I saw a patient recently for parasites.

I get a sinking feeling when I see that diagnosis on the schedule, as it rarely means a real parasite.  The great Pacific NW is mostly parasite free, so either it is a traveler or someone with delusions of parasitism.

The latter comes in two forms: the classic form and Morgellons. Neither are likely to lead to a meaningful patient-doctor interaction, since it usually means conflict between my assessment of the problem and the patients assessment of the problem.  There is rarely a middle ground upon which to meet. The most memorable case of delusions of parasitism I have seen was a patient who  I saw in clinic who, while we talked, ate a raw garlic clove about every minute.

“Why the garlic?” I asked.

“To keep the parasites at bay,” he told me.

I asked him to describe the parasite.  He told me they floated in the air, fell on his skin, and then burrowed in.  Then he later plucked them out of his nose.

At this point he took out a large bottle that rattled as he shook it.

“I keep them in here,” he said as he screwed off the lid and dumped about 3 cups with of dried boogers on the exam table.

To my credit I neither screamed nor vomited, although for a year I could not eat garlic.  It was during this time I was attacked by a vampire, and joined the ranks of the undead.

I have seen the occasional earthworm thought to be an intestinal parasite. Sometimes people start to pay attention to their stool, often for the first time, and note  tube like structures  that move in the water.  Most likely mucous or undigested fiber wafting in the gentle currents of the toilet water.  Doesn’t that sound romantic? The contents of the average stool, like hot dogs and laws, are better left unexamined.  In those patients, an examination of the stool for worms and worm eggs is usually unrevealing and makes me glad I am not a microbiology technician.

Morgellons is, as best I can tell, a variant of delusions of parasitism.

Here is a thing about germs in general and parasites specifically: they have patterns and can be seen. There are patterns of disease and patterns of their life cycle.  You can tell when a disease is probably delusional because the “organisms” have no understandable pattern in the life cycle, the disease, the physiology, the anatomy or the epidemiology.

And germs can be seen. Well, most germs.  Single celled organisms can be tricky and may require special stains to be seen under the microscope.  Viruses are, of course, too small to be seen by a lab microscope. But parasites? Worms? These wee beasties are multicellular.  They are big. Not a long way to the chemists big, but sizable, not hard to see with a microscope unless they have Romulan cloaking technology.

So what is Morgellons?

Before we continue, I would like to clarify one thing. I see patients self diagnosed with Chronic Candida Syndrome or Morgellons or Chronic Lyme or some other process.  I do not doubt these people are ill and have symptoms that can be severe and life altering.  What I may disagree with the patient is the reason for these symptoms.  As best I can tell none of the above are due to an infectious disease.

Unfortunately when the patient is convinced they have an etiology for their symptoms and I think that their reason is nonsense, it does not lead to a therapeutic physician-patient interaction.  I try and phrase it as gently and non-judgmentally  as possible, but it rarely leads to a good time in the clinic.

Morgellons has existed as a disease since about 2002 and is an internet phenomena right up there with Rebecca Black.  See.  For a 54 year old man, I am hip. Morgellons received its name from a paper from 1935 called SIR THOMAS BROWNE AND THE DISEASE CALLED THE MORGELLONS By C.E. KELLETT, M.D., M.R.C.P. and published in Annals of Medical History, n.s., VII (1935), 467-479,  where it refers to a disease from the 1600′s (yes 1600′s) described by said Thomas Browne.

“Hairs which have most amused me have not been in the face or head, but on the Back, and not in Men but Children, as I long ago observed in that endemial Distemper of little Children in Languedock, called the Morgellons, wherein they critically break out with harsh Hairs on their Backs, which takes off the unquiet symptoms of the Disease, and delivers them from Coughs and Convulsions.”

Who know what these hairs/worms really were; the 1600′s were not a time noted for its diagnostic accuracy. Unlike the modern disease, it was usually a disease of children and often fatal, so whether these “hairs”  had anything to do with the disease or were actual living creatures, one cannot say.

In  1715 when the first microscopist, Leuvenhoeck, took a look at the bristles and thought them “inanimate”, starting a long tradition of looking at the detritus presented by Morgellons patients and seeing nothing.  I, for one, always look at the fluff brought in by Morgellons patients and have yet to see anything resembling a living creature. Diseases have come and gone in the past, like the English Sweating Sickness, so maybe there was a plague of virulent hairs (that’s hair not hare, it was not a virulent bunny, for which Hef is undoubtedly grateful), but no longer.

Fast forward 400 years.  Round about 2002 this disease was described on the net in regards a child with the symptoms now referred to as Morgellons, and since others have had the disease.  It is transmissible as an internet meme, but not spread person to person.

What are the distinguishing characteristics of Morgellons?  Here are features as noted from the Morgellons Research Foundation

1. “Filaments” are reported in and on skin lesions and at times extruding from intact-appearing skin. White, blue, red, and black are common among described fiber colors. Size is near microscopic, and good clinical visualization requires 10-30 X. Patients frequently describe ultraviolet light generated fluorescence. They also report black or white granules, similar in size and shape to sand grains, on or in their skin or on clothing. Most clinicians willing to invest in a simple hand held commercial microscope have thus far been able to consistently document the filaments.
2. Movement sensations, both beneath and on the skin surface. Sensations are often described by the patient as intermittently moving, stinging or biting. Involved areas can include any skin region (such as over limbs or trunk), but may be limited to the scalp, nasal passages, ear canals, or face…and curiously, legs below the knees.
3. Skin lesions, both (a) spontaneously appearing and (b) self-generated, often with pain or intense itching. The former (a) may initially appear as “hive-like”, or as “pimple-like” with or without a white center. The latter (b) appear as linear or “picking” excoriations. Even when not self-generated (as in unreachable regions of babies’ skin), lesions often progress to open wounds that heal incompletely (e.g., heal very slowly with discolored epidermis or seal over with a thick gelatinous outer layer.). Evidence of lesions persists visually for years.
4. Musculoskeletal Effects and Pain is usually present, manifest in several ways. Pain distribution is broad, and can include joint(s), muscles, tendons and connective tissue. Both vascular and “pressure” headaches and vertebral pain are particularly common, the latter usually with premature (e.g., age 20) signs of degeneration of both discs and vertebrae.
5. Aerobic limitation is universal and significant enough to interfere with the activities of daily living. Most patients meet the Fukuda Criteria for Chronic Fatigue Syndrome as well (Fukuda, Ann. Int. Med., 1994). Cardiology data and consistently elevated heart rates suggest a persistent myocarditis creating lowered cardiac output that has been partially compensated for by Starling’s Law.
6. Cognitive dysfunction, includes frontal lobe processing signs interfering with logical thinking as well as short-term memory and attention deficit. All are measurable by Standard Psychometric Test batteries.
7. Emotional effects are present in most patients. Character typically includes loss or limitation of boundary control (as in bipolar illness) and intermittent obsessional state. Degree varies greatly from virtually absent to seriously life altering. “

It is the filaments.  Over the years I have  seen a smattering of Morgellons and they bring in the filaments and I look at them under the microscope. I see hairs, and threads, and non-specific detritus, but never anything that resembles the results of a living creature. I have looked carefully at the skin of these patients, and have never seen an intradermal fiber.

So you can see why I am skeptical that this is anything but a version of delusions of parasitism.  In one series of 25 patients

Most patients in this study (23 out of 25) had prior psychiatric diagnoses (most determined by specialists) as follows: 11 out of 25 bipolar disease; 7 out of 25 Adult ADD; 4 out of 25 Obsessive Compulsive Disorder (OCD); and 1 out of 25 Schizophrenia.

The same study had a hodgepodge of lab abnormalities, but there were not compared to matched controls. It may well be that the patients have some underlying inflammatory process that causes skin lesions and a feeling of the creepy crawlies and are misidentifying standard environmental material as associated with the diseases.  But I am skeptical.

Against this hypothesis are the case reports where Morgellons is cured with Pimozide, an antipsychotic.  Delusions of parasitism is often treated with olanzapine, another antipsychotic, but others have suggested pimozide is superior.  Most infections would be unlikely to respond to antipsychotics, but I have never been satisfied with response to treatment as a means for confirming a diagnosis, that is a path better not followed without good reason. In my world docs often think if patients are improving on antibiotics the response is considered evidence of infection.  I know better. But given the lack of a demonstrable parasite, a response to psychiatric medications is certainly suggestive.

So response to anti-psychotics would suggest patients with Morgellons could have  a psychosis, but I keep in mind it does not necessarily extrapolate to all patients.  I try to bear in mind that when patients present with odd symptoms that they attribute to worms and parasites, it may be simple misunderstanding.

As of this entry, no one has fulfilled Kochs postulates with Morgellons.

For those not immersed in infectious diseases, Koccs postulates were a series of criteria to demonstrate the causality of infections,  Here there are, with the word filament substituted for microorganisms:

1) The filament must be found in abundance in all organisms suffering from the disease, but should not be found in healthy organisms.
2) The micro filaments must be isolated from a diseased organism and grown in pure culture.
3) The cultured filament should cause disease when introduced into a healthy organism.
4) The filament must be re isolated from the inoculated, diseased experimental host and identified as being identical to the original specific causative agent.

So far proponents of the disease are 0 for 4.

But if this disease is due something that can be visualized with the naked eye or a magnifying glass, it should be simple enough to characterize.  Lets say you are a DNP and a member of ILADS. Well, I have to admit that you have lost some credibility with me.  But lets say you saw a series of patients with Morgellons and you could see the fibers.  There, right there. You can see them.  Would you not biopsy the fibers?  Would you not try to characterize them?  Nope.  So aggravating. It boggles the mind that someone could have a diagnostic coup right in front of them and let it pass.

Delusions of parasitism can be nosocomial. Well, not truly delusions, but patients can be convinced they have parasites when, in fact, they do not, and waste serious amounts of time and cash in pursuit of an imaginary diagnoses.

I recently saw a patient who had unexplained abdominal pain for a year and a half.  The patient had an extensive evaluation and no explanation for the symptoms, and,  looking for answers,  eventually wandered into the arms of a naturopath.

One of the shows my eldest liked to watch was I Love the 80′s on VH1.  The 80′s was the decade I was in medical school, residency and fellowship.  When I watched I Love the 80′s I recognized virtually nothing of popular culture of time.  Not the TV shows, the hair styles, the music. Nothing.   It really brought home how consuming becoming a doc and a subspecialist is.  A decade of my life was spent understanding medicine and infectious diseases. I am not complaining, mind you.  There are lots of reasons people go to an alt med provider, but I do not think gullibility is on the list.

The patient with the abdominal pain and their spouse are educated people, why would they see a naturopath?

Looking for answers.  Their areas of knowledge are totally removed from medicine and science, and while it is popular to bemoan the science illiteracy of the US population, and it is sorry, if your career arc was law, or finance or auto repair, or stoner at the 7/11,  are you going to find time to become literate in medicine?  Doubt it.  I can’t design a bridge or fly a jet.  Why would I expect someone who has mastered these tasks to understand medicine?  There are just so many hours in a day to accomplish tasks.

I have, as a further example, zero idea if my mechanic is giving me good diagnostic and repair advice on my car.  I have to take everything he says on faith.  I have neither the time or inclination to become expert in car repair, and most people do not have the time to become fluent in medicine.  Am I gullible?  I do not think so.

I had my epiphany years ago when I told a father of a meningitis patient, your daughter has an infection in the fluid that surrounds her brain and he replied, could you phrase that in a way I can understand it?  He had no idea of basic brain anatomy or infections, and why would he? So I drew him a picture.  It helped.

So anyway, the patient wandered  into the lair of a naturopath and was diagnosed with parasites.  Now mind you, the patient did not have symptoms that could be reasonably ascribed to parasites or worms, and, more importantly, had no risks for parasites or worms.  The industrialized West is reasonably free of worms and their brethren.  The naturopath did not do serology or blood work or even a simple stool study looking for the eggs of various worms.  It is how I, along with a history and physical looking for the pattern of disease that marks a parasite, come to a diagnosis. No, he or she (I do not remember the pronoun used at the time) proudly used electrodiagnosis.

Proudly.  As my patient related it to me, the naturopath, a graduate of Bastyr, (if there is an legitimate opportunity for a deliberate mispronunciation, it is with Bastyr) considered herself to be an expert in parasite treatment and diagnosis.

What is electrodiagnosis you ask?

There are many devices out there, so I do not know precisely which one the patient used.

My patient said they held an electrode in each hand, the naturopathic expert in parasitology twirled a dial, and told them that the reading indicated parasites. Really.  I am proud that I did not burst out laughing during the interview, as from my perspective it was a  ludicrous joke.  But, as I mentioned, not everyone knows what I do, and EEG’s and EKG’s can also diagnoses a variety of medical problems, so why not parasite infestation?

Electrodiagnosis are said to measure disturbances in the body’s flow of “electro-magnetic energy” along “acupuncture meridians” but are expensive galvanometers that measure electrical resistance of the patient’s skin when touched by a probe. Two pseudosciences in one.  I have seen better.   It is sometimes called electroacupuncture according to Voll, or EAV, and was pulled out of Dr. Volls backside in the 1950′s.

“The basic concept for all of the ElectroDermal screening devices, was the invention of Dr. Reinhardt Voll[1], who in the 1940s, discovered that the electrical resistance of the human body is not homogenous and that meridians existed over the body which may be demonstrated as electrical fields. Furthermore, he showed that the skin is a semi-insulator to the outside environment. By the 1950s Voll had learned that the body had at least 1000 points on the skin which followed the 12 lines of the classical Chinese meridians. Each of these points, Voll[2] called a Measurement Point (MP). Working with an engineer, Fritz Werner, Voll created an instrument to measure the skin resistance at each of the acupuncture points, patterned after a technique called Galvanic Skin Resistance (GSR). This was named Point Testing. In 1953, Voll had established the procedure that became known as Electro-Acupuncture according to Voll.”

There is zero validity to making any diagnosis this way. Except, of course, the E-Meter of Scientology.  I wouldn’t want to cross the them there Scientologists. Oh no, uh uh. No way.  E-meter forever. But those other electronic diagnostic devices? Pure bunkum.  I could not say it better than Quackwatch:

“The devices  are used to diagnose nonexistent health problems, select inappropriate treatment, and defraud insurance companies. The practitioners who use them are either delusional, dishonest, or both.”

That the  American Association of Naturopathic Physicians has a position statement on electrodiagnosis that considers it experimental is another sign that naturopaths have no business taking care of people.  To quote their position paper

“There are three levels of electro-diagnosis:
a. Meridian testing: Readings are interpreted in indicate strength of specific meridians, organ strength or physiologic function.
b. Remedy testing: Variations in readings are interpreted when remedies are given to the patient either orally, to hold or put on a “testing plate” wired to the electrodiagnostic equipment. Interpretations may include sensitivities, nutritional enhancement, or improved function.
c. Energy medicines: Electrodiagnostic equipment interprets information and manufactures an energy medicine which is given to the patient to take orally.
THEREFORE IT IS THE POSITION OF THE AANP THAT:
It is appropriate that the naturopathic profession pursue scientific research regarding the reproducibility and reliability .”

There is nothing on the Pubmeds on the validity of electrodiagnosis, and, on basic principals and prior probability, to suspect that electrodiagnosis would have any utility in the diagnosis of parasites  or anything other disease.

Despite this, my patient received prolonged courses of mebendazole, thiabendazole and praziquantel, all at half doses, and all out of pocket.

Uncertain of which parasite to kill, the naturopath tried to kill them all with under-dosed medications.  Good thing, come to think of it, that he did not use his infernal contraption to diagnose cancer, who knows how many anticancer treatments would have been prescribed.

And what is an energy medication and how does one manufacture them? Besides a triple shot of espresso?  The principals of EAV have been expanded for

“BioScan (remote DNA resonant testing) – This procedure utilizes extremely sensitive EAV computerized equipment to accurately measure stressors in the body. It bombards the clients sample DNA (usually hair) with up to 10,000 frequencies to locate bacteria, viruses, pesticides, heavy metals, industrial pollutants, chemicals, parasites, foods, allergies, dental materials, trees, weeds, pollens, inhalants, molds, yeast, fungus and many other substances that poison the environment today. These stressors and related deficiencies are identified in print form for the client along with the organs and glands affected by the stressors. Supplements are suggested that resonate with the test subject and homeopathics are customized to support the body to remove the stressors and return to homeostasis.”

Only 275 dollars, plus 5 dollars shipping and handling.  And they recommend a minimum of 4 evaluations.

Try as I might, I cannot write a satisfying concluding paragraph to this entry, so I will just stop.

In the comments to my previous article I had said I would tackle the topic of how Pharmaceutical Products are marketed and how the FDA is involved in that process. Then I managed to get a new job with a different company, and have been busy getting up to speed. I still do the same thing, but with a different company and more responsibility. All of that aside, I am now up to speed, and had the good fortune to be browsing the FDA’s website when I came across, the following article: “FDA issues warnings to marketers of unapproved ‘chelation’ products”. This seemed to me a good lead in to discuss the situation down at the FDA and why it is beneficial to have an outside party look at your marketing materials before you present them to the public.

In general, the promotional review process at the FDA works as follows. A Pharmaceutical, or CAM Company decides upon an advertisement they wish to have for their product. They review it internally to ensure compliance with the regulations as they understand them, then they send it to the FDA either as an informational piece or requesting a formal review. Which one they choose is dependent on how much of a risk they feel they are willing to take, which can also come down to the risk/benefit profile of the product in question. There is a group in each Center for the FDA which handles this. For the two Centers I have primarily dealt with on these issues, it is DDMAC (Division of Drug Marketing, Advertising and Communications) in CDER (Center for Drug Evaluation and Research) and APLB (Advertising and Promotional Labeling Branch, also pronounced “Apple-Bee”) in CBER (Center for Biologics Evaluation and Research). Now this is where the path between legitimate Pharmaceuticals and CAM takes a massive divergent twist.

Pharmaceuticals have a distinct disadvantage when it comes to marketing their products. For a Pharmaceutical advertisement to be acceptable, it must have three major parts to it, not including the biggest piece of all, FDA approval as a Marketable Product. The first of these, although it seems fairly obvious, is the Drug Name. After all, the consumer must know what product it is they are seeing information about. At this point both Pharmaceuticals and CAM are still relatively similar. The next two points is where divergence occurs.

The second most important tenet in Drug Marketing is having a truthful summary. This can be explained simply as the portion of the ad where the manufacturer tells you what the product does, and conforms to the product label. This is actually a good time to draw some attention to that word, “label”. In Regulatory terms, the label refers to not only the label on the actual medical packaging, but also that neatly folded origami-looking piece of paper that you get with your pill bottles, known as the Prescribing Information. The information contained in this label details the circumstances under which a drug should be prescribed, what adverse events are known and expected, effects on geriatric populations, pediatric populations, and pregnant populations. The list goes on, and it is all in the nice piece of paper. That label limits what claims can be said about a Pharmaceutical product.

For example, you cannot say, with a Pharmaceutical product for nasal decongestion that it cures cancer, as it is not in the label. Now, if there have been clinical trials done, and it shows that it does have effects on certain types of cancer, then you could make the claim, but you need accepted and peer-reviewed Science to back the claim. The same is not true for CAM. This is why, if you are a chronic insomniac like myself and you stay up way too late, you see products promising to cure every ill you may have from foot fungus to dehydration (water has been known to do this of course) to impotence.

It is telling that in some cases, these companies do get sued for their deceptive claims. One need only go so far as to look at Berkeley Neutraceuticals, the makers of Enzyte to see this. What they were really sued for was the false promise of “Double your money back” which they offered in their ads, however, it was entered during the trial that the product really did not perform as promised. I wonder if “Smiling Bob” is still smiling?

Another very key point to Pharmaceutical Advertising is what is known as fair balance, and here is where CAM comes up 100% deficient. The key to this is understanding that fair balance tells a complete picture of the story. It gives you both the negatives and the positives in your product. I am sure many of you have seen a drug advertised on television and been wondered about all those negative things that are mentioned. That is part of the fair balance, and it is required that Pharmaceutical companies tell you this. As most CAM is regulated under the Nutritional side of the FDA this fair balance does not exist. They are not under any obligation to say, for example, “Oh, my product contains only water, so while it may quench your thirst, it will not cure your cancer.”

This fair balance must also be clear and not misleading. This became a major issue back in 2008 when Robert Jarvik, M.D. began promoting Lipitor in television commercials. In the commercials, he used the line, “I’m glad I take Lipitor, as a doctor, and a dad.” This is a very very fine line that the FDA eventually stepped in on. Robert Jarvik is, indeed, a Medical Doctor. He did complete Medical School. What he did not do, and has never claimed to have done, is completed his medical internship/residency and is not licensed to prescribe. The FDA’s fear is that, since the advertisement began with the genial line of “I’m  Doctor Robert Jarvik, inventor of the Jarvik Artificial Heart.” that people would rely fully on Dr. Jarvik’s recommendation. After Pfizer was made aware of these concerns, they eventually pulled the advertisement. This is a beautiful case study on how one should always be careful not only of the message one is delivering, but also how that message is delivered.

As with everything where regulations are concerned, there are grey areas. This is where trained Regulatory Professionals come in, and we work to ensure that companies stay on the straight and narrow as much as is possible.

References:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm229320.htm

http://www.casewatch.org/cp/enzytecmp.pdf

21 CFR 201

21 CFR 202

http://abcnews.go.com/GMA/OnCall/story?id=4138702&page=1

Regulations have just gone into effect in the EU regarding the sale of herbal products. The regulations seem reasonable, but they have sparked near hysteria on the part of herbal sellers and advocates of “natural” medicine. They are calling the regulation a “ban” on herbal products, which much of the media has parroted, but it is not a true ban, just a requirement for registration.

The law was sparked by cases of toxicity from over-the-counter herbal products. For example, aristolochia is a toxic plant species that is either used deliberately or can be accidentally or carelessly substituted for other plant species. It is known to cause kidney damage – even leading to kidney failure is some cases. Another herb, kava, has been linked to liver damage.

The new EU law, which went into effect May 1, 2011, will require herbal products to be licensed, or prescribed by a licensed herbal practitioner. In order to be licensed evidence for safety of the product must be presented. It is estimated that it will cost between 80,000 and 120,000 British pounds to get an individual herbal product licensed.

I find it interesting, and completely predictable, that sellers of herbal products are wailing that this is all a conspiracy by “Big Pharma” to crush the little guy and steal all the herbal profits for themselves, or to ban herbal products to protect their drug profits. But this is a straw man. The real question here is the balance between marketing freedom and quality control – but those who want to defend their right to sell herbs don’t want to discuss the real issues, apparently.

Dr Rob Verkerk from a trade organization, the ANH, is quoted as saying:

“Thousands of people across Europe rely on herbal medicines to improve their quality of life. They don’t take them because they are sick – they take them to keep healthy. If these medicines are taken off the market, people will try and find them elsewhere, such as from the internet, where there is a genuine risk they will get low quality products, that either don’t work or are adulterated.”

First, he begs the question that the use of herbs improves anyone’s quality of life. That is, in fact, the entire question – are the risks worth the alleged benefits. The legislation is simply an attempt to provide a better risk/benefit for the consumer by putting into play better assurances of safety.

His next point if the same point that is always made against regulation – if you make X illegal then people will just obtain X illegally or from less regulated sources. This is not specific to herbal products. There is a point there – regulation is not easy, especially with a global market and the internet. But that does not mean we should abandon all efforts at quality control and honesty in marketing.

He concludes with an assumption that herbal products under the current scheme work for anything and have adequate quality control – but again, that is the very issue. In fact regulations are generally not adequate to assure quality control in terms of dose and purity. And there is virtually no regulation about the claims that can be made for herbal products.

In the US the 1994 DSHEA essentially allows herbal manufacturers to make a host of pseudo-health claims without any oversight. The same is and will continue to be true in the EU. One could argue that this legislation does not go far enough to protect the public against false claims and useless products.

Others argue that this legislation will put the small producers out of business. This is exactly what patent medicine sellers complained about when the FDA was proposed. In fact all of the objections are identical to those raised against regulation of drugs. Of course, the point of the FDA was to put the mom and pop patent medicine sellers out of business – because they were largely selling snake oil and did not have the resources to perform proper safety and efficacy testing.

Here the claims are even less relevant – because herbal remedies are a multi-billion dollar industry, and the relative cost to get licensing is much less than getting a drug through the FDA.

What we really have here is an industry that wants to continue selling poorly regulated products with health claims and without any burden of having to prove that their products are safe or that their health claims are based upon science.

I acknowledge that there is a real political debate here, and that some people might want to favor freedom and risk over government regulation. But I object to the way the debate is often framed by opponents to regulation. Even for those who would prefer to have a free market for herbal products would likely agree that the consumer deserves accurate information in order to make informed decisions. Right now, in most markets, the consumer does not have that.

Most people I talk to about this assume that herbs are more regulated than they currently are. People want both freedom and protection, and are not always aware of the degree to which the two are at cross purposes. So if you ask them if they want freedom in the market, they say yes. And if you ask them if they want assurance of safety and honesty, they also say yes. They want the freedom to choose, but only among products that are safe and effective.

With respect to herbal remedies, however, the evidence is largely against the efficacy that is being claimed for many products. If you look at the big sellers, like echinacea and Gingko biloba, the large well-controlled studies are largely negative – they don’t appear to work for the indications for which they are commonly marketed.

The industry has largely failed to self-regulate, and to use their profits to generate good science to back up their claims. And they consistently fight against regulation to force them to do so, and try to make it seem like they are on the side of the little guy against big corporate interests. But this is just spin – they are just another big industry protecting their interests. If they really cared about the little guy or the consumer they would be producing good science, and keeping their claims within the evidence, rather than fighting against attempts to make them do just that.

Under most current regulatory schemes, there is a disincentive to conduct good efficacy research. Such research is a lose-lose proposition for industry. They have to spend the money to do the research. If it’s positive, it is unclear how that will benefit them since they already can make health claims (or pseudo-health claims, like the so-called “structure function” claims under DSHEA). But if it’s negative, then they risk losing market share. The risk/benefit of doing efficacy research is simply not there, and that is probably why there is so little such industry-sponsored research into supplements. The only way to get the industry to spend some of their profits doing quality research is to make such research a requirement for entry into the marketplace.

In the end we should remember that herbs are drugs – they have pharmacological activity, they have toxicity, an they have drug-drug interactions. How much regulation and quality assurance do we want for our drug industries (no matter what they are called)?

A friend asked me to look at the evidence for hash oil as a treatment for glioma. His teenage daughter was recently diagnosed with brain cancer: a grade 3 anaplastic ependymoma. It recurred very rapidly after surgery and radiotherapy and the latest tissue diagnosis shows an aggressive grade IV glioma. Her prognosis is not good. No further attempts at curative therapy are indicated; the oncologist prescribed only palliative therapy with temozolomide. Her father, who had recently lost his wife to cancer (breast cancer metastatic to lungs and brain), was understandably devastated. As he puts it, he remains “focused on the belief that just maybe a cure can be found.” He stumbled on what he calls “earth-shattering news” regarding hash oil. He and his friends established a private wiki website which they are constantly updating with information about THC (tetrahydrocannabinol, the active ingredient in marijuana and hash) and other possible cancer cures: everything from curcumin to diet. He asked me to look at the information he has accumulated. He said

I hope to convince you in the same way I have done with my daughter’s GPs and her neuro-oncologist at BC Children’s Hospital.

The oncologist was not exactly convinced. He didn’t say he thought hash oil was likely to work; he only said it would be reasonable to try it as a complementary therapy. He said

the data published so far appears very preliminary, most of its potential effectiveness in vivo so far appears in colonic disease, having said that there doesn’t appear to be any obvious down side as a complementary therapy and may have synergistic effect, so may be reasonable as add on to temodal if she tolerates it

I wasn’t convinced either.

I will discuss two issues here:

1. What does the evidence say about gliomas and hash oil?
2. When is it reasonable to try an unproven treatment as a last resort?

What Does the Evidence Show?

Several plausible mechanisms have been demonstrated, suggesting that it might work; but the evidence consists almost entirely of in vitro (test tube) and animal studies, with only a couple of small pilot studies in humans and a lot of speculation.

The Guzman study was a pilot study of 2 patients who got THC injected directly into their tumors.

The Salazar study concluded

we identify what we believe is a new route that links the ER stress response to the activation of autophagy and promotes the apoptotic death of tumor cells. The identification of this pathway will help to understand the molecular events that lead to activation of autophagy-mediated cell death by anticancer drugs and may contribute to the design of new therapeutic strategies for inhibiting tumor growth.

The Kogan study elucidates cellular anti-cancer mechanisms of THC but warns “sometimes they can act also as pro-cancer agents, especially in low concentrations, acting mostly through growth factors and their receptors activation/induction.” It concludes

In summary, cannabinoids possess some anticancer activity. Possibly they may represent a new class of anticancer drugs that retard cancer growth, inhibit angiogenesis and the metastatic spreading of cancer cells.

None of these studies concluded that we should be treating glioma patients with any form of THC.

A study by Foroughi reports spontaneous regression in 2 glioma patients. One happened to have smoked pot almost every day, the other used it twice a week. They speculate that the THC might have had something to do with the regression. But it might just as well have been coincidental. Spontaneous regression is known to occur in gliomas. A 2004 German study showed spontaneous regression in a mouse model. A study in the Archives of Ophthalmology documented 13 cases of spontaneous regression in humans with large optic gliomas.

The literature is confusing because it addresses different doses, different compounds, and different routes of administration: THC, smoking pot, hash oil, injecting it directly into tumors, applying it topically to skin tumors, inhaling, taking it by mouth, etc. Positive pilot studies are an encouragement to further studies; they are not proof that the treatment works.

The information on the Internet includes glowing testimonials but is contaminated with obvious bias. Advocates come mostly from the ranks of notorious “legalize marijuana” activists. Emotions run high. Many arguments in favor are full of the kind of fallacies we often discuss here, including “they didn’t listen to Semmelweis.” Protestations that THC research is being unfairly suppressed are not credible. Cancer researchers want to find cures, and even Big Pharma stands to reap huge benefits if active molecules can be separated out, modified, and turned into prescription drugs.

I didn’t find anything I would call “earth-shattering” or even anything that could be considered credible evidence that hash oil can cure advanced gliomas. The most I can conclude from my research is that hash oil has promise and is worth studying.

Last Resort?

When a patient is out of options, it is natural to grasp at any straw. Even though the evidence for hash oil is inadequate, there are some preliminary indications that it might help, and some plausible mechanisms have been elucidated. Isn’t it better to try something that possibly might work than to just give up?

How do you know what to try? The private website addresses all kinds of other possible cancer treatments, including curcumin, garlic, diet, etc. Incidentally, it cites a lot of very untrustworthy sources, such as a book by a doctor who repeats the old myth about cancer and sugar and a company that is selling curcumin pills. Should you try all of these treatments at once? If you try hash oil, how do you decide how much and how often?

We read articles in the popular press, for instance in Reader’s Digest, about the child with the rare disease whose heroic parents refused to give up and kept searching until they found the one doctor in the world who was able to cure their child with a new treatment. We hear about these success stories because they are unusual.

We don’t hear about the vast majority of cases where parents wasted time and money in a futile search.

It disturbed me to read through the private wiki, because it was “déjà vu all over again.” I’ve seen this so many times. Someone desperately wants to find a cure, latches onto something that he thinks might work, locates a mass of evidence to confirm his bias, but fails to appreciate the limitations of that evidence and fails to seek out information that argues against his bias (like the possibility that cannabinoids might have pro-cancer effects, mentioned above). In the course of my long career I’ve seen so many promising treatments bite the dust that I have become not only skeptical but probably cynical about it.

Yes, hash oil might be an effective treatment for gliomas and for other cancers. But we can’t possibly know until we test it properly. A patient with glioma today can’t wait for the results of future tests. Forgoing the treatment might mean dying sooner than necessary, but it is far more likely that using the treatment will be useless. It’s a gamble. Where is that crystal ball when we need it?

When you try a treatment on your own, you are essentially acting as a guinea pig in an uncontrolled experiment. Ideally, you could enroll in a randomized controlled trial that would result in some useful knowledge for future patients. But such trials are not always available, and you might not get the treatment; you run the risk of being assigned to the placebo group.

Is aggressively pursuing a cure really the best goal? Success is possible but very unlikely; and the search can become obsessive; dominate the searcher’s life; and consume time, funds, and energy that might be best employed otherwise. How about pursuing other goals that have a much higher chance of success: spending quality time with the loved one, trying to make the most of whatever time she has left, helping her cope, trying to make her remaining life as worthwhile as possible, saying goodbye, creating good memories for the survivors?

I’m going to be mean and ask some difficult questions. Is this father really doing this for his child or for himself? He wants to be able to say he did everything possible and left no stone unturned, so he will have no guilt feelings afterwards. Is the daughter really on board with all this, or is she cooperating mainly to please her father, knowing that it gives him comfort? Is she giving up the foods she loves to follow a restricted diet that has no proven benefit? Would it be better for all concerned to accept the terrible prognosis and confront its reality in more constructive ways? Do false hopes do more harm than good? There are always real hopes: that palliative therapy might extend life, that a spontaneous regression might occur, that life might still be rich with meaningful experiences?

Conclusion

Hash oil has enough promise to warrant further research but not enough evidence to warrant prescribing it as a cancer cure. Is it worth trying anyway? I don’t know. I am asking questions, not condemning. I can’t imagine what it is like to learn that your beloved child has a fatal illness. I don’t know how I would react, or whether I would want to try something like hash oil. It’s possible that I might feel desperate enough that all my judgment, skepticism, and common sense would fly out the window and I might be persuaded to try even the most wildly irrational things. I do know that refusing to accept reality often has unfortunate consequences. It distresses me when families aggressively pursue a will-o’-the-wisp that ends in failure and uses up precious time they might have spent otherwise to make the patient’s last days more meaningful and to create lasting memories.

What would you do? I welcome readers’ input in the comments.

One theme that we at Science-Based Medicine keep revisiting again and again is not so much a question of the science behind medical therapies (although we do discuss that issue arguably more than any other) but rather a question of why. Why is it that so many people cling so tenaciously to pseudoscience, quackery, and, frequently, conspiracy theories used by believers to justify why various pseudoscience and quackery are rejected by mainstream science and medicine? Certainly, I’ve touched on this issue before on several occasions, for example, with respect to the anti-vaccine movement, the claim that abortion causes breast cancer, and how we as humans crave certainty.

It turns out that science and science-based medicine are hard for humans to accept because they often conflict with what our senses perceive and brains interpret as irrefutable evidence. The pattern-seeking function of our brain, when evaluating questions of causation in medicine, frequently betrays us. For instance, when a parent sees her child regress into autism sometime not long after being vaccinated, the easiest, most instinctive, and most emotionally compelling conclusion is that the vaccine must have had something to do with it. When scientists tell her that, no, in large studies looking at hundreds of thousands of children, there is no good evidence that vaccination confers an increased risk of autism and a lot of evidence that it does not, it’s a very hard message to believe, because it goes against how the parent interprets what she’s seen with her own eyes. Indeed, how often have we seen believers in the vaccine-autism link pour derision on the concept that when something like autistic regression happens in close temporal proximity to vaccination that the correlation does not necessarily equal causation? Similarly, believers in “alternative medicine” who experience improvement in their symptoms also pour derision on the observation, explained so well by R. Barker Bausell in Snake Oil Science, that people frequently take remedies when their symptoms are at their worst, leading them to attribute natural regression to the mean to whatever nostrum they started taking at the time.

These issues have come to the fore again, thanks to an article by an acquaintance of mine, Chris Mooney, author of The Republican War on Science, Storm World: Hurricanes, Politics, and the Battle Over Global Warming, and Unscientific America: How Scientific Illiteracy Threatens our Future (co-authored with Sheril Kirshenbaum). The article appeared in a recent issue of Mother Jones and was entitled, rather ironically, The Science of Why We Don’t Believe Science. Chris made his name as an author primarily in writing about the science of anthropogenic global warming and the political battles over policies intended to mitigate it and, to a lesser extent, over creationism and evolution denial. Of late he has written about the anti-vaccine movement as an anti-science movement, leading predictably to his being attacked by the likes of J.B. Handley as viciously as I and others have. Also of note, although he was widely praised for The Republican War on Science and Storm World, Mooney has been widely criticized in some circles for being too critical of “new atheists” and for lack of substance. In his current article, he discusses some of the science thus far about why people can cling to beliefs that science doesn’t just cast doubt upon but shows convincingly are totally wrong.

Motivated reasoning

In his article, Mooney sets the stage with a very famous example studied by Stanford University psychologist Leon Festinger in the 1050s of the Seekers. The Seekers were an apocalyptic cult in the Chicago area led by a Dianetics enthusiast named Dorothy Martin. Its members believed that they were communicating with aliens, one of whom was named “Sananda,” who was supposedly the astral incarnation of Jesus Christ. Martin also taught her followers that Sananda had told her the precise date of a world-ending cataclysm: December 21, 1954. As a result, some of Martin’s followers quit their jobs and sold their homes because they expected that a spaceship would rescue them right before the earth split open and the sea swallowed much of the United states. In fact, Martin’s followers even went so far as to rid themselves of all traces of metal, even removing underwire bras and taking the zippers out of their clothes, because they were told that such metal would pose a danger to the spaceships. Here’s Mooney’s account of what happened when December 21, 1954 came and went and, as those of us living today know, no cataclysm occurred:

At first, the group struggled for an explanation. But then rationalization set in. A new message arrived, announcing that they’d all been spared at the last minute. Festinger summarized the extraterrestrials’ new pronouncement: “The little group, sitting all night long, had spread so much light that God had saved the world from destruction.” Their willingness to believe in the prophecy had saved Earth from the prophecy!

From that day forward, the Seekers, previously shy of the press and indifferent toward evangelizing, began to proselytize. “Their sense of urgency was enormous,” wrote Festinger. The devastation of all they had believed had made them even more certain of their beliefs.

In the annals of denial, it doesn’t get much more extreme than the Seekers. They lost their jobs, the press mocked them, and there were efforts to keep them away from impressionable young minds. But while Martin’s space cult might lie at on the far end of the spectrum of human self-delusion, there’s plenty to go around. And since Festinger’s day, an array of new discoveries in psychology and neuroscience has further demonstrated how our preexisting beliefs, far more than any new facts, can skew our thoughts and even color what we consider our most dispassionate and logical conclusions. This tendency toward so-called “motivated reasoning” helps explain why we find groups so polarized over matters where the evidence is so unequivocal: climate change, vaccines, “death panels,” the birthplace and religion of the president (PDF), and much else. It would seem that expecting people to be convinced by the facts flies in the face of, you know, the facts.

I’ve actually written about motivated reasoning before a couple of years ago. At the time, I used a then-recent study that examined how impervious to evidence certain beliefs about politics were, specifically the belief that Saddam Hussein had been involved in planning 9/11, conspiring with Al Qaeda to destroy the World Trade Center twin towers (the “9/11 Truth” movement). In this study, even President George W. Bush’s own words stating that Hussein was not involved in planning 9/11 were not enough to convince believers. Another study cited used similar methodology regarding Saddam Hussein’s lack of weapons of mass destruction. In fact, in this study, there was a “backfire” effect, in which those exposed to disconfirmatory information about Saddam Hussein’s involvement with 9/11 were actually more likely to believe that he was, in fact, involved. Also discussed was the belief that President Barack Obama was not born in the United States and is therefore not eligible to be President (the “Birther” movement, which recently suffered a bit of a setback) and the belief that there were “death panels” written into the recently passed Patient Protection and Affordable Care Act. In the study I discussed, the authors based their analysis of motivated reasoning on its being driven primarily by cognitive dissonance, the the feeling we have when we are forced to become aware that we are holding two contradictory thoughts at the same time. The strength of the dissonance depends upon the importance of the subject to an individual, how sharply the dissonant thoughts conflict, and how much the conflict can be rationalized away, and cognitive dissonance theory thus posits that, when faced with evidence or occurrences that challenge their beliefs, people will tend to minimize the dissonance any way they can without giving up those beliefs.

To the list of examples provided by the authors, I also added the example of someone well-known to this blog, namely Andrew Wakefield, the (in)famous British gastroenterologist who in 1998 published a study in The Lancet that claimed to find a link between the MMR vaccine and “autistic enterocolitis.” When revelations of Wakefield’s financial fraud came to light, however, his fans in the anti-vaccine movement were motivated to cling all the more tightly to him, circling the wagons and attacking anyone who had the temerity to point out his fraud, bad science, bad medicine, and massive conflicts of interest. For example, just last month, in response to criticism of Andrew Wakefield, J.B. Handley, the founder of the anti-vaccine group Generation Rescue, pointed out that people like him view Andrew Wakefield as “Nelson Mandela and Jesus Christ rolled up into one.” Never mind that, scientifically speaking, Wakefield is just as discredited in his science as Dorothy Martin was in her predictions of global destruction. In the same article, anti-vaccine activist Michelle Guppy warned the reporter direly, “Be nice to him, or we will hurt you.” As you can see, despite the drip, drip, drip of allegations and evidence showing Andrew Wakefield to be a horrible scientist and even a research fraud have not had much of an effect on committed activists. I would argue, however, that they did have a significant effect on the media and the fence-sitters.

For the most part, most scientifically literate people know what cognitive dissonance is, but what is “motivated reasoning”? According to Mooney, to understand motivated reasoning, you first have to understand that what we humans call “reasoning” is not a cold, emotionless, Mr. Spock-like process. The way we human beings reason is actually suffused with emotion, or affect:

Not only are the two inseparable, but our positive or negative feelings about people, things, and ideas arise much more rapidly than our conscious thoughts, in a matter of milliseconds—fast enough to detect with an EEG device, but long before we’re aware of it. That shouldn’t be surprising: Evolution required us to react very quickly to stimuli in our environment. It’s a “basic human survival skill,” explains political scientist Arthur Lupia of the University of Michigan. We push threatening information away; we pull friendly information close. We apply fight-or-flight reflexes not only to predators, but to data itself.

We’re not driven only by emotions, of course—we also reason, deliberate. But reasoning comes later, works slower—and even then, it doesn’t take place in an emotional vacuum. Rather, our quick-fire emotions can set us on a course of thinking that’s highly biased, especially on topics we care a great deal about.

As a result, if this hypothesis is accurate, it can be expected that people will almost always respond to scientific or technical evidence in a way that justifies their preexisting beliefs. Examples of evidence that support this hypothesis are listed, including the study I discussed two years ago using the example of the persistent belief that Saddam Hussein had a hand in engineering 9/11. Also discussed was a classic study from 1979 in which pro- and anti-death penalty advocates were exposed to two fake studies, one supporting and one refuting the hypothesis that the death penalty deters violent crime. In addition, they were also shown detailed scientific critiques of each study that indicated that neither study was methodologically stronger than the other. In each case, advocates were more likely to find the study that supported their bias more convincing and to be more critical of the one that did not.

To anyone who understands human nature, this is not particularly surprising. After all, as Simon & Garfunkel sang in their 1970 song The Boxer (one of my all time favorite songs), “a man hears what he wants to hear and disregards the rest.” That’s not quite motivated reasoning, but close. Motivated reasoning would be more along the lines of saying, “a man pays attention to information that supports his beliefs and values and finds ways to disregard or discount the rest.” This principle, more than anything else, probably explains why believers in alt-med and anti-vaccine activists are immune to disconfirming evidence. Not just immune, either, they actively seek out confirming evidence and avoid disconfirming evidence, a task made much easier by the Internet and multiple different news outlets catering to different ideologies:

Okay, so people gravitate toward information that confirms what they believe, and they select sources that deliver it. Same as it ever was, right? Maybe, but the problem is arguably growing more acute, given the way we now consume information—through the Facebook links of friends, or tweets that lack nuance or context, or “narrowcast” and often highly ideological media that have relatively small, like-minded audiences. Those basic human survival skills of ours, says Michigan’s Arthur Lupia, are “not well-adapted to our information age.”

We see this in the CAM movement. An entire network of websites and blogs has sprouted up over the last decade or so. CAM believers, if they wish, can peruse sites like NaturalNews.com, Mercola.com, and Whale.to, watch television shows like The Dr. Oz Show, and never see a single piece of information or study that challenges their world view that because it’s natural it must be better, that conventional, scientific medicine is hopelessly in the thrall of big pharma, and that modalities that are nothing more than magical thinking can cure disease. Similarly, anti-vaccine activists have their own set of websites, including Generation Rescue, Age of Autism, the NVIC, the Orwellian-named International Medical Council on Vaccination (formerly “Medical Voices,” and discussed by Mark Crislip and myself), SafeMinds, and many others. These CAM and anti-vaccine sites also have their own scientific-seeming meetings, such as Autism One (which, by the way, is fast approaching again) and the AANP.

Wrapped safely in such a cocoon, believers seldom encounter arguments against their cherished beliefs, much less strong arguments against them. No wonder they’re often so poor at defending their favorite woo when they dare to stray out of the safe confines of their little world. However, one interpretation of motivated reasoning that I’ve come up with states that you don’t actually have to be good at producing arguments that convince other people; you just have to be good enough to cherry pick arguments that convince yourself.

Politics, CAM, and the anti-vaccine movement

While Mooney’s summary for the evidence for motivated reasoning is compelling, he stumbles a bit in trying to ascribe different forms of motivated reasoning to the right and the left. While it is clear that certain forms of anti-science do tend to cluster either on the right or the left (for example, anthropogenic global warming denialism is definitely far more common on the right), if motivated reasoning is a valid hypothesis that describes well how human beings react to information that challenges their belief systems and values matter more (at least initially) than facts and science, then it would only be expected that certain forms of science would be viewed more hostilely by the right than the left while other scientific findings would be viewed more hostilely by the left. Unfortunately, one of the examples Mooney picks is fairly dubious:

So is there a case study of science denial that largely occupies the political left? Yes: the claim that childhood vaccines are causing an epidemic of autism. Its most famous proponents are an environmentalist (Robert F. Kennedy Jr.) and numerous Hollywood celebrities (most notably Jenny McCarthy and Jim Carrey). The Huffington Post gives a very large megaphone to denialists. And Seth Mnookin, author of the new book The Panic Virus, notes that if you want to find vaccine deniers, all you need to do is go hang out at Whole Foods.

It’s hard not to note right here that the founder of Whole Foods, John Mackey, is an anti-union Libertarian and admirer of Ayn Rand. In any case, I really hate it when people like Mooney try to pin anti-vaccine views as being mainly “on the left.” True, left-leaning crunchy types are the primary face of anti-vaccine views, but there is an entire underground on the right that is virulently anti-vaccine. These include General Bert Stubblebine III‘s Natural Solutions Foundation, far right libertarians, and others who want to protect their “purity of essence.” In addition, FOX News isn’t above pushing anti-vaccine nonsense. For example, of late the FOX and Friends crew has been doing sympathetic pieces on Andrew Wakefield, interviews with Dr. Bob Sears, SafeMinds’ anti-vaccine PSA campaign, Louise Kuo Habakus (who is virulently anti-vaccine herself and politically active in New Jersey pushing for transparent “philosophical exemption” laws. Politically, some of the most rabid anti-vaccine activists in government are conservative, for instance Representative Dan Burton. Moreover, conservative fundamentalist religion is not uncommonly a motivation for anti-vaccine views. Not surprisingly, Mooney’s example ignited a rather intense debate in the blogosophere, which included Mike the Mad Biologist, Razib Khan, Joshua Rosenau, Andrew Sullivan, David Frum, and Kevin Drum, among others.

This debate didn’t go very far in either direction because there aren’t actually a lot of good data examining whether there is a correlation between political affiliation and anti-vaccine views. Ultimately, Mooney followed up with a post on his blog in which he did the best he could do with polling data on the politics of vaccine resistance. Reanalyzing a poll from 2009 asking about Jenny McCarthy’s anti-vaccine views, specifically how many people were aware of them and how many were more or less likely to agree with them, Brendan Nyhan and Chris Mooney found:

So here are the results: Liberals (41% not aware, 38 % aware but not more likely, 21 % aware and more likely); Moderates (48% not aware, 28% aware but not more likely, 24% aware and more likely); Conservatives (49% not aware, 28 % aware but not more likely, 23% aware and more likely).

These results basically suggest that there’s little or no political divide in terms of who falls for Jenny McCarthy’s misinformation. Notably, liberals were somewhat more aware of her claims and yet, nevertheless, were least likely to listen to them. But not by a huge margin or anything.

Mooney also noted another poll done by Pew regarding whether vaccines should be mandatory:

What’s interesting here is that Pew also provided a political breakdown of the results, and there was simply no difference between Democrats and Republicans. 71% of members of both parties said childhood vaccinations should be required, while 26% of Republicans and 27% of Democrats said parents should decide. (Independents were slightly worse: 67% said vaccinations should be required, while 30% favored parental choice.)

Bottom line: There’s no evidence here to suggest that vaccine denial (and specifically, believing that childhood vaccines cause autism) is a distinctly left wing or liberal phenomenon. However, I will reiterate that we don’t really have good surveys at this point that are clearly designed to get at this question.

Even though the evidence is admittedly weak and more studies and surveys would definitely be in order, Mooney’s conclusion is nonetheless in line with my experience. I’ve said before many times that anti-vaccine views are the woo that knows no political boundaries. Although I don’t have hard scientific data to support this my contention and therefore can’t definitively discount the possibility that my observations represent confirmation bias, I’ve noticed that right wing anti-vaccine activists tent to be suspicious of the government and appeal to “health freedom” as a reason for their resistance to vaccination, and tend to eschew any societal obligation to contribute to herd immunity. Left wing anti-vaccine activists tend to be suspicious of big pharma and believe that vaccines are somehow “unnatural.” I realize my interpretation might be biased, but until better data are available it’s all I have to work with. Similarly, alternative medicine use tends not to fall into an easy left-right dichotomy either. My favorite example to illustrate this point is that, even though alternative medicine is viewed as a crunchy, “New Age” phenomenon more prevalent on the left, the Nazi regime actively promoted naturopathy and various other “volkish” alternative medicine modalities. I trust that now someone will invoke Godwin’s law, but forgive me; I was intentionally using an extreme example to illustrate my point that all parts of the political spectrum can be prone to quackery.

Finally, Mooney makes another point that I quibble with:

Well, according to Charles Taber and Milton Lodge of Stony Brook, one insidious aspect of motivated reasoning is that political sophisticates are prone to be more biased than those who know less about the issues. “People who have a dislike of some policy—for example, abortion—if they’re unsophisticated they can just reject it out of hand,” says Lodge. “But if they’re sophisticated, they can go one step further and start coming up with counterarguments.” These individuals are just as emotionally driven and biased as the rest of us, but they’re able to generate more and better reasons to explain why they’re right—and so their minds become harder to change.

I would quibble somewhat with whether, in the case of science and medicine at least, that apparent “sophisticated” understanding of the issues possessed by ideologues is actually as sophisticated as it appears on the surface. In some cases it might be, but far more often it’s a superficial understanding that has little depth, mainly because few lay people have the detailed scientific and medical background to apply the information. It’s often a matter of knowing facts, but not having the scientific experience, understanding of mechanisms, or sophistication to put them in context or to apply them to the situation properly. Thus, the arguments of, for instance, anti-vaccine advocates often have the veneer of scientific sophistication, but to those knowledgeable about vaccines are easily identified as utter poppycock. Examples abound, and include this “review” article by a man named David Thrower is, and every “scientific review” published by, for example, Age of Autism.

I can’t remember how many times that, while “debating” in misc.health.alternative, I would have a study quoted to me as supporting an antivaccination or other alternative medicine viewpoint and find that, when I actually took the trouble to look up the study and download the PDF of the actual article rather than just reading the abstract (which is all most lay people have access to and therefore all they read), I would find a far more nuanced and reasonable point or even that the article didn’t support what the altie was saying. One other aspect that often comes into play is an extreme distrust of conventional medicine and/or the government such that few individual studies that question the safety of vaccines are given far more weight in their minds than the many more studies that show vaccines to be extraordinarily safe or large metanalyses. Certainly this is one reason why the infamous Wakefield study, despite being shoddily designed and now thoroughly discredited, keeps rearing its ugly head again and again and continues to be cited by antivaccination activists as strong evidence that the MMR vaccine causes autism. Basically, what is happening here is that highly intelligent and motivated people can construct arguments that seem better to the uninformed.

One thing that must be remembered about motivated reasoning is that we as skeptics and supporters of science-based medicine must remember that, as human beings, we are by no means immune to this effect. Indeed, as Mooney points out, citing recent research, it’s quite possible that reasoning is a better tool for winning arguments than it is for finding the truth, and when motivated reasoning combine with the echo chamber effect of modern social groups bound together by the Internet and like-minded media, the result can be disastrous for science:

But individuals–or, groups that are very like minded–may go off the rails when using reasoning. The confirmation bias, which makes us so good at seeing evidence to support our views, also leads us to ignore contrary evidence. Motivated reasoning, which lets us quickly pull together the arguments and views that support what we already believe, makes us impervious to changing our minds. And groups where everyone agrees are known to become more extreme in their views after “deliberating”–this is the problem with much of the blogosphere.

Actually, I’m constantly asking myself when I’m writing one of these logorrheic gems of analytic brilliance if I really am being analytically brilliant or am I being selectively analytically brilliant in order to bolster my pre-existing beliefs and values? In other words, am I doing from the other viewpoint the same things that anti-vaccine zealots, for example, do when they cherry pick and misrepresent studies in order to support their beliefs that vaccines cause autism? Of course, that’s where our readers come in, as does the fact that I (and, I have no doubt, every other SBM blogger) frequently ask myself that very question. As Richard Feynman famously said, “The first principle is that you must not fool yourself – and you are the easiest person to fool.” Science is simply a method for minimizing the chance that you will fool yourself. To say “I saw it with my own eyes” is not enough, but that is what our brains are hard-wired to believe.

That’s one reason why I’m far less concerned about winning over committed ideologues. Although such a task is possible and people do change their minds, sometimes even about things very important to them, for the most part expecting to win over someone like J.B. Handley, Jenny McCarthy, or Barbara Loe Fisher is a fool’s errand. The people who need to be educated are the ones who are either on the fence or otherwise susceptible to pseudoskeptical, sophisticated-sounding arguments from denialists because they do not understand science or the issues. Although it will by no means be easy, such a goal is at least achievable.

This essay is the latest in the series indexed at the bottom.* It follows several (nos. 10-14) that responded to a critique by statistician Stephen Simon, who had taken issue with our asserting an important distinction between Science-Based Medicine (SBM) and Evidence-Based Medicine (EBM). (Dr. Gorski also posted a response to Dr. Simon’s critique). A quick-if-incomplete Review can be found here.

One of Dr. Simon’s points was this:

I am as harshly critical of the hierarchy of evidence as anyone. I see this as something that will self-correct over time, and I see people within EBM working both formally and informally to replace the rigid hierarchy with something that places each research study in context. I’m staying with EBM because I believe that people who practice EBM thoughtfully do consider mechanisms carefully. That includes the Cochrane Collaboration.

To which I responded:

We don’t see much evidence that people at the highest levels of EBM, eg, Sackett’s Center for EBM or Cochrane, are “working both formally and informally to replace the rigid hierarchy with something that places each research study in context.”

Hallafrickin’loo-ya

Well, perhaps I shouldn’t have been so quick to quip—or perhaps that was exactly what the doctor ordered, as will become clear—because on March 5^th, nearly four months after writing those words, I received this email from Karianne Hammerstrøm, the Trials Search Coordinator and Managing Editor for The Campbell Collaboration, which lists Cochrane as one of its partners and which, together with the Norwegian Knowledge Centre for the Health Services, is a source of systematic reviews:

I just wanted you to let you know that I have been playing around with the same thoughts as you express in the EBM/SBM Redux series; having come across related problems in other reviews and finding the laetrile review by chance – as well as following the SBM blog (strangely enough I corresponded with Dr. Ernst concerning laetrile the day before you posted your correspondence with him – he must be getting tired of these e-mails!). For this reason a colleague and I wrote a letter to Cochrane, a letter which they have, to my surprise, accepted as an editorial and which will be published in mid March, I believe (The SBM blog is duly credited). Just wanted to let you know, and also that the response from Cochrane has been overwhelmingly positive.

Thanks for a very interesting, entertaining and educating blog!

Well, with no small sense of self-satisfaction I thanked her and forwarded her email to the other authors here, who got a kick out of it, but then I kinda forgot about it until trusty SBM commenter Peter Moran posted a link to the promised editorial. Lo and behold, woodja look at the very first sentence! Its citation is the post in which I’d dismissed Dr. Simon’s assertion about Cochrane placing research studies in context, and in which I reported my correspondence with Dr. Ernst regarding the Cochrane Laetrile review. But yes, I may have been a bit too facile in my dismissal of Prof. Simon’s contention, because it’s clear from the editorial and its ‘feedback’ that others, even among Cochrane reviewers themselves, have been similarly bothered. The problem, elsewhere dubbed EBM’s ‘scientific blind spot,’ nevertheless remains the rule rather than the exception. Two of the three feedback letters that are available as of this writing, moreover, don’t fully grasp the point.

Those of you who’ve been following this series know that I’ve already mentioned an exception to the EBM scientific blind spot at Cochrane, regarding its Laetrile review. It’s found not in the review itself, but in the form of Feedback from another Cochrane reviewer, who made arguments similar to my own. Today I’ll discuss another exception, the best that I’ve found so far, and for the second time today I’ll tip my hat to Scandinavians.

Intercessory Prayer

A 2009 revision of “Intercessory prayer for the alleviation of ill health” begins as follows:

This revised version of the review has been prepared in response to feedback and to re?ect new methods in the conduct and presentation of Cochrane reviews.

There are interesting changes in this revision, some of them having to do with what we’ve been talking about. Let’s go right to the punch line. The first sentence is old hat; the second is nearly revolutionary for EBM:

Authors’ conclusions

These ?ndings are equivocal and, although some of the results of individual studies suggest a positive effect of intercessory prayer, the majority do not and the evidence does not support a recommendation either in favour or against the use of intercessory prayer. We are not convinced that further trials of this intervention should be undertaken and would prefer to see any resources available for such a trial used to investigate other questions in health care.

Wow! Previous iterations of this review, spanning about a decade, had made the customary call for “further study.” What changed? Don’t get too excited, even though I’ve been goading you: what the authors left unstated were their reasons, intuitive though they might have been, for not being “convinced that further trials should be undertaken.” That, I suppose, would’ve been just too dicey.

Before discussing what actually changed, let me explain a couple of key features of this review. First, the authors take pains to acknowledge but, er, distance themselves from religious implications:

How the intervention might work

The mechanism(s) by which prayer might work is unknown and hypotheses about this will depend to a large extent on religious beliefs. This review seeks to answer the question of effect not mechanism and it does not seek to answer the question of whether any effects of prayer con?rm or refute the existence of God…

…the results of this review will be of interest to those who are involved with the ‘debate about God’ – both religious believers and atheists – but these results cannot directly stand as ‘proof ’ or ‘disproof ’ of the existence of God…We do not, therefore, seek to pose or answer any questions about the existence of God with this review.

They observe that there are “several challenges” in performing such trials, naming “contamination” (people outside of the study likely to be praying for the same patients) and “blinding” (when the putative agent of the effect is an omniscient being). However, assert the authors,

…these are theological questions, and this review proceeds on scienti?c principles in that it is a widely held belief that intercessory prayer is bene?cial for those who are unwell because God directs the outcome of those for whom prayers are offered differently from those for whom it is not. As noted above, we are not seeking to assess whether God is or is not the agent of action for prayer but, by using the same study designs used to test other interventions in healthcare we will assess the effects of the intervention. For this reason we also exclude from consideration such theological considerations as the injunction “Do not put the Lord your God to the test” (Deuteronomy 6:16) or questions as to whether God generally veils his presence from observation: in the words of the philosopher GF Hegel, “God does not offer himself for observation” (Hegel 2008).

Given their determination to measure “effect not mechanism” and to exclude theological considerations, it seems paradoxical that the authors chose to exclude “distant healing” (DH) studies that “may have included an element of prayer but did not specifically involve personal, focused, committed and organised intercessory prayer on behalf of another alone.” Thus they excluded one of the most famous, purportedly ‘positive’ studies in the field, which had recruited 40 “Healers” with

…an average of 17 years of experience and [who] had previously treated an average of 106 patients at a distance. Practitioners included healers from Christian, Jewish, Buddhist, Native American, and shamanic traditions as well as graduates of secular schools of bioenergetic and meditative healing.

Those ‘healers’ were told “to ‘direct an intention for health and well-being’ to the subject.” Thus, even though there was a religious theme to the choice of ‘healers,’ the imagined ‘mechanism’ of healing was decidedly psychokinetic—it was linear rather than angular, or non-stop rather than 1-stop, if you catch my drift. This was in keeping with the interests of the most important co-author, the late Elisabeth Targ, previously mentioned here.

That’s why the Cochrane authors excluded it and similar DH studies, but c’mon: an influential group of ‘CAM’ enthusiasts, including Targ, Larry Dossey, Victor Sierpina (Distinguished Teaching Professor at the University of Texas Medical School), Mehmet Oz (heh), Marilyn Schlitz (a former member of the NCCAM advisory council), naturopath Leanna Standish (also a former member of the NCCAM advisory council and the Director of Research at the Bastyr University AIDS Research Center), Andrew Weil, Kenneth Pelletier, James Gordon (Chairman of the White House Commission on Complementary and Alternative Medicine Policy), Jeanne Achterberg (who, together with Dossey and Gordon, chaired the “Mind-Body” panel of the 1992 “Workshop on Alternative Medicine,” whose report has debased medicine and medical research for nearly two decades), and many more fairly gush over the potential of ‘nonlocal healing.’ There’s a lotta research money wasted there, so it’s too bad that Cochrane hasn’t offered the same conclusion about the non-stop version of DH that it now has about the layover kind.

I also wonder if the reviewers would have included Targ’s study if that particular exclusion had not held, because Targ was later revealed to have rigged her study to yield “positive” results. She did this after the fact but before the publication, by “data dredging.” I’ve come to expect Cochrane reviewers to remain blissfully ignorant of such departures from polite methodology. Consider their ingenuous response to the Olszewer paper in the chelation review. In this “intercessory prayer” (IP) review are examples that needn’t require the reviewers to venture from the papers themselves. The review characterizes the most famous early ‘positive’ study, Byrd 1988, as double-blinded. That, presumably, follows from this statement in Byrd’s Methods section:

Patients were randomly assigned (using a computer-generated list) either to receive or not to receive intercessory prayer. The patients, the staff and doctors in the [coronary care] unit, and I remained “blinded”, throughout the study. As a precaution against biasing the study, the patients were not contacted again.

Well, OK, but consider this statement in the very next paragraph (emphasis added):

The patients’ first name, diagnosis, and general condition, along with pertinent updates in their condition, were given to the intercessors.

It seems that someone with access to that coronary care unit (CCU) musta not been blinded, and could easily have revealed subject allocation to the subjects themselves and to others. Just sayin’.

The review is ambivalent about the Byrd Score, a composite “severity” score that Byrd devised ostensibly to deal with the problem of multiple outcomes. Here are the results of those outcomes:

Byrd Table 2

Hmmm. The difference that jumps out at you is the incidence of congestive heart failure (CHF). All other differences reported to have achieved statistical significance—use of diuretics, intubation/ventilation, pneumonia, antibiotics, and even cardiopulmonary arrest—likely followed from CHF or from a common antecedent. Since such key outcomes as mortality and duration of CCU and hospital stay were no different between the two groups (surprising given the poor prognosis of CHF, especially 23 years ago), it seems reasonable to discount the CHF difference as either spurious or, as the Cochrane authors correctly acknowledged, due to chance in the context of multiple outcomes.

Not acknowledged by the reviewers were other curious findings in Byrd’s table: if 14 subjects in the control group suffered cardiopulmonary arrest—which involves a blood pressure of approximately zero—how could only 7 subjects in that group have experienced systolic blood pressures below 90? How could only 3 subjects in the IP group have suffered cardiopulmonary arrest—the final common pathway of dying, other than for the special category of ‘brain death’—when more than 4 times that many (13) actually died? Oh yeah, and dead people also have blood pressures below 90, except, apparently, several in each of the groups reported here. I dunno about you, but I’d like to think that any reasonably intelligent physician or scientist would look at that table for a couple of minutes and conclude, “Nope. Nuthin’ goin’ on there.”

The Cochrane reviewers included a study of “retroactive intercessory prayer.” Yup, it means what you’re afraid it means, your double-take notwithstanding. I am not making this up: Check it out.

All right, you must be thinking, so far I’ve shown you nothing but reasons to be more pessimistic than ever about Cochrane ‘CAM’ Reviews. Next they’ll be declaring that there is not enough evidence either in favour or against the use of exorcisms for demonic possessions, f’crissakes. But remember, the very same reviewers who went for time travel also politely called for a halt in intercessory prayer trials, so something must have swayed them.

Feedback

The answer seems to be found in two Feedback letters. The second is identified only as having been written by “Chris Jackson, anaesthetist.” I don’t know where he or she is from, but I’m guessing he’s what we in the U.S. call an ‘anesthesiologist.’ That’s what I am! Chris, you make me proud. This letter apparently jolted the Cochrane reviewers into noticing that a study they’d included for years, the infamous Cha Intercessory Prayer for IVF study, was, well, infamous enough to finally exclude (in 2009). Jackson also wrote that “RCTs of prayer are meaningless…There’s a lot of pseudoscience being done in this area,” which the reviewers, alas, didn’t buy.

The first Feedback letter is much longer, more adamant and less polite, and—what a kick!—written by other Cochrane reviewers. It begins with condemnation:

This review is riddled by serious flaws such as lack of critical appraisal of the included trials and findings, lack of a necessary discussion of the relevant sources of bias, and undue interference of theological reasoning.

It ends with a call for banishment:

This review does not live up to the scientific standards one can reasonably expect of a Cochrane review. The review as currently published should be withdrawn from the Cochrane Library, not least because it suggests that all scientific studies are meaningless, as we will never know whether one or more gods intervened in our carefully planned experiments.

The authors of this letter are identified as Karsten Juhl Jørgensen, Asbjørn Hrobjartsson and Peter C. Gøtzsche, from the Nordic Cochrane Centre, Rigshospitalet Dept. 3343, Copenhagen, Denmark. The cognoscenti among you might recognize Hrobjartsson and Gøtzsche as the authors of several reviews questioning the ‘power of the placebo,’ a topic that they’ve also reviewed for Cochrane.

I’m happy to report that I needn’t quote any more excerpts from that Feedback letter, even though you can’t read it without paying for the full review, because there’s an even better source. Jørgensen and colleagues turned their letter into a full article that you can read online in the aptly-named Journal of Negative Results in Biomedicine: “Divine Intervention? A Cochrane review on intercessory prayer gone beyond science and reason.” They make several of the points made above and elsewhere in this series (citing Bayes, for example), and many more, because unlike your semi-faithful blogger they were not too impatient to slog through the tedious religious formulations in the Cochrane IP review.

I suspect that it was this article and its associated Feedback letter that led the Cochrane IP reviewers to reverse their previous call for further studies, even if they failed to heed most of the arguments made by Jørgensen et al. Unfortunately, you would only know the last point if you had access to the full Cochrane review, where the exchange is found.

This post is already way too long, so I’ll end by telling you the most amusing example. By now I’m sure you either know or suspect that the “retroactive intercessory prayer” study included in the Cochrane IP review was a joke that the Cochrane reviewers didn’t get. The Danes explained this both in their article and in their Feedback letter, even providing a reference to a subsequent letter by the “retroactive” author in which he pretty much cops to the joke. The Cochrane reviewers, notwithstanding, responded:

Comments made about the Christmas issue of the BMJ and the Leibovici 2001 study in particular are not fully accurate. Several articles in the late December issues of the BMJ are written with humour and some in pure spoof. Most are not. They may be written with humour and have an odd perspective, but are, nevertheless, interesting and well thought out research. The Leibovici 2001 was not in jest. It is a rather serious paper, intended as a challenge.

Yikers.

…………

*The Prior Probability, Bayesian vs. Frequentist Inference, and EBM Series:

1. Homeopathy and Evidence-Based Medicine: Back to the Future Part V

2. Prior Probability: The Dirty Little Secret of “Evidence-Based Alternative Medicine”

3. Prior Probability: the Dirty Little Secret of “Evidence-Based Alternative Medicine”—Continued

4. Prior Probability: the Dirty Little Secret of “Evidence-Based Alternative Medicine”—Continued Again

5. Yes, Jacqueline: EBM ought to be Synonymous with SBM

6. The 2nd Yale Research Symposium on Complementary and Integrative Medicine. Part II

7. H. Pylori, Plausibility, and Greek Tragedy: the Quirky Case of Dr. John Lykoudis

8. Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 1

9. Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 2

10. Of SBM and EBM Redux. Part I: Does EBM Undervalue Basic Science and Overvalue RCTs?

11. Of SBM and EBM Redux. Part II: Is it a Good Idea to test Highly Implausible Health Claims?

12. Of SBM and EBM Redux. Part III: Parapsychology is the Role Model for “CAM” Research

13. Of SBM and EBM Redux. Part IV: More Cochrane and a little Bayes

14. Of SBM and EBM Redux. Part IV, Continued: More Cochrane and a little Bayes

15. Cochrane is Starting to ‘Get’ SBM!

Calcium is good for us, right? Milk products are great sources of calcium, and we’re told to emphasize milk products in our diets. Don’t (or can’t) eat enough dairy? Calcium supplements are very popular, especially among women seeking to minimize their risk of osteoporosis. Osteoporosis prevention and treatment guidelines recommend calcium and vitamin D as an important measure in preserving bone density and reducing the risk of fractures. For those who don’t like dairy products, even products like orange juice and Vitamin Water are fortified with calcium. The general perception seemed to be that calcium consumption was a good thing – the more, the better. Until recently.

In a pattern similar to that I described with folic acid, there’s new safety signals from trials with calcium supplements that are raising concerns. Two studies published in the past two years suggest that calcium supplements are associated with an significantly increased risk of heart attacks. Could the risks of calcium supplements outweigh any benefits they offer?

Why Calcium? Osteoporosis

Osteoporosis is a progressive bone condition of reduced bone mass and deterioration of bone tissue, and a correlating increase in fracture risk. 80% of those diagnosed are women. Hips and spines are the most common fracture locations, but they can appear in any bone, and osteoporosis makes fractures more likely. In postmenopausal women over the age of 50, the lifetime risk of a vertebral fracture is about one in three, and one in five for a hip fracture. Because they are so common, hip and vertebral fractures cause considerable aggregate and individual morbidity and mortality. So prevention and treatment are major health issues.

The initial strategy to preventing and managing osteoporosis is ensuring adequate calcium and vitamin D dietary intake, as both influence bone density. Calcium intake influences overall calcium balance: adequate vitamin D and calcium ensure calcium balance is positive. This occurs at about 1000mg per day in premenopausal women, and 1500mg per day in postmenopausal women not taking estrogen. The North American Menopause Society’s (NAMS) 2006 osteoporosis guidelines recommends [PDF] adequate calcium and vitamin D for all postmenopausal women, regardless of osteoporosis risk factors. The guidelines note that requirements increase with age owing to reduced absorption, and recommending adequate intake (preferably via diet) as the preferred sources. The 2010 Canadian guidelines [PDF] are similar, recommending 1200mg of calcium (diet and supplements) and vitamin D for all individuals over the age of 50. The Institute of Medicine recently updated its calcium and vitamin D guidelines (pdf) as well. It concluded with the caution that the consumption of levels beyond those recommended have not been shown to offer additional health benefits, and may in fact be linked to other health problems.

The effectiveness of calcium and vitamin D for the prevention and treatment of osteoporosis has been studied in both observational and prospective clinical trials. Wile there are data to demonstrate that calcium and vitamin D can prevent bone loss, the data on fracture prevention are much less convincing, with some trials showing no effect. Beyond density effects, calcium is also associated with generally positive effects on muscle strength, balance, and the risk of falls. So for most men and women with (or at risk of) osteoporosis, calcium and vitamin D are standard treatments. Given dietary intake in those at greater risk of osteoporosis may be below recommended levels, supplements are often used to meet recommended amounts.

The Safety Signals

Prior studies of calcium supplements have pointed to a possible relationship between calcium supplementation and cardiovascular events. Bolland et al specifically examined the relationship of calcium with the risk of heart attacks and cardiovascular events in a 2010 BMJ meta-analysis. It included all RCTs of calcium supplements (?500 mg/day), with a study size of 100 or more participants, an average age over 40, and a duration of more than one year. Trials that included vitamin D as an intervention were excluded. 15 trials were identified: some with patient-level data, and some with trial level data. Analyses of both sets of data identified a significant increase in heart attacks in those randomized to calcium supplements. The trial-level analysis show a hazard ratio (pdf) of 1.27 with a 95% confidence interval of 1.01 to 1.59 (p=0.038). The patient level analysis revealed a similar hazard ratio for myocardial infarction of 1.31 (95% confidence interval 1.02 to 1.67, p=0.035). Overall, the analysis suggests that calcium supplements increase the relative risk of myocardial infarction by about 30%. Reassuringly, there were no statistically significant increases in the risk of stroke, death, or the composite endpoint of MI+stroke+death in either analysis. Based on the patient-level data, the authors estimated that treating 69 people with calcium for five years will cause one additional heart attack. The authors suggested that in light of calcium’s unimpressive efficacy against fractures, that calcium’s role in osteoporosis prevention and treatment should be reevaluated.

Time to stop the calcium? As noted above, the data to support the use of calcium supplements alone to prevent fractures are, on balance, unimpressive. And there are possible models for how calcium could be causing these harms: vascular calcification is a potential (though not proven) consequence that might be more likely in the elderly patients. However, given calcification can take years, and harms appear shortly after dosing starts, it could be a due to effects on carotid plaque thickness, leading to aortic calcificiation, and subsequent cardiovascular events. (Reid describes potential mechanisms for these harms in a2010 paper in Clinical Endocrinology.)

What happened after this paper was released? There were criticisms of the endpoints, and the fact the composite endpoint was not significant. Concerns were also raised that the trials included were not designed with cardiovascular endpoints – a valid criticism. And many pointed to the fact the studies excluded vitamin D, contrary to treatment guidelines and common use. Now the same group has done a new analysis, incorporating vitamin D. Bolland and associates followed up their calcium-only therapy with a study of calcium + vitamin D. They used the Women’s Health Initiative (WHI) dataset to answer the vitamin D question, added in some other studies, and redid their meta-analysis.

The WHI was a massive 15-year trial of over 161,000 women that sought to answer a number of questions about women’s health. The most well known components were the hormone therapy trials which changed our understanding of the risks and benefits of hormone treatments. The calcium and vitamin D study was a component of the WHI which randomized 36,282 postmenopausal women aged 50-79 into two groups. One group received 1,000 mg of calcium carbonate and 400 UI of vitamin D once daily, the other, placebos. Interesting in the design was that 54% of women were already taking calcium, and 47% were already taking vitamin D, and they were allowed to continue with their therapy, even after randomization. This meant that actual calcium and vitamin D doses women consumed varied from zero to substantially more than the intervention dose. The clinical question the study sought to answer was to understand the effects on fracture risk and the prevention of colorectal cancer — and the results were disappointing: no effects on colorectal cancer, and insignificant effects on fractures (though in a subgroup analysis of compliant patients, significant reductions in hip fractures were noted.)

Bolland sought to analyze the WHI data for cardiovascular effects, and then add these data into the previous meta-analysis. In the over 16,000 women not taking their own calcium and vitamin D, there was a significant increase (hazard ratio 1.22) in myocardial infarction noted in the group randomized to calcium and vitamin D (p=0.04, 95% CI 1.00 to 1.50). Similarly, significant effects were also noted in other composite endpoints. In contrast, women taking their own calcium and vitamin D didn’t show any changes in their cardiovascular risk when randomized to calcium and vitamin D. In addition, no relationship was found between calcium dose and risk of cardiovascular events.

The authors then pooled their own WHI analysis with two other studies of calcium and vitamin D where trial-level data for cardiovascular events were available: In total, over 20,000 participants could be studied. In this pooled analysis, calcium and vitamin D were associated with a significant increases in myocardial infarction (relative risk 1.21), stroke (RR 1.20) and a composite endpoint of both (RR 1.16).

Finally the authors combined the trial level data from their calcium-only meta-analysis with their trial level calcium plus vitamin D data:, resulting in a pool of over 28,000 patients across nine trials. In this analysis, there was risk increase of 1.24 (95% confidence interval 1.07-1.45, P=0.004) for myocardial infarction and 1.15 for the combined endpoint (1.03-1.27, P=0.009).

Difficult to interpret? Yep. The lack of effect of “personal” use of calcium on endpoints, and the lack of dose response, means this isn’t case closed for the clinical question. But the persistent and significant correlation between randomization to calcium, with or without vitamin D, and myocardial infarction, does concern me. There are a number of additional criticisms outlined in the editorial that accompanied the Bolland WHI analysis, and the keen reader is referred there for more.

Evaluation

Is it possible that calcium supplements can be causing harms that could outweigh their benefits? Yes, but the evidence isn’t clear enough to give an definitive answer. These data need to be factored into individual evaluations of diet as well as risk factors for cardiovascular disease and osteoporosis. I’d like to see these findings validated by other groups, as both meta-analyses came from the same group of researchers. The meta-analysis can be a very useful tool, but it’s not without its own limitations, as is often pointed out by the contributors to this blog. Interestingly, a 2010 meta-analysis, from a different group of authors, and using a different methodology, has come to a different evaluation of calcium. So the question remains an open one. More data may help refine our estimates of number needed to treat, and number needed to harm, to inform treatment decisions. And it should help guide advice for younger, premenopausal women, as well as men. So until more data emerges, my tentative recommendations to consumers are as follows:

• Calcium supplementation has been associated with increased risks of cardiovascular events like heart attacks. Until there is more evidence to confirm or refute this association, it’s prudent to be cautious when taking calcium supplements.
• No harms have been shown from calcium consumption via dietary sources. Efforts should be made to first meet dietary requirements through food products, before considering supplements.
• Routine supplementation, in the absence of a dietary deficiency, is not necessary or advisable.
• Calcium supplements may still be advisable for those with low dietary intakes, or those at risk of or being treated for osteoporosis. The risk-benefit assessment for calcium supplements needs to consider risk factors for both osteoporosis and for cardiovascular disease.
• Vitamin D supplements are advisable for most people, and are recommended for the prevention and treatment of osteoporosis. The suggested doses of calcium and vitamin D may vary based on diet, medical conditions, and other considerations. Sources for target doses could include the IOM or recent osteoporosis guidelines (Canada) (USA).

Conclusion

The emerging safety data on calcium may yet become another cautionary tale about the unexpected and undesirable outcomes of targeted supplements. Until more evidence emerges, the safety of calcium supplements will continue to be questioned and debated. But that’s science-based practice: Data can be conflicting, messy, and difficult to interpret. There is always the possibility of unintended consequences when we make therapeutic decisions, and only by rigorously evaluating what we’re doing can we continue to improve the way we prevent and treat disease.

References
Bolland MJ, Avenell A, Baron JA, Grey A, MacLennan GS, Gamble GD, & Reid IR (2010). Effect of calcium supplements on risk of myocardial infarction and cardiovascular events: meta-analysis. BMJ (Clinical research ed.), 341 PMID: 20671013

Bolland, M., Grey, A., Avenell, A., Gamble, G., & Reid, I. (2011). Calcium supplements with or without vitamin D and risk of cardiovascular events: reanalysis of the Women’s Health Initiative limited access dataset and meta-analysis BMJ, 342 (apr19 1) DOI: 10.1136/bmj.d2040

NOTE: Dr. Novella has written up a detailed description of his experiences on The Dr. Oz Show. Please read it. Also note that the online video for Dr. Novella’s appearance is now available:

1. Controversial Medicine: Alternative Health, Part 1
2. Controversial Medicine: Alternative Health, Part 2
3. Controversial Medicine: Alternative Health, Part 3

When I first learned that our fearless leader and partner in crime for this blog, Dr. Steve Novella, Yale neurologist, blogger, and host of the popular skeptical podcast the Skeptics’ Guide to the Universe was going to be on The Dr. Oz Show, I was concerned. After all, this is the same physician who had in essence given up science-based medicine in favor of media stardom based on the promotion of alternative medicine. Of late Dr. Oz has been getting worse, too, promoting pseudoscience and what can only be described, in my opinion, as quackery. The snake oil that Dr. Oz has promoted over the last several months includes Dr. Joe Mercola, one of the biggest promoters of “alternative” health, whom Dr. Oz first had on his show about a year ago and then defiantly defended in a return appearance in early 2011, to be followed by a rapid one-two punch in which Dr. Oz had an ayurvedic yogi named Cameron Alborzian, who promoted highly dubious medicine, including “tongue diagnosis,” to be followed a few days later by something I would never, even in my most cynical assessment of Dr. Oz, expected, namely the appearance of faith healer Issam Nemeh on his show. ext Dr. Oz endorsed a diet that he once eschewed as quackery and then, to top it all off, invited psychic John Edward onto his show, asking Is talking to the dead a new kind of therapy? All of these offenses contributed to the reasons why in 2011 the James Randi Educational Foundation awarded him the The Media Pigasus Award for the second year in a row.

So right from the start I wasn’t very optimistic about how this whole thing would turn out. Fortunately, however, I was pleasantly surprised. Steve managed to hold his own in a completely hostile environment, with Dr. Oz asking him “Have you stopped beating your wife?”-style questions, with only minor stumbles. At one point, he even managed to hand Dr. Oz his posterior. Alas, I doubt it will make any difference to Dr. Oz’s viewers, but we can always hope to change a few minds. I also realize that, however a big deal being on Dr. Oz’s show was to Steve and many members of the skeptical movement (especially supporters of SBM), to Dr. Oz it was just one segment in one episode of one season of a daily talk show made up of well close to 150 episodes. Not to detract from Steve’s achievement at all (it’s truly amazing that he managed to get on the show and do as well as he did, given how the deck was stacked against him), but to us this is big; to Dr. Oz it’s just another episode. It’s entertainment. As giddy and anxious as we at SBM have been the last two weeks, we have to keep things in perspective.

So what happened?

As I watched the beginning of the segment, my experience having watched several episodes of Dr. Oz’s show led me to look for the not-so-subtle signs of the story that Dr. Oz and his producers intended to portray. In a television show like Dr. Oz’s, you always have to look for the story, and the story is revealed by how the issue being discussed is framed. I didn’t have long to wait. One thing I thought as I watched the opening minutes of this episode of Dr. Oz’s show is that that watching Oz really reminded me of was Kevin Trudeau, whose strategey for spreading snake oil was implicit in the title of his book, Natural Cures “They” Don’t Want You to Know About. The message is the same as Dr. Oz’s. It’s you (as in Dr. Oz’s audience or Kevin Trudeau’s readers) against the establishment. The Man is trying to keep you down and keep you from The Truth (a.k.a. “natural cures” that don’t rely on big pharma)! So, what are you, sheeple? Or are you among the enlightened, like Dr. Oz and his viewers? Why is your doctor afraid of alternative medicine? (Yes, that was the title of the segment.) It’s an appeal both to the appeal of outsider status and to the vanity of Dr. Oz’s audience. His audience is encouraged to feel not just like a maverick, bucking the system, but to feel superior than everyone else, “empowered” to “fight the power.” Right from the start, Dr. Oz frames the issue of “alternative medicine” as the little guy versus dogmatic physicians, as “taking control” from undefined outside forces. In doing so, he paints himself as the champion of the little person, willing to risk everything to tell his audience The Truth. It’s a load of fetid dingos’ kidneys of course. Dr. Oz is fabulously wealthy and famous in a large part because he’s embraced alternative medicine and found a way to preach it to the masses, all wrapped up in a lovely bit of framing:

Today I’m taking on a controversial issue in medicine that has everything to do with helping you take control of your health. There are a lot of doctors, including me, who are putting their reputations on the line because we’re using alternative therapies in our traditional practices. But many doctors claim that these therapies are nothing more than junk science and may even be dangerous. Your doctor could be one of them. Why are they so afraid of alternative medicine? Should you be too?

Note the “brave maverick doctor” pose. I have no idea if Dr. Oz is aware of this or not, but this is the same pose that quacks who think vaccines cause autism frequently take, that only they are “brave” enough, clever enough, or “open-minded” enough to reject that nasty, reductionistic “Western” science. Dr. Oz then uses the fallacy of argumentum ad populum; i.e., proclaiming that, since alternative medicine has “reached its tipping point” (in his opinion, at least) and people spend $35 billion a year on it in this country, that there must be something to it. It’s a silly argument. Lots of things are very popular; popularity doesn’t equal “scientifically valid.” I do have to admit one thing that made me totally chuckle here. Dr. Oz referred to chiropractic as “chiropractics.” I mean, seriously, Dr. Oz. If you can’t at least get the terminology right about something as commonplace as chiropractic, I find it very hard to take you seriously. Very hard indeed, even more so after he trots out the “superstars of alternative medicine” that he’s showcased on The Dr. Oz Show, including Andrew Weil, Christiane Northrup, Joe Mercola, and Deepak Chopra, to name a few.

Of course, there wouldn’t be any drama if there weren’t any “holdouts,” which is how the argument is framed. It’s very clever. Dr. Oz is the brave, open-minded doctor willing to try things outside the mainstream. Skeptics and proponents of science-based medicine are portrayed as going against the flow, as negative, as “holdouts” against what is portrayed as the inevitable triumph of alternative medicine, when the moon will be in the seventh house and Jupiter will align with Mars. And Dr. Oz is persecuted for it, too. Those nasty skeptics! They’ve portrayed him as having abdicated professional responsibility and gone to the Dark Side. Nasty skeptics!

Dr. Oz’s offense, real or imagined, aside, I’m much less amused by how Dr. Oz panders to his audience. It begins right at the very start of the segment, where Dr. Oz proclaims that you–yes, you!–his viewers (well, maybe not you, as in you who read this blog) “aren’t afraid to test the time-honored traditions of alternative medicine.” That’s because, obviously, if you watch Dr. Oz’s show, you must be a brave maverick, just like him. You’re the brave maverick, and he’s the brave maverick doctor–a perfect combination! If you’re not afraid of alternative medicine, then why should is your doctor? (Yes, Oz actually said that.) All of this was just the introduction, at which point the framing was complete. It’s Oz and his viewers against the world, which leads Oz to the very first question to Steve:

Why are there so many doctors out there–and doctors are our viewers–who don’t like alternative medicine? Why do you not want me to talk about these therapies on the show?

More framing. Notice now that Oz frames alternative medicine as a preference. To Oz and his viewers, doctors who support science-based medicine don’t object to alternative medicine because it is unscientific, because there’s no evidence that most alternative therapies work and a lot of evidence that they don’t, or because it’s a false dichotomy. (Yes, I’m talking about the fact that alternative medicine is by definition medicine that has not been shown to work scientifically or has actually been shown not to work. It can never be repeated too many times in this context that alternative medicine that has been shown to work scientifically ceases to be “alternative” and becomes just “medicine.”) Oh, no, those doctors just don’t like it, as many people don’t like Brussel sprouts, or as some people prefer Coke over Pepsi (or vice-versa). It’s a preference that doctors are trying to impose on their patients, those nasty, reductionist, doctors! Worse, as the language used by Dr. Oz reveals, not only is this opposition to alternative medicine a mere “dislike,” but it’s a “Western” dislike. Yes, Oz kept repeating the term “Western medicine” or “Western science,” another false dichotomy. Good science is good science; it doesn’t matter whether it was done in the “West” or the “East.”

Notice also how Oz takes on the mantle of the victim. It’s not about him talking nonsense about science and medicine, about him promoting quackery (which he has been doing a lot of in 2011). Oh, no! It’s all about skeptics like Steve trying to shut Dr. Oz up! As if we could! It’s a silly argument, obviously custom made to try to portray Dr. Oz’s critics and close-minded, dogmatic, simpletons. In reality, this is a distortion of our position. Nothing could be further from the truth to claim that supporters of SBM don’t want Dr. Oz to talk about these therapies. What we don’t want him to do is to promote them as efficacious when scientific findings indicate that they are not. What we want is a skeptical, science-based assessment of them. Despite the claim by Dr. Oz and his producers that we are “afraid” of alternative health, in actuality we crave an open dialogue based on science, both preclinical and clinical trials, not marketing hype, pseudoscientific claims, and testimonials.

After some minor stumbling, Steve explained very well how the very concept of alternative medicine is an artificial category that exists primarily to produce a double standard that favors modalities that can’t cut it based on science. Unfortunately, as is frequently the case in such “debates,” Steve was paired with a true believer, Dr. Mimi Guarneri, who did exactly what it is that I complain about all the time. She used the classic “bait and switch” of alternative medicine, claiming nutrition, exercise, and the like as “alternative” and then proclaiming them as not being “alternative.” Steve answered that quite well also, but I doubt it got through the audience. Much of the talk was dominated by herbs and supplements, rather than the more bizarre quackery that Dr. Oz has featured on his show in 2011, such as homeopathy, faith healing, and the psychic scammer John Edward. No doubt this is intentional, because herbs and supplements are at least potentially real drugs (impure drugs with highly variable quantities of the active ingredient, but drugs nonetheless). As such, they are the “bait,” used to lure in the credulous, after which the “switch” is made for the real woo, modalities like acupuncture, homeopathy, reiki, and the like.

One thing that cracked me up is that Oz defined alternative medicine rather artificially by dividing it into three categories. Why three? who knows? Perhaps it’s like the Holy Hand Grenade of Antioch, you know, “…then shalt thou count to three, no more, no less. Three shall be the number thou shalt count, and the number of the counting shall be three. Four shalt thou not count, neither count thou two, excepting that thou then proceed to three. Five is right out.” Whatever the reason for choosing the number three, Oz divides alternative medicine into things you can put in your mouth, things that are done to your body, and the “mind-body” connection. For each one of these divisions, Dr. Oz showed a brief video promoting their glories. Particularly irritating and, quite frankly, dishonest, is how Dr. Oz at each point tries to turn around Steve’s statements about how various alternative medical therapies have been studied and found not to work into a straw man in which a distorted version of Steve’s argument is repeated back to him, represented as saying that there aren’t any studies or that there aren’t enough studies. Dr. Oz and Dr. Guarneri then bat that straw man down with gleeful abandon. At one point, Oz even says, “I totally disagree that these have not been studied and some evidence been found to support them.” Of course, “some evidence” has been found to support that most ridiculous of quackeries, homeopathy; one has to look at the totality of evidence to know that not only is homeopathy ridiculous from a basic science standpoint but that the clinical evidence that exists is most consistent with nothing more than placebo effects.

The utter intellectual bankruptcy of this approach was demonstrated when Dr. Oz brought in Catherine Ulbricht, PharmD, MBA[c], chief editor of Natural Standard and editorial board member of Natural Medicine Journal, who touted Natural Standard. One thing I noticed about the journal for which she is on the editorial board is that it is the official journal of the American Association of Naturopathic Physicians (AANP), which is definitely a strike against it right there. (Actually, it’s two strikes.) Naturopathy is a hodge-podge of mostly unscientific treatment modalities based on vitalism and other prescientific notions of disease that fancies itself to be science-based. In fact, as if to emphasize the connection between Dr. Ulbricht and naturopathic quacks, I found in my e-mail box a mass mailing from the AANP touting her appearance on The Dr. Oz Show. Such are the “benefits” of being on the AANP mailing list. Let’s just put it this way. Dr. Ulbricht has published at least one review of homeopathic remedies, specifically Oscillococcinum, in which she concludes that it probably works and that more studies are needed. Amusingly, in the segment that follows Steve’s segment, Dr. Ulbricht even invokes the alt-med cliche of aspirin having been derived from willow bark and being perfectly safe. Of course, natural product pharmacology is in no way “alternative” (more bait and switch), and aspirin is not without risks, sometimes life-threatening.

If there’s one area that Steve managed to score against Dr. Oz in spite of the deck being stacked against him, it’s acupuncture. Steve pointed out that it doesn’t work above and beyond a placebo. As I like to say, it doesn’t matter where you stick the needles and it doesn’t even matter if you stick the needles. The results are the same, and there is a small risk to sticking needles into people’s bodies. Dr. Oz’s reaction is very telling; he says:

There are billions of people around the world who use as the foundation of their healthcare system. It’s the basis of ancient Chinese medicine. I just think it’s very dismissive of you to say because we couldn’t take this idea that exists with a different mindset and squeeze it into the way we think about it in the West then it can’t be possibly effective.

All of which is utter nonsense. First, it’s very arguable whether there are “billions of people” who use acupuncture as the foundation of their health care system. The Chinese, for instance, are actually moving away from traditional Chinese medicine and acupuncture back towards that evil reductionistic “Western” medicine because it works. But even more telling is that Dr. Oz has fallen back on the hoariest of hoary alt-med excuses for not being able generate evidence in favor of their woo: You can’t use “Western science” to study my woo! He even claims that “Western science” can’t understand acupuncture well enough to “know how to study it the way it has to be studied.” It’s special pleading, and it’s pathetic. In fact, Steve’s response was brilliant in that it managed to point out that popularity doesn’t equal efficacy and to liken acupuncture to bloodletting, a comparison that clearly irked the Great and Powerful Oz. Whether Dr. Oz realized it, this was the one part of the show where it can legitimately be said that Steve handed him his posterior, even in spite of everyone being against him. True, Oz would never admit it, but this was the one point in the segment where the mask slipped just a little bit and for a brief moment Dr. Oz looked quite unhappy. After all, he promoted acupuncture, and Steve had just likened it to bloodletting. On the other hand, Oz clearly got what he wanted out of Steve. Steve was fighting a battle based on science, reason, and evidence; Oz was playing to his audience and burnishing the Dr. Oz brand. He got to appear reasonable to his audience by acknowledging criticism while completely controlling the flow, and above all, the language of the discussion. Steve tried to punch his way out of the language box Dr. Oz was constructing and did about as well as anyone could hope to, but always had the last word and always controlled the forum.

It was bread and circuses all around, indeed, so much so that my wife ridiculed the later segments, in which Dr. Oz used huge bottles with huge labels, like “aspirin” as props to help Ulbricht “explain” what his audience should look for in supplements and “natural” remedies. I had never noticed that before, but going back to my past posts on Dr. Oz (particularly the one about Dr. Mercola’s appearance), I had to admit that my wife was spot on in her observation. I even kicked myself for not having noticed it before. Giant props, as if for a children’s show. Simplistic answers. It’s all there.

Finally, there were two very annoying bits in this whole exchange. First, Dr. Oz appropriates the alt-med trope of “individualization” (which in alt-med, really means “making it up as you go along“), even likening his favorite woo to a “bow and arrow” or a “stealth approach” to “hitting what you want to get that works in you” and science-based medicine to a “ballistic missile approach that we have so often become comfortable with.” “Ballistic missile approach”? You mean like Tarceva, Herceptin, Avastin, and other targeted therapies designed to hit very specific molecular targets?

In his “final word” on the topic, Dr. Oz then solidifies the bond with his intended audience. Oz fans, it’s you and him against the world! Check it out:

Alternative medicine, I think, is at the grassroots level, and because of that nobody owns it. Now, that stated, I think we got our homework to do. But I think alternative medicine empowers us, and that’s the big message–but only if you know more about it. And if it does work for you, trust me, do not let anybody take it away from you.

In other words, you brave maverick Dr. Oz viewers, don’t worry your little heads about science. Don’t listen to those buzz killer skeptics who just don’t like alternative medicine and Dr. Oz. They’re so much less interesting than cupping, acupuncture, homeopathy, reiki, and various other forms of mystical, magical woo. They’re paternalistic, too! (Never mind Dr. Oz oozes paternalism.) Be “empowered” by listening to whatever message that the latest seller of snake oil is promoting to you. “Learn” more about alternative medicine from Dr. Oz; don’t worry if the information is science-based. Be good Dr. Oz fans. Above all, take your “empowerment” to buy what Dr. Oz says you should buy (and, as the segment right after Steve’s segment takes great pains to point out to Dr. Oz fans, even to the point of bragging about the number of “cease and desist letters” Dr. Oz’s lawyers have sent to supplement hawkers claiming an endorsement, don’t buy goods not endorsed by Dr. Oz on his show–they sully and dilute the Dr. Oz brand, after all).

And, of course, keep watching his show.

Additional commentary:

1. Alternative Medicine: The Magic of Oz
2. Dear Dr. Oz: I Just Think it’s Very Dismissive of You to Reject Reality
3. The Dr. Oz Show: The Price is Right of Medical Woo
4. Steve Novella goes to Oz
5. Steve Novella on Dr. Oz
6. Steven Novella on Dr. Oz
7. Dr. Steven Novella vs. Dr. Oz

When an article is published in a medical journal, the authors must disclose any conflicts of interest. This is important, because even if they think owning stock in the drug company won’t influence their scientific judgment, we know that subtle biases can creep in to somehow affect the findings of studies. It has been shown that studies funded by drug companies are more likely to get positive results for their drug than studies funded by independent sources. Andrew Wakefield, author of the infamous retracted Lancet study suggesting a relationship between MMR vaccine and autism, was severely chastised for not disclosing that he received money from autism litigators and expected to earn a fortune from his own patented products if the MMR vaccine could be discredited.

I was recently contacted by an acupuncturist who plans to critique an article I wrote. It was a commentary in the journal Pain that accompanied a systematic review of systematic reviews of acupuncture by Ernst et al. For details of Ernst’s and my articles, see my previous post. He challenged my statement that I had no conflicts of interest to report. He apparently thinks I should have said I have a conflict of interest in that I am anti-CAM and anti-acupuncture. When he writes about my article, he plans to attack me for not declaring this alleged conflict of interest and he plans to set a good example with a conflict of interest statement of his own, divulging that he makes his living practicing acupuncture, has financial investments in it and many personal relationships, that his self-identity and prestige are dependent on his belief in acupuncture’s efficacy, and that he is biased towards constructivism and away from positivism. (I think this is a fancy way of saying he favors experience over the scientific method.) I agree that he has conflicts of interest, but was I wrong to say I had no conflicts of interest? I don’t think so.

He cited the International Committee of Medical Journal Editors (ICMJE) criteria on conflict of interest:

Public trust in the peer-review process and the credibility of published articles depends in part on how well conflict of interest is handled during writing, peer review, and editorial decision making….Conflict of interest exists when an author … has financial or personal relationships that inappropriately influence (bias) his or her actions… Financial relationships (such as employment, consultancies, stock ownership, honoraria, and paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine the credibility of the journal, the authors, and of science itself. However, conflicts can occur for other reasons, such as personal relationships, academic competition, and intellectual passion.

Financial relationships? Something that would make it financially advantageous for me to disparage acupuncture? Employment, consultancies, stock ownership, honoraria, paid expert testimony? Nope, nope, nope, nope, and nope. None of these apply to me. I’m retired, so I can’t even be accused of competing for patients with acupuncturists. I would have nothing to gain financially if acupuncture vanished from the earth overnight.

Personal relationships? Should Dr. Oz should divulge that his wife is a Reiki master before he pontificates about the wonders of Reiki on national television? I think he should; if it hasn’t influenced his views, I can’t imagine what his marriage is like.  Do I need to state that I associate in cyberspace with other science-based writers who have questioned the evidence for acupuncture? Do I need to say that I have 3 friends who accept acupuncture and 6 who reject it? I don’t think so.  Does a scientist doing a drug study need to divulge that his cousin or his next-door neighbor or one of his Facebook friends works for the drug company? I don’t think so.

Academic competition? I am not and have never been an academic. I’m a retired family physician with no ties to any academic institution.

Intellectual passion? My passion is for science and reason, not for or against acupuncture or any other particular treatment. I have no brief against acupuncture. I have had no personal experiences, good or bad, that would tend to prejudice me for or against it. My initial opinion of acupuncture was favorable. When I was in med school, the head of anesthesia, Dr. John Bonica, was enthusiastic about acupuncture and was actively investigating it as a possibly worthwhile addition to his field. He thought it worked by the gate control theory of pain. (As he studied it, his initial enthusiasm soon waned.)  I believed the first reports I heard about its effectiveness for surgical anesthesia and pain relief. Through the years, I read the reports that came out in the medical literature and I perceived that the weight of evidence was gradually turning against it. I also learned about the psychology of how patients and doctors can come to believe that a treatment works when it really doesn’t, and I learned some of the things that can go wrong in research to produce results that are not valid. Eventually I came to the provisional conclusion that acupuncture probably has no specific effects but is very good at eliciting non-specific effects of treatment. I don’t say that acupuncture doesn’t work: I only say that the entire body of published evidence is compatible with the hypothesis that it doesn’t work better than placebo.

I have never seen a conflict of interest statement that mentioned the authors’ worldview. No prayer study lists “I believe in God” as a conflict of interest. No scientist is expected to state “I believe the scientific method is the best way to evaluate claims.”

If conflicts of interest make an article less credible, should we also be required to disclose factors that would tend to make it more credible?  When Ernst writes an article critical of homeopathy, should he divulge that he was trained as a homeopath and used to work in a homeopathic hospital? Should we be more disposed to believe his criticisms of homeopathy because he is a “convert”? No, the content of the article can be judged on its own merits. Only significant conflicts of interest need be reported. We can keep them in the back of our mind to moderate our confidence in the study’s findings but we can never assume they mean the study is not credible.

I have no particular attachment to my provisional conclusion about acupuncture. It really makes no difference to me personally whether it works or not. Really. I would welcome proof that acupuncture works, as it would give me another option for treating any pains of my own. I am always ready to change my mind and have done so innumerable times in my career in response to better evidence. As Emerson said, “A foolish consistency is the hobgoblin of little minds.” It can’t hurt my pride to change my mind as long as I change it in response to evidence and reason; I am proud when I have learned that I was wrong about something and was able to correct my error.

If new evidence convinced me that acupuncture worked, I would write about it and explain the evidence and my reasoning. This wouldn’t hurt my reputation. If anything, it would enhance my prestige in the skeptical community. It would demonstrate that I didn’t have an ax to grind, that I was willing to follow the evidence wherever it led.

The acupuncturist’s arguments for more complete disclosure remind me of a “complete” informed consent for surgery that was written as a joke. It advised patients of everything that could possibly happen, including an earthquake during surgery and the chance that the surgeon could die suddenly of a heart attack and fall on top of the patient. Informed consent and disclosing conflicts of interest are both important, but it’s possible to get too carried away.

In summary, the acupuncturist would have a great deal to lose if he rejected acupuncture, while I would have nothing to lose if I accepted it. He has a conflict of interest. I don’t.

UPDATE 4/27/2011: Here’s the online video of Dr. Novella’s appearance on The Dr. Oz Show:

1. Controversial Medicine: Alternative Health, Part 1
2. Controversial Medicine: Alternative Health, Part 2
3. Controversial Medicine: Alternative Health, Part 3

Welcome, Dr. Oz viewers!

As managing editor of the Science-Based Medicine (SBM) blog, I am writing this post because our founder and exective editor Dr. Steven Novella was invited to be on The Doctor Oz Show. Later today, the episode in which he will appear will air in most of your local markets, and we wanted to make sure that any Dr. Oz viewer who sees the segment and as a result is intrigued (or angered) enough to wonder what it is that we are all about will have a convenient “primer,” so to speak, on the problem with Dr. Oz from a science-based perspective. In other words, who are these obnoxious upstart bloggers who are so critical of Dr. Oz are and, far more importantly, exactly why are we so critical? What is science-based medicine, anyway?

On to some of the answers!

Who is Steve Novella?

First of all, who is Dr. Steven P. Novella, the man who had the chutzpah to go into the proverbial lions’ den of Oz? An Assistant Professor of Neurology at the Yale School of Medicine and founder and president of the New England Skeptical Society, in his spare time Dr. Novella is also the host of the popular science and skepticism podcast, The Skeptics’ Guide to the Universe, as well as a blogger at his own personal blog, NeuroLogica Blog, and other related blogs, including The Rogues’ Gallery and SkepticBlog. A fellow of the Committee for Skeptical Inquiry and Chairman of the Board for the Institute for Science in Medicine, Steve was most recently named a Senior Fellow of the James Randi Educational Foundation (JREF) and director of its new Science-Based Medicine Project. As a result of this most recent appointment, SBM will be collaborating more closely with the JREF on projects related to science in medicine. As you can see, Dr. Novella’s activism on behalf of skepticism and SBM is extensive and varied. That’s why we can think of no better person to have appeared with Dr. Oz to try to explain what it is we at SBM find objectionable about how he covers many medical topics on his show.

What is science-based medicine?

Many readers have likely heard the term “evidence-based medicine” (EBM). It’s a (relatively) new buzzword designed ostensibly to describe medicine that is based on solid evidence, in contrast to much medicine practiced in the past that may or may not have been based on solid evidence. Indeed, I sometimes jokingly refer to some forms of medicine, particularly from more than a few decades ago, as “dogma-based” medicine or “tradition-based” medicine. We at SBM, however, have noted a problem with EBM. Specifically, EBM elevates clinical trial data to the highest level of its “hierarchy of evidence,” in particular, randomized, double blind clinical trial data. Under normal circumstances, where new treatments are developed “organically” from basic science and clinical observations, through preclinical experimentation (biochemistry, in vitro work, cell culture, and animal models), all the way to clinical trials, it is correct to rank randomized clinical trials as the “gold standard” of scientific evidence for or against a particular therapy. After all, many are the therapies and drugs that look promising in preclinical investigations, only to fail when tested in humans, many more than the therapies and drugs that succeed and prove their worth. Here’s the problem with EBM. While EBM works well for science-based medical interventions, it has a distressing tendency to break down when applied to medical interventions that are, from a basic scientific standpoint, highly improbable. And I’m not just talking mildly improbable, either, but interventions that are incredibly improbable.

To try to explain, my favorite example of this phenomenon is homeopathy. Homeopathy, you see, is improbable. Really improbable. You just won’t believe how hugely, mindbogglingly improbable it is. (Apologies to Douglas Adams.) Basically, homeopathy postulates two “laws,” the law of similars and the law of infinitesimals. The law of similars states that “like cures like”; for example, something that causes itching (poison ivy, for instance) can be used to cure itching. The law of infinitesimals then states that the more you dilute a remedy, the stronger it gets. It also postulates that the remedy is “potentized” by vigorous shaking between each dilution. A typical homeopathic remedy is diluted 30C, each “C” being a 100-fold dilution, which makes 30C a mixture that’s been diluted 100-fold thirty times. This results in a 10⁶⁰-fold dilution, a one with sixty zeroes after it (by comparison, a trillion is represented by a one with twelve zeroes after it). To understand the significance of this, you need to know that a unit that chemists use to measure quantities of chemicals is the mole. One mole is roughly 6 x 10²³ molecules. (One mole of table sugar, sucrose, for instance, weighs approximately 342 grams, which is less than 14 oz.) What this means is that typical homeopathic remedies are diluted way, way, way beyond the point where not a single molecule of original remedy remains. Indeed, some homeopathic remedies go up to 200C, which is a 10⁴⁰⁰-fold dilution. By comparison, the number of molecules in the known universe is estimated to be between 10⁷⁸ and 10⁸². Clearly, for homeopathy to work, huge swaths of what we know about chemistry, physics, and biology would have to be not just wrong, but spectacularly wrong. It’s about as close to being impossible as can be imagined in modern science. Yet Dr. Oz promoted homeopathy on his show not long ago, and millions still swear by it.

Why?

Given that homeopathy is nothing more than water, one reason is nonspecific placebo effects. Combine placebo effects with the fact that, by design based on the way we calculate whether the results of a clinical trial are statistically “significant,” at least 5% of clinical trial results will be false positives; i.e., give a “positive” result when the treatment really doesn’t work. This is true for drugs as well as implausible remedies like homeopathy. In fact, it’s considerably higher than a 5% chance of a false positive, because the 5% number is more theoretical than anything else. It applies only when a clinical trial is perfectly designed and perfectly carried out, and there’s no such thing as a perfect clinical trial. Unfortunately, EBM does not take into account the extreme implausibility of a treatment like, for example, homeopathy, reiki, therapeutic touch, or many other “energy healing” methods. Clinical trials are all that matter, and the flaws in clinical trials can lead to the appearance that such remedies have an effect. SBM, in marked contrast, is evidence-based medicine that takes scientific plausibility into account. Because all the ins and outs of SBM could take up a book, we’ve written up a primer describing the concept of SBM, along with a bunch of links for those interested in learning more about it. Personally, I suggest starting with four posts:

• Announcing the Science-Based Medicine Blog
• Yes, Jacqueline: EBM ought to be Synonymous with SBM
• Answering a criticism of science-based medicine
• Placebo effects without deception? Well, not exactly.

The bottom line is that we at SBM reject the whole concept of “alternative health” in the title of Dr. Oz’s segment featuring Steve Novella. “Alternative medicine” represents a false dichotomy. Indeed, I frequently repeat an old joke that asks: What do you call alternative medicine that has been scientifically proven to work?

The answer: Medicine.

That’s because alternative medicine by definition is medicine that either hasn’t been scientifically proven to work or has been scientifically proven not to work, while “integrative medicine” is nothing more than “integrating” unproven “alternative” medicine with medicine scientifically proven to work.

Which finally brings us back to Dr. Oz.

The trouble with Dr. Oz

I can’t speak for the rest of the bloggers here at SBM, but up until about a year ago, I really didn’t have that much of a problem with Dr. Oz. I really didn’t. Admittedly, he did annoy me a bit with his tendency towards credulity towards certain forms of dubious medicine, such as reiki (which, when you come right down to it, is faith healing based on Eastern mysticism rather than Christianity). Also admittedly, I found Dr. Oz’s on-air persona to be a bit on the cheesy side. However, for the most part, before he got his own show and even early on after he got his own show, most of Dr. Oz’s health advice was at least semi-reasonable, much of it even science-based. As time went on, however, we did notice that, more and more, Dr. Oz seemed to want to “go with the flow” and “give the people what they want.” Why? we wondered. Dr. Val Jones, formerly a regular blogger for SBM, thought she knew the answer:

I told him [a business colleague] that I was contributing to a blog called Science-Based Medicine in an effort to combat some of the medical quackery that is being promoted online. He looked at me and said I’d never be a success with that message. He said that people like Oprah and Mehmet Oz were successful because they “went with the flow” and gave people what they wanted.

“Most people don’t want to think critically about things – they want to hear about miracle cures, self-help, and vitamins. They already have the media they ‘deserve.’ You’ll never appeal to a mass audience with your skeptical message.”

Even if that’s true, we view it as our mission to try to change that and encourage as many people as we can reach to learn to think critically about medicine.

So why would Steve agree to be on Dr. Oz’s show? It was a difficult decision, actually. Even in our wildest dreams we had no idea that our criticisms were even being noticed by Dr. Oz or his producers, much less having any effect. So, on the one hand, we were grateful to Dr. Oz’s producers for inviting our representative on the show. On the other hand there was very little time for Steve to make a decision, much less prepare, and, given Dr. Oz’s history, Steve and the rest of us were all—understandably, I believe—wary about how he might end up being portrayed. In the end, given that the mission of this blog is to promote science in medicine and medicine based on good science, we agreed that this invitation was an opportunity that we had to seize, even knowing the risk that Steve might be portrayed unfavorably. Even though, as I write this, I haven’t seen the episode yet, I have seen the preview. What I see is that my fears weren’t unfounded. The very title (“Controversial medicine: Why your doctor is afraid of alternative health”) is clearly slanted against the SBM point of view. Worse, even in just the brief promo clip presented, Dr. Oz:

• Challenges Steve by asking, “Why do you not want me to talk about these therapies on the show?” This is a distortion of our position. Nothing could be further from the truth to claim that we don’t want Dr. Oz to talk about these therapies. What we don’t wnat him to do is to promote them as efficacious when they are not. What we want is a skeptical, science-based assessment of them. Despite the claim by Dr. Oz and his producers that we are “afraid” of alternative health, in actuality we crave an open dialogue based on science, both preclinical and clinical trials, not marketing hype, pseudoscientific claims, and testimonials.
• Says it’s “very dismissive” of Steve to challenge these therapies as not working. This is the infamous “don’t be close-minded” gambit. Of course, the problem with being too open-minded is that your brains might fall out.

No wonder our readers are pessimistic at how Steve will be portrayed in the episode, and no wonder I took umbrage at being called “afraid” of alternative medicine.

Still, that Dr. Oz apparently was sufficiently stung by our criticisms over the last several months that he felt the need to have Dr. Novella on his show tells me that there may well be more hope than is readily obvious. My optimism aside, though, it’s impossible for us to deny that at huge part of the reason that Dr. Oz’s show is so successful is, no doubt, because he does “go with the flow,” serving up for the most part lightweight, fluffy, uplifting entertainment which sometimes contains good medical information. In this, he clearly learned at the feet of the Master, his mentor and the person who got him started as a media doctor, Oprah Winfrey, who has come under considerable criticism herself for promoting pseudoscience and New Age mystical beliefs. He’s also apparently learned at the feet of Oprah how to gin up a controversy, as his promo for Steve’s appearance shows.

Most disturbingly, though, of late Dr. Oz has been also promoting pseudoscience and what can only be described, in my opinion, as quackery. The snake oil that Dr. Oz has promoted over the last several months includes Dr. Joe Mercola, one of the biggest promoters of “alternative” health, whom Dr. Oz first had on his show about a year ago and then defiantly defended in a return appearance in early 2011. Then, in a rapid one-two punch, Dr. Oz had an ayurvedic yogi named Cameron Alborzian, who promoted highly dubious medicine, including “tongue diagnosis,” to be followed a few days later by something I would never, even in my most cynical assessment of Dr. Oz, expected, namely the appearance of faith healer Issam Nemeh on his show. Worse, Dr. Oz showed zero signs of skepticism. Unfortunately, Dr. Oz wasn’t done. In rapid succession next Dr. Oz endorsed a diet that he once eschewed as quackery and then, to top it all off, invited psychic John Edward onto his show, asking Is talking to the dead a new kind of therapy? This latter episode so shocked me that I basically said, “Stick a fork in him, Dr. Oz is done when it comes to SBM.”

Dr. Oz’s descent was complete, and that is now the trouble with Dr. Oz and much of the reason why in 2011 the James Randi Educational Foundation awarded him the The Media Pigasus Award for the second year in a row. I fear he very well may three-peat in 2012. The only thing that might save him is listening to his critics, but I fear that is unlikely. We’ll see.

Further reading about Dr. Oz

I hope you, our regular readers, will comment on Dr. Novella’s appearance, both here and in Dr. Novella’s post about his experience, the latter of which will be posted this evening after he gets a chance to see how the segment turned out after editing. I also invite Dr. Oz viewers to join in. Just register a user name and password here. In the meantime, here is a collection of critical posts and articles about Dr. Oz. Also, don’t forget to dive into the discussion forums at Dr. Oz’s website after the episode with Steve airs in your area.

From Science-Based Medicine:

• Dr. Oz Embraces Joseph Mercola
• For shame, Dr. Oz, for promoting Joseph Mercola on your show!
• Dr. Mehmet Oz completes his journey to the Dark Side
• Dr. Oz, you’re not helping diabetics
• Dr. Oz and John Edward: Just when I thought Dr. Oz couldn’t go any lower, he proves me wrong
• Dr. Oz promotes homeopathy

From other sources:

• Dr. Oz: America’s doctor and the abdication of professional responsibility (apparently flashed on the screen at the beginning of Dr. Oz’s segment).
• Dr. Oz and John Edwards = Bad Medicine
• Dr. Oz asks who can we trust when it comes to Genetically Engineered Crops?
• Dr. Oz – so corrupted by fame he even sells himself out
• Emmys, don’t be led down Dr. Oz’s yellow brick road: Oprah’s favorite doctor promotes quackery
• The 5 Worst Promoters of Nonsense
• The Irresponsible Dr. Oz, Softening The Public Up for Charlatans
• Just in time for April Fools’ Day…Dr. Oz and the Pigasus Awards! (in which Dr. Oz also promotes homeopathy)
• More health tips from Dr. Oz
• Oz: The great and gullible
• Questioning Dr. Oz

UPDATE 4/27/2011: Here’s the online video of Dr. Novella’s appearance on The Dr. Oz Show:

1. Controversial Medicine: Alternative Health, Part 1
2. Controversial Medicine: Alternative Health, Part 2
3. Controversial Medicine: Alternative Health, Part 3

I must say I was a bit shocked two weeks ago when I was contacted by a producer for The Dr. Oz Show inviting me on to discuss alternative medicine. We have been quite critical of Dr. Mehmet Oz over his promotion of dubious medical treatments and practitioners, and I wondered if they were aware of the extent of our criticism (they were, it turns out).

Despite the many cautions I received from friends and colleagues (along with support as well) – I am always willing to engage those with whom I disagree. I knew it was a risk going into a forum completely controlled by someone who does not appear to look kindly upon my point of view, but a risk worth taking. I could only hope I was given the opportunity to make my case (and that it would survive the editing process).

The Process

Of course, everyone was extremely friendly throughout the entire process, including Dr. Oz himself (of that I never had any doubt). The taping itself went reasonably well. I was given what seemed a good opportunity to make my points. However, Dr. Oz did reserve for himself the privilege of getting in the last word—including a rather long finale, to which I had no opportunity to respond. Fine—it’s his show, and I knew what I was getting into. It would have been classy for him to give an adversarial guest the last word, or at least an opportunity to respond, but I can’t say I expected it.

In the end I decided that I had survived the taping of the show and did fairly well. After watching the final version that aired I feel that the editing was fair. They allowed me to make my major points, and did not change anything significant about the discussion. Again, the real problem was that Dr. Oz controlled the framing of the discussion and made many fallacious points at the end that I was given no opportunity to respond to.
Continue reading →

If there’s one thing about the anti-vaccine movement, it’s all about the ad hominem attack. Failing to win on science, clinical trials, epidemiology, and other objective evidence, with few exceptions, anti-vaccine propagandists fall back on attacking the person instead of the evidence. For example, as I’ve noted numerous times, Paul Offit has been the subject of unrelenting attacks from Generation Rescue and other anti-vaccine groups, having been dubbed “Dr. Proffit” and accused of being so in the pocket of big pharma that he’ll do and say anything for it. I personally have been accused by Jake Crosby of a conflict of interest that isn’t, based on conspiracy mongering and an utterly brain dead argument (which is much like every other argument Jake likes to make on this issue). Steve Novella, Paul Offit, Amy Wallace, Trine Tsouderos, and others were portrayed as cannibals sitting down to a Thanksgiving feast of baby. Meanwhile, anti-vaccine luminaries invoke the pharma shill gambit with abandon and try their best to smear journalists who write about how anti-vaccine views are endangering herd immunity, journalists such as Trine Tsouderos, Amy Wallace, Chris Mooney, and Seth Mnookin, to name a few.

Sometimes, however, for whatever reason karma, fate, God, or whatever you want to call it smiles on anti-vaccine activists, dropping a story into their laps that allow them to indulge the worst of their tendencies towards ad hominem attacks and seem superficially credible. So it was about a year ago when an financial fraud investigation was being undertaken in the case of Poul Thorsen, a Danish investigator who had contributed to two large Danish studies, one of which failed to find an association between the MMR and autism in the immediate wake of Andrew Wakefield’s falsified data suggesting such an assocation and one of which failed to find an association between mercury in the thimerosal preservative in vaccines and an increased incidence of autism. At the time longstanding anti-vaccine propagandist Robert F. Kennedy, Jr. tore into Thorsen with abandon before he was even indicted or charged (he was only under investigation at the time) as though, even if he actually did commit fraud, such fraud invalidated the two large studies regarding MMR and autism and thimerosal and autism with which he had been involved. Did it?

To find out, let’s hop into our SBM TARDIS and go back in time about a year, in order to see the genesis of this manufactorversy that AoA is currently flogging. Let’s look at the case of Danish investigator Poul Thorsen as it developed.

Thorsen in 2010: Robert F. Kennedy, Jr. parties like it’s 2005

It was back in March 2010. Andrew Wakefield had just had his 1998 Lancet paper retracted by the editors in the wake of his having lost his medical license in the U.K. as a result of his research misconduct. Just when times seemed darkest for those who promote the scientifically discredited notion that vaccines cause autism, a miracle occurred! So great was the miracle that it enticed Robert F. Kennedy, Jr., who for quite some time before had actually been pretty quiet about vaccine/autism issues, to let himself be pulled out of storage, dusted off, and sent once again to tilt at mercury windmills. Not unsurprisingly, he reappeared on that bastion of anti-vaccine pseudoscience, The Huffington Post, and the title of his post was Central Figure in CDC Vaccine Cover-Up Absconds With $2M. In what appeared to be a coordinated attack, the anti-vaccine group Generation Rescue‘s blog Age of Autism was promoting RFK, Jr.’s article and adding a few of its own with titles such as Poul Thorsen’s Mutating Resume by the not-so-dynamic duo of Mark Blaxill and Dan Olmsted and NBC 11 Atlanta Reports: Vaccine Researcher Flees with $2M, featuring this news report:

These were among the earliest reports about Poul Thorsen. So what was going on? Let’s look at RFK’s article and how he started it:

A central figure behind the Center for Disease Control’s (CDC) claims disputing the link between vaccines and autism and other neurological disorders has disappeared after officials discovered massive fraud involving the theft of millions in taxpayer dollars. Danish police are investigating Dr. Poul Thorsen, who has vanished along with almost $2 million that he had supposedly spent on research.

Thorsen was a leading member of a Danish research group that wrote several key studies supporting CDC’s claims that the MMR vaccine and mercury-laden vaccines were safe for children. Thorsen’s 2003 Danish study reported a 20-fold increase in autism in Denmark after that country banned mercury based preservatives in its vaccines. His study concluded that mercury could therefore not be the culprit behind the autism epidemic.

But was Thorsen really the driving force behind the Danish vaccine-autism studies that the anti-vaccine movement hates so much? I had been paying close attention to the vaccine-mercury-autism manufactroversy for nearly five years then, and I had never heard of him, although I had heard of one of his coauthors. If Thorsen was so important to the pro-vaccine movement, you wouldn’t have known it from the two studies that the mercury militia was hoping to discredit by turning up its propaganda machine to 11 about Thorsen’s possible criminal behavior. Those papers were:

• Madsen KM, Hviid A, Vestergaard M, Schendel D, Wohlfahrt J, Thorsen P, Olsen J, Melbye M. A population-based study of measles, mumps, and rubella vaccination and autism. N Engl J Med. 2002 Nov 7;347(19):1477-82.
• Madsen KM, Lauritsen MB, Pedersen CB, Thorsen P, Plesner AM, Andersen PH, Mortensen PB. Thimerosal and the occurrence of autism: negative ecological evidence from Danish population-based data. Pediatrics. 2003 Sep;112(3 Pt 1):604-6.

It is the Pediatrics paper that the mercury militia appeared to be concentrating mostly on because it directly deals with thimerosal in vaccines. But look at the citations above for both papers anyway. Do you notice something? Look where Thorsen’s name is in the list of authors in both studies. Notice that it is not first, nor is it last. This is important because author order matters in scientific and medical studies. In straight science studies, the two most important authors are usually the first author and the last author. The last author is usually the senior author in whose laboratory the work was done, while the first author is the person whose project the work represents and who was the primary author of the manuscript. In medical papers, as in Pediatrics or NEJM, the author list usually signifies the relative contribution of each author to the article, the first being the most important and the last being the least important. In both types of articles, there is always designated one author who is the corresponding author. In scientific papers, the corresponding author is almost always the last author; in medical papers it is usually the first author. The corresponding author is responsible for answering inquiries about the study and, way back in the age before PDF files, used to be the author to contact to request reprints. Not only that, the corresponding author is generally considered to be the primary author for the paper.

Notice something else?

That’s right. Poul Thorsen was not the first author for either of these studies. He was not the last author, either. He was not the corresponding author; that would be Kreesten M. Madsen, MD, who was corresponding author on both the NEJM and Pediatrics papers. As it turns out, Thorsen was safely ensconced in the middle of the pack of co-authors. That’s why, when RFK, Jr. referred to the Pediatrics study as “Thorsen’s study,” he had to be either grossly ignorant or intentionally misleading (Take your pick.) Anyone who knows anything about how the scientific literature works would be able to spot that immediately just by looking at the abstracts of these articles. Trust me, if studies this large really were Thorsen’s babies his name would not have been relegated to fourth or sixth on the list of authors. Basically, Thorsen’s position in the author lists of these two papers indicated that, whatever leadership position he may have held at Aarhus University and in its vaccine studies group, he clearly was not the primary contributor for these studies.

Not that that stopped the mercury militia from going out of its way to paint him as such, referring to him as a “central figure.” At the time, I had to tip my hat to RFK, Jr. his language throughout his article is truly Orwellian, a propaganda masterpiece of prestidigitation of language and innuendo. Here are just a few examples of perfectly loaded phrases sprinkled throughout the article, all designed to suggest concealment and conspiracy:

• …”built a research empire…”
• “…failed to disclose…”
• “…has disappeared…”
• “…damning e-mails surfaced…”
• “…culprit behind…”
• “…leading independent scientists have accused CDC of concealing the clear link between the dramatic increases in mercury-laced child vaccinations.”
• “…safe to inject young children with mercury…”
• “…CDC officials intent on fraudulently cherry picking…”

RFK, Jr. also parroted anti-vaccine talking points about the study that were hoary back when David Kirby first published the mercury militia Bible, Evidence of Harm, talking points like:

His study has long been criticized as fraudulent since it failed to disclose that the increase was an artifact of new mandates requiring, for the first time, that autism cases be reported on the national registry. This new law and the opening of a clinic dedicated to autism treatment in Copenhagen accounted for the sudden rise in reported cases rather than, as Thorsen seemed to suggest, the removal of mercury from vaccines. Despite this obvious chicanery, CDC has long touted the study as the principal proof that mercury-laced vaccines are safe for infants and young children. Mainstream media, particularly the New York Times, has relied on this study as the basis for its public assurances that it is safe to inject young children with mercury — a potent neurotoxin — at concentrations hundreds of times over the U.S. safety limits.

Notice how RFK Jr. really, really wanted you to believe that the Danish studies are the primary foundation upon which the science exonerating MMR and thimerosal-containing vaccines as a cause of autism rests, the be-all and end-all of the epidemiology studying thimerosal-containing vaccines, when in fact there are multiple studies and lines of evidence, of which the Danish studies are but a part. Also notice how he conflated a study’s being weak with its being fraudulent. The two are entirely different concepts, and it is entirely possible for a study to be poorly designed and executed without even a whiff of fraud. Be that as it may, the Danish studies, although they have weaknesses inherent in a retrospective design, are actually pretty darned good studies. As I said before, RFK’s whine in the passage above is the parroting of a hoary criticism of the Danish studies cribbed straight from anti-vaccine sites. The criticism goes like this. Anti-vaccine propagandists argue that because, beginning in 1994, outpatient records were used in addition to inpatient records for case ascertainment in Denmark for purposes of these studies, the whole set of studies must be crap. As Steve Novella pointed out, this change was not chicanery, and in fact Madsen et al tried to test whether the change in case reporting by doing this was significant. Here is a quote from Madsen et al:

In additional analyses we examined data using inpatients only. This was done to elucidate the contribution of the outpatient registration to the change in incidence. The same trend with an increase in the incidence rates from 1990 until the end of the study period was seen.

In other words, Madsen et al considered the possibility that adding outpatient records to inpatient records beginning in 1994 might change the results. They tested for that possibility and determined that the addition of outpatient cases did not change the trend of increasing autism diagnoses. Again, RFK, Jr. was either grossly ignorant of the facts or consciously distorting. (Take your pick–again.) The same was true of J.B. Handley when he repeated the same misinformation, and and of Ginger Taylor when she also repeated the same fallacious argument.

Here’s what was going on. In the wake of debacle the implosion of Andrew Wakefield represented, the anti-vaccine movement needed a distraction—badly—and they needed it fast. It would have been even better if the distraction were one that they could spin to make it look as though there were some dark corruption at the heart of the vaccine science. Like manna from heaven, about a year ago Dr. Thorsen’s case dropped seemingly from the sky. Never mind that it makes absolutely no difference to the science exonerating vaccines or thimerosal in vaccines as a cause of autism whether Thorsen is a criminal and thief or not. It was convenient propaganda, even though there is abundant evidence that Thorsen was not a major player in the Pediatrics and NEJM publications reporting the Danish studies.

Fast forward to 2011: The indictment of Poul Thorsen for fraud

As we have seen, in the wake of the commencement of an investigation of Poul Thorsen for fraud and embezzlement of CDC grant money, it was not surprising that the anti-vaccine movement struggled mightily to elevate him to being the prime mover and shaker of the Danish studies. The reason was obvious: They wanted to discredit “inconvenient” studies that did not support their belief that mercury in vaccines causes autism. It was an ad hominem attack, plain and simple, because the primary argument was not against the data or the studies, but against the man. It’s a form of poisoning the well or guilt by association. It’s the same thing as if I were to point to physicians who have defrauded Medicare or insurance companies and argue that all science-based medicine is thus somehow suspect. Unfortunately, this sort of tactic frequently works–which is why propagandists without moral qualms about smearing their opponents frequently use it.

It’s also why, when I saw this article a couple of weeks ago, I knew that it wouldn’t be long before Age of Autism and other anti-vaccine minions would be swarming. After all, in January the BMJ had published the rest of Brian Deer’s expose of Andrew Wakefield’s research fraud, showing his actions to be even worse than we had suspected. The anti-vaccine movement needed another distraction, and the indictment of Poul Thorsen was a convenient one, which is why it wasn’t long before the anti-vaccine blog Age of Autism was on the case after Thorsen had been indicted. Since then, Thorsen has been a regular feature on AoA (up to and including today’s post) and other anti-vaccine blogs and websites. You’ll see why from this news report:

A Danish man was indicted Wednesday on charges of wire fraud and money laundering for allegedly concocting a scheme to steal more than $1 million in autism research money from the Atlanta-based Centers for Disease Control and Prevention.

The indictment charges Poul Thorsen, 49, with 13 counts of wire fraud and nine counts of money laundering. The wire fraud counts each carry a maximum of 20 years in prison and the money laundering counts each carry a maximum of 10 years in prison, with a fine of up to $250,000 for each count.

The federal government also seeks forfeiture of all property derived from the alleged offenses, including an Atlanta residence, two cars and a Harley-Davidson motorcycle.

This is how Thorsen is now accused of having done it:

Once in Denmark, THORSEN allegedly began stealing the grant money by submitting fraudulent documents to have expenses supposedly related to the Danish studies be paid with the grant money. He provided the documents to the Danish government, and to Aarhus University and Odense University Hospital, where scientists performed research under the grant. From February 2004 through June 2008, THORSEN allegedly submitted over a dozen fraudulent invoices, purportedly signed by a laboratory section chief at the CDC, for reimbursement of expenses that THORSEN claimed were incurred in connection with the CDC grant. The invoices falsely claimed that a CDC laboratory had performed work and was owed grant money. Based on these invoices, Aarhus University, where THORSEN also held a faculty position, transferred hundreds of thousands of dollars to bank accounts held at the CDC Federal Credit Union in Atlanta, accounts which Aarhus University believed belonged to the CDC. In truth, the CDC Federal Credit Union accounts were personal accounts held by THORSEN. After the money was transferred, THORSEN allegedly withdrew it for his own personal use, buying a home in Atlanta, a Harley Davidson motorcycle, and Audi and Honda vehicles, and obtaining numerous cashier’s checks, from the fraud proceeds. THORSEN allegedly absconded with over $1 million from the scheme.

If Thorsen is convicted, I have no problem saying unequivocally that he should go to prison for a long time. As was pointed out in this Reuters story about the indictment, research dollars are a precious commodity. In fact, with the recent budget battles and cuts in Washington, government research grants haven’t been this hard to come by for 20 years, and there’s no sign of improvement in the situation in sight; it will likely be several years before things get better, if they ever get better at all. So, I’m as angry as anyone to see a researcher abuse research funds by, if the indictment is correct, buying a home and a Harley-Davidson motorcycle. Of course, having had to deal with the bureaucracy at my university and cancer institute that oversees my grants, I really don’t understand how it is even possible to buy a house and a Harley using grant funds. Every major expenditure (for me, at least) is closely tracked and matched to the approved budget. I can’t even envision how, even if I wanted to try to misuse large sums of my grant funds, I could even find a way to do it. I really can’t. To me, if Thorsen really did abuse his research funds this way, it points to a serious accounting and oversight problem in his university that allowed such chicanery to occur.

Be that as it may, reading between the lines I do find one bit of information that might explain some things about the Danish studies. Madsen was the first and corresponding author, but it’s pointed out that Thorsen became principal investigator of the CDC grant in 2002. That doesn’t help AoA at all, though. I went and looked up the two articles again and noticed something interesting that I hadn’t really paid attention to before.

The NEJM article lists its funding sources as:

Supported by grants from the Danish National Research Foundation; the National Vaccine Program Office and National Immunization Program, Centers for Disease Control and Prevention; and the National Alliance for Autism Research.

This article was, however, published in November 2002. Given that it takes months, sometimes even a year or more, for a manuscript to go from submission to publication, this work had almost certainly been completed and was in the publication pipeline before Thorsen took over as principal investigator of the CDC grant. The Pediatrics paper, which was published after Thorsen went back to Denmark, lists its funding thusly:

The activities of the Danish Epidemiology Science Centre and the National Centre for Register-Based Research are funded by a grant from the Danish National Research Foundation. This study was supported by the Stanley Medical Research Institute. No funding sources were involved in the study design.

That’s right. The Pediatrics thimerosal study was not even funded by the CDC! Even if it were, given that large epidemiological studies take years to carry out, it probably was in the last leg of its analysis when Thorsen showed up anyway. Even worse for the “guilt by association” crowd, all of the fraudulent charges to the grant are alleged to have occurred between 2004 and 2008, as described above–well after the Danish studies were published.

Of course, none of this stops AoA from opining:

We have written several articles about Dr. Poul Thorsen (4th from the left in the back row with his CDC colleagues), whose research known as “The Danish Study” is quoted extensively to “debunk” the autism vaccine connection. The mainstream media was silent when he disappeared. Here are some of the posts we’ve run on the topic along with today’s article in the Atlanta Bizjournals below. Will they give Thorsen “the Wakefield treatment” now, or have they been given their marching orders to look the other way?

Of course, not noted by the author is that Thorsen has already been treated far more harshly than Wakefield ever was! He’s been indicted on criminal charges; all that happened to Wakefield is that he was struck off the register of licensed UK physicians, and then only after a ridiculously long (two and a half year) hearing by the British General Medical Council. He just had a couple of his papers retracted, the most prominent of which being the Lancet paper from 1998 for which strong evidence was found that he had falsified data. In the meantime, he had moved to Texas to make big bucks applying his woo to autistic children, at least until the scandal led even his friends kick him out of the practice. Thorsen faces decades in prison if convicted of these crimes. My guess right now is that Thorsen is praying for “the Wakefield treatment.” It was so much less harsh than what he faces if he is convicted of defrauding the federal government. My other guess is that Thorsen would gladly take the “Wakefield treatment” over the possibility of 20+ years in a federal prison.

Not long after AoA, the anti-vaccine group Autism Action Network (formerly known as A-CHAMP) also piled on. If you read this “action alert,” you’ll notice the clever linking of Thorsen’s indictment for defrauding the federal government of research funds with baseless criticism of the two main Danish studies that provide strong epidemiological evidence that failed to find a link between the MMR vaccine and autism or thimerosal in vaccines and autism. It doesn’t matter that Thorsen’s alleged fraud didn’t even occur until at least a year after the publication of the thimerosal study.

Then, of course, the anti-vaccine group Safeminds had to weigh in with its own press release. Sallie Bernard, unfazed by reality and science, stares bravely into the abyss that was once what little credibility she has, and insists that “many biological studies support a link between mercury and autism, but these Danish studies have been used to suppress further research into thimerosal. With clear evidence of Dr. Thorsen’s lack of ethics, it is imperative to reopen this investigation.” And there you have it, the clearest and most honest statement of the intent of the anti-vaccine movement. In essence, all they want is any excuse they can find to try to demand “more studies,” even as the hypothesis that vaccines cause autism continues to pine for the fjords. Like Polly, however, it is still an ex-hypothesis, while, like Frankenstein, Bernard thinks she can infuse life into the dead. (I do so love to mix metaphors when it suits my purpose.) However, instead of using electricity from lightening Bernard uses nonsense like this:

In addition, internal emails obtained via FOIA document discussion between the Danish researchers and Thornsen which acknowledge that the studies did not include the latest data from 2001 where the incidence and prevalence of autism was declining which would be supportive of a vaccine connection. The emails also include requests from Thornsen to CDC asking that the agency write letters to the journal Pediatrics encouraging them to publish the research after it had been rejected by other journals. A top CDC official complied with the request sending a letter to the editor of the journal supporting the publication of the study which they called a “strong piece of evidence that thimerosal is not linked to autism”.

The latter accusation above is just plain silly, as this link shows. Basically, it’s a letter of support from the CDC for the Danish thimerosal article, and there’s nothing there in any way incriminating. I do find it odd, however, that clearly the second page of the letter is missing, which makes me wonder why that is. The e-mails already say who signed the letter. As for the e-mails about the data from 2001, it’s impossible to tell exactly what the correspondents are saying. There are only two brief e-mails, and much text is redacted with black marker, that consist of an exchange between Marlene Lauritsen, who’s second author on the paper, and Kreesten Madsen, the first author. It’s cryptically mentioned that the incidence and prevalence are “still decreasing in 2001,” but the sentence immediately following it is redacted. Most of Madsen’s reply to this e-mail is also redacted.

In other words, the e-mails tell us little or nothing. More importantly, as Sullivan has shown by listing the studies rejecting the vaccine-autism hypothesis on which Thorsen is a co-author, you could eliminate every study with which Thorsen was associated, and the literature refuting the hypothesis is only reduced slightly.

Finally, of all the reactions to the study, there is one that made me laugh out loud when I read it. I’m talking about Katie Wright:

Who would make serious health care decisions based upon the work of a thief and a fraud.

Come on CDC, you cannot be serious.

Given that Wright and the many AoA followers have routinely made health care decisions based upon the work of Andrew Wakefield, who, while not a thief, was clearly a scientific fraud, I posit that Wright owes me a new irony meter. She blew mine up again–melted that sucker into a pool of gurgling plastic, rubber, and copper wire so that it’s now sputtering pathetically on my desk. Yet Wright and her fellow travelers defend Wakefield to the death metaphorically speaking, with J.B. Handley, for example, even going so far in this weekend’s New York Times Magazine as to liken him to “Nelson Mandela and Jesus Christ rolled up into one” and Michelle Guppy, coordinator of the Houston Autism Disability Network, darkly threatening a reporter, “Be nice to him [Wakefield], or we will hurt you.”

Double standard? You be the judge.

Conclusion

To a certain extent, I understand the assertion of “once a cheat, always a cheat.” I understand that the lead author (Madsen) and Thorsen’s other co-investigators might now want to check over Thorsen’s contribution to the two papers (as relatively small as it appears to be compared to the other authors), even for the paper whose work was not funded by the CDC at all and therefore has zero financial dependency on the CDC. That’s normal caution. However, normal caution is most definitely not what these attacks by Safeminds and AoA are about. They’re about the denialist technique of spreading FUD (fear, uncertainty, and doubt) about vaccines. Let’s just put it this way. Let’s say the anti-vaccine movement’s wet dream about Thorsen came true and it was somehow discovered that his science was also falsified and that, further, his fraud was enough to call the conclusions of every study for which Thorsen was a co-author in doubt. Even in that highly unlikely scenario, in which both studies were somehow completely discredited as a result of Thorsen’s financial chicanery with grant funds, it would not be nearly enough for scientists to call into question the scientific consensus that neither the MMR nor thimerosal are associated with an increased risk for autism. The reason is that there’s so much other evidence that is consistent with the Danish studies and similarly shows that neither the MMR nor thimerosal in vaccines is associated with autism.

What AoA, Safeminds, and other denialists refuse to understand is that science is rarely, if ever, a matter of a scientific consensus being based on one study, two studies, or a handful of studies. A scientific consensus is based on examining all the evidence from all relevant studies, deciding which studies are most methodologically powerful, and then synthesizing it all into a conclusion. Contrast this to how the anti-vaccine movement treats its “brave maverick doctors” like Andrew Wakefield, Mark Geier, Rashid Buttar, et al, and the difference between real science and anti-vaccine pseudoscience couldn’t be clearer.

ADDENDUM: I can’t resist pointing you to a hilariously misguided attack against me that proves once again that, for the anti-vaccine activists, it’s all about the ad hominem. Clifford Miller, a.k.a. ChildHealthSafety, was apparently unhappy that in the comments of Seth Mnookin’s post complaining about J.B. Handley’s attacking him solely based on his having once been a heroin addict, an addiction that Seth managed to beat, I dared to criticize J.B. for an ad hominem attack. In response, Miller fired off a counterattack. Not only was he unhappy about a post of mine that was over a year old, but he regurgitated Jake Crosby’s fallacious pharma shill gambit that used against me last summer.

Thank you, Mr. Miller, for a hearty chuckle and for, in your utterly irony challenged manner, proving my point about the anti-vaccine movement and ad hominem attacks better than I ever could.

I can’t believe I’m saying this, but I want you all to tune in to The Dr. Oz Show on Tuesday, April 26. Either that, or DVR it. Why am I asking you to do this? Have I lost my mind? Have I suddenly gone woo? Of course not. The reason is that, an episode I’ve been waiting for since I learned it was in the works last week will air on that date.

That’s right. Our fearless leader Steve Novella will be on The Doctor Oz Show this Tuesday to do battle in the belly of the beast.

Unfortunately, I fear for the results. I know Steve acquitted himself quite well, at least as well or better than any skeptic and booster of SBM could hope to do in such a hostile environment, but get a load of the title of the segment, Controversial Medicine: Why your doctor is afraid of alternative health?

Afraid?

Afraid?

Afraid?

No, no, no, no! A thousand times no!

I do worry a bit how the producers edited Steve’s segment, though. Look at the promo. In it Dr. Oz is doing what I was afraid of, trying to portray himself as the voice of reason and accusing Steve of being “dismissive.” I was afraid Dr. Oz would play the “don’t be close-minded” or “you’re too dismissive” card, and he appears to have done it. Then get a load of the advertised segment that follows, showing Dr. Oz dictating what’s true and not in medicine, as in “Dr. Oz approved.”

Truly, the man has no shame.

I’ll have to wait until Tuesday to see what the final results are. Whatever happens, we at SBM are all incredibly proud of Steve for going into the proverbial lions’ den. As managing editor, I’m also enormously proud of our stable of bloggers; after all, it is a collective effort that got us noticed by the producers of The Dr. Oz Show. Also, now that Dr. Oz and his producers have noticed us, however the segment turns out we promise to keep holding Dr. Oz’s feet to the fire when he starts promoting nonsense like faith healers, psychic mediums, dubious diabetes treatments, and über-quacks like Joe Mercola. This should be facilitated by our new partnership with the James Randi Educational Foundation that was announced earlier this week.

You can also rest assured that Steve will blog about his experience after the episode airs, and I hope our readers will dive into the discussion forums after the show.

The White Man’s burden, a bit of racism from the 19th century:

The term “the white man’s burden” has been interpreted as racist, or taken as a metaphor for a condescending view of non-Western national culture and economic traditions, identified as a sense of European ascendancy which has been called “cultural imperialism.” An alternative interpretation is the philanthropic view, common in Kipling’s formative years, that the rich have a moral duty and obligation to help “the poor” “better” themselves whether the poor want the help or not. The term “the white man’s burden” has been interpreted as racist, or taken as a metaphor for a condescending view of non-Western national culture and economic traditions, identified as a sense of European ascendancy which has been called “cultural imperialism.” An alternative interpretation is the philanthropic view, common in Kipling’s formative years, that the rich have a moral duty and obligation to help “the poor” “better” themselves whether the poor want the help or not.

I will let the commentators debate the meaning of the poem. There are places in the world so devastated by poverty, disease and political corruption that it may be beyond the capacity of the local populations to overcome. They need outside help. Certainly, the impulse to help those less fortunate than yourselves is a noble tradition. Haiti, Central America and Uganda are parts of the world that need assistance in overcoming an incredible number of problems to reach even a basic level of material support for its population.

What better way to help people in dire need of the basic requirements for health and material well being than to provide them with Western SCAMs?  At least in the industrialized West, we have options. If acupuncture or homeopathy or reiki does not take care of our problem or our diseases worsen, we are a quick trip away from the ER.  We may not be able to afford the care, health care being the number one cause of bankruptcy in the US, but at least effective health care is available. Other societies do not have that option. Often their one point of contact with health care  providers and/or shamans is their only contact and there is no infrastructure to take care of the ill.  Uganda spends $135 per capita on health care,  and has 0.047  physicians per 1,000 people. 1,500 doctors for a population of 35 million. Haiti spends  $82 per capita. I spend more each year on my daily peanut butter and jelly sandwich for lunch ($1.10)  By comparison, the US spends $6,000 a year per capita on health care.

These are societies where small amounts of money spent carefully can have enormous impact. Relatively small amounts of money can do enormous good in impoverished parts of the world. Ten dollars can buy a mosquito net and prevent malaria.  The measles vaccine costs less than a dollar a dose and can prevent devastating outbreaks of disease.  One hundred dollars  can provide the hungry with 2 chickens and a goat. So why spend the money on nonsense?  I know it is a false choice.  Just because money is being spent on something useless like homeopathy or acupuncture does not mean that the same money would go to a more rational choice if it were otherwise available.

In medicine we are aware of the ethical issues in treating vulnerable populations.  The poor and uneducated do not have the resources to separate fact from fiction and may lack the background to make truly informed decisions.

Yet none of this stops the sCAM believers from exporting their nonsense to the poor, the hungry, the under educated and the desperate.

Research

The only thing necessary for the triumph of disease is for good men to do homeopathy.

Diarrhea is a major source of morbidity and mortality in large parts of the world, the second (I originally wrote number 2)  cause of infant death in the world.  Treatment and prevention of diarrheal illness is key to decreasing infant mortality world wide.  How might I make a major impact?  Provide clean water?  Rotavirus vaccination? Wait, I have it! Let’s give random homeopathic medications to the children in the slums of Nicaragua and compare it to placebo and see if it helps their diarrhea.  Treatment of acute childhood diarrhea with homeopathic medicine: a randomized clinical trial in Nicaragua did just that.

So what did they use for treatments of diarrhea and why (besides normal hydration)?

Who had oversight on this study? From the paper:

Informed consent was obtained from the parent or guardian using a disclosure statement that had been approved by the human subjects review committee of the University of Washington.”

One third of Nicaraguans are illiterate and only half get a fifth grade education. I would think, obviously erroneously, University of Washington would recognize that the parents of children in Nicaraguan slums may not have the background to understand informed consent or the essential irrationality, er, science,  of homeopathic nostrums, and one would hope that the University  of Washington would be interested in protecting those who cannot protect themselves.   Evidently not, since their faculty continues to export magic to vulnerable  children and adults in third world countries. Not yet ethically Tuskegee level research, but they are working on it.

I understand that one persons lapse in medical and scientific understanding is another’s opportunity for a nationally syndicated television show, but they might have well piled the money spent on the study and burned it for all the good it did the subjects and the medical literature.  At least they could have used the heat to pasteurize some milk.

Homeopaths Without Borders. Or sense.

Men never do bad medicine so completely and cheerfully as when they do it from a homeopathic conviction.

Doctors Without Borders,  also known as Médecins Sans Frontières, is an organization that sends physicians to some of the most needy parts of the world.   Using the style, but not the substance of Doctors without Borders, is Homeopaths without Borders, or, as the RationalWiki called it, Médecins Sans Médicaments.  Their goal is to send homeopathic care to those in need.  Based in Florida, it appears to be the work of one homeopath and almost all its work is in Haiti.

“the poor health of the people here is striking. So many girls and women have vaginal infections. So many children have infected cuts. So many men have reddened eyes, rotten teeth, and injuries that are healing badly. The nurses and docs here are as dedicated as anywhere else, but they lack supplies, and they don’t have medicines.”

They need help.  Shall we provide money for antibiotics? Dental Care? Good nutrition?  Clean water?

So lets supply them with water, and not even enough to wash those infected cuts.  I have to admit this brings conflicting emotions.  I have to admire anyone who will take the time to go to a disaster like Haiti and work to help those in need.  On the other hand, they offer nothing but false hope and magic, so cannot make the lives of Haitians any better. Time, money and resources, which could be used so much more productively, wasted.  I see many patients who have pissed away their lives and opportunity with heroin or alcohol or other bad choices.

“Look, if you had one shot, or one opportunity
To seize everything you ever wanted-One moment
Would you capture it or just let it slip?
Give effective therapy or a homeopathy? “

Wasted opportunities always inspires angst. So does Médecins Sans Médicaments.

It does show how powerful delusional states can be for believers of nonsense, since as RationalWiki states “Essentially, they go to nations with sub-standard healthcare, and dilute it even more to make it 10^-430 times as good as the healthcare in wealthier nations.”

PanAfrican Acupuncture Project

The evil that is in the world almost always comes of ignorance, and good intentions may do as much harm as malevolence if they lack understanding.

How best to spend very limited resources and maximize the health in Uganda, where AIDS, malaria, and Tb are endemic and have devastated the country?  Mosquito nets and condoms would be a good start to prevent these blood and mosquito borne illnesses.  Naw.  That might actually improve peoples lives.  Or we could use acupuncture instead:

“The PanAfrican Acupuncture Project trains healthcare workers in Africa to use simple and effective acupuncture techniques that enable them to treat the devastating and debilitating symptoms associated with HIV/AIDS, malaria, and TB.”

Again, I do admire the urge to go to Africa and help others.  They ask for donations and trainers on the website, expecting the trainers to provide their own airfare and $3,000 (aka 300 mosquito nets) to cover their own costs.  No small commitment. Of course, they provide a vulnerable population worthless magic, and I can only imagine what four grand could provide for clean water or malaria nets, interventions  that would actually benefit the Ugandans.

But what is scary is the web page.  Uganda is rife with HIV, which is spread, by, hmmmm, lets see, sex, blood and needles. Unsterilized needles.  In Africa, reuse of needles has been common, often due to lack of resources for sterilization, and has helped to spread HIV and perhaps other infectious diseases. So they have photos of people sticking needles into patients who could and do have HIV. Not a glove to be seen. Remember that blood borne illnesses are spread with acupuncture needles: Hepatitis B, hepatitis C and, rarely in the West, HIV.  It is rare to spread these diseases where good technique is followed scrupulously.  Poor societies are not known for the resources that allow them to fastidiously take care of proper cleaning.  Would anyone besides me worry that some acupuncture needles have a chance of being reused after poking an HIV positive patient?

As best as I can tell from the website, they are training people to potentially spread HIV between patients when and if sterilization breaks down and placing the acupuncturist at small, but real, risk should a needle stick injury occur.  The have trained over 100 local acupuncturists and hope to spread acupuncture, and the occasional blood borne viral illness, beyond Uganda to other African countries.  No benefit and all risk. The PanAfrican Acupuncture Project may have a commitment to philanthropy, but I am not convinced they have a commitment to preventing disease transmission.

“Give me your tired, your poor,
Your huddled masses yearning to breathe free,
The wretched refuse of your teeming shore.
Send these, the homeless, tempest-tost to me,
I lift my lamp beside the golden door!”
And waste their resources and health with CAM.

There are Chiropractors Without Borders and Naturopaths Without Borders who have three principles:

• Health care is a human right for all, not a privilege for the few.
• Everyone deserves the best healthcare, regardless of finances.
• Naturopathic Medicine is well suited for resource-poor settings.

Unfortunately, the third has no relationship to the first two.

There is Reiki Without Borders and Herbalists without Borders fortunately for the third world,  all seem to be the work of a few individuals, although Haiti appears to be the common destination.  Poor Haitians. They really need a border.

The West has a long and sordid history of exporting disaster to the third world.  It is nice to know that sCAMsters,  even if only a very small subset, are continuing the time honored tradition of maltreatment of indigenous peoples in the name of helping them.

Fortunately there are doctors, nurses, engineers, teachers, chemists and scientists without borders, who can offer substantive help.  Even Clowns without Borders would have something to offer, although not for everyone.

People aren’t either wicked or noble. They’re like chef’s salads, with good things and bad things chopped and mixed together in a vinaigrette of confusion and conflict and alternative medicine.

Not only his name and his titles of nobility were forged, but parts of the teachings of the man who introduced acupuncture to Europe were also invented. Even today, treatments are provided based on his fantasies.

– Hanjo Lehmann¹

Decades before President Nixon’s visit to communist China, and before the articles in the Western popular press on the use of acupuncture in surgery, a Frenchman by the name of George Soulié de Morant (1878-1955), published a series of colorful accounts of the use of acupuncture in early 20th-century China. His work led to the creation of a school of thought known as “French energetics,” which has become the theoretical foundation for many proponents of acupuncture in the West, including Joseph Helms, MD, the founder and former director of the American Academy of Medical Acupuncture (AAMA), and the founder of the acupuncture certification course for physicians.

But just as the medical community gradually learned that the reports of the use of acupuncture in surgery in communist China were inaccurate, exaggerated, or even fraudulent, we are now learning that the reports on the use and efficacy of acupuncture by Soulié de Morant were also fabricated.

According to a 2010 article published in Germany by Hanjo Lehmann in the Deutsches Ärzteblatt (a short version was published in Süddeutsche Zeitung), there is no real evidence that the Frenchman who is considered the father of Western acupuncture ever stuck a needle in anyone in China, and he probably never witnessed a needling.

A century prior to Soulié de Moran’s publications, the therapeutic use of needles enjoyed immense (though short-lived) popularity in Western Europe — mainly in France, Germany, Austria. This use of needles consisted mostly of the so-called locus dolendi treatment, where needles are placed solely in the vicinity of the affected area(s).² But due to its lack of significant efficacy, this treatment vanished just as rapidly and completely as it had appeared.

During that time, paradoxically, acupuncture was excluded from the Imperial Medical Institute of China by decree of the Emperor in 1822. The knowledge and skills were retained, however, either as an interest among academics or through everyday use by rural folk healers. With China’s increasing acceptance of scientific medicine at the start of the 20th-century, final ignominy for acupuncture arrived, when in 1929, it was outlawed, along with other forms of traditional medicine.³

The practice of acupuncture, however, reappeared in France a few years after it was outlawed in China, and from there it gradually spread to Western Europe and the US. This time, its theories were based on the laws of meridians (where points distant from the affected areas are needled according to intricate algorithms). This renaissance was largely due to Soulie de Morant’s legacy.

Soulié de Morant was born in Paris in 1878, and attended a Jesuit school. The prevailing story is that he was a child prodigy, and in addition to speaking fluent English and Spanish, he also learned Mandarin from a Chinese man who lived in Paris, and who (according to family friend Judith Gautier, a French writer) spent an afternoon with the young George writing Chinese characters (or ideograms) in the sand.

Soulié de Morant went to China at the turn of the 20th-century at the age of 21 to work for a French bank. The legend goes that he was fluent in Mandarin before going to China, and that once there, he also learned Mongolian. Reportedly, his language skills and his knowledge of Chinese culture brought him to the attention of the French Ministry of Foreign Affairs, who appointed him judge of the Joint French Court of Shanghai, and later the Vice-Consul of Foreign Affairs in Yunnan. Presumably, he then became the French Consul in several Chinese cities.

The legend also includes the story of how, while in office, Soulié de Morant witnessed a Chinese physician help the victims of a “terrible cholera epidemic that raged in Beijing at that time,” without recourse to modern medicine. His curiosity aroused, he began to read ancient medical texts, and studied acupuncture under several renowned physicians. Purportedly, he later practiced acupuncture himself, and it is reported that his knowledge and skills were such that he became respected by the Chinese — an incredible accomplishment for a foreigner, then or now.⁴

He returned to France in 1910, was married in Paris in 1911, and had two children. He then tried to return to China, but only succeeded to go back for a few months in 1917. After this final trip to China, he wrote several books on Chinese art and literature. Curiously, he didn’t mention acupuncture in any of his writings until 1929 — the same year it was outlawed in China.

Initially confronted with skepticism and derision, Soulié de Morant’s writings on acupuncture eventually managed to attract the support of several French physicians. His major work, L’acuponcture chinoise, outlines his “theory of energy” and its therapeutic manipulation by acupuncture. He is also known for coining the widespread term “meridian,” as a translation for the Chinese expression jingluo (??), which literally means “channel-network.” He translated the term qi (?), the Chinese equivalent of the Greek notion of pneuma (??????), into the modern term “energy.”

The 1994 translation of L’Acuponcture Chinoise. Image source: Paradigm Publications

One of the main people who challenge the authenticity of Soulié de Morant’s understanding of acupuncture and his interpretations of the Chinese classics is the American scholar, Donald (Deke) Kendall, PhD, who writes in the Dao of Chinese Medicine that by jingluo, the Chinese were simply referring to blood vessels. Kendall argues that Soulié de Morant’s theories are actually the result of profound misunderstandings and misinterpretations of the classics, which have resulted in the portrayal in the West of the rudimentary description of the vascular system by the Chinese as an elusive network of intangible “energy” channels.⁵

There is ample evidence in support of Kendall’s claims, including the work of the classics scholar Elizabeth Craik, who has convincingly argued that the Chinese notion of jingluo is quasi-identical to the Greek notions of phlebes (blood vessels in general) and neura (ligaments, nerves, etc.).⁶

But Hanjo Lehmann, the author of the recent article in Deutsches Ärzteblatt, goes a step further. Lehmann lists a set of contradictions and inconsistencies in Soulié de Morant’s account of his journey in the Far-East, which shed doubt on his overall character, the integrity of his narrative, and the credibility of his exposure to, and practice of, acupuncture in China. Lehmann calls him a scharlatan.

Lehmann first points out that it would be unlikely for a 21-year-old without any formal education in Chinese (and who had never lived in China) to master a complex language with several thousands of characters, even if he took courses regularly for several years. We recall that the only testimony of Soulié de Morant’s formal “studies” in Paris came from Judith Gautier (1845-1917), who affirmed that on one occasion, a Chinese friend of the family in Paris drew characters in the sand with him.

According to Lehmann, Soulié de Morant likely started his foreign service in 1903, as a low-level interpreter at the Shanghai Consulate, and not as a “judge” in Shanghai. The belief that he was actually nominated as a judge might come from the fact that in his book Exterritorialité et intérêts étrangers en chine, Soulié de Morant states that the French delegate in the Joint Court was “usually the first interpreter” of the consulate.

As for his consular nominations when he was only in his mid-twenties, Lehmann argues that they are certainly false. It is only after he left the French Foreign Office, (probably in 1924), that he received the title of “honorary consul.” In fact, it is only in his writings after 1925, that he calls himself Consul de France.

Lehmann also believes that his aristocratic name “Soulié de Morant” was a forgery, and that he was born simply Georges Soulié.

As for acupuncture, Soulié de Morant claims that he first saw and practiced the technique himself during a cholera outbreak in Bejing in 1908 — but no records of such an outbreak at that time exist. According to the History of Chinese Medicine by Wong and Wu, an epidemic of plague and typhus occurred roughly around that time, but in Hong Kong and Fuzhou in Jiangxi.⁷ There is no record of a cholera epidemic in Beijing or anywhere else.

Moreover, although Soulie de Morant recounts his studies with two renowned acupuncturists of academic rank, other Western writers remind us that during that time, only street practitioners and rural folk healers, worked with needles therapeutically; the use of needles was actually often associated with amulets and talismans, and thus frowned upon by the Chinese academia.⁸

These and dozens more inconsistencies that discredit Soulié de Morant, suggest that the his claims about acupuncture, and the lore of energy meridians and qi, are founded on sloppy translations, misconceptions, or even pure forgery. But the accuracy of these notions are never disputed by the Chinese, because — as Lehmann points out — the public image of acupuncture in China today is based mainly on its reputation in the West. The Chinese consider that any criticism or fundamental discussion would jeopardize that reputation.

Over the last half-century since his death, Soulié de Morant’s interpretation of the traditional tenets of acupuncture, known as “French energetics,” have inspired the creation of over a dozen methods, organizations, and schools abroad,⁹ each with different levels of orthodoxy, critical thinking, or even rationality.

Consider, for instance, a theoretical construct known as the “Energetics of Living Systems” that was developed by the French physician Maurice Mussat. He is one of the leaders of the French school of medical acupuncture, and has taught in the US under the auspices of Joseph Helms, MD. Mussast takes the fabulations of Soulié de Morant to the next level of absurdity by projecting cybernetics, complexity theory, and quantum mechanics onto meridian-based acupuncture.

Mussat indeed believes there is a parallelism between the energetics of the meridians and the “mathematical order inherent in the trigrams and hexagrams” of the I-Ching, a Chinese classic of geomancy (a type of divination based on patterns formed by tossed rocks, sticks, sand, etc.). Mussat, who believes he has connected the symbolism of the I-Ching with modern quantum physics, has devised “algebraic derivations” to measure meridian energetics, and has created a diagram that “incorporates nearly all of the fundamental energy relationships of acupuncture.”¹⁰ Mussat’s forced conflation of acupuncture and quantum physics is outlined in his 3-volume Energetics of the Living Systems Applied to Acupuncture, as well as in other creations of his overinclusive thinking.

A German book on Mussat’s “quantum-medicine” (1983). Image source: VGM Verlag GmbH for Integrative Medicine.

The cognitive derailments of Maurice Mussat have, in turn, greatly influenced Joseph Helms, the founder and former Director of the AAMA.¹¹ Helms, who combines family medicine, acupuncture, and homeopathy, served on the advisory panel of the Office of Alternative Medicine, NIH, and presented to the White House Commission on Complementary and Alternative Medicine Policy. In his book, Acupuncture Energetics, Helms writes:

Mussat inspired me with the strength of his conviction and his creative merging of two disparate traditions of thought and medicine. He guided me to perfect my clinical skills and to start teaching. My early clinical time with him, combined with the years we lectured together, created an indelible matrix of clear expression that I hope is manifested throughout this work.¹²

Since the 1980s, the AAMA has taught the fantasies of Soulié de Morant and Mussat on meridians and energy under the label of “medical acupuncture” to thousands of physicians in the US , many of whom were members of the military. In fact, in 2009, the office of the Surgeon General of the Air Force instituted a pilot program for active duty physicians to be trained by Helms Medical Institute, and gave out 32 scholarships on a competitive basis. According to Stars and Stripes, the US military’s independent news source, the program is now expanded to all service branches, and will certify 60 active duty physicians in 2011 as “medical acupuncturists.”

Meanwhile, well-conducted clinical trials have indicated over and over that needling location has little differential effect on outcomes, and that acupuncture is largely devoid of speci?c therapeutic effects.¹³ The support for this argument comes from a series of 8 large randomized controlled trials (RCTs) initiated by German health insurers. These RCTs were related to chronic back pain, migraine, tension headache, and knee osteoarthritis (2 trials for each indication). Their total sample size was in excess of 5000. Even though not entirely uniform, the results of these studies tend to demonstrate no or only small differences in terms of analgesic effects between real and placebo needling.¹⁴

This evidence indicates that the use of specific meridians, points, and particular types of stimulation are not critical factors independent of conditioning, expectancy or other neuropsychological factors. Needling seems to have a broad anti-inflammatory and antihyperalgesic effect, which could be attributed to the pain and tissue injury, or the neurostimualtion caused by the needle, regardless of the insertion point. In view of this, the meridian and point lore, and the premisses of “Acupuncture Energetics,” are all devoid of any scientific rationality.

Considering that acupuncture was reintroduced to the West based on a narrative that was apparently fraudulent; that its cultural assimilation has conflated it with New Age crackpottery; and that reliable RCTs contradict its medical claims, it’s time once-and-for-all to cease wasting taxpayer dollars on its dissemination.

NOTE: The opinions expressed here are those of the author, and do not reflect the positions of Hanjo Lehmann and Donald (Deke) Kendall.

REFERENCES

1. Lehmann H. Akupunktur im Westen: Am Anfang war ein Scharlatan. Dtsch Arztebl. 2010; 107(30): A-1454 / B-1288 / C-1268. Return to text
2. Feucht G. Streifzug Durch die Geschichte der Akupunktur in Deutschland, Deutsche Zeitschrift fur Akupunktur, 10. 1961. Return to text
3. Ma KW. The roots and development of Chinese acupuncture: from prehistory to early 20th century. Acupunct Med 1992;10(Suppl):92–9. Return to text
4. Soulié de Morant G. L’acuponcture chinoise. 2 vols. Paris: Mercure de France, 1939-1941. Published in English as Chinese Acupuncture, edited by Paul Zmiewski. Brookline, MA: Paradigm Publications. 1994. Return to text
5. Kendall DE. Dao of Chinese Medicine: Understanding an Ancient Healing Art. Oxford University Press, USA; 1 edition. 2002. Return to text
6. Craik EM. Hippocratic Bodily “Channels” and Oriental Parallels. Med Hist. 2009 January; 53(1): 105–116. Return to text
7. Wong KC, Wu TH. History of Chinese Medicine. Oriental Book Store. 1977. Return to text
8. Hillier SM, Jewell T. Health Care and Traditional Medicine in China 1800-1982. Routledge; 1 edition. 2005. Return to text
9. Hsu E. Outline of the History of Acupuncture in Europe, The Journal of Chinese Medicine, 29. 1989. Return to text
10. Mussat M. Energetique Physioloque de l’Acupuncture. Paris, France: Librairie le Francois. 1979. Return to text
11. Birch SJ, Felt RL. Understanding Acupuncture. Churchill Livingstone; 1 edition. 1999. Return to text
12. Helms JM. Acupuncture Energetics: A Clinical Approach for Physicians. Medical Acupuncture Publishers; 1st edition. 1995. Return to text
13. Ernst E. The American journal of medicine, Vol. 121, No. 12. December 2008. Return to text
14. Baecker M, Tao I, Dobos GJ. Acupuncture Quo Vadis? On the current discussion around its effectiveness and “point speci?city.” In: McCarthy M, Birch S, Cohen I, et al, eds. Thieme Almanac 2007: Acupuncture and Chinese Medicine. Stuttgart, Germany: Thieme; 2007:29-36. Return to text

Some of our readers have complained that we pick on alternative medicine while ignoring the problems in conventional medicine. That criticism is unjustified: we oppose non-science-based medicine wherever we find it. We find it regularly in alternative medicine; we find it less frequently in conventional medicine, but when we do, we speak out.   A new book by Dr. Peter Palmieri is aimed squarely at failure to use science-based medicine in conventional practice.

Dr. Palmieri is a pediatrician who strives to provide the best compassionate, cost-effective, science-based care to all his patients. Over 15 years of practice in various settings, he observed that many of his colleagues were practicing substandard medicine.  He tried to understand what led to that situation and how it might be remedied. The result is a gem of a book: Suffer the Children: Flaws, Foibles, Fallacies and the Grave Shortcomings of Pediatric Care. Its lessons are important and are not limited to pediatrics: every health care provider and every patient could benefit from reading this book.

The chapters cover these subjects:

• How doctors mishandle the most common childhood illnesses
• How doctors succumb to parental demands
• How they embrace superstition and magical beliefs
• How they fall prey to cognitive errors
• How they order the wrong test at the wrong time on the wrong patient
• How financial conflicts of interest defile the medical profession
• How doctors undermine parents’ confidence by labeling their children as ill
• A prescription for change

There have been huge advances in pediatric care in recent decades. As Palmieri aptly puts it,

Devastating infectious diseases such as polio, smallpox and diphtheria were so utterly vanquished that many otherwise reasonable people, apparently afflicted with an odd and dangerous form of selective amnesia, now openly embrace misguided anti-vaccination efforts.

Premature infants as small as 8.6 oz have survived; survival rates for childhood leukemia have soared; surgery is being performed on fetuses in the womb; organ transplants have become routine.

Unfortunately, these remarkable achievements in the high echelons have not translated into improvements at lower levels of pediatric care. The most common illnesses are handled poorly in many doctors’ offices. Antibiotics are given for viral illnesses where they can’t possibly work (Palmieri compares this to putting a mousetrap in the kitchen to combat an infestation of ants). Doctors often rationalize that antibiotics are needed to treat “occult bacteremia” or “sinusitis” when the patient really only has a routine cold. As a result, antibiotic resistance is rising and we have to worry about MRSA (Methicillin-resistant Staph aureus). Some physicians have forgotten or abandoned their scientific training and have adopted erroneous beliefs from dubious sources. They commit errors not through lack of knowledge or of intelligence, but as a result of human fallibilities in the context of complex interactions between patient, doctor, and society. Palmieri provides insights into how those errors arise, with trenchant stories of patients who suffered from those errors.

He debunks a number of common myths, such as the idea that fever is dangerous (the only real reason for treating it is comfort) and the belief that white coats frighten children (this was studied and shown to be false).  For treatment of vomiting and diarrhea, Palmieri points out that the traditional “bowel rest,” 24 hours on a clear liquid diet, and the BRAT diet (bananas, rice, applesauce and toast) are not based on evidence and are no longer recommended by the CDC or the American Academy of Pediatrics; yet the myth refuses to die.

This book cuts to the heart of why science-based medicine is important and why it is so difficult to implement. The subject of each chapter of Palmieri’s book deserves an SBM blog post of its own. I’ll just give one example here that highlights several of the issues at once.

A 14 year old boy with viral gastroenteritis had vomited several times over a few hours. The pediatrician decided he was dehydrated or about to become dehydrated and admitted him to the hospital for IV fluids and an overnight stay. Palmieri, who was responsible for his care in the hospital, estimated that he was only mildly dehydrated. He treated him with anti-emetic medication and oral rehydration. After a very short time, the boy was keeping fluids down, ate a light lunch, and felt much better. He improved enough to be discharged later the same day. Meanwhile, Palmieri was harassed by the parents, the referring pediatrician, and the hospital administrator. The father demanded to know why his son didn’t have an IV and why blood tests hadn’t been done; Palmieri provided him with a printout of CDC guidelines on dehydration and explained that he was following them precisely and would not need to start an IV unless oral rehydration failed. The father was still hostile, insisting that the pediatrician had clearly said his son would be spending the night in the hospital. The referring physician called Palmieri wanting to know why the child didn’t have an IV yet, insisting that he needed one because he was dehydrated. The administrator complained that the hospital wouldn’t be paid by the insurance company unless they inserted an IV to prove that he was sick enough to be in the hospital, and he wanted to know why Palmieri was being a troublemaker and refusing to do what all the other doctors did. Palmieri followed the standard of care, did what was best for the child, and minimized the cost and discomfort of treatment, but no one was happy (except the child). In the face of that kind of opposition, many doctors are tempted to take the easy way out, give in to the expectations of others, waste more money, do unnecessary tests and procedures, please the parents, and generate more profits.

When Mom insists that Tommy always gets an antibiotic for his runny nose and it is the only thing that cures his supposed “sinusitis,” it’s far easier to write another prescription than to go against all his previous doctors and try to explain why antibiotics aren’t indicated. And anyway, Mom won’t listen: her mind is firmly made up. She is going by what other trusted doctors have told her, by her personal experience, and by her strong desire to do what she believes is right for her child. If you don’t write the prescription, she will only find another doctor who will.

Current reimbursement systems reward poor medical care. A doctor may get $65 for an office visit to appropriately treat a child with an ear infection. If he codes it as “fever” he can be reimbursed for a barrage of unnecessary tests (flu, rapid Strep test, CBC, tympanometry, reimbursed at $15 per test) and charge for a higher complexity visit ($85), raising the total charge for an office visit to $145. And then if the white blood count is elevated, he can justify giving an antibiotic by intramuscular injection at an additional charge of $30-$50. One doctor told Palmieri he does circumcisions in his office because Medicaid pays for them, but he sends simple lacerations to the ER because Medicaid won’t pay for office suturing. Financial considerations are particularly tempting to pediatricians, since their incomes are typically the lowest of any specialty.

Palmieri argues that poor care inflates medical expenditures, while good care is cost-effective. The money that is being wasted on unnecessary measures would be sufficient to provide quality care to all the children who currently lack access to care.

This is not your typical doctor-bashing book. He does not criticize conventional medicine per se: he applauds those who practice it successfully in accordance with scientific evidence and only criticizes those who fail. And he is charitable to those who fail: he shows how easy, how human, how understandable it is to fall into error. He recognizes that his own bias in favor of scientific rigor might lead him into errors of his own, and he tries to keep that constantly in mind and guard against it.  He’s not just a critic: he has concrete recommendations for improvement. Parents should become better educated to recognize which symptoms are normal variants or self-limiting illnesses and should accept that not every complaint requires treatment. Doctors should

• Listen more carefully
• Observe more vigilantly
• Be more humble
• Constantly question what they know
• Be more diligent
• Improve their communication
• Work hard to maintain competency and engage in life-long learning
• Not succumb to financial temptations
• Care more deeply for their patients

Suffer the Children is available as an e-book at very low cost. It has some typos and grammatical infelicities that would have benefited from professional editing and proof-reading, but it is written with an engaging style and should appeal to everyone from the most science-illiterate layman to the most sophisticated medical subspecialist.  There is too much in this book to do it justice in a short review: it even provides a short course in cognitive errors and why doctors believe weird things. In future posts I’ll try to address some of the other important issues it brings up. Please read this book, and recommend it to all your friends (and enemies, for that matter), especially those with children.

I have been following the story of Dr. Zamboni, an Italian vascular surgeon who claims that multiple sclerosis (MS) is primarily caused by blockages in the veins that drain blood from the brain. This results in backup of blood in the brain, leading to inflammation around the blood vessels and MS. He sought to find the cause and cure for MS because his wife suffers from this disease – and he claims to have found one in his own specialty.

New ideas are presented in science and medicine all the time. This is healthy and necessary – we have to keep churning the pot so that new ideas can emerge and our thinking does not become calcified. But science is both a creative and destructive process, and most new ideas fall victim to the meatgrinder of research and peer-review. Ideally this process will take place mostly within  the halls of science, and then those ideas that survive at least initial examination will start to penetrate the broader culture.

This is not what often happens today, however. With the internet and mass media, preliminary speculative studies are often presented to the public as if they are a stunning breakthrough. When the scientific community responds with their typical and completely appropriate skepticism, this may lead some to think that they are being stodgy or dogmatic, or even that a cover-up is in the works. The originator of the speculative claim is usually portrayed as  a brave maverick, although sometimes the story can be framed as, “Brilliant scientist or dangerous crank? You decide.”  When the topic is a new medical treatment, the stakes can be quite high. In this case many patients with progressive MS are seeking treatment with the so-called liberation procedure to treat the highly speculative CCSVI as an alleged cause for their MS.

This story has all the makings of the kind of scientific and medical drama the mass media loves. While the controversy rages, the science is quietly being done in the background, and the results are not heading in a favorable direction for Zamboni. A recent study, the largest to date, drives a further stake into the heart of CCSVI as a cause of MS.

First, let us consider how to approach Zamboni’s claims. His data suggests that nearly 100% of patient with MS have CCSVI (detectable blockages in the veins that drain the brain) while 0% of non-MS patients do. This kind of evidence is correlation only, and does not prove (even if it might suggest) causation. Before we leap to treatment, the cautious scientific approach is to first confirm the correlation with replication. If the correlation holds, then studies need to be done that can shed light on causation – does the pattern of correlation fit the hypothesis that CCSVI causes MS, rather than MS causing CCSVI or both correlating with some other factor. Finally, before treating CCSVI, we would need to study this treatment directly in specific types of MS.

Proponents of the liberation procedure are skipping over all these research steps, and then use anecdotal evidence to support claims of efficacy. This is a story we have seen before, and it usually does not turn out well. Getting back to the first step – how have attempts to replication the correlation been going?

Last August I described the first four attempts at replication, three of which yielded negative results. Just last month I wrote a following up where I described three further studies of CCSVI – all negative. This month two more relevant studies have been published. The first compared 20 MS patients to 20 healthy controls, and found:

Only one healthy control and no MS patients fulfilled at least two criteria for CCSVI. Conclusions This triple-blinded extra- and transcranial duplex sonographic assessment of cervical and cerebral veins does not provide supportive evidence for the presence of CCSVI in MS patients. The findings cast serious doubt on the concept of CCSVI in MS.

Last week the largest CCSVI study was published, a study that enrolled 499 subjects, and compared MS patients to patients with other neurological disease (OND) and to healthy controls (HC). They found:

RESULTS: CCSVI prevalence with borderline cases included in the “no CCSVI” group was 56.1% in MS, 42.3% in OND, 38.1% in CIS, and 22.7% in HC (p < 0.001). The CCSVI prevalence figures were 62.5% for MS, 45.8% for OND, 42.1% for CIS, and 25.5% for HC when borderline cases were excluded (p < 0.001). The prevalence of one or more positive VH criteria was the highest in MS (81.3%), followed by CIS (76.2%), OND (65.4%), and HC (55.2%) (p < 0.001). CCSVI prevalence was higher in patients with progressive than in nonprogressive MS (p = 0.004).

CONCLUSIONS: Our findings are consistent with an increased prevalence of CCSVI in MS but with modest sensitivity/specificity. Our findings point against CCSVI having a primary causative role in the development of MS.

These findings are interesting – they do not entirely rule out a correlation between CCSVI and MS. However, the results are very ambiguous. There is a statistical correlation between MS and CCSVI, but there is also a correlation with other neurological diseases – with very different histories and probable causes than MS. CCSVI was also found in a quarter of healthy controls. So CCSVI is not specific to MS, and almost half of MS patients do not meet criteria for CCSVI.

Given the other negative studies, these results cannot be taken at face value but have to be put into context of the other research. At this time we can say that their might be a correlation, but it’s weak. It’s also still possible there is no correlation, and since there are some contradictory results more research would be helpful.

Even if there is a partial correlation, this study argues strongly against CCSVI being a significant cause of MS – if 44% of MS patients do not have it, and 42% of patients with OND do have CCSVI but not MS. This could mean that CCSVI only causes a subset of MS, or that it is a risk factor but not a direct cause. Or it could mean that MS (and apparently other diseases) cause CCSVI. This is plausible – we can imagine that the chronic inflammation caused by MS damages the veins over time resulting in CCSVI. It is even possible that this, in turn, will cause its own symptoms or worsen the MS and therefore treating it may be beneficial. This is all just speculation, however. In this case the phrase, “more research is needed” is appropriate.

One other recent study, that I have not written about previously, is worth mentioning. In this study researchers looked specifically at subjects at the very onset of their MS. If CCSVI causes MS then it should precede MS. They found no correlation, and concluded:

Our findings do not support a cause-effect relationship between CCSVI and pMS. Further studies are warranted to clarify whether CCSVI is associated with later disease stages and characterizes the progressive forms of MS.

Conclusion

With these latest studies the correlation between CCSVI and MS seems shaky – nonexistent to weak, but not entirely ruled out. That CCSVI is a significant cause of MS is even weaker. It cannot be ruled out as a late stage contributor, or a cause in a subset of MS patient, but neither is it established as a contributing cause at all, and the evidence is largely against it.

There is so far no controlled blinded studies of the liberation procedure in patients with CCSVI and MS. There is a controversy as to whether or not such studies would be ethical and appropriate. It would be getting ahead of the more basic research – we should determine that a phenomenon exists and is causative before studying a treatment of it. However, hype has generated great interest in the liberation procedure, and it is being done in various clinics. This is the Catch-22 that the modern information age has created for ethical medical researchers.

In a perfect world clinical trials of the liberation procedure would wait for more confirmatory studies, but we do not live in a perfect world. We may need to at least study those patients who are seeking out the treatment anyway, and provide useful data that future patients and practitioners can use to guide their decisions.

I’ve frequently lamented what might happen if the current trend towards quackademic medicine continues unabated, and quackery becomes fully “integrated” with science-based medicine as a co-equal. Interestingly, this concept has provided fodder for several comedians. For example, the first comedy sketch I discovered on this theme was homeopathic e.r. Then a couple of years ago, Mitchell and Webb brought us the British version of essentially the same idea (but done so much better), namely Homeopathic A&E. What I didn’t realize is that predating both of these was…Holistic E.R. (Embedding disabled, unfortunately.)

This sketch comes from an old sketch comedy show known as Almost Live!, which I had never heard of before, but if this sketch is any indication, it was brilliant. Favorite bits from Holistic E.R.: The part about vitamin C, the use of visualization, and, of course, the crystals. Sadly, with the way academic medicine is being infused with quackery such as energy healing, homeopathy, and even anthroposophic medicine at my medical alma mater, I could see this happening within my lifetime.

“Health freedom.” It’s a battle cry frequently used by supporters of “alternative” medicine against what they perceive to be persecution by the medical and scientific establishment that uses the Food and Drug Administration, the Federal Trade Commission, and other federal agencies charged with regulating pharmaceuticals, food, cosmetics, and medical devices in order to protect the public against fraud, adulterated food, and quackery. It’s a potent argument to those not versed in skepticism and science-based medicine, and even to many who are. After all, Who could argue with “health freedom”? How dare the government tell me what I can and can’t use to treat my own body? Of couse, as I (and others) have said many times before, in reality “health freedom” is a sham. In reality, “health freedom” is not an argument made for the benefit of the consumer; it’s an argument made for the benefit of the sellers of supplements. In practice “health freedom” really means freedom for quacks from any pesky laws and regulations that would prevent them from exercising their quackery.

So it was last week when I saw two websites known for anything but science-based medicine (SBM), namely the quackery-promoting website NaturalNews.com and the quackery apologist blog Vitamin Lawyer Health Freedom Blog promoting a bill that I hadn’t heard of before, namely H.R. 1364, entitled the “Free Speech About Science” (FSAS) Act of 2011. This bill is being touted in all the usual “health freedom” venues as an antidote to what supplement manufacturers apparently see as the “overreach” of the FDA. For example, Ethan A. Huff of NaturalNews.com (where’s Mike Adams, one wonders?) urges his readers to tell Congress to support the Free Speech about Science Act of 2011., while “vitamin lawyer” Ralph Fucetola subtitles his post HR 1364, S.216 and the Struggle for Health and Food Freedom Action Item. So what do these advocates for dubious supplements say?

First, Ethan Huff:

As many NaturalNews readers probably already know, the US Food and Drug Administration (FDA) has severely limited the free speech of practically everyone besides drug companies. Supplement manufacturers, natural food companies, and even produce growers are prohibited from making honest, scientifically-proven health claims about their products, even when such claims are supported by peer-reviewed studies. As a result, millions of Americans are left in the dark about how natural foods, herbs, and supplements can help them prevent and cure disease.

This is where FSAS comes in. If passed, the bill will amend current law to allow growers and manufacturers to freely share honest information about food and supplements with their customers. While the bill will still allow the FDA and the US Federal Trade Commission (FTC) to go after companies that are truly making false claims, the agencies will no longer be able to tyrannize those companies that simply share the truth with the public.

Now, Ralph Fucetola:

Our gripe is aimed not at all those good folk who turn to Congress for protection, but at the Congress-critters who vote to protect us (or not) only to do nothing when the FDA thumbs its collective nose at Congress and the People by ignoring the protective laws Congress has adopted.

Frankly, we thought we had won the battle over being allowed to communicate truthfully about health and food in Congress and in the Supreme Court.

We thought that’s what DSHEA was supposed to have done in 1994 with its Third Party Literature Provisions.

“Communicate truthfully.” You keep using that phrase, Mr. Fucetola. I do not think it means what you think it means. Of course, I suppose Mr. Fucetola could argue that he’s not being as disingenuous as I perceive him to be in that most of the supplement hawkers making health claims for their foods or supplements probably do believe them to be true and therefore are not, strictly speaking, lying. That doesn’t mean that such claims shouldn’t be regulated.

At least Mr. Fucetola is honest enough to point out that the purpose of the DSHEA of 1994 was to permit more—shall we say?—liberal “free speech” by supplement manufacturers and sellers. That “free speech” in practice frequently means “making stuff up.” Of course, many of us here at SBM have been quite critical of the DSHEA of 1994. Although well-intentioned to some extent in trying to clarify different standards for regulation for foods compared to medications, in essence the DSHEA has turned out to be a huge boondoggle that allows supplement manufacturers to label their supplements as “foods” when they are in reality being sold for medical purposes and even when it takes an even more “liberal” interpretation of the definition of “food” or “nutrient” to make them cover many of the supplements being sold in the U.S. Peter Lipson quite rightly referred to this law as a “travesty of a mockery of a sham,” basically pointing out that sellers of supplements, for example, have a “get out of jail free” card and can make almost whatever claims they want for supplements as long as they include a Quack Miranda warning and keep their claims vague enough, as in, for example, the ever-infamous “boosts the immune system” or “promote detoxification.” Reports from the Government Accounting Office and the Institute of Medicine recommending tighter regulation of dietary supplements have in general come to naught.

The reason such calls have come to naught is because supplement manufacturers have become an increasingly powerful lobbying force and as a result have successfully managed to beat back any serious modifications to the DSHEA. Some of this is due to the increasing popularity of supplements. (A recent survey found that 50% of adults take some form of supplement.) Some of it is also due to the increasing number of pharmaceutical companies manufacturing supplements, a product that allows them to make what they want with very little of that pesky interference from the FDA. Supplements are highly profitable, too, and it doesn’t cost $1 billion to bring a new supplement to market, as it does for many new drugs. As a result certain powerful legislators are in the pockets of the supplement industry. For example, about a year ago, Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), the former of whom has received large contributions from supplement manufacturers in his state and the latter of whom is a true believer most responsible for the creation of the National Center for Complementary and Alternative Medicine (NCCAM) beat back an attempt by Senators John McCain (R-AZ) and Byron Dorgan (D-ND) to pass the Dietary Supplement and Safety Act of 2010. This law would have eliminated some of the loopholes in the DSHEA of 1994. At the time John McCain was facing a serious primary challenge to his reelection effort from the Tea Party right and caved because he decided that he couldn’t be perceived as being in favor of more government regulation.

Not surprisingly, the FSAS Act of 2011 (H.R. 1364) was introduced by Representatives Jason Chaffetz (R-UT) and Jared Polis (D-CO). Utah is, as we have seen, Orrin Hatch’s home state and a major center for supplement manufacturing in the U.S. Chaffetz, too, is in the pocket of the Utah supplement industry. Indeed, he is not only a former industry executive but also co-chairman of the Congressional Dietary Supplement Caucus, and his district is one of the biggest producers of dietary supplements in the country, boasting itself as the home of companies such as Nu Skin, Usana, MonaVie, Xango, and Tahitian Noni. As a result, his longstanding activism in promoting supplements and his potential challenge to Orrin Hatch for his Senate seat next year have led to speculation that the supplement industry might be forced to take sides. Meanwhile, other members of the Dietary Supplement Caucus include Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), as well as Representatives Dan Burton (R-IN), Frank Pallone (D-NJ), and—surprise! surprise!—Jared Polis (D-CO). Truly, big pharma may be a potent force in Congress, but “big suppa” is nothing to sneeze at, and it has major bipartisan support. Of course, this is something that advocates such as Huff and Fucetola won’t tell you.

So what does the law propose to do, really? Before I get to that, let’s go back in time a bit for some history.

A BIT OF BACKGROUND

The United States counts among its founding principles freedom and the idea that we don’t like the government telling us what to do. We’ve seen these ideas in conflict with other principles that there is a role for the government in protecting its citizens against fraud and harm that can result from adulterated food or medicines that don’t do what their manufacturers claim they can do. When the U.S. was a mostly agrarian nation with few large cities, the problems that resulted from patent medicines and adulterated food were not as major a problem as they became as more and more Americans poured into metropolises like New York and Chicago. In fact, federal protections against these sorts of fraudulent activities are a relatively recent development in the history of the U.S. Before the 1900s, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals; instead there was a patchwork of state and local laws designed to outlaw unethical practices, such as misrepresenting the ingredients of pharmaceuticals or making claims for them that can’t be backed up.

In the wake of muckraking like Upton Sinclair’s The Jungle, which dramatized the horrific conditions in meatpacking plants and the lack of attention to sanitation, which was part of a confluence of events that pushed Congress to pass the Pure Food and Drug Act of 1906, also known as the Wiley Act after its chief advocate, which resulted in the creation of the Bureau of Chemistry, which later became the Food and Drug Administration. This first incarnation of the FDA was relatively limited in power and mainly concerned with ensuring that food and drugs that were transported across state lines were properly labeled as to content. By the 1930s, however, the weakness of the Food and Drug Act was becoming apparent in the wake of reports of dangerous products that were permissible at the time, including radioactive beverages and worthless “cures” for diabetes and tuberculosis. In 1937, over 100 people died after using a drug formulated with a toxic solvent (diethylene glycol). There was little the feds could do after that; the only way they managed to prosecute the company responsible (Massengill Company) was for mislabeling the product as an “elixir,” which violated the 1906 Pure Food and Drugs Act, which stated that a company could not call a product an “elixir’ if it had no alcohol in it. Massengill paid a minimal fine, and the resulting public outcry resulted in the passage of the Food, Drug, and Cosmetic Act of 1938, which replaced the 1906 statute and greatly tightened up regulations governing the production of food, drugs, and cosmetics in the U.S.

Ever since, those selling dubious non-science-based remedies and advocates promoting “alternative” medicine, “complementary and alternative medicine” (CAM), and, more recently “integrative medicine” (IM) have been in conflict with laws that, whatever their shortcomings, demand testing for safety and efficacy. Of course, this conflict was to some extent embedded within the law itself, which regulates and protects homeopathic preparations, using the Homeopathic Pharmacopoeia of the United States as an official drug compendium.

Be that as it may, in the early 1990s, Congress was considering bills that would have increased the regulatory powers of the FDA and FTC over supplements in the wake of high profile cases of harm caused by unregulated dietary supplements. As a result, the health food industry and supplement manufacturers rallied its troops to stop such legislation with claims that Congress would take away citizens’ rights to buy vitamins and that many businesses would go under as a result fo this legislation. The end result was that Congress acted, but not to tighten up regulation. Rather, it defined “dietary supplements” as a separate regulatory category and made that regulation quite lax. Stephen Barrett of Quackwatch characterized its effect and intent thusly:

The Food, Drug, and Cosmetic Act defines “drug” as any article (except devices) “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or function of the body.” These words permit the FDA to stop the marketing of products with unsubstantiated “drug” claims on their labels.

To evade the law’s intent, the supplement industry is organized to ensure that the public learns of “medicinal” uses that are not stated on product labels. This is done mainly by promoting the ingredients of the products through books, magazines, newsletters, booklets, lectures, radio and television broadcasts, oral claims made by retailers, and the Internet.

DSHEA worsened this situation by increasing the amount of misinformation that can be directly transmitted to prospective customers. It also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.

Given that the FDA is already chronically underfunded for the tasks it’s expected to carry out, for the most part, the FDA does little to regulate supplements because it has its hands full regulating pharmaceutical drugs. Perhaps the most insidious part of the DSHEA is that, while it allows so-called structure-function support claims (i.e., “boosts the immune system”) or claims based on nutritional support, it does not permit “drug claims.” The problem is, what constitutes a “drug claim” compared to a “structure-function” claim remains fairly vague, even after the FDA issued rules in 2000 that banned explicit claims that a product treats or prevents disease, there’s still considerable wiggle room, and enforcement isn’t exactly what we would call robust. In the meantime, supplement hawkers have cleverly used the Internet to circulate claims for these products that aren’t necessarily on the packages or in the package inserts.

H.R. 1364: The Free Speech about Science Act of 2011

In discussing H.R. 1364, it’s hard not to note how Orwellian the title of the act is. It’s very much of a piece with the term “health freedom.” After all, what red-blooded American could be against “free speech”? What are you, against the First Amendment or something? Are you un-American? That’s pretty much the tenor of the arguments being used to support this bill, whose full text can be found at The Library of Congress Thomas. In fact that sort of argument is right there, in the text of the bill:

The Congress finds the following:

(1) Federal regulators have forbidden–
(A) cherry growers and food producers to cite independent and respected scientific research on their produce that references health benefits; and
(B) a variety of dietary supplement makers to cite independent scientific research on health benefits from supplements from respected, peer-reviewed scientific journals.

(2) Americans want access and have a right to access legitimate scientific information about foods and dietary supplements to ensure informed decisions about diet and health care. While the American public is inundated daily with advertisements about prescription drugs for health conditions, many of which could be prevented through lifestyle changes, proper nutrition, and informed use of dietary supplements, Americans are denied access to the very information that assists in making informed lifestyle and health care decisions.

(3) Providing access to scientific information promotes self-responsibility, thereby empowering Americans to exercise independent judgment in caring for themselves and ultimately reducing health care costs and improving quality of life.

(4) The United States has a long commitment to the free dissemination of scientific research with the exception of limited extreme situations for national security. This commitment goes back to the First Amendment to the Constitution and has contributed vitally to the Nation’s economic progress.

Proponents like Huff cite cases that, on the surface at least, sound reasonable. For example, Huff makes a lot of hay over the case of Diamond Nuts, which made claims that its walnuts could lower cholesterol, protect against heart disease, lower the risk of stroke, inhibit tumor growth, and a number of other disease claims. Huff argues that these claims are “based entirely on results from legitimate scientific studies.” Of course I could argue that claims for the efficacy of homeopathy, reiki, and “energy healing” quackery could similarly be “based entirely on the results of scientific studies,” as well. That doesn’t make them any less quackery. In the case of walnuts, as you might expect, things are a bit more complicated. Basically, Diamond Nuts made its claim based on studies suggesting that omega-3 fatty acids have been suggested to do these things, and its walnuts contain omega-3 fatty acids. The FDA replied:

There is not sufficient evidence to identify a biologically active substance in walnuts that reduces the risk of CHD. Therefore, the above statement is an unauthorized health claim.

As foodsafeguru put it:

Nuts are good for you and cut out the unnecessary claims that could lead consumers to think that if they ate enough walnuts, their CHD would go away.

US Food Safety understands that nuts have had a bad wrap since last year, but say what walnuts really do for you instead of guilding the lilly and deceiving consumers.

Another case that Huff cites dates back to 2005, when the FDA sent certified letters of warning to 29 cherry manufacturers (most of them right here in Michigan!) for making undue health claims for their cherries, complaining that “such claims included the truthful statement that cherries help reduce inflammation, which they absolutely do.” Unfortunately, it was much more than that, as this typical FDA warning letter to one of the cherry growers demonstrates. In it are documented claims by Amon Orchards that cherries prevent cancer. Not only that, but, according to Amon Orchards, they also contain a “natural chemical that not only flushes cancer-causing substances out of the body, but also helps stunt the growth of cancerous cells” and “anti-inflammatory pain relievers 10 times stronger than aspirin or ibuprofen,” that can “relieve aches and pains.” Even a cherry grower in Michigan basically admits that cherry growers were making health claims about its cherries when he writes on his website:

The FDA does not want the cherry industry to tell people that recent studies show that tart cherries contain substances that are potentially 10 times stronger than aspirin or ibuprofen for relieving pain. It does not want the public to know that substances in tart cherries may kill cancer cells and prevent cancer. It makes no difference whether these statements are true. What’s important is that the public not be told that a natural substance (tart cherries) has been shown to work as well as or better than an unnatural one (ibuprofen). Only drugs, according to the FDA’s legal doctrine, can prevent, treat, mitigate, or cure disease.

This same cherry grower then goes on to list even more claimed health benefits of cherries. The problem, of course, is the same problem as with the walnuts in that most of these studies are either preclinical studies, studies using compounds isolated from natural sources, or otherwise studies whose direct applicability to health claims for the food in question are tenuous at best. None of this has stopped the health freedom movement from making histrionic claims about an overbearing FDA, perhaps the most ridiculous example of which is Bill Sardi’s assertion that the FDA had “blood on its hands” for going after the cherry growers. Also, it’s not just the little guys who get into trouble with these claims. Food giant General Mills recently got into the same sort of trouble with the FDA due to its claims that Cheerios can lower cholesterol.

I once coined a term for what the anti-vaccine movement wants parents to hear when it calls for “informing” parents: “misinformed consent.” I called it misinformed consent because the anti-vaccine movement, under the guise of informed consent, exaggerates the risks of vaccines while downplaying the benefits, all with the intent to persuade parents not to vaccinate while disingenuously claiming that that is not what they are about. What supporters of the FSAS Act of 2011 are doing is very similar in my opinion; they are trying to take away barriers to misinforming potential customers, exaggerating the potential benefits of their supplements while downplaying potential risks, all in the name of making a sale. Unlike the anti-vaccine movement, however, it’s not just ideology (in the case of anti-vaccine activists, an unshakable belief that vaccines cause autism and all sorts of other problems), but profit as well that appears to drive them. To that end, from my perspective I see them seeking the freedom to distort the medical literature to exaggerate the health benefits of their products and even make claims that they can prevent or treat disease, as the cherry growers and Diamond Nuts appear to have done.

So what would H.R. 1364 mean if it were actually passed? I must admit that I’m somewhat torn on this. On the one hand, to some extent the FDA letters do on the surface seem a bit ridiculous, at least in the case of walnuts and cherries. They even appear a bit paternalistic. On the other hand, notice how all the arguments for H.R. 1364 made by its proponents are based on examples like cherries and walnuts, rather than actual manufactured supplements. There’s a reason for that. The purpose behind this law really does appear to have very little to do with freedom of speech. Rather, its purpose appears to be to neuter the FDA with respect to claims by food and supplement manufacturers to treat diseases. Remember, under the DSHEA, supplements are considered more akin to food than medicine. In other words, for purposes of the FSAS Act, cherries, walnuts, and Cheerios function as a Trojan horse that, once brought into the protected walls of the FDA through H.R. 1364 (if made law), would soon disgorge its contents of all manner of supplement manufacturers making direct health claims to treat and cure disease based on the flimsiest of “legitimate medical evidence.” Don’t believe me? Check out this “white paper” on the FSAS Act from the Alliance for Natural Health:

A few critics will accept that there is a revolution taking place linking nutrition directly to health. But they think that we should just focus on food, not on food extracts and supplements. There are at least two problems with this. First, studies show that the nutritional content of food has been declining for as long as the last 50 years (see especially the work of Dr David Thomas). The USDA has recently confirmed this analysis for more recent years. The problem seems to lie in depleted soil.

Second, nutrients sometimes have to be concentrated to have full therapeutic benefit. No one can get enough Vit D from food. We also get it from exposure to sunlight on our skin, but use of sun lotion prevents it. Food supplements often make sense either for routine day to day use in lower potencies or as higher potency therapies devised and supervised by doctors.

See the Trojan horse? The FSAS Act would remove the barriers to health claims made for foods like cherries or walnuts but in doing so it would also at the same time remove the barriers for the same sorts of claims for supplements that are concentrated extracts of food ingredients. Even the existing weak protections of the DSHEA would be gutted. No wonder practically every woo-supporting blogger is supporting the bill. No wonder the Association of American Physicians and Surgeons is supporting H.R. 1364 on its Take Back Medicine blog, all in concert with the Alliance for Natural Health and General Bert Stubblebines’ Natural Solutions Foundation, the latter of which is pushing an “action item” for the bill. If that doesn’t make the picture clear enough for you, look at SECTION 4(c)(2), where the “burden of proof” regarding charges of false advertising is shifted from the seller making the claim to the FDA:

In any proceeding under section 13, the burden of proof shall be on the Commission to establish that the literature being disseminated is not legitimate scientific research.

In other words, supplement manufacturers could claim anything they want, as long as they cite a scientific paper or two, and it would be up to the FDA to prove that those scientific papers aren’t “legitimate research.” What about cases where supplement manufacturers misrepresent legitimate scientific research, as the cherry growers did when they represented in vitro experiments as being evidence that cherries provide the health effects claimed in humans?

The problem, of course, is the current law and how supplements are defined. Right now, “nutritional supplements” can include substances that are not by any stretch of the imagination scientifically supported nutrients, vitamins, or minerals that are needed as part of food. As I cited above, a logical definition of “dietary supplement” would be something that really is a dietary supplement, a nutrient. That’s not how the DSHEA defines “dietary supplement,” and as a result the FDA is forced to treat foods like walnuts and cherries exactly the same as it treats melatonin capsules, vitamin D supplements, and even a “supplement” that is in reality not necessary in the diet at all and in fact started its life as industrial chelators before being touted as a treatment for autism. True, the FDA did shoot Haley down, but the very fact that he got away with promoting his chemical as a “supplement” to treat autism for long points to the problem with current law. Moreover, under the current law, the FDA has no choice but to treat health claims for Boyd Haley’s OSR#1 (the aforementioned industrial chelator) the same way it treats health claims for walnuts and cherries and other products that are undeniably food. In fact, if the DSHEA were amended to eliminate that problem and to make a distinction between actual food and the various supplements manufacturers make that have only a tenuous connection with nutrition and food, I might even be able to support something like the FSAS act—but only if it were renamed the Free Speech About Food Act and meant it.

It won’t be, though. Supplement manufacturers benefit too much from the current law, which equates supplements, no matter how removed from having any role in the diet they might be, and food. Even though the FSAS Act of 2011 would be the worst of both worlds (supplements equalling “food” plus the ability of supplement hawkers to say anything they want to as long as they can point to a scientific study or two—which, by the way, they could fund just as pharmaceutical companies do), Orrin Hatch, Jason Chaffetz, Jared Polis, Dan Burton, Tom Harkin, and the many other political allies of the supplement industry, aided and abetted by the AAPS, the ANH, and many other “health freedom” organizations, will do their best to see to that.

After spending the first 21 years of life in New Jersey and Philadelphia, I ventured to the University of Florida for graduate school. For those who don’t know, UF is in the north-central Florida city of Gainesville – culturally much more like idyllic south Georgia than flashy south Florida.

It was in Gainesville – “Hogtown” to some – that I first encountered the analgesic powder. I believe it was BC Powder, first manufactured just over 100 years ago within a stone’s throw of the Durham, NC, baseball park made famous by the movie, Bull Durham. I remember sitting with my grad school buddy from Kansas City watching this TV commercial with hardy men possessing strong Southern accents enthusiastically espousing the benefits of BC. I looked at Roger – a registered pharmacist – and asked, “what in the hell is an analgesic powder?”

What I learned is that powders of analgesic compounds were one of the individual trademark products of Southern pharmacies during the early 1900s. Many of these powders became quite popular with mill and textile workers needing to calm headaches induced by long hot days with loud machinery. The original powders contained a precursor to acetaminophen called phenacetin. However, phenacetin was found to cause renal papillary necrosis, such as in this 1964 case report in Annals of Internal Medicine.

Today, most of these powders are comprised of aspirin, acetaminophen, and caffeine. This combination has also been adopted outside of the powder world with Excedrin’s migraine product the most popular of these. This 2010 review in the European Journal of Neurology covers the historical ground that tends to support the greater combined efficacy of this combination in headache and migraine than with monotherapy of any alone. However, I still have yet to find a convincing mechanistic explanation to account for the well-documented analgesic potentiation activity of caffeine.

Nevertheless, this combination as a powder is a cultural tradition of Southern pharmacy. Unfolding one of these packets in public in the northern US is a sure-fire way to attract suspicious eyes wondering if you are a cocaine addict. In the South, you either mix these with water and slam it back – the idea being that the powder form is absorbed more quickly than a tablet or capsule that needs to disintegrate in the gastrointestinal tract. However, the bitter taste of these compounds reminds me of why they were first formulated into tablets that had a very short residence time in the mouth.

In 1977, Goody’s powder became one of the first non-automotive sponsors of a NASCAR racer, beginning a long relationship with NC native and current resident, Richard Petty, a relationship that continues today. For fun, you have to read the page at Goody’s on how to take a powder:

How to take a powder
Let’s face it, Goody’s works incredibly fast because they’re powders, but that also means that they’re kind of different to take. There are three general approaches, but feel free to add your own personal touches.

The Dump and Chase
Probably the most popular technique. Open up the paper wrapper, fold it over, dump quickly on the back of your tongue and chase right down with your favorite drink. There, now that wasn’t so hard…

The Stir ‘N Sip
A technique preferred by the less adventurous. Just mix your Goody’s into a glass of water, juice or soda. Then drink up.

The Tough Guy
This is how The King does it. Very simple. Open it, fold, dump on your tongue and swallow. Then, very casually continue whatever you were doing.

How to take a powder tips

• The farther back on your tongue, the better.
• Fold wrapper so all the powder leaves the wrapper at once.
• Don’t inhale through your mouth with powder in there. It could get ugly.
• Beginners generally need a bit of coaching. Be gentle with them.
• Got a great technique? Shoot us an email and we may share it here.

Yes, folks, The King (Petty, not Elvis) does The Tough Guy.

Guess what? I tried to do The Tough Guy. I think I ended up with an esophageal erosion.

But why do I write this post other than because I’m a natural products pharmacologist living in the South?

Late yesterday afternoon, I learned from Raleigh News & Observer business editor, Alan Wolf, that GlaxoSmithKline is jettisoning 19 of their consumer health products, including Goody’s and BC.

From Wolf’s post:

“Individually, the brands to be divested have strong heritage and good prospects, but GSK has lacked sufficient critical mass in some product categories and certain brands have lacked focus due to other global priorities,” GSK wrote in a statement. “GSK therefore believes that other companies are better placed to maximise the potential they offer.”

I actually hadn’t known that GSK owned both powder brands. But it now makes sense to me. As recently as last summer, there had been a “Pick A Powder” battle online (at pickapowder.com, surprisingly) between Goody’s Richard Petty and BC’s country singer, Trace Adkins. Clever marketing: take your own products and pit them against one another with a fabricated battle between two celebrities that appeal to distinct but overlapping demographic groups.

But this rivalry isn’t all fun and games. Petty’s team raises money for Victory Junction Camp, established in honor of his son, Adam, to provide enriching experiences for kids with chronic or serious illnesses; Adkins raises money for the Wounded Warrior Project, a comprehensive non-profit program that serves our brave men and women injured in combat.

Hopefully, the companies that pick up these colorful, historic powders of Southern pharmacy will keep the rivalry and public service going on.

But my recommendation to all: no need to be “adventurous.” There’s no shame in “The Stir ‘N Sip.”

For further reading, The North Carolina History Project has separate entries for Goody’s and B.C. powders.