MD, PhD, FMedSci, FSB, FRCP, FRCPEd

bias

We had HOMEOPATHS WITHOUT BORDERS and now, I suggest, we acknowledge a similar organisation which could aptly be called CHIROPRACTORS WITHOUT SCRUPLES. This remarkable text from NATURAL NEWS explains it all, I think:

START OF QUOTE

The following chiropractors are speaking up to inform the public about the dangers of vaccines.

Dr. David Jockers, D.C.

Vaccines are one of medicine’s prized attempts to improve human performance. They use artificial laboratory derived medical technology to produce an immune response within the body in hopes it will lead to a long-term positive antibody response.

The vaccine ideology is based on the belief that people are created with inferior immune systems that are unable to keep up with the demands of the environment and need modern technology in the form of man-made vaccine formulations in order to bolster immunity.

According to the Centers for Disease Control, “The following substances are found in flu vaccines: aluminum, antibiotics, formaldehyde, human aborted fetal apparatus (dead human tissue), monosodium glutamate (MSG), and thimerosal (mercury).” Many of these same ingredients are in childhood vaccines. They are all very toxic for human physiology and have a track record for insulting the body’s immune system.

I would prefer to trust the innate ability of the body to overcome infectious microorganisms and I will fully support my body through healthy diet and lifestyle along with natural supplements and proper spinal alignment. I absolutely reject the idea that injecting a group of toxic, immune insulting chemicals into my bloodstream will improve someone’s long-term immune response.

Nancy Tarlow, D.C.

When you inject chemicals into your body that are toxic, there will be an effect. It may not be obvious at first. A child might have a fever that the doctor says is “normal”, but it isn’t. A fever or screaming could be that the brain is swelling and causing damage. The real problem is that children cannot convey to us how they feel. It’s not like an adult who can tell us that they felt great prior to a vaccination but then started having health problems.

Dr. Haroot Tovanyan, D.C.

I am a doctor of Chiropractic and I primarily work with autistic children.

Every single parent in my practice that has an autistic child has the same story. Child was born normal; child was developing normal. Child went in for their 12-month, 18-month, normal usually 24 or 36-month shots and regressed. This may be anecdotal, but when you hear it over and over and over again, there’s something to be said. These are children that have severe neurological issues. They’re not verbal; 8-10-year-old children that are still wearing diapers.

I have a quadriplegic niece in my family who received 4 shots, a total of 10 vaccines in 1 day. She was born normal. She developed normal until about a year and a half. At a year and a half she received 4 shots, 1, 2, 3, 4, and she … This was 1990 when they started doing multiple vaccines and they also quadrupled the number of shots that you’re normally receiving. She basically regressed. She’s a vegetable. I mean, she became a quadriplegic. Nowhere in nature would your child go to get exposed to let’s say 6 or 7 or 8 or 9, or in the case of my niece, 10 viruses and bacteria at the same time.

In nature that just doesn’t happen. They don’t co-exist like that. It’s not natural to put a combination of vaccines, combinations of viruses and bacteria that just don’t belong together or don’t co-exist in nature in a vial and inject it into a child and expect them to be healthy. The CDC schedule has never been tested for safety. There have never been double-blind studies. It’s never been tested for synergistic effect. They’ve refused to study un-vaccinated versus vaccinated.

END OF QUOTE

On this blog, we have discussed the issues related to chiropractic and immunisations repeatedly (for instance here, here, here and here).

In case you wonder about the origins of this odd and unethical behaviour, you best look into the history of chiropractic. D. D. Palmer, the magnetic healer who ‘invented’ chiropractic some 120 years ago, left no doubt about his profound disgust for immunisation: “It is the very height of absurdity to strive to ‘protect’ any person from smallpox and other malady by inoculating them with a filthy animal poison… No one will ever pollute the blood of any member of my family unless he cares to walk over my dead body… ” (D. D. Palmer, 1910)

D. D. Palmer’s son, B. J. Palmer  provided a more detailed explanation for chiropractors’ rejection of immunisation: “Chiropractors have found in every disease that is supposed to be contagious, a cause in the spine. In the spinal column we will find a subluxation that corresponds to every type of disease… If we had one hundred cases of small-pox, I can prove to you, in one, you will find a subluxation and you will find the same condition in the other ninety-nine. I adjust one and return his function to normal… There is no contagious disease… There is no infection…The idea of poisoning healthy people with vaccine virus… is irrational. People make a great ado if exposed to a contagious disease, but they submit to being inoculated with rotten pus, which if it takes, is warranted to give them a disease” (B. J. Palmer, 1909)

We are often told that such opinions have all but died out in today’s chiropractic profession. But is this true? I see precious little evidence to assume this to be true.

Today the anti-vaxx notions of chiropractors are mostly expressed in a less abrupt, more politically correct language: The International Chiropractors Association recognizes that the use of vaccines is not without risk. The ICA supports each individual’s right to select his or her own health care and to be made aware of the possible adverse effects of vaccines upon a human body. In accordance with such principles and based upon the individual’s right to freedom of choice, the ICA is opposed to compulsory programs which infringe upon such rights. The International Chiropractors Association is supportive of a conscience clause or waiver in compulsory vaccination laws, providing an elective course of action for all regarding immunization, thereby allowing patients freedom of choice in matters affecting their bodies and health.

Yes, I do realise that some chiropractors now acknowledge that immunisations have been one of the most successful interventions in the history of medicine. Yet, far too many others still vehemently adhere to the gospel of the Palmers, and statements like the following abound:

Vaccines. What are we taught? That vaccines came on the scene just in time to save civilization from the ravages of infectious diseases. That vaccines are scientifically formulated to confer immunity to certain diseases; that they are safe and effective. That if we stop vaccinating, epidemics will return…And then one day you’ll be shocked to discover that … your “medical” point of view is unscientific, according to many of the world’s top researchers and scientists. That many state and national legislatures all over the world are now passing laws to exclude compulsory vaccines….

Our original blood was good enough. What a thing to say about one of the most sublime substances in the universe. Our original professional philosophy was also good enough. What a thing to say about the most evolved healing concept since we crawled out of the ocean. Perhaps we can arrive at a position of profound gratitude if we could finally appreciate the identity, the oneness, the nobility of an uncontaminated unrestricted nervous system and an inviolate bloodstream. In such a place, is not the chiropractic position on vaccines self-evident, crystal clear, and as plain as the sun in the sky?

So, the opinions by chiropractors cited above seem more the rule than the exception. NATURAL NEWS is not normally one of my favourite publications; on this occasion, however, I am thankful to the editor for alerting us to what I might call CHIROPRACTORS WITHOUT SCRUPLES.

The fact that much of chiropractic might be bogus has frequently been discussed on this blog. A recent press-release provided me with more evidence for this notion. It proudly announced a new book entitled “Beyond the Back: The Chiropractic Alternative For Conditions Beyond Back Pain”

The text claimed that shortly after the launch, the book hit #1 on the Amazon.com best seller list out of all Chiropractor books and also reached #1 for the category of Holistic Medicine.

When I checked (22/12/2016), I was not able to confirm this statement: #47 in Kindle Store > Kindle eBooks > Medical eBooks > Alternative & Holistic > Holistic Medicine, #58 in Books > Medical Books > Allied Health Professions > Chiropractic. But let’s not be petty; let’s rather see what the book has to offer.

‘Beyond the Back’ focuses on how Chiropractic care can do so much more than just alleviate back pain, the press-release says. From avoiding knee surgery to resolving athletic injuries, chiropractic care allegedly is a 100% natural health solution for a wide variety of conditions… In fact, in some cases, chiropractors can help their patients get off medications entirely and even avoid surgery, the press-release continues.

In the book itself, the authors claim that chiropractic is effective for a multitude of conditions, including asthma and colic (in fact, the authors try to give the impression that chiropractic is a veritable panacea), and that there is sound evidence for all these indications from hundreds, if not thousands of studies. The authors make it very clear – even on the book cover – that chiropractic is not an adjunct to conventional healthcare but an alternative to it; an idea, of course, that goes back to the founding fathers of chiropractic. As if this were not enough, the book also promotes diagnostic techniques such as applied kinesiology.

Some commentators on this blog have argued that the chiropractic profession is in the midst of giving up much of the nonsense upon it was originally based and to which it has clung on for more than hundred years. This book, written by 9 US authors of the new generation of chiropractors, seems to demonstrate the opposite.

On Amazon, the book currently has one single customer review: Value information and an easy read! I am a strong believer of chiropractic and this makes it easy for me to share this info with my friends ! 

This comment is apt because it makes clear that chiropractic is a belief system. We must not expect rational thoughts or facts from what, in effect, is a religion for many. I can understand this in a way: belief can be a cosy shelter from the truth; it does not require much thinking; it hardly needs any learning, no changing of minds, etc. However, belief can never be a basis for good healthcare. In my view, ‘Beyond The Back’ provides a perfect example of that.

Yes, to a large extend, quacks make a living by advertising lies. A paper just published confirms our worst fears.

This survey was aimed at identifying the frequency and qualitative characteristics of marketing claims made by Canadian chiropractors, naturopaths, homeopaths and acupuncturists relating to the diagnosis and treatment of allergy and asthma.

A total of 392 chiropractic, naturopathic, homeopathic and acupuncture clinic websites were located in 10 of the largest metropolitan areas in Canada. The main outcome measures were: mention of allergy, sensitivity or asthma, claim of ability to diagnose allergy, sensitivity or asthma, claim of ability to treat allergy, sensitivity or asthma, and claim of allergy, sensitivity or asthma treatment efficacy. Tests and treatments promoted were noted as qualitative examples.

The results show that naturopath clinic websites had the highest rates of advertising at least one of diagnosis, treatment or efficacy for allergy or sensitivity (85%) and asthma (64%), followed by acupuncturists (68% and 53%, respectively), homeopaths (60% and 54%) and chiropractors (33% and 38%). Search results from Vancouver were most likely to advertise at least one of diagnosis, treatment or efficacy for allergy or sensitivity (72.5%) and asthma (62.5%), and results from London, Ontario were least likely (50% and 40%, respectively). Of the interventions advertised, few are scientifically supported; the majority lack evidence of efficacy, and some are potentially harmful.

[Legend to figure above: Percentage of alternative medicine clinic websites advertising at least one of diagnosis, treatment or efficacy for allergy/sensitivity or asthma. Presenting the data in this way demonstrates that the Canadian naturopath, homeopath and acupuncturist websites studied have >50% rates of making at least one health-related claim for both allergy/sensitivity and asthma.]

The authors concluded that the majority of alternative healthcare clinics studied advertised interventions for allergy and asthma. Many offerings are unproven. A policy response may be warranted in order to safeguard the public interest.

In the discussion section, the authors state: “These claims raise ethical issues, because evidence in support of many of the tests and treatments identified on the websites studied is lacking. For example, food-specific IgG testing was commonly advertised, despite the fact that the Canadian Society of Allergy and Clinical Immunology has recommended not to use this test due to the absence of a body of research supporting it. Live blood analysis, vega/electrodiagnostic testing, intravenous vitamin C, probiotics, homeopathic allergy remedies and several other tests and treatments offered all lack substantial scientific evidence of efficacy. Some of the proposed treatments are so absurd that they lack even the most basic scientific plausibility, such as ionic foot bath detoxification…

Perhaps most concerning is the fact that several proposed treatments for allergy, sensitivity or asthma are potentially harmful. These include intravenous hydrogen peroxide, spinal manipulation and possibly others. Furthermore, a negative effect of the use of invalid and inaccurate allergy testing is the likelihood that such testing will lead to alterations and exclusions in diets, which can subsequently result in malnutrition and other physiological problems…”

This survey originates from Canada, and one might argue that elsewhere the situation is not quite as bad. However, I would doubt it; on the contrary, I would not be surprised to learn that, in some other countries, it is even worse.

Several national regulators have, at long last, become aware of the dangers of advertising of outright quackery. Consequently, some measures are now beginning to be taken against it. I would nevertheless argue that these actions are far too slow and by no means sufficiently effective.

We easily forget that asthma, for instance, is a potentially life-threatening disease. Advertising of bogus claims is therefore  much more than a forgivable exaggeration aimed at maximising the income of alternative practitioners – it is a serious threat to public health.

We must insist that regulators protect us from such quackery and prevent the serious harm it can do.

The common cold is one of the indications for which homeopathy is deemed to be effective… by homeopaths that is! Non-homeopaths are understandably critical about this claim, not least because there is no good evidence for it. But, hold on, there is a new study which might change all this.

This study was recently published in COMPLEMENTARY THERAPIES IN MEDICINE which is supposed to be one of the better journals in this area. According to its authors, it was conducted “to determine if a homeopathic syrup was effective in treating cold symptoms in preschool children.” Children diagnosed with an upper respiratory tract infection were randomized to receive a commercial homeopathic cold syrup containing allium cepa 6X, hepar sulf calc 12X, natrum muriaticum 6X, phosphorous 12X, pulsatilla 6X, sulphur 12X, and hydrastasis 6X or placebo. Parents administered the study medication as needed for 3 days. The primary outcome was change in symptoms one hour after each dose. Parents also assessed the severity of each of the symptoms of runny nose, cough, congestion and sneezing at baseline and twice daily for 3 days, using a 4-point rating scale. A composite cold score was calculated by combining the values for each of the four symptoms. Among 261 eligible participants, data on 957 doses of study medication in 154 children were analyzed. There was no significant difference in improvement one hour after the dose for any symptom between the two groups. Analysis of twice daily data on the severity of cold symptoms compared to baseline values found that improvements in sneezing, cough and the composite cold score were significantly greater at both the first and second assessments among those receiving the cold syrup compared to placebo recipients.

The authors concluded that the homeopathic syrup appeared to be effective in reducing the severity of cold symptoms in the first day after beginning treatment.

Where to start? There are so many problems with this study that I find it difficult to chose the most crucial ones:

  • The study had a clearly defined primary endpoint; it was not affected by the homeopathic treatment which doubtlessly makes the study a negative trial. The only correct conclusion therefore is that THE HOMEOPATHIC SYRUP FAILED TO AFFECT THE PRIMARY OUTCOME MEASURE OF THIS STUDY. THEREFORE THE TRIAL DID NOT PRODUCE ANY EVIDENCE TO ASSUME THAT THE EXPERIMENTAL TREATMENT WAS EFFICACIOUS.
  • I don’t think that many of the primary or secondary outcome measures are validated or reliable.
  • All the positive results reported in the abstract and the article relate to secondary endpoints which are purely explanatory by nature. They should, in my view, not be mentioned in the conclusions at all.
  • The fact that some results turned out to be positive can be explained by the fact that the investigators ran dozens of tests for statistical significance which means that, by simple chance, some will turn out to produce a positive result.
  • A further explanation for the seemingly positive results might be the fact disclosed in the text of the article that the children in the homeopathy group received more conventional drugs than those in the placebo group.
  • Whatever the reason for these positive results, they certainly had nothing to do with the homeopathic syrup.
  • The study was funded by the company producing the syrup and for which one of the authors was employed as a consultant. This might be an explanation for the abominably poor science. In other words, this paper is not an exercise in testing a hypothesis but one in marketing.

While I might forgive the company for trying to maximise their sales figures, I do find it harder to forgive the authors, reviewers and editors for publishing such overtly false conclusions. In my view, they are all guilty of scientific misconduct.

The boom of alternative medicine in the US – and consequently in the rest of the developed world – is intimately connected with a NHI centre now called NCCIH (National Center for Complementary and Integrative Health). It was founded in the early 1990s because some politicians were bent on promoting quackery. Initially the institution had modest funding but, after more political interference, it had ample cash to pursue all sorts of activities, including sponsoring research into alternative therapies at US universities. A most interesting video summarising the history of the NCCIH can be seen here.

No other institution in the world had more funds for research into alternative medicine than the NCCIH, and it soon became the envy of alt med researchers globally. I have been invited by the NCCHI on several occasions and invariably was impressed by their apparent affluence. While we Europeans usually had to do our research on a shoe-string, our American colleagues seemed to be ‘rolling in it’.

I was often far less impressed with the research they sponsored. Not only it was invariably eye-wateringly expensive, but also its quality seemed often dismal. Sometimes, I even got the impression that research was used as a means of mainstreaming quackery for the unsuspecting American – and consequently world-wide – public.

An example of this mainstreaming is an article in JAMA published yesterday. Here is a short but telling excerpt:

Researchers led by Richard L. Nahin, PhD, MPH, lead epidemiologist at the NIH’s National Center for Complementary and Integrative Health (NCCIH), examined efficacy and safety evidence in 105 randomized controlled trials (RCTs) conducted between January 1966 and March 2016. The review—geared toward primary care physicians as part of the journal’s Symposium on Pain Medicine—focused on popular complementary approaches to common pain conditions.

Unlike a typical systematic review that assigns quality values to the studies, the investigators conducted a narrative review, in which they simply looked at the number of positive and negative trials. “If there were more positives than negatives then we generally felt the approach had some value,” Nahin explained. “If there were more negatives, we generally felt the approach had less value.” Trials that were conducted outside of the United States were excluded from the review.

Based on a “preponderance” of positive vs negative trials, complementary approaches that may offer pain relief include acupuncture and yoga for back pain; acupuncture and tai chi for osteoarthritis of the knee; massage therapy for neck pain; and relaxation techniques for severe headaches and migraine. Several other techniques had weaker evidence, according to the qualitative assessments, for specific pain conditions (see “Selected Complementary Health Approaches for Pain”). The treatments were generally safe, with no serious adverse events reported.

To me, this looks that NCCIH has now managed to persuade even the editors of JAMA to white-wash their dodgy science. The review referred to here is a paper we discussed some time ago on this blog. I then stated about it the following:

Reading the article carefully, it is impossible not to get troubled. Here are a few points that concern me most:

  • the safety of a therapy cannot be evaluated on the basis of data from RCTs (particularly as it has been shown repeatedly that trials of alternative therapies often fail to report adverse effects); much larger samples are needed for that; any statements about safety in the aims of the paper are therefore misplaced;
  • the authors talk about efficacy but seem to mean effectiveness;
  • the authors only included RCTs from the US which must result in a skewed and incomplete picture;
  • the article is from the National Center for Complementary and Integrative Health which is part of the NIH but which has been criticised repeatedly for being biased in favour of alternative medicine;
  • not all of the authors seem to be NIH staff, and I cannot find a declaration of conflicts of interest;
  • the discussion of the paper totally lacks any critical thinking;
  • there is no assessment of the quality of the trials included in this review.

My last point is by far the most important. A summary of this nature that fails to take into account the numerous limitations of the primary data is, I think, as good as worthless. As I know most of the RCTs included in the analyses, I predict that the overall picture generated by this review would have changed substantially, if the risks of bias in the primary studies had been accounted for.

I find it puzzling that the ‘lead epidemiologist at the NIH’s National Center for Complementary and Integrative Health’ would publish such dubious research. Why does he do it? If you have watched the video mentioned above, you are inclined to think that it might be because of political interference.

However, I suggest another, in a way much more damming reason or contributing factor: the NCCIH has so long indulged in such poor science that even its top people have forgotten what good science looks like. I know this is a bold hypothesis; so, let me try to support it with some data.

Several years ago, my team together with several other researches have looked at the NCCIH-sponsored research systematically according to 4 different subject areas. Here are the conclusions of our articles reporting the findings:

ACUPUNCTURE

Seven RCTs had a low risk of bias. Numerous methodological shortcomings were identified. Many NCCAM-funded RCTs of acupuncture have important limitations. These findings might improve future studies of acupuncture and could be considered in the ongoing debate regarding NCCAM-funding. [Focus on Alternative and Complementary Therapies Volume 17(1) March 2012 15–21]

HERBAL MEDICINE

This independent assessment revealed a plethora of serious concerns related to NCCAM studies of herbal medicine. [Perfusion 2011; 24: 89-102]

ENERGY MEDICINE

In conclusion, the NCCAM-funded RCTs of energy medicine are prime examples of misguided investments into research. In our opinion, NCCAM should not be funding poor-quality studies of implausible practices. The impact of any future studies of energy medicine would be negligible or even detrimental. [Focus on Alternative and Complementary Therapies Volume 16(2) June 2011 106–109 ]

CHIROPRACTIC

In conclusion, our review demonstrates that several RCTs of chiropractic have been funded by the NCCAM. It raises numerous concerns in relation to these studies; in particular, it suggests that many of these studies are seriously flawed. [https://www.ncbi.nlm.nih.gov/pubmed/21207089]

I think I can rest my case and urge you to watch the video mentioned above.

This randomized, double-blind study evaluated the efficacy of a homeopathic treatment in preventing excessive weight gain during pregnancy in overweight or obese women who were suspected of having a common mental disorder. For the homeopathic group (n=62), 9 homeopathic remedies were pre-selected: (1) Pulsatilla nigricans, (2) Sepia succus, (3) Lycopodium clavatum, (4) sulphur, (5) Lachesis trigonocephalus, (6) Nux vomica, (7) Calcarea carbonica, (8) phosphorus; and (9) Conium maculatum. From those 9 drugs, one was prioritized for administration for each participant. After the first appointment, a re-selection or selection of a new, more appropriate drug occurred, using the list of preselected drugs. The dosage was 6 drops orally 2 ×/day, in the morning and at night, on 4 consecutive days each week, with an interval of 3 d between doses, up until the next appointment medical appointment. The control group (n=72) took placebos. Both groups also received a diet orientation.

Weight change during pregnancy was defined as the difference between the body mass index (BMI) at the initial evaluation and that recorded at the final evaluation, adjusted for 40 weeks of gestation. In addition, the APGAR index in the newborn  (a measure of the health of the baby) was evaluated. The mean variation between baseline BMI and BMI at week 40 of gestation was +4.95 kg/m2 in the control group and +5.05 kg/m2 in the homeopathy group. The difference between the two groups was not significant. APGAR 10 at 5 min (59.6% in the homeopathy group and 36.4% in the control group) was statistically significant (P = .016).

The authors concluded that homeopathy does not appear to prevent excessive body mass gain in pregnant women who are overweight or obese and suspected of having a common mental disorder. Homeopathy did not change the APGAR score to modified clinical attention at delivery room. However, the evidence observed at APGAR 10 at minute 5 suggests that  homeopathy had a modulating effect on the vitality of newborns, warranting further studies designed to investigate it.

I have seen many odd studies in my time, but this must be one of the oddest?

  • What is the rationale for assuming that homeopathy might affect body weight?
  • Why take pregnant women with a weight problem who were suspected of having a common mental disorder?
  • Why try to turn a clearly negative result into a finding that is (at least partly) positive?

The last point seems the most important one to me. The primary outcome measure of this study (weight gain) was clearly defined and was not affected by the therapy. Yet the authors feel it justified to add to their conclusions that homeopathy had a modulating effect on the vitality of newborns (almost certainly nothing but a chance finding).

Are they for real?

I suppose they are: they are real pseudo-scientific promoters of quackery!

You probably remember: the US Federal Trade Commission’s (FTC) has issued a statement announcing that unsupported claims for homeopathic remedies will be no longer allowed. Specifically, they said that, in future, homeopathic remedies have to be held to the same standard as other medicinal products. In other words, American companies must now have reliable scientific evidence for health-related claims that their products can treat specific conditions and illnesses.

Now the AMERICAN INSTITUTE OF HOMEOPATHY (AIH) has published a rebuttal. It is hilarious and embarrassing in equal measure. Here it is in full (I have only omitted their references – they can be seen in the linked original –  and added footnotes in bold square brackets with my very short comments):

START OF QUOTE

November 30, 2016

The American Institute of Homeopathy applauds the Federal Trade Commission’s (FTC) goal of protecting the American public from false advertising claims, but in a recent circumstance we believe the FTC has overstepped its jurisdictional bounds and promulgated false information in what appears to be a bid to restrict health care choices [1] available to the American public.

In Response to the recent Enforcement Policy Statement1 and a Consumer Information Blog,2 both issued by the FTC on November 15, 2016, the American Institute of Homeopathy registers our strong concern regarding the content of the following inaccurate statements:

  1. “Homeopathy… is based on the view that disease symptoms can be treated by minute doses of substances that produce similar symptoms…”

Homeopathy is not based on a “view” or an opinion. It is based on reliable, reproducible, clinically acquired, empiric evidence [2] gathered through two centuries of corroborated data, assisted by thousands of practitioners worldwide [3], demonstrating the actions of different medicinal substances in living systems, aka: the science of homeopathy. In fact, the homeopathic scientific community were pioneers of the modern scientific method including the widespread adoption of blinded and placebo controlled studies in 1885 [4], decades before conventional medicine.3

Homeopathy is not based on a theory or on conjecture, but on principles that have been confirmed by long-studied clinical data, meticulously gathered and analyzed over many years [5].

  1. “Many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance.”

While the dilution and succussion process of formulating homeopathic medicines does reduce the concentration (and the toxicity) of the original substances, detectable amounts of these materials remain quantifiable in the form of nanoparticles [6] dispersed throughout.4 Multiple independent laboratories, worldwide have confirmed that these nanoparticles persist,5 and that they are biologically active.6 Many other homeopathic products (particularly those sold OTC and described as “low potency”) have dilute amounts of the original substance [7] that remain chemically detectable by straightforward titration.

  1. “…homeopathic product claims are not based on modern scientific methods…”

This statement is false and misleading. The active ingredients within most OTC homeopathic products have hundreds or thousands of case reports from physicians who have used these medicines [8]. These reports of direct clinical experiences establish a collective, real-world dataset that demonstrates which conditions have been observed to respond to treatment. Such historical data is similar to the types of information used to demonstrate effectiveness for many conventional OTC medicines on the market today [9].

The Homeopathic Pharmacopeia Convention of the United States (HPCUS) maintains a formulary describing the appropriate manufacturing standards for homeopathic medicines [10]. Every homeopathic manufacturer member of the American Association of Homeopathic Pharmacists in good ethical standing complies with both manufacturing and labeling standards set by the HPCUS. Consumers should be cautious when using any products that are not distinguished by conformance with “HPUS” on the label.

  1. “…the case for efficacy is based solely on traditional homeopathic theories…”

This statement is false. Neither homeopathy nor homeopathic efficacy is based on any theories. Efficacy for various homeopathic medicines has been established by scientifically reproducible clinical empiric research evidence [11] and cured patient cases followed over many years [12]. Homeopathy is an evidence-based medical subspecialty rooted in patient care.

  1. “…there are no valid studies using current scientific methods showing the product’s efficacy.”

While this statement may have limited accuracy with respect to some OTC products, it is false and misleading with respect to most homeopathic medicines listed in the Homeopathic Pharmacopeia of the United States. Hundreds of state-of-the-art double-blinded, randomized, placebo-controlled studies, many in peer-reviewed journals, demonstrate the superior efficacy of homeopathic medicines in a wide range of conditions, including asthma,7 depression and anxiety,8 chronic illness,9 allergic rhinitis,10 hypertension,11 headaches/migraines,12 sepsis,13 mild traumatic brain injury,14 otitis media,15 cancer,16 and many other conditions [13]. The American Institute of Homeopathy maintains and continually updates an extensive database, available free to the public, with over 6,000 research articles [14].17

Multiple meta-analyses published in peer reviewed medical journals that conclude that homeopathic medicine effects are superior to placebo [15] and that additional study of this therapeutic system is warranted.18,19,20,21,22,23  To that end, we encourage the National Institutes of Health to reverse their current position of blocking funding for homeopathic trials.24

  1. “…marketing claims that such homeopathic products have a therapeutic effect lack a reasonable basis and are likely misleading…”

The conclusion of whether a product has a “reasonable basis” is entirely irrelevant if that product has demonstrable clinical effectiveness. The important question, when it comes to homeopathy, is whether it is effective in clinical settings, not whether it has a “reasonable basis” for how it works. The mechanism by which homeopathy works differs from conventional medicines [16], but this fact does not make these products “misleading”.

Several recent class-action lawsuits brought against homeopathic manufacturers confirm that marketing practices were neither deceptive nor misleading [17].25

The FTC’s inability to formulate a reasonable basis for why homeopathic medicines work should not enter into any governmental enforcement policy statement. The FTC is not a medical organization, lacks expertise in interpreting scientific research [18], and is not qualified to make any comment on the validity of any field of medicine. To be less misleading, the FTC should exclude opinions from its policy statements.

  1. “Homeopathy: Not backed by modern science”

Homeopathy, as a system of medicine, does not fall under the purview of the FTC. Therefore, the FTC has been reckless in expressing an opinion of this magnitude. In this situation, the FTC’s comments can only be construed as being prejudicially biased and intentionally discriminatory against homeopathy. Such statements cause unwarranted harm to public trust and damage to a respected traditional system of medicine in the United States [19].

The American Institute of Homeopathy strongly objects to the FTC’s characterization of the entire field of homeopathic medicine as being without scientific evidence of efficacy. These comments are unqualified and wholly lacking in merit. The release of this Enforcement Policy Statement serves only to align the FTC with several recently released scientifically fraudulent [20] reports by a variety of pseudoscientists [21] and lowers the credibility of this valued consumer protection agency.

This type of misinformation should be embarrassing to a government organization striving to be nonpartisan and objective. The FTC owes an apology to the American Institute of Homeopathy as well as the many consumer groups that look toward this agency for fair and accurate information.

END OF QUOTE

My comments:

1 In healthcare, choice must be restricted to treatments which demonstrably generate more good than harm.

2 The AIH seems to be unaware of the difference between the nature of evidence, anecdote and experience.

3 Fallacy – appeal to popularity.

4 The first randomized, placebo-controlled study of homeopathy was, in fact, published in 1835 – its results were negative.

5 Fallacy – appeal to tradition.

6 The nano-particle explanation of homeopathy is but a theory (at best).

7 Fallacy – appeal to tradition.

8 Fallacy – appeal to authority.

9 Really? Which ones? Examples would help, but I doubt they exist.

10 The proper manufacturing of nonsense must still result in nonsense.

11 See footnote number 2

12 Fallacy – appeal to tradition.

13 For all of these conditions, the totality of the reliable evidence fails to demonstrate efficacy.

14 In this context, only clinical trials are relevant, and their number is nowhere near 6,000.

15 Most of the independent systematic reviews fail to be positive.

16 The mechanism is well-known and is called ‘placebo-effect’.

17 Many class actions also went against the manufacturers of homeopathic preparations.

18 I assume they ‘bought in’ the necessary expertise.

19 Surely, the damage is only to the cash-flow of firms selling bogus products.

20 Really? Name the report you libel here or be quiet!

21 Name the individuals you attack in this way or be quiet!

I must say, I had fun reading this. In fact, I cannot remember having seen a document by an organisation of healthcare professionals which was so embarrassingly nonsensical that it becomes comedy gold. If one of my PhD students, for instance, had submitted such drivel, I would have had no choice but to fail him or her.

Having said that, I need to stress to the AIH:

FULL MARKS FOR AMUSEMENT!!!

 

WHAT DOCTORS DON’T TELL YOU (WDDTY) is probably the most vile publication I know. It systematically misleads its readers by alarming news about this or that conventional treatment, while relentlessly promoting pseudoscientific non-sense. This article , entitled “MMR can cause skin problems and ulcers if your immune system is compromised” is a good example (one of a multitude):

The MMR vaccine can cause serious adverse reactions, researchers have admitted this week. The rubella (German measles) component of the jab increases the risk of infection from the rubella virus itself, and can cause serious skin inflammation and ulcers in anyone whose immune system is compromised.

The risk is highest among people with primary immunodeficiency diseases (PIDD), chronic genetic disorders that cause the immune system to malfunction.

Although the risk for people with compromised immune systems has been known, and is even included in the package inserts supplied with the vaccine, it was theoretical, say researchers from the Children’s Hospital of Philadelphia, who say they have uncovered “genuine evidence of harm.”

The researchers analysed the health profile of 14 people—four adults and 10 children—who suffered some form of a PIDD. Seven of them still had the rubella virus in their tissues, suggesting that their immune systems were too weak to get rid of the virus in the vaccine. The virus can damage skin cells and cause ulcers, and makes the person more susceptible to the actual rubella virus, the researchers say.

People with a poor immune system already have compromised T-cells—which are responsible for clearing viral infections—and the MMR makes the problem worse.

END OF QUOTE

And what is wrong with this article?

The answer is quite a lot:

  1. The research seems to be about a very specific and rare condition, yet WDDTY seem to want to draw much more general conclusions.
  2. The research itself is not described in a way that it would be possible to evaluate.
  3. The sample size of what seems to have been a case-control study was tiny.
  4. The study is not properly cited for the reader to verify and check; for all we know, it might not even exist.
  5. I was not able to find the publication on Medline, based on the information given.

Collectively, these points render the article not just useless, in my view, but make it a prime example of unethical, unhelpful and irresponsible scaremongering.

 

On 25 and 26 May of this year I wrote two posts about an acupuncture trial that, in my view, was dodgy. To refresh your memory, here is the relevant part of the 2nd post:

This new study was designed as a randomized, sham-controlled trial of acupuncture for persistent allergic rhinitis in adults investigated possible modulation of mucosal immune responses. A total of 151 individuals were randomized into real and sham acupuncture groups (who received twice-weekly treatments for 8 weeks) and a no acupuncture group. Various cytokines, neurotrophins, proinflammatory neuropeptides, and immunoglobulins were measured in saliva or plasma from baseline to 4-week follow-up.

Statistically significant reduction in allergen specific IgE for house dust mite was seen only in the real acupuncture group. A mean (SE) statistically significant down-regulation was also seen in pro-inflammatory neuropeptide substance P (SP) 18 to 24 hours after the first treatment. No significant changes were seen in the other neuropeptides, neurotrophins, or cytokines tested. Nasal obstruction, nasal itch, sneezing, runny nose, eye itch, and unrefreshed sleep improved significantly in the real acupuncture group (post-nasal drip and sinus pain did not) and continued to improve up to 4-week follow-up.

The authors concluded that acupuncture modulated mucosal immune response in the upper airway in adults with persistent allergic rhinitis. This modulation appears to be associated with down-regulation of allergen specific IgE for house dust mite, which this study is the first to report. Improvements in nasal itch, eye itch, and sneezing after acupuncture are suggestive of down-regulation of transient receptor potential vanilloid 1.

…the trial itself raises a number of questions:

  1. Which was the primary outcome measure of this trial?
  2. What was the power of the study, and how was it calculated?
  3. For which outcome measures was the power calculated?
  4. How were the subjective endpoints quantified?
  5. Were validated instruments used for the subjective endpoints?
  6. What type of sham was used?
  7. Are the reported results the findings of comparisons between verum and sham, or verum and no acupuncture, or intra-group changes in the verum group?
  8. What other treatments did each group of patients receive?
  9. Does anyone really think that this trial shows that “acupuncture is a safe, effective and cost-effective treatment for allergic rhinitis”?

In the comments section, the author wrote: “after you have read the full text and answered most of your questions for yourself, it might then be a more appropriate time to engage in any meaningful discussion, if that is in fact your intent”, and I asked him to send me his paper. As he does not seem to have the intention to do so, I will answer the questions myself and encourage everyone to have a close look at the full paper [which I can supply on request].

  1. The myriad of lab tests were defined as primary outcome measures.
  2. Two sentences are offered, but they do not allow me to reconstruct how this was done.
  3. No details are provided.
  4. Most were quantified with a 3 point scale.
  5. Mostly not.
  6. Needle insertion at non-acupoints.
  7. The results are a mixture of inter- and intra-group differences.
  8. Patients were allowed to use conventional treatments and the frequency of this use was reported in patient diaries.
  9. I don’t think so.

So, here is my interpretation of this study:

  • It lacked power for many outcome measures, certainly the clinical ones.
  • There were hardly any differences between the real and the sham acupuncture group.
  • Most of the relevant results were based on intra-group changes, rather than comparing sham with real acupuncture, a fact, which is obfuscated in the abstract.
  • In a controlled trial fluctuations within one group must never be interpreted as caused by the treatment.
  • There were dozens of tests for statistical significance, and there seems to be no correction for multiple testing.
  • Thus the few significant results that emerged when comparing sham with real acupuncture might easily be false positives.
  • Patient-blinding seems questionable.
  • McDonald as the only therapist of the study might be suspected to have influenced his patients through verbal and non-verbal communications.

I am sure there are many more flaws, particularly in the stats, and I leave it to others to identify them. The ones I found are, however, already serious enough, in my view, to call for a withdrawal of this paper. Essentially, the authors seem to have presented a study with largely negative findings as a trial with positive results showing that acupuncture is an effective therapy for allergic rhinitis. Subsequently, McDonald went on social media to inflate his findings even more. One might easily ask: is this scientific misconduct or just poor science?

END OF QUOTE

This and the previous post created lots of discussion and comments. However, the question whether the study in question amounted to scientific misconduct was never satisfactorily resolved. Therefore, I decided to write to the editor of ‘Ann Allergy Asthma Immunol‘ where the trial had been published. He answered by saying I would need to file an official complaint for him to address the issue. On 13 June, I therefore sent him the following email:

Thank you for your letter of 3/6/2016 suggesting I make a formal complaint about the paper entitled ‘EFFECT OF ACUPUNCTURE ON HOUSE DUST MITE…’ [ Ann Allergy Asthma Immunol 2016] by McDonald et al. I herewith wish to file such a complaint.

The article in question reports an RCT of acupuncture for persistent allergic rhinitis. It followed a parallel group design with 3 groups receiving the following interventions:

1.       Acupuncture

2.       Sham-acupuncture

3.       No treatment

There was a plethora of outcome measures and time points on which they were measured. A broad range of parameters was defined as primary endpoints.

The conclusion reached by the authors essentially was that acupuncture affected several outcome measures in a positive sense, thus supporting the notion that acupuncture is efficacious [“Symptoms and quality of life improved significantly and were still continuing to improve 4 weeks after treatment ceased.”] This conclusion, however, is misleading and needs correcting.

The main reasons for this are as follows:

·         Despite the fact that the authors did many dozens of statistical tests for significance, they did not correct for this multiplicity of tests. Consequently, some or most of the significant results are likely to be false positive.

·         Many of the positive results of this paper were not obtained by comparing one group to another but by doing before/after comparisons within one group. This approach defies the principle of a controlled clinical trial. For doing intra-group comparisons, we obviously do not need any control group at all. The findings from intra-group comparisons are prominently reported in the paper, for instance in the abstract, giving the impression that they originate from inter-group comparisons. One has to read the paper very carefully to find that, when inter-group comparisons were conducted, their results did NOT confirm the findings from the reported intra-group comparisons. As this is the case for most of the symptomatic endpoints, the impression given is seriously misleading and needs urgent correction.

On the whole, the article is a masterpiece of obfuscation and misrepresentation of the actual data. I urge you to consider the harm than can be done by such a misleading publication. In my view, the best way to address this problem is to withdraw the article.

I look forward to your decision.

Regards

E Ernst

END OF QUOTE

I had to send several reminders but my most recent one prompted the following response dated 7/11/ 2016:

Dear Professor Ernst,
Thank you for your patience while we worked through the process of considering your complaints levied on the article entitled ‘EFFECT OF ACUPUNCTURE ON HOUSE DUST MITE…’ [ Ann Allergy Asthma Immunol 2016] by McDonald et al. I considered the points that you made in your previous letter, sought input from our editorial team (including our biostatistics editor) , our publisher and the authors themselves. I sent the the  charges ( point by point) anonymously to the authors and allowed them time to respond which they did. I had their responses reviewed by selected editors and , as a result of this process, have decided not to pursue any corrective or punitive action based upon the following :
 
  1. Our editorial team recognizes that this is not the best clinical trial we have published in the Annals of Allergy, Asthma and Immunology. However, neither is is the worst. As in most published research studies, there are always things that could have been done better to make it a stronger paper. Never-the-less, the criticism falls fall short of any sort of remedy that would include withdrawal of the manuscript.
  2. Regarding your accusation that the multiple positive endpoint resulted in the authors making specific therapeutic claims, our assessment is that no specific therapeutic claim was made but rather the authors maintained that the data support the value of acupuncture in improving symptoms and quality of life in patients with AR. We do not believe there was overreach in those statements.
  3. The authors’ stated intent was to show immune changes associated with clinical markers of improvement in the active acupuncture group compared to controls. The authors maintain (and our editors agree) that their data assessments were primarily based upon three statistical tests not “dozens” (as stated in your original letter of complaint).  The power analysis and sample size calculations were presented to us and deemed adequate , making the probability of a type I error quite low.
  4. The authors acknowledge in their paper that there could be limitations to their data interpretation based upon potential disparities between intra- and intergroup comparisons. The editors felt their transparency was adequately disclosed.
In summary, as editor-in-chief of the Annals of Allergy, Asthma and Immunology, I did not find sufficient merit in your charges to initiate any corrective or punitive action for this manuscript. I understand you will strongly disagree with this decision and I regret that. However, in the final analysis, my primary intent is to preserve the objectivity, fairness, and integrity of our journal and its review process. I believe I have accomplished that in this instance.
 
Sincerely
END OF QUOTE
This seems to settle the issue: the study in question does not involve scientific misconduct!
Or does it?
I would be grateful for the view of the readers of this post.

I have published many articles on the risks of various alternative treatments (see for instance here, here, here, here, here and here) – not because I am alarmist but because I have always felt very strongly that, for a researcher into alternative medicine, the most important issue must be to make sure users of these therapies are as safe as possible. Usually I differentiated between direct and indirect risks. The former relate to the risks of the treatment and include, for instance, liver damage caused by a herbal remedy or stroke due to neck manipulation. The latter are mainly due to the poor, often irresponsible advice given by many therapists.

A recent article adopted the same terminology when reviewing the risks of alternative medicine specifically for cancer patients. As the indirect risks are often neglected, I will here quote the relevant section of this paper in full:

…Health care physicians and oncology experts have an ethical responsibility to initiate the communication regarding the use of complementary therapies with cancer patients. However, according to data obtained from this literature review, oncology doctors and physicians will discuss complementary therapies only when a patient him/herself raises this issue within a consultation. This passive attitude was linked to a lack of sufficient scientific evidence for positive outcomes of complementary therapies found in high quality randomized controlled trials (RCTs). Oncology nurses, on the other hand, sometimes actively promote complementary modalities that they find to correspond with their vision of holistic care.

According to the included studies, complementary providers often differ from conventional health care providers in their understanding of treatment concepts, philosophies and diagnostic procedures. This leads to different models of disease causality (cells, blood, nerves vs. energy, vital force, meridians) and treatment philosophy (reductionism vs. holism). As many complementary providers are philosophically oriented towards personal and spiritual growth, patients may feel guilty if the disease continues to advance despite the patients’ best spiritual and mental efforts. According to Broom and colleagues, such philosophies may also give patients false hope of recovery.

Another indirect risk connected to the combination of conventional and complementary treatment in cancer care is the lack of regulation and standardized education in many countries. Currently, there are, for example, no standard training requirements for complementary providers working in cancer care or any other health care setting in the EU. According to Mackareth et al., complementary providers in England need specific training to learn how to practice safely.

Moreover, there is a need for common medical terminology to bridge the communication gap between health care providers working outside the conventional health care system. Common medical terminology may reduce the existing communication gap between conventional and complementary providers about mutual patients. To minimize communication gap between physicians, oncology experts and complementary providers, a medical complementary record should include a treatment plan with conventional and complementary diagnosis, explanation of terminology, possible treatment interactions, description of the complementary treatment plan and goals. If possible, the quality of any complementary supplement given should be reported.

END OF QUOTE

As I said, I find it important to discuss the indirect risks of alternative medicine, and I am therefore pleased that the authors of this article addressed them. At the same time, I find their text remarkably tame.

Why are they not more open and forceful about what, after all, amounts to a serious public health issue? The answer might be simpler than expected: most of them are affiliated with the ‘National Research Center in Complementary and Alternative Medicine (NAFKAM), UiT The Arctic University of Norway, Tromsø, Norway’. Could it be that open warnings about outright quackery is not what suits this unit?

So, what might be an open and frank approach to discussing the indirect risks of alternative medicine? In my view, it should make several points abundantly clear and transparent:

  • Alternative practitioners (APs) are usually not trained to advise patients responsibly, particularly in cases serious disease.
  • The training of APs is often inadequate and sometimes resembles more to brain-washing than to proper education.
  • Consequently, APs often woefully over-estimate what their therapy can achieve.
  • The patients of APs are often desperate and ready to believe even the tallest tales.
  • APs have a huge conflict of interest – in order to make a living they need to treat as many patients as possible and are therefore not motivated to refer them to more suitable care.
  • APs are frequently in denial when it comes to the risks of their treatments.
  • APs are not educated such that they understand the full complexities of serious illness.
  • As a result, APs far too often misguide their patients to make tragically wrong choices thus putting their health at serious risk.
  • In most countries, the regulators turn a blind eye to this huge problem.

These are by no means trivial  points, and they have nothing to do with a ‘turf war’ between conventional and alternative medicine. They relate to our ethical duty to keep our patients as safe as we can. It has been estimated that, in oncology alone, 1 – 5% of deaths are due to patients opting to have alternative instead of conventional treatments. This amounts to an unbearably high absolute number of patients dying prematurely due to the indirect risks of alternative medicine.

It is high time, I think, that we tackle this issue systematically and seriously.

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