Everybody’s Doing It

One argument that often comes up when skeptics and proponents of so-called complementary and alternative medicine (CAM) debate is the question of the popularity of various CAM practices. Advocates of CAM often claim these practices are widely used and growing rapidly in popularity. Obviously, CAM proponents have an interest in characterizing their practices as widely accepted and utilized. Even though the popularity of an idea is not a reliable indication of whether or not it is true, most people are inclined to accept that if a lot of people believe in something there must be at least some truth to it. The evidence against this idea is overwhelming, but it is a deeply intuitive, intransigent notion that can only rarely be dislodged.

It might therefore be useful to get some idea of whether or not the claims of great popularity for CAM treatments are true. If they are not, fruitless debates about the probative value of such popularity could potentially be avoided, and it might be possible to diminish the allure associated with the belief that “everybody’s doing it.” 

Surveys of CAM Use

It is difficult to find good quality objective data on the popularity of particular CAM interventions, and many of the surveys that have been done are potentially misleading. For example,. the 2007 CDC National Health Interview Survey (NHIS) is widely cited as showing that about 30% of Americans use CAM therapies. A careful look at the details of this survey, however, shows that many of the supposed CAM therapies are really relaxation or exercise practices, such as massage and yoga, not medical therapies. Chiropractic is the only medical therapy generally classified as alternative that was used by more than 10% of people in the survey. And that was primarily for idiopathic lower back pain, an indication for which it is generally accepted, even by skeptics such as myself, as having some demonstrated benefit, about equal to standard medical interventions. These usage numbers haven’t changed in decades, which belies the notion that CAM is growing in popularity.

Similarly, much was made by the media of a recent CDC survey that supposedly showed widespread use of CAM therapies in hospice care facilities. A close analysis of this survey, also shows that most of the therapies listed are not truly alternative medical interventions and that fewer than half the facilities surveyed offered true CAM therapies, and fewer than 10% of patients in those facilities actually employed the CAM practices offered.

Studies of Acupuncture Use

I thought it might be useful to look at some of the data concerning the popularity acupuncture, since it is probably the most widely used and accepted CAM therapy after chiropractic, and there have been a few interesting studies in this area. There are certainly no comprehensive, high-quality data concerning how many people use acupuncture, for what indications, and with what sort of beliefs in its underlying theory or effectiveness. My purpose is not to make a definitive statement about how popular acupuncture is but simply to take a small step beyond vague impressions and unsupported claims about the popularity of this intervention and look at what research there is and what insight, if any, these numbers might give us. 

The 2007 NHIS data indicated 6.5% of Americans had reported ever using acupuncture. Of these, 22% had seen an acupuncturist in the last 12 months. 25% of those who had tried acupuncture had done so once, and 70% had seen an acupuncturist fewer than 5 times. The vast majority of those who had seen an acupuncturist had done so for some kind of pain, primarily arthritis and other orthopedic pain, headaches, or fibromyalgia. About 40% of the people who reported using acupuncture for a specific condition specifically reported not using conventional therapies for that condition, while 20-40% reported using some kind of conventional medical therapy for the same condition. 

It is often argued that lack of interest in the utilizing acupuncture is driven more by cultural prejudice or belief systems than by concerns about the evidence for its efficacy. There is likely some truth to the fact that people from different cultures prefer familiar styles of medical treatment, though of course this says nothing about what is actually safe or effective. And part of the appeal of acupuncture in the West is likely its exotic, “foreign” associations.

Some surveys of acupuncture use have looked at whether different ethnic groups in the West have differences in their utilization of acupuncture. Interestingly, one study from Canada found that while White and Chinese Canadians differed in their use of some CAM modalities, their overall use of CAM was the same, and their use of acupuncture specifically was about the same: roughly 8%. (Therapies included in definition of CAM in Quan et al 2008: Herbal remedies, massage therapy, chiropractic, acupuncture, amino acids, naturopathy, homeopathy, reiki, ayurvedic medicine, biofeedback, hypnosis.)

In contrast, a survey of Chinese Americans in a mental health services program found about 25% used acupuncture, and that this use was more prevalent among “less acculturated” individuals. This, of course, is a group not at all representative of the general population, so the relevance of this to overall acupuncture use among Chinese Americans and Americans of other ethnicities is not clear. Other studies have shown significant but complex relationships between ethnicity, education, and other variables and the likelihood of acupuncture use.

It seems reasonable that cultural traditions play some role in the acceptance or rejection of acupuncture as a medical therapy, but the current data do not support that cultural affiliation alone is the most important variable, and the reasons people use acupuncture seem quite consistent regardless of ethnicity or nationality. In any case, studies of populations in North America do not show anything approaching a majority of the population regularly using acupuncture as a medical therapy. Numbers vary from less than 10% to as high as 50% in some populations, but most tend to be in the lower end of that range.

Since acupuncture as it is currently understood and practiced in Europe and North America originated in China and has been employed there and in other Asian countries for a lot longer than it has been used in the West (though not nearly as long as is usually claimed), it makes sense that it would be far more widely used in that part of the world if it is truly as popular a therapy as its proponents claim.

One 2007 study in Taiwan found about 11% of beneficiaries of national health insurance had used acupuncture in a given year. Interestingly, while the survey found that overall use of Traditional Chinese Medicine (TCM) therapies was much higher than this (primarily due to use of herbal remedies), the use of TCM was still far behind the use of so-called “Western” medicine. TCM clinic visits accounted for only 9% of outpatient visits reimbursed under the national health insurance. This is similar to another study which found Chinese medicine (of all covered types) accounted for only 5% of the reimbursed care under the national health insurance system. The same study indicated that “Western” medicine was utilized more than Chinese medicine, especially among children, the elderly, and those with severe disease (consistent with the pattern of CAM use in the U.S., which is generally for self-limiting or chronic disease).

Yet another study in Taiwan specifically investigated acupuncture use and found about 6.2% of people covered by national health insurance utilized acupuncture in a given year, and over the seven years surveyed about 25% of covered individuals had received acupuncture treatment. As in the U.S., the vast majority of the acupuncture treatment sought was for musculoskeletal conditions or injuries (88%).

And a recently published series of surveys conducted in Japan found that about 5-7% of respondents used acupuncture in a given year, and that over a lifetime between 20-27% of respondents had at some time tried acupuncture. More than 80% of the use of acupuncture was for musculoskeletal complaints. About half of those who had used acupuncture indicated they would use it again, and about 37% indicated they would not.

The Bottom Line

So what does all of this mean? Well, probably not very much. Of course, differences in healthcare systems, insurance systems, study methods, and many other factors that are difficult to identify and asses, make direct comparisons between the use of specific CAM interventions in different countries very unreliable. I don’t believe the quality of the data generally allow very confident statements about the popularity of acupuncture or other specific CAM methods. However, proponents of acupuncture, and CAM generally often make such statements, trying to convey the impression that their approaches are growing rapidly in popularity and only perverse, closed-minded curmudgeons still resist them. The little evidence we have certainly does not support such claims. 

In the case of acupuncture, for example, the data show relatively low levels of utilization even in those countries generally regarded as having long historical traditions of using acupuncture. Informal investigations (e.g. 1, 2) have suggested that acupuncture and other CAM practices associated with China may not be as popular even in their native land as proponents in North America claim, and the formal studies I have discussed here seem to support that impression.

A large majority of people who seek acupuncture therapy, regardless of ethnicity or nationality, do so for treatment of musculoskeletal conditions and pain. There is good evidence that the therapeutic ritual of acupuncture has some symptomatic benefit for such indications. This is almost certainly a non-specific treatment effect (aka “placebo”). It does not seem to matter where needles are inserted or if they are inserted at all, and acupuncture therapy does not appear to measurably affect the course of any actual disease. (The Skeptic’s Dictionary has a clear and concise review).

The research data on acupuncture utilization suggests that from about 5-25% of people, regardless of nationality or ethnicity, will at some time try acupuncture for, mostly for some kind of musculoskeletal pain. Conventional therapies are often used along with acupuncture, and they are far more popular overall, especially for serious or acute conditions. So the little research there is suggests that acupuncture occupies a niche common to many CAM therapies. It is used at a low level by a small to moderate proportion of the population for conditions that are either mild, self-limiting, or without a definitive conventional treatment, and it is rarely used in lieu of conventional medical care. This is hardly a mounting wave of enthusiasm for acupuncture itself, much less the mystical theories and postmodern cognitive relativism often associated with it. 

So when proponents of acupuncture say it must work because it has been widely used for thousands of years in Asia and is growing rapidly in popularity in the West, rebutting the argumentum ad populum and argumentum ad antiquitatem fallacies may not be the skeptic’s only option. It may be worthwhile, and simpler, just to point out that acupuncture is neither as old nor as popular as is commonly supposed.

References

Chang LC. Huang N. Chou YJ. Lee CH. Kao FY. Huang YT. Utilization patterns of Chinese medicine and Western medicine under the National Health Insurance Program in Taiwan, a population-based study from 1997 to 2003. BMC Health Serv Res. 2008 Aug 9;8:170.

Chen FP. Chen TJ. Kung YY. Chen YC. Chou LF. Chen FJ. Hwang SJ. Use frequency of traditional Chinese medicine in Taiwan. BMC Health Serv Res. 2007 Feb 23;7:26.

Chen FP, Kung YY, Chen TJ, Hwang SJ. Demographics and patterns of acupuncture use in the Chinese population: the Taiwan experience. J Altern Complement Med. 2006 May;12(4):379-87.

Eisenberg DM. Kessler RC. Foster C. Norlock FE. Calkins DR. Delbanco TL. Unconventional medicine in the United States. Prevalence, costs, and patterns of use. N Engl J Med. 1993 Jan 28;328(4):246-52.

Ishizaki N. Yano T. Kawakita K. Public status and prevalence of acupuncture in Japan. eCAM 2010;7(4):493-500.

Quan H. Lai D. Johnson D. Verhoef M. Musto R. Complementary and alternative medicine use among Chinese and White Canadians. Can Fam Physician. 2008 Nov;54(11):1563-9.

Upchurch DM. Burke A. Dye C. Chyu L. Kusunoki Y. Greendale GA.A Sociobehavioral Model of Acupuncture Use, Patterns, and Satisfaction Among Women in the US, 2002Womens Health Issues. 2008; 18(1): 62–71. 

Imagine living 20 years spending 24 hours a day in a cage that tightly fits your body, not giving you room to stand up, stretch out, turn around, or move at all.

Imagine that twice a day during these years you would have a metal catheter inserted into a hole which has been cut into your abdomen, allowing the catheter to easily puncture your gall bladder, or maybe a long syringe inserted into your gall bladder, piercing through your skin again and again, by people who are not doctors.

Imagine becoming infected and cancerous because of this twice-daily physical invasion, and becoming neurotic due to your claustrophobic imprisonment.

Imagine having one or both of your hands cut off so someone can sell them for a lot of money.

Imagine you begin to chew at your hands, if you are lucky enough to have one or both left, due to your developing neuroticism, and to distract yourself from the pain you experience twice a day, every day, for your entire life.

This is reality for an estimated minimum of 12,000 bears across Asia.

– Sara Pegarella, JD

Currently, animal activists across China are up in arms because Gui Zhen Tang Pharmaceutical Corporation, a Fujian-based company that sells bear bile for use in Traditional Chinese Medicine (TCM), has tried to increase production through an initial public offering (IPO). The company is being accused of cruelty towards animals in the process of extracting their bile at an industrial scale. Bear bile, or Xiong Dan (??), is an important ingredient in TCM.

The issue is not new: since the early 2000s, animal activists have circulated hundreds of shocking articles, images, and videos that recount unimaginable cruelty towards caged bears in Asia. The practice has even outraged celebrities, such as Jackie Chan, who have pleaded with consumers to stop buying products made from bears and other endangered species. But now it’s all over the news. Gui Zhen Tang’s IPO has met with fierce public opposition, and has once again led environmentalists to appeal against the cruelty of live bear bile extraction.

As this documentary shows, bear bile is sold throughout Asia for a variety of conditions. The Chinese Herbal Medicine: Materia Medica (1986) by Dan Bensky, Andrew Gamble, and Ted Kaptchuk lists bear bile as a remedy for trauma, sprains, fractures, hemorrhoids, conjunctivitis, severe hepatitis, high fever, convulsions, and delirium. The Materia Medica also states that “because of the high price of bear bile (Xiong Dan), often cow bile, Fei Bovus (Niu Dan), is substituted at a higher dose.”¹ There is no mention, however, of the horrific means by which the animal bile is obtained. The guide also lists other animal products (rhinoceros horn, tiger bones, deer musk, and bat and squirrel feces [sic]) used as medicine.

Image 1. The bear bile entry in the 1986 version of Materia Medica by Bensky et al. The entry in the latest edition (3rd ed. 2004) has been moved to “Obsolete Substances.” Image used with the explicit permission of Eastland Press.

The globalization of TCM has lead to a dramatic increase in the demand for bear bile along with other traditional remedies. Bear bile is sold in Asian apothecaries throughout the world in the form of powder, solution or pills. It is likewise the key ingredient in many Asian “patent medicines” used for tapeworm, childhood nutritional impairment, hangovers, colds, and even cancer. Bear bile is even found in Chinese throat lozenges, shampoo, wine, and tea.

Image 2. Raw bear bile in both liquid and powder forms. Photo: Kathleen E. McLaughlin, the Chronicle Foreign Service correspondent in Beijing

Overall, the worldwide trade in bear parts, including bile, is estimated to be a $2 billion industry. Research in August 2007 by the animal rights group Animals Asia shows its staggering profitability: while the wholesale price of bile powder is around US$410 per kg in China, the retail price increases exponentially to 25 to 50 fold in South Korea, and to 80 fold in Japan (US$33,000 per kg)!

While the trade in bear products is prohibited under the Convention on International Trade in Endangered Species (CITES), and the importation and trade of bear bile products to North America is illegal under both US and Canadian law, many products are still openly offered for sale in Chinese stores. Back in 2001, when the World Society for the Protection of Animals conducted a probe of Asian shops in Canada and four US cities — Chicago, New York, Washington, and San Francisco — it found that 91% of the shops surveyed sold some form of bear part, including farmed bile powder, bile medicines, and whole gallbladders, which the merchants claimed originated from wild bears in China. When WildAid, an animal rights group based in San Francisco, sent an undercover investigator into Chinatown in 2004, two shopkeepers readily produced vials in velvet-lined boxes with pictures of a bears on the lid.

Bear bile is obtained through surgically implanting a tube in the animal, in a process called “milking,” that produces an average 15 ml (.5 oz) of bile each time. The Humane Society of the United States reports that the process of milking is so painful for the bears that they moan and often chew their paws during the procedure. In order to make access to the animals easier, the farmers often break the bears’ teeth and pull out their claws, sometimes brutally removing whole digits. If the bears stop producing bile, they are left to die, or are killed for their gallbladder and paws (considered a delicacy in China).

According to Jeanette McDermott, the founder of Ursa Freedom Project, bear farming in Asia increased during the 1980s in response to the dwindling supply of bear parts obtained from bears hunted in the wild. Tragically, the situation grew out of control, and by the early 1990s, there were over 400 bear farms in operation, containing more that 10,000 bears. Plans were in place to increase the number of bears in farms to 40,000 by the year 2000.

Today, China produces 7,000 kilos of bear bile annually, much of which is illegally exported to Japan, Korea, Australia, Canada, and the US. Whole bear gallbladders are also exported: the Humane Society of the United States says smugglers have been caught with gallbladders packed in coffee to conceal their smell, or dipped in chocolate to disguise them as chocolate-covered figs.

Most of the bears used in bile farming are Himalayan black bears (Ursus thibetanus), also known as “Asiatic black bears” or “Moon bears,” due to the cream-colored crescent moon shape on their chests. As their population has decreased by almost 40 percent over the past few decades, they have been listed (since 2000) as among the most critically endangered species on the International Union on Conservation of Nature’s Red List of Threatened Species.

A number of the bears in bile farms are captured illegally in the wild as cubs. Poachers either wait to capture new-born cubs until the mother leaves the den in search of food , or sometimes they simply kill her to get to the babies. Some of the cubs are born in captivity — but in either case, bear cubs rarely survive to adulthood — and those who do often grow into the bars of their cages as their bodies mature.

Image 3. Is this traditional medicine or savagery and barbarism? Photo: Cornelius Maarselar/Animals Asia

Animal activists posing as potential clients report that the caged bears moan, writhe in pain, and clutch their stomachs as the bile drains from their bodies. Sometimes the bears try to pull out the catheters. Those that succeed are immobilized in an iron corset. Under-nourished and highly stressed from horrific pain and unnatural confinement, the bears lie in agony, in their own filth.

According to Jeanette McDermott, bile is not the farmers’ only source of profit from the bears. Some farmers amputate one or two paws from live bears to sell to restaurants. When bears are no longer able to secrete bile, they are left to die from sickness or starvation. Bears might endure this torture for up to 25 years, making their lifetime a reality of suffering and pain in the name of “natural” and “traditional” medicine.

Image 4. This metal clamp is placed around bears who might struggle or move around excessively in order to ensure they remain still through the painful bile extraction. Photo: Animals Asia

There are a number of extremely painful techniques used for milking bear bile. Image 4, above, illustrates the common extraction technique that relies on plastic or metal catheters, and often necessitates a metal jacket in order to restrain the bears (the chilling details can be found at the Animals Asia website). Some farms rely on an ultrasound machine to guide a catheter connected to a medicinal pump. In this method, the bears are sedated — usually with ketamine — restrained with ropes, and have their abdomens jabbed repeatedly with four-inch needles until the gallbladder is located. Animals Asia suspects that this process leads to dangerous leakages of bile into the body, and to a slow and agonizing death from peritonitis.

In recent years, China has introduced a new, “humane,” free-dripping extraction method, which does away with the need for catheters. Free-dripping involves carving a permanent hole, or fistula, into the bear’s abdomen and gall bladder, from which bile drips out freely. The damage caused by the bile’s leaking back into the abdomen, together with infection from the permanently open puncture, is even worse than the catheters method, and results in a high mortality rate. Often, the bears’ livers and gallbladders become severely diseased through this process, and the collected bile is contaminated with pus, blood, urine and feces.

Image 5. Sometimes a hollow steel stick is pushed through the bear’s abdomen, and the bile runs into a basin under the cage. In this case, about half of the bears die from infections or other complications. Photo: Animals Asia

Image 6. Ultrasound bile extraction from a bear in Vietnam. Photo: Asia Wild Life

A healthy bear’s bile is as fluid as water, and ranges in color from bright yellow-orange to green. However, Animals Asia’s vets have described bile leaking from the gallbladders of farmed bears as “black sludge.” Eminent Chinese and Vietnamese pathologists have warned the public not to use bile taken from sick bears.

The active substance in bile (of bear and all other mammals) is ursodeoxycholic acid (UDCA), also known as Ursodiol, which is easily synthesized, and has been available for several decades. It is estimated that 100,000 kilos of synthetic UDCA are already being used each year in China, Japan, and South Korea, and that the total world consumption may double this figure.

Despite the availability and affordability of synthetic UDCA and suitable herbal alternatives, some practitioners obstinately continue to prescribe bear bile, which in turn drives up the market demand, and pressures the Chinese government to continue to allow the practice of bear farming.

The world’s appetite for bear bile and other parts has also led to the hunting and killing of wild bears in the North America. The media reports that the poaching of bear gallbladder for its use in TCM is on the rise in the US. The Los Angles Times, of August 22, 2008, writes that Fish and Game Wardens in California (CA) often report finding dead black bear carcasses that have been skinned and dismembered. The gallbladder is by far the most often stolen part (see the Los Angeles Times of November 29, 2010). The CA animal safety group, BEAR League, reports that since the beginning of 2007, as many as 87 dead bears have been found near state roadsides. On occasion, they report the bears’ heads or paws are cut off, but they also report finding bear carcasses with the gallbladder missing.

Image 7. This California black bear was struck and killed on State Highway 89 near Lake Tahoe in August 2008. State wildlife officials say the gallbladder was removed. Photo: BEAR League

The appalling impact of TCM on endangered species goes well beyond bears though. It affects the world’s most precious and protected animals, such as Bengal tigers, American bears and African rhinos. A worldwide interest in alternative medicine and the ease of international commerce now put dozens of species worldwide at risk. And while most of traditional Chinese medicines rely on herbs, the demand for products made at the expense of threatened animals continues to grow. In reality, many of the current claims associated with the medicinal value of animal products are spurious; but reality hasn’t stopped the rising demand for these illegal substances, and the profits to be made by poachers and smugglers rise.²

While the use of some animal products was perhaps justifiable in the past  — when there were no alternatives available, the extent of demand was limited, and the particular species were plentiful in their natural habitat — it is no longer sustainable, or justifiable, given our modern, globalized, and technically-advanced world. Today, with other approved therapeutic alternatives available, there is little justification for the use of endangered species such as the black bear.³

The belief advanced by the Counterculture of the 1960s and the New Age movement — that “natural” curatives are better than their synthetic equivalents — contributes enormously to TCM’s popularity in North America today. These groups originally objected to the growing over-consumption and over-reliance on synthetically-produced medicines, over natural alternatives. And while these concerns should be considered serious, the apologists of TCM and other types of traditional medicines fail to recognize that at present, their massive demand for “natural” products has made crime against animals commonplace. TCM has behind it a powerful, moneyed group of consumers whose “needs” now drive a whole black market economy — one that supports poachers, bear bile farmers, and all types of heinous torture.

As I wrote his article, I was overwhelmed with rage, and repulsed not only by the horrific images of the animal holocaust in Asia, but also by the enormous hypocrisy of the proponents of TCM, who effectively claim that pus-infested bear bile, and the by-products of animals tortured, disfigured, and dismembered in the name of the“natural” are better, safer, and “gentler” than synthetic pharmaceuticals.

With many thanks to Sara Pegarella, JD, and Kristin Koster, PhD, for their valuable comments.

The above mentioned animal rights advocacy groups (Animals Asia, Asia Wild Life, etc.) were not interviewed for this piece and any information attributable to them was taken from their websites. I encourage you to visit these sites to become more informed and involved.

REFERENCES

1. Bensky D, Gamble A, Kaptchuck T. Chinese Herbal Medicine: Materia Medica. Revised Edition. Eastland Press. 1986. Return to text
2. Ellis R. Tiger Bone & Rhino Horn: The Destruction of Wildlife for Traditional Chinese Medicine. Island Press; 1 edition. 2005. Return to text
3. Still J. Use of animal products in traditional Chinese medicine: environmental impact and health hazards. Complement Ther Med. 2003 Jun;11(2):118-22. Return to text

Mark Tonelli, MD has problems with evidence-based medicine (EBM). He has published a few articles detailing his issues, and he makes some legitimate points. We at science-based medicine (SBM) have a few issues with the execution of EBM as well, so I am sympathetic to constructive criticism.

In an article titled: Integrating evidence into clinical practice: an alternative to evidence-based approaches. The abstract states:

Evidence-based medicine (EBM) has thus far failed to adequately account for the appropriate incorporation of other potential warrants for medical decision making into clinical practice. In particular, EBM has struggled with the value and integration of other kinds of medical knowledge, such as those derived from clinical experience or based on pathophysiologic rationale. The general priority given to empirical evidence derived from clinical research in all EBM approaches is not epistemically tenable. A casuistic alternative to EBM approaches recognizes that five distinct topics, 1) empirical evidence, 2) experiential evidence, 3) pathophysiologic rationale, 4) patient goals and values, and 5) system features are potentially relevant to any clinical decision. No single topic has a general priority over any other and the relative importance of a topic will depend upon the circumstances of the particular case. The skilled clinician must weigh these potentially conflicting evidentiary and non-evidentiary warrants for action, employing both practical and theoretical reasoning, in order to arrive at the best choice for an individual patient.

I certainly agree that clinical evidence (what he he referring to by “empirical” evidence above) is not, and should not be, the sole type of knowledge that is incorporated into clinical decision-making. However, I think this criticism is a bit of a straw man, at least with regard to items 2, 4, and 5. The goals and values of the patient are definitely part of clinical decision-making, even in a rigorously evidence-based practice. We are, after all, treating people, not diseases. When I was in medical school this was called the biopsychosocial model of medicine. Now it is also not uncommon for quality of life measures and overall satisfaction to be incorporated as outcome measures in clinical trials, blurring the lines between empiricism and personal goals and values.

So while I agree that patient values and goals absolutely need to be taken into consideration when practicing medicine, I don’t see this as a new idea or one that is at odds with EBM, nor entirely distinct from empiricism. By including this as he does, however, there is the implication that EBM excludes such considerations, and I do not believe that is fair.

Where we likely mostly agree is on number 3 – pathophysiological rationale. I could expand this to include all of basic science – medical practices should be plausible. I also think he has a legitimate point in that EBM gives too much emphasis to clinical science and shortchanges basic science. But it is interesting to note that the EBM grading system for recommendations do allow for extrapolation (i.e grade B=.consistent level 2 or 3 studies or extrapolations from level 1 studies). Extrapolation involves considering pathophysiology and mechanism of action. While extrapolation (rather than direct evidence) downgrades the recommendation by one category (which is appropriate) it does not exclude it altogether.

Further, I think the real problem with failing to consider pathophysiology is not for support of a plausible treatment, but to be extra cautious about an implausible treatment. When the basic science dictates that a proposed treatment is highly implausible, the bar for clinical evidence should be raised proportionately.  I don’t think this is what Tonelli had in mind, however, as we will see.

Item #2- Experiential evidence, is highly problematic. While experience is great for some things, like recognizing diagnoses, being sensitive to the subtleties of history taking, and interfacing with patients – it is highly misleading when it comes to determining safety and efficacy. The simple fact is that personal experience is too limited, quirky, and uncontrolled, and is overwhelmingly likely to simply confirm our biases than actually lead us in the direction of truth.

In another related article (actually published in 2001, earlier than the 2006 paper above), Tonelli clarifies:

Empirical evidence, when it exists, is viewed as the “best” evidence on which to make a clinical decision, superseding clinical experience and physiologic rationale. But these latter forms of medical knowledge differ in kind, not degree, from empirical evidence and do not belong on a graded hierarchy.

He is partly correct here – these other forms of evidence are not necessarily below, but are tangential to, empirical evidence. But I think Tonelli is missing the context of EBM. EBM is not a method for solely determining clinical practice (clinical decision-making) but for determining safety and efficacy, which is one factor that informs practice. Values, the system, and the human side of medicine also go into clinical practice, but they should not be used to determine efficacy. So it seems his criticism is based upon a straw man constructed of his own confusion.

I might have been inclined to give Tonelli some benefit of the doubt, were it not for this:

The methods for obtaining knowledge in a healing art must be coherent with that art’s underlying understanding and theory of illness. Thus, the method of EBM and the knowledge gained from population-based studies may not be the best way to assess certain CAM practices, which view illness and healing within the context of a particular individual only. In addition, many alternative approaches center on the notion of non-measurable but perceptible aspects of illness and health (e.g., Qi) that preclude study within the current framework of controlled clinical trials. Still, the methods of developing knowledge within CAM currently have limitations and are subject to bias and varied interpretation. CAM must develop and defend a rational and coherent method for assessing causality and efficacy, though not necessarily one based on the results of controlled clinical trials. Orthodox medicine should consider abandoning demands that CAM become evidence-based, at least as “evidence” is currently narrowly defined, but insist instead upon a more complete and coherent description and defense of the alternative epistemic methods and tools of these disciplines.

This casts a new light on all of Tonelli’s other publications. It seems he is making an elaborate argument for the inclusion of other kinds of evidence (other than rigorous, controlled, clinical studies) as support for fanciful but ideologically appealing treatments.

This is a refrain that is becoming common in the CAM community -  that we need to redefine “evidence”, not restrict ourselves to narrow definitions of evidence, and that CAM modalities cannot be properly studied by traditional scientific methods. There is always a flavor that CAM must free itself from the tyranny of scientific evidence.

What is it, exactly, about scientific methods that they feel is incompatible with CAM methods – being thorough, counting all the data, controlling for variables, minimizing the effects of bias, carefully defining terms and outcomes, or being statistically rigorous?  Even individualized treatments can be studied rigorously – so that is an insufficient excuse. In the end, the call to expand the definition of evidence is just a deceptive way of asking for sloppy methods of research, because CAM modalities generally do not hold up under rigorous standards.

We don’t need to redefine or expand the methods of science – we need to return common sense to medicine.

David Kroll’s recent article on thunder god vine is a great example of what can be learned by using science to study plants identified by herbalists as therapeutic. The herbalists’ arsenal can be a rich source of potential knowledge. But Kroll’s article is also a reminder that blindly trusting herbalists’ recommendations for treatment can be risky.

Herbal medicine has always fascinated me. How did early humans determine which plants worked? They had no record-keeping, no scientific methods, only trial and error and word of mouth. How many intrepid investigators poisoned themselves and died in the quest? Imagine yourself in the jungle: which plants would you be willing to try? How would you decide whether to use the leaf or the root? How would you decide whether to chew the raw leaf or brew an infusion? It is truly remarkable that our forbears were able to identify useful natural medicines and pass the knowledge down to us.

It is equally remarkable that modern humans with all the advantages of science are willing to put useless and potentially dangerous plant products into their bodies based on nothing better than prescientific hearsay.

Ancient Sumerians used willow, a salicylate-rich plant that foreshadowed modern aspirin. Digitalis was used by the ancient Romans long before William Withering wrote about its use for heart failure. South American natives discovered that chinchona bark, a source of quinine, was an effective treatment for malaria. These early herbal remedies pointed the way to modern pharmaceuticals. How many other early remedies fell by the wayside? What else did the Sumerians, the Romans, and the natives use that did more harm than good? If “ancient wisdom” exists, so does “ancient stupidity.”

Plants undeniably produce lots of good stuff. Today researchers are finding useful medicines in plants that have no tradition of use. Taxol, the cancer-fighting product of Pacific yew trees, was discovered by the National Cancer Institute only by screening compounds from thousands of plants.

There is a reason pharmacology abandoned whole plant extracts in favor of isolated active ingredients. The amount of active ingredient in a plant can vary with factors like the variety, the geographic location, the weather, the season, the time of harvest, soil conditions, storage conditions, and the method of preparation. Foxglove contains a mixture of digitalis-type active ingredients but it is difficult to control the dosage. The therapeutic dose of digitalis is very close to the toxic dose. Pharmacologists succeeded in preparing a synthetic version: now the dosage can be controlled, the blood levels can be measured, and an antibody is even available to reverse the drug’s effects if needed.

“Ancient wisdom” argues that if an herbal remedy has been used for centuries, it must be both effective and safe. That’s a fallacy. Bloodletting was used for centuries but it wasn’t effective and it did more harm than good. If a serious side effect occurred in one in a thousand recipients of an herb, or even one in a hundred, no individual herbalist would be likely to detect it. If a patient died, they would be more likely to attribute the cause to other factors than to herbs that they believed were safe. Even with prescription drugs, widespread use regularly uncovers problems that were not detected with pre-marketing studies.

Arguments in favor of herbal remedies include:

• They’re natural. (So what? Strychnine is natural.)
• They’re safer than prescription drugs. (Maybe some are, some aren’t; how would you know?)
• They’re milder than prescription drugs. (That would depend on the dosage of active ingredient.)
• They’re less likely to cause side effects. (When they have been as well studied as prescription drugs, they may turn out to have just as many or more side effects. All effective drugs have side effects, and if an herbal medicine has fewer side effects it might have fewer therapeutic effects too. Formal systems for reporting adverse effects have long been in place for prescription drugs; not so for herbal remedies.)
• They’re different from prescription drugs. (Some are identical to prescription drugs, like red yeast rice which contains the same ingredient as prescription lovastatin; and some herbal products have been found contaminated with prescription drugs.)
• They’re less expensive. (True, but is a cheaper, inferior product a good bargain?)
• They’re easier to obtain. (True, you don’t have to make an appointment with a doctor; but that means you don’t get the benefit of a doctor’s knowledge.)
• The mixture of ingredients in a plant can have synergistic effects. (This is widely claimed but almost never substantiated. The other ingredients are just as likely to counteract the desired effect or to cause unwanted adverse effects.)
• For every disease, God has provided a natural remedy. (Perhaps this is a comforting thought for believers, but it is not based on any evidence and is not convincing to atheists and agnostics. And it doesn’t help us find that natural remedy.)

Even when an herbal remedy works, finding a safe and reliable source is problematic. Horror stories abound:

• Contaminants (such as heavy metals, pesticides, carcinogens, toxic herbs, and insect parts).
• Wild variation in content (from no active ingredient to many times the amount on the label).
• Mislabeled products that contain an entirely different herb.

I won’t list specific examples here; they are easy enough to find. I’ll just say that natural medicines are not regulated the way prescription drugs are, thanks to the infamous Diet Supplement and Health Education Act (DSHEA) of 1994.

When you take an herbal remedy, you are taking

1. An active ingredient that usually has not been adequately tested,
2. Other components that have not even been identified, much less tested,
3. An uncertain amount, and
4. Possible contaminants.

The term “street drugs” comes to mind: you don’t really know what you’re getting.

Here’s something for you all to check out. Trine Tsouderos, the journalist from The Chicago Tribune who’s distinguished herself as being one of the few reporters who “gets it” when it comes to quackery and the anti-vaccine movement (just put her name in the search box of this blog for some examples) will be hosting a web chat about vaccines featuring none other than Dr. Paul Offit, one of the gutsiest (if not the gutsiest) defender of vaccine science out there. The chat will occur here at noon CDT today. Questions can be submitted in advance to Tsouderos at ttsouderos@tribune.com.

Head on over, everyone. The anti-vaccine movement is clearly out in force in the comments. Although the usual intrepid defenders of science are there, reinforcements are always welcome.

Here at Science-Based Medicine, we try to be relatively apolitical. We might not always succeed, but in general our main concern is not so much with right-wing or left-wing politics, but rather with how prevailing government policies and regulation impact the delivery of medical care, in particular whether they tend to prevent, do nothing about, or promote the proliferation of non-science-based medical care. Consequently, when Kimball or I call for the disbanding of the National Center for Complementary and Alternative Medicine (NCCAM), it does not matter one whit to us who is President or which party controls Congress. All that matters is that we see NCCAM as a government entity that, through credulously studying many “alternative medicine” modalities, ends up inadvertently promoting them and providing them with the imprimatur of government approval. The same concept applies to state medical licensing boards licensing pseudoscientific modalities, such as naturopathy, acupuncture, and homeopathy. By regulating these “disciplines,” states also provide them with an unmerited mantle of respectability through their imprimatur of regulating them as professions, just like medicine and nursing.

As far as political views, although all of us have them and they occasionally even come to the fore in disagreements (remember when Wally Sampson occasionally clashed with others with differing political viewpoints?), we generally subsume them for purposes of the SBM blog experience into our advocacy for basing medicine on the best science available. Sometimes, however, when a pundit or politician makes claims that are either contrary to or distort science for ideological or political advantage, I feel the need to discuss those claims, sometimes even sarcastically. Such was the case last week, when Ann Coulter wrote a blisteringly ignorant column, entitled A Glowing Report on Radiation. She wrote this article in the wake of the fears arising in Japan and around the world of nuclear catastrophe due to the damage to the Fukushima nuclear power plant caused by the earthquake and tsunami that hit northern Japan on March 11. Coulter was subsequently interviewed by Fox News pundit Bill O’Reilly on The O’Reilly Factor on Thursday evening:

Yes, according to Coulter, radiation is good for you, just like toxic sludge! Even more amazing, in this video Bill O’Reilly actually comes across as the voice of reason, at least in comparison to Ann Coulter. He’s very skeptical of Coulter’s claims and even challenges her by saying, “So by your account we should all be heading towards the nuclear reactor.”

So, fellow SBM aficionados, is Coulter right? Are all those scientists warning about the dangers of even low-level radiation all wrong? Should we start hanging out in radioactive mine shafts, as Coulter mentions in her column (seriously) in order to boost our health and decrease our risk of cancer?

Not so fast, there, Ann. Here’s a hint: If Bill O’Reilly can lecture you on science and look more reasonable than you, you’re off the rails.

Coulter, hormesis, and “Don’t worry, be happy!”

Actually, the scientific assessment of what levels of exposure to ionizing radiation are dangerous is, as you might imagine, a wee bit more complicated than my little sarcastic rejoinder makes it, but you’d never know that from Ann Coulter’s article and her interview with Bill O’Reilly. The reason for my sarcastic characterization of Coulter’s scientific nonsense is because her article uses many of the same tactics as any denialist. Chief among these is that Coulter takes the germ of a scientific controversy and then uses it to try to imply that the scientific consensus is fatally flawed. In this case, the scientific controversy is over how dangerous low level exposure to radiation is used to imply that the radiation from a nuclear disaster is not potentially harmful. All you former residents of Chernobyl, take note! It’s fine to move back to your homes that you were forced to abandon 25 years ago!

Here is what Coulter claims in her article:

With the terrible earthquake and resulting tsunami that have devastated Japan, the only good news is that anyone exposed to excess radiation from the nuclear power plants is now probably much less likely to get cancer.

This only seems counterintuitive because of media hysteria for the past 20 years trying to convince Americans that radiation at any dose is bad. There is, however, burgeoning evidence that excess radiation operates as a sort of cancer vaccine.

As The New York Times science section reported in 2001, an increasing number of scientists believe that at some level — much higher than the minimums set by the U.S. government — radiation is good for you. “They theorize,” the Times said, that “these doses protect against cancer by activating cells’ natural defense mechanisms.”

What Coulter is referring to is the phenomenon of radiation hormesis. This is nothing more than a biphasic dose-response curve to radiation in which the curve initially goes down with increasing dose (less risk of disease with increasing radiation exposure) and then curves upward and at some point crosses a threshold where radiation exposure is no longer beneficial but harmful with further dose increases. Basically, it’s a scientific model wherein low level exposure to radiation is not only not harmful but in fact beneficial. The reason for this effect, if it exists in humans, is hypothesized to be that low level radiation activates DNA damage repair and other protective mechanisms that are not activated in the absence of radiation; moreover, it is further hypothesized that these mechanisms are activated more than they need to be, so that low level radiation is actually protective against radiation-induced diseases such as cancer.

The radiation hormesis model is markedly different from the currently prevailing model that is used for regulatory purposes by most governments, the linear no-threshold (LNT) model, which states that there is no such thing as a “safe” dose of radiation and that radiation dammage accumulates in a linear fashion with dose. For completeness sake, I will note that there is also at least one other model for the biological effects of radiation, specifically a model in which there is a threshold dose under which radiation is not harmful. In practice, distinguishing between a threshold model and a hormesis model can be very difficult.

In order to give you an idea of what hormesis would look like in a radiation dose-response curve, I stole this graph from Wikipedia. Actually, I didn’t steal it; it’s public domain because it’s a product of a U.S. government agency. However, it illustrates the concept of hormesis quite well:

Curve A demonstrates supralinearity, in which toxic effects are actually more intense per unit of radiation at lower doses; there is no evidence that this is indeed the case. Curve B is linear, and Curve C is linear-quadratic, in which low doses of radiation are less harmful per unit of radiation than higher doses. Curve D represents hormesis, where low doses of radiation are actually protective up to a certain threshold, where the curve shifts from a protective effect to a harmful effect with increasing radiation. The main contenders for the model that best describes radiation effects are either curve B, C, or D.

The key aspect of Coulter’s article that makes it so irresponsible is what she leaves out. What she neglects to mention is that, even if hormesis is an accurate model for radiation effects in humans, it only applies for very low dose exposures. (More on how low in the next section.) True, Coulter does at one point concede that it is “hardly a settled scientific fact that excess radiation is a health benefit,” throughout the rest of her article she presents the idea of hormesis as though it were–you guessed it!–a settled scientific fact. Indeed, Coulter’s earlier assertion that “excess radiation acts as sort of a cancer vaccine” is the sheerest exaggeration, even if hormesis is an accurate model of radiation exposure. Aside from this major exaggeration, how do Coulter’s assertions, which appear to be based largely on studies cited in a single NYT article that is nearly a decade old, stack up against science?

Not very well. Surprise! Surprise! As is the case with many denialists, Coulter takes a germ of actual science and then twists and exaggerates it beyond all recognition in order to support a preconceived notion, namely that those pointy-headed (and, of course, liberal) environmentalists are hiding the evidence that radiation at low doses is good for you. To accomplish this, Coulter cherry picks studies, failing to put them into their proper context with existing research, all for the purpose of advancing her ideological viewpoint.

Radiation hormesis: Ann Coulter’s claims versus reality

Before I discuss what the data regarding radiation hormesis actually show, it’s essential to discuss briefly why it is that the LNT model predominates when it comes to policy-making and setting limits on what is considered “safe” radiation exposure. The reason is not that biased scientists are “hiding” the evidence that radiation is good for you. Rather, it boils down to a few reasons. The first is probably that an LNT model is the simplest, most conservative model that can be fit to currently existing evidence. The problem with the LNT model is the same as the problem with the hormesis model. While at higher radiation doses, effects due to radiation are, like effects due to pretty much any other high-level environmental exposure, much more robust and reproducible, at lower radiation doses, the effects are weaker, and the scatter in the data is much greater. In other words, at low doses the signal-to-noise ratio is much lower due to a lot more “noise” and a lot less signal in the data. Moreover, the data are more difficult to collect, and variability from system to system, organism to organism, and cancer to cancer is likely to be much greater.

As imperfect as it is, the LNT model is a reasonable approximation for purposes of policy-making because it is conservative and safe. Admittedly, there are problems applying such a model when the doses get really low, as in lower than the normal background radiation that we all live in, but it’s a useful approximation. When it is very hard to distinguish between an LNT model and a hormesis model at very low radiation exposures, until better data can be gathered that clearly demonstrate the superiority of one model over another, the responsible and safe model to choose is the most conservative one that fits reasonably well. Basing public policy on a model that, if incorrect, has the potential to result in considerable harm in the form of increased radiation-induced disease prevalence is not wise policy at all, at least when the alternate model is not demonstrably wrong.

As far as Coulter’s reliance on an old NYT article, I thought I’d take a look at the article itself. As an aside, I can’t help but note that I really hate it when the online version of an article doesn’t include links to cited articles, and Coulter is no different in this regard. However, I do believe I managed to find this 2001 NYT article anyway from November 27, 2001, entitled For Radiation, How Much Is Too Much? It’s by Gina Kolata and discusses the controversy that had begun to bubble up about what doses of ionizing radiation might be considered safe. If you read it, you’ll see that it’s much more balanced than how it is portrayed by Coulter. For example, here is what Coulter writes about two studies cited by Kolata:

Among the studies mentioned by the Times was one in Canada finding that tuberculosis patients subjected to multiple chest X-rays had much lower rates of breast cancer than the general population.

Here is what Kolata actually wrote about these studies:

Now, some scientists even say low radiation doses may be beneficial. They theorize that these doses protect against cancer by activating cells’ natural defense mechanisms. As evidence, they cite studies, like one in Canada of tuberculosis patients who had multiple chest X-rays and one of nuclear workers in the United States. The tuberculosis patients, some analyses said, had fewer cases of breast cancer than would be expected and the nuclear workers had a lower mortality rate than would be expected.

Dr. Boice said these studies were flawed by statistical pitfalls, and when a committee of the National Council on Radiation Protection and Measurement evaluated this and other studies on beneficial effects, it was not convinced. The group, headed by Dr. Upton of New Jersey, wrote that the data “do not exclude” the hypothesis. But, it added, “the prevailing evidence has generally been interpreted as insufficient to support this view.”

Notice how the finding in “some analyses” that there were fewer cases of breast cancer than might be expected has magically morphed into “tuberculosis patients subjected to multiple chest X-rays had much lower rates of breast cancer than the general population” in Coulter’s words. Also note that this appears to be the NCRPM report that analyzed the data. Unfortunately, it would have cost me $40 to download the PDF; so I didn’t. But what about these studies?

The first study to which Coulter refers appears to be a study from Canada that was reported in the New England Journal of Medicine in 1989. This study examined the mortality from breast cancer in a cohort of 31,710 women who had been treated for tuberculosis at Canadian sanatoriums between 1930 and 1952. A significant proportion (26.4%) of these women had received radiation doses to the breast of 10 cGy or more from repeated fluoroscopic examinations during therapeutic pneumothoraxes. It should be noted that these sorts of doses of radiation are far in excess of anything likely to be received using modern radiological equipment, in particular given that we no longer perform fluoroscopy and therapeutic pneumothorax to treat tuberculosis. Interestingly, this is how the abstract summarizes the results of this study:

Women exposed to ? 10 cGy of radiation had a relative risk of death from breast cancer of 1.36, as compared with those exposed to less than 10 cGy (95 percent confidence interval, 1.11 to 1.67; P = 0.001). The data were most consistent with a linear dose–response relation. The risk was greatest among women who had been exposed to radiation when they were between 10 and 14 years of age; they had a relative risk of 4.5 per gray, and an additive risk of 6.1 per 10⁴ person-years per gray. With increasing age at first exposure, there was substantially less excess risk, and the radiation effect appeared to peak approximately 25 to 34 years after the first exposure. Our additive model for lifetime risk predicts that exposure to 1 cGy at the age of 40 increases the number of deaths from breast cancer by 42 per million women.

Oops! Maybe I found the wrong study! On the other hand, this is a Canadian study that looked at women with tuberculosis who received numerous chest X-rays (fluoroscopy, actually), and I can’t find another one like it. I also couldn’t find other publications with other analyses. The analysis that exists in the published literature, for better or for worse, concludes that the risk of breast cancer is elevated with exposures to radiation greater than 10 cGy. So, what are these other “analyses” that purport to claim that these patients actually had a lower risk of mortality from breast cancer? I smelled a rat.

My first hint came from an article published in the Journal of the Association of American Physicians and Surgeons (JPANDS) by Bernard Cohen entitled The Cancer Risk From Low Level Radiation: A Review of Recent Evidence. I’ve discussed JPANDS and how it plays fast and loose with science for ideological reasons before, in particular its antivaccine views and its publishing studies so bad that laughter is the only appropriate response. In his article, Cohen claims that hormesis “found for breast cancer among Canadian women exposed over longer periods of time to X-ray fluoroscopic examinations for tuberculosis (13); when appropriately evaluated, this evidence shows a decrease in risk with increasing radiation dose at least up to 20 cSv (20 rem).” Unfortunately, no evaluation of this evidence is included; Cohen simply asserts that this is so.

Fortunately, it didn’t take long for me to find other JPANDS articles making the same argument. For example, this one by Joel M. Kauffman. In it, Kaufmann divides up the subjects into several radiation dose ranges, while rejecting data from Nova Scotia because “too few” low radiation points were included. Conveniently he fails to define what “too few” is. However, if one looks at Table I in the NEJM paper, it’s obvious that in the dose range between 10 and 99 cSv, the death rate in Nova Scotia was much higher than the other provinces. One wonders if that had anything to do with leaving out the data, rather than writing the authors for a more detailed breakdown of the data between those dose levels, one does. In any case, what Kaufmann appears to have done is what JPANDS writers frequently do: Cherry pick the data. He took the lower end of the dose ranges, used “eyeball” fitting instead of statistical fitting to models, and left out any hint of a statistical analysis. The authors of the NEJM article went to great lengths to demonstrate that a LNT model was the best fit to their data; Kaufmann expects you to “eyeball” his graph and accept his claim of hormesis. Similarly, Jerry Cuttler and Myron Pollycove, in another JPANDS article, plotted the Canadian data on a semilog scale to make a hormesis effect look far more convincing than the actual data support, all the while simply claiming that a hormesis model fit the data better than an LNT model. Unfortunately, they didn’t “show their work,” so to speak. No discussion of how they modeled the data is included. No wonder the NCRPM found these “other” analyses unconvincing. Also, while it’s not surprising that Coulter would have gotten her data on this from JPANDS, it’s rather disappointing that Kolata didn’t look deeper back in 2001.

The second study cited by Kolata and exaggerated by Coulter was a study of U.S. nuclear industry workers. Regarding this sort of data, the scientists at the Lawrence Berkley National Laboratory have included on their website this analysis:

The results of individual studies have been inconclusive, and to investigate the matter further a combined analysis has been carried out of seven studies–three for sites in the United States (Hanford, Oak Ridge, and Rocky Flats), three for sites in the United Kingdom, and one for Canada. A total of 95,673 workers was included, of whom 60% received effective doses above 10 mSv (1 rem). In the entire population, there were 15,825 deaths, of which 3,976 were from cancer. The comprehensive results for all cancers taken together showed a very slight decrease in cancer rate with increasing dose. However, this result had no statistical significance. Of possible greater statistical significance is a slight increase with radiation dose for some types of leukemia. Overall, the statistical uncertainties were large enough that the analysis did not rule out linearity or any of the other alternative dose-response curves indicated in Figure 15-1–although it does set an upper limit on the possible magnitude of a hypothesized supra-linearity effect.

The study being discussed it this one, which, by the way, concludes:

These estimates, which did not differ significantly across cohorts or between men and women, are the most comprehensive and precise direct estimates of cancer risk associated with low-dose protracted exposures obtained to date. Although they are lower than the linear estimates obtained from studies of atomic bomb survivors, they are compatible with a range of possibilities, from a reduction of risk at low doses, to risks twice those on which current radiation protection recommendations are based. Overall, the results of this study do not suggest that current radiation risk estimates for cancer at low levels of exposure are appreciably in error.

Coulter also makes much of a study of shipyard workers from 1991:

A $10 million Department of Energy study from 1991 examined 10 years of epidemiological research by the Johns Hopkins School of Public Health on 700,000 shipyard workers, some of whom had been exposed to 10 times more radiation than the others from their work on the ships’ nuclear reactors. The workers exposed to excess radiation had a 24 percent lower death rate and a 25 percent lower cancer mortality than the non-irradiated workers.

The reference for this is:

Matanoski, G. M. (1991) Health Effects of Low-Level radiation in Shipyard Workers, Final Report, DOE/EV/10095-T2, National Technical Information Service, Springfield, Virginia, USA.

Unfortunately, I couldn’t get a hold of this report online over the weekend. I did, however, find the more recent reanalysis of the data from 2008 by Matanoski et al published in the Journal of Radiation Research. What Matanoski found wa that most of the differences in mortality and cancer rates found between shipyard workers who serviced nuclear ships and shipyard workers who did not were not significant, although there did appear to be trends towards increased risk of leukemias and other cancers with increasing dose. Overall, as far as saying anything about the association between radiation exposure and cancer, at best this study could be described as inconclusive. Certainly it’s exceedingly thin gruel to make such definitive statements about hormesis. As for the lower all-cause mortality among the nuclear workers, that is almost certainly due to phenomenon known as the “healthy worker effect“; i.e., the selective recruiting of healthier than average persons into the industry who have continued access to better than average health care.

Similarly thin gruel is this claim by Coulter:

In 1983, a series of apartment buildings in Taiwan were accidentally constructed with massive amounts of cobalt 60, a radioactive substance. After 16 years, the buildings’ 10,000 occupants developed only five cases of cancer. The cancer rate for the same age group in the general Taiwanese population over that time period predicted 170 cancers.

The people in those buildings had been exposed to radiation nearly five times the maximum “safe” level according to the U.S. government. But they ended up with a cancer rate 96 percent lower than the general population.

Not exactly. Actually, not at all. It’s not even thin gruel; it’s misrepresentation, either intentional or through Coulter’s laziness in researching the article. Coulter, as usual, is exhibiting willful ignorance by citing old data. In fact, more recent analyses of the Taiwanese population that lived in these buildings do not support her claims at all. The most recent followup study I could find was published in 2006 in the International Journal of Radiation Biology by Hwang et al. The results were:

A total of 7271 people were registered as the exposed population, with 101,560 person-years at risk. The average excess cumulative exposure was approximately 47.8 mSv (range 5 1 – 2,363 mSv). A total of 141 exposed subjects with various cancers were observed, while 95 developed leukemia or solid cancers after more than 2 or 10 years initial residence in contaminated buildings respectively. The SIR were significantly higher for all leukemia except chronic lymphocytic leukemia (n1?46, SIR1?43.6, 95% confidence interval [CI] 1.2–7.4) in men, and marginally significant for thyroid cancers (n1?46, SIR 1?4 2.6, 95% CI 1.0 – 5.7) in women. On the other hand, all cancers combined, all solid cancers combined were shown to exhibit significant exposure-dependent increased risks in individuals with the initial exposure before the age of 30, but not beyond this age.

Hwang et al concluded:

The results suggest that prolonged low dose-rate radiation exposure appeared to increase risks of developing certain cancers in specific subgroups of this population in Taiwan.

So, basically, Coulter is completely wrong about the Taiwan incident. There is an increased incidence of cancer in young people, at least, who lived in those apartment buildings. Science is hard, isn’t it? Coulter’s also on seriously dubious footing when she cites Professor Bernard L. Cohen, whose various studies of the relationship between radon and lung cancer buck the established consensus that radon is a risk factor for lung cancer. (Yes, this is the very same Bernard Cohen who wrote the JPANDS article I mentioned earlier in this post; to me his having published in JPANDS is to me a huge hit on any credibility he might have had.) It turns out that Cohen probably didn’t control adequately for smoking in his studies because a reanalysis of his reported data demonstrated similar, strongly negative correlations between radon exposure and cancers strongly linked to cigarette smoking and weaker negative correlations between radon and cancers moderately associated with smoking. No such correlation was found for cancers not linked to smoking. These results strongly suggest that Cohen didn’t adequately control for smoking in his analysis. Another criticism points out that Cohen fell prey to the ecological fallacy and suggested that county-level data probably do not represent the best units to detect a correlation between radon and lung cancer.

Coulter’s final claims center on the Chernobyl disaster and victims of the atomic bombings of Hiroshima and Nagasaki. In particular, she claims that only 30 people died in the plant as a direct result of the disaster and further downplays the risk of cancer in the survivors, stating:

Even the thyroid cancers in people who lived near the reactor were attributed to low iodine in the Russian diet — and consequently had no effect on the cancer rate.

As is usually the case for any scientific claims made by Coulter, this is utter rubbish. Unfortunately for Coulter, her timing in publishing her article was exquisitely bad. On the very next day after her article was published, the National Cancer Institute released the most comprehensive study yet of thyroid cancer in Chernobyl survivors. The findings indicated that radioactive iodine (¹³¹I) from the fallout from the reactor was likely responsible for thyroid cancers that are still occurring among people who lived near the reactor and that the risk of this cancer is not declining. In other words, no, Ann, the hugely elevated levels of thyroid cancer among people who live near Chernobyl when the reactor disaster occurred are not due to iodine deficiency in the Russian diet. There is some evidence that iodine deficiency might have increased the risk of ¹³¹I-induced cancers, particularly in the youngest, but that’s not what Coulter said. She implied that iodine deficiency could account for the elevated incidence of thyroid cancer among those affected by the fallout. Much more about the health effects of the Chernobyl disaster can be found here. It should also be noted that most people who lived in the area were not exposed to that much radiation according to the United Nations-sponsored team investigating. Most were exposed to about 9 mSv, about 1/3 the equivalent of a CT scan of the chest, abdomen, and pelvis, once the short-term doses to the thyroid were subtracted

Poor Ann. That’s what you get for not doing a bit more research. Basically, every claim she makes in her article can be shown to be either mistaken, grossly exaggerated, or based on old evidence. She even cites Tom Bethell, author of The Politically Incorrect Guide to Science, as a source. Bethell is an all-purpose right-wing science denialist, who, besides viewing scientists as attention whores who trump up alarmist findings in order to secure more research funding and castigates science for its commitment to “materialism,” also denies evolution and anthropogenic global warming. He even rejects relativity and embraces “AIDS reappraisal,” while extending his view on hormesis to argue that hormesis actually protects us from toxic chemicals in the environment that, according to him, we don’t have to worry about nearly as much as environmentalists say we do. In fact, Coulter includes a paragraph in her article that is so unintentionally hilarious that I can’t help but cite it:

Although it is hardly a settled scientific fact that excess radiation is a health benefit, there’s certainly evidence that it decreases the risk of some cancers — and there are plenty of scientists willing to say so. But Jenny McCarthy’s vaccine theories get more press than Harvard physics professors’ studies on the potential benefits of radiation. (And they say conservatives are anti-science!)

I doubt that Coulter appreciates the irony encompassed by this paragraph, given that this paragraph is further encompassed by an article that uses many of the same deceptive techniques of argumentation that the anti-vaccine movement, as epitomized by Jenny McCarthy, likes to use. She then digs herself in deeper by correctly mentioning that Botox is a poison that is safe to use at high doses (Jenny McCarthy loves Botox, actually) and then pointing out the principle that many poisons are safe and beneficial at low doses but dangerous at high doses. If these arguments didn’t occur within the context of her spewing of misinformation, Coulter might actually be making some sense. Too bad she couldn’t resist adding:

Every day Americans pop multivitamins containing trace amount of zinc, magnesium, selenium, copper, manganese, chromium, molybdenum, nickel, boron — all poisons.

They get flu shots.

Perhaps Coulter has more in common with Jenny McCarthy than she would like to admit. Actually, there’s no “perhaps” about it. Coulter will also say whatever fits her political viewpoint. Last week she was ranting about how radiation is good for you. Back in November, she was complaining that the new Transportation Security Administration scanners do pose a “radiological danger.”

These scanners result in a dose of 0.001 mSv for about 5 seconds of full body exposure, and even frequent fliers would be exposed to much less radiation than Coulter is claiming to be just fine. Indeed, Ann Coulter should be lining up to be scanned. After all, that little radiation is good for you!

Is hormesis a real phenomenon?

Despite my irritation, I was rather grateful for Coulter’s article. It did remind me of a rather fascinating debate in radiobiology over what model best describes the biological effects of radiation. Hormesis might indeed be a real phenomenon in humans, but it’s been very difficult to demonstrate. Even one of the best review articles I’ve found that argues for the existence of hormesis as a phenomenon, an article by Tubiana et al entitled The Linear No-Threshold Relationship Is Inconsistent with Radiation Biologic and Experimental Data doesn’t exactly argue for hormesis. Rather, it argues that the LNT model is inconsistent with the data and needs to be modified to more of a threshold model, in which doses below a certain threshold are probably harmless but above a certain threshold start to increase the risk of disease. Arrayed against these sorts of arguments are scientists like Rudi H. Nussbaum and Wolfgang Köhnlein, who call hormesis and the zero-risk threshold dose “scientifically refuted, but stubborn myths.” They even argue that in some cases the risk of low level radiation exposure might well be underestimated. Not surprisingly, in her article Coulter used nearly every myth that Nussbaum and Köhnlein deconstruct in their paper.

Hormesis is clearly an area of science that is as yet controversial. The reason is because it’s difficult to demonstrate definitively one way or another whether hormesis occurs in humans in response to low dose radiation. As I mentioned above, the signal-to-noise ratio for studies of low dose radiation is very low. Moreover, studies of low dose radiation have been conflicting, although we can say with a fair amount of confidence, based on my review of the literature, that, if hormesis occurs, it probably occurs only below doses of 100 mSv. Remember, 30 mSv is the dose received from a CT scan of the chest, abdomen, and pelvis and can be estimated to increase one’s lifetime risk of a fatal cancer by 1 in 1000 to 1 in 500 in pediatric patients, while most people receive around 3 mSv per year from background radiation. To put this all into context, XKCD has a very useful chart that describes how much radiation we receive from various sources. Another good perspective comes from a recent AP article on the topic, which takes a much more balanced perspective.

The bottom line is that we just don’t know whether hormesis is a real phenomenon for radiation response in humans. Lacking that knowledge, we do know that the LNT model is a reasonable approximation for purposes of regulation because it is simple and defensible. Even so, different professional organization bodies have started to question it. For example, the French Academy of Sciences and National Academy of Medicine published a report in 2005 that stated:

In conclusion, this report raises doubts on the validity of using LNT for evaluating the carcinogenic risk of low doses (< 100 mSv) and even more for very low doses (< 10 mSv). The LNT concept can be a useful pragmatic tool for assessing rules in radioprotection for doses above 10 mSv; however since it is not based on biological concepts of our current knowledge, it should not be used without precaution for assessing by extrapolation the risks associated with low and even more so, with very low doses (< 10 mSv), especially for benefit-risk assessments imposed on radiologists by the European directive 97-43.

The Health Physics Society’s position statement, revised in July 2010, states:

In accordance with current knowledge of radiation health risks, the Health Physics Society recommends against quantitative estimation of health risks below an individual dose of 5 rem in one year or a lifetime dose of 10 rem above that received from natural sources. Doses from natural background radiation in the United States average about 0.3 rem per year. A dose of 5 rem will be accumulated in the first 17 years of life and about 25 rem in a lifetime of 80 years. Estimation of health risk associated with radiation doses that are of similar magnitude as those received from natural sources should be strictly qualitative and encompass a range of hypothetical health outcomes, including the possibility of no adverse health effects at such low levels.

Again, we just don’t know. My guess is that hormesis, if it occurs in humans in response to radiation, is not nearly as potent a phenomenon as its adherents claim. My further guess is that the way hormesis is invoked as a scientific explanation for homeopathy doesn’t help its reputation. Be that as it may, until science settles the question, I do know that, contrary to what Coulter claims in her nonsensical arguments, low dose radiation is not a magical “cancer vaccine.” At the very best, low dose radiation might not hurt you or might have some very slight benefits. At worst, it might actually hurt you more than the current scientific consensus accepts. That’s too wide range of possibilities and too much uncertainty to be laying down a barrage of misinformation as intense as Coulter’s.

ADDENDUM: Here’s an amusing little takedown of Coulter’s nonsense, for your edification. I had a good chuckle at this comment by Gordon Bloyer, who writes:

Schultz telling anyone about science, LOL. Coulter wrote an extensive column using back-up from science. Sgt. Ed should learn to read.

Coulter didn’t give her “theory” she cited science. She is right and O’Reilly just shoots off his mouth before he lets others complete a sentence. In this case he had NO IDEA what Coulter was talking about.

I invite Gordon to read my discussion of hormesis and see that the “back-up from science” that Coulter used is anything but. I do thank Gordon, though, for a moment of hilarity in a painful day of grant writing. Ditto felixw, who comments:

I know that O’Reilly went to Harvard. And Ann Coulter graduated cum laude from Cornell, where she founded The Cornell Review before getting her law degree at the University of Michigan, where she edited the law review. Then she clerked for the United States Court of Appeals for the Eighth Circuit.

Given how much a law school education has to do with science, by this logic, I should be able to confidently and definitively make pronouncements on the law! After all, I graduated from the University of Michigan, too, just like Ann Coulter!