The FDA just made the following significant announcement:
The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.
April 20-21, 2015
9:00 am to 4:00 pm
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503A (Great Room)
Silver Spring, Maryland 20993
Attendance, Registration, and Oral Presentations
Registration is free and available on a first-come, first-served basis. If you wish to attend or make an oral presentation, please reference section III of the forthcoming Federal Register Notice (Attendance and/or Participation in the Public Hearing) for information on how to register and the deadline for registration.
If you cannot attend in person, information about how you can access a live Webcast will be located at Homeopathic Product Regulation
The agenda will be posted soon
And this is what Reuters reported about the planned event:
The hearing, scheduled for April 20-21, will discuss prescription drugs, biological products, and over-the-counter drugs labeled homeopathic, a market that has expanded to become a multimillion dollar industry in the United States. The agency is set to evaluate its regulatory framework for homeopathic products after a quarter century. (http://1.usa.gov/1Hxwup3) An Australian government study released this month concluded that homeopathy does not work. (http://bit.ly/1BheAmR) The FDA issued a warning earlier this month asking consumers not to rely on asthma products labeled homeopathic that are sold over the counter. (http://1.usa.gov/1EEuKrC) Homeopathic medicines include pellets placed under the tongue, tablets, liquids, ointments, sprays and creams. The basic principles of homeopathy, formulated by German physician Samuel Hahnemann in the late 18th century, are based on a theory that a disease can be treated using small doses of natural substances that in a healthy person would produce symptoms of the disease. The agenda for the hearing will be posted soon, the FDA said on Tuesday.
In my view, this is an important occasion for experts believing in evidence to make their position regarding homeopathy heard. I therefore encourage all my readers who have an evidence-based opinion on homeopathy to submit it to the hearing.
The other day, I received a request from THE GUARDIAN: could I write a piece on homeopathy in relation to the Australian report which had just come out; they gave me ~700 words and all of 3 hours to do it. I had an extremely busy day, but accepted the challenge nevertheless.
My article was published the next day and the ‘headliner’ at THE GUARDIAN had elected to call it There is no scientific case for homeopathy: the debate is over.
What followed was a flurry of debate – well over 2200 comments – which was more than a little ironic, considering the headline.
Essentially, my article had repeated the well-rehearsed arguments which have so often been made on this blog and elsewhere:
• Our trials failed to show that homeopathy is more than a placebo.
• Our reviews demonstrated that the most reliable of the 230 or so trials of homeopathy ever published are also not positive.
• Studies with animals confirmed the results obtained on humans.
• Surveys and case reports suggested that homeopathy can be dangerous.
• The claims made by homeopaths to cure conditions like cancer, asthma or even Ebola were bogus.
• The promotion of homeopathy is not ethical.
The comments that followed were mixed, of course; those that disagreed with me used a range of counter-arguments; in no specific order, these were the following:
- For several reasons, I cannot be trusted.
- I even once stated that I have treated my wife homeopathically.
- The Australian report was neither thorough nor reliable.
- The Australian expert panel were bought by Big Pharma.
- Homeopathic treatment must be individualised and can therefore not be tested in RCTs.
- Just because we don’t understand how homeopathy works, we should not conclude that it is ineffective.
- 200 years of positive experience with homeopathy clearly prove that it works.
- The huge popularity of homeopathy worldwide demonstrated its effectiveness.
- The fact that some very clever people support homeopathy shows that it works.
- Homeopathy works in animals and little children, therefore it cannot be just a placebo.
- The Queen and my aunt Doris use homeopathy.
- Placebos work.
- Patients must be able to choose; patient choice is an important principle in all health care.
- There’s more to evidence than just RCTs.
- Homeopathy works like vaccines.
With such an abundance of counter-arguments, the debate is clearly NOT over! Or is it? Let’s see how solid the arguments really are.
1) I cannot be trusted
Ad hominem attacks are no arguments at all; they are merely a sign that the person using them has no real arguments left.
2) I treated my wife homeopathically
This is true. At one stage in my life, I treated anyone who couldn’t run fast enough to escape me with homeopathy. What does that show? It simply shows that I can make mistakes too.
3) The Australian report was flawed
Perhaps it was not entirely faultless (no report ever is), but it certainly was rigorous – more so than any previous document in the entire history of homeopathy. If it excluded certain types of evidence, like the observational studies (which are so much loved by homeopaths), it did so because such data are wide open to bias.
4) The panel was not independent
Yes, it was! It even included a homeopath. The Australian National Health and Medical Research Council is internationally highly respected, and to defame it without evidence is, in a way, just another ad hominem attack.
5) Homeopathy must be individualised
This is a half-truth: classical homeopathy is mostly individualised, but lots of homeopathic prescribing is not individualised. And in any case, we have recently seen how totally unconvincing the results of strictly individualised trials of homeopathy are. This argument turns out to be a red herring.
6) We currently don’t understand how homeopathy works
What we do understand perfectly well, however, is the fact that no explanation exists which would not require throwing over board big chunks of the laws of nature. But even if we accepted that the mode of action is unknown, this would not change the lack of homeopathy’s clinical effectiveness. Lots of treatments work without us understanding how.
7) Experience shows it works
Experience is a very unreliable indicator of effectiveness; there are simply far too many confounders such as placebo effects, regression towards the mean or natural history of the disease. This is why we need evidence to be sure, and historically medicine finally started making progress when this lesson had been learnt.
8) The amazing popularity of homeopathy is proof of its effectiveness
This is the ‘argumentum ad populum’ fallacy. Think of the popularity of blood-letting to see how wrong this argument can be.
9) Homeopathy is backed by some very clever people
So what? Clever people are not always correct – look at me (just joking!)
10) Homeopathy works in animals and little children which proves that it is more than a placebo
First, animals and children do also show placebo-responses.
Second, the animal owner/parent might respond to placebo and thus mimic a placebo-response in the patient.
Third, the evidence for homeopathy is not positive neither in animals nor in children.
11) The Queen swears by homeopathy
Yes, so much so that, as soon as she is really ill, she makes use of what the very best of conventional medicine has to offer.
12) Placebos work
For sure! But that does not mean that we should prescribe placebos. If an effective treatment is given with compassion and empathy, the patient will also profit from a placebo effect – in addition to the effect of the treatment. Merely administering placebos means withholding the latter and is thus not in the best interest of the patient.
13) Patient choice
Yes, patient choice is important. However, it only applies to the choice between treatments that are demonstrably effective – if not choice becomes arbitrariness.
14) Evidence is more than just RCTs
True, there are many study designs other than RCTs. They all have their place in research – but when the research question is to test whether a treatment is effective beyond placebo, they are all open to different types of bias. The one that minimises bias best and thus produces more reliable findings than any other study design is the placebo-controlled, double-blind RCT.
15) Homeopathy works like vaccines
No! The ‘like cures like principle’ appears to be similar to the principles of vaccination, but this appearance is misleading. Vaccines contain small amounts of active material, while the typical homeopathic remedy doesn’t. Vaccines use the substance that causes the illness, e. g. (parts of) a virus, while homeopathy doesn’t.
So, is there still a debate? Obviously there is – the Guardian headliner was wrong – but it is a debate without reasonable arguments. And in the public domain, the debate is dominated by enthusiasts who endlessly repeat nonsensical notions which have been shown to be wrong over and over again.
In a nutshell:
Yes, there continues to be a debate.
No, there is no reasonable debate.
I have argued since many years that pharmacists should not be selling or promoting homeopathic and other remedies for which there is no proof of efficacy – the last time I published my view on this matter is even less than a week ago: Personally, I would go another step further and remind pharmacists who sell homeopathic remedies to the unsuspecting public that it is unethical to pretend they are more than placebos.
Despite my insistence and despite the fact that many agree with me (at least privately), there are precious few pharmacists who actually do something meaningful about the current situation. And there is very little visible change: in the UK, it is currently hard to find a pharmacy where homeopathic remedies are not on the shelves, and certainly all the major chains seem to put money before health care ethics.
I am, of course, speaking about the situation in the UK, France, Germany and some other European countries. Perhaps elsewhere things are different?
A NZ website seems to indicate that ‘down under’ the pharmacists are getting more active. Some strongly argue against unproven or disproven remedies in pharmacies:
Firstly, …it’s not a case that “pharmacists ‘should’ only be selling health products for which there is credible evidence of efficacy” (alterations mine, emboldened) but that they are obliged to—but choose not to. Their ethical guidelines state -
[PHARMACISTS] MUST:… Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.
…Secondly, the argument that ‘other businesses sell junk remedies therefore we shall’ is unsound. One of the key points about the ethical regulations for pharmacies is that customers should be able to walk into a store and have an expectation that the remedies within the store are basically sound. If other businesses elect to be unsound, that’s poor health practice, but no justification to do likewise. On the face of it, it would seem that the profit motive is ruling over sound and ethical practice.
Thirdly, that some GPs subscribe placebos should have no standing in this. There is some arguments for GPs to prescribe placebo remedies in some cases; others would argue that education is a better response in most cases. Either way—and just my opinion—it seems to me that GPs prescribing homeopathic remedies encourages people to think these have real remedial effects. I don’t work within the industry, but I am sure are ways of offering placebos that avoid using off-the-shelf commercial products. One might be that patients only get placebo ‘treatments’ via prescription.
…Fourthly, Pharmacy Today encourages that “pharmacies need to reconsider their stance in the light of this report”***. While this is an excellent idea, and one I thoroughly support, I suspect the underlying driver isn’t the report, but media presence on the topic. There is a long trail of evidence over many years showing that homeopathic remedies are not effective for anything.
The Australian study*** that prompted the latest round of interest drew this statement,
Based on the assessment of the evidence of effectiveness of homeopathy, NHMRC concludes that there are no health conditions for which there is reliable evidence that homeopathy is effective.
Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner.* Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
The National Health and Medical Research Council expects that the Australian public will be offered treatments and therapies based on the best available evidence.
…Why were the relevant professional bodies not onto this evidence sooner?…
I might add another one: why are the European professional bodies of pharmacy doing so little about this ongoing breach of their own ethical codes?
(*** the report that the author refers to is the one by the Australian National Health and Medical Research Council we discussed on this blog a few days ago.)
According to Bloomberg Markets, A Nelson & Co Ltd. manufactures and markets natural healthcare products. The company offers arnica creams that provide natural first aid for bruises; plant and flower based remedies that help in managing the emotional demands of everyday life; and over-the-counter homeopathic medicines for everyday ailments, such as relief from travel sickness and relief for the symptoms of hay fever. It also provides hemorrhoid relief creams and soothing hygienic wipes; anti-blemish range products for various skin types and age groups; multi-purpose cream that helps to soothe and restore skin; iron supplements; teething granules that provide relief from the symptoms and discomfort of teething; a range of creams, ointments, and sprays for a range of common skin conditions/complaints; and a range of commonly used herbal remedies. The company offers products for ailments, including aches and pains, mild anxiety, babies and children, colds and minor infections, digestion, emotional health, energy, everyday stresses, first aid, getting older, pets, quit smoking, skin, sleep, travel, and women’s health. It also operates a clinic; and a pharmacy that offers homeopathy and complementary healthcare products. The company offers its products through its pharmacy in the United Kingdom; and distributors in Europe, Latin America, and internationally. It also serves customers online. The company was formerly known as Armbrecht, Nelson & Co. The company was founded in 1860 and is based in London, United Kingdom with subsidiary offices in Boston, Massachusetts; and Hamburg, Germany. A Nelson & Co Ltd. operates as a subsidiary of Nelson and Russell Holdings Ltd.
In the journal ‘Chemist and Druggist’ we find an article informing us that, in 1930, Nelsons Homeopathic Pharmacy was approached by Dr Edward Bach who wanted help making and selling his products. He had created 38 flower remedies to rebalance emotions and later created an emergency remedy, a combination of five flower remedies that became Rescue. The relationship between Nelsons and the Dr Edward Bach Centre, based at Dr Bach’s former home at Mount Vernon in Oxfordshire, continues to this day and both the Bach Original Flower Remedies and Rescue are key ranges for Nelsons.
Nelson’s homeopathic pharmacy has a proud history:
Ernst Louis Armbrecht, a German pharmacist and disciple of Samuel Hahnemann, came to London and founded Nelsonsin 1860. Since then, Nelsons has been supplying homeopathic medicines. “Our wish today” they state “is the same as 152 years ago: to make homeopathy accessible and to provide the highest standards of medicine and advice.”
The highest standards of medicine and advice? It seems that the Advertising Standards Authority (ASA) disagrees. A recent ASA Adjudication on A Nelson & Co Ltd deals with an advertisement by Nelsons for ‘Bach Rescue Night’ which stated “I CAN’T SWITCH OFF…The RESCUE NIGHT range helps your mind switch off, so you can enjoy a natural night’s sleep”
A freelance health writer had challenged whether the claims “I can’t switch off … Rescue Night range helps your mind switch off, so you can enjoy a natural night’s sleep” was an authorised health claim in the EU Register of Nutrition and Health Claims for Foods (the EU Register).
The ASA noted that, according to EC Regulation 1924/2006 on Nutrition and Health Claims made on Foods (the Regulation), which was reflected in the CAP Code, only health claims which appeared on the list of authorised health claims (the Register) could be made in ads promoting foods, including food supplements. Health claims were defined as those that stated, suggested or implied that a relationship existed between a food category, a food or one of its constituents and health.
The ASA furthermore stated: We acknowledged Rescue Remedy’s assertion that their ad had not made specific claims to aid sleep or that it improved sleep. However, we considered that the use of visuals such as a crescent moon and stars on a dark background, that the letter ‘O’ in the word “OFF” resembled a simple on/ off light switch image, the text “… you can enjoy a natural night’s sleep” and the name of the product “Rescue Night” was likely to give the impression to consumers that it was a product that would aid sleep or that it would help consumers fall asleep easily. We understood that ‘unwanted thoughts’ was one reason why consumers might find it difficult to get to sleep and, again, considered this added to the impression that the product would contribute positively to sleep. We therefore considered that the ad made a health claim related to sleep involving a food item.
We understood that some Bach Flower Remedies contained levels of alcohol which would preclude them from bearing health claims altogether, however, we noted that Bach Rescue Night was alcohol free. We acknowledged Rescue Remedy’s points regarding EFSA and ‘on hold’ claims for botanicals. We understood that ‘on hold’ claims for such botanicals could be used in marketing, provided such use had the same meaning as the proposed claim and they were used in compliance with applicable existing national provisions (in this case the CAP Code). However, Rescue Remedy did not provide evidence that relevant proposed claims for white chestnut, or any of the other product ingredients were ‘on hold’. Nevertheless, we understood that there were no ‘on hold’ claims entered onto the Register for white chestnut or the other product ingredients. Furthermore, ‘on hold’ claims should also be supported with adequate substantiation which we did not receive.
Because the ad made health claims relating to Bach Rescue Night as a sleep aid and we had not seen evidence that relevant claims for the botanical ingredients contained in the product were ‘on hold’, we concluded that the ad breached the Code.
The ad breached CAP Code (Edition 12) rules 15.1, 15.1.1 and 15.7 (Food, food supplements and associated health or nutritional claims).
The ASA ruled that the ad must not appear again in its current form. We told A Nelson & Co Ltd t/a rescueremedy.co.uk not to make health claims for botanical ingredients if they did not comply with the requirements of the Regulation.
I am afraid that such a ruling will have very little effect on the sale of Bach Flower Remedies. In case you have any doubt, I should mention that these inventions of Dr Bach are not supported by good evidence. Here is the abstract of my systematic review on the subject:
Bach flower remedies continue to be popular and its proponents make a range of medicinal claims for them. The aim of this systematic review was to critically evaluate the evidence for these claims. Five electronic databases were searched without restrictions on time or language. All randomised clinical trials of flower remedies were included. Seven such studies were located. All but one were placebo-controlled. All placebo-controlled trials failed to demonstrate efficacy. It is concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos.
Bach Flower Remedies have no effect whatsoever!
Come to think of it, this is not entirely true: they obviously keep the ASA busy, they exploit the gullible public, and they are clearly good for the cash flow at Nelson’s.
Reflexology is the treatment of reflex zones, usually on the sole of the feet, with manual massage and pressure. Reflexologists assume that certain zones correspond to certain organs, and that their treatment can influence the function of these organs. Thus reflexology is advocated for all sorts of conditions. Proponents are keen to point out that their approach has many advantages: it is pleasant (the patient feels well with the treatment and the therapist feels even better with the money), safe and cheap, particularly if the patient does the treatment herself.
Self-administered foot reflexology could be practical because it is easy to learn and not difficult to apply. But is it also effective? A recent systematic review evaluated the effectiveness of self-foot reflexology for symptom management.
Participants were healthy persons not diagnosed with a specific disease. The intervention was foot reflexology administered by participants, not by practitioners or healthcare providers. Studies with either between groups or within group comparison were included. The electronic literature searches utilized core databases (MEDLINE, EMBASE, Cochrane, and CINAHL Chinese (CNKI), Japanese (J-STAGE), and Korean databases (KoreaMed, KMbase, KISS, NDSL, KISTI, and OASIS)).
Three non-randomized trials and three before-and-after studies met the inclusion criteria. No RCTs were located. The results of these studies showed that self-administered foot reflexology resulted in significant improvement in subjective outcomes such as perceived stress, fatigue, and depression. However, there was no significant improvement in objective outcomes such as cortisol levels, blood pressure, and pulse rate. We did not find any randomized controlled trial.
The authors concluded that this study presents the effectiveness of self-administered foot reflexology for healthy persons’ psychological and physiological symptoms. While objective outcomes showed limited results, significant improvements were found in subjective outcomes. However, owing to the small number of studies and methodological flaws, there was insufficient evidence supporting the use of self-performed foot reflexology. Well-designed randomized controlled trials are needed to assess the effect of self-administered foot reflexology in healthy people.
I find this review quite interesting, but I would draw very different conclusions from its findings.
The studies that are available turned out to be of very poor methodological quality: they lack randomisation or rely on before/after comparisons. This means they are wide open to bias and false-positive results, particularly in regards to subjective outcome measures. Predictably, the findings of this review confirm that no effects are seen on objective endpoints. This is in perfect agreement with the hypothesis that reflexology is a pure placebo. Considering the biological implausibility of the underlying assumptions of reflexology, this makes sense.
My conclusions of this review would therefore be as follows: THE RESULTS ARE IN KEEPING WITH REFLEXOLOGY BEING A PURE PLACEBO.
Henry Louis Mencken (1880-1956) was an outspoken American journalist, essayist and literary critic famous for his vitriolic attacks on what he considered to be the hypocrisy of much of American life. In 1924, he published an essay on chiropractic which, I think, is still poignant today. I take the liberty of reproducing here in a slightly abbreviated form.
This preposterous quackery [chiropractic] flourishes lushly in the back reaches of the Republic, and begins to conquer the less civilized folk of the big cities. As the old-time family doctor dies out in the country towns, with no competent successor willing to take over his dismal business, he is followed by some hearty blacksmith or ice-wagon driver, turned into a chiropractor in six months, often by correspondence… [Chiropractic] pathology is grounded upon the doctrine that all human ills are caused by pressure of misplaced vertebrae upon the nerves which come out of the spinal cord — in other words, that every disease is the result of a pinch. This, plainly enough, is buncombe. The chiropractic therapeutics rest upon the doctrine that the way to get rid of such pinches is to climb upon a table and submit to a heroic pummeling by a retired piano-mover. This, obviously, is buncombe doubly damned.
…Any lout with strong hands and arms is perfectly equipped to become a chiropractor. No education beyond the elements is necessary. The takings are often high, and so the profession has attracted thousands of recruits — retired baseball players, work-weary plumbers, truck-drivers, longshoremen, bogus dentists, dubious preachers, cashiered school superintendents. Now and then a quack of some other school — say homeopathy — plunges into it. Hundreds of promising students come from the intellectual ranks of hospital orderlies.
…[The chiropractor’s] trade is mainly with ambulant patients; they must come to his studio for treatment. Most of them have lingering diseases; they tour all the neighborhood doctors before they reach him. His treatment, being nonsensical, is in accord with the divine plan. It is seldom, perhaps, that he actually kills a patient, but at all events he keeps any a worthy soul from getting well.
…But chiropractic, of course, is not perfect. It has superb potentialities, but only too often they are not converted into concrete cadavers. The hygienists rescue many of its foreordained customers, and, turning them over to agents of the Medical Trust, maintained at the public expense, get them cured. Moreover, chiropractic itself is not certainly fatal: even an Iowan with diabetes may survive its embraces. Yet worse, I have a suspicion that it sometimes actually cures. For all I know (or any orthodox pathologist seems to know) it may be true that certain malaises are caused by the pressure of vagrant vertebra upon the spinal nerves. And it may be true that a hearty ex-boilermaker, by a vigorous yanking and kneading, may be able to relieve that pressure. What is needed is a scientific inquiry into the matter, under rigid test conditions, by a committee of men learned in the architecture and plumbing of the body, and of a high and incorruptible sagacity. Let a thousand patients be selected, let a gang of selected chiropractors examine their backbones and determine what is the matter with them, and then let these diagnoses be checked up by the exact methods of scientific medicine. Then let the same chiropractors essay to cure the patients whose maladies have been determined. My guess is that the chiropractors’ errors in diagnosis will run to at least 95% and that their failures in treatment will push 99%. But I am willing to be convinced.
Where is there is such a committee to be found? I undertake to nominate it at ten minutes’ notice. The land swarms with men competent in anatomy and pathology, and yet not engaged as doctors. There are thousands of hospitals, with endless clinical material. I offer to supply the committee with cigars and music during the test. I offer, further, to supply both the committee and the chiropractors with sound wet goods. I offer, finally, to give a bawdy banquet to the whole Medical Trust at the conclusion of the proceedings.
I imagine that most chiropractors would find this comment rather disturbing. However, I do like it for several reasons:
- it is refreshingly politically incorrect; today journalists seem to be obsessed with the notion of ‘balance’ thus often creating the impression that there are two valid sides to an issue where, in fact, there is only one;
- it gets right at the heart of several problems which have plagued chiropractic from its beginning;
- it even suggests a way to establishing the truth about the value of chiropractic which could easily been followed some 90 years ago;
- finally it predicts a result of such a test – and I would not be surprised, if it turned out to be not far from the truth.
Please let me know what you think, regardless of whether you are a chiropractor or not.
Chapter 5 of my memoir is entitled ‘OFF WITH HIS HEAD’. It describes the role that Prince Charles played in promoting what he now likes to call ‘integrated medicine’. The weird thing is that he was instrumental in creating my Exeter chair…and eventually in getting it shut down. Here is a short sample to whet your appetite:
With the wisdom of hindsight, it is clear to me now that my hope of bringing the scientific method to bear on alternative medicine was doomed from the start. Reason cannot negotiate with unreason any more than fire and water can commingle peacefully. In either case, a great deal of spitting and hissing is bound to ensue—and precious little else.
Soon after arriving in Exeter, in 1993, I learnt of the long-standing interest Prince Charles had in alternative medicine: he had asked via my Vice Chancellor for a copy of my inaugural lecture, and I remember being delighted at this request. As I never give lectures or speeches from a script, I even composed a summary specifically for him. In return, I received a polite note of thanks from one of his secretaries. This is great, I thought.
I was thrilled that someone as influential as Prince Charles would be interested in my work. What could be better than having support in such high places? Surely, there would come the time when I could meet the Prince and have an open exchange of views. I had no doubt that he would be keenly aware of the obvious necessity for rigorous research—in fact, he often enough had publicly stressed it—and would thus support my research endeavours.
How wrong can one be? Prince Charles turned out to be no supporter of my work. To the contrary: he seemed to be a staunch advocate of unreason and a formidable opponent of any attempt to bring science or critical thinking to bear on alter-native medicine. What is more, subsequent events suggested to me that his intervention played a part in the closure of my unit.
Neck pain is a common problem which often causes significant disability. Chiropractic manipulation has become one of the most popular forms of alternative treatment for such symptoms. This seems surprising considering that neck manipulations are neither convincingly effective nor free of adverse effects.
The current Cochrane review on this subject could not be clearer: “Done alone, manipulation and/or mobilization were not beneficial; when compared to one another, neither was superior.” In the absence of compelling evidence for efficacy, any risk of neck manipulation would tilt the risk/benefit balance into the negative.
Adverse effects of neck manipulations range from mild symptoms, such as local neck tenderness or stiffness, to more severe injuries involving the spinal cord, peripheral nerve roots, and arteries within the neck. A recent paper reminds us that another serious complication has to be added to this already long list: phrenic nerve injury.
The phrenic nerve is responsible for controlling the contractions of the diaphragm, which allows the lungs to take in and release air and make us breathe properly. The phrenic nerve is formed from C3, C4, and C5 nerve fibres and descends along the anterior surface of the scalenus anterior muscle before entering the thorax to supply motor and sensory input to the diaphragm. Its anatomic location in the neck leaves it vulnerable to traumatic injury. Phrenic nerve injury can result in paralysis of the diaphragm and often leads to deteriorating function of the diaphragm, which can lead to partial or complete paralysis of the muscle and, as a result, serious breathing problems.
Patients who experience such problems may require emergency medical treatment or surgery. Sudden, severe damage to the phrenic nerve can make it impossible for the diaphragm to contract on its own. In order to make sure that the patient can breathe, a breathing tube needs to be inserted, a process called intubation. Artificial respiration would then be required.
American neurologists published a case report of a healthy man who consulted a chiropractor for his neck pain. Predictably, the chiropractor employed cervical manipulation to treat this condition. The result was bilateral diaphragmatic paralysis.
Similar cases have been reported previously, for instance, here and here and here and here. Damage to other nerves has also been documented to be a possible complication of spinal manipulation, for instance, here and here.
The authors of this new case report conclude that physicians must be aware of this complication and should be cautious when recommending spinal manipulation for the treatment of neck pain, especially in the presence of preexisting degenerative disease of the cervical spine.
I know what my chiropractic friends will respond to this post:
- I am alarmist,
- I cherry-pick articles that are negative for their profession,
- these cases are extreme rarities,
- conventional medicine is much more dangerous.
To this I reply: Imagine a conventional therapy about which the current Cochrane review says that it has no proven effect for the condition in question. Imagine further that this therapy causes mild to moderate adverse effects in about 50% of all patients in addition to very dramatic complications which are probably rare but, as no monitoring system exists, of unknown frequency. Imagine now that the professionals using this treatment more regularly than any other clinicians steadfastly deny that the risk/benefit balance is way out of kilter.
Would you call someone who repeatedly tries to warn the public of this situation ‘alarmist’?
Would you not consider the professionals who continue to practice the therapy in question to be irresponsible?
Even though it has been published less than a month ago, my new book ‘A SCIENTIST IN WONDERLAND…‘ has already received many most flattering reviews. For me, the most impressive one was by the journal ‘Nature'; they called my memoire ‘ferociously frank’ and ‘a clarion call for medical ethics’.
I did promise to provide several little excerpts for the readers of this blog to enable them to make up their own minds as to whether they want to read it or not. Today I offer you the start of the chapter 6 entitled ‘WONDERLAND’. I do hope you enjoy it.
It has been claimed by some members of the lunatic fringe of alternative medicine that I took up the Laing Chair at Exeter with the specific agenda of debunking alternative medicine. This is certainly not true; if anything, I was predisposed to look kindly on it. After all, I had grown up and done my medical training in Germany where the use of alternative therapies in a supportive role alongside standard medical care was considered routine and unremarkable. As a clinician, I had seen positive results from alternative therapies. If I came to Exeter with any preconceived ideas at all, they were of a generally favourable kind. I was sure that, if we applied the rules of science to the study of alternative medicine, we would find plenty of encouraging evidence.
As if to prove this point, the managing director of a major UK homeopathic pharmacy wrote a comment on my blog in April 2014: “…I met you once in Exeter in the 90s when exploring a possible clinical study. I found you most encouraging and openly enthusiastic about homeopathy. I would go so far as to say I was inspired to go further in homeopathy thanks to you but now you want to close down something which in my experience does so much good in the world. What went wrong?”
The answer to this question is fairly simple: nothing went wrong, but the evidence demonstrated more and more indispu-tably that most alternative therapies are not nearly as effective as enthusiasts tried to make us believe…
Few alternative remedies are more popular than colloidal silver, i.e. tiny particles of silver suspended in a liquid, and few represent more irresponsible quackery. It is widely promoted as a veritable panacea. Take this website (one of thousands), for instance; it advertises colloidal silver in the most glowing terms:
Here are some of the diseases against which Colloidal Silver has been used successfully Acne, Allergies, Appendicitis, Arthritis, Blood parasites, Bubonic plague, Burns (colloidal silver is one of the few treatments that can keep severe burn patients alive), Cancer, Cholera, Conjunctivitis, Diabetes, Gonorrhoea, Hay Fever, Herpes, Leprosy, Leukaemia, Malaria, Meningitis, Parasitic Infections both viral and fungal, Pneumonia, Rheumatism, Ringworm, Scarlet Fever, Septic conditions of eyes, ears, mouth, throat, Shingles, Skin Cancer, Syphilis, all viruses, warts and stomach ulcer.In addition it also has veterinary uses, such as for canine Parvo virus. You’ll also find Colloidal Silver very handy in the garden since it can be used against bacterial, fungal / viral attacks on plants.It would also appear highly unlikely that any germ warfare agents could survive an encounter with CS, as viruses such as E Bola and Hanta are in the end merely viruses and bacteria.Colloidal Silver is non-toxic, making it safe for both children, adults and pets. Colloidal Silver is in fact a pre 1938 healing modality, making it exempt from FDA jurisdiction.
So why haven’t you heard of it? It’s suspected that the user friendly economics of Colloidal Silver may have something to do with its low profile in the media. Colloidal Silver shines a spotlight on the over expensive and deadly nature of the pharmaceutical industry, who are larger than the Pentagon economically.
That’s right, plenty of bogus claims (it goes without saying that there is no good evidence to support any of them) and, for good measure, some conspiracy theory as well – the perfect mix for making a fast buck!
But sometimes things do not work out as planned. The following text was recently published on the website of Essex County Council:
A man claiming to sell a cure for cancer has been fined £750 following an investigation by Essex Trading Standards. Steven Cook, 54, of East Road, West Mersea, was charged with an offence under the Cancer Act after suggesting Colloidal Silver was a treatment for cancer.
Mr Cook pleaded guilty at Colchester Magistrates’ Court on Friday 12 September. Magistrates imposed a fine of £750 and ordered him to pay £1,500 costs. Cllr Roger Hirst, Essex County Council’s cabinet member for Trading Standards, said: “Trading Standards’ advice to people who are considering whether to take any substance not prescribed for a medical purpose, either preventative or as a treatment, is to consult their doctor first.
“I hope the public feel safer knowing that Essex Trading Standards will take action where traders are trying to sell products which are neither medically proven nor safe.”
Mr Cook runs a website, www.colloidalsilveruk.com, selling various products containing silver. One of the products on sale was “Ultimate Colloidal Silver”, a liquid containing silver that Mr Cook made in his own home. Trading Standards said the website implied that the product can cure cancer – and this is an offence under the Cancer Act. Mr Cook has now updated the website and removed any claims that colloidal silver can cure some cancers.
So, there is some hope! Occasionally, fraudsters are being found out and punished. But the bad news, of course, is that this sort of thing occurs far too rarely and when it does happen, the punishment is far too lenient. Consequently, the public’s protection from fraudsters exploiting the most vulnerable patients is woefully insufficient.