The FDA just made the following significant announcement:
The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.
April 20-21, 2015
9:00 am to 4:00 pm
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503A (Great Room)
Silver Spring, Maryland 20993
Attendance, Registration, and Oral Presentations
Registration is free and available on a first-come, first-served basis. If you wish to attend or make an oral presentation, please reference section III of the forthcoming Federal Register Notice (Attendance and/or Participation in the Public Hearing) for information on how to register and the deadline for registration.
If you cannot attend in person, information about how you can access a live Webcast will be located at Homeopathic Product Regulation
The agenda will be posted soon
And this is what Reuters reported about the planned event:
The hearing, scheduled for April 20-21, will discuss prescription drugs, biological products, and over-the-counter drugs labeled homeopathic, a market that has expanded to become a multimillion dollar industry in the United States. The agency is set to evaluate its regulatory framework for homeopathic products after a quarter century. (http://1.usa.gov/1Hxwup3) An Australian government study released this month concluded that homeopathy does not work. (http://bit.ly/1BheAmR) The FDA issued a warning earlier this month asking consumers not to rely on asthma products labeled homeopathic that are sold over the counter. (http://1.usa.gov/1EEuKrC) Homeopathic medicines include pellets placed under the tongue, tablets, liquids, ointments, sprays and creams. The basic principles of homeopathy, formulated by German physician Samuel Hahnemann in the late 18th century, are based on a theory that a disease can be treated using small doses of natural substances that in a healthy person would produce symptoms of the disease. The agenda for the hearing will be posted soon, the FDA said on Tuesday.
In my view, this is an important occasion for experts believing in evidence to make their position regarding homeopathy heard. I therefore encourage all my readers who have an evidence-based opinion on homeopathy to submit it to the hearing.
I have argued since many years that pharmacists should not be selling or promoting homeopathic and other remedies for which there is no proof of efficacy – the last time I published my view on this matter is even less than a week ago: Personally, I would go another step further and remind pharmacists who sell homeopathic remedies to the unsuspecting public that it is unethical to pretend they are more than placebos.
Despite my insistence and despite the fact that many agree with me (at least privately), there are precious few pharmacists who actually do something meaningful about the current situation. And there is very little visible change: in the UK, it is currently hard to find a pharmacy where homeopathic remedies are not on the shelves, and certainly all the major chains seem to put money before health care ethics.
I am, of course, speaking about the situation in the UK, France, Germany and some other European countries. Perhaps elsewhere things are different?
A NZ website seems to indicate that ‘down under’ the pharmacists are getting more active. Some strongly argue against unproven or disproven remedies in pharmacies:
Firstly, …it’s not a case that “pharmacists ‘should’ only be selling health products for which there is credible evidence of efficacy” (alterations mine, emboldened) but that they are obliged to—but choose not to. Their ethical guidelines state –
[PHARMACISTS] MUST:… Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.
…Secondly, the argument that ‘other businesses sell junk remedies therefore we shall’ is unsound. One of the key points about the ethical regulations for pharmacies is that customers should be able to walk into a store and have an expectation that the remedies within the store are basically sound. If other businesses elect to be unsound, that’s poor health practice, but no justification to do likewise. On the face of it, it would seem that the profit motive is ruling over sound and ethical practice.
Thirdly, that some GPs subscribe placebos should have no standing in this. There is some arguments for GPs to prescribe placebo remedies in some cases; others would argue that education is a better response in most cases. Either way—and just my opinion—it seems to me that GPs prescribing homeopathic remedies encourages people to think these have real remedial effects. I don’t work within the industry, but I am sure are ways of offering placebos that avoid using off-the-shelf commercial products. One might be that patients only get placebo ‘treatments’ via prescription.
…Fourthly, Pharmacy Today encourages that “pharmacies need to reconsider their stance in the light of this report”***. While this is an excellent idea, and one I thoroughly support, I suspect the underlying driver isn’t the report, but media presence on the topic. There is a long trail of evidence over many years showing that homeopathic remedies are not effective for anything.
The Australian study*** that prompted the latest round of interest drew this statement,
Based on the assessment of the evidence of effectiveness of homeopathy, NHMRC concludes that there are no health conditions for which there is reliable evidence that homeopathy is effective.
Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner.* Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
The National Health and Medical Research Council expects that the Australian public will be offered treatments and therapies based on the best available evidence.
…Why were the relevant professional bodies not onto this evidence sooner?…
I might add another one: why are the European professional bodies of pharmacy doing so little about this ongoing breach of their own ethical codes?
(*** the report that the author refers to is the one by the Australian National Health and Medical Research Council we discussed on this blog a few days ago.)
Some time ago, my wife and I had the visit of a French couple. They came from Britany by ferry, and when we picked them up in Plymouth we saw two very pale, sick individuals staggering from the boat. It had been a rough crossing, and they had been sea-sick for 7 hours – enough to lose the will to live! “Why did you not take something against it?” we asked. “But we did”, they replied, “we even went especially to a pharmacy at home to get professional advice. They sold us this medication, but it just did not work.” To my amazement they showed me a homeopathic remedy marketed against sea-sickness in France.
I am sure most readers would have similar, perhaps even better stories to tell. But what do you do with people who happily sell you bogus treatments? Most of us do very little – and that is wrong, I think, very wrong. We need to protest in the sharpest terms each and every time this happens. I would even suggest we do like Mark Twain.
In 1905, Mark Twain sent the following letter to J. H. Todd, a salesman who had just attempted to flog a bogus medicine to the author by way of a letter and leaflet delivered to his home. According to the literature Twain received, the “medicine” in question — called “The Elixir of Life” — could cure such ailments as meningitis (which had previously killed Twain’s daughter in 1896) and diphtheria (which killed his 19-month-old son). Twain, himself of ill-health at the time and recently widowed after his wife suffered heart failure, was furious and dictated this reply.
Your letter is an insoluble puzzle to me. The handwriting is good and exhibits considerable character, and there are even traces of intelligence in what you say, yet the letter and the accompanying advertisements profess to be the work of the same hand. The person who wrote the advertisements is without doubt the most ignorant person now alive on the planet; also without doubt he is an idiot, an idiot of the 33rd degree, and scion of an ancestral procession of idiots stretching back to the Missing Link. It puzzles me to make out how the same hand could have constructed your letter and your advertisements. Puzzles fret me, puzzles annoy me, puzzles exasperate me; and always, for a moment, they arouse in me an unkind state of mind toward the person who has puzzled me. A few moments from now my resentment will have faded and passed and I shall probably even be praying for you; but while there is yet time I hasten to wish that you may take a dose of your own poison by mistake, and enter swiftly into the damnation which you and all other patent medicine assassins have so remorselessly earned and do so richly deserve.
Adieu, adieu, adieu!
(Source: Berry Hill & Sturgeon)
Most pharmacies worldwide sell any bogus treatment to their unsuspecting customers, it seems – as long as it makes a profit, anything goes! Not in New Zealand!
The New Zealand’s Pharmacy Council’s Safe Effective Pharmacy Practice Code of Ethics 2011 section 6.9 requires of pharmacists that:
“YOU MUST… Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.”
This instruction was the basis for a complaint against a New Zealand pharmacy selling a homeopathic remedy against jet lag called “No-Jet-Lag”. The New Zealand Advertising Standards Authority (ASA) considered the complaint and decided to uphold it. The complaint, which was lodged with the ASA by the Society for Science Based Healthcare in July 2014, alleged that the advertisement’s claims about the product that “It Really Works” for “Homeopathic Jet Lag Prevention” were unsubstantiated and misleading.
In defence of their advertising, the manufacturer of the product, Miers Laboratories, submitted a study they had conducted with their product. However, the Advertising Standards Complaints Board ruled that: “the trial population in the pilot study was small, the methodology was not robust and the results had not been published or peer reviewed. The Complaints Board also noted the study was an in-house trial conducted by the Advertiser rather than independent research…Given the weaknesses in the study, the majority of the Complaints Board said the Advertiser had not satisfactorily substantiated the claim the product “really works” and, as such, the Complaints Board said the advertisement had the potential to mislead consumers. Consequently, the Complaints Board said the advertisement did not observe a high standard of social responsibility required of advertisements of this type.”
However, today I found the following text still on the website of the company: Jet lag is the curse of modern jet travel, but it doesn´t have to spoil your trip. The unique homeopathic remedy No-Jet-Lag helps ensure holiday enjoyment and working efficiency even after long airline flights. No-Jet-Lag is raved about by satisfied travellers globally, including business executives, sports teams, tour operators, and flight crews. It is safe, easy to take, and proven effective in tests.
Are the days of “No-Jet-Lag” counted?
Why do not all countries’ pharmacists have such codes of ethics?
Have you ever wondered why homeopathic remedies cost relatively much money? The less they contain, the more expensive they seem to be. The typical homeopathic remedy contains not a single molecule of what it says on the bottle, yet it can cost quite a lot. Why?
The reason is, of course, that these remedies are ‘potentized’ – meaning that the starting material is diluted and subsequently ‘succussed’. The latter term describes the process of vigorously shaking the remedy at each dilution step. Succussion is essential for transferring the life-energy from one dilution to the next, homeopaths insist. The most commonly used OTC remedies are in the ‘C30’ potency. This means that some pharmacist had to do 30 dilutions 1: 100, and each time he or she made a new dilution, he or she had to do the vigorous shaking as well.
Homeopaths are still debating as to how often and how hard the remedy needs to be shaken for the optimal transference of the life-energy; Hahnemann did it by banging the vial on his bible. Meanwhile, inventive manufacturers have developed machines that can manage the succussions semi-automatically. But even then, the process needs to be supervised, and all of this takes time and costs money, of course.
And now you understand why these remedies cannot be as cheap as to reflect the total absence of an active molecule!
And perhaps you also understand why some pharmacists might get truly fed-up doing the dilution/succession knowing that they might as well just put distilled water in the final vial – nobody on this planet could possibly ever tell the difference! I have always imagined that many of them throw the homeopathic rule book in the bin and forget about this tedious procedure.
Actually, I have more than imagined this.
Since I have been giving lectures on homeopathy on a fairly regular basis, I have encountered several pharmacists who told me of their frustration when they had to manufacture homeopathic remedies. Over the years, I met three of them who told me that they became so annoyed with the whole thing that they did precisely what I hinted at above: they just skipped all the dilution and succession and decided to dispense distilled water. Apparently nobody ever noticed.
These are, of course, just stories which people have told me. They may not even be true. I have no evidence whatsoever to substantiate them. But now, an ex-employee of an US homeopathic manufacturer has gone one step further. He published a short report of the time when he worked in the homeopathic industry. His account is so unique that I took the liberty of re-publishing it here:
I have worked at a homeopathic manufacturing plant. Yes, there is always a starting material, however sometimes it can get really shady. Homeopathics are regulated by the FDA under CFR 211, so if you make stuff up (like lie about having a starting material), and they find out about it, you’re in big trouble.
For most herbals, the actual herb is purchased, then tested to make sure it’s the right variety. This can mean TLC (thin layer chromatography), which is what I was responsible for doing when I worked there. A lot of times we got in a different species of the herb, but used it anyway.
Sometimes a pathogenic starting material is used – in that case, we contacted out to a third party micro lab that keep strains in a controlled environment. We paid the micro guy a contract fee to do the dilutions himself which ended up being about $3500 because only he was licensed to deal with pathogens. We made 200 30 mL units out of that which sold for less than $1200 total. Such a waste.
Sometimes a material of animal origin is used. If it’s something weird, like bovine trachea, there really isn’t a good method to test it, so we kind of took the supplier’s word for it. Pretty shady.
One time we needed to do an extraction of “morning dew”, so we went outside in the morning, shook some water off of some weeds, weighed it, then did the dilution.
My favorite story is this one: We needed to do a dilution of uranium 200X. Problem, is you can’t get uranium (unless you’re Doc Brown), so we went to Hanford (this was a looong time ago) carrying a vial of water. When we got there and did a tour (the plant manager knew what we were going to do), we took the vial and held it up against a glass wall that was a close as we could get to the cooling chamber. That became our “1X” dilution. We went back to our lab and diluted it to 200X, in ethanol. We had a lot left over, and because it’s illegal in WA to dump large quantities of ethanol down the drain, we needed a disposal service. Unfortunately, when we tried to explain that it was a 200X dilution (and that there wasn’t even a single atom of uranium in there to begin with), they still wouldn’t take it, because it said “uranium” on the label. So we took a shovel and buried in the back of the plant, and never told anyone.
I told you his story was unique. Did I promise too much?
As a pharmacy professional, you must:
1. Make patients your first concern
2. Use your professional judgement in the interests of patients and the public
3. Show respect for others
4. Encourage patients and the public to participate in decisions about their care
5. Develop your professional knowledge and competence
6. Be honest and trustworthy
7. Take responsibility for your working practices.
Even though these 7 main principles were laid down by the UK General Pharmaceutical Council, they are pretty much universal and apply to pharmacists the world over.
On this blog, I have repeatedly criticised community pharmacists (here I am only discussing this branch of pharmacists) for selling remedies which are not just of debatable efficacy but which fly in the face of science and have been all but disproven. Recently, I came across this website of a working group of the Austrian Society of Pharmacists. It is in German, so I will translate a few sections for you.
They say that it is their aim to find “explanatory models for the mechanisms of action of homeopathy”. This is a strange aim, in my view, not least because there is no proven efficacy; why then search for a mechanism?
Things go from bad to worse when we consider the ‘Notfallapotheke’, the emergency kit which they recommend to consumers who might find themselves in desperate need for emergency care. It includes the following remedies, doses and indications:
Aconitum C 30 2 x 5 Glob, first remedy in cases of fever
Allium cepa C 12 3 x 5 Glob, hayfever or cold
Anamirta cocculusLM 12 : 2 x 5, travel sickness
Apis mellifica C 200 2 x 5 Glob, insect bites
Arnica C 200 1 x 5 Glob, injuries
Acidum arsenicosum C 12 3 – 5 x 5, food poisoning
Atropa belladonna C 30 2 x 5 Glob, high fever
Cephaelis ipecacuahna C 12 2 x 5 Glob, nausea and vomiting
Coffea arabica C 12 2 x 5 Glob, insomnia and restlessness
Euphrasia officinalis C 12 3 x 5 Glob, eye problems
Ferrum phosphoricum C 12 2 x 5 Glob, nose bleed
Lachesis muta C 30 1 x 5 Glob, infected wounds
Lytta vesicatoria C 200 1 – 2 x 5, burns,
Matricaria chamomilla C 30 1 x 3 Glob, toothache
Mercurius LM 12 2 x 5 Glob ear ache, weakness
Pulsatilla LM 12 2 x 5 Glob, ear ache, indigestion
Solanum dulcamara C12 3 x 5 Glob, cystitis
Strychnos nux vomica LM 12 2 x 5 Glob, hangover
Rhus toxicodendron C 200 2 x 5 Glob, rheumatic pain
Veratrum album C12, 3-5 x 3, watery diarrhoea, nausea, vomiting, circulatory problems, collapse.
I can well imagine that, after reading this, some of my readers are in need of some Veratrum album because of near collapse with laughter (or fury?).
We all know that most pharmacists sell such useless remedies; and we might pity them for such behaviour, as they claim they have no choice. But if pharmacists’ professional organisations put themselves so very clearly behind quackery thereby violating all ethical rules in the book, one is truly speechless.
Do I hear someone mutter “what has Austria to do with us?”?
Not a lot, perhaps – but have a look at the range of similar ‘homeopathic emergency kits’ sold outside Austria. Or be stunned by the plethora of homeopathic pharmacies across the globe here and UK-wide here. Or consider the fact that most non-homeopathic pharmacies in the world sell homeopathic remedies. Or let me remind you that a snapshot investigation into UK pharmacies revealed that 13 out of 20 pharmacisits failed to explain that there’s no clinical evidence that homeopathy works. Or be once again reminded that it is “the ethical role of the pharmacist is to give accurate, impartial information regarding the homeopathic therapy, the current scientific proof on their therapeutic effects, including the placebo effect.”
And what is the current scientific proof?
The most reliable verdict that I am aware of comes from the Australian ‘NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL’ (NHMRC) who have assessed the effectiveness of homeopathy. The evaluation concluded that “the evidence from research in humans does not show that homeopathy is effective for treating the range of health conditions considered.”
I rest my case.
In the early 1920s, a French physician thought he had discovered the virus that caused the Spanish flu. It oscillated under his microscope, and he thus called it oscillococcus. Not only did it cause the flu, in the opinion of his discoverer, but it was also responsible for a whole host of other diseases, including cancer. In fact, the virus does not exist, or at least nobody ever confirmed it existed, but that fact did not stop our good doctor to make a homeopathic remedy from it which he thought would cure all these diseases. His remedy, Oscillococcinum, is made from the liver and heart of a duck because the imaginative inventor believed that the fictitious virus was present in these organs of this animal.
To understand all this fully, one needs to know that the duck organs are so highly diluted that no molecule of the duck is present in the remedy. It is sold in the C200 potency. This means that one part of organ extract is diluted 1: 10 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 (a note to Boiron’s legal team: I had a hell of a time getting all these zeros right; in case, I got it wrong after all, it is an honest error – please do not sue me for it!). The dilution is so extreme that it amounts to a single molecule per a multitude of universes.
Given these facts it seems unlikely that the remedy has any effects on human health which go beyond those of a placebo. Let’s see what the current Cochrane review says about its effectiveness: There is insufficient good evidence to enable robust conclusions to be made about Oscillococcinum(®) in the prevention or treatment of influenza and influenza-like illness. Our findings do not rule out the possibility that Oscillococcinum(®) could have a clinically useful treatment effect but, given the low quality of the eligible studies, the evidence is not compelling. There was no evidence of clinically important harms due to Oscillococcinum(®).
Considering that the first author of this review works for the British Homeopathic Association and the senior author is the homeopath of the Queen, this seems a pretty clear statement, don’t you think?
Regardless of the scientific evidence, Oscillococcinum made of ‘Anas Barbariae Hepatis et Cordis Extractum‘, as it is officially called, became a homeopathic best-seller. In the US alone Boiron, the manufacturer, is said to sell US$ 15 m per year of this product. Not only that, in France, where the remedy is a popular medicine sold in virtually all pharmacies and often recommended as soon as you walk into a pharmacy, it is hard to find anyone who does not swear by the ‘potentized‘ duck or is willing to discuss its merits critically.
The amazing duck, it seems, has turned into a ‘holy cow’.
Boiron is the world’s biggest producer of homeopathic remedies. It also is a firm that is relatively active in research into homeopathy. Here is one of their investigations which I find most remarkable.
This study was designed to describe the sociodemographic and clinical characteristics of patients recommended allopathic and/or homeopathic medicines for influenza-like illness (ILI) or ear nose and throat ENT disorders by pharmacists in France and to investigate the effectiveness of these treatments.
The introduction of the article includes interesting information; it informs us that, although homeopathy is more popular in Europe than in the Unites States, sales of homeopathic medicines in the United States grew by more than 1,000% in the late 1970s and early 1980s and continue to grow. In parallel, the number of physicians specializing in homeopathy doubled between 1980 and 1982. In 2003, sales of homeopathic medicines in the United States were estimated to be between $300 and $450 million, with an average growth rate of approximately 8% per year. Homeopathic drugs are among the top 10 nonprescription products sold in the category of analgesics to treat coughs, colds, and flu. The sale of homeopathic medicines in the United States is controlled by the Food, Drug, and Cosmetic Act and regulations issued by the U.S Food and Drug Administration (FDA). Homeopathic medicines in the United States are subject to well-controlled regulatory processes that closely resemble those used for allopathic medicines. FDA regulations for the sale of homeopathic medicines in the United States state that they can only be sold without prescription if they are for self-limiting conditions such as the common cold…
Am I mistaken, or does that paragraph read a bit like a text written by the marketing team of Boiron wanting to establish their products in the US?
Anyway, the methodology and results of the study are described in the abstract as follows:
A prospective, observational, multicenter study was carried out in randomly selected pharmacies across the 8 IDREM medical regions of France. Pharmacies that agreed to participate recruited male or female patients who responded to the following inclusion criteria: age ≥ 12 years presenting with the first symptoms of an ILI or ENT disorder that were present for less than 36 hours prior to the pharmacy visit. All medicines recorded in the study were recommended by the pharmacists. The following data were recorded at inclusion and after 3 days of treatment: the intensity of 13 symptoms, global symptom score, and disease impact on daily activities and sleep. Two groups of patients were compared: those recommended allopathic medicine only (AT group) and those recommended homeopathic medicine with or without allopathic medicine (HAT group). The number and severity of symptoms, change in global symptom score, and disease impact on daily activities and sleep were compared in the 2 treatment groups after 3 days of treatment. Independent predictors of recommendations for homeopathic medicine were identified by multi- factorial logistic regression analysis.
A total of 242 pharmacies out of 4,809 (5.0%) contacted agreed to participate in the study, and 133 (2.8%) included at least 1 patient; 573 patients were analyzed (mean age: 42.5 ± 16.2 years; 61.9% female). Of these, 428 received allopathic medicines only (74.7%; AT group), and 145 (25.3%) received homeopathic medicines (HAT group) alone (9/145, 1.6%) or associated with allopathy (136/145, 23.7%). At inclusion, HAT patients were significantly younger (39.6 ± 14.8 vs. 43.4 ± 16.1 years; P less than 0.05), had a higher mean number of symptoms (5.2 ± 2.5 vs. 4.4 ± 2.5; P less than 0.01), and more severe symptoms (mean global symptom score: 24.3 ± 5.5 vs. 22.3 ± 5.8; P = 0.0019) than AT patients. After 3 days, the improvement in symptoms and disease impact on daily activities and sleep was comparable in both groups of patients.
From these findings, the authors draw the following conclusions: Patients recommended homeopathic medicine by pharmacists were younger and had more severe symptoms than those recommended allopathic medicine. After 3 days of treatment, clinical improvement was comparable in both treatment groups. Pharmacists have an important role to play in the effective management of ILI and ENT disorders.
And, to make perfectly clear what all this is about, the first sentence of the ‘discussion’ puts it to the point by stating that homeopathic medicine, with or without allopathic medicine, appears to be effective at alleviating the symptoms of ILI or ENT disorders.
As I have heard it said that Boiron seems to have the nasty habit of threatening their critics with legal action, I ought to be quite cautious in my assessment of this ‘masterpiece of promotion’. Yet a few comments must surely be permitted.
‘To describe the sociodemographic and clinical characteristics of patients recommended allopathic and/or homeopathic medicines’ is not what I personally find an interesting subject of research, nor is it anything that will affect health care meaningfully, I think. Yet ‘to investigate the effectiveness of these treatments’ is certainly interesting and important. I will therefore focus on this second aim of the study.
Hold on, was this really a ‘study’? On closer inspection, it seemed much more like a survey. People who felt that they were suffering from ILI and ENT disorders and thus went to a pharmacy to buy something for their problem were offered either homeopathic or conventional medicines. Those who accepted either of the recommendations were asked to fill out some self-assessment forms and received a phone call three days later to check their symptoms. 94% of all patients in the homeopathy group took homeopathic medicine in combination with ‘allopathic’ medicine (it is interesting, perhaps even telling, that this term used by the authors was invented by Hahnemann as an insult to conventional medicine!). There was no examination by a doctor to verify what condition the survey-participants were truly suffering from, and there was no verification that the information provided during the follow-up telephone call was in any way real. The most frequently recommended homeopathic medicine was Anas barbariae 200C (Oscillococcinum) which is Boiron’s famous homeopathically diluted (about one molecule per universe, I guess) duck-liver heavily promoted in France against colds and similar conditions.
As it turns out, those survey-participants who accepted the homeopathic recommendation were significantly younger than those who accepted the recommendation for a conventional treatment (many surveys confirm that younger people are more prone to trying alternative medicine than older ones). It stands to reason, that the younger (and therefore fitter) patients were in better general health and therefore might recover quicker than the older ones. But, in fact, they did not!
Could this be due to the homeopathic remedies actually delaying recovery? Of course not! Who would be silly enough to claim that homeopathy could have this (or any other) effect? According to the authors, it is due to the fact that this group ‘had more severe symptoms than those recommended allopathic medicine’. But, as I said, we have to take their word for it; there is no independent verification of this. It would, of course, be quite ridiculous to postulate that those survey-participants accepting homeopathy were also a little more introspective or concerned about their own health (perhaps even more gullible) and thus claimed more severe symptoms!
And what about the authors’ conclusion that clinical improvement was comparable in both treatment groups? Well, this is more than a little problematic, in my view: first, we have no independent verification of the ‘improvement’ in either group. Second, we don’t know that the conventional treatments actually worked, and it could well be that both approaches were similarly ineffective, and that the observed outcomes are merely a reflection of the natural history of the condition. And third, one might expect the homeopathic (younger) group to do not similarly well but slightly better, simply because the natural history of the illness would tend to be more benign in younger people.
Before I finish,I should make a brief comment about the authors’ courageous statement that homeopathic medicine, with or without allopathic medicine, appears to be effective at alleviating the symptoms of ILI or ENT disorders. I think, for the reasons I already provided, this is extremely doubtful. In my view, more critical scientists would have phrased the conclusions differently:
THIS SURVEY SHOWS THAT EVALUATING THE EFFECTIVENESS OF MEDICAL INTERVENTIONS REQUIRES A MORE RIGOROUS METHODOLOGY THAN THAT OF A SURVEY.
But perhaps this would be asking a little too much of the authors; after all, at the end of the article, we find this telling footnote: Laboratoires Boiron provided financial support for the study. Cognet-Dementhon, Thevenard, Duru, and Allaert received consulting fees from Laboratoires Boiron for this study. Danno and Bordet are employees of Laboratoires Boiron.
Recently, I have been invited by the final year pharmacy students of the ‘SWISS FEDERAL INSTITUTE OF TECHNOLOGY ZURICH‘ to discuss alternative medicine with them. The aspect I was keen to debate was the issue of retail-pharmacists selling medicines which are unproven or even disproven. Using the example of homeopathic remedies, I asked them how many might, when working as retail-pharmacists, sell such products. About half of them admitted that they would do this. In real life, this figure is probably closer to 100%, and this discrepancy may well be a reflection of the idealism of the students, still largely untouched by the realities of retail-pharmacy.
In our discussions, we also explored the reasons why retail-pharmacists might offer unproven or disproven medicines like homeopathic remedies to their customers. The ethical codes of pharmacists across the world quite clearly prohibit this – but, during the discussions, we all realised that the moral high ground is not easily defended against the necessity of making a living. So, what are the possible motivations for pharmacists to sell bogus medicines?
One reason would be that they are convinced of their efficacy. Whenever I talk to pharmacists, I do not get the impression that many of them believe in homeopathy. During their training, they are taught the facts about homeopathy which clearly do not support the notion of efficacy. If some pharmacists nevertheless were convinced of the efficacy of homeopathy, they would obviously not be well informed and thus find themselves in conflict with their duty to practice according to the current best evidence. On reflection therefore, strong positive belief can probably be discarded as a prominent reason for pharmacists selling bogus medicines like homeopathic remedies.
Another common argument is the notion that, because patients want such products, pharmacists must offer them. When considering it, the tension between the ethical duties as a health care professional and the commercial pressures of a shop-keeper becomes painfully obvious. For a shop-keeper, it may be perfectly fine to offer all products which might customers want. For a heath care professional, however, this is not necessarily true. The ethical codes of pharmacists make it perfectly clear that the sale of unproven or disproven medicines is not ethical. Therefore, this often cited notion may well be what pharmacists feel, but it does not seem to be a valid excuse for selling bogus medicines.
A variation of this theme is the argument that, if patients were unable to buy homeopathic remedies for self-limiting conditions which do not really require treatment at all, they would only obtain more harmful drugs. The notion here is that it might be better to sell harmless homeopathic placebos in order to avoid the side-effects of real but non-indicated medicines. In my view, this argument does not hold water: if no (drug) treatment is indicated, professionals have a duty to explain this to their patients. In this sector of health care, a smaller evil cannot easily be justified by avoiding a bigger one; on the contrary, we should always thrive for the optimal course of action, and if this means reassurance that no medical treatment is needed, so be it.
An all too obvious reason for selling bogus medicines is the undeniable fact that pharmacists earn money by doing so. There clearly is a conflict of interest here, whether pharmacists want to admit it or not – and mostly they fail to do so or play down this motivation in their decision to sell bogus medicines.
Often I hear from pharmacists working in large chain pharmacies like Boots that they have no influence whatsoever over the range of products on sale. This perception mat well be true. But equally true is the fact that no health care professional can be forced to do things which violate their code of ethics. If Boots insists on selling bogus medicines, it is up to individual pharmacists and their professional organisations to change this situation by protesting against such unethical malpractice. In my view, the argument is therefore not convincing and certainly does not provide an excuse in the long-term.
While discussing with the Swiss pharmacy students, I was made aware of yet another reason for selling bogus medicines in pharmacies. Some pharmacists might feel that stocking such products provides an opportunity for talking to patients and informing them about the evidence related to the remedy they were about to buy. This might dissuade them from purchasing it and could persuade them to get something that is effective instead. In this case, the pharmacist would merely offer the bogus medicine in order to advise customers against employing it. This strategy might well be an ethical way out of the dilemma; however, I doubt that this strategy is common practice with many pharmacists today.
With all this, we should keep in mind that there are many shades of grey between the black and white of the two extreme attitudes towards bogus medicines. There is clearly a difference whether pharmacists actively encourage their customers to buy bogus treatments (in the way it often happens in France, for instance), or whether they merely stock such products and, where possible, offer responsible, evidence-based advise to people who are tempted to buy them.
At the end of the lively but fruitful discussion with the Swiss students I felt optimistic: perhaps the days when pharmacists were the snake-oil salesmen of the modern era are counted?
According to a recent comment by Dr Larry Dossey, sceptics are afflicted by “randomania,” “statisticalitis,” “coincidentitis,” or “ODD” (Obsessive Debunking Disorder). I thought his opinion was hilariously funny; it shows that this prominent apologist of alternative medicine who claims that he is deeply rooted in the scientific world has, in fact, understood next to nothing about the scientific method. Like all quacks who have run out of rational arguments, he resorts to primitive ad hominem attacks in order to defend his bizarre notions. It also suggests that he could do with a little scepticism himself, perhaps.
In case anyone wonders how the long-obsolete notions of vitalism, which Dossey promotes, not just survive but are becoming again wide-spread, they only need to look into the best-selling books of Dossey and other vitalists. And it is not just lay people, the target audience of such books, who are taken by such nonsense. Health care professionals are by no means immune to these remnants from the prescientific era.
A recent survey is a good case in point. It was aimed at exploring US student pharmacists’ attitudes toward complementary and alternative medicine (CAM) and examine factors shaping students’ attitudes. In total, 887 student pharmacists in 10 U.S. colleges/schools of pharmacy took part. Student pharmacists’ attitudes regarding CAM were quantified using the attitudes toward CAM scale (15 items), attitudes toward specific CAM therapies (13 items), influence of factors (e.g., coursework, personal experience) on attitudes (18 items), and demographic characteristics (15 items).
The results show a mean (±SD) score on the attitudes toward CAM scale of 52.57 ± 7.65 (of a possible 75; higher score indicated more favorable attitudes). There were strong indications that students agreed with the concepts of vitalism. When asked about specific CAMs, many students revealed positive views even on the least plausible and least evidence-based modalities like homeopathy or Reiki.
Unsurprisingly, students agreed that a patient’s health beliefs should be integrated in the patient care process and that knowledge about CAM would be required in future pharmacy practice. Scores on the attitudes toward CAM scale varied by gender, race/ethnicity, type of institution, previous CAM coursework, and previous CAM use. Personal experience, pharmacy education, and family background were important factors shaping students’ attitudes.
The authors concluded: Student pharmacists hold generally favorable views of CAM, and both personal and educational factors shape their views. These results provide insight into factors shaping future pharmacists’ perceptions of CAM. Additional research is needed to examine how attitudes influence future pharmacists’ confidence and willingness to talk to patients about CAM.
I find the overwhelmingly positive views of pharmacists on even over quackery quite troubling. One of the few critical pharmacists shares my worries and commented that this survey on CAM attitudes paints a concerning portrait of American pharmacy students. However, limitations in the survey process may have created biases that could have exaggerated the overall perspective presented. More concerning than the results themselves are the researchers’ interpretation of this data: Critical and negative perspectives on CAM seem to be viewed as problematic, rather than positive examples of good critical thinking.
One lesson from surveys like these is they illustrate the educational goals of CAM proponents. Just like “integrative” medicine that is making its ways into academic hospital settings, CAM education on campus is another tactic that is being used by proponents to shape health professional attitudes and perspectives early in their careers. The objective is obvious: normalize pseudoscience with students, and watch it become embedded into pharmacy practice.
Is this going to change? Unless there is a deliberate and explicit attempt to call out and push back against the degradation of academic and scientific standards created by existing forms of CAM education and “integrative medicine” programs, we should expect to see a growing normalizing of pseudoscience in health professions like pharmacy.
I have criticised pharmacists’ attitude and behaviour towards alternative medicine more often than I care to remember. I even contributed an entire series of articles (around 10; I forgot the precise number) to THE PHARMACEUTICAL JOURNAL in an attempt to stimulate their abilities to think critically about alternative medicine. Pharmacists could certainly do with a high dose of “randomania,” “statisticalitis,” “coincidentitis,” or “ODD” (Obsessive Debunking Disorder). In particular, pharmacists who sell bogus remedies, i.e. virtually all retail pharmacists, need to remember that
- they are breaking their own ethical code
- they are putting profit before responsible health care
- by selling bogus products, they give credibility to quackery
- they are risking their reputation as professionals who provide evidence-based advice to the public
- they might seriously endanger the health of many of their customers
In discussions about these issues, pharmacists usually defend themselves and argue that
- those working in retail chains cannot do anything about this situation; head office decides what is sold on their premises and what not
- many medicinal products we sell are as bogus as the alternative medicines in question
- other health care professions are also not perfect, blameless or free of fault and error
- many pharmacists, particularly those not working in retail, are aware of this lamentable situation but cannot do anything about it
- retail pharmacists are both shopkeepers and health care professionals and are trying their very best to cope with this difficult dual role
- we usually appreciate your work and critical comments but, in this case, you are talking nonsense
I do not agree with any of these arguments. Of course, each single individual pharmacist is fairly powerless when it comes to changing the system (but nobody forces anyone to work in a chain that breaks the ethical code of their profession). Yet pharmacists have their professional organisations, and it is up to each individual pharmacist to exert influence, if necessary pressure, via their professional bodies and representatives, such that eventually the system changes. In all this distasteful mess, only one thing seems certain: without a groundswell of opinion from pharmacists, nothing will happen simply because too many pharmacists are doing very nicely with fooling their customers into buying expensive rubbish.
And when eventually something does happen, it will almost certainly be a slow and long process until quackery has been fully expelled from retail pharmacies. My big concern is not so much the slowness of the process but the fact that, currently, I see virtually no groundswell of opinion that might produce anything. For the foreseeable future pharmacists seem to have decided to be content with a role as shopkeepers who do not sufficiently care about healthcare-ethics to change the status quo.