MD, PhD, FMedSci, FSB, FRCP, FRCPEd

regulation

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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.

“Millions of people have adverse drug reactions to prescribed medicine; it is ranked as the third leading causes of death. In the US, health-care spending reached $1.6 trillion in 2003. Considering this enormous expenditure, we should have the best medicine in the world. But we don’t. Bottom line, people are suffering. The public is calling out for a reform in mainstream medicine.” These seem to be the conclusions of a new film about homeopathy entitled JUST ONE DROP. It was shown recently for the first time in London, and we already have a fascinating comment about it.

“This professional, eight-year effort attempted to be quite even-handed, while featuring many compelling and documented success stories”, states “The World’s No. 1 Authority on Intention, Spirituality and the New Science”, Lynne Mc Taggart. An ‘even-handed’ effort is worth pursuing, I thought, and so I read on.

When I reached the point where Lynne writes “The greatest revelation had to do with the dirty pool employed by the Australian government’s National Health and Medical Research Council (NHMRC), when it decided to assess the effectiveness of homeopathy by reviewing all research that had been done to date”, I got a little suspicious. We discussed the NHMRC report here and here and I had an entirely different impression of it.

Lynne also elaborated at length on the infamous ‘Swiss report’: “The Swiss team had comprehensively reviewed all the major evidence for homeopathy, everything from preclinical research to double-blind, placebo-controlled studies and meta-analyses. After assessing all the available data, the Swiss team concluded that the high-quality investigations of preclinical basic research proved that homeopathic high-potency remedies induce “regulative and specific changes in cells or living organisms”. Of the systematic reviews of human research, said the report, 20 out of 22 detected “at least a trend in favor of homeopathy”, and five showed “clear evidence for homeopathic therapy”.  The report found particularly strong evidence for the use of homeopathy for upper respiratory tract infections and allergic reactions.  Perhaps most significantly, the report concluded that the effectiveness of homeopathy “can be supported by clinical evidence” and “regarded as safe”.(Forsch Komple-mentmed, 2006; 13 Suppl 2: 19–29).”

This report has been evaluated by many experts (see for instance here). One expert even called it ‘research misconduct’ and concluded that “…the authors of this report adopted a very unusual strategy in what should have been an impartial evidence appraisal. It appears that their goal was not to provide an independent assessment but to choose criteria that would lead to their chosen conclusion that homeopathy is effective. To this end, they chose to adopt a highly questionable criterion of “real-world” effectiveness, ignore negative findings concerning homeopathy in favour of implausible reinterpretation of results, and attack RCTs. This use of a unique and suspect methodology in an appraisal designed to assess healthcare objectively gives cause for particular concern; one imagines that the Swiss government wanted homeopathy to be judged against existing standards rather than new ones created specially for the evaluation. In doing so the authors have distorted the evidence and misled the public; these actions, combined with their conflicts of interest, strongly suggest that they are guilty of research misconduct. It is extremely unfortunate that the Swiss government lent legitimacy to this report by attaching its name to it, and also unfair that the English-language text is not available free of charge to the public when it is being widely misrepresented all over the world as proof of the efficacy of homeopathy. It remains possible that homeopathy is effective, but the authors of this report do the practice a grave disservice.”

Could it be that Lynne does not know all this?

Or is she not interested in an ‘even-handed’ approach?

For me, the last drop arrived when Lynne started writing about my friend “Simon Singh, the self-appointed attack dog on all things alternative”, as she calls him. This is where I began to feel nauseous, so much so that I had to reach for my Nux Vomica C30. Alas, it did not help – Lynne’s writing was too overpoweringly sickening, particularly when she tried to motivate her readers to defend charities that endanger public health by promoting bogus treatments for life-threatening conditions: “If you value alternative medicine, here’s what to write the CC before the deadline: Tell them to read the Swiss report on homeopathy, the most contentious of alternative therapies, which shows very good evidence for it. Demand a level playing field. If they are going to challenge charities for alternative medicine based on scientific evidence, then they need to evaluate Cancer Research UK, Arthritis Research UK and every other charity partly or wholly funded by pharmaceutical companies, an estimated 75 percent of whose research is massaged, manipulated or fabricated.”

My only hope now is that the film JUST ONE DROP is less bonkers than Lynne’s comment about it!

On 13 March, the UK Charity Commission published the following announcement:

This consultation is about the Commission’s approach to deciding whether an organisation which uses or promotes CAM therapies is a charity. For an organisation to be charitable, its purposes must be exclusively charitable. Some purposes relate to health and to relieve the needs of the elderly and disabled.

We are seeking views on:

  • the level and nature of evidence to support CAM
  • conflicting and inconsistent evidence
  • alternative therapies and the risk of harm
  • palliative alternative therapy

Last year, lawyers wrote to the Charity Commission on behalf of the Good Thinking Society suggesting that, if the commission refused to revoke the charitable status of organisations that promote homeopathy, it could be subject to a judicial review. The commission responded by announcing their review which will be completed by 1 July 2017.

Charities must meet a “public benefit test”. This means that they must be able to provide evidence that the work they do benefits the public as a whole. Therefore the consultation will have to determine what nature of evidence is required to demonstrate that a CAM-promoting charity provides this benefit.

In a press release, the Charity Commission stated that it will consider what to do in the face of “conflicting or inconsistent” evidence of a treatment’s effectiveness, and whether it should approach “complementary” treatments, intended to work alongside conventional medicine, differently from “alternative” treatments intended to replace it. In my view, however, this distinction is problematic and often impossible. Depending on the clinical situation, almost any given alternative therapy can be used both as a complementary and as an alternative treatment. Some advocates seem to cleverly promote their therapy as complementary (because this is seen as more acceptable), but clearly employ it as an alternative. The dividing line is often far too blurred for this distinction to be practical, and I have therefore long given up making it.

John Maton, the commission’s head of charitable status, said “Our consultation is not about whether complementary and alternative therapies and medicines are ‘good’ or ‘bad’, but about what level of evidence we should require when making assessments about an organisation’s charitable status.” Personally, I am not sure what this means. It sounds suspiciously soft and opens all sorts of escape routes for even the most outright quackery, I fear.

Michael Marshall of the Good Thinking Society said “We are pleased to see the Charity Commission making progress on their review. Too often we have seen little effective action to protect the public from charities whose very purpose is the promotion of potentially dangerous quackery. However, the real progress will come when the commission considers the clear evidence that complementary and alternative medicine organisations currently afforded charitable status often offer therapies that are completely ineffective or even potentially harm the public. We hope that this review leads to a policy to remove such misleading charities from the register.”

On this blog, I have occasionally reported about charities promoting quackery (for instance here, here and here) and pointed out that such activities cannot ever benefit the public. On the contrary, they are a danger to public health and bring many good charities into disrepute. I would therefore encourage everyone to use this unique occasion to write to the Charity Commission and make their views felt.

 

The notorious tendency of pharmacist to behave like shop-keepers when it comes to the sale of bogus remedies has been the subject of this blog many times before. In my view, this is an important subject, and I will therefore continue to report about it.

On the website of the AUSTRALIAN JOURNAL OF PHARMACY (AJP), we find interesting new data on Australian pharmacists’ love affair with bogus alternative medicine. The AJP recently ran a poll asking readers: “Do you stock Complementary Medicines (CMs) in your pharmacy?” The results of this little survey so far show that 54% of all participating pharmacists say they stock CMs, including homeopathic products. About a quarter (28%) of respondents stock CMs but not homeopathic products. And 9% said they “only stock evidence-based CMs”. Three percent completely refuse to stock CMs, while 2% stock them but with clear in-store labels saying that they may not work. One person stated they stock CMs but have recently decided to no longer do so.

The President of the Pharmaceutical Society of Australia (PSA) Joe Demarte commented on these findings: “The latest survey results, showing over 40% of pharmacists are adhering to PSA’s Code of Ethics on complementary medicines, are very encouraging… However it’s disappointing that some pharmacists are still stocking homeopathy products, which are not supported by PSA’s Code of Ethics or our Position Statement on Complementary Medicines… Irrespective of the products stocked in a pharmacy, the important thing is when discussing the use of complementary medicines with consumers, pharmacists must ensure that consumers are provided with the best available information about the current evidence for efficacy, as well as information on any potential side effects, drug interactions and risks of harm… It’s important for pharmacists to provide a fair, honest and balanced view of the current evidence available on all complementary medicines,” Demarte added.

NSW pharmacist Ian Carr, who is a member of the Friends of Science in Medicine group, commented that many pharmacists may not have much choice when it comes to stocking complementary and alternative medicines. “CMs policy is not being filtered through the professional assessment of the pharmacist… It’s basically a business deal with the franchise, and as a pharmacist taking on a franchise you’ve basically got to sign those rights away about what you get to sell. Some of the chains offer basically everything that is available, no questions asked. As an independent pharmacist I am able to make my own decisions about what to stock… We’ve got a ‘de-facto’ corporatisation happening with marketing groups and franchises, and I’m concerned the government will look at this trend and ask, why are we not deregulating the industry to reflect the apparent reality of pharmacy today? We’re only playing into the hands of people who want deregulation… We should be telling people in no uncertain terms that if something is on the shelf it doesn’t mean it’s been assessed or approved by the TGA… There is no doubt that there has been a long-term relationship between the supplement industry and pharmacy. But it was also a few decades ago that researchers started applying the concept of evidence-based medicine to healthcare generally. That should have been the point where we said, ‘we’re not just going to be a conduit for your products without questioning their basis in evidence’. That’s where we lost the plot. The question now is: where do we draw that line? I’m really trying to say to my fellow pharmacists: Please let us reassess the unquestioning support of the CM industry, or we’ll all be tarred with the same brush. I and many others are concerned about – and fighting for – the reputation of the pharmacy profession.”

A BMC Complementary and Alternative Medicine survey by researchers from Alfred Hospital in Melbourne found that 92% thought pharmacists should provide safety information about CMs, while 93% thought it important for pharmacists to be knowledgeable about CMs. This shows a huge divide between what is happening in Australian pharmacy on the one side and ethical demands or public opinion on the other side. What is more, there is little reason to believe that the situation in other countries is fundamentally different.

And did you notice this little gem in the comments above?  “…over 40% of pharmacists are adhering to PSA’s Code of Ethics…” – the PSA president finds this ‘VERY ENCOURAGING’.

When I saw this, I almost fell off my chair!

Does the president know that this means that 60% of his members are violating their own code of ethics?

Is that truly VERY ENCOURAGING, I ask myself.

My answer is no, this is VERY WORRYING.

 

A recent article in the Guardian revealed that about one third of Australian pharmacists are recommending alternative medicines with little-to-no evidence for their efficacy, including useless homeopathic products and potentially harmful herbal products.

For this survey of 240 Australian pharmacies, mystery shoppers were sent in to speak to a pharmacist at the prescription dispensing counter and ask for advice about feeling stressed. The results show that three per cent of the pharmacists recommended homeopathic products, despite a comprehensive review of all existing studies on homeopathy finding that there is no evidence they work in treating any condition and that ‘people who choose homeopathy may put their health at risk if they reject or delay treatments’. Twenty-six percent of all pharmacists recommended Bach flower remedies to relieve stress. A comprehensive review of all existing studies on Bach flower remedies found no difference between the remedies and placebos. Fifty-nine per cent of people were just told the complementary and alternative product recommended to them worked, and 24% were told the product was scientifically proven, without any evidence being provided to them.

Asked about these findings, Dr Ken Harvey, a prominent Australian expert, said they demonstrated that some pharmacists were failing in their professional duty to consumers. “Pharmacists are giving crazy advice, and it is dangerous in some cases,” he said. “My view is that pharmacists, if they are going to sell these products, need to have a big shining sign over the shelves of the complementary and alternative medicine section that says ‘these products have not been assessed by the government regulators to see if they work, please talk to pharmacist’.Pharamacists are giving poor advice and they clearly have a conflict of interest,” Harvey said.

If you had hoped that in other countries pharmacists behave more responsibly, I must disappoint you. The information available shows that, when it comes to alternative medicine, pharmacists across the globe act much more like shop-keepers than like health care professionals. They are in the habit of putting profit before their duty to abide by the rules of evidence-based practice. And, in doing do, they violate their own ethical codes so regularly that I ask myself why they bothered to even implement one.

On this blog I have written so often about this issue that one could come to the conclusion that I have a bee under my bonnet:

The truth, however, is not that I am the victim of a bee.

The truth is that this is a very important public health issue.

The truth is that pharmacists show little signs of even trying to get to grips with it.

The truth is that pharmacists who sell bogus medicines put profit before professional ethics.

The truth is that such behaviour is not that of health care professionals but that of shop-keepers.

The truth is that I intend to carry on reminding these pharmacists that they are behaving like charlatans.

According to our friend Dana Ullman, “homeopathy has had a long tradition within Russia. Even though it was not officially recognized during the Communist regime, it was tolerated. And perhaps in part because it did not receive governmental sanction, the Russian people developed a trust in homeopathy. Due to the fact that homeopathic physicians worked outside of governmental medicine, homeopathy was a part of Russia’s “new economy”. People had to pay for homeopathic care, rather than receive it for free.

Homeopathy is still the minority practice. I was told that there are approximately one million medical doctors in Russia and its surrounding republics, with 15,000 medical doctors who use homeopathic medicines regularly, and about 3,000 medical doctors who specialize in classical homeopathy.”

But the ‘free ride’ of homeopathy seems to come to an end. We have seen this happening, for instance in the US, UK, Australia, and Germany. And now it is happening also in Russia:

It has just been reported that the Russian Academy of Sciences (RAS) has labelled homeopathic medicine a health hazard. The organization is now petitioning Russia’s Ministry of Health to abandon the use of homeopathic medicine in the country’s state hospitals, the RBC news outlet reported Monday.

A RAS committee warns that some patients were rejecting standard medicine for serious conditions in favour of homeopathic remedies, a move that almost inevitably puts their lives in danger. The committee also noted that, because of sloppy quality control during the manufacturing processes, some unlicensed homeopathic remedies contain toxic substances which harm patients in a direct fashion.

“The principles of homeopathy contradict known chemical, physical and biological laws and persuasive scientific trials proving its effectiveness are not available,” the committee stated in its report.

The move forms part of a growing backlash against homeopathy in Russia. Last month, students at the First Moscow State Medical University filed a petition to ban homeopathic principles from being taught in medical schools. Russia’s Federal Customs Service also introduced new rules in November 2016, forcing manufacturers to prove the effectiveness of any homeopathic products that they wish to sell.

To this, I have little to add; perhaps just this: ABOUT TIME TOO!

I am sure this  FDA press-release will interest many readers (we reported about this case before):

The U.S. Food and Drug Administration announced today that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.

In light of these findings, the FDA contacted Standard Homeopathic Company in Los Angeles, the manufacturer of Hyland’s homeopathic teething products, regarding a recall of its homeopathic teething tablet products labeled as containing belladonna, in order to protect consumers from inconsistent levels of belladonna. At this time, the company has not agreed to conduct a recall. The FDA recommends that consumers stop using these products marketed by Hyland’s immediately and dispose of any in their possession. In November 2016, Raritan Pharmaceuticals (East Brunswick, New Jersey) recalled three belladonna-containing homeopathic products, two of which were marketed by CVS.

“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. ”We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”

Homeopathic teething products have not been evaluated or approved by the FDA for safety or effectiveness. The agency is unaware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children. In September 2016, the FDA warned against the use of these products after receiving adverse event reports.

Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething products.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething products to the FDA’s MedWatch Adverse Event Reporting program:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The Agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

END OF PRESS RELEASE

Well, this will be irritating to many homeopathy-fans, not least to our friend Dana Ullman. He likes to publish articles alleging that the US authorities have recently taken to being ever so unfair to the homeopathic industry. I commented recently on his paper entitled “Extreme Bias in FTC’s Ruling on Homeopathic Medicine” where he displays the well-known biases and ignorance of his trade in exemplary fashion, including the often firm anti-vaccination stance of homeopaths. Dana can also not resist claiming that ‘the Swiss government’s “Health Technology Assessment” on homeopathic medicine is much more comprehensive than any previous governmental report written on this subject to date’ and – how could it be otherwise? – is sufficient proof that homeopathy works.

In case you believe in what Ullman says, you ought to read the intriguing evidence about Ullman after being called as an expert witness in an US class action. On this occasion, the judge stated:

The Defendant presented the testimony of Gregory Dana Ullman who is a homeopathic practitioner. He outlined the theory of homeopathic treatment and presented his opinion as to the value and effectiveness of homeopathic remedies. The Court found Mr. Ullman’s testimony to be not credible. Mr. Ullman’s bias in favor of homeopathy and against conventional medicine was readily apparent from his testimony. He admitted that he was not an impartial expert but rather is a passionate advocate of homeopathy. He posted on Twitter that he views conventional medicine as witchcraft. He opined that conventional medical science cannot be trusted.
[…]
Mr. Ullman’s testimony was unhelpful in understanding the purported efficacy of the ingredients of SnoreStop to reduce the symptoms of snoring. Although he is familiar with the theory of homeopathic treatment, his opinions regarding its effectiveness was unsupported and biased. The Court gave no weight to his testimony.(Rosendez v. Green Pharmaceuticals)

Say no more!

At a recent conference in Montréal (October 2016), the WFC (World Federation of Chiropractic) and the ACC (Association of Chiropractic Colleges) reached a consensus on education. Consequently, recommendations were produced that offer 12 key ‘take away messages’. I take the liberty of reproducing these statements entitled ‘Training Tomorrow’s Spine Care Experts’ (the square brackets were inserted by me and refer to brief comments I made below).

START OF QUOTE

1. Chiropractic educational institutions have a  responsibility to equip students with the skills and  attributes necessary to become future spinal health care experts. This includes a commitment to astute diagnostic ability, a comprehensive knowledge of spine-related disorders [1], appreciation for the contributions of other health professionals and a commitment to collaborative, patient-centered and evidence-informed care [2].

2. Technological advances [3] provide an opportunity for the chiropractic profession to enhance, evolve and standardize core education and practice. This is relevant to the teaching of chiropractic skills, sharing of learning resources and assessment of performance. Emerging technologies that support the development of clinically-competent practitioners should be embedded within chiropractic programs.

3. The teaching and learning of specialized manual assessment and treatment skills should remain a key distinguishing element of chiropractic curricula.

4. Surveys of the public have a demonstrated a desire for consistency in the provision of chiropractic services. Such consistency need not compromise the identities of individual institutions but will cultivate public trust and cultural authority [4].

5. Globally consistent educational and practice standards will facilitate international portability [5] and promote greater health equity in the delivery of spine care.

6. Chiropractic programs should espouse innovation and leadership in the context of ethical [6], sustainable business [7] practices.

7. Chiropractic educational curricula should reflect current evidence [8] and high quality guidelines [9], and be subjected to regular review to ensure that students are prepared to work in collaborative health care environments.

8. The training of tomorrow’ s spine care experts should incorporate current best practices in education.

9. Interdisciplinary collaboration and strategic partnerships present opportunities to position chiropractors as leaders [10] and integral team players in global spine care.

10. Chiropractic educational institutions should champion the integration of evidence informed clinical practice [11], including clinical practice guidelines, in order to optimize patient outcomes. This will in turn foster principles of lifelong learning and willingness to adapt practice methods in the light of emerging evidence [12].

11. Students, faculty, staff and administrators must all contribute to a learning environment that fosters cultural diversity, critical thinking [13], academic responsibility and scholarly activity.

12. Resources should be dedicated to embed and promote educational research activity in all chiropractic institutions.

END OF QUOTE

And here are my brief comments:

[1] Some chiropractors believe that all or most human conditions are ‘spine-related disorders’. We would need a clear statement here whether the WFC/ACC do support or reject this notion and what conditions we are actually talking about.

[2] ‘Evidence-informed’??? I have come across this term before; it is used more and more by quacks of all types. It is clearly not synonymous with ‘evidence-based’, but aims at providing a veneer of respectability by creation an association with EBM. In concrete terms, asthma, for instance, might, in the eyes of some chiropractors, be an evidence-informed indication for chiropractic. In other words, ‘evidence-informed’ is merely a card blanch for promoting all sorts of nonsense.

[3] It would be good to know which technical advances they are thinking of.

[4] Public trust is best cultivated by demonstrating that chiropractic is doing more good than harm; by itself, this point sounds a bit like PR for maximising income. Sorry, I am not sure what they mean by ‘cultural authority’ – chiropractic as a cult?

[5] ‘International portability’ – nice term, but what does it mean?

[6] I get the impression that many chiropractors do not know what is meant by the term ‘ethics’.

[7] But they certainly know much about business!

[8] That is, I think, the most relevant statement in the entire text – see below.

[9] Like those by NICE which no longer recommend chiropractic for back pain? No? They are not ‘high quality’? I see, only those that recommend chiropractic fulfil this criterion!

[10] Chiropractors as leaders? Really? With their (largely ineffective) manipulations as the main contribution to the field? You have to be a chiropractor to find this realistic, I guess.

[11] Again ‘evidence-informed’ instead of ‘evidence-based’ – who are they trying to kid?

[12] The evidence that has been emerging since many years is that chiropractic manipulations fail to generate more good than harm.

[13] In the past, I got the impression that critical thinking and chiropractic are a bit like fire and water.

MY CONCLUSION FROM ALL THIS

What we have here is, in my view, little more than a mixture between politically correct drivel and wishful thinking. If chiropractors truly want chiropractic educational curricula to “reflect current evidence”, they need to teach the following main tenets:

  • Chiropractic manipulations have not been shown to be effective for any of the conditions they are currently used for.
  • Other forms of treatment are invariably preferable.
  • Subluxation, as defined by chiropractors, is a myth.
  • Spine-related disorders, as taught in many chiropractic colleges, are a myth.
  • ‘Evidence-informed’ is a term that has no meaning; the proper word is ‘evidence-based’ – and evidence-based chiropractic is a contradiction in terms.

Finally, chiropractors need to be aware of the fact that any curriculum for future clinicians must include the core elements of critical assessment and medical ethics. The two combined would automatically discontinue the worst excesses of chiropractic abuse, such as the promotion of bogus claims or the financial exploitation of the public.

But, of course, none of this is ever going to happen! Why? Because it would mean teaching students that they need to find a different profession. And this is why I feel that statements like the above are politically correct drivel which can serve only one purpose: to distract everyone from the fundamental problems in that profession.

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