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

legal action

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Many people believe that homeopathy is essentially plant-based – but they are mistaken! Homeopathic remedies can be made from anything: Berlin wall, X-ray, pus, excrement, dental plaque, mobile phone rays, poisons … anything you can possibly think of. So, why not from vaccines?

This is exactly what a pharmacist specialized in homeopathy thought.

It has been reported that the ‘Schloss-Apotheke’ in Koblenz, Germany offered for sale a homeopathic remedy made from the Pfizer vaccine. This has since prompted not only the Chamber of Pharmacists but also the Paul Ehrlich Institute and Pfizer to issue statements. On Friday (30/4/2021) morning, the pharmacy had advertised homeopathic remedies based on the Pfizer/Biontech vaccine. The Westphalia-Lippe Chamber of Pharmacists then issued an explicit warning against it. “We are stunned by this,” said a spokesman. The offer has since disappeared from the pharmacy’s website.

On Friday afternoon, the manufacturer of the original vaccine also intervened. The Paul Ehrlich Institute released a statement making it clear that a vaccine is only safe “if it is administered in accordance with the marketing authorization.”

The Schloss-Apotheke had advertised the product in question with the following words:

“We have Pfizer/BioNTech Covid-19-Vaccine in potentized form up to D30 as globules or dilution (for discharge) in stock.”

The chamber of pharmacists countered with a warming under the heading “Facts instead of Fake News” on Facebook and Instagram:

“Whatever they might contain: These remedies are no effective protection against Covid-19.”

Pharmacy manager, Annette Eichele, of the Schloss-Apotheke claimed she had not sold homeopathic Corona vaccines and stressed that effective vaccines of this kind do not exist. According to Eichele, only an additional “mini drop” of the original Biontech vaccine had been used and “highly potentized” and prepared homeopathically. According to Eichele, Corona vaccinations that had already been administered were thus to have a “better and more correct effect with this supplementary product, possibly without causing side effects … but this is not scientifically proven”. The homeopathic product had been produced only on customer request and had been sold less than a dozen times in the past weeks. Ten grams of the remedy were sold for about 15 Euros. On Twitter, Eichele stated: „Wir haben nichts Böses getan, wir wollten nur Menschen helfen!“ (We have done nothing evil, we only wanted to help people). I am reminded yet again of Bert Brecht who observed:

“The opposite of good is not evil but good intentions”.

 

Guest post by Alan Henness

When I discovered a homeopath admitting on camera that she believed she and her fellow homeopaths had managed to unblind a triple-blinded homeopathy trial they were taking part in, I submitted a complaint to the journal that published the paper on the trial, the university of the researcher who had conducted the trial and the current university of the homeopath who had subsequently moved into research.

The paper concerned is the 2004 paper by Weatherley-Jones et al. A randomised, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome. This was published in the Journal of Psychosomatic Research.

The homeopath was Clare Relton, currently Senior Lecturer in Clinical Trials at the Centre for Primary Care and Public Health at Queen Mary University of London and Honorary Senior Research Fellow, School of Health and Related Research at the University of Sheffield.

She gave a presentation at the 2019 conference of the Homeopathy Research Institute. Billed as an International Homeopathy Research Conference, it was subtitled, Cutting edge research in homeopathy. The videos of the conference were sponsored by homeopathy manufacturing giant, Boiron.

My complaint email (see below) explains what I discovered and sets the context. As a result of the investigation by the journal, the current editor along with two former editors have just published a peer-reviewed paper on my complaint and their investigation:

When is lack of scientific integrity a reason for retracting a paper? A case study

Misconduct and unethical behaviour

It’s worth noting how serious the Journal of Psychosomatic Research considered the misconduct they identified by Relton and others. From the Results section of the paper:

We found the presentation by Dr. Relton disturbing on multiple grounds. This admission of unethical behavior calls her scientific integrity into question. The premise for her actions rests on an errant assumption widespread among clinicians, based on anecdotal experience, that one possesses an ultimate knowledge of what works and doesn’t work without the need for rigorous study. The history of medicine, unfortunately, has been littered by countless treatments that practitioners believed in and dispensed, only to be later found not beneficial or even harmful [4]. This underscores the importance of rigorous study for treatments where equipoise exists in the scientific community, as it arguably did for the use of homeopathy for chronic fatigue syndrome. Dr. Relton likely did not hold that equipoise herself, but if she had ethical concerns about the study, the appropriate action would have been to not participate in it. Instead, she purports to have enlisted colleagues to deliberately and systematically undermine the study.

In watching the presentation, the purpose of this admission seemed to be to discount the results of a rigorous but essentially negative study in the context of promoting her own ideas related to trial design. While we cannot know for certain that her motivation was to discount the results of this study, what she said clearly seeks to undermine the credibility of a trial whose results challenged her firmly held but untested beliefs about the benefit of a treatment that she had high allegiance to. Regardless of her intent or what actually happened during the trial, Dr. Relton’s presentation is ipso facto evidence of either an admitted prior ethical breach or is itself an ethical breach for the following reasons. Either she indeed undermined an ambitious effort to study of the efficacy of homeopathy for chronic fatigue syndrome, negating the work of all other investigators, study staff, and participants involved in the study as well as the investment of the public, or she is conducting a late and inappropriate attack on the study’s credibility. Her presentation certainly warrants formal censure from the scientific community, and this paper may contribute to that. Despite this clear indictment, after discussing and considering the complaint of Mr. Henness for several months, we ultimately decided not to retract the paper.

They decided not to retract the paper but instead use it for ethical reflection. However, they concluded I had highlighted “undisputable evidence of scientific misconduct” by the homeopaths concerned:

When is lack of scientific integrity a reason for retracting a paper? A case study

Objective: The journal received a request to retract a paper reporting the results of a triple-blind randomized placebo-controlled trial. The present and immediate past editors expand on the journal’s decision not to retract this paper in spite of undisputable evidence of scientific misconduct on behalf of one of the investigators.

Methods: The editors present an ethical reflection on the request to retract this randomized clinical trial with consideration of relevant guidelines from the committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE) applied to the unique contextual issues of this case.

Results: In this case, scientific misconduct by a blinded provider of a homeopathy intervention attempted to undermine the study blind. As part of the study, the integrity of the study blind was assessed. Neither participants nor homeopaths were able to identify whether the participant was assigned to homeopathic medicine or placebo. Central to the decision not to retract the paper was the fact that the rigorous scientific design provided evidence that the outcome of the study was not affected by the misconduct. The misconduct itself was thought to be insufficient reason to retract the paper.

Conclusion: Retracting a paper of which the outcome is still valid was in itself considered unethical, as it takes away the opportunity to benefit from its results, rendering the whole study useless. In such cases, scientific misconduct is better handled through other professional channels.

Ethical misconduct

The authors had additional ethical concerns:

Apart from the intention of ‘circumventing the blind’, there is another unethical aspect to the behavior of Dr. Relton, namely the fact that patients were systematically subject to an intervention (carcinosin administration) that was not part of the original research protocol and to which they did not consent as part of the study. Although the systematic administration of carcinosin was not part of the study protocol, it was administered only to patients taking part in the study, and because they took part in the study. Presumably, these patients were not properly informed, or maybe even misinformed, about the rationale of a double-blind trial design and/or the true reason for administrating carcinosin. Apparently, ‘deep listening and deep understanding’ does not necessarily need to be accompanied by an honest and open attitude towards patients that participate in research. Dr. Relton stated in her lecture ‘I’m not trained to be deceiving people’, but that is exactly what she did. Not only did she deceive patients, but also the researchers and study leaders that she is supposed to collaborate with as a colleague. [emphasis in original]

Sanctions

The authors said:

The authors are of the opinion that in case the misconduct was not conducted by or on behalf of the principal investigator – as is the case here -, the initiative for further action should lie with them. Not only is the principal investigator the one that was deceived, but they are in a better position to report the misconduct to the institution and funding body. If the principal investigator is responsible for the misconduct, the editor is probably the only one that can initiate further action, in which case the researcher’s institution should be informed and requested to take appropriate action.

It will be interesting to see what further action, if any, is taken by Weatherley-Jones as is suggested.

I had already brought my concerns to the attention of both the University of Sheffield and Queen Mary University of London. The former concluded:

This is to confirm that the University of Sheffield has now completed its assessment of this matter, and it has been agreed that it would not be appropriate for the University of Sheffield to undertake a research misconduct investigation of the allegation against Clare Relton, since she is not a current member of University staff, nor was she a member of staff at the time of the clinical trial in question.

In relation to the potential concerns about the reliability of the published research findings, the University is satisfied that the Journal of Psychosomatic Research is consulting with the authors and taking steps to address the concerns as appropriate. The University will therefore be taking no further action.

I received no response from Queen Mary University of London, despite their Principal being copied in on all the relevant correspondence.

I will be writing again to both and Weatherley-Jones now the paper has been published.

Acknowledgements

My thanks to Jess G. Fiedorowicz, Editor, Journal of Psychosomatic, for his thorough investigation of my complaint.


My complaint

Hi

The results of a trial were published in the Journal of Psychosomatic Research in 2004 (see attached copy):

A randomised, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome

doi:10.1016/S0022-3999(03)00377-5

Elaine Weatherley-Jones a,*, Jon P Nicholl a, Kate J Thomas a, Gareth J Parry a, Michael W McKendrickb, Stephen T Green b, Philip J Stanley c, Sean PJ Lynch d

a Medical Care Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK
b Communicable Diseases Directorate, Royal Hallamshire Hospital, Sheffield, UK
c Seacroft Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK
d St. James’s University Hospital, University of Leeds, Beckett Street, Leeds, UK

* Corresponding author. Tel.: +44-114-222-0744; fax: +44-114-222-0749.
E-mail address: e.weatherley-jones@sheffield.ac.uk (E. Weatherley-Jones)

The paper is indexed in PubMed here.

Elaine Weatherley-Jones is listed as the Corresponding author at the Medical Care Research Unit, School of Health and Related Research, University of Sheffield as are others.

One of the homeopaths involved in providing treatment was Clare Relton, currently Senior Lecturer in Clinical Trials at the Centre for Primary Care and Public Health at Queen Mary University of London.

The full list of those involved in providing treatment during the trial is given as:

The Homeopathic Trials Group: Homeopaths— Gill de Boer, MBChB, MFHom, Maryjoan Foster, RSHom, Susanne Hartley, RSHom, Jane Howarth, BRCPHom, Pat Mayborne RSHom, Georgina Ramsayer RSHom, Clare Relton, RSHom, Pat Strong, MBBS, MFHom, Angela Zajac, BSc, RSHom, BRCPHom.

Dr Relton gave a talk at the Conference in London of the Homeopathy Research Institute held 14 to 16 June 2019. The video of her talk has recently been published: https://www.hrilondon2019.org/films/#clip=eitxmhl1ilss. I have a copy of this video.

I invite you to watch all 30 minutes of it.

At about five minutes in, she begins to discuss the above trial, having just said she was a non-medical homeopath at the Wellforce Clinic in Sheffield. She is currently listed as Chair of Directors.

She then goes on to describe how she took part as one of the homeopaths in the trial and relates how she came up with “a cunning way of circumventing the blinding”.

I offer the following transcript of the segment of her talk where she discusses this (all transcription errors are mine):

Timestamp 05:12

So while I was still a homeopath in the Wellforce clinic, a researcher from the University of Sheffield which was actually only five minutes away from my clinic which was really handy came along and said, “I’ve got some money from Lord Sainsbury to do a trial of chronic fatigue syndrome of homoeopathy” and she described the design and I remember thinking, “not sure what that’s going to show”.

But anyway there were ten homeopaths recruited in Sheffield and Leeds and we saw patients with chronic fatigue syndrome.

A lot of us were getting patients with chronic fatigue syndrome anyway and particularly if they were never been well since glandular fever couple of doses of carcinosin 30 or 200 and they seem to make a really good recovery.

So we’re pretty confident about taking part in this trial.

So there were 130 or 140 patients recruited to the trial and then allocated to the homeopaths: there were five at our clinic and I was one of them.

Patients would arrive; you would do the normal thing, have the consultation with them. They seemed a bit standoffish, they were quite distant – I couldn’t work out why.

And then at the end of the consultation I had to say to them “well there’s a 50% chance that whatever I prescribe you is going to be a placebo”, which sort of sort of lowered the temperature in the in the in the Consulting room because you know they came because they have chronic fatigue; they came… didn’t come because they wanted to take part in an experimental game.

So we would ring the pharmacy up and tell them our prescription. Helios Pharmacy would then send out either placebo or the real remedy according to the allocation of the patient.

The patient would come back four weeks later and if they were better, great and if they weren’t it was really, really difficult. So, had I got the wrong prescription or were they on placebo?

So after about six months of this we started working out there was a cunning way of circumventing the blinding and we worked out, well if we give them all a dose of carcinosin they’re going to have some reaction: there’s going to be a dream there’s going to be some change and if when they come back at the second appointment they haven’t changed then we know they’re on placebo. So don’t bother doing all that trying to find the right remedy; just use all your other amazing skills you have as a homeopath: the deep listening we have the deep understanding of what we know about what’s toxic in our systems, about diet and counselling.

So that’s what we did. Because we’re homeopaths. We’re trained to treat people I’m not trained to be deceiving people. That’s what I do, that’s what I did then; that’s what all my colleagues did.

So ok, so the trial ended and at the end the results came out I’m sure quite a few of us are familiar with it.

There were two groups, so there was a group… everybody in the patient… everybody in the trial received treatment… a course of treatment by a homeopath and 50% of them received a placebo remedy 50% the real remedy, the verum.

And the results… both groups got better and the group that received the real remedy improved better than the group that received the placebo but was the difference clinically significant? Not quite. How many trials do we have that? So this trial was so much realisation, so many questions came out of my experience being inside, inside a double-blind placebo randomised controlled trial. What is seen as the… you know the… summit of evidence-based medicine in terms of rigorousness, I  just thought “what is this doing?” I don’t know what… I don’t know what this has shown.

This is what’s called an explanatory trial and I thought well it’s explaining nothing to me, apart from the fact that the system for designing and conducting randomised controlled trials at the moment isn’t working.

So lots of questions.

Timestamp 09:02

The paper states:

Patients were successfully blinded to their group allocation, and therefore we have assumed that whatever the reasons for nonresponse, they are the same for the treatment arm and the placebo arm and that the data are comparable. Therefore, intention to treat analyses was done on actual data plus imputed missing item data, but all unit missing data were excluded from analyses.

and:

Checking of double blinding showed that prediction of treatment group was made by neither homeopaths (j =. 07, P c.60) nor patients (j = 0.11, P c.48).

The trial was of a triple-blind design but there is no mention of the deliberate attempts to circumvent the blinding in the paper. The effects on participants by the actions – inadvertent or otherwise – of Relton and her colleagues are not considered and not known.

I believe the actions of Relton, the other four homeopaths at her clinic whom she clearly implicates in this circumvention of blinding, and possibly the remaining four homeopaths if they were all known to each other and in contact with each other since they were all in the same area of Leeds/Sheffield, compromised the trial design, rendered the results unreliable and seriously undermined the integrity of the paper and its conclusions. I do not believe it matters whether or not they were in fact able to circumvent the blinding, but it does matter that Relton and others believed they had because she admits it led to different behaviour on their part resulting in contamination of the results.

I believe the actions amount to misconduct.

I note additional criticism of this paper by Prof Edzard Ernst (see attached).

I ask that Sheffield University investigate this matter and that along with Queen Mary University of London and the Editor-in-chief of the Journal of Psychosomatic Research, Jess Fiedorowicz, MD, PhD, decide what actions to take. I ask that consideration is given to retracting this unsound paper.

Please consider this email as a formal complaint against Dr Clare Relton and others.

Please acknowledge receipt by return and keep me informed of your progress in investigating this matter and of your conclusions and outcome.

If you require any further information, please do not hesitate to contact me.

Best regards.
Alan Henness

The fact that the NHS England has stopped reimbursing homeopathy in 2018 is probably quite well known. France followed more recently, and then Germany too reported trouble for homeopaths on various levels. About two years ago, the manufacturer of homeopathic products, Hevert (Germany),  threatened legal action against several German critics of homeopathy for expressing the fact that highly diluted homeopathic remedies do not work beyond placebo. Crucially, the medical associations of many regions in Germany have – one after the next – discontinued their training in and recognition of homeopathy.

Now similar difficulties are being felt also by Austrian homeopaths. In 2019, the Vienna medical school closed its course on homeopathy because students had filed a complaint about its unethical content. And recently, it was reported by the Austrian ‘Initiative für Wissenschaftliche Medizin‘ that at a secret webinar run by lobbyists in Vienna things were reported to no longer going well for homeopathy. Faced with such problems, the lobbyist, Dr. Jens Behnke, recommended in the above-mentioned secret webinar an alliance of all so-called alternative medicine (SCAM):

“…..and if we do not form this broad alliance now, in order to make appropriate professional PR and lobbying … then everything will fall apart….”

Now a union of pseudomedicine and politics is being forged with the aim of stopping the decline of quackery and paving the way for pseudomedicine in Austria. A resolution has been tabled in the Austrian parliament with the following demands:

  1. Institutionalising of the field of “Complementary Medicine” as “Integrative Medicine” in the academic education at all medical schools.
  2. Appropriate support for and funding of complementary medicine research, especially in the university sector.
  3. Establishment of a broad range of complementary medicine in the hospital sector, in outpatient but also inpatient healthcare.
  4. Promotion of active knowledge transfer in the area of integrative and complementary medicine within the Austrian medical profession.
  5. Securing of complementary diplomas by the Austrian Medical Association.

The motion was introduced by the Freedom Party (FPÖ, the Austrian far-right party) on 21.12.2020, forwarded to the Health Committee for consultation, and is now scheduled for consultation there. The application was introduced by the FPÖ-Nationalratsabgeordnete Mag. Gerhard Kaniak (Chairman of the Health Committee of Parliament, pharmacist), Peter Wurm (entrepreneur), Dr. Dagmar Belakowitsch (physician), and “other deputies”. It is supported by members of the “Initiative Complementary Medicine at Austrian Universities” of the Austrian Society for Homeopathic Medicine. The list of signatories of the motion reads like the “Who’s Who” of pseudo-medicine procedures in Austria – foremost homeopathy, but also anthroposophic medicine, ozone therapy, functional myo-diagnostics (= kinesiology), Ayurvedic medicine, orthomolecular medicine, TCM, etc. It almost goes without saying that it also includes Prof Michael Frass (a prominent member of THE ALTERNATIVE MEDICINE HALL OF FAME), who regular readers of my blog would have met several times before.

__________________________

Instead of a comment (other than I sincerely wish that reason prevails in Austria and the motion is going to be defeated), I think I will quote the concluding phrases from my memoir (which incidentally also covers my most turbulent time in Vienna):

When science is abused, hijacked, or distorted in order to serve political or ideological belief systems, ethical standards will inevitably slip. The resulting pseudoscience is a deceit perpetrated on the weak and the vulnerable. We owe it to ourselves, and to those who come after us, to stand up for the truth, no matter how much trouble this might bring.

 

 

 

Guest post by Ken McLeod

On 31 March 2020, the Chiropractic Board of Australia issued a statement1 to all Australian chiropractors that they:

“should not make advertising claims on preventing or protecting patients and health consumers from contracting COVID-19 or accelerating recovery from COVID-19. To do so involves risk to public safety and may be unlawful advertising. For example, we are seeing some advertising claims that spinal adjustment/manipulation, acupuncture and some products confer or boost immunity or enhance recovery from COVID-19 when there is no acceptable evidence in support.

“Advertisers must be able to provide acceptable evidence of any claims made about treatments that benefit patients/health consumers. We will consider taking action against anyone found to be making false or misleading claims about COVID-19 in advertising. If the advertiser is a registered health practitioner, breaching advertising obligations is also a professional conduct matter which may result in disciplinary action, especially where advertising is clearly false, misleading or exploitative.”

What could be clearer than that?

So what was published by a registered chiropractor on 16 March 2020, two weeks before the Board’s warning, and is still on his website 10 months later? You guessed it, a video on the website of chiropractor Morgan Weber, a video ‘Coronavirus – Balancing the hysteria…’, 2 in which he says:

– the COVID-19 19 pandemic is all ‘hysteria’ and ‘what have we got to worry about’, because ‘Our body, (has) 51 trillion cells’ vs ‘A one single-cell virus,’ (sic.) ‘51 trillion cells that orchestrate our immune system, every function. Yet we seem to have more faith and trust in ‘medicine’ than we do in this amazing body we call home. Crazy, right? Crazy.’

Weber further downplays the crisis by saying ‘Enough of this nonsense about the big bad bug and all the worry about washing your hands.’

Weber, after denigrating evidence-based medicine, recommends instead:

– ‘Keep up with your chiropractic adjustments….’

Weber is a registered chiropractor practicing at Wave Chiropractic, Maroochydore, Queensland, Australia. His AHPRA registration is CHI0001601286. Weber’s webpage home site is at https://www.wavechiropractic.com.au/index.php

WEBER’S VIDEO:

Since 16 March 2020 Weber has posted a video on his website a video ‘Coronavirus – Balancing the hysteria…’. 3

Weber says:

BEGINS TRANSCRIPT

00:00. Hi everyone. Hasn’t it been fascinating lately? The news, the hysteria. Everything has gone almost upside-down. Crazy. I found it so fascinating.

00:12. So today we thought we would have a bit of a chat and sort of balance the scales and the story getting told out there in the mass media. I hope you’ve got your toilet paper stockpiled and sorted ha ha ha ha. It’s hilarious to see people coming and going with huge amounts under their arms as they come out of the grocery store. Crazy isn’t it, crazy times.

00:42. So let’s think about if for a second, and if we bypass all that hysteria and noise and just think a little bit about this. Our body, 51 trillion cells. A one single-cell virus. My gosh. What have we got to worry about? We have this amazing system. 51 trillion cells that orchestrate our immune system, every function. Yet we seem to have more faith and trust in ‘medicine’ than we do in this amazing body we call home. Crazy, right? Crazy.

01:20 ‘The other story, the other sort of facts behind what we do, and I (unintelligible) told a fair few of you of this already, how the immune system works. So, across the road from Waves, we have a really kind of bare patch of grass, just before you go onto the beach. Now if I took a handful of seeds. Now this is an analogy for how our system works, and how amazing our body’s immune system is. If I took a bunch of seeds and dropped them onto the ground, some grass seeds, not all of those seeds would take. There needs to be a hospitable environment, a moist warm sunlit area for those seeds to take, then root and grow into a fully mature grass and perpetuate on and on and on. However that area across the road is barren rocky sandy and yuck. You drop those seeds, most of those are going to blow off and away because that area is a no-go, it’s got a strong resistance, a barrier, a non-hospitable environment.

02:18. Now that is how our immune system works. Now the story I feel that should be out there, is what are you doing to nurture your body to do the best it can be, to have the strongest barrier it can be.

02: 30. Enough of this nonsense about the big bad bug and all the worry about washing your hands. ‘Cause I tell you what, if you are neglecting to nurture your body and the 51 trillion cells to be the best they can be, watch out, that may not be enough, washing your hands.

02:47. So let’s talk about that. How do we orchestrate a healthy system that has a strong immune barrier to anything that’s out there? And really guys, this should be a day-to-day forte (?) for everyone who just wants to be their best.

03:00. So let’s go through it. Boosting your barriers. You need to trust your body. First and foremost, the 51 trillion cells are remarkable. Trust in that.

03: 12. You’ve gotta eat well. Eat well with nutrient-dense, mineral-dense foods. Stay well hydrated. Move. You’ve gotta move well. Exercise your body regularly, moving all parts in all directions. Enjoy healthy sunlight exposure. You’ve gotta think well. Follow your passions and purpose. Think positively. Perhaps switch off the TV.

03:41. Keep up with your chiropractic adjustments. An optimal brain and body communication via the nervous system is vital so ensuring your body is in a surviving state. Do all these things guys. Up the ante of them. Go in harder with your (unintelligible) exercises, your hydration etcetera, and trust in your body. It’s amazing. It’s built with this in-built protective mechanism. Foster it. Help to balance that story out there, and help people to take on a more useful interpretation of this current crisis out there.

04:19. I hope this was of value and you guys enjoy.

END TRANSCRIPT

The regulator has been informed. As the world’s death toll rockets past 2 million, we wait to see if they really meant what they said about disciplinary action.

 

One of my last posts re-ignited the discussion about the elementary issue of informed consent, specifically about informed consent for chiropractors. As it was repeatedly claimed that, in Australia, informed consent is a legal requirement for all chiros, I asked on Wednesday 11 November 2020 at 07:12

FOUR QUESTIONS TO DC + CRITICAL CHIRO (CC):

1) what does the law say about informed consent for Australian chiros?
2) what info exactly do you have to provide?
3) who monitors it?
4) what published evidence do we have about compliance?

CC then posted this reply:

Here we go again you demand evidence while providing little if any for your own assumptions (poor case studies do not count. The pleural of anecdote does not equal evidence whether it’s from chiro’s or you).
We have been over this many times over many years, I cite research/provide links yet you still find it challenging to take it onboard. It is human nature to feel obligated once making a public statement to defend it no matter how much evidence is sent your way. So not surprising.

“1) what does the law say about informed consent for Australian chiros?”
It is all freely available on the national regulators website (as you know and as I have referenced in the past):
https://www.chiropracticboard.gov.au/Codes-guidelines/Code-of-conduct.aspx
https://www.chiropracticboard.gov.au/Search.aspx?q=Informed+consent
Some research by chiropractors on this topic (cited many times in the past):
Risk Management for Chiropractors and Osteopaths. Informed consent
A Common Law Requirement (2004):
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2051308/
Quick advanced PubMed with filters set to “Chiropractic” AND “Informed consent”.
https://www.ncbi.nlm.nih.gov/pmc/?term=(Chiropractic)+AND+Informed+consent
Not rocket science
Latest paper that you wrote an ill informed blog on and the comments were not going as you expected (So I expected you to double down like Donald Trump with a new blog within days. Your getting predictable).
https://chiromt.biomedcentral.com/articles/10.1186/s12998-020-00342-5
This paper questions the legal implications of vertebral subluxations with high powered legal input and is a broadside by evidence based chiropractors against vitalistic chiropractors. You respond a snide fantasy informed consent dialogue when you should be supporting the authors:
https://edzardernst.com/2020/11/informed-consent-why-chiropractors-dont-like-it/

“2) what info exactly do you have to provide?”
“4) what published evidence do we have about compliance?”
We have discussed this as well. It is a common law requirement for every profession and is checked upon re-registration by AHPRA every year and by the professional indemnity insurers every year. No informed consent, no registration and no professional indemnity insurance.
Checked AHPRA’s panel decisions and went back 5 YEARS and found ONE decision relating to informed consent:
https://www.ahpra.gov.au/Publications/Panel-decisions.aspx

“3) who monitors it?”
Another of your tired old arguments that we have discussed many times over the years.
In the UK there is the “‘Chiropractic Reporting and Learning System’ (CRLS)” but this is set up by the association representing chiropractors and not the registration board that advocates for patients. Right idea and step in the right direction, wrong organization.
Here years ago there was a trial of an adverse event reporting system in a Melbourne emergency department systematically collected relevant AE information on all professions which was sent to the relevant board for investigation.
It was supported by doctors and chiropractors while physio’s were not involved. A doctor involved told me it was killed off by ER doctors who “snivelled” about the extra paperwork.
There is no AE reporting system for physio’s, chiro’s, osteo’s, GP’s in private practice etc.
Over the years you have harped on and on about this topic as if it is a failing purely of the chiropractic profession when we have supported initiatives for its implementation.
You have also kept up with the research even commenting on an chiropractic researcher on AE’s Charlotte Leboeuf-Yde (who you highly regard) yet ignored until you could take issue with two sentences written in a blog then you wrote this hatchet blog:
https://edzardernst.com/2017/04/we-have-an-ethical-legal-and-moral-duty-to-discourage-chiropractic-neck-manipulations/
So you are asking for evidence yet willfully ignore an author who “I have always thought highly of Charlotte’s work”.

Stop the cynical cherry picked blogs and start supporting the researchers and reformers otherwise you are just someone standing on the sidelines blindly throwing grenades. You do not care who you hit or the damage you do to the chiropractors leading the reform you demand yet consistently fail to support.

____________________________________

I thought the tone of this response was oddly aggressive and found that CC had failed to understand some of my questions. Yet the link to the chiro’s code of conduct https://www.chiropracticboard.gov.au/Codes-guidelines/Code-of-conduct.aspx was useful. This is what it says about informed consent:

3.5 Informed consent
Informed consent is a person’s voluntary decision about healthcare that is made with knowledge and understanding of the benefits and risks involved. A useful guide to the information that chiropractors need to give to patients is available in the National Health and Medical Research Council (NHMRC) publication General guidelines for medical practitioners in providing information to patients.3 The NHMRC guidelines cover the information that chiropractors should provide about their proposed management or approach, including the need to provide more information where the risk of harm is greater and likely to be more serious, and advice about how to present information. Good practice involves:
a) providing information to patients in a way they can understand before asking for their consent
b) providing an explanation of the treatment/care recommended, its likely duration, expected benefits and cost, any alternative(s) to the proposed care, their relative risks/benefits, as well as the likely consequences of no care
c) obtaining informed consent or other valid authority before undertaking any examination or investigation, providing treatment/care (this may not be possible in an emergency) or involving patients in teaching or research, including providing information on material risks
 d) consent being freely given, without coercion or pressure
 e) advising patients, when referring a patient for investigation or treatment/ care, that there may be additional costs, which they may wish to clarify before proceeding
 f) obtaining (when working with a patient whose capacity to give consent is or may be impaired or limited) the consent of people with legal authority to act on behalf of the patient, and attempting to obtain the consent of the patient as far as practically possible
 g) being mindful of additional informed consent requirements when supplying or prescribing products not approved or made in Australia, and
h) documenting consent appropriately, including considering the need for written consent for procedures that may result in serious injury or death.
_______________________________________
This does indeed clarify some of my questions. Related to the fictional patient with neck pain who consults a chiropractor in my previous post, this means the chiro must inform the patient that:
  • the chiro suggests a manipulation of the neck;
  • this often involves forcing a spinal joint beyond its physiological range of motion;
  • the treatment will be short but needs repeating several times during the coming weeks;
  • the expected benefits are a reduction of pain and improvement of motion;
  • the total cost of the treatment series will be xy;
  • there are many other treatment options for neck pain;
  • most of these have a better risk/benefit profile than neck manipulation;
  • having no treatment for neck pain at all is likely to lead to full resolution of the problem over time.

Apart from any doubts that chiropractors would actually comply with these requirements, the question remains: is the listed information sufficient? Does it outline a truly a fully informed consent? I think that essential aspects of informed consent are missing.

  • The code does not explicidly require an explanation about the possible harms of spinal manipulation (i.e. 50% of all patients will suffer mild to moderate adverse effects lasting 2-3 days, and occasionally patients will have a stroke of which some have died).
  • Moreover, the code mentions EXPECTED benefits, but not benefits supported by evidence. Chiros may well EXPECT their treatment to work, but what does the evidence show? As often discussed on this blog, the evidence is negative or very week, depending how you want to interpret it. The code does not require a chiro to inform his patients about this fact.

So, the way I see it, the code does not expressedly demand the chiro to explain his patient that the treatment he is being asked to consent to is

  1. not supported by sound evidence for effectiveness,
  2. nor that the treatment is burdened with significant risks.

And what about the other questions listed above? An Australian chiropractor who will remain anonymous gave me the following answers:

Who monitors Informed Consent?
 
The short answer here is nobody monitors informed consent.  Typically informed consent is a side issue whenever a negligence claim is made.  Similarly, clinical records are a side issue as well.   Thus, when a patient alleges they were injured a complaint is lodged.  As part of the investigation consideration is given regarding the consent process.  If the analysis determines that the adverse outcome was maloccurence rather than negligence  but valid consent was not obtained, the practitioner will still face disciplinary action. 
 
As we are all too well aware, the Boards show little or no desire to be proactive.  I have yet to see any results from the pilot advertising audit project which began approximately 2 years ago.
 
What published evidence have we ab​out compliance?
 
Good question.  To my knowledge Langworthy & Flemming’s 2005 paper is the only one looking at compliance.  Their results suggest that the majority of respondents would be unable to successfully defend a negligence in consent liability charge.  In my experience providing expert opinions in Australian cases, valid consent was not obtained in a single case.  The most bizarre case had the practitioner their expert argue that consent obtained 7 years prior to the injury was still valid.  
 
Langworthy J.M., Cambron J. Consent: its practices and implications in United Kingdom and the United States chiropractic practice. J Manip Physiol Ther. 2007;(6):419–431.

_____________________________________

Yet, Australian chiropractors claim that they abide by the ethical imperative of informed consent. Are they taking the Mickey?

Perhaps not. Perhaps they are merely trying to make sure they do not lose the majority of their clientele. As I already pointed out in my previous post, fully informed consent would make most chiropractic patients turn round and run a mile.

I was alerted to an outstanding article by an unusual author, a law firm, on the subject of chiropractic. Allow me to quote a few passages from it (without changing a word or adding a comment):

When Katie May passed away suddenly from a stroke at just 34 years old, it was initially ruled an accident. After further investigation, a coroner determined the stroke that claimed the model and single mother’s life was caused by injuries sustained during neck manipulation by a chiropractor. And Ms. May is not the first to be affected by this seemingly harmless procedure…

What health issues can be caused by chiropractic manipulation?

Chiropractors typically use their hands to apply pressure to joints, aiming to help alleviate pain and improve body function. This is referred to as a chiropractic adjustment.

Adjustments are commonly performed for neck and/or back pain. Although the Mayo Clinic says the risk of a serious complication is relatively small, these complications can include:

  • A herniated disk, or worsening of an existing herniated disk
  • Compression of nerves in the lower spinal column
  • Stroke, which can result in paralysis or death

The last item on this list is particularly concerning.

Patients who receive neck manipulation are at risk for a stroke caused by vertebral artery dissection. Located in the neck, the vertebral arteries supply blood to the brain and can be torn by stretching and sudden force applied during a neck adjustment.

Studies have shown that vertebral artery dissection occurs in approximately 1 in 100,000 people and can be caused by something as simple as cracking your neck.

How could a chiropractor be responsible for a patient’s injury?

Although the risk of being seriously injured by a chiropractor is low, tragic accidents can and do happen. If you or a loved one believe you have been the victim of medical malpractice, please contact an experienced personal injury attorney.

Explaining how an injury or medical error occurred will help your attorney determine the potential liability of a chiropractor and any other involved parties. A chiropractor’s liability could fall into a legal category such as:

  • Failure to Diagnose a Medical Condition – The chiropractor breaches a duty of care to their patients by failing to diagnose an underlying medical condition. This could occur when a patient reveals or exhibits symptoms of a severe issue, such as a stroke, and is not referred for appropriate medical attention.
  • Lack of Informed Consent – A patient is treated without being properly informed of the potential risks or side effects, and experiences an injury from that treatment.
  • Negligent Manipulation – The patient’s body is adjusted by the chiropractor in such a way that it causes a new injury or worsens an existing injury. This could also include manipulation of a patient who is pregnant and goes into premature labor.
  • Chiropractic Induced Injury – A patient suffers injury, permanent irreversible damage such as paralysis or wrongful death as the direct result of a chiropractic manipulation.

To find out whether or not you may have a case, please discuss your concerns with a qualified personal injury attorney.

What should I do if I think I have been injured by chiropractic manipulation?

A personal injury attorney can help recover compensation for victims of medical malpractice, including those who have experienced a chiropractic injury. Surviving loved ones can also pursue their case after a family member’s wrongful death.

An attorney will help you collect documents, photos and other items pertaining to your case – but staying organized early in the process will be helpful. Try to preserve important documents, such as:

  • Photographs before and after treatment
  • Medical records and medical bills
  • Receipts, appointment confirmations and other paperwork from your chiropractor

There is a time limit to file a medical malpractice lawsuit, referred to as a statute of limitations…

It has been pointed out to me that my recent posts on the thorny subject of Donald Trump have angered many of his devoted fans. I am so sorry! Now that Trump is (almost) history, these poor, disappointed people need our help; they urgently need some effective anger management before they start firing those weapons they have been amassing.

This is why, in the spirit of building bridges and in the interest of peace, I have made an effort and put together a list of so-called alternative medicines (SCAMs) that might be useful.

Various pharmaceutical medications are available for treating anxiety, stress and anger problems:

Anxiolytics e.g. Alprazolam, Diazepam,
Antidepressants e.g. Paroxetine, Fluoxetine,
Antipsychotics e.g. Paliperidone, Risperidone,
Mood regulators e.g. Lithium, Valproate.

Oh, sorry! I have angered you again! I forgot, you are SCAM only. Let me have a look into my own book and find something that works for your problems.

ANXIETY

  • Massage
  • Music therapy
  • Various relaxation techniques

DEPRESSION

  • St John’s wort

Yes, these are the only SCAMs that are listed as being supported by sound evidence.

What, you say, you care a f**k about evidence? Of course, I should have known!

But my book offers nothing for delusional disorders, sorry.

Not good enough, you say? Alright, alright, keep your gun where it is. I better look elsewhere.

Found something. Thanks heavens for homeopathy! One can always rely on homeopaths to offer help, and they certainly know a thing or two about delusions! One website has this long list of remedies for delusional disorders:

Stramonium

Vision of animals, black dogs etc. (It also cured pneumonia on these symptoms). Thinks himself double, tall and a part missing and objects around him small. Cannot bear solitude and darkness; must have light and company. Sees ghosts, hears voices and talks with spirits. Feeling as if a long trail of bedbugs is pursuing her, and after them a procession of beetles and then comes crawling over her a host of cockroaches. Sees horrifying images at his side than in front of him. Sings amorous songs and utters obscene speeches. Hallucination and delirium. Attempts to stab and bite. Calls things by wrong names, his boots the logs of wood; his bedroom the stable. Has communication from God, delivers sermons, prophecies.

Lactuca Virosa

As if swimming in the air or walking above the ground.

Chloralum

Night terrors. Sees visions of arches. Hears voices when in the dark or when eyes are shut.

Lac Can

Delusions about snakes. Imagines he is surrounded by them. Afraid of closing the eyes for fear of being bitten by a snake. Feels to be walking in air. Tormenting thoughts. No reality in things; thinks that everything she says is a lie; she is not herself; her properties not her own; wears someone else’s nose.

Sabadilla

Erroneous impressions as to the state of her body e.g. that she is pregnant when she is merely swollen with flatus.

Platinum

Pride or over-estimate of one-self. Thinks she is superior to all others. Thinks her body is longer than those of others. Arrogant and haughty.

Camphor

Everything that moves is a ghost and inanimate things in the room become alive and terrify him. Extreme nervousness. Fear of strangers and of the dark.

Calcarea Carb

Sees and talks to persons who are not present. Imagines as if she is surrounded by dogs. Aversion to do any business. She is sad and melan­choly. Full of fear, weary of life.

Ailanthus

Feels as if a rat or something small is crawling up the limb and over the body.

Anacardium

The patient finds himself to be between good and evil will. His external will wants him to do some­thing evil, but his internal will stops him from doing this.

Indecisive

One moment he thinks it is so and the next moment has enough reason left that it is not so. Low spirited, disheartened, fears he is pursued by someone; looks for thieves, expects enemies, fears everything and everybody. He is pursuaded by his evil will to do acts of violence and injustice, but is withheld and restrained by his good will. (See also Hyosc, Bell., and Stram.) Hears voices of sister and mother who are far away.

Helleborus Nig

Stupefaction and sluggishness of the body and mind. Stupor from which he can be aroused with” difficulty and when so aroused he will talk about spirits or say that he sees devils with horns and tails. Hallucination.

Causticum

Conscience stricken as if she had committed a crime.

Ferrum Iod:

As if body had grown 30 feet high.

Baptisia T:

Feels as if body scattered into pieces.

Chamomilla

Hearing voices of absent persons which disturb his sleep.

Zincum Met

Voices from within him speaking in abusive and filthy language.

Belladonna

Sees frightful faces and monsters. Bites and strikes. Patient will not injure himself or others unless he thinks he is acting in self-defence. He will attack the person who is “acting against the patient’s will.

Spigelia

For apprehensive and nervous persons. Will not use razor, as something is constantly urging him to cut throat with it. Urge to commit suicide with fork when at dining table and so on. Afraid of sharp and pointed instruments.

Thuja

Sensation as though a living child were in the abdomen. Feels body thin and delicate, frail, easily breakable as if made of glass.

Cannabis Ind

Errors of perception as to space and as to time. The patient feels as if he had not taken any food for the last six months, although he had just finished his meals. A mile distance looks as if it were a hundred miles. Mind is full of unfinished ideas. Delusion of rhinoceros and elephants following him up. Imagines he hears sweet music, shuts his eyes and is lost in most delicious thoughts and dreams. Imagines someone calling him. Imagines as if he exists without form throughout a vast extent of space. His body seems to expand and the arch of his skull to be broader than the vault of heaven. All seem unreal. Feels himself unreal. All impressions extremely exaggerated. Hears voices and most sublime music; sees vision of beauty and glory, only to be equalled in paradise.

Arsenic Alb

Imagines house full of thieves. Runs through the house in search of them or hides himself in the house on account of fear.

Cicuta Virosa

Feels as if he were in a strange place and not living in ordinary conditions; everything appeared strange and almost frightful. Contempt of mankind. Runs away from his friends on account of disgust with their follies.

Viscum Alb

Delusion as if upper part of the body is floating in the air.

Coculus

Delusion as if something is rolling on walls, chairs, floor or elsewhere and will also roll on him.

Hyoscyamus

Talks to imaginary people as if they are sitting by his side. Talking to dead wife, sister or husband as if they were here again on earth. Imagines the things are worms, vermin, rats, cats, and mice. Feels as if his hands and fingers are too large.

Cocaine

Thinks he hears unpleasant remarks about himself; hallucination of hearing. Cannot sleep for hours after retiring. Sees and feels bugs and worms in his room and bed. Moral sense blunted.

Alumina

When he says anything, he feels as if another person has said it. Similarly if he sees anything, he feels as if another person had seen it, or as if he could transfer himself into another person and then only he could see. Confusion of personal identity.

Glonoine

Chin feels elongated to knees. Touching the chin repeatedly to be sure that it was not so.

Carboneum Sul

Hears voices and believes he has committed robbery.

Lachesis

When she sees anyone in whispering conversation, she thinks they are talking about her to her detriment. She thinks herself under superhuman control whose commands (partly in dream) she must obey. Fears that she is pursued by enemies; the medicine is a poison; that there are robbers in the house and she wants to jump out of window.

Melilotus

Delusion; thinks everyone is looking at her; fears to talk aloud; wants to run away.

Agnus C

Delusion of smell as of herring (kind of fish) or musk.

Coca

Delusion; of worms on the skin or clothing.

Aethusa

Delusion; sees cats and dogs; wants to jump out of bed or window.

Asarum Europ

As if hovering in the air. Vertigo as if drunk.

Baryta Carb

As if everything rocks with him, as in a ship.

Crocus

As if something alive is in abdomen. Imaginary pregnancy. Alternating mood.

Morphinum

As if room filled with babies. Man at foot of bed. Cannot describe symptoms.  Sobs at trifles.

Medorrhinum

Feels as if things done today were done a week ago; as if someone is whispering behind her, faces appearing from behind the furniture and look at her and say, “come”. Feels life unreal like a dream. Had committed unpardonable sin, and was going to hell. Not caring whether she goes to hell or heaven. Impatient, very selfish.

Mercurius

Feels as if worm rising in throat; apple-core stuck in throat; ice hi ear; cold water running from ears.

Palladium

Feels that she has been neglected. Wounded pride.

Petroleum

Imagines that another person or a child is in bed with her. Dreams that she is two or more. That her limbs are double.

Psorinum

Feels as if brain separated from the body; as if there is not enough room in forehead; as if he heard with ears not his own.

Cyclamen

Thinks herself impure and wants to take bath every time she touches somebody or something. Every thing seems double. As if person lying in bed. Ailments from duty not done or bad act committed.

Staphisagria

When he walks he feels as if someone were following him. This causes anxiety and fear and he cannot look behind.

Sulphur

Everything turns into beauty. Old rag and old stick looks to be a beautiful piece of workmanship. Every thing looks pretty which the patient takes fancy to. Wishing to touch everything.

Cannabis Sat

Hears hissing whisper to kill himself. This is an order from the Most High Command.

Cuprum Aceticum

Delusion that a policeman has come to seize him. Hallucinations of all kinds of figures and premises, especially in the evening, when shutting eyes or when going to sleep.

Oleander

Washes herself and her clothes after touching anything or any person, as she believes she has touched a dirty thing as a result of which she must wash.

Pyrogenium

Hallucination that he is very wealthy and has a large sum of money in the bank.

Nux Moschata

Seems as if he is two persons and watches his other self playing. He seems lost, and when spoken to would come to himself confused. Feels as if she has two heads.

________________________________

Did you find something that fits?

No?

Then let me help you: Pride or over-estimate of one-self. Thinks she is superior to all others. Arrogant and haughty. Yes, that must be for you; PLATINUM it is!!!

Hope you get better soon.

And, if I may, I suggest PYROGENIUM for your idol.

____________________________

 

 

PS

A personal note: during the last 4 years, I have turned down all invitations for lectures in the US and argued that I do not travel to counties with fascistoid leaders. Once the pandemic is under control, I’d be happy to reconsider.

The issue of informed consent has made regular appearances on this blog. It is important and has many intriguing aspects, particularly for so-called alternative medicine (SCAM). On the one hand, it is a ‘conditio sine qua non’ for any form of healthcare, while, on the other hand, it is a near impossibility in SCAM practice.

In this new article published in a chiro-journal, the authors review the origins of informed consent and trace the duty of disclosure and materiality through landmark medical consent cases in four common law (case law) jurisdictions. The duty of disclosure has evolved from a patriarchal exercise to one in which patient autonomy in clinical decision making is paramount. Passing time has seen the duty of disclosure evolve to include non-medical aspects that may influence the delivery of care. The authors argue that a patient cannot provide valid informed consent for the removal of vertebral subluxation. Further, vertebral subluxation care cannot meet code of conduct standards because it lacks an evidence base and is practitioner-centered.

The uptake of the expanded duty of disclosure has been slow and incomplete by practitioners and regulators. The expanded duty of disclosure has implications, both educative and punitive for regulators, chiropractic educators and professional associations. The authors discuss how practitioners and regulators can be informed by other sources such as consumer law. For regulators, reviewing and updating informed consent requirements is required. For practitioners it may necessitate disclosure of health status, conflict of interest when recommending “inhouse” products, recency of training after attending continuing professional development, practice patterns, personal interests and disciplinary findings.

The authors conclude that, ultimately such matters are informed by the deliberations of the courts. It is our opinion that the duty of a mature profession to critically self-evaluate and respond in the best interests of the patient before these matters arrive in court.

In their paper, the authors also provide a standard list of items required for ‘informed’ consent:

(1) emphasizing the patient’s role in shared decision-making

(2) disclosure of information

a. explaining the patient’s medical status including diagnosis and prognosis

b. describing the proposed diagnostic and therapeutic intervention, including the likelihood and effect of associated risks and benefits of the proposed action, including material risks

c. discussing alternatives to the proposed intervention, including doing nothing

(3) prompting and answering patient questions related to the proposed course of action (NB. this involves probing for understanding, not simply asking ‘do you have any questions’), and

(4) eliciting the patient’s preference (usually by signature). (NB. A signed form is not consent. The conversation between the clinician and the patient or carer is the true process of obtaining informed consent. The signature on the consent form is proof that the conversation took place and that the patient understood and agreed.)

The authors of this article – I do commend it to all chiropractors – take a mostly judicial view of informed consent (for an ethical perspective on the subject, I recommend our book). They do not discuss, whether chiropractors do, in fact, adhere to the ethical imperative of informed consent. As I have stated before, there is not much research on this issue. But the little that does exist fails to show that chiropractors care much about it.

But why?

If it’s an ethical imerative, why do chiropractors not abide by it?

The answer to this question is not difficult to find. Just imagine a conversation between a chiropractor (C) and a patient with neck pain (P):

  • P: What’s your diagnisis?
  • C: You are suffering from acute neck pain.
  • P: Thanks, that much was clear to me. What do you suggest I do?
  • C: I will perform a manipulation of your neck, if you agree.
  • P: Why would this help?
  • C: It can realign the vertebrae that are out of place, simply put.
  • P: And my pain will disappear?
  • C: Sometimes it does, yes.
  • P: But will it disappear quicker than without manipulation.
  • C: Some of the evidence says so.
  • P: Ok, but what does the most reliable evidence say?
  • C: It is not entirely clear cut.
  • P: Hmm, that does not sound too good.
  • P: So, tell me, are there any risks?
  • C: About 50% of patients suffer from minor to moderate pain for 2-3 days afterwards.
  • P: That’s a lot!
  • P: Anything else?
  • C: In some cases, neck manipulation was followed by a stroke.
  • P: Gee that’s bad; how often has this happened?
  • C: We know of about 500 such cases.
  • P: Heavens!
  • C: Now, do you want the treatment or not?
  • P: How much will you charge?
  • C: Only 60 Euros per session.
  • P: You mean I have to come back for more, each time risking a stroke?
  • C: Well… You don’t have to.
  • P: Thanks for the info; I am off. Cherio!

I rest my case. 

 

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

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

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

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

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

But this is equally puzzling.

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

But ‘clinical studies‘?

None!

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

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

Design:

Random double-blind placebo-controlled study

Setting:
Dr. Jamdar Hospital, Jabalpur, India

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

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

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

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

This is odd in several ways:

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

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

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

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

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

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

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

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

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

 

 

 

PS

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

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

Anyone who has followed the comments’ section of this blog knows that science communicators don’t always have it easy. In fact, they have to endure regular attacks. Now, this phenomenon has (as far as I know, for the first time) been investigated systematically.

The objective in this survey was to establish a taxonomy of common negative experiences encountered by those communicating medical science, and suggest guidelines so that they may be circumvented. A total of 142 prominent medical science communicators (defined as having >1000 Twitter followers and experience communicating medical science on social and traditional media platforms) were invited to take part in the survey. One hundred and one responses could be analysed.

The results show that:

  • 92% of the participants has experienced abusive behaviour (91.9%), including persistent harassment (69.3%) and physical violence and intimidation (5.9%).
  • 39% had received vexatious complaints to their employers, professional bodies or legal intimidation.
  • 62% reported negative mental health sequelae due to public outreach, including depression, anxiety and stress.
  • 20% had been obligated to seek police advice or legal counsel due to actions associated with their outreach work.
  • the majority targeted with vexatious complaints felt supported by their employer/professional body and 32% reported neutral, poor or non-existent support.

Here is a selection of the responses from the participants:

  • Accusations—including by one Senator—that [we are] uncaring, dismissive, neglectful, arrogant, or paid by pharma companies when advocating for vaccines. (Misrepresentation)
  • I find my expertise is questioned—this often seems to be when men find it difficult to accept women with intelligence and qualifications. Sexist insults are a typical go-to response. (Discreditation)
  • The worst one that hurt me professionally and personally was that activists gathered my emails using [Freedom of Information Requests] and handed chosen packets of them with a story to different reporters. (Misrepresentation/Discreditation/Dubious Amplification)
  • Persistent negative comments on twitter; usually it doesn’t last long but it can feel very intense while it’s happening! (Intimidation)
  • I have been served with a SLAPP lawsuit in order to silence my outreach work. Frequently receive harassing emails, malicious comments made on blog. (Malicious Complaints)
  • Social media co-ordinated intimidation, implied threats of legal action (for defamation). Mocking, undermining, condescension and attacks for being an industry shill, although. I am just a patient advocate. Being called a liar, that I never had cancer, that I deserved cancer due to my attitude, that I have been mutilated by conventional medical treatment, and that I am no longer a woman (having had mastectomy for cancer). That my cancer will return and I deserve that. (Dubious Amplification/Misrepresentation/Discreditation)
  • I have had anti-vaccine organizations and individuals attempt to prevent my public appearances and have been the subject of numerous online smear campaigns accusing me of being ‘a shill for Big Pharma’ etc. (Discreditation/Dubious Amplification)
  • Those who attack me very frequently try to do it by targeting me at my job, sending bogus complaints to my bosses and the university. From my observation, that is the go-to attack, the first thing these groups do. (Malicious Complaints)
  • I had to contact the police, who visited the person who was harassing me. I also involved social services. We bought a CCTV to monitor our front door after a strange envelope was hand delivered. The person involved has targeted several people before and continues to target individuals who advocate vaccination. (Intimidation)
  • Abuse and accusations of corruption are the most common adverse reaction I get. Sometimes a particular group petition one’s employer and try to create trouble for them. I have been lucky in the past when this happened to have had supportive universities who appreciate my outreach work. I have in the past had slightly unhinged individuals writing rambling, implicitly threatening letters to my office which ultimately required police intervention. (Discreditation/Malicious Complaints/Intimidation)
  • The worst are gendered insults (being called a cunt, etc.) and rape/death threats. I have had one empty legal threat that was widely publicized. (Intimidation/Malicious Complaints)
  • Regular threats to sue for defamation. (Malicious Complaints)
  • Attempts to get me fired, public records act requests for emails, verbal attacks on my children. (Malicious Complaints, Intimidation)
  • One of the most unpleasant things is that certain people or groupings will use very underhanded tactics to respond to perceived criticism. If they can’t refute the science, it isn’t uncommon for them to go after you personally, alleging all manner of things to anyone who’ll listen; that you’re incompetent, or unethical, or perverted. It seems they throw things wildly to see what sticks, but it can be extraordinarily unpleasant to endure. (Dubious Amplification/Discreditation)
  • My main concern has been obsessed individuals who declare their enmity and seem to be unconstrained by civil norms. (Intimidation)
  • Homeopathy advocates looked up my LinkedIn profile and called my employer to complain about my comments on the radio. My employer did not support me and I ended up having to stop the activity I had been planning. (Misrepresentation/Malicious Complaints)
  • Being threatened with physical violence. (Intimidation)
  • A delusional supporter of [an individual] I wrote about accused me and my lawyer of stalking him and killing his in-laws. He sent accusing emails to the faculty of my school and all the police departments in my state. [They] also accused me of being a terrorist and complained about me to the FBIs Terrorism Joint Task Force. That gave me many nervous, sleepless nights. (Discreditation/Malicious Complaints)
  • Death threats received, employer unhelpful, sorted myself. (Intimidation)
  • I haven’t experienced many negative encounters because I would say I am only lightly involved in public engagement. However the reason I don’t become more heavily involved in this area is fear of this kind of abuse and vexatious complaints to my employer or regulatory body. (Malicious Complaints)

The authors concluded as follows: The question of how we best communicate health science in the modern era is an area where more research is urgently required, especially on the role of social media, and optimum ways physicians, researchers and other public-facing figures can promote good medical science and mitigate falsehoods. The suggestions herein ought to be taken as a starting point, with discussion evolving as improved evidence materialises. There are wider problems implicit in all this that those communicating science cannot tackle in isolation; social media regulation particularly is a serious issue, both in regard to the spreading of misinformation/disinformation, and with respect to procedures preventing the potential weaponisation of social media platforms. Social media platforms must ultimately be made answerable to regulatory oversight, just as every other important aspect of life is; claims of innocence are unconvincing when their business model is so clearly dependent on advertising engagement at the cost of lives. The problem of poor reporting and false balance in conventional media outlets also must be considered, and there is significant scope for scientists and doctors to contribute to policy in these areas. There is ample evidence that physicians and scientists have an important role to play in combatting health disinformation, as has recently been argued by one of the authors in relation to vaccination for British Medical Journal opinion. But equally, it is crucial that those engaging in this vital work have the requisite support from their institutions, so that deleterious consequences of laudable outreach work might be circumvented. It is increasingly clear that disinformation about medicine and illness has become ubiquitous, with severe consequences for both our collective health and public understanding of medical science. Scientists and physicians must be at the vanguard of the pushback against these dangerous falsehoods—our societal well-being depends on it.

_______________________________________

This is an important paper, in my view. It is well worth reading in full.

I know many scientists who will no longer engage in science communication (other than publishing their papers and attending conferences) because they had one or two bad experiences. I certainly had hundreds of bad (some very bad) experiences, but I have taken the opposite decision.

Thus I started this blog, authored several books aimed at the consumer, give public lectures, etc. I have done this for many years despite the lack of support from my university and sometimes despite the opposite of support from my peers.

Why?

Why do I work tirelessly trying to inform consumers about so-called alternative medicine (SCAM)?

Because, in view of the plethora of (often dangerous) misinformation, it is hugely important to get the word out to the men and women in the street. I pity the ones who regularly allege that I do all this because of the money I earn from such activity (on the whole, it costs me money). In fact, I do what I do because I hope it might

  • stimulate rational thought,
  • help people to make wise therapeutic decisions,
  • make a small contribution to public health,
  • and perhaps occasionally even save a life.

And the threats which I continue to receive merely indicate that I might be doing this job well, and prove how important the task really is.

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