commercial interests

Kinesiology tape is all the rage. Its proponents claim that it increases cutaneous stimulation, which facilitates motor unit firing, and consequently improves functional performance. But is this just clever marketing, wishful thinking or is it true? To find out, we need reliable data.

The current trial results are sparse, confusing and contradictory. A recent systematic review indicated that kinesiology tape may have limited potential to reduce pain in individuals with musculoskeletal injury; however, depending on the conditions, the reduction in pain may not be clinically meaningful. Kinesiology tape application did not reduce specific pain measures related to musculoskeletal injury above and beyond other modalities compared in the context of included articles. 

The authors concluded that kinesiology tape may be used in conjunction with or in place of more traditional therapies, and further research that employs controlled measures compared with kinesiology tape is needed to evaluate efficacy.

This need for further research has just been met by Korean investigators who conducted a study testing the true effects of KinTape by a deceptive, randomized, clinical trial.

Thirty healthy participants performed isokinetic testing of three taping conditions: true facilitative KinTape, sham KinTape, and no KinTape. The participants were blindfolded during the evaluation. Under the pretense of applying adhesive muscle sensors, KinTape was applied to their quadriceps in the first two conditions. Normalized peak torque, normalized total work, and time to peak torque were measured at two angular speeds (60°/s and 180°/s) and analyzed with one-way repeated measures ANOVA.

Participants were successfully deceived and they were ignorant about KinTape. No significant differences were found between normalized peak torque, normalized total work, and time to peak torque at 60°/s or 180°/s (p = 0.31-0.99) between three taping conditions. The results showed that KinTape did not facilitate muscle performance in generating higher peak torque, yielding a greater total work, or inducing an earlier onset of peak torque.

The authors concluded that previously reported muscle facilitatory effects using KinTape may be attributed to placebo effects.

The claims that are being made for kinesiology taping are truly extraordinary; just consider what this website is trying to tell us:

Kinesiology tape is a breakthrough new method for treating athletic sprains, strains and sports injuries. You may have seen Olympic and celebrity athletes wearing multicolored tape on their arms, legs, shoulders and back. This type of athletic tape is a revolutionary therapeutic elastic style of support that works in multiple ways to improve health and circulation in ways that traditional athletic tapes can’t compare. Not only does this new type of athletic tape help support and heal muscles, but it also provides faster, more thorough healing by aiding with blood circulation throughout the body.

Many athletes who have switched to using this new type of athletic tape report a wide variety of benefits including improved neuromuscular movement and circulation, pain relief and more. In addition to its many medical uses, Kinesiology tape is also used to help prevent injuries and manage pain and swelling, such as from edema. Unlike regular athletic taping, using elastic tape allows you the freedom of motion without restricting muscles or blood flow. By allowing the muscles a larger degree of movement, the body is able to heal itself more quickly and fully than before.

Whenever I read such over-enthusiastic promotion that is not based on evidence but on keen salesmanship, my alarm-bells start ringing and I see parallels to the worst type of alternative medicine hype. In fact, kinesiology tapes have all the hallmarks of alternative medicine and its promoters have, as far as I can see, all the characteristics of quacks. The motto seems to be: LET’S EARN SOME MONEY FAST AND IGNORE THE SCIENCE WHILE WE CAN.

It has been estimated that 40 – 70% of all cancer patients use some form of alternative medicine; may do so in the hope this might cure their condition. A recent article by Turkish researchers – yet again – highlights how dangerous such behaviour can turn out to be.

The authors report the cases of two middle-aged women suffering from malignant breast masses. The patients experienced serious complications in response to self-prescribed use of alternative medicine practices to treat their condition in lieu of evidence-based medical treatments. In both cases, the use and/or inappropriate application of alternative medical approaches promoted the progression of malignant fungating lesions in the breast. The first patient sought medical assistance upon development of a fungating lesion, 7∼8 cm in diameter and involving 1/3 of the breast, with a palpable mass of 5×6 cm immediately beneath the wound. The second patient sought medical assistance after developing of a wide, bleeding, ulcerous area with patchy necrotic tissue that comprised 2/3 of the breast and had a 10×6 cm palpable mass under the affected area.

The authors argue that the use of some non-evidence-based medical treatments as complementary to evidence-based medical treatments may benefit the patient on an emotional level; however, this strategy should be used with caution, as the non-evidence-based therapies may cause physical harm or even counteract the evidence-based treatment.

Their conclusions: a malignant, fungating wound is a serious complication of advanced breast cancer. It is critical that the public is informed about the potential problems of self-treating wounds such as breast ulcers and masses. Additionally, campaigns are needed to increase awareness of the risks and life-threatening potential of using non-evidence-based medical therapies exclusively.

I have little to add to this; perhaps just a further reminder that the risk extends, of course, to all serious conditions: even a seemingly harmless but ineffective therapy can become positively life-threatening, if it is used as an alternative to an effective treatment. I am sure that some ‘alternativists’ will claim that I am alarmist; but I am also convinced that they are wrong.

In 2004, I published an article rather boldly entitled ‘Ear candles: a triumph of ignorance over science’. Here is its summary:

Ear candles are hollow tubes coated in wax which are inserted into patients’ ears and then lit at the far end. The procedure is used as a complementary therapy for a wide range of conditions. A critical assessment of the evidence shows that its mode of action is implausible and demonstrably wrong. There are no data to suggest that it is effective for any condition. Furthermore, ear candles have been associated with ear injuries. The inescapable conclusion is that ear candles do more harm than good. Their use should be discouraged.

Sadly, since the publication of this paper, ear candles have not become less but more popular. There are about 3 000 000 websites on the subject; most are trying to sell products and make claims which are almost comically misguided; three examples have to suffice:

I said ALMOST comical because such nonsense has, of course a downside. Not only are consumers separated from their cash for no benefit whatsoever, but they are also exposed to danger; again, three examples from the medical literature might explain:

  • Otolaryngologists from London described a case of ear candling presenting as hearing loss, and they concluded that this useless therapy can actually cause damage to the ears.
  • A 50-year-old woman presented to her GP following an episode of ear candling. After 15 minutes, the person performing the candling burned herself while attempting to remove the candle and spilled candle wax into the patient’s right ear canal. On examination, a piece of candle wax was found in the patient’s ear, and she was referred to the local ear, nose, and throat department. Under general aesthetic, a large mass of solidified yellow candle wax was removed from the deep meatus of the ear. The patient had a small perforation in her right tympanic membrane. Results of a pure tone audiogram showed a mild conductive hearing loss on the right side. At a follow-up appointment 1 month later, the perforation was still there, and the patient’s hearing had not improved.
  • case report of a 4-year-old girl from New Zealand was published. The patient was diagnosed to suffer from otitis media. During the course of the ear examination white deposits were noticed on her eardrum; this was confirmed as being caused by ear candling.

I should stress that we do not know how often such events happen; there is no monitoring system, and one might expect that the vast majority of cases do not get published. Most consumers who experience such problems, I would guess, are far to embarrassed to admit that they have been taken in by this sort of quackery.

It was true 10 yeas ago and it is true today: ear candles are a triumph of ignorance over science. But also they are a victory of gullibility over common sense and the unethical exploitation of naive hope by greedy frauds.

If you believe herbalists, the Daily Mail or similarly reliable sources, you come to the conclusion that herbal medicines are entirely safe – after all they are natural, and everything that is natural must be safe. However, there is plenty of evidence that these assumptions are not necessarily correct. In fact, herbal medicines can cause harm in diverse ways, e. g. because:

  • one or more ingredients of a plant are toxic,
  • they interact with prescribed drugs,
  • they are contaminated, for instance, with heavy metals,
  • they are adulterated with prescription drugs.

There is no shortage of evidence for any of these 4 scenarios. Here are some very recent and relevant publications:

German authors reviewed recent case reports and case series that provided evidence for herbal hepatotoxicity caused by Chinese herbal mixtures. The implicated remedies were the TCM products Ban Tu Wan, Chai Hu, Du Huo, Huang Qin, Jia Wei Xia Yao San, Jiguja, Kamishoyosan, Long Dan Xie Gan Tang, Lu Cha, Polygonum multiflorum products, Shan Chi, ‘White flood’ containing the herbal TCM Wu Zhu Yu and Qian Ceng Ta, and Xiao Chai Hu Tang. the authors concluded that stringent evaluation of the risk/benefit ratio is essential to protect traditional Chinese medicines users from health hazards including liver injury.

A recent review of Nigerian anti-diabetic herbal remedies suggested hypoglycemic effect of over 100 plants. One-third of them have been studied for their mechanism of action, while isolation of the bioactive constituent(s) has been accomplished for 23 plants. Several plants showed specific organ toxicity, mostly nephrotoxic or hepatotoxic, with direct effects on the levels of some liver function enzymes. Twenty-eight plants have been identified as in vitro modulators of P-glycoprotein and/or one or more of the cytochrome P450 enzymes, while eleven plants altered the levels of phase 2 metabolic enzymes, chiefly glutathione, with the potential to alter the pharmacokinetics of co-administered drugs

US authors published a case of a 44-year-old female who developed subacute liver injury demonstrated on a CT scan and liver biopsy within a month of using black cohosh to resolve her hot flashes. Since the patient was not taking any other drugs, they concluded that the acute liver injury was caused by the use of black cohosh. The authors concluded: we agree with the United States Pharmacopeia recommendations that a cautionary warning about hepatotoxicity should be labeled on the drug package.

Hong Kong toxicologists recently reported five cases of poisoning occurring as a result of inappropriate use of herbs in recipes or general herbal formulae acquired from books. Aconite poisoning due to overdose or inadequate processing accounted for three cases. The other two cases involved the use of herbs containing Strychnos alkaloids and Sophora alkaloids. These cases demonstrated that inappropriate use of Chinese medicine can result in major morbidity, and herbal formulae and recipes containing herbs available in general publications are not always safe.

Finally, Australian emergency doctors just published this case-report: A woman aged 34 years presented to hospital with a history of progressive shortness of breath, palpitations, decreased exercise tolerance and generalised arthralgia over the previous month. A full blood count revealed normochromic normocytic anaemia and a haemoglobin level of 66 g/L. The blood film showed basophilic stippling, prompting measurement of lead levels. Her blood lead level (BLL) was 105 µg/dL. Mercury and arsenic levels were also detected at very low levels. On further questioning, the patient reported that in the past 6 months she had ingested multiple herbal preparations supplied by an overseas Ayurvedic practitioner for enhancement of fertility. She was taking up to 12 different tablets and various pastes and powders daily. Her case was reported to public health authorities and the herbal preparations were sent for analytical testing. Analysis confirmed high levels of lead (4% w/w), mercury (12% w/w), arsenic and chromium. The lead levels were 4000 times the maximum allowable lead level in medications sold or produced in Australia. Following cessation of the herbal preparations, the patient was commenced on oral chelation therapy, iron supplementation and contraception. A 3-week course of oral DMSA (2,3-dimercaptosuccinic acid) was well tolerated; BLL was reduced to 13 µg/dL and haemoglobin increased to 99 g/L. Her symptoms improved over the subsequent 3 months and she remains hopeful about becoming pregnant.

So, how safe are herbal medicines? Unfortunately, the question is unanswerable. Some herbal medicines are quite safe, others are not. But always remember: whenever you administer a treatment you should ask yourself one absolutely crucial question: do the documented benefits outweigh the risks? There are several thousand different herbal medicines, and for less than a dozen of them can the honest answer to this question be YES.

Niacin – also known as vitamin B3 or nicotinic acid – is a natural compound (formula C
) and an essential nutrient for humans. It is water-soluble, which means it is not stored in the body. Excess amounts of the vitamin leave the body through the urine. That means we need a continuous supply of niacin in your diet.

Niacin is found in variety of foods, including liver, chicken, beef, fish, cereal, peanuts and legumes. It can also be synthesized from tryptophan, an essential amino acid found in protein. Niacin has long been an accepted treatment for high cholesterol. It is well-documented to increase the levels of high-density cholesterol (HDL or “good cholesterol”) and to decrease the levels of low-density cholesterol (LDL or “bad cholesterol”).

But what do these effects really mean? Do they translate into true health benefits? A brand-new study casts doubt on the value of niacin therapy:

After a pre-randomization run-in phase to standardize the background statin-based LDL cholesterol-lowering therapy and to establish participants’ ability to take extended-release niacin without clinically significant adverse effects, the researchers randomly assigned 25,673 adults with vascular disease to receive 2 g of extended-release niacin and 40 mg of laropiprant or a matching placebo daily. The primary outcome was the first major vascular event (non-fatal myocardial infarction, death from coronary causes, stroke, or arterial revascularization).

During a median follow-up period of 3.9 years, participants who were assigned to extended-release niacin-laropiprant had an LDL cholesterol level that was 10 mg per deciliter (0.25 mmol/l) lower and an HDL cholesterol level that was 6 mg per deciliter (0.16 mmol/l) higher than the levels in those assigned to placebo. Thus the lipid-effects of previous studies were confirmed.

However, assignment to niacin-laropiprant, as compared with assignment to placebo, had no significant effect on the incidence of major vascular events Niacin-laropiprant was associated with an increased incidence of disturbances in diabetes control that were considered to be serious and with an increased incidence of diabetes diagnoses as well as increases in serious adverse events associated with the gastrointestinal system, the musculoskeletal system, the skin and infections and bleeding.

Based of these data, the authors arrived at the following conclusion: among participants with atherosclerotic vascular disease, the addition of extended-release niacin-laropiprant to statin-based LDL cholesterol-lowering therapy did not significantly reduce the risk of major vascular events but did increase the risk of serious adverse events.

This extremely well-done trial is a poignant reminder of the fact that, in health care, we must never take our assumptions for granted. Here the underlying assumption was that the Niacin-induced lipid changes lead to a reduction of cardiovascular risks. Not only it proved to be erroneous but, through serious adverse effects, Niacin actually decreased patients’ health status.

The lessons from all this are straight forward, I think:

  • ‘Natural’ does not necessarily mean safe.
  • Long-established does not necessarily mean efficacious.
  • Assumptions are merely assumptions, nothing more; if we want to make sure that they hold, we need to test them.
  • When we finally do test assumptions, we better do it rigorously.

Have you noticed?

Homeopaths, acupuncturists, herbalists, reflexologists, aroma therapists, colonic irrigationists, naturopaths, TCM-practitioners, etc. – they always smile!

But why?

I think I might know the answer. Here is my theory:

Alternative practitioners have in common with conventional clinicians that they treat patients – lots of patients, day in day out. This wears them down, of course. And sometimes, conventional clinicians find it hard to smile. Come to think of it, alternative practitioners seem to have it much better. Let me explain.

Whenever a practitioner (of any type) treats a patient, one of three outcomes is bound to happen:

  1. the patient gets better,
  2. the patients roughly remains how she was and experiences no improvement,
  3. the patient gets worse.

In scenario one, everybody is happy. Both alternative and conventional practitioners will claim with a big smile that their treatment was the cause of the improvement. There is a difference though: the conventional practitioner who adheres to the principles of evidence-based medicine will know that the assumption is likely to be true, while the alternative practitioner is probably just guessing. In any case, as long as the patient gets better, all is well.

In scenario two, most conventional clinicians will get somewhat concerned and find little reason to smile. Not so the alternative practitioner! He will have one of several explanations why his therapy has not produced the expected result all of which allow him to carry on smiling smugly. He might, for instance, explain to his patient:

  • You have to give it more time; another 10-20 treatment sessions and you will be as right as rain (unfortunately, further sessions will come at a price).
  • This must be because of all those nasty chemical drugs that you took for so long – they block up your system, you know; we will have to do some serious detox to get rid of all this poison (of course, at a cost).
  • You must realize that, had we not started my treatment when we did, you would be much worse by now, perhaps even dead.

In scenario three, any conventional clinician would have stopped smiling and begun to ask serious, self-critical questions about his diagnosis and treatment. Not so the alternative practitioner. He will point out with a big smile that the deterioration of the symptoms only appears to be a bad sign. In reality it is a very encouraging signal indicating that the optimal treatment for the patient’s condition has finally been found and is beginning to work. The acute worsening of the complaints is merely an ‘aggravation’ or’ healing crisis’. Such a course of events had to be expected when true healing of the root cause of the condition is to be achieved. The thing to do now is to continue with several more treatments (at a cost, of course) until deep healing from within sets in.

Many of us want the cake and eat it – but alternative practitioners, it seems to me, have actually achieved this goal. No wonder they smile!

Times are hard, also in the strange world of chiropractic, I guess. What is therefore more understandable than the attempt of chiropractors to earn a bit of money from people who want to lose weight? If just some of the millions of obese individuals could be fooled into believing that chiropractic is the solution for their problem, chiropractors across the world could be laughing all the way to the bank.

But how does one get to this point? Easy: one only needs to produce some evidence suggesting that chiropractic care is effective in reducing body weight. An extreme option is the advice by one chiropractor to take 10 drops of a homeopathic human chorionic gonadotropin product under the tongue 5 times daily. But, for many chiropractors, this might be one step too far. It would be preferable to show that their hallmark therapy, spinal adjustment, leads to weight loss.

With this in mind, a team of chiropractors performed a retrospective file analysis of patient files attending their 13-week weight loss program. The program consisted of “chiropractic adjustments/spinal manipulative therapy augmented with diet/nutritional intervention, exercise and one-on-one counselling.”

Sixteen of 30 people enrolled completed the program. At its conclusion, statistically and clinically significant changes were noted in weight and BMI measures based on pre-treatment (average weight = 190.46 lbs. and BMI = 30.94 kg/m(2)) and comparative measurements (average weight = 174.94 lbs. and BMI = 28.50 kg/m(2)).

According to the authors of this paper, “this provides supporting evidence on the effectiveness of a multi-modal approach to weight loss implemented in a chiropractic clinic.”

They do not say so, but we all know it, of course: one could just as well combine knitting or crossword puzzles with diet/nutritional intervention, exercise and one-on-one counselling to create a multi-modal program for weight loss showing that knitting or crossword puzzles are effective.

With this paper, chiropractors are not far from their aim of being able to mislead the public by claiming that CHIROPRACTIC CARE IS A NATURAL, SAFE, DRUG-FREE AND EFFECTIVE OPTION IN THE MANAGEMENT OF OBESITY.

Am I exaggerating? No, of course not. There must be thousands of chiropractors who have already jumped on the ‘weight loss band-waggon’. If you don’t believe me, go on the Internet and have a look for yourself. One of the worst sites I have seen might be ‘DOCTORS GOLDMINE’ (yes, most chiropractors call themselves ‘doctor these days!) where a chiropractor promises his colleagues up to $100 000 per month extra income, if they subscribe to his wonderful weight-loss scheme.

It would be nice to be able to believe those who insist that these money-grabbing chiropractors are but a few rotten apples in a vast basket of honest practitioners. But I have problems with this argument – there seem to be far too many rotten apples and virtually no activity or even ambition to get rid of them.

Some practitioners of alternative medicine (doctors, naturopaths, chiropractors and others) earn a lot of money with the claim that chelation therapy (an effective mainstream treatment for acute heavy metal poisoning) is an effective means to  treat cardiovascular disease. However, the notion is controversial and implausible. Several systematic reviews of the best evidence concluded less than optimistically:

…more controlled studies are required to determine the efficacy of chelation therapy in cardiovascular disease before it can be used broadly in the clinical setting.

The best available evidence does not support the therapeutic use of EDTA chelation therapy in the treatment of cardiovascular disease.

Given the potential of chelation therapy to cause severe adverse effects, this treatment should now be considered obsolete.

The available data do not support the use of chelation in cardiovascular diseases.

More recently, important new evidence has emerged. The largest study of chelation therapy (TACT) ever conducted cost ~ $ 30 million and concluded that among stable patients with a history of MI, use of an intravenous chelation regimen with disodium EDTA, compared with placebo, modestly reduced the risk of adverse cardiovascular outcomes, many of which were revascularization procedures. These results provide evidence to guide further research but are not sufficient to support the routine use of chelation therapy for treatment of patients who have had an MI.

At the time, the TACT trial was heavily and rightly criticised for a whole host of reasons. For instance, because of the result of the FDA inspection of the highest accruing TACT site:

  • The investigators didn’t conduct the investigation in accordance with the signed statement and investigational plan. Several examples were given of shoddy procedures, prefilled forms, and failure to train personnel.
  • Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others. Examples are given, including failure to report the deaths of patients on the study in a timely fashion (in one case the death wasn’t reported to the IRB until four months later; in another case it was never reported at all). In other cases, adverse event reports were not submitted to the IRB.
  • Failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation.
  • Investigational drug disposition records are not adequate with respect to dates, quantity, and use by subjects.

Despite these problems, the study was published in JAMA, albeit with a very critical editorial:

Differential dropout in TACT suggests unmasking, but the problem of intentional unblinding is more concerning. The sponsors of the trial, the National Heart, Lung, and Blood Institute (NHLBI) and the National Center for Complementary and Alternative Medicine (NCCAM), were unblinded throughout the trial. The National Institutes of Health policy unwisely allows the sponsor access to unblinded trial data, and both organizations sent observers to the closed sessions of the data monitoring committee. This gave them access to confidential data during each of the 11 interim analyses. The unblinding of the study sponsor represents a serious deviation from acceptable standards of conduct for supervision of clinical trials. If a pharmaceutical company sponsoring a trial were allowed access to actual outcome data during the study, there would be major objections. Like any sponsor, the NHLBI and NCCAM cannot be considered unbiased observers. These agencies made major financial commitments to the trial and may intentionally or inadvertently influence study conduct if inappropriately unblinded during the study…

Given the numerous concerns with this expensive, federally funded clinical trial, including missing data, potential investigator or patient unmasking, use of subjective end points, and intentional unblinding of the sponsor, the results cannot be accepted as reliable and do not demonstrate a benefit of chelation therapy. The findings of TACT should not be used as a justification for increased use of this controversial therapy.

Orac, makes several further critical points about the published trial:

First, the primary endpoint (i.e., the aggregated serious cardiovascular events) did indeed show a modest difference, namely 30% of placebo subjects versus 26.5% of the EDTA chelation subjects (hazard ratio 0.82 for chelation). However, one notes that the result is just barely statistically significant, p = 0.035, with the 99% confidence interval for the hazard ratio ranging from 0.69 to 0.99. (The predetermined level for statistical significance for purposes of this study was 0.036; so this is statistically significant by the barest margin.) More importantly, if you look at the individual endpoints that make up that aggregate, there was no statistically significant difference in death, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. Subgroup analysis (always a questionable analysis that requires replication, even when preplanned, as in TACT) purported to show a much greater benefit for diabetics, with a hazard ratio of 0.61 (p=0.002), while patients without diabetes showed no statistically significant difference in any of the outcome measures, including the aggregated total bad outcomes.

Now a paper that has just emerged describes the intent-to-treat comparison of this trial in patients with diabetes.

This was a double-blind, placebo-controlled, 2 × 2 factorial multicenter randomized trial of 1,708 post-myocardial infarction (MI) patients ≥50 years of age and with creatinine ≤2.0 mg/dL randomized to receive 40 EDTA chelation or placebo infusions plus 6 caplets daily of a 28-component multivitamin-multimineral mixture or placebo. The primary end point was a composite of total mortality, MI, stroke, coronary revascularization, or hospitalization for angina.

Median age was 65 years, 18% were female, 94% were Caucasian, 37% were diabetic, 83% had prior coronary revascularization, and 73% were on statins. Five-year Kaplan-Meier estimates for the primary end point was 31.9% in the chelation + high-dose vitamin group, 33.7% in the chelation + placebo vitamin group, 36.6% in the placebo infusion + active vitamin group, and 40.2% in the placebo infusions + placebo vitamin group. The reduction in primary end point by double active treatment compared with double placebo was significant (hazard ratio 0.74, 95% CI 0.57-0.95, P = .016). In patients with diabetes, the primary end point reduction of double active compared with double placebo was more pronounced (hazard ratio 0.49, 95% CI 0.33-0.75, P < .001).

The authors conclude that in stable post-MI patients on evidence-based medical therapy, the combination of oral high-dose vitamins and chelation therapy compared with double placebo reduced clinically important cardiovascular events to an extent that was both statistically significant and of potential clinical relevance.

I fear that these conclusions are erroneous and misleading: the marginally positive finding might have nothing to do with chelation per se; most likely they are due to the fact that the ‘vitamin’ mixture administered along with chelation contained ingredients like heparin and procaine which are potentially beneficial for cardiovascular conditions. Moreover, the placebo contained a considerable amount of glucose which could easily explain the better outcome of the diabetic subgroup receiving the verum – in other words, the verum generated better results not because it was effective but because the ‘placebo’ had detrimental effects.

Arnold Relman has died aged 91. He was a great personality, served for many years as editor-in-chief of ‘The New England Journal of Medicine’ and was professor of medicine and social medicine at Harvard Medical School. He also was an brilliantly outspoken critic of alternative medicine, and I therefore believe that he deserves to be remembered here. The following excerpts are from an article he wrote in 1998 about Andrew Weil, America’s foremost guru of alternative medicine; I have taken the liberty of extracting a few paragraphs which deal with alternative medicine in general terms.

Until now, alternative medicine has generally been rejected by medical scientists and educators, and by most practicing physicians. The reasons are many, but the most important reason is the difference in mentality between the alternative practitioners and the medical establishment. The leaders of the establishment believe in the scientific method, and in the rule of evidence, and in the laws of physics, chemistry, and biology upon which the modern view of nature is based. Alternative practitioners either do not seem to care about science or explicitly reject its premises. Their methods are often based on notions totally at odds with science, common sense, and modern conceptions of the structure and the function of the human body. In advancing their claims, they do not appear to recognize the need for objective evidence, asserting that the intuitions and the personal beliefs of patients and healers are all that is needed to validate their methods. One might have expected such thinking to alienate most people in a technologically advanced society such as ours; but the alternative medicine movement, and the popularity of gurus such as Weil, are growing rapidly…

That people usually “get better,” that most relatively minor diseases heal spontaneously or seem to improve with simple common remedies, is hardly news. Every physician, indeed every grandmother, knows that. Yet before we accept Weil’s contention that serious illnesses such as “bone cancer,” “Parkinson’s disease,” or “scleroderma” are similarly curable, or respond to alternative healing methods, we need at least to have some convincing medical evidence that the patients whom he reports in these testimonials did indeed suffer from these diseases, and that they were really improved or healed. The perplexity is not that Weil is using “anecdotes” as proof, but that we don’t know whether the anecdotes are true.

Anecdotal evidence is often used in the conventional medical literature to suggest the effectiveness of treatment that has not yet been tested by formal clinical trials. In fact, much of the mainstream professional literature in medicine consists of case reports — “anecdotes,” of a kind. The crucial difference between those case reports and the testimonials that abound in Weil’s books (and throughout the literature of alternative medicine) is that the case reports in the mainstream literature are almost always meticulously documented with objective data to establish the diagnosis and to verify what happened, whereas the testimonials cited by alternative medicine practitioners usually are not. Weil almost never gives any objective data to support his claims. Almost everything is simply hearsay and personal opinion.

To the best of my knowledge, Weil himself has published nothing in the peer-reviewed medical literature to document objectively his personal experiences with allegedly cured patients or to verify his claims for the effectiveness of any of the unorthodox remedies he uses. He is not alone in this respect. Few proponents of alternative medicine have so far published clinical reports that would stand the rigorous scientific scrutiny given to studies of traditional medical treatments published in the serious medical journals. Alternative medicine is still a field rich in undocumented claims and anecdotes and relatively lacking in credible scientific reports…

… Thus Weil can believe in miraculous cures even while claiming to be rational and scientific, because he thinks that quantum theory supports his views.

Yet the leading physicists of our time do not accept such an interpretation of quantum theory. They do not believe quantum theory says anything about the role of human consciousness in the physical world. They see quantum laws as simply a useful mathematical formulation for describing subatomic phenomena that are not adequately handled by classical physical theory, although the latter remains quite satisfactory for the analysis of physical events at the macro-level. Steven Weinberg has observed that “quantum mechanics has been overwhelmingly important to physics, but I cannot find any messages for human life in quantum mechanics that are different in any important way from those of Newtonian physics.” And overriding all discussions of the meaning of quantum physics is the fundamental fact that quantum theory, like all other scientific law, is only valid to the extent that it predicts and accords with the evidence provided by observation and objective measurement. Richard Feynman said it quite simply: “Observation is the ultimate and final judge of the truth of an idea.” Feynman also pointed out that scientific observations need to be objective, reproducible, and, in a sense, public — that is, available to all interested scientists who wish to check the observations for themselves.

Surely almost all scientists would agree with Feynman that, regardless of what theory of nature we wish to espouse, we cannot escape the obligation to support our claims with objective evidence. All theories must conform to the facts or be discarded. So, if Weil cannot produce credible evidence to validate the miraculous cures that he claims for the healing powers of the mind, and if he does not support with objective data the claims he and others make for the effectiveness of alternative healing methods, he cannot presume to wear the mantle of science, and his appeal to quantum theory cannot help him.

Some apologists for alternative medicine have argued that since their healing methods are based on a “paradigm” different from that of traditional medicine, traditional standards of evidence do not apply. Weil sometimes seems to agree with that view, as when he talks about “stoned thinking” and the “ambivalent” nature of reality, but more recently — as he seeks to integrate alternative with allopathic medicine — he seems to acknowledge the need for objective evidence. This, at least, is how I would interpret one of his most recent and ambitious publishing ventures, the editorship of the new quarterly journal Integrative Medicine***.

Integrative Medicine describes itself as a “peer-reviewed journal … committed to gathering evidence for the safety and efficacy of all approaches to health according to the highest standards of scientific research, while remaining open to new paradigms and honoring the healing power of nature.” The Associate Editors and Editorial Board include prominent names in both alternative medicine and allopathic medicine, who presumably support that mission. Yet the first two issues will disappoint those who were looking for original clinical research based on new, objective data. Perhaps subsequent issues will be different, but in any case it is hard to understand the need for Weil’s new journal if he truly intends to hold manuscripts to accepted scientific standards: there already exist many leading peer-reviewed medical journals that will review research studies of alternative healing methods on their merits. During the past decade or so, only a few such studies have passed rigorous review and have been published in first-rate journals. Recently, more studies have been published, but very few of them report significant clinical effects. And that is pretty much where matters now stand. Despite much avowed interest in research on alternative medicine and increased investment in support of such research, the evidentiary underpinnings of unconventional healing methods are still largely lacking…

The alternative medicine movement has been around for a long time, but it was eclipsed during most of this century by the success of medical science. Now there is growing public disenchantment with the cost and the impersonality of modern medical care, as well as concern about medical mistakes and the complications and side-effects of pharmaceuticals and other forms of medical treatment. For their part, physicians have allowed the public to perceive them as uninterested in personal problems, as inaccessible to their patients except when carrying out technical procedures and surgical operations. The “doctor knows best” attitude, which dominated patient-doctor relations during most of the century, has in recent decades given way to a more activist, consumer-oriented view of the patient’s role. Moreover, many other licensed health-care professionals, such as nurse-practitioners, psychotherapists, pharmacists, and chiropractors, are providing services once exclusively reserved to allopathic physicians.

The net result of all these developments has been a weakening of the hegemony that allopathic medicine once exercised over the health care system, and a growing interest by the public in exploring other healing approaches. The authority of allopathic medicine is also being challenged by a swelling current of mysticism and anti-scientism that runs deep through our culture. Even as the number and the complexity of urgent technological and scientific issues facing contemporary society increase, there seems to be a growing public distrust of the scientific outlook and a reawakening of interest in mysticism and spiritualism.

All this obscurantism has given powerful impetus to the alternative medicine movement, with its emphasis on the power of mind over matter. And so consumer demand for alternative remedies is rising, as is public and private financial support for their study and clinical use. It is no wonder that practicing physicians, the academic medical establishment, and the National Institutes of Health are all finding reasons to pay more attention to the alternative medicine movement. Indeed, it is becoming politically incorrect for the movement’s critics to express their skepticism too strongly in public…

There is no doubt that modern medicine as it is now practiced needs to improve its relations with patients, and that some of the criticisms leveled against it by people such as Weil — and by many more within the medical establishment itself — are valid. There also can be no doubt that a few of the “natural” medicines and healing methods now being used by practitioners of alternative medicine will prove, after testing, to be safe and effective. This, after all, has been the way in which many important therapeutic agents and treatments have found their way into standard medical practice in the past. Mainstream medicine should continue to be open to the testing of selected unconventional treatments. In keeping an open mind, however, the medical establishment in this country must not lose its scientific compass or weaken its commitment to rational thought and the rule of evidence.

There are not two kinds of medicine, one conventional and the other unconventional, that can be practiced jointly in a new kind of “integrative medicine.” Nor, as Andrew Weil and his friends also would have us believe, are there two kinds of thinking, or two ways to find out which treatments work and which do not. In the best kind of medical practice, all proposed treatments must be tested objectively. In the end, there will only be treatments that pass that test and those that do not, those that are proven worthwhile and those that are not. Can there be any reasonable “alternative”?


*** the journal only existed for a short period of time

Dr. Oz, famous through his TV show promoting all types of quackery, recently testified before a US Senate subcommittee hearing on protecting consumers from false and deceptive advertising of weight loss products. This event turned out to be less than flattering for Dr Oz. One journalist commented that he “might as well be a cowardly lion — sent home with his tail between his legs after being accused at a congressional hearing of lying on his show about weight-loss claims.”

“I don’t get why you need to say this stuff, because you know it’s not true,” said Senator Claire McCaskill, who led the commerce subcommittee hearing. “The scientific community is almost monolithically against you in terms of the efficacy of the products you called ‘miracles,’ ” the Democratic senator from Missouri told Oz. “It’s a major problem when people are spending more and more money and they’re gaining more and more weight,” said Senator Amy Klobuchar.“Either you don’t talk about these things at all, or you’re going to have to be more specific because right now . . . this is not working.”

A source close to Dr Oz said he was perplexed: “We were invited down to Washington to testify at a hearing about scams and instead it became all about how much we hate your show.” Oz himself testified that he “heard the message…I do personally believe in the items that I talk about.”

“I intensively study them. I have given my family these products. . . . If you can lose a pound a week more than you would have lost by using them, it jump-starts you and gets you going. I think it makes sense.” “I’m surprised you’re defending this,” McCaskill replied. “It’s something that gives people false hope. I don’t see why you need to go there.”

Another journalist commented that the Senators repeatedly placed him on the defense over his weight loss products: “I know you know how much power you have. I know you know that. You are very powerful and [with] power comes a great deal of responsibility,” Senator Claire McCaskill , who led the Senate’s consumer protection hearing titled “Protecting Consumers from False and Deceptive Advertising of Weight-Loss Products…You are being made an example of today because of the power you have in this space…We didn’t call this hearing to beat up on you but we did call this hearing to talk about a real crisis in consumer protection. You can either be part of the police here or you can be part of the problem.”

Oz insisted he was no huckster but admitted the products promoted on his show don’t always have “the scientific muster” to present their benefits as “fact…I actually do personally believe in the items that I talk about in the show. I passionately studied them. I recognize that oftentimes they don’t have the scientific muster to present as fact but nevertheless I would give my audience the advice I give my family all the time. And I have given my family these products,” he said.

Dr Oz also said that some alternative treatments, such as prayer, cannot be tested scientifically. “I don’t think this ought to be a referendum on the use of alternative medical therapies. Because if that’s the case, listen, I’ve been criticized for having folks coming on my show talking about the power of prayer,” he said. “I can’t prove that prayer helps people survive an illness.”

No, Dr Oz! I know you are mistaken! I have done the research – both on alternative slimming aids and on spiritual healing. The results quite clearly show that these methods are not more effective than a placebo.

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