Public health and individual health

Recent posts about vaccines point to an inevitable conflict between public policy and individual autonomy. The risk can be greatly diminished of epidemics capable of sickening and even killing many people, but the price is the induced sickness and even death of a few individuals.

One anecdote in the NOVA program featured a lad who was crippled by polio contracted through vaccination by the oral polio vaccine. Despite his own sad experience, he was shown supporting the principle and practice of vaccination nevertheless. “Only” 2 or 3 in a million people experience this misfortune. An “expert” pointed out that as a result of this unfortunate case, it was realized that the less dangerous injected vaccine should supplant the oral one, “showing that the system worked”. He also mentioned that since the only cases of polio reported for many years had been those actually caused by the oral vaccine, clearly more attention ought to have been paid to making the vaccine as safe as possible. In other words, the system did NOT work — it took some personal tragedies for the system to do something that rationality could have foreseen the need for.

Yet no matter how well “the system” might work, the fundamental conflict remains: some unknown number of individuals, albeit a small number, will be harmed by actions that (are believed to) decrease risk for a large number of others. “Are believed to” to emphasize that one cannot in fact know that risk is being decreased in the case of diseases that have essentially disappeared in developed countries: If the risk of polio in the USA is 1 in a million from vaccination, what is the risk — if not vaccinated — of actually getting polio from an infected traveler from some other country? The cited experience of many years indicates that risk to be less than 1 in a million. Not vaccinating against polio may be less risky than vaccinating, apparently?

That point is easy enough to see when it comes to vaccines. Perhaps surprising, though, is that the same point applies to the use of clinical trials in the developing of drugs. Clinical trials can only gauge average effects, and it is far from obvious that all individuals should be treated according to such average results. This issue is argued in great detail in David Healy’s Pharmageddon (University of California Press, 2012).  For a short discussion, see my just-published “Clinical trials with surrogate outcomes have brought bad medicine(s)” .

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NOVA’s vaccine propaganda: Media coverage

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

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

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

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

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

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

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

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

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

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

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

Big Pharma beware: The comedians are on to you

Authoritarian regimes, and politicians in general for that matter, are terrified of being made fun of.  In present-day Egypt, for example, the local equivalent of The Daily Show is being persecuted. So it is a very promising development that our very own Daily Show last night, Tuesday 16 September, had a segment featuring  Peter Gøtzsche describing the drug companies as organized crime, as in his book, Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare.

It was mentioned that Pharma’s propaganda for painkillers like oxycontin and percocet is misleading and damaging, and some of Pharma’s ads were satirized.

I would like to think that the clip was quite genuine, that showed a Pfizer person — perhaps a security guard? — waving away the Daily Show correspondent and the camera.

NOVA on Vaccines: Documentary or Propaganda?

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

Anti-obesity surgery: Weight loss prevents Alzheimer’s? (Anti-obesity fuss IV)

Being obese is bad for you, so everyone is saying just now; everyone including professional societies, official agencies, and drug companies who sell mind-altering drugs to curb your appetite that may also cause “potentially life-threatening serotonin syndrome . . . . confusion, Cognitive Impairment, disturbances in attention or memory . . . , Psychiatric Disorders including euphoria and dissociation, . . . depression or suicidal thoughts” [emphasis added] as well as priapism (erections lasting longer than 4 hours) [1].

Lest this possibility of literally fatal harm suggests that the possible benefit is not worth the risk and dissuades potential customers for these drugs, we’re now told that the drugs might not only harm the brain, they could actually do the very opposite too:

“Weight-loss surgery can boost brain power and ‘cut the risk of developing Alzheimer’s’”

• Scientists in Brazil found gastric bypass surgery can affect brain activity
• Found the operation curbed changes in the brain associated with obesity
• They noted improvements in planning, strategising and organising
• Researchers also found evidence operation could reduce risk of Alzheimer’s

All this from a study of just 17 obese women, comparing them before bariatric surgery and 24 weeks after surgery.

“[S]ome areas of their [obese women’s] brains metabolised sugars at a higher rate than normal weight women. . . . in a part of the brain linked to the development of Alzheimer’s disease . . . . Since bariatric surgery reversed this activity, we suspect the procedure may contribute to a reduced risk of Alzheimer’s disease and other forms of dementia. . . .

The new research focused on a procedure known as a Roux-en-Y gastric bypass (RYBG) which combines the two types of bariatric surgery.

Brain scans and a range of psychological tests were used to assess its effect over a period of six months. . . .
bariatric surgery seemed to improve the performance of the obese women in a test of ‘executive function’. . . . the brain’s ability to connect past experience and current action . . . involved in planning, organising and making strategic decisions. Other tests measuring various aspects of memory and thinking ability showed no change after bariatric surgery”.

 

The original article on which this account is based is Marques et al., “Changes in neuropsychological tests and brain metabolism after bariatric surgery”, Journal of Clinical Endocrinology and Metabolism, 26 August 2014: jc.20142068. Its 6 pages are replete with speculation and do nothing to decrease my skepticism that lack of improvement in “various aspects of memory and thinking ability” could accompany improved performance in “planning, organising and making strategic decisions”.

This speculation is without any reasonable basis at all because Alzheimer’s Disease (AD) is far from well understood. It is simply not known that there is “a part of the brain linked to the development of Alzheimer’s disease”. There is considerable evidence against the mainstream hypothesis that AD is characterized by amyloid plaques [2].

TV’s 60 Minutes of 31 August 2014 reported results of continuing research with cohorts of old (≥90 years) people, observing their behavior and cognitive abilities together with in vivo recording of brain activity. The researchers expressed surprise that the amyloid plaques and tau tangles thought to be the cause of AD were present in some people who showed no signs of dementia; while some individuals with dementia had no sign of amyloid plaques or tau tangles. Instead, there were indications that tiny strokes had effectively killed small parts of the brain, strokes so small that the affected individual would have had no immediate indication of their occurrence.

 

Lay people might regard those findings as further evidence that amyloid and tau have nothing to do with AD, or indeed with dementia in general.
Those who believe that science rejects hypotheses when the evidence contradicts them might also imagine that the mainstream is now discarding the notion that AD is caused by accumulation of plaques of amyloid protein.

But that’s not what happens in the real world. The researchers suggested on 60 Minutes that maybe the brains of non-demented individuals with tau tangles and amyloid plaques had found some way or other to “get around” those indications of AD . . . . They didn’t try to explain why some AD victims had no tau tangles or amyloid plaques.

 

Those of us who are familiar with the ignoring of evidence that contradicts mainstream dogmas recognize this as routine, cognitive dissonance in the service of mainstream denialism.

 

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[1] Belviq®, revised 08/2012

[2]  Pp. 108-9 in Dogmatism in Science and Medicine: How Dominant Theories Monopolize Research and Stifle the Search for Truth, McFarland (2012)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The anti-obesity fuss: II — Worse than useless Official Reports

Clinical Guidelines on the Identification , Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report [1] from the National Institutes of Health has the typical flaws of official Reports that I’ve illustrated elsewhere [2]: Excessive verbiage hiding rather than revealing essential issues; incompetent drawing of conclusions; innumerable eminent names — “panel members” or “committee members” — shown as the purported authors, while the actual research and writing was done by non-eminent staff.

This particular Report has 262 pages, but what is worth saying would take no more than a few pages.

Typically, all the right things are said — and then ignored. For example, that BMI (body mass index) alone is not a decisive determinant of risks supposedly associated with obesity — followed by defining obesity precisely by BMI slightly modified by waist size:

The Report’s unnecessary verbiage includes many such banalities as:

“Standard obesity treatment approaches should be tailored to the needs of various patients or patient groups. The possibility that a standard approach to weight loss will work differently in diverse patient populations must be considered when setting expectations about treatment outcomes. Evidence Category B” [italics in original].
[“Category B pertains when few randomized trials exist, they are small in size, and the trial results are somewhat inconsistent, or the trials were undertaken in a population that differs from the target population of the recommendation” (p. xiii)]
Does it really need to be said that individual patients should be treated as individuals? Is an Evidence Category necessary to support that recommendation?
Further: The description of Evidence Category B amounts to saying that it isn’t really evidence at all, just inadequate trials and no replication, no better than anecdotes. But this is far from the weakest “evidence” on which this Report bases its pretentious conclusions and recommendations. Some of them are “supported” only at level C or D:

C describes anecdotes, which mainstream sources typically pooh-pooh when they contradict official dogma. As for D, “Panel Consensual Judgment” sounds so much more impressive than the equally correct description, “Mere opinion in absence of evidence upon which an informed opinion could be based”.
Other things that don’t need to be said include
“A diet that is individually planned . . . to help create a deficit of 500 to 1,000 kcal/day should be an integral part of any weight loss program” (p. xix).
“An integral part”? How about the whole thing? As I pointed out in an earlier post, an effective diet is easily constructed.

And then there’s this:
“An increase in physical activity is an important component of weight loss therapy, although it will not lead to substantially greater weight loss over 6 months” (p. xix). “An important component” that doesn’t do anything?

And also this:
“Family involvement” helps against progression of obesity (p. 11).
What a surprise!

Not only is over-eating medicalized as “obesity”, more research is needed (p. 21) to confirm or disconfirm that obesity may be related to psychological disorders. In the meantime, such future research is preempted by already defining “binge eating disorder (BED)” “characterized by eating larger amounts of food than most people would eat in a discrete time period (e.g., 2 hours) with a sense of lack of control during these episodes”.
Hardly a precise definition; and presumably one would exclude fraternity rites of passage or eating contests as only sociologically but not individually psychopathological.

There is also a “Treatment Algorithm” that adds nothing to common sense but serves presumably to add to the illusion that there is something scientific and worthwhile here:

The Report’s goals bear little relation to the asserted risk: “The initial goal of weight loss therapy is to reduce body weight by approximately 10 percent from baseline. If this goal is achieved, further weight loss can be attempted, if indicated through further evaluation” (p. xix).

But how often would that be a meaningful reduction of risk? With extreme obesity, 10% lower would get at most from “extremely high risk” to “very high risk”. With “very high” risk, not everyone in that class would get to merely “high”. How meaningful would those apparent reductions in estimated risk be?

That remains inscrutable because there is not even claimed to be definitive evidence of any real benefit:
“Although there have been no prospective trials to show changes in mortality with weight loss in obese patients, reductions in risk factors would suggest that development of type 2 diabetes and CVD would be reduced with weight loss” (pp. xiii-xiv).
”Would suggest?” Once again this is guesswork, speculation, not an evidence-based conclusion.
Moreover, ”risk factors” are mere correlations, symptoms, and reduction in risk factors is not the same as reduction of actual risk; treating symptoms is not the same as treating the underlying condition.

The Report has not only unnecessary verbiage and banalities, it can also be misguided and misleading, for instance that “Prevention of overweight and obesity is as important as treatment” (p. 11).
Utter nonsense. Prevention is the only truly effective treatment, because it prevents any possible harm; subsequent treatment cannot negate harm already done. Furthermore, it is much better and much more feasible not to get into bad habits in the first place than it is to change bad habits after they are entrenched.

All this illustrates how common sense takes leave when human behavior is treated as a medical condition — and when bureaucracies try to justify their existence by promulgating lengthy Reports. It is perfectly sensible to say that prevention of infection (cholera, malaria, syphilis, etc. etc.) should be given as much attention as treatment of cases that could not be prevented; it makes little sense to say that learning not to over-eat in the first place is as important as learning not to over-eat after the habit has been formed; the former is clearly much more desirable, i.e. important.

These sad aspects of the Report are far from the worst, however.
Most reprehensible is the medicalization of over-eating as “obesity”, a condition calling for medical treatment. The pharmaceutical industry for several decades has looked to re-defining normal conditions into diseases to be treated [3], and officialdom has gone along with this health-damaging and expensive sleight of words. In the present Report, this is done by using BMI numbers as a basis for several types of conditions, even though there is no evidentiary warrant for dividing a continuum into discrete categories nor for the assignment of risk levels.
This façade of “scientific” appearance lends tacit approval to the use of drugs (and also surgery) to “treat obesity”.

Of course the right things are again said, namely, that drugs should be used only in addition to diet control when the latter alone does not suffice. But this is totally unrealistic. The only individuals who might need assistance from drugs or surgery are those suffering endogenous obesity, pathologically high weight owing to hereditary factors. In practice, doctors prescribe drugs without being able to monitor whether patients actually control their diets; and we are all prone to take our pills in the hope that they will make us lose weight no matter how we continue to over-eat.
And those pills can kill.

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[1] Publication 98-4083, September 1998, National Institutes of Health: National Heart, Lung, and Blood Institute in cooperation with The National Institute of Diabetes and Digestive and Kidney Disease
[2] Henry H. Bauer, Dogmatism in Science and Medicine: How Dominant Theories Monopolize Research and Stifle the Search for Truth, McFarland (2012), Chapter 8
[3] Moynihan & Cassels, Selling Sickness: How the World’s Biggest Pharmaceutical Companies Are Turning Us All Into Patients, Nation Books (2005). The point is also made in quite a few of the other works listed in What’s Wrong with Medicine [link loads slowly, sorry]

The anti-obesity fuss: I — Where is the common sense?

There’s an “epidemic” of “obesity”, so we’re told.

Already by 1998, “An estimated 97 million adults in the United States are overweight or obese, a condition that substantially raises their risk of morbidity from hypertension, dyslipidemia, type 2 diabetes, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea and respiratory problems, and endometrial, breast, prostate, and colon cancers. Higher body weights are also associated with increases in all-cause mortality. Obese individuals may also suffer from social stigmatization and discrimination. As a major contributor to preventive death in the United States today, overweight and obesity pose a major public health challenge” [1].

No ifs, ands, or buts.

Such official anti-obesity propaganda illustrates the flaws and failings of contemporary medical practices: purportedly “scientific” assertions as valid as the Emperor’s New Clothes; official Reports that do nothing to clarify and that make little if any sense; a drug industry that peddles dangerous substances by exploiting the lack of sensible regulation and the lack of informed media coverage.

That the proclaimed “obesity epidemic” is a relatively recent phenomenon shows that it is not caused by genetics or heredity. A very small proportion of humans are born with genetically determined metabolisms that produce dangerous-to-health obesity (“endogenous obesity”) virtually independent of lifestyle including diet. The circumstances of these individuals (or families) and the medical care appropriate for them have nothing whatsoever to do with the rest of us whose weight is determined entirely by lifestyle, primarily diet.
In other words, there is no epidemic of “obesity”: There is only an epidemic of unhealthy eating, mainly over-eating but also eating and drinking foolishly, for instance sugar-infused “soft” drinks at 100-200 Calories per dose.

The solution is obvious and simple, as my mother’s doctor told her decades ago:

EAT   LESS

Public policy should be to persuade people to eat sensibly, and to persuade food processors to place a premium on health — or failing that, to regulate them into doing so, possibly with such help as heavy taxes levied on clearly unhealthy products.

Putting that into practice is not so simple a matter, of course, but sustained effort could have the desired effect: after all, the campaign against tobacco has been very effective.
Only a few decades ago, smoking was a socially welcomed habit, it was good manners to offer cigarettes to whoever one was with, and advertisements cited the approval of the medical profession:  “More doctors smoke Camels”; savor those old ads by Googling “Images” for “Doctors recommend Camels”.
It seems unlikely that addiction to unhealthy over-eating could be harder to overcome than the addiction to tobacco, which is a double whammy of physical and psychological addictions.

Persuasion toward healthy eating ought to be helped by the fact that there is a very simple, easy, and effective way to diet:
Don’t change what you eat, but begin every meal by removing one quarter (say) of what you had been used to eating. (It is your choice whether to throw it away or to keep it as “left-overs” or in take-home “doggy bags”). Your caloric intake is thereby cut by 25%, which easily meets the typically suggested goal of 500 to 1000 Calories. A useful corollary is to use smaller plates: a heaped but small plate gives no impression of deprivation, whereas the same amount of food spread thinly on a large plate looks skimpy. The enormous psychological barrier to drastically changing what you eat, which all the elaborately designed special diets demand, is avoided by this simple procedure.

A further, slightly more difficult but far from impossible corollary is to eat slowly, which brings a feeling of adequacy with a smaller total amount of food than when it is gobbled rapidly.

Such a “regimen” also avoids the problem that typically plagues all the special diets and officially recommended procedures: the almost universal regaining of weight after the 6 months or so of laboriously controlled special diet. As one gets used to eating less and slowly, stomach and appetite adjust and a new habit is formed.

Instead of obvious and straightforward solutions, however, there has grown up a whole industry generating a variety of diets, official Reports purporting to bring sophisticated science into the issue, and worst of all, a government-pharmaceutical-academic-professional complex that peddles drugs.

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[1] National Heart, Lung, and Blood Institute in cooperation with The National Institute of Diabetes and Digestive and Kidney Disease, Clinical Guidelines on the Identification , Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report, Publication 98-4083, September 1998, National Institutes of Health