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

homeopathy

I have become used to lamentably poor research in the realm of SCAM, particularly homeopathy. Thus, there is little that can amaze me these days; at least this is what I had thought. But this paper is an exception. The new trial is entitled ‘ETHICAL CLINICAL TRIAL OF LESSER KNOWN HOMEOPATHIC REMEDIES IN INFERTILITY IN FEMALES’, and it is truly outstanding. Here is the abstract:

Background & Objective:  Homoeopathy with time honoured results, has a great number of cured cases of infertility, but without much evidence. So, it is imperative to show scientifically the scope of homoeopathy in treating infertility cases. Materials and Methodology: 7 lesser known medicines (Alteris farinosa, Janosia Ashoka, Viburnum opulus, Euphonium, Ustilago, Bacillus sycocuss, Bacillus morgan) were prescribed to the sample size (n=23), at the project site O.P.D/I.P.D. of Homoeopathy university, Saipura, Jaipur and Dr Madan Pratap Khunteta Homoeopathic Medical College, Hospital & Research Centre, Station Road, Jaipur & its extension O.P.D.’s. for study within 12 months. Result-In the present study 7 (30.43%) patients were prescribed Janosia Ashoka amongst whom 2(28.57%) showed marked improvement, while 5(71.43%) remained in the state of status quo. Conclusion- Study has shown encouraging and effective treatment in infertility in females.

It does not tell us much; therefore, let me copy several crucial passages from the paper itself:

Objectives of the study-

  • To study the efficacy of homoeopathic medicines in the treatment of infertility in females.
  • To enhance the knowledge of materia medica in cases of infertility in females.

Material and Methodology-

The study was conducted at O.P.D./I.P.D.of Homoeopathy University, Saipura, Sanganer and Dr M.P.K. Homoeopathic Medical College &Research Centre, Station Road, Jaipur from 2010 to 2013 for a total period of 3 Years. A sample size of n=23 and 7 lesser known remedies were selected for the studies.

Result-

Inferences- Based on clinical symptoms and pathological investigations. It was inferred that out of 23 patients taken for study, 2 (8.69%) patients showed marked improvement, while 21 (91.31%) patients remained in the state of status quo.

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No, I am not kidding you. There is no further relevant information about the trial methodology nor about the results. Therefore, I feel unable to even criticise this study; it is even too awful for a critique.

As I said: outstanding!

And all this could be quite funny – except, of course, some nutter will undoubtedly use this paper for claiming that there is evidence for homeopathy to efficiently treat female infertility.

You have to be a homeopath to call this an ethical trial!

My friend and colleague Willem Betz has died on 8 June 2019. He was a physician and professor emeritus at the Belgian university Vrije Universiteit Brussel. Willem was a leading sceptic and a founding member of the Belgian sceptic organization SKEPP.

After having worked 20 years as a general practitioner, he made a career change and became a teacher of general practice and a researcher. As a clinician, he received training in several alternative therapies and practiced them of a short while. Soon, he started questioning the validity of these methods and thus became a dedicated sceptic. He served SKEPP as vice-president and as president and became a fellow of the Committee for Scientific Inquiry.

His last paper was published less than a year ago. Here is its abstract:

Conventional treatment of multiple sclerosis (MS) is often disappointing. As a result, some of these patients seek salvation in traditional and complementary medicine (T&CM). The aim of this study is to describe how many patients with MS use T&CM and what their motives and expectations are in doing so. Methods. Ninety-nine patients with diagnosed MS, attending the service of ambulatory revalidation of the National Clinic for Multiple Sclerosis in Melsbroek (Belgium) were included in February 2004 in this retrospective study. All patients had MS resulting in motoric or psychosocial symptoms. The disability was not quantified for this study. Participants were interviewed by means of a structured questionnaire on their current treatment of MS including T&CM. Results. In total 44% of the participants had experiences with T&CM. The most frequently used T&CM were homeopathy and acupuncture. Participants using conventional treatment were more satisfied with the support (p=0.006) and the treatment outcome (0.018) than T&CM users. The use of T&CM was not related to gender, education, living conditions, causal treatment such as disease modifying-therapy (DMT), grade of disability or subtype of the disease. Conclusion. Patients diagnosed with MS seek hope in T&CM such as homeopathy or acupuncture. The results of this study suggest that MS patients need more professional support in their personal search for alternative therapies. Key point. 50% of patients diagnosed with multiple sclerosis search relief in traditional and complementary medicine such as homeopathy or acupuncture. These patients often feel compelled to try every opportunity to heal, often stimulated or urged on by friends or relatives. Multiple sclerosis patients are more satisfied with their conventional treatment than with the traditional and complementary medicine.

Through his personality, enthusiasm, analytical mind, humour and dedication, Willem has inspired an entire generation of sceptics. We will miss you Willem.

You might remember my post from last October:

On Twitter and elsewhere, homeopaths have been celebrating: FINALLY A PROOF OF HOMEOPATHY HAS BEEN PUBLISHED IN A TOP SCIENCE JOURNAL!!!

Here is just one example:

#homeopathy under threat because of lack of peer reviewed studies in respectable journals? Think again. Study published in the most prestigious journal Nature shows efficacy of rhus tox in pain control in rats.

But what exactly does this study show (btw, it was not published in ‘Nature’)?

The authors of the paper in question evaluated antinociceptive efficacy of Rhus Tox in the neuropathic pain and delineated its underlying mechanism. Initially, in-vitro assay using LPS-mediated ROS-induced U-87 glioblastoma cells was performed to study the effect of Rhus Tox on reactive oxygen species (ROS), anti-oxidant status and cytokine profile. Rhus Tox decreased oxidative stress and cytokine release with restoration of anti-oxidant systems. Chronic treatment with Rhus Tox ultra dilutions for 14 days ameliorated neuropathic pain revealed as inhibition of cold, warm and mechanical allodynia along with improved motor nerve conduction velocity (MNCV) in constricted nerve. Rhus Tox decreased the oxidative and nitrosative stress by reducing malondialdehyde (MDA) and nitric oxide (NO) content, respectively along with up regulated glutathione (GSH), superoxide dismutase (SOD) and catalase activity in sciatic nerve of rats. Notably, Rhus Tox treatment caused significant reductions in the levels of tumor necrosis factor (TNF-α), interleukin-6 (IL-6) and interleukin-1β (IL-1β) as compared with CCI-control group. Protective effect of Rhus Tox against CCI-induced sciatic nerve injury in histopathology study was exhibited through maintenance of normal nerve architecture and inhibition of inflammatory changes. Overall, neuroprotective effect of Rhus Tox in CCI-induced neuropathic pain suggests the involvement of anti-oxidative and anti-inflammatory mechanisms.

END OF QUOTE

I am utterly under-whelmed by in-vitro experiments (which are prone to artefacts) and animal studies (especially those with a sample size of 8!) of homeopathy. I think they have very little relevance to the question whether homeopathy works.

But there is more, much more!

It has been pointed out that there are several oddities in this paper which are highly suspicious of scientific misconduct or fraud. It has been noted that the study used duplicated data figures that claimed to show different experimental results, inconsistently reported data and results for various treatment dilutions in the text and figures, contained suspiciously identical data points throughout a series of figures that were reported to represent different experimental results, and hinged on subjective, non-blinded data from a pain experiment involving just eight rats.

Lastly, others pointed out that even if the data is somehow accurate, the experiment is unconvincing. The fast timing differences of paw withdraw is subjective. It’s also prone to bias because the researchers were not blinded to the rats’ treatments (meaning they could have known which animals were given the control drug or the homeopathic dilution). Moreover, eight animals in each group is not a large enough number from which to draw firm conclusions, they argue.

As one consequence of these suspicions, the journal has recently added the following footnote to the publication:

10/1/2018 Editors’ Note: Readers are alerted that the conclusions of this paper are subject to criticisms that are being considered by the editors. Appropriate editorial action will be taken once this matter is resolved.

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Well, it took a while, but now there is some news about this case:

‘Science Reports’, just published a retraction note:

Retraction of: Scientific Reports https://doi.org/10.1038/s41598-018-31971-9, published online 10 September 2018

Following publication, the journal received criticisms regarding the rationale of this study and the plausibility of its central conclusions. Expert advice was obtained, and the following issues were determined to undermine confidence in the reliability of the study.

The in vitro model does not support the main conclusion of the paper that Rhus Tox reduces pain. The qualitative and quantitative composition of the Rhus Tox extract is unknown. Figures 1G and 1H are duplicates; and figures 1I and 1J are duplicates. The majority of experimental points reported in figure 3 panel A are duplicated in figure 3 panel B. The collection, description, analysis and presentation of the behavioural data in Figure 3 is inadequate and cannot be relied upon.

As a result the editors are retracting the Article. The authors do not agree with the retraction.

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Does that mean the suspect paper has been declared fraudulent?

I think so.

In any case: another victory of reason over unreason!

Indian doctors have just published the case of a 38-year old man with cirrhosis of the liver due to compensated non-alcoholic fatty-liver-disease. He presented with acute worsening of his chronic liver disease. The acute event was not discernible even after extensive work up. Eventually, a transjugular liver biopsy revealed features suggestive of severe alcoholic hepatitis.

The patient and the family denied occult alcohol use when questioned over multiple times. According to the authors, the culprit ‘alcohol’ was found to be the homoeopathy medicines: the patient had been consuming a homeopathic remedy over a month for treatment of Gilbert’s syndrome. The researchers retrieved and tested the homoeopathy drug for alcohol content and found it contained 18% of ethanol. This, they felt, confirmed their diagnosis of alcoholic liver disease caused by the regular consumption of a homeopathic remedy.

Why did the patient help from a homeopath? Gilbert’s syndrome doesn’t usually require any treatment at all. Two weeks into his new treatment, the patient claimed he was feeling drowsy and slurring his speech, as if intoxicated. The liquid homeopathic formulation was therefore reduced at this stage. A further two weeks passed when his eyes yellowed, his urine darkened, and his legs began to swell. A liver tests confirmed a spike in his bilirubin 10 times above normal, with liver enzymes also elevated. All signs were thus pointing to an acute form of hepatitis commonly associated with alcohol binges. With the patient adamant he hadn’t touched alcohol, the doctors looked for other causes of hepatitis. None were found. When the patient admitted using homeopathy, his doctors thought to have found an explanation for the problem.

Despite starting the patient on a range of treatments and referring him to a liver transplant centre for further management, the damage to the patient’s liver proved to be irreversible. One month and 12 days later, the patient developed multiple organ failure and passed away. The authors of this case report point out “at risk patients and the general population need to be educated regarding the fact that complementary and alternative medications are not without side-effects.”

I do agree with their comment, but I very much doubt that their diagnosis of homeopathy-induced liver disease was correct. If the alcohol in the homeopathic remedy truly had been the cause, the patient would have needed to consume well in excess of one litre of it per day. The authors do not tell us about the volume of consumption, but I doubt that a patient would be able to afford such an orgy in homeopathy.

Highly diluted homeopathic remedies contain nothing, it is often said. This is not entirely true. In the case of solid preparations (globuli), they do contain sugar, and in the case of liquid remedies, they contain alcohol. Yet, as a source of either ingredient, they are neither practical nor economical. I fear therefore that the medical team of the diseased man are mistaken when accusing homeopathy of being the cause of their patient’s death.

My former institution, the medical school of Vienna, had invited me to give the key-note for a conference entitled ‘Esoterik in der Medizin‘ (22/5/2019). The event was to celebrate the success of a new course for medical students which was initiated after Prof Frass’ lectures on homeopathy had been discontinued. Remarkably, this move had been prompted by complaints from students arguing that Frass was promoting non-evidence-based, bogus concepts.

Whenever I go back to Vienna, I have mixed feelings; pleasant and not so pleasant memories (see below) come to the fore. This time, however, all turned out well, and I was more than delighted.

The new course signifies the realisation that so-called alternative medicine (SCAM) must be covered in any sound medical curriculum. Once graduated, students will be asked by patients about SCAM and have an ethical duty to inform them responsibly. Thus they need to know the essential facts and not the biased perspective that Frass and other enthusiasts tend to convey.

I have always considered this to be important but, as far as I can see, very few medical school manage to deal with this issue adequately. More often than not, the task of running such courses is given to proponents of SCAM who then try to brain-wash the unsuspecting students. The result can be seriously harmful to generations of patients. I am delighted to report that my former medical school has successfully avoided this pitfall. Quackademia has come to an end in Vienna!

In my view, the highlight of the recent event was the students’ presentation of their course-work. They had been supervised in small groups to research selected topics related to SCAM and were given 5 minute slots to present their findings. I truly felt this was impressive. The dedication, the quality of the research and the clarity of the presentations were extraordinary. In my 40 odd years of teaching medical students, I have never seen anything remotely similar (here I should mention perhaps that, 25 years ago when I was teaching in Vienna, medical students seemed to be as unmotivated as they get).

The students’ presentation were followed by 90 minutes of moderated discussion of the audience (the event was open to the public) and 4 experts. Here too, I was positively surprised by the quality of the contributions and the general openness of the debate.

So, overall the both the meeting and, more importantly, the new course for students can be considered a great success, and the organisers must be congratulated on it. For me personally, the most significant aspect was a matter entirely unrelated to SCAM. It was the introductory speech of the dean of the medical school. He announced me as the key-note speaker by praising my research on the Nazi history of the faculty. It was this research that, to some considerable degree, made me leave Vienna in 1993. To see it now appreciated by my former colleagues is deeply moving.

 

A pro-homeopathy site (to be taken with a pinch of salt) claims that today 300 homeopathic MDs belong to the “Unio Homoeopathica Belgica” and 4,000 MDs (about 10% of all doctors) are prescribing homeopathics at least occasionally.

See the source image

One-fourth of the Belgian population uses homeopathy. As of 1998, only MDs can legally practice homeopathy. But now it seems that the free ride for Belgian homeopathy is coming to an end. Belgium has joined the long list of countries (e.g. UK, US, Spain, France, Sweden, Russia) where the usefulness of homeopathy is being questioned.

‘Test Achats’ is a Belgian not-for-profit organization which promotes consumer protection. It was founded in 1957 and publishes research in a subscription magazine. It has been reported that this organiation has issued a crushing report on homoeopathy, describing it as “unacceptable” that homeopathic remedies are allowed to be described by practitioners as medication.

Il est inacceptable que des médicaments homéopathiques et des médicaments traditionnels à base de plantes puissent être vendus en tant que “médicament” en pharmacie sans que leur efficacité n’ait été démontrée. Il en va de même pour un certain nombre de médicaments classiques et de médicaments ordinaires à base de plantes, pour lesquels nous avons également de gros doutes quant à leur efficacité et/ou leur sécurité. Le statut de “médicament” leur confère une aura de crédibilité qu’ils ne méritent absolument pas. Notre banque de données de médicaments met un terme à cette tromperie et distingue les médicaments utiles de ceux qui ne le sont pas…

Pour les 55 médicaments homéopathiques avec indication, ces pourcentages sont … 84 % à “utilité contestable” et 16 % “à déconseiller”.

“The requirements of effectiveness, safety and quality to bring a product to market and be allowed to use the name of medication are sadly not the same for all products,” commented a spokesperson for Test-Achats. “Homeopathic products are required to be accompanied by a minimum of documentation, and the effectiveness of the product barely has to be proven.”

‘Test-Achats’ describes homoeopathy as “quack medicine,” and states that “there are conditions where the patient really has no time to lose on products whose effectiveness has not been demonstrated. People who are suffering from very real heart and vascular conditions should immediately seek treatment by a doctor, and with truly effective medication.”

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This is all very good news, I think.
It almost reads as though ‘Test Achat’ have discovered my blog.
Welcome!

Homeopathy has had a long and profitable ride in France; nowhere else in Europe is it more popular, nowhere in Europe are the profit margins higher, and nowhere have I seen pharmacists pushing so hard to earn a few extra Euros on useless homeopathic remedies.

But, since a few months, sceptics have started to raise their voices and object to homeopathic reimbursement (currently at the rate of 30%) and to homeopathy in general.

  • A group of doctors protested against homeopathy by publishing an open letter in ‘Le Figaro’.
  • The French Academies of Medicine and Pharmacy published a report confirming the lack of evidence for homeopathy.
  • The medical school in Lille suspended its degree in homeopathy.

The French health secretary, the oncologist Dr Agnès Buzyn, reacted wisely, in my view. She initially stated that the effect of homeopathy is ‘probably a placebo effect‘. Subsequently, she asked the regulator, La Haute Autorite de Sante (HAS), to look into the matter and prepare a full analysis of the evidence. This report has now been published.

An article in ‘FRANCE INFO’ reports that HAS found no good evidence in support of the ~ 1 200 homeopathic remedies currently on the French market. The document is currently being considered by Dr Buzyn who will announce her decision about reimbursement in June. It is considered to be highly likely that she will stop reimbursement.

If so, consumers will soon have to pay in full for homeopathic preparations out of their own pocket. In addition, they would have to pay the VAT, and it is foreseeable that this change would signal the end of the French consumers’ love affair with homeopathy. This development is bound to seriously hurt Boiron, the world’s largest producer of homeopathics. The firm has already announced that they suspended its trading on the stock market and is now arguing that the move would endanger its sizable workforce.

The question I now ask myself is whether Boiron is powerful enough to do something about all this. Personally, I have been impressed by the rational approach of Dr Buzyn. She will no doubt see through Boiron’s bogus argument of saving a form of obsolete quackery in the name of employment. Therefore, I expect that the days of homeopathy’s reimbursement in France are counted.

(For those who can read French, I add the original ‘ FRANCE INFO’ article below.)

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Les granules homéopathiques offrent “un service médical rendu insuffisant” selon la HAS.

La Haute autorité de santé (HAS) recommande de ne plus rembourser les granules homéopathiques, alors que leur efficacité est controversée, selon les informations de franceinfo jeudi 16 mai. La HAS a envoyé aux laboratoires fabriquant des médicaments homéopathiques son projet d’avis pour les informer.Après avoir étudié 1 200 médicaments homéopathiques, la Haute autorité de santé estime que ces granules offrent un “service médical rendu insuffisant”. Elles demandent donc que les médicaments homéopathiques, jusque-là remboursés à hauteur de 30%, ne le soient désormais plus du tout.

Avis définitif en juin

Cet avis avait été réclamé par la ministre de la Santé il y a plusieurs mois face à la montée de la polémique entre médecins pro et anti-homéopathie. 124 médecins avaient relancé le débat l’an dernier en qualifiant les homéopathes de “charlatans”.

Désormais, lors d’une phase contradictoire, les laboratoires vont pouvoir répondre à la HAS, qui rendra son avis définitif en juin. La ministre de la Santé, Agnès Buzyn, avait par le passé annoncé qu’elle se rangerait à cet avis.

1 000 emplois menacés, selon Boiron

Les pro-homéopathie eux, s’insurgent. Selon eux, les granules ne coûtent que 130 millions d’euros par an à la Sécurité sociale, contre 20 milliards pour les médicaments classiques. Et il existe d’après eux, au minimum, un effet placebo. Pour les laboratoires Boiron, leader mondial du secteur, si l’homéopathie n’est plus remboursée, ce sont 1 000 emplois qui sont directement menacés.

Par ailleurs, dans un communiqué commun, trois laboratoires (Boiron, Lehning et Weleda) s’émeuvent de découvrir à travers un média la teneur d’un avis d’une agence indépendante qui devait être tenu confidentiel. Les laboratoires Boiron précisent à franceinfo qu’ils n’ont pas encore reçu le projet d’avis de la Haute autorité de santé. Boiron, entreprise française cotée, annonce “suspendre” son cours de bourse.

 

‘Rationable’ has recently published a remarkable article on homeopathy. Its author starts admitting that for most of my life, I have taken it for granted that homoeopathy worked. I didn’t know how or why, I just knew that my parents and most other people swore by it, so there had to be something to it. I was treated with homoeopathy several times. In one case, it actually made things worse. The homoeopathic doctor responded with, “Things sometimes have to get worse before they get better.” I have to admit, as much as I wasn’t impressed with that answer, I liked the taste of the medicines. Always sugary and sweet or even with that little bit of alcohol. What more does a kid need in his life than to eat something sugary sweet for medicine!

The article is lengthy but well worth reading. I take the liberty of merely quoting its conclusion:

Here I am, a decade later, seeing homoeopathy from a completely different perspective than what I used to. It’s probably one of the most profound discoveries in my life and has been one of the factors that have led me to question everything, including, most importantly, myself.

Now, homoeopathy has become one of the most studied fields in the world, with an impenetrable mountain of evidence that has piled up against its claims. These studies have been done by many independent teams and analysed and reviewed by some of the most reliable scientific organisations in the world. There’s just no denying it. There is no evidence for it working…ever. Why? Because it’s just water. And if it’s brought into contact with sugar, it somehow transfers its memories to it. The more I think about it, the more implausible it sounds.

And it’s not just me. Many governmental bodies like UK’s National Health Service (NHS), The American Medical Association, the FASEB and National Health and Medical Research Council of Australia, have stated that there is no evidence to support the use of homoeopathic treatments. Even representatives of the WHO have said that homoeopathic remedies should not be used to treat tuberculosis or diarrhoea.

So, what do you think? Is it worth your time and money to buy water and sugar pills that have shown no evidence of working, or would you instead go to a regular doctor and get real medication that has a good chance of treating you? I, for one, will be going to the latter.

TL;DR

As promised, here’s the short version of this topic:

Homoeopathy is an ancient practice created in the 1700s as a counter treatment to bloodletting and other rather horrific medical practices

Homoeopathy is a process of diluting a small amount substance in more water than the whole earth can contain to treat your ailment

There has been no evidence to show that it works any better than a placebo, even after hundreds of clinical trials have been conducted.

Dig Deeper

https://www.theguardian.com/science/blog/2012/apr/03/homeopathy-why-i-changed-my-mind

https://skeptoid.com/blog/2011/09/18/homeopathy-a-drop-in-10-billion-oceans/

https://nccih.nih.gov/health/homeopathy

https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/complementary-alternative-therapies/individual-therapies/homeopathy

https://www.livescience.com/31977-homeopathy.html

https://www.nhs.uk/conditions/homeopathy/

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I am always delighted to see how individuals who start thinking critically can change things for themselves and others. The evidence suggests that people who are strong on either intelligence or critical thinking experience fewer negative events, but critical thinkers tend to do better. I hope that, one day, all readers of this blog manage to benefit from the great potential of critical thinking.

Prince Charles is visiting Germany. According to the British press, he will say (or, by now, probably has said):

“… Our countries and our people have been through so much together… As we look towards the future, I can only hope that we can also pledge to redouble our commitment to each other and to the ties between us… For some of us, of course, these connections are particularly personal…

And right he is!

Charles is Britain’s staunchest supporter of and meddler in SCAM, while the Germans seem to be the most prolific innovators of SCAM.

Just think of

  • von Bingen, Hildegard – inventor of a form of herbal medicine;
  • Hahnemann, Samuel – inventor of homeopathy;
  • Hamer, Ryke Geerd – inventor of New German Medicine;
  • Huneke, Ferdinand – inventor of neural therapy;
  • Kneipp, Sebastian – co-inventor of naturopathy;
  • Mesmer, Anton – inventor of hypnotherapy;
  • Morlell, Franz – inventor of bioresonance;
  • Reckeweg, Hans -inventor of homotoxicology;
  • Schimmel, Helmut – co-inventor of the Vega test;
  • Schulz, Heinrich – inventor of autogenic training;
  • Steiner, Rudlof – inventor of anthroposophical medicine;
  • Voll, Reinhold – inventor of a form of electroacupuncture;
  • Wegman, Ita – co-inventor of anthroposophical medicine.

Why did I compile this list?

Actually, I am not quite sure. But now that it is in front of me, a few thoughts go through my mind:

  1. Germany seems to be the promised land for quacks; in addition to the list above, think of the Heilpraktiker or the German alternative cancer clinics.
  2. On this blog, we have discussed most of these SCAMs, yet the list gave me several ideas for future posts;
  3. With only three exceptions, these SCAMs are fairly recent. They were invented when conventional medicine was already making big strides towards progress. There was no need for them. Why then were they invented?
  4. Almost all of these treatments were the brainchild of a single person. Could this be a hallmark for quackery?
  5. With only two exceptions, the inventors were male. Is the innovation of SCAM a male prerogative?
  6. With just one or two exceptions, these SCAMs are ineffective, useless and superfluous. Not attributes, of course, that would link them to Charles!

 

The U.S. Food and Drug Administration posted warning letters to 4 US companies producing homeopathic products for significant violations of current good manufacturing practice (CGMP) regulations, including a letter to King Bio Inc. of Asheville, N.C. The FDA previously warned the public about the agency’s serious concerns with the quality of drug products produced by King Bio.

Please allow me to copy the FDA’s announcement unaltered and without comment:

“In late 2017, the FDA proposed a comprehensive, risk-based enforcement approach to drug products labeled as homeopathic and marketed without the required FDA approval. While the agency continues to examine this approach, the homeopathic industry has continued to grow, and we need to continue to address, consistent with our current enforcement policies, situations where products labeled as homeopathic are being marketed for serious diseases and/or conditions where the products haven’t been shown to offer clinical benefits. We’re committed to continue taking appropriate actions when we believe patients are being put at risk by products that contain potentially harmful ingredients or have significant quality issues. One company that continues to concern us because of the low quality of their operation and the threat their products pose to consumers is King Bio. Despite previous actions we’ve taken, our concerns remain. The warning letter we’re sending is a formal notice to King Bio outlining a number of ongoing, serious violations with their manufacturing operations that must be corrected,” said FDA Commissioner Scott Gottlieb, M.D. “Today we’ve also posted warnings letters to three other homeopathic drug manufacturers for additional concerns we’ve observed – from the use of toxic substances like snake venom that has the potential to cause harm and does not have demonstrated benefit, to other firms whose products we’ve found to be contaminated. These actions build on similar steps we’ve taken over the past year, as we continue to see products labeled as homeopathic that are being marketed without approval for a wide array of diseases and conditions, from chronic pain to cancer. In addition to our concerns with contamination, some products labeled as homeopathic may not deliver any benefit and may have the potential to cause harm. That’s why we’ve proposed a new regulatory approach to prioritize additional enforcement and regulatory actions against certain products labeled as homeopathic. We’re focused on products that have the greatest potential to cause risk to patients, including products for vulnerable populations like children. The actions we’ve taken recently, and over the course of the past year are further warning to all companies that these types of products must be manufactured and labeled appropriately. We’re working to finalize our draft guidance in the coming months to help ensure that products that reach consumers are not harmful to their health.”

Products labeled as homeopathic have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality. Products labeled 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. These products are often marketed as natural, safe and effective alternatives to approved prescription and nonprescription products and are widely available in the marketplace. These unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured, which can lead to contamination, or may contain active ingredients that aren’t adequately tested or disclosed to patients, such as belladonna, which the agency has previously warned against.

The warning letter to King Bio Inc. provides details of flaws in manufacturing operations and quality assurance systems found during a July 2018 FDA inspection of the facility. Beyond the violations found during the inspection, the FDA collected and tested samples of finished homeopathic drug products; results revealed inordinately high microbiological contamination. Additionally, evidence collected during the FDA’s inspection indicated recurring microbial contamination associated with the water system used to manufacture drugs. The microbiological contamination of the water system led, in part, to a voluntary recall of more than 900 potentially homeopathic drug products manufactured by King Bio. Following the July 2018 inspection, the FDA alerted consumers and pet owners not to use drug products, including homeopathic drug products, made by King Bio and labeled as Dr. King’s, as these products may pose a safety risk to people (especially infants, children, pregnant women and those with compromised immune systems), as well as pets due to the high levels of microbial contamination identified at the manufacturing site. The company recalled all drug products made with water marketed for humans and animals.

King Bio manufactures a range of products including those for children, adults and pets. Since August 2018, more than 900 potentially contaminated products manufactured by King Bio have been recalled, including those labeled as Aquaflora, Canada, Dr. King’s Natural Medicine(s), Natural Pet, People’s Best and SafeCare. Additionally, other products manufactured by King Bio and distributed by other companies under different brand names were also recalled due to contamination. These include products sold under the brand names Sprayology, Silver Star Brand, HelloLife, Beaumont Bio Med and BioLyte Laboratories.

Today, the FDA also posted warning letters to additional companies for products labeled as homeopathic due to various quality and misbranding violations.

  • Red Mountain Incorporated, Oakland Park, Fla.warning letter for lacking quality oversight while manufacturing homeopathic drug products containing ingredients with potentially toxic effects for consumers, including snake venom.
  • Tec Laboratories Incorporated, Albany, Ore.warning letter for releasing products marketed for use with children, without conducting testing to ensure they were free from objectionable levels of microbial contamination. The company also did not adequately investigate test results that found high microorganism levels in its water system
  • B. Jain Pharmaceuticals Pvt. Ltd., Rajasthan, Indiawarning letter after FDA investigators observed insects in the facility and in ingredients used to make its products.

The FDA has taken similar actions this year, including a warning letter to Nutra Pharma Corp., Boca Raton, Fla.; as announced earlier this month, the FDA issued a warning letter regarding the company illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain; the agency also alerted consumers to this health fraud scam. In February, the FDA issued a warning letter to Pure Source LLC, Doral, Fla. for distributing drugs made with contaminated raw materials.

In December 2017, the FDA proposed a risk-based enforcement approach that prioritizes enforcement and regulatory actions involving drug products labeled as homeopathic and marketed without the required FDA approval that have the greatest potential to cause risk to patients. Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, the FDA stated when it issued the draft guidance that it would consider taking additional enforcement and/or regulatory actions, consistent with its current compliance policies, in the interest of protecting the public. We expect to finalize this guidance soon.

The FDA encourages healthcare 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.

 

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