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

regulation

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The fact that homeopathy is under siege in France, has been discussed before. Now even the international media have picked up the story. Here are some excerpts from an interesting article in Bloomberg:

… The looming brawl gets to the heart of conflicting visions of the state’s involvement in the country’s health system at a time of eroding quality and services. Jobs are also at stake: France is home to Boiron SA, the leader in a global homeopathy market estimated at more than $30 billion.

Boiron’s pills and tinctures have long coexisted with conventional care in France, prescribed by regular doctors and dispensed in almost every pharmacy. Ending public support for the remedies would discredit homeopathy and “send a shock wave” through the industry worldwide, says Boiron’s chief executive officer, Valerie Poinsot. “We’ve been caught in this storm for the past year,” Poinsot says. “Why the hostility, when we contribute to caring for patients?”

Facing a possible backlash, Boiron, based in Lyon, teamed with rivals Weleda AG of Switzerland and closely held family group Lehning to fund a campaign called MyHomeoMyChoice. The push has garnered just over 1 million signatures in an online petition and placed bright-colored posters framed with the recognizable little white pills at pharmacies across the country. “Homeopathy has treated generations of French patients,” says one slogan. “Why deprive future generations?”

For now, French people can walk into any pharmacy and buy a tube of Arnica granules — recommended for shocks and bruises — or roughly a thousand other similar remedies for 1.6 euros ($1.80) with a prescription, because the state health system shoulders about 30% of its cost. In some cases, private insurers cover the remainder and patients pay nothing. That may all soon change. A science agency is wrapping up a study of the relative benefits of alternative medicine that will inform the government’s position: Keep the funding, trim it or scrap it altogether.

If the government cuts funding, Boiron would instantly feel the pain. Poinsot estimates that sales of reimbursed treatments could plummet by 50% in France, where the company brings in almost half its revenue. The company’s stock price has lost about 13% since May 15, when a French newspaper wrote that the panel reviewing homeopathy funding would probably rule against it…

In France, the controversy first erupted last year when the influential Le Figaro newspaper published a letter from a doctor’s collective called FakeMed lambasting alternative medicines. The authors called for ending support of “irrational and dangerous” therapies with “no scientific foundation.” The ensuing debate prompted Health Minister Agnes Buzyn to place funding under review and ask the country’s High Authority for Health to rule on homeopathy’s scientific merits…

David Beausire, a doctor in palliative care at the hospital in Mont de Marsan, in southwest France, is among those who signed the FakeMed letter. Beausire, who sees many terminally ill patients, said he regularly gets people who consult too late because they first explored alternative medicine paths that include homeopathy. “I am not an extremist,” he says. But homeopathy’s reimbursement by the state health system gives it legitimacy when “there’s no proof that it works.”…

Stung by accusations of quackery, Antoine Demonceaux, a doctor and homeopath in Reims, founded a group called SafeMed last November to relay the message that homeopathy has a role to play alongside standard care. He points to the growing number of cancer centers offering consultations to relieve treatment-related symptoms, such as nausea, with homeopathic medicine. Demonceaux says neither he nor his colleagues would ever use homeopathy as a substitute for treatments intended to, say, shrink tumors. “A general practitioner or a specialist who’d claim to be a homeopath and to cure cancer with homeopathy? Just sack him,” he says. “Let’s get real. We are doctors.”

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On the whole, this is a good report which – as far as I can see – describes the situation quite well and provides interesting details. What, however, with this articles and many like it is this: journalists (and others) are too often too lethargic or naïve to check the veracity of the claims that are being made during these disputes. For instance, it would not have been all that difficult to discover that:

  1. Hahnemann called clinicians who used homeopathy alongside conventional treatments ‘traitors‘! He categorically forbade it and denied that such an approach merits the name ‘HOMEOPATHY’. In other words, let’s get real and let’s not pull wool over the eyes of the public (and let’s be honest, it is not possible to practice homeopathy within the boundaries of medical ethics).
  2. Many homeopaths do advocate homeopathy as a sole treatment for cancer and other serious conditions (see for instance here, here and here).

The obvious risk of such lack of critical thinking is that homeopathy might be kept refundable on the basis of big, fat lies. And clearly, that would not be in the interest of anyone (with the exception of family Boiron, of course).

‘Acute-on-chronic liver failure’ (ACLF) is an acute deterioration of liver function in patients with pre-existing liver disease. It is usually associated with a precipitating event and results in the failure of one or more organs and high short term mortality.

An international team of researchers published a analysis examining data regarding drugs producing ACLF. They evaluated clinical features, laboratory characteristics, outcome, and predictors of mortality in patients with drug-induced ACLF. They identified drugs as precipitants of ACLF among prospective cohort of patients with ACLF from the Asian Pacific Association of Study of Liver (APASL) ACLF Research Consortium (AARC) database. Drugs were considered precipitants after exclusion of known causes together with a temporal association between exposure and decompensation. Outcome was defined as death from decompensation.

Of the 3,132 patients with ACLF, drugs were implicated as a cause in 10.5% of all cases and other non-drug causes in 89.5%. Within the first group, so-called alternative medications (SCAMs) were the commonest cause (71.7%), followed by combination anti-tuberculosis therapy drugs (27.3%). Alcoholic liver disease (28.6%), cryptogenic liver disease (25.5%), and non-alcoholic steatohepatitis (NASH) (16.7%) were common causes of underlying liver diseases. Patients with drug-induced ACLF had jaundice (100%), ascites (88%), encephalopathy (46.5%), high Model for End-Stage Liver Disease (MELD) (30.2), and Child-Turcotte-Pugh score (12.1). The overall 90-day mortality was higher in drug-induced (46.5%) than in non-drug-induced ACLF (38.8%).

The authors concluded that drugs are important identifiable causes of ACLF in Asia-Pacific countries, predominantly from complementary and alternative medications, followed by anti-tuberculosis drugs. Encephalopathy, bilirubin, blood urea, lactate, and international normalized ratio (INR) predict mortality in drug-induced ACLF.

The fact that some SCAMs can damage the liver has long been known. Here, for example, is 2003 our review of herbal medicine and liver problems:

Systematic literature searches were performed on Medline, Embase, The Cochrane Library, Amed and Ciscom. To identify additional data, searches were conducted by hand in relevant medical journals and in our own files. The screening and selection of articles and the extraction of data were performed independently by the two authors. There were no restrictions regarding the language of publication. In order to be included articles were required to report data on hepatotoxic events associated with the therapeutic use of herbal medicinal products.

Single medicinal herbs and combination preparations are associated with hepatotoxic events. Clinically, the spectrum ranges from transient elevations of liver enzyme levels to fulminant liver failure and death. In most instances hepatotoxic herbal constituents are believed to be the cause, while others may be due to herb-drug interactions, contamination and/or adulteration.

A number of herbal medicinal products are associated with serious hepatotoxic events. Incidence figures are largely unknown, and in most cases a causal attribution is not established. The challenge for the future is to systematically research this area, educate all parties involved, and minimize patient risk.

Despite these warnings, progress is almost non-existent. If anything the problem seems to increase in proportion with the rise in the use of SCAM. Hence, one cannot but agree with the conclusion of a more recent overview: The actual incidence and prevalence of herb-induced liver injury in developing nations remain largely unknown due to both poor pharmacovigilance programs and non-application of emerging technologies. Improving education and public awareness of the potential risks of herbals and herbal products is desirable to ensure that suspected adverse effects are formally reported. There is need for stricter regulations and pre-clinical studies necessary for efficacy and safety.

Homeopathy has had a long and profitable ride in France; nowhere else in Europe is it more popular, nowhere in Europe are the profit margins higher, and nowhere have I seen pharmacists pushing so hard to earn a few extra Euros on useless homeopathic remedies.

But, since a few months, sceptics have started to raise their voices and object to homeopathic reimbursement (currently at the rate of 30%) and to homeopathy in general.

  • A group of doctors protested against homeopathy by publishing an open letter in ‘Le Figaro’.
  • The French Academies of Medicine and Pharmacy published a report confirming the lack of evidence for homeopathy.
  • The medical school in Lille suspended its degree in homeopathy.

The French health secretary, the oncologist Dr Agnès Buzyn, reacted wisely, in my view. She initially stated that the effect of homeopathy is ‘probably a placebo effect‘. Subsequently, she asked the regulator, La Haute Autorite de Sante (HAS), to look into the matter and prepare a full analysis of the evidence. This report has now been published.

An article in ‘FRANCE INFO’ reports that HAS found no good evidence in support of the ~ 1 200 homeopathic remedies currently on the French market. The document is currently being considered by Dr Buzyn who will announce her decision about reimbursement in June. It is considered to be highly likely that she will stop reimbursement.

If so, consumers will soon have to pay in full for homeopathic preparations out of their own pocket. In addition, they would have to pay the VAT, and it is foreseeable that this change would signal the end of the French consumers’ love affair with homeopathy. This development is bound to seriously hurt Boiron, the world’s largest producer of homeopathics. The firm has already announced that they suspended its trading on the stock market and is now arguing that the move would endanger its sizable workforce.

The question I now ask myself is whether Boiron is powerful enough to do something about all this. Personally, I have been impressed by the rational approach of Dr Buzyn. She will no doubt see through Boiron’s bogus argument of saving a form of obsolete quackery in the name of employment. Therefore, I expect that the days of homeopathy’s reimbursement in France are counted.

(For those who can read French, I add the original ‘ FRANCE INFO’ article below.)

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Les granules homéopathiques offrent “un service médical rendu insuffisant” selon la HAS.

La Haute autorité de santé (HAS) recommande de ne plus rembourser les granules homéopathiques, alors que leur efficacité est controversée, selon les informations de franceinfo jeudi 16 mai. La HAS a envoyé aux laboratoires fabriquant des médicaments homéopathiques son projet d’avis pour les informer.Après avoir étudié 1 200 médicaments homéopathiques, la Haute autorité de santé estime que ces granules offrent un “service médical rendu insuffisant”. Elles demandent donc que les médicaments homéopathiques, jusque-là remboursés à hauteur de 30%, ne le soient désormais plus du tout.

Avis définitif en juin

Cet avis avait été réclamé par la ministre de la Santé il y a plusieurs mois face à la montée de la polémique entre médecins pro et anti-homéopathie. 124 médecins avaient relancé le débat l’an dernier en qualifiant les homéopathes de “charlatans”.

Désormais, lors d’une phase contradictoire, les laboratoires vont pouvoir répondre à la HAS, qui rendra son avis définitif en juin. La ministre de la Santé, Agnès Buzyn, avait par le passé annoncé qu’elle se rangerait à cet avis.

1 000 emplois menacés, selon Boiron

Les pro-homéopathie eux, s’insurgent. Selon eux, les granules ne coûtent que 130 millions d’euros par an à la Sécurité sociale, contre 20 milliards pour les médicaments classiques. Et il existe d’après eux, au minimum, un effet placebo. Pour les laboratoires Boiron, leader mondial du secteur, si l’homéopathie n’est plus remboursée, ce sont 1 000 emplois qui sont directement menacés.

Par ailleurs, dans un communiqué commun, trois laboratoires (Boiron, Lehning et Weleda) s’émeuvent de découvrir à travers un média la teneur d’un avis d’une agence indépendante qui devait être tenu confidentiel. Les laboratoires Boiron précisent à franceinfo qu’ils n’ont pas encore reçu le projet d’avis de la Haute autorité de santé. Boiron, entreprise française cotée, annonce “suspendre” son cours de bourse.

We have discussed the diagnostic methods used by practitioners of alternative medicine several times before (see for instance here, here, here, here, here and here). Now a new article has been published which sheds more light on this important issue.

The authors point out that the so-called alternative medicine (SCAM) community promote and sell a wide range of tests, many of which are of dubious clinical significance. Many have little or no clinical utility and have been widely discredited, whilst others are established tests that are used for unvalidated purposes.

  1. The paper mentions the 4 key factors for evaluation of diagnostic methods:
    Analytic validity of a test defines its ability to measure accurately and reliably the component of interest. Relevant parameters include analytical accuracy and precision, susceptibility to interferences and quality assurance.
  2. Clinical validity defines the ability to detect or predict the presence or absence of an accepted clinical disease or predisposition to such a disease. Relevant parameters include sensitivity, specificity, and an understanding of how these parameters change in different populations.
  3. Clinical utility refers to the likelihood that the test will lead to an improved outcome. What is the value of the information to the individual being tested and/or to the broader population?
  4. Ethical, legal and social implications (ELSI) of a test. Issues include how the test is promoted, how the reasons for testing are explained to the patient, the incidence of false-positive results and incorrect diagnoses, the potential for unnecessary treatment and the cost-effectiveness of testing.

The tests used by  SCAM-practitioners range from the highly complex, employing state of the art technology, e.g. heavy metal analysis using inductively coupled plasma-mass spectrometry, to the rudimentary, e.g. live blood cell analysis. Results of ‘SCAM tests’ are often accompanied by extensive clinical interpretations which may recommend, or be used to justify, unnecessary or harmful treatments. There are now a small number of laboratories across the globe that specialize in SCAM testing. Some SCAM laboratories operate completely outside of any accreditation programme whilst others are fully accredited to the standard of established clinical laboratories.

In their review, the authors explore SCAM testing in the United States, the United Kingdom and Australia with a focus on the common tests on offer, how they are reported, the evidence base for their clinical application and the regulations governing their use. They also review proposed changed to in-vitro diagnostic device regulations and how these might impact on SCAM testing.

The authors conclude hat the common factor in all these tests is the lack of evidence for clinical validity and utility as used in SCAM practice. This should not be surprising since this is true for SCAM practice in general. Once there is a sound evidence base for an intervention, such as a laboratory test, then it generally becomes incorporated into conventional medical practice.

The paper also discusses possible reasons why SCAM-tests are appealing:

  • Adding an element of science to the consultation. Patients know that conventional medicine relies heavily on laboratory diagnostics. If the SCAM practitioner orders laboratory tests, the patient may feel they are benefiting from a scientific approach.
  • Producing material diagnostic data to support a diagnosis. SCAM lab reports are well presented in a format that is attractive to patients adding legitimacy to a diagnosis. Tests are often ordered as large profiles of multiple analytes. It follows that this will increase the probability of getting results outside of a given reference interval purely by chance. ‘Abnormal’ results give the SCAM practitioner something to build a narrative around if clinical findings are unclear. This is particularly relevant for patients who have chronic conditions, such as CFS or fibromyalgia where a definitive cause has not been established and treatment options are limited.
  • Generating business opportunities using abnormal results. Some practitioners may use abnormal laboratory results to justify further testing, supplements or therapies that they can offer.
  • By offering tests that are not available through traditional healthcare services some SCAM practitioners may claim they are offering a unique specialist service that their doctor is unable to provide. This can be particularly appealing to patients with unexplained symptoms for which there are a limited range of evidenced-based investigations and treatments available.

Regulation of SCAM laboratory testing is clearly deficient, the authors of this paper conclude. Where SCAM testing is regulated at all, regulatory authorities primarily evaluate analytical validity of the tests a laboratory offers. Clinical validity and clinical utility are either not evaluated adequately or not evaluated at all and the ethical, legal and social implications of a test may only be considered on a reactive basis when consumers complain about how tests are advertised.

I have always thought that the issue of SCAM tests is hugely important; yet it remains much-neglected. A rubbish diagnosis is likely to result in a rubbish treatment. Unreliable diagnostic methods lead to false-positive and false-negative diagnoses. Both harm the patient. In 1995, I thus published a review that concluded with this warning “alternative” diagnostic methods may seriously threaten the safety and health of patients submitted to them. Orthodox doctors should be aware of the problem and inform their patients accordingly.

Sadly, my warning has so far had no effect whatsoever.

I hope this new paper is more successful.

Robert Verkerk, Executive & scientific director, Alliance for Natural Health (ANH), seems to adore me (maybe that’s why I kept this post for Valentine’s Day?). In 2006, he published this article about me (it is lengthy, and I therefore shortened a bit, but feel free to study it in its full beauty):

START OF QUOTE

PROFESSOR EDZARD ERNST, the UK’s first professor of complementary medicine, gets lots of exposure for his often overtly negative views on complementary medicine. He’s become the media’s favourite resource for a view on this controversial subject…

The interesting thing about Prof Ernst is that he seems to have come a long way from his humble beginnings as a recipient of the therapies that he now seems so critical of. Profiled by Geoff Watts in the British Medical Journal, the Prof tells us: ‘Our family doctor in the little village outside Munich where I grew up was a homoeopath. My mother swore by it. As a kid I was treated homoeopathically. So this kind of medicine just came naturally. Even during my studies I pursued other things like massage therapy and acupuncture. As a young doctor I had an appointment in a homeopathic hospital, and I was very impressed with its success rate. My boss told me that much of this success came from discontinuing main stream medication. This made a big impression on me.’ (BMJ Career Focus 2003; 327:166; doi:10.1136/bmj.327.7425.s166)…

After his early support for homeopathy, Professor Ernst has now become, de facto, one of its main opponents. Robin McKie, science editor for The Observer (December 18, 2005) reported Ernst as saying, ‘Homeopathic remedies don’t work. Study after study has shown it is simply the purest form of placebo. You may as well take a glass of water than a homeopathic medicine.’ Ernst, having done the proverbial 180 degree turn, has decided to stand firmly shoulder to shoulder with a number of other leading assailants of non-pharmaceutical therapies, such as Professors Michael Baum and Jonathan Waxman. On 22 May 2006, Baum and twelve other mainly retired surgeons, including Ernst himself, bandied together and co-signed an open letter, published in The Times, which condemned the NHS decision to include increasing numbers of complementary therapies…

As high profile as the Ernsts, Baums and Waxmans of this world might be—their views are not unanimous across the orthodox medical profession. Some of these contrary views were expressed just last Sunday in The Sunday Times (Lost in the cancer maze, 10 December 2006)…

The real loser in open battles between warring factions in healthcare could be the consumer. Imagine how schizophrenic you could become after reading any one of the many newspapers that contains both pro-natural therapy articles and stinging attacks like that found in this week’s Daily Mail. But then again, we may misjudge the consumer who is well known for his or her ability to vote with the feet—regardless. The consumer, just like Robert Sandall, and the millions around the world who continue to indulge in complementary therapies, will ultimately make choices that work for them. ‘Survival of the fittest’ could provide an explanation for why hostile attacks from the orthodox medical community, the media and over-zealous regulators have not dented the steady increase in the popularity of alternative medicine.

Although we live in a technocratic age where we’ve handed so much decision making to the specialists, perhaps this is one area where the might of the individual will reign. Maybe the disillusionment many feel for pharmaceutically-biased healthcare is beginning to kick in. Perhaps the dictates from the white coats will be overruled by the ever-powerful survival instinct and our need to stay in touch with nature, from which we’ve evolved.

END OF QUOTE

Elsewhere, Robert Verkerk even called me the ‘master trickster of evidence-based medicine’ and stated that Prof Ernst and his colleagues appear to be evaluating the ‘wrong’ variable. As Ernst himself admitted, his team are focused on exploring only one of the variables, the ‘specific therapeutic effect’ (Figs 1 and 2). It is apparent, however, that the outcome that is of much greater consequence to healthcare is the combined effect of all variables, referred to by Ernst as the ‘total effect’ (Fig 1). Ernst does not appear to acknowledge that the sum of these effects might differ greatly between experimental and non-experimental situations.

Adding insult to injury, Ernst’s next major apparent faux pas involves his interpretation, or misinterpretation, of results. These fundamental problems exist within a very significant body of Prof Ernst’s work, particularly that which has been most widely publicised because it is so antagonistic towards healing cultures that have in many cases existed and evolved over thousands of years.

By example, a recent ‘systematic review’ of individualised herbal medicine undertaken by Ernst and colleagues started with 1345 peer-reviewed studies. However, all but three (0.2%) of the studies (RCTs) were rejected. These three RCTs in turn each involved very specific types of herbal treatment, targeting patients with IBS, knee osteoarthritis and cancer, the latter also undergoing chemotherapy, respectively. The conclusions of the study, which fuelled negative media worldwide, disconcertingly extended well beyond the remit of the study or its results. An extract follows: “Individualised herbal medicine, as practised in European medical herbalism, Chinese herbal medicine and Ayurvedic herbal medicine, has a very sparse evidence base and there is no convincing evidence that it is effective in any [our emphasis] indication. Because of the high potential for adverse events and negative herb-herb and herb-drug interactions, this lack of evidence for effectiveness means that its use cannot be recommended (Postgrad Med J 2007; 83: 633-637).

Robert Verkerk has recently come to my attention again – as the main author of a lengthy report published in December 2018. Its ‘Executive Summary’ makes the following points relevant in the context of this blog (the numbers in his text were added by me and refer to my comments below):

  • This position paper proposes a universal framework, based on ecological and sustainability principles, aimed at allowing qualified health professionals (1), regardless of their respective modalities (disciplines), to work collaboratively and with full participation of the public in efforts to maintain or regenerate health and wellbeing. Accordingly, rather than offering ‘fixes’ for the NHS, the paper offers an approach that may significantly reduce the NHS’s current and growing disease burden that is set to reach crisis point given current levels of demand and funding.
  • A major factor driving the relentlessly rising costs of the NHS is its over-reliance on pharmaceuticals (2) to treat a variety of preventable, chronic disorders. These (3) are the result — not of infection or trauma — but rather of our 21st century lifestyles, to which the human body is not well adapted. The failure of pharmaceutically-based approaches to slow down, let alone reverse, the dual burden of obesity and type 2 diabetes means wider roll-out of effective multi-factorial approaches are desperately needed (4).
  • The NHS was created at a time when infectious diseases were the biggest killers (5). This is no longer the case, which is why the NHS must become part of a wider system that facilitates health regeneration or maintenance. The paper describes the major mechanisms underlying these chronic metabolic diseases, which are claiming an increasingly large portion of NHS funding. It identifies 12 domains of human health, many of which are routinely thrown out of balance by our contemporary lifestyles. The most effective way of treating lifestyle disorders is with appropriate lifestyle changes that are tailored to individuals, their needs and their circumstances. Such approaches, if appropriately supported and guided, tend to be far more economical and more sustainable as a means of maintaining or restoring people’s health (6).
  • A sustainable health system, as proposed in this position paper, is one in which the individual becomes much more responsible for maintaining his or her own health and where more effort is invested earlier in an individual’s life prior to the downstream manifestation of chronic, degenerative and preventable diseases (7). Substantially more education, support and guidance than is typically available in the NHS today will need to be provided by health professionals (1), informed as necessary by a range of markers and diagnostic techniques (8). Healthy dietary and lifestyle choices and behaviours (9) are most effective when imparted early, prior to symptoms of chronic diseases becoming evident and before additional diseases or disorders (comorbidities) have become deeply embedded.
  • The timing of the position paper’s release coincides not only with a time when the NHS is in crisis, but also when the UK is deep in negotiations over its extraction from the European Union (EU). The paper includes the identification of EU laws that are incompatible with sustainable health systems, that the UK would do well to reject when the time comes to re-consider the British statute books following the implementation of the Great Repeal Bill (10).
  • This paper represents the first comprehensive attempt to apply sustainability principles to the management of human health in the context of our current understanding of human biology and ecology, tailored specifically to the UK’s unique situation. It embodies approaches that work with, rather than against, nature (11). Sustainability principles have already been applied successfully to other sectors such as energy, construction and agriculture.
  • It is now imperative that the diverse range of interests and specialisms (12) involved in the management of human health come together. We owe it to future generations to work together urgently, earnestly and cooperatively to develop and thoroughly evaluate new ways of managing and creating health in our society. This blueprint represents a collaborative effort to give this process much needed momentum.

My very short comments:

  1. I fear that this is meant to include SCAM-practitioners who are neither qualified nor skilled to tackle such tasks.
  2. Dietary supplements (heavily promoted by the ANH) either have pharmacological effects, in which case they too must be seen as pharmaceuticals, or they are useless, in which case we should not promote them.
  3. I think ‘some of these’ would be more correct.
  4. Multifactorial yes, but we must make sure that useless SCAMs are not being pushed in through the back-door. Quackery must not be allowed to become a ‘factor’.
  5. Only, if we discount cancer and arteriosclerosis, I think.
  6. SCAM-practitioners have repeatedly demonstrated to be a risk to public health.
  7. All we know about disease prevention originates from conventional medicine and nothing from SCAM.
  8. Informed by…??? I would prefer ‘based on evidence’ (evidence being one term that the report does not seem to be fond of).
  9. All healthy dietary and lifestyle choices and behaviours that are backed by good evidence originate from and are part of conventional medicine, not SCAM.
  10. Do I detect the nasty whiff a pro-Brexit attitude her? I wonder what the ANH hopes for in a post-Brexit UK.
  11. The old chestnut of conventional medicine = unnatural and SCAM = natural is being warmed up here, it seems to me. Fallacy galore!
  12. The ANH would probably like to include a few SCAM-practitioners here.

Call me suspicious, but to me this ANH-initiative seems like a clever smoke-screen behind which they hope to sell their useless dietary supplements and homeopathic remedies to the unsuspecting British public. Am I mistaken?

The PGIH (currently chaired by the Tory MP David Tredinnick) was founded in 1992 (in the mid 1990, they once invited me to give a lecture which I did with pleasure). Its overriding aim is to bring about improvements in patient care. The PGIH have conducted a consultation that involved 113 SCAM-organisations and other stakeholders. The new PGIH-report is based on their feedback and makes 14 recommendations. They are all worth studying but, to keep this post concise, I have selected the three that fascinated me most:

Evidence Base and Research

NICE guidelines are too narrow and do not fit well with models of care such as complementary, traditional and natural therapies, and should incorporate qualitative evidence and patient outcomes measures as well as RCT evidence. Complementary, traditional and natural healthcare associations should take steps to educate and advise their members on the use of Measure Yourself Medical Outcome Profiles (MYMOP), and patient outcome measures should be collated by an independent central resource to identify for what conditions patients are seeking treatment, and with what outcomes.

Cancer Care

Every cancer patient and their families should be offered complementary therapies as part of their treatment package to support them in their cancer journey. Cancer centres and hospices providing access to complementary therapies should be encouraged to make wider use of Measure Yourself Concerns and Wellbeing (MYCaW) to evaluate the benefits gained by patients using complementary therapies in cancer support care. Co-ordinated research needs to be carried out, both clinical trials and qualitative studies, on a range of complementary, traditional and natural therapies used in cancer care support.

Cost Savings

The government should run NHS pilot projects which look at non-conventional ways of treating patients with long-term and chronic conditions affected by Effectiveness Gaps, such as stress, arthritis, asthma and musculoskeletal problems, and audit these results against conventional treatment options for these conditions to determine whether cost savings and better patient outcomes could be achieved.

END OF QUOTE

Here are a few brief comments on those three recommendations.

Evidence base and research

NICE guidelines are based on rigorous assessments of efficacy, safety and costs. Such evaluations are possible for all interventions, including SCAM. Qualitative data are useless for this purpose. Outcome measures like the MYMOP are measures that can and are used in clinical trials. To use them outside clinical trials would not provide any relevant information about the specific effects of SCAM because this cannot account for confounding factors like the natural history of the disease, regression towards the mean, etc. The entire paragraph disclosed a remarkable level of naivety and ignorance about research on behalf of the PGIH.

Cancer care

There is already a significant amount of research on SCAM for cancer (see for instance here). It shows that no SCAM is effective in curing any form of cancer, and that only very few SCAMs can effectively improve the quality of life of cancer patients. Considering these facts, the wholesale recommendation of offering SCAM to cancer patients can only be characterised as dangerous quackery.

Cost savings

Such a pilot project has already been conducted at the behest of Price Charles (see here). Its results show that flimsy research will generate flimsy findings. If anything, a rigorous trial would be needed to test whether more SCAM on the NHS saves or costs money. The data currently available suggests that the latter is the case (see also here, here, here, here, etc.).

Altogether, one gets the impression that the PGIH need to brush up on their science and knowledge (if they invite me, I’d be delighted to give them another lecture). As it stands, it seems unlikely that their approach will, in fact, bring about improvements in patient care.

The General Chiropractic Council (GCC) is the statutory body regulating all chiropractors in the UK. Their foremost aim, they claim, is to ensure the safety of patients undergoing chiropractic treatment. They also allege to be independent and say they want to protect the health and safety of the public by ensuring high standards of practice in the chiropractic profession.

That sounds good and (almost) convincing.

But is the GCC truly fit for purpose?

In a previous post, I found good reason to doubt it.

In a recent article, the GCC claimed that they started thinking about a new five-year strategy and began to shape four key strategic aims. So, let’s have a look. Here is the crucial passage:

 

A clear strategy is vital but, of course, implementation and getting things changed are where the real work lie. With that in mind, we have a specific business plan for 2019 – the first year of the new strategic plan. You can read it here. This means you’ll see some really important changes and benefits including:

  • Promote standards: review and improvements to CPD processes, supporting emerging new degree providers, a campaign to promote the public choosing a registered chiropractor
  • Develop the profession: supporting and enabling work with the professional bodies
  • Investigate and act: a full review of, and changes to, our Fitness to Practice processes to enable a more ‘right touch’ approach within our current legal framework, sharing more learning from the complaints we receive
  • Deliver value: a focus on communication and engagement, further work on our culture, a new website, an upgraded registration database for an improved user experience.

The changes being introduced, backed by the GCC’s Council, will have a positive effect. I know Nick, the new Chief Executive and Registrar and the staff team will make this a success. You as chiropractors also have an important role to play – keep engaging with us and take your own action to develop the profession, share your ideas and views as we transform the organisation, and work with us to ensure we maintain public confidence in the profession of chiropractic.

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Am I the only one who finds this more than a little naïve and unprofessional? More importantly, this statement hints at a strategy mainly aimed at promoting chiropractors regardless of whether they are doing more good than harm. This, it seems, is not in line with the GCC’s stated aims.

  • How can they already claim that the changes being introduced will have a positive effect?
  • Where in this strategy is the GCC’s alleged foremost aim, the protection of the public?
  • Where is any attempt to get chiropractic in line with the principles of EBM?
  • Where is an appeal to chiropractors to adopt the standards of medical ethics?
  • Where is an independent and continuous assessment of the effectiveness of chiropractic?
  • Where is a critical evaluation of its safety?
  • Where is an attempt to protect the public from the plethora of bogus claims made by UK chiropractors?

I feel that, given the recent history of UK chiropractic, these (and many other) points should be essential elements in any long-term strategy. I also feel that this new and potentially far-reaching statement provides little hope that the GCC is on the way towards getting fit for purpose.

The over-use of X-ray diagnostics by chiropractors has long been a concern (see for instance here,and here). As there is a paucity of reliable research on this issue, this new review is more than welcome.

It aimed to summarise the current evidence for the use of spinal X-ray in chiropractic practice, with consideration of the related risks and benefits. The authors, chiropractors from Australia and Canada who did a remarkable job in avoiding the term SUBLUXATION throughout the paper, showed that the proportion of patients receiving X-ray as a result of chiropractic consultation ranges from 8 to 84%. I find this range quite staggering and in need of an explanation.

The authors also stated that current evidence supports the use of spinal X-rays only in the diagnosis of trauma and spondyloarthropathy, and in the assessment of progressive spinal structural deformities such as adolescent idiopathic scoliosis. MRI is indicated to diagnose serious pathology such as cancer or infection, and to assess the need for surgical management in radiculopathy and spinal stenosis. Strong evidence demonstrates risks of imaging such as excessive radiation exposure, over-diagnosis, subsequent low-value investigation and treatment procedures, and increased costs. In most cases the potential benefits from routine imaging, including spinal X-rays, do not outweigh the potential harms. The authors state that the use of spinal X-rays should not be routinely performed in chiropractic practice, and should be guided by clinical guidelines and clinician judgement.

The problem, however, is that many chiropractors do not abide by those guidelines. The most recent data I am aware of suggests that  only about half of them are even aware of radiographic guidelines for low back pain. The reasons given for obtaining spinal X-rays by chiropractors are varied and many are not supported by evidence of benefit. These include diagnosis of pathology or trauma; determination of treatment options; detection of contraindications to care; spinal biomechanical analysis; patient reassurance; and medicolegal reasons.

One may well ask why chiropractors over-use X-rays. The authors of the new paper provide the following explanations:

  • lack of education,
  • ownership of X-ray facilities,
  • and preferred chiropractic technique modalities (i. e. treatment techniques which advocate the use of routine spinal X-rays to perform biomechanical analysis, direct appropriate treatment, and perform patient reassessment).

Crucially, the authors state that, based on the evidence, the use of X-ray imaging to diagnose benign spinal findings will not improve patient outcomes or safety. For care of non-specific back or neck pain, studies show no difference in treatment outcome when routine spinal X-rays have been used, compared to management without X-rays.

A common reason suggested by chiropractors for spinal X-ray imaging is to screen for anomalies or serious pathology that may contraindicate treatment that were otherwise unsuspected by the clinical presentation. While some cases of serious pathology, such as cancer and infection, may not initially present with definitive symptoms, X-ray assessment at this early stage of the disease process is also likely to be negative, and is not recommended as a screening tool.

The authors concluded that the use of spinal X-rays in chiropractic has been controversial, with benefits for the use of routine spinal X-rays being proposed by some elements of the profession. However, evidence of these postulated benefits is limited or non-existent. There is strong evidence to demonstrate potential harms associated with spinal X-rays including increased ionising radiation exposure, over-diagnosis, subsequent low-value investigation and treatment procedures, and increased unnecessary costs. Therefore, in the vast majority of cases who present to chiropractors, the potential benefit from spinal X-rays does not outweigh the potential harms. Spinal X-rays should not be performed as a routine part of chiropractic practice, and the decision to perform diagnostic imaging should be informed by evidence based clinical practice guidelines and clinician judgement.

So, if you consult a chiropractor – and I don’t quite see why you should – my advice would be not to agree to an X-ray.

According to the 2014 European Social Survey, Spain is relatively modest when it comes to using alternative therapies. While countries such as Austria, Denmark, Estonia, Finland, France, Germany, Lithuania, Sweden and Switzerland all have 1-year prevalence figures of over 30%, Spain only boasts a meagre 17%. Yet, its opposition to bogus treatments has recently become acute.

In 2016, it was reported that a master’s degree in homeopathic medicine at one of Spain’s top universities has been scrapped. Remarkably, the reason was “lack of scientific basis”. A university spokesman confirmed the course was being discontinued and gave three main reasons: “Firstly, the university’s Faculty of Medicine recommended scrapping the master’s because of the doubt that exists in the scientific community. Secondly, a lot of people within the university – professors and students across different faculties – had shown their opposition to the course. Thirdly, the postgraduate degree in homeopathic medicine is no longer approved by Spain’s Health Ministry.”

A few weeks ago, I had the great pleasure of being invited to a science festival in Bilbao and was impressed by the buoyant sceptic movement in Spain. At the time, two of my books were published in Spanish and received keen interest by the Spanish press.

 

And now, it has been reported that Spain’s Ministry of Health has released a list of only 2,008 homeopathic products whose manufacturers will have to apply for an official government license for if they wish to continue selling them. The homeopathic producers have until April 2019 to prove that their remedies actually work, which may very well completely slash homeopathic products in Spain.

It’s the latest blow for Spain’s homeopathy industry, once worth an estimated €100 million but which has seen a drop in public trust and therefore sales of around 30 percent in the last five years. Spain’s Health Ministry stopped allowing homeopathy treatments from being prescribed as part of people’s social security benefits, along with acupuncture, herbal medicine and body-based practices such as osteopathy, shiatsu or aromatherapy.

“Homeopathy is an alternative therapy that has not shown any scientific evidence that it works” Spanish Minister of Health Maria Luisa Carcedo is quoted as saying in La Vanguardia in response to the homeopathic blacklist. “I’m committed to combatting all forms of pseudoscience.”

Even though illegal and unethical, many remedies used in Traditional Chinese Medicine (TCM) still contain animal parts. This fact has long concerned critics. Not only is there no evidence that these ingredients have any positive health effects, they also endanger the survival of endangered species. In the past, China has paid lip service to conservation and evidence. However, even these half-hearted pronouncements seem to be a thing of the past.

China’s State Council is now replacing its 1993 ban on the trade of tiger bones and rhino horn. Horns of rhinos or bones of tigers that were bred in captivity can hence force be used “for medical research or clinical treatment of critical illnesses” under the new rules. The fact that no critical illness responds to either of these remedies seems to matter little.  Grave concern has therefore been voiced by the World Wildlife Fund (WWF) over China’s announcement.

“It is deeply concerning that China has reversed its 25 year old tiger bone and rhino horn ban, allowing a trade that will have devastating consequences globally”, said Margaret Kinnaird, WWF Wildlife Practice Leader. “Trade in tiger bone and rhino horn was banned in 1993. The resumption of a legal market for these products is an enormous setback to efforts to protect tigers and rhinos in the wild. China’s experience with the domestic ivory trade has clearly shown the difficulties of trying to control parallel legal and illegal markets for ivory. Not only could this lead to the risk of legal trade providing cover to illegal trade, this policy will also stimulate demand that had otherwise declined since the ban was put in place.”

Both tiger bone and rhino horn were removed from the TCM pharmacopeia in 1993, and the World Federation of Chinese Medicine Societies released a statement in 2010 urging members not to use tiger bone or any other parts from endangered species. Even if restricted to antiques and use in hospitals, the WWF argue, this trade would increase confusion by consumers and law enforcers as to which products are and are not legal, and would likely expand the markets for other tiger and rhino products. “With wild tiger and rhino populations at such low levels and facing numerous threats, legalized trade in their parts is simply too great a gamble for China to take. This decision seems to contradict the leadership China has shown recently in tackling the illegal wildlife trade, including the closure of their domestic ivory market, a game changer for elephants warmly welcomed by the global community,” Kinnaird added.

WWF calls on China to set a clear plan and timeline to close existing captive tiger breeding facilities used for commercial purposes. Such tiger farms pose a high risk to wild tiger conservation by complicating enforcement and increasing demand in tiger products.

China’s announcement comes at the precise moment when we learnt from the 2018 edition of the Living Planet Report that, between 1970 and 2014, there was 60% decline, on average, among 16,700 wildlife populations around the world. The Living Planet report, issued every two years to track global biodiversity, is based on the Living Planet Index, put out every two years since 1998 in collaboration with the Zoological Society of London and based on international databases of wildlife populations. The two previous reports, in 2014 and 2016, found wildlife population declines of 50% and 58%, respectively, since 1970.

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