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HPV does not cause cervical cancer; HPV vaccination can be deadly

Posted by Henry Bauer on 2018/09/16

Evidence continues to mount that the presumed connection between HPV and cervical cancer is no more than a statistical association, not a causative relationship:

The Gardasil controversy: as reports of adverse effects increase, cervical cancer rates rise in HPV-vaccinated age groups 

Annette Gartland

“The Gardasil vaccines continue to be vaunted as life-saving, but there is no evidence that HPV vaccination is reducing the incidence of cervical cancer, and reports of adverse effects now total more than 85,000 worldwide. Nearly 500 deaths are suspected of being linked to quadrivalent Gardasil or Gardasil 9.
As Merck’s latest human papillomavirus (HPV) vaccine, Gardasil 9, continues to be fast tracked around the world, the incidence of invasive cervical cancer is increasing in many of the countries in which HPV vaccination is being carried out.”

Once again independent scientists without conflicts of interest are maltreated by bureaucratic organizations with conflicts of interest to commercial interests, drug companies in particular:

“This article was updated with information from the AHVID on 14/09/2018.
Update 15/9/2018:
Peter Gøtzsche has been expelled from the Cochrane Collaboration. Six of the 13 members of the collaboration’s governing board voted for his expulsion.
. . . . .
‘This is the first time in 25 years that a member has been excluded from membership of Cochrane. This unprecedented action taken by a minority of the governing board . . . . ‘
In just 24 hours, Gøtzsche said, the Cochrane governing board had lost five of its members, four of whom were centre directors and key members of the organisation in different countries.
Gøtzsche says that, in recent years, Cochrane has significantly shifted more to a profit-driven approach.
‘Even though it is a not-for-profit charity, our ‘brand’ and ‘product’ strategies are taking priority over getting out independent, ethical and socially responsible scientific results,’ he said'”.

 

 

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How science changed — IV. Cutthroat competition and outright fraud

Posted by Henry Bauer on 2018/04/15

The discovery of the structure of DNA was a metaphorical “canary in the coal mine”, warning of the intensely competitive environment that was coming to scientific activity. The episode illustrates in microcosm the seismic shift in the circumstances of scientific activity that started around the middle of the 20th century [1], the replacement of one set of unwritten rules by another set [2].
The structure itself was discovered by Watson and Crick around 1950, but it was only in 1968, with the publication of Watson’s personal recollections, that attention was focused on how Watson’s approach and behavior marked a break from the traditional unwritten rules of scientific activity.
It took even longer for science writers and journalists to realize just how cutthroat the competition had become in scientific and medical research. Starting around 1980 there appeared a spate of books describing fierce fights for priority on a variety of specific topics:
Ø    The role of the brain in the release of hormones; Guillemin vs. Schally — Nicholas Wade, The Nobel Duel: Two Scientists’ 21-year Race to Win the World’s Most Coveted Research Prize, Anchor Press/Doubleday, 1981.
Ø    The nature and significance of a peculiar star-like object — David H. Clark, The Quest for SS433, Viking, 1985.
Ø    “‘Mentor chains’, characterized by camaraderie and envy, for example in neuroscience and neuropharmacology” — Robert Kanigel, Apprentice to Genius: The Making of a Scientific Dynasty, Macmillan, 1986.
Ø    High-energy particle physics, atom-smashers — Gary Taubes, Nobel Dreams: Power, Deceit, and the Ultimate Experiment, Random House, 1986.
Ø    “Soul-searching, petty rivalries, ridiculous mistakes, false results as rivals compete to understand oncogenes” — Natalie Angier, Natural Obsessions: The Search for the Oncogene, Houghton Mifflin, 1987.
Ø    “The brutal intellectual darwinism that dominates the high-stakes world of molecular genetics research” — Stephen S. Hall, Invisible Frontiers: The Race to Synthesize a Human Gene, Atlantic Monthly Press, 1987.
Ø    “How the biases and preconceptions of paleoanthropologists shaped their work” — Roger Lewin, Bones of Contention: Controversies in the Search for Human Origins, Simon & Schuster, 1987.
Ø    “The quirks of . . . brilliant . . . geniuses working at the extremes of thought” — Ed Regis, Who Got Einstein’s Office: Eccentricity and Genius at the Institute for Advanced Study, Addison-Wesley, 1987.
Ø    High-energy particle physics — Sheldon Glashow with Ben Bova, Interactions: A Journey Through the Mind of a Particle Physicist and the Matter of the World, Warner, 1988.
Ø    Discovery of endorphins — Jeff Goldberg, Anatomy of a Scientific Discovery, Bantam, 1988.
Ø    “Intense competition . . . to discover superconductors that work at practical temperatures “ — Robert M. Hazen, The Breakthrough: The Race for the Superconductor, Summit, 1988.
Ø    Science is done by human beings — David L. Hull, Science as a Process, University of Chicago Press, 1988.
Ø    Competition to get there first — Charles E. Levinthal, Messengers of Paradise: Opiates and the Brain, Anchor/Doubleday 1988.
Ø    “Political machinations, grantsmanship, competitiveness” — Solomon H. Snyder, Brainstorming: The Science and Politics of Opiate Research, Harvard University Press, 1989.
Ø    Commercial ambitions in biotechnology — Robert Teitelman, Gene Dreams: Wall Street, Academia, and the Rise of Biotechnology, Basic Books, 1989.
Ø    Superconductivity, intense competition — Bruce Schechter, The Path of No Resistance: The Story of the Revolution in Superconductivity, Touchstone (Simon & Schuster), 1990.
Ø    Sociological drivers behind scientific progress, and a failed hypothesis — David M. Raup, The Nemesis Affair: A Story of the Death of Dinosaurs and the Ways of Science, Norton 1999.

These titles illustrate that observers were able to find intense competitiveness wherever they looked in science; though mostly in medical or biological science, with physics including astronomy the next most frequently mentioned field of research.
Watson’s memoir had not only featured competition most prominently, it had also revealed that older notions of ethical behavior no longer applied: Watson was determined to get access to competitors’ results even if those competitors were not yet anxious to reveal all to him [3]. It was not only competitiveness that increased steadily over the years; so too did the willingness to engage in behavior that not so long before had been regarded as improper.
Amid the spate of books about how competitive research had become, there also was published. Betrayers of the Truth: Fraud and Deceit in the Halls of Science by science journalists William Broad and Nicholas Wade (Simon & Schuster, 1982). This book argued that dishonesty has always been present in science, citing in an appendix 33 “known or suspected” cases of scientific fraud from 1981 back to the 2nd century BC. These actual data could not support the book’s sweeping generalizations [4], but Broad and Wade had been very early to draw attention to the fact that dishonesty in science was a significant problem. What they failed to appreciate was why: not that there had always been a notable frequency of fraud in science but that scientific activity was changing in ways that were in process of making it a different kind of thing than in the halcyon few centuries of modern science from the 17th century to the middle of the 20th century.
Research misconduct had featured in Congressional Hearings as early as 1981. Soon the Department of Health and Human Services established an Office of Scientific Integrity, now the Office of Research Integrity. Its mission is to instruct research institutions about preventing fraud and dealing with allegations of it. Scientific periodicals began to ask authors to disclose conflicts of interest, and co-authors to state specifically what portions of the work were their individual responsibility.
Academe has proliferated Centers for Research and Medical Ethics [5], and there are now periodicals entirely devoted to such matters [6]. Courses in research ethics have become increasingly common; it is even required that such courses be available at institutions that receive research funds from federal agencies.
In 1989, the Committee on the Conduct of Science of the National Academy of Sciences issued the booklet On Being a Scientist, which describes proper behavior; that booklet’s 3rd edition, titled A Guide to Responsible Conduct in Research, makes even clearer that the problem of scientific misconduct is now widely seen as serious.
Another indication that dishonesty has increased is the quite frequent retraction of published research reports: Retraction Watch estimates that 500-600 published articles are retracted annually. John Ioannidis has made a specialty of reviewing literature for consistency, and reported: “Why most published research findings are false” [7]. Nature has an archive devoted to this phenomenon [8].

Researchers half a century ago would have been aghast and disbelieving at all this, that science could have become so untrustworthy. It has happened because science changed from an amateur avocation to a career that can bring fame and wealth [9]; and scientific activity changed from a cottage industry to a highly bureaucratic corporate industry, with pervasive institutional as well as individual conflicts of interest; and researchers’ demands for support have far exceeded the available supply.

And as science changed, it drew academe along with it. More about that later.

===============================================

[1]    How science changed — III. DNA: disinterest loses, competition wins
[2]    How science has changed— II. Standards of Truth and of Behavior
[3]    The individuals Watson mentioned as getting him access corrected his recollections: they shared with him nothing that was confidential. The significant point remains that Watson had no such scruples.
[4]    See my review, “Betrayers of the truth: a fraudulent and deceitful title from the journalists of science”, 4S Review, 1 (#3, Fall) 17–23.
[5]   There is an Online Ethics Center for Engineering and Science. Physical Centers have been established at: University of California, San Diego (Center for Ethics in Science and Technology); University of Delaware (Center for Science, Ethics and Public Policy); Michigan State University (Center for Ethics and Humanities in the Life Sciences); University of Notre Dame (John J. Reilly Center for Science, Technology, and Values).
[6]    Accountability in Research (founded 1989); Science and Engineering Ethics (1997); Ethics and Information Technology (1999); BMC Medical Ethics (2000); Ethics in Science and Environmental Politics (2001).
[7]    John P. A. Ioannidis, “Why Most Published Research Findings Are False”, PLoS Medicine, 2 (2005): e124. 
[8]    “Challenges in irreproducible research”
[9]    How science has changed: Who are the scientists?

Posted in conflicts of interest, fraud in medicine, fraud in science, funding research, media flaws, science is not truth, scientific culture, scientists are human | Tagged: , | Leave a Comment »

How science has changed — II. Standards of Truth and of Behavior

Posted by Henry Bauer on 2018/04/08

The scientific knowledge inherited from ancient Babylon and Greece and from medieval Islam was gained by individuals or by groups isolated from one another in time as well as geography. Perhaps the most consequential feature of the “modern” science that we date from the 17th-century Scientific Revolution is the global interaction of the people who are doing science, and especially the continuity over time of their collective endeavors.
These interactions among scientists began in quite informal and individual ways. An important step was the formation of academies and societies, among which the Royal Society of London is usually acknowledged to be the earliest (founded 1660) that has remained active up to the present time — though it was not the earliest such institution and even the claim of “longest continually active” has been challenged [1].
Even nowadays, the global community of scientists remains in many ways informal despite the host of scientific organizations and institutions, national and international: the global scientific community is not governed by any formal structure that lays down how science should be done and how scientists should behave.
However, observing the actualities of scientific activity indicates that there had evolved some agreed-on standards generally seen within the community of scientists as proper behavior. Around the time of the Second World War, sociologist Robert Merton described those informal standards, and they came to be known as the “Mertonian Norms” of science [2]. They comprise:

Ø    Communality or communalism (Merton had said “communism”): Science is an activity of the whole scientific community and it is a public good — findings are shared freely and openly.
Ø    Universalism: Knowledge about the natural world is universally valid and applicable. There are no separations or distinctions by nationality or religion race or anything of that sort.
Ø    Disinterestedness: Science is done for the public good and not for personal benefit; scientists seek to be impartial, objective, unbiased, and not self-serving.
Ø    Skepticism: Claims and reported findings are subject to critical appraisal and testing throughout the scientific community before they can be accepted as proper scientific knowledge.

Note that honesty is not mentioned; it was simply taken for granted.
These norms clearly make sense for a cottage industry, as ideal behavior that individuals should aim for; but they are not appropriate for a corporate environment, they cannot guide the behavior of individuals who are part of some hierarchical enterprise.
In the late 1990s, John Ziman [3] discussed the change in scientific activity as it had morphed from the activities of an informal, voluntary collection of individuals seeking to understand how the world works to a highly organized activity with assigned levels of responsibility and authority and where sources of research funding have a say in what gets done, and which often expect to get something useful in return for their investments, something profitable.
The early cottage industry of science had been essentially self-supporting. Much could be done without expensive equipment. People studied what was conveniently at hand, so there was little need for funds to support travel. Interested patrons and local benefactors could provide the small resources needed for occasional meetings and the publication of findings.
Up to about the middle of the 20th century, universities were able to provide the funds needed for basic research in chemistry and biology and physics. The first sign that exceptional resources could be needed had come in the 1920s when Lawrence constructed the first large “atom-smashing machine”; but that and the need for expensive astronomical telescopes remained outliers in the requirements for the support of scientific research overall.
From about the time of the Second World War, however, research going beyond what had already been accomplished began to require ever more expensive and specialized equipment as well as considerable infrastructure: technicians to support the equipment, glass-blowers and secretaries and book-keepers and librarians, and managers of such ancillary staff; so researchers increasingly came to need support beyond that available from individual patrons or universities. Academic research came to rely increasingly on getting grants for specific research projects from public agencies or from wealthy private foundations.
Although those sources of research funds typically claim that they want to support simply “the best science”, their view of what the best science is does not necessarily jibe with the judgments of the individual researchers [4].
At the same time as research in universities was calling on outside sources of funding, an increasing number of industries were setting up their own laboratories for research specifically toward creating and improving their products and services. Such product-specific “R&D” (research and development) sometimes turned up novel basic knowledge, or revealed the need for such fundamentally new understanding. One consequence has been that some really striking scientific advances have come from such famous industrial laboratories as Bell Telephone Laboratories or the Research Laboratory of General Electric. Researchers employed in industry have received a considerable number of Nobel Prizes, often jointly with academics [5].
Under these new circumstances, as Ziman [3] pointed out, the traditional distinction between “applied” research and “pure” or “basic” research lost its meaning.
Ziman rephrased the Mertonian norms as the nice acronym CUDOS, adding the “O” for originality, quite appropriately since within the scientific community credit was and is given to for the most innovative, original contributions; CUDOS, or preferably “kudos”, being the Greek term for acclaim of exceptional accomplishment. By contrast, Ziman proposed for the norms that obtain in a corporate scientific enterprise, be it government or private, the acronym PLACE: Researchers nowadays get their rewards not by adhering to the Mertonian norms but by producing Proprietary findings whose significance may be purely Local rather than universal, the subject of research having been chosen under the Authority of an employer or patron and not by the individual researcher, who is Commissioned to do the work as an Expert employee.

Ziman too did not mention honesty; like Merton he simply took it for granted.
Ziman had made an outstanding career in solid-state physics before, in his middle years, he began to publish, starting in 1968 [6] highly insightful works about how science functions, in particular what makes it reliable. In the late 1960s, it had still been reasonable to take honesty in science for granted; but by the time Ziman published Prometheus Bound, honesty in science could no longer be taken for granted; Ziman had failed to notice some of what was happening in scientific activity. Competition for resources and for career advancement had increased to a quite disturbing extent, presumably the impetus for the increasing frequency with which scientists were found to have cheated in some way. Even published, supposedly peer-reviewed research failed later attempted confirmation in many cases, and all too often it was revealed as simply false, faked [7].
More about that in a following blog post.

==========================================

[1]    “The Royal Societies [sic] claim to be the oldest is based on the fact that they developed out of a group that started meeting in Gresham College in 1645 but unlike the Leopoldina this group was informal and even ceased to meet for two years between 1658 and 1660” — according to The Renaissance Mathematicus, “It wasn’t the first but…”
[2]    Robert K. Merton, “The normative structure of science” (1942); most readily accessible as pp. 267–78 in The Sociology of Science (ed. N. Storer, University of Chicago Press, 1973) a collection of Merton’s work
[3]    John Ziman, Prometheus Bound: Science in a Dynamic Steady State, Cambridge University Press, 1994
[4]    Richard Muller, awarded a prize by the National Science Foundation, pointed out that truly innovative studies are unlikely to be funded and need to be carried out more or less surreptitiously; and Charles Townes, who developed masers and lasers, testified to his difficulty in getting research support for that ground-breaking work, or even encouragement from some of his distinguished older colleagues —
Richard A. Muller, “Innovation and scientific funding”, Science, 209 (1980) 880–3
Charles Townes, How the Laser Happened: Adventures of a Scientist, Oxford University Press , 1999
[5]    Karina Cummings, “Nobel Science Prizes in industry”;
Nobel Laureates and Research Affiliations
[6]    John Ziman, Public Knowledge (1968); followed by The Force of
Knowledge
(1976); Reliable Knowledge (1978); An Introduction to Science
Studies
(1984); Prometheus Bound (1994); Real Science (2000);
all published by Cambridge University Press
[7]    John P. A. Ioannidis, “Why most published research findings are false”,
         PLoS Medicine, 2 (2005) e124
Daniele Fanelli, “How many scientists fabricate and falsify research? A systematic review and meta-analysis of survey data”,
PLoS ONE, 4(#5, 2009): e5738

Posted in conflicts of interest, fraud in medicine, fraud in science, funding research, peer review, resistance to discovery, science is not truth, scientific culture, scientists are human | Tagged: , | Leave a Comment »

Politics, science, and medicine

Posted by Henry Bauer on 2017/12/31

I recently posted a blog about President Trump firing members of the Presidential Advisory Council on HIV/AIDS in which I concluded with
”Above all, the sad and bitter fact is that truth-seeking does not have a political constituency, be it about HIV, AIDS, or anything else”.

That sad state of affairs, the fragile foothold that demonstrable truth has in contemporary society, is owing to a number of factors, including that “Science is broken” and the effective hegemony of political correctness (Can truth prevail?).

A consequence is that public policies are misguided about at least two issues of significant social impact: HIV/AIDS (The Case against HIV), and human-caused global warming (A politically liberal global-warming skeptic?).

Science and medicine are characterized nowadays on quite a number of matters by dogmatic adherence to views that run counter to the undisputed evidence (Dogmatism in Science and Medicine: How Dominant Theories Monopolize Research and Stifle the Search for Truth, McFarland, 2012). To cite just one absurdity (on a matter that has no significant public impact): in cosmology, the prevailing Big-Bang theory of the universe requires that “dark matter” and “dark energy” make up most of the universe, the “dark” signifying that they have never been directly observed; and there are no credible suggestions for how they might be observed directly, and nothing is known about them except that their postulated influences are needed to make Big-Bang theory comport to the facts of the real world. Moreover, a less obviously flawed theory has been available for decades, the “steady-state” theory that envisages continual creation of new matter, observational evidence for which was collected and published by Halton Arp (Qasars, Redshifts and Controversies, Interstellar Media, 1987; Seeing Red: Redshifts, Cosmology and Academic Science, Apeiron, 1998).

Dozens of books have documented what is wrong with contemporary medicine, science, and academe:
Critiques of contemporary science and academe;
What’s wrong with present-day medicine.

The common feature of all the flaws is the failure to respect the purported protocols of “the scientific method”, namely, to test hypotheses against reality and to keep testing theories against reality as new evidence comes in.

Some political commentators have described our world as “post-truth”, and a variety of social commentators have held forth for decades about a “post-modern” world. But the circumstances are not so much “post-truth” or “post-modern” as pre-Enlightenment.

So far as we know and guess, humans accepted as truth the dogmatic pronouncements of elders, shamans, priests, kings, emperors and the like until, perhaps half a millennium ago, the recourse to observable evidence began to supersede acceptance of top-down dogmatic authority. Luther set in motion the process of taking seriously what the Scriptures actually say instead of accepting interpretations from on high. The religious (Christian only) Reformation was followed by the European Enlightenment; the whittling away of political power from traditional rulers; the French Revolution; the Scientific Revolution. By and large, it became accepted, gradually, that truth is to be found by empirical means, that explanations should deal with the observed natural world, that beliefs should be tested against tangible reality.

Science, in its post-17th-century manifestation as “modern science”, came to be equated with tested truth. Stunning advances in understanding confirmed science’s ability to learn accurately about the workings of nature. Phenomena of physics and of astronomy came to be understood; then chemistry; then sub-atomic structure, relativity, quantum mechanics, biochemistry … how could the power of science be disputed?

So it has been shocking, not fully digested by any means, that “science” has become untrustworthy, as shown in the last few decades by, for instance, increasing episodes of dishonesty, fraud, unreproducible claims.

Not yet widely realized is the sea change that has overtaken science since about the middle of the 20th century, the time of World War II. It’s not the scientific method that determines science, it’s the people who are doing the research and interpreting it and using it; and the human activity of doing science has changed out of sight since the early days of modern science. 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.

What science is purported to say is determined by people; actions based on what science supposedly says are chosen by people; so nowadays it is political and social forces that determine beliefs about what science says. Thus politically left-leaning people and groups acknowledge no doubt that HIV causes AIDS and that human generation of carbon dioxide is the prime forcer of climate change; whereas politically right-leaning people and groups express doubts or refuse flatly to believe those things.

For more detailed discussion of how the circumstances of science have changed, see “Three stages of modern science”; “The science bubble”; and chapter 1 in Science Is Not What You Think: How It Has Changed, Why We Can’t Trust It, How It Can Be Fixed (McFarland 2017).

For how to make science a public good again, to make science truly reflect evidence rather than being determined by political or religious ideology, see chapter 12 in Science Is Not What You Think: How It Has Changed, Why We Can’t Trust It, How It Can Be Fixed (McFarland 2017).

Posted in conflicts of interest, fraud in medicine, fraud in science, global warming, politics and science, science is not truth, science policy, scientists are human, the scientific method, unwarranted dogmatism in science | Tagged: | 1 Comment »

Science is broken: Illustrations from Retraction Watch

Posted by Henry Bauer on 2017/12/21

I commented before about Science is broken: Perverse incentives and the misuse of quantitative metrics have undermined the integrity of scientific research.  The magazine The Scientist published on 18 December “Top 10 Retractions of 2017 —
Making the list: a journal breaks a retraction record, Nobel laureates Do the Right Thing, and Seinfeld characters write a paper”, compiled by Retraction Watch. It should be widely read and digested for an understanding of the jungle of unreliable stuff nowadays put out under the rubric of “science”.

See also “Has all academic publishing become predatory? Or just useless? Or just vanity publishing?”

 

Posted in conflicts of interest, fraud in medicine, fraud in science, media flaws, science is not truth, scientific culture, scientists are human | Tagged: , | Leave a Comment »

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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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: | 1 Comment »

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

Posted by Henry Bauer on 2015/07/02

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

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

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

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

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

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

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

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

Who looks at evidence? Almost no one

Posted by Henry Bauer on 2015/06/28

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

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

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

Why don’t people look at evidence?

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

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

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

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

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

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

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

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

[Corrected 8 August 2015 in paragraph 7]

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

How (not) to measure the efficacy of drugs

Posted by Henry Bauer on 2015/02/19

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

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

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

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

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

More examples are given by Peter Elias.

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

StatinsNNT

 

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

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

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

 
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