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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

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: | Leave a Comment »

Political Correctness in Science

Posted by Henry Bauer on 2017/03/06

Supposedly, science investigates via the scientific method: testing the validity of hunches (hypotheses) against reality and allowing reality to establish beliefs, thereby discarding disproved pre-judgments, hunches, prejudices, biases. Scientific theories. are determined by facts, evidence.   Science is empirical, pragmatic; it does not accept beliefs on authority or from tradition.

Historians, philosophers, sociologists, scholars of Science & Technology Studies have long recognized that this view of science is mythical (i), but it continues to be taught in schools and in social-science texts and it is the conventional wisdom found in the media and in public discourse generally. A corollary of the misconception that scientific theories have been successfully tested against reality is the widespread belief that what science says, what the contemporary scientific consensus is, can safely be accepted as truth for all practical purposes.

So it seems incongruous, paradoxical, that large numbers of scientists should disagree violently, on any given issue, over what science really says. Yet that is the case on a seemingly increasing range of topics (ii), some of them of great public import, for instance whether HIV causes AIDS (iii) or whether human-generated carbon dioxide is the prime cause of global warming and climate change. On those latter matters as well as some others, the difference of opinion within the scientific community parallels political views: left-leaning (“liberal”) opinion regards it as unquestionably true that HIV causes AIDS and that human-generated carbon dioxide is the prime cause of global warming and climate change, whereas right-leaning (“conservative”) opinion denies that those assertions constitute “settled science” or have been proved beyond doubt. Those who harbor these “conservative” views are often labeled “denialists”; it is not to be countenanced that politically liberal individuals should be global warming skeptics (iv).

In other words, it is politically incorrect to doubt that HIV causes AIDS or that human-generated carbon dioxide is the prime cause of global warming. It requires no more than cursory observation of public discourse to recognize this pervasive phenomenon. Governments and Nobel-Prize committees illustrate that those beliefs are officially acted on as though they were established truths. One cadre of mainstream scientists even wants criminal charges laid (v) against those who question that global warming is caused primarily by human-generated carbon dioxide. So political correctness is present within the scientific community in the USA.

I’m of a sufficient age to be able to testify that half a century ago it would not have occurred to any researchers in a democratic society to urge the government to prosecute for criminal conspiracy other researchers who disagreed with them. Declaring certain scientific research programs as politically incorrect and therefore substantively without merit, and persecuting those who perpetrated such research, characterized totalitarian regimes, not free societies. Stalin’s Soviet Union declared wrong the rest of the world’s understanding of genetics and imprisoned exponents of it; it also declared wrong the rest of the world’s understanding of chemical bonding and quantum mechanics. Nazism’s Deutsche Physik banned relativity and other “Jewish” science.

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Political correctness holds that HIV causes AIDS and that human-generated carbon dioxide is the prime cause of global warming. Those beliefs also characterize left-leaning opinion. Why is political correctness a left-wing phenomenon?

In contemporary usage, political correctness means “marked by or adhering to a typically progressive orthodoxy on issues involving especially ethnicity, gender, sexual orientation, or ecology” (vi) or “conforming to a belief that language and practices which could offend political sensibilities (as in matters of sex or race) should be eliminated” (vii), evidently “progressive” or “liberal” or Left-ish views. But those descriptions fail to capture the degree of fanatical dogmatism that can lead practicing scientists to urge that those of differing views be criminally prosecuted; political correctness includes the wish to control what everyone believes.

Thus political correctness has been appropriately called “liberal fascism”, which also reveals why it is a phenomenon of the ultra-extreme Left. Attempted control of beliefs and corresponding behavior is openly proclaimed, unashamedly, by the extreme Right; it is called, and calls itself, fascism, Nazism, and needs no other name. But the Left, the “liberals”, claim to stand for and to support individual freedom of belief and speech; so a name is needed for the phenomenon by which proclamations of liberal ideals are coupled with attempts to enforce adherence to particular beliefs and social norms. Political correctness is the hypocrisy of self-proclaimed liberals functioning as authoritarian fascists.

That hypocrisy pervades political correctness, I was able to observe at first hand during my years in academic administration. People say things they don’t mean, and that they know everyone knows they don’t mean, and no one dares point to the absence of the Emperor’s clothes. For instance, the Pooh-Bahs assert that affirmative action means goals and not quotas, even as hiring practices and incentives demonstrate that they are quotas. For innumerable examples gathered over the years, see the newsletter I edited from 1993 until my retirement at the end of 1999 (viii).

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Science had represented for a long time the virtues associated with honest study of reality. Around the 1930s and 1940s, sociologist Robert Merton could describe the norms evidently governing scientific activity as communal sharing of universally valid observations and conclusions obtained by disinterested people deploying organized skepticism. That description does not accommodate researchers urging criminal prosecution of peers who disagree with them about evidence or conclusions. It does not accommodate researchers lobbying publishers to withdraw articles accepted for publication following normal review; and those norms do not describe the now prevalent circumstances in which one viewpoint suppresses others through refusal to allow publication or participation in scientific meetings (ix).

Science, in other words, is not at all what it used to be, and it is not what the popular view of it is, that common view having been based on what scientific activity used to be. It has not yet been widely recognized, how drastically science has changed since about the middle of the 20th century (x). Among the clues indicative of those changes are the spate of books since the 1980s that describe intense self-interested competition in science (xi) and the increasing frequency of fraud, again beginning about in the 1980s, that led to establishment of the federal Office of Research Integrity. That political correctness has surfaced within the scientific community is another illustration of how radically different are the circumstances of scientific activity now compared to a century ago and by contrast to the outdated conventional wisdom about science.

Political correctness began to pervade society as a whole during the same years as science was undergoing drastic change. The roots of political correctness in society at large may be traceable to the rebellious students of the 1960s, but the hegemony of their ideals in the form of political correctness became obvious only in the 1980s, when the term “political correctness” came into common usage:

The origin of the phrase in modern times is generally credited to gallows humor among Communists in the Stalin era (xii):

“Comrade, your statement is factually incorrect.”
“Yes, it is. But it is politically correct.”

That political correctness is in contemporary times a Left-ish phenomenon is therefore true to its modern origin.

How seriously political correctness corrupts science should be obvious, since it more than breaks all the traditional norms. Those norms are often summarized as universalism, communalism, disinterestedness, skepticism — taking for granted as well simple honesty and absence of hypocrisy. Nowadays what was taken for granted no longer applies. It is simply dishonest to assert that something has been proven beyond doubt when strong contrary evidence exists that is taken seriously by competent researchers. One cannot, of course, look into the minds of those who assert certainty where there is none (xiii), but among possible explanations, hypocrisy may be the least culpable.

Science cannot be isolated from the rest of society, so the incursion of political correctness into science is understandable. Moreover, what used to be the supposedly isolated ivory tower of academe is nowadays the very epicenter where political correctness breeds and from where it spreads. Whatever the causes may be, however, it is important to recognize how science has changed and that it can be corrupted by the same influences as the rest of society.

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i        Henry H. Bauer, Scientific Literacy and Myth of the Scientific Method, University of Illinois Press 1992; http://www.press.uillinois.edu/books/catalog/77xzw7sp9780252064364.html.

ii       Henry H. Bauer, Dogmatism   in Science and Medicine: How Dominant Theories Monopolize Research and Stifle the Search for Truth, McFarland 2012.

iii      Henry H. Bauer, The Origin, Persistence and Failings of HIV/AIDS Theory, McFarland 2007.

iv      Henry H. Bauer, “A politically liberal global-warming skeptic?”, 2012/11/25; https://scimedskeptic.wordpress.com/2012/11/25/a-politically-liberal-global-warming-skeptic.

v       Letter to President Obama, Attorney General Lynch, and OSTP Director Holdren, 1 September 2015; http://scienceblogs.com/gregladen/2015/09/19/letter-to-president-obama-investigate-deniers-under-rico.
The original pdf posted in 2003 at http://www.iges.org/letter/LetterPresidentAG.pdf is no longer there. The Wayback Machine says, “The letter that was inadvertently posted on this web site has been removed. It was decided more than two years ago that the Institute of Global Environment and Society (IGES) would be dissolved when the projects then undertaken by IGES would be completed. All research projects by IGES were completed in July 2015, and the IGES web site is in the process of being decommissioned”.
As of March 2017, however, a Google search for “Institute of Global Environment and Society” led to a website with that header, albeit augmented by “COLA”: http://www.m.monsoondata.org/home.html accessed 4 March 2017. Right-leaning Internet sources offer insight into this seeming mystery: http://www.breitbart.com/big-government/2015/09/22/lead-climate-scientist-behind-obamarico-letter-serious-questions-answer/ and http://leftexposed.org/2015/10/institute-of-global-environment-and-society, both accessed 4 March 2017.

vi      http://www.dictionary.com/browse/politically-correct?s=t (accessed 4 March 2017).

vii     https://www.merriam-webster.com/dictionary/politically%20correct (accessed 4 March 2017).

viii    https://web.archive.org/web/20131030115950/http://fbox.vt.edu/faculty/aaup/index4.html.

ix      Ref. ii, especially chapter 3.

x       Henry H. Bauer, “Three stages of modern science”, Journal of Scientific Exploration, 27 (2013) 505-13; https://www.dropbox.com/s/xl6jaldtx3uuz8b/JSE273-3stages.pdf?dl=0.

xi      Natalie Angier, Natural Obsessions: The Search for the Oncogene, Houghton Mifflin 1987; David H. Clark, The Quest for SS433, Viking 1985; Sheldon Glashow with Ben Bova, Interactions: A Journey through the Mind of a Particle Physicist and the Matter of the World, Warner 1988; Jeff Goldberg Anatomy of a Scientific Discovery, Bantam 1988; Stephen S. Hall, Invisible Frontiers: The Race to Synthesize a Human Gene, Atlantic Monthly Press 1987; Robert M. Hazen, The Breakthrough: The Race for the Superconductor, Summit 1988; David L. Hull, Science as a Process: An Evolutionary Account of the Social and Conceptual Development of Science, University of Chicago Press 1988; Robert Kanigel, Apprentice to Genius: The Making of a Scientific Dynasty, Macmillan 1986; Charles E. Levinthal,. Messengers of Paradise: Opiates and the Brain, Anchor/Doubleday 1988; Roger Lewin, Bones of Contention: Controversies in the Search for Human Origins, Simon and Schuster 1987; Ed Regis, Who Got Einstein’s Office: Eccentricity and Genius at the Institute for Advanced Study, Addison-Wesley 1987; Bruce Schechter, The Path of No Resistance: The Story of the Revolution in Superconductivity, Touchstone (Simon and Schuster) 1990; Solomon H. Snyder, Brainstorming: The Science and Politics of Opiate Research, Harvard University Press 1989; Gary Taubes, Nobel Dreams: Power, Deceit, and the Ultimate Experiment, Random House 1986; Robert Teitelman, Gene Dreams: Wall Street, Academia, and the Rise of Biotechnology, Basic Books 1989; Nicholas Wade, The Nobel Duel: Two Scientists’ 21-Year Race to Win the World’s Most Coveted Research Prize, Doubleday 1981.

xii     Jon Miltimore, “The historical origin of ‘political correctness’”, 5 December 2016, http://www.intellectualtakeout.org/blog/historical-origin-political-correctness; Angelo M. Codevilla, “The rise of political correctness”, Claremont Review of Books, Fall 2016, pp. 37-43; http://www.claremont.org/download_pdf.php?file_name=1106Codevilla.pdf.

xiii    Henry H. Bauer , “Shamans of Scientism: Conjuring certainty where there is none”, Journal of Scientific Exploration, 28 (2014) 491-504.

 

Posted in legal considerations, media flaws, politics and science, science is not truth, scientific culture, scientists are human, the scientific method, unwarranted dogmatism in science | Tagged: | Leave a 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 »

NOVA’s vaccine propaganda: Media coverage

Posted by Henry Bauer on 2014/09/18

NOVA’s presentation on vaccination  was obviously one-sided, and a few observers noted as much:

Verne Gay at Newsday recognized  the program to be “designed as an ironclad, insistent, well-reported film that, in the very nicest way possible, tells those who have decided not to vaccinate their children that they are — essentially — blithering idiots. There is no debate, or should be no debate, or if there is a debate, those doing the debating have spent way too much time on the Internet. . . . like an industry film in support of a product”.

Dave Walker at the Times-Picayune allowed the program’s producer, Sonya Pemberton, to confess her bias. She described herself as “from a medical family” and rather immodestly as “scientifically educated”, whatever that might mean substantively. In practice, of course, it’s spin intended to inveigle her audience that she knows what’s science and what isn’t. She was “trying to take people on this journey so that they can come to the conclusions that the science clearly supports”, in other words not presenting pro- and con- but only the one side. As Walker observes, “That point of view will cause some viewers to write off Pemberton’s journey before it starts”; though I would put it that it should cause all viewers to write off Pemberton’s journey.

Paula Apsell, NOVA’s senior executive producer, was fully in favor of making propaganda rather than a documentary: “to present the scientific facts to people in a convincing way . . . . we’re all going to be very curious as to how the ‘anti-vaxxers,’ as they are called, the people who really don’t accept vaccination, react to this film”. Evidently like Pemberton, Apsell thinks “vaccination” is unproblematically good always and everywhere, when in fact any halfway “scientifically educated” person — or anyone with common sense who thinks about it even briefly — can recognize that vaccination against an infectious disease to guard against epidemics could be an entirely different matter than vaccination against something endemic in the population, let alone against something not yet proven to cause any harm at all.

I was curious about the term “anti-vaxxer”, which was new to me. Through Google I was able to trace it to no earlier than 2009. Perhaps it is not coincidental that the HPV vaccine Gardasil was approved by the Food and Drug Administration in 2006, and within a few years some severe adverse reactions were being reported by parents. Perhaps as a result of public concerns over parental rights as well as adverse reactions, Merck claimed to be suspending its lobbying to have vaccination with Gardasil made compulsory for school attendance [1].
That the reports of serious harm from Gardasil and Cervarix have not faded away is illustrated by the 2013 decision in Japan to suspend vaccination “because several adverse reactions to the medicines have been reported” [2]. In Britain, reports of adverse events were allegedly suppressed [3].

There is no need to speculate about why it was in Japan that official public notice was taken of the fact that serious adverse events from Gardasil and Cervarix are far more frequent than with other vaccines: None of the Big Pharma companies  are Japanese-owned. This is not a conspiracy theory: “conspiracy” implies secrecy, and the misdeeds of Big Pharma have been described and documented in dozens of books and articles.
The same non-conspiracy fact explains why the mass media in the USA did not disseminate this action by Japanese authorities.

The Japanese findings also answer a question that the NOVA program posed but did not answer: Why there has been an unusual amount of controversy about Gardasil and Cervarix by comparison to other vaccines? It’s because of the much greater frequency and considerably greater seriousness of adverse reactions to those vaccines.

As with drugs, a largely unrecognized danger is that there exists no systematic monitoring of adverse events once a drug, a medical device, or a vaccine has been approved. Physicians are not well placed to discern whether an adverse reaction results from a drug or from some other condition, typically the ailment for which the drug is prescribed in the first place. A study comparing systematic monitoring with spontaneous reporting found that under-reporting was as high as 98% [4]. In other words, adverse events might be 50 times as frequent as official data reveal.

At any rate, it seems not unlikely that the term “anti-vaxxer” was introduced by determined supporters of mainstream practices as a way of maligning and discrediting those who were bringing to public attention the reports of such serious consequences of vaccination by Gardasil or Cervarix as blindness, convulsions, deafness, paralysis.

Back to media coverage of the NOVA puff-piece:
While a few observers like Verne Gay at Newsday and Dave Walker at the Times-Picayune recognized how one-sided a piece of propaganda this is, others were taken in, or simply too lazy or thoughtless to see it. According to the Pittsburgh Post-Gazette, it was “balanced” and concluding “gently” that vaccines are “safe and effective”, “without dodging or downplaying the mild, occasional serious and rare deadly risks vaccines can pose”. Chris Mooney, whose own biases are worn on his sleeve [5], was gullible and enthusiastic: “If you care about science, it’s something you should watch” is a remarkable and reprehensible comment about a program that avoided any discussion of the scientific issues and argued purely from authority. Mooney was also taken in by the program’s featuring of a “decision psychologist”, citing “our faulty risk perceptions around vaccines”.
I would put this to Mooney, Sonya Pemberton, and other groupies of universal vaccination: The NOVA program mentioned that officially required vaccinations for attending school vary from State to State within the USA, demonstrating that they are not based on science.

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[1] Linda A. Johnson, Merck suspends lobbying for vaccine
[2] Cervix vaccine issues trigger health noticeJapan withdraws HPV Vaccine recommendation for girlsJapan’s suspension of recommendation for Gardasil & Cervarix HPV Vaccines for women – Caused by large numbers of unexplained serious adverse reactionsJapan and the HPV Vaccine ControversyJapan: International medical researchers issue warning about HPV Vaccine side effects
[3] UK Drug Safety Agency falsified Vaccine Safety Data for 6 million
[4] A. P. Fletcher, “Spontaneous adverse drug reaction reporting vs event monitoring: a comparison”, Journal of the Royal Society of Medicine, 84 (1991) 341-4
[5] Henry H. Bauer, “Not even wrong about science and politics”, Journal of Scientific Exploration, 27 (2013) 540-52 — essay review of Mooney, The Republican War on Science and Berezow & Campbell, Science Left Behind: Feel-Good Fallacies and the Rise of the Anti-Scientific Left

Posted in conflicts of interest, legal considerations, media flaws, medical practices, prescription drugs, science policy | 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.

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Anti-obesity drug-peddling (Anti-obesity fuss III)

Posted by Henry Bauer on 2014/09/04

There is no epidemic of obesity: there is only an epidemic of eating unhealthily and too much (Anti-obesity fuss part I). However, official reports (Anti-obesity fuss part II) and professional organizations abet Big Pharma’s re-definition of lifestyle issues as conditions to be treated medically, including by drugs and even surgery. As is all too typical, the risks associated with drugs fail to be emphasized, and there is no demonstration that the possible benefits of medical intervention exceed those risks.

“In carefully selected patients, appropriate drugs can augment LCDs [low-calorie diets], physical activity, and behavior therapy in weight loss. Weight loss drugs that have been approved by the FDA for long-term use can be useful adjuncts to dietary therapy and physical activity for some patients with a BMI of ≥ 30 with no concomitant risk factors or diseases, and for patients with a BMI of ≥ 27 with concomitant risk factors or diseases. The risk factors and diseases considered important enough to warrant pharmacotherapy at a BMI of 27 to 29.9 are hypertension, dyslipidemia, CHD, type 2 diabetes, and sleep apnea. Continual assessment by the physician of drug therapy for efficacy and safety is necessary” (p. xx in [1], emphases added).

All this may seem unexceptionable, yet it is dangerously misleading:

  •  In the real world of actual medical practice, patients are far from “carefully selected”, and prescriptions are written without the doctor having good evidence that the prescribing actually augments rather than replacing what should have been tried first and for some reasonable length of time, namely diet.
  •  The naming of BMI ranges where drugs are appropriate depending on “concomitant risk factors” makes no sense since that range of BMI, 27 to 29.9, is already itself such a risk: “All . . . adults . . . with a BMI of ≥25 are considered at risk for developing associated morbidities or diseases such as hypertension, high blood cholesterol, type 2 diabetes, coronary heart disease, and other diseases” (p. xii).
  • FDA-approved drugs have often had to be later withdrawn because the initial approval was unwarranted. Thus “At the present time [1998], sibutramine is available for long-term use” (p. xx), but it was withdrawn in 2010 “based on information from a recent clinical study”  showing increased incidence of heart attack and stroke.
    Why had that not shown up in pre-approval clinical trials?
    That question is rhetorical and cynical. Clinical trials submitted in support of drug approval are carefully designed and chosen to emphasize benefits and to mask deleterious “side” effects. It is normal for later studies to show more harm and less benefit [2].
    But even in 1998, the risk-to-benefit ratio did not look good. “It enhances weight loss modestly and can help facilitate weight loss maintenance” [emphases added] hardly describes something that is genuinely effective; on the other hand, “side” effects weree known to be potentially serious: “increases in blood pressure and heart rate may occur.”

In 1998, orlistat was being considered for approval, which was soon granted. Orlistat disrupts the body’s normal fat-metabolizing mechanisms in order to decrease the absorption of fat in the diet. In 2010, the Food and Drug Administration issued a warning about potentially severe liver damage from orlistat, either the prescription form (Xenical, 120 mg) or the over-the-counter[!] version (Alli, 60 mg).
Another rhetorical question: Who would have guessed that disrupting the body’s fat-metabolizing mechanisms could cause liver damage (as well as Lord knows what else)?

Our bodies are complex systems in which substances and mechanisms are shared and interact in many ways, with feedbacks and regulators. It is naïve, stupid, ignorant, to imagine that one can disrupt one reaction or mechanism without producing multiple effects; yet drug treatments are based on that mistaken assumption. Hence “side” effects are universal, and all too often they are significanty harmful. For example, the same reaction pathway that generates cholesterol also generates ubiquinone (Coenzyme Q10) which is an essential part of the body’s energy-producing reactions; therefore weakening of muscles is an inevitable “side” effect of statins (Statins: Scandalous new guidelines; Statins weaken muscles by design).

The peddling of anti-obesity drugs proceeds even as their claimed benefits are small to non-existent. It is reported that lifestyle changes alone can yield weight loss of about 10% in a year (pp. xxv, xxvi in [1]), yet the FDA’s criterion for approving anti-obesity drugs is an even smaller weight loss (p. 7 in Guidance for Industry Developing Products for Weight Management):

“In general, a product can be considered effective for weight management if after 1 year of
treatment either of the following occurs:
• The difference in mean weight loss between the active-product and placebo-treated
groups is at least 5 percent and the difference is statistically significant
• The proportion of subjects who lose greater than or equal to 5 percent of baseline body
weight in the active-product group is at least 35 percent, is approximately double the
proportion in the placebo-treated group, and the difference between groups is statistically
significant”

This trivial goal has allowed approval of drugs that turned out to be lethal. Fen-phen (fenfluramine/phentermine) damaged lungs and heart valves and yielded damages of billions of dollars to subsequent law-suits. Sibutramine, once approved for long-term use had to be withdrawn only a dozen years later (I’m reminded of the monument I saw in Strasburg in 1958: “The Thousand-Year Reich — 1933-1945”).

These drugs suppress appetite by acting on the brain’s neurotransmitters, primarily serotonin, in other words they mess with brain functioning, affecting substances that are involved in much more than appetite, for example serotonin is targeted also by anti-depressants.

Since this Guidance for Industry had been published in 2007 and labeled a “guidance document . . . distributed for comment purposes only”, I sought a later version. There is none [3]:
“The 2007 Draft Guidance for Industry Developing Products for Weight Management is the most up to date version of the guidance. Unfortunately this guidance is not final and we do not have an estimated date of when this will become final”.
These blog posts were stimulated by recent plaudits for purportedly brand-new anti-obesity drugs:
“Not a moment too soon — Why new diet drugs, Belviq and Qsymia, are just in time”.
According to this story, more than one-third of the USA population is obese and 300,000 die annually from “related complications”.

However, these “new” wonder drugs are the same thing all over again.

Belviq ((lorcaserin) “is a serotonin 2C receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults” [emphases added].
It should only be used if diet alone hasn’t worked, and it messes up brain function, so it’s not at all surprising that its “side” effects include “potentially life-threatening serotonin syndrome . . . . confusion, Cognitive Impairment, disturbances in attention or memory . . . , Psychiatric Disorders including euphoria and dissociation, . . . depression or suicidal thoughts” [emphasis added] as well as priapism (erections lasting longer than 4 hours) [4].

Qsymia® (formerly QNEXA) goes one better than Belviq by combining two medicals, phentermine and topiramate. Phentermine is an amphetamine that was part of fen-phen: “deemed safe but was not effective in weight control without its [heart-failure-inducing] partner [fenfluramine]”.  Its new partner, topiramate, “previously FDA-approved for epilepsy. . . . is unrelated to any other drug . . . . No one really knows how topiramate works on the brain, exactly, but it seems to influence a wide range of neuropsychiatric symptoms”.
So Qsymia also messes up brain functioning — moreover in a manner that isn’t understood! — so again it’s no surprise that its “side” effects include suicidal thoughts or actions, depression, anxiety, agitation, panic attacks, insomnia, irritability, aggression, anger, violence, acting on dangerous impulses, mania . . . . As well as increased heart rate and serious eye problems, sudden decrease in vision that could bring permanent blindness (About Qsymia).

The merest hint of these possible “side” effects ought to disqualify these drugs from being used in anything other than cases of imminently life-threatening obesity. It is nothing short of absurd to suggest, let alone recommend, that over-eating should be treated with drugs that disrupt the body’s fat metabolism or the brain’s functioning.

However, the interests vested in drug-based anti-obesity measures are vast. Bureaucracies and jobs are at stake, and research careers. The decisive interest, though, comes from the drug industry. Big Pharma is fixated on blockbuster drugs, things that many people will take over long periods, hence the relentless marketing of statins, blood-pressure- and blood-sugar-lowering drugs, bone-density-increasing drugs, etc.
Big Pharma has no interest in anti-obesity drugs to treat that tiny proportion of people who might actually need them, those with hereditary (”endogenous”) obesity. Instead there are intensive advertising campaigns to convince doctors as well as the general public that drugs are an appropriate way to combat the epidemic of over-eating.

This is yet another illustration that drug companies nowadays market diseases [5] in order to sell supposed remedies. Perfectly normal conditions are “medicalized” by equating them with their extremes: that feeling low, disappointed, grieving, is essentially the same as debilitating clinical depression, say; that declining libido with increasing age is “erectile dysfunction”; that blood pressure higher than normal for twenty-year-olds constitutes “hypertension” [6] and so on and on.

——————————————————————-
[1] National Heart, Lung, and Blood Institute in cooperation with The National Institute of Diabetes and Digestive and Kidney Disease, Clinical Guidelines on the Identification , Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report, Publication 98-4083, September 1998, National Institutes of Health
[2] John P. A. Ioannidis, “Why most published research findings are false”, PLoS Medicine, 2 (2005) 696-701; “Contradicted and initially stronger effects in highly cited clinical research”, JAMA, 294 (2005) 218-28
[3] E-mail of 22 August 2014 from “CDER DRUG INFO” <DRUGINFO@fda.hhs.gov>
[4] Belviq®, revised 08/2012
[5] Moynihan & Cassels. Selling Sickness: How the World’s Biggest Pharmaceutical Companies Are Turning Us All Into Patients, Nation Books (2005) and many others, see “What’s wrong with present-day medicine” 
[6] Henry H. Bauer, “Seeking Immortality? Challenging the drug-based medical paradigm”, Journal of Scientific Exploration, 26 (2012) 867-80

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Crime pays — if you are a drug company

Posted by Henry Bauer on 2014/03/13

In Crimes of the Drug Industry I listed 11 evils perpetrated routinely by the mainstream pharmaceutical industry (“Big Pharma”).

In the text of that blog post, I also pointed out that “companies regard the fines as a small part of the costs of doing business and they continue their illegal tactics”. Peter Gøtzsche (Deadly Medicines and Organised Crime, Radcliffe, 2013) suggests a solution like the Danish treatment of tax evasion:  penalties three times what the miscreant illegally got away with.

How huge the profits are that all the big drug companies make, predominantly through illegal marketing for off-label use, are demonstrated as they find fines of billions of dollars to be trivial compared to the profits from their illegality. During just the last 5 years, they have paid fines of up to $3 billion dollars — $3,000,000,000 — without admitting guilt or changing their behavior; see Big Pharma’s Big Fines.

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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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Quis custodiet ipsos custodes? Who oversees the overseers?

Posted by Henry Bauer on 2014/01/02

Who oversees the overseers?

Who is responsible for knowing what goes on in one’s own bailiwick?
Where do bucks stop, and what’s the penalty for culpable negligence?

The previous post illustrated this issue in HIV/AIDS research and funding: The principal investigator on a $19 million research project didn’t know what was being done by one of his team who had claimed a discovery of enormous potential significance. The official responsible for supervising grants at the funding agency shrugged his shoulders helplessly, and took no initiative to pull the grant back or to demand refunding of the money spent on fraud. The university took no action to discipline the principal investigator. The fraudster himself merely agreed not to seek federal funds for a period of 3 years, after which he was presumably judged responsible enough to get federal grants again.

One very general context is that white-collar crimes are punished — if at all — much more leniently than others, as is well known and acknowledged without any sign that such crimes, which affect huge numbers of people indirectly as well as directly, are likely to be taken more seriously in the foreseeable future. Help bring about a near-collapse of global financial structures and you are sentenced to retire with a golden parachute.

A slap on the wrist is what happened to researcher Dong-Pyou Han. Now there’s less than 3 years in jail for John Beale, a top official at the Environmental Protection Agency who drew $200,000 a year plus enormous travel expenses for doing absolutely nothing:

“Beale Street Blues; EPA Top Dog’s Astonishing Fraud”

“Climate change expert sentenced to 32 months for fraud, says lying was a ‘rush’”

“John Beale’s EPA: An amazing fraud by an architect of government climate policies”

Beale’s punishment is certainly more appropriate than was the HIV/AIDS researcher’s — “Beale . . . agreed to pay $886,186 in restitution and to forfeit another $507,207. . . . he was [also] sentenced to 32 months in federal prison”.

But what about the people who were Beale’s supervisors?

Well, his immediate supervisor was promoted to head the EPA.

“From 1989 until 2013, Beale was employed in the EPA’s Office of Air and Radiation (OAR), which develops policies and regulations related to air pollution and climate change. It is the most powerful office within one of Washington’s most powerful agencies . . . . And for much of his time Beale was senior policy adviser. . . . [H]is specific duties included assisting the head of OAR ‘in planning, policy implementation, direction, and control of EPA programs.’
From 2009 until 2013, the head of OAR was Gina McCarthy, who is currently the EPA Administrator. So not only was Beale within view of senior managers as he pulled off his astounding fraud, he was directly managed by the woman who now runs the place. [emphasis added]
At 10:44 a.m. EST on December 3, 2010, Ms. McCarthy wrote to her staff at OAR and reported: ‘I am pleased to let you know that John Beale will be resuming his role as the Immediate Office’s lead for all of OAR’s international work.’ She added: ‘Most of you know John well as he has been a very large presence in much of OAR’s work for over 20 years. In addition to lead roles in the 1990 Clean Air Act Amendments, the early implementation of the Act, the development and negotiation of the National Low Emission Vehicle Program, and the 1997 [National Ambient Air Quality Standards] review, John served as OAR’s lead for international work from 1990 thru [sic] 2005. Beginning in 1999, John managed OAR’s work on climate change as well as all other international work.’
Ms. McCarthy further gushed that ‘I am very excited to finally get the opportunity to work closely with him. In addition to the international work John will continue to work on various special projects for me.’
There’s more. In an odd conclusion to that December 2010 staff bulletin, Ms. McCarthy wrote that Beale ‘is supposed to be sitting in 5426B of Ariel Rios North, but good luck finding him. We are keeping him well hidden so he won’t get scooped away from OAR anytime soon.’”

Please note the “I am very excited to finally get the opportunity to work closely with him” — even though he had already been Ms. McCarthy’s “senior policy adviser” for at least a year.

The EPA seems to be attempting a whitewash of its chief administrator: “EPA spokeswoman Alisha Johnson . . . said the fraud was uncovered by new EPA Administrator Gina McCarthy during her time as the head of the agency’s Office of Air and Radiation”. That hardly jibes with McCarthy becoming head of OAR in 2009, praising Beale profusely at the end of 2010, and questioning his lies only two years later: “EPA officials didn’t question Beale’s claim to be a CIA employee until November 2012”.

Bad enough that the EPA seems unable to recognize the faulty science in allegedly human-caused global warming. Its chief administrator seems not to know what goes on even with her own chief advisors.

What does it take for a highly placed administrator or bureaucrat or corporate functionary to be fired?

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