MD, PhD, FMedSci, FSB, FRCP, FRCPEd

regulation

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We have repeatedly discussed on this blog the fact that many alternative practitioners are advising their patients against vaccinations, e. g.:

There is little doubt that this phenomenon contributes to low immunisation rates. This, in turn, is a contributing factor to outbreaks of measles and other infectious diseases. The website of the European Centre for Disease Prevention and Control has recently published data on measles outbreaks in Europe:

Bulgaria: There is an increase by three cases since 21 July 2017. Since the beginning of 2017 and as of 16 July, Bulgaria reported 166 cases. During the same time period in 2016 Bulgaria reported one case.

France: On 27 July 2017 media quoting the French Minister of Health reported the death of a 16-year-old unvaccinated girl. She had fallen sick in Nice and died on 27 June 2017 in Marseille.

Germany: There is an increase by four cases since the last report on 21 July 2017. Since the beginning of 2017 and as of 26 July, Germany reported 801 cases. During the same time period in 2016 Germany reported 187 cases.

Italy: There is an increase by 170 cases since 21 July 2017. Since the beginning of 2017 and as of 25 July, Italy reported 3 842 cases, including three deaths. Among the cases, 271 are healthcare workers. The median age is 27 years, 89% of the cases were not vaccinated and 6% received only one dose of vaccine.

Romania: There is an increase by 229 cases, including one additional death, since 21 July 2017. Since 1 January 2016 and as of 21 July 2017, Romania reported 8 246 cases, including 32 deaths. Cases are either laboratory-confirmed or have an epidemiological link to a laboratory-confirmed case. Infants and young children are the most affected groups. Timis, in the western part of the country closest to the border with Serbia, is the most affected district with 1 215 cases. Vaccination activities are ongoing in order to cover communities with suboptimal vaccination coverage.

Spain: There is an increase by seven cases since 14 July 2017. Since the beginning of 2017 and as of 25 July, Spain reported 145  measles cases.

United Kingdom: Public Health Wales reported two additional cases related to the outbreak in Newport and Torfaen, bringing the total to ten cases related to this outbreak. In England and Wales there is an increase by 76 cases since 21 July 2017. Since the beginning of 2017 and as of 23 July 2017, England and Wales reported 922 cases. In the same time period in 2016, they reported 946 cases.

In addition to the updates listed above ECDC produces a monthly measles and rubella monitoring report with surveillance data provided by the member states through TESSy. The last report was published on 11 July 2017 with data up to 31 May 2017.

Measles outbreaks continue to occur in EU/EEA countries. There is a risk of spread and sustained transmission in areas with susceptible populations. The national vaccination coverage remains less than 95% for the second dose of MMR in the majority of EU/EEA countries. The progress towards elimination of measles in the WHO European Region is assessed by the European Regional Verification Commission for Measles and Rubella Elimination (RVC). Member States of the WHO European Region are making steady progress towards the elimination of measles. At the fifth meeting of the RVC for Measles and Rubella in October 2016, of 53 countries in the WHO European Region, 24 (15 of which are in the EU/EEA) were declared to have reached the elimination goal for measles, and 13 countries (nine in the EU/EEA) were deemed to have interrupted endemic transmission for between 12 and 36 months, meaning they are on their way to achieving the elimination goal. However, six EU/EEA countries were judged to still have endemic transmission: Belgium, France, Germany, Italy, Poland and Romania. More information on strain sequences would allow further insight into the epidemiological investigation.

All EU/EEA countries report measles cases on a monthly basis to ECDC and these data are published every month. Since 10 March 2017, ECDC has been reporting measles outbreaks in Europe on a weekly basis and monitoring worldwide outbreaks on a monthly basis through epidemic intelligence activities. ECDC published a rapid risk assessment on 6 March.

END OF QUOTE

Personally, I believe that it is high time to stop the rhetoric and actions of the anti-vaccination movements. This includes educating alternative practitioners and their patients. If necessary, we need regulation that prohibits their dangerous and unethical activities.

In my previous post, I reported that the NHS has included homeopathy and herbal medicine on the list of medications that might no longer get reimbursed. The news was reported by most newspapers in the UK. All of the papers correctly quote NHS England giving their reasons for black-listing homeopathy and herbal remedies. Some papers also quote critics of homeopathy providing short ‘sound bites’ and opinions. None of the articles bother to explain in any detail why homeopathy is so ridiculously implausible or how strong the evidence against it has become. In this post, I intend to analyse some of this press coverage by copying those excerpts from the newspaper articles which I find odd or misleading and by adding short comments by myself.

THE DAILY MAIL claimed that homeopathic remedies are treatments using heavily diluted forms of plants, herbs and minerals. This is factually incorrect; think of remedies like X-ray! The Mail also quoted Don Redding, director of policy at National Voices, stating: ‘Whilst some treatments are available to purchase over the counter, that does not mean that everyone can afford them. There will be distinct categories of people who rely on NHS funding for prescriptions of remedies that are otherwise available over the counter. Stopping such prescriptions would break with the principle of an NHS “free at the point of use” and would create a system where access to treatments is based on a person’s ability to pay.’  This argument might apply to medicines that are proven to work; it does, however, not apply to homeopathy.

THE INDEPENDENT cited Professor Helen Stokes-Lampard, chair of the Royal College of GPs, who said: “If patients are in a position that they can afford to buy over the counter medicines and products, then we would encourage them to do so rather than request a prescription – but imposing blanket policies on GPs, that don’t take into account demographic differences across the country, or that don’t allow for flexibility for a patient’s individual circumstances, risks alienating the most vulnerable in society.” Again, this argument might apply to medicines that are proven to work; it does, however, not apply to homeopathy.

THE DAILY TELEGRAPH also reported the quote from Don Redding, Director of Policy at National Voices which I cited above.

THE DAILY MIRROR quoted The Royal Pharmaceutical Society claiming that such a move raised “serious concerns” for poorer Brits. RPS England Board Chair Sandra Gidley said: “A blanket ban on prescribing of items available to buy will not improve individual quality of life or health outcomes in England. “Those on low incomes will be disproportionately affected.” THE MIRROR also reported what had to say and added that the NHS constitution states that: “Access to NHS services is based on clinical need, not an individual’s ability to pay; NHS services are free of charge, except in limited circumstances sanctioned by parliament.”

THE NEWS & STAR repeated the above quote from The Royal Pharmaceutical Society.

THE GUERNSEY PRESS repeated what RPS England board chair Sandra Gidley said: “We would encourage people with minor health problems to self-care with the support of a pharmacist and to buy medicines where appropriate and affordable to the individual. However, expecting everyone to pay for medicines for common conditions will further increase health inequalities and worsen the health of patients who cannot afford them. A blanket ban on prescribing of items available to buy will not improve individual quality of life or health outcomes in England. Those on low incomes will be disproportionately affected. They should not be denied treatment because of an inability to pay.”

THE TIMES also quoted the RPS and Don Redding misleadingly (see above and below) and concluded their article by citing Cristal Summer, chief executive of the British Homeopathic Association saying: Patients will be prescribed more expensive conventional drugs in place of homeopathy, which defeats the object of the exercise. The NHS also claims it wants to reduce the amount of prescription drugs patients take, then stops offering complementary therapies which can help achieve this. This clearly ignores the fact that ‘the object of the exercise’ for any health service must be to provide effective treatments and avoid placebo therapies like homeopathy. 

THE SUN quoted The Royal Pharmaceutical Society saying such a move raised “serious concerns” for poorer Brits. But it said banning NHS-funded homeopathy was long overdue. THE SUN continued by citing John O’Connell, Chief Executive of the TaxPayers’ Alliance: “The NHS are absolutely right to look at removing homeopathy from their approved prescription list and it’s astonishing that it hasn’t happened sooner.”

METRO pointed out that actress Gwyneth Paltrow, ex-Beatle Paul McCartney and world record sprinter Usain Bolt are all known to swear by homeopathic remedies.

Generally speaking, the newspaper coverage was not bad, in my view. The exception evidently is THE TIMES (see above). Several other articles also have a slight whiff of false balance, introducing seemingly rational counter-arguments where none exist. Even though the headlines invariably focus on homeopathy, some of the quotes used by the papers are clearly about other medicines black-listed. This seems particularly obvious with the quotes by the RPS. Many readers might thus be misled into thinking that there is opposition by reputable organisations to the ban on homeopathy. None of the articles that I read quoted a homeopath at the end saying something like  WE KNOW OF MANY PATIENTS WHOSE LIVES WERE SAVED BY HOMEOPATHY. JUST BECAUSE WE DON’T UNDERSTAND HOW IT WORKS DOES NOT MEAN IT DOES NOT WORK. A BAN WOULD PUT PUBLIC HEALTH AT RISK.

Only a few years ago, this type of conclusion to an article on homeopathy would have been inevitable! Could it be that UK journalists (with the exception of those at THE TIMES?) are slowly learning?

 

NHS England have published a list of medicines that they propose to stop funding. Items were considered for inclusion if they were:

  • Items of low clinical effectiveness, where there is a lack of robust evidence of clinical effectiveness or there are significant safety concerns;
  • Items which are clinically effective but where more cost-effective products are available, including products that have been subject to excessive price inflation; or
  • Items which are clinically effective but, due to the nature of the product, are deemed a low priority for NHS funding.

The list includes both herbal and homeopathic remedies!!!

The document states that the annual Spend on homeopathy amounts to £92,412. It refers to the report by the House of Commons Science and Technology Committee which found that the use of homeopathy was not evidence based and any benefits to patients was down to placebo effect. The group agreed with the findings of the committee for the lack of evidence and considered homeopathy suitable for inclusion in the proposed list.  They advise CCGs that prescribers in primary care should not initiate homeopathic items for any new patient. They also advise CCGs to support prescribers in deprescribing homeopathic items in all patients and, where appropriate, ensure the availability of relevant services to facilitate this change.

A comment published by PULSETODAY stated: NHS England is planning to stop the prescribing of homeopathy as part of new guidance for CCGs on medicines that can be considered to be of low priority for funding. Homeopathy is a new item on the list of possible low-value medicines that GPs will be banned from prescribing. Originally NHS England said that it would review just 10 items, but it has added eight new treatments, including homeopathy and herbal treatments… The original consultation document failed to include homeopathy in its treatments that should be banned. However, following a consultation, a paper presented at today’s NHS England board meeting said: ‘NHS England’s view is that, at best, homeopathy is a placebo and a misuse of scarce NHS funds which could better be devoted to treatments that work. ‘Data on the residual use and cost of homeopathy on the NHS are hard to come by. A recent Freedom of Information request by a third party suggested that at least £578,000 has been spent on prescribed homeopathy over the past five years, with the total cost being higher than that when the cost of consultations was factored in.’ Talking at the NHS England Board meeting today NHS England medical director Sir Bruce Keogh said: ’I think this (homeopathy) has been an issue which has concerned scientific professionals for a long period of time. We can no longer shy away from addressing this particular issue. If we want our NHS to be evidence based and outcomes focused, then we must expect to have difficult conversations over difficult issues.’

This almost sounds as though Sir Bruce has been following the discussions on this blog. I have felt for a long time that the reimbursement of homeopathy by the NHS made a mockery of evidence-based medicine. It is time to end the mockery and use the money for something useful!

But before we start celebrating a victory of rationality, we should consider what happens next. There will be a consultation, and I would not be surprised to hear that the author of multiple ‘spider memos’ is already at it again. So, maybe we should hold our breath and wait.

Isn’t it wonderful when your long-held views are confirmed by someone with influence?

This, of course, is a rhetorical question – I can tell you: it is wonderful!

Matthew Stanbrook, MD PhD recently published an editorial in CMAJ which I find delightful; let me present you a few quotes from it:

The multibillion-dollar market for “natural” health products has flourished under lax government regulations. These regulations have enabled manufacturers to exploit the public’s difficulty in distinguishing nonprescription drugs, with scientifically proven therapeutic benefits, from herbal or homeopathic preparations and supplements that often make similar health claims with little or no evidence and are frequently grounded in unscientific belief systems about health and disease…

In pharmacies, supermarkets and convenience stores, natural health products are displayed side by side with nonprescription drugs. Both tout their approval by Health Canada as an implicit endorsement of efficacy and safety on package labels that make similar health claims. However, although nonprescription drugs and their therapeutic claims require scientific evidence that is carefully scrutinized by Health Canada, natural health products have a separate regulatory system that typically imposes such minimal requirements that it is effectively a rubber stamp. Unlike nonprescription drugs, if a problem arises with a natural health product, Health Canada has little or no authority to compel any changes to its manufacture, labelling or sale.

…Risk is often difficult to perceive accurately without direct evidence. For example, under the proposed framework, Health Canada would continue to classify most homeopathic preparations as low-risk products and, thus, exempt from scientific review. Recently, a homeopathic product sold in the United States that claimed to relieve teething pain in infants and supposedly contained a very dilute extract from the belladonna plant was associated with several deaths of infants who manifested classic signs of anticholinergic poisoning…

…If consumers are unable to separate products with no scientific proof behind them from products supported by evidence, then we need to separate them in stores. Natural health products should be pulled from the shelves where they are mixed with nonprescription drug products and confined to their own separate section, away from any signage implying a therapeutic use.

The double standard perpetuated by both regulators and retailers that enables the deception of unsuspecting Canadians must end. Alternative medicines with claims based on alternative facts do not deserve an alternative, easy regulatory road to market — at the very least, they need to be moved to an alternative shelf.

END OF QUOTES

This, of course, is Canada. But elsewhere progress is also being made.The Australian reported about plans in Australia whereby pharmacies would be banned from selling useless and possibly dangerous homoeopathic remedies. The Australian last year ­revealed a review of pharmacy regulation, headed by Stephen King from the Productivity ­Commission, identified a potential conflict of interest in pharmacists selling vitamins, for example, that may not have a significant ­evidence base, alongside more stringently regulated and government-subsidised medicines. In its interim report, the review panel was “concerned that the sale of complementary medicines alongside other medicines may mislead consumers”. It therefore concludes that “complementary medicines should be held in a separate area within community pharmacies, where customers can easily access a pharmacist for appropriate advice.”

“To avoid potential harm, or the confusion between the efficacies of different types of medicines, pharmacists need to be easily ­accessible to give needed advice when consumers choose a complementary or pharmacy-only medicine,” the review panel said. It was scathing of homo­eopathy and the perception of legitimacy given to those so-called remedies sold in pharmacies. “The only defence put to the panel regarding homoeopathy was that it was harmless and able to be used as a placebo in certain circumstances,” the review panel noted. “The panel does not believe that this argument is sufficient to justify the continued sale of these products in pharmacies …”

AUSTRALIAN JOURNAL OF PHARMACY (AJP) noted that the interim report of the Review of Pharmacy Remuneration and Regulation states that “there are unacceptable risks where community pharmacies are allowed to sell homeopathic products”.

In 2015 Pharmaceutical Society of Australia (PSA) said it did not support the sale of homeopathy in pharmacy. “Our position is that pharmacists must use their professional judgement to prevent the supply of products with evidence of no effect,” PSA president Joe Demarte said at the time. Ian Carr, of Saxby’s Pharmacy in Taree, NSW, and Friends of Science in Medicine member, told the AJP that “in terms of homeopathic products being recommended not to be sold by PBS-approved pharmacies, I one hundred per cent heartily agree with that finding. “I love saying that I believe homeopathy works. But it has never been shown to work better than placebo. There are many things that will work as well as placebo, but it’s not ethical to be selling them as a cure or treatment for something. I would have a bit more time for it if there was a plausible theory behind it, but its basis is entirely implausible – it pushes all the buttons for being a pseudoscience, so I agree it has no place in Australian pharmacy. However, I am at a bit of a loss to understand why they haven’t carried some of that logic over into the comments on complementary medicines generally.”

Mr Carr also told the AJP that “If one conceives of complementary medicines as being vitamins and minerals, that’s one thing. But the marketing of those items has become so diffuse and so wide that on most of these CM shelves we have traditional medicines, we’ve got herbal medicines, we’ve got items that are basically just marketing formulas for certain conditions. The evidence behind most of these things is very very slim, and we still have the possibility of health fraudsters just marching in and taking advantage of the lack of regulation in the industry.”

So, Canada and Australia are making progress in protecting consumers from bogus healthcare products and from pharmacists selling them.

Hurray!!!

When, I ask myself, are the UK, the US and other countries following suit?

 

Alternative medicine differs from conventional medicine in numerous ways. One important difference is that patients often opt to try this or that product without consulting any healthcare professional at all. In such cases, the pharmacist might be the ONLY professional who can advise the patient who is about to purchase such a product.

This is why the role of the pharmacist in alternative medicine is crucial, arguably more so than in conventional medicine. And this is why I am banging on about pharmacists who far too often behave like shop-keepers and not like ethical healthcare professionals. A new review addresses these issues and provides relevant information.

Pharmacists from the University of Macau in Macau, China conducted a literature review to extract publications from 2000 to 2015 that related pharmacist to alternative medicine products. 41 publications which reported findings from exploratory studies or discussed pharmacists’ responsibilities towards such products were selected for inclusion.

Seven major responsibilities emerged:

  • to acknowledge the use of alternative medicine products;
  • to be knowledgeable about such products;
  • to ensure safe use of such products;
  • to document the use of such products;
  • to report ADRs related to such products;
  • to educate about such products;
  • to collaborate with other health care professionals in respect to such products.

One point that is not directly covered here is the duty of pharmacists to comply with their own ethical codes. As I have pointed out ad nauseam, this would mean in many instances to not sell alternative medicine products at all, because there is no good evidence to show that they are generating more good than harm and thus are potentially harmful as well as wasteful.

Some pharmacists have realised that there is a problem. Some pharmacists are trying to initiate discussions about these issues within their profession. Some pharmacists are urging to change things. Some pharmacists are well-aware that healthcare ethics are being violated on a daily basis.

All this has been going on now for well over a decade.

And has there been any noticeable change?

Not as far as I can see!

Perhaps it is time to realise that not merely the sale of bogus medicines by pharmacists is unethical, but so is dragging one’s feet in initiating improvements.

 

According to Wikipedia, “the Bundesverband der Pharmazeutischen Industrie (BPI) with headquarters in Berlin is an Eingetragener Verein and the German industry association/trade group for the pharmaceutical industry. It represents 240 German pharmaceutical and Biotech companies in with altogether approximately 70,000 employees. BPI has an office in Brussels. The focus of the BPI is on political consulting and public relations on the EU-level.” 

The BPI has recently published a remarkable press-release about homeopathy. As it is in German, I will translate it for you (and append the original text for those who can read German).

HERE WE GO:

Homeopathy is a recognised and proven therapy for patients in Germany [1]. This is demonstrated by a new, BPI-sponsored survey [2]. About half of all questioned had experience with homeopathic remedies [3]. More than 70% of those people are satisfied or very satisfied with their effectiveness and safety [4].

“Homeopathic remedies are important for many patients in Germany”[3], says Dr. Norbert Gerbsch, deputy chair of the BPI. ” If therapists and patients use them correctly, they can support the therapeutic success [5]. Therefore, they should be recognised by conventional medicine as an integrative medicine [5] – that is what patients in Germany clearly want [6].”

Two thirds of the people surveyed think it is important or very important, that therapies like anthroposophical medicine and homeopathy are supported politically next to conventional medicine [7]. More than 70% find it personally important or very important that health insurances pay for selected anthroposophical and homeopathic services [8]. More than 80% said they would favour this. Thus, the majority is for keeping homeopathy amongst the services that can be chosen by the insurances for reimbursement [8].

Dr. Norbert Gerbsch: “The survey proves that very many individuals integrate, use and treasure homeopathy as an additional and usually safe therapy [3]. Those who aim at curtailing therapeutic freedom patronise numerous patients in Germany who can benefit from it [9]. There are numerous diseases for which homeopathy can be used as an integrative therapeutic option [10]. Thus, many conventional physicians employ homeopathic and anthroposophic remedies in parallel to guideline-orientated medicine [3, 11].”

(Homöopathie ist eine anerkannte und bewährte Therapieform für Patienten in Deutschland. Das belegt eine neue, vom BPI beauftragte Forsa-Umfrage. Rund die Hälfte der Befragten hat demnach bereits Erfahrung mit homöopathischen Arzneimitteln. Über 70 Prozent von ihnen sind zufrieden oder sehr zufrieden mit der Wirksamkeit und Verträglichkeit.

„Homöopathische Arzneimittel haben für viele Patienten in Deutschland einen hohen Stellenwert“, sagt Dr. Norbert Gerbsch, stellvertretender BPI-Hauptgeschäftsführer. „Wenn Behandler und Patienten sie richtig und verantwortungsvoll einsetzen, kann sie den Therapieerfolg unterstützen. Sie sollte insofern als wichtige Ergänzung der Schulmedizin im Sinne einer Integrativen Medizin anerkannt werden – das wünschen sich die Patienten in Deutschland eindeutig.“

Fast zwei Drittel der von Forsa Befragten finden es wichtig bis sehr wichtig, dass sich die Politik neben schulmedizinischen Behandlungsmethoden auch aktiv für Heilmethoden wie etwa Homöopathie oder Anthroposophische Medizin einsetzt. Über 70 Prozent finden es persönlich wichtig bis sehr wichtig, dass Krankenkassen ihren Versicherten auch die Kosten für ausgewählte Leistungen aus dem Bereich der homöopathischen Medizin erstatten. Mit über 80 Prozent überdurchschnittlich häufig plädieren Befragte mit Homöopathie-Erfahrung für die Kostenübernahme ausgewählter Leistungen durch die Krankenkassen. Damit stimmt die Mehrheit für den Erhalt der Homöopathie im Rahmen von sogenannten Satzungsleistungen, die von den Krankenkassen individuell festgelegt werden können.

Dr. Norbert Gerbsch: „Die Umfrage belegt, dass sehr viele Menschen Homöopathie als ergänzende und in der Regel nebenwirkungsarme Therapieoption in die Behandlung integrieren, sie nutzen und achten. Wer die Therapiefreiheit und -vielfalt beschneiden will, bevormundet zahlreiche Patienten in Deutschland, die davon profitieren können. Es gibt eine Vielzahl an Erkrankungen, bei denen homöopathische Arzneimittel als integraler Bestandteil von Therapien einsetzbar sind. So nutzen viele Schulmediziner neben dem gesamten Spektrum der leitlinienorientierten Medizin gleichzeitig die integrativen Angebote der Homöopathie und Anthroposophischen Medizin.“)

I DO APPOLOGISE FOR MY POOR TRANSLATION; I HAVE ALWAYS FOUND THAT IT IS VERY HARD TO TRANSLATE SOMETHING THAT SIMPLY DOES NOT MAKE SENSE!

I have rarely seen such an unscientific, irrational, nonsensical and promotional comment from an organisation and an individual that should know better. Mr. Gerbsch studied biotechnology and graduated in 1997 in bioprocess engineering. He headed a scientific team following his promotion to director of a trans-departmental research topic with 13 professorships at the Technical University of Berlin. He later took on responsibilities as commissioner, officer and director of various companies. Since 2006, Mr. Gerbsch works as department manager of biotechnology / research & development at BPI and is responsible for the biotechnology department and innovation & research committee.

Here are just a few short points of criticism referring to the numbers I have added in my translation:

  1. Homeopathy is recognised and proven to be a pure placebo-therapy.
  2. A survey of this nature can at best gauge the current opinion.
  3. Fallacy: appeal to popularity.
  4. Perceived effectiveness/safety is not the same as true effectiveness/safety.
  5. There is no good evidence for this statement.
  6. What patients want might be interesting, but it cannot determine what they need; medicine is not a supermarket!
  7. I suspect this is the result of a leading question.
  8. This is where the BPI discloses the aim of the survey and their comment about it: they want the German health insurances to continue paying for homeopathic and anthroposophical placebos because some of their member companies earn their money selling them. In other words, the BPI actively hinder progress.
  9. No, those who advocate not paying for placebos want to encourage progress in healthcare for the benefit of patients and society.
  10. “Can be used” is an interesting phraseology! It is true, one can use homeopathy – but one cannot use it effectively because it has no effect beyond placebo.
  11. Yes, many physicians are sadly more focussed on their own cash-flow than on the best interest of their patients. Not all that different from the BPI, it seems.

It is beyond me how an organisation like the BPI can produce such shamefully misleading, dangerous and unethical drivel. Not one word about the fact that all international bodies have condemned homeopathy as being a useless and dangerous placebo-therapy! Who ever thought that the BPI was an independent organisation (homeopathy manufacturers belong to its membership) has been proven wrong by the above press-release.

The BPI clearly needs reminding of their duty to inform the public responsibly. I recommend that the leading heads of this organisation urgently attend one course on critical thinking followed by another on medical ethics.

In 2006, the World Health Organization and UNICEF created the ‘Global Immunization Vision and Strategy’, a 10-year strategy with 4 main goals:

  1. to immunize more people against more diseases,
  2. to introduce a range of newly available vaccines and technologies,
  3. to integrate other critical health interventions with immunization,
  4. to manage vaccination programmes within the context of global interdependence.

More than a decade later, we have to realise that this vision has been frustrated, not least by fans of alternative medicine (FAMs). They are almost by definition more negative about the value and achievements of conventional medicine and science. This shows in all sorts of ways; the clearest this phenomenon is documented must be the FAMs’ attitude towards immunisations. Few rational thinkers would doubt that vaccinations are amongst the most important achievement in the history of medicine.

Vaccination is a miracle of modern medicine. In the past 50 years, it’s saved more lives worldwide than any other medical product or procedure.”

Yet FAMs are not impressed by such statements and often refuse to have their kids vaccinated according to the recommended schedule. This trend has significantly contributed to vaccination rates that, in some parts of the world, are now dropping so low that our ‘herd immunity’ is jeopardised.

One such place is Germany, and the German government is now making a controversial move against parents who choose to refrain from vaccinating their children. Germany is presently passing a law that will force kindergartens to inform the authorities, if parents don’t provide evidence that they have gotten advice from their doctor on vaccinations for their children.

The US ‘FEDERAL TRADE COMMISSION’ has issued an important statement about homeopathic products. The full text with references can be found here; below are a few quotes which I thought were crucial:

“…Homeopathy, which dates back to the late-eighteenth century, is based on the view that disease symptoms can be treated by minute doses of substances that produce similar symptoms when provided in larger doses to healthy people.  Many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance.  In general, homeopathic product claims are not based on modern scientific methods and are not accepted by modern medical experts, but homeopathy nevertheless has many adherents…

Efficacy and safety claims for homeopathic drugs are held to the same standards as similar claims for non-homeopathic drugs.  As articulated in the Advertising Substantiation Policy Statement, advertisers must have “at least the advertised level of substantiation.”  Absent express or implied reference to a particular level of support, the Commission, in evaluating the types of evidence necessary to substantiate a claim, considers “the type of claim, the product, the consequences of a false claim, the benefits of a truthful claim, the cost of developing substantiation for the claim, and the amount of substantiation experts believe is reasonable.”  For health, safety, or efficacy claims, the FTC has generally required that advertisers possess “competent and reliable scientific evidence,” defined as “tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by qualified persons and [that] are generally accepted in the profession to yield accurate and reliable results.”  In general, for health benefit claims, particularly claims that a product can treat or prevent a disease or its symptoms, the substantiation required has been well-designed human clinical testing.

For the vast majority of OTC homeopathic drugs, the case for efficacy is based solely on traditional homeopathic theories and there are no valid studies using current scientific methods showing the product’s efficacy.  Accordingly, marketing claims that such homeopathic products have a therapeutic effect lack a reasonable basis and are likely misleading in violation of Sections 5 and 12 of the FTC Act.  However, the FTC has long recognized that marketing claims may include additional explanatory information in order to prevent the claims from being misleading.  Accordingly, the promotion of an OTC homeopathic product for an indication that is not substantiated by competent and reliable scientific evidence may not be deceptive if that promotion effectively communicates to consumers that: (1) there is no scientific evidence that the product works and (2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.  To be non-misleading, the product and the claims must also comply with requirements for homeopathic products and traditional homeopathic principles.  Of course, adequately substantiated claims for homeopathic products would not require additional explanation.

Perfunctory disclaimers are unlikely to successfully communicate the information necessary to make claims for OTC homeopathic drugs non-misleading.  The Commission notes:

• Any disclosure should stand out and be in close proximity to the efficacy message; to be effective, it may actually need to be incorporated into the efficacy message.

• Marketers should not undercut such qualifications with additional positive statements or consumer endorsements reinforcing a product’s efficacy.

• In light of the inherent contradiction in asserting that a product is effective and also disclosing that there is no scientific evidence for such an assertion, it is possible that depending on how they are presented many of these disclosures will be insufficient to prevent consumer deception.  Marketers are advised to develop extrinsic evidence, such as consumer surveys, to determine the net impressions communicated by their marketing materials.

• The Commission will carefully scrutinize the net impression of OTC homeopathic advertising or other marketing employing disclosures to ensure that it adequately conveys the extremely limited nature of the health claim being asserted.  If, despite a marketer’s disclosures, an ad conveys more substantiation than the marketer has, the marketer will be in violation of the FTC Act.

In summary, there is no basis under the FTC Act to treat OTC homeopathic drugs differently than other health products.  Accordingly, unqualified disease claims made for homeopathic drugs must be substantiated by competent and reliable scientific evidence.  Nevertheless, truthful, nonmisleading, effective disclosure of the basis for an efficacy claim may be possible.  The approach outlined in this Policy Statement is therefore consistent with the First Amendment, and neither limits consumer access to OTC homeopathic products nor conflicts with the FDA’s regulatory scheme.  It would allow a marketer to include an indication for use that is not supported by scientific evidence so long as the marketer effectively communicates the limited basis for the claim in the manner discussed above.”

 

 

We have discussed this notorious problem before: numerous charities (such as one that treats HIV and malaria with homeopathy in Botswana, or the one claiming that homeopathy can reverse cancer) are a clear danger to public health. I have previously chosen the example of ‘YES TO LIFE’ and explained that they promote unproven and disproven alternative therapies as cures for cancer (and if you want to get really sickened, look who act as their supporters and advisors). It is clear to me that such behaviour can hasten the death of many vulnerable patients.

Yet, many such charities get tax and reputational benefits by being registered charities in the UK. The question is CAN THIS SITUATION BE JUSTIFIED?

Currently, the UK Charity commission want to answer it. Specifically, they are asking you the following question:

  • Question 1: What level and nature of evidence should the Commission require to establish the beneficial impact of CAM therapies?
  • Question 2: Can the benefit of the use or promotion of CAM therapies be established by general acceptance or recognition, without the need for further evidence of beneficial impact? If so, what level of recognition, and by whom, should the Commission consider as evidence?
  • Question 3: How should the Commission consider conflicting or inconsistent evidence of beneficial impact regarding CAM therapies?
  • Question 4: How, if at all, should the Commission’s approach be different in respect of CAM organisations which only use or promote therapies which are complementary, rather than alternative, to conventional treatments?
  • Question 5: Is it appropriate to require a lesser degree of evidence of beneficial impact for CAM therapies which are claimed to relieve symptoms rather than to cure or diagnose conditions?
  • Question 6: Do you have any other comments about the Commission’s approach to registering CAM organisations as charities?

I am sure that most readers of this blog have something to say about these questions. So, please carefully study the full document, go on the commission’s website, and email your response to: legalcharitablestatus@charitycommission.gsi.gov.uk . Don’t delay it; do it now!

THANK YOU!

CBC news (Canada) reported yesterday that, more than a decade ago, the Manitoba Chiropractic Health Care Commission had been tasked to review the cost effectiveness of chiropractic services. It therefore prepared a report in 2004 for the Manitoba province and the Manitoba Chiropractors Association. Since then, this report has been kept secret. The report makes 37 recommendations, including:

  • Manitoba Health should limit its funding to “chiropractic treatment of acute lower back pain.”
  • Manitoba Health should provide “limited coverage of the treatment of neck pain.” The report called the literature around the efficacy of chiropractic care for neck pain “ambiguous or at best weakly supportive” and noted such treatment carried a “not insignificant safety risk.”
  • Manitoba Health should not fund chiropractic treatment anyone under 18 “as the literature does not unequivocally justify” the “efficacy or safety” of such treatment.

A Manitoba Ombudsman’s Office report from 2012 might shed some light on why the Manitoba Chiropractic Health Care Commission’s report was never made public. Someone had attempted to get a copy of the report, but large parts of it were redacted. “Access to this record was refused on the basis that disclosure would be harmful to a third party’s business interest,” the ombudsman report notes, “and harm the economic or financial interests or negotiating position of a public body.”

The report also challenged claims that chiropractic treatments can be address a wide variety of medical conditions. It stated that there was not enough evidence to conclude chiropractic treatments are effective in treating muscle tension, migraines, HIV, carpal tunnel syndrome, gastrointestinal problems, infertility or cancer, or as a preventive care treatment. It also said there was not enough evidence to conclude chiropractic treatments are effective for children.

The report urged Manitoba Health to establish a monitoring system to keep a closer eye on “the advertising practices of the Manitoba Chiropractors Association and its members to ensure claims regarding treatments are restricted to those for which proof of efficacy and safety exist.” It suggested the government should have regulatory powers over chiropractic ads.

A recent CBC I-Team investigation found Manitoba chiropractors advertising treatment for a wide range of conditions including Alzheimer’s, autism and pediatric services. The commission report contained sharp criticisms of previous reports that suggested funding chiropractic care could save the health-care system money. Dr. Pranlal Manga authored two widely cited reports which claim that by offering publicly funded chiropractic care, provinces can cut health-care costs. “The Manga study on Manitoba must be rejected as a guide to public policy,” the commission report states, “because its assumptions, methodology and costing of recommendations are all deeply flawed.” The reports states, “What limited evidence the Commission has suggests he [Manga] grossly exaggerates possible medical savings.” Dr. Manga did not respond to CBC’s repeated attempts to contact him.

The commission report also made recommendations around the use of X-ray machines by chiropractors. It suggested chiropractors not own and operate X-ray machines “Given the restrictive conditions under which X-rays are advisable, their poor correlation with low-back problems, their apparent limitation as a guide to appropriate treatment …[and] the apparent complete lack of monitoring [of] the use of X-ray by chiropractors.”  Instead, it recommended consulting with radiologists when imaging is deemed necessary. “The Commission is of the view that the public interest, and even chiropractic itself, would be better served if chiropractors had access to radiologists for this service, rather than perform it themselves,” the report said.

All three report authors declined comment. Calls to Dave Chomiak, who was health minister at the time the report was prepared, were not returned. In an email to CBC, Manitoba Chiropractors Association president Perry Taylor said, “I personally have never seen this 13-year-old document and [it] pre-dates my time as President. As such I have no comment on this.” The CBC I-Team offered to go through the report with Taylor but he did not respond.

MY COMMENT:

This report seems to confirm much of what we have discussed repeatedly on this blog: Chiropractic is not nearly as effective and safe as chiropractors try to make us believe. To hide this fact is certainly dishonest and unethical, but it is in some ways understandable: this knowledge would directly threaten the income of most chiropractors.

Yesterday I commented on another post: “the conflict of interest seems obvious: if homeopaths speak the truth, they are out of business. therefore, they are taught untruths from the first day of their training and eventually end up believing them. there is only one solution, as far as I can see: regulators must prevent them from making false claims. if not, this will go on for another 200 years and damage many patients’ health”. In the light of the above report, I will now re-phrase this: the conflict of interest seems obvious: if chiropractors allowed the truth to be known, they would soon be out of business. Therefore, they are taught untruths from the first day of their training and many end up believing them. There is only one solution, as far as I can see: regulators must prevent chiropractors from making false claims. If not, this abuse will go on for another 120 years and damage many patients’ health.

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