Monthly Archives: December 2016
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:
- “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].
- “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.
- “…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.
- “…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.
- “…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
- “…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.
- “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.
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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!!!
WARNING: THIS POST IS NOT ABOUT ALTERNATIVE MEDICINE
My first ever scientific paper, a spin-off from my MD thesis, was published exactly 40 years ago. Since then, I have written many more articles. Readers of this blog might think that they are all on alternative medicine, but that is not the case. My most cited paper is (I think) one which combined my research in haemorheology with that in epidemiology. Yet, I would not consider it to be my most important article.
So, what is my most important publication?
It is one that relates to the history of medicine.
How come?
In 1990, I was appointed as chair of Rehabilitation Medicine at the University of Vienna. On the occasion of the official opening of the new 2000-bed university hospital in Vienna, I was asked to say a few words and thought that a review of the history of my department might be a fitting subject. But I was wrong. What I discovered while researching it turned out to be totally unfitting for the event; in fact, it contributed to my decision to leave Vienna in 1993. I did, however, summarize my findings in an article – and it is this paper that I consider my most important publication. Here is its abstract:
Misguided by the notion that the decline of the German race would be prevented by purifying “Aryan blood” and eliminating foreign, particularly Jewish, influences, the Nazis evicted all Jews from universities within their growing empire during the Third Reich. The Medical Faculty of Vienna suffered more than any other European faculty from “race hygiene.” Within weeks of the Nazi annexation of Austria in 1938, 153 of the Faculty’s 197 members were dismissed. By far the most frequent reason for dismissal was Jewish origin. Most victims managed to emigrate, many died in concentration camps, and others committed suicide. The “cleansing” process encountered little resistance, and the vacant posts were quickly filled with persons known not for their medical expertise but for their political trustworthiness. It was in this climate that medical atrocities could be committed. After the collapse of the Third Reich, most members of the Faculty were burdened with a Nazi past. Most remained in office, and those who had to leave were reinstituted swiftly. The Jews evicted in 1938 were discouraged from returning. These events have significantly–and with long-lasting effects–damaged the quality of a once-leading medical school. This story needs to be told to honor its victims and to fortify us so that history does not repeat itself.
As I pointed out in my memoir, it “was not published until 1995, by which time I was no longer at the University of Vienna but had left Austria and gone joyfully back to the U.K. to take up my post at the University of Exeter. When the paper was published, it had a considerable impact and important consequences. On the one hand, I received a torrent of hate-mail and threats, and was even accused by the more sensationalistic elements of the Austrian press of having stolen considerable amounts of money from my department at the University of Vienna – an entirely fabricated story, of course, and so ridiculous that I couldn’t even take it seriously enough to instigate legal action.”
So, what else happened as a consequence of the paper?
The answer is ‘lots’.
The Nazi-dean of the medical faculty in 1938, Eduard Pernkopf, became the author of one of the world’s best anatomical atlas. Here is a short excerpt from a website on Pernkopf and his work which outlines some of the consequences of my paper:
START OF QUOTE
Following Dr. Edzard Ernst’s, revelations in the Annals of Internal Medicine (1995) about the source of Pernkopf’s “models,” Yad Vashem (the Holocaust Authority in Israel) requested that the Universities of Vienna and Insbruck conduct an independent inquiry to determine who the subjects in Pernkopf’s Atlas were and how they died. The request from Yad Vashem was initially denied; but the issue did not end. The following year, a letter by Dr. Seidelman and Dr. Howard Israel, an oral surgeon at Columbia University published in JAMA (November, 1996) in which they stated: “The abuses of medicine perpetrated during the Hitler regime pervaded the entire medical profession of the Third Reich including the academic elite. One legacy of the tragic era endures today through the continued publication of a critically acclaimed atlas, Pernkopf Anatomy…” Their letter prompted a report by the New York Times (1996).
In 1997, Alfred Ebenbauer, the rector of the University of Vienna, wrote to JAMA indicating that an investigation had been initiated and that preliminary findings indicated that the anatomy department had indeed, routinely received corpses of executed persons, among them renowned dissidents, and “brain preparations derived from children under the euthanasia program in psychiatric institutes were still stored there…” For the first time, he acknowledged publicly systematic suppression and even denial of the university’s Nazi past and its failure to conduct relevant investigations. Ebenbauer explained that this attitude had changed because of ‘‘increasing pressure from abroad’’ and a new political atmosphere in Austria (Ethics and Access…Pernkopf atlas, Bulletin of the Medical Library Association 2001; Hildebrandt, 2006).
The final report of University of Vienna investigation found that at least 1,377 bodies of executed victims (guillotined or shot by the Gestapo at a rifle range); about 7,000 bodies of fetuses and children; and “8 victims of Jewish origin” had been received by the Anatomy Institute. A statement for users of Pernkop’s Atlas sent out by the U of V to all libraries states: “it is therefore within the individual user’s ethical responsibility to decide whether and in which way he wishes to use this book.” (Hildebrandt, 2006). Hildebrandt states: “the influx of bodies from executions increased so much during the NS [Nazi] regime that the rooms of the anatomy institute were sometimes overfilled and executions had to be postponed because of this.” However, she notes that the true numbers are not known because of incomplete documentation.
Howard M. Spiro, M.D., director of Yale’s Program for Humanities in Medicine and professor of internal medicine, was among the noted speakers at the convocation in Vienna marking (1998) the 60th anniversary of the dismissal of Jewish faculty members from the Vienna Medical School. In his address The Silence of Words, Dr. Spiro said, “the things that we avoid and don’t talk about are the matters that mean the most to us. The shame that has no vent in words makes other organs weep.” Dr. Spiro acknowledged that current officials of the University of Vienna are attempting to recover information that has either been hidden or destroyed and trying to locate former faculty who were interned and exiled. “There is a new generation that has taken over, and they are not afraid to look into these atrocities.”
It is now understood that many of the incredibly detailed illustrations in Pernkopf’s atlas depicted the bodies of victims of Nazi terror.
END OF QUOTE
Why do I bring this up again today?
For two reasons: firstly, I have been invited to give two lecture about these events in recent weeks. Secondly and much more importantly, we seem to live in times when the threat of fascism in several countries has again become worrisomely acute, and I think reminding people of my conclusion drawn in 1995 might not be a bad idea:
This story needs to be told to honor its victims and to fortify us so that history does not repeat itself.
Not being a native English speaker, I was not entirely sure what precisely slapping means. A dictionary informed me that it stands for “hitting somebody/something with the flat part of your hand”. And ‘slapping therapy’? What on earth is that? It occurred to me that there might be several types of slapping therapy.
HITTING SOMEONE WHO DISAGREES
Yes, it might be therapeutic to do that! Imagine you discuss with someone and realize that you do not have very good arguments to defend an irrational position. Eventually, you are cornered and angry. All you can think of is to slap your opponent.
No, not very constructive, but all too human, I suppose.
This sort of thing has happened to me several times during discussions at conferences: my opponents went so mad that I saw them clinching their fists or raising their hands. Fortunately, I can run quite fast and (so far) always managed to avoid the impending physical violence.
INSULTING SOMEONE WHO DISAGREES
That sort of thing happens regularly. I have written posts about the phenomenon here, here, here and here, for instance. If you read the comments sections of this blog, you regrettably find plenty of examples.
If I am honest, I must admit that, on some occasions, I have in desperation joined into such mud-battles. I am not proud of it but sometimes it just happens. We are all just human, and it certainly feels therapeutic to be rude to someone who is a continuous and deplorable nuisance by hurling insults at opponents.
Having made this confession, I must stress (again) that, on this blog, we ought to avoid this sort of slapping therapy. In the long run, it is unhelpful and only escalates the aggression.
KINKY SLAPPING
When I googled ‘slapping’ I was referred to all sorts of sleazy websites which were essentially displaying maso-sadistic pornography that involved one person slapping another for sexual pleasure. Personally, I do not get a kick out of this type of slapping therapy and find it sad that some people obviously do.
PAIDA
Paida is the form of slapping therapy that recently made headlines and which therefore prompted this post. Paida in Chinese means to slap your body. Sure enough, the TCM people have made it into an alternative treatment which is usually called SLAPPING THERAPY (what will they think of next? you may well ask!). Already the sexual version of slapping therapy was not really funny, but this certainly is where the satire stops!
Hongchi Xiao, a Chinese-born investment banker, popularised this treatment some time ago. It involves slapping the body surface with a view of stimulating the flow of ‘chi’. Slapping therapists – no, they are not called ‘slappers’!!! – believe that this ritual restores health and eliminates toxins. In fact, they claim that the bruises which patients tend to develop after their treatment are the visible signs of toxins coming to the surface.
The treatment is not based on evidence — I know of not even a single clinical trial showing that it works — and it is certainly not agreeable. But at least it’s safe! No, you’d be wrong to think so: if slapping therapy, or any other bizarre and useless intervention is being employed as a replacement for treating a serious condition, it inevitably becomes life-threatening.
Recently, it was reported that a woman from East Sussex died after receiving slapping therapy; other fatalities have been documented previously. The latest victim had been suffering from diabetes and was led to believe that Paida was an effective treatment for her condition. Consequently, she discontinued her medication, a decision which eventually killed her.
Deaths after apparently harmless alternative treatments are being reported with depressing regularity. However, much more often, the resulting harm is not quite so dramatic, simply because the conditions treated are fortunately not life-threatening. In such cases, the ineffectiveness of the treatment does not lead to disaster, but it nevertheless causes unnecessary expense and prolongation of suffering.
We live in a time where we are constantly being told, for instance by ‘experts’ like Prince Charles, that we ought to be respectful towards ancient traditions of healthcare. So, let’s be clear: I am all for respect towards other cultures, but in medicine there should be limits. I do not see any benefit in either respecting or implementing ancient, obsolete notions of life energies, meridians, toxins and other disproven assumptions of alternative practitioners. They originate from a pre-scientific era and have been disproven. They do not belong in modern treatment manuals; at best, they belong in the history books of medicine.
Guest post by Frank Van der Kooy
“….the concept of circulation of energy is paramount in Chinese Medicine. The Chinese physicians have always said there’s more than just blood circulating in the body, there’s also energy, human energy of some sort circulating in the body. We don’t know how to measure that yet.”
This is a quote from a radio interview where the wonderful and mysterious world of TCM was explained to the unsuspecting Australian public – this interview took place about 16 years ago. You can find more details regarding this very interesting interview here. From the above quote, it is clear that the circulation of “energy” is paramount to TCM and that, at the time, it could not be measured nor could its existence be shown. The quote, however, ends with the word ‘yet’, indicating there is full support for the notion that this energy field do indeed exist and that it is only a matter of time before it will be detected.
Now, just imagine if someone do indeed discover this energy field with a simple experiment that can be independently reproduced by others. As soon as you can measure it, you can influence it and hence control it, which implies that you will be able to significantly improve and personalise your TCM treatments – and this will almost certainly lead to a Nobel prize in medicine and you might even become stinking rich as well. Fame and fortune up for grabs. It therefore stands to reason that TCM researchers worldwide including those at the National Institute of Complementary Medicine (NICM), the latter who are well funded and have excellent research facilities, would have had more than enough incentive and would’ve spent a significant amount of research effort to detect this energy field in the 16 years since they gave the interview.
So, have they done any research on this very fundamental issue? They can vindicate TCM and for that matter most of complementary medicine if they did, never mind the major improvements in healthcare that might flow from this. The short answer is, no, they haven’t. I am not aware of any study done by any TCM researcher, or anyone at the NICM, past or present, investigating this extremely important issue. So, no progress, but also absolutely no interest in studying this extremely important aspect of TCM. But why is this?
The answer is really quite simple: As soon as you conduct a well-designed experiment you are bound to end up with a yes/no answer – or at least this is what you want. Yes, my hypothesis is correct or no, it is incorrect. Granted, you can also design an experiment that will almost always give you a positive result such as the A + B vs B clinical trial (well known to integrative medicine researchers). But for argument sake, let’s assume that they did study this aspect in a well-designed experiment and that they came up empty handed – which is quite likely because you cannot detect something if it does not exist – this will then be further evidence that the fundamental principles of TCM is absolutely rubbish. And this is of course something that they cannot publish or admit, so it is far better for the TCM researchers and the NICM to completely ignore this issue.
A second reason is that they know damn well that this energy field do not exist but they have to continue to sell this idea to the public in order to import more and more TCM modalities into Australia – for them it is all about business (it is that $170 billion TCM market that they want to tap into). This is the most likely explanation for their failure to investigate this fundamental principle of TCM.
There is however a couple of other general issues: There is a true believe that this energy field exist because in the TCM world all modalities work – evidence for this concept is that close to a 100% of TCM clinical trials conducted in China gives a positive result. That the NICM and TCM practitioners believe this (either because they truly believe it or they make as if they believe it for the sake of their business interests) can be seen if you look at the long list of medical conditions for which something like Rhino horn is considered to be an effective treatment; “High fever, sun stroke, trauma, mania, convulsion, sore throat, epilepsy, febrile disease, infectious disease, macula, bad skin conditions, subcutaneous bleeding.” It works for just about everything. And this goes for all TCM modalities. TCM researchers are completely happy to entertain this notion because they are actively trying to sell the energy concept to the public, and once accepted by the public, they will flood the market with TCM modalities.
It is also remarkable to think, and please correct me if I am wrong, that there are still people in China that die due to any medical condition after receiving a specific TCM treatment – if this energy field exist this should not really happen. Granted, due to logistical issues, some people might not receive their lifesaving TCM modalities in time but surely there are people who died even after timely administration of a TCM remedy? And for that matter, if TCM works so well, why would China import or use modern conventional medicine which is, according to the TCM proponents, ineffective, toxic, expensive etc. Surely, you are not going to replace something that works (TCM) with something that doesn’t work (conventional medicine)! Or is maybe the other way around?
Another interesting aspect regarding TCM is that it seems to be impossible to make a mistake (is it even possible to misdiagnose a patient?). Take acupuncture for example: the theory, or should I say, hypothesis, is that pain is caused by either an excess or deficiency of energy (as explained by the NICM in the very interesting radio interview). Acupuncture restores this energy balance and hence your back pain, which might have been diagnosed as an excess of energy, will now dissipates. But what will happen if an inexperienced acupuncturist use too many, or too few needles and maybe even insert them at the wrong acupoints? According to the hypothesis, too much energy will now flow from your lower back and this will cause an excess of energy somewhere else (causing pain in that region), but your backpain will still be there because you now have a deficiency of energy in your lower back. Is this sort of treatment ‘mistakes’ known to happen in acupuncture? Puncturing of an organ or infection due to dirty needles is well known but I am not aware of any examples where the above-mentioned treatment ‘mistakes’ have been documented. If these energy fields do exist this should happen quite regularly. The only explanation that this doesn’t really happen is that these energy fields simply do not exist.
TCM researchers including the NICM have no interest in studying the “energy” aspect of TCM and their only purpose is to sell these pseudoscientific principles to the public. More TCM products means more profit. For the NICM this should pave the way to open their very own TCM hospital in Sydney where the Australian population will be used as guinea pigs. I truly feel sorry for Australians because it appears that it is not only their cricket team that is struggling at the moment, some of their universities are in real trouble because they decided to put profits and pseudoscience, before science, scientific education and the welfare of the public.
