MD, PhD, FMedSci, FSB, FRCP, FRCPEd

regulation

Medical ethics are central to any type of healthcare – and this includes, of course, alternative medicine. The American Medical Association (AMA) have just published their newly revised code of ethics, AMA Principles of Medical Ethics.

It has long been my impression that, in alternative medicine, ethics receive no or far too little attention. Some alternative practitioners thrive to be able to call themselves ‘physicians’. Therefore, it seems interesting to ask whether they would also be able to comply with the ethical duties of a physician as outlined by the AMA.

The following 9 points are taken without change from the new AMA code; in brackets I have put my own, very brief comments pertaining to alternative practitioners. There is much more to be said about each of these points, of course, and I encourage my readers to do so in the comments section.

  1. A physician shall be dedicated to providing competent medical care, with compassion and respect for human dignity and rights. [Most alternative practitioners use unproven treatments; I doubt whether this can be called ‘competent medical care’.]
  2. A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities. [Treating patients with unproven therapies in the absence of fully informed consent is arguably unprofessional, dishonest and deceptive. Crucially, alternative practitioners never object to even the worst excesses of quackery that occur in their realm.]
  3. A physician shall respect the law and also recognize a responsibility to seek changes in those requirements which are contrary to the best interests of the patient. [Treatment with unproven therapies can hardly be in the best interest of the patient.]
  4. A physician shall respect the rights of patients, colleagues, and other health professionals, and shall safeguard patient confidences and privacy within the constraints of the law. [The right of patients includes full informed consent which is, according to my impression, rare in alternative medicine.]
  5. A physician shall continue to study, apply, and advance scientific knowledge, maintain a commitment to medical education, make relevant information available to patients, colleagues, and the public, obtain consultation, and use the talents of other health professionals when indicated. [Alternative medicine is frequently out of line with or even opposed to medical knowledge.]
  6. A physician shall, in the provision of appropriate patient care, except in emergencies, be free to choose whom to serve, with whom to associate, and the environment in which to provide medical care.
  7. A physician shall recognize a responsibility to participate in activities contributing to the improvement of the community and the betterment of public health. [Some activities of some alternative practitioners are directly opposed to public health, for instance when they advise against immunising children.]
  8. A physician shall, while caring for a patient, regard responsibility to the patient as paramount. [Arguably this is not possible when using unproven therapies.]
  9. A physician shall support access to medical care for all people. [Some alternative practitioners advise their patients against accessing conventional healthcare.]

As I stated above, medical ethics are neglected in alternative medicine. The 9 points of the AMA together with my comments go some way towards explaining why this is so. If ethical principles were applied to alternative medicine, much of it would have to stop instantly.

Yesterday, a press-release reached me announcing that a Chinese herbal medicine, ‘Phynova Joint and Muscle Relief Tablets’, containing the active ingredient Sigesbeckia, is now on sale in the UK for the first time in Boots The Chemist: 

Sigesbeckia is the first traditional Chinese treatment granted a traditional herbal registration (THR) under the traditional herbal medicines product directive in the UK, by drug safety watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA).  Oxford based Phynova which manufactures the product was granted the UK licence last year. 

Containing 500mg of the active ingredient, Phynova Joint and Muscle Relief Tablets are specially formulated for the relief of backache, arthritis, minor sports injuries, rheumatic or muscular pains and general aches and pains in muscles or joints.  Two tablets are taken each day, one in the morning and one in the evening. They have no known side effects and are non-addictive. .. 

The product, which retails at £19.99 for one month’s supply of 60 tablets, is available in 950 UK Boots outlets and online via Click and Collect from all stores.  It will be sold both Over the Counter (OTC) by pharmacist staff and off the shelf as part of Boots’ pain relief fixture… 

END OF QUOTE

What on earth is a ‘joint and muscle relief’? Personally I do not want to be relieved of my joints and muscles!!!

Yes, I know, they probably mean ‘joint and muscle pain relief’ but were not allowed to say so because this is a medical indication.

And what about the claim of ‘no side-effects’; is it possible that a pharmacological treatment has positive effects without any risks at all? This is not what they told me during my pharmacology course, if I remember correctly. And anyway, even placebos have side-effects!

I admit, I was puzzled.

The covering letter of the press-release provided more amazement: it informed me that “Phynova joint and muscle relief contains the active ingredient Sigesbeckia which has been through clinical trials and has been used for pain relief in China for hundreds of years…” It was the remark about clinical trials (PLURAL!!!) that caught my interest most.

So, I looked up ‘Sigesbeckia’ on Medline and found as good as nothing. This is mainly because the plant is spelled correctly ‘Siegesbeckia’ in honour of the famous botanist Siegesbeck.

Looking up ‘Siegesbeckia’, I found many pre-clinical studies but no clinical trials.

Next I searched for a comment from the MHRA and discovered that their account makes it very clear that a licence has been granted to this product “exclusively upon long standing use… and not upon data from clinical trials.”

So, who is right?

Are there clinical trials of this product or not? And, if there are any, where are they?

Perhaps someone from Phynova can enlighten us?

 

Nobody can doubt that, during the last 200 years, conventional medicine has made monumental progress. Homeopathy, however, has remained more or less like Hahnemann invented it. But now it seems as though homeopathy can celebrate an unprecedented step ahead. As so often in medicine, it originates from a commercial enterprise.

Genexa is a US firm that produces natural health products. On their website, they state that “At Genexa, we believe medicine should be free from unhealthy fillers and toxins”. They recently published a press-release introducing a line of homeopathic medicines certified organic by the U.S. Department of Agriculture and Non-GMO Project verified. They are keen to point out that these products “do not contain any genetically modified ingredients.” In fact, several of their remedies do not contain any active ingredients to speak of: they are homeopathic!

“We are extremely proud of our organic and non-GMO certifications – the seals are prominently featured on all our products and website for easy label reading and patient education,” stated David Johnson, CEO of Genexa, in their press-release. “Our quality standards are among the highest in the over-the-counter medicine industry.”

Genexa’s 11 homeopathic formulations are being advertised for the treatment of common health issues such as flu, cold, allergies, stress, pain, leg cramps, sleeplessness and jet lag. An entire line of products is, according to the press-release, specially formulated for children and includes treatments for cold, allergy and calming.

Genexa’s CMO proudly announced that “It’s important to us that our retail customers feel confident in the products and know they can trust they are purchasing medicines free from unhealthy fillers and toxins and simply focus on healing.” Presumably that trust must include the trust into the efficacy of the homeopathic remedies! Yes, I am pleased to report that, apparently it does; elsewhere they confirm this by stating that “Genexa holds itself to the highest standards in both quality and ethics.” The highest standards of ethics surely include that the remedies in question are demonstrably efficacious.

But how can we be sure? Are any of these homeopathic remedies supported by reasonably strong evidence? Oddly enough, despite all these affirmations, I did get my doubts when I tried to dig a bit deeper.

Take the homeopathic remedy called SLEEPOLOGY, for instance. The website informs us that “This homeopathic formulation consists of nine leading remedies designed to treat sleeplessness, inability to fall asleep, frequent waking, restless sleep and sleeplessness from stress, exhaustion, nervousness, excitability, restlessness, worries, irritability, and pain.” So, it’s a complex homeopathic remedy with 9 different ingredients. But is there any evidence of efficacy for this mixture? I am not aware of any clinical trials that have tested its efficacy. But I must be wrong, because on the website we are being told that “Clinical trials have demonstrated efficacy for treating sleeplessness for piper methysticum, and valeriana officinalis.” That may be so, but the trials were done with herbal extracts, not with homeopathic potencies! Could the statement therefore be more than a little misleading?

On the internet, I found all sorts of fascinating bits about the new homeopathic lines (my compliments to the PR firm that organised the launch!); for instance the revelation that: “The company’s proprietary medicines were created by and are regularly reviewed and enhanced by its chief medical officer, Dr. Todd Rowe*, a nationally respected physician with an expertise in homeopathic medicine formulation. Working with the Genexa team, Dr. Rowe and his team of chemists and pharmacists spent hundreds of hours meticulously formulating and testing the products. The result is a line of effective, potent medicines that are certified organic by the USDA and non-GMO verified by the Non-GMO Project. “Our formulations are based on tried and true principles for miasmatic and energetic balance, so that the remedies potentiate each other and promote the most positive patient outcomes,” said Dr. Rowe. “These powerful medicines work with your body to help it heal itself.”” However, I was unable to find out which potencies are being used for the Genexa homeopathic products. This information might not be that relevant: according to the homeopathic ‘like cures like’ principle, the effects of a substance are reversed through potentiation. This is why coffee, for instance, is potentised by homeopath to generate a sleeping remedy. Does it not follow then that, potentising two or more herbal ingredients that have hypnotic effects (as in SLEEPOLOGY), must generate a remedy for preventing sleep? A similarly puzzling lack of ‘homeopathic logic’ seems to apply to several other products in Genexa’s line of homeopathic remedies.

I have to admit, I am confused.

Could it be that the ‘breakthrough’ turns out to be a breakdown of ‘homeopathic logic’?

Let’s hope someone from Genexa reads these lines and can enlighten us.

[*he is the President of the American Medical College of Homeopathy]

I am sure that most of us have had enough of the endless discussions, information and foremost disinformation about Brexit; we truly had to endure them ad nauseam. And here I come with a post about the very subject.

Have I lost my senses?

Bear with me and find out for yourself.

There has been little mention of alternative medicine in the debates about last week’s referendum. For the Remain campaigners, there was perhaps no reason to go into this divisive topic because, in their view, all would stay as it is. And the ‘Brexiters’ obviously had other things on their minds. It seemed almost as though they were too busy inventing new lies on a daily basis. To me, it seems fairly obvious though that, in the realm of alternative medicine, quite a lot could change after disastrous vote to leave the EU .

My main fears are twofold;

  1. Politicians who are short-sighted enough to campaign for Brexit might also be sufficiently stupid to go for unproven medicine. This fear seems to be confirmed by Nigel Farage who once claimed that BIG HARMA was lobbying in Brussels to put alternative medicine producers out of business. But we should take that with a pinch of salt, of course; anything this man says is hardly worth taking any notice of, in my view.
  2. Consumers who are gullible enough to believe the false arguments of the Brexiters might also be sufficiently naïve to believe the fallacies and falsehoods of alternative medicine promoters.

So, are there reasonable predictions as to how Brexit might impact on the alternative medicine scene in Britain? I searched for some evidence on this question and was surprised how little there was to be found.

Dr Jan Knight from Knight Scientific, a medical research company, was quoted saying: “A lot of the complementary/alternative medicine lobby are rubbing their hands because they think they’ll be able to do anything, but I don’t think the regulations will change.”

The excellent QUACKOMETER published an entire article on the subject which is well worth reading and essentially agrees with this view. Here are its conclusions: “EU laws about alternative medicine are not that great in number. The UK is free to choose who it licenses as a medical practitioner. It can allow chiropractors and osteopaths to have statutory regulation and does so. It can fund any such treatment publicly if it so wished without EU interference. It can police the sale of products on the High Street by funding Trading Standards and training them (but it chooses not to.) The UK government can come up with its own schemes to register herbalists and homeopaths and in doing so misleads the public about them. In short, it is possible to suggest that the UK governments do indeed exercise sovereignty over how alternative medicine manifests itself, how well the public is protected and how much public money is spent on it. Leaving the EU is not going to make much difference that way. Although I do suspect that staying might indeed over the years steadily increase the level of regulation around the matter. Successive UK governments have not done a lot. The EU just a little more.”

Perhaps the regulatory framework might not change a lot. But what about the prevalence of alternative medicine usage? It seems difficult to predict in which direction it will go. The reason is that I see influences in both directions.

FACTORS THAT COULD INCREASE THE USE OF ALTERNATIVE MEDICINE

The Brexiters managed to style themselves as the anti-establishment. It is obvious that much of alternative medicine understands itself as an anti-establishment movement within healthcare. This means there could be a natural affinity between the two. On second thought, however, I think we can reject this possibility. The reason is that the Brexiters’ anti-establishment stance was nothing but a campaign ploy; in truth it is as genuine as a 4£ note.

What is much more real, in my view, is the well-documented inability of the Brexiters to correctly interpret the evidence (one could put this more simply by pointing out their ability to twist and turn the truth such that it suits their aims). These are qualities which I have often observed in promoters of alternative medicine, and it is this type of affinity that eventually might stimulate a general upwards trend of alternative medicine in the UK.

In a similar vein, we have to account for the influence of our future king. Prince Charles clearly has an alternative bee under his bonnet. Once we are outside the EU, it is likely that his influence on health politicians and other decision makers will be felt more powerfully. The Prince of Wales might even revive the ‘Smallwood Report’ which he commissioned to convince politicians that money could be saved by using more alternative therapies in the NHS. Charles and his views usually generate bewilderment on the EU-level, while here in the UK we still have many who take him seriously. His influence in a post-Brexit Britain is likely to be strengthened and will therefore be a factor that has the potential to boost alternative medicine in the UK.

FACTORS THAT COULD DECREASE THE USE OF ALTERNATIVE MEDICINE

It has been reported that our suicidal move out of the EU has led to a contraction of wealth in Britain which is bigger than anything seen since 1921. Apparently, £ 120 billion have been wiped off the value of the stock market within just a few hours. To assume that this will hit only those who are rich enough to own shares, is more than naïve. It will hit all Brits and might even drive us into another recession.

Such developments are, of course, most unwelcome but nevertheless important in relation to alternative medicine usage. Those who employ alternative treatments usually pay for them out of their own pocket. Alternative medicine has always been a bit of a luxury item for those who had more money than sense. The consequence is that financially hard times are almost automatically associated with a reduction of alternative medicine use.

CONCLUSION

All of this is, of course, akin to an exercise in reading tea leafs. But if I am correct, we will now see a significant decrease in the demand for alternative medicine in the ‘Disunited Kingdom’. Once the financial misery is over – and that could take many years – Prince Charles and other ‘irrationalists’ might succeed in bringing about a moderate increase in the use of unproven treatments.

We tend to trust charities; many of us donate to charities; we think highly of the work they do and the advice they issue. And why shouldn’t we? After all, a ‘charity’ is ‘an institution or organization set up to provide help, money, etc, to those in need’. Not a hint at anything remotely sinister here – charities are good!

Except, of course, those that are not so good!

By ‘not so good’ I mean charities that misinform the public to a point where they might even endanger our health, well-being and savings. Yes, I am speaking of those charities that promote unproven or disproven alternative therapies – and unfortunately, there are many of those around today.

Our recent letter in the SUNDAY TIMES, tried to alert the public to this problem and to the fact that the UK regulator seems to be failing to do much about it. A Charity Commission spokesman, in turn, replied that his organisation had received the letter and would respond formally to it:

“The Commission is required to register organisations as charities which are established for exclusively charitable purposes for the public benefit,” he said. “Charitable purposes for the advancement of health include conventional methods as well as complementary, alternative or holistic methods which are concerned with healing mind, body and spirit in the alleviation of symptoms and the cure of illness. Those organisations dealing with complementary and alternative medicines must be able to demonstrate that they are capable of promoting health otherwise they will not be for the public benefit.

“The Commission is the registrar and regulator of charities however it is not the authority in the efficacy of any and every non-traditional medical treatment. These are issues of substantial debate with a variety of opinions. Each case is considered on its merits based on the evidence available. To be charitable there needs to be sufficient evidence of the efficacy of the method to be used. The Commission must further be assured that any potential harm that might be said to arise does not outweigh the benefit identified by the method.

“The Commission expects charities to provide information that is factually accurate with legitimate evidence.” 

But is the information provided by all charities factually accurate?

Take, for instance, YES TO LIFE! Have a good look and then decide for yourself.

On their website they state: “We provide support, information and financial assistance to those with cancer seeking to pursue approaches that are currently unavailable on the NHS. We also run a series of educational seminars and workshops which are aimed at the general public who want to know more and practitioners working with people who have cancer.”

The website informs us about many alternative therapies and directly or indirectly promote them for the curative or supportive treatment of cancer. I have chosen 5 of them and copied the respective summaries as published by YES TO LIFE. My main selection criterion was having done some research myself on the modality in question. Here are the 5 cancer treatments which I selected; the text from YES TO LIFE is in bold, and that of my published research is in normal print with a link to the published paper:

CARCTOL

Carctol is a relatively inexpensive product, specifically formulated to assist cells with damaged respiration, it is also a powerful antioxidant that targets free radicals, the cause of much cellular damage. It also acts to detoxify the system.

The claim that Carctol is of any benefit to cancer patients is not supported by scientific evidence.

LAETRILE

Often given intravenously as part of a programme of Metabolic Therapy, Laetrile is a non-toxic extract of apricot kernels. The claimed mechanism of action that is broken down by enzymes found in cancer cells. Hydrogen cyanide, one of the products of this reaction then has a local toxic effect on the cells.

The claims that laetrile or amygdalin have beneficial effects for cancer patients are not currently supported by sound clinical data. There is a considerable risk of serious adverse effects from cyanide poisoning after laetrile or amygdalin, especially after oral ingestion. The risk-benefit balance of laetrile or amygdalin as a treatment for cancer is therefore unambiguously negative.

MISTLETOE

Mistletoe therapy was developed as an adjunct to cancer treatment in Switzerland in 1917-20, in the collaboration between Dr I Wegman MD and Dr Rudolf Steiner PhD (1861-1925). Mistletoe extracts are typically administered by subcutaneous injection, often over many years. Mistletoe treatment improves quality of life, supports patients during recommended conventional cancer treatments and some studies show survival benefit. It is safe and has no adverse interactions with conventional cancer treatments.

None of the methodologically stronger trials exhibited efficacy in terms of quality of life, survival or other outcome measures. Rigorous trials of mistletoe extracts fail to demonstrate efficacy of this therapy.

UKRAIN

A type of low toxicity chemotherapy derived from a combination of two known cytotoxic drugs that are of little use individually, as the doses required for effective anticancer action are too high to be tolerated. However the combination is effective at far lower doses, with few side effects.

The data from randomised clinical trials suggest Ukrain to have potential as an anticancer drug. However, numerous caveats prevent a positive conclusion, and independent rigorous studies are urgently needed. [To judge the validity of this last treatment, I also recommend reading a previous post of mine.]

Finally, it might be informative to see who the individuals behind YES TO LIFE are. I invite you to have a look at their list of medical advisors which, I think, speaks for itself. It includes, for instance, Dr Michael Dixon of whom we have heard before on this blog, for instance, here, here and here.

Say no more!

In 2008, I published a paper entitled ‘CHIROPRACTIC, A CRITICAL EVALUATION’ where I reviewed most aspects of this subject, including the historical context. Here is the passage about the history of chiropractic. I believe it is relevant to much of the current discussions about the value or otherwise of chiropractic.

The history of chiropractic is “rooted in quasi-mystical concepts.”  Bone-setters of various types are part of the folk medicine of most cultures, and bone-setting also formed the basis on which chiropractic developed.

The birthday of chiropractic is said to be September 18, 1895. On this day, D.D. Palmer manipulated the spine of a deaf janitor by the name of Harvey Lillard, allegedly curing him of his deafness. Palmer’s second patient, a man suffering from heart disease, was also cured. About one year later, Palmer opened the first school of chiropractic. There is evidence to suggest that D.D. Palmer had learned manipulative techniques from Andrew Taylor Still, the founder of osteopathy. He combined the skills of a bone-setter with the background of a magnetic healer and claimed that “chiropractic was not evolved from medicine or any other method, except that of magnetic.” He coined the term “innate intelligence” (or “innate”) for the assumed “energy” or “vital force,” which, according to the magnetic healers of that time, enables the body to heal itself. The “innate” defies quantification. “Chiropractic is based on a metaphysical epistemology that is not amenable to positivist research or experiment.”

The “innate” is said to regulate all body functions but, in the presence of “vertebral subluxation,” it cannot function adequately. Chiropractors therefore developed spinal manipulations to correct such subluxations,  which, in their view, block the flow of the “innate.” Chiropractic is “a system of healing based on the premise that the body requires unobstructed flow through the nervous system of innate intelligence.” Anyone who did not believe in the “innate” or in “subluxations” was said to have no legitimate role in chiropractic.

“Innate intelligence” evolved as a theological concept, the representative of Universal Intelligence ( = God) within each person. D.D. Palmer was convinced he had discovered a natural law that pertained to human health in the most general terms. Originally, manipulation was not a technique for treating spinal or musculoskeletal problems, it was a cure for all human illness: “95% of all diseases are caused by displaced vertebrae, the remainder by luxations of other joints.” Early chiropractic pamphlets hardly mention back pain or neck pain, but assert that, “chiropractic could address ailments such as insanity, sexual dysfunction, measles and influenza.” D.D. Palmer was convinced that he had “created a science of principles that has existed as long as the vertebra.” Chiropractors envision man as a microcosm of the universe where “innate intelligence” determines human health as much as “universal intelligence” governs the cosmos; the discovery of the “innate intelligence” represents a discovery of the first order, “a reflection of a critical law that God used to govern natural phenomena.”

Early chiropractic displayed many characteristics of a religion. Both D.D. Palmer and his son, B.J. Palmer, seriously considered establishing  chiropractic as a religion. Chiropractic “incorporated vitalistic concepts of an innate intelligence with religious concepts of universal intelligence,” which substituted for science. D.D. Palmer declared that he had discovered the answer to the timeworn question, “What is life?” and added that chiropractic made “this stage of existence much more efficient in its preparation for the next step – the life beyond.”

Most early and many of today’s chiropractors agree: “Men do not cure. It is that inherent power (derived from the creator) that causes wounds to heal, or a part to be repaired. The Creator…uses the chiropractor as a tool…chiropractic philosophy is truly the missing link between Religion or Power of the various religions.” Today, some chiropractors continue to relate the “innate” to God. Others, however, warn not to “dwindle or dwarf chiropractic by making a religion out of a technique.”

Initially, the success of chiropractic was considerable. By 1925, more than 80 chiropractic schools had been established in the United States. Most were “diploma mills” offering an “easy way to make money,” and many “were at one another’s throats.” Chiropractors believed they had established their own form of science, which emphasized observation rather than experimentation, a vitalistic rather than mechanistic philosophy, and a mutually supportive rather than antagonist relationship between science and religion. The gap between conventional medicine and chiropractic thus widened “from a fissure into a canyon.” The rivalry was not confined to conventional  medicine; “many osteopaths asserted that chiropractic was a bastardized version of osteopathy.”

Rather than arguing over issues such as efficacy, education, or professional authority, the American Medical Association insisted that all competent health care providers must have adequate knowledge of the essential subjects such as anatomy, physiology, pathology, chemistry, and bacteriology. By that token, the American Medical Association claimed, chiropractors were not fit for practice. Some “martyrs,” including D.D. Palmer himself, went to jail for practicing medicine without a licence.

Chiropractors countered that doctors were merely defending their patch for obvious financial reasons (ironically, chiropractors today often earn more than conventional doctors), that orthodox science was morally corrupt and lacked open-mindedness. They attacked the “germo-anti-toxins-vaxiradi-electro-microbioslush death producers” and promised a medicine “destined to the grandest and greatest of this or any age.”

Eventually, the escalating battle against the medical establishment was won in “the trial of the century.” In 1987, sections of the U.S. medical establishment were found “guilty of conspiracy against chiropractors,” a decision which was upheld by the U.S. Supreme Court in 1990. In other countries, similar legal battles were fought, usually with similar outcomes. Only rarely did they not result in the defeat of the “establishment:” In 1990, a Japanese Ministry of Health report found that chiropractic is “not based on the knowledge of human anatomy but subjective and unscientific.”

These victories came at the price of “taming” and “medicalizing” chiropractic. In turn, this formed the basis of a conflict within the chiropractic profession – the dispute between “mixers” and “straights” – a conflict which continues to the present day.

The “straights” religiously adhere to D.D. Palmer’s notions of the “innate intelligence” and view subluxation as the sole cause and manipulation as the sole cure of all human disease. They do not mix any non-chiropractic techniques into their therapeutic repertoire, dismiss physical examination (beyond searching for subluxations) and think medical diagnosis is irrelevant for chiropractic. The “mixers” are somewhat more open to science and conventional medicine, use treatments other than spinal manipulation, and tend to see chiropractors as back pain specialists. Father and son Palmer warned that the “mixers” were “polluting and diluting the sacred teachings” of chiropractic. Many chiropractors agreed that the mixers were “bringing discredit to the chiropractic.”

The “straights” are now in the minority but nevertheless exert an important influence. They have, for instance, recently achieved election victories within the British General Chiropractic Council. Today, two different chiropractic professions exist side by sided “one that wishes to preserve the non-empirical, non-positivist, vitalist foundations (the straights) and the other that wishes to be reckoned as medical physicians and wishes to utilize the techniques and mechanistic viewpoint of orthodox medicine (the mixers).” The International Chiropractic Association represents the “straights” and the American Chiropractic Association the “mixers.”

(for references, see the original article)

On their website, the American Chiropractic Association (ACA) recently updated its members on their lobbying activities aimed at having US chiropractors recognised as primary care physicians. The president of the ACA posted the following letter to ACA members:

Last February the ACA House of Delegates passed a formal resolution directing ACA to make achieving full physician status in Medicare a top priority of the association.

For much of this past year, ACA’s staff and key volunteers have been laying the groundwork to achieve just that — quietly spending time building key support on Capitol Hill for this important legislative change. As you know, our progress advanced to the point where we were able on Oct. 27 to publically launch our grassroots campaign centered on the widespread circulation of our National Medicare Equality Petition.

Since the launch of our campaign, through very public and transparent means, ACA has received the support of various organizations and individuals within the profession. These supporters fully understand the importance of eliminating any and all provider discrimination by CMS. Further they fully understand and agree with the soundness of the strategic and tactical decisions we have made and continue to make an effort to achieve the desired reformation in Medicare.

Towards building a unified consensus within the profession for our objectives and plans to accomplish them, we have engaged in prolonged discussions, mostly via the Chiropractic Summit Steering Committee and Roundtable process that includes ACA, COCSA, ACC, ICA, NBCE, FCLB and CCE. Throughout this process we have provided for them written legal opinions and analyses relative to the precise legislative language needed to achieve the full-physician status we seek. We have outlined our strategy numerous times; have shared our materials and updates with any group wishing to review them; and have repeatedly urged state chiropractic associations, chiropractic colleges, corporate partners and individual DCs to join with us and enthusiastically support this reformation campaign.

While there was high consensus on the objective of Medicare reform during the Summit Roundtable process, there was much discussion surrounding the proposed legislative language. Specifically, whether or not “detection and correction of subluxation of the spine through manual manipulation” would need to be eliminated and replaced with language simply designating DCs as physician level providers on the same level as MDs and DOs who report/bill services to Medicare based on their individual state laws.

ACA is of the opinion that nothing less than removal of the “subluxation” language in the definition of physician section will accomplish our objectives. Historically, the facts are that this language has proven to be the major barrier within HHS and CMS when we advocated for regulatory remedies expanding our reimbursement and coverage for the full range of services provided by a DC. ACA (and our profession) has expended massive resources over the past decade or longer to no avail through regulatory channels (HHS, CMS). Based on these experiences, the only reasonable recourse to eliminate 40+ years of Medicare discrimination is through a thoughtful profession-wide legislative effort.

During the Roundtable discussions, compromise language was reached placing the current “subluxation language” into the preamble of a proposed law stating that DCs must continue to have the ability to detect and correct subluxations of the spine for Medicare beneficiaries. Six of seven Summit Roundtable organizations voted in favor of this language that was offered by the Association of Chiropractic Colleges.

ACA`s intent on removing the “subluxation” reference in the Social Security Administrative statute is in no way an attempt to quash our ability to perform those services that so many of the Medicare population need and deserve. Rather, the ultimate goal of this historic effort is to gain the privilege to manage our Medicare patients within state scopes of practice and allow reimbursement for all those services that the Medicare beneficiaries are currently forced to pay out of pocket. ACA supports fully our continued ability to correct subluxations through appropriate active care and, in fact, achieve coverage for manipulation of all areas, not simply limited to the spine.

Expanding Medicare scope reimbursement will allow our profession to practice contemporary chiropractic and to potentially increase utilization of our services to the ever-increasing aging population. Expansion and reformation will also place DCs in a position to participate in alternative payment models, quality healthcare initiatives, community health centers, hospitals and other integrated settings which are vital to professional growth.

In conclusion, should you as an HOD member be questioned on our intent you should be able to answer unequivocally that ACA supports the right to manage our patients as dictated by our training and competencies based on state scopes of practice. Further, we support those who wish to provide necessary active subluxation care for the Medicare population. Please support this initiative and let’s join together to encourage your state association, colleges and universities, corporate partners, patients and individual DCs to become true partners in order to make this a success for our patients and for our grand profession.

A list of talking points will be distributed in the coming days.

Sincerely, Tony Hamm, DC President, ACA

Do I read this correctly?

The term subluxation is a hindrance to business. Therefore chiros need to do something about it. Never mind that the principle of subluxation as used in the realm of chiropractic is nonsense!

This might throw an entirely different light on those chiros who want to get rid of the term ‘subluxation’.

And what about chiros as primary care physicians?

Recently Dave Newell posted on this blog: “chiropractors in the UK … are primary care clinicians”. I objected and he insisted to be correct because “Primary Care is defined as a clinician that is the first port of call for patients seeking help.” Frank Odds then countered: “This business of “primary care provider” is becoming enervating! Edzard has now spelt out the meaning of the term as defined by Wikipedia. You are quite right that a dentist is a primary care provider: people go to a dentist when they have symptoms affecting their mouth in general — more often their teeth and gums in particular. They know that’s what dentists deal with. A general practitioner is a primary care provider: people go to a GP when they have symptoms anywhere. They know that’s what GPs deal with. A chiropractor is indeed a primary care provider: of chiropractic. ”

I think that primary care physicians are doctors who are capable of handling everything or at least most of what primary care may present to them. Chiros do not fulfil this criterion, I think.

I would be interested what you feel on this important issue.

The Independent asked me yesterday to write a 500-word piece on homeopathy. I accepted with pleasure. About two hours after I had sent it, my article appeared on their website. As I had not even seen their edited version, I was surprised how much they changed without my permission.

No, I am not cross about this – I know by now how journalists function. Yet I think that some of their changes did change my meaning, and therefore I have decided to post here the original. Since I did not get paid nor sign a copyright transfer, I think I am perfectly entitled to do that.

HERE IT IS

Time to get real about homeopathy

EDZARD ERNST, EMERITUS PROFESSOR, UNIVERSITY OF EXETER

The National Health and Medical Research Council of Australia recently published what might be the most thorough evaluation of homeopathy in the 200-year long history of this therapy. They assessed a total of 57 systematic reviews summarizing 176 individual clinical trials focused on 68 different conditions. They concluded that, firstly, there is no evidence that homeopathy works better than placebo, and, secondly, that patients may harm themselves, if they nevertheless employ homeopathy instead of effective therapies. Already in 2002, on the basis of a similar but less comprehensive analysis, I concluded that “the best clinical evidence for homeopathy available to date does not warrant positive recommendations for its use in clinical practice” [http://www.ncbi.nlm.nih.gov/pubmed/12492603]. Yet homeopaths around the world seemed shocked by this news and are now on the war-path to rubbish or suppress it.

This reaction is as surprising as it is ridiculous. The conclusion that highly diluted homeopathic remedies are pure placebos had already been derived from the utter implausibility of Hahnemann’s theories that like cures like and that diluting a remedy would render it not weaker but stronger. Oliver Wendell Holmes, for instance, famously wrote in 1842 that homeopathy is “a mingled mass of perverse ingenuity, of tinsel erudition, of imbecile credulity, and of artful misinterpretation, too often mingled in practice…with heartless and shameless imposition.”

Homeopaths, however, claimed for the last 200 years that science was not yet able to explain how homeopathy works, in other words, that homeopaths are ahead of their time. The fact, however, is that scientists have always been perfectly able to affirm that there cannot be an explanation for homeopathy that does not fly in the face of science.

“The proof is in the pudding”, homeopaths countered, “if patients benefit from homeopathy, it works regardless what the science tells us!” This argument too has long been shown to be based on little more than the delusion of homeopaths. Patients benefit from the therapeutic encounter, from the placebo-effect and from other phenomena that are unrelated to the sugar pills dished out by homeopaths. To convey such benefits to their patients, clinicians do not need placebos. Administering truly effective treatments with compassion will make them benefit from both the specific and the non-specific effects of the therapy in question. This means that just using placebos like homeopathics is unethical and amounts to cheating the patient.

Given the overwhelming evidence against homeopathy it seems now time to act. There is no reason any longer for consumers, patients, politicians, journalists etc. to believe in homeopathy. Pretending there is room for a legitimate debate is merely misleading the public. There is also no reason to have homeopathy on the NHS, to pay for homeopathic hospitals or to invest into further research. After researching the subject for more than two decades, I am convinced that the only legitimate place for homeopathy is in the history books.

Germany is, as we all know, the home of homeopathy. Here it has an unbroken popularity, plenty of high level support and embarrassingly little opposition. The argument that homeopathy has repeatedly been shown to merely rely on placebo effects seems to count for nothing in Germany.

Perhaps this is going to change now. On January 30, a group of experts from all walks of life have met in Freiburg to discuss ways of informing the public responsibly and countering the plethora of misinformation that Germans are regularly exposed to on the subject of homeopathy. They founded the ‘Information Network Homeopathy’ and decided on a range of actions.

No doubt, some will ask where does their financial support come from? And no doubt, some will claim that we are on the payroll of ‘Big Pharma’. The truth is that we have no funding; everyone gives his/her own time free of charge and pays for his/her own expenses etc. And why? Because we believe in progress and feel strongly that it is time to improve healthcare by relegating homeopathy to the history books.

One of the first fruits of the network’s endeavours is the Freiburger Erklärung zur Homöopathie’, the ‘Freiburg Declaration on Homeopathy’. I have the permission to reproduce the document here in full (the translation is mine):

HOMEOPATHY IS NEITHER NATUROPATHY NOR MEDICINE

Despite the support of politicians and the silence of those who should know better, homeopathy has remained a method which is in clear opposition to the proven basics of science. The members and supporter of the ‘Information Network Homeopathy’ view homeopathy as a stubbornly surviving belief system, which cannot be accepted as part of naturopathy nor medicine. The information network is an association of physicians, pharmacists, veterinarians, biologists, scientists and other critics of homeopathy who are united in their aim to disclose this fact more openly and make the public more aware of it.

NO SPECIAL STATUS FOR HOMEOPATHY

During the more than 200 years of its existence, homeopathy has not managed to demonstrate its specific effectiveness. Homeopathy only survives because it has been granted special status in the German healthcare system which is, in the opinion of the experts of the network, unjustified. Drugs have to prove their effectiveness according to objective criteria, but homeopathics are exempt from this obligation. We oppose such double standards in medicine.

Homeopathy has also not managed to demonstrate a plausible mode of action. Instead its proponents pretend that there are uncertainties which need to be clarified. We oppose such notions vehemently. Homeopathy is not an unconventional method that requires further scientific study. Its basis consists of long disproven theories such as the ‘law of similars’, ‘vital force’ or ‘potentisation by dilution’.

SELF-DECEPTION OF PATIENT AND THERAPIST

We do not dispute the therapeutic effects of a homeopathic treatment. But they are unrelated to the specific homeopathic remedy. The perceived effectiveness of homeopathics is due to suggestion and auto-suggestion of the patient and the therapist. The mechanisms of such (self-) deceit are multi-fold but well-known and researched. Symptomatic improvements caused by context-effects must not be causally associated with the homeopathic remedy. We assume that many physicians and alternative practitioners using homeopathy are unaware of the existence and multitude of such mechanisms and are acting in good faith. This, however, does not alter the fact that their conclusions are wrong and thus potentially harmful.

MEDICINE AND SCIENCE

We do not claim that the scientific method which we uphold can currently research and explain everything. However, it enables us to explain that homeopathy cannot explain itself. The scientific method shows the best way we have for differentiating effective from ineffective treatments. A popular belief in therapeutic claims nourished by politicians and journalists can never be a guide for medical activities.

AIM OF THIS DECLARATION

Our criticism is not aimed at needy patients or practising homeopathic clinicians; it is aimed at the school of homeopathy and the healthcare institutions which could have long recognised the nonsensical nature of homeopathy, but have chosen not to interfere. We ask the players within our science-based healthcare system to finally reject homeopathy and other pseudoscientific methods and to return to what should be self-evident: scientifically validated, fair and generally reproducible rules promoting top-quality medicine for he benefit of the patient.

Authors:

Dr.-Ing. Norbert Aust, Initiator Informationsnetzwerk Homöopathie

Dr. med. Natalie Grams, Leiterin Informationsnetzwerk Homöopathie

Amardeo Sarma, GWUP Vorsitzender und Fellow von CSI (Committee for Skeptical Inquiry)

Signatories:

Edzard Ernst, Emeritus Professor, Universität Exeter, UK

Prof. Dr. Rudolf Happle, Verfasser der Marburger Erklärung zur Homöopathie

Prof. Dr. Wolfgang Hell, Vorsitzender des Wissenschaftsrates der GWUP

Prof. Norbert Schmacke, Institut für Public Health und Pflegeforschung, Universität Bremen

Dr. rer. nat. Christian Weymayr, freier Medizinjournalist

A friend alerted me to this website: Hungarian Academy of Sciences statement proposing the same scientific standards for homeopathic drug registration as for normal drugs

Members of the Section of Medical Sciences of the Hungarian Academy of Sciences (HAS) voted unanimously on 9 November 2015 for supporting the earlier proposal of the Royal Swedish Academy of Sciences. The Swedish statement requested that the homeopathic remedies should go through the same efficacy trials as normal drugs should.

The Hungarian statement refers to various recent scientific statements for example to the study of the Australian Government’s National Health and Medical Research Council that analysed 175 publications and concluded that there was no reasonable scientific proof for the efficacy of homeopathy for any health conditions. The HAS also refers to the European Academies Science Advisory Council that is allegedly considering an investigation among the academies of the UN countries about this topic. The statement points out that another Hungarian scientific body (Health Science Committee – Egészségügyi Tudományos Tanács) had made a similar statement already in 1991 and opposed using and registering those drugs for that efficacy had not been proved and that had not gone through adequate research procedures.

József Mandl – biochemist, member of HAS, president of Health Science Committee said: “The Australian and Swedish statements had raised the interest of the Hungarian scientific community and now members of the Medical Sciences Section of the Hungarian Academy of Sciences voted unanimously to join the Swedish initiation… Science has well defined, rigorous methods and systems. Homeopathy can’t be fitted to these. Homeopathic remedies don’t meet the criteria of evidence based medicine. There might be various hypotheses, theories, but everything should be proved. This is what science means and this is what we would like to highlight now.”

Well said, indeed!

It is high time that the authorities concede that there can be only one standard in medicine regulation. The ‘free ride’ homeopathy has had for 200 years must now come to an end.

This notion also seems to be increasingly supported by the legal profession. An Australian lawyer just published this abstract:

The 2010 report of the United Kingdom Science and Technology Committee of the House of Commons and the 2015 report of the Australian National Health and Medical Research Council have overtaken in significance the uncritical Swiss report of 2012 and have gone a long way to changing the environment of tolerance toward proselytising claims of efficacy in respect of homeopathy. The inquiry being undertaken in the United States by the Food and Drug Administration during 2015 may accelerate this trend. An outcome of the reports and inquiries has been a series of decisions from advertising regulators and by courts rejecting medically unjustifiable claims in respect of the efficacy of homeopathy. Class actions have also been initiated in North America against manufacturers of homeopathic products. The changing legal and regulatory environment is generating an increasingly scientifically marginalised existence for homeopathy. That new environment is starting to provide effective inhibition of assertions on behalf of homeopathy and other health modalities whose claims to therapeutic efficacy cannot be justified by reference to the principles of evidence-based health care. This has the potential to reduce the financial support that is provided by insurers and governments toward homeopathy and to result in serious liability exposure for practitioners, manufacturers and those who purvey homeopathic products, potentially including pharmacists. In addition, it may give a fillip to a form of regulation of homeopaths if law reform to regulate unregistered health practitioners gathers momentum, as is taking place in Australia.

As though this is not enough, today it was reported that the UK NHS is considering to blacklist homeopathic remedies:

The Good Thinking Society has been campaigning for homeopathy to be added to the NHS blacklist – known formally as Schedule 1 – of drugs that cannot be prescribed by GPs. Drugs can be blacklisted if there are cheaper alternatives or if the medicine is not effective. After the Good Thinking Society threatened to take their case to the courts, Department of Health legal advisers replied in emails that ministers had “decided to conduct a consultation”. Officials have now confirmed this will take place in 2016.

It seems to me that the position of homeopathy as a form of health care is less and less tenable. Its place is in the history books. To satisfy the need for consumer/patient choice, the remedies should be moved to the confectionary shelves of the supermarkets.

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