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

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The fact that homeopathy is under siege in France, has been discussed before. Now even the international media have picked up the story. Here are some excerpts from an interesting article in Bloomberg:

… The looming brawl gets to the heart of conflicting visions of the state’s involvement in the country’s health system at a time of eroding quality and services. Jobs are also at stake: France is home to Boiron SA, the leader in a global homeopathy market estimated at more than $30 billion.

Boiron’s pills and tinctures have long coexisted with conventional care in France, prescribed by regular doctors and dispensed in almost every pharmacy. Ending public support for the remedies would discredit homeopathy and “send a shock wave” through the industry worldwide, says Boiron’s chief executive officer, Valerie Poinsot. “We’ve been caught in this storm for the past year,” Poinsot says. “Why the hostility, when we contribute to caring for patients?”

Facing a possible backlash, Boiron, based in Lyon, teamed with rivals Weleda AG of Switzerland and closely held family group Lehning to fund a campaign called MyHomeoMyChoice. The push has garnered just over 1 million signatures in an online petition and placed bright-colored posters framed with the recognizable little white pills at pharmacies across the country. “Homeopathy has treated generations of French patients,” says one slogan. “Why deprive future generations?”

For now, French people can walk into any pharmacy and buy a tube of Arnica granules — recommended for shocks and bruises — or roughly a thousand other similar remedies for 1.6 euros ($1.80) with a prescription, because the state health system shoulders about 30% of its cost. In some cases, private insurers cover the remainder and patients pay nothing. That may all soon change. A science agency is wrapping up a study of the relative benefits of alternative medicine that will inform the government’s position: Keep the funding, trim it or scrap it altogether.

If the government cuts funding, Boiron would instantly feel the pain. Poinsot estimates that sales of reimbursed treatments could plummet by 50% in France, where the company brings in almost half its revenue. The company’s stock price has lost about 13% since May 15, when a French newspaper wrote that the panel reviewing homeopathy funding would probably rule against it…

In France, the controversy first erupted last year when the influential Le Figaro newspaper published a letter from a doctor’s collective called FakeMed lambasting alternative medicines. The authors called for ending support of “irrational and dangerous” therapies with “no scientific foundation.” The ensuing debate prompted Health Minister Agnes Buzyn to place funding under review and ask the country’s High Authority for Health to rule on homeopathy’s scientific merits…

David Beausire, a doctor in palliative care at the hospital in Mont de Marsan, in southwest France, is among those who signed the FakeMed letter. Beausire, who sees many terminally ill patients, said he regularly gets people who consult too late because they first explored alternative medicine paths that include homeopathy. “I am not an extremist,” he says. But homeopathy’s reimbursement by the state health system gives it legitimacy when “there’s no proof that it works.”…

Stung by accusations of quackery, Antoine Demonceaux, a doctor and homeopath in Reims, founded a group called SafeMed last November to relay the message that homeopathy has a role to play alongside standard care. He points to the growing number of cancer centers offering consultations to relieve treatment-related symptoms, such as nausea, with homeopathic medicine. Demonceaux says neither he nor his colleagues would ever use homeopathy as a substitute for treatments intended to, say, shrink tumors. “A general practitioner or a specialist who’d claim to be a homeopath and to cure cancer with homeopathy? Just sack him,” he says. “Let’s get real. We are doctors.”

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On the whole, this is a good report which – as far as I can see – describes the situation quite well and provides interesting details. What, however, with this articles and many like it is this: journalists (and others) are too often too lethargic or naïve to check the veracity of the claims that are being made during these disputes. For instance, it would not have been all that difficult to discover that:

  1. Hahnemann called clinicians who used homeopathy alongside conventional treatments ‘traitors‘! He categorically forbade it and denied that such an approach merits the name ‘HOMEOPATHY’. In other words, let’s get real and let’s not pull wool over the eyes of the public (and let’s be honest, it is not possible to practice homeopathy within the boundaries of medical ethics).
  2. Many homeopaths do advocate homeopathy as a sole treatment for cancer and other serious conditions (see for instance here, here and here).

The obvious risk of such lack of critical thinking is that homeopathy might be kept refundable on the basis of big, fat lies. And clearly, that would not be in the interest of anyone (with the exception of family Boiron, of course).

Green tea is said to have numerous health benefits. Recently, a special green tea, matcha tea, is gaining popularity and is claimed to be more powerful than simple green tea. Matcha tea consumption is said to lead to higher intake of green tea phytochemicals compared to regular green tea.

But what is matcha tea? This article explains:

The word matcha literally means “powdered tea”. Drinking a cup or two of the tea made from this powder could help you tackle your day feeling clear, motivated and energized, rather than foggy, stressed out, and succumbing to chaos.

Matcha tea leaves are thrown a lot of shade (literally). They’re grown in the dark. The shade growing process increases matcha’s nutrients, especially chlorophyll, a green plant pigment that allows plants to absorb energy from sunlight. Chlorophyll is rich in antioxidants, and gives matcha it’s electrifying green colour. Shade growing also increases the amount of L-theanine, which is the amino acid known for promoting mental clarity, focus, and a sense of calm. It’s called nature’s “Xanax” for a reason.

The high amino acid content is also what gives matcha it’s signature umami taste. Umami is the “fifth” taste that describes the savory flavor of foods like miso, parmesan cheese, chicken broth, spinach, and soy sauce. You know you’ve got a premium matcha when you taste balanced umami flavors, hints of creaminess, and the slightest taste of fresh cut grass. You shouldn’t need to add any sweetener to enjoy sipping it. When choosing a high quality matcha powder, it’s important to remember: a strong umami flavour = higher in amino acids = the more L-theanine you’ll receive.

Once matcha leaves are harvested, they get steamed, dried, and ground up into a fine powder that you can mix with hot or cold water. The key difference here is that you’re actually consuming the nutrients from the entire leaf— which is most concentrated in antioxidants, amino acids, and umami flavour. This is unlike traditional brewed tea, where you’re only drinking the dissolvable portions of the leaf that have been steeped in water.

The article also names 5 effects of matcha tea:

1. Promotes Relaxation, Mood, and Mental Focus

2. Supports Healthy Cognitive Function

3. Supports Detoxification

4. Fights Physical Signs of Aging

5. Promotes a Healthy Heart

None of the sources provided do actually confirm that matcha tea conveys any of these benefits in humans. My favourite reference provided by the author is the one that is supposed to show that matcha tea is a detox remedy for humans. The article provided is entitled Low-dose dietary chlorophyll inhibits multi-organ carcinogenesis in the rainbow trout. Who said that SCAM-peddlers have no sense of humour?

Joking aside, is there any evidence at all to show that matcha tea has any health effects in humans? I found two clinical trials that tested this hypothesis.

Trial No1:

Intake of the catechin epigallocatechin gallate and caffeine has been shown to enhance exercise-induced fat oxidation. Matcha green tea powder contains catechins and caffeine and is consumed as a drink. We examined the effect of Matcha green tea drinks on metabolic, physiological, and perceived intensity responses during brisk walking. A total of 13 females (age: 27 ± 8 years, body mass: 65 ± 7 kg, height: 166 ± 6 cm) volunteered to participate in the study. Resting metabolic equivalent (1-MET) was measured using Douglas bags (1-MET: 3.4 ± 0.3 ml·kg-1·min-1). Participants completed an incremental walking protocol to establish the relationship between walking speed and oxygen uptake and individualize the walking speed at 5- or 6-MET. A randomized, crossover design was used with participants tested between Days 9 and 11 of the menstrual cycle (follicular phase). Participants consumed three drinks (each drink made with 1 g of Matcha premium grade; OMGTea Ltd., Brighton, UK) the day before and one drink 2 hr before the 30-min walk at 5- (n = 10) or 6-MET (walking speed: 5.8 ± 0.4 km/hr) with responses measured at 8-10, 18-20, and 28-30 min. Matcha had no effect on physiological and perceived intensity responses. Matcha resulted in lower respiratory exchange ratio (control: 0.84 ± 0.04; Matcha: 0.82 ± 0.04; p < .01) and enhanced fat oxidation during a 30-min brisk walk (control: 0.31 ± 0.10; Matcha: 0.35 ± 0.11 g/min; p < .01). Matcha green tea drinking can enhance exercise-induced fat oxidation in females. However, when regular brisk walking with 30-min bouts is being undertaken as part of a weight loss program, the metabolic effects of Matcha should not be overstated.

Trial No 2:

Matcha tea is gaining popularity throughout the world in recent years and is frequently referred to as a mood-and-brain food. Previous research has demonstrated that three constituents present in matcha tea, l-theanine, epigallocatechin gallate (EGCG), and caffeine, affect mood and cognitive performance. However, to date there are no studies assessing the effect of matcha tea itself. The present study investigates these effects by means of a human intervention study administering matcha tea and a matcha containing product. Using a randomized, placebo-controlled, single-blind study, 23 consumers participated in four test sessions. In each session, participants consumed one of the four test products: matcha tea, matcha tea bar (each containing 4g matcha tea powder), placebo tea, or placebo bar. The assessment was performed at baseline and 60min post-treatment. The participants performed a set of cognitive tests assessing attention, information processing, working memory, and episodic memory. The mood state was measured by means of a Profile of Mood States (POMS). After consuming the matcha products compared to placebo versions, there were mainly significant improvements in tasks measuring basic attention abilities and psychomotor speed in response to stimuli over a defined period of time. In contrast to expectations, the effect was barely present in the other cognitive tasks. The POMS results revealed no significant changes in mood. The influence of the food matrix was demonstrated by the fact that on most cognitive performance measures the drink format outperformed the bar format, particularly in tasks measuring speed of spatial working memory and delayed picture recognition. This study suggests that matcha tea consumed in a realistic dose can induce slight effects on speed of attention and episodic secondary memory to a low degree. Further studies are required to elucidate the influences of the food matrix.

Not impressed?

Me neither!

However, I was impressed when I looked up the costs of matcha tea: £17.95 for 30 g of powder does not exactly seem to be a bargain. So, matcha tea does after all help some people, namely all those engaged in flogging it to the gullible SCAM fraternity.

 

Time for celebrations and congratulations!

Why?

You might remember the story; over a year ago, I reported that a SCAM practitioner was suing a critic:

‘Doctor’ Colleen Huber (DCH) is the US naturopath who is currently suing Britt Hermes. For me, this is enough reason to do a bit of reading and find out who DCH is and what motivates her. Here is what I found out (I added some * to the quotes [all in italics] and comments below).

DCH has an impressive presence on the Internet. One website, for instance, tells us that DCH is a Naturopathic Medical Doctor* in Tempe, Arizona. Her clinic, Nature Works Best Cancer Clinic, has had the most successful results of any clinic in the world reporting its results over the last 9 years **.

Dr. Huber authored the largest and longest study*** in medical history on sugar intake in cancer patients, which was reported in media around the world in 2014. Her other writing includes her book, Choose Your Foods Like Your Life Depends On Them ****, and she has been featured in the books America’s Best Cancer Doctors and Defeat Cancer. Dr. Huber’s academic writing has appeared in The Lancet *****, the International Journal of Cancer Research ***** and Molecular Mechanisms *****,  and other medical journals ******. Her research interests are in the use of therapeutic approaches targeting metabolic aspects of cancer…

*I am puzzled by this title. Is it an official one? I only found this, and it omits the ‘medical’: Currently, 20 states, five Canadian provinces, the District of Columbia, and the U.S. territories of Puerto Rico and the U.S. Virgin Islands have passed laws regulating naturopathic doctors. Learn more about licensure from the Association of Accredited Naturopathic Medical Colleges. It seems that Arizona is the only state where the ‘medical’ is allowed. However, don’t take this to mean that DCH went to medical school.

** ‘most successful results of any clinic in the world’? Really? Where are the comparative statistics?

*** the study had all of 317 patients and was published in an obscure, non-Medline listed journal.

**** currently ranked  #1,297,877 in Books on Amazon.

***** no such entries found on Medline.

****** sorry, but my Medline search for ‘huber colleen’ located only 2 citations, both on arthritis research conducted in an US Pfizer lab and therefore probably not from ‘our’ DCH.

Another website on or by DCH informs us that her outfit Nature Works Best is a natural cancer clinic located in Tempe, Arizona, that focuses on natural, holistic, and alternative cancer treatments. Our treatments have proved to be an effective alternative to traditional chemotherapy and radiation, which we do not use in our treatments. Rather, we have developed a natural method of treating cancers based on intravenous vitamin therapy which may include Vitamin-C, Baking Soda, and other tumor fighting agents as well as a simple food plan. *

Our team of naturopathic medical doctors have administered an estimated 31,000 IV nutrient treatments, used for all stages and types of tumors. As of July 2014, 80% of patients who completed our treatments alone went into remission, 85% of patients who completed our treatments and followed our food plan went into remission. **

* Give me a break! Vitamin-C and Baking Soda are claimed to have proved to be an effective alternative to traditional chemotherapy and radiation ? I would like to see the data before I believe this!

** Again, I would like to see the data before I believe this!

Finally, a further website proudly repeats that her academic writing has appeared in The Lancet and Cancer Strategies Journal, and other medical journals. It even presents an abstract of her published work; here it is:

Recent recommendations for the more widespread prescription of statin drugs in the U.S. have generated controversy.  Cholesterol is commonly thought to be the enemy of good health.  On the other hand, previous research has established the necessity of cholesterol in production of Vitamin D and steroid hormones, among other purposes, some of which have been shown to have anti-cancer effect.  We compare total serum cholesterol (TC) in cancer survivors vs cancer fatalities, and we assess the value of deliberately lowering TC among cancer patients.  We also examined diet in the survivors as well as those who then died of cancer.

In this original previously unpublished research, we conducted a double-blind retrospective case series, in which we looked back at data from all 255 cancer patients who came to and were treated by our clinic with either current dietary information, and/or a recent serum TC level, measured by an unaffiliated laboratory or an unaffiliated clinic over the previous seven years, comparing TC in the surviving cancer patients versus those cancer patients who died during that time.

Surviving cancer patients had 24.0 points higher mean total cholesterol than the mean for deceased cancer patients.  A number of dietary differences between cancer survivors and those who then died of cancer were also found to be notable.

Caution is advised before attempting to lower cholesterol in cancer patients with close to normal TC levels.  Those cancer patients with higher TC were more likely to survive their cancer.

I don’t know about you, but I am not impressed. Surviving cancer patients had 24.0 points higher mean total cholesterol than the mean for deceased cancer patients. Has DCH thought of the possibility that moribund patients quite simply eat less? In which case, the observed difference would be a meaningless epiphenomenon.

At this point, I stopped my reading; I now knew more than I needed to know about DCH (if you want to read more, I recommend this or this post).

As I mentioned at the beginning of this post, DCH is currently suing Britt Hermes for libel…

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Yesterday Britt Hermes reported that she has won the court case:

On May 24, 2019, the District Court (Landgericht) of Kiel, Germany ruled against naturopathic cancer quack Colleen Huber in a defamation lawsuit she brought against me. Huber filed suit in September 2017 over my opinions about the dubious treatments and human subjects research at her cancer clinic in Tempe, Arizona (USA), and also over my suspicions that Huber was cybersquatting domains in my name…

In a blog post from December 2016, I theorized that Huber or someone in her close orbit had registered domains using my first and last names to misrepresent my position on naturopathic “doctors.” You can view the archive of brittmariehermes.com from 31 March 2016 here. In my post, I also wrote about Huber’s dubious cancer treatments of intravenous baking soda, mega-doses of intravenous vitamin C, and a strict sugar-free diet. Huber advocates against state-of-the-art oncology, especially chemotherapy and radiation, because she thinks these therapies strengthen cancer…

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I am sure that many readers of the blog want to join me in congratulating Britt.

VERY WELL DONE INDEED!

Many cancer patients use so-called alternative medicine (SCAM) such as Traditional Chinese Medicine (TCM). On this blog, we have repeatedly discussed whether this does more good than harm. This study sheds new light on the question. Specifically, it aims to explore the benefits of TCM therapy in the long-term survival of patients with hepatocellular carcinoma in China.

In total, 3483 patients with HCC admitted to the Beijing Ditan Hospital of Capital Medical University were enrolled. The researchers used 1:1 frequency matching by sex, age, diagnosis time, Barcelona Clinic Liver Cancer staging, and type of treatments to compare the TCM users (n = 526) and non-TCM users (n = 526). A Cox multivariate regression model was employed to evaluate the effects of TCM therapy on the HR value and Kaplan-Meier survival curve for mortality risk in HCC patients. A log-rank test was performed to analyse the effect of TCM therapy on the survival time of HCC patients.

The Cox multivariate analysis indicated that TCM therapy was an independent protective factor for 5-year survival in patients with HCC. The Kaplan-Meier curve also showed that after PS matching, TCM users had a higher overall survival rate and a higher progression-free survival rate than non-TCM users. TCM users, regardless of the classification of etiology, tumor stage, liver function level, or type of treatment, all benefited significantly from TCM therapy. The most commonly used Chinese patent medications used were Fufang Banmao Capsule, Huaier Granule, and Jinlong Capsule.

The authors concluded that using traditional Chinese medications as adjuvant therapy can probably prolong median survival time and improve the overall survival among patients with HCC. Further scientific studies and clinical trials are needed to examine the efficiency and safety.

I was unable to access the full article and therefore am unable to provide a detailed critique of it. From reading the abstract, I should point out, however, that this was not an RCT. To minimise bias, the researchers used a matching technique to generate two comparable groups. Such methods can be successful in matching for the named parameters, but they cannot match for the plethora of variables that might be relevant but were not measured. Therefore, the survival difference between the two groups might be due not to the therapies they received, but to the fact that the groups were not comparable in terms of factors that impact on survival.

Another important point about this paper is the obvious fact that it originates from China. We know from several independent investigations that such studies almost never report negative findings. We also know that TCM is a hugely important export item for China. Adding two and two together should therefore make us sceptical. I for one take the present findings with more than a pinch of salt.

“Eating elderberries can help minimise influenza symptoms.” This statement comes from a press release by the University of Sydney. As it turned out, the announcement was not just erroneous but it also had concealed that the in-vitro study that formed the basis for the press-release was part-funded by the very company, Pharmacare, which sells elderberry-based flu remedies.

“This is an appalling misrepresentation of this Pharmacare-funded in-vitro study,” said associate professor Ken Harvey, president of Friends of Science in Medicine. “It was inappropriate and misleading to imply from this study that an extract was ‘proven to fight flu’.” A University of Sydney spokeswoman confirmed Pharmacare was shown a copy of the press release before it was published.

This is an embarrassing turn of events, no doubt. But what about elderberry (Sambucus nigra) and the flu? Is there any evidence?

A systematic review quantified the effects of elderberry supplementation. Supplementation with elderberry was found to substantially reduce upper respiratory symptoms. The quantitative synthesis of the effects yielded a large mean effect size. The authors concluded that these findings present an alternative to antibiotic misuse for upper respiratory symptoms due to viral infections, and a potentially safer alternative to prescription drugs for routine cases of the common cold and influenza.

WHAT?!?!

The alternative to antibiotic misuse can only be the correct use of antibiotics. And, in the case of viral infections such as the flu, this can only be the non-use of antibiotics. My trust in this review, published in a SCAM journal of dubious repute, has instantly dropped to zero.

Perhaps a recent overview recently published in THE MEDICAL LETTER provides a more trustworthy picture:

No large randomized, controlled trials evaluating the effectiveness of elderberry for prevention or treatment of influenza have been conducted to date. Elderberry appears to have some activity against influenza virus strains in vitro. In two small studies (conducted outside the US), adults with influenza A or B virus infection taking elderberry extract reported a shorter duration of symptoms compared to those taking placebo. Consuming uncooked blue or black elderberries can cause nausea and vomiting. The rest of the plant (bark, stems, leaves, and root) contains sambunigrin, which can release cyanide. No data are available on the safety of elderberry use during pregnancy or while breastfeeding. CONCLUSION — Prompt treatment with an antiviral drug such as oseltamivir (Tamiflu, and generics) has been shown to be effective in large randomized, controlled trials in reducing the duration of influenza symptoms, and it may reduce the risk of influenza-related complications. There is no acceptable evidence to date that elderberry is effective for prevention or treatment of influenza and its safety is unclear.

Any take-home messages?

Yes:

  1. Elderberry supplements are not of proven effectiveness against the flu.
  2. The press officers at universities should be more cautious when writing press-releases.
  3. They should involve the scientists and avoid the sponsors of the research.
  4. In-vitro studies can never tell us anything about clinical effectiveness.
  5. SCAM-journals’ articles must be taken with a pinch of salt.
  6. Consumers are being misled left, right and centre.

In the bizarre world of chiropractic, the war between vitalistic subluxationists and reformers has reached a new climax. The World Federation of Chiropractic (WFC) has just announced that its president, Laurie Tassell, has resigned. The move follows what the International Chiropractor’s Association (ICA) called a “blatant offensive behaviour on a public stage” that “speaks for itself” and “cannot be excused under any circumstances.” The ICA’s alleged an embarrassing display of unprofessional and disruptive behaviour of presenters and attendees at the WFC Conference in Berlin in March 2019. It involved attacks on subluxationist chiropractors and included the throwing of water bottles onto the stage and clapping and cheering as the management of subluxation was denigrated.

The ICA President, Stephen Welsh, subsequently demanded that:

  1. The current Chair of the WFC Research Council be immediately removed from his current position and denied future participation in any activities on behalf of the WFC.
  2. An additional member of the WFC Research Council be publicly reprimanded and sanctioned and prohibited from the opportunity to serve in any leadership role at the WFC for at least 5 years.
  3. The sponsoring organization that coordinated, reviewed and permitted the alleged questionable presentations be sanctioned for conduct not reflecting the professional, inclusive and collegial respect for the values embedded in the WFC Strategic Plan, Governing Documents and the WFC Official Policy Statements.

According to Welsh, and others who attended, the Chair of the WFC Research Council, Greg Kawchuk DC, Ph.D, compared bringing a child to a vitalistic chiropractor to bringing them to a Catholic priest at a children’s school.

The WFC has now announced the appointment of Vivian Kil DC as Interim President to take over from Tassel. Kil is a graduate of the AECC, full-time clinician and the owner of a multidisciplinary clinic in the Netherlands. Kil is an advocate for chiropractors as practitioners of so called “primary spine care”. She stated her vision as follows:

  1. That we will (the chiropractic profession) set aside our differences within the profession, unite as a profession, and agree that becoming the source of nonsurgical, nonpharmacological, primary, spine care expertise and management should be a primary common goal.
  2. That for us to do the necessary work to fulfill this role and do it with the entire profession, every chiropractor will be involved and not just a small active group of leaders.
  3. And finally, that we will become the source of nonsurgical, nonpharmacological, primary, spine care expertise and management worldwide.

In my view, the problem of the chiropractic profession is unsolvable. Giving up Palmer’s obsolete nonsense of vitalism, innate intelligence, subluxation etc. is an essential precondition for joining the 21st century. Yet, doing so would abandon any identity chiropractors will ever have and render them physiotherapists in all but name. Neither solution bodes well for the future of the profession.

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.

Fibromyalgia (FM) is one of the most frequent generalized pain disorders. It accounts for a sizable proportion of healthcare costs. Despite extensive research, the etiology (the ‘root cause’) of FM remains unknown – except, of course, to SCAM practitioners!

Most types of SCAM are said to be effective for FM (while the evidence for such claims is less than solid).

And almost every one of them claims to treat the ‘root cause’ of the condition. Which must mean that they are able to tackle its etiology, usually some disturbance of the ‘vital force’ or ‘energy’ flow. To patients, this sadly sounds impressive.

But what, if the etiology of FM is something entirely different?

New research shows that most (if not all) patients with FM belong to a distinct population that can be segregated from a control group by their glycated haemoglobin A1c (HbA1c) levels, a surrogate marker of insulin resistance (IR). This was demonstrated by analysing the data after introducing an age stratification correction into a linear regression model. This strategy showed highly significant differences between FM patients and control subjects (p < 0.0001 and p = 0.0002, for two separate control populations, respectively).

A subgroup of FM patients meeting criteria for pre-diabetes or diabetes (patients with HbA1c values of 5.7% or greater) who had undergone treatment with metformin showed dramatic improvements of their widespread myofascial pain. This was shown comparing pre and post-treatment numerical pain rating scale (NPRS). Response to metformin plus standard treatment (ST) was followed by complete resolution of the pain (report of 0 of 10 in the NPRS) in 8 of 16 patients who had been treated with metformin (50%), a degree of improvement never observed before in such a large proportion of FM patients subjected to any available treatment. In contrast, patients treated with ST alone improved, but complete resolution of pain was generally not observed. Interestingly, some patients responded only to metformin and not to ST with NSRIs or membrane stabilizing agents. Importantly, there was a long-term retention of the analgesic effect of metformin.

The authors concluded that these findings suggest a pathogenetic relationship between FM and IR, which may lead to a radical paradigm shift in the management of this disorder.

From my perspective, these findings also suggest that all the many SCAMs allegedly claiming to tackle the ‘root cause’ of FM have been barking up the wrong tree. In fact, all these claims of SCAM practitioners about treating the ‘root causes’ can easily be disclosed as a simple (and sadly effective) marketing gimmick. Six years ago, I even challenged the world of SCAM to name a single treatment that treats the ‘root cause’ of any disease. As yet, nobody has come forward with a convincing suggestion.

Reiki is a form of energy healing popularised by the Japanese Mikao Usui (1865-1926). ‘Rei’ means universal spirit (sometimes thought of as a supreme being), and ‘ki’ is the assumed universal life energy. Reiki is broadly based on some of the obsolete concepts of Traditional Chinese Medicine. Reiki practitioners believe that they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind.

This study (entitled ‘ The Power of Reiki’) was conducted to pilot testing the feasibility and efficacy of Reiki to provide pain relief among pediatric patients undergoing hematopoietic stem cell transplantation (HSCT). Paediatric patients undergoing HSCT during the inpatient phase in the Stem Cell Transplantation Unit were eligible to participate. Short and medium effects were assessed investigating the increase or decrease of patient’s pain during three specific time periods (“delta”) of the day: morning of the Reiki session versus assessment before Reiki session (within subjects control period), assessment before Reiki session versus assessment after Reiki session (within subjects experimental period) and assessment after Reiki session versus morning the day after Reiki session (within subject follow-up period). The effect of 88 Reiki therapy sessions in nine patients was analysed following a short, medium, and long-term perspective. Repeated-measures analysis of variance revealed a significant difference among the three periods: a decrease of the pain occurred in the experimental period in short and medium term, while in the follow-up period, the pain level remained stable.

The authors concluded that this study demonstrates the feasibility of using Reiki therapy in pediatric cancer patients undergoing HSCT. Furthermore, these findings evidence that trained pediatric oncology nurses can insert Reiki into their clinical practice as a valid instrument for diminishing suffering from cancer in childhood.

This is an unusual conclusion in that it is strictly speaking correct. What is wrong, however, that the abstract reports findings related to the alleged effectiveness of Reiki. A feasibility study is not designed for that purpose. I therefore suggest to ignore all allusions to therapeutic effects.

This, I think, begs the question as to why it is necessary or productive to study Reiki in clinical trials.

  • The treatment is not plausible.
  • There have been many trials already.
  • The ones that are sufficiently rigorous fail to show that it has any effects beyond placebo.
  • The medical literature is already highly polluted with Reiki studies reporting false-positive results.
  • This can only confuse researchers who attempt to conduct reviews on the subject.
  • Reiki studies discredit clinical research.
  • They are a waste of valuable resources.
  • Arguably, they are even unethical.

If you ask me, it is high time to stop researching such implausible nonsense.

 

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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