HIV=AIDS Controversy: Statistical EvaluationsThe following is an excerpt from an article which appeared in the Feb/Mar 1997 issue of Continuum supplement, vol. 4, no. 5, by Peter Duesberg and David Rasnick, titled, The Drug-AIDS Hypothesis. The entire article is quite lengthy and contains extensive footnotes, but is quite as readable as this excerpt and perhaps is the authors' most important contribution to the subject. To obtain a copy of the article send a request to the publisher at: The Drug-AIDS Hypothesisby Peter Duesberg and David Rasnick
The war on the new AIDS epidemic has been a complete failure in terms of public health benefits: 50,000 to 75,000 Americans develop AIDS per year and over $8 billion are spent annually on AIDS research and treatment by the US taxpayer alone, but there is no vaccine, and no effective drug, and not one AIDS patient has been cured. It is proposed here that this failure is the responsibility of the hypothesis that AIDS is caused by a virus named HIV. This hypothesis has monopolized AIDS research and treatment since 1984, but it neither explains nor predicts numerous AIDS facts, nor has it produced any public health benefits. In order to solve AIDS we propose here the drug-AIDS hypothesis.
(...) 4. THE EPIDEMIC OF AZT AND OTHER ANTI-HIV/AIDS MEDICATIONS4.1. DNA terminators licensed as a cure.In 1987 the American and European illicit drug epidemic had been joined by a new epidemic of toxic legal drugs, the DNA chain-terminators, such as AZT, that are prescribed to hundreds of thousands of HIV-positives together with a litany of other orthodox and unorthodox anti-HIV/AIDS drugs (see 4.2. and Table 6). In America, AZT was licensed in record time as an antiviral drug in 1987 by the Food and Drug Administration (FDA) based on studies conducted by its sister institutions from the Department of HHS, the National Cancer Institute142 and the NIAID143 together with the drug's manufacturer Burroughs Wellcome. The fast approval of AZT--despite its inherent toxicity--was a major coup of AIDS researchers144. By going public more aggressively than any other scientists before, American AIDS researchers from the NIAID, NCI and CDC had mobilized patients, homosexual AIDS risk groups and journalists to demand protection from the predicted AIDS explosion at any cost. As a result of this pressure the FDA and AIDS researchers fast-tracked first the approval of AZT and then that of ever-more untested anti-HIV/AIDS drugs145. Surprisingly, all of these drugs were eagerly welcomed by the medical and public press and above all by unsuspecting AIDS patients. The politics behind the approval of AZT first by the FDA and the American medical orthodoxy, and then by the rest of the world has been described in two recent books, Good Intentions146 and Inventing the AIDS Virus10. AZT and other DNA chain-terminators are now used both as AIDS prophylaxis and therapy in the hope that they will terminate HIV DNA synthesis without terminating cell DNA synthesis147. However, there are several problems with this optimistic plan: 1) The licensing study conducted in 1986 by the National Cancer Institute (NCI) and Burroughs Wellcome has erroneously underestimated the toxicity of AZT for human cells a 1000-fold142! Although at least 7 independent studies have since pointed out this 1000-fold error148-254, the recommended prescription dose has only been reduced 3-fold, from 1.5g of AZT per day in 1987 to 0.5g now155, 156. 2) The initial success of the American clinical licensing study conducted by the NIAID and Burroughs Wellcome, that claimed a 19-fold reduced AIDS-mortality143, could not be reproduced by numerous independent studies from other countries, including the UK157, France158, The Netherlands159, Australia160, and also not by an independent American study that was not supported by the NIAID and Burroughs Wellcome161. 3) Contrary to the manufacturer's information, DNA chain-terminators, such as AZT, ddI ddC, 3TC and d4T were not designed to kill viruses but to kill human cells. Most of them were originally synthesized over 30 years ago, long before AIDS was known, to kill human cells as cancer chemotherapy by terminating cellular DNA synthesis162. Thus DNA chain-terminators are inevitably cytotoxic144. 4) Even in the light of the HIV-AIDS hypothesis, AZT treatment as anti-HIV therapy is irrational. Since only about 1 in 1000 T-cells of AIDS patients is infected24, 25, 29-31, AZT will kill 999 uninfected T-cells for every one that is infected144, 146, 163, 164. Such a therapeutic index predicts that AZT cannot be beneficial as an anti-HIV drug. Moreover, since HIV is postulated to cause AIDS by killing T-cells, it is irrational to kill the same HIV-infected cells twice--once with HIV and again with AZT25. 5) Although AZT and other DNA chain terminators are prescribed since 1987 to healthy and ill HIV-positives for the rest of their lives, there are as yet no animal experiments that have ever tested to what degree these inevitably toxic substances accelerate death. Moreover, animal experiments would be necessary to determine how AZT and other anti-viral prescription drugs interact with the many recreational drugs that are, or have been, consumed by most AZT recipients--a question that none of the licensing studies has even addressed. It is therefore not possible to know how HIV-positives could possibly benefit from AZT's hypothetical anti-HIV effects in view of its certain cell toxicity. As of 1996 the DNA chain-terminators are prescribed in combination with another group of experimental anti-HIV drugs, the protease inhibitors, under new labels, that give the impression that these "cocktails" are entirely new treatments28, 165-268. But the morbidity and mortality of the long-term consumption of protease inhibitors alone or in combination with DNA chain-terminators has neither been determined in animals nor in humans. Surprisingly, the fate of the first two groups of AIDS patients that are claimed to have benefited by protease inhibitors published in two articles and two editorials in Nature in January 1995 has not been mentioned since32, 33, 344, 345. The absence of any follow-up of these promising claims is particularly odd since Nature has published numerous articles on AIDS and protease inhibitors.
4.2 Epidemiology of AZT and supplemental anti-HIV/AIDS medications.
In other words AZT is now prescribed to cancer and psoriasis patients to kill growing cells by inhibiting cellular DNA synthesis. But according to Glaxo Wellcome, it is prescribed to HIV-positives and AIDS patients as a specific inhibitor of HIV DNA synthesis because it "interferes with the HIV viral RNA dependent DNA polymerase (reverse transcriptase) and thus inhibits viral replication. ... Chain termination has not been demonstrated with cellular alpha-DNA polymerase to this date"147. Thus Wellcome and the HIV/AIDS orthodoxy offer the same drug as inhibitor of cell DNA synthesis to cancer and psoriasis patients, and as a specific inhibitor of HIV DNA synthesis to AIDS patients. Clever marketing that is! In view of this, one wonders how soon AZT will also be offered as an abortion pill, like methotrexate another chemotherapeutic drug178. According to an FDA official the prescription of AZT as an abortion pill would not require a new license, because once approved by the FDA "it can be prescribed for dandruff."179.
2) Other anti-HIV/AIDS drugs. The consumption of AZT and other DNA chain-terminators by healthy HIV-positives at risk for AIDS and AIDS patients is typically supplemented by a bewildering list of further prescription and over-the-counter drugs. A list of 23 anti-HIV/AIDS drugs taken by 2801 American HIV-positives, including 524 AIDS patients, is recorded in Table 640. Nearly all of these HIV-positives were male homosexuals (83%) or intravenous drug users (12%) who took those drugs because they wanted to prevent or cure AIDS.
Most of the children are receiving multiple chronic medications, with 90.5% (38-42) receiving antiretroviral therapy, 78.6% (33 of 42) receiving PCP prophylaxsis, 33.3% (14 of 42) receiving fungal prophylaxis, and 23.8% (10 of 42) receiving herpes virus prophylaxsis. Among the children receiving antiretroviral therapy, 78.9% (30 of 38) are receiving zidovudine [AZT]. Other medications frequently prescribed include meter dose inhalers for reactive airway disease in 33.3% (14 of 42) of patients and nutritional supplements for failure to thrive and wasting syndrome in 52.4% (22 of 42) of patients. Only 2 of the 42 children in the cohort are not receiving any medications, with 4 receiving one medication, 14 receiving two, 10 receiving between 3 and 5, and 12 receiving between 6 and 12 different medications daily. Sixty-two percent (26-42) of the children receive monthly intravenous infusions of immunoglobulin182.4.3. Diseases caused by AZT and other anti-HIV medicines. AZT functions as an analog of natural thymidine (T). If AZT is incorporated instead of T into a growing DNA chain, DNA synthesis terminates for lack of a 3'OH end, and the cell dies (see Fig. 3). A standard daily prescription of 0.5g AZT corresponds to about 1021 molecules per body, or 107 per human cell, enough to kill most growing cells, especially the fastest growing ones--the immune cells, red cells and epithelial cells--by terminating DNA synthesis154, 183. Stopping the regeneration of these cells over several days causes anemia, nausea, lymphocytopenia, hepatitis, and wasting disease25, 147, 184, 185. AZT also prevents mitochondrial DNA synthesis in non-proliferating cells. Specifically, non-renewal of mitochondrial DNA causes muscle atrophy, hepatitis, and dementia25, 112, 154, 186. In addition, AZT is carcinogenic25, 187. The long catalog of AZT diseases overlaps extensively with the CDC's even longer catalog of AIDS defining diseases16. Considering the toxicity and mode of action of the DNA chain-terminators, it is not surprising that to date the professional literature has yet to offer the first AIDS cure with AZT or the other anti-HIV drugs10, 24. In 1993, the British-French Concorde trial, the largest controlled study of its kind, even buried the hope that AZT might prevent AIDS188. Instead, the final report of the trial confirmed in 1994 that AZT is not only unable to prevent AIDS, but even increases the mortality of recipients by 25% compared to the untreated controls155. Once the ice of absolute control on AZT by the NIAID, NCI, and Glaxo Wellcome was broken by the non-American Concorde trial, a series of American and European studies confirmed and extended the predictable toxicity of AZT. Although in coded language and with disclaimers that a specific detrimental outcome does not discredit the presumed merits of AZT these results show that AZT not only fails to prevent AIDS, but actually causes AIDS diseases and accelerates death (see 7.9.): 1) An American study of intravenous drug users observed in 1993 that, "The rate of CD4 lymphocyte depletion did not appear to slow after the initiation of zidovudine therapy..."86. 2) An Indian-English collaboration reported in 1994 that among 104 babies of AZT-treated pregnant women 8 aborted spontaneously, 8 were aborted "therapeutically" and another 8 were born with serious birth defects, including holes in the chest, abnormal indentations at the base of the spine, misplaced ears, triangular faces, hearts defects, extra digits and albinism189. Zidovudine users in this study may have experienced more rapid CD4+ cell depletion. And according to the magazine Science an unpublished study from the National Cancer Institute in Bethesda MD "showed an increase in cancer in the offspring of pregnant mice treated with high doses of AZT."355 The article betrays the journal's bias for AZT therapy by implying a normal incidence of cancer in the offspring of mice which was reportedly increased by AZT. Obviously there is no detectable spontaneous incidence of cancer in newborn mice. 3) The American MAC study of 5000 male homosexual men observed that, "HIV dementia among those reporting any antiretroviral use (AZT, ddI, ddC, or d4T) was 97% higher than among those not using this antiretroviral therapy"112. 4) Another analysis of homosexual men from the MAC study revealed that AZT treatment increased the risk of pneumonia 2 to 4-fold190. 5) And four years after introducing AZT prophylaxis against AIDS156, Paul Volberding et al. published in 1994 "the average time with neither a progression of disease nor adverse event was 15.7, 15.6, and 14.8 months for patients receiving placebo, 500mg zidovudine, and 1500mg zidovudine, respectively."191. Thus even Volberding now confirms the Concorde study's conclusion that AZT does not prolong life or prevent AIDS, but instead accelerates AIDS. 6) An independent British study even found that AZT prophylaxis reduced survival from 3 to 2 years and also observed AZT-specific AIDS diseases, "wasting syndrome, cryptosporidiosis, and cytomegalovirus infection ... almost exclusively" in AZT-treated AIDS patients192. This result confirmed Concorde's observation, in particular the 25% higher mortality of those on AZT. 7) The results of AIDS prophylaxis by AZT proved even more devastating for American hemophiliacs: The AIDS risk of hemophiliacs on AZT was 4.5 times higher and their mortality was 2.7 times higher than that of untreated controls193. 8) The mortality of British HIV-positive hemophiliacs has increased even 10-fold since 1987, since most are subjected to AZT and other anti-HIV/AIDS treatments21-23, 37, 173. 9) In 1996 an American study from the National Institute of Child Health and Human Development concluded that AIDS prophylaxis with AZT also harms children: "In contrast with anecdotal clinical observations and other studies indicating that zidovudine favorably influences weight-growth rates, our analysis suggests the opposite."194. 10) Even before the Concorde study a rare publication critical of AZT by the NCI reported in 1990 that AZT increased the annual lymphoma risk 50-fold compared to untreated controls187. But despite the devastating evidence that AZT enhances morbidity and accelerates death by causing AIDS defining diseases on its own, the faith of the medical orthodoxy in FDA approved AZT seems unshakable. No news is bad enough to discourage AZT prescriptions28, 165 (see 7.9.). Nevertheless, recently a few mainstream AIDS doctors have openly registered dissent, although not in the form of dedicated articles. Says Jay Levy, professor of medicine at the University of California at San Francisco, "With all the hoopla about antiviral drugs, and you get any virologist aside and they'll say this is not how we are going to win, it's high time we look at the immune system"195. Lecturing his medical students, another professor of medicine at the University of California at San Francisco, Donald Abrams, is even more direct according to a university magazine: In contrast with many of my colleagues at SFGH [San Francisco General Hospital] in the AIDS program, I am not necessarily a cheerleader for anti-retroviral therapy. I have been 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. Some of the most damning admissions to the existence of AZT-specific AIDS diseases come from the suppliers of the drug themselves. The warnings on the product label of an AZT bottle supplied by Sigma, a non-medical provider of the drug, points out, with skull and cross bones, AZT's toxicity to the bone marrow, the very source of T-cells (Fig. 4). Even the primary provider of AZT, the Glaxo Wellcome company states in the Physicians Desk Reference that, "It was often difficult to distinguish adverse events possibly associated with zudovudine [AZT] administration from underlying signs of HIV disease..."147. Finally, the National Institutes of Child Health and Development recently confirmed that, "Zidovudine use is confounded by progression of HIV disease"194 The inevitable damage caused by AZT prescriptions is compounded by many of the concomitant medicines taken by most, if not all HIV-positive Americans with AIDS and at risk for AIDS (Table 6). For example, some of the antiviral drugs like ganciclovir and acyclovir are also DNA chain terminators that are nearly as toxic as AZT196. As expected they were observed to produce "pancytopenia"197 by killing hemopoietic cells, and to have "direct [toxic] effects on myeloid and erythroid progenitor cells"147, 198. Moreover, even American AIDS researchers are concerned that many of the anti-infectives used as anti-HIV/AIDS drugs have "nephrotoxic, cytotoxic, and myelosuppressive [effects], such as amphotericin B, co-trimoxazole, dapsone, interferon, pentamidine, vincristine, flucytosine, adriamycin, vinblastine, and others [which] could potentially increase the risk of hematologic toxicities in patients being treated with ZDV [AZT]"198 (see also Table 6). In other words these drugs are immunosuppressive because they intoxicate and kill immune cells. As yet there are no placebo-controlled human or even animal studies in the literature on the toxic effects of protease inhibitors, although over 60,000 Americans are daily users of the most popular brand347. However, the popular press acknowledges effects such as "suicidal thoughts, twitching, central nervous disorders...extreme nausea, hallucinations, intense trembling" after server months on the drug 346. And the HIV/AIDS researcher Jerome Groopman of the Beth Israel Medical Center in Boston informed Newsweek in December 1996 that, "some patients have been 'showing signs of the benefits wearing off'"--an effect that is termed "crashing" by the magazine. Even the surrogate markers of presumed benefits of protease inhibitors, like decreased "viral load"32, 33, 344, are lost over several months as "viral load has shot back up again and no one knows why"347. In an article "The media's love affair with AIDS research: Hope vs. hype" even Science now makes a careful retreat from the hype of protease inhibitors: "From the moment researchers first reported these data...they raised red flags. Not only are these studies small and ongoing...Also drug-resistant strains of HIV [the HIV orthodoxy's euphemism for drug toxicity] already have taken over in some patients and may eventually spoil the gains seen in most--especially given the trouble many patients have in keeping to the regimen of taking dozens of pills every day."355
4.4. Conclusions.
8. A POSSIBLE SOLUTION AT LASTIt is concluded that the HIV hypothesis has been unproductive and nonpredictive because AIDS is neither an infectious epidemic nor caused by HIV. Thus, far from solving AIDS, the HIV hypothesis has actually escalated the epidemic by monopolizing AIDS research and therapy, and by delivering harmful medications. As the theoretical basis of all anti-AIDS treatments the HIV hypothesis is solely responsible for over 1 million year-long prescriptions of AZT and all other toxic antiviral drugs that have never cured and AIDS patient. On the contrary, AZT and other anti-HIV/AIDS drugs have been shown to accelerate death.The HIV hypothesis is also responsible for the promotion of recreational drug use. By ignoring, obscuring and even directly refuting in the professional literature, the possibility that nitrites, cocaine and heroin could cause diseases, the medical orthodoxy misinforms a vulnerable and trusting public about the medical consequences of recreational drug use15, 80, 325. The long arm of the international AIDS establishment even reaches out specifically to the public with targeted press releases to convince everybody that drugs are harmless as long as they are taken with clean needles and condoms to protect against HIV infection319, 320, 334. This misinformation campaign and the campaign that clean needles for unsterile street drugs (!) and condoms protect against all medical consequences of drug use encourage rather than discourage recreational drug use by the unsuspecting public7, 10, 96. by contrast, our independent analysis of the AIDS epidemic reveals that AIDS is simply the clinical consequence of the American/European drug epidemic. The drug hypothesis resolves all long-standing paradoxes and contradictions of the HIV-hypothesis and predicts AIDS exactly, the hallmark of a good hypothesis. Therefore, it should have a very high priority in AIDS research. Drug toxicity could be tested experimentally in animals, and in human cells in tissue culture. In addition, drug toxicity could be tested epidemiologically in humans who are addicted to recreational drugs or are prescribed AZT. Such tests could be conducted at a microscopic fraction of the cost that is now invested in the HIV hypothesis. According to the drug hypothesis AIDS would be entirely preventable and at least partially curable, if: 1) AZT and all other anti-HIV drugs were banned, 2) illicit recreational drug use was terminated, 3) AIDS patients were treated for their specific diseases with proved medications, e.g., tuberculosis with antibiotics, Kaposi's sarcoma with conventional cancer therapy, and weight loss with good nutrition. In addition to saving about 50,000 to 75,000 lives per year from AIDS, the drug hypothesis could save the American taxpayer up to $23 billion annually. Eight of the $23 billion are spent on AIDS treatment, research, and education based on the unproductive HIV hypothesis335, 336, and $15 billion are spent on the War on Drugs50, 52, 61, 335, 336. The War on Drugs is "primarily focused on supply control efforts"50, 52, but has failed completely to stop the American drug epidemic. But if the wars on AIDS and drugs were based on the health consequences of long-term drug use, they could be just as successful as the federal anti-smoking program. Based on education that smoking causes lung cancer, emphysema and heart disease, smoking has dropped in the US from 42% of the adult population in 1965 to 25% in 1995235. And only 15.5% of Californians smoked regularly in 1995, down from 26% in 1984. In view of this the CDC's director of the Office of Smoking and Health proudly announced, "Not only are these states are looking at them and seeing that this works"337. Thus by adopting the drug-AIDS hypothesis the CDC could also win the war on AIDS. However, there are a number of monumental obstacles, 15 years in the making, that block the possible solution of AIDS based on the drug hypothesis: 1) The HIV/AIDS orthodoxy's annual budget of $8 billion from the US taxpayer alone, 2) The thousands of AIDS organization, including countless public health and activist careers and the tens of thousands of scientific reputations that are exclusively built on HIV7, 10, 3) The numerous medical and social benefits available to HIV-positive activists and patients338, 4) The staggering commercial interests in HIV-tests, over 20 million tests per year at $50 or more in the US alone, HIV-vaccines and anti-HIV drugs, 5) The prospects of numerous complaints and malpractice suits against the HIV/AIDS orthodoxy from those who were told they are destined to die based on HIV tests or were helped to die with AZT, 6) The prospect of a profound loss of confidence of the American public in its medical and scientific elite7, 10. Thus the current HIV/AIDS orthodoxy cannot afford the drug hypothesis, and must do everything in its power to keep it from being presented to the American people. Likewise, the $15 billion federal establishment that conducts the War on Drugs would risk its large budget and thousands of career positions if the War on Drugs were won in the name of the hypothesis that drugs cause AIDS. In sum, the drug hypothesis is testable and predicts that AIDS is entirely preventable and treatable by controlling drug use. The solution of AIDS and significant progress in the War on Drugs are as close as a very testable and affordable non-HIV/AIDS hypothesis. ✳ ✳ ✳ |