is probably a false hypothesis.

For two decades, I've made my living analyzing statistical data. Before analyzing data, there are two things one needs to know. Number one, are the data good? And number two, are the premises correct-is the study design good? I maintain with regard to AZT that much of the data are bad, and in some cases manifestly fraudulent. And secondly, that most of the AZT research is based on a false hypothesis--the hypothesis that a retrovirus, tendentiously named the Human Immunodeficiency Virus (HIV) is the cause of AIDS.

I am the author of a book, which has become an underground best seller. It is called Poison By Prescription: The AZT Story. It gives quite a different viewpoint from what you have heard here. In this book I come to three main conclusions. Number one: AZT is highly toxic. Number two: AZT was approved for marketing on the basis of research which was not just bad and sloppy and so on, but was overtly, manifestly fraudulent. And three, there is really no scientifically credible evidence that AZT has any benefits.

With regard to toxicity, I would point out that the issue of cancer has been swept under the rug. I didn't hear cancer mentioned once at this meeting. And yet four different lines of proof, of reasoning, indicate that AZT will cause cancer in the long run. First, there are the biochemical properties of the drug itself. Peter Duesberg has pointed out that when a nucleoside analogue is incorporated into a cell, there are only two possible outcomes. Either the cell dies, or, if the cell is lucky, it mutates and the patient gets cancer. Second, there is the Cell Transformation Assay, which was performed several years ago. The results of this test indicated that AZT was highly positive, and therefore should be presumed to be a potential carcinogen. Third, there are the rodent carcinogenicity studies, which found that AZT causes cancer in animals, and therefore probably will in humans as well. And fourth is the correlation, which is becoming ever more clear, between AZT therapy and cancer of the lymph system. The issue of cancer must be taken into consideration when recommending a drug for long term use.

With regard to the charge of fraud, which I realize is quite serious, I would point out that the Phase II AZT trials occurred when Frank Young was FDA Commissioner. Consumer advocates, such as Sidney Wolfe, charged that Young's reign was one of lawlessness, in terms of collusion between industry and government. Young had to resign, under the shadow of the generic drugs scandal. Illegal collusion between the FDA and drug companies is nothing new. There have been a number of exposès on this topic--by Morton Mintz, by a Ralph Nader study group, and others. Collusion is really business as usual.

With regard to the conflict-of-interest issue, I notice that some of the speakers are identified on the program as Burroughs Wellcome scientists. That's fine, you know that's like truth in advertising or labelling. One is alerted that these people may be giving sales pitches rather than objective presentations of data. However, other people like Margaret Fischl, are not identified as being in the Burroughs Wellcome camp. And yet remuneration, in whatever form it takes, direct or indirect, including grants to institutions, should be taken into account and recognized.

On the question of markers, which was the topic yesterday, I have been writing for some time that the P-24 antigen test is no good. Harvey Bialy, in a forceful editorial in BioTechnology several years ago, pointed out that the P-24 antigen test was no good, and that the results from it, which appeared in medical journals, were absurd. It is good to see it recognized now, finally, that the test is useless. However, one should realize that for several years the P-24 antigen test was used to claim benefits for AZT. One can't just forget that. Furthermore, it is more than likely that the P-24 antigen test doesn't mean much for the simple reason that HIV is not the cause of AIDS.

With regard to the CD4 test-it was clear from yesterday's talks that the CD4 test isn't really all that good. However, this is the test that is the basis for giving AZT to people who are objectively healthy. And you are the committee that made the recommendations- to give AZT routinely to people with HIV antibodies, whose CD4 counts fall below 500. I maintain that we are confronted with nothing less than pharmacogenic manslaughter at this point--125,000 people, more or less, are now undergoing AZT therapy. Many of these are objectively healthy people, who ought to live for another 20, 30, or 40 years. I don't think that they will. I think that they will die of AZT poisoning. And I think this committee must realize that it has responsibility. In fact, if I am correct, and we will know in a few years, this committee has blood on its hands. If some of you have consciences, and are not beholden to particular industrial interests, then you should do what you can, now, to stop this genocide.

I know that some people refuse to believe in the possibility of genocide. But genocide has occurred at other times and in other places, and it is happening here and now.

There have been many other drug scandals. Take thalidomide, when the head of the FDA did everything he could to prevent Frances Kelsey from doing her job. It was one single independent woman, a maverick, who prevented thalidomide from entering the United States. If Frances Kelsey had not stood up to her superiors, if the FDA had done business as usual, then thalidomide would have been marketed in the United States, with the consequences being thousands of monstrously deformed infants. And I submit to you that the thalidomide scandal was utterly trivial--it didn't amount to a hill of beans--compared to the AZT scandal that is happening now.

I know some of these people on AZT. You know, it's not real to think of 125,000 people. But I know three, or four, or five of the nicest people I could . . . I could describe. Young, intelligent people, who ought to live for a long time. And they will not. They have been persuaded through lies to take a drug which will surely terminate their lives long before their time.

Please do your job. Find out the real facts. Don't believe everything you hear at these meetings, or that you read in medical journals, about the alleged benefits of AZT. It is elementary that when researchers have committed fraud in the past, as was certainly the case in the Phase II trials, they can do so again.

It is your duty to learn the truth and speak out-to stop the tragedy that is now taking place."