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

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.

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’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.