Skepticism about science and medicine

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Posts Tagged ‘Pre-Exposure Prophylaxis against HIV’

When prophecy fails

Posted by Henry Bauer on 2014/07/13

True believers do not question their belief when evidence disproves it, for example when predictions turn out to be wrong. Instead they find ways to modify the predictions while keeping the core belief intact, illustrating the phenomenon of cognitive dissonance: the inability to recognize facts that contradict one’s beliefs.

The classic study is When Prophecy Fails: A Social and Psychological Study of a Modern Group that Predicted the Destruction of the World by Leon Festinger, Henry Riecken, & Stanley Schachter (University of Minnesota Press, 1956).

This is often cited in connection with religious cults and similarly disparaged groups. However, the lesson is just as applicable to true believers of all sorts, including true believers in the conventional wisdom and acolytes of scientism, true believers in the religion of Science (Scientism, the Religion of Science).

Scientists themselves are not immune. Half a century ago, Thomas Kuhn [1] pointed out that the history of science is a record of maintaining theories long after the evidence has disproved them. Bernard Barber [2] pointed out that what are now the most applauded advances in science were fiercely resisted at the time they were first proposed. Gunther Stent [3] pointed to “premature discoveries” like continental drift and quantitative genetics that were dismissed for several decades before gaining acceptance. Imre Lakatos [4] pointed out that scientists routinely make ad hoc adjustments to theories in order to maintain the core belief, just as Ptolemy added epicycles — wheels upon wheels — to sustain the credibility of Earth-centered astronomy.

The popular view that scientific theories are continually tested against evidence is wrong. It’s only in the long run that science eventually acknowledges its errors and corrects them, and sometimes that long run is very long indeed.

A contemporary case in point is HIV/AIDS theory. The evidence has long been quite plain that “HIV” is not infectious, is not transmitted sexually, and doesn’t cause “AIDS” (The Case against HIV). Prediction after prediction of the theory has been disproved, for example, that an AIDS epidemic would sweep across the heterosexual world (section 4.1 in The Case against HIV). Innumerable individuals continue to be dreadfully harmed, to the point of death, by supposedly life-saving antiretroviral drugs (section 5 in The Case against HIV). People continue to be told that they are “HIV-infected” despite the fact that there is no approved test for “HIV infection”, and increasingly the mainstream is doubling down on the harm it causes by calling for more and more widespread “HIV testing”.

Perhaps most incredibly, the idea is now being promulgated assiduously that perfectly healthy, HIV-negative people should take up a permanent regime of toxic drugs in order to decrease the likelihood of becoming “HIV-positive”:
Healthy gay men urged to take HIV drugs — WHO:
“The World Health Organization (WHO) is urging all sexually active gay men to take antiretroviral drugs to reduce the spread of HIV. The organisation says the move may help prevent a million new HIV infections over 10 years”.

What exactly is the evidence that antiretroviral drugs can prevent infection?
The Centers for Disease Control & Prevention (CDC) cite 4 trials of Pre-Exposure Prophylaxis (PrEP).
Like peer review, clinical trials are widely thought to safeguard the quality and reliability of scientific publication, but that is not now the case: vested interests of drug companies and researchers and others have made clinical trials tools for marketing drugs instead of for discovering truth [5]; innumerable devices are employed to slant results of clinical trials in directions desired by the sponsor [6, 7].

The four studies cited by CDC illustrate that great skepticism is called for.
1. “Preexposure chemoprophylaxis for HIV prevention in men who have sex with men” (New England Journal of Medicine 363 [2010] 2587-99 by Robert M. Grant (corresponding author) and 34 other authors “for the iPrEx Study Team” listed in a Supplementary Appendix on the NEJM website.
2499 subjects were followed for a median of 1.2 years. 36 in the PrEP group administered FTC (emtricitabine) plus TDF (tenofovir) became infected compared to 64 on placebo, yielding a claimed effective reduction of 44% in infection rate. How this is calculated is rather obscure, since the paper’s Figure 2 shows cumulative probabilities of infection as about 9% and about 7.5%; that decrease of 1.5% from 9% is a decrease by 1/6 which is about 15%  rather than 44%.

PrEP-Grant

 Beyond that apparent contradiction, certain details in this report seem unbelievable. Both placebo and drug recipients supposedly had identical rates of adverse events (70% and 69% respectively) and of serious adverse events (5% each).

There’s something obviously wrong here. Participants must have been significantly unhealthy if some 70% on placebo experienced adverse events and 5% serious adverse events, in little more than a year and when the average ages were 26.8 and 27.5 years in placebo and drug groups respectively. There were only very minor differences between the groups: Drugs caused more nausea (2% vs. <1%, p = 0.04) but placebo caused more diarrhea (61 vs. 49 events p = 0.36, insignificant).
More specifically: It has long been known that TDF is toxic in a number of ways, notably by causing kidney failure: Poisonous “prophylaxis”: PrEP (Pre-Exposure Prevention); Treatment Guidelines are dangerous; Unlimited insanity: Truvada to prevent HIV; Spinning Truvada; Kidney-disease denialism (a special case of HAART denialism); Tenofovir and the ethics of clinical trials.

2. “Antiretroviral prophylaxis for HIV-1 prevention among heterosexual men and women” (New England Journal of Medicine 367 [2012] 399-410) by Jared M. Baeten (corresponding author) and 44 others “for the Partners PrEP Study Team” that are listed in a Supplement.
The same oddity is reported here, of similar rates of adverse events (~85%) in two separate drug-administered cohorts as well as in the placebo group. Serious adverse events were also reported as similar at 7.3 or 7.4%. The study extended over 3 years.
Again one wonders why people on placebo, with median age in the low 30s, would experience a 2.5% per year rate of serious adverse events, even in Kenya and Uganda.
The subjects were 4758 couples, and HIV infection was reported at 0.65 per 100 person-years with TDF alone, 0.50 with FTC/TDF, and 1.99 on placebo; thus reductions of 67% and 75% respectively: about twice the 44% reported by Grant for FTC/TDF.

3. “Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana” (New England Journal of Medicine 367 [2012] 423-34) by Michael C. Thigpen (corresponding author) and 23 others plus further members of the TDF2 Study Group listed in the Supplementary Appendix.
1219 individuals were studied for a median of 1.1 years, with reported efficacy of TDF/FTC at 62.2%: 1.2 and 3.1 infections per 100 person-years, respectively. The drugs did produce more “nausea (18.5% vs. 7.1%, P<0.001), vomiting (11.3% vs. 7.1%, P = 0.008), and dizziness (15.1% vs. 11.0%, P = 0.03) than the placebo group, but the rates of serious adverse events were similar (P = 0.90)” [emphasis added].
Once again it seems more than strange that the rates of serious adverse events on placebo should be the same as on the drugs: why would 7% of people healthy enough to enroll in a clinical trial experience a serious adverse event in little more than a year? When the average age was only in the 20s?
But incredible details aside, this article should never have been published: “Because of
low retention and logistic limitations, we concluded the study early and followed
enrolled participants through an orderly study closure rather than expanding enrollment”. It is an elementary principle that when protocols cannot be followed, “results” must not be given any credence.

4. “Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial” (Lancet 381 [2013] 2083-90) by Michael Martin (corresponding author) and 16 others “for the Bangkok Tenofovir Study Group”.
2413 individuals were assigned to TDF or placebo, with apparent infection rates of 0.35 and 0.68 per 100 person-years respectively, presumably from sharing of infected needles rather than from sexual transmission. One may be excused for being skeptical about this given that other studies have shown that drug abusers who don’t share needles tend to be “infected” at a greater rate than those who do share needles (section 3.3.8 in The Case against HIV).
Here again the “occurrence of serious adverse events was much the same between the two groups”, albeit ill health among drug abusers is to be expected; median age was 31. “Nausea was more common in participants in the tenofovir group than in the placebo group (p=0·002)”.

Those are the data that supposedly justify administering highly toxic drugs to perfectly healthy individuals continually during their years of sexual activity.
What the reports actually demonstrate is that clinical trials can be and are biased unscrupulously to produce highly misleading “data”, “showing” for example that a drug of known toxicity is no more harmful than placebo.

In an honest world, the perpetrators of such schemes, Big Pharma and its “researcher” shills, would be charged with manslaughter if not murder.
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[1] Thomas S. Kuhn, The Structure of Scientific Revolutions, University of Chicago Press, 1970
[2] Bernard Barber, “Resistance by scientists to scientific discovery”,  Science, 134 (1961) 596-602
[3] Gunther Stent, “Prematurity and uniqueness in scientific discovery”, Scientific American, December 1972, 84-93
[4] Imre Lakatos, “History of Science and its Rational Reconstruction”, pp. 1-40 in Method and Appraisal in the Physical Sciences, ed. Colin Howson, Cambridge University Press, 1976
[5] David Healy, Pharmageddon, University of California Press, 2012
[6] Ben Goldacre, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, Faber & Faber, 2013
[7] Peter C. Gøtzsche, Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare, Radcliffe, 2013

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