MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

homeopathy

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This recently published survey aimed to investigate the use of so-called alternative medicine (SCAM) among long-term cancer survivors and its links with healthy behaviour. Data was used from the VICAN survey, conducted in 2015-2016 on a representative sample of French cancer survivors 5 years after diagnosis.

Among the 4174 participants, 21.4% reported using SCAM at the time of the survey, including 8.4% who reported uses not associated with cancer. The most frequently cited reasons for using SCAM were:

  • to improve their physical well-being (83.0%),
  • to strengthen their body (71.2%),
  • to improve their emotional well-being (65.2%),
  • to relieve the side effects of treatment (50.7%).

The SCAM users who reported using SCAM to cure cancer or prevent relapses (8.5% of the participants) also used SCAM for other reasons. They had more often experienced cancer progression, feared a recurrence, and had a poorer quality of life because of sequelae, pain, and fatigue. They also consulted their general practitioners more frequently and had changed their lifestyle by adopting more healthy practices.

The authors concluded that the use of SCAM is not an alternative but a complementary means of coping with impaired health. Further research is now required to determine whether the use of SCAM reflects a lifestyle change or whether it assists survivors rather to make behavioural changes.

The 2012 data from the same survey had previously reported that, among the participants, 16.4% claimed to have used SCAM, and 45.3% of this group had not used SCAM before cancer diagnosis (new SCAM users). Commonly, SCAMs used were:

  • homeopathy (64.0%),
  • acupuncture (22.1%),
  • osteopathy (15.1%),
  • herbal medicine (8.1%),
  • diets (7.3%),
  • energy therapies (5.8%).

SCAM use was found to be significantly associated with younger age, female gender and a higher education level. Previous SCAM use was significantly associated with having a managerial occupation and an expected 5-year survival rate ≥80% at diagnosis; recent SCAM use was associated with cancer progression since diagnosis, impaired quality of life and higher pain reports.

In nearly half of the SCAM users, cancer diagnosis was one of the main factors which incited patients to use SCAM. Opting for SCAM was a pragmatic response to needs which conventional medicine failed to meet during the course of the disease.

These surveys mostly confirm what has been shown over and over again in other countries. What I find remarkable with these results, however, is the increase in SCAM use over time and the extraordinary high use of homeopathy by French cancer patients (more recently, the reimbursement of homeopathy in France has changed, of course). As homeopathy has no effects beyond placebo, this suggests that SCAM use by French cancer patients is far from being driven by evidence.

So, what then does determine it?

My best answer I can give to this question is this: relentless promotion through pharmacies, advertisements and journalists. These have all been very powerful in France in relation to homeopathy (hardly surprising, as the world’s largest homeopathic producer, Boiron, is based in France).

This leads me to the conclusion that SCAM is far more commercially driven than its enthusiasts would ever admit. They think of the pharmaceutical industry as the evil exploiter of the sick. It is now time to realise that the SCAM industry is, to a large extent, part of the pharmaceutical industry and often behaves just as badly or even worse: because what could be more unethical that selling placebos to desperate and vulnerable cancer patients?

When I discuss published articles on this blog, I usually focus on recent papers. Not so today! Today I write about a small study we published 17 years ago. It was conducted in Canada by researchers whom I merely assisted in designing the protocol and interpreting the findings.

They trained 8 helpers to pretend being customers of health food stores. They entered individually into assigned stores; the helpers had been informed to browse in the store until approached by an employee. At this time they would declare that their mother has breast cancer. They disclosed information on their mother’s condition, use of chemotherapy (Tamoxifen) and physician visits, only if asked. The helpers would then ask what the employee recommend for this condition. They followed a structured, memorized, pretested questionnaire that asked about product usage, dosage, cost, employee education and product safety or potential for drug interactions.

The helpers recorded which products were recommended by the health food store employees, along with the recommended dose and price per product as well as price per month. Additionally, they inquired about where the employee had obtained information on the recommended products. They also noted whether the employees referred them on to SCAM practitioners or recommended that they consult a physician. Full notes on the encounters were written immediately after leaving the store.

The findings were impressive. Of the 34 stores that met our inclusion criteria, 27 recommended SCAMs; a total of 33 different products were recommended. Here are some further findings:

  • Essiac was recommended most frequently.
  • The mean cost of the recommended products per month was $58.09 (CAD) (minimum $5.28, median $32.99, maximum $600).
  • Twenty-three employees (68%) did not ask whether the patient took prescription medications.
  • Fifteen (44%) employees recommended visiting a healthcare professional; these included: naturopaths (9), physicians (5) and nutritionists (1).
  • Health food store employees relied on a variety of sources of information. Twelve employees (35%) said they had received their information from books, 5 (15%) from a supplier, 3 (9%) had formal education in SCAM, 2 (6%) had in-store training, and 12 (35%) did not disclose their sources of information.

Since our paper has been published, several other investigations have addressed similar issues. Here are a few excerpts:

But why do I mention all this today?

The answer is that firstly, I think it is important to warn consumers of the often dangerous advice they might receive in HFSs. Secondly, I feel it would worthwhile to do further research, check whether the situation has changed and repeat a similar study today. Ideally, a new investigation should be conducted in different locations comparing several countries. If you have the possibility to plan and conduct such an experiment, please drop me a line.

Retraction Watch has alerted us to a “Paper urging use of homeopathy for COVID-19 appears in peer-reviewed public health journal”. The paper in question is readily available on the Internet. Here is its abstract:

Today, humanity is living through the third serious coronavirus outbreak in less than 20 years, following SARS in 2002–2003 and MERS in 2012. While the final cost on human lives and world economy remains unpredictable, the timely identification of a suitable treatment and the development of an effective vaccine remain a significant challenge and will still require time.

The aim of this study is to show that the global collective effort to control the coronavirus pandemic (Covid 19) should also consider alternative therapeutic methods, and national health systems should quickly endorse the validity of proven homeopathic treatments in this war against coronavirus disease.
Subject and methods With the help of mathematics, we will show that the fundamental therapeutic law on which homeopathy is founded can be proved.
Results The mathematical proof of the law of similarity justifies perfectly the use of ultra – high diluted succussed solution products as major tools in the daily practices of homeopathy.
Conclusion It is now time to end prejudice and adopt in this fight against Covid-19 alternative therapeutic techniques and practices that historically have proven effective in corresponding situations.

And the full conclusions from the body of the paper read as follows:

Today, it is imperative that ever-safe medicinal products such as homeopathic ultra – high diluted succussed solutions are tested in this pandemic. Epidemiological research has to be carried out to include homeopathic treatment and compare it to established treatments. Patients should be assigned randomly in two different groups of at least 200–400 individuals, and receive respectively established and homeopathic treatment. The evaluation of the results from both groups could reveal which group has a superior outcome in survival, general health conditions, etc., and to what extent.

If there were a competition for the craziest paper published on so-called alternative medicine (SCAM) during 2020, this one would, I am sure, win by some margin! The authors seem to have little idea of the nature of evidence in healthcare or medicine; and they use mathematics like a drunken man uses a lamp-post: not for enlightenment, but for support.

So, who are the authors of this showcase of pseudoscience?

They are D. Kalliantas, M. Kallianta, Ch. S. Karagianni from the Department of Materials Science and Engineering, School of Chemical Engineering, NTUA, GR15780, Athens, Greece; the National Technical University of Athens, 9 Heroon Polytechniou Str. Zografos Campus, 15780 Athens, Greece; and the School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece.

The first author has previously published weird stuff including a self-published book: Kalliantas D (2008) The Chaos theory of disease. Kallianta A Publications, Eleusis, GreeceOn Medline, I also found this paper by two of the three authors:

Trituration is a mechanical process (a form of comminution) for reducing the particle size of a substance. In this manuscript, six different Raw Solid Materials (RSM) which are used in Homeopathy after successive grindings are studied before they are turned into homeopathic solutions. The impact of trituration, with the presence of α‑lactose monohydrate (milk sugar) seems to be quite great and interesting because of the variety of grain size which largely differentiate the properties of the materials. The grain sizes obtained triturations by hand according to C. Herring’s suggestion leads, finally, measurement scale dimensions. The obtained results can be useful information for all the pharmacy industries, as well as for preparing any kind of powder.

Sadly, this renders my suspicion unlikely that the new article is a hoax in which some pranksters were trying to show that any odd nonsense can pass the peer-review of a scientific journal.

And which journal would publish a paper that looks like a hoax but is none? It is the Journal of Public Health: From Theory to Practice (Springer). On the website, the journal tells us that:

The Journal of Public Health: From Theory to Practice is an interdisciplinary publication for the discussion and debate of international public health issues, with a focus on European affairs. It describes the social and individual factors determining the basic conditions of public health, analyzing causal interrelations, and offering a scientifically sound rationale for personal, social and political measures of intervention. Coverage includes contributions from epidemiology, health economics, environmental health, management, social sciences, ethics, and law.

  • An interdisciplinary publication for the discussion and debate of international public health issues
  • Includes contributions from epidemiology, health economics, environmental health, management, social sciences, ethics, and law
  • Offers a scientifically sound rationale for personal, social and political measures of intervention
  • 94% of authors who answered a survey reported that they would definitely publish or probably publish in the journal again.

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The twice mentioned term SCIENTIFICALLY SOUND does not quite ring true in the present instance, does it?

New German Medicine?

German New Medicine?

What on earth is that?

German New Medicine (GNM) is the creation of Ryke Geerd Hamer (1935-2017), a German doctor. The name is reminiscent of the ‘Neue Deutsche Heilkunde’ created by the Nazis during the Third Reich. Hamer received his medical licence in 1963 but was later struck off because of malpractice. He then continued his practice as a ‘Heilpraktiker’. According to proponents, GNM Therapy is a spoken therapy based on the findings and research of the Germanic New Medicine of Dr.Hamer. On the understanding that every disease is triggered by an isolating and shocking event, GNM Therapy assists in finding the DHS (shocking moment) in our lives that preceded the dis-ease and in turn allowing our bodies to complete its natural healing cycle back to full health. Hamer believed to have discovered the ‘5 laws of nature’:

  • The Iron Rule of Cancer
  • The two-phased development of disease
  • Ontogenetic system of tumours and cancer equivalent diseases
  • Ontogenetic system of microbes
  • Natures biological meaning of a disease

Hamer also postulated that:

  • All diseases are caused by psychological conflicts.
  • Conventional medicine is a conspiracy of Jews to decimate the non-Jewish population.
  • Microbes do not cause diseases.
  • AIDS is just an allergy.
  • Cancer is the result of a mental shock.

None of Hamer’s ‘discoveries’ and assumptions are plausible or based on facts, and none of his therapeutic approaches have been shown to be effective.

 These days, I do not easily get surprised by what I read about so-called alternative medicine (SCAM), but this article entitled ‘Homoeopathy And New German Medicine: Two German Siblings‘ baffled me greatly. Here are a few short excerpts:

… German New Medicine (GNM) like Homoeopathy is one of the gentle healing methods. As siblings, they have some common features as well as their own unique features. So, let’s explore a unique relationship between these two siblings.

1) Holistic aspect:
Both therapeutic methods are believed in holistic concept of body. The disease condition in Homoeopathy and conflict in GNM are very similar in expression as they are reflecting on mental as well as physical level also. In Homoeopathy, Mind, Body and Soul are one of the important trios to understand the Homoeopathic philosophy. While in GNM, Psyche, Brain, Body are important aspect in learning the GNM. Let’s see these trio in their founder’s language,

• Homoeopathy:
Dr. Hahnemann in his oragnon of medicine, 6th edition mentioned about a unity of materialistic body and vital force. Last lines of aphorism 15 are as follows, “…although in thought our mind separates these two unities into distinct conceptions for the sake of easy comprehension.

• German New Medicine:
Dr. Ryke Geerd Hamer, founder of GNM said that, “The differentiation between psyche, brain and the body is purely academic. In reality, they are one.”

2) Disease origin concept:

• Homoeopathy:
In Homoeopathy, disease originates from the dynamic disturbances and followed by functional and pathological changes.

• German New Medicine:
In GNM, morbid condition starts from conflict in the psyche level and later it reflects on body. The common feature is the disturbance is at the all levels of man.

3) Cause of disease:

• Homoeopathy:
In Homoeopathy, among the web of causations, psyche (mind) is also considers as a cause of disease.

• German New Medicine:
So, in GNM, psyche is playing important role in cause of disease. When Conflict starts, its dynamic effect perceived first at mind level.

4) Individuality:

• Homoeopathy:
In Homoeopathy, diathesis is a predisposition for disease condition. i.e. According to the diathesis every individual suffers with their own individual morbid dispositions. Rheumatic diathesis, gouty diathesis, etc. are the examples of diathesis.

• German New Medicine:
In GNM, every individual suffers from the disease condition after the receiving conflict. It is different and depending upon the type of conflict they are receiving. E.g. lung cancer- death fright conflict, cervical cancer –female sexual conflict…

Conclusion:
Some similarities and with some own characteristics, these two healing methods are developing at a good length in medical science. The main aim of these both methods is – “to serve the suffering humanity in gentle way”…

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Could it be that the author forgot the most striking similarities between GNM and homeopathy? How about these points:

  • There is nothing truly gentle about either methods.
  • Both are based on bizarre fantasies, far removed from reality.
  • Both pretend to be a panacea.
  • Both lack proof of efficacy.
  • Both have the potential to kill patients (mostly through neglect).
  • Both mislead consumers.
  • Both are deeply anti-scientific.
  • Both dissuade patients from using evidence-based healthcare.
  • Both are in conflict with medical ethics.
  • Both have cult-like features.
  • Both are far from being recognised by proper healthcare.
  • Both have been repeatedly in conflict with the law.
  • Both were invented by deludes fanatics.

On his website, Phillip Hughes – D. Hom (Med), M.A.R.H, describes himself as follows:

In the early 1990’s my life was turned upside-down by a prolapsed disk in my back, putting me in traction in a hospital for 6 weeks! The doctor’s prognosis was poor, leaving me with little hope of full mobility, and no choice but to seek treatment elsewhere.

I decided on Homeopathy, and after treatment I experienced real change in my condition within a month, and was completely well within 3 months. I was so inspired by this I decided to study Homeopathy myself – and in 1994 I enrolled at the Hahnemann College of Homeopathy in London, qualifying in 1998.

After qualifying I set up my first clinic in Waterloo, Liverpool. I also became a senior lecturer at the Hahnemann College of Homeopathy, and founder of the Liverpool branch of the Hahnemann College.

I then moved my clinic to College Road Crosby, when I took up the role of secretary of Homeopathic Medical Association (since resigned). It was during this time that my wife Rosa found a lump in her breast, motivating us again to seek safer and alternative treatments, this time using Thermography. We now run Thermography and Homeopathic clinics side by side.

I had never heard of Mr Hughes until yesterday, when it was reported that he had treated a Sean Walsh, a young musician, for Hodgkin lymphoma that had initially been controlled with chemotherapy, but had later returned. Here is an excerpt from the sad story:

Sean was having scans at a clinic – Medical Thermal Imaging – run by a couple called Philip and Rosa Hughes. Philip Hughes, a homeopath, had previously told Sean’s parents he’d successfully treated Rosa for breast cancer. Dawn [Sean’s girlfriend] went along to Sean’s first appointment. “Phil was just talking all about how damaging chemotherapy is, you know, on the human body… saying, ‘I’ve had lots of people come to my clinic, but by the time I get them, they’re shot with all this chemotherapy, so I can’t help them … And then he was talking all about how you can change your diet, which can reverse cancer. He’d said that Rosa had developed breast cancer. She’d had a lump in her breast, and she decided not to do hospital treatment, and she was going to, you know, reverse the cancer herself. So obviously Sean’s listening to this thinking, ‘Well, if one person’s done it, and then I’m hearing other little stories off them, I can do this’. Sean’s scans did carry a disclaimer, stating that thermography does not see or diagnose cancer and recommending further clinical investigation. But the scan results seemed reassuring – and Sean was convinced his cancer had gone. ‘Medical Thermal Imaging’ describe their scans as “100% safe and radiation-free”.

To find out more about the service the Hughes were offering, a BBC reporter went to the clinic where Sean had his scans, posing as a patient who’d found a lump. They were seen by Rosa Hughes, who had provided scans for Sean. Rosa told our reporter that when she went to the breast clinic to have her lump investigated, she should have an ultrasound rather than a mammogram. This is a transcript of what she said: “Not a mammogram, because you’re going to get radiated, and it’s going to squash… and the amount of women that have had their tumours, the tumour burst, that spreads cancer.”

[The BBC] asked cancer specialist Prof Andrew Wardley, of Manchester’s Christie Hospital, to review the medical claims Rosa Hughes made to our reporter. “That’s preposterous. You don’t burst tumours, they are solid. You do squash the breast down to do a mammogram, it is unpleasant but it’s a short-term thing. You do not spread cancer by doing a mammogram, that’s a complete fallacy.” Rosa and Philip Hughes say they “utterly reject” the allegation that they gave Mr Walsh inappropriate advice. They added they had “consistently made clear” that thermography can only be used alongside other tests, such as MRIs or mammograms.

At first Sean believed he had cured his own cancer. But tragically Sean was wrong. Gradually his health declined, until he was rushed to hospital in Liverpool where medical staff found he had multiple tumours in his stomach and chest. He did eventually receive chemotherapy but it was too late.

Sean died in January 2019.

On Philip Hughes’ website, he advertises his services with the help of several testimonials from happy customers. Here is one of them:

In November 2000, I had an aggressive Sarcoma Tumour removed along with my left lung. Shortly after surgery I was referred to Weston Park Hospital, Sheffield for ‘follow up’ treatments where I was offered both chemotherapy and radiotherapy. At around the same time, I first visited Waterloo Homeopathic Clinic on a friends recommendation. After this initial introduction to Homeopathy I began ti educate myself about my condition and possible treatments. Consequently I considered chemotherapy to be a crude option and decided to refuse it. However, the frightening thought of this aggressive tumour returning encourages me to go ahead with a six week course of radiotherapy as a precaution alongside Homeopathic treatment. Accordingly this holistic approach resulted in my immune system being boosted by Homeopathy and my body prepared for this medical treatment. Leading up to the radiotherapy and during the six weeks of treatments, I took a rang of Homeopathic remedies. Radium Brom, in my opinion, was undoubtedly the input that enabled me to go through an intense course of treatment daily and continue my healthy recovery. I didn’t miss a days work and finished a half marathon only three weeks after completing the radiotherapy. I have since remained in good health and all checks been clear.

I have said it often, but it seems I have to say it again: the homeopathic remedy might be harmless, but the homeopath isn’t!

 

 

 

PS

The BBC documentary provides many more details about Sean and another of Mr Hughes’ patients. It also shows some rare footage from the inside of the Gerson clinic in Mexico where Sean went for a while. Very sad but well worth watching!!!

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.”

 

Already in 2017, the Russian Academy of Sciences (RAS) had issued a statement saying that “The principles of homeopathy contradict known chemical, physical and biological laws and persuasive scientific trials proving its effectiveness are not available.”Now Russia’s ‘Commission against Pseudoscience’ called homeopathy a “pseudoscience” whose effectiveness hasn’t been proven, which is harmful to patients because they spend money and time on ineffective treatments.Since 1995, qualified doctors who are also trained in homeopathy have been licensed to practice homeopathic medicine in Russian hospitals and clinics, and their practice has been regulated. However, the Commission has now recommended that Russia’s Ministry of Health forbid doctors from prescribing homeopathic medicine and ban the homeopathic medicines themselves from state medical institutions. “Homeopathy is not harmless: patients spend a lot of money on drugs that don’t work and neglect means of treatment with proven effectiveness. This can lead to adverse outcomes, including death of the patient,” the Commission wrote.

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.

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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:

  1. wasting people’s money,
  2. distracting patients from effective treatments,
  3. the ill-conceived advice homeopaths give to patients,
  4. making a mockery of evidence-based medicine,
  5. violating the principles of medical ethics,
  6. 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.

 

 

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.

When tested rigorously, the evidence for so-called alternatives medicine (SCAM) is usually weak or even negative. This fact has prompted many SCAM enthusiasts to become utterly disenchanted with rigorous tests such as the randomised clinical trial (RCT). They seem to think that, if the RCT fails to generate the findings we want, let’s use different methodologies instead. In other words, they are in favour of observational studies which often yield positive results.

This line of thinking is prevalent in all forms of SCAM, but probably nowhere more so that in the realm of homeopathy. Homeopaths see that rigorous RCTs tend not to confirm their belief and, to avoid cognitive dissonance, they focus on observational studies which are much more likely to confirm their belief.

In this context, it is worth mentioning a recent article where well-known homeopathy enthusiasts have addressed the issue of observational studies. Here is their abstract:

Background: Randomized placebo-controlled trials are considered to be the gold standard in clinical research and have the highest importance in the hierarchical system of evidence-based medicine. However, from the viewpoint of decision makers, due to lower external validity, practical results of efficacy research are often not in line with the huge investments made over decades.

Method: We conducted a narrative review. With a special focus on homeopathy, we give an overview on cohort, comparative cohort, case-control and cross-sectional study designs and explain guidelines and tools that help to improve the quality of observational studies, such as the STROBE Statement, RECORD, GRACE and ENCePP Guide.

Results: Within the conventional medical research field, two types of arguments have been employed in favor of observational studies. First, observational studies allow for a more generalizable and robust estimation of effects in clinical practice, and if cohorts are large enough, there is no over-estimation of effect sizes, as is often feared. We argue that observational research is needed to balance the current over-emphasis on internal validity at the expense of external validity. Thus, observational research can be considered an important research tool to describe “real-world” care settings and can assist with the design and inform the results of randomised controlled trails.

Conclusions: We present recommendations for designing, conducting and reporting observational studies in homeopathy and provide recommendations to complement the STROBE Statement for homeopathic observational studies.

In their paper, the authors state this:

It is important to realize three areas where observational research can be valuable. For one, as already mentioned, it can be valuable as a preparatory type of research for designing good randomized studies. Second, it can be valuable as a stand-alone type of research, where pragmatic or ethical reasons stand against conducting a randomized study. Additionally, it can be valuable as the only adequate method where choices are involved: for instance, in any type of lifestyle research or where patients have very strong preferences, such as in homeopathy and other CAM. This might also lead to a diversification of research efforts and a broader, more realistic, picture of the effects of therapeutic interventions.

My comments to this are as follows:

  1. Observational research can be valuable as a preparatory type of research for designing good randomized studies. This purpose is better fulfilled by pilot studies (which are often abused in SCAM).
  2. Observational research can be valuable as a stand-alone type of research, where pragmatic or ethical reasons stand against conducting a randomized study. Such situations rarely arise in the realm of SCAM.
  3. Observational research can be valuable as the only adequate method where choices are involved: for instance, in any type of lifestyle research or where patients have very strong preferences, such as in homeopathy and other CAM. I fail to see that this is true.
  4. Observational research leads to a diversification of research efforts and a broader, more realistic, picture of the effects of therapeutic interventions. The main aim of research into the effectiveness of SCAM should be, in my view, to determine whether the treatment per se works or not. Observational studies are likely to obscure the truth on this issue.

Don’t get me wrong, I am not saying that observational studies are useless; quite to the contrary, they can provide very important information. But what I am trying to express is this:

  • We should not allow double standards in medical research. The standards and issues of observational research as they exist in conventional medicine must also apply to SCAM.
  • Observational studies cannot easily determine cause and effect between the therapy and the outcome.
  • Observational studies cannot be a substitute for RCTs.
  • Depending on their exact design, observational studies measure the outcome caused by a whole range of factors, including the therapy per se, the placebo-effect, the natural history of the disease, the regression towards the mean.
  • Observational studies are particularly useful in effectiveness research, AFTER the efficacy of a therapy has been established by RCTs.
  • If RCT fail to show that a therapy is effective and observational studies seem to indicate that they work, the therapy in question is probably a placebo.
  • SCAM-enthusiasts’ preference for observational studies is transparently due to motivated reasoning.

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, LLCMediNatura, 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

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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:

  • “Arnica,”
  • “Calmvalera comp.,”
  • “Gelsemium comp.,”
  • “Hepar comp.,”
  • “Lymphaden comp.”

The FDA referred to the following injectable homeopathic products from 8046255 Canada:

  • “Articula,”
  • “Mesenchyme,”
  • “Connectissue,”
  • “MuSkel-Neural,”
  • “Ouch,”
  • “Ithurts,”
  • “Adipose,”
  • “Systemic Detox,”
  • “Hair,”
  • “Neuro 3,”
  • “Infla,”
  • “Collagen,”
  • “Prolo,”
  • “Lymph 1,”
  • “GI,”
  • “Neuro,”
  • “Arthros,”
  • “Male+,”
  • “Immunexx,”
  • “Relief+,”
  • “Intra-Cell,”
  • “Facial,”
  • “ANS/CNS”.

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,”
  • “Vanicel,”
  • “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.

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