regulation
During the last few days, several journalists have asked me about ayahuasca. Apparently, Harry Windsor said in an interview that it changed his life! However, the family of a young woman who took her own life after using ayahuasca has joined campaigners condemning his comments. Others – including myself – claim that Harry is sending a worrying message talking about his ‘positive’ experience with ayahuasca, saying it ‘brought me a sense of relaxation, release, comfort, a lightness that I managed to hold on to for a period of time’.
So, what is ayahuasca?
This paper explains it quite well:
Ayahuasca is a hallucinogen brew traditionally used for ritual and therapeutic purposes in Northwestern Amazon. It is rich in the tryptamine hallucinogens dimethyltryptamine (DMT), which acts as a serotonin 5-HT2A agonist. This mechanism of action is similar to other compounds such as lysergic acid diethylamide (LSD) and psilocybin. The controlled use of LSD and psilocybin in experimental settings is associated with a low incidence of psychotic episodes, and population studies corroborate these findings. Both the controlled use of DMT in experimental settings and the use of ayahuasca in experimental and ritual settings are not usually associated with psychotic episodes, but little is known regarding ayahuasca or DMT use outside these controlled contexts. Thus, we performed a systematic review of the published case reports describing psychotic episodes associated with ayahuasca and DMT intake. We found three case series and two case reports describing psychotic episodes associated with ayahuasca intake, and three case reports describing psychotic episodes associated with DMT. Several reports describe subjects with a personal and possibly a family history of psychosis (including schizophrenia, schizophreniform disorders, psychotic mania, psychotic depression), nonpsychotic mania, or concomitant use of other drugs. However, some cases also described psychotic episodes in subjects without these previous characteristics. Overall, the incidence of such episodes appears to be rare in both the ritual and the recreational/noncontrolled settings. Performance of a psychiatric screening before administration of these drugs, and other hallucinogens, in controlled settings seems to significantly reduce the possibility of adverse reactions with psychotic symptomatology. Individuals with a personal or family history of any psychotic illness or nonpsychotic mania should avoid hallucinogen intake.
In other words, ayahuasca can lead to serious side effects. They include vomiting, diarrhea, paranoia, and panic. Ayahuasca can also interact with many medications, including antidepressants, psychiatric medications, drugs used to control Parkinson’s disease, cough medicines, weight loss medications, and more. Those with a history of psychiatric disorders, such as schizophrenia, should avoid ayahuasca because this could worsen their psychiatric symptoms. Additionally, taking ayahuasca can increase your heart rate and blood pressure, which may result in dangerous consequences for those who have a heart condition.
Thus ayahuasca is an interesting albeit dangerous herb (in most countries it is illegal to possess or consume it). Currently, it is clearly under-researched, which means we know very little about its potential benefits and even less about the harm it can do.
Considering this, one would think that any half-intelligent person with loads of influence would not promote or encourage its use – but, sadly, it seems that one would be mistaken.
Norbert Hofer is the former leader of the Austrian right-wing FPÖ party who almost became Austria’s President. Currently, he is the 3rd member of the National Council. Hofer is a man full of surprises; he stated, for instance, that the Quran was more dangerous than COVID-19 during a speech held at a 2020 campaign event. As a result, he was sued for hate-speech.
Hofer’s latest coup is not political but commercial: Hofer is launching his own dietary supplement on the market. It is called “Formula Fortuna” and contains:
- L-tryptophan; a Cochrane review concluded that “a large number of studies appear to address the research questions, but few are of sufficient quality to be reliable. Available evidence does suggest these substances are better than placebo at alleviating depression. Further studies are needed to evaluate the efficacy and safety of 5‐HTP and tryptophan before their widespread use can be recommended. The possible association between these substances and the potentially fatal Eosinophilia‐Myalgia Syndrome has not been elucidated. Because alternative antidepressants exist which have been proven to be effective and safe the clinical usefulness of 5‐HTP and tryptophan is limited at present.”
- Hydroxypropylmethylcellulose, a common delivery system.
- Rhodiola rosea extracts; human studies evaluating R. rosea did not have sufficient quality to determine whether it has properties affecting fatigue or any other condition.The U.S. Food and Drug Administration (FDA) has issued warning letters to manufacturers of R. rosea dietary supplement products unapproved as new drugs, adulterated, misbranded and in federal violation for not having proof of safety or efficacy for the advertised conditions of alleviating Raynaud syndrome, altitude sickness, depression or cancer.
- Ginseng root extract. Although ginseng has been used in traditional medicine for centuries, modern research is inconclusive about its biological effects. Preliminary clinical research indicates possible effects on memory, fatigue, menopause symptoms, and insulin response in people with mild diabetes. Out of 44 studies examined between 2005–2015, 29 showed positive, limited evidence, and 15 showed no effects. As of 2021, there is insufficient evidence to indicate that ginseng has any health effects. A 2021 review indicated that ginseng had “only trivial effects on erectile function or satisfaction with intercourse compared to placebo”. The constituents include steroid saponins known as ginsenosides, but the effects of these ginseng compounds have not been studied with high-quality clinical research as of 2021, and therefore remain unknown. As of 2019, the United States FDA and Federal Trade Commission have issued numerous warning letters to manufacturers of ginseng dietary supplements for making false claims of health or anti-disease benefits, stating that the “products are not generally recognized as safe and effective for the referenced uses” and are illegal as unauthorized “new drugs” under federal law. Concerns exist when ginseng is used chronically, potentially causing side effects such as headaches, insomnia, and digestive problems. Ginseng may have adverse effects when used with the blood thinner warfarin. Ginseng also has adverse drug reactions with phenelzine, and a potential interaction has been reported with imatinib, resulting in hepatotoxicity, and with lamotrigine. Other side effects may include anxiety, insomnia, fluctuations in blood pressure, breast pain, vaginal bleeding, nausea, or diarrhea.
- Zinc gluconate which has been used in lozenges for treating the common cold. However, controlled trials with lozenges which include zinc acetate have found it has the greatest effect on the duration of coldsInstances of anosmia (loss of smell) have been reported with intranasal use of some products containing zinc gluconate. In September 2003, Zicam faced lawsuits from users who claimed that the product, a nasal gel containing zinc gluconate and several inactive ingredients, negatively affected their sense of smell and sometimes taste. Some plaintiffs alleged experiencing a strong and very painful burning sensation when they used the product. Matrixx Initiatives, Inc., the maker of Zicam, responded that only a small number of people had experienced problems and that anosmia can be caused by the common cold itself. In January 2006, 340 lawsuits were settled for $12 million.
- Pyridoxine hydrochloride (vitamin B6) is usually well tolerated, though overdose toxicity is possible. Occasionally side effects include headache, numbness, and sleepiness. Pyridoxine overdose can cause a peripheral sensory neuropathy characterized by poor coordination, numbness, and decreased sensation to touch, temperature, and vibration.
‘Formula Fortuna’ allegedly is for lifting your mood. If I, however, tell you that you need to pay one Euro per day for the supplement, your mood might even change in the opposite direction.
What next?
I think I might design a dietary supplement against stupidity. It will not carry any of the risks of Hofer’s new invention but, I am afraid, it might be just as ineffective as Hofer’s ‘Formual Fortuna’.
I recently came across this editorial from the NEJM. I find it extremely relevant to the many discussions we have about so-called alternative medicine (SCAM) we have on this blog. I, therefore, take the liberty to copy a small section of it here without further comment, and encourage everyone to read the full paper:
…expertise and authority are increasingly seen as means for elites to establish and support existing hierarchies. There is, of course, some substance to this argument: although orthodox doctors may believe that their dominance and privilege are attributable to the rigor of the methods they use and that other schools of medicine were vanquished because of the superior results achieved by science-based practice, another version of the story sees the suppression of other approaches to healing (e.g., naturopathy, homeopathy, or chiropractic) as the result of ruthless actions by the American Medical Association and other forms of organized medicine. These critiques aren’t new; as Lewis Grossman writes in Choose Your Medicine, “medical freedom” arguments have long been used to oppose institutions intended to protect consumers, such as medical licensure and the FDA.3 The difference today is that the antiexpertise perspective has moved into the mainstream. With Google and Amazon having created a world in which people can frictionlessly obtain both information and nearly any product they want, it’s not hard to portray expert gatekeepers as barriers to patients’ ability to exercise choice.
Perhaps the most substantial threat to expertise is that members of the public are coming to believe that facts don’t exist — that all facts are political and therefore a matter of opinion. This mindset is fundamentally incompatible with the scientific practice of medicine, which depends on a shared commitment to backing up hypotheses with empirical evidence. Indeed, modern medicine owes much of its privileged position to a broad acceptance that the methods it uses can be relied on to make medical choices that are likely to do more good than harm.
A 1902 Supreme Court case, American School of Magnetic Healing v. McAnnulty, offers an instructive example of what could happen if all medical facts were seen as purely matters of opinion. The American School of Magnetic Healing in Nevada, Missouri, received 3000 pieces of mail every day, largely consisting of checks, money orders, and cash to purchase the healing services that the school advertised in newspapers throughout the United States. Patients who sent payments were instructed to lie down at a specified time wherever they were, and the healers at the magnetic school would, from Nevada, channel the healing energy of the universe into their bodies to heal them.3 The Post Office Department (which predated the Postal Service) concluded that this practice was a fraudulent operation using the mail and, after a hearing conducted by the postmaster general, stopped delivering mail to the school. The school sued, and the case went to the Supreme Court, which found in its favor.
Writing for the Court, Justice Rufus Peckham essentially rejected the existence of medical facts. “Just exactly to what extent the mental condition affects the body,” he wrote, “no one can accurately and definitely say.… Because the [school] might or did claim to be able to effect cures by reason of working upon and affecting the mental powers of the individual… who can say that it is a fraud?… Those who might deny the existence or virtue of the remedy would only differ in opinion from those who assert it. There is no exact standard of absolute truth by which to prove the assertion false and a fraud.”4 Although this decision was never expressly overruled, both Congress and the courts have since rejected the premise that the efficacy of treatments is purely a matter of opinion.
Differences of opinion within medicine are necessary for progress, and both licensing and certifying boards must therefore be careful to leave room for the expression of divergent views. Moreover, there is ongoing debate regarding the extent to which free-speech protections cover professional speech. But despite the existence of divergent views and areas for legitimate debate, there are some opinions that have been so thoroughly repudiated by existing evidence as to be considered definitively wrong.5 Constructive debates are possible only within a shared epistemic framework and with a commitment to the idea of verifiable facts. It’s incumbent on licensing and certifying boards to defend the existence of facts and to give the public a way to know when practitioners are making claims that are incompatible with reality.
When it comes to disciplining doctors, boards haven’t always lived up to public expectations — but that’s not a reason they should fall short yet again, especially during a lethal pandemic. Although there are many gray areas in medicine, some propositions are objectively wrong. For example, when a licensed physician insists that viruses don’t cause disease or that Covid-19 vaccines magnetize people or connect them to cell towers, professional bodies must be able to take action in support of fact- and evidence-based practice.
The public relies on the medical profession in times of grievous vulnerability and need. For the profession to earn and maintain the public’s trust — along with the privileges associated with the status of being licensed practitioners — medical boards must be able to differentiate practitioners who are providing fact-based advice from those who are not.
Guest post by Hans-Werner Bertelsen
As a self-confessed Asterix fan, I made a proposal to the Bremen Medical Association in 2019 that it should no longer orient itself towards the mainstream in the area of further training, but rather towards Klein-Bonum. The board found my proposal very good and unanimously deleted “homeopathy” from the postgraduate training regulations at the next board meeting. The media echo was tremendous. Words of “dam bursting” and “revolution” did the rounds. The “domino effect” was also often quoted in this context, because in the following years, many other German state medical associations followed the Bremen example and removed “homeopathy” from their further training regulations: Saxony-Anhalt, North Rhine, Schleswig-Holstein, Baden-Württemberg, Hamburg, Hesse, Brandenburg, Berlin, Mecklenburg-Western Pomerania, Lower Saxony, Saarland, and Bavaria.
Following the principle of logical plausibility, according to which it makes no sense to support dubious therapies that are not in one’s own training portfolio, but are still reimbursed by many health insurance funds, by convenient billing modalities, the Association of Statutory Health Insurance Physicians Bremen (KVHB) drew a line under the matter and terminated corresponding contracts on my advice. With the termination of the criticized selective contracts, the small federal state of Bremen thus set new standards in 2021. Since the termination, doctors can no longer conveniently provide “homeopathic services” online but have to bill their patients for their services.
But that was not all: the drumbeat of terminated billing contracts had not yet died down in the ears of the “homeopaths”, when only 3 months later, at the meeting of the Federal Medical Association, the next one followed: After a delegate from Bremen (do you want to know if this was a coincidence?) had submitted a motion for the deletion of “homeopathy” from the Model Continuing Medical Education Ordinance (MWBO), this was carried out after a democratic vote at the medical congress in Bremen. The Federal Medical Association thus officially declares this type of sham therapy to be no longer up-to-date, dispensable, and unworthy of further training.
In view of the vote democratically given by the Board, it seems bizarre that the Bavarian Medical Association, despite its own decision to remove “homeopathy” from the WBO, now invokes prolongations because of “transitional periods” in order to be able to continue offering courses in “homeopathy”. Contracts in this regard are to be considered secondary and no longer current. Therefore, the justification given by the ÄND proves to be flimsy and not stringent. The protection of patients from dangerous sham therapies in the case of the omission of indication-appropriate therapies saves lives and thus clearly represents the higher legal interest. Calls for “transitional periods” are redundant and negligently endanger the health of many people. On top of that, an unnecessary extension is a disrespect to the decision made by its own members in the democratic process.
But I remain optimistic that logical plausibility – free of backlogs (!) – will prevail in Bavaria as well. The vote has proven that there is a majority for this and that this majority will not be dominated by money or self-deception.
References
https://www.dr-bertelsen.de/documents/Screenshot_2023-02-10_at_11-36-05_Warum_eine_Aerztekammer_noch_immer_Homoeopathie-Kurse_anbietet-AEND.png
https://publikum.net/die-konigl-bayerische-zuckerkugel/
Chiropractors are famous for being against COVID vaccinations and other protective measures. This recent case is an apt example.
It has been reported that the tribunal of Alberta’s regulatory body for chiropractors has ruled against Calgary chiropractor, Curtis Wall, for not wearing a mask during the pandemic. The College of Chiropractors of Alberta (CCA) sought to discipline Wall for not wearing a mask at his clinic, not observing two meters of social distancing while unmasked, not installing a plexiglass barrier in his reception area, and not requiring patients to be masked either, beginning around June 2020. In a statement issued Feb. 1, 2023, the CCA’s hearing tribunal wrote: “[T]he Hearing Tribunal has found Dr. Curtis Wall’s conduct does constitute ‘unprofessional conduct’ and their decision for penalty is forthcoming.”
Lawyer James Kitchen who represented Wall, railed against the ruling: “[T]he decision is riddled with errors of fact and law and is so poorly decided it is an embarrassment to the chiropractic profession. It is shocking the lengths the tribunal went to dismiss the evidence of Dr. Wall, three of his patients, and his four expert witnesses while blithely accepting all the evidence of the College…The decision is an egregious manifestation of pre-determined, results-oriented decision-making.”
In an interview, Kitchen said: “I set this whole case up knowing that the tribunal would likely do whatever the college and the college’s expert told him to do. I set the case up such that if the tribunal did that, they would have to make themselves look very foolish to do so. If I’m really putting my cynical hat on, I don’t know if there’s anything that surprises me, really. It should shock me the degree to which they twisted the evidence, left out the evidence. The only thing that surprises me a little bit is the lack of effort they put in to hide their bias.”
The communications manager of the CCA, Dana Myckan, commented: “Pursuant to the Health Professions Act, all Hearing Tribunal decisions are posted publicly on the CCA website. This is the extent of the information that the CCA can share on behalf of the Hearing Tribunal.”
The ruling noted that Wall initially wore a mask, but in June 2020, he “self-diagnosed as having an anxiety disorder. He believed that his self-diagnosis qualified him for a medical exemption from wearing a mask. As a result, he stopped wearing a mask when treating patients.” It added that Wall never contacted the college to let it know his condition or request an exemption, and said Wall’s son also worked at the clinic and did not wear a mask.
Kitchen said Wall could face a suspension of his practice but will appeal this ruling or any attempt to make him pay the CCA’s legal costs, which the college stated during the hearings were in excess of $200,000. Kitchen said a recent court precedent suggests the CCA will be unable to recoup costs in a ruling.
An appeal would be heard by the council of the college, which is the college’s governing body. It consists of five chiropractors elected by their peers along with five members of the public appointed by the government. Should Wall lose there, he could take his case to the Alberta Court of Appeal. Kitchen said Wall will go the distance. “I warned them that this is how I expected it to go. So he was prepared,” Kitchen said. “He’s still pretty dismayed that people could have this much evidence staring them in the face and just ignore it and follow the narrative. It’s hard for him. He’s an idealist. He’s really big on truth and people doing what’s right.”
________________________
To all of this, I have but two questions:
- Is the CCA not also guilty of professional misconduct for calling Wall “Dr. Wall” without making it clear that he is not medically trained?
- If Wall is “big on truth”, how come he works as a chiropractor?
The All-Party Parliamentary Group (APPG) on Beauty and Wellbeing, UK, has undertaken an investigation into the ‘complementary therapies sector’, to consider how the sector can support everyone’s physical health, mental health, and well-being and take pressure off the NHS. In their recent document, they state:
The complementary therapies industry is an integral part of the Personal Care sector, which includes beauty, wellbeing, and alternative therapies. These therapies can be key to supporting everyone’s health and mental wellbeing…
To ensure complementary therapies can adequately support the NHS, we need to attract more talent into the sector and ensure all therapists receive the right training to become highly skilled professionals.
We also need to enhance the perception of the professionalism within the sector, so that it is no longer seen as ‘frivolous and fluffy’ and non-essential. Building awareness and understanding of its value in supporting our nation’s health is one step. However, it also important to crack down on any bad practice and the ‘underground market’ of poor treatment…
The committee makes the following recommendations:
1. The Government must work with NHS England to better promote the benefits of social prescribing with GPs, nurses and other health and care professionals, and how they can refer people to non-clinical complementary therapy services.
2. The Personal Care sector team in the Department for Business, Energy, Industry and Strategy must work with officials within the Department for Health and Social Care responsible for social prescribing to better integrate complementary therapy services into the NHS, and produce guidance to support health professionals and therapists in doing so.
3. The Department for Health and Social Care must undertake or fund research studies to demonstrate the value of integrating complementary therapy services into the NHS through social prescribing.
4. The Department for Education must revisit the gap between the apprentice wage and minimum wage for apprentices aged 19+, and provide financial incentives for employers to take on learners on any ‘job ready ‘qualification.
5. The Government must give Environmental health officers (EHOs) greater powers to act quickly to deal with bad practice and lead a crack-down on tax evading businesses that are driving down prices and undermining legitimate businesses under pressure.
…
…
…
Conclusions
The evidence that we have received during this investigation clearly demonstrate that greater support
and recognition is needed for the complementary therapies sector to ensure that they are able support
everyone’s physical health, mental health and wellbeing and take pressure off the NHS.
We hope the Government will review our recommendations in order to support the complementary
therapies sector and ensure they have adequate funding and acknowledgement.
In case you are wondering what therapies they refer to, here is their complete list of the treatments (including links to what they seem to think about them):
This could have made me laugh, had it not been so serious. The committee is composed of MPs who might be full of goodwill. Yet, they seem utterly clueless regarding the ‘complementary therapies sector’. For instance, they seem to be unaware of the evidence for some of the treatments they want to promote, e.g. craniosacral therapy, aromatherapy, Reiki, shiatsu, energy healing, or reflexology (which is far less positive than they seem to assume); and they aim at enhancing the “perception of the professionalism” instead of improving the PROFESSIONALISM of the therapists (which obviously would include adherence to evidence-based practice). And perhaps the committee might have given some thought to the question of whether it is ethical to push dubious therapies onto the unsuspecting public.
I could go on, but the perplexing wooliness of the document speaks for itself, I think.
And in case you are wondering who the MP members of the committee are, here is the list of its members:
• Carolyn Harris MP – Co-Chair
• Judith Cummins MP – Co-Chair
• Jessica Morden MP – Vice-Chair
• Jackie Doyle-Price MP – Vice-Chair
• Peter Dowd MP – Treasurer
• Nick Smith MP – Secretary
• Caroline Nokes MP – Member
• Sarah Champion MP – Member
• Alex Davies-Jones MP – Member
• Kate Osamor MP – Member
• John McNally MP – Member
• Kevan Jones MP – Member
• Gagan Mohindra MP- Member
The Secretariat for this APPG is Dentons Global Advisors with support from the National Hair and Beauty Federation, the Federation of Holistic Therapists and spabreaks.com.
PS
Two hours after having posted this, I begin to feel bad about being so dismissive. Let me thus try to do something constructive: I herewith offer to give one or more lectures to the committee about the evidence as it pertains to the therapies they included in their report.
Drip IV is “Australia’s first and leading mobile healthcare company specialising in assisting with nutritional deficiencies”. They claim to provide a mobile IV service that is prescribed and tailored individually to your nutritional needs. Treatment plans and customised infusions are determined by a medical team to suit individual requirements. They deliver vitamins, minerals and amino acids directly to the body via the bloodstream, a method they state allows for optimal bioavailability.
These claims are a little puzzling to me, not least because vitamins, minerals and amino acids tailored individually to the nutritional needs of the vast majority of people would mean administering nothing at all. But I guess that virtually every person who consults the service will get an infusion [and pay dearly for it].
The Australian Therapeutic Goods Administration (TGA) seems to have a similarly dim view on Drip IV. The TGA has just issued 20 infringement notices totalling $159,840 to the company and to one of its executive officers. The reason: unlawful advertising of intravenous infusion products to Australian consumers on a company website and social media. Ten notices totalling $133,200 were issued to the company and ten notices totalling $26,640 were issued to an executive officer. The TGA considers the intravenous infusion products to be therapeutic goods because of the claims made about them, and the advertising to be unlawful because the advertisements allegedly:
- contained prohibited representations, such as claims regarding cancer.
- contained restricted representations such as that the products would alleviate fatigue caused by COVID-19, assist in the treatment of Graves’ Disease and Alzheimer’s Disease, and support the treatment of autoimmune diseases such as Multiple Sclerosis. No TGA approval had been given to make such claims.
- referred to ingredients that are prescription only, such as glutathione. Prescription medicines cannot be advertised directly to the public in Australia.
- contained a statement or picture suggesting or implying the products were ‘TGA Approved’. Advertising of therapeutic goods cannot include a government endorsement.
- contained a statement or picture expressing that the goods were ‘miraculous’.
Vitamin infusions have become very popular around the globe. There are now thousands of clinics offering this service, and many of them advertise aggressively with claims that are questionable. Here is just one example from the UK:
Modern life is hectic. If you are looking to boost your wellbeing, increase your energy levels, lift your mood and hydrate your body, Vitamin IV Infusions are ideal. Favoured by celebrities such as Madonna, Simon Cowell and Rihanna, Vitamin IV Infusions are an easy, effective way of delivering vitamins, minerals and amino acids directly into your bloodstream via an IV (intravenous) drip. Vitamins are essential for normal growth and staying healthy – but our bodies can’t produce all of the nutrients we need to function and thrive. That’s why more than one in three people take daily vitamin supplements – often without realising that only 15% of the active nutrients consumed orally actually find their way into their bloodstream. With Vitamin IV Infusions, the nutrients enter your bloodstream directly and immediately, and are delivered straight to your cells. We offer four different Vitamin IV Infusions, so you can choose the best combination for your personal needs, while boosting your general health, energy and wellbeing.
My advice to consumers is a little different and considerably less costly:
- to ensure you get enough vitamins, minerals, and amino acids, eat a balanced diet;
- to boost your well-being, sit down and calculate the savings you made by NOT using such a service;
- to increase your energy levels, take a nap;
- to lift your mood, recount the money you saved and think of what nice things you might buy with it;
- to hydrate your body drink a glass of water.
Perhaps it is time the authorities in all countries had a look at what these clinics are offering and what health claims they are making. Perhaps it is time they act as the TGA just did.
It has been reported that a German consumer association, the ‘Verbraucherzentrale NRW’, has first cautioned the manufacturer MEDICE Arzneimittel Pütter GmbH & Co. and then sued them for misleading advertising statements. The advertisement in question gave the wrong impression that their homeopathic remedy MEDITONSIN would:
- for certain generate a health improvement,
- have no side effects,
- be superior to “chemical-synthetic drugs”.
The study used by the manufacturer in support of such claims was not convincing according to the Regional Court of Dortmund. The results of a “large-scale study with more than 1,000 patients” presented a pie chart indicating that 90% of the patients were satisfied or very satisfied with the effect of Meditonsin. However, this was only based on a “pharmacy-based observational study” with little scientific validity, as pointed out by the consumer association. Despite the lack of evidence, the manufacturer claimed that their study “once again impressively confirms the good efficacy and tolerability of Meditonsin® Drops”. The Regional Court of Dortmund disagreed with the manufacturer and agreed with the reasoning of the consumer association.
“It is not permitted to advertise with statements that give the false impression that a successful treatment can be expected with certainty, as suggested by the advertising for Meditonsin Drops,” emphasizes Gesa Schölgens, head of “Faktencheck Gesundheitswerbung,” a joint project of the consumer centers of North Rhine-Westphalia and Rhineland-Palatinate. According to German law, this is prohibited. In addition, the Regional Court of Dortmund considered consumers to be misled by the advertising because the false impression was created that no harmful side effects are to be expected when Meditonsin Drops are taken. The package insert of the drug lists several side effects, according to which there could even be an initial worsening of symptoms after taking the drug.
The claim of advantages of the “natural remedy” represented by the manufacturer in comparison with “chemical-synthetic medicaments, which merely suppress the symptoms”, was also deemed to be inadmissible. Such comparative advertising is inadmissible.
__________________________________
This ruling is, I think, interesting in several ways. The marketing claims of so-called alternative medicine (SCAM) products seem all too often not within the limits of the laws. One can therefore hope that this case might inspire many more legal cases against the inadmissible advertising of SCAMs.
Osteopathy is currently regulated in 12 European countries: Cyprus, Denmark, Finland, France, Iceland, Italy, Liechtenstein, Luxembourg, Malta, Portugal, Switzerland, and the UK. Other countries such as Belgium and Norway have not fully regulated it. In Austria, osteopathy is not recognized or regulated. The Osteopathic Practitioners Estimates and RAtes (OPERA) project was developed as a Europe-based survey, whereby an updated profile of osteopaths not only provides new data for Austria but also allows comparisons with other European countries.
A voluntary, online-based, closed-ended survey was distributed across Austria in the period between April and August 2020. The original English OPERA questionnaire, composed of 52 questions in seven sections, was translated into German and adapted to the Austrian situation. Recruitment was performed through social media and an e-based campaign.
The survey was completed by 338 individuals (response rate ~26%), of which 239 (71%) were female. The median age of the responders was 40–49 years. Almost all had preliminary healthcare training, mainly in physiotherapy (72%). The majority of respondents were self-employed (88%) and working as sole practitioners (54%). The median number of consultations per week was 21–25 and the majority of respondents scheduled 46–60 minutes for each consultation (69%).
The most commonly used diagnostic techniques were: palpation of position/structure, palpation of tenderness, and visual inspection. The most commonly used treatment techniques were cranial, visceral, and articulatory/mobilization techniques. The majority of patients estimated by respondents consulted an osteopath for musculoskeletal complaints mainly localized in the lumbar and cervical region. Although the majority of respondents experienced a strong osteopathic identity, only a small proportion (17%) advertise themselves exclusively as osteopaths.
The authors concluded that this study represents the first published document to determine the characteristics of the osteopathic practitioners in Austria using large, national data. It provides new information on where, how, and by whom osteopathic care is delivered. The information provided may contribute to the evidence used by stakeholders and policy makers for the future regulation of the profession in Austria.
This paper reveals several findings that are, I think, noteworthy:
- Visceral osteopathy was used often or very often by 84% of the osteopaths.
- Muscle energy techniques were used often or very often by 53% of the osteopaths.
- Techniques applied to the breasts were used by 59% of the osteopaths.
- Vaginal techniques were used by 49% of the osteopaths.
- Rectal techniques were used by 39% of the osteopaths.
- “Taping/kinesiology tape” was used by 40% of osteopaths.
- Applied kinesiology was used by 17% of osteopaths and was by far the most-used diagnostic approach.
Perhaps the most worrying finding of the entire paper is summarized in this sentence: “Informed consent for oral techniques was requested only by 10.4% of respondents, and for genital and rectal techniques by 21.0% and 18.3% respectively.”
I am lost for words!
I fail to understand what meaningful medical purpose the fingers of an osteopath are supposed to have in a patient’s vagina or rectum. Surely, putting them there is a gross violation of medical ethics.
Considering these points, I find it impossible not to conclude that far too many Austrian osteopaths practice treatments that are implausible, unproven, potentially harmful, unethical, and illegal. If patients had the courage to take action, many of these charlatans would probably spend some time in jail.
I know, I have often posted nasty things about integrative medicine and those who promote it. Today, I want to make good for all my sins and look at the bright side.
Imagine you are a person convinced of the good that comes from so-called alternative medicine (SCAM). Imagine you believe it has stood the test of time, is natural, holistic, tackles the root problems of illness, etc., etc. Imagine you are such a person.
Your convictions made you support more research into SCAM because you feel that evidence is needed for it to be more generally accepted. So, you are keen to see more studies proving the efficacy of this or that SCAM in the management of this or that condition.
This, unfortunately, is where the problems start.
Not only is there not a lot of money and even fewer scientists to do this research, but the amount of studies that would need doing is monstrously big:
- There are hundreds of different types of SCAM.
- Each SCAM is advocated for hundreds of conditions.
Consequently, tens of thousands of studies are needed to only have one trial for each specific research question. This is tough for a SCAM enthusiast! It means he/she has to wait decades to see the light at the end of the tunnel.
But then it gets worse – much worse!
As the results of these studies come in, one after the other, you realize that most of them are not at all what you have been counting on. Many can be criticized for being of dismal quality and therefore inconclusive, and those that are rigorous tend to be negative.
Bloody hell! There you have been waiting patiently for decades and now you must realize that this wait did not take you anywhere near the goal that was so clear in your sight. Most reasonable people would give up at this stage; they would conclude that SCAM is a pipedream and direct their attention to something else. But not you! You are single-minded and convinced that SCAM is the future. Some people might even call you obsessed – obsessed and desperate.
It is out of this sense of desperation that the idea of integrative medicine was born. It is a brilliant coup that solves most of the insurmountable problems outlined above. All you need to do is to take the few positive findings that did emerge from the previous decades of research, find a political platform, and loudly proclaim:
SCAM does work.
Consumers like SCAM.
SCAM must be made available to all.
Consumers deserve the best of both worlds.
The future of healthcare evidently lies in integrated medicine.
Forgotten are all those irritating questions about the efficacy of this or that treatment. Now, it’s all about the big issue of wholesale integration of SCAM. Forgotten is the need for evidence – after all, we had decades of that! – now, the issue is no longer scientific, it is political.
And if anyone has the audacity to ask about evidence, he/she can be branded as a boring nit-picker. And if anyone doubts the value of integrated medicine, he/she will be identified as a politically incorrect dinosaur.
Mission accomplished!
