MD, PhD, FMedSci, FSB, FRCP, FRCPEd

commercial interests

Yesterday I received an electronic Christmas card from two homeopathic institutions called ‘Homeopathic Associates and The Homeopathic College’. It read: WISHING YOU THE BEST OF HEALTH AND HAPPINESS FOR THE NEW YEAR!

Naturally I was puzzled, particularly since I had no recollection of ever having been in contact with them. The card was signed by Manfred Mueller, MA, DHM, RSHom(NA), CCH, and I decided to find out more about this man. It turns out that Manfred Mueller developed The Mueller Method or “Extra-Strength Homeopathy” to meet today’s complex chronic conditions, drug induced disorders, vaccine injuries, toxic overload, radiation-induced health problems, cancers, etc.

Now, this sounds interesting, I thought, and read on. Just a few clicks further, Mueller offers his wisdom on homeopathic cancer treatments in a lengthy article entitled ‘Is Homeopathy an Effective Cancer Treatment?

According to Mueller, the answer to his question is a clear yes. I will spare you the torture of reading the entire paper (if you have masochistic tendencies, you can read it via the link I provided above); instead, I will just copy Mueller’s conclusion:

START OF QUAOTE

Laboratory studies in vitro and in vivo show that homeopathic drugs, in addition to having the capacity to reduce the size of tumors and to induce apoptosis, can induce protective and restorative effects. Additionally homeopathic treatment has shown effects when used as a complementary therapy for the effects of conventional cancer treatment. This confirms observations from our own clinical experience as well as that of others that when suitable remedies are selected according to individual indications as well as according to pathology and to cell-line indications and administered in the appropriate doses according to the standard principles of homeopathic posology, homeopathic treatment of cancer can be a highly effective therapy for all kinds of cancers and leukemia as well as for the harmful side effects of conventional treatment. More research is needed to corroborate these clinical observations.

Homeopathy over almost two decades of its existence has developed more than four hundred remedies for cancer treatment. Only a small fraction have been subjected to scientific study so far. More homeopathic remedies need to be studied to establish if they have any significant action in cancer. Undoubtedly the next big step in homeopathic cancer research must be multiple comprehensive double-blinded, placebo-controlled, randomized clinical trials. To assess the effect of homeopathic treatment in clinical settings, volunteer adult patients who prefer to try homeopathic treatment instead of conventional therapy could be recruited, especially in cases for which no conventional therapy has been shown to be effective.

Many of the researchers conducting studies — cited here but not discussed — on the growing interest in homeopathic cancer treatment have observed that patients are driving the demand for access to homeopathic and other alternative modes of cancer treatment. So long as existing cancer treatment is fraught with danger and low efficacy, it is urgent that the research on and the provision of quality homeopathic cancer treatment be made available for those who wish to try it.

END OF QUOTE

Amazing! What could be more wrong than this?

But it’s the season of joy and love; so, let’s not go into the embarrassing details of this article. Instead, I feel like returning the curtesy of Mr Mueller’s Christmas card. Therefore, I have decided to post this open ‘Christmas card’ to him:

Dear Mr Mueller,

thank you for your card, the good wishes, and the links you provided to your websites, articles, etc. I only read the one on cancer but was impressed. It is remarkably misguided, unethical and dangerous. Crucially, it has the potential to shorten the lives of many desperate patients. I therefore urge you to desist making your opinions public or from applying them in your clinical practice. I say this not merely because I am concerned about the patients that have the misfortune to fall into your hands, but also to prevent you from getting into trouble for immoral, unethical or unlawful behaviour.

In this spirit, I wish you happiness for the New Year.

Edzard Ernst

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.

HOMEOPATHIC REMEDIES CANNOT POSSIBLY  PLACEBOS BECAUSE THEY WORK IN ANIMALS!

How often have we heard this argument?

And how often have we pointed out that it is wrong on more than one level?

On this blog alone, we have done so here, here, here and here, for instance. But homeopaths and their followers seem to be strangely immune to facts. Presumably, they will therefore also ignore a recent paper that re-confirms what has already been said so often.

This new systematic review assessed the efficacy of homeopathy in cattle, pigs and poultry. Only peer-reviewed publications dealing with homeopathic remedies, which could possibly replace or prevent the use of antibiotics in the case of infective diseases or growth promotion in livestock were included. Search results revealed a total number of 52 trials performed within 48 publications fulfilling the predefined criteria. Twenty-eight trials were in favour of homeopathy, with 26 trials showing a significantly higher efficacy in comparison to a control group, whereas 22 showed no medicinal effect. Cure rates for the treatments with antibiotics, homeopathy or placebo varied to a high degree, while the remedy used did not seem to make a big difference. No study had been repeated under comparable conditions. Consequently, the use of homeopathy cannot claim to have sufficient prognostic validity where efficacy is concerned. When striving for high therapeutic success in treatment, the potential of homeopathy in replacing or reducing antibiotics can only be validated if evidence of efficacy is confirmed by randomised controlled trials under modified conditions.

I think this, together with the previous systematic reviews on the subject, speaks for itself, and there is little to add – except perhaps the bravely outspoken letter by Oliver Kamm in THE TIMES which alludes to the above named paper:

START OF QUOTE

Using highly diluted substances to cure ailments is a better idea than the medieval practices of bloodletting by leeches or administering hemlock as an anaesthetic. That’s the best you can say for homeopathy: it isn’t outright dangerous. As medicine, however, it’s junk. Study after study has confirmed that homeopathic remedies are inert and no more effective than either a placebo or just allowing an illness to run its course.

Now research published in the Veterinary Record concludes that there is insufficient evidence to support the use of homeopathic treatments in livestock, either, as a way to prevent or treat infectious diseases. Two scientists from the university of Kassel in Germany reviewed studies of the effectiveness of homeopathic treatments in cattle, pigs and poultry. They say the “evidence in favour of homeopathy lacks reproducibility and therefore cannot claim to have sufficient prognostic validity”.

Over 200 years, homeopaths have failed to substantiate their claims. It may seem bizarre that anyone in the 21st century could take seriously the notion of homeopathic treatments for animals. But that is to reckon without the Prince of Wales and his lifetime enthusiasm for zaniness on science, medicine, aesthetics and linguistics. He once gave a speech declaring himself proud for having been “accused once of being the enemy of the Enlightenment”. A few months ago he stunned a conference of scientists and public officials by disclosing that he uses only homeopathic remedies when treating his cattle and sheep on his country estate at Highgrove.

Prince Charles’s knowledge of science may be a joke but his contributions to public debate aren’t funny. They bestow prestige on atavistic superstitions that have no place in modern healthcare and animal welfare. NHS guidelines are clear there “is no good-quality evidence that homeopathy is effective as a treatment for any health condition”. Likewise in veterinary medicine. Out of more than 20,000 vets licensed in the UK, around 50 practise homeopathy. That is 50 too many. The same is true of the roughly 500 farmers who employ homeopathy. They can’t even claim a placebo effect as the animals are unaware of their purported medical treatment.

Yet the quacks are undaunted. The British Association of Homeopathic Veterinary Surgeons even claims success in curing dogs of cancer through homeopathy. This is nonsense — and if it persuades farmers and pet owners to forgo evidence-based treatments, it’s also wanton cruelty. It’s past time to shut these people down.”

END OF QUOTE

Actually, the exact quote was slightly different: What we’re dealing with here is the big lie, being perpetrated by corrupt government officials on the payroll of Pharma” (the bold lettering is from the original). It comes from the pen of  who has featured on this blog before (see also here).

Strong words indeed! But not as strong as those of the title of his new article: BRING THE CRIMINALS TO JUSTICE. What were they directed against? They were in protest against the recent rulings of the British Advertising Standards Authority and the American FCT  out-lawing the advertising of bogus claims for homeopathy.

Alan V Schmukler continues his article as follows: “It’s time to hold these people accountable. There are laws in every country against officials taking bribes and malfeasance in office. Write to your legislators and demand that they investigate and bring these criminals to justice. Send them the links to hundreds of homeopathy studies, including disease prevention with homeopathy, at the end of this article.   Tell them that the regulatory agencies are protecting Pharma profits, not the public.

Meanwhile, let us insist that pharmaceutical drugs be labeled honestly, like this:

“This drug was tested by the same company that profits from it, and which company has been fined millions of dollars in the past for lying about test results. This drug does not cure any medical condition, but only suppresses symptoms which may ultimately make the patient sicker. This drug has already  killed or injured X  number of people.”

There are not many homeopaths who can render me speechless; I have been used to a lot. But this man almost did. Almost!

After recovering my self-control, all I want to say to this is: THANK YOU ALAN V SCMUKLER! Not only have you made me laugh harder than when I last watched ‘Faulty Towers’, but, more importantly, you have shown us how deluded some (or could this be ‘all’?) of the leading homeopaths really are.

PS

Alan, if you read this, perhaps you want to have a look a this post.

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.

Alternative medicine suffers from what might be called ‘survey overload’: there are far too much such investigations and most of them are of deplorably poor quality producing nothing of value except some promotion for alternative medicine. Yet, every now and then, one finds a paper that is worth reading, and I am happy to say that this survey (even though it has several methodological shortcomings) belongs in this category.

This cross-sectional assessment of the views of general practitioners towards chiropractors and osteopaths was funded by the Department of Chiropractic at Macquarie University. It was designed as a quantitative descriptive study using an anonymous online survey that included closed and open-ended questions with opportunities provided for free text. The target population was Australian general practitioners. Inclusion criteria included current medical registration, membership of the Royal Australian College of General Practitioners and currently practicing as a general practitioner in Australia. The data being reported here were collected between May and December, 2014.

There were 630 respondents to the online survey during this period representing a response rate of 2.6 %. Results were not uniform for the two professions. More general practitioners believed chiropractic education was not evidence-based compared to osteopathic education (70 % and 50 % respectively), while the scope of practice was viewed as similar for both professions. A majority of general practitioners had never referred a patient to either profession (chiropractic: 60 %; osteopathy: 66 %) and indicated that they would not want to co-manage patients with either profession. Approximately two-thirds of general practitioners were not interested in learning more about their education (chiropractors: 68 %; osteopaths: 63 %).

The authors concluded that this study provides an indication of the current views of Australian general practitioners towards chiropractors and osteopaths. The findings suggest that attitudes may have become less favourable with a growing intolerance towards both professions. If confirmed, this has the potential to impact health service provision. The results from this cross-sectional study suggest that obtaining representative general practitioner views using online surveys is difficult and another approach is needed to supplement or replace the current recruitment strategy.

The authors do not speculate on the reasons why the attitudes of general practitioners towards chiropractic and osteopathy might have become more critical. Therefore I decided to offer a few possibilities here. The more negative views could be due to:

  • better education of general practitioners,
  • tightening of healthcare budgets,
  • recent ‘bad press’ and loss of reputation (for instance, the BCA’s libel action against Simon Singh),
  • the work of sceptics in informing the public about the numerous bogus claims made by osteopaths and chiropractors,
  • the plethora of overtly bogus claims which nevertheless continue to be made by these practitioners on a daily basis,
  • a more general realisation that these therapies can cause very serious harm,
  • a mixture of the above factors.

Whatever the reasons are, the finding that there now seems to be a growing scepticism (in Australia, but hopefully elsewhere as well) about the value of chiropractic and osteopathy is something that cheers me up no end.

Recently, the UK Advertising Standards Authority (ASA) together with the UK General Osteopathic Council (GOsC) have sent new guidance to over 4,800 UK osteopaths on the GOsC register.  The guidance covers marketing claims for pregnant women, children and babies. It also provides examples of what kind of claims can, and can’t, be made for these patient groups.

Regulated by statute, osteopaths may offer advice on, diagnosis of and treatment for conditions only if they hold convincing evidence.  Claims for treating conditions specific to pregnant women, children and babies  are not supported by the evidence available to date.

The new ASA guidance is intended to help osteopaths talk about the healthcare they provide in a way that complies with the Advertising Codes and to protect consumers from being misled. It provides some basic principles and many examples of claims that are, and aren’t, acceptable. The ASA hopes it will provide greater clarity to osteopaths on how to advertise osteopathic care for pregnant women, children and babies responsibly.

Specifically, the guidance points out that “osteopaths may make claims to treat general as well as specific patient populations, including pregnant women, children and babies, provided they are qualified to do so.  Osteopaths may not claim to treat conditions or symptoms presented as specific to these groups (e.g. colic, growing pains, morning sickness) unless the ASA or CAP has seen evidence for the efficacy of osteopathy for the particular condition claimed, or for which the advertiser holds suitable substantiation. Osteopaths may refer to the provision of general health advice to specific patient populations, providing they do not make implied and unsubstantiated treatment claims for conditions.”

Examples of claims previously made by UK osteopaths which are “unlikely to be acceptable” include:

  • Osteopaths often work with lactation consultations where babies are having difficulty feeding. 
  • Osteopaths are qualified to advise and treat patients across the full breadth of primary care practice.
  • Osteopaths often work with crying, unsettled babies.
  • Birth is a stressful process for babies.
  • Babies’ skulls are susceptible to strain or moulding, leading to asymmetrical or flattened head shapes. This usually resolves quickly but can sometimes be retained. Osteopathy can help.
  • If your baby suffers from excessive crying, sometimes known as colic, osteopathy might help.
  • Children often complain of growing pains in their muscles and joints; your osteopath can treat these pains.
  • Osteopathy can help your baby recover from the trauma of birth; I will gently massage your baby’s skull.
  • Midwives often recommend an osteopathic check-up for babies after birth.
  • Osteopathy can help with breast soreness or mastitis after birth.
  • If your baby is having difficulty breastfeeding, osteopathy might be able to help.
  • Many pregnant women experience pain in the pelvic girdle area.  Osteopaths offer safe, gentle manipulation and stretches.
  • Many pregnant women find osteopathy relieves common symptoms such as nausea and heartburn.
  • Use of osteopathy can limit perineum or pelvic floor trauma.
  • If your baby suffers from constipation then osteopathy could help.
  • Osteopathy can also play an important preventative role in the care of a baby, child or teenager and bring the body back to a state of balance in health.
  • In assessing a newborn baby, an osteopath checks for asymmetry or tension in the pelvis, spine and head, and ensures that a good breathing pattern has been established.
  • Cranial osteopathy releases stresses and strains in the skull and throughout the body.
  • Osteopaths can feel involuntary motion and mechanisms within the body.
  • Cranial osteopathy aims to reduce restrictions in movement.

Elsewhere in the ASA announcement, we find the statement that “The effectiveness of osteopathy for treating some conditions is underpinned by robust evidence”. The two examples provided are rheumatic pain and joint pain. I have to say I was mystified by this. I am not aware of robust evidence for these two indications. Perhaps someone could help me out here and provide some references?

The only condition for which there is enough encouraging evidence is, as far, as I know low back pain – and even here I would not call the evidence ‘robust’. Am I mistaken? If you think so, please supply the evidence with links to the references.

But, in general, the new guidance is certainly a step in the right direction. Now we have to wait and see whether osteopaths change their advertising and behaviour accordingly and what happens to those who don’t.

WATCH THIS SPACE

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!!!

 

A press-release from a company based in Germany recently caught my attention. I here present only the most relevant sections from this document:

Natural remedies like medicinal mushrooms also called vitality mushrooms haven proven helpful in prevention and as a support in the therapy, of diabetes type 2. This could be shown by long-time observational studies in naturopathy, for example by MykoTroph – Institute for Medicinal Mushrooms. Medicinal mushroom Coprinus has regenerating effects on the pancreas; it also helps the sensitization of the receptors responsible for the absorption of insulin and claims to have a blood sugar lowering effect.

Medicinal mushroom Maitake has positive effects on the fat metabolism and the sensitivity of insulin receptors. Diabetes type 2 is often linked to circulation problems, vascular diseases and hypertension. Therefore, regular monitoring of the blood pressure, blood lipids, triglycerides and body weight is highly important. The intake of Maitake can help ‒ even in a preliminary stage ‒ to get a grip on these determining factors.

Within the scope of a holistic therapy of diabetes type 2 with metabolic syndrome, the combined intake of medicinal mushrooms and Nopal juice (prickly pear) can be very reasonable. Nopal juice has a lowering effect on the glycemic index of ingested food. The consequence is a slower release of carbohydrates in the intestines and is therefore favorable for a healthy level of blood sugar…

Medicinal mushrooms are available as mushroom powder capsules. According to observational studies of MykoTroph – Institute for Medicinal Mushrooms, especially mushroom powder derived from the whole mushroom has proven effective. Only if the mushroom powder is derived from the whole mushroom, the powder will contain all of the effective ingredients of medicinal mushrooms. It should also be taken care that the mushrooms are from certified organic production. For further information, please visit us on http://www.mykotroph.com
a Japanese study participants comprised 726 Japanese T2DM outpatients free of history of CVD. Life styles were analyzed using self-reported questionnaires. The relationship between dietary patterns, identified by factor analysis, and potential risk factors for CVD was investigated by linear and logistic regression analyses….The “Seaweeds, Vegetables, Soy products and Mushrooms” pattern, characterized by high consumption of seaweeds, soy products and mushrooms, was associated with lower use of diabetes medication and healthier lifestyles.

END OF QUOTE

These are claims that could be relevant to millions of diabetic patients worldwide – but are they true?

The study cited above did indeed show an association; but an association is not necessarily a causal relationship! So what evidence is there fore a causal relationship between mushroom-consumption and diabetes? The answer is: frustratingly little.

A Cochrane review concluded that “evidence from a small number of randomised controlled trials does not support the use of G lucidum [Ganoderma lucidum (also known as lingzhi or reishi)] for treatment of cardiovascular risk factors in people with type 2 diabetes mellitus. Future research into the efficacy of G lucidum should be placebo-controlled and adhere to clinical trial reporting standards.”

The authors of another Cochrane review concluded that “our review did not find sufficient evidence to justify the use of G. lucidum as a first-line treatment for cancer. It remains uncertain whether G. lucidum helps prolong long-term cancer survival. However, G. lucidum could be administered as an alternative adjunct to conventional treatment in consideration of its potential of enhancing tumour response and stimulating host immunity. G. lucidum was generally well tolerated by most participants with only a scattered number of minor adverse events. No major toxicity was observed across the studies. Although there were few reports of harmful effect of G. lucidum, the use of its extract should be judicious, especially after thorough consideration of cost-benefit and patient preference. Future studies should put emphasis on the improvement in methodological quality and further clinical research on the effect of G. lucidum on cancer long-term survival are needed. An update to this review will be performed every two years.”

A further study determined whether a supplement of Agaricus blazei Murill extract improves insulin resistance in type 2 diabetes. It was designed as a clinical randomized, double-blind, placebo-controlled trial. Diabetic patients were randomly assigned to either receiving supplement of Agaricus blazei Murill (ABM) extract or placebo (cellulose) 1500 mg daily for 12 weeks. At the end of the study, the subjects who received supplement of ABM extract (n = 29) showed significantly lower HOMA-IR index than the control group (n = 31). The plasma adiponectin concentration increased by 20% in the ABM group after 12 weeks of treatment, but decreased 20% among those taking the placebo. The authors concluded that “ABM extract improves insulin resistance among subjects with type 2 diabetes. The increase in adiponectin concentration after taking AMB extract for 12 weeks might be the mechanism that brings the beneficial effect. Studies with longer periods of follow-up should be conducted in the future.”

On the basis of all this evidence, it seems fair to conclude that mushrooms have little or no effect on diabetes.

And what about the above press-release?

Diabetes is a serious condition that can be well-controlled with diet, exercise and drugs. Many diabetics are nevertheless fed up with taking drugs throughout their entire life and would only be too happy to exchange them for ‘something natural’. Therefore patients might try mushrooms or other natural ‘cures’, if they are promoted in this way. However, this decision could prove fatal (examples of such tragedies abound).

In view of these considerations, I find such promotion irresponsible, unethical and outright dangerous.

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