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Vaccines: The good, the bad, and the ugly

Posted by Henry Bauer on 2017/05/21

Only in recent years have I begun to wonder whether there are reasons not to follow official recommendations about vaccination. In the 1930s, I had the then-usual vaccinations, including (in Austria, perhaps Europe) against smallpox. A few others in later years when I traveled quite a bit.

But the Andrew Wakefield affair *, and the introduction of Gardasil **, showed me that official sources had become as untrustworethy about vaccines as they have become about prescription drugs.

It seems that Big Pharma had just about run out of new diseases to invent against which to create drugs and had turned to snake-oil-marketing of vaccines. We are told, for example, that 1 in 3 people will experience shingles in their lifetime and should get vaccinated against it. Have one in three of your aged friends ever had shingles? Not among my family and friends. One of my buddies got himself vaccinated, and came down with shingles a couple of weeks later. His physician asserted that the attack would have been more severe if he hadn’t been vaccinated — no need for a control experiment, or any need to doubt official claims.

So it’s remarkable that the Swedish Government has resisted attempts to make vaccinations compulsory (“Sweden bans mandatory vaccinations over ‘serious health concerns’” by Baxter Dmitry, 12 May 2017).

That article includes extracts from an interview of Robert F. Kennedy, Jr., on the Tucker Carlson Show, which included such tidbits as the continued presence of thimerosal (organic mercury compound) in many vaccines including the seasonal flu vaccines that everyone is urged to get; and the huge increase in number of things against which vaccination is being recommended:

“I got three vaccines and I was fully compliant. I’m 63 years old. My children got 69 doses of 16 vaccines to be compliant. And a lot of these vaccines aren’t even for communicable diseases. Like Hepatitis B, which comes from unprotected sex, or using or sharing needles – why do we give that to a child on the first day of their life? And it was loaded with mercury.”

 

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“Autism and Vaccines: Can there be a final unequivocal answer?”
      “YES: Thimerosal CAN induce autism”

** See “Gardasil and Cervarix: Vaccination insanity” and many other posts recovered with SEARCH for “Gardasil” on my blogs: https://scimedskeptic.wordpress.com/?s=gardasil and https://hivskeptic.wordpress.com/?s=gardasil

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Posted in fraud in medicine, legal considerations, medical practices, politics and science, prescription drugs, science is not truth, science policy, unwarranted dogmatism in science | Tagged: | 1 Comment »

All vaccines are not the same; some are worse than useless

Posted by Henry Bauer on 2015/07/02

I am not among those who question the value of all vaccines on principle. I don’t doubt the value of vaccines in controlling smallpox, measles, polio. I do question the use of adjuvants and preservatives in vaccines, and I do think it makes sense to vaccinate babies against measles and the rest in single shots administered over a period of time instead of all at once in multiple vaccines.

But it gets difficult not to over-react as Big Pharma concentrates on generating vaccines that do more harm than any good that has ever been proven.

It seems that Big Pharma has been running out of new diseases to invent (see Moynihan & Cassels, Selling Sickness: How the World’s Biggest Pharmaceutical Companies Are Turning Us All Into Patients and other works listed in “What’s Wrong with Present-Day Medicine”) and has been turning increasingly to inventing vaccines supposed to guard against old or new infections.

The expected but not forthcoming “swine flu” epidemic led to rapid invention and marketing of a vaccine that turned out to have nasty “side” effects, for example, “How a swine flu shot led to narcolepsy”.

Gardasil and Cervarix, anti-HPV vaccines claimed to prevent cervical cancer, are a scandalous illustration; see for example “Merck Dr. Exposes Gardasil as Ineffective, Deadly, Very Profitable”  and related links. The only suggestion that HPV causes cervical cancer — or rather, that 4 out of four or five times that number of strains of HPV cause cervical cancer — comes from a correlation: those strains have often been found in women who have cervical cancer.

But correlations never, never, never prove causation, no matter that too many medical “experts” ignore this well established, long established fact.

I’ve become all too cynical about Big Pharma, lack of regulation, conflicts of interest, and the like. Yet I was taken aback to find that the National Institutes of Health profit from royalties from sales of Gardasil, and that there are exemptions to the Freedom of Information Act that enable them to hide that fact and the amounts involved.

Posted in conflicts of interest, fraud in medicine, funding research, legal considerations, medical practices, politics and science, prescription drugs | Tagged: , , | 7 Comments »

Who looks at evidence? Almost no one

Posted by Henry Bauer on 2015/06/28

I’ve been a crank for a long time about Loch Ness Monsters, frustrated because I can’t get people to look at Tim Dinsdale’s 1960 film which shows quite clearly a huge animal swimming in Loch Ness, submerging while still throwing up a massive wake.

For more than a decade, I’ve been a crank about HIV not causing AIDS, frustrated because I can’t get people to look at the clear evidence that HIV tests don’t track something infectious, and that the numbers in plain sight on the website of the Centers for Disease Control & Prevention, rates of sexual transmission at less than 1 per 1000 acts of unprotected intercourse, mean that HIV cannot cause an epidemic.

Now I’ve become a crank about human-caused climate change, frustrated because people won’t look at the clear evidence that carbon dioxide has been increasing steadily even as the global temperature was level or dropping form the 1940s into the 1970s, when the experts were predicting an Ice Age; and as the global temperature has not increased since the end of the 1990s.

Why don’t people look at evidence?

Because, I’ve finally realized, they don’t want to risk having to change their mind. There is no positive incentive and plenty of negative incentive. It’s beyond cognitive dissonance, which is to evade the significance of evidence after having come across it. It’s obviously even better not to have come across the evidence at all.

On human-caused climate change (HCCC), disbelief is expressed loudly and publicly by “conservatives” (in my view more accurately described as reactionaries) who have that opinion for the wrong reasons, namely the belief that economic free markets are the most important thing and regulating anything is bad.

“Liberals” or “progressives”, on the other hand (who are actually not liberal or progressive but simply knee-jerk politically correct) don’t look at the evidence because they don’t need to, it’s of no interest to them, they would take their stance that humans cause environmental damage no matter what. And they maintain perfect deniability, they are blameless, they were just accepting what the authorities, the experts, have been saying loudly and incessantly.

Most of my family and friends treat my “reactionary” stance on HCCC as a minor flaw, allowing me space because I tend to get caught up in Quixotic stuff all the time. They have no interest in looking at the evidence because they are completely comfortable with the notion of HCCC because it fits their anti-reactionary political views — which I happen to share. If it turns out that this HCCC is mistaken, there would be all sorts of undesirable consequences, in particular that reactionary views might appear to have been vindicated.

I was distressed when Stephen Colbert took HCCC as proven. I am not happy when all the MSNBC crowd does so, but they’ve become too extreme for me anyway and I rarely watch. But I was very unhappy when Jon Stewart took HCCC as proven. And Pope Francis may have been the last straw (in the wind, as far as ever changing public opinion). Though I did get a sort of sardonic enjoyment from the pundits who pointed out that the Pope knew what he was talking about because he had been a chemist. And I am getting continuing Schadenfreude over the contortions of the Republican presidential candidates as they are forced to comment on the Pope’s encyclical.

Evidence-seeking, I realize, is an obsession of perhaps the tiniest minority there is. On the dangers of modern medical practice, there are just a few dozen voices crying out publicly in the wilderness. On HIV/AIDS, there is our Rethinking AIDS  group of some dozens of people, with a few thousand more quietly agreeing. On HCCC, there are a few academic types like myself who got here because of the evidence, and who subsist uncomfortably in the association with people whose political and social views we do not share, to put it mildly.

I’m beginning to accept that none of the items in my bucket list will see the light of an enlightened day within my lifetime: Nessie discovery, rejection of HIV=AIDS, rejection of carbon-dioxide-is-hurting-us.

But I do remain curious about how the “authorities” will adjust when reality eventually catches up with them irrevocably.

[Corrected 8 August 2015 in paragraph 7]

Posted in consensus, denialism, fraud in medicine, fraud in science, global warming, media flaws, medical practices, politics and science, science is not truth, science policy, unwarranted dogmatism in science | Tagged: , , , , | 11 Comments »

How (not) to measure the efficacy of drugs

Posted by Henry Bauer on 2015/02/19

Innumerable books and articles have described the flaws of contemporary drug-based medicine, notably the way drugs are approved: the Food and Drug Administration requires only 2 successful trials of 6 months duration — even if there have been many unsuccessful trials as well. Accordingly, drugs have had to be withdrawn from the market because of their toxicity sooner and sooner after their initial approval (p. 238 ff. in Dogmatism in Science and Medicine, McFarland 2012). It is becoming quite common to see a drug being advertised by its manufacturers at the same time as a law firm is canvassing for patients harmed by the drug to join their class-action suit (today, for example, with Xarelto, approved in 2008 and for extended uses in 2011).

Not widely noted or understood is that the statistical criterion for efficacy of a drug is inappropriate. What concerns patients (and ought to concern doctors) is how big an effect a drug has; but the approval process only requires that it be better than placebo, or than a competing drug, at “statistical significance” of p≤ 0.05. The latter is already a very weak criterion, allowing the result to be wrong once in 20 trials. But even more inappropriate is that the effect size need not be large. If one uses a large enough number of guinea pigs, even a tiny difference can become “statistically significant”. For instance, clopidogrel (Plavix) is prescribed for prevention of stroke, and a study found it better at 75 mg/day, at statistical significance of p = 0.043, than aspirin at 325 mg/day. But it took nearly 20,000 trial subjects to reach this conclusion, because the reduction in risk of an adverse event was only from 5.83% (per year) to 5.32% *. One might judge this as trivial and not worth the extra cost and extra danger of side effects compared to aspirin, one of the safest drugs as demonstrated by decades of use.

Moreover, meaningful for patients is the change in absolute risk brought about by an intervention, not the relative reduction in risk compared to something else. The occurrence of an adverse (stroke) event is about 5% per year in older people; the absolute reduction brings it to perhaps 4.5%, about 1 in 22 instead of 1 in 20. Trivial, especially considering that such small differences, even from large trials, may actually be artefacts of some flaw or other in the trial protocol or practice.

The easiest measure of efficacy to understand, but almost never shared with patients or doctors, is NNT: the number of patients that needs to be treated in order to achieve the desired result in 1 patient. These numbers reveal an aspect of drug treatment that is not much emphasized: no drug is 100% effective in every patient.
Even less commonly shared is NNH: the number of patients who must receive a drug in order to have 1 patients harmed by that drug. This reveals an aspect of drug treatment that is not at all emphasized, indeed deliberately avoided: every drug has adverse effects to some degree.

A fine exposition of this appeared in the New York Times: “How to measure a medical treatment’s potential for harm”: to prevent 1 heart attack over a 2-year period, 2000 patients need to be treated (NNT = 2000 — the benefit is 1 in 1000); but aspirin can also cause bleeding, NNH = 3333. So the chance of benefit — very small to start with — is only about twice the chance of harm. In other cases — mammograms are mentioned, and antibiotics to treat ear infections in children, NNH is large compared to NNT; yet current medical practice goes against this evidence.

More examples are given by Peter Elias.

Statins show up very badly indeed when evaluated in this manner:

StatinsNNT

 

For other critiques of using statins, see “STATINS are VERY BAD for you, especially FOR YOUR MUSCLES”;  “Statins weaken muscles by design”;  “Statins are very bad also for your brain”;  “Statins: Scandalous new guidelines”.

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* Melody Ryan, Greta Combs, & Laroy P. Penix, “Preventing stroke in patients with Transient Ischemic Attacks”, American Family Physician, 60(1999) 2329-36

Posted in fraud in medicine, medical practices, prescription drugs | Tagged: , , , | 5 Comments »

Contemporary science and medicine are losing credibility

Posted by Henry Bauer on 2014/12/31

“The Demise of Science? Hundreds of computer generated studies have been published in respected scientific journals” describes more problems than just the publication of fake articles generated by computer programs.

“Independent research, where funding is unrelated to findings, has become a rarity, and the end result is a dramatic deterioration of credible science” is spot on. What used to be the place for independent purely truth-seeking “basic” research, the “ivory tower” of academe, has become a place where budding researchers must find their own research support from outside sources if they are to have a career — see e.g. Science has become another Bubble; Science rewards hucksters and spin artists, not soundly tested science; The business of for-profit “science”;  and links in those articles.

“The Demise of Science?” cites the increase in articles retracted because of falsification and other breaches of proper conduct.

Clinical trials are biased, and prescription drugs are now responsible for more deaths than anything but cancer and heart disease (David Healy, Pharmageddon, University of California Press, 2012; Peter C. Gøtzsche, Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare, Radcliffe, 2013).

A large proportion of published studies in medical matters cannot be reproduced.
Inveterate defenders of the mainstream will seek to discount the facts discussed in “The Demise of Science?” by noting that it is an Internet publication on a website that favors alternative medicine; but the same critique was made years ago by Marcia Angell, a former editor of the New England Journal of Medicine:

It is simply no longer possible to believe
much of the clinical research that is published,
or to rely on the judgment of trusted physicians
or authoritative medical guidelines

Drug companies and doctors: a story of corruption
New York Review of Books, 15 January 2009

Posted in fraud in medicine, fraud in science, funding research, science is not truth, scientific culture | Tagged: , | 2 Comments »

Corrupt “science” publications and meetings

Posted by Henry Bauer on 2014/12/20

The “publish-or-perish” syndrome, together with the low cost of “publishing” on-line, has brought an endless spate of new “journals” put out by entrepreneurs ready to cash in; and quality control is not a consideration, even as some of the “publishers” pay lip-service to peer review.

A correspondent  to my HIV/AIDS blog  contributed a link to a story at Retraction Watch  that shows how the urge to make money by “publishing” is not restricted to new entrepreneurs, it is alive and well at corporate giants like Elsevier, whose prime interest in proliferating publications means that they do not even exercise ordinary care in overseeing how they accept articles: they had to retract a number of published articles that had been accepted after faked “peer review” because the article authors were allowed to choose who the “peer reviewers” would be.

Elsevier, of course, also published advertisements for drug companies under the pretense that they were journals (Corruption in medical science: Ghostwriting), and emasculated the innovative Medical Hypotheses after unfounded initiatives by HIV/AIDS vigilantes (see Chapter 3 in Dogmatism in Science and Medicine).

A related phenomenon to fake and shoddy “journals” is the proliferation of “conferences” whose only purpose is self-promotion by individuals, institutions, or even perhaps countries, since China is a prominent venue for these occasions; again see Fake, deceptive, predatory Science Journals and Conferences. The invitations to pseudo-conferences are often so incompetently composed that they remind one of the emails from Nigeria that one has won a huge prize at a lottery or inherited a huge amount from a previously unknown relative. Below is a just-received specimen; note that I never responded to earlier invites as well as other signs that this is an unedited from letter; note the poor written expression and syntax; but above all, browse the list of “Keynote Speakers” and “Part” listing of “renowned speakers”; a number of academics are quite happy to enjoy a grant-paid sightseeing vacation in China at an event organized primarily by Big Pharma and an entrepreneurial pseudo-conference-arranging outfit. Don’t neglect the link to the organizational home to note the huckstering of sponsorships, exhibition space, and the registration fees that range from $1300 to $2000; as well as the list of eight other concurrent “conferences” .

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Dear Henry H. Bauer,

How are you? I wish everything goes well with you!

This is an email to follow up my previous invitations. I have not heard from you for a couple of weeks since my first letter. Now we have received well responding from worldwide experts in planned sessions, in case you won’t miss it, we’ d like to extend our invitation again. I am writing to confirm whether you would like to attend this grand congress and present a speech. Would you please give me a tentative reply? Thank you very much.

I apologize for the inconvenience if the letter disturbed you more than once. On behalf of the Meeting Organizing Committee, it is my pleasure and privilege to invite you to be the Session speaker in the 7th Annual International Congress of Antibodies (ICA-2015).

The conference with the theme “Innovations from Defending Surface to Penetrating the Membrane” will be held during April 25-28, 2015 in Nanjing, China. If the suggested thematic session is not your current focused core, you may look through the whole sessions and transfer another one that fits your interest. We sincerely wish your participation.

Keynote Speakers:

Dr. Brian E. Harvey, Vice President, Pfizer Inc., USA
Dr. Liangzhi Xie, Founder & CEO, Sino Biological Inc., China
Dr. Andrew Wang, Chairman, Taiwan Antibody Association, Taiwan
Dr. Jonathan Milner, CEO, Abcam, UK
Dr. Chien-Hsing Ken Chang, Vice President, Research and Development, Immunomedics, Inc., USA
Dr. Michael Yu, Presidert, Innovent Biologics, Inc., China

We look forward to seeing you in Nanjing in 2015 for this influential event.

If you need any assistance about the conference, please do not hesitate to contact us at any time!

For more information, please visit: http://www.bitcongress.com/ica2015/default.asp
Sincerely yours,

Dannie
Organizing Commission of ICA-2015
East Area, F11, Building 1,
Dalian Ascendas IT Park,
1 Hui Xian Yuan,
Dalian Hi-tech Industrial Zone,
LN 116025, China
Tel: 0086-411-84575669-860
Email: dannie@bit-ica.com

PS: Part of Renowned Speakers:
Mr. Homan Chan, Investigator, Novartis Institute of Biomedical Research, USA
Dr. Tao Wu, Principal Scientist, Boehringer Ingelheim, USA
Dr. Liming Liu, Merck Research Laboratories, USA
Dr. Joshua DiNapoli, Senior Scientist, Sanofi Pasteur, USA
Dr. Ostendorp Ralf, Vice President, MorphoSys AG, Germany
Dr. Abdul Wajid, Senior Director, XOMA, USA
Dr. Ernesto Oviedo-Orta, Clinical Sciences Expert, Novartis Vaccines Diagnostics Siena, Italy
Dr. Guohong Wang, VP, Immunalysis Corporation, USA
Dr. Rong-Rong Zhu, Senior Scientist, EMD Millipore, USA
Dr. David P. Humphreys, Senior Group Leader, UCB-New Medicines, UK
Dr. Jian Li, Principal Scientist, Pfizer Inc., USA
Dr. Bing Kuang, Principal Scientist, Pfizer, USA
Dr. William Haseltine, Founder, Chairman of the Board and CEO, Human Genome Sciences, USA
Dr. Martin Lemmerer, Principal Scientist, Novartis Institutes for BioMedical Research, Inc., USA
Dr. Jijie Gu, Senior Principal Research Scientist, AbbVie Pharmaceuticals, Inc., USA
Dr. Ronald C. Desrosiers, Professor, Harvard Medical School, USA
Dr. Eva Kimby, Professor, Karolinska University Hospital, Sweden
Dr. Joseph F. John, Professor and Chief, Medical University of South Carolina, USA
Dr. Dongfeng Tan, Professor, the University of Texas M. D. Anderson Cancer Center, USA
Dr. Paul Fisch, Group leader and Professor, University of Freiburg, Germany
Dr. Koshi Mimori, Professor & Director, Kyushu University Beppu Hospital, Japan
Dr. Peggy Hsieh, Professor, Florida State University, USA
Dr. Rudiger Schade, Professor, Charité-University Medicine of Berlin, Germany
Dr. Tae Young Jang, Professor, Inha University, Korea
Dr. Oddmund Bakke, Professor, University of Oslo, Norway
Dr. Rajat Sethi, Chair, California Health Sciences University, USA
Mr. Tim Bernard, CEO, Pivotal Scientific Limited, UK
Dr. Dan Zhang, Chairman and CEO, Fountain Medical Development Ltd., China
Dr. Kaia Agarwal, President, Regulatory Compass, LLC., USA
Ms. Sandra Frantzen, Shareholder, McAndrews, Held Malloy, Ltd., USA
Dr. Seth D. Ginsberg, President, Global Healthy Living Foundation, USA
Dr. James R Harris, CEO, Healthcare Economics LLC., USA
Dr. Martin Gleeson, CSO, Genalyte Inc., USA
Dr. Mingjiu Chen, President and CEO, biosynergics Inc., China
Dr. Jane Dancer, Chief Operating Officer, F-star, UK
Dr. Xiaodong Yang, President and CEO, Apexigen, USA
Dr. Wenzhi Tian, President and CEO, Huabo Biopharm Co Ltd, China
Dr. Ralph V. Boccia, Director, Center for Cancer and Blood Disorders, USA
Dr. Jun Bao, Senior Vice President, Shenogen Pharma Group, China
Dr. Francesc Mitjans, Chief Scientific Officer, Lykera Biomed, Spain
Dr. Fiona Greer, Director, SGS M-Scan, UK
Dr. Albrecht Gröner, Head Pathogen Safety, CSL Behring, Germany
Dr. Chung-Chou Lee, CEO of Medigen Vaccinology Corporation, Taiwan
Dr. Chengbin Wu, President of RD, Shanghai CP Guojian Pharmaceutical, China
Dr. Ni Jian, General Manager, National Engineering Research Center of Antibody Medicine, China
Dr. Ian Q. Li, Chief scientific Officer, ATGCell Inc., Canada
Dr. Terry Dyck, President, CEO, IGY Immune Technologies Life Sciences Inc., Canada
Dr. Vijay E-Bionary, CEO, E-Bionary Technologies, India
Dr. Allan Riting Liu, Vice President & Senior Advisor, Wanbang Biopharmaceutical Group, China
512

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All I can say is, FOR SHAME, to everyone associated with such scams.

Posted in conflicts of interest, fraud in medicine, fraud in science, peer review, scientific culture | Tagged: , , | 1 Comment »

Public health VERSUS individual health

Posted by Henry Bauer on 2014/11/23

“Public health and individual health”  pointed out that “public health” deals in statistics and averages, and some public-health policies and practices can bring actual harm to some individuals unless physicians recognize the danger and treat each patient as the unique individuals that they are.

It seems that things are even considerably worse than I knew.

“How medical care is being corrupted”  reveals that some insurance companies have taken it on themselves to reward doctors for choosing particular drugs and treatments and penalizing them for not doing so. The article is no outsiders’ radical rant: it is by two physicians at Harvard Medical School and is published in the New York Times.

The insurance companies have financial considerations as their prime motive, and their criteria are inevitably statistical and “on the average”. To drive doctors into practicing by the insurance company guidelines means driving doctors not to treat their patients as unique individuals.

Half a century ago already, health-insurance considerations brought into being the damaging belief that “high” blood pressure represents a risk of cardiovascular disease or adverse events, because blood pressure correlates with such events. But it correlates only because both blood pressure and risk of cardiovascular problems both increase with age, naturally and inevitably. No correlations ever prove causation, furthermore. For half a century, medical practice has continued the absurd practice of defining “hypertension” independently of age, thereby classifying as “illness” levels of blood pressure that are perfectly normal at a given age. Something like 75% of American seniors are being exposed chronically, lifelong, to the continuing negative “side” effects of blood-pressure-lowering drugs for no good reason and with no expectable benefit.

The present direct incentives to doctors to harm their patients seems a natural, normal, progression of allowing health-care policies to be determined by the financial marketplace.

You get what you pay for.

Posted in conflicts of interest, fraud in medicine, medical practices, prescription drugs | Tagged: | Leave a Comment »

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.

Posted in fraud in medicine, legal considerations, medical practices, prescription drugs | Tagged: , , | Leave a Comment »

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

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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