big pharma
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.)
_________________________________________________________________
Les granules homéopathiques offrent “un service médical rendu insuffisant” selon la HAS.
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.
A series of article in The Times yesterday (to which I had made several minor contributions) focussed on the dangers of homeoprophylaxis/homeopathic vaccinations. Sadly, the paper is behind a paywall. I therefore will try to summarise some of the relevant points.
A courageous Times-reporter went under cover to extract some of the anti-vaccination views from a lay homeopath. This particular homeopath happened to charge £330 from customers who want to protect themselves or their family from infectious diseases (£130 for a homeopathic remedy kit, plus £200 for the compulsory instructions via skype that automatically come with the kit). Here are some of the most obvious porkies uttered by that homeopath:
- Only 30% of healthcare professionals get vaccinated.
- Rubella is a very mild disease.
- Cancer patients don’t get fever.
- Measles mainly kills children with severe disease.
- Anything which messes with natural immunity could contribute to autism.
- Health officials devised a seven-step recipe to scare consumers into vaccinating their kids.
- Fevers should be celebrated.
This new undercover research by the Times is reminiscent of our own investigation of 2002. At the time, we contacted 168 homoeopaths, of whom 104 (72%) responded, 27 (26%) withdrawing their answers after debriefing. We also contacted 63 chiropractors, of whom 22 (44%) responded, six (27%) withdrawing their responses after debriefing. Only 3% of professional homoeopaths and 25% of the chiropractors advised in favour of the MMR vaccination. Almost half of the homoeopaths and nearly a fifth of the chiropractors advised against it. (This tiny and seemingly insignificant study almost cost me my job: some homeopaths complained to my peers at Exeter University who then, in their infinite wisdom, conducted a most unpleasant investigation into my allegedly ‘unethical’ research; full details of this amazing story are provided in my memoir.)
But perhaps you think that homeoprophylaxis might be effective after all? In this case, you would be mistaken! As discussed a couple of weeks ago, a recent study demonstrated that such treatments are ineffective. Its authors concluded that homeopathic vaccines do not evoke antibody responses and produce a response that is similar to placebo. In contrast, conventional vaccines provide a robust antibody response in the majority of those vaccinated.
The Times article stated that about half of all new parents have been exposed to anti-vaxx propaganda. Consequently, global measles cases have risen by 300% in the first three months of this year compared to last year. Faced with measles outbreaks across the world, it is hard to deny that homeopaths who promote homeopathic vaccinations are a significant risk to public health.
The Times considered the issue sufficiently important to add an editorial. Its opening sentence sums up the issue well, I think: The evidence supporting claims that homeopathic remedies offer an effective alternative to the measles vaccine can be summarised in one word: zero. And its concluding sentences are even clearer: Tobacco companies are obliged to carry prominent public health warnings on their products. Homeopaths should too.
If one agrees with this sentiment, I suggest, we also consider the same for some:
- chiropractors;
- doctors of anthroposophical medicine;
- naturopaths;
- doctors practising integrative medicine.
And furthermore I suggest we disregard the many pro-vaccination statements by the professional organisations of these clinicians – they are nothing but semi-transparent fig-leaves and a politically-correct lip services which they neither enforce nor even truly mean.
The ‘International Federation of Anthroposophic Medical Associations’ have just published a ‘Statement on Vaccination‘. Here it is in its full beauty:
Vaccines, together with health education, hygiene and adequate nutrition, are essential tools for preventing infectious diseases. Vaccines have saved countless lives over the last century; for example, they allowed the eradication of small pox and are currently allowing the world to approach the elimination of polio.
Anthroposophic Medicine fully appreciates the contribution of vaccines to global health and firmly supports vaccination as an important measure to prevent life threatening diseases. Anthroposophic Medicine is not anti-vaccine and does not support anti-vaccine movements.
Physicians with training in Anthroposophic Medicine are expected to act in accordance with national legislation and to carefully advise patients (or their caregivers) to help them understand the relevant scientific information and national vaccination recommendations. In countries where vaccination is not mandatory and informed consent is needed, this may include coming to agreement with the patient (or the caregivers) about an individualized vaccination schedule, for example by adapting the timing of vaccination during infancy.
Taking into account ongoing research, local infectious disease patterns and socioeconomic risk factors, individual anthroposophic physicians are at times involved in the scientific discussion about specific vaccines and appropriate vaccine schedules. Anthroposophic Medicine is pro-science and continued scientific debate is more important than ever in today’s polarized vaccine environment.
Already in 2010, The European Council for Steiner Waldorf Education published a press release, implying a similar stance:
We wish to state unequivocally that opposition to immunization per se, or resistance to national strategies for childhood immunization in general, forms no part of our specific educational objectives. We believe that a matter such as whether or not to innoculate a child against communicable disease should be a matter of parental choice. Consequently, we believe that families provide the proper context for such decisions to be made on the basis of medical, social and ethical considerations, and upon the perceived balance of risks. Insofar as schools have any role to play in these matters, we believe it is in making available a range of balanced information both from the appropriate national agencies and qualified health professionals with expertise in the filed. Schools themselves are not, nor should they attempt to become, determiners of decisions regarding these matters.
Such statements sound about right. Why then am I not convinced?
Perhaps because there are hundreds of anthroposophic texts that seem to contradict this pro-vaccination stance (not least those from Rudolf Steiner himself). Today, anthroposophy enthusiasts are frequently rampant anti-vax; look at this quote, for instance:
… anthroposophic and conventional medicine have dramatically different viewpoints as to what causes common childhood illnesses. Conventional medicine views childhood illnesses for which vaccines have been developed as a physical disease, inherently bad, to be prevented. Their main goal, therefore, is protection against contracting the disease making one free of illness. In contrast, these childhood illnesses are viewed by anthroposophic medicine as a necessary instrument in dealing with karma and, as discussed by Husemann, and Wolff, 6 the incarnation of the child. During childhood illnesses, anthroposophic medical practitioners administer medical remedies to assist the child in dealing with the illness not only as a disease affecting their physical body in the physical plane, but also for soul spiritual development, thereby promoting healing. In contrast, allopathic medicaments are aimed at suppression of symptoms and not necessarily the promotion of healing.
In Manifestations of Karma, Rudolf Steiner states that humans may be able to influence their karma and remove the manifestation of certain conditions, i.e., disease, but they may not be liberated from the karmic effect which attempted to produce them. Says Steiner, “…if the karmic reparation is escaped in one direction, it will have to be sought in another … the souls in question would then be forced to seek another way for karmic compensation either in this or in another incarnation.” 7
In his lecture, Karma of Higher Beings 8, Steiner poses the question, “If someone seeks an opportunity of being infected in an epidemic, this is the result of the necessary reaction against an earlier karmic cause. Have we the right now to take hygienic or other measures?” The answer to this question must be decided by each person and may vary. For example, some may accept the risk of disease but not of vaccine side effects, while others may accept the risk associated with vaccination but not with the disease.
Anthroposophic medicine teaches that to prevent a disease in the physical body only postpones what will then be produced in another incarnation. Thus, when health measures are undertaken to eliminate the susceptibility to a disease, only the external nature of the illness is eliminated. To deal with the karmic activity from within, Anthroposphy states that spiritual education is required. This does not mean that one should automatically be opposed to vaccination. Steiner indicates that “Vaccination will not be harmful if, subsequent to vaccination, a person receives a spiritual education.”
Or consider this little statistic from the US:
Waldorf schools are the leading Nonmedical Exemption [of vaccinations] schools in various states, such as:
- Waldorf School of Mendocino County (California) – 79.1%
- Tucson Waldorf Schools (Arizona) – 69.6%
- Cedar Springs Waldorf School (California) – 64.7%
- Waldorf School of San Diego (California) – 63.6%
- Orchard Valley Waldorf School (Vermont) – 59.4%
- Whidbey Island Waldorf School (Washington) – 54.9%
- Lake Champlain Waldorf School (Vermont) – 49.6%
- Austin Waldorf School (Texas) – 48%
Or what about this quote?
Q: I am a mother who does not immunize my children. I feel as though I have to keep this a secret. I recently had to take my son to the ER for a tetanus shot when he got a fish hook in his foot, and I was so worried about the doctor asking if his shots were current. His grandmother also does not understand. What do you suggest?
A: You didn’t give your reasons for not vaccinating your children. Perhaps you feel intuitively that vaccinations just aren’t good for children in the long run, but you can’t explain why. If that’s the case, I think your intuition is correct, but in today’s contentious world it is best to understand the reasons for our decisions and actions.
There are many good reasons today for not vaccinating children in the United States I recommend you consult the book, The Vaccination Dilemma edited by Christine Murphy, published by SteinerBooks.
So, where is the evidence that anthroposophy-enthusiasts discourage vaccinations?
It turns out, there is plenty of it! In 2011, I summarised some of it in a review concluding that numerous reports from different countries about measles outbreaks centered around Steiner schools seem nevertheless to imply that a problem does exist. In the interest of public health, we should address it.
All this begs a few questions:
- Are anthroposophy-enthusiasts and their professional organisations generally for or against vaccinations?
- Are the statements above honest or mere distractions from the truth?
- Why are these professional organisations not going after their members who fail to conform with their published stance on vaccination?
I suspect I know the answers.
What do you think?
Boiron is the world’s largest manufacturer of homeopathic products. The 2016 sales figures of the company amounted to 614 489 000 Euro. Boiron has recently been very active promoting its products, not least on Twitter where I note about 10 of their promotional tweets every day. I saw the following tweet yesterday:
Acidil temporarily relieves occasional heartburn, acid indigestion, bloating or upset stomach. (link: http://bit.ly/2gCARdu)
This prompted me to look up what this product contains. The ingredients (potencies) are as follows:
- Abies nigra (4C)
- Carbo vegetablilis (4C)
- Nux vomica (4C)
- Robinia pseudoacacia (4C)
Just to remind you, 4C means the substance is diluted at a rate of 1: 100 000 000. Even the most deadly poison would be ineffective at such a dilution.
So, how can they claim that it is effective?
To find the answer, I did a Medline search and found the only listed trial of Acidil (if anyone knows of further studies, please let me know). Here is its abstract:
BACKGROUND:
It is unclear whether the benefits that some patients derive from complementary and integrative medicine (CIM) are related to the therapies recommended or to the consultation process as some CIM provider visits are more involved than conventional medical visits. Many patients with gastrointestinal conditions seek out CIM therapies, and prior work has demonstrated that the quality of the patient-provider interaction can improve health outcomes in irritable bowel syndrome, however, the impact of this interaction on gastroesophageal reflux disease (GERD) is unknown. We aimed to assess the safety and feasibility of conducting a 2 x 2 factorial design study preliminarily exploring the impact of the patient-provider interaction, and the effect of an over-the-counter homeopathic product, Acidil, on symptoms and health-related quality of life in subjects with GERD.
METHODS:
24 subjects with GERD-related symptoms were randomized in a 2 x 2 factorial design to receive 1) either a standard visit based on an empathic conventional primary care evaluation or an expanded visit with questions modeled after a CIM consultation and 2) either Acidil or placebo for two weeks. Subjects completed a daily GERD symptom diary and additional measures of symptom severity and health-related quality of life.
RESULTS:
There was no significant difference in GERD symptom severity between the Acidil and placebo groups from baseline to follow-up (p = 0.41), however, subjects who received the expanded visit were significantly more likely to report a 50% or greater improvement in symptom severity compared to subjects who received the standard visit (p = 0.01). Total consultation length, perceived empathy, and baseline beliefs in CIM were not associated with treatment outcomes.
CONCLUSION:
An expanded patient-provider visit resulted in greater GERD symptom improvement than a standard empathic medical visit. CIM consultations may have enhanced placebo effects, and further studies to assess the active components of this visit-based intervention are warranted.
The question I have is simple: why are they allowed to make false medical claims?
Is there anyone out there who can answer it?
Samuel Hahnemann invented homeopathy about 200 years ago. His placebos were better than (or not as bad as) the ‘heroic’ medicine of his time which frequently was more dangerous than the disease it aimed to cure. Thus, homeopathy took Germany by storm. When, about 100 years ago, medicine finally became scientific and was able to offer more and more effective treatments, the popularity of homeopathy began to wane. Yet, before its natural demise, during the Third Reich, it received a significant boost from Nazi-greats such as Hess and Himmler. After this nightmare was over, German homeopathy went into another slow decline. But when the New Age movement and the current boom in alternative medicine reached Germany, homeopathy seemed to thrive once again.
In the 1990s evidence-based medicine (EBM) grew into one of the central concepts of medicine. In Germany, however, EBM had a relatively hard time to get established. This might be one of the reasons why homeopathy continued to prosper, despite the arrival of ever clearer evidence that highly diluted homeopathic remedies are pure placebos. While, in the UK, we had an increasingly lively debate about the uselessness of homeopathy, Germany remained the promised land of homeopathy. Sales figures of homeopathics continued to increase steadily and reached a level of about half a billion Euros per annum.
The golden age of German homeopathy had dawned:
- The media, often sponsored by homeopathic interest groups, kept on promoting homeopathy largely unopposed.
- The mighty Carstens Stiftung worked tirelessly to promote it.
- Homeopathy became established in many medical schools.
- Homeopathy was available and often advertised in almost all pharmacies.
- The public was convinced that homeopathy worked.
- The Heilpraktiker adopted homeopathy fully.
- The medical and other conventional healthcare professions embraced it to a large degree.
- The adult education institutes (Volkshochschulen) offered courses.
- Politicians were squarely on the side of homeopathy,
- Health insurances, paid for it.
Of course, there were also some (and always had been) opposing voiced and organisations, such as the GWUP (the German sceptic organisation), for example. But somehow, they remained relatively low-key. When, every now and then, courageous journalists dared to think of a critical take on homeopathy, they had to search far and wide to find a German-speaking expert who was willing or able to tell them the truth: that homeopathy is neither biologically plausible nor evidence-based and therefore an expensive, potentially harmful waste of money that makes a mockery of EBM. During this period, journalists (far too) often asked me for some critical comments. I hardly ever published my research in German, but they nevertheless would find me via my Medline-listed papers. I often felt like a very lone voice in a German desert.
For the German homeopathic industry, I evidently was more than just a lone voice. Unbeknown to me, they clubbed together and financed a PR-man/journalist (at the tune of Euro 30 000/year) to write as many defamatory articles about me as he could muster. First, I was bewildered by his activity, then I tried to communicate with him (only to get mis-quoted), and eventually I ignored his writings. Yet, a German investigative journalist found Fritzsche’s one-sided activities offensive and started investigating. His research and subsequent article disclosed the fact that he was being paid by the homeopathic industry. Once I learn about this scandal, I wrote to some of the financiers directly and asked for an explanation. As a result, they discontinued their sponsorship. Shortly afterwards, Fritzsche committed suicide.
At heart, I have always been an optimist and strongly believe that in medicine the truth, in this case the evidence, will always prevail, no matter what obstacles others might put in its way. Recent developments seem to suggest that I might be right.
In the last few years, several individuals in Germany have, from entirely different angles, taken a fresh look at the evidence on homeopathy and found it to be desperately wanting. Independent of each other, they published articles and books about their research and insights. Here are 5 examples:
Die Homöopathie-Lüge: So gefährlich ist die Lehre von den weißen Kügelchen, Christian Weymayr, Nicole Heißmann, 2012
In Sachen Homöopathie: Eine Beweisaufnahme, Norbert Aust, 2013
Homöopathie neu gedacht: Was Patienten wirklich hilft, Natalie Grams, 2015
Der Glaube an die Globuli: Die Verheißungen der Homöopathie, Norbert Schmacke, Bernd Hontschik, 2015
Der wahrscheinlich teuerste Zucker der Welt: Was Sie über Homöopathie und Alternativmedizin wissen sollten, Oliver Grunau, 2017
Inevitably, these individuals came into contact with each other and subsequently founded several working-groups to discuss their concerns and coordinate their activities. Thus the INH and the Muensteraner Kreis were born. So, now we have at least three overlapping groups of enthusiastic, multidisciplinary experts who voluntarily work towards informing the German public that paying for homeopathy out of public funds is unethical, nonsensical and not in the interest of progress:
- the GWUP,
- the INH
- and the Muensteraner Kreis.
No wonder then, that the German homeopathic industry and other interested parties got worried. When they realised that (presumably due to the work of these altruistic enthusiasts) the sales figures of homeopathics in Germany had, for the first time since many years, started declining, they panicked.
Their reaction was, as far as I can see, similar to their previous response to criticism: they started a media campaign in an attempt to sway public opinion. And just like before, they have taken to employing PR-people who currently spend their time defaming all individuals voicing criticism of homeopathy in Germany. Their prime targets are those experts who are most exposed to activities of responsibly informing the public about homeopathy via lectures, publications social media, etc. All of us currently receive floods of attack, insults and libellous defamations. As before (innovation does not seem to be a hallmark of homeopathy), these attacks relate to claims that:
- we are incompetent,
- we do not care about the welfare of patients,
- we are habitual liars,
- we are on the payroll of the pharmaceutical industry,
- we aim at limiting patient choice,
- we do what we do because we crave the limelight.
So, what is going to happen?
I cannot read tea leaves but am nevertheless sure of a few things:
- The German homeopathy lobby will not easily give up; after all, they have half a billion Euros per year to lose.
- They will not argue on the basis of science or evidence, because they know that neither are in their favour.
- They will fight dirty and try to defame everyone who stands in their way.
- They will use their political influence and their considerable financial power.
AND YET THEY WILL LOSE!
Not because we are so well organised or have great resources – in fact, as far as I can see, we have none – but because, in medicine, the evidence is invincible and will eventually prevail. Progress might be delayed, but it cannot be halted by those who cling to an obsolete dogma.
If you thought that Chinese herbal medicine is just for oral use, you were wrong. This article explains it all in some detail: Injections of traditional Chinese herbal medicines are also referred to as TCM injections. This approach has evolved during the last 70 years as a treatment modality that, according to the authors, parallels injections of pharmaceutical products.
The researchers from China try to provide a descriptive analysis of various aspects of TCM injections. They used the the following data sources: (1) information retrieved from website of drug registration system of China, and (2) regulatory documents, annual reports and ADR Information Bulletins issued by drug regulatory authority.
As of December 31, 2017, 134 generic names for TCM injections from 224 manufacturers were approved for sale. Only 5 of the 134 TCM injections are documented in the present version of Ch.P (2015). Most TCM injections are documented in drug standards other than Ch.P. The formulation, ingredients and routes of administration of TCM injections are more complex than conventional chemical injections. Ten TCM injections are covered by national lists of essential medicine and 58 are covered by China’s basic insurance program of 2017. Adverse drug reactions (ADR) reports related to TCM injections account for over 50% of all ADR reports related to TCMs, and the percentages have been rising annually.
The authors concluded that making traditional medicine injectable might be a promising way to develop traditional medicines. However, many practical challenges need to be overcome by further development before a brighter future for injectable traditional medicines can reasonably be expected.
I have to admit that TCM injections frighten the hell out of me. I feel that before we inject any type of substance into patients, we ought to know as a bare minimum:
- for what conditions, if any, they have been proven to be efficacious,
- what adverse effects each active ingredient can cause,
- with what other drugs they might interact,
- how reliable the quality control for these injections is.
I somehow doubt that these issues have been fully addressed in China. Therefore, I can only hope the Chinese manufacturers are not planning to export their dubious TCM injections.
“Homeopathic remedies are inherently harmless” this is what many seem to think – homeopathy friends and foes alike. After all, they contain nothing – so, how can it cause harm?
The notion is, of course, not entirely true. Homeopathic remedies can be directly harmful, if:
- they are not highly dilute (low potency) – imagine Arsenic C1;
- they are contaminated with harmful substances – this might happen with poor quality control during the manufacturing process;
- they might not be as dilute as advertised – this too might happen with poor quality control during the manufacturing process.
A reminder that these are not merely theoretical considerations was just published in the shape of a press-release by the US Food and Drug Administration:
King Bio is voluntarily recalling four lots of Aquaflora Candida HP9, Lymph Detox, and Baby Teething liquids to the consumer level. During a routine inspection by the U.S. Food and Drug Administration, the products were found to contain microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans.
Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. King Bio has not received reports of injury or illness.
The Aquaflora HP9 product is used as a Candida control product. The Lymph Detox product is used for symptoms associated with lymphatic toxicity. The Baby Teething product is used for symptoms of teething pain, irritated gums, delayed teething, etc.
| Product | UPC | Lot Numbers | Expiration Date | Distribution |
|---|---|---|---|---|
| Aquaflora Candida HP9 8 oz. liquid in a carton |
3-57955-80018-7 | 120217R 102017C 101017G 111417C |
12/02/19 10/20/19 10/10/19 11/14/19 |
8,000 bottles nationwide to retail stores and websites |
| King Bio Lymph Detox 2 oz. liquid in a carton |
3-57955-50632-4 | 010118BE | 01/01/20 | 276 bottles nationwide to retail stores and websites |
| King Bio Baby Teething 2 oz liquid in a carton |
020118F | 13 bottles marked NOT FOR RESALE |
King Bio is notifying its distributors and customers by letter and is arranging for return and/or replacement. of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using/and contact King Bio prior to returning the product.
Consumers with questions regarding this recall can contact King Bio by 866-298-2740 or e-mail [email protected], Monday – Friday 830am – 430pm, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: http://www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
END OF QUOTE
KingBio have a website where they disclose their mission statement:
- To provide safe, all-natural medicines without harmful side effects.
- To offer affordable natural medicines that help people overcome common health challenges.
- To achieve the trust and respect of our customers and uphold the best product quality.
- To empower people with the most effective ways to achieve abundant health.
… The FDA classifies homeopathic medicines as pharmaceutical drug products. King Bio is an FDA-registered pharmaceutical manufacturer and is strictly compliant with FDA guidelines and current good manufacturing practices (cGMP). Unlike most pharmaceutical drug products, homeopathic medicine offers gentle symptomatic relief, without recorded harmful side effects.
SAY NO MORE!
On this blog, we have seen more than enough evidence of how some proponents of alternative medicine can react when they feel cornered by critics. They often direct vitriol in their direction. Ad hominem attacks are far from being rarities. A more forceful option is to sue them for libel. In my own case, Prince Charles went one decisive step further and made sure that my entire department was closed down. In China, they have recently and dramatically gone even further.
This article in Nature tells the full story:
A Chinese doctor who was arrested after he criticized a best-selling traditional Chinese remedy has been released, after more than three months in detention. Tan Qindong had been held at the Liangcheng county detention centre since January, when police said a post Tan had made on social media damaged the reputation of the traditional medicine and the company that makes it.
On 17 April, a provincial court found the police evidence for the case insufficient. Tan, a former anaesthesiologist who has founded several biomedical companies, was released on bail on that day. Tan, who lives in Guangzhou in southern China, is now awaiting trial. Lawyers familiar with Chinese criminal law told Nature that police have a year to collect more evidence or the case will be dismissed. They say the trial is unlikely to go ahead…
The episode highlights the sensitivities over traditional Chinese medicines (TCMs) in China. Although most of these therapies have not been tested for efficacy in randomized clinical trials — and serious side effects have been reported in some1 — TCM has support from the highest levels of government. Criticism of remedies is often blocked on the Internet in China. Some lawyers and physicians worry that Tan’s arrest will make people even more hesitant to criticize traditional therapies…
Tan’s post about a medicine called Hongmao liquor was published on the Chinese social-media app Meipian on 19 December…Three days later, the liquor’s maker, Hongmao Pharmaceuticals in Liangcheng county of Inner Mongolia autonomous region, told local police that Tan had defamed the company. Liangcheng police hired an accountant who estimated that the damage to the company’s reputation was 1.4 million Chinese yuan (US$220,000), according to official state media, the Beijing Youth Daily. In January, Liangcheng police travelled to Guangzhou to arrest Tan and escort him back to Liangcheng, according to a police statement.
Sales of Hongmao liquor reached 1.63 billion yuan in 2016, making it the second best-selling TCM in China that year. It was approved to be sold by licensed TCM shops and physicians in 1992 and approved for sale over the counter in 2003. Hongmao Pharmaceuticals says that the liquor can treat dozens of different disorders, including problems with the spleen, stomach and kidney, as well as backaches…
Hongmao Pharmaceuticals did not respond to Nature’s request for an interview. However, Wang Shengwang, general manager of the production center of Hongmao Liquor, and Han Jun, assistant to the general manager, gave an interview to The Paper on 16 April. The pair said the company did not need not publicize clinical trial data because Hongmao liquor is a “protected TCM composition”. Wang denied allegations in Chinese media that the company pressured the police to pursue Tan or that it dispatched staff to accompany the police…
Xia is worried that the case could further silence public criticism of TCMs, environmental degredation, and other fields where comment from experts is crucial. The Tan arrest “could cause fear among scientists” and dissuade them from posting scientific comments, he says.
END OF QUOTE
On this blog, we have repeatedly discussed concerns over the validity of TCM data/material that comes out of China (see for instance here, here and here). This chilling case, I am afraid, is not prone to increase our confidence.
The ‘European Scientific Cooperative on Anthroposophic Medicinal Products‘ claim that there is a need for a regulatory framework for anthroposophic medicinal products (AMPs) in Europe. The existing regulatory requirements for conventional medicinal products are not appropriate for AMPs. Special registration procedures exist in some countries for homeopathic products and in the European Union for herbal products. However, these procedures only apply to a proportion of AMPs and the particular properties of AMPs are only in part accounted for. Suitable registration procedures especially for AMPs exist only in Germany and Switzerland.
The European Commission has acknowledged the existence of therapy systems, whose products have no adequate regulation, and it has proposed that the suitability of a separate legal framework for products of certain traditions such as Anthroposophic Medicine should be assessed. This statement should be seen in the context of developments in international trade, whereby representatives of therapy systems such as Traditional Chinese Medicine and Ayurveda wish to market their products in Europe.
It seems obvious that the safety of AMPs must be demonstrated, if regulators are to comply with the wishes of the AMP-industry. In other words, they require evidence. As luck has it, a recent paper provides just what they need.
The main objective of this analysis was to determine the frequency of adverse drug reactions (ADRs) to AMPs, relative to the number of AMP prescriptions.
The researchers conducted a prospective pharmacovigilance study with the patients of physicians in outpatient care in Germany. Diagnoses and prescriptions were extracted from the electronic medical records. A total of 38 German physicians trained in AM were asked to link all AMP prescriptions to the respective indications (diagnoses), and to document all serious ADRs as well as all ADRs of intensity III–IV. In addition, a subgroup of 7 ‘prescriber physicians’ agreed to also document all non-serious ADRs of any intensity. The study was conducted under routine care conditions with ADRs identified at ordinary follow-up consultations, without any additional scheduled follow-up visits. Physicians were remunerated with 15 Euro for each ADR report but not for their regular participation; patients received no remuneration. Patients were eligible for this analysis, if they had one or more AMP prescription in the years 2001–2010, followed by one or more physician visit.
A total of 44,662 patients with 311,731 AMP prescriptions, comprising 1722 different AMPs, were included. One hundred ADRs to AMPs occurred, caused by 83 different AMPs. ADR intensity was mild, moderate, and severe in 50% (n = 50/100), 43%, and 7% of cases, respectively; one ADR was serious. ADRs of any intensity occurred in 0.071% (n = 67/94,734) of AMP prescriptions and in 0.502% (n = 65/12,956) of patients prescribed AMPs. The highest ADR frequency was 0.290% of prescriptions for one specific AMP. Among all patients, serious ADRs occurred in 0.0003% (n = 1/311,731) of prescriptions and 0.0022% (n = 1/44,662) of patients.
The authors concluded that in this analysis from a large sample, ADRs to AMP therapy in outpatient care were rare; ADRs of high intensity as well as serious ADRs were very rare.
Most AMPs are highly diluted, and therefore, one would not expect frequent or serious ADRs. Yet, I still find these incidence figures mysterious. The reason is simple: even the ARDs of pure placebos (such as most AMPs) are known to be much more frequent. In other words, the nocebo-effects of drugs are much more common than these results seem to reflect.
This, I think, leads to one of two possible conclusions:
- AMPs are somehow miraculously exempt from the known facts of ADRs.
- There is something fundamentally wrong with this study.
I let you decide which is the case.
Oh, I almost forgot. At the end of this paper there is a not unimportant note:
The EvaMed study was funded by the Software AG-Stiftung. This analysis and publication was commissioned by the European Scientific Cooperative on Anthroposophic Medicinal Products (http://www.escamp.org) with financial support from foundations (Christophorus-Stiftung, Damus-Donata-Stiftung, Ekhagastiftelsen, Mahle-Stiftung, Software AG-Stiftung) and manufacturers (Wala, Weleda). The sponsors had no influence on the planning or conduct of the EvaMed study; the collection, preparation, analysis or interpretation of data for this paper; nor on the preparation, review or approval of the manuscript.
This is the title of an editorial by Alan Schmukler. You probably remember him; I have featured him before, for instance here, here, and here. This is what was recently on Schmukler’s mind (I have added a few references referring to comments of mine added below):
England’s National Health Service (NHS) is proposing that NHS doctors no longer be permitted to prescribe homeopathic remedies [1]… They claim lack of evidence for effectiveness. Anyone who’s been remotely conscious the last 10 years will see this as a pretext. Homeopathy is practiced by board certified physicians in clinics and hospitals around the world [2]. The massive Swiss review of homeopathy, found it effective, safe and economical, and the Swiss incorporated homeopathy into their national health care system [3]…
The reason given for banning homeopathy and these nutrients is a lie. Why would the NHS ban safe, effective and affordable healing methods? [4] Without these methods, all that is left are prescription drugs. Apparently, someone at the NHS has an interest in pushing expensive prescription drugs [5], rather than safer and cheaper alternatives. That someone, also wishes to deny people freedom of choice in medicine [6]. I say “someone”, because organizations don’t make decisions, people do. Who is that someone? In looking for a suspect, we might ask, who is the chief executive of the organization? Who introduced this plan and is promoting it? Who at the NHS has the political clout? Who was it that recently declared: “Homeopathy is a placebo and a misuse of scarce NHS funds which could better be devoted to treatments that work”.
The quote is from Simon Stevens, NHS England’s chief executive. He got the job in 2014, after ten years as a top executive at UnitedHealth, the largest health insurance company in America. His past work experiences and current activities show that he favors privatization [7]. That would make him an odd choice to run a healthcare system based on socialized medicine. In fact, he has been moving the NHS towards privatization and the corporate, profit based American model. [8] The last thing a privatizer in healthcare would want, are non-proprietary medicines, for which you can’t charge exorbitant fees [9]. Banning homeopathy on the NHS is just one small part of a larger plan to maximize corporate profits by letting corporations own and control the health care system [10]. Before they can do this, they have to eliminate alternative methods of treatment.
Personally, I think Schmukler is wrong – here is why:
1 The current argument is not about what doctors are permitted to do, but about what the NHS should do with our tax money.
2 Argumentum ad populum
3 Oh dear! Anyone who uses this report as evidence must be desperate – see for instance here.
4 Why indeed? Except highly dilute homeopathic remedies are pure placebos.
5 Maybe ‘someone’ merely wants to use effective medications rather than placebos.
6 Freedom of choice is a nonsense, if it is not guided by sound evidence – see here.
7 No, that’s Jeremy Hunt! But in any case privatisation might be more profitable with homeopathy – much higher profit margins without any investment into R&D.
8 No, this is Hunt again!
9 Homeopathic remedies are ideal for making vast profits: no research, no development, no cost for raw material, etc., etc.
10 I am sure Boiron et al would not mind stepping into the gap.
I very much look forward to the next outburst of Alan Schmukler and hope he will manage to think a bit clearer by then.
