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

big pharma

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Recently, I have received this message via the comments section of my blog:

“you’re actually an evil old nut-job Ed—been following your pharma ‘science’ bullshit for years—all opinion and ignorance and anti-science”

Don’t get me wrong, such attacks do not bother me – not any more. On the contrary, they amuse me. At one stage, I even started collecting them. Nowadays, I usually ignore them.

But this one is somewhat special. Therefore, I decided to analyse it a bit. The author essentially makes 9 claims:

  1. I am evil.
  2. I am old.
  3. I am a nut-job.
  4. I am called Ed.
  5. I conduct pharma science.
  6. I publish bullshit.
  7. All I state is opinion.
  8. I am ignorant.
  9. I am anti-science.

Yes, that’s quite a list. Let me try to tackle it one by one.

  1. Am I evil? I have had many ad hominem attacks before but, as far as I remember, nobody has yet alleged that I am evil. I looked it up, evil means: wicked · bad · wrong · morally wrong · wrongful · immoral · sinful · ungodly · unholy · foul · vile · base · ignoble · dishonorable · corrupt · iniquitous · depraved · degenerate · villainous · nefarious · sinister · vicious · malicious · malevolent · demonic · devilish · diabolic · diabolical · fiendish · dark · black-hearted · monstrous · shocking · despicable · atrocious · heinous · odious · contemptible · horrible · execrable · lowdown · stinking · dirty · shady · warped · bent · crooked · dastardly · black · egregious · flagitious · peccable. I am obviously the wrong person to judge, but I do not think that these attributes describe me all that well.
  2. Yes, I am old, 72 to be precise.
  3. Am I a nut-job? I looked that one up too. It’s a mentally unbalanced person. Call me biased, but I don’t think that this applies to me at all.
  4. No, I am not called Ed.
  5. I am not quite sure what ‘pharma science’ is supposed to mean, but one thing I do know for sure: since I research so-called alternative medicine (SCAM) – and that’s about 30 years now – I have not taken research funds from the pharmaceutical industry. And before I very rarely did.
  6. As I have published a sizable amount of papers and blog-posts, there must have been a bit of BS in some of it. But I do not think it can be much.
  7. All I state is opinion? Oh really! Opinion comes into blog-posts regularly; without it my stuff would be boring like hell. But ALL of it? I don’t think so.
  8. Am I ignorant? Yes, certainly; there are lots of things I don’t know, even in medicine. But in SCAM I do know quite a bit – even if I say so myself.
  9. Anti-science? That last allegation is probably the most far-fetched of them all. No, I am not anti-science, never have been and never will be.

So, Paul – the author of the comment preferred to remain anonymous and simply calls himself Paul – I have tried to give you credit where I could but, on the whole, I fear your ad hominem attack is yet another victory of reason over unreason. I thank you Paul for two reasons:

  • firstly for the just-mentioned victory; it always feels good to be on a winning side,
  • secondly for the stimulus and motivation to carry on doing what I have been doing for many years; your comment has shown me how much needed my work is in disclosing quackery, correcting errors, teaching critical thinking and responsibly informing the public.

THANKS PAUL

During the last decades, the sales-figures for so-called alternative medicine (SCAM) have been increasing steadily and substantially. A recent report predicts this trend to continue:

… The global market for alternative and complementary medicines is projected to experience substantial growth in the next few years. The rising expenditure of the healthcare facilities is considered as the major factor that is likely to encourage the growth of the overall market in the coming years. In addition, the increasing number of initiatives being taken by Governments across the globe to promote alternative and complementary medicines is projected to accelerate the market’s growth. Thanks to these factors, the global alternative and complementary medicine market is likely to exhibit a promising growth rate in the near future.

A significant rise in the number of initiatives by NGOs and government organizations to encourage the use of alternative and complementary medicines is estimated to bolster global market in the near future. In addition to this, technological advancements in this field and the rising inclination of consumers towards these medicines and practices are likely to offer lucrative growth opportunities for the leading players operating in the alternative and complementary medicine market across the globe. However, the lack of scientific results is expected to hamper the overall growth of the market in the next few years…

From a regional perspective, Europe is considered as one of the leading segment, thanks to the significant revenue contribution in the last few years. This region is expected to account for a large share of the global alternative and complementary medicine market with the rising use of botanicals. In addition to this, the increasing awareness among consumers regarding the availability of effective alternative and complementary medicines and the benefits they offers are expected to encourage the growth of the Europe market in the coming years.

Furthermore, with the rising popularity of medical tourism, the alternative and complementary medicine market in Asia Pacific is projected to witness a steady growth in the next few years. Moreover, the presence of a large number of new players operating in this region is likely to offer promising growth opportunities over the forecast period. The Middle East and Africa segment is anticipated to experience a healthy growth in the alternative and complementary medicine market in the near future.

The global market for alternative and complementary medicines is presently at a highly competitive stage and is predicted to experience an intense level of competition among the leading players in the coming years. The prominent players in the market are focusing on the expansion of the product portfolio so as to attract a large number of consumers across the globe. This is likely to help them in creating a brand name and acquiring a leading position in the global market. Some of the leading players operating in the alternative and complementary medicine market across the globe are Herb Pharm, Yoga Tree, Quantum Touch Inc., Helio USA Inc., Pure encapsulations, Inc., Pacific Nutritional Inc., Deepure Plus, Herbal Hills, Iyengar Yoga Institute, The Healing Company, and Nordic Naturals.

Yes, I know, this is little more than hot air mixed with platitudes and advertisements to purchase the full report. I used to buy such documents for my department and research but was invariably disappointed. They provide are expensive and of very little of value.

Yet, one thing has been confirmed over the years: the prediction of steady growth of the SCAM-industry is rarely wrong (certain sections, such as homeopathy, have been shrinking in some regions, but the industry as a whole is financially healthy). The scientific evidence seems to get less and less convincing, yet consumers buy more and more of these products. They may do little good and have the potential to cause quite a bit of harm, but consumers continue to waste their money on them.

The question is: why?

There are, of course, many reasons. An important one is that the gullible public wants to believe in SCAM, and the SCAM-industry is highly skilled in misleading us. What is worse: many governments, instead of limiting the damage, are mildly or even overtly supportive of the SCAM-industry.

Whenever I contemplate this depressing state of affairs, I realise that my blog is important. It is only a drop in the ocean, I know, but still…

 

 

 

Dr Mathias Rath, the German born purveyor of multiple food supplements, and his organisation puzzle me a great deal. As previously reported, the ‘Dr Rath Foundation’ published an article about me. In it, the author got my name right, but not much more. Here is its opening passage [the numbers in square brackets refer to my comments below].

Professor Edzard Ernst: A Career Built On Discrediting Natural Health Science? [1]

Professor Edzard Ernst, a retired German [2] physician and academic, has recently [3] become a prominent advocate of plans that could potentially outlaw [4] the entire profession of naturopathic doctors [5] in Germany. Promoting the nonsensical idea that naturopathic medicine somehow poses a risk to public health, Ernst attacks its practitioners as supposedly having been educated in “nonsense” [6]. Tellingly, however, given that he himself has seemingly not published even so much as one completely original scientific trial of his own [7], Ernst’s apparent attempts to discredit natural healthcare approaches are largely reliant instead on his analysis or review of handpicked negative studies carried out by others [8].

  1. When I was appointed at Exeter to research alternative medicine in 1993, I had already been a full professor at Hannover, Germany and subsequently at Vienna, Austria. If anything, coming to Exeter was a big step down in terms of ‘career’, salary, number of co-workers etc. (full details in my memoir)
  2. I am German-born, became an Austrian citizen in 1990, and since 2000 I am a British national.
  3. I have been critical about the German ‘Heilpraktiker’ for more than 20 years.
  4. This refers to the recent ‘Muensteraner Memorandum’ which is the work of an entire team of multidisciplinary experts and advocates reforming this profession.
  5. ‘Heilpraktiker’ are certainly not doctors; they have no academic or medical background.
  6. This is correct, and I stand by my statement that educating people in vitalism and other long-obsolete concepts is pure nonsense.
  7. Since I am researching alternative medicine, I have conducted and published about 40 ‘scientific trials’, and before that time (1993) I have published about the same number again in various other fields.
  8. This refers to systematic reviews which, by definition, include all the studies available on a defines research question, regardless of their conclusion (their aim is to minimise random and selection biases)  .

Rath states about himself that “Dr. Rath heads a research and development institute in nutritional and Cellular Medicine. His institute is conducting basic research and clinical studies to scientifically document the health benefits of micronutrients in fighting a multitude of diseases.”

But this is equally puzzling.

Firstly, because research does not aim ‘to scientifically document the health benefits of ‘ anything; it is for testing hypotheses; Rath surely must know that. Secondly, on Medline, I find dozens of publications by Rath. These refer mostly to mechanistic in-vitro or animal studies about the mode of action of vitamins and other natural compounds.

But ‘clinical studies‘?

None!

Hold on! My Medline searches did deliver one clinical trial – just one – (Rath himself lists more, but they seem to be meaningless observational studies without a control group). It was published as an abstract on his own website. Here is the abstract:

Healing of bone fractures is a prolonged process that can be affected by nutrition. Our objective was to critically evaluate the effect of supplementation with an essential nutrient complex, containing ascorbic acid, lysine, proline, and vitamin B6 on healing time of tibial fractures.

Design:

Random double-blind placebo-controlled study

Setting:
Dr. Jamdar Hospital, Jabalpur, India

Subjects and Intervention:
113 patients with unilateral displaced closed or grade I open tibial fractures were randomized to receive either standard care with placebo or with supplementation with an essential nutrient complex containing ascorbic acid, lysine, proline, and vitamin B6. Qualifying patients, on admission to the study, were clinically examined, radiographs of the affected limbs taken, fractures reduced under anesthesia, and above knee plaster casts applied. Radiographs were taken at each follow-up visit to confirm reduced alignment of fracture and proper callus formation.

Primary Outcome Measure:
The primary outcome measure was the number of weeks required for fracture to be healed. Healing was defined as absence of abnormal mobility at fracture site clinically, absence of pain elicited by stressing the fracture or by walking, and radiographic confirmation of callus formation.

Results:
Data analysis demonstrated reduced fracture-healing time associated with experimental supplementation. For PP analysis group, fracture healing time in 75% of the supplemented group of patients (N=21) was 17 weeks or less and 19 weeks or less in 75% of the placebo group patients (N=36). The percentage of patients with fractures healing in 10 weeks or less was 33.3% for the supplemented group and 11.1% for the placebo group. However, the difference in healing time between the two groups did not reach statistical significance.

Conclusion:
Results showed encouraging trends that fracture-healing time is reduced by supplementation with an essential nutrient complex containing ascorbic acid, lysine, proline, and vitamin B6. In addition, the nutrient supplemented participants reported improved feeling of well-being with use of the supplement.

This is odd in several ways:

  1. Even though the conclusions hide it quite well, the trial was in fact negative, i. e. it failed to show a significant difference between the verum and the placebo in the primary outcome measure.
  2. The trial was never published as a peer-reviewed full paper. The website refers to its publication as a ‘letter to the editor’ (LTTE) in the notorious JACM (a LTTE is not normally peer-reviewed).
  3. Why was it never properly published?
  4. Could it be because there was no ethics approval [none was mentioned in the LTTE]?
  5. Could it be because there was no informed consent [none was mentioned in the LTTE]?
  6. The LTTE mentions that a larger study with 200 patients is planned. This was 16 years ago, and to date there is no trace of such a trial.

Rath’s latest contribution to the world of science is a paper implying that his supplements could play a role in the fight against the present pandemic; it is entitled ‘Effective and safe global public health strategy to fight the COVID-19 pandemic: Specific micronutrient composition inhibits Coronavirus cell-entry receptor (ACE2) expression’. Here is the abstract which clearly shows that Rath has not a jot of clinical evidence:

Optimum micronutrient intake is the only scientifically proven way to improve general immune resistance against infections, a fact documented in every leading textbook of biology.  This study provides scientific evidence that, in addition, specific micronutrient compositions are powerful tools in the fight against the COVID-19 pandemic.

Both, SARS-CoV-2 – the virus that causes the current pandemic – and other coronaviruses enter body cells via a specific receptor, the Angiotensin-Converting-Enzyme 2 (ACE2). The ACE2 receptor is expressed by many cell types, including lung epithelial cells as well as endothelial cells of the vascular system.

Based on our earlier research that demonstrated that specific micronutrients can block several mechanisms of viral infections, we tested the efficacy of these natural compounds in suppressing the expression of the ACE2 receptor on human endothelial cells and small airway epithelial cells.

Our results show that a micronutrient composition comprising vitamin C as well as certain amino acids, polyphenols, and trace elements is able to suppress this viral ‘entry door’ into the body under both normal and inflammatory conditions, which are associated with infections.

Thus, vitamin-rich nutrition and micronutrient supplementation should be implemented as effective, safe and affordable public health strategies to fight the COVID-19 pandemic and help prevent future outbreaks.  Optimizing the micronutrient status of the entire population should form the basis for any global strategy to help prevent future pandemics across the world, including the developing nations.

The Wiki-page on Rath lists 10 (!) legal cases in which he has been involved. This looks like he easily sues people who disagree with his often bizarre views and sales techniques. Considering this suspicion, I better be careful what I say here. Therefore let me conclude by meekly repeating the title of this post which comes from my friend Ben Goldacre who, together with THE GUARDIAN won a famous and expensive legal battle against Rath:

Rath is an example of the worst excesses of the alternative therapy industry.

 

 

 

PS

What I like best about the many supplements sold by Rath is the footnote in the patient leaflets:

THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE

Prof Ernst is far too critical about homeopathy!

He is biased against it!

He cherry-picks the evidence!

He does not understand homeopathy!

If you are one of the many who believe such notions, please read on.

The website of the NHS England has a fairly detailed account of homeopathy. Here is the section entitled ‘What can we conclude from the evidence?‘ – but I recommend reading the full text:

There have been several reviews of the scientific evidence on the effectiveness of homeopathy.

The House of Commons Science and Technology Committee said there’s no evidence that homeopathy is effective as a treatment for any health condition.

There’s no evidence behind the idea that substances that cause certain symptoms can also help treat them.

Nor is there any evidence behind the idea that diluting and shaking substances in water can turn those substances into medicines.

The ideas that underpin homeopathy aren’t accepted by mainstream science, and aren’t consistent with long-accepted principles on the way the physical world works.

The Committee’s 2010 report on homeopathy said the “like cures like” principle is “theoretically weak”, and that this is the “settled view of medical science”.

For example, many homeopathic remedies are diluted to such an extent that it’s unlikely there’s a single molecule of the original substance remaining in the final remedy. In cases like these, homeopathic remedies consist of nothing but water.

Some homeopaths believe that, as a result of the succussion process, the original substance leaves an “imprint” of itself on the water. But there’s no known mechanism by which this can occur.

The 2010 report said: “We consider the notion that ultra-dilutions can maintain an imprint of substances previously dissolved in them to be scientifically implausible.”

Some people who use homeopathy may see an improvement in their health condition as the result of a phenomenon known as the placebo effect.

If you choose health treatments that provide only a placebo effect, you may miss out on other treatments that have been proven to be more effective.

__________________________________

Since 1948, homeopathy had been part of the NHS, there were 5 homeopathic NHS hospitals, and the costs for homeopathy were covered. Why would the NHS decision makers suddenly turn against it? They must have loved homeopathy for at least 4 reasons:

      1. It is inexpensive.
      2. It has support in high places.
      3. It did not cause any direct harm.
      4. It had many supporters who fought tooth and nail for it.

It is therefore hardly reasonable to assume that the NHS is biased against homeopathy. But, why do they now say that it is

  • implausible,
  • not effective beyond placebo,
  • and can cause harm by making people miss out on effective therapies?

 

The answer is simple: BECAUSE THESE STATEMENTS ARE IN ACCORDANCE WITH THE OVERWHELMING MAJORITY OF THE BEST EVIDENCE AVAILABLE TO DATE.

So, here you are: the NHS now confirms what I (and many other experts) have been saying since years. And we all insist on the fact that this not because we are biased, stupid, uninformed, paid by BIG PHARMA, or want to deprive anyone of anything. We do it for one reason only:

BECAUSE IT’S THE TRUTH!

The purpose of this feasibility study was to:

(1) educate participants about the concept of Reiki,

(2) give participants the opportunity to experience six Reiki therapy sessions and subsequently assess outcomes on chronic pain,

(3) assess participants’ impression of and willingness to continue using and recommending Reiki therapy as adjunct for the treatment of chronic pain.

Using a prospective repeated measures pre- and postintervention design, a convenience sample of 30 military health care beneficiaries with chronic pain were educated about Reiki and received six 30-minute Reiki sessions over 2 to 3 weeks. Pain was assessed using a battery of pain assessment tools as well as assessment of impression of and willingness to share the concept of Reiki.

Repeated measures ANOVA analyses showed that there was significant decrease (P < 0.001) in present, average, and worst pain over the course of the six sessions with the most significant effect occurring up to the fourth session. When a variety of descriptor of pain was assessed, Reiki had a significant effect on 12 out of the 22 assessed, with the most significant effect on pain that was described as tingling/pins and needles (P = 0.001), sharp (P = 0.001), and aching (P = 0.001). Pain’s interference with general activity, walking, relationships, sleep, enjoyment of life, and stress significantly decreased (P < 0.001 to P = 0.002). Impression of improvement scores increased 27 % by session 6, and one’s knowledge about Reiki improved 43%. Eighty-one percent of the participants stated that they would consider scheduling Reiki sessions if they were offered with 70% desiring at least four sessions per month.

The authors concluded that 30-minute Reiki session, performed by a trained Reiki practitioner, is feasible in an outpatient setting with possible positive outcomes for participants who are willing to try at least four consecutive sessions. Reiki has the ability to impact a variety of types of pain as well as positively impacting those activities of life that pain often interferes with. However, education and the opportunity to experience this energy healing modality are key for its acceptance in military health care facilities as well as more robust clinical studies within the military health care system to further assess its validity and efficacy.

Where to begin?

  • As a feasibility study, this trial should not evaluate outcome data; yet the paper focusses on them.
  • To educate people one does certainly not require to conduct a study.
  • That Reiki ‘is feasible in an outpatient setting‘ is obvious and does not need a study either.
  • The finding that ‘Reiki had a significant effect’ is an unjustified and impermissible extrapolation; without a control group, it is not possible to determine whether the treatment or placebo-effects, or the regression towards the mean, or the natural history of the condition, or a mixture of these phenomena caused the observed outcome.
  • The conclusion that ‘Reiki has the ability to impact a variety of types of pain as well as positively impacting those activities of life that pain often interferes with’ is quite simply wrong.
  • The authors mention that ‘This study was approved by the U.S. Army Medical Research and Materiel Command Institutional Review Board’; I would argue that the review board must have been fast asleep.

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

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

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

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

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

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

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

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

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

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

So, what then does determine it?

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

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

The U.S. Food and Drug Administration has issued warning letters to four companies for selling unapproved injectable drug products labelled as homeopathic that can pose serious risks to patient health and violate federal law, as part of the agency’s efforts to protect Americans from potentially harmful products that are labelled as homeopathic.

The FDA is particularly concerned about unapproved injectable drug products labelled as homeopathic because they are injected directly into the body, often directly into the bloodstream and bypass some of the body’s key natural defences against toxins, toxic ingredients and dangerous organisms that can cause serious and life-threatening harm. Additionally, unapproved drugs that claim to cure, treat or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.

“The FDA’s drug approval requirements are designed to protect patients by ensuring, among other things, that drugs are safe and effective for their intended uses. These unapproved injectable drugs are particularly concerning because they inherently present greater risks to patients because of how they are administered,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “These products are further concerning given that they are labelled to contain potentially toxic ingredients intended for injection directly into the body. These warning letters reflect our continued commitment to patient safety.”

No currently marketed drug products labelled as homeopathic have been approved by the FDA for any use and the agency cannot assure these drugs meet modern standards for safety, effectiveness and quality. Products labelled as homeopathic can be made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, and they can include known poisons or toxins. These drugs are often marketed as natural, safe and effective alternatives to approved prescription and non-prescription products and are widely available in the marketplace. Additionally, the lack of premarket quality review is particularly concerning for injectable drugs, which generally pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defences.

The FDA issued the warning letters to Hevert Pharmaceuticals, LLCMediNatura, Inc.8046255 Canada, Inc., doing business as Viatrexx; and World Health Advanced Technologies, Ltd. The products included in the warning letters are new drugs because they are not generally recognized as safe and effective for their labelled uses, and FDA has not approved these products. Some drugs, such as “Enercel,” marketed by World Health Advanced Technologies, Ltd., are intended for serious diseases such as tuberculosis and hepatitis B and C.

Many of the drugs were labelled to contain potentially toxic ingredients such as nux vomica, belladonna (deadly nightshade), mercurius solubilis (mercury), and plumbum aceticum (lead). For example, nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents. The agency is concerned that these potentially toxic ingredients present additional risks of serious harm when delivered directly into the body, including directly into the bloodstream.

Drugs labelled as homeopathic may also cause significant and even irreparable harm if they are poorly manufactured. Viatrexx was also cited for substandard manufacturing practices for sterile drugs.

The foreign manufacturers of the injectable drugs sold by Hervert Pharmaceuticals, LLC; MediNatura New Mexico, Inc.; and Viatrexx were also placed on import alert 66-41 to stop these drugs from entering the U.S.

The FDA has taken steps to clarify for both consumers and industry how the potential safety risks of these products are assessed. On Oct. 24, 2019, the FDA withdrew Compliance Policy Guide (CPG) 400.400 “Conditions Under Which Homeopathic Drugs May be Marketed,” because it was inconsistent with the agency’s risk-based approach to regulatory and enforcement actions. The FDA also issued a revision of its draft guidance, titled Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry, for public comment. When finalized, this guidance will explain the categories of homeopathic drug products that we intend to prioritize under our risk-based enforcement approach. In the interim, before the draft guidance is finalized, the FDA intends to apply its general approach to prioritizing risk-based regulatory and enforcement action.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of any of these products to the FDA’s MedWatch Adverse Event Reporting program. To report adverse drug events in animals, see How to Report Animal Drug Side Effects and Product Problems

_____________________________________

 

Hevert is of course well known to readers of this blog for their attempt to silence critics of homeopathy in Germany. The FDA’s warning letter refers to their following injectable products:

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

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

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

The FDA warning to World Health Advanced Technologies, Ltd referred to:

  • “Enercel AM,”
  • “Enercel Forte,”
  • “Enercel Max,”
  • “Enercel Mist-Nasal,”
  • “Enercel Mist Nebulizer,”
  • “Enercel PM,”
  • “Vanicel,”
  • “Enercel Plus,”
  • “Enercel Plus IM.”

The FDA warning referred to the following products by MediNatura, and the claims made for them include:

  • Zeel Injection Solution: “… treatment of arthrosis/osteoarthritis, and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.”
  • Traumeel Injection Solution: … treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.”
  • Engystol Injection Solution:  support of the immune system to reduce severity and duration of symptoms in viral infections, particularly in the early stages of colds and influenza-like illnesses.”
  • Neuralgo-Rheum Injection Solution: “… treatment of nerve pain, soft tissue rheumatism and symptoms of disc protrusion.”
  • Lymphomyosot X Injection Solution: “… improvement of lymphatic drainage, the non-specific immune defense, and conditions such as benign hypertrophy of lymph nodes, chronic tonsillitis, tonsillar hypertrophy and lymphatic edema.”
  • Spascupreel Injection Solution: “… relief of spasms of the smooth musculature of the gastrointestinal and urogenital tract as well as general muscle spasms.”

The FDA has requested the companies to respond within 15 working days. The letter also states that failure to correct any violations could result in legal action against the company, including seizure and injunction.

Asked for comment, Cliff Clive, founder and CEO for MediNatura, stated that he is disappointed with the FDA’s actions and the company is in the process of developing their response. “The FDAs statements that the MediNatura injectable products present greater risk to consumers is without factual basis,” Clive said. “The MediNatura injectable products are labelled for use only under the care of licensed practitioners [and] are manufactured in [Good Manufacturing Practice]-compliant facilities to assure their quality and sterility.”

Disputing several of the claims made in the letter, Clive noted that rather than protecting patients, “the FDA’s actions threaten to remove valuable alternatives relied upon by medical practitioners in treating their patients. These injections have been used legally by thousands of medical doctors for more than 30 years in the U.S., and in over 50 other countries for more than 60 years, with rigorous monitoring of adverse events,” Clive said. “As a result, there is a substantial amount of epidemiological data which shows that MediNatura’s injection products have a superb safety profile.”

As far as I can see, none of the above-named products are supported by sound evidence. If you ask me, it is time that homeopaths understand what proofs of safety and efficacy amount to, that they stop confusing the public, and that they stop marketing illegal products.

People who use so-called alternative medicines (SCAM) tend to be more vaccine hesitant. One possible conclusion that can be drawn from this is that trusting SCAM results in people becoming more vaccine hesitant. An alternative possibility is that vaccine hesitancy and use of SCAM are both consequences of a distrust in conventional treatments. an International team of researchers conducted analyses designed to disentangle these two possibilities.

They measured vaccine hesitancy and SCAM use in a representative sample of Spanish residents (N = 5200). They also quantified their trust in three CCAM interventions;     

  1. acupuncture,
  2. reiki,
  3. homeopathy                                                                  

and in two conventional medical interventions:

  1. chemotherapy,
  2. antidepressants.

Vaccine hesitancy turned out to be strongly associated with (dis)trust in conventional medicine, and this relationship was particularly strong among SCAM users. In contrast, trust in SCAM was a relatively weak predictor of vaccine hesitancy, and the relationship was equally weak regardless of whether or not participants themselves had a history of using SCAM.

According to the authors of this paper, the implication for practitioners and policy makers is that SCAM is not necessarily a major obstacle to people’s willingness to vaccinate, and that the more proximal obstacle is people’s mistrust of conventional treatments.

This is an interesting study. Yet, it begs a few questions:

  1.  Is it possible to reliably establish trust in SCAM by asking about just 3 specific therapies?
  2. Is it possible to reliably establish trust in conventional medicine by asking about just 2 treatments?
  3. Why those therapies out of hundreds of options?
  4. Could it be that here are national differences (in other countries distrust in conventional medicine is not a strong determinant of SCAM use)?
  5. Is trust in SCAM and distrust in conventional medicine perhaps the common expression of an anti-science attitude or cultist tendencies?

For complete newcomers to this blog, I should preface this post with four statements of fact (evidence to support them can be found in numerous previous posts on this blog or in my book entirely dedicated to homeopathy):

  1. Homeopathic remedies are usually so highly diluted that they do not contain enough active molecules to have any effect whatsoever.
  2. The evidence from clinical trials fails to show that homeopathic remedies are more than placebos.
  3. Boiron is the world’s largest manufacturer of homeopathic remedies.
  4. Therapeutic claims made for homeopathic remedies are bogus.

_____________

BOIRON USA, seem to employ someone who does little else but tweet irresponsible advertisements that mislead and endanger the public. On 5/5/2020, for instance, I saw within a matter of just hours in my Twitter timeline dozens of advertisements by Boiron USA . I copied a few examples:

  • Oscillococcinum USA Clinical studies show that Oscillococcinum reduces the duration and severity of flu-like symptoms such as body aches, headache, fever, chills, and fatigue.*
  • Boiron USA Ignatia amara relieves a lump in throat, hypersensitivity or intolerance to light, noise, or smells, frequent sighing, difficulty breathing, spasms, & cramps related to stress. It may help those who feel moody or emotional from added #stress. Claim basis: bit.ly/2VaVt0o
  • Boiron USA Calendula officinalis (Garden marigold) offers more than its good looks. This flower has healing power! Calendula has been used for centuries as a healing and soothing substance for skin irritations like cuts, scrapes, chafing, minor burns and sunburn. bit.ly/2srZqPI

And here are four more from 6/5/2020:

  • #Homeopathic Sabina relieves profuse and painful periods with red blood clots and pain spreading to the tops of the thighs. Dosage: Dissolve 5 pellets under the tongue 4 times a day. Decrease frequency with improvement. Claim basis: bit.ly/2I1L3sN
  • Colocynthis 6C relieves abdominal & menstrual cramps improved by bending over, strong pressure and heat. Dosage: Dissolve 5 pellets under the tongue every 30 minutes. Decrease frequency with improvement. Claim basis: bit.ly/2oMa9RX
  • Caulophyllum thalictroides 30C relieves menstrual cramps occurring at the onset of periods, with scanty flow. Dosage: Dissolve 5 pellets under the tongue 4 times a day. Decrease frequency with improvement, Claim basis: bit.ly/2q7Ea2Q
  • #Homeopathic Cimicifuga racemosa 6C relieves cramps associated with #PMS and aggravated by cold and humidity. Dosage: Dissolve 5 pellets under the tongue twice a day. Decrease frequency with improvement. Claim basis: bit.ly/2Kj57Yk

(Please do click on the links for ‘claim basis’ and be surprised!)

As far as I can tell, Boiron USA have been doings this sort of thing incessantly since years. Why does someone not stop them? All of these advertisements make claims that are bogus, unethical, and potentially harmful for many consumers. How can this be legal? Should there not be some sort of consumer protection?

But perhaps there is something all of my US readers can do quite effortlessly: on their website, Boiron USA state that they are

committed to providing top-quality products to our customers. Subject to the Terms, Conditions and Limitations below, if within 30 days of purchase, you are not completely satisfied with our medicines for any reason, we’ll give you your money back.

To receive your refund, please send us the following items within 30 days of purchase at the address below:

    • Your name, address and telephone number
    • The original UPC from the Boiron product purchased
    • The original dated cashier register receipt with the purchase price circled

Boiron Information Center
Attn: Refunds
4 Campus Boulevard
Newtown Square, PA 19073

So, how about buying the preparations advertised and then insisting on a refund, if they did not achieve what was promised in their advertisement on Twitter? That might soon stop them misleading the public!

There are uncounted different forms of bogus so-called alternative medicines (SCAMs), and many have been discussed on this blog. What do I mean by ‘bogus’? A bogus SCAM is one, in my view, that is being promoted for conditions for which it does not demonstrably generate more good than harm.

Ten popular examples are:

  • alternative cancer ‘cures’,
  • applied kinesiology,
  • Bach Flower Remedies,
  • CEASE,
  • chiropractic,
  • detox treatments,
  • homeopathy,
  • osteopathy,
  • paranormal or energy healing techniques,
  • slimming aids.

These treatments are diverse in many ways: history, basic assumption, risks, etc. But they nevertheless tend to have certain features in common:

  1. Most SCAMs originate from the ideas developed by a single, often charismatic individual who proclaimed to have seen the light. Think of Gerson, Bach, Palmer, Hahnemann, Still.
  2. They are recommended by enthusiasts as a panacea, a ‘cure all’.
  3. They are heavily promoted by celebrities, hyped by the press and marketed via books or the Internet, but they are far less or not at all supported by published studies in the peer-reviewed medical literature.
  4. The clinical trials of SCAM that have been published are flimsy, lack independent replication, yet are celebrated by proponents as though they represent robust evidence.
  5. SCAMs target either the most desperately ill patients who understandably tend to cling to every straw they can find. Or they go for the ‘worried well’ who have nothing truly wrong with them and plenty of cash to waste.
  6. Proponents of SCAM use scientific-sounding terminology, while simultaneously displaying a profoundly anti-scientific attitude.
  7. Entrepreneurs of SCAM are efficient at selling false hope at excessive prices.
  8. SCAMs sometimes seem to work because many of the therapists are skilled at maximising the placebo-response.
  9. SCAM is awash with conspiracy theories, for instance, the notion that ‘the establishment’ is supressing SCAM. (If a SCAM ever showed real promise, it would rapidly scrutinised by researchers and, if effectiveness were confirmed, adopted by conventional medicine. The notion of an alternative cure for any disease is idiotic, because it presupposes that conventional healthcare professionals shun a potentially valuable treatment simply because it emerged from elsewhere.)
  10. Most SCAMs can do direct harm. For instance, oral treatments can be toxic or interact with prescription drugs. Or spinal manipulations can cause a stroke. Or acupuncture can cause a pneumothorax.
  11. SCAMs are dangerous even if they do not cause direct harm. There are many examples of people who died needlessly early because they used SCAM as an alternative to conventional medicine (Steve Jobs is a prominent example).
  12. Moreover, SCAMs cause harm by undermining the principles of EBM and, more importantly, by undermining rational thinking in our society.
  13. SCAM practitioners violate fundamental rules of medical ethics on a daily basis. One could even argue that the ethical practice of SCAM is rarely possible.

 

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