Cocktail Evangelism, Activism, Clinical Trial Misconduct and Fraud — A Primer for Dissent
Question:
writes: Of course we know what REALLY happened in that Fischl trial (ACTG016) — the AZT group of patients was contaminated by Fischl and the other investigators who violated the protocol of the study — they decided to give Bactrim to some in the AZT group.
Yes, and also to the placebo group as well. Their journal report admits the addition of Bactrim but claimed no proof of efficacy for PCP prevention!
No exclamation point necessary, since PCP prophylaxis was similar in both groups. Thus, proof of PCP prevention by this route could not be proved in this trial. Fischl DID prove it in another trial, but not with the same patients. They then made the very dubious claim that those who received Bactrim were statistically insignificant (the data to "prove" these claims with any certainty were not disclosed).
It’s only dubious because you don’t want to believe it. If you think it’s a lie, then what’s the point of seeing more data? You’d just have to assume that was a lie also. Actually, you probably COULD have access to that data, if you contacted Fischl and asked for it. Hell, Lauritsen got data just as nitty gritty on the same study, through the FOI act (since it’s a government study). The results of this first AZT trial (lasting 12 weeks) were so impressive because many victims in the placebo control group died of PCP (1 death in the AZT group, 19 deaths in the placebo group). At that time, Fischl and the others running the trial were being paid by the drug companies (they wouldn’t admit it at that time, but this was disclosed later). In their published study, Fischl et al denied any proof that Bactrim was useful as a PCP preventive agent. These doctors, of course, had to know better, because they were contradicting Sonnabend and other researchers who knew Bactrim was effective several years earlier.
Not at all. Sonnabend had not proved his case. The Fischl 016 study didn’t either. Weather the doctors believed or suspected that PCP antibiotics improved survival is another matter– believing and being able to say your study SHOWS something are two different things. Therefore, it is safe to say the original ACTG016 AZT trial that led to the FDA approval of AZT (under extreme drug activist pressure) was based on misconduct and fraud — it only lasted about 12 weeks — and once the results were announced, AZT was approved almost immediately (about one and one-half weeks later — I will be posting the original FDA announcement of 3/20/87, which not only confirms my suspicions about this human experimentation, but offers some startling commentary that qualified a specific population of patients who would "benefit" from AZT). Can you guess what population of those with AIDS saw the "benefit" from AZT? If you guessed those with PCP, you’re correct!
No, you’re not correct. You have absolutely NO evidence that this was true. Fischl says it wasn’t, and the ONLY thing you have to decide otherwise is your believe that she can’t be telling the truth, because the result doesn’t fit your theory. Bullshit. Of course, the astounding results of this original 12 week study have never been reproduced — something that would normally raise very serious questions of misconduct in scientific circles — but not in AIDS "science". Nope — misconduct is rewarded in AIDS research!
Get a grip on it. There’s the possibility of misconduct ONLY when somebody TRIES to reproduce the results, and can’t. (And even then, the first study can be an honest mistake). In the case of ACTG 016, nobody ever tried to replicate it after Fischl. Subsequent studies were done with healthier people at an earlier stage of the disease. The results were not as good, but that hardly makes Fischl a liar. It only means that AZT use alone has a relatively short effect, and you waste it on clinically healthy people, who will be expected to stay healthy anyway through the period where the virus becomes resistant to AZT. After that, AZT monotherapy doesn’t help, and (in high doses like in the Concorde) probably hurts. Steve Harris, M.D.
Response:
Cocktail Evangelism, Activism, Clinical Trial Misconduct and Fraud A Primer for Dissent The following article was summarized and excerpted from the Sunday, February 5, 1995, San Francisco Examiner, page A-1. This article is revealing of the issues of two years ago that shaped the events leading to the present. I am offering some additional background information to fill in many of the missing pieces and provide some eye-opening insights for those who are truly interested in the events that have brought us the current drug treatments that are often presented as politically correct "choices" for each PWHIV. Each person considering these "choices" has the right to all the facts — not just those the treatment activists deem worthy of their seal of approval (that is, censorship). Unfortunately, the present atmosphere of drug advocacy for the protease inhibitor combination "cocktails", has become evalgelistic — based purely on "testimonials", hysteria, zealotry and utter intolerance of anyone who dares to suggest alternate and scientific explanations for what is being reported and claimed as "success" for these treatments. The arguments these individuals offer to support their claims are not based on the science. Rather, they point to erratic declines in hospital admissions, obituaries, reported deaths, etc. as the only "proof" of treatment success. Unfortunately, these individuals have lost their objectivity and refuse to accept the fact that the trend in AIDS deaths was well underway BEFORE these cocktails were even available. Improvements in diagnosing, prophylaxing and treating the OIs is the best candidate to explain what we are seeing today (according to Tony Fauci in an MSNBC interview, 12/2/96 — I posted this a week or so ago). The issues raised in the San Francisco Examiner two years ago answer many of the questions being raised today regarding the evolution of these clinical trials — with some interesting quotes from Margaret Fischl, Robert Schooley, Kessler and Delaney. I wonder why Abrams and Fauci — and the handful of those who are typically quoted in such articles — are missing here, replaced by those who have admitted conflicts of interests with the drug industry (Fischl, Schooley, Volberding etc.)? There are some interesting statements that reveal the influence of the drug "treatment activists" (ACTUP Golden Gate, Project Inform, ACTUP New York, etc) in deciding how these trials should be designed in terms of one group on one combination of drugs being compared against another group on a different group of combination drugs. This is only part of the problem that Dr. Donald Abrams (UCSF & San Francisco General Hospital, AIDS Program Director) has articulated on many occasions when he blamed the treatment activist community for the present mess in the drug study and approval process (see UCSF student paper Synapse, Vol 41, No. 6 10/10/96 article by Mark Tanaka, posted recently on misc.health.aids). Abrams states: "In contrast with many of my colleagues at SFGH in the AIDS Program, I am not necessarily a cheerleader for anti-retroviral therapy. I am one of the people who’s questioned, from the beginning, whether or not we’re really making an impact with HIV drugs and, if we are making an impact, if it’s going in the right direction". Abrams assigns blame to the "drug treatment activist" community for interfering with the trial process from the very first AZT study which was cut short and unblinded half way through because "of statistically significant differences in deaths between the two groups". The Synapse article states: "Abrams blamed the ‘very powerful rhetoric’ of the emerging community of AIDS activists, who demanded an end to clinical trials. ‘Somebody should write a book about the impact of that decision on HIV clinical trials history,’ added Abrams, ‘because everything changed because of that demand’. " Of course we know what REALLY happened in that Fischl trial (ACTG016) — the AZT group of patients was contaminated by Fischl and the other investigators who violated the protocol of the study — they decided to give Bactrim to some in the AZT group. Their journal report admits the addition of Bactrim but claimed no proof of efficacy for PCP prevention! They then made the very dubious claim that those who received Bactrim were statistically insignificant (the data to "prove" these claims with any certainty were not disclosed). The results of this first AZT trial (lasting 12 weeks) were so impressive because many victims in the placebo control group died of PCP (1 death in the AZT group, 19 deaths in the placebo group). At that time, Fischl and the others running the trial were being paid by the drug companies (they wouldn’t admit it at that time, but this was disclosed later). In their published study, Fischl et al denied any proof that Bactrim was useful as a PCP preventive agent. These doctors, of course, had to know better, because they were contradicting Sonnabend and other researchers who knew Bactrim was effective several years earlier. Therefore, it is safe to say the original ACTG016 AZT trial that led to the FDA approval of AZT (under extreme drug activist pressure) was based on misconduct and fraud — it only lasted about 12 weeks — and once the results were announced, AZT was approved almost immediately (about one and one-half weeks later — I will be posting the original FDA announcement of 3/20/87, which not only confirms my suspicions about this human experimentation, but offers some startling commentary that qualified a specific population of patients who would "benefit" from AZT). Can you guess what population of those with AIDS saw the "benefit" from AZT? If you guessed those with PCP, you’re correct! Of course, the astounding results of this original 12 week study have never been reproduced — something that would normally raise very serious questions of misconduct in scientific circles — but not in AIDS "science". Nope — misconduct is rewarded in AIDS research! At the Vancouver AIDS Conference in July, 1996, the Treatment Activist community was caught elbow-to-elbow with the drug company representatives to hear the words of wisdom from Drs. Fischl and some of the other researchers who brought us the original AZT studies, ACTG016 and ACTG019. Fischl, Volberding, Schooley et al were thus providing the treatment community with the latest "standard of care", as THEY have defined it — and now includes the newest protease inhibitors (keep in mind that nobody appointed this task to them — they created their own organization to define the standard of care — and with two exceptions, all members of that organization have declared their conflicts of interests with the drug companies as they have been required to do so by certain journals). It is also important to note that the Treatment Activists were in the audience with their typical "we’re not worthy" facial expression which is often seen when they are in the presence of the many luminaries of AIDS research who contradict the basic science and tell them what they want to hear. Shortly after the standard of care presentation began, there was an outburst: the only street AIDS activist organization yet remaining — ACTUP San Francisco — burst into the meeting room, and before an audience of about 1000 doctors, drug company people and drug "activists", displayed their contempt for these doctors (Fischl, Volberding, etc.) by baptizing them with a mixture of tomato and cranberry juice — symbolic of the blood of those whose lives were shortened by these "healers". Meantime, the drug activists led their audience in a chorus of "shame, shame, shame!", directed towards ACTUP San Francisco, which they later labeled as "terrorists". After the baptism, Fischl and others changed their clothes and resumed their misinformation meeting an hour or so later. What I found most amusing was the fact that, only a day earlier, the drug activists of ACTUP Golden Gate were threatening to "mug" the very drug company representatives they were caught brown-nosing at this meeting. Even funnier was the staged protests for pricing and distribution for the drugs — these protests were choreographed and scheduled by the drug companies — however, what showed up on America’s television looked like "real" activism — it wasn’t, those protests were as phony as the treatment activists themselves. ACTG016 represented the original fraud in AIDS drug treatments. That trial proved nothing more than the power that drug company money has on "researchers" who are paid to make "findings" of a product’s efficacy so that it can be marketed. The subsequent cloning of AZT into the analog drugs — d4T, 3TC, ddI, ddC etc. — simply illustrates the snowball effect from the original sin — which was powered by the panic and hysteria whipped up by the "drug treatment activists" (they used to call themselves "AIDS Activists", but if you haven’t noticed, they now call themselves "Treatment Activists" — there IS a big difference). How did we get in the mess of clinical trials that have no control groups and no longer use placebos? Just guess. Here San Francisco Examiner’s Lisa Krieger explains: "Another (idea), supported by many Clinical Trial Group researchers and San Francisco-based activists, advocates a trial in which patients would be assigned randomly to combinations of drugs that might include experimental drugs. As these patients switch in and out, they would be tracked closely for evidence of improvement." The defense of the concept of excluding placebo study groups is based on the arrogant and scientifically bankrupt ideas that the "standard of care" drugs must become the "control group" and the absolutely UNPROVEN assumption that the drugs in the "control" group (sometimes they … read more »
Response:
Filed under: Student activism
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