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Big Pharma beware: The comedians are on to you

Posted by Henry Bauer on 2014/09/17

Authoritarian regimes, and politicians in general for that matter, are terrified of being made fun of.  In present-day Egypt, for example, the local equivalent of The Daily Show is being persecuted. So it is a very promising development that our very own Daily Show last night, Tuesday 16 September, had a segment featuring  Peter Gøtzsche describing the drug companies as organized crime, as in his book, Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare.

It was mentioned that Pharma’s propaganda for painkillers like oxycontin and percocet is misleading and damaging, and some of Pharma’s ads were satirized.

I would like to think that the clip was quite genuine, that showed a Pfizer person — perhaps a security guard? — waving away the Daily Show correspondent and the camera.


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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%.


 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.
[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

Posted in conflicts of interest, fraud in medicine, fraud in science, medical practices, prescription drugs, unwarranted dogmatism in science | Tagged: , , , | 4 Comments »

More reviews of DOGMATISM book

Posted by Henry Bauer on 2014/05/22

Two substantial reviews offering much room for further thought have just been published of Dogmatism in Science and Medicine: How Dominant Theories Monopolize Research and Stifle the Search for Truth:

Journal of Scientific Exploration, 28 (2014) 142-48, by Donald J. DeGracia
Dogmatism in Science and Medicine (DSM) by Henry H. Bauer is about the corruption of modern science. For practicing scientists it is a disturbing book to read. Medicine is bitter, yet we put up with it to get better. DSM is bitter medicine intended to improve the health of science.
. . . .
Dr. Bauer does a professional, competent, and important job bringing the corruption of modern science into the light. The criticisms offered above do not detract from the fundamental correctness of the picture DSM paints, but instead underscore its seriousness, and the need to further refine the picture. To scoff at DSM or to think it is off-base is merely to reveal that the scoffer is woefully uninformed about the transformations that have occurred in science over the past decades. If one is a practicing scientist, or a concerned citizen of good will, one ignores this book at one’s own peril.

Journal of Scientific Exploration, 28 (2014) 149-52, by Brian Josephson
At the end of this fascinating book, Bauer asks the question: Can 21st century science become trustworthy again? He suggests that change must come from outside the existing institutions, which merely serve to perpetuate knowledge monopolies, but first the need for change must become generally recognized . Possibilities discussed include a Science Court; independent, publicly funded institutions that can assess scientific claims of public importance; and designated funds for non-mainstream research. Something of this nature is clearly needed.




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Critiques of science, medicine, academe

Posted by Henry Bauer on 2014/02/25

A request for information led me to update my bibliography of books and articles describing deficiencies and flaws in present-day science, medicine, and academe. It’s posted on my personal homepage and also here.

Posted in conflicts of interest, consensus, fraud in medicine, fraud in science, legal considerations, media flaws, medical practices, peer review, politics and science, prescription drugs, science policy, scientific culture, scientism, unwarranted dogmatism in science | Tagged: | Leave a Comment »

Crimes of the Drug Industry

Posted by Henry Bauer on 2014/02/04

By which I mean the Prescription Drug Industry, not the illegal drugs business.

Here are some of the main evils perpetrated by the mainstream pharmaceutical industry (“Big Pharma”):
1. Many new drugs are not effective — they don’t do what they’re claimed to do.
2. Many new drugs are not safe. Their “side” effects can outweigh any possible benefits.
3. Many new drugs are not as good as, but are more expensive than the ones they replace.
4. New drugs are approved without proper assessment of the evidence. The Food and Drug Administration (FDA) is paid by the drug manufacturers for the costs of approval, which introduces a conflict of interest. FDA administrators have sometimes overruled their technical staff to approve a drug found wanting on the evidence.
5. Clinical trials are biased in favor of finding drugs apparently safe and effective even when they may be neither.
6. The industry pays for clinical trials and controls the data, some or all of which are then withheld from regulators and researchers. Negative results are not divulged.
7. PR spin by the drug industry is dishonest. Twice as much is spent on marketing than on drug development.
8. The drug industry buys influence with (i.e. bribes) doctors and hospital administrators under the guise of consultantships, sponsored research, lecture fees, medical education.
9. The drug industry buys influence with (bribes) medical journals by paying large sums for advertisements and by buying reprints of favorable articles for enormous sums, as much as hundreds of thousands of dollars for reprints of a single article which is then distributed to physicians by sales people.
10. The drug industry uses incessant propaganda to persuade the public that perfectly natural, normal conditions are really illnesses that can be vanquished by medication; e.g. seasonal affective disorder, erectile dysfunction, low testosterone, female sexual dysphoria, etc., etc.

None of this is secret. Many books and articles by industry insiders and medical professionals give chapter and verse with innumerable examples and illustrations about all this — see my sample bibliography. Most recent and perhaps most trenchant is Deadly Medicines and Organised Crime (Radcliffe, 2013) by Peter Gøtzsche.

Gøtzsche charges Big Pharma with literally criminal behavior, and makes a good case, in particular by comparing Big Pharma to Big Tobacco, which hid and denied for decades its knowledge of the dangers of smoking and the addictiveness of cigarettes; top executives perjured themselves.
But Gøtzsche acknowledges that most of the people who work in Big Pharma are not being deliberately dishonest, they’re just doing their jobs and not asking difficult questions. The whole system is dysfunctional, and blame for that is very widely shared. For example, government regulators and justice departments allow companies to pay fines without acknowledging guilt and without criminal charges being laid against the responsible individuals, so that companies regard the fines as a small part of the costs of doing business and they continue their illegal tactics, for instance using indirect means to lobby physicians to prescribe drugs “off label”.
Deliberately intended or not, the result has been a huge number of deaths from approval of unsafe drugs that offered no benefit over existing ones and from inappropriate use of prescription drugs:

In the United States and Europe,
drugs are the third leading cause of death
after heart disease and cancer
(Gøtzsche, p. 1)

One contributing factor is the misnomer “side effect”. As Frank Ofner, MD, used to say:

“Side” effects are MAIN effects that doctors don’t want to talk about.

As a result, many people are now being made ill, sometimes to the point of death, from so-called “side” effects of prescription drugs whose potential benefits have never been soundly established, for example, statins:
Cholesterol is good for you
 STATINS are VERY BAD for you, especially FOR YOUR MUSCLES
Statins weaken muscles by design
Statins are very bad also for your brain

Society’s addiction to prescription drugs may stem ultimately from the mistaken notion that because drugs have been effective against infectious diseases, therefore they can be effective against other ailments including the natural consequences of aging.

The dangers of prescription drugs and the criminal or near-criminal actions of Big Pharma are becoming ever more widely known, but the enormous political will required to do something about it remains lacking. In the meantime, not only technical books describe the horrors but also fiction and films. Recently I came across the French movie, “The New Protocol” (2008; original title “Le nouveau protocole”). It features a man investigating his son’s death who learns some horrific truths about Big Pharma, including the use of Africa as a venue for testing a new vaccine. Among the highlights for me was a recalling of the Tuskegee syphilis “trial”, for which President Clinton apologized 45 years later, and repetition of which is avoided in the First World by holding clinical trials in the Third World, principally Africa. The film points out that Big Pharma is now Capitalism’s biggest money-maker. It persuades us that we are all ill and in need of medication — for sleep disorder, take a pill. For creeping baldness, for weight gain, there are pills to take. Pills can be a miracle cure for all our ills.
Depressed? There are pills against that.
Afraid of aging? Estrogen for her, testosterone for him.
Too cheerful? Let’s call it “Gaiety Disorder”.
Rich but nevertheless sad? “Paradise Syndrome”, a bankable disease, administer serotonin to the idle rich.

Perhaps the only defense against such Big Pharma-induced social insanity is laughter, and a personal resolve not to take any prescription drug without doing personal research into its supposed benefits and its down-played toxic “side” effects.

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