2750 signatories from 44 countries have signed it [I was number 11] and today is its official launch. I am delighted to present to you the full text of the English version:
Let’s be clear: pseudoscience kills. And they are being used with total impunity thanks to European
laws that protect them.
They kill thousands of people, with names and families. People such as Francesco Bonifaz, a 7-yearold boy whose doctor prescribed homeopathy instead of antibiotics. He died in Italy . People like Mario Rodríguez, who was 21 years old and was told to use vitamins to treat his cancer. He died in Spain . People like Jacqueline Alderslade, a 55-year-old woman whose homeopath told her to stop taking her asthma medication. She died in Ireland . People like Cameron Ayres, a 6-month-old baby, whose parents did not want to give their child “scientific medicine”. He died in England . People like Victoria Waymouth, a 57-year-old woman who was prescribed a homeopathic medication to treat her heart problem. She died in France . People like Sofia Balyaykina, a 25-year-old woman, who had a cancer that was curable with chemotherapy but was recommended an “alternative treatment”, a mosquito bite treatment. She died in Russia . People like Erling Møllehave, a 71-year-old man whose acupuncturist pierced and damaged his lung with a needle. He died in Denmark . People like Michaela Jakubczyk-Eckert, a 40-year-old-woman whose therapist recommended the German NewMedicine to treat her breast cancer. She died in Germany . People like Sylvia Millecam, a 45-year-old woman whose New Age healer promised to cure her cancer. She died in the Netherlands .
European directive 2001/83/CE has made –and still makes— possible the daily deception of thousands of hundreds of European citizens . Influential lobbyists have been given the opportunity to redefine what a medicine is, and now they are selling sugar to sick people and making them believe it can cure them or improve their health. This has caused deaths and will continue to do so until Europe admits an undeniable truth: scientific knowledge cannot yield to economic interests, especially when it means deceiving patients and violating their rights.
Europe is facing very serious problems regarding public health. Overmedication, multi-resistant bacteria and the financial issues of the public systems are already grave enough, without the additional problem of gurus, fake doctors or even qualified doctors claiming they can cure any disease by manipulating chakras, making people eat sugar or using “quantic frequencies”. Europe must not only stop the promotion of homeopathy but also actively fight to eradicate public health scams. More than 150 pseudo-therapies have been identified as being in use throughout Europe. Thousands of citizens lives depend on this being prevented. In fact, according to a recent research, 25.9 % of Europeans have used pseudo-therapies last year. In other words, 192 million patients have been deceived .
Some believe there is a conflict between freedom of choice for a treatment and the removal of pseudo-therapies, but this is not true. According to article 25 of the Universal Declaration of Human Rights, every person has a right to medical care. Lying to patients in order to sell them useless products that could kill them breaks their right to correct information about their health. This way, even if a citizen has a right to refuse medical treatment when he or she is properly informed, it is also true that nobody has the right to lie to obtain profit at the expense of someone else’s life. Only in a world in which lying to a sick person would be considered ethical, could homeopathy —or any other pseudo-therapy— be allowed to continue to be sold to citizens.
Effective treatments being replaced by false ones is not the only danger of pseudo-therapies. Obvious delays in therapeutic care occur when a person gets false products instead of medication at the early stages of a disease. Many times, it is then too late by the time they get treated with proper medicine. Moreover, several of these practices have serious effects on their own and may cause damage or even death because of their side effects.
Many pseudo-therapists argue that “the other medicine” comes with side effects as well, which is indeed true. However, the difference resides in that pseudo-therapies cannot cure a disease or improve your health, and because of that patients assume risks in exchange of promises that are a scam, according to the full weight of the scientific evidence available. Lying to a sick person is not another type of medicine, it is simply lying to a sick person.
Every country has to face the pseudo-therapies issue in its own ways. Yet it is not acceptable that European laws protect the distortion of scientific facts so that thousands of citizens can be deceived or even lead to their deaths.
We, the signatories of this manifest, therefore declare that:
1. Scientific knowledge is incompatible with what pseudo-therapies postulate, as in the case
2. European laws that protect homeopathy are not acceptable in a scientific and technological
society that respects the right of the patients not to be deceived.
3. Homeopathy is the best known pseudo-therapy, but it is not the only one nor the most
dangerous one. Others, such as acupuncture, reiki, German New Medicine, iridology,
biomagnetism, orthomolecular therapy and many more, are gaining ground and causing
4. Measures must be taken to stop pseudo-therapies, since they are harmful and result in
thousands of people being adversely affected.
5. Europe needs to work towards creating legislation that will help stop this problem.
Europe being concerned about the misinformation phenomena but at the same time protecting one the most dangerous types of it, health misinformation, is just not coherent. This is why the people signing this manifesto urge the governments of European countries to end a problem in which the name of science is being used falsely and which has already cost too many lives.
 Homeopathy boy died of encephalitis. Redazione ANSA, 2017.
 Grieving dad sues over ‘cure cancer with vitamins’ therapy, The local. Emma Anderson, 2016.
 Asthmatic ‘told to give up drugs’. The Irish News, 2001.
 Homeopaths warn of further tragèdies. BBC News, 2000.
 Alternative cure doctor suspended. BBC News, 2007.
 Футболист рассказал трагичную историю жены. Она умерла от рака в 25 лет. Sport24, 2018.
 Mand døde efter akupunktur – enke vil nu lægge sag an mod behandleren, TV2, 2018.
http://nyheder.tv2.dk/samfund/2018-01-23-mand-doede-efter-akupunktur-enke-vil-nu-laegge-sag-an-modbehandleren  The price of refusing science-based medical and surgical therapy in breast càncer, Science Blogs, 2012.
 Psychic ‘misled actress to hopeless cancer death’. Expatica. 2004.
 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001.
 Use of complementary and alternative medicine in Europe: Health-related and sociodemographic
determinants. Scandinavian Journal of Public Health. Laura M. Kemppainen et al. 2018.
Guest post by Ken McLeod
‘Ayurvedic Medicine,’ or Ayurveda, is an alternative medicine system which originated in India as long as 5,000 years ago, according to its proponents. Science-based medicine refers to it as pseudoscientific and the Indian Medical Association (IMA) characterises it as quackery.  Ayurvedic practitioners claim that its popularity through the ages vindicates it as safe and effective.
That last bit is of course the appeal to antiquity, or the appeal to tradition (also known as argumentum ad antiquitatem.  This proposes that if something was supported by people for a long time it must be valid. That is bunkum; many ancient ideas have long since been discredited; the Earth is not flat, no matter for how long people thought it was.
Nevertheless, ‘Ayurvedic Medicine’ has many practitioners and supporters in the supposedly rational West, including Bondi Junction here in Australia. Despite the many warnings about it,  people still go to practitioners, and occasionally they are injured.
One such injury and the consequent complaint to the New South Wales regulator, the Health Care Complaints Commission, (HCCC), has resulted in a Public Warning dated 18 September concerning levels of heavy metals in Ayurvedic Medication. 
The HCCC said:
‘The NSW Health Care Complaints Commission is concerned about a complaint received regarding the prescription of “Manasamithra Vatika,” (Manasamitram Pills) an Ayurvedic medication.
‘The complaint related to prescription of this medication to a child for treatment of autism.
‘This medication was found to contain concerning levels of lead and other heavy metals.’
That’s all very bland, no headlines there. But then it got into:
“The Commission strongly urges those individuals seeking alternative therapies to be vigilant in their research prior to proceeding with any natural therapy medications or medicines and to discuss any such proposed therapies with their treating registered health practitioner.”
Not so bland there; that’s very comprehensive; ‘any natural therapy medications or medicines’ and ‘discuss any such proposed therapies with their treating registered health practitioner.” ‘Note the HCCC’s emphasis on “registered.” That rules out Ayurvedic Medicine practitioners, homeopaths, and other assorted cranks; go to a real doctor.
Surely that is headline material; a regulator responsible for promoting the health of citizens warns them to go to real doctors before going to these quacks.
Then it gets better, (or worse if you are an Ayurvedic Medicine practitioner). At the same time the HCCC issued an Interim Prohibition Order against Mr Rama Prasad (“Ayurveda Doctor Rama Prasad.”)  The HCCC’s Order says:
‘The NSW Health Care Complaints Commission (“the Commission”) is currently investigating Mr Rama Prasad in relation to his prescribing of the Ayurvedic Medication “Manasamithra Vatika” (Manasamitram Pills) to both children and adults and about his claims that his treatments can reverse several aspects of autism in children.
‘The Ayurvedic Medication “Manasmithra Vatika” (Manasamitram Pills) was found to contain elevated levels of lead and other heavy metals.
‘One case with mildly elevated blood level was notified to the South Eastern Sydney Public Health Unit after consuming this product.
‘Clients residing in NSW who are considered to have been placed at possible risk have now been contacted by NSW Health public health personnel.
‘The Commission has issued an interim prohibition order in relation to Mr Rama Prasad, under section 41AA of the Health Care Complaints Act 1993 (‘The Act’). Mr Prasad is currently prohibited from providing any health services, either in paid employment or voluntarily, to any member of the public.
‘This interim prohibition order will remain in force for a period of eight weeks and may be renewed where appropriate in order to protect the health or safety of the public.’
That should send chills down the spine of any Ayurvedic Medicine practitioner. A complete Prohibition Order ordering Prasad not to engage in providing any health service as defined in the Act  for eight weeks, which may be renewed or even made permanent, depending on what the investigation finds. The Act includes a comprehensive list of activities that comprise a ‘health service’:
‘health service includes the following services, whether provided as public or private services:
- (a) medical, hospital, nursing and midwifery services,
- (b) dental services,
- (c) mental health services,
- (d) pharmaceutical services,
- (e) ambulance services,
- (f) community health services,
- (g) health education services,
- (h) welfare services necessary to implement any services referred to in paragraphs (a)–(g),
- (i) services provided in connection with Aboriginal and Torres Strait Islander health practices and medical radiation practices,
- (j) Chinese medicine, chiropractic, occupational therapy, optometry, osteopathy, physiotherapy, podiatry and psychology services,
- (j1) optical dispensing, dietitian, massage therapy, naturopathy, acupuncture, speech therapy, audiology and audiometry services,
- (k) services provided in other alternative health care fields,
- (k1) forensic pathology services,’
Note the inclusion of ‘health education.’ This is where so many cranks fall foul of the law; setting yourself up as a health educator makes you subject to the Act. Even if you claim to be a master chef, homeopath or Ayurvedic Medicine Practitioner, you are not exempt.
It’s early days yet in this particular saga, and there are many questions to be answered, for example:
- – How did this “medicine” get past Australia’s Therapeutic Goods Administration, (Australia’s equivalent to the US FDA)?
- – Did the TGA list or register it?
- – If not why not? If it was who is responsible?
- – Was this detected only after a child was so sickened that they were taken to hospital?
- – Why is the practitioner concerned still advertising his Ayurvedic medicine courses?  Is this a breach of his Prohibition Order which prohibits ‘health education services’?’
So stay tuned for updates as this case progresses. In the meantime note that an Australian Health regulator is advising the public to seek advice from real doctors before going to alternative therapists, including ‘Ayurvedic Medicine’ practitioners. That is a real headline.
 Such as from the Victoria Dept of Health at https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/ayurveda
 Health Care Complaints Act 1993 https://www.legislation.nsw.gov.au/view/html/inforce/current/act-1993-105
… The global market for alternative and complementary medicines is projected to experience substantial growth in the next few years. The rising expenditure of the healthcare facilities is considered as the major factor that is likely to encourage the growth of the overall market in the coming years. In addition, the increasing number of initiatives being taken by Governments across the globe to promote alternative and complementary medicines is projected to accelerate the market’s growth. Thanks to these factors, the global alternative and complementary medicine market is likely to exhibit a promising growth rate in the near future.
A significant rise in the number of initiatives by NGOs and government organizations to encourage the use of alternative and complementary medicines is estimated to bolster global market in the near future. In addition to this, technological advancements in this field and the rising inclination of consumers towards these medicines and practices are likely to offer lucrative growth opportunities for the leading players operating in the alternative and complementary medicine market across the globe. However, the lack of scientific results is expected to hamper the overall growth of the market in the next few years…
From a regional perspective, Europe is considered as one of the leading segment, thanks to the significant revenue contribution in the last few years. This region is expected to account for a large share of the global alternative and complementary medicine market with the rising use of botanicals. In addition to this, the increasing awareness among consumers regarding the availability of effective alternative and complementary medicines and the benefits they offers are expected to encourage the growth of the Europe market in the coming years.
Furthermore, with the rising popularity of medical tourism, the alternative and complementary medicine market in Asia Pacific is projected to witness a steady growth in the next few years. Moreover, the presence of a large number of new players operating in this region is likely to offer promising growth opportunities over the forecast period. The Middle East and Africa segment is anticipated to experience a healthy growth in the alternative and complementary medicine market in the near future.
The global market for alternative and complementary medicines is presently at a highly competitive stage and is predicted to experience an intense level of competition among the leading players in the coming years. The prominent players in the market are focusing on the expansion of the product portfolio so as to attract a large number of consumers across the globe. This is likely to help them in creating a brand name and acquiring a leading position in the global market. Some of the leading players operating in the alternative and complementary medicine market across the globe are Herb Pharm, Yoga Tree, Quantum Touch Inc., Helio USA Inc., Pure encapsulations, Inc., Pacific Nutritional Inc., Deepure Plus, Herbal Hills, Iyengar Yoga Institute, The Healing Company, and Nordic Naturals.
Yes, I know, this is little more than hot air mixed with platitudes and advertisements to purchase the full report. I used to buy such documents for my department and research but was invariably disappointed. They provide are expensive and of very little of value.
Yet, one thing has been confirmed over the years: the prediction of steady growth of the SCAM-industry is rarely wrong (certain sections, such as homeopathy, have been shrinking in some regions, but the industry as a whole is financially healthy). The scientific evidence seems to get less and less convincing, yet consumers buy more and more of these products. They may do little good and have the potential to cause quite a bit of harm, but consumers continue to waste their money on them.
The question is: why?
There are, of course, many reasons. An important one is that the gullible public wants to believe in SCAM, and the SCAM-industry is highly skilled in misleading us. What is worse: many governments, instead of limiting the damage, are mildly or even overtly supportive of the SCAM-industry.
Whenever I contemplate this depressing state of affairs, I realise that my blog is important. It is only a drop in the ocean, I know, but still…
Misinformation seems to be everywhere and perhaps nowhere more intense than in so-called alternative medicine (SCAM). Correcting it is one of the main reasons/ambitions of this blog. But are such activities effective?
A meta-analysis estimated the efficacy of correcting health-related misinformation on social media. To better understand the causal relationship between exposure to corrective messages on social media and subsequent effects on health-related outcomes, the researchers restricted the meta-analysis to experimental studies that attempted to debunk health misinformation.
The findings indicate that correction can often mitigate the influence of misinformation but the size of the effect is usually small to moderate. The pooled effect was comparable with previous meta-analyses that focused on the correction of misinformation in contexts such as crime, politics, and science. The results provide no evidence of a so-called “boomerang” or backfire effect, whereby attempts to correct misinformation can unintentionally increase people’s acceptance of the falsehood.
The authors concluded that, although there is still much to be learned, the current study’s results are cause for optimism. The vast majority of corrective interventions are at least somewhat successful in diminishing the impact of misinformation, and our findings regarding moderating factors should inform future research into designing effective countermeasures. The continued efforts of the broader research community will only further refine our understanding of best practices to address the threat presented by health misinformation on social media.
What better motivator to carry on?
The Society of Homeopaths (SoH) is the UK’s professional organisation of ‘lay-homeopaths’, therapists who treat patients without having studied medicine. They prefer the term ‘professional homeopathy’, but there is little professional about them, it seems. The SoH has a long track record of endangering public health by promoting anti-vaxx nonsense.
A few months ago, it was reported that Linda Wicks, chair of the Society of Homeopaths (S0H), has shared a series of petitions claiming that childhood immunisations are unsafe. Mrs Wicks also posted a petition supporting Andrew Wakefield, the disgraced former doctor who falsely linked the MMR vaccine to autism claiming that the scientific establishment’s rejection of his flawed research was ‘the greatest lie ever told’.
In 2018, I pointed out that the SoH was violating its own code of ethics. At the time, two new members were appointed to the Society’s Public Affairs (PAC) and Professional Standards (PSC) committees, and both were promoting the deeply anti-vaxx CEASE therapy.
Today, THE TELEGRAPH reports that Sue Pilkington, the SoH’s ‘Head of Standards’, has been promoting anti-vaxx propaganda online. On April 14, she posted anti-vaxx content made by the ‘Children’s Health Defense’ – an organisation accused by NBC News last year as being one of the largest global creators of spreading misinformation’. The page advised that any new vaccine could trigger “lethal” immune reactions.
In a separate post on Facebook, Pilkington shared a post that describes vaccines as “poison” – alongside medical advice declaring that no child should be vaccinated, if any member of their family has a skin disorder. Pilkington also tried to contact Health Secretary Matt Hancock, attempting to share with him a video of content from an American comedian claiming that it’s ‘realistic’ for vaccines to cause autism.
As though this were not enough nonsense, Pilkington also promotes homeopathy as a solution to the current epidemic. On her homeopathy business website, she has section on coronavirus which states the following: “The current primary homeopathic remedy advised for Coronavirus (2019-nCoV) symptoms is Gelsemium with a possible following remedy of Eupatorium Perforatum, Bryonia or Belladonna depending on how the symptoms progress”. Other homeopathic remedies are in common use for people with influenza and pneumonia, according to Pilkington, these do not “prevent viruses” but may “reduce the severity and length of illness”. She also claims that homeopathy has a “great track record of success in epidemics” – referencing both the Spanish influenza pandemic and the bird flu pandemic.
“In our opinion, the Professional Standards Authority (PSA) has a simple choice to make: remove the SoH and their uninformed vaccination paranoia from the register, or continue to allow homeopaths to make these dangerous claims with the tacit approval of the PSA.” said Michael Marshall, projector director of the Good Thinking Society.
A government health spokesperson was quoted in today’s TELEGRAPH article stating this: “Vaccine misinformation in any form – book, film, website or otherwise – is completely unacceptable.” The spokesperson added that NICE does not recommend homeopathy for the treatment of any health condition and noted that vaccines “save lives and are a foundation of public health.”
In response to the recommendation, the health ministry announced the formation of a working group of medical experts to suggest proposals for further regulation of homeopathy. A spokesman said that medicines whose efficiency is not clinically proven should not be procured using public funds, nor prescribed to treat the sick.
Russia has proved a profitable market for foreign suppliers of homeopathic medicine such as French company Boiron, which opened its Russian subsidiary in 2005. “Today, the Russian market is our company’s fourth largest in terms of turnover, after France, the US and Italy. Russia has always been interesting for Boiron because of the large population, and a relatively high incidence of illness and lower level of medicine consumption in comparison with Europe,” general director of Boiron in Russia Irina Nikulina said.
According to figures from Russian pharmaceutical market analysts DSM Group, Boiron sold 35 percent of all the homeopathic medicine sold in Russia last year, or 2.88 billion rubles (USD 49.5 million) worth of medicine. Boiron produces Russia’s most popular homeopathic medicine, called Oscillococcinum, which is marketed to relieve flu symptoms and accounted for 18.98 percent of all homeopathic medicines sold in 2016.
The many international initiatives aimed at minimising the harm done by homeopathy are slowly beginning to yield results. It took many years for politicians to realise that the supposedly harmless homeopathy is, in fact, not harmless at all. Homeopathy causes harm by:
- wasting people’s money,
- distracting patients from effective treatments,
- the ill-conceived advice homeopaths give to patients,
- making a mockery of evidence-based medicine,
- violating the principles of medical ethics,
- undermining rational thinking in society.
One therefore has to applaud Russia’s ‘Commission against Pseudoscience’, hope that the working group does produce robust advice, and support similar initiatives in other countries.
As parts of Australia are going back into lock-down because of the increasingly high COVID-19 infection rates, the Chiropractic Board of Australia (CBA) has issued a statement on chiropractors’ claims regarding immunity:
The Board is particularly concerned that during the ongoing COVID-19 pandemic there are claims in advertising that suggest spinal adjustments and/or manipulation can boost or improve general immunity or the immune system.
There is insufficient acceptable evidence to support such claims in advertising. Acceptable evidence mostly encompasses empirical data from formal research or systematic studies, in the form of peer-reviewed publications. Information about what constitutes acceptable evidence for advertising can be found in the Advertising resources section of the Ahpra website.
Advertising that there is a relationship between manual therapy (e.g. spinal adjustments and/or manipulation) and achieving general wellness or boosting or improving immunity contravenes the National Law and the Guidelines for advertising regulated health services.
Although many claims do not directly reference spinal adjustments and/or manipulation preventing or protecting from COVID-19, there is currently greater awareness of immunity issues and the public is seeking information on ways to prevent or protect themselves from the disease. Consequently, there is a greater risk that claims about spinal adjustments and/or manipulation boosting or improving general immunity may be interpreted to be claims about boosting or improving immunity to COVID-19.
Making claims in advertising that spinal adjustments and/or manipulation can boost or improve general immunity or the immune system is likely to result in regulatory action being taken by the Board.
“… IS LIKELY TO RESULT IN REGULATORY ACTION …”???
Come on, pull the other one!
Bogus claims have been made by chiropractors since ages.
Bogus claims are what chiropractors thrive on.
Without them, they would go bust.
Every now and then some regulator makes some noises reminding chiropractors that bogus claims are bogus. But have they EVER taken any action?
Have they ever even INTENDED to take action?
I doubt it.
In fact, statements of this nature seem to be the chiropractic way of sanctioning false claims. The somewhat paradoxical way this works is as follows: chiropractors make bogus claims all the time; we all got so much used to them that hardly anyone bats an eyelash. But every now and then the bogus nature of the claims become noticeable to the wider public – like now with COVID-19 – and some people or organisations take offence. This is clearly not good for the chiro-business or image. Therefore, the professional chiro organisations step in by issuing a statement – like the one above – condemning the claims and threatening action. All the chiros know, of course, what this is about and change absolutely nothing. The desired effect is guaranteed: chiros can carry on as before, but the image is saved and the business can continue.
I very much doubt that, in the coming weeks, the CBA will do much about the many Australian chiropractors who will continue to mislead the public about COVID-19 or any other issues.
Nice window dressing perhaps, but no substance at all.
If you disagree with my view, please send me the details of any decisive regulatory action which the CBA took regarding immunity claims, and I will delete this post.
In 2015, the Hungarian Academy of Sciences stated that “Homeopathic remedies don’t meet the criteria of evidence based medicine” and that homeopathic products should follow the same strict scientific standards as conventional drugs. In 2017, the Scientific Advisory Board of European Academies (EASAC) concluded that there is no substantial evidence that homeopathy works and may even be harmful to our health.
Now, Hungary is about to act. New regulation is tightening the marketing of homeopathic products in Hungary. From Wednesday this week, homeopathic remedies can only be distributed in Hungary without a therapeutic indication or claim. The reason for this move is that none of the products’ efficacy have been adequately confirmed by rigorous clinical trials.
In a statement, the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI) said the changes are due to a law amendment that came into effect last year. The new regulation only allows homeopathic medicines with therapeutic indications authorized before Hungary’s accession to the EU (2004), to be marketed after July 1, 2020, if they have complied with the EU regulations on the marketing of these medicines.
Currently, Hungary has no homeopathic product with therapeutic efficacy proven in clinical trials. The product license of homeopathic products – in compliance with the legislation of the European Union – can be obtained by two different procedures in Hungary. The so-called simplified procedure can be used for “high-dilution products” marketed without a therapeutic indication, in which case the effectiveness of the product does not need to be certified.
The “normal” procedure is applicable to homeopathic medicinal products marketed for a therapeutic indication, in which case, just as any other medicinal products, therapeutic efficacy must be clinically proven. OGYÉI emphasized that from July 1st, the advertising of marketable homeopathic remedies may only contain the label text of the product, no additional information.
The move by the Hungarian authorities is, of course, most welcome. It brings Hungary finally in line with the rest of the EU. The many enthusiasts of homeopathy will no doubt suspect a worldwide conspiracy against homeopathy. If so, they merely disclose how far they have put their heads into the sand. Such measures are nothing but the long overdue actions towards abolishing double standards that have existed far too long and have helped nobody except the homeopathic industry.
The U.S. Food and Drug Administration has issued warning letters to four companies for selling unapproved injectable drug products labelled as homeopathic that can pose serious risks to patient health and violate federal law, as part of the agency’s efforts to protect Americans from potentially harmful products that are labelled as homeopathic.
The FDA is particularly concerned about unapproved injectable drug products labelled as homeopathic because they are injected directly into the body, often directly into the bloodstream and bypass some of the body’s key natural defences against toxins, toxic ingredients and dangerous organisms that can cause serious and life-threatening harm. Additionally, unapproved drugs that claim to cure, treat or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.
“The FDA’s drug approval requirements are designed to protect patients by ensuring, among other things, that drugs are safe and effective for their intended uses. These unapproved injectable drugs are particularly concerning because they inherently present greater risks to patients because of how they are administered,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “These products are further concerning given that they are labelled to contain potentially toxic ingredients intended for injection directly into the body. These warning letters reflect our continued commitment to patient safety.”
No currently marketed drug products labelled as homeopathic have been approved by the FDA for any use and the agency cannot assure these drugs meet modern standards for safety, effectiveness and quality. Products labelled as homeopathic can be made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, and they can include known poisons or toxins. These drugs are often marketed as natural, safe and effective alternatives to approved prescription and non-prescription products and are widely available in the marketplace. Additionally, the lack of premarket quality review is particularly concerning for injectable drugs, which generally pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defences.
The FDA issued the warning letters to Hevert Pharmaceuticals, LLC; MediNatura, Inc.; 8046255 Canada, Inc., doing business as Viatrexx; and World Health Advanced Technologies, Ltd. The products included in the warning letters are new drugs because they are not generally recognized as safe and effective for their labelled uses, and FDA has not approved these products. Some drugs, such as “Enercel,” marketed by World Health Advanced Technologies, Ltd., are intended for serious diseases such as tuberculosis and hepatitis B and C.
Many of the drugs were labelled to contain potentially toxic ingredients such as nux vomica, belladonna (deadly nightshade), mercurius solubilis (mercury), and plumbum aceticum (lead). For example, nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents. The agency is concerned that these potentially toxic ingredients present additional risks of serious harm when delivered directly into the body, including directly into the bloodstream.
Drugs labelled as homeopathic may also cause significant and even irreparable harm if they are poorly manufactured. Viatrexx was also cited for substandard manufacturing practices for sterile drugs.
The foreign manufacturers of the injectable drugs sold by Hervert Pharmaceuticals, LLC; MediNatura New Mexico, Inc.; and Viatrexx were also placed on import alert 66-41 to stop these drugs from entering the U.S.
The FDA has taken steps to clarify for both consumers and industry how the potential safety risks of these products are assessed. On Oct. 24, 2019, the FDA withdrew Compliance Policy Guide (CPG) 400.400 “Conditions Under Which Homeopathic Drugs May be Marketed,” because it was inconsistent with the agency’s risk-based approach to regulatory and enforcement actions. The FDA also issued a revision of its draft guidance, titled Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry, for public comment. When finalized, this guidance will explain the categories of homeopathic drug products that we intend to prioritize under our risk-based enforcement approach. In the interim, before the draft guidance is finalized, the FDA intends to apply its general approach to prioritizing risk-based regulatory and enforcement action.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of any of these products to the FDA’s MedWatch Adverse Event Reporting program. To report adverse drug events in animals, see How to Report Animal Drug Side Effects and Product Problems…
Hevert is of course well known to readers of this blog for their attempt to silence critics of homeopathy in Germany. The FDA’s warning letter refers to their following injectable products:
- “Calmvalera comp.,”
- “Gelsemium comp.,”
- “Hepar comp.,”
- “Lymphaden comp.”
The FDA referred to the following injectable homeopathic products from 8046255 Canada:
- “Systemic Detox,”
- “Neuro 3,”
- “Lymph 1,”
The FDA warning to World Health Advanced Technologies, Ltd referred to:
- “Enercel AM,”
- “Enercel Forte,”
- “Enercel Max,”
- “Enercel Mist-Nasal,”
- “Enercel Mist Nebulizer,”
- “Enercel PM,”
- “Enercel Plus,”
- “Enercel Plus IM.”
The FDA warning referred to the following products by MediNatura, and the claims made for them include:
- Zeel Injection Solution: “… treatment of arthrosis/osteoarthritis, and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.”
- Traumeel Injection Solution: “… treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.”
- Engystol Injection Solution: “… support of the immune system to reduce severity and duration of symptoms in viral infections, particularly in the early stages of colds and influenza-like illnesses.”
- Neuralgo-Rheum Injection Solution: “… treatment of nerve pain, soft tissue rheumatism and symptoms of disc protrusion.”
- Lymphomyosot X Injection Solution: “… improvement of lymphatic drainage, the non-specific immune defense, and conditions such as benign hypertrophy of lymph nodes, chronic tonsillitis, tonsillar hypertrophy and lymphatic edema.”
- Spascupreel Injection Solution: “… relief of spasms of the smooth musculature of the gastrointestinal and urogenital tract as well as general muscle spasms.”
The FDA has requested the companies to respond within 15 working days. The letter also states that failure to correct any violations could result in legal action against the company, including seizure and injunction.
Asked for comment, Cliff Clive, founder and CEO for MediNatura, stated that he is disappointed with the FDA’s actions and the company is in the process of developing their response. “The FDAs statements that the MediNatura injectable products present greater risk to consumers is without factual basis,” Clive said. “The MediNatura injectable products are labelled for use only under the care of licensed practitioners [and] are manufactured in [Good Manufacturing Practice]-compliant facilities to assure their quality and sterility.”
Disputing several of the claims made in the letter, Clive noted that rather than protecting patients, “the FDA’s actions threaten to remove valuable alternatives relied upon by medical practitioners in treating their patients. These injections have been used legally by thousands of medical doctors for more than 30 years in the U.S., and in over 50 other countries for more than 60 years, with rigorous monitoring of adverse events,” Clive said. “As a result, there is a substantial amount of epidemiological data which shows that MediNatura’s injection products have a superb safety profile.”
As far as I can see, none of the above-named products are supported by sound evidence. If you ask me, it is time that homeopaths understand what proofs of safety and efficacy amount to, that they stop confusing the public, and that they stop marketing illegal products.
By guest blogger Loretta Marron
If scientists were fearful of a clinical trial’s producing negative results, would they even pursue it? A draft Chinese regulation issued in late May aims to criminalise individual scientists and organisations whom China claims damage the reputation of Traditional Chinese Medicine (TCM).
Beijing has a reputation for reprimanding those who decry TCM. Such criticism is blocked on Chinese Internet. Silencing doctors is becoming the norm.
In January 2018, former anaesthetist, Tan Qindong, was arrested and spent more than three months in detention after criticising a widely advertised, best-selling ‘medicinal’ TCM liquor. Claiming that it was a ‘poison’, he believed that he was protecting the elderly and vulnerable patients with high blood pressure. Police claimed that a post on social media damaged the reputation of the TCM ‘liquor’ and of the company making it. Shortly after release, he suffered post-traumatic stress and was hospitalised.
On 30 December 2019, Chinese ophthalmologist, the late Dr Li Wenliang, was one of the first to recognise the outbreak of COVD-19. He posted a private warning to a group of fellow doctors about a possible outbreak of an illness resembling severe acute respiratory syndrome (SARS). He encouraged them to protect themselves from infection. Days later, after his post when viral, he was summoned to the Public Security Bureau in Wuhan and forced to “admit to lying about the existence of a worrying new virus”. Li was accused of violating the provisions of the “People’s Republic of China Public Order Management and Punishment Law” for spreading “unlawful spreading of untruthful topics on the internet” and of disturbing the social order. He was made to sign a statement that he would “halt this unlawful behaviour”.
In April 2020, Chinese physician Yu Xiangdong, a senior medico who worked on the front line battling COVID-19, posted on Weibo, a Twitter-like site, a criticism of the use of antibiotics and TCM to treat COVID-19. He was demoted from his positions as assistant dean at the Central Hospital in the central city of Huangshi and director of quality management for the city’s Edong Healthcare Group. Well known for promoting modern medicine amongst the Chinese, Yu had almost a million followers on social media. All his postings vanished.
Beijing insists that TCM has been playing a crucial role in COVID-19 prevention, treatment and rehabilitation. Claims continue to be made for “effective TCM recipes”. However, no randomised clinical trial has been published in any reputable journal.
TCM needs proper scrutiny, but criticising it could land you years in prison. If the benefits of suggested herbal remedies are to be realised, good clinical studies must be encouraged. For TCM, this might never be permitted.
Don’t think for a moment that you are safe in Australia.
Traditional Chinese Medicine Services (“TCM”)
- Within the relevant committees to be established in accordance with this Agreement, and subject to available resources, Australia and China shall cooperate on matters relating to trade in TCM services.
- Cooperation identified in paragraph 2 shall:
(a) include exchanging information, where appropriate, and discussing policies, regulations and actions related to TCM services; and
(b) encourage future collaboration between regulators, registration authorities and relevant professional bodies of the Parties to facilitate trade in TCM and complementary medicines, in a manner consistent with all relevant regulatory frameworks. Such collaboration, involving the competent authorities of both Parties – for Australia, notably the Department of Health, and for China the State Administration of Traditional Chinese Medicine – will foster concrete cooperation and exchanges relating to TCM.