A nice way to conclude this year’s ‘homeopathy awareness week’, I think, is to review some of the more important homeopathy-related events from across the world that have been reported (on this blog) in the past 12 months.
- A few weeks ago, it was reported that a master’s degree in homeopathic medicine at one of Spain’s top universities has been scrapped. Remarkably, the reason was “lack of scientific basis”. A university spokesman confirmed the course was being discontinued and gave three main reasons: “Firstly, the university’s Faculty of Medicine recommended scrapping the master’s because of the doubt that exists in the scientific community. Secondly, a lot of people within the university – professors and students across different faculties – had shown their opposition to the course. Thirdly, the postgraduate degree in homeopathic medicine is no longer approved by Spain’s Health Ministry.”
- On January 30, a group of experts from all walks of life met in Freiburg to discuss ways of informing the public responsibly and countering the plethora of misinformation that Germans are regularly exposed to on the subject of homeopathy. They founded the ‘Information Network Homeopathy‘ and decided on a range of actions.
- Earlier that month, the Nobel laureate Venkatraman Ramakrishnan called homeopathy ‘bogus’. “They (homeopaths) take arsenic compounds and dilute it to such an extent that just a molecule is left. It will not make any effect on you. Your tap water has more arsenic. No one in chemistry believes in homeopathy. It works because of placebo effect,” he was quoted saying.
- We have confirmed that Dana Ulman (the ‘spokesman’ for homeopathy in the US) fails to understand science or medicine. He excels in producing one fallacy after the next. If he were on a mission to give homeopathy a bad name, he would be doing a sterling job!
- I identified Prof Frass as one of the most magical of all homeopathy researchers: he never fails to produce a positive result with his placebos.
- In an interview, Christian Boiron, the general manager of the world’s largest producer of homeopathics, carried the debate about homeopathy to a new level of stupidity. He pointed out that “Il y a un Ku Klux Klan contre l’homéopathie” My translation: THERE IS A KU KLUX KLAN AGAINST HOMEOPATHY.
- In a similar vein, Dr Michael Dixon, advisor to Prince Charles, defended homeopathy by stating that omitting it from the NHS “would be a mean-minded act of outside interference by many who do not treat patients themselves, denying patient choice and signifying a new age of intolerance and interference. It is a threat to the autonomy of general practice that should concern every GP and patient whatever their views on homeopathy.”
- The Hungarian Academy of Sciences statement proposing the same scientific standards for homeopathic drug registration as for normal drugs Members of the Section of Medical Sciences of the Hungarian Academy of Sciences (HAS) voted unanimously on 9 November 2015 for supporting the earlier proposal of the Royal Swedish Academy of Sciences. The Swedish statement requested that the homeopathic remedies should go through the same efficacy trials as normal drugs should.
- The US Federal Trade Commission (FTC) announced that they are considering whether advertisements for homeopathic products have any evidence to back the numerous claims that are being made for them. A meeting took place on 21 September, and the first details have emerged.
- A legal challenge in the UK failed to produce the results homeopaths had hoped for. Honor Watt, 73 had sued Lothian Health Board after the authority stopped in June 2013 to provide homeopathic treatments to patients. Ms Watt’s lawyers decided to challenge the board’s decision in the Court of Session claiming the health board acted illegally. There is reason to believe that Ms Watt was assisted by a professional organisation of homeopathy ( the judgement mentions that the Board’s submission stated that ‘the real force behind the petition was a charity, not the petitioner’). The case went to court and the judge, Lord Uist, ruled that the health board had acted legally. He therefore refused to overturn the board’s original decision. In a written judgement issued on Friday, Lord Uist confirmed that the health board acted correctly: “It is clear to me from an examination of the relevant documents that the board was from the outset consciously focusing on its PSED.”
- The first International Conference on Homeoprophylaxis announce its guest speaker: ex-doctor Andrew Wakefield.
- The Royal Pharmacy Society’s Chief Scientist Professor Jayne Lawrence has blogged on the history of homeopathy and asked why, even in the face of the lack of evidence, people are still actively seeking homeopathic treatment today. Jayne layed down a challenge to the profession: “… are we ready to remove homeopathy from the shelves of pharmacies?And here are the relevant passages from Jayne Lawrence’s post:…it is easy to see why homeopathy, with its use of ultralow doses of the treatment material, became so popular so quickly, despite the fact that a clinical trial performed as early as 1835 showed that homeopathy as a method of treatment was wholly ineffective.…for homeopathy to work as claimed, we would have to completely revise our understanding of science. Any scientific evidence claiming to support homeopathy has either been shown to be flawed or not repeatable under controlled conditions. Furthermore, systematic reviews of modern clinical trials have supported the first early clinical trial showing that homeopathy has no more clinical effect than a placebo…The public have a right to expect pharmacists and other health professionals to be open and honest about the effectiveness and limitations of treatments. Surely it is now the time for pharmacists to cast homeopathy from the shelves and focus on scientifically based treatments backed by clear clinical evidence.”
- And finally, there is this impressive graph (published not by me but) by the formidable Nightingale Collaboration. It speaks for itself, I think:
NO, ONE CANNOT SAY THAT IT WAS A GOOD YEAR FOR HOMEOPATHY – BUT, PLEASE, LET THAT NOT SPOIL YOUR CELEBRATORY MOOD.
An article in the Australian Journal of Pharmacy seems well worth mentioning on this blog. It throws some light on what is happening in Australia regarding an issue that I have repeatedly written about: the sale of homeopathic remedies by pharmacists.
Pharmaceutical Society of Australia have apparently published a ‘Complementary Medicines Position Paper’ which states that complementary medicines may be used as an adjunctive therapy with conventional medicines, provided there is evidence to support their use. The president of the PSA, Joe Demarte, says that the PSA is committed to supporting pharmacists help consumers make informed decisions regarding complementary medicines and continued to advocate strongly for a partnership approach with consumers to promote the Quality Use of Medicines and responsible self-medication. “This is a partnership between the pharmacist and the consumer where the pharmacist as the medicines expert can advise on the appropriate use of complementary medicines the consumer may be considering,” Demarte is quoted saying. He continues: “There is a wealth of information available about complementary medicines which can be confusing and the pharmacist can assist in ensuring that consumers are provided with the best available information about the current evidence for efficacy, as well as information on any potential side effects, drug interactions and risks of harm. In the event that a consumer chooses to use a product with limited evidence, the pharmacist must advise the consumer on the risks of rejecting or delaying treatments for which there is good evidence for safety and effectiveness. PSA strongly encourages all consumers considering taking complementary medicines to first consult their pharmacist for sound, evidence-based advice.”
So far so good – but what about disproven treatments such as homeopathy, I wonder.
Demarte says the PSA endorses the NHMRC report, released in March 2015, which found there were no health conditions for which there was reliable evidence that homeopathy was effective. And he states that the PSA does not support the sale of homeopathy products in pharmacies: “Our position is that pharmacists must use their professional judgement to prevent the supply of products with evidence of no effect.”
This surely is good news for all who stand up for evidence-based medicine and foremost for patients. It comes only a few months after the RPS Chief Scientist of the UK Royal Pharmaceutical Society, Professor Jayne Lawrence stated very similar things: “The public have a right to expect pharmacists and other health professionals to be open and honest about the effectiveness and limitations of treatments. Surely it is now the time for pharmacists to cast homeopathy from the shelves and focus on scientifically based treatments backed by clear clinical evidence.”
Now that we are (almost) all in perfect agreement, we only need one thing: adequate action by pharmacists!
I have always wondered how pharmacists might justify using or recommending or selling homeopathic remedies. So far, I have not come across a pharmacist who would want to stick his/her neck out for homeopathy. Many pharmacists earn money by selling homeopathic preparations – but most seem to be embarrassed by this fact and don’t want to defend it.
Therefore, I was pleased when I found this interview with the pharmacist Christophe Merville. He got introduced to homeopathy as a 11 year old boy suffering from hay fewer; after using homeopathy, “the crises became less severe and less frequent”. Later, he studied to become a pharmacist in France and, in 1990, he joined Boiron, the world’s largest manufacturer of homeopathic remedies. The following is an extensive excerpt (I did not want to cite him ‘out of context’) from his interview about his views on homeopathy.
I remember attending the delivery of a woman and the contractions were very strong, and painful. She had some homeopathic medicine to take just at that time to make those contractions more regular and useful: less intense but longer and less brusque. I saw that happening within minutes, and I was thinking, “That’s very impressive.” That’s probably the time when I concluded that there is something to it.
I witnessed the action of homeopathic medicines on pets also, on young children. I had enough personal anecdotes that I could say there is something more than just suggestion, or placebo, or just the simple act of being cared for. My attitude is to say, “There are enough signs to say that it’s really worth exploring more why it works, how it works, when does it work.” We are past the stage where we can say, “No, there is nothing.” It has been around for a long time and if was just mere placebo effect, it would have gone away, as so many different techniques did.
If you look at the history of science, you find many instances where people first said, for example, “The theory of gravity explains everything.” And when some things are discovered that show it didn’t work in certain very narrow cases, there’s an understanding that we have to adjust. But every time you have to make that adjustment, there is a great body of people who say, “No, it cannot be.”
The main argument against homeopathy is that a remedy is very, very diluted, so it cannot work. My reaction to that is to examine what happens when you dilute something. The act of dilution is not very simple. Those molecules are interacting together, they are interacting with the walls of the container, they are interacting with the solvent, and this interaction does not adhere to a precise mathematical law. The skeptics say, “You divide the number of molecules by 100 each time, so after awhile, there is less than one chance to find one single molecule.” They have their math right, but they have their physics wrong.
Chemists try to use very pure substances. When you buy your reagent, you buy it at 99.999 percent pure. But you don’t have anything that’s 100 percent pure. It would take an infinite amount of energy to get rid of the last impurity. What I think we should explore is the fact that after a certain number of dilutions, the process is not very efficient at removing the last molecules. So there is always something that stays. That’s one thing.
The second thing is in pharmacology for years, we were interested in the ability of large quantities of substances. But what about small ones? I always use the example of butterflies that can sense pheromones at great distances, salmon finding their way back to their native creek from far away, to sharks being able to detect blood in a huge amount of water. Biology uses very small quantities. In cells, you have communication between cells using a few molecules of a certain substance—and it works.
I don’t pretend that I’ve put A and B and C together, and I’m able to provide you with a complete explanation. But I would say those are things to explore. Already the research that exists points to possible action of homeopathic dilution on activation or deactivation of genes. I won’t go into details, but I welcome the skepticism, I think it’s very constructive. But what I don’t really like is people whose mind is set on their misconception of what exactly a dilution is. Of course homeopathy doesn’t violate the laws of physics and chemistry, because that’s absurd.
My first role is pharmacy development. I look at what are the tools that allow pharmacists to know what homeopathy is and for a certain number of them, how to use homeopathy. I consider how to train them, how to have them integrate homeopathy in their practice, because the goal isn’t about replacing other medicines with homeopathy. My first role is to say to pharmacists, “You have to know what it is because these are drugs. If you don’t believe in them, you don’t have to use them, but at least you need to be able to answer customers, your patients.”
And the second thing is that for those who are interested in knowing more, I translate books from France, I design trainings, activities, interactions, so they are placed in a situation of recommending and deciding if it is appropriate to recommend homeopathy, and what treatment is adapted to that particular person.
“Before coming to the conference, I researched what homeopathy is, and you will have a hard time telling me that it can work.” I talk with them to explore a little bit more what it is. We speak the language of pharmacology together, and what strikes me is that very soon, they are into it. They say, “Okay, we see the logic of it.” They realize that they have a tool where they can relieve without doing any harm, without interactions, so their interest is piqued. And they recognize that the mode of action of conventional medicines is not as clear as we thought.
Pharmacists are very pragmatic people—you cannot tell them fairy tales. When they see it, explore it, and use it, then when I meet them later, they tell me, “That stuff works.” And I ask, “Yeah, but do you know how it works?” They don’t, but they see the patient coming back happy.
Of course, they are interested in the research and knowing how it works, but I just give them what we know in clinical research and we discuss it. They see that there is ongoing research and one day we’ll find more. But meanwhile, they are using the product.
You have two approaches. What I call “the user approach” is when people may not really completely understand how a medicine works, but they’re interested in taking it for stress or for allergies, whatever it might be, to see if it works for them. They’re interested in how this medicine will affect them, how should they take it. If it works for them, then great.
Then you have what I call the “intellectual approach”—which is concerned about more cultural, philosophical, and social questions: what is the place of homeopathic medicine in today’s medicine, what are its principles, its history, its perspective. Is it a philosophy, is it a cult, what is it? My role is to try to give context for what homeopathy is. It’s a simple tool in the toolbox—we don’t exactly know all the details of how it works. And this is what we know, and this is what we don’t know, and this is what we speculate might be the way it works. People educate themselves.
Every day, I say, homeopathy doesn’t vaccinate, homeopathy doesn’t cure cancer, homeopathy doesn’t cure diabetes. It can relieve some of the symptoms or side effects of the treatments, but it has limits like every therapy. I fight against those outrageous claims and sometimes people that are really fanatical advocates for homeopathy do much worse for the cause. And I have to tell them: You cannot say that. It is untrue and it is dangerous. This is why I think pharmacists listen to me, because I’m not telling them to change their practice and their ethics. I’m telling them, this is another tool and this is how to use it properly. But there are fundamentals that are still there and will be there for a long time. You cannot replace vaccination by any other techniques—it’s unethical, it’s dangerous, it’s deadly. So we don’t do that. I’m completely against these kinds of claims.
Let’s explore that: a patient suffering with AIDS, advanced infection with HIV, with immunity that decreases. Or a patient treated with antiretroviral therapy, they still have sometimes diarrhea, because their immune system is not able to fight everything. They still have side effects or anxiety. We want their treatment to be as comfortable as possible, because we want them to keep using the treatment. The same thing with cancer. The patient says, “I don’t want to have chemotherapy because it’s hurting me, it’s very difficult and uncomfortable.” We have with homeopathy ways to reduce nausea, for instance, then we increase the comfort of the patient, and the outcome is always better. That’s the framework. Someone who would say, “Oh, you have AIDS, throw away your antiretrovirals, I’m going to treat you with homeopathy”—that person would be a murderer.
We develop tools to help people self-medicate. We say, “Okay, you’re stressed out, you need to sleep a little bit, you’re lacking sleep. Take this for a certain period of time—if it works for you, fine. If it doesn’t, doesn’t, stop it.” For people with what we call “self-limiting conditions”— a cold or a cough—we have good tools with warnings and precautions and things like that for them to self-medicate. And in the warnings, we tell them, “If you experience that kind of fever, if you have that symptom, see a doctor.” We don’t say see a homeopath, we say see a doctor. And among these doctors, there are doctors who have added in different techniques and some of them are using homeopathy when appropriate. For me, what is most important, is that a patient sees someone who is medically qualified.
For people who want to further explore the possibilities that homeopathy offers, I recommend that they see a physician who is skilled in homeopathy but will not use homeopathy for everything. And is able to diagnose. A physician will tell you, “In this case, I can do something with homeopathy, or, in that case, I cannot use homeopathy.”
As I have once worked as a junior doctor in a homeopathic hospital (the full story is here), I knew of course all these arguments and fallacies. Nevertheless, I still ask myself: HOW CAN PHARMACISTS GET CONVINCED IN THIS WAY? ARE THEY REALLY CONVINCED? OR DO THEY JUST DO IT FOR THE MONEY?
I do not feel like prejudging these questions just now. But I do hope to hear from my readers, particularly from the pharmacists amongst them, what they think.
Today, I came across this intriguing bit of information:
This week is homeopathy awareness week and once again the controversial practice is in the news.
The Royal Pharmaceutical Society does not endorse homeopathy as a form of treatment. In its reference guide on homeopathic and herbal products, the RPS makes it clear that there is no evidence of the clinical efficacy of homeopathic products, beyond a placebo effect, and no scientific basis for the practice.
The RPS Chief Scientist Professor Jayne Lawrence has blogged on the history of homeopathy and why even in the face of the lack of evidence that it works, people are still actively seeking homeopathic treatment today. Jayne lays down a challenge to the profession; are we ready to remove homeopathy from the shelves of pharmacies?
And here are the relevant passages from Jayne Lawrence’s post:
…it is easy to see why homeopathy, with its use of ultralow doses of the treatment material, became so popular so quickly, despite the fact that a clinical trial performed as early as 1835 showed that homeopathy as a method of treatment was wholly ineffective.
…for homeopathy to work as claimed, we would have to completely revise our understanding of science. Any scientific evidence claiming to support homeopathy has either been shown to be flawed or not repeatable under controlled conditions. Furthermore, systematic reviews of modern clinical trials have supported the first early clinical trial showing that homeopathy has no more clinical effect than a placebo.
Is homeopathy’s popularity due to a distrust of modern medicines as has been recently suggested by the Chief Medical Officer for England who has just called for an independent review of the safety and efficacy of medicines? Or it is that patients are worried about the side effects associated with medicines, preferring what they perceive to be a safer approach; after all homeopathic preparations have not unsurprisingly no known toxic effects in over 200 years of use? Whatever the reason, as an evidence-based profession, why do we continue to sell homeopathic preparations in our pharmacies when the evidence shows that they do not work?
The public have a right to expect pharmacists and other health professionals to be open and honest about the effectiveness and limitations of treatments. Surely it is now the time for pharmacists to cast homeopathy from the shelves and focus on scientifically based treatments backed by clear clinical evidence.
Read the Royal Pharmaceutical Society Homeopathic and herbal products quick reference guide.
And here are the ‘key points’ of this ‘reference guide’:
• There is no evidence to support the clinical efficacy of homeopathic products beyond a placebo effect, and no scientific basis for homeopathy.
• Pharmacists selling homeopathic products must be competent to do so and be able to discuss with patients the lack of evidence for the efficacy of homeopathic products and their formulation.
• Pharmacists should ensure, wherever possible, that patients do not stop taking their prescribed conventional medication when they take a homeopathic product.
• Pharmacists should be aware that patients requesting homeopathic products may have serious underlying undiagnosed medical conditions that would require referral to another healthcare professional.
• Pharmacists should not knowingly sell homeopathic products for serious medical conditions. However, it is recognised people will self select homeopathic products from open display often without consulting a pharmacist.
• Royal Pharmaceutical Society does not endorse homeopathy as a form of treatment.
And finally, here is my very brief and somewhat impatient comment on all this.
I have pointed out these facts ad nauseam for many years. At one stage, pharmacists used to invite me to their conferences for me to tell them so. When this became too unpopular, I published articles and blog posts about this issue. Some pharmacists agreed with me, but their majority seemed just not interested. Some argued that, in the large chain pharmacies, they have little choice but to comply with their employer’s demands. Some found even more lame excuses. I usually replied that there is no choice: pharmacists have ethical codes that clearly prohibit the sale of bogus remedies. Selling homeopathic remedies in pharmacies means violating important ethical principles. Pharmacists have to decide whether they want to be shop keepers or health care professionals.
IT IS HIGH TIME THAT WORDS ARE FOLLOWED BY ACTIONS FROM PHARMACISTS AND THEIR PROFESSIONAL ORGANISATIONS.
The Royal Australian College of General Practitioners (RACGP) just issued an important statement on homeopathy which, in several ways, goes beyond previous announcements on this subject. I take the liberty of reproducing it here in full:
The RACGP supports the use of evidence-based medicine, in which current research information is used as the basis for clinical decision-making. In light of strong evidence to confirm that homeopathy has no effect beyond that of placebo as a treatment for various clinical conditions, the position of the RACGP is:
1. Medical practitioners should not practice homeopathy, refer patients to homeopathic practitioners, or recommend homeopathic products to their patients.
2. Pharmacists should not sell, recommend, or support the use of homeopathic products.
3. Homeopathic alternatives should not be used in place of conventional immunisation.
4. Private health insurers should not supply rebates for or otherwise support homeopathic services or products.
The contention that homeopathy is an effective treatment is not supported by evidence from systematic literature reviews. The National Health and Medical Research Council (NHMRC) analysed the scientific evidence for the effectiveness of homeopathy in treating a range of clinical conditions and released a position statement  in March 2015. The NHMRC’s review concluded homeopathy does not produce health benefits over and above that of placebo, or equivalent to that of another treatment. Crucially, the report states that there are “no health conditions for which there is reliable evidence that homeopathy is effective” as a treatment.
While not covered in the NHMRC’s review, it is also the case that homeopathic alternatives to conventional vaccination do not prevent communicable diseases or increase protective antibodies to disease. The National Centre for Immunisation Research and Surveillance has advised that there are no studies of sufficient quality to demonstrate the safety or effectiveness of ‘homeopathic vaccines’ for protection against disease. Indeed, there is no plausible biological mechanism of action by which these products could prevent infection.
Harms associated with homeopathy
Homeopathic products are sometimes considered harmless as they are generally administered at a high dilution. Some may not even contain a single molecule of the original source material. However, there are a number of risks associated with the use of homeopathy.
Delaying or avoiding conventional medical care
When the use of homeopathy causes a person to delay or avoid consultation with a registered medical practitioner or reject conventional medical approaches, serious and sometimes fatal consequences can occur. As evidenced by recent Australian court findings, spurious claims made by homeopathic practitioners and retailers can mislead individuals about the effectiveness of conventional medicine. When homeopathic vaccines are used as an alternative to conventional immunisation, both the individual and the community are left exposed to preventable diseases.
Problems associated with unregulated products
Although homeopathic products manufactured in Australia are regulated as medicines under the Therapeutic Goods Act 1989, products sold on international websites may not meet Australian quality and safety standards. These products may be of particular concern when materials from problematic sources are employed in the preparation (e.g., pathogenic organs or tissues; causative agents such as bacteria, fungi, parasites, ova, yeast, and virus particles; disease products; excretions or secretions; heavy metals and toxins such as aconitum, kerosene and thallium). Impurities of source material and contamination associated with poor manufacturing processes also present threats to the quality and safety of these products.
Direct adverse effects
Various direct harms associated with the use of homeopathic products have been noted in the literature, including allergic reaction, drug interactions, and complications related to the ingestion of toxic substances.
The importance of patient-centred practice
The RACGP supports the concept of patient-centred practice, in which the values, preferences, and personal healthcare philosophy of the patient are respected and individuals play an important role in their own healthcare. An estimated six per cent of Australians use homeopathy over the course of a year. It is important that these patients feel comfortable in discussing their use of complementary and alternative medicines with all members of their treatment team.
It is good practice for medical practitioners to initiate conversations with patients about their use of or intention to use homeopathy, and assist patients to think critically about the efficacy and safety of homeopathy so that they may make informed healthcare decisions.
Private health insurance and homeopathy
Many private health insurers provide ancillary (extras) cover that subsidises homeopathic treatment, and the individual’s costs in taking out this cover are subsidised under the Australian Government’s private health insurance rebate. The RACGP is concerned that health insurance premiums continue to rise as funds disburse significant sums for the use of homeopathy and other natural therapies lacking rigorous evidentiary support. In the 2013–14 financial year, health insurers paid out $164 million in benefits for natural therapies, up by almost 60 per cent from 2010–11.
The RACGP also notes that offering subsidies for the use of homeopathy sends a confusing message to consumers. Listing homeopathic treatments alongside evidence-based modalities in a list of member benefits lends legitimacy to a practice that is not supported by scientific data.
1. National Health and Medical Research Council. NHMRC Statement: Statement on Homeopathy. Canberra: NHMRC; 2015.
2. National Health and Medical Research Council. NHMRC Information Paper: Evidence on the effectiveness of homeopathy for treating health conditions. Canberra: NHMRC; 2015.
3. National Centre for Immunisation Research and Surveillance. Homeopathy and vaccination [fact sheet].2014 [cited 2015 April]. Available from http://www.ncirs.edu.au/immunisation/factsheets/homeopathyvaccination-
4. Commonwealth Department of Health and Ageing. Myths and realities: Responding to arguments against vaccination. A guide for providers. Canberra: DoHA; 2013.
5. Coronial inquest into the death of Penelope Dingle. State Coroner of Western Australia, 2010.
6. Australian Competition and Consumer Commission v Homeopathy Plus! Pty Ltd. FCA, 2014.
7. World Health Organization. Safety issues in the preparation of homeopathic medicines. Geneva: WHO; 2009.
8. Posadzki P, Alotaibi A, Ernst E. Adverse effects of homeopathy: a systematic review of published case reports and case series. International Journal of Clinical Practice 2012 Dec;66(12): 1178–88.
9. Xue CCL, Zhang AL, Lin V, Da Costa C, Story DF. Complementary and alternative medicine use in Australia: a national population-based survey. Journal of Alternative and Complementary Medicine 2007; 13(16):643–50.
10. Private Health Insurance Administration Council. Operations of the Private Health Insurers Annual Report 2013–14. Canberra: PHIAC; 2014.
I think this is a very good statement:
- it is based on the best evidence currently available,
- it is concise and to the point,
- it covers all the necessary ground,
- it provides valuable and practical recommendations.
Perhaps I should mention that it came as a complete surprise to me, and I was not involved in any way.
Finally, I would like to express my hope that this statement will be adopted in Australia and send a powerful signal to organisations across the world to issue similar recommendations for the benefit of vulnerable patients who still fall victim to bogus claims by homeopaths every day.
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?