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Who guards the guardians? Who guards science?

Posted by Henry Bauer on 2018/06/24

Quis custodiet ipsos custodes? This quotation attributed to Juvenal describes the inescapable dilemma as to how societies can be governed .

Today’s guardian of reliable knowledge is science. It is the acknowledged authority on the natural world, on what exists in the world and on how those things behave. Most governments accept as reliable, as true for all practical purposes, whatever the current scientific consensus is: on matters of health, the environment, the solar system, the universe. The mass media, too, accept that scientific consensus; and that largely determines what the general public believes, “what everyone knows”.

Nowadays in that category of “what everyone knows” there are literally innumerable things; among them that the universe began with a Big Bang; that ghosts and Loch Ness Monsters do not exist; that HIV causes AIDS; that hypertension causes heart attacks and strokes; that carbon dioxide released by burning fossil fuels is causing climate change and bringing more frequent and more extreme and more damaging events like hurricanes; etc., etc.

But what guards against the scientific consensus being wrong?

Nothing and nobody.

That really matters, because the history of science is crystal clear that contemporary science, the contemporary scientific consensus, has almost invariably been wrong until further progress superseded and replaced it.

That steady improvement over the centuries gave rise to a comforting shibboleth, that “science is self-correcting”. At any given moment, however, the scientific consensus stands possibly uncorrected and awaiting future “self”-correction. One cannot justifiably assert, therefore, that any contemporary scientific consensus is known to be unquestionably true. It is not known with absolute certainty that the universe began with a Big Bang; that ghosts and Loch Ness Monsters do not exist; that HIV causes AIDS; that hypertension causes heart attacks and strokes; that carbon dioxide released by burning fossil fuels is causing climate change and bringing more frequent and more extreme and more damaging events like hurricanes; etc., etc.

Nevertheless, contemporary society treats these and other contemporary scientific consensuses as true. This amounts to what President Eisenhower warned against: that “public policy could itself become the captive of a scientific-technological elite” [1]. Science can indeed mislead public policy, as when tens of thousands of Americans were forcibly sterilized in the misguided belief that this improved the genetic stock [2]. Science is far from automatically or immediately self-correcting [3].

I’ve wondered how Eisenhower could have been so prescient in 1960, because the conditions that conduce to public policies being misled by science were then just beginning to become prominent: the massive governmental stimulation of scientific activity that has produced today’s dysfunctional hyper-competitiveness, with far too many would-be researchers competing for far too few reliably permanent positions and far too little support for the resources that modern research needs [4]. Moreover, the scientific consensus is guarded not only by the scientists who generated it, powerful societal institutions are vested in the correctness of the scientific consensus [4]: It is virtually inconceivable, for instance, that official bodies like the National Institutes of Health, the Food and Drug Administration, the Centers for Disease Control & Prevention, the World Health Organization, and the like would admit to error of the views that they have promulgated; try to imagine, for example, how it could ever be officially admitted that HIV does not cause AIDS [5].

SUGGESTION TO THE READER:
Reflect on how you formed an opinion about — Big-Bang theory? Loch Ness Monsters? Ghosts? Climate change? … etc. etc. Almost always it will not have been by looking into the evidence but rather by trusting someone’s assertion.

Who has the interest, time, and energy to study all those things? Obviously we must take our beliefs on many matters from trusted authorities; and for a couple of centuries the scientific consensus has been a better guide than most others. But that is no longer the case. The circumstances of 21st-century science mean that society needs guardians to check that what the scientific consensus recommends for public policy corresponds to the best available evidence. On many issues, a minority of experts differs from the scientific consensus, and it would be valuable to have something like a Science Court to assess the arguments and evidence pro and con [6].

I’ve had the luxury of being able to look into quite a few topics because that was appropriate to the second phase of my academic career, in Science & Technology Studies (STS). Through having made a specialty of studying unorthodoxy in science, I stumbled on copious examples of the scientific consensus treating, in recent times, competent minority opinions well within the scientific community with the same disdain, or even worse, as that traditionally directed towards would-be science, fringe science — Loch Ness Monsters, ghosts, UFOS, and the like.

In Dogmatism in Science and Medicine [7], I pointed to the evidence that the contemporary scientific consensus is wrong about Big-Bang theory, global warming and climate change, HIV/AIDS, extinction of the dinosaurs, and more, including what modern medicine says about prescription drugs. The failings of the scientific consensus in modern medicine have been detailed recently by Richard Harris [8] as well as in many works of the last several decades [9]. That the scientific consensus is wrong about HIV and AIDS is documented more fully in The Origin, Persistence and Failings of HIV/AIDS Theory (McFarland, 2007). Why science has become less believable is discussed in [4], which also describes many misconceptions about science and about statistics, the latter bearing a large part of the blame for what’s wrong with today’s medical practices.

But my favorite obsession over where the scientific consensus is wrong remains the existence of Loch Ness “Monsters”, Nessies. It was my continuing curiosity about this that led to my career change from chemistry to STS, which brought many unforeseeable and beneficial side-effects. My 1986 book, The Enigma of Loch Ness: Making Sense of a Mystery [10], showed how the then-available evidence could be interpreted to support belief in the reality of Nessies but could also be plausibly enlisted to reject the reality of Nessies. However, the book’s chief purpose was to explain why seeking to “discover” Nessies was not a sensible task for organized science.

Now in 2018 quite proper science, in the guise of “environmental DNA”, has offered a good chance that my belief in the reality of Loch Ness “Monsters” may be vindicated within a year or so by mainstream science. I plan to say more about that soon.

—————————————————————–

[1]  Farewell Address to the Nation, 17 January 1961
[2]  “Bauer: Could science mislead public policy?”
[3]  Science is NOT self-correcting (How science has changed — VII)
[4]  Science Is Not What You Think — how it has changed,
why we can’t trust it, how it can be fixed
(McFarland, 2017)
[5]   “OFFICIAL!   HIV does not cause AIDS!”
[6]    For a detailed history and analysis of the concept of a Science Court,
see chapter 12 in [4]
[7]    Dogmatism in Science and Medicine: How Dominant Theories Monopolize Research and Stifle the Search for Truth (McFarland, 2012)
[8]    Richard Harris, Rigor Mortis — How Sloppy Science Creates Worthless Cures, Crushes Hope, and Wastes Billions (Basic Books, 2017)
[9]    What’s Wrong with Present-Day Medicine, a bibliography last updated 17 April 2017
[10]  The Enigma of Loch Ness: Making Sense of a Mystery, University of Illinois Press, 1986;
in Cassette Book format, RC 25592, narrated by Richard Dorf, 1988;
U.K. edition, Stirling (Scotland): Johnston & Bacon 1991;
re-issued by Wipf & Stock, 2012

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Posted in conflicts of interest, consensus, funding research, global warming, media flaws, medical practices, peer review, politics and science, prescription drugs, resistance to discovery, science is not truth, science policy, unwarranted dogmatism in science | Tagged: | 3 Comments »

Dangerous knowledge III: Wrong knowledge about science

Posted by Henry Bauer on 2018/01/29

In the first post of this series (Dangerous knowledge) I pointed to a number of specific topics on which the contemporary scientific consensus is doubtfully in tune with the actual evidence. That disjunction is ignored or judged unimportant both by most researchers and by most observers; and that, I believe, is because the fallibility of science is not common knowledge; which in turn stems from ignorance and wrong knowledge about the history of science and, more or less as a consequence, about science itself.

The conventional wisdom regards science as a thing that is characterized by the scientific method. An earlier post (Dangerous knowledge II: Wrong knowledge about the history of science) mentioned that the scientific method is not a description of how science is done, it was thought up in philosophical speculation about how science could have been so successful, most notably in the couple of centuries following the Scientific Revolution of the 17th century.

Just as damaging as misconceptions about how science is done is the wrong knowledge that science is even a thing that can be described without explicit attention to how scientific activity has changed over time, how the character of the people doing science has changed over time, most drastically since the middle of the 20th century. What has happened since then, since World War II, affords the clearest, most direct understanding of why contemporary official pronouncements about matter of science and medicine need to be treated with similar skepticism as are official pronouncements about matters of economics, say, or politics. As I wrote earlier (Politics, science, and medicine),

In a seriously oversimplified nutshell:

The circumstances of scientific activity have changed, from about pre-WWII to nowadays, from a cottage industry of voluntarily cooperating, independent, largely disinterested ivory-tower intellectual entrepreneurs in which science was free to do its own thing, namely the unfettered seeking of truth about the natural world, to a bureaucratic corporate-industry-government behemoth in which science has been pervasively co-opted by outside interests and is not free to do its own thing because of the pervasive conflicts of interest. Influences and interests outside science now control the choices of research projects and the decisions of what to publish and what not to make public.

 

For a detailed discussion of these changes in scientific activity, see Chapter 1 of Science Is Not What You Think: How It Has Changed, Why We Can’t Trust It, How It Can Be Fixed (McFarland 2017); less comprehensive descriptions are in Three Stages of Modern Science  and The Science Bubble.

Official pronouncements are not made primarily to tell the truth for the public good. Statements from politicians are often motivated by the desire to gain favorable attention, as is widely understood. But less widely understood is that official statements from government agencies are also often motivated by the desire to gain favorable attention, to make the case for the importance of the agency (and its Director and other personnel) and the need for its budget to be considered favorably. Press releases from universities and other research institutions have the same ambition. And anything from commercial enterprises is purely self-interested, of course.

The stark corollary is that no commercial or governmental entity, nor any sizable not-for-profit entity, is devoted primarily to the public good and the objective truth. Organizations with the most laudable aims, Public Citizen,  say, or the American Heart Association, etc. etc. etc., are admittedly devoted to doing good things, to serving the public good, but it is according to their own particular definition of the public good, which may not be at all the same as others’ beliefs about what is best for the public, for society as a whole.

Altogether, a useful generalization is that all corporate entities, private or governmental, commercial or non-profit, have a vested self-interest in the status quo, since that represents the circumstances of their raison d’être, their prestige, their support from particular groups in society or from society as a whole.

The hidden rub is that a vested interest in the status quo means defending things as they are, even when objective observers might note that those things need to be modified, superseded, abandoned. Examples from the past are legion and well known: in politics, say, the American involvement in Vietnam and innumerable analogous matters. But not so well known is that unwarranted defense of the status quo is also quite common on medical and scientific issues. The resistance to progress, the failure to correct mis-steps in science and medicine in any timely way, has been the subject of many books and innumerable articles; for selected bibliographies, see Critiques of Contemporary Science and Academe and What’s Wrong with Present-Day Medicine. Note that all these critiques have been effectively ignored to the present day, the flaws and dysfunctions remain as described.

Researchers who find evidence that contradicts the status quo, the established theories, learn the hard way that such facts don’t count. As noted in my above-mentioned book,  science has a love-hate relationship with the facts: they are welcomed before a theory has been established, but after that only if they corroborate the theory; contradictory facts are anathema. Yet researchers never learn that unless they themselves uncover such unwanted evidence; scientists and engineers and doctors are trained to believe that their ventures are essentially evidence-based.

Contributing to the resistance against rethinking established theory is today’s hothouse, overly competitive, rat-race research climate. It is no great exaggeration to say that researchers are so busy applying for grants and contracts and publishing that they have no time to think new thoughts.

Posted in conflicts of interest, consensus, medical practices, peer review, resistance to discovery, science is not truth, scientists are human, the scientific method, unwarranted dogmatism in science | Tagged: | 1 Comment »

Dangerous knowledge

Posted by Henry Bauer on 2018/01/24

It ain’t what you don’t know that gets you into trouble.
It’s what you know for sure that just ain’t so.

That’s very true.

In a mild way, the quote also illustrates itself since it is so often attributed wrongly; perhaps most often to Mark Twain but also to other humorists — Will Rogers, Artemus Ward, Kin Hubbard — as well as to inventor Charles Kettering, pianist Eubie Blake, baseball player Yogi Berra, and more (“Bloopers: Quote didn’t really originate with Will Rogers”).

Such mis-attributions of insightful sayings are perhaps the rule rather than any exception; sociologist Robert Merton even wrote a whole book (On the Shoulders of Giants, Free Press 1965 & several later editions) about mis-attributions over many centuries of the modest acknowledgment that “If I have seen further it is by standing on the shoulders of giants”.

No great harm comes from mis-attributing words of wisdom. Great harm is being done nowadays, however, by accepting much widely believed and supposedly scientific medical knowledge; for example about hypertension, cholesterol, prescription drugs, and more (see works listed in What’s Wrong with Present-Day Medicine).

The trouble is that “science” was so spectacularly successful in elucidating so much about the natural world and contributing to so many useful technologies that it has come to be regarded as virtually infallible.

Historians and other specialist observers of scientific activity — philosophers, sociologists, political scientists, various others — of course know that science, no less than all other human activities, is inherently and unavoidably fallible.

Until the middle of the 20th century, science was pretty much an academic vocation not venturing very much outside the ivory towers. Consequently and fortunately, the innumerable things on which science went wrong in past decades and centuries did no significant damage to society as a whole; the errors mattered only within science and were corrected as time went by. Nowadays, however, science has come to pervade much of everyday life through its influences on industry, medicine, and official policies on much of what governments are concerned with: agriculture, public health, environmental matters, technologies of transport and of warfare, and so on. Official regulations deal with what is permitted to be in water and in the air and in innumerable man-made products; propellants in spray cans and refrigerants in cooling machinery have been banned, globally, because science (primarily chemists) persuaded the world that those substances were reaching the upper atmosphere and destroying the natural “layer” of ozone that absorbs some of the ultraviolet radiation from the sun, thereby protecting us from damage to eyes and skin. For the last three decades, science (primarily physicists) has convinced the world that human generation of carbon dioxide is warming the planet and causing irreversible climate change.

So when science goes wrong nowadays, that can do untold harm to national economies, and to whole populations of people if the matter has to do with health.

Yet science remains as fallible as it ever was, because it continues to be done by human beings. The popular illusion that science is objective and safeguarded from error by the scientific method is simply that, an illusion: the scientific method describes how science perhaps ought to be done, but how it is done depends on the human beings doing it, none of whom never make mistakes.

When I wrote that “science persuaded the world” or “convinced the world”, of course it was not science that did that, because science cannot speak for itself. Rather, the apparent “scientific consensus” at any given time is generally taken a priori as “what science says”. But it is rare that any scientific consensus represents what all pertinent experts think; and consensus is appealed to only when there is controversy, as Michael Crichton pointed out so cogently: “the claim of consensus has been the first refuge of scoundrels[,] … invoked only in situations where the science is not solid enough. Nobody says the consensus of scientists agrees that E=mc2. Nobody says the consensus is that the sun is 93 million miles away. It would never occur to anyone to speak that way”.

Yet the scientific consensus represents contemporary views incorporated in textbooks and disseminated by science writers and the mass media. Attempting to argue publicly against it on any particular topic encounters the pervasive acceptance of the scientific consensus as reliably trustworthy. What reason could there be to question “what science says”? There seems no incentive for anyone to undertake the formidable task of seeking out and evaluating the actual evidence for oneself.

Here is where real damage follows from what everyone knows that just happens not to be so. It is not so that a scientific consensus is the same as “what science says”, in other words what the available evidence is, let alone what it implies. On any number of issues, there are scientific experts who recognize flaws in the consensus and dissent from it. That dissent is not usually mentioned by the popular media, however; and if it should be mentioned then it is typically described as misguided, mistaken, “denialism”.

Examples are legion. Strong evidence and expert voices dissent from the scientific consensus on many matters that the popular media regard as settled: that the universe began with a Big Bang about 13 billion years ago; that anti-depressant drugs work specifically and selectively against depression; that human beings (the “Clovis” people) first settled the Americas about 13,000 years ago by crossing the Bering Strait; that the dinosaurs were brought to an end by the impact of a giant asteroid; that claims of nuclear fusion at ordinary temperatures (“cold fusion”) have been decisively disproved; that Alzheimer’s disease is caused by the build-up of plaques of amyloid protein; and more. Details are offered in my book, Dogmatism in Science and Medicine: How Dominant Theories Monopolize Research and Stifle the Search for Truth (McFarland, 2012). That book also documents the widespread informed dissent from the views that human-generated carbon dioxide is the prime cause of global warming and climate change, and that HIV is not the cause of AIDS (for which see the compendium of evidence and sources at The Case against HIV).

The popular knowledge that just isn’t so is, directly, that it is safe to accept as true for all practical purposes what the scientific consensus happens to be. That mistaken knowledge can be traced, however, to knowledge that isn’t so about the history of science, for that history is a very long story of the scientific consensus being wrong and later modified or replaced, quite often more than once.

Further posts will talk about why the real history of science is so little known.

 

Posted in consensus, denialism, global warming, media flaws, medical practices, prescription drugs, science is not truth, scientific literacy, scientism, scientists are human, the scientific method, unwarranted dogmatism in science | Tagged: , | 4 Comments »

Blood pressure: Official guidelines make no sense

Posted by Henry Bauer on 2017/11/28

These guidelines make no sense because

  1. BP increases normally with age, as known for more than half a century; yet guidelines for what is said to be “normal” and what is called “hypertension” ignore the correlation with age.
  2. The guidelines are not based on pertinent data because the dependence on age is not properly taken into account.

It’s no wonder, then, that the guidelines were changed in one way in 2013 and in the opposite way just four years later.

At the end of 2013, the most authoritative recommendations for managing blood pressure stated that “There is strong evidence to support treating hypertensive persons aged 60 years or older to a BP goal of less than 150/90 mmHg and hypertensive persons 30 through 59 years of age to a diastolic goal of less than 90 mmHg; however, there is insufficient evidence in hypertensive persons younger than 60 years for a systolic goal, or in those younger than 30 years for a diastolic goal, so the panel recommends a BP of less than 140/90 mmHg for those groups based on expert opinion” [emphases added].

Note first that the criterion for describing someone as “hypertensive” is based on insufficient evidence, which has not prevented modern medicine from being quite dogmatic about calling people of any age hypertensive when their BP exceeds what is the common average in healthy 30-40-year-olds, namely about 140/90.

Then note that the goal of ≤150 systolic not as low as what had been recommended dogmatically for the previous three decades or more.

And then contemplate how to value “expert opinion” that is based on insufficient evidence.

In “Don’t take a pill if you’re not ill”  I made a point I’ve not seen elsewhere: population-average numbers for blood sugar, cholesterol, and BP are taken as the desirable upper limits and medication is administered to lower everyone’s numbers to those levels; yet no consideration is given to raising the numbers if they are lower than the average, even as there is evidence that, for example, higher cholesterol is good for older people since it is associated with lower mortality (1, 2). If the population average is more desirable than higher numbers, why aren’t the averages regarded as better than lower numbers as well?

In “Everyone is sick?” I cited the Institute of Medicine finding that measures like (and including) BP are not symptoms of illness even as they are treated as such; discussed further re BP in “‘Hypertension’: An illness that isn’t illness”.

“60 MINUTES on aging — correlations or causes?” cited the finding that mini-strokes in older people were less frequent with higher blood pressure, the very opposite of the official dogma.

So now in 2017 the guidelines call for significantly lower BP than the 2013-14 set, namely “normal (<120/80 mmHg), elevated (120-129/<80 mmHg), stage 1 hypertension (130-139/80-89 mmHg), or stage 2 hypertension(³140/90 mmHg)”; though it is conceded that this is merely a “strong recommendation” based on “moderate-quality evidence” (3).

Defining hypertension as ≥130 makes it likely that some of this “moderate-quality” evidence came from the SPRINT trial, which concluded (4) that “Among patients at high risk for cardiovascular events but without diabetes, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in lower rates of fatal and nonfatal major cardiovascular events and death from any cause, although significantly higher rates of some adverse events were observed in the intensive-treatment group” [emphasis added].

There is here a conundrum: How could there be lower rates of “fatal and nonfatal major cardiovascular events” when Table S5 in the Supplementary Appendix reports only 118 “Serious Adverse Events and Conditions of Interest Classified as Possibly or Definitely Related to the Intervention” under standard treatment (to ≤140) by contrast to 220 under the intensive treatment? With the latter confirming “significantly higher rates of some adverse events were observed in the intensive-treatment group”?

At any rate, all these data are incapable of delivering a meaningful answer about possible risks posed by high BP. Since BP increases with age, the only way to detect its possible risk would be to monitor the health and mortality rates of cohorts of people of the same age, and this is not the case in the SPRINT Trial.

There are plenty of other reasons to be wary of the SPRINT study. The Supplementary Appendix asserts that “All components of the SPRINT study protocol were designed and implemented by the investigators. The investigative team collected, analyzed, and interpreted the data. All aspects of manuscript writing and revision were carried out by the coauthors. The content is solely the responsibility of the authors”. But which ones exactly? There are 6 pages of names; there were 102 clinical sites; a trial coordinating center and centers for MRI reading and electrocardiography reading; an independent data and safety monitoring board; institutional review boards at each clinical site; and a steering committee (13 members) and a writing committee (members not detailed in the Appendix).

When everyone is responsible, then in practice no one is responsible.

Rhetorical questions:

Ø      Who conceived the idea of testing more stringent criteria than formerly for controlling BP?

Ø      What data stimulated that idea, given that the 2013 guidelines cited above revealed a lack of evidence for a systolic goal in persons younger than 60?

Ø      Why are there no statements about conflicts of interest? Biomedical research requires funding. Research articles typically list potential conflicts of interest, and it is well known that most biomedical scientists have some sort of consulting or other relationship with drug companies. Here the only possible clue lies in the Acknowledgments: “The SPRINT investigators acknowledge the contribution of study medications (azilsartan and azilsartan combined with chlorthalidone) from Takeda Pharmaceuticals International, Inc.”

The official BP guidelines make no sense because

  1. BP increases normally with age, as known for more than half a century; yet guidelines for what is said to be “normal” ignore the correlation with age.
  2. The guidelines are not based on pertinent data but on admittedly “moderate-quality” evidence; that is actually of much lower quality than that because it does not offer age-specific information.

**************************************************************************

  1. Schatz et al., “Cholesterol and all-cause mortality in elderly people from the Honolulu Heart Program: a cohort study”, Lancet, 358 (2001) 351-5.
  2. Chapter 3 in Joel M. Kaufmann, Malignant Medical Myths, Infinity Publishing, 2006; ISBN 0-7414-2909-8.
  3. Adam S. Cifu & Andrew M. Davis, “JAMA Clinical Guidelines Synopsis: Prevention, detection, evaluation, and management of high blood pressure in adults”, JAMA; published online 20 November 2017; Clinical Review & Education, E1-3.
  4. The SPRINT Research Group, “A randomized trial of intensive versus standard blood-pressure control”, New England Journal of Medicine, 373 (2015) 2103-16.

 

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Fog Facts: Side effects and re-positioning of drugs

Posted by Henry Bauer on 2017/11/23

Fog Facts: things that are known and yet not known —
[not known to the conventional wisdom, the general public, the media
but known to those (few) who are genuinely informed about the subject]

For that delightful term, Fog Facts, I’m grateful to Larry Beinhart who introduced me to it in his novel “The Librarian”. There it’s used in connection with political matters, but it’s entirely appropriate for the disconnect between “what everyone knows” about blood pressure, cholesterol, prescription drugs, and things of that ilk, and what the actual facts are in the technical literature.

For example, the popular shibboleth is that drug companies spend hundreds of millions of dollars in the development of a new drug, and that’s why they need to make such large profits to plough back into research. The truth of the matter is that most new drugs originate in academic research, conducted to a great extent at public expense; and drug companies spend more on advertising and marketing than they do on research. All that is known to anyone who cares to read material other than what the drug-company ads say and what the news media disseminate; and yet it’s not known because too few people read the right things, even books by former editors of medical journals and academic researchers at leading universities and published by mainstream publishers; see “What’s wrong with modern medicine”.

When it comes to drug “development”, the facts are all hidden in plain view. There’s even a whole journal about it, Nature Reviews — Drug Discovery, that began publication in 2002. I came to learn about this because Josh Nicholson had alerted me to an article in that journal, “Drug repositioning: identifying and developing new uses for existing drugs” (by Ted T. Ashburn and Karl B. Thor, 3 [2004] 673-82). I had never heard of “drug repositioning”. What could it mean?

Well, it means finding new uses for old drugs. And the basic reason for doing so is that it’s much easier and more profitable than trying to design or discover a new drug, because old drugs have already been approved as safe, and it’s already known how to manufacture them.

What seems obvious, however — albeit only as a Fog Fact — is that the very success of repositioning drugs should be a red flag warning against the drug-based medicine or drug-first medicine or drug-besotted medicine that has become standard practice in the United States. The rationale for prescribing a drug is that it will fix what needs attending to without seriously and adversely affecting anything else, in other words that there are no serious “side” effects. But repositioning a drug shows that it has a comparably powerful effect on something other than its original target. In other words, “side” effects may be as powerful and significant as the originally intended effect. Ashburn and Thor give a number of examples:

Cymbalta was originally prescribed to treat depression, anxiety, diabetic peripheral neuropathy, and fibromyalgia (all at about the same dosage, which might cause one to wonder how many different mechanisms or systems are actually being affected besides the intended one). The listed side effects do not include anything about urination, yet the drug has been repositioned as Duloxetine SUI to treat “stress urinary incontinence (SUI), a condition characterized by episodic loss of urine associated with sharp increases in intra-abdominal pressure (for example, when a person laughs, coughs or sneezes)”; and “Lilly is currently anticipating worldwide sales of Duloxetine SUI to approach US $800 million within four years of launch”.

Dapoxetine was not a success for analgesia or against depression, but came into its own to treat premature ejaculation.

Thalidomide was originally marketed to treat morning sickness, but it produced limb defects in babies. Later it was found effective against “erythema nodosum laprosum (ENL), an agonizing inflammatory condition of leprosy”. Moreover, since the birth defects may have been associated with blocking development of blood vessels, thalidomide might work against cancer; and indeed “Celgene recorded 2002 sales of US $119 million for Thalomid, 92% of which came from off-label use of the drug in treating cancer, primarily multiple myeloma . . . . Sales reached US $224 million in 2003 . . . . The lesson from the thalidomide story is that no drug is ever understood completely, and repositioning, no matter   how unlikely, often remains a possibility” [emphasis added: once the FDA has approved drug A to treat condition B, individual doctors are allowed to prescribe it for other conditions as well, although drug companies are not allowed to advertise it for those other uses. That legal restriction is far from always honored, as demonstrated by the dozens of settlements paid by drug companies for breaking the law.]

Perhaps the prize for repositioning (so far) goes to Pfizer, which turned sildenafil, an unsuccessful treatment for angina, into Viagra, a very successful treatment for “erectile dysfunction”: “By 2003, sildenafil had annual sales of US $1.88 billion and nearly 8 million men were taking sildenafil in the United States alone”.

At any rate, Ashburn and Thor could not be more clear: The whole principle behind repositioning is that it’s more profitable to see what existing drugs might do than to look for what might be biologically speaking the best treatment for a given ailment. So anti-depressants get approved and prescribed against smoking, premenstrual dysphoria, or obesity; a Parkinson’s drug and a hypertension drug are prescribed for ADHD; an anti-anxiety medication is prescribed for irritable bowel syndrome; Alzheimer’s, whose etiology is not understood, gets treated with Reminyl which, as Nivalin, (generic galantamine) is also supposed to treat polio and paralysis. Celebrex, a VIOXX-type anti-arthritic, can be prescribed against breast and colon cancer; treatment of enlarged prostate is by the same drug used to combat hair loss; the infamous “morning after” pill for pregnancy termination can treat “psychotic major depression”; Raloxifene to treat breast and prostate cancer is magically able also to treat osteoporosis.

And so on and so forth. This whole business of drug repositioning exposes the fallacy of the concept that it is possible to find “a silver bullet”, a chemical substance that can be introduced into the human body to accomplish just one desired thing. That concept ought to be recognized as absurd a priori, since we know that human physiology is an interlocking network of signals, feedback, attempted homeostasis, defenses against intruders.

It is one thing to use, for brief periods of time, toxins that can help the body clear infections — sulfa drugs, antibiotics. It is quite another conceit and ill-founded hubris to administer powerful chemicals to decrease blood pressure, lower cholesterol, and the like, in other words, to attempt to alter interlocking self-regulating systems as though one single aspect of them could be altered without doing God-only-knows-what-else elsewhere.

The editorial in the first issue (January 2002) of Nature Reviews Drug Discovery was actually clear about this: “drugs need to work in whole, living systems”.

But that editorial also gave the reason for the present-day emphasis on medicine by drugs: “Even with vastly increased R & D spending, the top 20 pharmaceutical companies still churn out only around 20 drugs per year between them, far short of the 4-5 new drugs that analysts say they each need to produce to justify their discovery and development costs”.

And the editorial also mentions one of the deleterious “side” effects of the rush to introduce new drugs: “off-target effects . . . have led to the vastly increased number of costly late-stage failures seen in recent years (approximately half the withdrawals in the past 20 years have occurred since 1997)” — “off-target effects” being a synonym for “side” effects.

It’s not only that new drugs are being rushed to market. As a number of people have pointed out, drug companies also create their own markets by inventing diseases like attention-deficit disorder, erectile dysfunction, generalized anxiety disorder, and so on and on. Any deviation of behavior from what might naively be described as “normal” offers the opportunity to discover a new disease and to re-position a drug.

The ability of drug companies to sell drugs for new diseases is helped by the common misconception about “risk factors”. Medication against hypertension or high cholesterol, for example, is based on the presumption that both those raise the risk of heart attack, stroke, and other undesirable contingencies because both are “risk factors” for such contingencies. But “risk factor” describes only an observed association, a correlation, not an identified causation. Correlation never proves causation. “Treating” hypertension or high cholesterol makes sense only if those things are causes, and they have not been shown to be that. On the other hand, lifelong ingestion of drugs is certainly known to have potentially dangerous consequences.

Modern drug-based, really drug-obsessed medical practice is as misguided as “Seeking Immortality”.

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HPV vaccination: a thalidomide-type scandal

Posted by Henry Bauer on 2017/09/17

I’ve posted a number of times about the lack of proof that HPV causes cervical cancer and that the anti-HPV vaccines are being touted widely by officialdom as well as manufacturers even though the vaccines have been associated with an unusually high number of adverse reactions, some of them very severe, literally disabling.

Long-time medical journalist and producer of award-winning documentaries, Joan Shenton, has just made available the first of a projected trilogy, Sacrificial Virgins, about the dangers of anti-HPV vaccines: https://www.youtube.com/watch?v=KAzcMHaBvLs&feature=youtu.be

The website, WHAT DOCTORS WON’T TELL YOU, comments in this way: “HPV vaccine ‘a second thalidomide scandal’, says new YouTube documentary”

 

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American Medicine Needs Reform — or perhaps revolution

Posted by Henry Bauer on 2017/09/10

Dozens of books and myriad articles have been published over the last few decades about What’s Wrong With Present-Day Medicine.

A recent addition is An American Sickness: How Healthcare Became Big Business and How You Can Take It Back by Elisabeth Rosenthal, lauded in a lead review  in the New York Times (4 & 9 April 2017) and with 250 customer reviews on amazon.com, >80% of them 5-starred.

The New York Times review is titled “Why an open market won’t repair American health care”, which indicates clearly enough why it may take a revolution, and perhaps a President Bernie Sanders, and certainly a squashing of the Republican Party’s free-market-above-all ideology, to bring American citizens the guaranteed and affordable heath care that is enjoyed by the citizens of every other major country on Earth.

It is far from only the political left that recognizes this need. Angus Deaton, 2015 Nobel Prize for economic science, wrote: “I would add [to possible ways of reducing income inequality] the creation of a single-payer health system; not because I am in favor of socialized medicine but because the artificially inflated costs of health care are powering up inequality by producing large fortunes for a few while holding down wages; the pharmaceutical industry alone had 1,400 lobbyists in Washington in 2014. American health care does a poor job of delivering health, but is exquisitely designed as an inequality machine, commanding an ever-larger share of G.D.P. and funneling resources to the top of the income distribution” (review of The Crisis of the Middle-Class Constitution — Why Economic Inequality Threatens Our Republic by Ganesh Sitaraman, New York Times, 20 March 2017)

 

 

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Another medical dogma deconstructed: DO NOT restrict sodium intake

Posted by Henry Bauer on 2017/08/01

Medical dogma has long been that blood pressure should be lowered to a level that is normal for young people, and that taking in salt increases blood pressure significantly.

The facts are otherwise. Lowering salt intake has a virtually negligible effect in lowering blood pressure, but low sodium causes tangible harm: Rethinking the War on Salt

The book-length discussion is The Salt Fix.

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HPV vaccines: risks exceed benefits

Posted by Henry Bauer on 2017/07/09

“Vaccination” is publicly argued in black/white, yes/no fashion, as though one had to be either for or against ALL vaccinations. But the fact is that the benefits of some vaccinations far outweigh the dangers of occasional harmful “side” effects whereas that is not clear with other vaccines. Polio vaccine, for example, seems to have been wonderfully effective and is still so in many countries; on the other hand, in regions where polio is no longer endemic, the risk of contracting polio from oral vaccine exceeds the danger of contracting it when not vaccinated (see links near the end of What to believe? Science is a red herring and a wild-goose chase).

Immune systems are complex and not fully understood, and there are individual variations galore — as when one of my friends came down with shingles shortly after being vaccinated against shingles. (The doctor of course assured him that the outbreak would have been more painful had he not been vaccinated; an ex cathedra assertion without possibility of verification.)

I was reminded of the issue of HPV vaccination by a brouhaha in Europe between the European Medicines Agency (EMA) and medical practitioners and researchers who had come across a substantial number of cases of harm seemingly following HPV vaccination, harm specifically in the form of chronic autoimmune ailments. Since vaccination affects the immune system, such an undesired effect in some individuals seems perfectly plausible.

The Nordic Cochrane Center exists for the purpose of evaluating the evidence underlying medical practices. The Cochrane Center and others have been campaigning for many years to have the data from clinical trials made available to all researchers (1). Last year it lodged a complaint (2) against EMA for conflicts of interest with drug companies exacerbated by the secrecy of discussions that led to criticism of physicians’ reports about autoimmune symptoms appearing after vaccination against HPV. That secrecy is truly extraordinary, virtually an admission of conspiracy: “experts who are involved in the process are not named and are bound by lifelong secrecy about what was discussed” (3).

An EMA publication had severely criticized publications by Louise Brinth and others who had published reports of autoimmune symptoms following vaccination (4); Brinth has delivered a blistering response to the EMA insinuations (5).

The supposed benefit of vaccinating against HPV is to decrease the risk of certain cancers, primarily of the cervix. There are perhaps a hundred types of HPV, of which about 40 are sexually transmitted, and two to four of these seem to be statistically correlated with cancer:
“High-risk HPV strains include HPV 16 and 18 . . . . Other high-risk HPV viruses include 31, 33, 45, 52, 58, and a few others. Low-risk HPV strains, such as HPV 6 and 11, cause about 90% of genital warts, which rarely develop into cancer” (What is HPV?).

HPV infections are the most common sexually transmitted infection: “HPV is so common that nearly all sexually active men and women get the virus at some point in their lives” (Human Papillomavirus (HPV) Statistics). Thus most infections do not lead to cancer, which might induce thought about what “cause” could mean in this context. About 4% of Americans are infected each year with a “high-risk” strain, about 6 million women (USA population is about 320 million, so roughly 160 million women). There are only about 12,000 cases annually of cervical cancer: thus only about 1 in 500 of even “high-risk” infections is associated with this cancer. Thus vaccinating about 500 “high-risk” women might prevent 1 cervical cancer; NNT (number needed to be treated for 1 person to benefit) = 500.

On the other hand, there appears to be about 1 chance in 200 of an adverse effect from vaccination by Gardasil (Gardasil and the sad state of present-day medical practices); about 8% (~ 1 in 12) of adverse events are “serious”, so there’s about 1 chance in 2500 of a serious adverse event. NNH (number needed to be treated for one person to be seriously harmed) = 2500.

For any medical treatment to be desirable, it should be necessary to treat many more people to harm a single one than the number needed to be treated to benefit a single person; NNH should exceed NNT by a substantial amount.
The numbers just mentioned yield a ratio of only 5 — in other words, there’s something like a 1 in 5 chance, 20%, that HPV vaccination would harm rather than benefit. But those numbers apply if only those women infected with high-risk strains are vaccinated. However, the advocates of HPV vaccination, which includes official agencies in the USA and some other countries, recommend HPV vaccination for all girls. That increases NNT by a factor of 25 and reverses drastically the benefit/cost ratio: It is 5 times more likely that an HPV vaccination will result in a serious adverse event than that the vaccination prevents a case of cervical cancer — even if HPV is the actual cause of cervical cancer, which remains to be proved beyond a mere weak statistical correlation.

It is simply not known whether HPV causes cancer at all. Certainly it does not always cause cancer. An extended article on the invaluable Snopes.com website that debunks urban legends is judicious on this matter by pointing out that the claimed association of HPV vaccination with autoimmune symptoms is only speculative. On the other hand, it also concludes in an update of 12 June 2017:
“An earlier version of this story incorrectly stated that countries with high HPV vaccination rates show declines in cervical cancer diagnoses. Both Gardasil and Cervarix have demonstrated efficacy in preventing HPV infections that cause cervical cancer, and evidence suggests declines in precancerous lesions and other abnormal growths as a result of HPV vaccination. There is debate over evidence for declines in cervical cancer diagnoses — as well as over how much time it would take after the introduction of the vaccine to see any effect on cancer diagnoses” [italics added].

The vaccines against HPV are successful against HPV — but it has never been proved that HPV (or the four strains of it supposed to be associated with cervical cancer) actually causes cancer. Since the rate of HPV infections exceeds the rate of cervical cancer by a huge amount, any “causative” action of HPV must be very indirect, especially since only a small percentage of HPV strains shows even a statistical association with cancer.
Recall that the usual test of “statistical significance” in medicine is p ≤ 0.05, meaning that there is less than a 5% chance that the association is owing only to chance. If there are 100 possible associations, about 5 of them will seem significant even though they are not, being picked out purely by chance because of the (weak!) criterion for statistical significance (6). If there are 100 strains of HPV, then at p ≤ 0.05, purely by chance about 5 strains will seem to be correlated with cervical cancer — or with just about anything else.
Before accepting any role fort HPV in cervical cancer, one should want a demonstration of the mechanism of the claimed causative effect.

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(1) “Opening up data at the European Medicine”, Peter Gøtzsche & Anders Jørgensen, British Medical Journal, 342 (28 MAY 2011) 1184-6; “EMA must improve the quality of its clinical trial reports”, Corrado Barbui , Cinzia Baschirotto & Andrea Cipriani, ibid., 1187-9
(2) Complaint to the European Medicines Agency (EMA) over maladministration at the EMA, 26 May 2016
(3) “Complaint filed over EMA’s handling of HPV Vaccine safety issues”, Zosia Chustecka, 5 July 2016
(4) “Suspected side effects to the quadrivalent human papilloma vaccine”, Louise Brinth, Ann Cathrine Theibel1, Kirsten Pors & Jesper Mehlsen, Danish Medical Journal, 62 (#4, 2015) A5064
(5) “Responsum to Assessment Report on HPV-vaccines released by EMA November 26th 2015” by Louise Brinth, MD PhD, Syncope Unit, Bispebjerg and Frederiksberg Hospital, Copenhagen, December 15th 2015
(6) For a thorough discussion of the pitfalls of interpreting p values, see Gerd Gigerenzer, “Mindless Statistics”, Journal of Socio-Economics, 33 (2004) 587-606.

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How to interpret statistics; especially about drug efficacy

Posted by Henry Bauer on 2017/06/06

How (not) to measure the efficacy of drugs  pointed out that the most meaningful data about a drug are the number of people needed to be treated for one person to reap benefit, NNT, and the number needed to be treated for one person to be harmed, NNH.

But this pertinent, useful information is rarely disseminated, and most particularly not by drug companies. Most commonly cited are statistics about drug performance relative to other drugs or relative to placebo. Just how misleading this can be is described in easily understood form in this discussion of the use of anti-psychotic drugs.

 

That article (“Psychiatry defends its antipsychotics: a case study of institutional corruption” by Robert Whitaker) has many other points of interest. Most important, of course, the potent demonstration that official psychiatric practice is not evidence-based, rather, its aim is to defend the profession’s current approach.

 

In these ways, psychiatry differs only in degree from the whole of modern medicine — see WHAT’S WRONG WITH PRESENT-DAY MEDICINE  — and indeed from contemporary science on too many matters: Dogmatism in Science and Medicine: How Dominant Theories Monopolize Research and Stifle the Search for Truth, Jefferson (NC): McFarland 2012.

Posted in conflicts of interest, consensus, media flaws, medical practices, peer review, prescription drugs, scientific culture, unwarranted dogmatism in science | Tagged: , | Leave a Comment »

 
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