I was reliably informed that the ‘Australian Acupuncture and Chinese Medicine Association’ (AACMA) are currently – that is AFTER having retracted the falsehoods they previously issued about me – distributing a document which contains the following passage:
It is noted that Mr Ernst derives income from editing a journal called Focus on Alternative and Complementary Medicine which is published by the British Pharmaceutical Society and listed in pharamcologyjournals.com. Ernst has not declared his own pecuniary conflicts of interest and links with the pharmaceutical industry. I note that the FSM webpage declares that:
‘None of the members of the executive has any vested interests in pharmaceutical companies such that our views or opinions might be influenced’.
This statement is disingenuous and deceptive if instead you base your critique on the blog of a person with such pharmaceutical interests without declaring it.
This is a repetition of the lies which the AACMA have already retracted (see comments section of my previous post on this matter). In my view, this is highly dishonest and actionable. For this reason, I today sent them this ‘open letter’ which I also publish here:
As explained more fully in this blog-post, you have recently accused me of undeclared links to and payments from the pharmaceutical industry. This is a serious, potentially liable allegation.
My objections were followed by your retraction of these allegations (see the comments section of my above-mentioned blog-post). However, your retraction displays an embarrassing level of ignorance and contains several grave errors (see the comments section of my above-mentioned blog-post). Crucially, it implies that I formerly had an undeclared conflict of interest. This is untrue. More importantly, you currently distribute a document that continues to allege that I currently have ‘pharmaceutical interests’. This too is untrue.
I urge you to either produce the evidence for your allegations, or fully retract them. This strategy would not merely be the only decent and professional way of dealing with the problem, it also might prevent damage to your reputation, and avoid libel action against you.
We probably all heard about the horrific stories related to Larry Nassar who, on January 24, 2018, was sentenced to 40 to 175 years in a Michigan state prison after pleading guilty to the sexual assault of numerous minors and US gymnasts. But few of us, I think, had any idea that these stories also relate to alternative medicine. This is an excerpt from an article in the LOS ANGELES TIMES.
… McKayla Maroney, the Olympic gold medalist who says she was paid $1.25 million by the United States Olympic Committee and USA Gymnastics to stop her from speaking out, put it flatly: “Dr. Nassar was not a doctor.”
No wonder the survivors chose to crush that word. “Doctor” was Nassar’s supreme and founding lie. It notarized him as a professional pledged to heal, and launched his 20-year child-molestation spree, gaining him a sturdy disguise, a complicity network, access to victims and a savage sense of entitlement.
What allowed Nasser to use the honorific? In 1993, he received a doctorate in osteopathic medicine from Michigan State University. MSU, of course, went on to protect and pay Nassar, the almighty and trusted doctor, as a faculty member for 20 years. Lou Anna Simon, MSU’s president, resigned this week amid charges that the university covered for Nassar and enabled him. USA Gymnastics, where Nassar also passed as a doctor, is similarly accused of giving safe harbor to a known criminal, while hushing and deceiving his victims. Under pressure, the group announced this week that the entire USAG board would resign.
Osteopathic medicine focuses on the joints, muscles and spine. Historically, though, osteopathy — its original name — was closely associated with a set of esoteric massage styles that some researchers now consider ineffective or worse. For its part, MSU’s College of Osteopathic Medicine still teaches these unusual manipulations — a special “benefit” unique to osteopathic medicine — describing them as a form of “hands-on diagnosis and treatment.”
Some historical context: Andrew Taylor Still, the founder of osteopathy, wrote of his medical discoveries in 1897: “I could twist a man one way and cure flux … shake a child and stop scarlet fever … cure whooping cough in three days by a wring of the child’s neck.”
Modern osteopathic medicine uses none of these techniques to treat infections — or anything else. But the specter of violence and child abuse that Still conjured in his early writings continues to haunt the fringes of osteopathic medicine. These practices include intravaginal manipulation. Fisting. This was the “medical procedure” Nassar performed on so many young girls.
According to his victims, Nassar’s attention wasn’t on their hamstrings or ACLs; instead, he focused on their anuses, breasts and vaginas. In January 2017, one victim spelled it out in her complaint: “Nassar digitally penetrated Plaintiff Jane A. Doe’s vagina multiple times without prior notice and without gloves or lubricant.” Other victims describe Nassar’s forcing his “dry fingers” into their anuses and vaginas. The violent fisting was excruciating. “I’d want to scream,” said Kassie Powell, an MSU pole vaulter. As Amy Labadie, a gymnast, put it: “My vagina was sore during my competition because of this man.”
Then came the gaslighting. When the girls blew the whistle, Nassar and his enablers tirelessly reasserted his privileges as a doctor. “We were manipulated into believing that Mr. Nassar was healing us as any normal doctor is supposed to do,” Capua testified. Just last year, the American Osteopathic Assn. released a statement to MLive.com, the Michigan news service, saying that intravaginal manipulations are indeed an approved, if rare, osteopathic treatment for pelvic pain…
END OF EXCERPT
I feel sick and am speechless.
But before my detractors point it out: yes, such monserous transgressions do occur in conventional healthcare too. And no, I am not implying that all osteopaths are criminal perverts.
Sorry, but something I stated in my last post was not entirely correct!
I wrote that “I could not find a single study on Schuessler Salts“.
Yet, I do know of a ‘study’ of Schuessler Salts after all; I hesitate to write about it because it is an exceedingly ugly story that goes back to the ‘Third Reich’, and some people do not seem to appreciate me reporting about my research on this period.
The truth, however, is that I already did mention the Schuessler salts before on this blog: “…in 1941 a research unit was established in ‘block 5’ [of the Dachau Concetration Camp] which, according to Rascher’s biographer, Sigfried Baer, contained his department and a homeopathic research unit led by Hanno von Weyherns and Rudolf Brachtel (1909-1988). I found the following relevant comment about von Weyherns: “Zu Jahresbeginn 1941 wurde in der Krankenabteilung eine Versuchsstation eingerichtet, in der 114 registrierte Tuberkulosekranke homöopathisch behandelt wurden. Leitender Arzt war von Weyherns. Er erprobte im Februar biochemische Mittel an Häftlingen.” My translation: At the beginning of 1941, an experimental unit was established in the sick-quarters in which 114 patients with TB were treated homeopathically. The chief physician was von Weyherns. In February, he tested Schuessler Salts [a derivative of homeopathy still popular in Germany today] on prisoners.”
Wikipedia provides further details: [Im Dritten Reich] konnten erstmals mit staatlicher Billigung und Förderung Untersuchungen durchgeführt werden, in denen die behauptete Wirksamkeit „biochemischer“ Arzneimittel überprüft wurde. Solche Versuche fanden auch in den Konzentrationslagern Dachau und Auschwitz statt, unter Leitung des Reichsarztes SS Ernst-Robert Grawitz. Dabei wurden unter anderem künstlich herbeigeführte Fälle von Blutvergiftung und Malaria weitgehend erfolglos behandelt. Für die Häftlinge nahmen diese Experimente in den meisten Fällen einen tödlichen Ausgang.
My translation: During the Third Reich, it became possible for the first time possible to conduct with governmental support investigations into the alleged effectiveness of ‘biochemical’ Schuessler Salts. Such tests were carried out in the concentration camps of Dachau and Auschwitz under the leadership of Reichsarzt SS Ernst-Robert Grawitz. They involved infecting prisoners with sepsis and malaria and treating them – largely without success. Most of the prisoners used for these experiments died.
I also found several further sources on the Internet. They confirm what was stated above and also mention the treatment of TB with Schuessler Salts. Furthermore, they state that the victims were mostly Polish priests:
- Versuchsstation im Krankenrevier des KZ Dachau, in der Tuberkulosekranke mit homöopathischen Mitteln behandelt werden. Leitender Arzt ist Dr. von Weyherns, 114 Versuchspersonen sind registriert.
- Zu Jahresbeginn 1941 wurde in der Krankenabteilung eine Versuchsstation eingerichtet, in der 114 registrierte Tuberkulosekranke homöopathisch behandelt wurden. Leitender Arzt war von Weyherns.
- Dr. Rudolph Kießwetter, (andere Schreibweise: Kiesewetter), Biochemiker aus Magdeburg, spritzte 10 Häftlingen Eiter in die Oberschenkel bzw. in die Venen, 7 starben. (Experimente mit Entzündungen: vgl. Sulfonamid-Experimente von Karl Gebhardt)
- Mitte Juni 1942 wurde Heinrich Schütz Leiter der Biochemischen Versuchsstation im Krankenrevier des Konzentrationslagers Dachau. Dort erprobte er biochemische Heilmittel an Häftlingen, die er mit bakteriellen Eitererregern infiziert hatte. Die Opfer waren vor allem polnische Priester im Pfarrerblock (KZ Dachau). Hintergrund war die These, dass Krankheiten auf einer Störung der Gewebesalze in den Körperzellen beruhen und durch Mineralzufuhr in homöopathischer Verdünnung geheilt werden könnten. Obwohl die meisten Versuche mit dem Tod der Erkrankten endeten, wurden die biochemischen Mittel weiter erprobt, ungeachtet der Tatsache, dass mit den Sulfonamiden wirksame Medikamente zur Verfügung standen. Bei diesen Versuchen halfen ihm unter anderem Waldemar Wolter und Karl Babor.
- Ab Mitte Juni 1942 waren Babor und Waldemar Wolter Assistenzärzte in der „Biochemischen Versuchsstation“ im KZ Dachau. Dort wurden unter der Leitung von Heinrich Schütz an Häftlingen Sepsisversuche durchgeführt, um die Wirksamkeit von biochemischen Heilmethoden gegenüber Sulfonamiden bei Infektionen zu testen. Insgesamt wurden zwischen Mitte und Ende 1942 vier Versuchsreihen durchgeführt. Bei den äußerst schmerzhaften und inhumanen Versuchen, bei denen Häftlingen auch der eigene Eiter injiziert wurde, starben mindestens 28 Häftlinge.
The last source claims that at least 28 prisoners died as a result of these unspeakably cruel experiments.
The most detailed account (and even there, it is just 2 or 3 pages) about these experiments that I could find is in the superb and extremely well-researched book ‘AUSCHWITZ, DIE NS MEDIZIN UND IHRE OPFER’ by Ernst Klee. In it (p 146), Klee cites Grawitz’s correspondence with Himmler where Grawitz discloses that, prior to the Dachau ‘Schuessler experiments’, there were also some in Auschwitz where all three victims had died. Apparently Grawitz tried to persuade Himmler to stop these futile and (even for his standards) exceedingly cruel tests; the prisoners suffered unimaginable pain before their deaths. However, Himmler reprimanded him sharply and instructed him to continue. Dr Kiesswetter was subsequently recruited to the team because he was considered to be an expert on the clinical use of Schuessler Salts.[Another book entitled ‘Der Deutsche Zentralverein homöopathischer Ärzte im Nationalsozialismus‘ also mentions these experiments. Its author claims that Weyherns was not a doctor but a Heilpraktiker (all other sources agree that he was a medic). In general, the book seems to down-play this deplorable story and reads like an attempt to white-wash German homeopathy during the Third Reich] .
Klee concludes his chapter by reporting the post-war fate of all the doctors involved in the ‘Schuessler experiments’:
Dr Waldemar Wolter was sentenced to death and executed.
Dr Hermann Pape disappeared.
Dr Rudolf Kiesswetter disappeared.
Dr Babor fled to Addis Abeba.
Dr Laue died.
Dr Heinrich Schuetz managed to become a successful consultant in Essen. Only in 1972, he was charged and tried by a German court to 10 years of jail. Several of his colleagues, however, certify that he was too ill to be imprisoned, and Schuetz thus escaped his sentence.
Why do I dwell on this most unpleasant subject?
Surely, this has nothing to do with today’s use of Schuessler Salts!
Do I do it to “smear homeopathy and other forms of complementary medicine with a ‘guilt by association’ argument, associating them with the Nazis“, as Peter Fisher once so stupidly put it?
I have other, more important reasons:
- I do not think that the evidence regarding Schuessler Salts is complete without these details.
- I believe that these are important historical facts.
- I feel that the history of alternative medicine during the Third Reich is under-researched and almost unknown (contrary to that of conventional medicine for which a very large body of published evidence is now available).
- I feel it should be known and ought to be much better documented than it is today.
- I fear that we live in times where the memory of such atrocities might serve as a preventative for a resurgence of fascism in all its forms.
There has been a flurry of legal actions against manufacturers of homeopathic products (mostly) in the US. Many of these cases seem to settle out of court which means that we hardly hear about them. Of those that go to court, most are being won by the plaintiffs, but unfortunately some are also lost.
The recent case of Allen v. Hyland’s, Inc. is such an incidence. The US lawyer Robert G Knaier has analysed this case in detail and recently published a paper about it. The article is fascinating and well worth reading in full.
Here I take the liberty to show you a (shorted) section of Knaier’s paper where he asks what went wrong:
… How did a jury decide that Hyland’s did not misrepresent the efficacy of its products? Surely, the court’s instruction that Hyland’s would be liable only if the plaintiffs proved homeopathy “cannot work” contributed to the result. So long as defense experts were able to propose ways that homeopathy might work, the jury was left with the difficult decision—for laypersons, in any event—of rejecting that testimony.
But should the jury ever have been put in the position of having to make that choice? Should the defense experts ever have been allowed to testify? Had the court in Allen granted the plaintiffs’ motions to exclude those experts, the case likely would have ended with a settlement. Without the ability to put on evidence supporting its products, Hyland’s may very well have recognized that it had no realistic chance of prevailing at trial. But the court denied those motions.
In this respect, the court erred. There can be little doubt that expert testimony in support of the efficacy of homeopathy fails tests of admissibility. Consider the Federal Rules of Evidence and the factors that courts should evaluate under Daubert and its progeny. Is testimony that homeopathy is effective “the product of reliable principles and methods”?
In other words, does it have a “reliable foundation”? Is “the reasoning or methodology underlying [it] . . . scientifically valid”? As explained above, homeopathy’s core principles—provings, like cures like, and the law of minimum dose—are based on little more than Samuel Hahnemann’s late eighteenth-century speculations. They were not developed through, nor have they been validated by, controlled scientific studies… the principles and efficacy of homeopathy have been “tested” and “subjected to peer review and publication” — but they have consistently failed those tests and the scrutiny of that review process… Indeed, the FDA has stated that it simply is “not aware of scientific evidence to support homeopathy as effective.”
Thus, homeopathy’s “rate of error” is known, and far from gaining “general acceptance” in the scientific and medical community, it has gained near-universal condemnation. The defense of homeopathy, in some respects, presents a classic example of “unjustifiably extrapolat[ing] from an accepted premise to an unfounded conclusion.” Advocates extrapolate from the efficacy of vaccines that similia similibus currentur has a sound scientific basis, and from the concept of hormesis that providing ultralow doses is well-founded methodology. But as one contemporary skeptic has explained, unlike homeopathic remedies, vaccines actually “contain measurable numbers of antigen molecules,” and “act by well-understood scientific mechanisms”; and hormesis, even in the limited circumstances in which it appears to operate, “describes a response to a low dose, not to no dose.” As Martin Gardner noted many decades ago, the defense of homeopathy thus begins with plausible-sounding principles, and then “exaggerate[s] them to the point of absurdity.” In other words, it impermissibly extrapolates to “unfounded conclusion[s].”
Finally, the defense of homeopathy glaringly fails to “account for obvious alternative explanations.” Do people who take homeopathic remedies sometimes feel better? Of course they do. But studies of homeopathy have overwhelmingly concluded that the reason for this is not that homeopathy is actually efficacious, but rather because it is “the ideal placebo.” It is cheap. It has no side effects (unless, as discussed below, it is adulterated). And practitioners spend substantial time with their “patients,” thus encouraging psychosomatic effects.
In the end, advocates of homeopathy may have little to stand on other than that many people—including some “experts” who would gladly be paid to testify—inexplicably seem to believe that it works. But this will not do. That homeopathy has many believers does not validate it as a scientifically sound “field of expertise,” or color it, against nearly 200 years of evidence to the contrary, as one “known to reach reliable results for the type of opinion the expert would give.” As our Supreme Court perhaps most saliently observed, “general acceptance” of a principle cannot “help show that an expert’s testimony is reliable where the discipline itself lacks reliability.” As the Court explained, general acceptance of “principles of astrology or necromancy,” for example, would not transform those subjects into appropriately reliable subjects of expert testimony. The Court could easily have added homeopathy to that list.
Thus, in allowing the jury to receive testimony about the principles of homeopathy—not as a matter of historic curiosity, but as a matter of scientific validity—the Allen court arguably abdicated its gatekeeping responsibility to screen out unreliable expert testimony. By permitting “experts” to testify in favor of a field the bases of which defy basic principles of biology, chemistry, and physics — indeed, in some respects “basic logical principles” — the “integrity and fairness of the trial process” was compromised.
END OF QUOTE
I fully agree with Knaier. Allowing the ‘flat earth society’ to present to a court their views about the shape of our planet, while instructing the jury that they must accept them as ‘evidence’ (unless the plaintiff can prove it to be untrue) cannot be the right way forward. In fact, it is a method of preventing progress. Following this logic, I cannot imagine the proponents of any absurdity – however ridiculous – to not be victorious in court.
Knaier’s ultimate conclusion is, I think correct: “Trial courts have robust power and clear responsibility to preclude litigants from introducing irrelevant and unreliable evidence in support of purportedly scientific claims… To the extent that courts continue abdicating their evidentiary gatekeeping role in this way, they may contribute to a waste of time and resources, financial harm to consumers, and risks to public health. But to the extent that litigants and courts strengthen their spines in this regard, take seriously the dangers of unfounded expert testimony, and make genuine efforts to seek and grant its exclusion, they might contribute to the health and well-being of both the courts and those who turn to them for help.”
Herbal and homeopathic lobby groups have petitioned to stop NHS England from removing herbal and homeopathic medicines: NHS England is consulting on recommendations to remove herbal and homeopathic medicines from GP prescribing. The medicines cost very little and have no suitable alternatives for many patients. Therefore we call on NHS England to continue to allow doctors to prescribe homeopathy and herbal medicine. The petition received around 16 500 signatures.
Now the UK government has responded. I take the liberty of posting the full response below:
Information from NHS England (NHSE) shows that in 2015, the cost for all prescriptions dispensed in primary care, not including any dispensing costs or fees, was £9.27 billion, a 4.7% increase on the previous year. Due to the increasing cost, NHSE is leading a review of medicines which can be considered as being of low clinical value and develop new guidance for Clinical Commissioning Groups (CCGs).
On 21 July, NHSE launched a three month consultation on the draft guidance on low value prescription items which is based on the latest clinical evidence, including that from the National Institute of Health and Care Excellence (NICE). Careful consideration has been given to ensure that particular groups of people are not disproportionately affected, and that principles of best practice on clinical prescribing are adhered to.
The commissioning guidance, upon which NHSE is consulting, will be addressed to CCGs to support them to fulfil their duties around the appropriate use of prescribing resources. This will need to be taken into account by CCGs in adopting or amending their own local guidance to their clinicians in primary care.
The aim of this consultation is to provide individuals with information about the proposed national guidance and to seek people’s views about the proposals. NHSE welcomes the views of the public, patients, clinicians, commissioners and providers through this consultation process to help inform the final guidance. The consultation ends on 21 October. Links to the consultation can be found here:
It is the responsibility of local NHS organisations to make decisions on the commissioning and funding of any healthcare treatments for NHS patients, such as homeopathy, taking account of issues to do with safety, clinical and cost-effectiveness and the availability of suitably qualified and regulated practitioners.
Complementary and alternative medicine (CAMs) treatments can, in principle, feature in a range of services offered by local NHS organisations. A treating clinician would take into account an individual’s circumstances and medical history in deciding what would be the most appropriate treatment for their condition. CCGs will have specific policies on the commissioning and funding of CAMs, and may have also developed local policies on priorities with regards to the funding of treatments. A GP would have to work within such policies in providing any treatments on the NHS.
The Department of Health supports an approach to evidence-based prescribing which does not support the commissioning of services which are not clinically and cost effective. We are not aware of any evidence that demonstrates the therapeutic effectiveness of homeopathic products. The National Institute for Health and Care Excellence (NICE) does not currently recommend that homeopathy should be used in the treatment of any health condition, whilst primary care prescribing data shows that there has been a significant decline in the prescribing of homeopathic products over the last 10 years. Furthermore, a good number of NHS organisations are reviewing their funding of homeopathic treatments and some have already stopped funding such treatment altogether.
Department of Health
END OF QUOTE
This hardly needs a comment. Perhaps just this:
I find phraseology such as “We are not aware of any evidence that demonstrates the therapeutic effectiveness of homeopathic products” regrettable. It enables homeopaths and their supporters to counter that the government or anyone else who use this argument are ill-informed. There are, of course, quite a few positive trials of homeopathy. To deny it is a mistake, in my view, and one that would be easily avoidable.
I would have formulated this sentence differently: “We are not aware that the totality of the reliable evidence demonstrates the therapeutic effectiveness of homeopathic products”.
That is a correct and relevant statement.
Isn’t it wonderful when your long-held views are confirmed by someone with influence?
This, of course, is a rhetorical question – I can tell you: it is wonderful!
The multibillion-dollar market for “natural” health products has flourished under lax government regulations. These regulations have enabled manufacturers to exploit the public’s difficulty in distinguishing nonprescription drugs, with scientifically proven therapeutic benefits, from herbal or homeopathic preparations and supplements that often make similar health claims with little or no evidence and are frequently grounded in unscientific belief systems about health and disease…
In pharmacies, supermarkets and convenience stores, natural health products are displayed side by side with nonprescription drugs. Both tout their approval by Health Canada as an implicit endorsement of efficacy and safety on package labels that make similar health claims. However, although nonprescription drugs and their therapeutic claims require scientific evidence that is carefully scrutinized by Health Canada, natural health products have a separate regulatory system that typically imposes such minimal requirements that it is effectively a rubber stamp. Unlike nonprescription drugs, if a problem arises with a natural health product, Health Canada has little or no authority to compel any changes to its manufacture, labelling or sale.
…Risk is often difficult to perceive accurately without direct evidence. For example, under the proposed framework, Health Canada would continue to classify most homeopathic preparations as low-risk products and, thus, exempt from scientific review. Recently, a homeopathic product sold in the United States that claimed to relieve teething pain in infants and supposedly contained a very dilute extract from the belladonna plant was associated with several deaths of infants who manifested classic signs of anticholinergic poisoning…
…If consumers are unable to separate products with no scientific proof behind them from products supported by evidence, then we need to separate them in stores. Natural health products should be pulled from the shelves where they are mixed with nonprescription drug products and confined to their own separate section, away from any signage implying a therapeutic use.
The double standard perpetuated by both regulators and retailers that enables the deception of unsuspecting Canadians must end. Alternative medicines with claims based on alternative facts do not deserve an alternative, easy regulatory road to market — at the very least, they need to be moved to an alternative shelf.
END OF QUOTES
This, of course, is Canada. But elsewhere progress is also being made.The Australian reported about plans in Australia whereby pharmacies would be banned from selling useless and possibly dangerous homoeopathic remedies. The Australian last year revealed a review of pharmacy regulation, headed by Stephen King from the Productivity Commission, identified a potential conflict of interest in pharmacists selling vitamins, for example, that may not have a significant evidence base, alongside more stringently regulated and government-subsidised medicines. In its interim report, the review panel was “concerned that the sale of complementary medicines alongside other medicines may mislead consumers”. It therefore concludes that “complementary medicines should be held in a separate area within community pharmacies, where customers can easily access a pharmacist for appropriate advice.”
“To avoid potential harm, or the confusion between the efficacies of different types of medicines, pharmacists need to be easily accessible to give needed advice when consumers choose a complementary or pharmacy-only medicine,” the review panel said. It was scathing of homoeopathy and the perception of legitimacy given to those so-called remedies sold in pharmacies. “The only defence put to the panel regarding homoeopathy was that it was harmless and able to be used as a placebo in certain circumstances,” the review panel noted. “The panel does not believe that this argument is sufficient to justify the continued sale of these products in pharmacies …”
AUSTRALIAN JOURNAL OF PHARMACY (AJP) noted that the interim report of the Review of Pharmacy Remuneration and Regulation states that “there are unacceptable risks where community pharmacies are allowed to sell homeopathic products”.
In 2015 Pharmaceutical Society of Australia (PSA) said it did not support the sale of homeopathy in pharmacy. “Our position is that pharmacists must use their professional judgement to prevent the supply of products with evidence of no effect,” PSA president Joe Demarte said at the time. Ian Carr, of Saxby’s Pharmacy in Taree, NSW, and Friends of Science in Medicine member, told the AJP that “in terms of homeopathic products being recommended not to be sold by PBS-approved pharmacies, I one hundred per cent heartily agree with that finding. “I love saying that I believe homeopathy works. But it has never been shown to work better than placebo. There are many things that will work as well as placebo, but it’s not ethical to be selling them as a cure or treatment for something. I would have a bit more time for it if there was a plausible theory behind it, but its basis is entirely implausible – it pushes all the buttons for being a pseudoscience, so I agree it has no place in Australian pharmacy. However, I am at a bit of a loss to understand why they haven’t carried some of that logic over into the comments on complementary medicines generally.”
Mr Carr also told the AJP that “If one conceives of complementary medicines as being vitamins and minerals, that’s one thing. But the marketing of those items has become so diffuse and so wide that on most of these CM shelves we have traditional medicines, we’ve got herbal medicines, we’ve got items that are basically just marketing formulas for certain conditions. The evidence behind most of these things is very very slim, and we still have the possibility of health fraudsters just marching in and taking advantage of the lack of regulation in the industry.”
So, Canada and Australia are making progress in protecting consumers from bogus healthcare products and from pharmacists selling them.
When, I ask myself, are the UK, the US and other countries following suit?
In 2006, the World Health Organization and UNICEF created the ‘Global Immunization Vision and Strategy’, a 10-year strategy with 4 main goals:
- to immunize more people against more diseases,
- to introduce a range of newly available vaccines and technologies,
- to integrate other critical health interventions with immunization,
- to manage vaccination programmes within the context of global interdependence.
More than a decade later, we have to realise that this vision has been frustrated, not least by fans of alternative medicine (FAMs). They are almost by definition more negative about the value and achievements of conventional medicine and science. This shows in all sorts of ways; the clearest this phenomenon is documented must be the FAMs’ attitude towards immunisations. Few rational thinkers would doubt that vaccinations are amongst the most important achievement in the history of medicine.
Yet FAMs are not impressed by such statements and often refuse to have their kids vaccinated according to the recommended schedule. This trend has significantly contributed to vaccination rates that, in some parts of the world, are now dropping so low that our ‘herd immunity’ is jeopardised.
One such place is Germany, and the German government is now making a controversial move against parents who choose to refrain from vaccinating their children. Germany is presently passing a law that will force kindergartens to inform the authorities, if parents don’t provide evidence that they have gotten advice from their doctor on vaccinations for their children.
The US ‘FEDERAL TRADE COMMISSION’ has issued an important statement about homeopathic products. The full text with references can be found here; below are a few quotes which I thought were crucial:
“…Homeopathy, which dates back to the late-eighteenth century, is based on the view that disease symptoms can be treated by minute doses of substances that produce similar symptoms when provided in larger doses to healthy people. Many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance. In general, homeopathic product claims are not based on modern scientific methods and are not accepted by modern medical experts, but homeopathy nevertheless has many adherents…
Efficacy and safety claims for homeopathic drugs are held to the same standards as similar claims for non-homeopathic drugs. As articulated in the Advertising Substantiation Policy Statement, advertisers must have “at least the advertised level of substantiation.” Absent express or implied reference to a particular level of support, the Commission, in evaluating the types of evidence necessary to substantiate a claim, considers “the type of claim, the product, the consequences of a false claim, the benefits of a truthful claim, the cost of developing substantiation for the claim, and the amount of substantiation experts believe is reasonable.” For health, safety, or efficacy claims, the FTC has generally required that advertisers possess “competent and reliable scientific evidence,” defined as “tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by qualified persons and [that] are generally accepted in the profession to yield accurate and reliable results.” In general, for health benefit claims, particularly claims that a product can treat or prevent a disease or its symptoms, the substantiation required has been well-designed human clinical testing.
For the vast majority of OTC homeopathic drugs, the case for efficacy is based solely on traditional homeopathic theories and there are no valid studies using current scientific methods showing the product’s efficacy. Accordingly, marketing claims that such homeopathic products have a therapeutic effect lack a reasonable basis and are likely misleading in violation of Sections 5 and 12 of the FTC Act. However, the FTC has long recognized that marketing claims may include additional explanatory information in order to prevent the claims from being misleading. Accordingly, the promotion of an OTC homeopathic product for an indication that is not substantiated by competent and reliable scientific evidence may not be deceptive if that promotion effectively communicates to consumers that: (1) there is no scientific evidence that the product works and (2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts. To be non-misleading, the product and the claims must also comply with requirements for homeopathic products and traditional homeopathic principles. Of course, adequately substantiated claims for homeopathic products would not require additional explanation.
Perfunctory disclaimers are unlikely to successfully communicate the information necessary to make claims for OTC homeopathic drugs non-misleading. The Commission notes:
• Any disclosure should stand out and be in close proximity to the efficacy message; to be effective, it may actually need to be incorporated into the efficacy message.
• Marketers should not undercut such qualifications with additional positive statements or consumer endorsements reinforcing a product’s efficacy.
• In light of the inherent contradiction in asserting that a product is effective and also disclosing that there is no scientific evidence for such an assertion, it is possible that depending on how they are presented many of these disclosures will be insufficient to prevent consumer deception. Marketers are advised to develop extrinsic evidence, such as consumer surveys, to determine the net impressions communicated by their marketing materials.
• The Commission will carefully scrutinize the net impression of OTC homeopathic advertising or other marketing employing disclosures to ensure that it adequately conveys the extremely limited nature of the health claim being asserted. If, despite a marketer’s disclosures, an ad conveys more substantiation than the marketer has, the marketer will be in violation of the FTC Act.
In summary, there is no basis under the FTC Act to treat OTC homeopathic drugs differently than other health products. Accordingly, unqualified disease claims made for homeopathic drugs must be substantiated by competent and reliable scientific evidence. Nevertheless, truthful, nonmisleading, effective disclosure of the basis for an efficacy claim may be possible. The approach outlined in this Policy Statement is therefore consistent with the First Amendment, and neither limits consumer access to OTC homeopathic products nor conflicts with the FDA’s regulatory scheme. It would allow a marketer to include an indication for use that is not supported by scientific evidence so long as the marketer effectively communicates the limited basis for the claim in the manner discussed above.”
CBC news (Canada) reported yesterday that, more than a decade ago, the Manitoba Chiropractic Health Care Commission had been tasked to review the cost effectiveness of chiropractic services. It therefore prepared a report in 2004 for the Manitoba province and the Manitoba Chiropractors Association. Since then, this report has been kept secret. The report makes 37 recommendations, including:
- Manitoba Health should limit its funding to “chiropractic treatment of acute lower back pain.”
- Manitoba Health should provide “limited coverage of the treatment of neck pain.” The report called the literature around the efficacy of chiropractic care for neck pain “ambiguous or at best weakly supportive” and noted such treatment carried a “not insignificant safety risk.”
- Manitoba Health should not fund chiropractic treatment anyone under 18 “as the literature does not unequivocally justify” the “efficacy or safety” of such treatment.
A Manitoba Ombudsman’s Office report from 2012 might shed some light on why the Manitoba Chiropractic Health Care Commission’s report was never made public. Someone had attempted to get a copy of the report, but large parts of it were redacted. “Access to this record was refused on the basis that disclosure would be harmful to a third party’s business interest,” the ombudsman report notes, “and harm the economic or financial interests or negotiating position of a public body.”
The report also challenged claims that chiropractic treatments can be address a wide variety of medical conditions. It stated that there was not enough evidence to conclude chiropractic treatments are effective in treating muscle tension, migraines, HIV, carpal tunnel syndrome, gastrointestinal problems, infertility or cancer, or as a preventive care treatment. It also said there was not enough evidence to conclude chiropractic treatments are effective for children.
The report urged Manitoba Health to establish a monitoring system to keep a closer eye on “the advertising practices of the Manitoba Chiropractors Association and its members to ensure claims regarding treatments are restricted to those for which proof of efficacy and safety exist.” It suggested the government should have regulatory powers over chiropractic ads.
A recent CBC I-Team investigation found Manitoba chiropractors advertising treatment for a wide range of conditions including Alzheimer’s, autism and pediatric services. The commission report contained sharp criticisms of previous reports that suggested funding chiropractic care could save the health-care system money. Dr. Pranlal Manga authored two widely cited reports which claim that by offering publicly funded chiropractic care, provinces can cut health-care costs. “The Manga study on Manitoba must be rejected as a guide to public policy,” the commission report states, “because its assumptions, methodology and costing of recommendations are all deeply flawed.” The reports states, “What limited evidence the Commission has suggests he [Manga] grossly exaggerates possible medical savings.” Dr. Manga did not respond to CBC’s repeated attempts to contact him.
The commission report also made recommendations around the use of X-ray machines by chiropractors. It suggested chiropractors not own and operate X-ray machines “Given the restrictive conditions under which X-rays are advisable, their poor correlation with low-back problems, their apparent limitation as a guide to appropriate treatment …[and] the apparent complete lack of monitoring [of] the use of X-ray by chiropractors.” Instead, it recommended consulting with radiologists when imaging is deemed necessary. “The Commission is of the view that the public interest, and even chiropractic itself, would be better served if chiropractors had access to radiologists for this service, rather than perform it themselves,” the report said.
All three report authors declined comment. Calls to Dave Chomiak, who was health minister at the time the report was prepared, were not returned. In an email to CBC, Manitoba Chiropractors Association president Perry Taylor said, “I personally have never seen this 13-year-old document and [it] pre-dates my time as President. As such I have no comment on this.” The CBC I-Team offered to go through the report with Taylor but he did not respond.
This report seems to confirm much of what we have discussed repeatedly on this blog: Chiropractic is not nearly as effective and safe as chiropractors try to make us believe. To hide this fact is certainly dishonest and unethical, but it is in some ways understandable: this knowledge would directly threaten the income of most chiropractors.
Yesterday I commented on another post: “the conflict of interest seems obvious: if homeopaths speak the truth, they are out of business. therefore, they are taught untruths from the first day of their training and eventually end up believing them. there is only one solution, as far as I can see: regulators must prevent them from making false claims. if not, this will go on for another 200 years and damage many patients’ health”. In the light of the above report, I will now re-phrase this: the conflict of interest seems obvious: if chiropractors allowed the truth to be known, they would soon be out of business. Therefore, they are taught untruths from the first day of their training and many end up believing them. There is only one solution, as far as I can see: regulators must prevent chiropractors from making false claims. If not, this abuse will go on for another 120 years and damage many patients’ health.
On 13 March, the UK Charity Commission published the following announcement:
This consultation is about the Commission’s approach to deciding whether an organisation which uses or promotes CAM therapies is a charity. For an organisation to be charitable, its purposes must be exclusively charitable. Some purposes relate to health and to relieve the needs of the elderly and disabled.
We are seeking views on:
- the level and nature of evidence to support CAM
- conflicting and inconsistent evidence
- alternative therapies and the risk of harm
- palliative alternative therapy
Last year, lawyers wrote to the Charity Commission on behalf of the Good Thinking Society suggesting that, if the commission refused to revoke the charitable status of organisations that promote homeopathy, it could be subject to a judicial review. The commission responded by announcing their review which will be completed by 1 July 2017.
Charities must meet a “public benefit test”. This means that they must be able to provide evidence that the work they do benefits the public as a whole. Therefore the consultation will have to determine what nature of evidence is required to demonstrate that a CAM-promoting charity provides this benefit.
In a press release, the Charity Commission stated that it will consider what to do in the face of “conflicting or inconsistent” evidence of a treatment’s effectiveness, and whether it should approach “complementary” treatments, intended to work alongside conventional medicine, differently from “alternative” treatments intended to replace it. In my view, however, this distinction is problematic and often impossible. Depending on the clinical situation, almost any given alternative therapy can be used both as a complementary and as an alternative treatment. Some advocates seem to cleverly promote their therapy as complementary (because this is seen as more acceptable), but clearly employ it as an alternative. The dividing line is often far too blurred for this distinction to be practical, and I have therefore long given up making it.
John Maton, the commission’s head of charitable status, said “Our consultation is not about whether complementary and alternative therapies and medicines are ‘good’ or ‘bad’, but about what level of evidence we should require when making assessments about an organisation’s charitable status.” Personally, I am not sure what this means. It sounds suspiciously soft and opens all sorts of escape routes for even the most outright quackery, I fear.
Michael Marshall of the Good Thinking Society said “We are pleased to see the Charity Commission making progress on their review. Too often we have seen little effective action to protect the public from charities whose very purpose is the promotion of potentially dangerous quackery. However, the real progress will come when the commission considers the clear evidence that complementary and alternative medicine organisations currently afforded charitable status often offer therapies that are completely ineffective or even potentially harm the public. We hope that this review leads to a policy to remove such misleading charities from the register.”
On this blog, I have occasionally reported about charities promoting quackery (for instance here, here and here) and pointed out that such activities cannot ever benefit the public. On the contrary, they are a danger to public health and bring many good charities into disrepute. I would therefore encourage everyone to use this unique occasion to write to the Charity Commission and make their views felt.