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

progress

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… Many proponents of so-called alternative medicine (SCAM) are keen to point out that, while mainstream medicine may be good at treatment of diseases, particularly acute conditions, SCAM’s forte lies in the prevention of disease. Patients seem to have intuitively accepted this notion; a recent survey suggest that more than 50% of those Americans who use SCAM do so not to treat ailments but to remain healthy, i.e. to prevent disease and illness. If one looks closer at the evidence for or against SCAM’s role in disease prevention, one is stunned by the contrast of firmly held beliefs and the lack of reliable evidence to support them…

… Unfortunately the subject is more complex than normally appreciated within SCAM. Until we have convincing data, it is not possible to state with confidence that a given form of SCAM is effective in preventing a given condition. It follows

  1. that we now should prepare to carry out the much needed (but difficult) research related
    to preventative,
  2. that we should be cautious and abstain from overstating the largely unproven role of SCAM in the prevention of disease and illness.

These lines were written by me and published exactly 20 years ago. As far as I can see, very little has changed since.

  • SCAM providers continue to make big claims about disease prevention.
  • Many consumers continue to believe them.
  • And the evidence continues to be absent or flimsy.

It follows, I fear, that charlatans who advocate their SCAM as a means to prevent disease are dishonestly defrauding the public.

I do hope that someone disagrees with me and shows me the evidence proving me wrong!

The World Federation of Chiropractic, Strategic Plan 2019-2022 has just been published. It is an odd document that holds many surprises. Sadly, none of them are positive.

As the efficacy and safety of chiropractic spinal manipulations, the hallmark treatment that close to 100% of all chiropractic patients receive, are more than a little doubtful, one would expect that such a strategy would focus on the promotion of rigorous clinical research to create more certainty in these two important areas. If you are like me and were hoping for a firm commitment to such activities, you will be harshly disappointed.

Already in the introduction, the WFC sets an entirely different agenda:

We believe that everyone deserves access to chiropractic. We believe in chiropractors being accessible throughout the world. We believe that societies can thrive where chiropractors are available as a part of people’s health care teams.

If you are not put off by such self-serving, nauseous nonsense and read on, you find what the WFC call the ‘FOUR STRATEGIC PILLARS’

  1. SUPPORT
  2. EMPOWERMENT
  3. PROMOTION
  4. ADVANCEMENT

The text supporting the first three pillars consists of insufferable platitudes, and I will therefore not burden you with it. But the title of No4 did raise my hopes of finding something along the lines of an advancement of the evidence-base of chiropractic. Sadly, this turned out to be over-optimistic. Here is the 4th pillar in its full beauty:

Advancing the chiropractic profession together under the banner of evidence-based, people-centered, interprofessional and collaborative care.

Around the world health is delivered according to prevailing societal, cultural and political factors. These social determinants mean that chiropractors must adapt to the environment in which they practice.

As a global federation we must continuously strive to advance awareness of chiropractic under a banner of ethical, evidence-based, people-centered care.

Through consensus-building, shared understanding and respectful dialogue with partners in the health system, chiropractic should become a valued partner in contributing enhanced population health.

Throughout our 7 world regions, we must advance public utilization of chiropractors to optimize the health of nations.

Through the identification of common values and a commitment to patient-centered care, we can advance the identity of chiropractors as spinal health care experts in the health care system.

The WFC will:

– Advance awareness of chiropractic among the general public, within health systems and among health professionals.

– Advance access to chiropractors for all people and broaden the integration of chiropractic services

– Advance interprofessional collaboration and the integration of chiropractic into health systems

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END OF QUOTE

The essence of the WFC strategy for the next 3 years thus seems to be as follows:

  1. Avoid any discussion about the lack of evidence of chiropractic.
  2. Promote chiropractic to the unsuspecting public at all cost.
  3. Make sure chiropractors’ cash flow is healthy.

There are some commentators on this blog who regularly try to make us believe that chiropractic is about to reform, leave obsolete concepts behind, and become a respectable, ethical and evidence-based healthcare profession. After reading the appalling drivel the WFC call their ‘strategic plan’, I am not optimistic that they are correct.

As reported on this blog, the Spanish minister of health want to change the EU law that governs homeopathy. Now the INH has taken action in support of this idea:

THE COMMENT

… the Spanish government … no longer wants to accept the medicinal status of homeopathy, wants to ban homeopathy from pharmacies and has already “discontinued” the first batch of homoeopathics which could not present a valid proof of efficacy upon request. England is currently performing a complete “blacklisting”, i.e. a process that means the end of any registration for homeopathic medication with a drug authority.

The EU Medicines Directive does not regulate in detail how exactly the member states deal with homeopathy in health care. However, it does fix two key points: It includes homeopathy in its definition of a medical drug and obliges the states to regulate a simplified registration procedure for homeopathy instead of the usual drug approval. If one seriously wants to dispute the status of homeopathic medicinal products (and thus their privileges), one cannot completely ignore EU law.

Spain knows that. At various levels (including that of the government), there are efforts to achieve a revision of the EU directive on medicinal products in the field of homeopathy. These efforts need support. The INH has therefore addressed the following letter to German MEPs, which is initially intended to provide basic information on the facts of the case and support Spain’s position in the expected discussion. This seems all the more necessary as the European homeopathic manufacturers and associations have for a long time maintained a lobby organisation directly in Brussels, which apparently has quite good material and personnel resources and whose task is to exert direct influence “on the spot”. We do not have such resources, but we do have the facts. And who knows – perhaps one or the other national government will even join Spain and become active in the EU?

_________________________________________________________________

THE LETTER TO ALL GERMAN MEPs

7 August 2019

Homeopathy in the EU Medicines Directive

Dear Madam / Sir,

The European Medicines Directive (Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use,  Official Journal of the European Community L 311, 28.11.2001) classifies homeopathic preparations as medicinal products and requires national governments to establish a simplified registration procedure outside the otherwise prescribed rules for marketing authorisation for pharmaceutical remedies.

However, the consensus of the worldwide scientific community has long since classified homeopathy as a specifically ineffective sham therapy, the spread and “popularity” of which have completely different bases than those of medical relevance (evidence). In many countries, this insight is now gaining acceptance. It will be in the well-understood interest of the public’s health to take consequences of this. The misguiding of the public that homeopathy is a form of therapy expressly recognised by the legislator and therefore endowed with the credit of efficacy and harmlessness may not be continued.

In this respect, the Kingdom of Spain is already campaigning for an amendment to European pharmaceutical law, which not only grants homeopathic preparations the status of medicinal products by definition, but also grants them the additional privilege of registration (see also http://www.europarl.europa.eu/doceo/document/E-8-2018-004948-ASW_EN.html). This special legal framework has no objective justification, as the EASAC – as official advisor to the EU institutions – clearly stated in its statement of 20.09.2017 (https://easac.eu/publications/details/homeopathic-products-and-practices/).

In the interest of a science-based, honest and patient-oriented health policy, also on behalf of the German Consumer Association e.V. and its regional associations, we ask you to support a revision of the Medicines Directive in the sense described, in order to clear the way for appropriate national regulations under Community law.

You can inform yourself about the scientific status of homeopathy on the (multilingual) website of our association: www.network-homeopathy.info .

Yours sincerely

For the  Information Network Homeopathy

Dr. Natalie Grams – Dr. Ing. Norbert Aust – Dr. Christian Lübbers

__________________________________________________________________

IF YOU FEEL LIKE SUPPORTING THIS INITIALIVE, PLEASE WRITE TO YOUR MEP.

Facebook and YouTube have in the past been Eldorados for quacks who used it to promote their nonsensical products, false messages, and bogus treatments. A recent article in the Washington Post explained that this might be about to change.

Hundreds of thousands of enthusiasts of so-called alternative medicine (SCAM) persuade each other on Facebook that baking soda, apple cider vinegar, frankincense, apricot kernels, tiger bones, Essiac, bleach, homeopathics, Bach flower remedies etc. are cures that doctors don’t want you to know about. But recently Facebook announced that it is taking steps to limit the reach of false and sometimes dangerous therapeutic claims by treating them similar to clickbait or spam.

Facebook will “down-rank” posts that contain certain types of health misinformation, meaning those posts will appear in the news feeds of fewer users, and less prominently. The down-ranking process will use keywords and phrases that commonly appear in posts containing exaggerated or false health claims, but tend to be absent in posts containing accurate information on the same topics. Facebook’s News Feed algorithms will use those suspicious phrases, which the company has identified with the help of health-care professionals, to predict which posts might contain sensational health claims.

“Misleading health content is particularly bad for our community,” Travis Yeh, a Facebook product manager, wrote in a blog post. “So, last month we made two ranking updates to reduce (1) posts with exaggerated or sensational health claims and (2) posts attempting to sell products or services based on health-related claims.”

In a media statement, YouTube said: “Misinformation is a difficult challenge and any misinformation on medical topics is especially concerning … We’ve taken a number of steps to address this, including surfacing more authoritative content across our site. Our systems are not perfect, but we’ve seen progress within this space.”

Without question, these moves are a steps in the right direction. Whether they amount to more than a lip-service, whether they are able to out-smart the quacks, and whether they will make a real difference to the ubiquitous promotion of quackery, has to be seen.

One of the favourite arguments of proponents of so-called alternative medicine (SCAM) is that conventional medicine is amongst the world’s biggest killers. The argument is used cleverly to discredit conventional medicine and promote SCAM. It has been shown to be wrong many times, but it nevertheless is much-loved by SCAM enthusiasts and thus refuses to disappear. Perhaps this new and important review might help instilling some realism into this endless discussion? Here is its abstract:

Objective To systematically quantify the prevalence, severity, and nature of preventable patient harm across a range of medical settings globally.

Design Systematic review and meta-analysis.

Data sources Medline, PubMed, PsycINFO, Cinahl and Embase, WHOLIS, Google Scholar, and SIGLE from January 2000 to January 2019. The reference lists of eligible studies and other relevant systematic reviews were also searched.

Review methods Observational studies reporting preventable patient harm in medical care. The core outcomes were the prevalence, severity, and types of preventable patient harm reported as percentages and their 95% confidence intervals. Data extraction and critical appraisal were undertaken by two reviewers working independently. Random effects meta-analysis was employed followed by univariable and multivariable meta regression. Heterogeneity was quantified by using the I2 statistic, and publication bias was evaluated.

Results Of the 7313 records identified, 70 studies involving 337 025 patients were included in the meta-analysis. The pooled prevalence for preventable patient harm was 6% (95% confidence interval 5% to 7%). A pooled proportion of 12% (9% to 15%) of preventable patient harm was severe or led to death. Incidents related to drugs (25%, 95% confidence interval 16% to 34%) and other treatments (24%, 21% to 30%) accounted for the largest proportion of preventable patient harm. Compared with general hospitals (where most evidence originated), preventable patient harm was more prevalent in advanced specialties (intensive care or surgery; regression coefficient b=0.07, 95% confidence interval 0.04 to 0.10).

Conclusions Around one in 20 patients are exposed to preventable harm in medical care. Although a focus on preventable patient harm has been encouraged by the international patient safety policy agenda, there are limited quality improvement practices specifically targeting incidents of preventable patient harm rather than overall patient harm (preventable and non-preventable). Developing and implementing evidence-based mitigation strategies specifically targeting preventable patient harm could lead to major service quality improvements in medical care which could also be more cost effective.

________________________________________________________________

One in 20 patients is undoubtedly an unacceptably high proportion, but it is nowhere close to some of the extraordinarily alarming claims by SCAM enthusiasts. And, as I try regularly to remind people, the harm must be viewed in relation to the benefit. For the vast majority of conventional treatments, the benefits outweigh the risks. But, if there is no benefit at all – as with some form of SCAM – a risk/benefit balance can never be positive. Moreover, many experts work hard and do their very best to improve the risk/benefit balance of conventional healthcare by educating clinicians, maximising the benefits, minimising the risks, and filling the gaps in our current knowledge. Do equivalent activities exist in SCAM? The answer is VERY FEW?

Chiropractors often claim that they are working tirelessly towards increasing public health. But how seriously should we take such claims?

The purpose of this study was to investigate weight-loss interventions offered by Canadian chiropractors. It is a secondary analysis of data from the Ontario Chiropractic Observation and Analysis STudy (Nc = 42 chiropractors, Np = 2162 patient encounters). Its results show that around two-thirds (61.3%) of patients who sought chiropractic care were either overweight or had obesity. Very few patients had weight loss managed by their chiropractor. Among patients with body mass index equal to or greater than 18.5 kg/m2, guideline recommended weight management was initiated or continued by Ontario chiropractors in only 5.4% of encounters. Chiropractors did not offer weight management interventions at different rates among patients who were of normal weight, overweight, or obese (P value = 0.23). Chiropractors who graduated after 2005 who may have been exposed to reforms in chiropractic education to include public health were significantly more likely to offer weight management than chiropractors who graduated between 1995 and 2005.

The authors concluded that the prevalence of weight management interventions offered to patients by Canadian chiropractors in Ontario was low. Health care policy and continued chiropractic educational reforms may provide further direction to improve weight-loss interventions offered by doctors of chiropractic to their patients.

This paper seems to confirm my suspicion that the claim of chiropractors working for public heath is little more than an advertising gimmick. If we also consider the often negative attitude of chiropractors towards vaccination, the claim even deteriorates into a sick joke. Chiropractors, I have previously argued, are undermining public health and are being educated to become a danger to public health.

The NHS England has stopped paying for homeopathy in 2017. France has just announced to do likewise. What about Germany, the homeland of homeopathy?  

In Germany there are about 150,000 doctors, and around 7,000 specialize in homeopathy. Multiple surveys confirm that Germans do like their SCAMs, particularly homeopathy. Two examples:

  • A 2016 cross-sectional analysis conducted among all patients being referred to the Department of Internal and Integrative Medicine at Essen, Germany, over a 3-year period showed that 35% of the 2,045 respondents reported having used homeopathy for their primary medical complaint.  359 (50.2%) patients reported benefits and 15 (2.1%) reported harm.
  • More recently, a questionnaire survey concerning current and lifetime use of SCAM was distributed to German adults with autism spectrum disorder (ASD). The results suggested that 45% of the respondents were currently using or had used at least one SCAM modality in their life. Homeopathy and acupuncture were most frequently used SCAMs, followed by mind-body interventions.

But since a few years, the German opposition to homeopathy has become much more active. In particular the INH, the GWUP, and the Muensteraner Kreis have been instrumental in informing the public about the uselessness and dangers of homeopathy. The press has now taken up this message and, as this article explains, now the debate about homeopathy has finally reached the political level.

The head of the main doctors’ association and the SPD’s health specialist have called for an end to refunds for homeopathy treatments in Germany. The head of the National Association of Statutory Health Insurance Physicians (KBV), which represents 150,000 doctors and psychotherapists in Germany, recently urged health insurance companies to stop funding homeopathic services. “There is insufficient scientific evidence for the efficacy of homeopathic procedures,” Andreas Gassen told the Rheinische Post. “If people want homeopathic remedies, they should have them — but not at the expense of the community.

Gassen’s comments follow those of the Social Democrat (SPD) health issues specialist and lawmaker Karl Lauterbach who has pressed for a law banning refunds for homeopathy. “We have to talk about it in GroKo,” Lauterbach said earlier this month, suggesting a discussion in the government grand coalition. He said the benefits paid for by insurers should be medically and economically sensible. He has the support of the Federal Joint Committee which decides on what is covered by payments from the statutory health funds.

So, what is going to happen?

As I have written previously, one can only be sure of this:

  • The German homeopathy lobby will not easily give up; after all, they have half a billion Euros per year to lose.
  • They will not argue on the basis of science or evidence, because they know that neither are in their favour.
  • They will fight dirty and try to defame everyone who stands in their way.
  • They will use their political influence and their considerable financial power.

AND YET THEY WILL LOSE!

Not because we are so well organised or have great resources – in fact, as far as I can see, we have none – but because, in medicine, the evidence is invincible and will eventually prevail. Progress might be delayed, but it cannot be halted by those who cling to an obsolete dogma.

 

 

I have reported about the French activities against homeopathy before (see here and here). Yesterday, this article brought considerable more clarity into the situation. Here is my (not entirely literal) translation and below the French original:

Unsurprisingly, the French health regulator (HAS) has voted on Wednesday with a very large majority (only one vote against) for the discontinuation of the reimbursement of homeopathic products. This decision, which is not denied by the health ministry, will be officially announced this Friday morning by the president of the authority, Prof Dominique Le Guludec, during a press conference. Then it will be up to the health minister, Agnès Buzyn, to decide or not on the discontinuation of reimbursement.

I will follow the advice of the health authority‘ the health minister declared only recently. This advice is the direct consequence of a first meeting of the commission which took place in Mid May and gave an opinion that already went into that direction. The laboratories concerned had the right to be heard and to present their view. Obviously this was not convincing.

______________________________________________________________

Sans surprise, la Commission de la transparence de la Haute autorité de santé a voté ce mercredi à la très grande majorité (une seule voix contre) le déremboursement des produits homéopathiques. Cette décision, que ne dément pas le ministère de la Santé, sera annoncée officiellement vendredi matin par la présidente de la Haute Autorité de santé, la professeur Dominique Le Guludec, au cours d’une conférence de presse. A charge ensuite à la ministre de la Santé, Agnès Buzyn, de décider ou non ce déremboursement.

«Je me tiendrai à l’avis de la Haute Autorité de santé», a encore récemment déclarée la ministre. Cet avis est la conséquence directe d’une première réunion, qui s’est tenue à la mi mai, de la dite Commission, qui avait alors rendu un avis transitoire, allant clairement dans ce sens. Comme le stipule le processus, les laboratoires concernées avaient le droit d’être entendus et de se défendre. Manifestement, ces derniers n’ont pas convaincus.

Tian Jiu (TJ) therapy is a so-called alternative medicine (SCAM) that has been widely utilized in the management of allergic rhinitis (AR). TJ is also known as “drug moxibustion” or “vesiculating moxibustion.” Herbal patches are applied on the selected acupoints or the diseased body part. In TCM, this treatment is said to regulate the functions of meridians and zang-fu organs, warm the channels, disperse coldness, invigorate qi movement, harmonize nutrient absorption and defence mechanisms, and resolve stagnation in the body and stasis of the blood.

But does it work? This single-blinded, three-arm, randomized controlled study evaluated the efficacy of TJ therapy in AR. A total of 138 AR patients were enrolled. The TJ group and placebo group both received 4-weeks of treatment with either TJ or placebo patches for 2 hours. The patches were applied to Dazhui (GV 14), bilateral Feishu (UB 13), and bilateral Shenshu (UB 23) points. Patients received one session per week and then underwent a 4-week follow-up. The waitlist group received no treatment during the corresponding treatment period, but would be given compensatory TJ treatment in the next 4 weeks.

The primary outcome was the change of the Total Nasal Symptom Score (TNSS) after treatment. The secondary outcomes included the changes of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and rescue medication score (RMS).

After the treatment period, the total TNSS in TJ group was significantly reduced compared with baseline, but showed no statistical difference compared with placebo. Among the four domains of TNSS, the change of nasal obstruction exhibited statistical difference compared with placebo group. The total RQLQ score in TJ group was significantly reduced compared with both placebo and waitlist groups. The needs of rescue medications were not different between the two groups.

There were no serious adverse events. The common adverse events included flush, pruritus, blister, and pigmentation, occurring in 17, 23, 3, and 36 person-times among TJ group, and 3, 7, 1, and 4 person-times among placebo group, respectively. These adverse events were generally tolerated and disappeared quickly after removing the patches.

The authors (from the Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University) concluded that this randomized, single-blinded, controlled trial served primary evidence of the efficacy and safety of TJ therapy on AR in Hong Kong. This pilot study provided a fundamental TJ protocol for future research. Through adjusting treatment timing, frequency, retention time, and even body response settings, it has the potential to develop into an optimal therapeutic method for future application.

The authors of this poorly written paper seem to ignore their own findings by concluding as they do. The fact is that the primary endpoint of this trial failed to show a significant difference between TJ and placebo. Moreover, TJ does have considerable adverse effects. Therefore, this study  fails to demonstrate both the effectiveness and the safety of TJ as a treatment of AR.

PS

I often hesitate whether or not to discuss the plethora such frightfully incompetent research. The reason I sometimes do it is to alert the public to the fact that so much utter rubbish is published by incompetent researchers in trashy (but Medline-listed) journals, passed by incompetent ethics committees, supported by naïve funding agencies, accepted by reviewers and editors who evidently do not do their job properly. Do all these people have forgotten that they have a responsibility towards the public?

It is time to stop this nonsense!

It gives a bad name to science, misleads the public and inhibits progress.

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

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

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

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

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

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

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

 

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