MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

medical ethics

The UK ‘Faculty of Homeopathy’ (FoH) is the professional body of British doctors who specialise in homeopathy. As doctors, FoH members have been to medical school and should know about evidence, science etc., I had always thought. But perhaps I was mistaken?

The FoH has a website with an interesting new post entitled ‘Scientific evidence and Homeopathy’. Here I have copied the section on CLINICAL TRIALS OF HOMEOPATHY. I have read it several times and must admit: it is a masterpiece, in my view – not a masterpiece in accurate reporting, but a masterpiece in misleading the public. The first and most obvious thing that struck me is the fact that is cites not a single clinical trial. But read for yourself (the numbers in round brackets were inserted by me and refer to my comments below):

START OF QUOTE

By August 2017 1,138 clinical trials of homeopathy had been published (1). Details can be found on the CORE-HOM database also maintained by the Carstens Foundation and accessible without charge: http://archiv.carstens-stiftung.de/core-hom

Four (2) systematic review/meta-analyses of homeopathy for all conditions have been published.[26],[27],[28]  Of these, three (3) reached a positive conclusion: that there is evidence that homeopathy is clinically effective (4). The exception is the review by Shang et al.46  This meta-analysis was controversial, particularly because its conclusions were based on only eight clinical trials whose identity was concealed until several months after the publication, precluding informed examination of its results (5) (6). The only undisputed conclusion (7) of this paper is that clinical trials of homeopathy are of higher quality than matched trials of conventional medicine: of 110 clinical trials each of homeopathy and conventional medicine, 21 trials of homeopathy but only 9 trials of conventional medicine were of ‘higher quality’.[29] [30]

A leading Swedish medical researcher (8) remarked: To conclude that homeopathy lacks clinical effect, more than 90% of the available clinical trials had to be dis­regarded.  Alternatively, flawed statistical methods had to be applied.”[31] Higher quality equates to less risk of bias, Mathie et al analysed randomized clinical trials of individualized homeopathy, showing that the highest quality trials yielded positive results (9).[32]

Systematic reviews of randomized controlled trials of homeopathy in specific clinical situations have also yielded positive results, including: allergies and upper respiratory tract infections (2 systematic reviews),[33],[34] (10) (11) Arnica in knee surgery,[35] (12) Childhood diarrhoea,[36] Post-operative ileus,[37] (13) Rheumatic diseases,[38] (14) Seasonal allergic rhinitis (hay fever) (2 systematic reviews),[39] [40] (15) (16) and vertigo.[41] (17)

END OF QUOTE

MY COMMENTS:

  1. This is a wild exaggeration which was made possible by counting all sorts of clinical reports as ‘clinical trials’. A clinical trial  “follows a pre-defined plan or protocol to evaluate the effects of a medical or behavioral intervention on health outcomes.” This would exclude most observational studies, case series, case reports. However, the figure cited here includes such reports.
  2. The author cites only three!
  3. Does the author mean ‘two’?
  4. This is not quite true! I have dedicated an entire post to this issue.
  5. True, the Shang meta-analysis has been criticised – but exclusively by homeopaths who, for obvious reasons, were unable to accept its negative findings. In fact, it is a solid piece of research.
  6. Why does the author not mention the most recent systematic review of homeopathy?  Perhaps because it concluded: 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.
  7. Really? Undisputed? Even by the logic of the author’s last sentence, this would be disputed.
  8. The ‘leading researcher’ is Prof Hahn who has featured many times on my blog. He seems to be more than a little unhinged when it comes to the topic of homeopathy.
  9. The author forgot to mention that Mathie – who was sponsored by the British Homeopathic Association – included this little caveat in his conclusions: The low or unclear overall quality of the evidence prompts caution in interpreting the findings.
  10. Reference 33 is the infamous ‘Swiss report’ that has been shown to be fatally flawed over and over again.
  11. Reference 34 refers to a review that fails to adhere to almost all the criteria of a systematic review.
  12. This review concluded: In all three trials, patients receiving homeopathic arnica showed a trend towards less postoperative swelling compared to patients receiving placebo. However, a significant difference in favour of homeopathic arnica was only found in the CLR trial. Only a deluded homeopath can call this a ‘positive result’.
  13. This is a systematic review by my team. It showed that several flawed trials produced a false positive result, while the only large multicentre trial was negative. Our conclusions therefore include the statement that  several caveats preclude a definitive judgment. Only a deluded homeopath can call this a ‘positive result’.
  14. This reference refers to the following abstract: Despite a growing interest in uncovering the basic mechanisms of arthritis, medical treatment remains symptomatic. Current medical treatments do not consistently halt the long-term progression of these diseases, and surgery may still be needed to restore mechanical function in large joints. Patients with rheumatic syndromes often seek alternative therapies, with homeopathy being one of the most frequent. Homeopathy is one of the most frequently used complementary therapies worldwide. Only a deluded homeopath can call this a ‘positive result’.
  15. The first reference refers to a paper where the author analysed three of his own studies.
  16. Reference 40 refers to a review that fails to adhere to almost all the criteria of a systematic review.
  17. This reference refers to a review of Vertigoheel@ that includes observational studies. One of its authors was an employee of the manufacturer of the product. Vertigoheel is not a homeopathic remedy (it does not adhere to the ‘like cures like’ principle) but a homotoxicologic product. Homotoxicology is a method inspired by homeopathy which was developed by Hans Heinrich Reckeweg (1905 – 1985). He believed that all or most illness is caused by an overload of toxins in the body. The toxins originate, according to Reckeweg, both from the environment and from the malfunction of physiological processes within the body. His treatment consists mainly in applying homeopathic remedies which usually consist of combinations of single remedies, because health cannot be achieved without ridding the body of toxins. The largest manufacturer and promoter of remedies used in homotoxicology is the German firm Heel. Our own systematic review of RCTs of homotoxicology included 7 trials which were mostly of a high methodological standard, according to the Jadad score. The trials tested the efficacy of seven different medicines for seven different indications. The results were positive in all but one study. Important flaws were found in all trials. These render the results of the primary studies less reliable than their high Jadad scores might suggest. Despite mostly positive findings and high ratings on the Jadad score, the placebo-controlled, randomised clinical trials of homotoxicology fail to demonstrate the efficacy of this therapeutic approach.

So!

What do we make of all this?

To say that it is disappointing would, I think, be an understatement. The FoH is not supposed to be a lobby group of amateurs ignorant of science and evidence; it is a recognised professional organisation who must behave ethically. Patients and consumers should be able to trust the FoH. The fact that the FoH publish misinformation on such a scale should, in my view, be a matter for the General Medical Council.

I have mentioned the German alt med phenomenon of the ‘Heilpraktiker’ before. For instance, a year ago I wrote this:

…The German ‘Heilpraktiker’ (literally translated: healing practitioner) is perhaps best understood by its fascinating history. When the Nazis came to power in 1933, German health care was dominated by lay practitioners who were organised in multiple organisations struggling for recognition. The Nazis felt the need to re-organise this situation to bring it under their control. At the same time, the Nazis promoted their concept of ‘Neue Deutsche Heilkunde’ (New German Medicine) which entailed the integration – perhaps more a shot-gun marriage – of conventional and alternative medicine. I have published about the rather bizarre history of the ‘New German Medicine’ in 2001:

The aim of this article is to discuss complementary/alternative medicine (CAM) in the Third Reich. Based on a general movement towards all things natural, a powerful trend towards natural ways of healing had developed in the 19(th)century. By 1930 this had led to a situation where roughly as many lay practitioners of CAM existed in Germany as doctors. To re-unify German medicine under the banner of ‘Neue Deutsche Heilkunde’, the Nazi officials created the ‘Heilpraktiker‘ – a profession which was meant to become extinct within one generation. The ‘flag ship’ of the ‘Neue Deutsche Heilkunde’ was the ‘Rudolf Hess Krankenhaus’ in Dresden. It represented a full integration of CAM and orthodox medicine. An example of systematic research into CAM is the Nazi government’s project to validate homoeopathy. Even though the data are now lost, the results of this research seem to have been negative. Even though there are some striking similarities between today’s CAM and yesterday’s ‘Neue Deutsche Heilkunde’ there are important differences. Most importantly, perhaps, today’s CAM is concerned with the welfare of the individual, whereas the ‘Neue Deutsche Heilkunde’ was aimed at ensuring the dominance of the Aryan race.

The Nazis thus offered to grant all alternative practitioners official recognition by establishing them under the newly created umbrella of ‘Heilpraktiker’. To please the powerful lobby of conventional doctors, they decreed that the ‘Heilpraktiker’ was barred from educating a second generation of this profession. Therefore, the Heilpraktiker was destined to become extinct within decades.

Several of the Nazi rulers were staunch supporters of homeopathy and other forms of alternative medicine. They hoped that alternative medicine would soon have become an established part of ‘New German Medicine’. For a range of reasons, this never happened.

After the war, the Heilpraktiker went to court and won the right to educate their own students. Today they are a profession that uses homeopathy extensively. The German Heilpraktiker has no mandatory medical training; a simple test to show that they know the legal limits of their profession suffices for receiving an almost unrestricted licence for practicing medicine as long as they want…

END OF QUOTE

Since about two years, a group of German scientists, clinicians and various other experts (I was a member of the panel), led by a prominent ethicist, worked on a document that was published this week. Here are its conclusions (in German):

Medizinische Parallelwelten mit radikal divergierenden Qualitätsstandards, wie sie aktuell im deutschen Gesundheitswesen in Form von Doppelstandards bei Ergebnisbewertung und Qualitäts kontrolle bestehen, sind für eine aufgeklärte Gesellschaft nicht akzeptabel. Bei Heilpraktikern stehen aufgrund ihrer ungenügenden, kaum regulierten Ausbildung die Qualifikationen und Tätigkeitsbefugnisse in einem eklatanten Missverhältnis. Heilpraktiker bieten schwer punktmäßig alternativ­ oder komplementärmedizinische Verfahren an, die in den meisten Fällen wissenschaftlich unhaltbar sind. Dies führt zu einer Gefährdung von Patienten. Abhilfe verspricht nur ein gleichzeitiges Vorgehen auf mehreren Ebenen:

(1.) eine einheitliche Bewertung der Patientendienlichkeit in allen Bereichen der Medizin;

(2.) ein verstärktes Engagement für die Erfordernisse einer gelingenden Kommunikation mit Patienten;

(3.) eine verstärkte Förderung wissenschaftstheoretischer Kompetenzen in Ausbildung und Studium gesundheitsbezogener Berufe; sowie

(4.) eine Abschaffung des Heilpraktikerwesens oder eine radikale Anhebung und Sicherstellung des Kompetenzniveaus von Heilpraktikern.

Wir haben uns hier auf die Reform des Heilpraktikerwesens konzentriert und dafür zwei Lösungsvorschläge skizziert: Wir empfehlen entweder die gänzliche Abschaffung des Heilpraktikerberufs oder dessen Ablösung durch die Einführung spezialisierter „Fach­Heilpraktiker“ als Zusatzqualifikation für bestehende Gesundheitsfachberufe. Für die Übergangsphase empfehlen wir eine gesetzliche Beschränkung des Heilpraktikerwesens auf weitgehend gefahrlose Tätigkeiten. Auf diese Weise ließen sich die Gefahren für Patienten reduzieren und die Patientenversorgung langfristig wesentlich verbessern.

END OF QUOTE

Essentially, we are saying that, the Heilpraktiker has introduced two hugely different quality standards into the German healthcare system. In the interest of the patient and of good healthcare, this double standard must be addressed. We are demanding the profession of the Heilpraktiker either is completely abolished, or is reformed such that it no longer poses a threat to public health in Germany. Our document makes concrete suggestions for such reforms.

Our suggestions have already received lots of attention in Germany, and we are therefore hopeful that they will be taken seriously, start a much-needed debate and eventually bring about progress.

A recent comment by a chiropractor told us this:

“If the critics do not take step 2 [point out what’s right and support] then they are entrenched carpet bombers who see reform and reformers as acceptable collateral damage. That makes them just as much a part of the problem when it comes to reform as the subbies.”

Similar words have been posted many times before.

So, are we critics of chiropractic carpet bombers?

Personally, I find the term very distasteful and misplaced. But let’s not be petty and forget about the terminology.

The question is: should I be more supportive of chiropractors who claim to be reformers?

I feel that the claim to be a reformer is hardly enough for gaining my support. I prefer to support clinicians who do the right things. And what would that be?

Here is a list; clinicians would receive my  support, if they:

  • adhere to the principles of evidence-based medicine;
  • follow the rules of medical ethics.

What does that mean in relation to chiropractic?

I think it means that clinicians should:

  • use interventions that demonstrably do more good than harm,
  • make no false claims,
  • advocate the best available treatments for their patients,
  • abstain from treating patients for which their therapy is not demonstrably effective,
  • obtain fully informed consent from their patients which includes information about the nature of the condition, about the risks of their treatments, about other therapeutic options.

As soon as I see a chiropractor or a group of chiropractors who fit these criteria, I will support them by publicly stating that they are doing alright (as should be normal for responsible healthcare practitioners). Until this time, I reject being called a carpet bomber and call such name-calling a stupid defence of quackery.

How often have we heard that chiropractic has moved on and has given up the concept of subluxation/malalignment? For sure there is no evidence for such nonsense, and it would be high time to give it up!  But, as has been argued here and elsewhere, if chiros give it up, what is there left? What then would differentiate them from physios ? The answer is not a lot.

In any case, chiros have by no means given up subluxation. One can argue this point ad nauseam; yet, most chiros remain in denial.

For this post, I have chosen a different approach to make my point. I simply went on twitter and had a look what messages chiros tweet. The impression I got is that the majority of chiros are totally immersed in subluxation. To provide some proof, I have copied a few images – if chiros do not listen to words, perhaps they understand pictures, I thought.

So, here we go – enjoy!

[please click to see them full size]

 

This press-release caught my eye today. It relates to an article that does not seem to be available yet (at least when I looked it was not on Medline). As it is highly relevant to issues that we have repeatedly discussed on this blog, let me quote the important sections of the press-release instead:

To investigate alternative medicine use and its impact on survival compared to conventional cancer treatment, the researchers studied 840 patients with breast, prostate, lung, and colorectal cancer in the National Cancer Database (NCDB) — a joint project of the Commission on Cancer of the American College of Surgeons and the American Cancer Society. The NCDB represents approximately 70% of newly diagnosed cancers nationwide. Researchers compared 280 patients who chose alternative medicine to 560 patients who had received conventional cancer treatment.

The researchers studied patients diagnosed from 2004 to 2013. By collecting the outcomes of patients who received alternative medicine instead of chemotherapy, surgery, and/or radiation, they found a greater risk of death. This finding persisted for patients with breast, lung, and colorectal cancer. The researchers concluded that patients who chose treatment with alternative medicine were more likely to die and urged for greater scrutiny of the use of alternative medicine for the initial treatment of cancer.

We now have evidence to suggest that using alternative medicine in place of proven cancer therapies results in worse survival,” said lead author Dr. Skyler Johnson. “It is our hope that this information can be used by patients and physicians when discussing the impact of cancer treatment decisions on survival.”

Dr. Cary Gross, co-author of the study, called for further research, adding, “It’s important to note that when it comes to alternative cancer therapies, there is just so little known — patients are making decisions in the dark. We need to understand more about which treatments are effective — whether we’re talking about a new type of immunotherapy or a high-dose vitamin — and which ones aren’t, so that patients can make informed decisions.”

END OF QUOTE

Regular readers of my blog will not be surprised; we have discussed similar findings before:

Korean researchers evaluated whether complementary/alternative medicine (CAM) -use influenced the survival and health-related quality of life (HRQOL) of terminal cancer patients. From July 2005 to October 2006, they prospectively studied a cohort study of 481 cancer patients. During a follow-up of 163.8 person-years, they identified 466 deceased patients. Their multivariate analyses of these data showed that, compared with non-users, CAM-users did not have better survival. Using mind-body interventions or prayer was even associated with significantly worse survival. CAM users reported significantly worse cognitive functioning and more fatigue than nonusers. In sub-group analyses, users of alternative medical treatments, prayer, vitamin supplements, mushrooms, or rice and cereal reported significantly worse HRQOL. The authors conclude that “CAM did not provide any definite survival benefit, CAM users reported clinically significant worse HRQOLs.”

A Norwegian study examined the association between CAM-use and cancer survival. Survival data were obtained with a follow-up of 8 years for 515 cancer patients. A total of 112 patients used CAM. During the follow-up period, 350 patients died. Death rates were higher in CAM-users (79%) than in those who did not use CAM (65%). The hazard ratio of death for CAM-use compared with no use was 1.30. The authors of this paper concluded that “use of CAM seems to predict a shorter survival from cancer.”

This study from the US was aimed at determining whether CAM use impacts on the prognosis of breast cancer patients. Health Eating, Activity, and Lifestyle (HEAL) Study participants (n = 707) were diagnosed with stage I-IIIA breast cancer. Participants completed a 30-month post-diagnosis interview including questions on CAM use (natural products such as dietary and botanical supplements, alternative health practices, and alternative medical systems), weight, physical activity, and comorbidities. Outcomes were breast cancer-specific and total mortality, which were ascertained from the Surveillance Epidemiology and End Results registries in Western Washington, Los Angeles County, and New Mexico. Cox proportional hazards regression models were fit to data to estimate hazard ratios (HR) and 95 % confidence intervals (CI) for mortality. Models were adjusted for potential confounding by socio-demographic, health, and cancer-related factors. Among the 707 participants, 70 breast cancer-specific deaths and 149 total deaths were reported. 60.2 % of participants reported CAM use post-diagnosis. The most common CAM were natural products (51 %) including plant-based estrogenic supplements (42 %). Manipulative and body-based practices and alternative medical systems were used by 27 and 13 % of participants, respectively. No associations were observed between CAM use and breast cancer-specific (HR 1.04, 95 % CI 0.61-1.76) or total mortality (HR 0.91, 95 % CI 0.63-1.29). The authors concluded that CAM use was not associated with breast cancer-specific mortality or total mortality. Randomized controlled trials may be needed to definitively test whether there is harm or benefit from the types of CAM assessed in HEAL in relation to mortality outcomes in breast cancer survivors.

MY CONCLUSION:

Some forms of CAM might be effective in supportive or palliative care of cancer patients. However, if it is used or recommended as a cancer therapy, our alarm bells should start ringing.

 

PS

I just found the new article; here is its abstract:

There is limited available information on patterns of utilization and efficacy of alternative medicine (AM) for patients with cancer. We identified 281 patients with nonmetastatic breast, prostate, lung, or colorectal cancer who chose AM, administered as sole anticancer treatment among patients who did not receive conventional cancer treatment (CCT), defined as chemotherapy, radiotherapy, surgery, and/or hormone therapy. Independent covariates on multivariable logistic regression associated with increased likelihood of AM use included breast or lung cancer, higher socioeconomic status, Intermountain West or Pacific location, stage II or III disease, and low comorbidity score. Following 2:1 matching (CCT = 560 patients and AM = 280 patients) on Cox proportional hazards regression, AM use was independently associated with greater risk of death compared with CCT overall (hazard ratio [HR] = 2.50, 95% confidence interval [CI] = 1.88 to 3.27) and in subgroups with breast (HR = 5.68, 95% CI = 3.22 to 10.04), lung (HR = 2.17, 95% CI = 1.42 to 3.32), and colorectal cancer (HR = 4.57, 95% CI = 1.66 to 12.61). Although rare, AM utilization for curable cancer without any CCT is associated with greater risk of death.

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

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

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

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

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

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

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

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

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

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

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

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

END OF QUOTE

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

‘Alternative truth’ is a term that I used first in 2013 . Since then I had to employ it with increasing frequency. Disturbingly, since then similar terms, such as ‘alternative facts’, ‘alternative science’ etc., have become ‘en vogue’. In an NEJM-editorial on the subject, Alta Caro from the University of Wisconsin Law School, Madison, US recently concluded: Reasonable people may disagree about how to interpret data, but they do not ignore scientific method by giving credence to flawed, fraudulent, or misrepresented studies … Whether in the debates regarding climate change, evolutionary theory, or human reproduction, alternative facts are just fiction, and alternative science is just bad policy.

I am tempted to add AND ALTERNATIVE TRUTHS ARE JUST LIES!!!

On this blog, we are confronted with so many lies that it would be only normal, if we gradually got used to them.

  • I think we must resist this temptation.
  • I think we should expose those who tell untruths again and again.
  • I think it is our moral and ethical duty.
  • I think the truth is far too precious to allow it to be eroded by anyone.

Because I feel strongly about this issue, I would like to use this post to give two of my former colleagues the opportunity to correct the untruths they have published about me and my actions.

The 1st is Prof Harald Walach;

as I pointed out in a previous post, he stated the following untruth (his remarks were in German, and this is my translation):

“My friend and colleague George Lewith from Southampton gave a keynote lecture on his review of chiropractic interventions for infant colic. This was prompted by the claim, made by Singh and Ernst a few years ago, that chiropractic was dangerous, that no data existed showing its effectiveness, and that it had dangerous side-effects, particularly for children. The chiropractors had sued the science journalist Singh for libel and won the case. George Lewith had provided the expert report for the court and has now extended his analysis on children.

To put it briefly: the intervention is even very effective; the effect-size is about one standard deviation. The children cry less long and more rarely. And the search of the literature for dangerous side-effects resulted in no – literally: not one – case of side-effects, not to mention dangerous ones. The fuzz had started back then because an unqualified person had walked over the back of a thin woman and had thus broken her neck. The press had subsequently hyped the whole thing to a “deadly side-effect of a chiropractic intervention”. 

The 2nd is Dr Peter Fisher;

as I pointed out in another post, he too published an untruth about me:

In this article which he published as Dr. Peter Fisher, Homeopath to Her Majesty, the Queen, he wrote: “There is a serious threat to the future of the Royal London Homoeopathic Hospital (RLHH), and we need your help…Lurking behind all this is an orchestrated campaign, including the ’13 doctors letter’, the front page lead in The Times of 23 May 2006, Ernst’s leak of the Smallwood report (also front page lead in The Times, August 2005), and the deeply flawed, but much publicised Lancet meta-analysis of Shang et al…”

And why bring this up again?

For the reasons mentioned above.

And for giving Walach and Fisher the opportunity to correct their errors. If they don’t, their untruths will be henceforth called lies.

This post is based on an article by Ken Harvey, Associate Professor, School of Public Health and Preventive Medicine, Monash University, Australia. I took the liberty of slightly modifying his text for the purpose of this blog. The article informs us about the regulation of nonsense which, as I have often argued, is likely to result in nonsense.

Australia’s drugs regulator seems to be endorsing unfounded claims about homeopathy and traditional Chinese medicine as part of its review of how complementary medicines are regulated. In the latest proposed changes, the Therapeutic Goods Administration (TGA) is looking at what suppliers can claim their products do, known as “permitted indications”. An example of a “low level” permitted indication might be “may relieve the pain of mild osteoarthritis”.

If approved, suppliers will be able to use the permitted indication to market their products. The resulting problem is obvious.  For instance, despite the TGA’s Complaints Resolution Panel upholding complaints of a lack of evidence that magnesium and homeopathy “relieve muscle cramps (and restless legs)”, this permitted indication is on its draft list. Other examples of dodgy claims include “supports transport of oxygen in the body”, “regulates healthy male testosterone levels”. The list contains around 140 traditional Chinese medicine indications, such as “Harmonise middle burner (Spleen and Stomach)”, “Unblock/open/relax meridians”, “Balance Yin and Yang”. None of them have any basis in fact or science. There are also around 900 additional indications for unspecified “traditions”.

Traditional medicines are not necessarily safe, as emerging data highlights how common adverse reactions and drug interactions really are. For example, Hyland’s homeopathic baby teething products were recalled by the US Food and Drug Administration and then the TGA because they contained high levels of belladonna alkaloids which caused adverse events in hundreds of babies. In China, out of the 1.33 million case reports of adverse drug event reports received by the National Adverse Drug Reaction Monitoring Center in 2014, traditional Chinese medicine represented around 17.3% (equivalent to around 230,000 cases).

Listed medicines are supposed to contain pre-approved, relatively low-risk ingredients. They should be produced with good manufacturing practice and only make “low-level” health claims for which evidence is held. However, the TGA does not check these requirements before the product is marketed. To safeguard shoppers, consumer representatives, suggested the proposed list of permitted indications should be short and only contain wordings such as, “may assist” or “may help”. For consumers to make an informed purchase, claims based on “traditional use” should always have a disclaimer along the lines of what the US Federal Trade Commission uses for homeopathic products. For example, “This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts. There is no good scientific evidence that this product works”.

MY CONCLUSION

As I see it, the problem is that the evidence for many of the claims which are about to be allowed is either absent, seriously flawed or negative. Yet, the purpose of any regulation of this kind must be to protect consumers from purchasing ineffective and sometimes dangerous products. Regulators are keen to balance this aim against another aim: helping an industry to thrive. It is never easy to get such a balance right. But to allow nonsense, pseudoscience and overt falsehoods to creep in, must surely be wrong, unethical and illegal.

 

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

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

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

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

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

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

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

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

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

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

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

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

 

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

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

The list includes both herbal and homeopathic remedies!!!

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

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

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

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

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