A common question of skeptics and science-based thinkers is “How could anyone believe that?” People do believe some really weird things and even some obviously false things. The more basic question is how we form all our beliefs, whether false or true.

Michael Shermer’s book Why People Believe Weird Things has become a classic. Now he has a new book out: The Believing Brain: From Ghosts and Gods to Politics and Conspiracies: How We Construct Beliefs and Reinforce Them as Truths It synthesizes 30 years of research into the question of how and why we believe what we do in all aspects of our lives.

Some of the content is repetitious for those of us who have read Shermer’s previous books and heard him speak, but the value of the new book is that it incorporates new research and it puts everything together in a handy package with a new focus.

Shermer says

I’m a skeptic not because I do not want to believe, but because I want to know. How can we tell the difference between what we would like to be true and what is actually true? The answer is science.

He includes a pithy quotation from Richard Feynman that I had not seen before:

If it disagrees with experiment, it is wrong. In that simple statement is the key to science. It doesn’t make any difference how beautiful your guess is, how smart you are, who made the guess, or what his name is. If it disagrees with experiment, it’s wrong. That’s all there is to it.

Our schools tend to teach what science knows rather than how science works. The scientific method is a teachable concept. But

our most deeply held beliefs are immune to attack by direct educational tools, especially for those who are not ready to hear contradictory evidence.

This is a problem. Shermer does not offer a solution.

The brain is a belief engine. It relies on two processes: patternicity and agenticity. It finds meaningful patterns in both meaningful and meaningless data. It infuses patterns with meaning, and imagines intention and agency in inanimate objects and chance occurrences. We believe before we reason. Once beliefs are formed, we seek out confirmatory arguments and evidence to justify them. We ignore contrary evidence or make up rationalizations to explain it away. We do not like to admit we are wrong. We seldom change our minds.

Our thinking is what Morgan Levy has called “intelligently illogical.” If our ancestors assumed that the wind rustling the bushes was a lion and they ran away, that wasn’t a big problem. If there really was a lion and they didn’t run away, they were in trouble. Natural selection favors strategies that make many false causal assumptions in order to not miss the true ones that are essential to survival. Superstition and magical thinking are natural processes of a learning brain. People believe weird things because of our evolved need to believe nonweird things.

Belief comes quickly and naturally, skepticism is slow and unnatural, and most people have a low tolerance for ambiguity.

We rely on a feeling of conviction, but that feeling can be uncoupled from good reasons and good evidence. Science hopes to counteract false beliefs by recoupling through counterarguments with even better reasons and evidence.

As science advances, the things we once thought of as supernatural acquire natural explanations. Thunderstorms are caused by natural processes of electricity in clouds, not by a god throwing thunderbolts.

Belief in God is hardwired into our brains through patternicity and agenticity.  We see patterns even when they are not there (the Virgin Mary on a toasted cheese sandwich), and we interpret events as having been deliberately caused by a conscious agent (the AIDS virus was created in a government lab for genocidal purposes). God is the ultimate pattern and agent that explains everything. And religious belief had survival value for human groups, encouraging conformity, group cooperation, and altruism.

Shermer covers a variety of subjects, from alien abductions to cosmology, from economics to politics, from belief in the afterlife to evolution, from ESP to morality, with a lot of entertaining examples.  He doesn’t give much space to medical topics but he does mention AIDS denial, the vaccine/autism brouhaha, and alternative medicine, which he calls “a form of pseudoscience.”

Conspiracy theories abound, from Holocaust denial to 9/11 Truthers to the spread of AIDS.  This is a result of wide-open pattern detection filters and to the assumption that there must be a conscious agent behind everything. Shermer provides a handy list of 10 characteristics of a conspiracy theory that indicate that it is likely to be false; for instance, the more people who would have to have been involved in a cover-up, and the longer the alleged cover-up has lasted, the less likely that no one would have spilled the beans by now.

He provides a useful discussion of the various biases we are prone to, from confirmation bias to the status quo bias, and points out that science is the ultimate bias-detection machine.  He revisits the “Gorillas in our midst” video to remind us that we don’t see things that we’re not looking for. (In case you don’t know, that was an experiment demonstrating inattentional blindness:  a gorilla walks through a group of people playing basketball and we don’t see him because our attention is fixed on counting the number of times the players in white shirts passed the ball.) He quotes Upton Sinclair:

It is difficult to get a man to understand something when his job depends on not understanding it.

When I read that, Dana Ullman came to mind.

I particularly got a kick out of one of Shermer’s examples. Galileo used an early telescope to observe 4 moons around Jupiter. One colleague of Galileo’s refused to even look through the telescope, calling it a parlor trick, saying he didn’t believe anyone else would see what Galileo saw, and saying that looking through glasses would only make him dizzy. Other colleagues who did look were similarly dismissive; one tested the telescope in a series of experiments and said it worked fine for terrestrial viewing, but when pointed at the sky it somehow deceived the viewer. One professor of mathematics accused Galileo of putting the moons of Jupiter inside the tube.

We are beginning to develop a new understanding of how the brain generates beliefs and reinforces them. Mr. Spock is science fiction; humans are often illogical and emotional. We need emotion to motivate us and help us function. An emotional leap of faith beyond reason is often required for us to make decisions or just to get through the day.

This thought-provoking book is a good read and a good reference. Takeaway lessons:

• Beliefs come first, reasons follow.
• False beliefs arise from the same thought processes that our brains evolved to enable them to learn about the world.
• Our faulty thinking mechanisms can’t be eliminated but our errors can be corrected by science.

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We frequently write about the consequences and costs of not vaccinating and how the anti-vaccine movement is causing real harm to real people through its assaults on public health. For example, through his fear mongering in the U.K., Andrew Wakefield, aided and abetted by a credulous and sensationalistic British media, managed to reverse decades of progress that had resulted in measles having come under control; as a result of plummeting vaccination rates in the wake of his 1998 Lancet case series, measles came roaring back in the U.K. Now it appears to be roaring back in Europe as well.

It’s bitterly ironic that news of measles outbreaks in the U.S. and Europe have come to the fore even as, over the long Memorial Day weekend, promoters of the scientifically discredited notion that vaccines cause autism gathered in a suburb of Chicago to sell “biomedical” treatments for autism and promote an anti-vaccine world view as part and parcel of the yearly autism quackfest known as Autism One. Adding to the grim irony is that last Thursday Nature published an issue with a special section devoted specifically to vaccines. The timing seemed just too deliciously appropriate to ignore. Think of it. In the Chicago area, there was a collection of anti-vaccine crackpots meeting to present fallacious “science” claiming that vaccines cause autism and all manner of chronic health problems. In contrast, one of the oldest and most distinguished scientific journals in existence publishes several articles in a single issue about vaccines. The karma was even stronger, given that the week before the CDC published a new Morbidity and Mortality Weekly Report (MMWR) last week discussing the status of measles in the U.S.

The Nature vaccine issue has a number of articles on the topic of vaccines, ranging from an editorial, to news items, to scientific articles. For my purposes, three articles caught my attention:

• The case of measles
• The real issues in vaccines safety
• Target the fence-sitters

The article discussing the case of measles is particularly relevant today, as we are in the middle of a resurgence of measles cases, both here in the U.S. and a much worse outbreak in Europe. In the U.S. we have had thus far this year 118 cases of confirmed measles, the most cases since 1996. Of these cases, 47 resulted in hospitalization and 9 in pneumonia. Fortunately, none had encephalitis, and none died, but that’s only because the risk of encephalitis is between 1:1,000 and 1:5,000. In an outbreak of 118, there’s only around a 10% chance (at the most) of having a case of measles encephalitis among the children. However, the more children there are who are infected, the greater the chance of complications such as encephalitis, and let’s not forget that we already have an 8% pneumonia rate.

Fortunately, MMR vaccine uptake in the U.S. remains generally high, although there are increasingly pockets of low uptake susceptible to outbreaks. Indeed, that’s what appears to be happening. As reported in Nature and the MMWR report cited above, measles was in essence eliminated from the U.S. in 2000. This was not easy to do; measles is one of the most contagious viruses that exist. Indeed, it’s the contagiousness of the measles virus that has allowed it to find its way back into the U.S. from other countries, as described in the MMWR report:

Among the 118 cases, 105 (89%) were import-associated, of which 46 (44%) were importations from at least 15 countries (Table), 49 (47%) were import-linked, and 10 (10%) were imported virus cases. The source of 13 cases not import-associated could not be determined. Among the 46 imported cases, most were among persons who acquired the disease in the WHO European Region (20) or South-East Asia Region (20), and 34 (74%) occurred in U.S. residents traveling abroad.

More worrisome, of the 47 hospitalized patients, all but one were unvaccinated, and the statistics were:

Unvaccinated persons accounted for 105 (89%) of the 118 cases. Among the 45 U.S. residents aged 12 months?19 years who acquired measles, 39 (87%) were unvaccinated, including 24 whose parents claimed a religious or personal exemption and eight who missed opportunities for vaccination. Among the 42 U.S. residents aged ?20 years who acquired measles, 35 (83%) were unvaccinated, including six who declined vaccination because of philosophical objections to vaccination. Of the 33 U.S. residents who were vaccine-eligible and had traveled abroad, 30 were unvaccinated and one had received only 1 of the 2 recommended doses.

Do you see the pattern here?

Leaving a child unvaccinated leaves that child at a greatly increased susceptibility to measles and therefore a highly elevated risk of catching the virus when exposed. This is particularly true when enough people refuse vaccines to compromise herd immunity, so that the unvaccinated can no longer rely on the herd, which they’ve gotten away with doing in the past. Nowhere is this more evident than in Europe, where more than 6,500 cases were reported in 2010, and we have Andrew Wakefield to thank for decreased vaccination rates that are only now starting to recover, as this story in–of all places–The Huffington Post describes:

To prevent measles outbreaks, officials need to vaccinate about 90 percent of the population. But vaccination rates across Europe have been patchy in recent years and have never fully recovered from a discredited 1998 British study linking the vaccine for measles, mumps and rubella to autism. Parents abandoned the vaccine in droves and vaccination rates for parts of the U.K. dropped to about 50 percent.

The disease has become so widespread in Europe in recent years that travelers have occasionally exported the disease to the U.S. and Africa.

Although overall vaccine uptake rates are high, thanks to Andrew Wakefield, there are pockets of children whose parents fear the vaccine more than measles and have therefore not vaccinated. These pockets have been enough to allow measles not just to come roaring back in Europe, but to allow Europe to export its measles to the U.S.

Perhaps the most interesting perspective this week on the issue of vaccine rejectionism is the second article I cited above, Vaccines: The real issues in vaccine safety by Roberta Kwok, who notes in the beginning of her article that “hysteria about false vaccine risks often overshadows the challenges of detecting the real ones.” She begins by citing the case of John Salamone. We’ve met him before in the context of my review of Paul Offit’s most recent book, Deadly Choices: How the Anti-vaccine Movement Threatens Us All. Salamone’s son is an example of a real adverse reaction to a vaccine. Basically, his son got polio from the live oral polio vaccine, a known complication. His son got that vaccine, even though an inactivated polio virus vaccine known to be safer was available at the time, because the oral polio vaccine was cheaper and more easily administered. As a result, Salamone became a real vaccine safety activist, in contrast to the anti-vaccine activists at Generation Rescue masquerading as “vaccine safety” activists. He and other parents worked together to effect change, and the U.S. shifted to the safer vaccine in the late 1990s.

Kwok’s overall point is that these fake vaccine safety scares, such as the widespread belief that vaccines cause autism, have made it more difficult to identify real vaccine safety issues:

Vaccines face a tougher safety standard than most pharmaceutical products because they are given to healthy people, often children. What they stave off is unseen, and many of the diseases are now rare, with their effects forgotten. So only the risks of vaccines, low as they may be, loom in the public imagination. A backlash against vaccination, spurred by the likes of Andrew Wakefield — a UK surgeon who was struck off the medical register after making unfounded claims about the safety of the measles, mumps and rubella (MMR) vaccine — and a litany of celebrities and activists, has sometimes overshadowed scientific work to uncover real vaccine side effects. Many false links have been dispelled, including theories that the MMR vaccine and the vaccine preservative thimerosal cause autism. But vaccines do carry risks, ranging from rashes or tenderness at the site of injection to fever-associated seizures called febrile convulsions and dangerous infections in those with compromised immune systems.

Serious problems are rare, so it is hard to prove that a vaccine causes them. Studies to confirm or debunk vaccine-associated risks can take a long time and, in the meantime, public-health officials must make difficult decisions on what to do and how to communicate with the public.

It’s true, too. So much time and effort of legitimate researchers, not to mention scarce research funds, have been wasted demonstrating again and again that there is no detectable link between vaccines and autism suggestive of a causative relationship. None of it is enough to convince the believers. Whenever yet another in a long line of studies is published that fail to find any detectable link between vaccines and autism or vaccines and other chronic conditions or diseases, the anti-vaccine believers brush it away and demand “more research.” Either that, or they demonize the researchers and those who point to those studies as being “pharma shills” or somehow possessing of nefarious motives of some sort or another. And so it goes.

The article then goes on to describe how public health officials have become increasingly vigilant about vaccine side effects, setting up intensive surveillance systems, most recently and famously for the 2009 H1N1 pandemic. Specifically, scientists were looking above all for evidence of a link between the H1N1 vaccine and Guillain-Barré syndrome, based on studies that suggested a link between the 1976 swine flu vaccine and this debilitating neurological syndrome. Studies thus far have not shown a link between the latest H1N1 vaccine and Guillain-Barré, which is good, but vigilance continues, not just for H1N1 vaccines but for every vaccine. The result of this surveillance has been to find a link between a rotavirus vaccine and intestinal intussusception, as well as a link between the measles, mumps, rubella and varicella (MMRV) vaccine and febrile convulsions. As a result, the MMRV was no longer recommended as a preferred choice.

Unfortunately, links are often not clear, and during the period of uncertainty between the first report of a possible vaccine complication and studies that either confirm or refute the link, public health officials are forced to make decisions on incomplete evidence. One current example is the possible link between the H1N1 vaccine Pandemrix and narcolepsy in young people. It is not yet clear whether this association is spurious or likely to indicate causation. Another aspect of this issue is whether there are genetic susceptibilities to adverse reactions due to vaccines. Contrary to what the anti-vaccine movement claims, scientists have never denied that there might be genetic factors resulting in increased susceptibility to vaccine injury. However, in science actual evidence is required, rather than speculation, and what we have now on this issue is, for the most part, speculation. It’s also not at all a straightforward issue to determine genetic determinants of increased risk for adverse reactions. Just as finding a genetic cause of autism has been difficult and full of dead ends, despite clear evidence of a strong heritable component, finding evidence of a genetic predisposition to vaccine injury is anything but a trivial task. Moreover, even in children who might have such a hypothetical predisoposition to vaccine injury, when the risk-benefit calculation is done it may well end up that the benefits of vaccines still outweigh the risks. Such would seem to be the case for children with mitochondrial disorders.

So how do we convince parents that the fear mongering by the anti-vaccine movement about vaccines and autism (or vaccines and all the other the movement tries to link with them, for that matter) is without basis in evidence and science and that it is safe to vaccinate? I agree with Julie Leask is at the National Centre for Immunisation Research and Surveillance, Discipline of Paediatrics and Child Health, School of Public Health, University of Sydney, New South Wales 2006, Australia, who wrote the last article that caught my interest, Target the fence-sitters. This is the way to go; the hard core anti-vaccine believers are not going to change their minds, no matter how much evidence you throw at them. We’ve seen this time and time again right here on this very blog, right here in the comments, stretching back over six years.

That’s why it’s a waste of time and effort to try to change the mind of the likes of J.B. Handley, Jenny McCarthy, Barbara Loe Fisher, Ginger Taylor, and others. There was a time when I thought that I could, but six and a half years of beating my head against the wall has taught me that I’m about as likely to succeed in changing their minds as I am to convince the Pope to become an atheist. It’s just not going to happen. What does happen is that I (and others) are attacked for our efforts. The bottom line is that I no longer care about changing, for example, J.B. Handley’s mind; I only care about countering his influence whenever possible. The fence-sitters can still be reached. They haven’t (yet) fallen down the rabbit hole of pseudoscience, autism “biomed,” and conspiracy mongering. There’s still hope to reach them, and reach them I try to do, using a variety of techniques ranging from pure sarcasm and full frontal assault to humor to dispassionate discussions of scientific papers. What works the best? I really don’t know, because I have no way of measuring. I do, however, keep trying. So do several other members of the SBM blog, who all have different styles, different levels of—shall we say?—aggressiveness in attacking pseudoscientific and unscientific claims about vaccines.

In the meantime, as the MMWR report on the 2011 measles outbreak in the U.S. and the articles in Nature demonstrate, the anti-vaccine movement is doing real damage as it reverses hard-won gains made against measles over the last four decades.

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A good case of smallpox may rid the system of more scrofulous, tubercular, syphilitic and other poisons than could otherwise be eliminated in a lifetime. Therefore, smallpox is certainly to be preferred to vaccination. The one means elimination of chronic disease, the other the making of it.

Naturopaths do not believe in artificial immunization . . .

—Harry Riley Spitler, Basic Naturopathy: a textbook (American Naturopathic Association, Inc., 1948). Quoted here.

Here’s what a good case of smallpox will do for you:

If you’re lucky enough to beat the reaper (20-60%; 80% or higher in infants) or blindness (up to 30%), those blisters will leave you scarred for life. Oh, and the next time a good smallpox epidemic comes around, your children born since the last one will catch it and contribute their fair share to the death rate. But not you because you’ll be immune, so you’ll have the “preferred” experience of watching your children die well before you do.

Variolation and Vaccination

Except that none of this will happen, because the disease has been eradicated from the world—thanks, of course, to vaccination, which Napoleon reasonably called “the greatest gift to mankind.”

Smallpox was “the most terrible of the ministers of death.” It began at least several thousand years ago and rapidly spread wherever its human carriers traveled, eventually to the entire populated world. In endemic regions, it wiped out 1/4 to 1/3 of children in epidemics that occurred every few years. In epidemics among people who had not previously seen it, such as the natives of the Western Hemisphere during the early years of European explorations, it wiped out as many as 90% of everyone. It brought down armies and empires. Monarchs dropped like flies; it spared no socioeconomic class. Gods were invented in its name. There was never an effective treatment for it once it had begun.

Prior to the advent of vaccination, there was a heroic method that proved useful in reducing the severity of the disease. This was inoculation (‘variolation’): crude matter from a pustule of someone with the disease was etched into the skin of an uninfected person. This resulted in somewhat more indolent clinical cases, with death rates of ‘only’ around 2%, but the disease remained terrible and those so infected could still transmit it to others by means other than inoculation.

Vaccination, as many readers already know, was introduced near the end of the 18th century in England by the physician Edward Jenner. Jenner neither discovered it—it seems to have been discovered by milkmaids (and their close associates) who had noticed that after experiencing a cowpox blister, they never caught smallpox—nor was he the first to use it purposefully or even to write about it. He was the first, however, to conduct and report a series of convincing experiments demonstrating that people previously infected with cowpox could not subsequently be infected with smallpox (by variolation). He also showed that cowpox could be transferred from person to person by inoculation of matter from the cowpox blister, thus offering the first method for widespread use. Jenner is thus given credit not only for having introduced vaccination for smallpox, but for having introduced the concept of vaccination in general, although he would not live to see another example.

The Antivax Movement is Born

Opposition to smallpox vaccination (the name comes from the Latin for “cow”) began almost immediately after Jenner’s reports and remained substantial for more than 100 years. Some opposition was explicitly religious; some was based on disbelief in the method or, later, in the Germ Theory; some objectors claimed that vaccination caused terrible diseases, including smallpox itself; some voiced a political objection to state mandated vaccination programs. An early cartoon suggested that if Jenner had his way, people would start to look like cows:

Two antivax organizations in 19th century Britain were the National Anti-Vaccination League and the Society for the Abolition of Compulsory Vaccination. They sought to discredit Jenner’s reports and to argue, in keeping with the popular “hygiene” and “sanitation” movements of the day, that “cleanliness is more likely to prevent smallpox than [is] introducing filthy matter into the body.”

The Holy Trinity of American Quackery

These were, in the late 19th and early 20th centuries, homeopathy, chiropractic/osteopathy, and naturopathy. Hahnemann himself had approved of his contemporary Jenner’s assertion, believing that it confirmed “like cures like” (ably refuted by Oliver Wendell Holmes, Sr.). Constantine Hering, however, the “Father of American Homeopathy,” was the first homeopath to declare his opposition to vaccination. He called it “always a poisoning” and asserted, “we learn from year to year a more certain and better way of curing small-pox homeopathically.” He nevertheless admitted in 1883, near the time of his death, that this ‘better way’ had not achieved the certainty of prevention by vaccination.

In 1918, Benedict Lust, the “Father of American Naturopathy,” wrote this:

Like the alchemist of old who circulated the false belief that he could transmute the baser metals into gold, in like manner the vivisector claims that he can coin the agony of animals into cures for human disease. He insists on cursing animals that he may bless mankind with such curses.

To understand how revolting these products are, let us just refer to the vaccine matter which is supposed to be an efficient preventive of smallpox. Who would be fool enough to swallow the putrid pus and corruption scraped from the foulest sores of smallpox that has been implanted in the body of a calf? Even if any one would be fool enough to drink so atrocious a substance, its danger might be neutralized by the digestive juices of the intestinal tract. But it is a far greater danger to the organism when inoculated into the blood and tissues direct, where no digestive substances can possibly neutralize its poison.

The natural system for curing disease is based on a return to nature in regulating the diet, breathing, exercising, bathing, and the employment of various forces to eliminate the poisonous products in the system, and so raise the vitality of the patient to a proper standard of health.

Official medicine has in all ages simply attacked the symptoms of the disease without paying any attention to the causes thereof, but natural healing is concerned far more with removing the causes of disease…

In those words we find several of the recurring themes in quackery that were evident in the 19th century and remain so today. We know that naturopaths continued to espouse this view of vaccination at least until 1968, when the quotation at the top of this essay was among the materials they submitted to the Department of HEW in an unsuccessful attempt to be covered by Medicare. They’ve since learned to be somewhat more subtle about the issue, possibly because of the 1968 failure, but their distaste for vaccinations in general persists, as explained here.

An Aside: the “Cause of Disease,” Naturopathy-style

I’m sure you’ve been wondering, so here it is, right from the pen of Harry Riley Spitler, the author of the quotation that began this piece (courtesy of the 1968 HEW report):

The primary cause of disease is reaction to unnatural environment . . . When the body is weighted down by toxins in excess of the amount with which the vital force is able to cope, then enervation… supervenes and there is a lag in the body’s power to expel the “ashes” of metabolism… Enervation leads to the secondary cause of so-called disease — toxemia. Toxemia is the state of auto-intoxication resulting from the accumulation ot poisons in the body – poisons taken in from without in the form of incorrect food, impure water, vitiated air, etc., and which are not thrown off by the body because of its enervated state, and in addition thereto the poisons formed within the body itself by the processes of metabolism. . . The presence of these poisons within the blood stream and tissues causes the vital force to make efforts to eradicate toxemia, and these efforts are what is called “diseased crises.” . . . Disease, therefore, is not a hostile entity to be attacked, but is rather a manifestation of vital force in its efforts to continue to live and to remove anti-vital conditions caused by man’s deliberate, or ignorant, breaking of the laws of health and life … Disease, then, is the result of stagnation and accumulation of filth in the blood stream and in the tissues.

And the cure? Back to Lust:

The Program of Naturopathic Cure

 1. ELIMINATION OF EVIL HABITS, or the weeds of life, such as over-eating, alcoholic drinks, drugs, the use of tea, coffee and cocoa that contain poisons, meat-eating, improper hours of living, waste of vital forces, lowered vitality, sexual and social aberrations, worry, etc.

2. CORRECTIVE HABITS. Correct breathing, correct exercise, right mental attitude. Moderation in the pursuit of health and wealth.

3. NEW PRINCIPLES OF LIVING. Proper fasting, selection of food, hydropathy, light and air baths, mud baths, osteopathy, chiropractic, and other forms of mechano-therapy, mineral salts obtained in organic form, electropathy, heliopathy, steam or Turkish baths, sitz baths, etc.

And, of course, enemas.

Natural healing is the most desirable factor in the regeneration of the race.

 Wow. It’s all kind of fascistic, no? But I’m digressing.

More on the Holy Trinity

You probably noticed Lust’s approval of chiropractic, another field with a rich tradition of antivax fervor. Some chiropractors have learned to be a bit more subtle; others have not (and not all contemporary chiropractors are opposed to vaccinations). If you’ve perused the 1968 HEW report, you also know that the American naturopathic schools of the mid-20th century were mostly spawned by chiropractors, and that for some time there was little distinction between naturopaths and “mixer” chiropractors. Many “NDs” of that time also had “DC” after their names.

You may also know that contemporary naturopaths love homeopathy. Lust didn’t include it in his NEW PRINCIPLES OF LIVING, probably because of his emphasis on “drugless healing.” Nevertheless, he praised Hahnemann for having shown “the physicians of his day…that just as good results could be brought about by means so gentle that even a delicate child could be treated, without the slightest particle of danger.” It seems to have been left to the next generation of American naturopaths to fully embrace homeopathy, and this was done most conspicuously by a man who himself embodied the Holy Trinity of Quackery: John Bastyr, N.D., D.C. (1912-1995), the “Father of Modern Naturopathic Medicine.”

Bastyr was also described as a

…third-generation homeopath from Dr. Adolph von Lippe. His teacher was Dr. C. P. Bryant (who had been, in 1939, president of the International Hahnemannian Association). C. P. Bryant had been taught by Walter Bushrod James who had been one of Lippe’s closest students. He received doctorate degrees in naturopathy and chiropractic from Northwest Drugless Institute and Seattle Chiropractic College, respectively. He became licensed to practice naturopathic medicine in 1936. He is also credited with being the Father of Modern Naturopathic Medicine. Because of Bastyr’s influence naturopaths have been at the forefront of the rebirth of homeopathy in this country. He made sure that homeopathy shared equal emphasis with nutrition, hydrotherapy and botanical medicine in naturopathic education. Dr. Bastyr considered manipulation the most important therapy in his practice.

So there you have it: the mystical unity of three seemingly incompatible True Causes (Psora, Subluxations, Toxemia), and of three seemingly incompatible True Cures (similia similibus curentur, spinal manipulation, enemas). No wonder that John Bastyr the chiropractor is credited with having been the Saviour of naturopathy and homeopathy in the United States.

Another Aside: Early Vaccinations really were Dangerous

It’s ironic to consider that many of the early objections to smallpox vaccinations were somewhat justified, far more so than are contemporary objections to contemporary vaccinations. Material gathered from cowpox blisters, transferred from human to human, was invariably contaminated. Diseases plausibly attributed to such “arm to arm” vaccinations, in the era before the Germ Theory elucidated such risks in advance, included syphilis, hepatitis, and even smallpox itself, due to contamination from variolations occurring within the same hospitals or clinics. The advent of exclusively animal sources of cowpox didn’t occur until the mid-19th century, and “arm to arm” vaccinations weren’t outlawed in Britain until 1898. Preparations of pure virus—vaccinia—were introduced only in the mid-20th century.

The political objection to mandatory vaccinations also had more clout in the early days, when the concept of “herd immunity” had yet to be introduced.

“All this has happened before, and all this will happen again.”

This is from a meeting of the Connecticut Homeopathic Medical Examining Board, March 12, 2003:

TREATMENT OF SMALLPOX

The Board reviewed the following procedures for the prevention and treatment of smallpox as submitted by Dr. Mullen:

PREVENTION

Malandrinum

It is recommended to administer it at a potency of 30 CH twice a day for up to 5 days as a preventive. This remedy is also very useful to combat the ill effects of Allopathic small pox vaccination, as well as to control the disease that happens when a person gets unwillingly infested by the vaccine received from another.

Sarracenia

It is recommended to administer this remedy at potencies of up to 9 CH. I believe a good dosage schedule would be once a week for 2 or 3 weeks. It is recommended to administer this remedy at a potency of 6 CH every 8 days. Also useful in recent and distant ill effects of Allopathic vaccination.

Vaccininum

An indication for the use of vaccininum would be a patient’s fear of contracting smallpox.

Variolinum

Both Drs. Allen and Vosin enthusiastically endorse this remedy for the prevention of small pox. I would advice to administer it at potencies of 30 CH or 200 CH weekly for 3 or 4 weeks.

TREATMENT

Malandrinum

It is recommended to administer it at a potency of 30 CH. This remedy is particularly useful in patients whose symptoms are more evident in the lower half of the body. I would recommend daily administration for 5 consecutive days and then re-evaluate the patient.

Mercurius 200 CH every other day alternating with Thuja 200 CH.

I would recommend to use this combination up to 10 consecutive days and then re-evaluate the patient.

Sarracenia

It is recommended to administer this remedy at a potency of 9 CH. I would recommend to use it for 5 consecutive days and then re-evaluate the patient. This remedy can stop the disease in its earliest stages, including the development of pustules. The patient may be very sensitive to light, weak in the shoulder area and have shooting pains in zigzag from the lumbar region to the middle of the scapula.

Variolinum

It is recommended to administer it at any potency. I would recommend using it for up to 5 consecutive days, depending on the potency, and then re-evaluate. Variolinum is useful in patients with mild and uncomplicated small pox. Also when pustules are surrounded by a red halo and are often very itchy. Every other day for up to 10 consecutive days and then reevaluate the patient.

Thuja 200 CH

Every other day for up to 10 consecutive days and then re-evaluate the patient.

Wow. What exquisite, quaint, balderdash. Here’s a fun exercise that readers might enjoy: see what contradictions you can find between what you’ve just read and other efforts of the Connecticut Department of Public Health. Hint: start here. Then look at some of the practice acts, such as those for homeopathy, naturopathy, and chiropractic. Does one hand know what the other is doing?

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Paradoxically, the less evidence that exists to support the use of of a treatment, the more passionate its supporters seem to be. I learned this early in my career as a pharmacist. One pharmacy I worked at did a steady business in essential oils. And king of the oils was oil of oregano. Not only were there several different brands of the basic oil, they were different forms, including capsules, creams and even nasal sprays. Not aware of any therapeutic benefits, I would ask customers what they were using it for. I rarely heard the same condition described: skin infections, athlete’s foot, head lice, colds, sore throats, “parasites”, “yeasts”, diabetes, allergies and ringworm were apparently no match against the judicious use of oregano oil. Intrigued, I took a closer look.

Long before our scientific understanding of bacteria and antimicrobials, infected wounds were packed with different products in an attempt to minimize the odour, and hopefully speed healing. It’s likely that someone happened upon a fragrant herb and discovered that it seemed to help treat wounds (or at least, cover some of the smell). Given there have been some amazing drugs with powerful effects that have emerged from natural products, it’s certainly plausible that oil of oregano could have biological and therapeutic effects. Oregano (Origanum vulgare) leaves contain a wide variety of chemical compounds, including leanolic acids, ursolic acids, and phenolic glycosides. Phenolic compounds make up to 71% of the oil. Carvacrol, thymol, cymene, and terpinine and are found in oregano leaves and do appear to have biological effects. It’s these chemicals that are proposed to be the parts with beneficial effects.

The claims made by one manufacturer are unambiguous:

Oreganol P73 is the most powerful germ killer with scientifically proven results against almost every virus, bacteria, parasite, and fungi. The complexity of the phytochemical matrix in Oreganol P73 possesses a broad spectrum of antimicrobial properties that are safe for prolonged use. The oil can be used topically and internally. Oreganol P73 is the medicine chest in a bottle, especially since it is proven never to harm the internal organs, even when used daily for health maintenance.

So if we accept the manufacturer’s claims at face value, there should be evidence demonstrating oregano oil is both safe and effective when used internally and externally. There is apparently also adequate long-term safety data to demonstrate that it can be safely used on a daily basis.

Effectiveness

When we contemplate administering a chemical to deliver a medicinal effect, we need to ask the following:

1. Is it absorbed into the body at all?
2. Does enough reach the right part of the body to have an effect?
3. Does it actually work for the condition?
4. Does it have any hazardous, unwanted effects?
5. Can it be safely eliminated from the body?

These questions are usually answered through a series of investigations, starting with preclinical (test-tube) studies, and moving into to animal trials, and then to human clinical trials that start with validating safety, and then progress to investigating efficacy and safety.

The short answer is that there’s little beyond animal studies to demonstrate that the ingredients in oregano oil have any effects. One of the best reviews seems to come from the McCormick Science Institute (yes, the spice company).  They commissioned a paper on oregano by Keith Singletary that appeared in the journal Nutrition Today in 2010. Happily, though the journal is paywalled, McCormick is hosting the paper on its own website.

1. Is oil of oregano absorbed? Some parts of the oregano do appear to be absorbed but the bioavailability of its different chemical constituents has not been verified. So we can’t be certain which components are reaching the circulation.

2. Does enough reach the right part of the body to have any beneficial effect? It’s not clear where the chemicals in oil of oregano act in the body, as no research has been done to show that it is adequately absorbed. However, there is some evidence to suggest that oregano may be implicated in inducing abortions in mice, so some parts of the herb must be absorbed, if this a causal effect. When applied to body surfaces or skin for topical effect, oil of oregano is more likely to reach high concentrations, at least locally, and then possibly deliver a medicinal effect. This makes topical effects seem much more plausible than ones that require ingestion.

3. Does it actually work for the condition? There is no published evidence to demonstrate that that oil of oregano is effective for any medical condition or illness. The McCormick review notes that that data for every condition evaluated is “preliminary, inconclusive.”  There is some very limited evidence to suggest that it might be useful for parasite infections — but given the evidence consists of only one study with 14 patients, and no placebo comparison, we really have no idea if the oregano oil itself was effective.

Let’s consider how oil of oregano might treat an infection. Bacteria are killed by antimicrobials based on a specific dose-response relationship. The minimum inhibitory concentration (MIC) must be reached at the site of an infection. Then there’s a concentration range where the bacteria (or viruses, or fungi, or parasites, depending on what you’re treating) are killed, typically in rough proportion to the dose. Keep increasing the dose, and the effect plateaus. If you can hit the MIC without causing side effects or toxicity, congratulations: you have a potential therapeutic agent.

There’s some evidence out there demonstrating that oil of oregano will kill different species of bacteria, etc in the test tube or Petri dish ( in vitro).  If I pour a pile of salt, lime juice, Cointreau, or tequila on a Petri dish, it will likely kill most bacteria too — but that doesn’t mean margaritas can treat pneumonia. It’s not difficult to kill bacteria if you change the conditions enough that it cannot live. So while it’s easy to get high concentrations of oregano in a test tube and subsequent positive effects, these effects are meaningless in the human body unless we can achieve similar concentrations, without any toxicity. And this has not been demonstrated with oil of oregano, or its individual chemical ingredients.

4. Does oil of oregano have any hazardous, unwanted effects? Natural does not mean safe. There are some reports of gastrointestinal upset with oil of oregano. There are also reports of allergic reactions. There is no evidence to suggest that oil of oregano, used at high (medicinal) amounts, may be used safely in pregnant or breast feeding women. However, when used in cooking, and as part of a regular diet, there is also no evidence that causes harm in pregnancy or breastfeeding. Animal studies show that if you give enough carvacrol, it will kill, though.

5. Can oil of oregano be safely eliminated from the body? So little published research exists on oil of oregano there is no way to determine if oregano oil is non-toxic. Certainly, at low doses, when used as a food, there is no reason to have any concerns. But at higher doses, and particularly with regular use, there is no data to sugges it’s safe to consume all that carvacrol, thymol, cymene, and terpinine. As we have no idea if and how oregano oil works, we have no information to estimate what a proper dose might be. Doses published by manufacturers are not based on any published evidence.

Conclusion

Oil of oregano, and the claims attached to it, is a great example of how interesting laboratory findings can be wildly exaggerated to imply meaningful effects in humans. A few small studies have been conducted, mainly in the lab, and advocates argue this is evidence of effectiveness. The rest is all anecdotes.

Despite the hype, there is no persuasive evidence to demonstrate that oil of oregano does anything useful in or on our bodies. And while it is popular, there is no science to support the use of oil of oregano for any medical condition. Suggesting that this herb is can effectively treat serious medical conditions like diabetes, asthma, and cancer is foolish and dangerous. If you’re ill, stick to the proven science, and save your oregano for cooking.

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This year The Amazing Meeting 9 (designated TAM9 From Outer Space) will be held in Las Vegas from July 14-17. If you have not registered, do it fast – this year the conference will likely sell out.

Among the many incredible speakers and events at TAM9 there will be a Science-Based Medicine workshop and an SBM panel discussion. The prominence of SBM at TAM9 partly reflects the new collaboration between SBM and the James Randi Educational Foundation (JREF), who organizes TAM.

The SBM website is now a joint project of the New England Skeptical Society (who founded SBM) and the JREF – two non-profit educational organizations dedicated to promoting the public understanding of science. I am delighted that the JREF is making SBM a priority, and we all look forward to working closely with them in promoting high standards of science in medicine and improved public understanding of the relationship between science and the practice of medicine.

As part of this new relationship I have accepted a position at the JREF of Senior Fellow and Director of their Science-Based Medicine project.

The SBM Workshop at TAM9 (which must be registered for separately) will include names familiar to our readers: David Gorski, Kimball Atwood, Mark Crislip, Harriet Hall, and yours truly. Because it is a workshop we want to focus on practical information for the professional and non-professional alike. The title of this year’s workshop is, “Oh, no. Not Again!: Recurring Themes in Medical Mythology.” After examining unscientific and sectarian health claims for years it becomes clear that the same basic concepts are being repackaged over and over again. Even looking back over the centuries and millennia at the history of medicine we see the same recurring concepts.

We will discuss the most common recurring themes in sectarian medicine and give examples of how they have evolved over the years. We will demonstrate that many of the “new” treatments and claims that are being marketed today are in reality nothing new, but just a reworking of themes that have been dissected and discarded by previous generations.

The goal of the workshop is to give attendees a working knowledge of how sectarian medical beliefs originate and are typically formulated. There is and endless succession of new dubious health claims out there – too many to address every single one individually. But by understanding the common themes underlying these claims, and the flawed science and logic used to promote them, one can recognize the flaws in “new” claims as they occur. Before long you too will be saying in response to the latest “new” health claim, “Oh, no. Not again!”

The SBM panel will take place during the TAM9 main program. I will moderate the panel, which will also include the workshop presenters as well as Rachel Dunlop and Ginger Campbell. The title of the panel discussion is, “Placebo Medicine: The Mechanisms and Misunderstanding of the Mysterious Placebo.”

The nature of placebo effects is more complex than most realize, and I find that even among otherwise savvy scientists and skeptics there remain a great deal of misconceptions about how placebos work, and don’t work. We will explore not only the nature of placebos but the ethics of their use in medicine, and their role in clinical trials.

We hope to meet many of our regular readers there (it’s good to put faces to pseudonyms), so please come up and introduce yourself to us, or just to say hi if we have met you at previous meetings.

Thanks again to the JREF for their support of SBM. We are all looking forward to the conference and collaborating with the JREF in the future to make the practice of medicine a little bit more scientific.

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People tend to limit their reading to sources that agree with their beliefs. We find ourselves mostly preaching to the choir; our message usually doesn’t reach those who most need to hear it. I recently received an inquiry from a science-based medical doctor asking how to approach others in building a bridge to clarify so much misinformation.

My first thought was that you can build a bridge but the real challenge is persuading people to cross that bridge. Like leading a horse to water…

How to approach others? That’s a tough question. The best approach varies with the individual and with where he is in his journey. Confrontation seldom works: it just makes people angry. It is counterproductive: it only serves to make them invent more rationalizations to defend their beliefs. Although sometimes anger can be a good thing. I got an e-mail from an acupuncturist who was incensed by an article I wrote saying that acupuncture was not based on good evidence. He set out to prove me wrong by looking up the evidence behind what he had been taught by his teachers about acupuncture’s efficacy for specific conditions, and when he couldn’t find any, he realized that his teachers and his textbooks had misled him with lies. He gave up acupuncture and went back to school to learn a science-based health profession.

If someone has never had his belief challenged and thinks it a universally accepted truth, it might do some good to show him otherwise. When I was in the dentist’s office earlier this week he asked me what I thought about detoxification. I told him I thought it was a pseudoscientific concept with no scientific validity, that proponents couldn’t even tell you what those “toxins” were, much less measure how much had been removed, and that there was no evidence that detox objectively benefitted patients. He had me repeat this to his assistant who was currently doing a detox. She looked at me very strangely and I may have created an enemy for life. But just possibly I may have started a small crack in her certainty that might someday widen to let accurate information seep in.

Some people respond to accurate information. I belong to the Healthfraud discussion list on Quackwatch and we have had several people thank us for providing accurate information, debunking false information, showing the fallacies in arguments for claims, and helping them learn about the scientific process. They tell us they have discarded their previous false beliefs because of what they read there.

When I spoke at a local college I mentioned that diet supplements are not regulated like FDA approved drugs and have been found contaminated with everything from insect parts to prescription drugs, and that dosages sometimes vary wildly from what the label says. One older student got very upset and said she was going right home to clean out her cabinet and throw all those products away.

I have gotten e-mails from people who decided not to waste their money at the Amen Clinics or on treatments with the DRX-9000 spinal decompression machine after reading my articles.

Unfortunately, many people do not respond to accurate information. Some people choose to form strong beliefs on hearsay or personal perceptions or ideological grounds without any input from science. Scientific information is irrelevant to them so they are not likely to change their minds no matter how much evidence from scientific studies you throw at them. It is useful to ask people what evidence it would take to change their minds. True believers frequently say nothing would change their minds: they know they are right and they are sure that testing would only serve to demonstrate the truth of their beliefs. It’s a waste of time to talk to these people.

I met a believer in dowsing and I gave him a book explaining the ideomotor effect, showing that dowsers had never been able to pass controlled tests, and debunking dowsing in detail. We held a public debate afterwards, and what he said was as if he had never read the book. He managed to just ignore everything in it: his “pro” side of the argument boiled down to two points: he’d personally seen it work and lots of people believed in it. That was enough for him.

Then there are people who are capable of responding to new information but don’t want to hear it. Don’t confuse me with the facts; my mind’s made up. It’s more comforting to have a belief and stick to it than to deal with uncertainty.

Something I haven’t tried yet but want to: ask them if they know of something that doesn’t work but that some other people believe in. Once you find something they reject, you might be able to argue that logical consistency requires that their pet remedy be rejected on the same grounds. For instance, if they reject bloodletting to balance the humors but accept reflexology, you might point out that during the many centuries bloodletting was used, there were far more testimonials from patients and doctors than there are for reflexology today. So if they accept reflexology on the basis of testimonials, they should logically accept bloodletting on the same basis. If they reject bloodletting because science showed it didn’t work, they should look more closely at what science says about reflexology.

Humor can be effective in making a point, like the comedian who said “Of course science doesn’t know everything; it KNOWS it doesn’t know everything, otherwise it would stop.” And like Mark Crislip’s “Alternative Flight.”

The best strategy would be to guide people to discover the truth for themselves and claim it as their own, but I’m afraid I don’t have the patience or the psychological acumen to carry that out. It’s too bad Socrates isn’t around to help.

I am not foolish enough to think I could ever influence true believers; but even for them, it might be possible to plant a tiny seed of doubt that might be reinforced by future experiences and might eventually grow into a plant. Dripping water can wear away the hardest stone over time. But realistically, I can only hope to reach the fence-sitters: those who have not yet irrevocably made up their mind.

I hope readers will share their own success stories and bridge-building ideas in the comments section.

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It’s the toxins.

Toujours les toxines.

How many times have I read or heard from believers in “alternative” medicine that some disease or other is caused by “toxins”? I honestly can’t remember, but in alt-world, no matter what the disease or condition under discussion is, there’s a good chance that sooner or later it will be linked to “toxins.” It doesn’t matter if it’s cancer, autism, heart disease, diabetes, hypertension, or that general malaise that comes over people who, as British comedians Mitchell and Webb put it, have more money than sense; somehow, some way, someone will invoke “toxins.”

I was reminded of this obsession among believers in unscientific medicine last Friday when I came across an article by Guy Trebay in the New York Times entitled The Age of Purification. The article appeared, appropriately enough, in the Fashion section and was festooned with photos of cupping, surely one of the silliest of the many “detoxification” modalities that alternative medicine practitioners use to claim to draw the “toxins” out of their clients through the application of, well, cups or various other containers in which the air had been heated in order to generate negative pressure when sealed to the skin and presumably thus bring them to a greater level of purification and health. Indeed, the only “detoxification” rituals sillier than cupping that I can think of off the top of my head are detoxifying footpads and “detox foot baths.”

Oh, wait. Scratch that. I forgot about ear candling, which must surely be the undisputed silliest “detox” treatment of all time—until someone thinks of an even sillier one. Or not. There are just so many silly “detox” procedures that it’s hard to select a “winner.”

Be that as it may, Trebay mixes sarcasm with exposition throughout his article in a rather amusing way that’s worth quoting:

My friend, like everyone else around, seemed to believe that mysterious, amorphous sludge had lodged in the anatomical crannies of half the local adult population. Unseen toxins were lurking, like Communists during the Red Scare.

The “toxins” required elimination, somehow, and thus at lunches, at cocktails, at dinner parties, normal conversations turned abruptly from the day’s news to progress reports on juice fasts, energy alignments, radical purging. From painful sessions with traditional healers to toxin-leaching treatments designed, it might seem, to clean out not just body but wallet, a surprising number of New Yorkers (not all of them well-to-do neurotics) are caught up in a new New Age, the Age of Purification.

How had it happened, I wondered, that so many otherwise sensible, urban people found themselves in the grip of a dreadful feeling that systems are down? “I just bought five pounds of carrots, ginger and kale and put it all in my Breville juicer and pounded that all day,” said a corporate adviser of my acquaintance, far from a credulous woo-woo type.

Of course, as we have noted so many times before, hard-nosed skepticism in one area of one’s life does not necessarily translate to other areas. Many are the people who would never ever fall prey to scams in business, for example, but happily fork over money for scams such as “detox footpads”—or fall for anti-vaccine quackery, like J.B. Handley. Whatever the case, why this fascination with “detoxification” in alternative medicine? Why do so many of its treatments, be they dietary, chelation therapy, purges, colon cleanses, or whatever, claim to eliminate “toxins”? Why is it that, if you Google “alternative medicine” and “detoxification,” you find so many references, some of which claim external toxins need to be eliminated, some of which claim that internal toxins need to be purged, and still more of which blame various “parasites” for all manner of health distress? In this post, I’ll try to explain, but first a little history—self-history that is.

“You’re poisoning yourself from within”

My first encounter with the concept of “detoxification” (at least, as it is described in alternative medicine terms) occurred perhaps 10 or 15 years ago, after I had been out of medical school several years and completed my surgery education. Basically, a acquaintance of mine had on her bookshelf on “body cleansing.” Given how much I’ve delved into “alternative” medical practices in the last several years, it’s truly amazing to realize that for the majority of my adult life I had no clue what “detoxification” was or what “colon cleanses” were. My ignorance at the time aside, I don’t remember the title, and I don’t remember the author, but I do remember that, as I leafed through the book, it became rapidly clear to me that “body cleansing” had nothing to do with taking a shower or a bath, at least not in this book. In particular, my attention was riveted to a chapter entitled “Death begins in the colon.”

It turns out that the admonition to beware of your colon trying to kill you came from a chiropractor named Dr. Bernard Jensen, DC, who is apparently known as the “father of colonics.” Personally, that would not be a name or title that I’d be particularly interested in having ascribed to me, but then I’m not a chiropractor. My avoidance of icky titles aside, this was my first ever real encounter with the nitty-gritty (much of the grit within the stool) of colon cleansing. What followed were two chapters, the first telling readers how supposedly up to 20 lbs. of fecal waste lurks in their colons, producing “toxins” that slowly poison them, the symptoms of which manifest themselves as lethargy and a sense of not feeling well, coupled with any or all of a huge number of potential conditions, including diabetes, hypertension, asthma, rheumatoid arthritis, and many others. What’s the solution?

Guess.

Yes, the solution, as I wrote about long ago, is colon cleansing, and this was my first encounter, up close and personal, so to speak, with the concept. What followed were long and rather lovingly limned descriptions of the vast quantities of feces, along with—dare I say it?—almost pornographic-seeming photos of what people fish out of their toilet after colon cleanses. (For examples of the sorts of photos that I encountered, click here, but only if you have a strong stomach.) In the text were passages like this:

It is no longer possible to ignore the importance of alimentary toxemia or autointoxication as a fact in the production of disease. To no other cause is it possible to attribute one-tenth as many various and widely diverse disorders. It may be said that almost every chronic disease known is directly or indirectly due to the influence of bacterial poisons absorbed from the intestine. The colon may be justly looked upon as veritable Pandora’s Box, out of which come more human misery and suffering, mental and moral, as well as physical than from any other known source.

The colon is a sewage system, but by neglect and abuse it becomes a cesspool. When it is clean and normal we are well and happy; let it stagnate, and it will distill the poisons of decay, fermentation and putrefaction into the blood, poisoning the brain and nervous system so that we become mentally depressed and irritable; it will poison the heart so that we are weak and listless; poisons the lungs so the breath is foul; poisons the digestive organs so that we are distressed and bloated; and poisons the blood so that the skin is sallow and unhealthy. In short, every organ of the body is poisoned, and we age prematurely, look and feel old, the joints are stiff and painful, neuritis, dull eyes and a sluggish brain overtake us; the pleasure of living is gone.

Even back then, having recently finished my general surgery residency, I knew this to be utter nonsense. The reason, of course, is that I was still doing abdominal surgery back then, and I had done a lot of colectomies in urgent situations, where there was no time to prep the colon using GoLytely or something similar. Never once had I seen anything resembling the sorts of horrors delineated in this book. While that didn’t rule out that some patients might be as described in the passage above, it certainly indicates that having 20 lbs of fecal waste clogging up one’s insides is not nearly as common as the colon cleansers seem to believe. Similarly, I had done a number of colonoscopies in patients with unprepped colons, and, similarly, had never seen anything like this. None of this means such a thing is not possible, but in reality if a person’s colon has 20+ lbs of impacted fecal matter that person is going to be suffering not from chronic illness or a vague sense of illness. That person is likely to be, to use a scientific term beloved among the surgeons under whom I trained as a resident, sick as snot. In other words, while it is true that the fecal matter in our colons can make us sick, it’s quite uncommon that it does make us sick. Becoming ill from our own fecal waste matter usually only happens when something bad happens to break down the protective barrier of the colon and allow wee beasties that normally reside there to translocate into the bloodstream. For example, common causes of such breakdowns in mucosal barrier function usually involve severe physiological insults resulting in too little blood getting to the colon; i.e., sepsis, shock due to massive bleeding, or acute cardiac failure. These are usually not subtle things.

I told my acquaintance that whoever had written that book was full of…well, never mind. My experience, however, had been, if you’ll excuse the term, indelibly stained. I also came quickly to realize that the concept of autointoxication seems to have a lot more to do with religious concepts than science:

“The body as hotbed of festering sin was first examined by St. Augustine,” said Caroline Weber, a professor of French literature at Barnard College and Columbia University and a writer who often explores the weird byways of shifting cultural mores. “It was adopted later by monastic orders in the form of practices like self-flagellation, the wearing of hair-shirts, ritual fasting and the mortifications of the flesh.”

What is “detoxification” but ritual purification in another guise?

Attack of the toxins

If we are to believe the “detox” cult, our bodies are a pestilent sea of toxins, arising both from internal sources (the colon being but one example) and external sources. That’s why it’s useful to divide our “toxic exposure” from an alt-med perspective into two general kinds: External and internal, the latter of which is often referred to as “autointoxication.” External toxins are easy to understand and consist of pretty much anything that is viewed as toxic that enters the body from the environment. This term thus encompasses diet, pollution, and, of course, the ever-favorite bugaboo, “toxic chemicals.” Don’t get me wrong; there is no doubt that certain chemicals can be toxic. Further, there is no doubt that some environmental exposures can make us sick. Even further still, I do not deny that there have been times when chemical companies have behaved, to put it mildly, less than admirably when it comes to chemical spills and their consequences (Love Canal, anyone?)

That’s why I want to make it absolutely clear that these sorts of demonstrated, defined adverse health events are not what’s meant most of the time when when alt-med believers discuss “toxins.”

As for “internal” toxins, there is the aforementioned belief in “autointoxication” due to massive build up of fecal matter, and then there is—well, let me allow naturopath Robert Groves explain, given how heavily naturopathy emphasizes “detoxification”:

Autointoxication is poisoning by toxic substances generated within the body. In this process the body breaks down the parts that have served their function and attempts to, but fails to fully (or in the proper amount of time) neutralize their poisons and transports them out of the body. When these substances are not properly neutralized and/or eliminated, they damage our other cells causing dysfunction and disease. This continual cycle of destroying and eliminating the old worn out materials and cells happens in a time frame from split seconds to many years depending upon the type of cells and the substances. As an example of this regenerative process, your liver regenerates itself in about 3 weeks. The old cells are now waste to breakdown and move out. The body does this in a number of ways with the help of a few friends such as antioxidants, minerals, vitamins, viruses, bacteria, etc.

Anyone who has a basic understanding of human physiology should immediately recognize how poor an understanding of bodily function the article by Groves represents. Indeed, while the above passage is superficially correct about how the body is continually renewing itself, the conclusions Groves draws from this knowledge are so wrong they’re not even wrong, particularly his answer to the question of why detoxification is necessary:

If you don’t detoxify, you’ll blow up! It sounds like I’m kidding and in some ways I am and other ways I’m not. If there is intake and metabolism, but not elimination of the substances ingested or byproducts produced, an increase in size will occur. This is a matter of physics, the old saying “if you eat more calories than you burn you will gain weight” routine. Without proper elimination of unnecessary substances, obesity will be a problem at the very least. Bacterial and yeast overgrowth will increase bloating and create rotting of the entire digestive system. The cells of your body will no longer have room to take in nutrients and burn them (metabolism) resulting in fatigue. Consequently, the cells will fill with waste within and also in the interstitial space or area surrounding them (toxemia). In this state they will starve, as they are unable to absorb nutrients (malnutrition), and/or be denied oxygen causing cells to suffocate (hypoxia), and finally will die (necrosis). When enough tissues die, your organs die, and when enough organs die, you die.

Again, this is utter nonsense, too. First of all, there is no reason why the amount of waste must necessarily precisely equal the amount of food ingested. After all, what happens to the part of the food that we actually use for energy? How on earth is it that Groves thinks that if we take in too many nutrients we will “run out of room” to use any more, resulting in fatigue? After all, one might well argue part of the problem with our physiology is that it is too efficient in using calories far beyond what our bodies need, happily storing them as fat. Be that as it may, the body has very finely tuned and efficient mechanisms for disposing of waste material or recycling it into other molecules that the body needs, such as proteins, nucleic acids, and lipids. The liver is incredibly adept at getting rid of various waste products, as are the colon, lung, and kidneys. Except when these organs fail, help is rarely necessary; the body can “detoxify” itself just fine, thank you very much. Groves makes an analogy to an automobile in which the owner rarely changes the oil, rarely replaces the filters, and uses bad gasoline. Of course, an automobile is not capable of self-renewal the way that the human body is, which is why, although this analogy may seem attractive, it is too off-base to have even a whiff of a hint of any validity.

In all fairness, it should be noted that the very concept of “autointoxication” was not an alternative medicine concept per se, at least not 100 years ago. True, it is an ancient concept that dates back to the ancient Egyptians, who believed that a putrefactive principle associated with feces was somehow absorbed by the body, where it acted to produce fever and pus, and the ancient Greeks, who extended the idea beyond digestive waste in the colon to include the four humors and incorporate the concept into the humoral theory of medicine. Even so, it was also a concept promulgated by proponents of scientific medicine in the late 1800s and early 1900s. The concept was very much like what I’ve described so far, namely that putrefactive products of digestion remained in the colon, there to leech into the bloodstream and sicken patients due to autointoxication. Indeed, some surgeons, chief among them Sir W. Arbuthnot Lane, advocated total colectomy for the autointoxication that was thought to be the cause of diseases ranging from lassitude to epilepsy. Given that there were no antibiotics effective against colonic flora back then, intestinal surgery was still fraught with peril due to the high rate of sepsis and death, making this approach reckless indeed, even by the standards of the time. Eventually, even Sir Arbuthnot Lane came to the same conclusion and by the 1920s had changed his mind, deciding that diet was the answer. In any case, also by the 1920s, science had shown that the various symptoms observed in patients with chronic constipation were largely due to distension of the bowel and were not due to autointoxication. As is its wont, scientific medicine moved on from a failed hypothesis.

In marked contrast, as is their wont, alternative medicine practitioners clung all the more tightly to this failed hypothesis, an embrace that continues to this day.

What are these “toxin” things, anyway?

The first thing you need to understand when trying to figure out what toxins are is to realize that what an alt-med practitioner means when he or she mentions toxins resemble what a physician, scientist, or toxicologist means when he or she mentions toxins only by coincidence. In science, the formal definition of a “toxin” is actually quite narrow. Basically, a toxin is a poisonous substance produced by living cells or organisms. Man-made substances that are poisonous are not considered, strictly speaking, “toxins” by this definition. Rather, they are called toxicants. In marked contrast, alt-med practitioners do not distinguish between “toxin” and “toxicant,” lumping them all together as “toxins,” be they the products of autointoxication, heavy metals, pesticides, or industrial chemicals. To the alt-med practitioner, they are all “toxins,” which is why at this point I tend to make like Gunnery Sergeant Hartman and proclaim that I do not discriminate based on toxins, toxicants, or heavy metals. To me, in alt-med usage, they are all equally worthless.

Nomenclature aside, however, perhaps the most important differences in how science views toxins versus how alt-med views toxins is in demonstrating an understanding of (1) identity and (2) how the dose makes the poison. When toxicologists speak of toxins or toxicants, they tend to be very specific about the identity of the toxin or toxicant; they do their best to identify the specific compound or chemical that is causing illness, regardless of its source. This is often not an easy task, because there are frequently many confounders. Rarely are we fortunate enough to have a smoking gun like Minamata disease for mercury poisoning or the syndrome associated with Thalidomide dosing. This is particularly true for chronic disease as opposed to acute poisoning. In marked contrast, alt-med aficionados are almost intentionally vague when discussing toxins. To them, it seems, toxins are either all-purpose nasty substances without specific identities or substances whose toxicity appears not to depend upon dose. In the former case, toxins might as well be miasmas. If you’ll recall, the miasma theory of disease stated that infectious diseases were caused by a “miasma”; i.e., “bad air.” This was not an unreasonable concept before the germ theory of disease, because before germ theory the agents through which infectious disease was transmitted were unknown, but it’s not so reasonable now. Alternatively, “toxins” often seem to function like evil humors in the humoral theory of disease. Either way, alt-med toxins do not correspond to anything resembling toxins or toxicants in science.

My favorite example of this comes from the anti-vaccine movement. Remember our old friend Dr. Jay Gordon, pediatrician to the children of the stars and anti-vaccine apologist? A couple of years ago, “Dr. Jay” (as he likes to call himself) asserted that formaldehyde is a horrible toxin in vaccines. Yet, formaldehyde is a normal product of metabolism and ubiquitous in the environment. As I pointed out at the time, Dr. Jay breathes far more formaldehyde sitting in L.A. traffic jams than is in the entire vaccine scheduled, and human infants have many times more formaldehyde circulating in their bloodstream than would be contained in any vaccine. Believe it or not, I personally engaged in a long exchange with Dr. Jay trying to get him to understand why the “formaldehyde” gambit makes no sense from a medical or scientific standpoint. I’m still not sure whether I got through, because periodically he pulls in essence the “toxins” gambit, in which ingredients in vaccines are listed, along with all sorts of scary potential adverse effects, with no mention given as to the dose required to result in those toxic effects.

When it comes right down to it, alt-med “toxins” are as fantastical as the sympathetic magic that is the basis of homeopathy.

But how do you get rid of toxins?

Given that these magical, mystical “toxins” are ubiquitous, the methods proposed to eliminate them are legion. Still, they tend to break down into five main methods. Often two or more of these methods are combined in order to flush out those evil humors toxins:

• Diet. Key to many “detox” regimens is diet. These can range from all juice diets such as the “Master Cleanse” diet, which consists of lemonade, maple syrup, and Cayenne peppers (I kid you not) to raw food diets such as the ones I’ve discussed (cooking food apparently loads it up with toxins) to any number of other bizarre diets.
• Colon cleansing. Discussed in depth by yours truly three years ago and better known as regularity über alles.
• Heavy metals. This is where “chelation” therapy comes in. In essence, the claim is that we are all overloaded with “toxic” heavy metals. The treatment is, of course, chelation therapy. Unfortunately for quacks (and fortunately for us), genuine heavy metal poisoning is increasingly uncommon. Removing lead from paint has made it less and less common for babies to be poisoned when they put paint chips in their mouth, and removing lead from gasoline has decreased the amount of lead people breathe in. Moreover, there are specific criteria for the diagnosis of poisoning due to specific metals, and chelation is only useful for some metals. It’s also important to remember that, for all the claims of anti-vaccine activists that mercury in the thimerosal preservative that used to be in some childhood vaccines causes autism, not only is there no evidence to support this claim, but there is a lot of evidence against it. Worse, often the diagnosis of “heavy metal toxicity” made by alt-med practitioners is based on “provoked” urine levels, a methodology that has no validity.
• Skin detoxification methods. These methods claim to purge the “toxins” by eliminating them through the skin. They include modalities such as “cupping”, pads like the infamous Kinoki footpads whose manufacturers claim they can draw toxins out through the soles of the feet, and the even more infamous “detox foot bath,” where the water turns colors regardless of whether your feet are in there or not.
• Manipulative methods. These tend to break down into methods like massage therapy and “lymphatic drainage,” basically manual methods that claim to “improve lymph flow” and thus “detoxify” the tissues. Examples include rolfing and lymphatic drainage massage (which, while feeling good, doesn’t remove any toxins that anyone can show).

The bottom line is that in medicine, “detoxification” has a specific meaning, and alt-med “detox” believers have appropriated the term for something that has little or nothing to do with its real medical meaning. Basically, in real medicine “detoxification” means removing a real and specific toxin or toxicant (or set of toxins and/or toxicants). In the case of real heavy metal poisoning, chelation therapy is real detoxification. Similarly, using lactulose to decrease the production absorption of ammonia by the gut is an example of detoxification. In contrast, alt-med “detoxification” is far more akin to the exorcism of evil spirits, the removal of evil humors, or the driving away of miasmas.

Fashionable nonsense

It’s not clear to me what’s behind this latest wave of detox faddism, but it’s clear that the concept that we are somehow being “contaminated” or poisoned is nothing new. Perhaps my favorite pop culture example is from a movie that’s nearly 50 years old, Dr. Strangelove or: How I Learned to Stop Worrying and Love the Bomb. In this blackest of black comedies, U.S. Air Force Brigadier General Jack D. Ripper has a paranoid delusion that fluoridation of water is a Communist plot that will lead to the contamination of the “precious bodily fluids” of every American. Acting on this belief, General Ripper initiates an all out first strike nuclear attack on the Soviet Union, and the rest of the movie involves the increasingly darkly funny efforts of the U.S. government to recall the bombers and abort the attack in order to prevent global Armageddon. The idea “contamination” and the need for “purification” goes back much farther than that, though, as Trebay notes:

The idea of toxicity is a constant in Western culture, said Noah Guynn, director of the humanities program at the University of California, Davis, and a researcher into the cultural meanings of ritual cleansing. “We’re obsessed with the idea that our environments have turned against us, that they are poisoning us and we have no choice in the matter,” Dr. Guynn added. “We’ve been contaminated by something that you cannot eradicate, you can only treat.”

Whatever the reason for the resurgence of belief in various “detox” modalities, one thing’s for sure. Unnamed, unknown, undefined “toxins” are the new evil humors and miasmas, and detoxification is the newest fashionable form of ritual purification.

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It is hard to get infected. The immune system is robust and has a multitude of interlinking defenses that are extremely efficient in beating off most pathogens. Most of the time.

Fortunately, it is a minority of microbes that have evolved to be virulent in humans. Bacteremia is common with our own microbiome. When you brush or floss, bacteria leak into the blood stream:

We identified oral bacterial species in blood cultures following single-tooth extraction and tooth brushing. Sequence analysis of 16S rRNA genes identified 98 different bacterial species recovered from 151 bacteremic subjects. Of interest, 48 of the isolates represented 19 novel species of Prevotella, Fusobacterium, Streptococcus, Actinomyces, Capnocytophaga, Selenomonas, and Veillonella.

but with a good immune system, low virulence bacteria and no place to go, unfortunately the bacteria rarely cause infections.

Even heroin users rarely get infection. Heroin is a rich melange of  with bacteria and, on occasion, yeasts (I hate to say contaminated, since avoiding microbes is hardly a worry of heroin manufacturers), and the water used for injection is rarely sterile, yet infections are relatively rare despite the filth in which many heroin users exist.

I used to be somewhat fatalistic about hospital acquired infections. However, as the institutions in which I have worked have proven, almost all infections in the hospital are preventable if the institutions aggressively pursue high standards of care.

There are many systems in place in society to prevent infections: flush toilets, good nutrition, public health, vaccines, antibiotics, good hygiene, and an understanding of disease epidemiology, and I suspect people forget there are bugs out there that are pathogenic, just waiting to sicken and kill us. At least a couple of times a year I see patients come into the hospital, previously healthy, who rapidly die of acute infections.  But for most people, most of the time,  it takes a lot of effort to get an infection.

From my perspective we are Charlie Chaplain on skates , mostly unaware of the infections that awaits us if we do something silly, or even when we act with the best intentions to avoid illness. The odds are small we will get a life threatening or serious infection in the US, just as the odds are small we will drown or be killed in a car accident. The germs are there, waiting, and in the end, no matter what we do, we will be consumed by the microbial world.

It is that perspective that leads to a lack of understanding as to why some people seem to love tipping the odds in favor of the bacteria. Avoiding vaccines is perhaps the most popular method for getting infections that could otherwise be avoided, but dietary habits are an curious way to acquire preventable infections.

Humans and cows have a long history of sharing infectious diseases. Measles is either a variant of rinderpest, a cattle illness, or they share a common ancestor. On the beneficial side of the relationship was cowpox, which lead to the small pox vaccination.

While I am a bit of a foodie (for example, while I do not remember by first kiss, I remember the epiphany of my first gourmet restaurant meal), I cannot grok (see how old I am) people who either think a specific food is to be avoided at all costs or is the panacea for preventing illness. Like cows milk.

There is school of thought that cows milk should be never be consumed: it is filled with pus, blood, hormones, foreign protein and antibiotics.  And not only does milk not build strong bones, it leads to cancer. And if you can’t trust a kinesologist, who can you trust?

It’s not natural for humans to drink cow’s milk. Humans milk is for humans. Cow’s milk is for calves.

Sounds like a metaphorical argument for cannibalism to me.

And, as the anti-cows milk proponents note,  milk has infectious diseases swimming in the white murk. A cesspool of bovine feces and bacteria that should be avoided, although how you can eat a homemade chocolate chip cookie without it, I cannot imagine.

So milk is one of the bad foods and should be avoided. Except when you shouldn’t. Newtons Law states that for every SCAM, there is an equal and opposite SCAM. Milk is dangerous, except when it is a panacea, when the milk should be raw milk, fresh from the organic, happy, contented cow.

Why raw milk? Pasteurization and homogenization rids the milk of the beneficial components: white cells, proteins, lactoferrin, immunoglobulins, fats, cholesterol and bacteria, curiously all the substances that the anti-milk faction says are the root of milky evil. I suppose that, for a raw milk aficionado, there would be no greater dietary sin than a warm glass of milk at bed time or a cup of hot chocolate after skiing.

The truth? I do not doubt that flash heating (usually to 165 degrees for 15 seconds) is going to have some nutritional effects on the milk and, if my diet consisted entirely of milk, it would be a concern. However, what small decrements in nutritional value occur would, and should, be made up with a varied diet. Milk is not, unless turned into Baskin Robbins Chocolate Chip ice cream, a miracle food. I also have no reason to doubt that there is a subset of people who have allergic issues with cows milk. Not everyone can drink bovine proteins with impunity.

Taste, of course, is a personal matter, and I cannot gainsay those who say raw milk tastes better. In my family everyone is picky about their milk; it cannot come in plastic and has to be a specific brand, Dairygold. My wife insists Oregon milk is inferior in flavor to Minnesota milk. French milk tasted weird, and I though everything else tasted better in France. Pasteurization has mild effects on the nutritional components of milk, and perhaps the taste.

But what raw milk is, above all,  a source for infection. There have been outbreaks with Campylobacter, Salmonella, E. coli associated with raw milk and other organisms can be found in raw milk, some not common in the US, including  Brucella, Listeria, Mycobacterium bovis (a cause of tuberculosis), Salmonella, Shigella, Yersinia, Giardia, and norovirus. Some are found in cows milk, and some, such as Brucella, more common from goat’s milk. These outbreaks have lead to hospitalizations and a few deaths.

Warm liquid filled with protein, fat and sugars. A good growth media for a bacteria, if they can gain access to the milk. Impossible. Proponents of raw milk point to the clean cows and clean environments that produce raw milk, but you cannot deny both microbiology and gravity. The colons of cows are frequently colonized with the aforementioned potential pathogens and the udder sits below, waiting to be splashed with cow pie. MMMMmmmmmm. Milk and pie. Seriously. Would you lick any cow udder, no matter how clean?

Still, people want their raw milk for the taste and health benefits. Some obtain raw milk illegally at milk speakeasies where I bet the password is Swordfish. You can time share a cow and get the milk straight from the source, although you have to see a presentation on time sharing cows to get the free weekend on the farm. This is good news for me. Since we have instituted aggressive infection control at my hospitals nosocomial infections have plummeted. Once upon a time milk was associated with 25% of infection outbreaks; in part due to pasteurization those rates fell to 1%. Thanks to the raw milk advocates, infections are looking up. The sad thing is parents will feed their children milk supplemented with cow poo. Adults have the right to be stupid; it is what makes America great. But it is a shame that children should suffer as a result of their parents goofy idée fixe.

There is a tendency for humans to have the oddest dietary obsessions, both for and against.

God told Moses certain animals were “clean” to eat — those with cloven hoofs which chewed the cud such as cattle, goats, sheep, deer, and so forth. All fish with fins and scales, and insects of the locust family were also “clean.” The pig and the camel, however, were “unclean” and were not to be eaten. All carnivorous birds, sea creatures without fins and scales, most insects, rodents, reptiles, and so forth were “unclean.

Milk is not on the list. Milk can be an enjoyable part of a diverse diet for most people, but like most foods it should not be filled with live organisms. Pasteurization is a good thing. Except for Hefeweizen. Give me my raw beer.

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An Embarrassment of Riches?

Much has been written here about the dietary supplement business, a multibillion dollar industry with powerful political connections, and about the woeful inadequacy of regulation which allows widespread marketing of supplements without a solid basis in science or scientific evidence. 

The veterinary supplement market is a pittance compared to the human market, but still a billion-dollar pittance that is growing rapidly. Unfortunately, the resources available for good quality research in veterinary healthcare are also a pittance, and it is not at all unusual for our pets to suffer, or even be euthanized, as a result of treatable diseases for want of money to pay for needed care. So $1 billion a year spent on nutritional supplements may not be such a good deal if these products don’t effectively prevent or treat disease. 

The variety of supplements available is staggering. Many proprietary concoctions of vitamins, minerals, herbs, and other ingredients are marketed for health maintenance, “boosting the immune system,” retarding aging, or treating specific diseases. A comprehensive review of this multitude of moving targets is impossible. But the lion’s share of the pet supplement market goes to a few specific compounds, so I will focus on these. Most of these ingredients are also among the most popular supplements for humans, so there will be substantial overlap with previous discussions of the plausibility and evidence for many of these substances. 

1. Glucosamine

The biggest name in the veterinary supplement world by a large margin is glucosamine. It is sold alone or in combination with chondroitin, MSM, green-lipped mussle extract, and a zillion other ingredients. It is sold over-the-counter and through veterinarians and as an additive in commercial pet foods, and it is ubiquitous. It is also widely believed by pet owners and veterinarians to be an effective treatment for osteoarthritis. 

Glucosamine for arthritis in humans has been discussed at length here before. There is some reasonable plausibility to the underlying theory, but decades of clinical trials have failed to find any consistent benefit, and the balance of the evidence strongly suggests it is no better than a placebo in treating arthritis in humans. Given the subjective nature of pain and the multitude of ways biologically inert interventions can influence people’s perceptions of their own discomfort, this placebo effect might be of marginal value in humans, but the same kind of psychology does not apply to dogs and cats, though it certainly does apply to their owners.

There is very little clinical research on glucosamine as a treatment for arthritis in dogs and cats. In preparing a recent brief literature review, I found only two clinical trials in dogs. One found no benefit for glucosamine and the other, which had a weaker design, showed little benefit. Both showed far greater and more predictable benefit to non-steroidal anti-inflammatory (NSAID) therapy, which is a consistent feature of clinical research on glucosamine.

Because cats are poorly tolerant of NSAIDs, there is particularly great interest in glucosamine and other nutraceutical therapies for osteoarthritis in this species. Nevertheless, I have found no published clinical trials studying this supplement in arthritis cats. The closest is a study of a diet containing glucosamine, chondroitin, and a number of other supplements purported to have benefits in managing arthritis. I have addressed this study in detail elsewhere, but in brief there were not consistent differences between the experimental diet and the control diet even on subjective measures of comfort and no differences at all on objective measures of activity. And, of course, the role of glucosamine, if any, in any effect that might have been seen would not be demonstrable in a study of a diet with many other ingredients.

Glucosamine is also marketed for treatment of feline interstitial cystitis, an uncomfortable and potentially very serious chronic inflammatory disease of the urinary bladder. However, the only clinical trial to investigate this use did not find any evidence of benefit.

2. Fish Oil

After glucosamine, one of the most popular supplements for pets is fish oil. In humans, the most common use of this supplement is for lowering blood lipid levels and prevention of cardiovascular disease. There is some controversy about exactly how much of which components is useful for which specific conditions, and whether eating fish is better than taking fish oil supplements, but in general there is good evidence for some benefit in cardiovascular disease prevention.

Cats and dogs don’t have the problems humans do with atherosclerosis and cardiovascular disease, so this is not a reason for use of fish oils. Instead, this supplement is most commonly used in the treatment of skin allergies. A 2010 narrative review of the evidence for various approaches to treating canine skin allergies concluded that there was some evidence that fish oil supplements can improve coat quality and reduce the dosage of steroid medications needed to control itching, but that these effects are small and not great enough to substitute for other therapies. There is also not evidence to support the use of any particular source, dosage, or formulation of fish oil over any other. 

The other common use of fish oils in pets is for treatment of arthritis. There is weak evidence in humans for the use of fish oil supplements as an adjunctive treatment in patients with rheumatoid arthritis, but in general this is not a well-supported intervention for degenerative osteoarthritis in people. There have been several studies of fish oil as a therapy for osteoarthritis in dogs, which I have reviewed in detail (here and here). These are pretty well-designed studies, all by the same group of investigators, and as is common for studies of dietary supplements, they report mostly negative results but then focus on the few statistically significant findings, generally with subjective measures, to conclude the studies are proof of a benefit. The idea that fish oil supplements might have some small benefit for arthritis in dogs and cats is not out of the question, but so far the evidence is not encouraging.

3. Probiotics

Mark Crislip has eloquently addressed the theory and science of probiotics for humans, and the bottom line for pets appears to be much the same. We understand very little about the important and complex ecology of the gastrointestinal tract, about what bugs are there and what they do for or to us. So while the idea of influencing this flora to restore or maintain health makes some sense, adding a few Lactobacillus to the mix and expecting it to have a major effect seems a bit like tossing a few grass seeds into the Amazon rain forest and expecting a golf course to grow there (thanks Mark!). 

Clinical studies in humans support some benefits for some conditions, particularly antibiotic-associated diarrhea, but many of the claims made for probiotic products, especially for health maintenance or “boosting the immune system” are unsupported. There is less research on probiotics for dogs and cats, but there are some encouraging studies which show a likely benefit of some products for acute idiopathic diarrhea in dogs (e.g. here and here, analyzed in detail here). There are also serious problems with the quality control of largely unregulated veterinary probiotics. A recent study found the majority of products tested had inaccurate labels, with many not containing the amount or species of organisms claimed on the label. There are also many products marketed with ridiculous and completely unsupported claims. 

So overall, the idea of probiotics as a therapy for gastrointestinal disease seems promising, and there are some early suggestions that some products may be useful for some conditions. But this optimism must be tempered by the very limited, preliminary understanding we have of gut ecology and how to manipulate it, the minimal reliable clinical trial evidence to support probiotic use, and the concerns about poor quality control and exaggerated, unscientific claims for probiotic products.

4. Multivitamins

Multivitamins are widely touted as a preventative health measure or as “insurance” for a nutritionally imperfect diet. As Harriet Hall has discussed previously, taking a multivitamin is more a form of self-administered psychotherapy than a preventative health practice. A 2006 review of the available evidence, as well as more recent studies, do not support claims of health benefits in humans from vitamin supplementation in the absence of confirmed deficiencies. And there are circumstances in which vitamin supplementation can be harmful (for example raising cancer risk, interfering with cancer therapy, or even increasing mortality). 

As usual, there is virtually no research on the subject in dogs and cats. Commercial pet diets are nutritionally balanced in a way that the rather haphazard eating habits of most humans is not, so there is even less reason to think a multivitamin would be necessary in dogs and cats eating such a diet. In fact, such supplementation could very well lead to excessive, even toxic levels of fat soluble vitamins or some minerals. Homemade and raw food pet diets, however, are more likely to be nutritionally inadequate, so multivitamin supplementation might be more appropriate when feeding such diets. However, the bottom line is there is no good quality epidemiological or experimental research to suggest that dietary deficiencies are common or that non-targeted vitamin supplementation of apparently healthy pets eating a balanced diet has any value. And there is some evidence that supplementation under certain circumstances can be harmful (for example, calcium in growing large-breed dogs). 

The lack of evidence may preclude a definitive statement that such supplements are unnecessary or harmful, but it also makes the confident, sweeping claims of supplement marketers entirely unjustified. 

5. Lysine

Lysine is an amino acid which is hypothesized to be useful in the prevention and treatment of Feline Herpesvirus (FHV-1) infections. This virus is extremely common, and many cats will be exposed and become infected as kittens. Clinical symptoms include sneezing, nasal congestion, and conjunctivitis, and they range from mild and self-limiting to very severe. Most cats will get over the initial infection, but many remain chronically infected. With suppression of immune function from stress, medication, or disease, the virus can re-emerge and cause symptoms again. A small subset of cats may develop chronic, ongoing symptoms associated with this infection. Vaccination reduces the severity of symptoms but does not prevent infection. 

Lysine is proposed to interfere with the replication of FHV-1 by blocking the uptake of another amino acid, arginine. There are theoretical concerns that lysine supplementation could make cats arginine deficient, but experimental studies suggest this is unlikely in practice. So it appears to be safe, but does it work?

Well, maybe. For once, numerous studies have been done, but there is no clear, consistent pattern of results. Some show that oral supplementation is ineffective and might even make infection worse (Drazenovich, 2009; Rees, 2008; Maggs, 2007). Others do seem to demonstrate some benefit (Maggs, 2003; Stiles, 2002). So while lysine supplementation appears to be safe and there is a plausible rationale for its use, no definitive conclusion about its efficacy is justified.

6. Milk Thistle

Milk thistle is an herbal product that is widely recommended and used. Like glucosamine, it is a supplement which has leapt over the gap between alternative and conventional medicine. The active ingredient is a cluster of compounds called silymarin. There has been extensive in vitro research on silymarin, and it has a wide range of potentially useful effects. It appears to interfere with pro-inflammatory chemicals, functions as an anti-oxidant, and may interfere with the metabolism of some chemicals into toxic compounds in the liver. It also has some activity which could be potentially harmful, including interfering with the metabolism of a number of drugs and stimulating the effects of hormones like estrogen.

The primary uses of silymarin in humans are to protect or treat liver damage from toxins and infectious diseases, to improve the condition of diabetics, and to protect the kidneys from toxins. In dogs and cats the primary use of for non-specific “support” of the liver regardless of the specific disease. 

In humans, clinical trial evidence is mixed. A couple of studies have suggested it reduces insulin resistance in diabetic and may lower blood lipid levels. A Cochrane review of 13 studies including 915 people “could not demonstrate significant effects of milk thistle on mortality or complications of liver disease in patients with alcoholic and/or hepatitis B or C liver disease.” High quality trials were negative, and low quality trials suggested a benefit. 

Very little research exists in dogs and cats. A small study of 20 cats given acetaminophen, a known liver toxin, found that those given a single oral dose of silymarin did not show the elevation of liver enzyme levels seen in those not given the compound. A similar study in dogs found some differences in elevations of kidney values between those that got silymarin and those that didn’t following exposure to a kidney toxin, though there was not a completely consistent pattern.

A study done in 1978 showed that dogs given a toxic mushroom compound orally and then given silymarin intravenously did not show the increase in liver enzymes that was seen in control dogs. Another in 1984 found that 30% of the control dogs died whereas none of the dogs given IV silymarin along with the mushroom toxin died, and the livers from the treated dogs did not appear damaged by the toxin. What relevance this has for the value of oral supplementation isn’t clear.

As far as risks, there appear to be few. Nausea, diarrhea, and other gastrointestinal effects are sometimes seen in humans and animals, and allergic reactions have been reported in humans.

So overall, the in vitro and laboratory animal evidence indicates it is plausible that milk thistle extract might have beneficial effects, though harmful effects in some situations could be possible as well. In humans, the clinical trials show weak evidence for benefit in some conditions and no evidence of benefit in others. Very little experimental, and apparently no high quality or controlled clinical research exists in dogs and cats. So once again, harm seems unlikely and a benefit is possible for some dose and some form of silymarin in some conditions, but we lack the information to use the compound rationally or to know for certain if it is even useful in most cases.

7. S-adenosyl methionine (SAM-e)

SAM-e is a chemical which occurs throughout the body and has a fascinating array of in vivo functions and in vitro effects. In humans, it is marketed for use in depression and arthritis, and a variety of other conditions. The clinical trial evidence is mixed and not generally high quality (for example, Cochrane Reviews for arthritis and alcoholic liver disease, Mayo Clinic summary for various conditions). 

In pets it is primarily promoted as protecting the liver from damage due to disease of toxins, often in combination with Milk Thistle, though its use for arthritis and other conditions is also sometimes recommended. While the theoretical arguments for these uses, especially in the case of liver disease, are plausible, there is virtually no clinical research that the compound actually benefits patients when given as an oral supplement. There is one study which found no significant benefit in preventing liver changes associated with steroid use, one case report claiming some possible benefit in a dog with acetaminophen toxicosis, and one clinical study that suggest some possible value in treating age-related cognitive dysfunction in dogs. And despite how widely used this supplement is, and how sweeping the claims made for it often are, that’s about it.

8. Digestive Enzymes

The claims made for digestive enzyme supplements are often sweeping and dramatic, and they can make you wonder how anyone ever digests their food without them. The usual arguments are that these enzymes exist in raw foods but are destroyed in the production of commercial pet foods, so if you are so foolish as to feed a nutritionally balanced commercial diet, you’d better give your pet these supplements, or else! These exaggerated, unsupported, sometimes outright mythical claims for raw food diets in humans and dogs have been discussed here before. They are based on fundamental misconceptions about digestive physiology and nutrition, and they hold no water.

Healthy humans and dogs have all the enzymes they need to effectively digest foods. The organs that produce such enzymes do not become stressed or fatigued by doing what is, after all, their normal function. Commercial diets and their constituent ingredients are extensively tested for digestibility, and there is no evidence that any deficiency of enzymes in these foods creates nutritional deficiencies or any specific health problem. 

In addition to use in healthy individuals, enzymes are also recommended for cancer treatment, anti-inflammatory effects, and treatment of many other disease conditions. Though the occasional study is published to support these recommendations, often in “integrative medicine” journals, there is no consistent, high-quality clinical evidence in humans that digestive enzymes are effective therapy for any condition other than true pancreatic enzyme deficiency. And there is evidence that this approach may be ineffective or even harmful. 

There is, surprise surprise, no clinical research at all on the subject in cats and dogs. Apart from pancreatic insufficiency, in which enzyme supplementation is often effective, the claims made for the use of enzyme supplements are based solely on anecdote, theory, or extrapolation from in vitro research. 

9. Coenzyme Q10

Like most dietary supplements, coenzyme Q10, also known as ubiquinone, is recommended for a wide range of apparently unrelated conditions. It is recommended in humans for cardiovascular disease, Alzheimer’s disease, migraines, diabetes, and many others, as well as a general tonic and, of course, the inevitable “boosting” of the immune system. In dogs and cats it has primarily been recommended for treatment or prevention of heart disease and age-related cognitive dysfunction. 

There is controversy about many of the recommended uses in humans, with mixed and generally low-quality clinical trial evidence for most uses. And, as you will no doubt have anticipated by now, there is virtually no reliable research on its use in pets. One small experimental study failed to find evidence of decreased Coenzyme Q10 levels in dogs with congestive heart failure. There appear to be no clinical trials for any specific indication, and the recommendations for this supplement are again based entirely on theory, anecdote, and pre-clinical research or clinical research conducted in humans.

10. Azodyl

Azodyl is a proprietary mixture of probiotic organisms and prebiotics (substances intended to promote the growth of supposedly beneficial gastrointestinal bacteria) that is marketed for the treatment of kidney failure in dogs and cats. The theoretical argument advanced to support its use is “enteric dialysis,” the idea that populating the gastrointestinal tract with bacteria that breakdown some of the nitrogenous wastes the kidneys normally remove from the body can lower the levels of these substances and improve clinical symptoms of renal failure. While this idea is not inherently unreasonable, it does suffer from the weakness of other probiotic therapies in that it requires relatively small additional to the gastrointestinal flora to have significant systemic physiologic effects, which may or may not actually be possible. In any case, it is not a concept that has been validated in practice.

A single pilot clinical trial of the product in humans, sponsored by the manufacturer, has been published. This identified statistically significant changes in one out of three laboratory measures and in a subjective assessment of clinical symptoms. An unblinded, uncontrolled case series in 7 cats reported small changes in laboratory values in 6 of the subjects. And similar small studies in vitro and in rats and miniature pigs, again all supported by the manufacturer, have reported some positive changes in some measures of kidney disease.

Overall, the theory is possible but of uncertain plausibility in the real world, and the clinical evidence is limited and highly vulnerable to bias in terms of methods and funding source.

Bottom Line

So to answer the original question, do these popular supplements work? Well, glucosamine almost certainly does not, and the case for multivitamins and digestive enzymes are extremely weak. Fish oil likely does have small benefit for allergies, and no definitive conclusion can be made concerning arthritis, though the early veterinary trials haven’t been promising. Probiotics are a promising avenue for research, and there is reasonable evidence for some benefit in acute idiopathic diarrhea, but overall they are really not ready for prime time. Lysine, SAM-e, Milk Thistle, and Coenzyme Q10 all have reasonable theoretical foundations based on preclinical research, and none have adequate clinical evidence to draw any firm conclusions.

So should veterinarians and pet owners use these products? The decision whether or not to employ a particular medical intervention is always a matter of balancing the urgency of acting with the risks and benefits of the therapy, and always in the context of the limitations on the available information. In cases where the therapy is very unlikely to provide a benefit, such as glucosamine, there is really no rational argument for its use even if it is harmless, and the resources wasted on such treatments could better be spent on more plausible therapies or research to find better treatments.

In cases where there is a plausible theoretical rationale but inadequate clinical evidence to make a firm conclusion, I am personally reluctant to recommend using such supplements because in the face of such uncertainty we are as likely to do harm as good. For example, Milk Thistle and the combination SAM-e and Milk Thistle products seem to induce loss of appetite in cats and dogs fairly frequently in my experience, and they are usually given to patients who are pretty sick and already taking many other medications. So in the absence of stronger evidence of benefit it seems imprudent to use them routinely. However, in urgent cases where there is no validated therapy and the clinical circumstances are dire, I can’t fault anyone for grasping at straws, and I have certainly done so myself. 

And, of course, if there is a sound theoretical rational and some reasonable clinical evidence, as in the case of fish oils for allergies and probiotics for acute uncomplicated diarrhea, use of such supplements seems perfectly reasonable. We must be careful not to let the perfect become the enemy of the good, and in veterinary medicine where the quantity and quality of the research evidence will always be less than optimal, we are justified in trying out things that are reasonable but unproven if the clinical circumstances warrant it. 

Of course, the marketing used to promote these supplements goes well beyond anything justified by real scientific evidence and is almost universally untrustworthy. Likewise, the testimonials and anecdotes about their effects, whether from patients, pet owners, veterinarians, or Nobel Laureates, are all just stories with almost no probative value. And since most good ideas in medicine ultimately fail to become real, effective clinical therapies, it is likely that many even of the more plausible of these products will turn out not to be useful or to have unknown risks. Without adequate supporting evidence and without effective quality control, regulation, and post-market surveillance, we can never be sure we are helping and not harming our patients by using them. 

However, it is also possible that some of these products will survive the rigors of real scientific investigation, if they are ever subjected to them, and will turn out to be truly useful therapies. And in the meantime, it may be reasonable to use some of them if the existing evidence and clinical need of the particular case are sufficient to justify doing so.

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A new study looks into the disorder known as delusional parasitosis, which many dermatologists believe is the true diagnosis behind the controversial disorder called Morgellon’s disease. Morgellons is a controversial disorder because many patients with symptoms believe they are being infected by an unusual organism, causing excessive itching, but no offending organism has been found. Some patients claim they have strange fibers exuding from the sores in their skin.

The term “Morgellons” was coined in 2002 by Mary Leitao, who was trying to find a diagnosis for her son who was suffering from skin lesions. Since then it has become a grassroots diagnosis – used by some patients to describe themselves but not accepted by the medical community.

Most dermatologists, rather, feel that the disorder is actually a manifestation of delusional parasitosis – a mental disorder. This has set up an unnecessarily confrontational situation. And of course, some charlatans are exploiting the situation by taking the side of the patients and offering them their nostrums as a cure.

These situations are always helped, but rarely resolved, by better information. It is in this context that Hylwa et al performed a retrospective analysis of patients diagnosed with delusional parasitosis at the Mayo dermatology clinic. They analyzed records from 108 patients who had either a skin biopsy (80 patients) or presented their own sample (a patient-provided specimen – also 80 patient), or both (52 patients).

They found that in all 108 cases no evidence of infection or infestation was found.

They did find, however, that 48% of biopsies showed dermatitis – inflammation of the skin. This finding has two plausible interpretations. The first is that in some patients with delusional parasitosis, they may have an underlying skin condition that causes non-specific dermatitis (an allergy, for example) and the symptoms of this dermatitis triggers the psychological reaction that results in the belief that they are infested with something foreign. In this case they could be simply misinterpreted their skin sensations. Further the chronic symptoms can cause stress and lack of sleep and result in the anxiety and depression that often accompanies this disorder.

The other plausible interpretation is that the dermatitis is secondary to scratching and perhaps treating the skin with irritating substances intended to treat the problem. The current study is not capable of distinguishing between these two possibilities.

The authors acknowledge the limitations of this study – mainly that it was retrospective. It also needs to be considered that their search criteria was for patients diagnosed with delusional parasitosis – not all patients with unknown or mysterious skin lesions. In that respect the results are not surprising – the diagnosis may result from a negative biopsy or sample analysis, and so of course patients with that diagnosis will have had a negative biopsy.

The authors do not even address the controversy surrounding Morgellons. Rather they are asking if skin biopsy is useful in patients presenting clinically with delusional parasitosis. Again – given the retrospective nature of this study I don’t think it answers that question.

This study does, however, review a large series of cases demonstrating a lack of biopsy or sample analysis findings in patients who fit within the clinical syndrome that is labeled as either Morgellons or delusional parasitosis. It should further be noted that those who claim that Morgellons is a distinct disease caused by a skin infestation cannot point to any objective evidence of an actual infestation to support that claim.

What proponents do have are mysterious fibers sometimes found in the skin lesions of people with this syndrome. The fibers often cannot be specifically identified, or they are identified as foreign fibers consistent with clothing. They usually do not appear to be of organic origin. At best the fibers represent an anomaly, and are not specific evidence of any underlying cause.

What is especially disturbing about the Morgellons phenomenon is the tone of the discussion, the extent to which the controversy has been politicized. Often irrelevant issues are brought to the forefront, such as patient empowerment or medical authority. Not that these issues are not important – they are just not relevant to the real question of what, exactly, is the underlying cause of what is referred to as Morgellons.

Patients who suffer from this syndrome are best served by bringing objective scientific evidence to bear to discover exactly what the cause(s) and best treatments for their symptoms are. But this issue is often derailed by accusations that the medical community is dismissing them and their claims. By grabbing the reigns of diagnosis and treatment such patients are given a false sense of empowerment, but are likely just cutting short earnest attempts to understand and treat their condition.

And of course, good science has to follow the evidence wherever it leads, even if the answer is not what is hoped. The truth does not care what people need or want – it is what it is.

Conclusion

This latest study will likely not change the debate about Morgellons vs delusional parasitosis. Although it should be kept in mind that delusional parasitosis (DP) is a disorder in its own right, and pre-existed any notion of Morgellons. Morgellons is likely just a recent manifestation of DP – a cultural entity spreading mainly on the internet. It should also be noted that DP likely contains two or more subgroups that have distinct causes – such as the two causes of dermatitis I discussed above.

At present there is no compelling evidence that Morgellons exists as a discrete entity separate from DP. The CDC is currently studying the condition (which they are calling unexplained dermopathy) but has not yet made any report of their findings.

My review of the evidence is that it best supports the conclusion that Morgellons is a mostly a psychocultural condition (it may be triggered in cases by an underlying skin condition). It is a combination of a cultural phenomenon spreading mostly online, giving specific manifestation to an underlying psychological condition. I am willing to be convinced that there is a biological process going on, but so far no compelling evidence to support this hypothesis has been put forward.

I also think that specific harm can be done to individuals with this syndrome by the spread of false information. Sufferers can easily be made to settle prematurely on a false conclusion, and in fact can reinforce their delusions if that is ultimate cause of their symptoms. They can be lured away from practical interventions and the medical community to dubious treatments that are, if nothing else, a waste of their resources.

The situation represents a challenge to the medical community. Perhaps the only solution is to explain and promote the scientific approach to diagnosis and treatment.

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Explanatory studies are done under controlled conditions to determine whether a treatment has any efficacy compared to a placebo. Pragmatic studies are designed to assess how the intervention performs in everyday real world practice. Pragmatic studies measure practical success but don’t determine actual efficacy: that requires a proper randomized controlled trial (RCT) with an appropriate control. Pragmatic studies have their place, but they can sometimes make an ineffective treatment look good: a phenomenon I have christened Cinderella Medicine.

Research studies don’t always predict how a treatment will perform post-marketing. A study might be done on men aged 30 to 70 with no other illnesses. Once the drug is out on the market, it will probably be taken by women, by people who are under 30 or over 70, and by those who have concurrent diseases like diabetes or atherosclerosis or are taking a lot of other medications; and the dose or frequency may vary from the study protocol.

A good example is the clot-busting drug t-PA. In clinical trials, it clearly improved the outcome of stroke patients, but in actual use in community ERs the death rate was almost twice as high in patients who received it as in patients who did not. There are many possible explanations: perhaps it was offered to patients with more severe strokes, perhaps the protocol wasn’t followed as carefully, perhaps some patients were mis-diagnosed, perhaps they had confounding factors that were not present in the research studies.

Pragmatic studies are useful for the questions they are designed to answer: how a treatment performs outside the limited environment of a research study, which of two treatments should be preferred by doctors, patients, and policymakers, deciding how limited resources can be best utilized. They are an integral part of comparative effectiveness research.

But they have limitations. They are unblinded and the patients are generally self-selected. Larger studies are needed to compare two active treatments than to compare an active treatment to a placebo. Lack of compliance and a high drop-out rate can skew results. Patient self-assessments of subjective outcomes are not as reliable as objectively measurable outcomes.

Pragmatic trials can’t determine which components of a “package” of care are essential, and they can’t assess the contributions of the therapeutic relationship. When used for studying a treatment with a strong placebo effect, they may make an ineffective treatment look better than an effective one. CAM proponents like pragmatic studies because they are often the only studies that seem to support them. They are attempting to bypass good science by showing that, in practice, their methods seem to work.

Cinderella didn’t look very pretty in her rags and ashes. Imagine that her Ugly Stepsister had a complete makeover, with hair styling, expertly applied cosmetics, jewels, and a beautiful designer dress. Maybe tooth whitening or even orthodontia, charm school, modeling classes, and elocution lessons. If you entered her in a beauty contest along with the unadorned, dirty Cinderella in her original rags, the Ugly Stepsister might win hands down. But it wouldn’t be a fair beauty contest unless both were in their original unenhanced state or unless you compared the makeover-enhanced stepsister to the Fairy-Godmother-enhanced Cinderella. (Or if, for a really well-controlled study, you managed to persuade the FG to do her magic on both of them.)

Acupuncture’s makeover

Studies comparing acupuncture to standard treatment have shown that acupuncture works better. Standard treatment is like the original Cinderella in her rags: plain and unenhanced in any way. The doctor may only see the patient for one visit and tell him “You have a common garden variety backache; we don’t know why people get these, but they usually resolve spontaneously in a few weeks; while it is going away on its own, I could offer you a prescription for pain pills or a referral to physical therapy.” He doesn’t spend much time with the patient and may seem bored and unsympathetic.

Acupuncture is like the Ugly Stepsister after her complete makeover. The treatment itself (insertion of needles) is like the Ugly Stepsister before her makeover. It doesn’t have any specific effects (it is no more effective than touching the skin with a toothpick). But the acupuncturist surrounds the treatment with all kinds of enhancements that produce “nonspecific effects” that are not due to the treatment itself, but rather to the interaction with the provider.

• The acupuncturist assures the patient that he knows how to relieve the back pain, and he provides a complicated explanation with all kinds of impressive, esoteric oriental terminology.
• He explains that his system is derived from ancient Chinese wisdom and that his needles will adjust the flow of qi through the patient’s meridians to restore health.
• He takes the patient into a quiet back room, has him lie down and relax, and spends half an hour or more doing up-close-and-personal hands-on treatment.
• He is charismatic, shows great interest in the patient, asks a lot of questions, and may uncover another unrelated problem that needs treatment.
• After treatment, he prompts “You feel better now, don’t you?” and the patient feels a social pressure to agree.
• Instead of dismissing the patient with a prescription, he asks him to return over and over, maybe 3 times a week for several weeks; and when the initial course of treatment is finished, he may want the patient to keep seeing him for treatments to maintain health and prevent future problems. He develops a strong, caring doctor-patient relationship.

The plain needle insertion has been given the Cinderella treatment and transformed into an enhanced package of suggestion, expectation, relaxation, ancillary psychological effects, personal interactions, etc. Acupuncture treatment is ready to go to the ball and wow the prince. It is the ideal placebo package; it’s hard to imagine how anything could be devised that would be better at eliciting placebo responses.

So acupuncture, with no specific effects but many nonspecific treatment effects, will appear to outperform a standard treatment that offers some small specific effects but little in the way of nonspecific enhancements.

The common argument is that it doesn’t matter how a treatment succeeds: it should be used because patients report feeling better faster than with standard care, that it is more effective in a practical sense. But fooling patients with nonsense about imaginary meridians, qi, and acupuncture points amounts to lying. Using placebos and offering fantastic explanations undermine the doctor-patient relationship; and this kind of thing leads people to think non-critically, to accept other kinds of pseudoscience, and to reject science-based treatments that might help them objectively or even save their life in the future.

Cinderella treatments: beautified and dressed up with added enhancements. Why not add as many as possible of these Cinderella enhancements to standard, science-based treatments? Without lying or misrepresenting our knowledge? These pragmatic trials don’t show that acupuncture works; they show that the way standard treatments are offered provides fewer nonspecific effects and could stand a bit of a makeover. That should be our goal.

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Dr. Andrew Weil is a rock star in the “complementary and alternative medicine” (CAM) and “integrative medicine” (IM) movement. Indeed, it can be persuasively argued that he is one of its founders, at least a founder of the its most modern iteration, and I am hard-pressed to think of anyone who did more in the early days of the CAM/IM movement, back before it ever managed to achieve a modicum of unearned respectability, to popularize CAM. In fact, no physician that I can think of has over the course of his lifetime done more to promote the rise of quackademic medicine than Dr. Weil. The only forces greater than Dr. Weil in promoting the infiltration of pseudoscience into academic medicine have been the Bravewell Collaborative and the National Center for Complementary and Alternative Medicine (NCCAM). Before there was Dr. Mehmet Oz, Dr. Dean Ornish, Dr. Mark Hyman, or any of the other promoters of IM, there was Dr. Weil.

And why not? Dr. Weil looks like an aging 1960s rock star, and, operating from his redoubt at the University of Arizona, is quite charismatic. For all the world he has the appearance of a kindly, benevolent Arizona desert Santa Claus, an ex-hippie turned respectable dispensing advice about “natural” medicines, writing books, and making himself ubiquitous on television and radio whenever the topic of alternative medicine comes up. Before Dr. Oz told Steve Novella that “Western” science and medicine can’t study woo like acupuncture, Dr. Weil was there, paving the way for such arguments, previously considered ludicrous, to achieve a patina of respectability.

In fact, he’s still at it, doing it far better and far more subtly than the ham-handed Dr. Oz. Unfortunately, it’s the same anti-science message and the same appeal to other ways of knowing built upon tearing down straw men versions of evidence-based medicine (EBM) with gusto. This was brought home last week when Dr. Weil co-authored an opinion piece with Drs. Scott Shannon and Bonnie J. Kaplan for the journal Alternative and Complementary Therapies entitled Safety and Patient Preferences, Not Just Effectiveness, Should Guide Medical Treatment Decisions, an article that was noted at the blog Booster Shots in a credulous, fawning post entitled Dr. Weil says there’s a better approach to evaluating clinical drug trials. In contast, Steve Novella put it far more succinctly (and accurately) in the title of his post: Andrew Weil Attacks EBM. That’s exactly what Weil and company did in this article.

While Steve is absolutely correct, I also see it more as Dr. Weil demonstrating once again that, upstarts like Dr. Oz aside, he is still the master of CAM/IM apologia, much as, even though both were Sith Lords, Emperor Palpatine remained master over Darth Vader until just before the end. You’ll see why in terms of the arguments, both subtle and not-so-subtle, that Dr. Weil and his acolytes make. Moreover, even though his disciple Shannon is granted the coveted first author position, the arguments presented leave little doubt that it’s Weil who’s driving the bus.

Efficacy, effectiveness, and safety, oh, my!

Shannon et al begin by emphasizing that there is a difference between “efficacy” and “effectiveness,” and from the very beginning take pains to separate their definitions of the two, pointing out that they will not use the terms interchangeably. Specifically, they refer to the definition of “efficacy” as “demonstration of benefit under ideal conditions, typically in randomized controlled trials” and “effectiveness” as “demonstration of benefit in real-life conditions.” These are relatively new concepts, comparatively speaking. Even so, they are nothing “alternative,” being instead firmly within the bailiwick of EBM. This doesn’t stop Shannon et al from presenting these concepts as though EBM and science-based medicine (SBM) don’t consider questions of whether treatments work under real-life conditions. As you will see, it is also the opening volley in a rather complex set of fallacious arguments designed to support the watering down of scientific rigor in order to allow CAM/IM modalities that can’t stand up under close scientific investigations to be labeled as “effective” (or at least acceptable).

First of all, let’s see a bit more what Weil and company are up to when they compare “effectiveness” with “efficacy.” Mostly, it’s meant to attack the reliance of EBM randomized clinical trials (RCTs) in order to set the stage for proposing something else more to their liking:

The value of efficacy lies mainly in its ability to indicate potential for effectiveness accurately. Sadly, in the drive to emphasize the importance of delineating clearly sound measures of clinical effectiveness, modern medicine has come to equate RCTs as the final arbitrators of clinical decision making. As discussed below, RCTs are but one tool to sort out these complex questions. In integrative medicine (IM), particularly, with its emphasis on patient variables and practitioner participation, evaluation of efficacy is not sufficient.

I agree that one major value of efficacy in RCTs is that it indicates the potential for effectiveness in the real world. I also even partially agree that EBM overemphasizes RCTs as the final arbiters of clinical decision-making, although, I note, not for the same reason as Weil and his acolytes. We at SBM frequently make the argument that plausibility based on science should be a much more important consideration in evaluating treatments than it is in EBM. Indeed, this is a major reason that the term science-based medicine, as opposed to evidence-based medicine, was coined in the first place. EBM emphasizes RCTs without considerations of prior plausibility, relegating basic science considerations that conclusively demonstrate CAM/IM modalities like homeopathy to be so implausible as to be not worth studying in humans to its lowest rung in its scale of evidence. So, while we agree somewhat that EBM overemphasizes RCTs, we most definitely do not agree with Dr. Weil about how it does so. Whereas Dr. Weil seems to think that RCTs are overemphasized because they are too standardized and do not adequately take into account real-world conditions, he most definitely would not like SBM’s plea to EBM to consider scientific plausibility, because doing so would relegate modalities like energy healing, homeopathy, and acupuncture to the hopelessly implausible.

Dr. Weil also does a very clever thing with his argument. While he correctly points out that evaluation of efficacy is not sufficient to determine whether a treatment is effective, as Steve Novella pointed out, Dr. Weil conveniently neglects to acknowledge that it is at the very least necessary. If RCTs indicate that a therapy is not detectably more efficacious than a placebo, which is the case for the vast majority of CAM/IM modalities, then there is no point in doing trials in “real world” conditions because there is no reason to expect the to be effective. Basically, RCTs serve as a screening test to identify promising therapies that are likely to be effective in real world use. In essence, Dr. Weil is echoing the same two-pronged attack that CAM/IM advocates make against RCTs, the first being the claim that “Western science” can’t study his woo, which is the same fallacious argument that Dr. Oz made regarding acupuncture. The second prong of the attack is to point to what Weil calls “alternative sources of valid information” as demonstrating that his woo works when RCTs do not support its efficacy. Although Dr. Weil is careful never to state this explicitly or even use the term “pragmatic trial,” his emphasis on “effectiveness” over “efficacy” is in essence a plea for relying much more heavily on observational trials, in particular pragmatic trials.

But what are “pragmatic” trials? They are trials that seek to determine if a treatment is effective outside the confines of an RCT, in other words, out there in the “real world.” RCTs, because they seek to determine efficacy, need to control for as many potentially confounding factors as possible, which makes them inherently artificial to one extent or another. Once efficacy is established under controlled conditions, it is sometimes then useful to determine whether this efficacious treatment is effective under usual circumstances in the “real world,” where patient compliance might be poor, either due to side effects, cost, or difficulty in adhering to the therapy; where complicated protocols might be more problematic to follow compared to academic medical centers; and where use of the treatment will inevitably be expanded to patient populations not represented in the RCTs used to approve the drug.

Pragmatic trials can go one of two ways. In the case of treatments demonstrated efficacious in RCTs, most commonly pragmatic trials demonstrate a lower level of effectiveness than the efficacy measured in RCTs might indicate. As Harriet Hall discussed a couple of years ago, a classic example of a treatment that was shown to be efficacious in RCTs but potentially more dangerous in pragmatic studies of actual use in community hospitals was the clot-busting drug t-PA, which was effective for ischemic strokes in RCTs but resulted in a higher death rate. For efficacious interventions, the “real world” is almost always less hospitable than the “ideal world” of RCTs. There is one case, however, where the “real world” can make a treatment seem more effective than it is by any objective measure, and that’s for treatments that are essentially placebos. Outside of the rigorous, carefully controlled world of RCTs, placebo medicine can seem to have effectiveness, which is exactly why proponents of pseudoscientific medicine love pragmatic trials. The populations aren’t as well-defined; often there is no placebo control; and they are almost always unblinded. There is a good reason why, after well-designed RCTs have demonstrated acupuncture to be no more efficacious than placebo or sham acupuncture, acupuncturists have returned to pragmatic studies, as, I will note in a shameless plug, Harriet Hall will discuss tomorrow. The hospitableness of pragmatic trials to placebo medicine is also behind much of the attack on RCTs by advocates of pseudoscience, and Shannon et al certainly engage in such attacks with gusto:

RCTs have dominated decision making about efficacy in health care for almost 50 years. Many researchers have explored the difficulty of subjecting IM treatment approaches to RCTs. There are some characteristics of IM interventions that make RCTs particularly difficult to carry out, and perhaps even less relevant, than for conventional allopathic medicine. As Fønnebø pointed out, the gap between published studies of integrative approaches on the one hand, and the clinical reports by practitioners on the other hand, may partially result from the fact that placebo-controlled RCTs are designed to evaluate pharmaceutical interventions.

Or, more likely, they result from the biases and lack of adequate controls for placebo effects inherent in “clinical reports” by practitioners. Also note the Oz-like argument that RCTs can’t evaluate Weil’s favored woo.

Granted, uncontrolled clinical reports from practitioners can, if carefully documented, represent one form of pragmatic trials; more often they are at best preliminary data and at worst nothing more than anecdotes. To support their attack, Shannon et al cite a prominent New England Journal of Medicine study, namely Concato et al, which found that well-designed observational studies often produce the same results as RCTs, meaning that placing observational studies lower on the rung of the EBM hierarchy might not be justified. Unfortunately, the authors failed to note that Concato et al only looked at studies of clinical questions with objective outcomes, including the Bacille Calmette-Guérin vaccine and tuberculosis, mammography and mortality from breast cancer, cholesterol levels and death due to trauma, treatment of hypertension and stroke, and treatment of hypertension and coronary heart disease. Moreover, Concato et al have been criticized for cherry picking their examples. In contrast, most CAM modalities are designed to treat symptoms with a major subjective component. Also going against Weil’s argument that, because RCTs are designed for pharmaceutical treatments, they might not be so good evaluating non-pharmaceutical treatments is a more recent study comparing effects in RCTs versus observational studies in digestive surgery, which found that a quarter of observational studies gave different results than randomized trials and that between-study heterogeneity was more common in observational studies. If this study holds up, it would appear that RCTs work just fine (and better than observational studies) for surgical interventions.

The merits and flaws of Concato et al aside, it is a false dichotomy that we must choose either controlled RCTs or or less rigorously controlled observational studies. EBM and SBM encompass them all; they simply disagree on how much relative weight to give each type of evidence. Fortunately, Weil doesn’t make the argument that we must favor one or the other. Unfortunately, he’s more subtle than that. What he does instead is to argue for decreased influence of RCTs by arguing that they should be only one part of the picture, an argument he makes by bringing up the Bradford-Hill criteria.

Trying to shrink the importance of the RCT

The heart of the argument in this paper is that RCTs should be only one (presumably of many) factors that determine whether medicine considers and intervention to be effective or not. As the title suggests, safety and patient preferences play a prominent role in Weil’s argument, but first Weil yokes poor Sir Austin Bradford-Hill, FRS, a pioneering early to mid-20th century epidemiologist best known for his work linking smoking to lung cancer and pioneering the RCT, into his service. Bradford-Hill proposed a set of criteria for drawing causality about disease etiology, but his nine criteria are sometimes used in considering the effectiveness of treatments.

Shannon et al set the stage:

As he [Bradford-Hill] pointed out, not all criteria are appropriate for all issues being analyzed, but he listed nine in total from which appropriate ones should be selected for any given situation:

1. Strength—referring to the robustness of the association between the causative agent and the outcome
2. Consistency—meaning being able to obtain similar results across different research sites and methodologies (i.e., replication)
3. Specificity—by which Bradford-Hill meant one disease having one specific outcome, which may not be relevant to complex disorders (e.g., psychiatric problems)
4. Temporality—referring to the commonsense notion that the cause always precedes the outcome
5. Biologic gradient—which is best described as a dose– response curve: increased treatment would presumably result in a proportionate increase in the effect (again, not relevant in all disorders)
6. Plausibility—referring to whether the results are biologically sound
7. Coherence—which refers to the agreement of a study’s findings with what is already known (hence, not relevant in situations of truly novel interventions)
8. Experiment—the situation in which randomly introducing the causative agent results in the outcome
9. Analogy—which is the idea that a similar cause results in a similar outcome.

It is particularly interesting to note that the Bradford-Hill criteria, specified by the individual who influenced the methodology we now accept for RCTs massively, lists experiment with randomization methods as only one of nine criteria for establishing causality.

See, you nasty, reductionist scientists? RCTs are only one criteria! They’re not the be-all and end-all of clinical evidence! I can’t help but point out that there is an implicit straw man here in that embedded in many of the Bradford-Hill criteria are the same sorts of arguments we make at SBM, particularly criteria numbers 1, 2, 5, 6, and 7. In particular, we at SBM like criteria numbers 6 and 7. Key to the very concept of SBM is that interventions should have biological plausibility. They should also be congruent with what is known about the disease or, if not congruent, the evidence supporting an intervention must be sufficiently compelling that it justifies overthrowing the existing paradigm (for example, in the case of the discovery that H. pylori causes peptic ulcers). I also can’t help but point out that most CAM/IM treatments still fail most of Bradford-Hill’s criteria. In particular, CAM/IM treatments almost always run afoul of all of Bradford-Hill’s criteria other than #4, and, quite frankly, sometimes the wackier ones even seems as though they could run afoul of #4 as well.

Perhaps realizing this, Weil says nothing more about Bernard-Hill criteria other than to mention them again briefly in his conclusion. Instead, he and his merry trio of woo-apologists move on, Gish gallop-like, to other deficiencies in the “Western, reductionistic” model.

Use and abuse of systems biology and “holistic” methods

Unable to abuse poor Bradford-Hill anymore, Weil moves on to list “unique” features of CAM/IM research that—surprise!—turn out to be not-so-unique and not nearly as difficult to take into account in SBM (or even in EBM) as he implies:

For instance, the healing relationship of a doctor and patient is generally excluded or “controlled for” in conventional RCTs, whereas some researchers would argue that unconditional positive regard forms the underpinnings of the healing relationship between two people.

The enhanced focus on the healing relationship is thus another factor delineating IM from conventional health care models. A second example is the concept of individualized care, which is rarely included in RCTs (perhaps the MTA study in childhood ADHD is a notable exception). The notion that each patient is unique and quite different permeates IM.

I like the admission that most CAM/IM is placebo medicine, though. Oh, you didn’t see that? The emphasis on the “healing relationship” between practitioner and patient tells you that what Weil is talking about is placebo medicine. After all, that relationship is very important to placebo effects.

Be that as it may, I’ve discussed the so-called “individualization” of CAM treatments before, as well as the difference between the “personalized medicine” when practitioners of SBM use the term versus when CAM/IM advocates use the term. For the full discussion click on the links; the CliffsNotes version follows. Basically, the notion that each patient is unique is a notion that is recognized in EBM and SBM. It’s also utterly facile and obvious, given that no two people are alike. What EBM and SBM try to do is to classify and stratify patients based on science-based characteristics that can be objectively related to disease severity, etiology, and response to therapy. As genomic medicine, systems biology, proteomics, and metabolomics become more sophisticated, it has become possible to make finer and finer distinctions between patients based on biology. The hope is that ultimately knowing these fine distinctions will allow us to “personalize” therapies to individual patients, thus ushering in an era of truly personalized medicine.

In contrast, in CAM/IM the idea of “individualization” and “personalized” medicine most frequently boils down to making it up as the practitioner goes along and doing whatever the practitioner feels like, all without a basis in sound science and evidence. In fact, Weil appeals to just such “personalization” or “individualization” based on magic and fairy dust as being a problem with applying RCTs to CAM/IM:

However, classic RCT research design requires patients to be broken out into groups with a similar diagnosis, which impairs the ability to evaluate an individualized treatment system, such as classical homeopathy, Traditional Chinese Medicine, or Ayurveda. In each of these systems, the patient must be individualized into a quite unique pattern that does not lend itself to a more broad disease generalization such as that found in conventional allopathic medicine. Curiously, the cutting edge of modern medicine anticipates that customized and individualized care looms as a result of advances in single nucleotide polymorphisms (SNPs) and the ability to create a specific genetic fingerprint for each individual.

Imagine that! Using groups that are based on diagnosis and actual disease biology, rather than based on prescientific vitalistic thinking! The nerve of those reductionistic “Western” physicians!

Here’s a hint: Genome variations, as demonstrated by SNPs, are not an example of the sorts of classifications one finds in homeopathy, traditional Chinese medicine, or Ayurveda, although I am impressed at the attempt to liken CAM classifications to “cutting edge” genomic variations and science-based classification systems. Sadly, though, leaving aside the utter ridiculousness of the analogy, Weil appears to be behind the times when it comes to personalized medicine and genomics. Ask any systems biologist or geneticist. SNPs aren’t even really “cutting edge” anymore. Maybe they were ten years ago (possibly even five years ago), but other methods and markers are rapidly supplanting SNPs, in particular direct sequencing of relevant parts of the genome, a technique made practical by next generation sequencing technologies and the concomitant exponential plummeting of the cost of such analyses. Also, as Harriet Hall has pointed out, the claim to “personalization” is a sham; many CAM/IM therapies ultimately appeal to one of many examples of the “One True Cause of Disease” fallacy.

Speaking of shams, so is Dr. Weil’s claim of being “holistic”:

A third methodological issue that distinguishes IM from the environment of pharmaceutical RCTs involves systems thinking. With its roots in holistic, natural, and aboriginal medicine, IM has always embraced a more systems-based orientation to patient care than conventional care. It should come as no surprise that a narrow modality for evaluating treatment effectiveness would become increasingly limiting to IM research. The movement toward increasingly narrow scientific evaluations may create an artificial and arbitrary view of human health, medicine, and treatment effectiveness. Fritjof Capra, PhD, the well-known physicist, indicated that the great surprise of twentieth century science was that complex systems cannot be understood by analysis. Ecology and epigenetics are examples of the strong movement toward systems thinking in modern biology.

This is, of course, utter nonsense. “Holistic,” “natural,” and aboriginal medicine relied upon a prescientific, not a “holistic,” understanding of biology and patient care. Appealing to “systems” thinking based on prescientific or outright religious systems, such as homeopathic provings, traditional Chinese medicine, Ayurveda, and “energy healing,” is meaningless when the systems being invoked are without a grounding in science—or even reality. The rise of systems theory in biology and elsewhere has nothing to do with the sort of false “holistic” thinking invoked by Weil and his ilk. Rather, it has to do with the increasing ability to analyze more than one aspect of a complex system at once. For example, in my field (cancer), thirty years ago it was only possible to analyze one gene or perhaps handful of genes at a time. Then, beginning in the late 1990s, the development of cDNA microarray chips made it possible to analyze hundreds, then thousands of genes simultaneously—then every gene in the genome. As technology and computing power increased and scientists and mathematicians developed techniques to analyze ever larger datasets, it became possible to take the data from these sorts of experiments and begin to understand the complex networks inherent in the expression of the thousands of genes that are produced in human cells. Today, it is becoming increasingly possible to integrate massive quantities of data from various sources, including genomics, proteomics, and metabolomics and begin to understand the vastly complex networks that they form, how they resist perturbation, and how they can be restored when they are perturbed.

That is real holism. Not homeopathy. Not traditional Chinese medicine. Not Ayurveda. What Weil represents as “holism” is in reality a series of pretenders to “holistic” understanding that substitute non-evidence-based prescientific belief systems for science, gussying them up in “science-y”-sounding language that co-opts new science the way CAM/IM co-opts science-based modalities like diet and exercise as being somehow “alternative.”

The rest of the rest

Those who have actually read Dr. Weil’s article will note that I have not yet mentioned one point that Weil hammered on relentlessly, apparently thinking himself Maxwell bringing his silver hammer down upon the heads of those who think scientifically, the better to knock the propensity towards SBM (or even EBM) out of them. That issue is safety. Weil goes on and on about patient safety, even going so far as to propose a ranking system for patient safety. This part of his article is, quite frankly, an insult to physicians’ intelligence. Physicians practicing EBM already weigh efficacy/effectiveness versus safety; all Weil is doing is to rename and rebrand something that EBM does already. To a small extent he has a point that EBM does not yet have a as rigorous “hierarchy” of risk or harm to evaluate treatments as it does levels of evidence for efficacy, but even if we did have such a rigorous hierarchy, risk-benefit estimates still require weighing benefit versus risk. If the expected benefit is zero, or near zero, then even a tiny risk can quickly become unacceptable. To take one example, in the case of acupuncture, where the benefit is not distinguishable from that of placebo, then even a tiny risk of, say, a pneumothorax from a needle stuck too deep becomes very problematic. In other words, Weil’s classification system is unlikely to make CAM seem as attractive as he seems to think it will, although no doubt his intent is to make that evil “reductionistic” allopathic medicine seem more dangerous by comparison.

In addition, Weil makes a big show of complaining about commercial influence, in essence using a weaker form of the “pharma shill” gambit to dismiss pharma-funded RCTs whose conclusions he does not like. This serves, more than anything else, as a ploy to imply guilt by association, given that virtually all pharmaceuticals are manufactured for profit. As we have written about here on numerous occasions, commercial influence is a problem that is recognized in EBM (and SBM). It is increasingly appreciated as an issue, and practitioners of EBM do consider funding sources when considering clinical trial results. Indeed, one can’t help but wonder why Dr. Weil’s concern about pharma influence is so conveniently limited. Does he complain about the influence of supplement manufacturers (which, by the way, are increasingly owned by various pharmaceutical companies and wield a great deal of clout in Congress)? If he does, I haven’t seen evidence of it. Steve was right; this part is just window-dressing, as is Weil’s proposal for a different five-level hierarchy of evidence that not-so-subtly tilts the playing field so that some observational studies and other studies that can’t be considered RCTs could be considered Level One evidence.

What’s truly ironic is that Weil would never admit that there are few, if any, CAM modalities that can meet the criteria of level one evidence even under his own proposed system! In fact, most of the very best-supported CAM modalities would fall either into level four (“Weak indicators of uncertain value: poorly designed studies without strong support from the Hill criteria; small observational studies”) to level five (“Very weak indicators of efficacy or effectiveness: expert opinion of effectiveness; case series; multiple anecdotal reports”). That’s why it’s tempting simply to grant Weil his new system and then challenge him to show more than a pitiful handful of CAM modalities that have evidence to support them stronger than level four.

Finally, two of the more pernicious proposals in Weil’s paper are related. First, he repeats his explicit argument for favoring placebo medicine:

Given the history and philosophical preferences of allopathic medicine, it should come as no surprise that the factors defining the healing response become minimized or ignored in current practice. This failing must be remedied, as these factors account for a huge component of how humans heal and recover. The healing relationship has taken a much larger role in IM as practitioners in nearly all CAM modalities place a much higher emphasis on it. The importance of these issues can be demonstrated most clearly in psychiatry research, where the placebo response plays a huge role accounting for as much as 40%–90%+ of the total response.²⁶

Significant placebo and expectancy responses inhabit other areas of medical practice, such as dealing with pain and even life expectancy in patients with terminal cancer. Clearly, patient factors must compose a significant part of all treatment selection processes. Ideally, every treatment should be matched to the individual’s belief system to reach the highest level of response possible.

Aside from stating, “CAM is placebo medicine, and we should use placebo medicine when it fits in with patient beliefs,” a more explicit admission that what is being proposed in this opinion piece is placebo medicine I cannot imagine. Worse, it’s based on misinformation, the most egregious of which is Weil’s claim that placebo and expectancy effects can increase life expectancy in patients with terminal cancer. Would that it were true, but unfortunately it’s not, either in late stage cancer or early stage cancer. Nor is there any evidence that it has an effect on recurrence. This is where Weil’s second, related thrust occurs. Using this assumption that placebo medicine “works” better if its tenets match the patient’s belief system, he proposes turning the entire concept of informed consent on its head with respect to medical decision-making (MDM):

The ideal process in MDM would remodel the process of informed consent. The actively engaged patient would be offered a quick overview of appropriate treatments (both CAM and conventional) with an unbiased reflection of both safety and effectiveness. The patient would then declare a preference for one over the other(s). Once a practitioner ascertains the basic worldview of a patient (natural versus conventional; safety versus effectiveness) many simple elements of MDM would flow quickly in the future.

This is a process that to which I’ve referred in the context of two other discussions, vaccines and supplements. In essence, what Dr. Weil is proposing is an ideology-based version of misinformed consent. Although Dr. Weil would not doubt strenuously object to my comparison, when you boil it all down, what he is doing, although more subtle, is not materially different than what anti-vaccine groups do when they grossly exaggerate the risks of vaccination and downplay its benefits or what “health freedom” groups do when they exaggerate the benefits (and the scientific evidence for such benefits) of supplements. What these groups each do is to give patients a skewed view of the risks and benefits of an intervention, intentionally making it more likely that patients will choose the “alternative” option. Weil is doing the same thing by trying to confuse the issue of efficacy/effectiveness by throwing in the issue of “patient belief” and placebo medicine. As is the case with anti-vaccine activists and supplement hawkers, the purpose is, having failed to win on “conventional science,” to find a way to tilt the playing field back towards the “alternative” using other means.

Conclusion

The proposals in Shannon et al are nothing original, although I must grudgingly tip my hat to Weil and his acolytes for having repackaged old ideas in a very attractive, slick new package. In essence, they boil down to a massive appeal to other ways of knowing, hence the attack on RCTs in which they point out deficiencies that those of us advocating SBM and EBM have recognized for decades; the emphasis on effectiveness over efficacy that ignores the fact that it’s necessary to have good evidence of efficacy before even considering effectiveness in the “real world”; the tarting up of safety considerations as though EBM doesn’t take safety into account; and a direct appeal to placebo medicine via the methodology of misinformed consent. All of these strategies are clearly designed to try to give CAM/IM a leg up on science that it can’t achieve through science alone. Unfortunately, although such strategies are transparent to SBM bloggers (and, I daresay, many of our readers), to others they are not so obvious, even to proponents of EBM. I also can’t help but think: If Dr. Weil detests EBM so much, he’s really not going to like SBM at all. Not one bit.

Perhaps the most ironic part of all of this is that many of us at SBM actually agree with the contention that EBM relies on RCTs too much. Many of us would even agree with several of the Bradford-Hill criteria as considerations that are worthy of more emphasis in EBM. Where we differ is in how to do this. Most importantly, we emphasize much more strongly scientific/biological plausibility. Prior probability appears to be anathema to Weil, given that he mentions it as part of the Bradford-Hill criteria and then completely ignores it thereafter. No doubt, he knows how scientifically implausible many CAM/IM modalities are. Instead, Dr. Weil Gish gallops off to emphasize, as he does in the title of his article, patient preferences and safety, in essence using these issues to bolster an explicit plea for placebo medicine. Rather than accepting that rigorous scientific examination of his favorite CAM/IM modalities fails to find any benefit over placebo, Dr. Weil cleverly embraces placebo medicine and argues for lower scientific standards to permit pseudoscientific and unscientific medicine to appear to be co-equal with EBM.

Unfortunately, such are the arguments that have been the wedge used to insert quackademic medicine into medical academia. Even more unfortunately, they are working.

REFERENCE:

Shannon, S., Weil, A., & Kaplan, B. (2011). Medical Decision Making in Integrative Medicine: Safety, Efficacy, and Patient Preference Alternative and Complementary Therapies, 17 (2), 84-91 DOI: 10.1089/act.2011.17210

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The following post appeared earlier this week at my Chemical & Engineering News CENtral Science blog, Terra Sigillata. For some odd reason – perhaps this week’s frantic academic schedule of commencement activities – it was not highly read there. I thought that our Science-Based Medicine readers would appreciate it because this new prescription drug is derived from a family of fungi that have been used in traditional Chinese medicine. A few editorial changes have been made later in the post to increase the relevance to our readership here.

A very well-written review of an orally-active drug for multiple sclerosis has just appeared in the April 25th issue of the Journal of Natural Products, a joint publication of the American Chemical Society and the American Society of Pharmacognosy.

The review, Fingolimod (FTY720): A Recently Approved Multiple Sclerosis Drug Based on a Fungal Secondary Metabolite, is co-authored by Cherilyn R. Strader, Cedric J. Pearce, and Nicholas H. Oberlies. In the interest of full disclosure, the latter two gentlemen are research collaborators of mine from Mycosynthetix, Inc. (Hillsborough, NC) and the University of North Carolina at Greensboro. My esteemed colleague and senior author, Dr. Oberlies, modestly deflected my request to blog about the publication of this review.

So, I am instead writing this post to promote the excellent work of his student and first author, Cherilyn Strader. As of [Wednesday] morning, this review article is first on the list of most-read articles in the Journal. This status is noteworthy because the review has moved ahead of even the famed David Newman and Gordon Cragg review of natural product-sourced drugs of the last 25 years, the JNP equivalent of Pink Floyd’s The Dark Side of the Moon (the album known for its record 14-year stay on the Billboard music charts.).

Reproduced from Strader et al., J. Nat. Prod. 2011, 74, 900–907.

The story of fingolimod is a fascinating journey from early 1970s work on fungal-derived immunosuppressants in Japan to synthetic organic synthesis by Tetsuro Fujita at Kyoto University in 1992 that has led to a non-injectable option for patients with multiple sclerosis. Some of these fungi are ones that infect insects and their fruiting bodies have been used in traditional Chinese medicine as elixirs.

From the review:

Isaria sinclairii is native to Asia, mainly China, Korea, and Japan, and is classified as an entomopathogenic fungus. It is the imperfect stage of Cordyceps sinclairii (Clavicipitaceae) and is closely related to Cordyceps sinensis Sacc., whose Chinese name, Dong Chong Xia Cao, means “winter worm, summer grass”; this species was reclassified recently to Ophiocordyceps sinensis. Fungal spores infect the larvae of suitable insect hosts, including members of the order Hymenoptera and Lepidoptera; the fungus is parasitic, growing within the host and resulting in death of the insect. The fungus completely colonizes the insect cadaver, and in the spring and summer white fruiting bodies appear as stalks up to 6 cm in height. Fungi at this stage of development are regarded as mysterious and mystical in some Asian cultures and have been used for thousands of years in traditional Chinese medicine, as they are believed to impart eternal youth.

From a biology standpoint, Ms. Strader very nicely describes the in vitro and in vivo assays used to identify the natural product progenitor from Isaria sinclairii, myriocin (ISP-1), as an immunosuppressant agent. A clever mixed lymphocyte assay was used by Fujita and colleagues to detect inhibition of T-cell proliferation when splenocytes from two strains of mice were co-cultured in the presence of alloantigen. To confirm activity in vivo, the investigators then used rat skin transplant model where tissue would normally be rejected when transplanted from one rat strain to another. Active compounds were scored based on their ability to prolong the viability of the transplant. This work from the Journal of Antibiotics is available here as free full text.

In both the in vitro and in vivo assays, ISP-1 exhibited activity superior to that of the immunosuppressant, cyclosporin A. But as with many natural products, the compound has some toxicity and solubility issues. Several groups went on to synthesize over 50 analogs of the ISP compounds and Ms. Strader details the reaction schemes and strategies, again pointing out that the two biological assays were crucial to evaluating the structure-activity relationships.

Strader discusses how the molecular mechanism of action of the lead, fingolimod, was then picked up by the group at Novartis, the company that licensed the compound. In this currently-free paywalled article in the “Case Histories” section of Nature Reviews Drug Discovery, Brinkmann et al. detail how fingolimod is actually a prodrug, requiring phosphorylation by sphingosine 2-kinase (SPHK2) to inhibit a series of G-protein-coupled receptors in the sphingosine 1-phosphate (S1P) family. These receptors that bind sphingosine lipids mediate actions of T-cells and endothelial cells that lead to the neuroinflammation of multiple sclerosis.

Most relevant from a drug discovery standpoint is that this mechanism of action is distinct from other immunosuppressants such as FK506 and cyclosporin A which act upstream in this pathway to inhibit serine palmitoyltransferase. This observation is a central theme in natural products pharmacology: naturally-occurring compounds often revealed novel mechanisms of therapeutic action. A far more detailed description of these investigations can be found in this cited review.

Strader then continues in her JNP review to discuss the clinical pharmacology and pharmacokinetics of fingolimod and the other potential uses of the compound, specifically in organ transplantation and cancer therapy. Her review is a lovely example of a comprehensive story that spans from traditional Chinese medicine – where fungi have been used for centuries – to modern drug development.

Why do I single out this review?
As a biologist and pharmacology instructor, I appreciated learning about the chemistry of the drug and the painstaking dissection of its mechanism of action, all directed by a clever battery of bioassays to probe some excellent synthetic work.

Moreover, Strader’s review demonstrates that fungal natural products, while part of our history, remain today a robust source of leads for drug discovery. When studied using solid, science-based techniques, even something as bizarre as an insect fungus can give rise to useful therapeutic agents. In particular, this work demonstrates that drug companies are indeed interested in natural products and can generate new intellectual property and patents: the chemical modifications to ISP-1 created the new composition of matter claim for fingolimod.

Finally, I believe that this published review originated as a graduate class assignment by Cherilyn’s instructor. Ms. Strader seized upon the encouragement of her professor to further develop this story, expanding and refining it to the quality and breadth required to be considered for publication. Cherilyn could have just stopped and gotten an A for the original assignment. Instead, she took on this additional effort under the guidance of my colleagues. She is deserving of congratulations on achieving this milestone. It certainly doesn’t hurt one’s career development prospects to have a review paper among the most highly-read articles in an official journal of the ACS and American Society of Pharmacognosy.

Regular readers know that I am driven to use this blog as a mechanism to recognize the efforts of the next generation of chemists and pharmacologists – students, postdocs, and early-career scientists. As such, please feel free to recommend to me other cases of such publications and interesting backstories that are deserving of this less traditional mode of dissemination.

While this review is currently behind the ACS paywall, many of you should be able to access it via institutional or personal subscriptions.

Reference: Strader, C., Pearce, C., & Oberlies, N. (2011). Fingolimod (FTY720): A Recently Approved Multiple Sclerosis Drug Based on a Fungal Secondary Metabolite Journal of Natural Products, 74 (4), 900-907 DOI: 10.1021/np2000528

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Late last week, the anti-vaccine underground was all atwitter. The reason was the announcement of an impending press conference, scheduled for yesterday at noon in Washington, DC that proclaimed:

Investigators and Families of Vaccine-Injured Children to Unveil Report Detailing Clear Vaccine-Autism Link Based on Government’s Own Data

Report Demands Immediate Congressional Action

Directors of the Elizabeth Birt Center for Autism Law and Advocacy (EBCALA), parents and vaccine-injured children will hold a press conference on the steps of the U.S. Court of Federal Claims (717 Madison Place, NW in Washington, DC) on Tuesday, May 10 at 12:00 PM to unveil an investigation linking vaccine injury to autism. For over 20 years, the federal government has publicly denied a vaccine-autism link, while at the same time its Vaccine Injury Compensation Program (VICP) has been awarding damages for vaccine injury to children with brain damage, seizures and autism. This investigation, based on public, verifiable government data, breaks new ground in the controversial vaccine-autism debate.

The investigation found that a substantial number of children compensated for vaccine injury also have autism. The government has asserted that it “does not track” autism among the vaccine-injured. Based on this preliminary investigation, the evidence suggests that autism is at least three times more prevalent among vaccine-injured children than among children in the general population.

I could hardly wait.

After all, the anti-vaccine flacks at Age of Autism started flogging this press conference announcing this report relentlessly immediately upon its announcement. So did other anti-vaccine groups, including SafeMinds, the Autism Action Network, and others. I knew this because I’m on the mailing list for a number of anti-vaccine groups. I do it for you, to keep my finger on the pulse of the anti-vaccine movement and as an early warning system to let me know when they’re up to various forms of chicanery. Being thus plugged in to anti-vaccine blogs and various mailing lists, I can report that the entire anti-vaccine crankosphere was abuzz with excitement and anticipation over the release of this report, so much so that I was starting to wonder if there would be anything there that might be be worth paying attention to. Even FOX News took the bait:

As is usually the case when the anti-vaccine movement announces the impending announcement of some “blockbuster” study or report that will demonstrate—or so they say—beyond a shadow of a doubt that, even against the mountains of epidemiological evidence indicating no correlation between vaccines and autism, there really, truly is a good scientific reason to suspect that all that evidence is wrong and that vaccines are the cause of an “autism epidemic,” when the press conference rolled around yesterday and the report was published, I was disappointed. I thought it would be a challenge. It wasn’t. Still, I view it as my duty to explain why this report is a whole lot of nothing that in fact is entirely consistent with the current scientific consensus that vaccines don’t cause autism, not so much because I have any hope of changing any minds among those who released the report, but for the good of the fence sitters who might come across this report and find it convincing.

Not surprisingly, the report was written by anti-vaccine stalwarts, namely Mary Holland, Louis Conte, anti-vaccine lawyer Robert Krakow, and Lisa Colin and is entitled Unanswered Questions from the Vaccine Injury Compensation Program: A Review of Compensated Cases of Vaccine-Induced Brain Injury. Apparently the buildup was too great. Now that I’ve actually read this report I can’t believe it. It’s just that bad.

If there’s one thing that cranks routinely do when they can’t win their case on science is to shift to other venues to convince people that they are not, in fact, cranks. After all, if they stuck to arguing facts, science, and evidence, they wouldn’t be cranks. They also wouldn’t have a prayer of obtaining influence because the science is so much against them. So, failing at science yet again, what the anti-vaccine movement has done yet again is to move over to law. In essence, they are implying that legal decisions can mean that there is a scientific case to be made in favor of the hypothesis that vaccines cause autism. This is an utterly fallacious argument at its core, because findings of law all too often have very little to do with findings of science. Examples abound, but my favorite one is the scare over silicone breast implants during the 1980s and 1990s. The science supporting the claims that silicone from these implants was causing systemic diseases, such as cancer, autoimmune diseases, and a panoply of other conditions, was never good. In fact, it was weak to nonexistent. None of that stopped an avalanche of lawsuits from bankrupting Dow-Corning in 1995 Later, as more studies were carried out, it was found that there was no correlation between silicone implants and the conditions attributed to them. Even so, it wasn’t until 2006 that the FDA approved these implants again for cosmetic use.

Basicaly, law is not science, and, as much as lawyers would like you to think that the law can deal with science easily, the two cultures, law and science, are very, very different. In law, for example, the object is to win your case, not to find out how nature works and develop models (i.e., theories) that accurately describe it and predict its behavior. In law, there are no truly objective right or wrong answers about issues of science. There is only the law and how it has been interpreted by courts. Advocacy for one’s position, using every tool at one’s disposal and denigrating or ignoring evidence that conflicts with that position, is not just acceptable, but mandatory. And that’s what Holland et al do, with little exception. In fact, they go so far as to use the common legal tactic of making like Humpty Dumpty in this passage from Lewis Carroll’s Through the Looking Glass:

‘When I use a word,’ Humpty Dumpty said, in rather a scornful tone, ‘it means just what I choose it to mean — neither more nor less.’

‘The question is,’ said Alice, ‘whether you can make words mean so many different things.’

‘The question is,’ said Humpty Dumpty, ‘which is to be master — that’s all.’

Alice was too much puzzled to say anything; so after a minute Humpty Dumpty began again. ‘They’ve a temper, some of them — particularly verbs: they’re the proudest — adjectives you can do anything with, but not verbs — however, I can manage the whole lot of them! Impenetrability! That’s what I say!’

And that’s what Holland et al also appear to say, as well. Impenetrability based on legal jargon is their shield and their sword. They also fall back on the famous “just asking questions” ploy, so beloved of cranks, which is colloquially known among critical thinkers as JAQing off, which they do blatantly here:

This assessment of compensated cases showing an association between vaccines and autism is not, and does not purport to be, science. In no way does it explain scientific causation or even necessarily undermine the reasoning of the decisions in the Omnibus Autism Proceeding based on the scientific theories and medical evidence before the VICP. Nor does this article have anything to say about state childhood immunization mandates in general.

What this article does point to are unanswered questions about vaccines and autism, a thorny issue that affects approximately one in one hundred and ten children.10 On this point, this study strongly suggests the need for further Congressional and scientific investigation to explore the association between vaccine-­induced brain injury and autism and the integrity of this federally-­administered compensation program.

If you admit that what you are peddling is not science (and it most definitely is not), and you can’t show convincing evidence of an association between vaccines and autism (which can only be shown by science anyway), then why even bother? The answer is easy if you understand the authors’ purpose. It is not to demonstrate whether there is a true correlation between vaccination and autism or whether vaccines do cause or increase the risk of autism. Rather, it is advocacy. It is persuasion. It is a tool to use to try to get legislators to change the law, science be damned.

It is propaganda.

The core of the argument in Holland et al appears to boil down to three claims. First, they claim to have found 83 cases of autism associated with vaccine-induced brain injury, which, they claim, makes autism three times more prevalent in children compensated by the Vaccine Injury Compensation Program (VICP). Second, because they base this estimate primarily on children for whom there are reports of “autistic-like” symptoms or who ultimately developed autism, they argue that there is no difference between autism and having been noted to exhibit “autism-like” behaviors or symptoms. Finally, they claim that this means that autism is three times more prevalent in VICP-compensated children than in the general population. Let’s look at these one at a time.

Looking at the second claim first, only a non-physician could make such a risibly silly argument as this and not be expected to be subjected to ridicule:

Because autistic disorder is defined only by an aggregation of symptoms, there is no meaningful distinction between the terms “autism” and “autism-­like symptoms.” This article makes the distinction only to accurately reflect the terms that the Court of Federal Claims, caregivers, and others use. It is not a distinction to which the authors attach significance.

It is not as uncommon as we would like in medicine for conditions and diseases to be defined primarily (or even only) by aggregations of symptoms. Irritable bowel syndrome is an example. Ditto tension headache. Moreover, it is often the context within which those symptoms arise that distinguish one diagnosis from another. In any case, the DSM-IV provides fairly clear diagnostic criteria for autism. If the child doesn’t have enough of these criteria to be diagnosed as autistic, that child could have “autism symptoms” but not autism. In other words, if a child shows a number of odd behaviours but not the classic triad of impairments, then they might have ASD or Asperger’s Syndrome or HFA, but they don’t have autism because the diagnosis of autism depends upon a specific set of diagnostic criteria, and the child doesn’t meet those criteria. If he did, he’d have a diagnosis of autism. It’s just that simple, but Holland et al try to obfuscate by trying to make terms like “autism-like symptoms and similar terms mean what they want them to mean.

Humpty Dumpty indeed.

Nor are diagnostic criteria for a condition like autism spectrum disorders a difficult concept for most people; certainly they aren’t for doctors. Apparently, however, they represent a very difficult concept indeed for Holland et al, who seem to be arguing that any child with autism-like symptoms must have autism. This is akin to arguing that anyone who has a belly ache or diarrhea must have irritable bowel syndrome or that someone who experiences a headache must have migraines. In addition, such an argument assumes that all symptoms are equal when it comes to making the diagnosis of autism.

Regarding the first claim, if we take at face value the claim that there are 83 children compensated by the VICP, it is first essential to compare this number to the number of children compensated by the VICP. This the authors try to do but utterly miss the point in doing it:

This discussion must start with the caveat that we are able only to interpret the subgroup of eighty-­three compensated cases that we have located. Out of a total number of approximately two thousand five hundred compensated vaccine injury claims,137 we recognize that this is a small subset. It is our hope that this preliminary study will lead to more complete study of all cases of compensated vaccine injury. Such a study might provide a far more comprehensive understanding of vaccine injury.

83/2,500 results in an estimated prevalence rate of approximately 3.3%. On the surface, this seems to support the claim that the prevalence of autism/ASD is three-fold higher in VICP-compensated children than it is estimated to be in the general population (around 1%). Of course, there’s at least one problem. The authors are even forced to admit it. Specifically, of these 83 children, Holland et al could only find documentation of autistic symptoms for only 39. The rest of those 83 were “diagnosed” solely on the basis of a parental questionnaire. This lower number results in an estimated prevalence of autism of around 1.6% in the VICP-compensated population, an estimate that is falling into the range of what we would expect in the general population. Given that the VICP population is a skewed sample, most of whom have developmental disabilities, I’d be shocked if the prevalence of autism/ASD symptoms in this group weren’t significantly higher than they are in the general population, given how much overlap there is between symptoms exhibited by children with developmental delay and children with autism. Of course, this “study” is not good evidence that the prevalence of autism/ASD even is higher in the VICP-compensated population. Taking into account the skewed population and the noise inherent in looking at a small population over 20 years, the prevalence of autism in VICP-compensated children does not appear to be detectably different than it is in the general population. That’s even accounting for very loose criteria used by the authors to define who might be autistic. As Prometheus put it:

If the prevalance is higher among people compensated by the VICP, there is a basis for further investigation. It still wouldn’t “prove” that vaccines cause autism – it would simply be an indication for further study.

If, on the other hand, the prevalence of autism among people compensated by the VICP is the same as the general population (or less – see below), the argument that “vaccines cause autism” receives yet another (totally redundant) nail in its coffin.

The problem is that the autism prevalence numbers for the general population – even the educational numbers – use much tighter criteria than used by the authors of this study.

According to a Generation Rescue telephone survey (in other words, a “study” by the anti-vaccine movement iteself), the prevalence of autism is even higher than what Holland et al found in the VICP-compensated group of children. It’s even worse than that, though. In fact, the timing of this study’s release is very, very bad indeed. In an ironic twist of fate that leads me to think that there might justice in the universe after all, shortly before the anti-vaccine movement tried to make hay out of this poorly argued, scientifically nonsensical report, a real scientific study, was released out of South Korea that found the prevalence of autism to be considerably higher than previously believed. Steve Novella even discussed this study earlier today. Basically, in this study, researchers administered a screening test for autism spectrum disorders in a population and then did more detailed tests on children who screened positive. Their results were stunning. The study estimated that the prevalence of autism spectrum disorders was 2.64% in the population studied and that 2/3 of those cases were undiagnosed. True, this study will need to be replicated, but it adds more support for the hypothesis that autism spectrum disorders are more common than previously thought and that a significant proportion of them are subclinical and thus undiagnosed. The timing of this study, of course, couldn’t be worse for Holland et al, because it simply reemphasizes that the prevalence of autism that they think they measured in the VICP population is almost certainly not higher than the prevalence in the general population.

In other words, Holland et al did all that work and wrote all those words in order to add yet more evidence to support what we already know from copious evidence from a large and robust existing body of studies: That vaccines do not cause autism.

They just refuse to realize or admit that that’s what they’ve done.

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Whether it’s acupuncture, homeopathy or the latest supplement, placebo effects can be difficult to distinguish from real effects. Today’s post sets aside the challenge of identifying placebo effects and look at how placebos are used in routine medical practice.  I’ve been a pharmacist for almost 20 years, and have never seen a placebo in practice, where the patient was actively deceived by the physician and the pharmacist. So I was quite surprised to see some placebo usage figures cited by Tom Blackwell, writing in the National Post last week:

The practice is discouraged by major medical groups, considered unethical by many doctors and with uncertain benefit, but one in five Canadian physicians prescribes or hands out some kind of placebo to their often-unknowing patients, a new study suggests.

The article references a paper in the Canadian Journal of Psychiatry which, sadly, does not have much of a web presence. The article continues:

McGill’s Prof. Raz and his team conducted a survey of specialists throughout Canada, receiving responses from 606 doctors, 257 of them psychiatrists. About 20% of both psychiatrists and non-psychiatrists said they had used placebos in treating patients. The specific treatments they confirmed using included actual placebo tablets, sugar pills and saline injections. Some — including 35% of psychiatrists — said they also used “sub-therapeutic” doses of real drugs, amounts too small to have any chemical effect on the patient.

One in five physicians actively using placebos? Even if they’re being used sporadically, that’s a lot more use than I would have expected, and what my own practice would suggest. Is my experience typical? I put a short post on my own blog and on Twitter, and I was surprised by the responses. While use seems to be uncommon, it’s definitely  still happening, and some pharmacists participate in the charade. I was surprised to see that there are even some impressive-looking commercially-manufactured placebo capsules out there, too. (I wonder if they’re covered by insurance plans?)

I was able to obtain a full copy of the article, and it provided some context to the prevalence numbers. The web-based survey (still online) was sent to 7600 academic physicians, plus an undisclosed number of psychiatrists. Given the response rate was so low (though perhaps not unexpected for a survey), there is no information to suggest that the sample that responded is representative of the broader physician population. Given the subject matter, I’d expect that supporters of placebo use might be more inclined to respond. All of this leads me to conclude that, yes, it is happening, but no, it’s probably not one in five physicians.

The usage of placebos in active practice is one that David Gorski has discussed before, and he had some serious ethical problems with their use. Gorski reviewed a paper by Tiburt et al, which was a survey of 1,200 internists and rheumatologists, and noted that among the 57% that responded, about half reported prescribing placebo treatments on a regular basis. Big numbers, and a much better response rate. But  it also could have been skewed towards placebo prescribers.

I turned to the biomedical literature for some prevalence information. PubMed looked kindly upon my request: A 2010 paper entitled Frequency and circumstances of placebo use in clinical practice – a systematic review of empirical studies. In their study, Fässler and colleagues searched the literature with a wide net, looking for articles on the frequency of placebo use and attitudes among health professionals, students or patients.

Before we dive into the results, it must be noted that not all placebos are the same. And this might explain the disconnect between the surveys, and my pharmacy observations.  “Pure” placebos are truly inert: they contain no active ingredients. These are the sugar/lactose pills, saline injections, and most homeopathy (products diluted beyond 12C, at least).  “Impure” placebos, on the other hand, actually contain active ingredients, but are ineffective for the condition being treated. This could be because of a sub-therapeutic dose, or the active ingredient has no effectiveness against the condition being treated (e.g., antibiotics for viral infections, or the less-dilute homeopathic products). So perhaps those prevalence numbers may not be so wrong – subtherapeutic doses or antibiotics are less obviously detectable as being prescribed with placebo effect intent.

The review identified 22 studies of relevance, some dating back as far as 1973. (The Tiburt paper referenced above was among them.) Most were quantitative studies, based on interviews or questionnaires. Studies were conducted in a range of countries, with North America being reasonably well represented. The data quality was not impressive. Most of the sampling was non-random, none of these surveys used consistent questions, and response rates were all over the map. Even the definition of placebo varied between studies.

All of the studies that looked at frequency of placebo prescribing reported some use: 17-80% for pure placebos, and 41-99% for impure placebos. Pure placebos seemed to be more commonly used in hospital settings, and impure placebos were reported more in the primary care setting. The frequency of use of both pure and impure placebos was low: less than once per month in most studies. So overall, it seems consistent with the Canadian data reported last week.

Under what circumstances would deceiving a patient be felt to be acceptable? Without a systematic survey, it’s impossible to quantify the conditions and reasons for use. But some of the themes identified include:

Pure Placebos

• pain, insomnia, anxiety, risk of substance abuse
• difficult/demanding patients

Impure Placebos

• desire of patients to receive a prescription
• take advantage of placebo effects
• avoid conflicts with patients
• as a supplemental treatment for non-specific symptoms

Respondents in the different studies generally believed that placebo could be effective in a subset of patients, ranging from 5% to 42%. Among physicians and medical students, up to a third believed that placebos can induce objective, physiological changes. The overall appropriateness of placebo use led to some divergent opinions. From an ethical perspective, very few thought the use of placebos should be prohibited, though many considered the use problematic. A surprising number considered the use of placebos acceptable if used for patient benefit.

Another interesting paper, not included in the Fässler review, was published in 2010 in the journal Family Medicine. Kerman et al reported on a survey of 412 physicians in the paper Family physicians believe the placebo effect is therapeutic but often use real drugs as placebos [PDF]. Again, the response rate (43%) was poor, but among responders, 56% reported using a placebo in active practice, with 19% doing so more than 10 times per year. The most common placebo cited was the use of antibiotics (43%) followed by vitamins (23%) and herbal supplements (12%). Pure placebos were infrequently used.

Survey responders had very positive opinions of placebo use, with 85% believing that placebos have psychological and physical benefits. Remarkably, 92% supported placebo use in clinical practice. Only 8% felt placebo use should be prohibited. The most common reasons for placebo use were “unjustified” demand for medication (32%) followed by the desire to calm the patient (20%) and after therapeutic options were exhausted (20%).

It’s the impure placebos that concern me the most. The popularity of antibiotics as placebo treatments is alarming. While generally well tolerated, they’ve got a long list of side effects, which can be serious in rare cases. And antibiotic resistance, driven by misuse, has public health consequences. The use of vitamins and herbal supplements is also troubling: it’s increasingly clear that these products can cause harms, too. And it leaves me wondering what proportion of physician-recommended use of vitamins and supplements that I see is just a deliberate attempt to harness placebo effects.

The literature can tell us much about the placebo, but much less about how these products are actively used in the practice of medicine. The data are poor, but there’s enough to suggest that deliberate placebo prescribing is taking place, albeit with some ethical discomfort for many prescribers. Outside of perhaps a hospital setting where a “pure” placebo could be evaluated somewhat more objectively, I can’t imagine any situation where their provision would be ethically acceptable. As a pharmacist, my responsibility is to the patient, not the physician, and in a community pharmacy setting, I’d refuse to provide any treatment that would require me to deceive the patient about true nature of  prescription. The idea of placebo effects may be tantalizing, but not at the cost of patient autonomy, or inappropriate prescribing.

References

Fässler, M., Meissner, K., Schneider, A., & Linde, K. (2010). Frequency and circumstances of placebo use in clinical practice – a systematic review of empirical studies BMC Medicine, 8 (1) DOI: 10.1186/1741-7015-8-15

Kermen R, Hickner J, Brody H, & Hasham I (2010). Family physicians believe the placebo effect is therapeutic but often use real drugs as placebos. Family medicine, 42 (9), 636-42 PMID: 20927672

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Crossposted from NeuroLogica Blog

Over the last 20 years the prevalence of autism (now part of autism spectrum disorder, ASD) has been increasing. The medical community is largely agreed that this increase is mostly due to expanding the diagnostic category and greater efforts at surveillance. There remains some controversy over whether or not these factors explain all of the measured increase, or if there is a small real increase hidden in there as well. But largely – we are finding more children with ASD because we are casting a wider net with smaller holes.

If this is true, then we do not yet know what the true prevalence of ASD is. There must be a pool of undiagnosed children out there. Eventually the measured prevalence will hit the ceiling of the true prevalence (unless, of course, we expand the definition further) – but where is the ceiling?

That is the question researchers recently set out to answer, and they did so with a comprehensive 5 year study conducted in South Korea. The results surprised even them:

Results: The prevalence of ASDs was estimated to be 2.64% (95% CI=1.91–3.37), with 1.89% (95% CI=1.43–2.36) in the general-population sample and 0.75% (95% CI=0.58–0.93) in the high-probability group. ASD characteristics differed between the two groups: the male-to-female ratios were 2.5:1 and 5.1:1 in the general population sample and high-probability group, respectively, and the ratios of autistic disorders to other ASD subtypes were 1:2.6 and 2.6:1, respectively; 12% in the general-population sample had superior IQs, compared with 7% in the high-probability group; and 16% in the general-population sample had intellectual disability, compared with 59% in the high-probability group.

The previous estimate of autism prevalence was 1% of the population, or about one child in 100. This study found a prevalence of 2.64%, or about one child in 38 – more than twice the previous estimate. They came upon their higher measurement by taking a thorough survey of the general population. Previous studies have looked at high probability groups – children receiving special services or who have already been diagnosed. This study went into the general population and did a thorough survey for undiagnosed cases. Therefore there is a vast untapped pool of potential ASD diagnoses out there.

The results above also indicate that children with undiagnosed ASD in the general population had less intellectual disability than those in the recognized high probability group. They were also less likely to be male and less likely to have classic autism rather than a more subtle variant than the high probability group – which is not surprising. In other words, the undiagnosed children in the general population met the diagnostic features to be considered on the spectrum, but were largely functioning well in mainstream classrooms. In some cases parents were in denial about their child’s condition, in other cases the parents simply had no idea. In South Korea there is apparently still some stigma attached to the diagnosis.

While the authors conclude that their results indicate the need for still better detection of ASD, many of the undiagnosed children would likely not require or even benefit from special services. Although some would, and of course it would be desirable to capture all of those children.

While 2.6% is a high number for any such disorder, it is not out of line with other common mental disorders such as anxiety, depression, or ADHD. Of course these questions always bring up the very relevant issue of where to draw the line between “normal” and “disordered.” As I discussed recently, categorizing brain function is tricky business. Any identifiable psychological or neurological trait seems to vary at least along the classic bell-curve. You can therefore take any trait and declare two standard deviations to either side as the cut-off for “normal” (a standard practice in much of medicine) and declare those at the fringes to have one or another disorder. That would result in 5% of the population being abnormal.

But it takes more than being at the tails of the bell curve to be considered as having a disorder. The definition also requires that the identified traits are associated with (and plausibly cause) some dysfunction or negative outcome. In the case of ASD the disorder is a lack of social ability (not just learned skills, but the raw neurological hardwiring that underlies our ability to socialize). Interestingly, the current measured rate of 2.64% is almost exactly two standard deviations to the left of the curve (the other 2.5%, making a total of 5%, is the cutoff to the right of the curve – those with high social ability, which is generally not considered a disorder).

Since many of the children captured in the current study seemed to be doing fine, it is possible that the current definition of ASD is simply capturing the left two standard deviations of human variability along the bell curve of social ability. Perhaps the definition is therefore too broad, and needs to be tied more closely with some measure of disability. That is a subject for future research.

The bell curve hypothesis also can be used to support those in the “neurodiversity” community. They argue that ASD is just what I described – normal human neurological variation. I agree with this view to some degree, and I think the data above support that. However – when you get out far enough to the left side of the bell curve you do get to the point where dysfunction is undeniable. At some point it is useful to consider a neurological phenomenon to be a disorder. Children with low social ability (even if they make up for it in other ways) tend to have difficulty in school, with making friends, and later in life functioning in the work environment. No matter what you choose to call it, it is useful to identify children who can benefit from programs to help them compensate for their lack of social ability.

Also – we cannot assume that ASD is simply everyone more than two standard deviations to the left of the bell curve. It is possible that the actual curve is not a pristine bell-shape but is bi-modal, representing one hump of normal human variation, and then another hump at the low end of social ability that represents a theoretically definable separate population. This second hump might represent those with one of a group of genetic variants that leads to what we recognize as autism. This is almost certainly true, as children with autism have a higher incidence of intellectual impairment and seizures, suggesting a neurological disorder and not just normal variation. There is also increasing evidence of genetics links to autism.

Further – the low end of the bell curve of normal variation would blend imperceptibly into the second hump of autism disorder. At present the diagnosis of ASD is based entirely on clinical features, making it difficult to separate out different underlying causes. (As I stated above, we can make subtype distinctions based upon associated neurological conditions, but this is still a clinical inference rather than a distinction based upon known cause.)

As neuroscience advances, h0wever, it may become possible to tease out the current mixed bag of clinical ASD by identifying specific underlying genetic or neurological conditions. We may undo the lumping of all these children into one ASD spectrum by identifying subtypes by either their genetic profile, or perhaps their neurological function as examined by functional MRI scanning or a similar functional scan. We are already making significant progress in this area, but this is still an area ripe for further research.

Conclusion

This study adds an interesting data point to the whole picture of ASD. If correct, then the theoretically upper limit of ASD prevalence is about 2.6% of the population, more than twice the previous estimate. It also indicates that when you undergo a program of thorough searching, you will find more diagnoses. No one can reasonably think that the true prevalence of ASD suddenly doubled.

While it doesn’t prove that the steady increase in ASD diagnoses over the last 20 years was due to increased surveillance, it does support that hypothesis by showing the potential of just looking harder. Those children with ASD were always there, they were simply not identified.

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In my recent review of Peter Palmieri’s book Suffer the Children I said I would later try to cover some of the many other important issues he brings up. One of the themes in the book is the process of critical thinking and the various cognitive traps doctors fall into. I will address some of them here. This is not meant to be systematic or comprehensive, but rather a miscellany of things to think about. Some of these overlap.

Diagnostic fetishes

Everything is attributed to a pet diagnosis. Palmieri gives the example of a colleague of his who thinks everything from septic shock to behavior disorders are due to low levels of HDL, which he treats with high doses of niacin. There is a tendency to widen the criteria so that any collection of symptoms can be seen as evidence of the condition. If the hole is big enough, pegs of any shape will fit through. Some doctors attribute everything to food allergies,  depression, environmental sensitivities,  hormone imbalances, and other favorite diagnoses.  CAM is notorious for claiming to have found the one true cause of all disease (subluxations, an imbalance of qi, etc.).

Favorite treatment.

One of his partners put dozens of infants on Cisapride to treat the spitting up that most normal babies do.  Even after the manufacturer sent out a warning letter about babies who had died from irregular heart rhythms, she continued using it. Eventually the drug was recalled.

Another colleague prescribed cholestyramine for every patient with diarrhea: not only ineffective but highly illogical.

When I was an intern on the Internal Medicine rotation, the attending physician noticed one day that every single patient on our service was getting guaifenesin.  We thought we had ordered it for valid reasons, but I doubt whether everyone benefited from it.

Recognizing warblers.

Like birdwatchers, hospitalists like Palmieri learn to identify which doctor admitted a patient. Child doesn’t appear sick; admitting diagnosis is “occult bacteremia”; patient was given an intramuscular injection of Cephotaxime in the office — oh, that must be Dr. X.

Rapid identification vs pareidolia

Humans are good at pattern recognition. This allows experienced clinicians to make rapid diagnoses, but it also allows us to see the Virgin Mary on a grilled cheese sandwich.

Rooster syndrome

Rooster crows, sun comes up; therefore rooster made sun come up. Baby had colic, was given treatment X, colic resolved; therefore X cures colic. In reality, colic resolves spontaneously by 3-4 months of age and X was useless.

Copycats

Mimicking what other physicians in the community are doing.

Availability

Choosing a drug because you have samples handy that the drug rep left.

Ulysses syndrome

Ulysses went from one adventure to another in the odyssey of returning home from the Trojan War. A false positive test can lead to a fruitless odyssey of further investigation: tests lead to more tests, maybe even invasive procedures and harm to the patient. Eventually it is realized that the patient has been healthy all along.

Unnecessary lab tests

Sometimes tests are done in a scattershot attempt to find something, anything. Palmieri’s pathologist wife directs a laboratory and frequently gets calls from doctors who have ordered an unfamiliar test and have no idea what to do when they get an abnormal result. Instead of getting an individual chemistry test, we get SMAC panels because the machine is there and it’s so convenient and cheap. With 20 tests on these panels, there is a 66% probability that at least one test will be outside normal limits on a perfectly healthy normal person.

Defensive medicine

With the present legal climate, doctors sometimes do tests or treatments with an eye to how things would look in court, rather than for the direct benefit of the patient.

Showmanship

Ordering tests to impress the patient that the doctor is being thorough and is actually doing something.

Hardwired fallibility

Our brains do not function in a rational, objective, logical way. We have built-in psychological mechanisms and defects in information processing; our brains have evolved a repertoire of tricks and shortcuts that serve us well in everyday life but that must be overcome for critical thinking and science.

Confirmation bias

Once we form a belief, we seek out evidence that confirms it and reject evidence that contradicts it. We are all biased, but by being aware of our biases we can activate a self-correcting mechanism.

Over-generalization

We form opinions about the many based on our experience of a few. We may base our idea of a disease on a patient who had an atypical presentation, or tend to avoid using a drug because of a patient who had an uncommon side effect. Radiologists who have missed a diagnosis are tempted to over-interpret x-ray findings for a time afterwards.

Anchoring

We tend to reach an early diagnosis and cling to it even when subsequent evidence doesn’t fit. We tend to accept the diagnosis of the referring physician rather than going back to square one to make up our own mind.

Diagnosis momentum

An early possibility becomes a presumptive diagnosis and gains legitimacy as it is repeated by more and more health care providers.

Framing

We seek a diagnosis within the context of how the information is presented to us. Palmieri tells about a boy who presented with “frequent throat infections.” He was referred to ENT and even had a tonsillectomy before it was discovered that he had never even had a sore throat, only unexplained fevers that had been falsely attributed to throat infections but that eventually turned out to be due to juvenile rheumatoid arthritis.

Miscommunication and assumptions

Palmieri describes a case where an ENT consultant was called in directly by the worried parents of a child hospitalized with an ear infection. He assumed that they and the pediatrician must have wanted him to put in PE tubes; otherwise there would have been no earthly reason for a consult. He had booked an OR and scheduled the patient for surgery before it became clear that the child had a first ear infection that was responding to treatment, that ENT input was unnecessary, and that PE tubes were clearly not indicated.

Algorithms

We simplify our approach to complex problems by following algorithms like “if the white count is over 15,000, give antibiotics.” This is not always appropriate. Algorithms provide a convenient framework, not an unalterable directive.

Tunnel vision

We are cautioned against thinking of zebras every time we hear hoofbeats, but we often fall into the opposite trap: we tend to fixate on the diagnoses we commonly see in our practice and not consider rare possibilities. On a recent episode of the television show “Untold Stories from the ER” there was a toddler who was refusing to walk because of leg pain. They took x-rays looking for fractures to confirm their initial diagnosis of child abuse. It turned out he had scurvy, a vitamin C deficiency that simply doesn’t occur in the 21^st century US — but it did, because he was refusing all foods but oatmeal and his uneducated parents didn’t know there was anything wrong with catering to his wishes.

Conclusion

In medical school, doctors learn science but they may not learn to think like a scientist. Once out in practice, they become vulnerable to unproven claims, myths, and pseudoscience; and they are encouraged to give advice based on common sense and intuition rather than on evidence. Not just doctors but everyone needs to better understand the cognitive traps we all fall into. Since our human brains are inherently fallible, only critical thinking and good science can keep us on track. A major theme of this blog is that good science is essential for correcting our errors.

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One of the most persistent myths is one that’s been particularly and doggedly resistant to evidence, science, clinical trials, epidemiology, and reason. It’s also a myth that I’ve been writing about a long time. Specifically, I’m referring to the now scientifically discredited myth that the mercury-containing thimerosal preservative that used to be in quite a few childhood vaccines causes autism. The myth began in the late 1990s and was later fed by the publication of David Kirby’s book Evidence of Harm, which was basically a paean to various brave maverick doctors who promoted the claim that mercury in vaccines cause autism. Among the “scientists” promoted by David Kirby were the father-son team of Mark and David Geier. Mark Geier is a physician who also has a PhD and represents himself as a medical geneticist; his son David has no medical degree, leading to my wondering from the very beginning how it was that he got away with helping his father evaluate and treat autistic children, in essence practicing medicine without a license.

The Geiers are most infamous for their “Lupron protocol,” which I first learned about back in 2006. As I wrote about it in 2009, when the mainstream media finally noticed the Geiers’ dubious medicine and how they were franchising it to different states, it was chemical castration for autism. The short version is that, somehow some way, Mark Geier got the idea in his head that testosterone contributes to autism. That in and of itself isn’t woo, given that scientists have from time to time hypothesized that very thing. What made the Geiers’ conclusions pseudoscience is their explanation. Basically, Geier claimed that testosterone binds mercury from vaccines, making it more “toxic” to the brain and also making it harder to get rid of the mercury using chelation therapy. Never mind that the only paper showing testosterone binding to mercury did it in benzene (hint: your blood is not benzene) under extreme conditions. What was worse, however, was the Geiers’ “solution” to this problem, which was to add to the autism quackery known as chelation therapy another potentially harmful form of quackery, namely chemical castration using Lupron, a drug that shuts down the production of sex hormones, including testosterone. It’s a drug that’s used to treat metastatic prostate cancer, a treatment that replaced the old treatment for metastatic prostate cancer, namely surgical castration. (Not coincidentally, it’s also used to chemically castrate sex offenders.) Even worse still, the Geiers somehow got away with a highly unethical clinical trial in which they packed the Institutional Review Board overseeing it with their cronies, going merrily on their way offering an unethical “clinical trial” untouched and seemingly untouchable.

Finally, the law acts

For over five years now, I’ve been wondering just how in the world the Geiers got away with such unethical pseudoscience and how they got away with it for so long. I couldn’t figure it out. Not only did they ply their dubious medicine on autistic children, but David Geier appeared to be functioning as a “diagnostician,” somehow fooling the State of Maryland’s Autism Commission into appointing him as a member, even though he completely lacks expertise to be practicing medicine and does not have a medical or clinical degree of any kind. Meanwhile, evidence suggested that the Geiers appeared to be playing fast and loose with insurance companies by making lots of diagnoses of “precocious puberty,” a very uncommon diagnosis. Truly, I wondered what was wrong with the State of Maryland…until last week, when online acquaintances, not to mention some of you started sending me the news that Mark Geier has had his medical license suspended by the State of Maryland, as outlined in this 48-page court order. Kathleen Seidel, as usual, is already on the case as well.

Yes, the Maryland State Board of Physicians has finally acted. All I can say is: It’s about time. Let’s take a look at some of the relevant sections of the order. First, here’s the money section, namely the summary statement, which I cite nearly in its entirety:

The Respondent misdiagnosed autistic children with precocious puberty and other genetic abnormalities and treated them with potent hormonal therapy (“Lupron Therapy” or “Lupron Protocol”), and in some instances, chelation therapy, both of which have a substantial riskof both short-term and long-term adverse side effects. The Respondent’s treatment exposed the children to needless risk of harm.

The Respondent, in addition to being a physician, is certified as a genetic counselor. His assessment and treatment of autistic children, as described herein, however, far exceeds his qualifications and expertise. The extensive and extensive batteries of laboratory studies the Respondent initially orders, many of which he orders to be repeated on a monthly basis, are outside the standard quality of care for a work-up for an autistic patient or to determine the underlying cause of autism. The Respondent failed to conduct adequate physical examinations of any of the patients and in several instances, began his Lupron Protocol based merely on a telephone consultation with the child’s parent and the results of selected laboratory tests he ordered. The Respondent’s omission of a comprehensive physical examination constitutes a danger because his treatment is based on a diagnosis that requires documentation of sexual development beyond that expected for the age of the child. Moreover, his treatment may constitute more of a risk to a child with an underlyingl medical condition.

The Respondent failed to provide adequate informed consent to the parents of the autistic children he treated. In one (1) instance, he misrepresented that his treatment protocol had been approved by a federally approved IRB.

[...]

The Respondent endangers autistic children and exploits their parents by administering to the children a treatment protocol that has a known substantial risk of serious harm and which is neither consistent with evidence-based medicine nor generally accepted in the relevant scientific community.

In the order, Mark Geiers’ numerous other offenses are listed, including his corrupt, crony-packed IRB overseeing his clinical trial, possible insurance fraud (billing insurance companies for services never rendered), failing to obtain informed consent, misdiagnosing children with “precocious puberty” in most egregious ways (such as diagnosing children who did not meet the age criteria for precocious puberty) and writing medical necessity letters based on this mistaken diagnosis, and misrepresenting himself as a geneticist. Basically, regarding this latter charge, Mark Geier claimed to be a geneticist, which is a “physician who evaluates a patient for genetic conditions, which may include performing a physical examination and ordering tests,” even though he is not a medical geneticist; rather, he is a genetic counselor, which is “an individual with a master’s degree who helps to educate the patient and provides an assessment of the risk of the condition recur in the family.” I know genetic counselors. I work with genetic counselors. They don’t diagnose genetic conditions; rather, they counsel patients after either a genetic diagnosis has been rendered or the patient has developed a condition (such as breast cancer at a young age) that might indicated a genetic predisposition to a disease. It turns out that Geier also misrepresented himself as a board-certified epidemiologist when he is not.

Particularly disturbing are the treatments to which Mark Geier submitted children in his care. Case studies described in the report include include a battery of over 40 tests, spironolactone for misdiagnosed hyperaldosteronism, chelation therapy for “heavy metal toxicity,” Lupron, and methyl B12 drops for unclear and undocumented indications. One patient, patient F, a female, was given Femara, an aromatase inhibitor, which is used to treat estrogen receptor-positive breast cancer. It’s used mainly in post-menopausal women to shut down hormone production in the peripheral tissues. (It doesn’t work in premenopausal women because their ovaries make lots of estrogen, far more than the small amount made in peripheral tissues.) The presumed rationale, I have to guess, would be the same as in younger woman with breast cancer, where sometimes it is necessary to shut down ovarian hormone production and then to top it off by shutting down peripheral hormone production. My guess is that Geier somehow thought he needed to shut down not just ovarian sex hormone production in this girl but peripheral production as well. Why, I have no idea, but its profoundly idiotic and potentially harmful, particularly when combined with chelation therapy. Meanwhile, in other patients, Mark Geier proposed adding another anti-androgen drug, Androcur.

The abuse of autistic children was staggering. As a result, the Board made a finding of law:

Based on the foregoing facts, the Board concludes that the public health, safety or welfare imperatively require emergency action in this case, pursuant to Md. State Gov’t Code Ann. § 10-226 (c) (2) (i) (2009 Repl. Vol.).

That’s right, not just action but emergency action. I guess the State of Maryland has a different definition of “emergency,” given that the Geiers have been at this for at least six years, but I’ll take what I can get. At least when finally roused from its torpor, the Maryland State Board of Physicians recognized the Geiers for the threat to autistic children that they are and, as a result, ordered that Mark Geier’s license to practice medicine in the State of Maryland be summarily suspended. As a result, Mark Geier was required to surrender the following to the Board:

• his original Maryland License D24250
• his current renewal certificate
• his Maryland Controlled Dangerous Substance Registration
• all controlled dangerous substances in the Respondent’s possession and/or practice;
• all Medical Assistance prescription forms
• all prescription forms and pads in the Respondent’s possession and/or practice
• any and all prescription pads on which his name and DEA number are imprinted

Excellent.

I only have a couple of remaining questions. First, what will be the response of the anti-vaccine movement. One thing I’ve noticed over the last couple of years, since the mainstream media first noticed his Lupron protocol is that the anti-vaccine movement seems to have distanced itself from the Geiers. They’re almost never mentioned anymore on Age of Autism these days, even though they used to be regular features there a couple of years ago. They’re not the headliners at the yearly Autism One quackfest anymore; they are, however, still listed as speakers for this year’s quackfest. One has to wonder whether they’ll be quietly disinvited now that Geier has had his medical license yanked, or whether Lisa Sykes will remove the Geiers’ epilogue from her book. Probably not, I’d guess. Most likely the Autism One organizers will see the loss of Mark Geier’s medical license as evidence of his cred as a “brave maverick doctor,” much as Wakefield’s cred remains high in the anti-vaccine movement. Even so, in the several days since the suspension of Geiers’ license became widely known, I’ve seen almost nothing written about them by the anti-vaccine movement, which is in marked contrast to the wailing and gnashing of teeth observed after Andrew Wakefield lost his medical license in the U.K.

Be that as it may, I’m now left wondering how long it will be before the conspiracy theories come out. The most obvious one hasn’t hit the blogosphere yet, at least not as I write this. How long do you think it’ll be before an anti-vaccine loon claims that stripping Mark Geier of his medical license (just like another brave maverick doctor, Andrew Wakefield!) was a plot by the miltiary-industrial-pharma-CDC complex to distract attention from the case of Poul Thorsen. You know it’s coming sooner or later.

Finally, what of the metastatic deposits of Geier père et fils quackery in other states? After all, besides Maryland, the Geiers have spread their clinics to Kentucky, Missouri, Florida, Illinois, and Indiana. Will these states now act to shut down the Geier clinics there, known as ASD Centers, LLC? I know I’ve complained about how long it took the State of Maryland to do the right thing. Even so, I’m glad that the Board there finally acted. It’s time for the medical boards in these other states to do likewise.

Fallout

There was one truly odd aspect about this incident, as long overdue as it was and as happy as I was to learn about it. Basically I learned something else along the way that I hadn’t known. In fact, I was pretty shocked to find this out, and I wanted to know how something like this could possibly have happened. I’m referring to the fact that Mark Geier’s son David Geier had somehow slimed his way onto the State of Maryland Commission on Autism as a “diagnostician.” As I pointed out at the time, David Geier is not a physician and has no qualifications to diagnose or treat autism (or anything other medical condition, for that matter). Not that that’s stopped him thus far; he does it anyway.

By way of the Baltimore Sun, I now learn that part of the fallout in the aftermath of Mark Geier’s humiliation is that, not only is the state trying to get rid of David Geier but people are asking–shall we say?–inconvenient questions about how he was appointed to the Commission on Autism in the first place:

A day after Dr. Mark Geier’s medical license was suspended in Maryland over allegations of putting children with autism at risk, state officials were seeking to remove his son from a state commission that advises the governor on the disorder.

The officials were also struggling to explain why David Geier, who has an undergraduate degree in biology and does not have a medical license, was identified by the Commission on Autism as its “diagnostician.” The commission’s website had listed him as a doctor until Wednesday, which officials said was a clerical error. The commission’s listing also includes the Geiers’ company, ASD Centers LLC, whose website lists a corporate center in Silver Spring but is not registered in Maryland.

“Under the circumstances, we do not believe it’s appropriate for David Geier to serve on the autism commission,” said David Paulson, a spokesman for the state Department of Health and Mental Hygiene, which submitted 19 names to the governor, including David Geier’s, for approval to the panel. “Unfortunately, he declined to resign his commission. … As a result, we are considering the appropriate next steps.”

Leave it to a Geier not to take the hint when not wanted, leading the state to try to get rid of him. Like father, like son, I suppose. However it is a very interesting question. How could someone like David Geier, a man with no qualifications, associated with pseudoscience like the Geiers’ Lupron protocol get on such a panel? While it’s true that he has been caught in the past inflating his credentials, I doubt that explains it. The explanation coming from the Department of Health and Mental Hygiene doesn’t sound particularly convincing:

Paulson said the state was aware of “the controversial nature of David Geier’s views” when he was recommended for the position on the commission, which was formed by the legislature in 2009. But officials were looking for a “diverse” panel.

“Controversial.” You keep using that word. I do not think it means what you think it means. David Geier’s views are most definitely not “controversial,” at least not from a scientific standpoint. They’re demonstrably wrong. They’re pseudoscientific. They’re advocacy of abuse of autistic children. But controversial? Not so much. One potential explanation for David Geier’s presence on the panel has been suggested by Robert Goldberg, author of Tabloid Medicine: How the Internet is Being Used to Hijack Medical Science for Fear and Profit, who asks how an autism quack got on the Maryland autism panel and then tries to answer the question:

Here’s a clue: The Geiers did have their association with John L. Young, MD.

Who is Dr. Young and why might he be connected to David Geier’s appointment?
In 2009, Dr. Young “was the President of the Montgomery County Medical Society, the largest component medical society in Maryland. From 2007 to 2009, he was asked by Maryland Governor Martin O’Malley to serve as a Commissioner for the Maryland Community Health Resources Commission, and in 2009, was appointed by Governor O’Malley to serve on the Board of Regents for the University System of Maryland.”

That information is taken from the website of ASD Centers, which the Geiers set up to peddle Lupron and other dangerous and disproven autism treatments. That’s because John L. Young, MD — founded in 2008 — along with Mark Geier — ASD Centers.

http://www.autismtreatmentclinics.com/Staff.html

And there’s more: The Geiers set up an Institutional Review Board (IRBs are established to review the impact of clinical research on human subjects) to approve their own research, conducted by ASD Centers of course. The IRB called the Institute for Chronic Illnesses turned out to be Mark Geier’s home.
More problematic, John Young was a ‘co-investigator’ with Mark and David Geier in their Lupron research.

Even worse, Young was also a member of the IRB.

http://www.neurodiversity.com/weblog/article/98/

It certainly does look suspicious, doesn’t it?

Whether Dr. Young is the conduit through which David Geier managed to find a seat on Maryland’s autism panel or not, the Geiers have built a virtual “autism biomed” empire in Maryland, Illinois, Indiana, Texas, Florida, New Jersey, Missouri, Kentucky, and Washington based on, in essence, the chemical castration of children. We have to remember that Geier’s only been shut down in one state. True, it’s the state of his current residence, which is huge, but that doesn’t stop the Geiers from simply relocating to one of the other states in which Mark Geier holds a medical license. Heck, if Dr. Geier were to relocate to Virginia, he might not even have to move out of his very large, very expensive home; he could just deal with a longer commute. The problem, as I’ve discussed before, boils down to ineffective state medical boards, many of which are overburdened and hampered by laws that mistake giving doctors due process with viewing a medical license as a right. It’s not; it’s a privilege. In any case, the ineffectual regulation of physicians by many state medical boards have allowed “unconventional” doctors like Rashid Buttar to continue their dubious medicine with impunity, in essence thumbing their noses at the medical establishment.

Which is what the Geiers are still doing in Illinois, Indiana, Texas, Florida, New Jersey, Kentucky, and Washington.

So, how to stop them? In most states, for the medical board to act, there have to be complaints, either from patients or fellow health care professionals. Whether there have been complaints about the Geiers or not, I don’t know, but there should be. Also, a license suspension in one state can trigger an investigation in another state. At the very least, the Mark Geier will have to report it the next time he applies for renewal of his license in the several states in which he is licensed, a convenient list of which has been kindly provided here.

I have two hopes right now. The first, and lesser, of the two is that David Geier will be kicked off of the Maryland Commission on Autism. He should never have been on that panel in the first place, and it would be very, very interesting to find out exactly who pushed for his appointment, given that the competition for the spots on that committee was pretty fierce. I highly doubt that David Geier got a spot on the committee on his merits; almost certainly someone somewhere pulled some strings, possibly Dr. Young. The second, and more important, hope is that the State of Maryland’s action, as long overdue as it may have been, ultimately cascades, and Mark Geier finds himself losing his medical license in each and every state in which he holds one.

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The anti-vaccine movement is a frequent topic on the Science-Based Medicine blog. There are a number of reasons for this, not the least of which being that the anti-vaccine movement is one of the most dangerous forms of pseudoscience, a form of quackery that, unlike most forms of quackery, endangers those who do not partake of it by breaking down herd immunity and paving the way for the resurgence of previously vanquished diseases. However, anti-vaccine beliefs share many other aspects with other forms of quackery, including the reliance on testimonials rather than data. Even so, although the intelligentsia (and I do use the term loosely) of the anti-vaccine movement realizes and exploits the power of anecdotes and testimonials and how human beings tend to value such stories over dry scientific data, leaders of the anti-vaccine movement realize that science is overwhelmingly against them and that testimonials alone are not adequate to counter that science in the realm of public policy and relations.

That’s why, over the years, various anti-vaccine “scientists” (and I use that term very loosely as well) have produced poor quality, sometimes even fraudulent studies, which are then touted as evidence that vaccines cause autism or at least as evidence that there is actually still a scientific controversy when in fact from a scientific standpoint the vaccine-autism hypothesis is pining for the fjords. Examples abound, including the work of Mark and David Geier, whose studies led the to use chemical castration to treat autistic children; Andrew Wakefield, whose small case series almost certainly included fraudulent data; a truly incompetent “phone survey” commissioned by Generation Rescue designed to compare “vaxed versus unvaxed” children; and an even more incompetent “study” in which Generation Rescue used a cherry picked group of nations to try to argue that nations that require more vaccines have higher rates of infant mortality. These efforts continue. For example, last year Generation Rescue requested $809,721 from the Airborne settlement to set up a “vaxed versus unvaxed” study, despite the known difficulties with such a study and the low likelihood of finding anything without huge numbers of children.

Last week, they were at it again.

The return of the revenge of the claim that more vaccines equal more infant mortality

Over the last week or so, anti-vaccine activists have been busy touting two “studies” or “reports,” one I can write about now, one that will have to wait. I’ll start with the one that has to wait first:

Investigators and Families of Vaccine-Injured Children to Unveil Report Detailing Clear Vaccine-Autism Link Based on Government’s Own Data

Report Demands Immediate Congressional Action

Directors of the Elizabeth Birt Center for Autism Law and Advocacy (EBCALA), parents and vaccine-injured children will hold a press conference on the steps of the U.S. Court of Federal Claims (717 Madison Place, NW in Washington, DC) on Tuesday, May 10 at 12:00 PM to unveil an investigation linking vaccine injury to autism. For over 20 years, the federal government has publicly denied a vaccine-autism link, while at the same time its Vaccine Injury Compensation Program (VICP) has been awarding damages for vaccine injury to children with brain damage, seizures and autism. This investigation, based on public, verifiable government data, breaks new ground in the controversial vaccine-autism debate.

The investigation found that a substantial number of children compensated for vaccine injury also have autism. The government has asserted that it “does not track” autism among the vaccine-injured. Based on this preliminary investigation, the evidence suggests that autism is at least three times more prevalent among vaccine-injured children than among children in the general population.

Stay tuned. This appears to be the same “study” that anti-vaccine activist Robert F. Kennedy, Jr. was originally going to announce in front of the White House back in April, but his press conference was ultimately canceled. Apparently, this publication was to appear in the Pace University Law School journal, which, of course, the sort of venue that is always preferable to the peer-reviewed scientific literature, at least to cranks.

Whatever the announcement turns out to be, the second example is indeed a study that somehow made it into the peer-reviewed literature. I found out about it from two sources, first, you our readers, several of whom have sent me links to the study, and, second, the ever-popular all-purpose quackery website, NaturalNews.com, which announced triumphantly last week that nations requiring the most vaccines tend to have the worst infant mortality rates:

A new study, published in Human and Experimental Toxicology (http://het.sagepub.com/content/earl&hellip;), a peer-reviewed journal indexed by the National Library of Medicine, found that nations with higher (worse) infant mortality rates tend to give their infants more vaccine doses. For example, the United States requires infants to receive 26 vaccines — the most in the world — yet more than six U.S. infants die per every 1000 live births. In contrast, Sweden and Japan administer 12 vaccines to infants, the least amount, and report less than three deaths per 1000 live births.

Before we get to the study itself—which, as you might imagine, has…flaws—let’s take a look at the authors. The first author, Neil Z. Miller, is described as an “independent researcher, and the second author, Gary S. Goldman, is described as an “independent computer scientist.” This is not a promising start, as neither of them appear to have any qualifications that would lead a reader to think that they have any special expertise in epidemiology, vaccines, or science. Still, I suppose one could look at the fact that these two somehow managed to get a paper published in a peer-reviewed journal as being pretty strong evidence for the democratic nature of science, where you don’t necessarily have to be affiliated with a university or a biotech or pharmaceutical company in order to publish in the scientific literature. On the other hand, even though it is stated that this was not funded by any grants or companies, I still see a conflict of interest. Specifically, the NaturalNews.com article points out that the “National Vaccine Information Center (NVIC) donated $2500 and Michael Belkin donated $500 (in memory of his daughter, Lyla) for open access to the journal article (making it freely available to all researchers).” The NVIC, as you recall, was founded by Barbara Loe Fisher and is one of the oldest and most influential anti-vaccine groups in the U.S., having recently teamed up with Joe Mercola to promote anti-vaccine views.

Not a promising start.

It’s also not surprising. I did a bit of Googling, as is my wont whenever I encounter someone whose name I don’t recognized, and I found abundant evidence in his Wikipedia entry that Miller has a long history of anti-vaccine activism, having written books with titles like Vaccine Roulette: Gambling With Your Child’s Life, Immunization Theory vs Reality: Expose on Vaccinations, and Vaccines: Are They Really Safe and Effective?, among others. But that’s not all; he’s also the director of the ThinkTwice Global Vaccine Institute and in fact is hosting a copy of this study on his website. Gary S. Goldman is even more interesting. It turns out that he is the President and Founder of Medical Veritas, a rabidly anti-vaccine “journal” that is into HIV/AIDS denialism, having published dubious “reanalyses” of autopsy results of victims of AIDS, such as Eliza Jane Scovill. He also notes at his website that he’s written books entitled The Chickenpox Vaccine: A New Epidemic of Disease and Corruption.

Even less promising.

Still, one might wonder why I pointed this out. Isn’t that an ad hominem attack? Not at all. I’m not arguing that this latest paper is wrong because its authors are clearly members of the anti-vaccine fringe. Who knows? They might be on to something. I’m merely pointing out that what’s good for the goose is good for the gander when it comes to pointing out conflicts of interest (COIs) and, as Harriet has recently discussed COIs do not necessarily have to be financial. As I’ve pointed out time and time again, COIs do not necessarily mean that a study is in error, poorly done, or out-and-out wrong. They merely demand a bit more skepticism, particularly when they are not disclosed, which they are not in the actual paper, which fails to list the connection to NVIC, Medical Veritas, and ThinkTwice. Why didn’t Miller list himself as editor or founder of ThinkTwice or Goldman as founder and editor of Medical Veritas? One wonders, one does. Knowing that these two hold those positions is every bit as relevant as knowing when a pharmaceutical company publishes a study about its latest blockbuster drug.

But who knows? Maybe I’m wrong. Well, actually, I don’t think I am, but it will take delving into the actual paper to show why.

Infant mortality as a function of number of vaccines

The first thing you need to know is that this is a really, really simple paper. In fact, I’d go so far as to say it is simple-minded more than just simple. Basically, Miller and Goldman went to The World Factbook maintained by, of all organizations, the Central Intelligence Agency. Noting that in 2009 the U.S. ranked 34th in infant mortality, they looked up the infant mortality rates from the U.S. and all the nations that have lower infant mortality rates than the U.S. and then compared them to the number of vaccine doses each nation require. They then graphed the infant mortality rate as a function of vaccine dose, and this resulted in Figure 1:

Whenever I see a paper like this, I ask myself: What would I say about it if it had been sent to me as a peer reviewer. This graph leads to a number of questions. First, why did the authors use 2009 data? The cited reference notes that the data were accessed back in April 2010. That’s over a year ago. Did it really take over a year between submission and publication. Be that as it may, whenever I see investigators trying to correlate two variables like infant mortality and the number of vaccines I ask: What is the rationale? I also note that the authors here seem to have pulled the same trick that J.B. Handley and crew like to pull when trying to convince people that U.S. infants are “overvaccinated” by artificially pumping up the apparent number of vaccine doses by counting multivalent vaccines as more than one. For instance, the MMR and DTaP are counted as three each because each vaccine is trivalent; i.e., containing vaccines against three different diseases.

After pointing out that the U.S. has a poor infant mortality rate (IMR) relative to its wealth and what it spends on health care, the authors state:

There are many factors that affect the IMR of any given country. For example, premature births in the United States have increased by more than 20% between 1990 and 2006. Preterm babies have a higher risk of complications that could lead to death within the first year of life.⁶ However, this does not fully explain why the United States has seen little improvement in its IMR since 2000.⁷

Nations differ in their immunization requirements for infants aged less than 1 year. In 2009, five of the 34 nations with the best IMRs required 12 vaccine doses, the least amount, while the United States required 26 vaccine doses, the most of any nation. To explore the correlation between vaccine doses that nations routinely give to their infants and their infant mortality rates, a linear regression analysis was performed.

This is known as starting with a reasonable observation and then switching to a hypothesis with little or no scientific justification, in essence pulling it out of thin air. The second question I would have is: Why a linear relationship? No justification is given for performing a linear regression analysis. My third question would be: Why this data set?

Actually, this third question is probably the most interesting of all. Miller and Goldman only looked at one year’s data. There are many years worth of data available; if such a relationship between IMR and vaccine doses is real, it will be robust, showing up in multiple analyses from multiple years’ data. Moreover, the authors took great pains to look at only the United States and the 33 nations with better infant mortality rates than the U.S. There is no statistical rationale for doing this, nor is there a scientific rationale. Again, if this is a true correlation, it will be robust enough to show up in comparisons of more nations than just the U.S. and nations with more favorable infant mortality rates. Basically, the choice of data analyzed leaves a strong suspicion of cherry picking. Were I reviewing this paper, I would insist on the use of one or two other data sets. For example, I would ask for different years and/or perhaps the use of the rankings by the United Nations Population Division, which can be found in the Wikipedia entry containing the list of countries by infant mortality rate. And I would insist on doing the analysis so that it includes several nations with worse IMRs than the U.S. Indeed, since the focal point of the analysis seems to be the U.S., which, according to Miller and Goldman, requires more vaccine doses than any other nation, then it would make sense to look at the 33 nations with worse IMRs than the U.S.

Be that as it may, I looked at the data myself and played around with it One thing I noticed immediately is that the authors removed four nations, Andorra, Liechenstein, Monaco, and San Marino, the justification being that because they are all so small, each nation only recorded less than five infant deaths. Coincidentally, or not, when all the data are used, the r²=.426, whereas when those four nations are excluded, r² increases to 0.494, meaning that the goodness of fit improved. Even so, it’s not that fantastic, certainly not enough to be particularly convincing as a linear relationship. More dubiously, for some reason the authors, not content with an weak and not particularly convincing linear relationship in the raw data, decided to do a little creative data manipulation and divide the nations into five groups based on number of vaccine doses, take the means of each of these groups, and then regraph the data. Not surprisingly, the data look a lot cleaner, which was no doubt why this was done, as it was a completely extraneous analysis. As a rule of thumb, this sort of analysis will almost always produce a much nicer-looking linear graph, as opposed to the “star chart” in Figure 1. Usually, this sort of data massaging is done when a raw scatterplot doesn’t produce the desired relationship.

Finally, it’s important to remember that IMRs are very difficult to compare across nations. In fact, the source I most like to cite to illustrate this is, believe it or not, an article by Bernadine Healy, the former director of the NIH who has over the last three or four years flirted with the anti-vaccine movement:

First, it’s shaky ground to compare U.S. infant mortality with reports from other countries. The United States counts all births as live if they show any sign of life, regardless of prematurity or size. This includes what many other countries report as stillbirths. In Austria and Germany, fetal weight must be at least 500 grams (1 pound) to count as a live birth; in other parts of Europe, such as Switzerland, the fetus must be at least 30 centimeters (12 inches) long. In Belgium and France, births at less than 26 weeks of pregnancy are registered as lifeless. And some countries don’t reliably register babies who die within the first 24 hours of birth. Thus, the United States is sure to report higher infant mortality rates. For this very reason, the Organization for Economic Cooperation and Development, which collects the European numbers, warns of head-to-head comparisons by country.

Infant mortality in developed countries is not about healthy babies dying of treatable conditions as in the past. Most of the infants we lose today are born critically ill, and 40 percent die within the first day of life. The major causes are low birth weight and prematurity, and congenital malformations. As Nicholas Eberstadt, a scholar at the American Enterprise Institute, points out, Norway, which has one of the lowest infant mortality rates, shows no better infant survival than the United States when you factor in weight at birth.

It’s ironic that Bernadine Healy, who’s associated herself so heavily with the anti-vaccine movement, to the point of having been named Age of Autism’s Person of the Year in 2008, provided such a nice, concise explanation about why it’s so problematic to compare infant mortality rates between nations. Miller and Goldman claim that they tried to correct for these differences in reporting for some of the nations who do not use reporting methods consistent with WHO guidelines, but they do not say how they did so or what data source they used to do so. Note that these children who die within the first day of life also tend to be the ones who have either received no vaccines yet or only the birth dose of the hepatitis B vaccine (here in the U.S.). Given that infant mortality is defined as the fraction of children who die before one year of age and many infants lost die very early, many of them have had few or no vaccines, given that the bulk of the U.S. vaccine schedule does not really start until two months of age. In other words, no effort was made to determine if there was actually any sort of correlation between vaccine dose number whether the infants who died actually died at an age where they would be expected to have received most of the vaccines required within the first year. Worse, no real attempt was made to correct for many potential confounding factors. Not that that stops the authors from asking:

Among the 34 nations analyzed, those that require the most vaccines tend to have the worst IMRs. Thus, we must ask important questions: is it possible that some nations are requiring too many vaccines for their infants and the additional vaccines are a toxic burden on their health? Are some deaths that are listed within the 130 infant mortality death categories really deaths that are associated with over-vaccination? Are some vaccine-related deaths hidden within the death tables?

Never mind that the authors present no real data to justify such a speculation. They do speculate, however. Oh, how they speculate! The spend two whole pages trying to link vaccines to sudden infant death syndrome and argue that SIDS deaths, hinting at some sort of conspiracy to cover up the number of SIDS deaths by reclassifying them and then cite old studies that suggested a correlation between vaccination and SIDS while neglecting the more recent data that show that the risk of SIDS is not increased after immunization and that, if anything, vaccination is probably protective against SIDS. Indeed, one of the studies the authors discuss is an abstract presented in 1982, not even a paper published in a peer-reviewed journal.

Finally, there is the issue of ecological fallacy. The ecological fallacy can occur when an epidemiological analysis is carried out on group level data rather than individual-level data. In other words, the group is the unit of analysis. Clearly, comparing vaccination schedules to nation-level infant mortality rates is the very definition of an ecological analysis. Such analyses have a tendency to magnify any differences observed, as Epiwonk once described while analyzing–surprise, surprise!–a paper by Mark and David Geier:

To make this jump from group-level to individual-level data is The Ecological Fallacy, which can be defined simply as thinking that relationships observed for groups necessarily hold for individuals.

The ecological fallacy was first described by the psychologist Edward Thorndike in 1938 in a paper entitled, “On the fallacy of imputing the correlations found for groups to the individuals or smaller groups composing them.” (Kind of says it all, doesn’t it.) The concept was introduced into sociology in 1950 by W.S. Robinson in 1950 in a paper entitled, “Ecological correlations and the behavior of individuals,” and the term Ecological Fallacy was coined by the sociologist H.C. Selvin in 1958. The concept of the ecological fallacy was formally introduced into epidemiology by Mervyn Susser in his 1973 text, Causal Thinking in the Health Sciences, although group-level analyses had been published in public health and epidemiology for decades.

To show you one example of the ecological fallacy, let’s take a brief look at H.C. Selvin’s 1958 paper. Selvin re-analyzed the 1897 study of Emile Durkheim (the “father of sociology”), Suicide, which investigated the association between religion and suicide. Although it’s difficult to find Selvin’s 1958 paper, the analyses are duplicated in a review by Professor Hal Morgenstern of the University of Michigan. Durkheim had data on four groups of Prussian provinces between 1883 and 1890. When the suicide rate is regressed on the percent of each group that was Protestant, an ecologic regression reveals a relative risk of 7.57, “i.e. it appears that Protestants were 7½ times as likely to commit suicide as were other residents (most of whom were Catholic)….ln fact, Durkheim actually compared suicide rates for Protestants and Catholics living in Prussia. From his data, we find that the rate was about twice as great among Protestants as among other religious groups, suggesting a substantial difference between the results obtained at the ecologic level (RR = 7.57) and those obtained at the individual level (RR = 2).” Thus, in Durkheim’s data, the effect estimate (the relative risk) is magnified by 4 by ecologic bias. In a recent methodological investigation of bias magnification in ecologic studies, Dr. Tom Webster of Boston University shows that effect measures can be biased upwards by as much as 25 times or more in ecologic analyses in which confounding is not controlled.

The bottom line is that Miller and Goldman’s ecological analysis virtually guaranteed overestimating any relationship found, the way some studies of radiation hormesis have done. Given that the difference between the highest and lowest IMR is only around two-fold, in essence, given this data set it is highly unlikely that there is any relationship there. This is particularly true given that the authors cannot possibly have controlled for the major confounders. Add to that the fact that they only used one data set and didn’t even include nations with higher IMRs than that of the U.S., and I declare this paper to be utterly worthless. It’s an embarrassment to Human and Experimental Toxicology that its peer reviewers didn’t catch all these problems and that an editor let this paper see print. The Editor-in-Chief Kai Savolainen and the Editor for the Americas A. Wallace Hayes ought to be ashamed of themselves.

Conclusion

The current study joins a long list of poorly planned, poorly executed, poorly analyzed studies that purport to show that vaccines cause autism, neurological diease, or even death. It is not the first, nor will it be the last. The question is: How do we respond to such studies? First off, we as skeptics have to be very careful not to become so jaded that knee-jerk hostility predominates. As unlikely as it is, there is always the possibility that there might be something worth taking seriously there. Next off, we have to be prepared to analyze these studies and explain to parents, when appropriate (which is the vast majority of the time) exactly why it is that they are bad science or why their conclusions are not supported by the data presented. Finally, we have to be prepared to provide these analyses fast. The Internet is speed. Already, if you Google the terms “infant mortality” and “vaccine,” anti-vaccine blogs gloating over Miller and Goldman’s study and the study itself appear on the very first page of search results.

Such is the power of a bad study coupled with the reach of the Internet and the naivete of peer reviewers and journal editors who don’t realize when they’re being played.

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First Oz, now this. Too bad his appearance was so short:

At least they got Banachek to do a quick and dirty trial that helped to demonstrate that these bracelets do not work.

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