Skepticism about science and medicine

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Posts Tagged ‘Gardasil’

Trust medical science at your peril: Correlations never prove causation

Posted by Henry Bauer on 2016/06/28

It was a long-known empirical fact that poverty, vagrancy, criminality, and apparently deficient intelligence all correlated with heredity to a considerable extent; they all ran in families and clans. The scientific confirmation that characteristics of animals are passed on from generation to generation, and the Darwin-Wallace explanation of evolution by natural selection of the fittest, made it possible to understand those aspects of human society. It was an obvious, scientifically sound conclusion that human societies could be steadily improved by restricting reproduction of the less fit and expanding the fertility of the fittest. Hence the eugenics movement, promoted by the most progressive, liberal people who were also the best educated, with an apparently justified faith in the reliability of what was at the time the most up-to-date the scientific knowledge (Trust science at your peril: Beware of scientism and political correctness). Those circumstances led to forced sterilization of tens of thousands in America and reinforced Nazis in their doctrines and practices of mass killing of the unfit — Jews, gypsies, homosexuals (Edwin Black, War Against the Weak, 2003).

Only in hindsight did the flaws and errors of the earlier scientific consensus become clear. We now appreciate that environmental and developmental influences can modify heritable traits quite dramatically. “Ill-bred” can be the result of social, economic, environmental factors as much, perhaps even more than any pre-ordained verdict of genetics; and “well-bred” individuals can spring from what might seem the least promising hereditary stock. In other words, the observed correlation between undesired social characteristics and clans was misinterpreted through neglecting the variable of environmental effects.

One lesson to be drawn is that bad science, wrong science, what some even call pseudo-science, can remain the accepted scientific consensus for decades, even in quite modern times, say, the middle of the 20th century. It is unlikely that a mere half-a-century later our societies have become immune from assuming that a mainstream scientific consensus must be true to Nature. Nothing guards our times from treating unjustified, misguided scientific claims as good science.

Unwarranted claims coming from scientists continue to be accepted if they appear minimally plausible and if they are consistent with world-views and vested interests of financial, social, or political powers.

The most sweeping lesson that remains to be learned is that correlations must never be taken as demonstrating a cause-and-effect relationship: there might always be in play an unsuspected variable. One of the earliest axioms taught in Statistics 101 is that correlations never prove causation. The evident correlation between biological kinship and undesirable behavioral traits was not a cause-and-effect relationship.

Many or most people have never learned that basic truth that correlations are not causes. Many others “know” it as a generalization but fail to apply it in specific instances, when an evident correlation could plausibly reflect cause and consequence — just as a genetic basis for undesirable characteristics seemed quite plausible to educated and expert people not so long ago.

Indeed, a large swath of modern medical practices is based on mistaking mere correlations for evidence of causation (“Correlations: Plausible or implausible, NONE prove causation”). For example:

HPV and cervical cancer

The National Cancer Institute offers a great deal of information about this:

Human papillomaviruses (HPVs) are a group of more than 200 related viruses. . . Sexually transmitted HPV types fall into two categories:
— Low-risk HPVs, which do not cause cancer but can cause skin warts (technically known as condylomata acuminata) on or around the genitals, anus, mouth, or throat. For example, HPV types 6 and 11 cause 90 percent of all genital warts. HPV types 6 and 11 also cause recurrent respiratory papillomatosis, a less common disease in which benign tumors grow in the air passages leading from the nose and mouth into the lungs.
— High-risk HPVs, which can cause cancer. About a dozen high-risk HPV types have been identified. Two of these, HPV types 16 and 18, are responsible for most HPV-caused cancers. . . .
>> Cervical cancer: Virtually all cases of cervical cancer are caused by HPV, and just two HPV types, 16 and 18, are responsible for about 70 percent of all cases . . . .
>> Anal cancer: About 95 percent of anal cancers are caused by HPV. Most of these are caused by HPV type 16.
>> Oropharyngeal cancers (cancers of the middle part of the throat, including the soft palate, the base of the tongue, and the tonsils): About 70 percent of oropharyngeal cancers are caused by HPV. In the United States, more than half of cancers diagnosed in the oropharynx are linked to HPV type 16 (9).
>> Rarer cancers: HPV causes about 65 percent of vaginal cancers, 50 percent of vulvar cancers, and 35 percent of penile cancers (. . . .) Most of these are caused by HPV type 16.

The Centers for Disease Control & Prevention offer advice on avoiding HPV cancers:

— Bivalent, quadrivalent and 9-valent HPV vaccines each target HPV 16 and 18, types that cause about 66% of cervical cancers and the majority of other HPV-associated cancers in both women and men in the United States. 9-valent HPV vaccine also targets five additional cancer causing types (HPV 31, 33, 45, 52, 58) which account for about 15% of cervical cancers. Quadrivalent and 9-valent HPV vaccines also protect against HPV 6 and 11, types that cause anogenital warts.
— Quadrivalent and 9-valent HPV vaccines are licensed for use in females and males; bivalent HPV vaccine is licensed for use in females.
What percent of HPV-associated cancers in females and males are caused by the 5 additional types in the 9-valent HPV vaccine?
— About 14% of HPV-associated cancers in females (approximately 2800 cases annually) and 4% of HPV-associated cancers in males (approximately 550 cases annually) are caused by the 5 additional types in the 9-valent HPV vaccine.

What evidence is there for these extremely specific claims of causation?

None, actually. The cited facts are merely that the stated strains of HPV have been detected in those proportions of those cancers. Those correlations don’t begin to indicate causation.

It may be worth recalling that the Centers for Disease Control & Prevention in the early 1990s had officially stated, on the basis of the same sort of data (epidemiology, i.e. correlations), that cervical cancer was an AIDS disease, caused by HIV.

One may sympathize with medical researchers for the impossibility of conducting experiments that would be capable of proving cause-and-effect; ethical, legal, and moral restraints make it unfeasible to use human beings as experimental guinea pigs. There would also be practical barriers: To determine whether a given treatment, in this case a vaccine, actually prevents cancer, a clinical trial would be necessary that spanned over decades and enrolled large numbers of human guinea-pigs, some of whom (controls) would not get potentially-cancer-preventing vaccine.

However, the inability to obtain proof does not justify proclaiming as fact, as these official agencies do, causative relations that are no more than speculation based on statistical correlations.

[The vaccines] “Gardasil and Cervarix have not been shown to be of any significant health benefit. They have been demonstrated to cause serious injuries. It’s scandalous that they were ever approved, and it’s scandalous that they remain on the market.

And they are far from alone on those scores among new prescription medications introduced in the last couple of decades” (Deadly vaccines, 2013/04/17 http://wp.me/p2VG42-24).

Alzheimer’s Disease

Sleep disorders may raise risk of Alzheimer’s, new research shows
Sleep disturbances such as apnea may increase the risk of Alzheimer’s disease, while moderate exercise in middle age and mentally stimulating games, such as crossword puzzles, may prevent the onset of the dementia-causing disease, according to new research to be presented Monday

A daily high dose of Vitamin E may slow early Alzheimer’s disease

Again, these are correlations speculated to be possible causes.

Semantics no doubt plays a role. One could report that sleep disorders, and lack of vitamin E, seem to be associated with a risk of Alzheimer’s. Medical jargon puts it like this: “sleep disorders, and lack of vitamin E, are risk factors for Alzheimer’s”. Then the media and public conclude that “risk factor” means something that tends to cause the associated effect.

See also “60 MINUTES on aging — correlations or causes?

Biomarkers

It is not feasible to test treatments for chronic conditions by actual outcome, because one would have to wait a couple of decades to determine whether regimen A or drug B reduces morbidity and mortality apparently associated with high blood pressure, or high cholesterol, or high blood sugar, or low bone density, etc. All those are statistically correlated with increased morbidity and mortality. They are risk factors.

Present-day medical dogma makes them biomarkers for cardiovascular disease, diabetes, bone fracture, in other words indicators of whether the disease is present. But that is tantamount to making those quantities measures of actual risk, in other words regarding them as measures of what causes those ailments, in other words equating risk factors with causes.

Official reports, however, as well as the many studies on which those reports are based, find that biomarkers are not proper measures of risk after all. See:

“Everyone is sick?”

“‘Hypertension’: An illness that isn’t illness”

“Cholesterol is good for you”

 

Unfortunately, they were not joking

“Magical statistics: Hearing loss causes dementia”

 

The overall lesson:

“Don’t take a pill if you’re not ill”

The ignorant acceptance of correlations as capable of demonstrating causation is greatly reinforced in medical matters by the pharmaceutical industry, which sells drugs as palliatives and preventatives based on nothing more than correlations with biomarkers.

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Posted in conflicts of interest, consensus, media flaws, medical practices, prescription drugs | Tagged: , , , , , , , | 5 Comments »

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

Posted by Henry Bauer on 2015/07/02

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

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

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

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

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

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

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

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

NOVA on Vaccines: Documentary or Propaganda?

Posted by Henry Bauer on 2014/09/16

On Wednesday, 10 September 2014, PBS TV broadcast NOVA’s “Vaccines: Calling the Shots”.  It makes the case that everyone should be vaccinated and that doubts and worries about side effects are misplaced, originating with a tiny number of ideological “anti-vaxxers”.

This program is propaganda, not a documentary:
1. Misdirection diverts attention from fundamental substantive points.
2. Authorities are quoted but the scientific issues are neither described nor argued.
3. Questioning specific vaccinations and corollaries of vaccination are misrepresented as opposition to vaccination in general.

Misdirection is illustrated by the choice of experts, in particular Dr. Brian Zikmund-Fisher, a Decision Psychologist at the University of Michigan. What place does a decision psychologist have when the issue concerns the safety of a vaccine? He is shown at several places, described as an expert on risks and decision-making: so his role is to “expertly” declare that the other “experts” should be believed, who asserted the risk of adverse reactions to vaccination to be “negligible”, “minuscule”, and the like
This is argument from authority at its very worst, demeaning viewers as incapable of weighing risks and benefits for themselves. Yet they might be capable of doing that if only the program had presented the evidence regarding both risks and benefits, which it does not. “Trust us — we’re the experts”, in other words. But philosophy has long discarded such argument from authority as invalid, a logical fallacy. In any case, experience has amply shown that experts are quite commonly wrong about matters in their own field of expertise; copious illustrations can be found in a number of places [1].

The program begins with a heart-rending tear-jerker about a baby with whooping cough (pertussin) acquired before the usual time for vaccination. Several later tear-jerking anecdotes feature measles, polio, and cervical cancer. At the same time, “anti-vaxxers” are charged with appealing to emotion with anecdotes instead of arguing science. But it is this program that appeals to emotion and fails to argue the scientific issues.

Despite the unquestioned successes of measles, polio, and smallpox vaccination, some parents are said to be worried nowadays — without scientific justification — about such possible side-effects as autism. The program acknowledges parents’ rights to be worried, but asserts that on the other hand it is the task of public-health doctors and officials to worry about saving lives. Emotion-appealing misdirection again, away from the substantive issue: that people worry about saving lives doesn’t entail that they know what they’re doing.

The claim that autism can result from MMR vaccine is dismissed unequivocally. Highly speculative and very early research is cited suggesting that something happens genetic-mutation-wise at between 10 and 24 weeks of gestation that predisposes to later development of autism: therefore  vaccinations after birth can’t possibly be the cause of autism. I trust that such conclusion-drawing on the basis of slim-to-none actual data is sufficiently parody-like that it needs no further critique. Not mentioned — perhaps the program was made too soon? — is the public acknowledgment by a scientist at the Centers for Disease Control & Prevention that data were fudged to hide the observed possible consequence of autism among some African-American boys vaccinated with MMR [2].

Utterly avoided or evaded are the several scientific questions:

  • Are side effects, albeit rare, more common with multiple simultaneous vaccinations than with sequential ones?
    A priori one would regard sequential as safer. After all, vaccines are challenges — insults — to the immune system, intended to summon defensive reactions, and such challenges are known to be dangerous: how HIV causes AIDS remains a mystery [3], and a popular current hypothesis is that it brings about chronic activation of the immune system [4]; and worsening illness of AIDS patients on antiretroviral treatment is ascribed to reconstitution of previously damaged immune systems [5].
  • Is there any evidence that multiple simultaneous vaccinations offer superior protection over sequential ones?
    If not, what harm would there be if parents were allowed to make the choice?
  • The program’s dogmatic insistence that mercury in thimerosal does not cause autism is not an honest reflection of the published literature [6]. In any case, it is well known that organic compounds of mercury (as well as other heavy metals) can cause brain damage. Recall the long and bitter campaign to eliminate tetraethyl-lead additives from gasoline after incontrovertible evidence that babies were harmed by even the truly minuscule amounts they absorbed from ambient air.
  • From what stems the need for preservatives like thimerosal; and for such toxic “adjuvants” as aluminum or squalene? Presumably it would be more expensive and inconvenient to replace preservatives with refrigeration. But what makes a substance a preservative is that it acts by killing biological intruders; since preservatives are biologically highly toxic, it is hardly unreasonable to worry about what they do to babies whose brains and bodies are rapidly developing. Adjuvants are substances that stimulate immune systems unselectively, in other words they offer a strong challenge, a harsh insult, to immune systems. There is nothing unreasonable about worrying over the possible damage from that to babies in particular.

The worst feature of the program comes with its discussion of what it describes as an unusual amount of confusion and controversy over the anti-HPV vaccine that prevents cancer: cervical cancer in women, throat cancer in men. There are no ifs, ands, or buts: HPV causes cancer and HPV vaccines are safe.

In this program, the confusion is generated deliberately, one must infer, since the producer set out “to make a film that was largely in support of vaccination” [7].

Argument from authority is exemplified by Dr. Amy Middleman invoking her role as “mother and pediatrician” to set everyone straight. She acknowledges reports of adverse events after HPV vaccination but points out — quite correctly — that none have been proven to be associated “in a causal way”.
Misdirection once more: HPV hasn’t been shown to be associated with cancer “in a causal way” in the first place; there is no proof of a causative relation between HPV and cancer:

  • The established relationship is simply that HPV infection was found in many cases of cervical cancer. But such correlations never prove causation.
  • There are about a hundred strains of HPV [8], but only a few seem “associated” with cervical cancer.
    Association is evaluated by “statistical significance”. The criterion for that typically used in medicine (and in social science) is that p ≤ 0.05: the probability is less than 5% that the apparent associations is owing to chance and means nothing substantive. In other words, 5 of every 100 possible “associations” can be ascribed to purely random chance. Therefore, if one is seeking possible causes for cervical cancer and canvasses all the conceivable ones, 5% of them will show up as “statistically significant” when they are not significant at all: one might call them false positives. Given 100 strains of HPV, one would expect 5 of them to be “statistically significantly associated” by chance with any given illness. In point of fact, only 2 strains (16 and 18) are claimed to cause 70% of all cervical cancers. This is anything but strong let alone convincing let alone conclusive evidence that HPV has anything at all to do with cervical cancer.
  • The program acknowledges that HPV is so common that 80% of Americans are infected at any given time. Some 25,000 cases annually of cervical cancer and throat cancer are associated with HPV. That is an incidence of about 25,000 in an infected population of about 250,000,000, in other words 1 case in 10,000. What sort of indication of causation is this?
    Here the program was criminally negligent in failing to point to the difference between measles, polio, smallpox, and the like on the one hand, where infection brings immediate reactions and often serious illness even to death, and on the other hand a dogmatic claim that because 1 in 10,000 people infected with HPV will eventually experience a cancer, therefore it was caused by HPV.
  • That HPV causes cervical cancer in women but throat cancer in men seems very odd. Why shouldn’t women get throat cancer at the same rate as men? The program made no attempt to discuss this assertion.
    The obvious explanation lies in statistics. The claimed “causes” of both cervical and throat cancers are simply statistical correlations that turned up by chance because so many possible associations were canvassed. Since both are chance correlations, there is no reason why they should be for the same cancers.
  • Even if there were substance to the dogmatic statements by Middleman and others that “HPV causes cancer”, whether HPV vaccines might then prevent cancer could only be decided far in the future if sufficiently large numbers of vaccinated and unvaccinated people were to be followed for many decades. In the meantime, significant numbers of people suffer damaging “side” effects [9].

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[1] For example, A. M. Low, What’s the World Coming To? Science Looks at the Future, J. B. Lippincott, 1951; Christopher Cerf & Victor S. Navasky, The Experts Speak : The Definitive Compendium of Authoritative Misinformation, 1984 and several later editions.
[2] See Celia Farber’s blog for continuing coverage of this whistleblowing, including documentation: “CDC Whistleblower Thompson Text Exchange With Mrs. Wakefield: “..Your husband’s career was unjustly damaged…” and earlier posts.
[3] The Pathogenesis of AIDS
[4] Paiardini & Müller-Trutwin, “HIV-associated chronic immune activation”, Immunological Reviews, 254 (2013) 78-101; Highleyman, “Inflammation, Immune Activation and HIV”, BETA, Winter/Spring 2010, 12-26
[5] Section 4.7.15 and associated references in The Case against HIV 
[6] YES: Thimerosal CAN induce autism
[7] David Templeton, NOVA documentary tackles debate over vaccines 
[8] HPV/Genital Warts Health Center 
[9] Deadly vaccines; U.S. Court Awards $6 Million in Damages to Gardasil Victims

Posted in media flaws, medical practices, science policy, unwarranted dogmatism in science | Tagged: , , , , , | 9 Comments »