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

malpractice

The UK Royal Pharmaceutical Society have published a quick reference guide on homeopathy. In it, they make the following 5 ‘key points’:

  • The Royal Pharmaceutical Society (RPS) does not endorse homeopathy as a form of treatment because there is no scientific basis for homeopathy nor any evidence to support the clinical efficacy of homeopathic products beyond a placebo effect.
  • The RPS does not support the prescribing of homeopathic products on the NHS.
  • Pharmacists should ensure, wherever possible, that patients do not stop taking their prescribed conventional medication, if they are taking or are considering taking a homeopathic product.
  • Pharmacists must be aware that patients requesting homeopathic products may have serious underlying undiagnosed medical conditions which may require referral to another healthcare professional.
  • Pharmacists must advise patients considering a homeopathic product about their lack of efficacy beyond that of a placebo.

This publication is a few months old, but I only saw it recently. It could not be clearer and it is much more to the point than the General Pharmaceutical Council’s ‘Standards for Pharmacy Professionals‘ which state:

People receive safe and effective care when pharmacy professionals reflect on the application of their knowledge and skills and keep them up-to-date, including using evidence in their decision making. A pharmacy professional’s knowledge and skills must develop over the course of their career to reflect the changing nature of healthcare, the population they provide care to and the roles they carry out. There are a number of ways to meet this standard and below are examples of the attitudes and behaviours expected.

People receive safe and effective care when pharmacy professionals:

  • recognise and work within the limits of their knowledge and skills, and refer to others when needed
  • use their skills and knowledge, including up-to-date evidence, to deliver care and improve the quality of care they provide
  • carry out a range of continuing professional development (CPD) activities relevant to their practice
  • record their development activities to demonstrate that their knowledge and skills are up to date
  • use a variety of methods to regularly monitor and reflect on their practice, skills and knowledge

The two statements together should suffice to finally get some sense into UK pharmacies when it comes to the sale of homeopathic remedies. What is needed now, I think, is an (under-cover?) investigation to see how many UK community pharmacists abide by this guidance.

If anyone has the means to conduct it, I would be delighted to advise them on the best methodology.

I remember reading this paper entitled ‘Comparison of acupuncture and other drugs for chronic constipation: A network meta-analysis’ when it first came out. I considered discussing it on my blog, but then decided against it for a range of reasons which I shall explain below. The abstract of the original meta-analysis is copied below:

The objective of this study was to compare the efficacy and side effects of acupuncture, sham acupuncture and drugs in the treatment of chronic constipation. Randomized controlled trials (RCTs) assessing the effects of acupuncture and drugs for chronic constipation were comprehensively retrieved from electronic databases (such as PubMed, Cochrane Library, Embase, CNKI, Wanfang Database, VIP Database and CBM) up to December 2017. Additional references were obtained from review articles. With quality evaluations and data extraction, a network meta-analysis (NMA) was performed using a random-effects model under a frequentist framework. A total of 40 studies (n = 11032) were included: 39 were high-quality studies and 1 was a low-quality study. NMA showed that (1) acupuncture improved the symptoms of chronic constipation more effectively than drugs; (2) the ranking of treatments in terms of efficacy in diarrhoea-predominant irritable bowel syndrome was acupuncture, polyethylene glycol, lactulose, linaclotide, lubiprostone, bisacodyl, prucalopride, sham acupuncture, tegaserod, and placebo; (3) the ranking of side effects were as follows: lactulose, lubiprostone, bisacodyl, polyethylene glycol, prucalopride, linaclotide, placebo and tegaserod; and (4) the most commonly used acupuncture point for chronic constipation was ST25. Acupuncture is more effective than drugs in improving chronic constipation and has the least side effects. In the future, large-scale randomized controlled trials are needed to prove this. Sham acupuncture may have curative effects that are greater than the placebo effect. In the future, it is necessary to perform high-quality studies to support this finding. Polyethylene glycol also has acceptable curative effects with fewer side effects than other drugs.

END OF 1st QUOTE

This meta-analysis has now been retracted. Here is what the journal editors have to say about the retraction:

After publication of this article [1], concerns were raised about the scientific validity of the meta-analysis and whether it provided a rigorous and accurate assessment of published clinical studies on the efficacy of acupuncture or drug-based interventions for improving chronic constipation. The PLOS ONE Editors re-assessed the article in collaboration with a member of our Editorial Board and noted several concerns including the following:

  • Acupuncture and related terms are not mentioned in the literature search terms, there are no listed inclusion or exclusion criteria related to acupuncture, and the outcome measures were not clearly defined in terms of reproducible clinical measures.
  • The study included acupuncture and electroacupuncture studies, though this was not clearly discussed or reported in the Title, Methods, or Results.
  • In the “Routine paired meta-analysis” section, both acupuncture and sham acupuncture groups were reported as showing improvement in symptoms compared with placebo. This finding and its implications for the conclusions of the article were not discussed clearly.
  • Several included studies did not meet the reported inclusion criteria requiring that studies use adult participants and assess treatments of >2 weeks in duration.
  • Data extraction errors were identified by comparing the dataset used in the meta-analysis (S1 Table) with details reported in the original research articles. Errors included aspects of the study design such as the experimental groups included in the study, the number of study arms in the trial, number of participants, and treatment duration. There are also several errors in the Reference list.
  • With regard to side effects, 22 out of 40 studies were noted as having reported side effects. It was not made clear whether side effects were assessed as outcome measures for the other 18 studies, i.e. did the authors collect data clarifying that there were no side effects or was this outcome measure not assessed or reported in the original article. Without this clarification the conclusion comparing side effect frequencies is not well supported.
  • The network geometry presented in Fig 5 is not correct and misrepresents some of the study designs, for example showing two-arm studies as three-arm studies.
  • The overall results of the meta-analysis are strongly reliant on the evidence comparing acupuncture versus lactulose treatment. Several of the trials that assessed this comparison were poorly reported, and the meta-analysis dataset pertaining to these trials contained data extraction errors. Furthermore, potential bias in studies assessing lactulose efficacy in acupuncture trials versus lactulose efficacy in other trials was not sufficiently addressed.

While some of the above issues could be addressed with additional clarifications and corrections to the text, the concerns about study inclusion, the accuracy with which the primary studies’ research designs and data were represented in the meta-analysis, and the reporting quality of included studies directly impact the validity and accuracy of the dataset underlying the meta-analysis. As a consequence, we consider that the overall conclusions of the study are not reliable. In light of these issues, the PLOS ONE Editors retract the article. We apologize that these issues were not adequately addressed during pre-publication peer review.

LZ disagreed with the retraction. YM and XD did not respond.

END OF 2nd QUOTE

Let me start by explaining why I initially decided not to discuss this paper on my blog. Already the first sentence of the abstract put me off, and an entire chorus of alarm-bells started ringing once I read further.

  • A meta-analysis is not a ‘study’ in my book, and I am somewhat weary of researchers who employ odd or unprecise language.
  • We all know (and I have discussed it repeatedly) that studies of acupuncture frequently fail to report adverse effects (in doing this, their authors violate research ethics!). So, how can it be a credible aim of a meta-analysis to compare side-effects in the absence of adequate reporting?
  • The methodology of a network meta-analysis is complex and I know not a lot about it.
  • Several things seemed ‘too good to be true’, for instance, the funnel-plot and the overall finding that acupuncture is the best of all therapeutic options.
  • Looking at the references, I quickly confirmed my suspicion that most of the primary studies were in Chinese.

In retrospect, I am glad I did not tackle the task of criticising this paper; I would probably have made not nearly such a good job of it as PLOS ONE eventually did. But it was only after someone raised concerns that the paper was re-reviewed and all the defects outlined above came to light.

While some of my concerns listed above may have been trivial, my last point is the one that troubles me a lot. As it also related to dozens of Cochrane reviews which currently come out of China, it is worth our attention, I think. The problem, as I see it, is as follows:

  • Chinese (acupuncture, TCM and perhaps also other) trials are almost invariably reporting positive findings, as we have discussed ad nauseam on this blog.
  • Data fabrication seems to be rife in China.
  • This means that there is good reason to be suspicious of such trials.
  • Many of the reviews that currently flood the literature are based predominantly on primary studies published in Chinese.
  • Unless one is able to read Chinese, there is no way of evaluating these papers.
  • Therefore reviewers of journal submissions tend to rely on what the Chinese review authors write about the primary studies.
  • As data fabrication seems to be rife in China, this trust might often not be justified.
  • At the same time, Chinese researchers are VERY keen to publish in top Western journals (this is considered a great boost to their career).
  • The consequence of all this is that reviews of this nature might be misleading, even if they are published in top journals.

I have been struggling with this problem for many years and have tried my best to alert people to it. However, it does not seem that my efforts had even the slightest success. The stream of such reviews has only increased and is now a true worry (at least for me). My suspicion – and I stress that it is merely that – is that, if one would rigorously re-evaluate these reviews, their majority would need to be retracted just as the above paper. That would mean that hundreds of papers would disappear because they are misleading, a thought that should give everyone interested in reliable evidence sleepless nights!

So, what can be done?

Personally, I now distrust all of these papers, but I admit, that is not a good, constructive solution. It would be better if Journal editors (including, of course, those at the Cochrane Collaboration) would allocate such submissions to reviewers who:

  • are demonstrably able to conduct a CRITICAL analysis of the paper in question,
  • can read Chinese,
  • have no conflicts of interest.

In the case of an acupuncture review, this would narrow it down to perhaps just a handful of experts worldwide. This probably means that my suggestion is simply not feasible.

But what other choice do we have?

One could oblige the authors of all submissions to include full and authorised English translations of non-English articles. I think this might work, but it is, of course, tedious and expensive. In view of the size of the problem (I estimate that there must be around 1 000 reviews out there to which the problem applies), I do not see a better solution.

(I would truly be thankful, if someone had a better one and would tell us)

It has been reported that the faculty of medicine of Lille unversity in France has suspended its degree in homeopathy for the 2018-19 academic year. The university announced its decision on Twitter, and the faculty of medicine’s dean, Didier Gosset, confirmed it to the AFP news agency: “It has to be said that we teach medicine based on proof – we insist on absolute scientific rigour – and it has to be said that homeopathy has not evolved in the same direction, that it is a doctrine that has remained on the margins of the scientific movement, that studies on homeopathy are rare, that they are not very substantial,” he explained. “Continuing to teach it would be to endorse it.”

The decision is, of course, long overdue and must be welcomed. Personally, however, I wonder why defenders of reason like Prof Gosset often employ such unclear lines of argument. Would it not be clearer to make (some of) these simple points?

  1. The assumptions on which homeopathy is based are obsolete and implausible.
  2. It is not that we do not understand homeopathy’s mode of action, but we understand that there cannot be one that does not fly in the face of science.
  3. The clinical evidence fails to show that highly diluted homeopathic remedies are more than placebos.
  4. Homeopathy can cause significant harm, e. g. through neglect.
  5. Homeopathy costs millions which would be much better used for evidence-based treatments.
  6. The practice of homeopathy hinders progress and does not provide benefit for the public.
  7. Teaching homeopathy at university-level is unscientific, unethical and nonsensical.

The French are among the world’s largest consumers of homeopathic remedies. The French social security system does normally reimburse homeopathic therapy. A group of doctors challenged this situation in an open letter in Le Figaro newspaper in March 2018. They called practitioners of homeopathy and other alternative medicines “charlatans”, pointing to a 2017 report by the European Academies Science Advisory Council that stressed, like a plethora of previous reports, the “absence of proof of homeopathy’s efficacy”. They challenged the French medical council to stop allowing doctors to practice homeopathy and asked the social security system to stop paying for it. Subsequently, a group of French homeopaths filed a formal complaint with the medical council against the signatories of this letter.

France’s health ministry has asked France’s National Health Authority to prepare and publish a report on whether homeopathy works and should be paid for by the public purse. It is due to be delivered in February 2019.

WATCH THIS SPACE

By guest blogger Hans-Werner Bertelsen

Holistic ideas are booming, and they do not stop at dental medicine, where procedures and techniques that take an alleged ‘holistic’ approach are becoming more and more popular. Are these procedures and techniques effective, and do they offer a benefit over their conventional counterparts, or is it rather the providers of such procedures and techniques who benefit from a lack of knowledge and understanding in patients who seek out this so-called alternative dentistry? This paper will take a look at three topics—the concept of projections, material testing approaches, amalgam removal—that form the basis for many procedures and techniques in so-called alternative dentistry, to examine whether they offer a sound foundation for said procedures and techniques, or whether they are merely empty promises. Might they be nothing but marketing tricks?

The concept of projections suggests that conventional medicine does look closely enough at the human body, ignoring as of yet undiscovered energy lines and other mysterious linkages. Material testing approaches claim to detect harmful and allergenic components, the removal of which may be beneficial in case of systemic diseases, possibly even curing them. Beginning on July 1, 2018, the use of amalgam will be strongly restricted all throughout Europe. This easy-to-use material has received much attention for decades, as it contains a large proportion of mercury, which is known for its high neurotoxicity, and is, therefore, suspected of causing illness in the long term.

Normally, we think of projections as requiring a screen, onto which something then can be projected. Teeth, however, are also ideally suited as a dumping ground for the underlying causes of somatic and/or mental diseases, from where they can radiate out as so-called projections. Once these are identified as the true cause of disease, other potential causes such as age-related wear and tear, detrimental behaviors, or harmful eating habits can be readily ignored. This concept of projections may have particularly harmful and negative consequences in patients with tumors, as it may cause feelings of guilt, although in many cases no definite cause of tumor development can be discerned. Projected feelings of guilt, in turn, can be a negative influence on a person’s health.

The so-called “system of meridians” assigns relationship qualities to individual teeth, meaning that there are strict relationships of individual teeth to the body’s organs and individual entities. [1]

According to this system, an inflammation of the urinary bladder would be related to the number 1 teeth, the incisors. Rheumatism is linked to the number 8 teeth, the wisdom teeth. In between, there are the teeth of the ordinal numbers 2 to 7, distinguished by their locations on the left or right, in the upper or lower jaw, which offer a wealth of opportunities to assign a “guilty tooth” to clinically common physical complaints. However, this mysterious connection is postulated not only for teeth and major organs, but also for joints, vertebral levels, sensory organs, tonsils, and glands, with the relationships neatly organized in ten groups and subgroups. Multiplied by the number of teeth—eight per each of the four quadrants, 32 in total—these afford the “holistic dentist” 320 opportunities for projecting physical complaints ranging from asthma to zonulitis onto a tooth. Those who believe in this system of projections are not deterred by the fact that there is no scientific proof whatsoever for this odd thesis.

On the other hand, it is basic medical knowledge that pathogens may spread hematogenically and affect remote organs. Seeking adequate specialist counsel when dealing with rheumatic diseases, fevers of unclear etiology, or in conjunction with orthopedic joint surgeries, is, therefore, mandated by guidelines and an obvious standard in the practice of medicine. So-called alternative dentistry makes no particular mention of these general facts, but instead focuses on occult-seeming correlations in order to use a mysterious, almost conspiratorial idea of a disease to legitimize the often invasive treatment options it then recommends. Most patients will not realize that these interpretations often mistake synchronicity for causality. For example, most infections of the urinary bladder will resolve over time, regardless of whether any work was done on the upper incisors or not. However, if during the period of healing one of the incisors was treated by a dentist, it is easy enough to associate this treatment with the resolving bladder infection. From a psychological viewpoint, this constitutes a simple manipulation technique, applied to demonstrate the seemingly superior diagnostics of alternative dentistry: a simple, and easily recognized marketing strategy.

When asked what would happen to these doubtful projections in case of an autologous transplantation during which a tooth would move to another tooth’s original place in the jaw, three leading representatives of the so-called alternative dentistry answered in an evasive and even manipulative manner. [2]

There are reports of invasive therapies, conducted following dubious, often electromedical diagnostic procedures, that not only lead to high costs for the repair of the damage they caused, but also to a lasting mutilation of the patients’ jaws and dentitions. [3-6]

Another supposedly holistic school of thought that is similar to that of the system of meridians exists in some fields of dentistry regarding temporo-mandibular joint dysfunction (TMJD, TMD). These theories suggest that a disbalance in the interaction between jaw bones and masticatory muscles may be responsible for all kinds of diseases. [7]

According to the German self-appointed “TMJD Umbrella Organization” (CMD-Dachverband e. V.), TMJD is a “multifaceted disease.” The claim is that TMJD may not only cause back pain, vertigo, and tinnitus, but also sleep apnea, snoring, neck and shoulder pain, hip and knee pain, headaches, migraines, visual, mood swings, and even depression. However, there is no scientific evidence for any of these claims. [8,9]

Jens C. Türp of the University Center for Dental Medicine Basel’s Department of Oral Health & Medicine, Division Temporomandibular Disorders and Orofacial Pain, has called this standard diagnosis, offered by TMJD diagnosticians whenever a patient shows signs of nocturnal teeth grinding, “nonsense that makes your hair stand on end.”

“For a variety of general symptoms, it is claimed that they are caused by a TMJD: Tinnitus, ocular pressure, differences in the lengths of a person’s legs, back pain, hip pain, and knee pain, balance disorders, tingling in the fingers and many more. ‘A relationship [with TMJD] has never been proven for any of these symptoms’, says Türp. According to him, true TMJD causes problems with chewing and pain. Affected patients have difficulties opening their mouth wide or closing it fully. The “CMD-Arztsuche” (Find a TMJD Specialist) website recommends ‘a lasting correction of a person’s bite’ as treatment. This should be achieved with the help of ceramic inlays, dental crowns, and implants— all of which are expensive and unnecessary measures, in the opinion of Jens Türp. He treats his TMJD patients–almost always successfully, as he says–with occlusal splints, physiotherapy, and relaxation exercises.” (Translated from German [10])

In general, any patient should be advised, therefore, to seek a second opinion whenever confronted with a diagnosis requiring invasive treatments.

References:

1. Madsen, H. Studie zur Kieferorthopädie in der Alternativmedizin: Darstellung der Grundlagen und kritische Bewertung. Doctoral dissertation, Poliklinik für Kieferorthopädie der Universität Würzburg. Würzburg 1994

2. Schulte von Drach, M.C. Wenn Zähne fremdgehen. Süddeutsche Zeitung May 15, 2012.

3. Staehle, H.J. Der Patientin wurde das Gebiss verstümmelt. Zahnärztliche Mitteilungen 2000.

4. Dowideit, A. Wenn nach der “Störfeld-Messung” alle Backenzähne fehlen. Welt June 3, 2017.

5. Bertelsen, H.-W. Die Attraktvität “ganzheitlicher” Zahnmedizin – Teil 1: Bohren ohne Reue. skeptiker 2012, 4.

6. Bertelsen, H.-W. Die Attraktivität “ganzheitlicher” Zahnmedizin – Teil 2: Bohren ohne Reue. skeptiker 2013, 4.

7. CMD Dachverband e. V. Craniomandibuläre Dysfunktion – Ursachen & Symptome. http://www.cmd-dachverband.de/fuer-patienten/ursachen-symptome/ (May 11, 2018),

8. Wolf, T. Die richtige Hilfe bei Kieferbeschwerden. Spiegel Online July 7, 2014, 2014.

9. Türp, J.C.; Schindler, H.-J.; Antes, G. Temporomandibular disorders: Evaluation of the usefulness of a self-test questionnaire. Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen 2013, 107, 285-290.

10. Albrecht, B. Teure Tricks der Zahnärzte – so schützen Sie sich vor Überbehandlung. stern February 18, 2016.

 

On this blog, I have ad nauseam discussed the fact that many SCAM-practitioners are advising their patients against vaccinations, e. g.:

The reason why I mention this subject yet again is the alarming news reported in numerous places (for instance in this article) that measles outbreaks are now being reported from most parts of the world.

The number of cases in Europe is at a record high of more than 41,000, the World Health Organization (WHO) warned. Halfway through the year, 2018 is already the worst year on record for measles in Europe in a decade. So far, at least 37 patients have died of the infection in 2018.

“Following the decade’s lowest number of cases in 2016, we are seeing a dramatic increase in infections and extended outbreaks,” Dr. Zsuzsanna Jakab, WHO Regional Director for Europe, said in a statement. “Seven countries in the region have seen over 1,000 infections in children and adults this year (France, Georgia, Greece, Italy, the Russian Federation, Serbia and Ukraine).”

In the U.S., where measles were thought to be eradicated, the Centers for Disease Control and Prevention has reported 107 measles cases as of the middle of July this year. “This partial setback demonstrates that every person who is not immune remains vulnerable no matter where they live, and every country must keep pushing to increase coverage and close immunity gaps,” WHO’s Dr. Nedret Emiroglu said.  95 percent of the population must have received at least two doses of measles vaccine to achive herd immunity and prevent outbreaks. Some parts of Europe have reached that target, while others are even below 70 percent.

And why are many parts below the 95% threshold?

Ask your local SCAM-provider, I suggest.

 

A few days ago, I published an article in the ‘Sueddeutsche Zeitung’ (a truly rare event, as I have never done this before) where I argued that German pharmacists should consider stopping the sale of homeopathic remedies. It violates their ethical code, I suggested.

While this discussion has been going on for a while in the UK (British pharmacists have stopped inviting me to their gatherings because I get on their nerves with banging on about this!), it is relatively novel in Germany.

After I had submitted my copy to the SZ, an article was published which is highly relevant to this subject. Here I first copy an extract of the German original, and below I try to briefly explain its content to those who do not read German.

________________________________________________________________________________

In vielen Apotheken werden Kunden nicht hinreichend gut zu Homöopathika beraten. Zu diesem Ergebnis kommt Professor Tilmann Betsch, an der Universität Erfurt Leiter der Professur für Sozial-, Organisations- und Wirtschaftspsychologie, der mit seinem Team 100 zufällig ausgewählte Apotheken in Stuttgart, Erfurt, Leipzig und Frankfurt auf Herz und Nieren geprüft hat. Im Mittelpunkt der Kundengespräche stand eine Beratung zu einem erkälteten Familienmitglied.

“Zum einen zeigen unsere Ergebnisse, dass im Falle eines grippalen Infektes die überwiegende Mehrzahl von ihnen zu schulmedizinischen Präparaten rät, die mit hoher Wahrscheinlichkeit zu einer Linderung der Symptome führen”, erläutert Betsch. Was die Wirkung von Homöopathika betreffe, so zeichne das Untersuchungsergebnis ein eher düsteres Bild, ergänzt er. Denn in nur fünf Prozent aller Beratungsgespräche sei gesagt worden, dass es für die Wirkung von Homöopathie keine wissenschaftlichen Belege gäbe. In 30 Prozent sei dagegen behauptet worden, die Wirkung von Homöopathie sei entweder in Studien nachgewiesen oder ergebe sich aus dem Erfahrungswissen.

“Nach den Leitlinien der Bundesapothekenkammer soll jedoch die Beurteilung der Wirksamkeit von Präparaten nach pharmakologisch-toxikologischen Kriterien erfolgen. Zumindest was die Begründung ihrer Empfehlungen betrifft, folgte die überwiegende Mehrheit der von uns befragten Apotheker diesen Leitlinien nicht”, so Betschs Fazit. Während die Empfehlungen der Apotheker in der Regel nachweislich wirksame Medikamente enthalten hätten, habe sich ihr Wissen über die Wirkung von Homöopathie mehrheitlich nicht von Laien-Meinungen unterschieden.

____________________________________________________________________________________

Professor Tilmann Betsch has conducted a study showing that German pharmacists fail their customers when advising them on homeopathy. His team went under cover as patients with flue-like symptoms to 100 randomly selected pharmacists. Only 5% of the pharmacists admitted that homeopathics have no proven efficacy, while 30% claimed homeopathics have been proven to work in studies and through experience. This behaviour, Betsch explains, violates the current guidelines for pharmacists.

_____________________________________________________________________________________

I am delighted with these findings; they confirm my arguments perfectly.

Since, in Germany, homeopathics are sold only in pharmacies, German pharmacists have a pivotal role here. They are ethically bound to inform their customers based on the current best evidence. So, in my day-dreams, I imagine a dialogue between a customer and an ethical pharmacist:

CUSTOMER: I have a flu, is there a homeopathic remedy against it?

PHARMACIST: Yes, there is.

CUSTOMER: Can I have it please?

PHARMACIST: If you insist; but I must warn you: it has been shown not to work, and there is absolutely nothing in it that could possibly work.

CUSTOMER: What? Why do you sell it then?

PHARMACIST: Because some people like it.

CUSTOMER: Even though it does not work?

PHARMACIST: Yes.

CUSTOMER: Is it expensive?

PHARMACIST: Yes.

CUSTOMER: And some people still buy it?

PHARMACIST: Yes.

CUSTOMER: Well, not I! I am not a fool. But thank you for your honest information. Can I have something else that alleviates my symptoms?

PHARMACIST: With pleasure!

________________________________________________________________________________

The fate of homeopathy in Germany is largely in the hands of pharmacists, it seems.

But, is it in good, ethical hands? Is there hope that progress can be made?

We will see – so far, I have heard of just one!!! pharmacy that has stopped displaying homeopathics on its shelves.

We probably have all heard of predatory journals. The phenomenon of ‘predatory conferences’ seems to be less-well appreciated. Hardly a day goes by that I do not receive emails like the one below:

________________________________________________________

Dear Dr. E Ernst ,

Good day!

After the success of Traditional Medicine-2018 in Rome, Italy, on behalf of the Organizing committee, we are delighted to invite you to be a speaker at our upcoming “3rd World Congress and Expo on Traditional and Alternative Medicine” (Traditional Medicine-2019) which will be held during June 06-08, 2019 in Berlin, Germany.

Traditional Medicine-2019 will focus on the theme “Natural and Scientific Approach for Treatment and Rehabilitation”…

_________________________________________________________

I have chosen this particular one because it refers to the success of a recent conference in Rome. This is a conference where I was a member of  the organising committee and have been listed as a keynote speaker. Here is the original entry from the programme:

Keynote Forum 09:15-09:55

Title: Integrative Medicine: Hype or Hope? Ernst Edzard, University of Exeter, United Kingdom

And here is the strange tale how it all came about:

After receiving a barrage of similar invitations and having ignored them for months, I thought that maybe I am unnecessarily suspicious – perhaps these conferences are not as dodgy as they appear to be. So, I responded to one email and stated the usual things:

  • I do not insist on a fee,
  • I want my expensed paid,
  • I need a topic that I feel comfortable with,
  • I need to know who else is speaking,
  • I must know who is sponsoring the event,
  • the whole thing must fit into my time-table.

I got an enthusiastic response and, even though not all my questions were answered, they agreed to fund my travel and hotel costs with a lump sum of 300 Euro. They asked me to act as chair of the entire meeting and as ‘signing authority for the conference’ (I don’t know what this means) but I declined. Yet I wanted to see how the whole thing would play out. So, I accepted a keynote lecture, agreed to be a member of the organising/scientific committee, and send them my abstract.

Then I did not hear anything for a long time (normally, I would, as a member of the organising/scientific committee, have expected to receive abstract submissions for review and other material). When someone sent me an email about it, I noted that the organisers were advertising the conference with my name and photo. I was irritated by that, but decided to play along so that I could get to the bottom of all this. Then, about 6 weeks before the event came this email from the organisers:

Dear Dr. Ernst ,

Greetings of the day!!

We are glad to have your presence at Traditional Medicine 2018.

Hope this mail finds you in good spirits.

Kindly find the attached final program for the Conference.

Could you please confirm us your check in & check out dates.

Revert back to me for further queries…

I replied as follows:

I will look at the possibilities of trains, flights etc., once you send me the promised funds for buying my tickets.

e ernst

________________________________________________________

And the rest was silence!

I did not hear a word from them after telling them that they need to send me the money before I commit myself into buying flight tickets etc. Nor did I expect to hear from them after that.

The run-up to the conference was too bizarre, in my view, for a credible conference:

  • The organisers seemed to know next to nothing about the topic of the conference.
  • They signed with English names and had a London address, but their language skills seem to be limited.
  • They had few of the features that are typical for a serious conference.
  • Almost all of their emails seemed strangely vague.
  • I got the impression that the entire organisation is not run by a thinking person but by a computer.
  • They seemed to organise dozens of conferences at any one time.
  • All their conferences were in towns that might seem attractive to visit.
  • None were associated with a leading scientist’s place of work.
  • They wanted my commitments but never committed themselves to anything tangible.

In a word, they seemed phony!

Of course, in the end, I did not fly to Rome and did not deliver my keynote lecture. Evidently, this did not stop them to email me soon after stating “After the success of Traditional Medicine-2018in Rome, Italy, on behalf of the Organizing committee…”

The reason for writing this is to warn you: there are obviously quite a few (not so) clever people out there who want to get hold of your cash by tempting you to attend an apparently interesting conference in an attractive town which, once you participate, turns out to be a waste of time, money and effort.

I have written about the ethics of pharmacists selling homeopathic preparations pretending they are effective medicines often – not just on this blog, but also in medical journals (see for instance here and here) and in our recent book. So, maybe I should give it a rest?

No!

I believe that the issue is far too important not to remain silent about it.

A recent article in the ‘Australian Journal of pharmacy’ caught my eye. As it makes a new and relevant point, I will quote some short excerpts for you:

One of the greatest criticisms pharmacists face is the ranging of homeopathic products in pharmacies. It is difficult to deny that ranging homeopathic products provides a level of legitimacy to these products that they do not deserve.

Conclusive evidence now exists [1] that homeopathy does not work. This is different from a lack of evidence for an effect; this is specific evidence that shows that this modality cannot and does not provide any of the purported benefits or mechanisms of action.

This evidence for lack of effect is important, due to the ethical responsibilities of pharmacists to provide evidence-based medicine. Specifically, from the Pharmaceutical Society of Australia’s Code of Ethics [2]:

Care Principle 1 g)

Before recommending a therapeutic product, considers available evidence and supports the patient to make an informed choice and only supplies a product when satisfied that it is appropriate and the person understands how to use it correctly.

It is not possible to adhere to this principle while also selling homeopathic and other non-EBM products – it is incumbent on pharmacists to always notify a patient that homeopathic medicines cannot work. Ranging homeopathic products therefore opens a pharmacist up to conflict of interest, where their professional judgement tells them that there is no benefit to a product, yet a patient wishes to purchase it anyway, even when advised not to. Not ranging a product is the only method of preventing this conflict.

Pharmacists may also find themselves in position where the pharmacy they work in ranges homeopathic or other non-EBM products, yet they do not want to be involved in the sale or recommendation of these products. In this situation, it is important to remember that the code of ethics requires that a pharmacist does not undertake any action or role if their judgement determines that this is not the correct course of action.

Integrity Principle 2

A pharmacist only practises under conditions which uphold the professional independence, judgement and integrity of themselves and others.

Professional misconduct

This leads to the professional risk a pharmacist puts themselves in when recommending or selling a product that lacks evidence … any breach of the code of ethics can be the basis of a report to the Pharmacy Board for professional misconduct. If a pharmacist were to be referred to the Pharmacy Board for recommending a non-EBM product, pharmacists will be put in the position of having to justify their decision to supply a product that has no evidence, especially if this supply harms a patient or delays them from accessing effective treatment. In addition, it will not be possible to make a case defending the decision to supply non-EBM products based on pressures from employers wishes, due to Integrity Principle 2.

Clearly, the use of Non-EBM products, including homeopathy, puts consumers at risk due to delayed treatment and the risk of unexpected outcomes. It also puts pharmacists at risk of professional and ethical reprimand. Relying on evidence, and having a working knowledge of how to access and assess this evidence, remains a critical part of the role of pharmacists in all areas of practice.

[1] https://www.nhmrc.gov.au/guidelines-publications/cam02

[2] https://www.psa.org.au/downloads/codes/PSA-Code-of-Ethics-2017.pdf

END OF QUOTE

I find this comment important: we all knew (and I have dwelled on it repeatedly) that pharmacists can put consumers at risk when they sell homeopathic remedies masquerading as medicines (while in truth they are placebos that cure absolutely nothing). What few people so far appreciated, I think, is the fact that pharmacists also put themselves at risk.

Of course, you might say, this is a view from Australia, and it might not apply elsewhere. But I think, because the codes of ethics differ only marginally from country to country, it might well apply everywhere. If that is so, pharmacists across the globe – most of them do sell homeopathics regularly – are in danger of breaking their own codes of ethics, if they recommend or sell homeopathic products. And violating professional ethics must mean that pharmacists are vulnerable to reprimands.

Perhaps we should all go to our next pharmacy, ask for some advice about homeopathy, and test this hypothesis!

Needle acupuncture in small children is controversial, not least because the evidence that it works is negative or weak, and because small children are unable to consent to the treatment. Yet it is recommended by some acupuncturists for infant colic. This, of course, begs the questions:

  1. Does the best evidence tell us that acupuncture is effective for infant colic?
  2. Are acupuncturists who recommend acupuncture for this condition responsible and ethical?

This systematic review and a blinding-test validation based on individual patient data from randomised controlled trials was aimed to assess its efficacy for treating infantile colic. Primary end-points were crying time at mid-treatment, at the end of treatment and at a 1-month follow-up. A 30-min mean difference (MD) in crying time between acupuncture and control was predefined as a clinically important difference. Pearson’s chi-squared test and the James and Bang indices were used to test the success of blinding of the outcome assessors [parents].

The investigators included three randomised controlled trials with data from 307 participants. Only one of the included trials obtained a successful blinding of the outcome assessors in both the acupuncture and control groups. The MD in crying time between acupuncture intervention and no acupuncture control was -24.9 min at mid-treatment, -11.4 min at the end of treatment and -11.8 min at the 4-week follow-up. The heterogeneity was negligible in all analyses. The statistically significant result at mid-treatment was lost when excluding the apparently unblinded study in a sensitivity analysis: MD -13.8 min. The registration of crying during treatment suggested more crying during acupuncture.

The authors concluded that percutaneous needle acupuncture treatments should not be recommended for infantile colic on a general basis.

The authors also provide this further comment: “Our blinding test validated IPD meta-analysis of minimal acupuncture treatments of infantile colic did not show clinically relevant effects in pain reduction as estimated by differences in crying time between needle acupuncture intervention and no acupuncture control. Analyses indicated that acupuncture treatment induced crying in many of the children. Caution should therefore be exercised in recommending potentially painful treatments with uncertain efficacy in infants. The studies are few, the analysis is made on small samples of individuals, and conclusions should be considered in this context. With this limitation in mind, our findings do not support the idea that percutaneous needle acupuncture should be recommended for treatment of infantile colic on a general basis.”

So, returning to the two questions that I listed above – what are the answers?

I think they must be:

  1. No.
  2. No.

“Homeopathic remedies are inherently harmless” this is what many seem to think – homeopathy friends and foes alike. After all, they contain nothing – so, how can it cause harm?

The notion is, of course, not entirely true. Homeopathic remedies can be directly harmful, if:

  • they are not highly dilute (low potency) – imagine Arsenic C1;
  • they are contaminated with harmful substances – this might happen with poor quality control during the manufacturing process;
  • they might not be as dilute as advertised – this too might happen with poor quality control during the manufacturing process.

A reminder that these are not merely theoretical considerations was just published in the shape of a press-release by the US Food and Drug Administration:

King Bio is voluntarily recalling four lots of Aquaflora Candida HP9, Lymph Detox, and Baby Teething liquids to the consumer level. During a routine inspection by the U.S. Food and Drug Administration, the products were found to contain microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans.

Administration or use of drug  products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. King Bio has not received reports of injury or illness.

The Aquaflora HP9 product is used as a Candida control product. The Lymph Detox product is used for symptoms associated with lymphatic toxicity. The Baby Teething product is used for symptoms of teething pain, irritated gums, delayed teething, etc.

Product UPC Lot Numbers Expiration Date Distribution
Aquaflora
Candida HP9 8
oz. liquid in a
carton
3-57955-80018-7 120217R
102017C
101017G
111417C
12/02/19
10/20/19
10/10/19
11/14/19
8,000 bottles
nationwide to
retail stores and
websites
King Bio
Lymph Detox
2 oz. liquid in a
carton
3-57955-50632-4 010118BE 01/01/20 276 bottles
nationwide to
retail stores and
websites
King Bio Baby
Teething 2 oz
liquid in a
carton
020118F 13 bottles
marked NOT
FOR RESALE

King Bio is notifying its distributors and customers by letter and is arranging for return and/or replacement. of all recalled products.  Consumers/distributors/retailers that have product which is being recalled should stop using/and contact King Bio prior to returning the product.

Consumers with questions regarding this recall can contact King Bio by 866-298-2740 or e-mail custcare1@kingbio.com, Monday – Friday 830am – 430pm, EST.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

END OF QUOTE

KingBio have a website where they disclose their mission statement:

  • To provide safe, all-natural medicines without harmful side effects.
  • To offer affordable natural medicines that help people overcome common health challenges.
  • To achieve the trust and respect of our customers and uphold the best product quality.
  • To empower people with the most effective ways to achieve abundant health.

… The FDA classifies homeopathic medicines as pharmaceutical drug products. King Bio is an FDA-registered pharmaceutical manufacturer and is strictly compliant with FDA guidelines and current good manufacturing practices (cGMP). Unlike most pharmaceutical drug products, homeopathic medicine offers gentle symptomatic relief, without recorded harmful side effects. 

SAY NO MORE!

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