Simon Singh Wins a Victory in BCA Libel Suit

As many of you may know, there is a libel cases in Britain that has been followed very closely by those of us supportive of evidence-based medicine, that of Simon Singh versus the British Chiropractic Association (BCA). Dr. Singh is a science journalist and author, and with Edzard Ernst he wrote Trick or Treatment: The Undeniable Facts about Alternative Medicine, which I have previously reviewed. The lawsuit stems from an article Dr. Singh wrote in the Guardian newspaper criticizing the BCA for promoting chiropractic treatment for clearly inappropriate conditions despite clear evidence against doing so. In the article, Dr. Singh says:

“The British Chiropractic Association claims that their members can help treat children with colic, sleeping and feeding problems, frequent ear infections, asthma and prolonged crying, even though there is not a jot of evidence. This organization is the respectable face of the chiropractic profession and yet it happily promotes bogus treatments.”

The BCA alleges that “happily promotes bogus treatments” implies deliberate fraud or deception, despite the fact that Dr. Singh has clearly stated his opinion that the organization and its members quite likely believe in the bogus therapy they practice. In Britain, libel law places the burden of proof on the defendant, and it can be very difficult to prove that one did not mean what the plaintiff alleges one meant. This practice makes scientists and others who criticize CAM practices on the basis of sound evidence against them vulnerable to expensive and demoralizing lawsuits intended to intimidate them, and the media which might otherwise publish their critique.

Initially, Dr. Singh faced a significant setback in the lawsuit when a judge ruled his comments were factual assertions, not expressions of opinion, which meant that unless he could prove to a high degree of certainty that the BCA intentionally promoted therapies it knew were ineffective, he would be guilty of libel. An appeals court has now reversed that ruling, declaring Dr. Singh’s statements as opinions, which carries a much lower burden of proof for defending against libel claims.

What is encouraging about this ruling is the language of the opinion, which suggests the higher court recognizes that libel laws are structured in a way to make them easy to abuse in attempts to intimidate legitimate critics of unfounded medical practices. The justice wrote:

“The opinion [expressed in an article like Singh’s] may be mistaken, but to allow the party which has been denounced on the basis of it to compel its author to prove in court what he has asserted by way of argument is to invite the court to become an Orwellian ministry of truth…[those claiming they had been libelled] cannot, by simply filing suit and crying ‘character assassination!’, silence those who hold divergent views, no matter how adverse those views may be to plaintiffs’ interests.

Scientific controversies must be settled by the methods of science rather than by the methods of litigation. More papers, more discussion, better data, and more satisfactory models – not larger awards of damages – mark the path towards superior understanding of the world around us.”

Of course, the court has no authority to alter the law. However, there is an active movement in Britain to reform libel laws so as to allow open scientific debate and the kind of vigorous criticism based on logic and evidence needed to ensure good ideas in medicine prosper and bad ideas are cast aside. It is shameful that Dr. Singh has spent £200,000 and two years of his life battling this clear attempt at intimidation, and his battle is not yet over. But perhaps his case will be the stone that starts an avalanche of real libel reform.

Posted in Chiropractic, Law, Regulation, and Politics | 5 Comments

Micronutrients and Cancer

A recent editorial in the Journal of the National Cancer Institute (JNCI) addresses the issue of whether micronutrients, such as vitamins, have a clear role in cancer prevention. It is fairly common in broad  epidemiological survey studies to look for associations between levels of risk of a particular disease and lifestyle variables. Casting such a broad net often snags a number of associations, some of which may later prove causal and important, many of which will turn out to be spurious or at least complex and not direct cases of the lifestyle variable being responsible for the greater or lesser risk of the disease observed.

The vitamin content of the diet is a common variable found to be associated with lower risk of some diseases, including cancer, and this tends to suggest that vitamin supplementation may be protective. However, the logic behind that assumption is quite shaky. For one thing, there is a huge difference between eating foods rich in folate or Vitamin C or omega 3 fatty acids or whatever, and taking these as supplements. Foods are complex mixture of nutrient and non-nutrient substances, and while in some cases individual nutrients are clearly critically important for health (such as Vitamin C for preventing scurvy), many times the overall pattern of the diet may be more important than any individual component.

But because of the historical success of vitamin supplementation eliminating a few common diseases that were due to vitamin deficiencies, we tend to have a warm and fuzzy feeling about vitamins. And, of course, in America if some is good more is always better! Except when it isn’t.

The editorial in JNCI points to many studies in which vitamin supplementation proved to be useless for cancer prevention, and even a few in which vitamin supplementation appeared to increase cancer risk. For example, beta carotene and Vitamin E have been shown to increase the rate of lung cancer, and overall mortality, in smokers. Diets high in folic acid have been associate with a lower rate of colorectal cancers, but some experimental trials on folic acid supplementation shown no benefit and even suggest they may increase the rate of this disease, and also prostate cancer.

Such research evidence reminds us that as much as we desires simple stories, and clear good guys and bad guys, health and disease are complex. Vitamins can be beneficial, useless, or harmful like any other potential preventative or treatment, and we must rely on solid evidence rather than assume the benefit or safety of such substances, whether “natural” or not.

Posted in Nutrition | Leave a comment

Nice Post on Equine CAM by Alison Averis

Being a small animal  vet, I don’t have much first-hand experience with equine CAM. But our recent guest blogger, Alison Averis, is very involved in equine issues, and she has a nice article in the Equine Independant on judging alternative claims in this area. She is also dealing with the usual sorts of critiques that defend CAM and challenge science-based medicine without ever resorting to facts or evidence but trying to find fallacious rhetorical strategies to undermine arguments without addressing them. She’s holding her own just fine, but it wouldn’t hurt to offer her some support if you can, particularly those of you more familiar with horse medicine.

Posted in Guest Posts, Miscellaneous CAVM | 3 Comments

More Natural Nonsense and Unethical CAM Marketing

A colleague recently saw an older dog who had vomited up roundworms and was doing some coughing. He diagnosed and treated the patient appropriately, but the client later contacted him with questions about some alternative remedies that had been recommended to her by the folks at Native Remedies. The owner had the common misconception that “natural” is a word with a real and precise meaning in medicine (as opposed to a marketing term invented to take advantage of the fear of “toxic” modern life) and that using it to describe a remedy somehow guaranteed safety. The folks trying to sell her such products took full advantage of this idea in their letter to her.

They began by flattering her, “You are to be commended for researching the use of natural alternatives.” They then recommended a host of herbal and homeopathic products.

Several were claimed to be homeopathic products: Respo-K, Sinu-Rite, and KC-Defense. These contain a variety of ingredients all diluted in the usual homeopathic way. 100% safe? You bet! Why–because they’re 100% water! (Well, technically some of the ingredients are diluted less then 12C, so they could possibly contain a few molecules of the original substance, but still quite likely much less than needed to have any measurable physiologic effect). The seller did engage in a bit of deceptive advertising. They repeatedly stressed the products are “FDA registered.” Well, doesn’t this mean they are tested and approved by the FDA?

Actually, not at all. The issue of how homeopathic preparations are regulated is a complex, and fuzzy one. Homeopathic products for human use were grandfathered, without any scientific testing or validation, into the original legislation establishing the FDA and its mandate as a concession to an influential senator who was a homeopath. These products can be marketed with medical claims as long as they have been included in the Homeopathic Pharmacopeia of the Untied States, an index of such remedies maintained by an independent organization of homeopaths which sets rigorous standards for proving the safety and efficacy of water in a way totally inconsistent with the rest of medical science. The over-the-counter sale of such remedies is limited to disease that are “self-limiting” and which an average consumer should be expected to recognize and be able to treat on their own. If the homeopathic “drugs” are used for serious illnesses, they require a prescription, though for obvious reasons they seldom are so used.

With regard to the veterinary use of homeopathic “drugs,” the FDA has stated that it does not considered this activity to be covered under the same rules as the human use of these products, so veterinary homeopathy is technically a use of unapproved veterinary drugs and so illegal, though doubtless lawyers could wade through the voluminous legislation and make all sorts of arguments for and against this claim. In any case, the FDA has neither the will nor the resources to enforce any such position and has generally agreed to ignore homeopathy when used in companion animals.

All of this is simply to illustrate that “FDA registered” when applied to a homeopathic drug 1) implies no scientific testing of safety and efficacy and 2) only properly applies to human use, which was allowed in the 1930s as a political concession. Thus, the term is meaningless from the point of view of legitimizing any claims sellers of these products may make.

Because these remedies are essentially only water, and so harmless in themselves, there is not likely ever to be any interest among politicians in the controversial and thankless task of requiring them to either prove themselves scientifically or be banned. But it is clear that they should not be expected to have any benefit for real disease, nor should they be used in place of scientific medicine which has demonstrated safety and efficacy in a legitimate way.

The other two recommended products were herbal concoctions, and so have some potential to be helpful or harmful. The usual caveats apply to these remedies, namely that they are in no way regulated and all quality control is voluntary, so cases in which the label does not accurately reflect the ingredients and toxic or pharmaceutical contaminates are present are common. I have a long, and growing, list of examples of this problem.

The first nostrum reocmmended was Parasite Dr., which the sellers claim is a mixture of wormwood (Atremesia absinthinium), Cloves (Eugenia caryophyllata), Neem (Azadirachta indica), and Herb of Grace (Ruta graveolens).

Wormwood has been used medicinally and as a flavoring agent for centuries, most notoriously in the alcoholic drink absinthe. Limited in vitro studies have shown some toxicity to roundworms, however, these must always be interpreted cautiously since bleach can poison worms in a test tube too, but that doesn’t make it a safe and effective deworming agent. There is one in vivo trial in sheep conducted in India in which water and alcohol extracts of the plant had some effects on parasite egg counts, but again when one takes extracts from a plant and purifies them, one has a drug, not an herbal remedy. How much of which compounds from wormwood are in this product is completely unknown, so even if wormwood had antiparasitic properties, which is far from demonstrated, that doesn’t mean this product would. As for toxicity, one small rat study found no obvious toxic effects, however neurologic and GI symptoms have been reported from ingestion of compounds in wormwood, so the safety of this product is as much a mystery as its efficacy. No evidence concerning safety or effectiveness in dogs appears to exist.

Clove oil has also had a history of medicinal and flavoring use. The NCCAM has concluded there is insufficient evidence to support any use other than as a mild topical analgesic, and a review of traditional veterinary herbal remedies for GI and parasite problems has concluded there is insufficient evidence to justify its veterinary use. There have also been reports of an increased risk of bleeding, particularly when used concurrently with non-steroidal anti-inflammatory medications, and allergic reactions have been seen. No evidence concerning safety or efficacy in dogs specifically appears to exist.

Neem is currently quite popular among gardeners as an insect repellant, and has a history of use as an anti-parasitic. There is reasonable evidence for its topical use on animals and plants, including one study showing some flea repellent effects in dogs and cats. Extracts have been tested in several trials in sheep, and most have found little or no efficacy in reducing intestinal parasites. (1, 2, 3, 4). A review of the limited safety data available for humans and lab animals finds minimal toxicity, and the EPA has exempted some neem products from its more stringent pesticide regulations under the presumption of safety. However, no data on the safety or oral use in dogs appears to exist.

Finally Rue or Herb of Grace is primarily known in traditional herbal use as a substance used to induce abortion. There is limited data on it’s safety and efficacy, and nothing to support its use for parasites or gastrointestinal disease generally. Some pretty serious toxicity, including photosensitivity (blisters and ulcers developing with sun exposure after use of rue) and potential mutagenic and carcinogenic properties have been reported.

So the pattern is clear. Minimal or no evidence of effectiveness, limited evidence of safety or even known risks, and no assurance of any particular ingredient or dose or the absence of toxic contaminants. Yet we are supposed to rest comfortably in the confidence that because it’s “natural” it must be good regardless of whether there is any evidence either way.

The folks at Native Remedies are very tricky in their marketing of this and the other products recommended. When one searches their web site for Parasite Dr, for example, the search turns up a clear (and illegal) medical claim: 

1.

Parasite Dr. – Naturally treats canine and feline parasites, hookworm, heart worm, roundworm.
… and Roundworms. Parasite Dr.™ is a …
… canine and feline parasites, hookworm, heart …

However, when one follows the link to the actual page, they are very careful only to make allowable “structure and function” claims, such as these:

Parasite Dr. Benefits:

  • Promote digestive health and balance
    Calm and soothe the digestive system
  • Cleanse and detox the digestive system and improve digestive functioning
  • Cleanse the blood
  • Support correct balance of intestinal flora
  • Act as a tonic for the entire digestive system
  • Support the immune system

They even go so far as to note, “ Disclaimer: Testimonials have been edited to comply with FDA regulations. While positive results are likely, the testimonials used are general results and are not intended to represent or guarantee that anyone will achieve the same or similar results – individual results may vary.”

Unfortunately, this is merely an effort to comply with the letter of the law, and they show no restraint in making illegal and unethical claims in their e-mail to the client. The nostrum is promised to “rid your pet of unhealthy infestations of internal parrasites without the unwanted side effects sometimes associated with synthetic parasite medication…As an added bonus, Parasite Dr . also helps to cleanse the system and contains herbs with antifungal properties, thus helping to reduce systemic yeast infections which compromise health…” Clearly, the evidence supports none of these claims, and the old saw about “yeast infections” as a cause of illness is a bit of popular CAM mythology which has nothing to do with this patient’s problem.

The most disturbing and ethically offensive part of the marketing materials, however, concerns heartworm disease. This is a serious parasitic infection which is widespread in much of the United States and which is routinely fatal if acquired. There are, however, safe and effective, FDA approved and adequately tested, preventatives in common use. The native Remedies representative, however, claims their product is an effective preventative for this deadly disease, which it almost certainly is not. They also imply conventional preventatives “can undermine the liver” (which is not at all true, while they have risks like any drugs, these have nothing to do with the liver), and they then try to sell another herbal concoction, Detox Plus, to treat this. Any owner unfortunate enough to believe these lies and who lives in an area where heartworm disease is endemic is likely to see their pet die from heartworm infection if they follow this advice. That is why such claims are illegal, not some sinister conspiracy of government and the pharmaceutical industry to deny people effective natural medicines. It is only a pit that the government has not the will or resources to enforce such laws, and that pets and people must inevitably suffer for it.

Posted in General, Miscellaneous CAVM | 8 Comments

Yunnan Paiyao–Secret Herbal Formula to Stop Bleeding?

Call it coincidence, confirmation bias, or a trend, but I once again ran into the issue of a specialist I refer to recommending a questionable therapy for one of my patients. I recently diagnosed a dog with a nasal cancer and sent him to a board-certified oncologist to consult of options for advanced therapy. The particular disease can’t be cured, but radiation and chemotherapy can have some symptomatic benefit and may prolong a reasonable quality of life. The owner, however, didn’t feel the possible benefits justified the risks and costs, which I think was a reasonable decision. So the oncologist was only able to offer minimal symptomatic care. He offered a non-steroidal anti-inflammatory for pain, and also told the owner to go to a human herbal remedy shop and find the Chinese herbal preparation yunnan paiyao to help with the intermittent nosebleeds the cancer was causing.

I expect specialists to be more cognizant of the need for evidence-based practice than general practitioners, but I am beginning to doubt the truth of this assumption. I accept that sometimes, when there is a compelling need to treat and no established effective treatment available or acceptable to the owner, it may be appropriate to try things that have a weak basis in basic or clinical evidence. However, I am still concerned about the wisdom of recommending therapies that we don’t have at least some reasonable evidence are safe or effective.

Absence of evidence is not, of course, proof something doesn’t work. But it is absence of any good reason to think it does. And the reverse is true for safety. Absence of evidence of harm does not mean it isn’t harmful, only that we don’t know whether it is or not. Yet anecdotal experience is used to justify both safety and efficacy despite the clear evidence of history that this isn’t reliable. Of course, this logic is preferentially applied to CAM therapies. If clinical testing of a pharmaceutical company medicine finds no significant side effects, and then rare harm does appear once the drug is in widespread use, this is trumpeted as a failure of the whole scientific testing paradigm and proof of the evil venality of drug companies and the innately poisonous nature of their products. Yet we seem very comfortable prescribing herbal products about which almost nothing is known concerning safety or efficacy, with the assumption that they must be safe and that even if the only evidence they work is anecdotal at least we they can’t do any harm.

So what is yunnan paiyao, and what is the evidence for or against it? It is an herbal concoction apparently invented in China in the early 20th century, and the details of the ingredients are still kept secret. However, it is widely considered to consist primarily of Panax notoginseng of pseudoginseng root, with a number of other possible plant ingredients. Right away I wonder at the wisdom of prescribing a remedy when no one knows exactly what is in it. Can you imagine a major pharmaceutical company getting away with selling a drug that doctors actually prescribed without disclosing the actual ingredients?! And given the well-documented problem of heavy metal and pharmaceutical contamination of Chinese herbal remedies, and the general inconsistency of such preparations, it is remarkable that any doctor, much less a boarded specialist, would feel comfortable assuming the safety of such a product based on personal experience and anecdotes.

There have been a few papers published in China and in some alternative medicine publications that show the substance has some influence on platelet aggregation, an important step in blood clotting. However, you can mix sand or many other substances in a test tube with platelets and they will activate. One of the reasons it is so hard to make a safe artificial heart is that it’s tough to find substances that don’t trigger platelet aggregation. Some studies have compared the effect of yunnan paiyao with wheat flour or other substances to show it is more likely to cause clotting than these others, but the reliability of the tests and the choice of substances doesn’t make a very convincing case. And we have to remember the problem with the reliability of different sources of published research. Publication bias (the publishing of only positive results and “round-filing” of negative studies) is a problem everywhere. But Chinese journals almost never publish negative studies, and CAM journals are especially prone to select only those papers for publication that support the kinds of therapies the journals were started to promote.

The same issue arises in considering the few clinical trials in humans. A small number of trials with a small number of patients conducted and/or published in low reliability sources might be enough to justify further research, but not to justify widespread clinical use of the product. And, of course, the testimonials and anecdotes of clinicians and users have the same lack of reliability. If the product has been in use for over 100 years, and in that time we have only a handful of small studies of it, I think that is fair reason to be skeptical. If the drug truly has a dramatic impact on bleeding, topically or orally, it shouldn’t be difficult to conduct and publish a well-designed trial for a mainstream journal. Even one such trial would doubtless excite enough interest, through NCCAM or private industry, to stimulate more. Whether this has never been done because the proponents of such therapies don’t see the need for such evidence, or because the drug doesn’t truly have enough promise to survive such a test, is an open question.

Finally, I have found only two published veterinary trials investigating yunnan paiyao. An abstract presented at the 2002 International Veterinary Emergency and Critical Care Symposium took a group of 6 healthy ponies, and anesthetized them twice to check activated clotting time (ACT) and template bleeding time (TBT). The ACT is a moderately reliable test of blood clotting, though it can be affected by temperature, how vigorously and consistently the test tube is shaken, and a number of other factors. The TBT is a much less reliable and more subjective test in which a lancet is used to cut the patient (usually on the oral mucosa) and the time it takes for the cut to stop bleeding is measured.

The only difference reported in methods between the control trial and the yunnan paiyao trial was the position of the patients. They were on their side in the control trial and on their back in the test trial. I wonder if this might affect TBT since the  blood flow to different parts of the body is affected by body position, but there isn’t any information in the abstract to determine if this is a factor. The study reported no difference in the ACT value with or without the yunnan paiyao but did report a non-chance difference in the TBT.

The other trial was a placebo-controlled trial of yunnan paiyao and another herbal preparation called Single Immortal using five Thoroughbred horses. The horses were run on a treadmill after having received either one of the herbal preparations or the placebo (cornstarch) orally twice a day for 3 days before the experiment. A number of variables were measured, with the main goal to see if there was any effect on exercised-induced pulmonary hemorrhage (EIPH), bleeding in the lungs during exercise. No effect of either remedy on EIPH was seen.

So we have a treatment with uncertain and unregulated ingredients, no demonstrated plausible mechanism of action, a few in vitro and lab animal studies in journals of questionable reliability, a few small human clinical trials in similarly questionable sources, and two very small veterinary trials in equids which found no effect except possibly on a poorly reliable and subjective test of blood clotting. At the same time, we have almost no published reports of adverse effects. There is one case report in a Chinese journal of a contact dermatitis reaction and some suggestion that high doses or chronic use may affect bone marrow cells. And we have a well-established history of toxic contamination and poor quality control in Chinese herbal remedies in general.

For me, this information clearly shows the oncologist’s use of this preparation in my patient to me essentially an uncontrolled experiment with no reasonable assurance of safety or efficacy. It is disturbing to me and certainly shakes my confidence in the judgment and recommendations of this particular specialist, though I fear he may not be at all exceptional but simply part of a larger phenomenon in which anecdote, personal experience, and “expert” opinion is given undue weight and the need for more reliable evidence is underestimated in veterinary medicine.

References:

Epp TS, McDonough P, Padilla DJ, et al. The effect of herbal supplementation on the severity of exercise-induced pulmonary haemorrhage. Equine and Comparative Exercise Physiology 2005;2:17-25.

Graham L. Yunnan Paiyao–Where’s the clinical evidence? Veterinary Botanical Medicine Association Symposium Archive 2005. Available at: http://www.vin.com/Members/proceedings/Proceedings.plx?CID=VBMA&PID=13730&Print=1&O=VIN

Graham L, Farnsworth K, Cary J. The effect of yunnan baiyao on the template bleeding time and activated clotting time in healthy halothane anesthetized ponies. Proceedings International Veterinary Emergency and Critical Care Symposium 2002, San Antonio, TX. Journal of Veterinary Emergency and Critical Care 2002;12(4):279. Abstract only.

Robinson N. Yunnan Paiyao; The following references come from Dr. Robinson’s document:

1 Bergner P. Panax notoginseng Yunnan bai yao): A must for the first aid kit. Medical Herbalism. 10-31-94 6(3):12.

2 Fratkin J. Chinese Herbal Patent Formulas – A Practical Guide. Santa Fe: Shya Publications, 1986. P. 133.

3 Fratkin J. Chinese Herbal Patent Formulas – A Practical Guide. Santa Fe: Shya Publications, 1986. P. 133.

4 Zheng YN et al. Comparative analysis of the anti-haemorrhagic principle in ginseng plants. Acta Agriculturae Universitatis Jilinesis. 1989;11(1):24-27, 102. [Article in Chinese].

5 Jin H, Cui XM, Zhu Y, et al. Effects of meteorological conditions on the quality of radix Notoginseng. Southwest China Journal of Agricultural Sciences. 2005;18(6):825-828.

6 Fan C, Song J, and White CM. A comparison of the hemostatic effects of notoginseng and Yun Nan Bai Yao to placebo control. Journal of Herbal Pharmacotherapy. 2005;5(2):1-5.

7 Fratkin J. Chinese Herbal Patent Formulas – A Practical Guide. Santa Fe: Shya Publications, 1986. P. 133.

8 Liu Y, Xie M-X, Kang J, et al. Studies on the interaction of total saponins of panax notoginseng and human serum albumin by Fourier transform infrared spectroscopy. Spectrochimica Acta. Part A. 2003;59:2747-2758.

9 Chan RYK, Chen W-F, Dong A, et al. Estrogen-like activity of ginsenoside Rg1 derived from Panax notoginseng. Journal of Clinical Endocrinology and Metabolism. 2002;87(8):3691-3695.

10 Cicero AFG, Vitale G, Savino G, et al. Panax notoginseng (Burk.) effects on fibrinogen and lipid plasma level in rats fed on a high-fat diet. Phytotherapy Reearch. 2003;17:174-178.

11 Epp TS, McDonough P, Padilla DJ, et al. The effect of herbal supplementation on the severity of exercise-induced pulmonary haemorrhage. Equine and Comparative Exercise Physiology. 2004;2(1):17-25.

12 Chung VQ, Tattersall M, and Cheung HTA. Interactions of a herbal combination that inhibits growth of prostate cancer cells. Cancer Chemotherapy and Pharmcology. 2004;53:384-390.

13 Chen FD, Wu MC, Wang HE, et al. Sensitization of a tumor, but not normal tissue, to the cytotoxic effect of ionizing radiation using Panax notoginseng extract. American Journal of Chinese Medicine. 2001;29(3/4): 517-524.

14 Chen FD, Wu MC, Wang HE, et al. Sensitization of a tumor, but not normal tissue, to the cytotoxic effect of ionizing radiation using Panax notoginseng extract. American Journal of Chinese Medicine. 2001;29(3/4): 517-524.

15 Leung KS-Y, Chan K, Chan C-L, et al. Systematic evaluation of organochlorine pesticide residues in Chinese materia medica. Phytotherapy Research. 2005;19:514-518.

16 Leung KS-Y, Chan K, Chan C-L, et al. Systematic evaluation of organochlorine pesticide residues in Chinese materia medica. Phytotherapy Research. 2005;19:514-518.

17 Leung KS-Y, Chan K, Chan C-L, et al. Systematic evaluation of organochlorine pesticide residues in Chinese materia medica. Phytotherapy Research. 2005;19:514-518.

18 Leung KS-Y, Chan K, Chan C-L, et al. Systematic evaluation of organochlorine pesticide residues in Chinese materia medica. Phytotherapy Research. 2005;19:514-518

Posted in Herbs and Supplements | 78 Comments

Specialist’s Statement on Integrative Methods

A colleague recently received the following statement, as part of a follow-up report from a board-certified specialist to whom she had referred a case. The pet received a number of alternative medical therapies as well as conventional treatment for its condition.

“Integrative medicine can increase the variety of many different treatment plans and has the opportunity to reach a more successful health plateau for your patient. Invariably, integrative medicine acts as a adjunct protocol and offers more than a healthy body. Integrative medicine also provides a healthy sense of well being. As we progress towards newer and more extensive technology we lose the art of the basic touch and hands on treatment. In this day and age with our society relying heavily on technology and invasive sciences we must not look to holistic care as an alternative but as a way back to our soul.”

There are a number of elements to both the concepts and the logic of this statement which I find disturbing, especially coming from a specialty center to which I sometimes refer patients, and in which I must have confidence in order to keep doing so. It also illustrates one of the biggest problem in defending science-based medicine: overcoming the conflation of unproven or ineffective CAM treatments with a warm and caring therapeutic relationship.

1. “Integrative medicine can increase the variety of many different treatment plans”

This seems a variety of the bogus “health care choice” argument. Yes, adding unproven or implausible therapies to what we do gives us more things to do, but if these interventions aren’t shown to have a benefit, and might even be harmful, then so what? Variety is not itself a good thing, especially if it only serves our psychological need to do something without truly benefitting our patients.

2. “has the opportunity to reach a more successful health plateau for your patient”

This statement is meaningless without evidence to show it is true. CAM proponents freely claim better health through their methods, but shampoo makers freely claim their product is “New and Improved” every few months too. Should we believe it just because they say so?

3. “Invariably, integrative medicine acts as a adjunct protocol and offers more than a healthy body.”

Same problem. The assumption is made that adding this stuff helps, but I expect any doctor, especially a second-tier specialist, to have more than anecdote and faith to back up their claim that their treatments can help my patient. This statement suggests any and all CAM interventions added to conventional therapy will “invariably” bring benefit. No side effects? No interference with conventional therapies? No possibility of failure? If it sounds too good to be true that’s because it is.

4. “Integrative medicine also provides a healthy sense of well being”

Here we begin to get into the underlying philosophical position that will fully emerge later. These added interventions aren’t really about making the patient better in terms of their disease but about making them feel better. Of course, since we can’t access our pets inner feelings in any detail (well, except for pet psychics, of course), we have to decide if they get a sense of “well being” from CAM therapies. And given that both as doctors and owners we desperately want them to be and feel better, there is great risk of our projecting our needs and feelings onto them. CAM placebo effects certainly have an impact of people’s perceptions of their own disease, and they have an impact on their perceptions of how their animals feel (as the recent guest post illustrated), but I have yet to see anything more convincing than testimonial to show that they really affect our pets’ feelings as this statement presumes they do.

5. “As we progress towards newer and more extensive technology we lose the art of the basic touch and hands on treatment.”

Ah, we begin to see the cliché New Age notion that modern medicine is all about technology and that in the mythical Golden Age medicine was about caring and healing the whole person. There is no question the dramatic proliferation of knowledge and the subsequent necessary division of doctors into ever narrower specialties has affected the patient/client-doctor relationship, and this is part of why people are driven to the often warmer and more personal ethos of CAM. Scientific medicine must address this problem to protect our patients from turning to physically ineffective but more psychologically appealing methods.

However, the fact remains we live longer, suffer less, lose fewer of our children, and overall enjoy a far better quality of life and health than any humans who have ever lived, largely thanks to technology. We now have the luxury to indulge our search for meaning and fulfillment because most of us aren’t always battling to feed ourselves or struggling with an endless stream of physical ailments. I for one see no reason we can’t enjoy the opportunity for “self-actualization” technology has provided, and improve on the gains we’ve made, without jettisoning the very technology that has given us the opportunity to do so. I would love to have a close, supportive relationship with my health care provider. But I see no reason why that should require I also accept a host of implausible, vitalistic, and ultimately often ineffective therapeutic interventions too.

Finally, one must ask again if we are projecting our needs onto our pets. I believe I am as gentle, caring, and empathetic as any vet, and I generally have good success interacting with my patients. But frankly, many of my patients don’t appear to take comfort from being handled, however caringly, by strangers. The acupuncture and chiropractic sessions I’ve seen often involve a great deal of supportive, caring treatment of the client, who then feels their pet must enjoy the relationship as much as they do. However, judging from the behavior of the animals themselves, I remain unconvinced. They generally seem no more nor less distressed when receiving chiropractic or acupuncture than they do during my physical examination or vaccination procedures. Yet somehow, everyone involved believes the animals share their owners’ feelings the “spiritual” aspects of these encounters.

6. “In this day and age with our society relying heavily on technology and invasive sciences we must not look to holistic care as an alternative but as a way back to our soul.”

It isn’t entirely clear from the passage (especially given the awkwardness of some of the language which suggests to me it might have been written by someone not a native speaker of English) whether or not the use of “soul” here is intended literally or  is just a way of referring emphatically to feelings and emotions. It wouldn’t surprise me if it is meant literally since the notion that disease is fundamentally a spiritual rather than physical phenomenon is widespread in alternative medicine. Either way, however, the sentence echoes the theme of the statement as a whole, which seems to be that scientific medicine is cold and machinelike and that we need some “old-fashioned” psychological support from our doctors.

There is an element of truth to this, certainly for humans, though I think it is sometimes debatable whether what our pets need or desire in terms of a therapeutic relationship is the same as what we think they want. However, once again there is no reason this needs to be connected to alternative, unconventional medical treatments. The answer to a more supporting, warmer health care environment and better human relationships between health care providers and patients/clients isn’t to give up scientific medical therapies that work, or even to add unproven therapies to them. It is to change the economics and structure of the health care system to provide both the highest quality, most effective physical care and meet the emotional needs of patients/clients. This won’t be easy, and it will likely be more expensive, but turning to CAM isn’t the answer.

Linking CAM to the perception that modern medicine is cold and uncaring is a marketing triumph, but it doesn’t make the specific methods any more likely to be effective. This is why so much CAM is used by people with complex, chronic diseases, often for which scientific medicine has not yet found effective treatment. When choosing care for discrete, acute, critical illnesses few people choose CAM methods of questionable effectiveness. People want medicine that works, and though they want to feel cared for also, they shouldn’t have to accept bogus treatments along with emotional support.

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Fooling Yourself-A Guest Post By Alison Averis

A reader recently sent me an account of a case which demonstrates the placebo effect by proxy and the general unreliability of our subjective assessments of medical interventions. Her story is engaging and nicely illustrates these common issues, and she has kindly agreed to allow me to reproduce it here. Enjoy!

 

AN EXAMPLE OF HOW TO FOOL YOURSELF – AND HOW THE PLACEBO EFFECT CAN WORK IN ANIMALS
Alison Averis

Once upon a time, a horse owner said to an alternative therapist: “Thanks very much for treating Billy last week. He was much more relaxed than usual in the stable that night, and he went really well when I rode him the next day – more forward going, more supple and more willing than usual.  I’d like you to come and do him again”.

Very satisfactory for all concerned.  The horse was going well, the owner was happy and the therapist had a new client.  Except for one thing – the therapist hadn’t treated Billy last week.  She’d gone to the yard as requested and met not the owner but the groom, who through a misunderstanding had asked her to treat another horse.  The owner, not knowing this, had ridden Billy the next day and had attributed her good ride to the treatment she thought the horse had had the day before.

Now this alternative therapist had an enquiring and scientific mind and decided to conduct an experiment.  She asked a friend of hers whether she could give the friend’s horse a free session of her therapy.  She didn’t want the friend to watch what she did, but she did want the friend to give her feedback afterwards.  And she didn’t do anything to the horse at all.  While the friend thought she was doing the treatment, she was actually sitting in the manger reading a book and the horse was eating his hay.  When the therapist later asked the friend what had happened, she was not altogether surprised to hear a tale about a very relaxed horse who “went so much better than usual when I rode him the next day”.

Unlike most stories that begin ‘once upon a time’, this one is true.  It illustrates very nicely the danger of attributing a change in our horse’s behaviour or performance to something we have just done.  Or, as in this case, that we think we have done.

The therapy in question, unlike many, actually had some biological plausibility: it was a manipulative technique that many people find relaxing and invigorating, and it is not beyond the bounds of possibility to suppose that horses might also get at least temporary benefits.  The point is that the intervention (or non-intervention) could have been anything: a veterinary treatment; a new feed or feed supplement; a new saddle or bridle; a visit from the farrier or equine dentist – you name it.  The only necessity was for the owner to believe that any improvement in the horse’s behaviour following the intervention must have been a result of that intervention.  As we have seen, the intervention didn’t even have to happen.  All that was required was for the owner to want to make that connection.

The fact is that a horse will vary from day to day in how lively, enthusiastic, supple or willing he feels and there can be many reasons for this: working hard the day before, a slip in the field, more time than usual in the stable, the weather, the time of day, his social relationships and the amount of sleep he’s had, to name only a few of the possibilities.  It is just unfortunate that we, with our pattern-recognizing, all-too-human brains, are likely to come to the wrong conclusions about the reasons why, because of what we want to believe.  If we have given the horse something we believe will improve his performance – and especially if we’ve paid a lot of money for it – we are likely to think that any subsequent improvement in performance is a result of what we did.  As you can see, the fact that a change in behaviour followed an intervention does not prove that the intervention caused the change, and this is why the scientific method is necessary.

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Ape, Not Monkey Comic–What’s the Harm?

Alternative Medicine Whats The Harm

A nice reminder from Ape, Not Monkey of something we rarely consider. Many alternative ad folk remedies make use of plant and animal parts which, in addition to being of questionable safety and efficacy, may come from endangered plant or animal species. Ben Radford at Live Science has several examples, including the odd fact that the introduction of viagra to Kenya may have reduced poaching of rhino horn there.  The World Wildlife Fund, International Fund for Animal Welfare, and a number of other conservation organizations have also addressed this problem in their advocacy efforts.

While this issue is not my central objection to unproven alternative therapies, it is yet another reaon why the widespread use of unvalidated traditional remedies should be discouraged. Even with government oversight and the necessary efforts of advocacy groups, it is difficult enough to control the mainstream pharmaceutical industry’s efforts to exploit the possible medicinal value of natural plant and animal substances. The unregulated CAM industry, which seems to be automatically assumed to be “green” and more environmentally friendly than scientific medicine, is likely to be as great or greater a threat to endangered plant and animal species if no effort is made to ensure that only renewable and sustainable sources of raw materials are used. It is especially tragic to lose forever animal or plant species due to their exploitation for likely ineffective folk remedies.

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Does the Truth Matter?

One of the most common responses I get when I point out the lack of evidence for particular CAM therapies is, “So what? If it doesn’t do any harm and if people feel better, even just because of a placebo effect, then why do you want to convince them this stuff doesn’t work?”

Of course, the first answer to this has to be challenging the assumption of safety which seems to adhere to most CAM therapies, and I have done that at length. However, beyond that issue, it seems to me a fair question whether the truth matters when it takes away something benign that people want to believe and which might offer some relief from symptoms via a psychological mechanism, if not by way of actually changing the underlying disease process. I have several answers to this question, some personal and philosophical, others more pragmatic and directly relevant to medicine.

On a personal level, I share the sentiments of R. Barker Bausell, author of Snake Oil Science. He sees investigating the truth about the claims of alternative medicine as part of the larger project of science, and his research and writing are motivated at least “partly [by] a common professional objective for a scientist: to be able to claim a personal victory in one small skirmish in the perpetual struggle between knowledge and ignorance.” Though I understand that many, perhaps most, people don’t share the sentiment, a lot of us in science are driven by a visceral sense that truth matters, and that even unpleasant truths are to be embraced and comforting untruths disdained. I don’t see imparting this sense to others as a core goal, or justification, for challenging bogus medical claims, though I do hope my passion for what is true may resonate with some readers. But I must be honest and confess that this feeling is a large part of why I engage in my various projects promoting science-based medicine.

On a more practical level, there is clear evidence that the comfort taken from untrue beliefs in medicine does harm beyond the direct damage particular medical therapies may cause. While some turn to CAM only when they have exhausted the options provided by science-based medicine, CAM therapies are often promoted as an alternative to scientific medicine. However, when CAM is used in lieu of the more effective, better understood therapies of scientific medicine, people suffer and sometimes die unnecessarily. We see this happen in the asthma patients who have poorer compliance with drug therapy, and poorer quality of life scores, then they substitute herbs for medicine, and in the cancer patients who eschew effective mainstream treatment or palliation in favor of alternative therapies, leading to greater suffering and earlier death. What is more, because CAM therapies are so amenable to placebo effects and to false assessments of real efficacy, even casual experimental use in conjunction with conventional therapies can lead to a belief in not only the efficacy of the alternative interventions but create sympathy with the philosophical underpinnings of these interventions and skepticism of the underlying foundations of science.

CAM proponents frequently emphasizes supposed philosophical differences between alternative medicine and science. Some of these are marketing points rather than true differences, such as the nonsense about CAM treating the whole patient rather than just the disease, or scientific medicine treating only symptoms while CAM treats root causes of illness. However, there are some genuine philosophical differences between science as an epistemological approach and the world view of many CAM adherents. CAM often rests on a foundation of vitalism, the notion that invisible spiritual or “energy” forces are the true source of animation for living beings, and that disease is not a manifestation of disorders in the physical body but in these mystical forces. Vitalists claim to be able to sense and manipulate such forces, but these claims are never demonstrable by any objective means and must be accepted on the basis of faith alone.

This is in contrast to the position of methodological naturalism, in which scientists agree to put aside any personal intuition or revelation of a spiritual nature when investigating and treating the causes of disease, and focus solely on mechanisms and causes which can be objectively and repeatedly demonstrated to anyone. The claims of some CAM advocates that this approach is doomed to failure because it ignores the “real” nature of life and health are belied by the astounding success of the technology and medicine it has generated. Millennia of vitalist approaches to medicine failed to achieve the improvements in health and longevity a naturalistic approach has accomplished in only a couple of centuries. There’s a reason why mystical health care theories have had more success being adopted in the treatment of chronic diseases, particularly involving subjective symptoms like pain, and have failed to be widely accepted in acute, life-threatening situations. Homeopathic birth control hasn’t caught on too well either, so perhaps there is more to be said for “reductionism” than CAM proponents often credit.

Yet vitalist philosophies have an emotional and aesthetic appeal, and I understand the historical and psychological reasons they are so attractive and widespread. Nevertheless, I feel the evidence of history conclusively demonstrates naturalism to be a more accurate and successful model of reality, and there are real dangers in choosing to ignore this reality and adhere to comforting but unsuccessful paradigms when dealing with health and disease.

Similarly, many CAM advocates hold to an extreme relativism born of the post-modernist philosophical movement. This sees all models of reality as purely social constructs with no sound basis to give preference to one over another. Any attempt to assert one model is more faithful to an objective physical reality than another is dismissed as merely an attempt to justify a particular social and political power structure, to the advantage of one cultural group over others. Thus, even claiming objective reality exists and can be described is denounced as a form of political and cultural oppression. All points of view are held to be equally valid, and no truth claims are defensible.

This philosophy has had much success in the rarefied air of academe, though even there it is beginning to fray. It is buttressed by the reality that all of our models of reality are in fact  influenced by cultural factors, and that oppression is often justified by its intellectual apologists through the promulgation of scientific and pseudoscientific theories. However, postmodernism throws the baby out with the bathwater, and in an attempt to eliminate xenophobia and ethnocentrism it eliminates any hope of understanding the universe or improving our lives. Again, the history of science, technology, and medicine clearly and forcefully demolish the notion that there is no objective reality and that we can have no true knowledge of it. Such a perspective has no usefulness, and should have no place in medicine.

On a more practical level, one reason to care about the efficacy of CAM methods is simple economics. A 2009 study from the NCCAM found Americans spent $33.9 billion on “alternative” therapies (though the definition used in the study was quite loose). This is a lot of money to put into treatments of dubious effectiveness, and even if they have some positive effects in terms of subjective symptoms like pain or nausea, I think it is fair to wonder whether such resources could be better spent discovering more effective therapies or making health care more available to those who cannot afford even basic care.

Finally, Simon Singh and Edzard Ernst make the case in Trick or Treatment: The Truth about Alternative Medicine that it is nearly impossible to benefit from the placebo effect of a medical therapy without either lying to the patient or at a minimum deliberately ignoring the evidence against the placebo therapy. Most CAM practitioners obviously genuinely believe their methods work. However, maintaining this belief requires ignoring the principles and practice of science and evidence-based medicine. In today’s world, with the knowledge that scientific research has accumulated in the last few hundred years, sticking with such an attitude requires a kind of deliberate ignorance. CAM practitioners who utilize clearly disproven methods or concepts, such as homeopathy, the vertebral subluxation, and so on, must reject the very principles of science and the most basic, and well-established scientific understanding of the world. This is an act of faith that makes their approach more of a religion than a medical science.

There are those who honestly try to apply the principles of science and evidence to CAM. Unfortunately,  there are few CAM therapies that one can honestly justify in this way. Acupuncture for pain and nausea, chiropractic for idiopathic back pain, and a few well-studied herbal remedies and nutritional supplements are about all CAM can justly claim to be supportable by any sort of real research evidence, and even some of these claims amount to a primarily psychological, rather than disease-modifying, set of effects. There are important ethical questions associated with the use of placebo therapies, whether in mainstream medicine (where antibiotics and vitamins are often used to this end) or in CAM (where arguably the majority of the benefits seen are placebo-based). As I’ve argued before (here and here), the benefits may well be outweighed by the harm done to the caregiver/patient or client relationship by introducing deliberate deception, or even more the more subtly disingenuousness in sticking with what one’s experiences and intuition say and ignoring robust evidence against one’s approach, into this relationship. Though it is a philosophical point, and as such not provable in any objective way, I cannot help but feel that we are better served by honesty and a commitment to the truth than by accepting the short-term benefits associated with deceiving others or even ourselves.

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Why People Believe Weird Things by Michael Shermer

There are many excellent books out there on skepticism generally, on the specific mistakes we tend to make in our judgments that lead us to believe what isn’t true, and on the more specific questions of CAM and evidence-based health care. As part of an ongoing project, I am re-reading a number of the classics in the skeptic’s bookshelf, including the almost iconic Why People Believe Weird Things by Michael Shermer.

I came from a position of vague but rather superficial skepticism, to a deeply held and (I hope) methodologically rigorous position on how best to evaluate medical claims through a process that stretched out over years and is still ongoing. The first and key step in this process was coming to understand the nature of how we form and maintain our beliefs, and where this process so often goes wrong. The first book that really hit home for on this subject was Thomas Kida’s Don’t Believe Everything You Think, which I hope to review in the near future. However, many skeptics cite Shermer’s book as the seminal popular work on the subject, and it certainly does an articulate and cogent job of making the case that uncertainty is inevitable but real knowledge can be gained despite the limitations of our cognitive processes if we follow the tenets of sound scientific and skeptical method.

As Shermer puts it, “unless we rigorously use human reason both to discover and acknowledge nature’s factuality, and to follow logical implications for efficacious human actions that such knowledge entails, we will lose out to the frightening forces of irrationality, romanticism, [and] uncompromising “true” belief…” He goes on to argue, and demonstrate, that skepticism must not be merely destructive of fale ideas but a positive approach to knowledge; “Skepticism is not a position; skepticism is an approach to claims…Proper debunking is done in the interest of an alternate model of explanation, not as a nihilistic exercise. The alternate model is rationality itself, tied to moral decency…”

Shermer makes effective use of personal experiences and anecdotes, his own of those of others, to illustrate, though not to prove, his arguments. I certainly fall into the category of scientists and intellectuals who find it difficult to write in a style that is engaging to those not similarly inclined, but Shermer has the ability to make complex ideas, and even ambiguity, clear and accessible. He begins by introducing the skeptical and scientific approach and contrasting it with pseudoscience. He then summarizes the barriers to thinking and reasoning soundly which these approaches are intended to correct.

There follows a series of chapters illustrating the application of the skeptical method to a variety of “weird” ideas, including near-death experiences, alien abduction, creationism, and Holocaust denialism. Many of the specific arguments and points of evidence may not be new to those already familiar with the methods and arguments of skepticism applied to these topics, but they are solid, persuasive summaries and reference sources. One of my favorite chapters, though it seems a little dated, is his critique of the Objectivist movement founded by Ayn Rand as having characteristics of a cult. This is a particularly interesting commentary coming from a self-identified libertarian.

Finally, he reviews how people come to and maintain false beliefs, and makes what I believe is a telling point of great relevance to medical professionals, which is that smart and educated people are not immune to such beliefs. As he says, “Smart people believe weird things because they are skilled at defending beliefs that arrived at for non-smart reasons.” Skepticism is an epistemological position that one often arrives at, contrary to popular belief, out of a deep personal humility that arises when one begins to understand how tenuous and unreliable our perceptions, memories, and judgments all too often are. Such humility comes hardest for those who most need it, those who are intelligent, educated, and recognized by others as such.

I highly recommend reading Why People Believe Weird Things not only for those interested in the specific subjects addressed but also those who want to better understand how we all come to our beliefs and how we can guard against the natural human tendancies that sometimes lead us astray.

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