medical ethics
You may feel that homeopaths are bizarre, irrational, perhaps even stupid – but you cannot deny their tenacity. Since 200 years, they are trying to convince us that their treatments are effective beyond placebo. And they seem to get more and more bold with their claims: while they used to suggest that homeopathy was effective for trivial conditions like a common cold, they now have their eyes on much more ambitious things. Two recent studies, for instance, claim that homeopathic remedies can help cancer patients.
The aim of the first study was to evaluate whether homeopathy influenced global health status and subjective wellbeing when used as an adjunct to conventional cancer therapy.
In this pragmatic randomized controlled trial, 410 patients, who were treated by standard anti-neoplastic therapy, were randomized to receive or not receive classical homeopathic adjunctive therapy in addition to standard therapy. The main outcome measures were global health status and subjective wellbeing as assessed by the patients. At each of three visits (one baseline, two follow-up visits), patients filled in two questionnaires for quantification of these endpoints.
The results show that 373 patients yielded at least one of three measurements. The improvement of global health status between visits 1 and 3 was significantly stronger in the homeopathy group by 7.7 (95% CI 2.3-13.0, p=0.005) when compared with the control group. A significant group difference was also observed with respect to subjective wellbeing by 14.7 (95% CI 8.5-21.0, p<0.001) in favor of the homeopathic as compared with the control group. Control patients showed a significant improvement only in subjective wellbeing between their first and third visits.
Our homeopaths concluded that the results suggest that the global health status and subjective wellbeing of cancer patients improve significantly when adjunct classical homeopathic treatment is administered in addition to conventional therapy.
The second study is a little more modest; it had the aim to explore the benefits of a three-month course of individualised homeopathy (IH) for survivors of cancer.
Fifteen survivors of any type of cancer were recruited by a walk-in cancer support centre. Conventional treatment had to have taken place within the last three years. Patients scored their total, physical and emotional wellbeing using the Functional Assessment of Chronic Illness Therapy for Cancer (FACIT-G) before and after receiving four IH sessions.
The results showed that 11 women had statistically positive results for emotional, physical and total wellbeing based on FACIT-G scores.
And the conclusion: Findings support previous research, suggesting CAM or individualised homeopathy could be beneficial for survivors of cancer.
As I said: one has to admire their tenacity, perhaps also their chutzpa – but not their understanding of science or their intelligence. If they were able to think critically, they could only arrive at one conclusion: STUDY DESIGNS THAT ARE WIDE OPEN TO BIAS ARE LIKELY TO DELIVER BIASED RESULTS.
The second study is a mere observation without a control group. The reported outcomes could be due to placebo, expectation, extra attention or social desirability. We obviously need an RCT! But the first study was an RCT!!! Its results are therefore more convincing, aren’t they?
No, not at all. I can repeat my sentence from above: The reported outcomes could be due to placebo, expectation, extra attention or social desirability. And if you don’t believe it, please read what I have posted about the infamous ‘A+B versus B’ trial design (here and here and here and here and here for instance).
My point is that such a study, while looking rigorous to the naïve reader (after all, it’s an RCT!!!), is just as inconclusive when it comes to establishing cause and effect as a simple case series which (almost) everyone knows by now to be utterly useless for that purpose. The fact that the A+B versus B design is nevertheless being used over and over again in alternative medicine for drawing causal conclusions amounts to deceit – and deceit is unethical, as we all know.
My overall conclusion about all this:
QUACKS LOVE THIS STUDY DESIGN BECAUSE IT NEVER FAILS TO PRODUCE FALSE POSITIVE RESULTS.
Dear Professor Robinson,
please forgive me for writing to you in a matter that, you might think, is really none of my business. I have been following the news and discussions about the BLACKMORE CHAIR at your university. Having been a professor of complementary medicine at Exeter for ~20 years and having published more papers on this subject than anyone else on the planet, I am naturally interested and would like to express some concerns, if you allow me to.
With my background, I would probably be the last person to argue that a research chair in alternative medicine is not a good and much-needed thing. However, accepting an endowment from a commercially interested source is, as you are well aware, a highly problematic matter.
I am confident that you intend to keep the sponsor at arm’s length and plan to appoint a true scientist to this post who will not engage in the promotional activities which the alternative medicine scene might be expecting. And I am equally sure that the money will be put to good use resulting in good and fully independent science.
But, even if all of this is the case, there are important problems to consider. By accepting Blackmore’s money, you have, perhaps inadvertently, given credit to a commercially driven business empire. As you probably know, Blackmores have a reputation of being ‘a bit on the cavalier side’ when it comes to rules and regulations. This is evidenced, for instance, by the number of complaints that have been upheld against them by the Australian authorities.
For these reasons, the creation of the new chair is not just a step towards generating research, it could (and almost inevitably will) be seen as a boost for quackery. It is foremost this aspect which might endanger the reputation of your university, I am afraid.
My own experience over the last two decades has taught me to be cautious and sceptical regarding the motives of many involved in the multi-billion alternative medicine business. I have recently published my memoir entitled ‘A SCIENTIST IN WONDERLAND. SEARCHING FOR TRUTH AND FINDING TROUBLE’; it might be a helpful read for you and the new professor.
I hope you take my remarks as they were meant: constructive advice from someone who had to learn it all the hard way. If I can be of further assistance, please do not hesitate to ask me.
Sincerely
Edzard Ernst
Prince Charles’ meddling beyond his constitutional role is yet again in the press today. I was sent the 2nd batch of ‘spider memos’ yesterday, studied them and commented as follows:
The letters demonstrate yet again that Prince Charles relentlessly meddles in UK health politics and thus disrespects his constitutional role. His arguments in favour of CAM, and in particular homeopathy, show a devastating lack of knowledge and understanding; they are ill-informed, invalid and embarrassingly naïve – but at the same time they are remarkably persistent. Charles tries to give the impression that he is motivated by passion and compassion, but in health care such drivers need solid evidence and expertise. Charles has neither which is not just regrettable, it is arrogant on his part and potentially harmful for public health.
If you get the feeling that I have little patience with Charles’ meddling, you may be right. I have little doubt that it was his interfering that led to the closure of my research unit at Exeter. In my book, A SCIENTIST IN WONDERLAND, I provide the full details of what happened. Here I would just like to reproduce the incredible ‘spider memo’ in question.
It was not actually authored by Charles but by Sir Michael Peat, his 1st private secretary. On 22 September 2005, Peat wrote on Clarence House note-paper to the Vice Chancellor of Exeter University wrongly accusing me of a serious breach of confidentiality:
I am writing both as The Prince of Wales’ Private Secretary and as Acting Chairman of His Royal Highness’ Foundation for Integrated Health.
There has been a breach of confidence by Professor Edzard Ernst in respect of a draft report on the efficacy of certain complementary therapies sent to him by Mr. Christopher Smallwood. The report was commissioned by The Prince of Wales.
Mr. Smallwood sent Professor Ernst an early and, at that stage, incomplete draft of the report for comment. The accompanying e-mail requested and stressed the need for confidentiality. Professor Ernst implicitly agreed to comment on the report on this basis but then, as you probably saw, gave his views about the report to the national press. I attach a copy of a letter from the Editor of the Lancet published by The Times which summarises the issues well. I also attach a copy of the e-mail sent to Professor Ernst by Mr. Smallwood.
I apologise for troubling you, but I felt that you should have this matter drawn to your attention.
What followed was embarrassing and shameful: my uni started a 13 month investigation, eventually I was pronounced innocent but my unit was closed down. Unbelievably, Clarence house denied that Charles even knew about this amazing attempt to meddle in academic affairs. As I say, you need to read my memoir to understand this story fully.
The principal aim of this survey was to map centres across Europe that provide public health services and operating within the national health system in integrative oncology.
Information was received from 123 (52.1 %) of the 236 centres contacted. Forty-seven out of 99 responding centres meeting inclusion criteria (47.5 %) provided integrative oncology treatments, 24 from Italy and 23 from other European countries. The number of patients seen per year was on average 301.2 ± 337. Among the centres providing these kinds of therapies, 33 (70.2 %) use fixed protocols and 35 (74.5 %) use systems for the evaluation of results. Thirty-two centres (68.1 %) were research-active.
The alternative therapies most frequently provided were acupuncture 26 (55.3 %), homeopathy 19 (40.4 %), herbal medicine 18 (38.3 %) and traditional Chinese medicine 17 (36.2 %); anthroposophic medicine 10 (21.3 %); homotoxicology 6 (12.8 %); and other therapies 30 (63.8 %).
Treatments were mainly directed to reduce adverse reactions to chemo-radiotherapy (23.9 %), in particular nausea and vomiting (13.4 %) and leucopenia (5 %). The alternative treatments were also used to reduce pain and fatigue (10.9 %), to reduce side effects of iatrogenic menopause (8.8 %) and to improve anxiety and depression (5.9 %), gastrointestinal disorders (5 %), sleep disturbances and neuropathy (3.8 %).
The authors concluded that mapping of the centres across Europe is an essential step in the process of creating a European network of centres, experts and professionals constantly engaged in the field of integrative oncology, in order to increase, share and disseminate the knowledge in this field and provide evidence-based practice.
DISSEMINATE KNOWLEDGE?
EVIDENCE-BASED PRACTICE?
WHAT KNOWLEDGE?
WHAT EVIDENCE-BASED PRACTICE?
Where is the evidence that homeopathy or homotoxicology or Chinese medicine are effective for any of the conditions listed above? The answer, of course, is that it does not exist.
I fear the results of this survey show foremost one thing: ‘integrative oncology’ is little else but a smokescreen behind which quacks submit desperate patients to bogus treatments.
The Royal Australian College of General Practitioners (RACGP) just issued an important statement on homeopathy which, in several ways, goes beyond previous announcements on this subject. I take the liberty of reproducing it here in full:
The RACGP supports the use of evidence-based medicine, in which current research information is used as the basis for clinical decision-making. In light of strong evidence to confirm that homeopathy has no effect beyond that of placebo as a treatment for various clinical conditions, the position of the RACGP is:
1. Medical practitioners should not practice homeopathy, refer patients to homeopathic practitioners, or recommend homeopathic products to their patients.
2. Pharmacists should not sell, recommend, or support the use of homeopathic products.
3. Homeopathic alternatives should not be used in place of conventional immunisation.
4. Private health insurers should not supply rebates for or otherwise support homeopathic services or products.
Background
The contention that homeopathy is an effective treatment is not supported by evidence from systematic literature reviews. The National Health and Medical Research Council (NHMRC) analysed the scientific evidence for the effectiveness of homeopathy in treating a range of clinical conditions and released a position statement [1] in March 2015. The NHMRC’s review concluded homeopathy does not produce health benefits over and above that of placebo, or equivalent to that of another treatment.[2] Crucially, the report states that there are “no health conditions for which there is reliable evidence that homeopathy is effective” as a treatment.
While not covered in the NHMRC’s review, it is also the case that homeopathic alternatives to conventional vaccination do not prevent communicable diseases or increase protective antibodies to disease. The National Centre for Immunisation Research and Surveillance has advised that there are no studies of sufficient quality to demonstrate the safety or effectiveness of ‘homeopathic vaccines’ for protection against disease.[3] Indeed, there is no plausible biological mechanism of action by which these products could prevent infection.[4]
Harms associated with homeopathy
Homeopathic products are sometimes considered harmless as they are generally administered at a high dilution. Some may not even contain a single molecule of the original source material. However, there are a number of risks associated with the use of homeopathy.
Delaying or avoiding conventional medical care
When the use of homeopathy causes a person to delay or avoid consultation with a registered medical practitioner or reject conventional medical approaches, serious and sometimes fatal consequences can occur. As evidenced by recent Australian court findings, spurious claims made by homeopathic practitioners[5] and retailers[6] can mislead individuals about the effectiveness of conventional medicine. When homeopathic vaccines are used as an alternative to conventional immunisation, both the individual and the community are left exposed to preventable diseases.
Problems associated with unregulated products
Although homeopathic products manufactured in Australia are regulated as medicines under the Therapeutic Goods Act 1989, products sold on international websites may not meet Australian quality and safety standards. These products may be of particular concern when materials from problematic sources are employed in the preparation (e.g., pathogenic organs or tissues; causative agents such as bacteria, fungi, parasites, ova, yeast, and virus particles; disease products; excretions or secretions; heavy metals and toxins such as aconitum, kerosene and thallium). Impurities of source material and contamination associated with poor manufacturing processes also present threats to the quality and safety of these products.[7]
Direct adverse effects
Various direct harms associated with the use of homeopathic products have been noted in the literature, including allergic reaction, drug interactions, and complications related to the ingestion of toxic substances.[8]
The importance of patient-centred practice
The RACGP supports the concept of patient-centred practice, in which the values, preferences, and personal healthcare philosophy of the patient are respected and individuals play an important role in their own healthcare. An estimated six per cent of Australians use homeopathy over the course of a year.[9] It is important that these patients feel comfortable in discussing their use of complementary and alternative medicines with all members of their treatment team.
It is good practice for medical practitioners to initiate conversations with patients about their use of or intention to use homeopathy, and assist patients to think critically about the efficacy and safety of homeopathy so that they may make informed healthcare decisions.
Private health insurance and homeopathy
Many private health insurers provide ancillary (extras) cover that subsidises homeopathic treatment, and the individual’s costs in taking out this cover are subsidised under the Australian Government’s private health insurance rebate. The RACGP is concerned that health insurance premiums continue to rise as funds disburse significant sums for the use of homeopathy and other natural therapies lacking rigorous evidentiary support. In the 2013–14 financial year, health insurers paid out $164 million in benefits for natural therapies, up by almost 60 per cent from 2010–11.[10]
The RACGP also notes that offering subsidies for the use of homeopathy sends a confusing message to consumers. Listing homeopathic treatments alongside evidence-based modalities in a list of member benefits lends legitimacy to a practice that is not supported by scientific data.
References
1. National Health and Medical Research Council. NHMRC Statement: Statement on Homeopathy. Canberra: NHMRC; 2015.
2. National Health and Medical Research Council. NHMRC Information Paper: Evidence on the effectiveness of homeopathy for treating health conditions. Canberra: NHMRC; 2015.
3. National Centre for Immunisation Research and Surveillance. Homeopathy and vaccination [fact sheet].2014 [cited 2015 April]. Available from http://www.ncirs.edu.au/immunisation/factsheets/homeopathyvaccination-
fact-sheet.pdf
4. Commonwealth Department of Health and Ageing. Myths and realities: Responding to arguments against vaccination. A guide for providers. Canberra: DoHA; 2013.
5. Coronial inquest into the death of Penelope Dingle. State Coroner of Western Australia, 2010.
6. Australian Competition and Consumer Commission v Homeopathy Plus! Pty Ltd. FCA, 2014.
7. World Health Organization. Safety issues in the preparation of homeopathic medicines. Geneva: WHO; 2009.
8. Posadzki P, Alotaibi A, Ernst E. Adverse effects of homeopathy: a systematic review of published case reports and case series. International Journal of Clinical Practice 2012 Dec;66(12): 1178–88.
9. Xue CCL, Zhang AL, Lin V, Da Costa C, Story DF. Complementary and alternative medicine use in Australia: a national population-based survey. Journal of Alternative and Complementary Medicine 2007; 13(16):643–50.
10. Private Health Insurance Administration Council. Operations of the Private Health Insurers Annual Report 2013–14. Canberra: PHIAC; 2014.
I think this is a very good statement:
- it is based on the best evidence currently available,
- it is concise and to the point,
- it covers all the necessary ground,
- it provides valuable and practical recommendations.
Perhaps I should mention that it came as a complete surprise to me, and I was not involved in any way.
Finally, I would like to express my hope that this statement will be adopted in Australia and send a powerful signal to organisations across the world to issue similar recommendations for the benefit of vulnerable patients who still fall victim to bogus claims by homeopaths every day.
On 26/5/2015, I received the email reproduced below. I thought it was interesting, looked up its author (“Shawn is a philosopher and writer educated at York University in Toronto, and the author of two books. He’s also worked with Aboriginal youth in the Northwest Territories of Canada”) and decided to respond by writing a blog-post rather than by answering Alli directly.
Hello Dr. Ernst, this is Shawn Alli from Canada, a blogger and philosopher. I recently finished a critical article on James Randi’s legacy. It gets into everything from ideological science, manipulation, ESP, faith healing, acupuncture and homeopathy.
Let me know what you think about it:
http://www.shawnalli.com/james-randi-disingenuous-legacy.html
It’s quite long so save it for a rainy day.
So far, the reply from skeptical organizations range from: “I couldn’t read further than the first few paragraphs because I disagree with the claims…” to one word replies: “Petty.”
It’s always nice to know how open-minded skeptical organizations are.
Hopefully you can add a bit more.
Sincerely,
Shawn
Yes, indeed, I can but try to add a bit more!
However, Alli’s actual article is far too long to analyse it here in full. I therefore selected just the bit that I feel most competent commenting on and which is closest to my heart. Below, I re-produce this section of Alli’s article in full. I add my comments at the end (in bold) by inserting numbered responses which refer to the numbers (in round brackets [the square ones refer to Alli’s references]) inserted throughout Alli’s text. Here we go:
Homeopathy & Acupuncture:
A significant part of Randi’s legacy is his war against homeopathy. This is where Randi shines even above mainstream scientists such as Dawkins or Tyson.
Most of his talks ridicule homeopathy as nonsense that doesn’t deserve the distinction of being called a treatment. This is due to the fact that the current scientific method is unable to account for the results of homeopathy (1). In reality, the current scientific method can’t account for the placebo effect as well (2).
But then again, that presents an internal problem as well. The homeopathic community is divided by those who believe it’s a placebo effect and those that believe it’s more than that, advocating the theory of water memory, which mainstream scientists ridicule and vilify (3).
I don’t know what camp is correct (4), but I do know that the homeopathic community shouldn’t follow the lead of mainstream scientists and downplay the placebo effect as, it’s just a placebo (5).
Remember, the placebo effect is downplayed because the current scientific method is unable to account for the phenomenon (3, 5). It’s a wondrous and real effect, regardless of the ridicule and vilification (6) that’s attached to it.
While homeopathy isn’t suitable as a treatment for severe or acute medical conditions, it’s an acceptable treatment for minor, moderate or chronic ones (7). Personally, I’ve never tried homeopathic treatments. But I would never tell individuals not to consider it. To each their own, as long as it’s within universal ethics (8).
A homeopathic community in Greece attempts to conduct an experiment demonstrating a biological effect using homeopathic medicine and win Randi’s million dollar challenge. George Vithoulkas and his team spend years creating the protocol of the study, only to be told by Randi to redo it from scratch. [29] (9) I recommend readers take a look at:
Randi’s war against homeopathy is an ideological one (10). He’ll never change his mind despite positive results in and out of the lab (11). This is the epitome of dogmatic ideological thinking (12).
The same is true for acupuncture (13). In his NECSS 2012 talk Randi says:
Harvard Medical School is now offering an advanced course for physicians in acupuncture, which has been tested endlessly for centuries and it does not work in any way. And believe me, I know what I’m talking about. [30]
Acupuncture is somewhat of a grey area for mainstream scientists and the current scientific method. One ideological theory states that acupuncture operates on principles of non-physical energy in the human body and relieving pressure on specific meridians. The current scientific method is unable to account for non-physical human energy and meridians.
A mainstream scientific theory of acupuncture is one of neurophysiology, whereby acupuncture works by affecting the release of neurotransmitters. I don’t know which theory is correct; but I do know that those who do try acupuncture usually feel better (14).
In regards to the peer-reviewed literature, I believe (15) that there’s a publication bias against acupuncture being seen as a viable treatment for minor, moderate or chronic conditions. A few peer-reviewed articles support the use of acupuncture for various conditions:
Eight sessions of weekly group acupuncture compared with group oral care education provide significantly better relief of symptoms in patients suffering from chronic radiation-induced xerostomia. [31]
It is concluded that this study showed highly positive effects on pain and function through the collaborative treatment of acupuncture and motion style in aLBP [acute lower back pain] patients. [32]
Given the limited efficacy of antidepressant treatment…the present study provides evidence in supporting the viewpoint that acupuncture is an effective and safe alternative treatment for depressive disorders, and could be considered an alternative option especially for patients with MDD [major depressive disorder] and PSD [post-stroke depression], although evidence for its effects in augmenting antidepressant agents remains controversial. [33]
In conclusion: We find that acupuncture significantly relieves hot flashes and sleep disturbances in women treated for breast cancer. The effect was seen in the therapy period and at least 12 weeks after acupuncture treatment ceased. The effect was not correlated with increased levels of plasma estradiol. The current study showed no side effects of acupuncture. These results indicate that acupuncture can be used as an effective treatment of menopausal discomfort. [34]
In conclusion, the present study demonstrates, in rats, that EA [electroacupuncture] significantly attenuates bone cancer induced hyperalgesia, which, at least in part, is mediated by EA suppression of IL-1…expression. [35]
In animal model of focal cerebral ischemia, BBA [Baihui (GV20)-based Scalp acupuncture] could improve IV [infarct volume] and NFS [neurological function score]. Although some factors such as study quality and possible publication bias may undermine the validity of positive findings, BBA may have potential neuroprotective role in experimental stroke. [36]
In conclusion, this randomized sham-controlled study suggests that electroacupuncture at acupoints including Zusanli, Sanyinjiao, Hegu, and Zhigou is more effective than no acupuncture and sham acupuncture in stimulating early return of bowel function and reducing postoperative analgesic requirements after laparoscopic colorectal surgery. Electroacupuncture is also more effective than no acupuncture in reducing the duration of hospital stay. [37]
In conclusion, we found acupuncture to be superior to both no acupuncture control and sham acupuncture for the treatment of chronic pain…Our results from individual patient data meta-analyses of nearly 18000 randomized patients in high-quality RCTs [randomized controlled trials] provide the most robust evidence to date that acupuncture is a reasonable referral option for patients with chronic pain. [38]
While Randi and many other mainstream scientists will argue (16) that the above claims are the result of ideological science and cherry picking, in reality, they’re the result of good science going up against dogmatic (17) and profit-driven (17) ideological (17) science.
Yes, the alternative medicine industry is now a billion dollar industry. But the global pharmaceutical medical industry is worth hundreds of trillions of dollars. And without its patients (who need to be in a constant state of ill health), it can’t survive (18).
Individuals who have minor, moderate, or chronic medical conditions don’t want to be part of the hostile debate between alternative medicine vs. pharmaceutical medical science (19). They just want to get better and move on with their life. The constant war that mainstream scientists wage against alternative medicine is only hurting the people they’re supposed to be helping (20).
Yes, the ideologies (21) are incompatible. Yes, there are no accepted scientific theories for such treatments. Yes, it defies what mainstream scientists currently “know” about the human body (22).
It would be impressive if a peace treaty can exist between both sides, where both don’t agree, but respect each other enough to put aside their pride and help patients to regain their health (23).
END OF ALLI’S TEXT
And here are my numbered comments:
(1) This is not how I understand Randi’s position. Randi makes a powerful point about the fact that the assumptions of homeopathy are not plausible, which is entirely correct – so much so that even some leading homeopaths admit that this is true.
(2) This is definitely not correct; the placebo effect has been studied in much detail, and we can certainly ‘account’ for it.
(3) In my 40 years of researching homeopathy and talking to homeopaths, I have not met any homeopaths who “believe it’s a placebo effect”.
(4) There is no ‘placebo camp’ amongst homeopaths; so this is not a basis for an argument; it’s a fallacy.
(5) They very definitely are mainstream scientists, like F Benedetti, who research the placebo effect and they certainly do not ‘downplay’ it. (What many people fail to understand is that, in placebo-controlled trials, one aims at controlling the placebo effect; to a research-naïve person, this may indeed LOOK LIKE downplaying it. But this impression is wrong and reflects merely a lack of understanding.)
(6) No serious scientist attaches ‘ridicule and vilification’ to it.
(7) Who says so? I know only homeopaths who hold this opinion; and it is not evidence-based.
(8) Ethics demand that patients require the best available treatment; homeopathy does not fall into this category.
(9) At one stage (more than 10 years ago), I was involved in the design of this test. My recollection of it is not in line with the report that is linked here.
(10) So far, we have seen no evidence for this statement.
(11) Which ones? No examples are provided.
(12) Yet another statement without evidence – potentially libellous.
(13) Conclusion before any evidence; sign for a closed mind?
(14) This outcome could be entirely unrelated to acupuncture, as anyone who has a minimum of health care knowledge should know.
(15) We are not concerned with beliefs, we concerned with facts here, aren’t we ?
(16) But did they argue this? Where is the evidence to support this statement?
(17) Non-evidence-based accusations.
(18) Classic fallacy.
(19) The debate is not between alt med and ‘pharmaceutical science’, it is between those who insist on treatments which demonstrably generate more good than harm, and those who want alt med regardless of any such considerations.
(20) Warning consumers of treatments which fail to fulfil the above criterion is, in my view, an ethical duty which can save much money and many lives.
(21) Yes, alt med is clearly ideology-driven; by contrast conventional medicine is not (if it were, Alli would have explained what ideology it is precisely). Conventional medicine changes all the time, sometimes even faster than we can cope with, and is mainly orientated on evidence which is not an ideology. Alt med hardly changes or progresses at all; for the most part, its ideology is that of a cult celebrating anti-science and obsolete traditions.
(22) Overt contradiction to what Alli just stated about acupuncture.
(23) To me, this seems rather nonsensical and a hindrance to progress.
In summary, I feel that Alli argues his corner very poorly. He makes statements without supporting evidence, issues lots of opinion without providing the facts (occasionally even hiding them), falls victim of logical fallacies, and demonstrates an embarrassing lack of knowledge and common sense. Most crucially, the text seems bar of any critical analysis; to me, it seems like a bonanza of unreason.
To save Alli the embarrassment of arguing that I am biased or don’t know what I am talking about, I’d like to declare the following: I am not paid by ‘Big Pharma’ or anyone else, I am not aware of having any other conflicts of interest, I have probably published more research on alt med (some of it with positive conclusions !!!) than anyone else on the planet, my research was funded mostly by organisations/donors who were in favour of alt med, and I have no reason whatsoever to defend Randi (I only met him personally once). My main motivation for responding to Alli’s invitation to comment on his bizarre article is that I have fun exposing ‘alt med nonsense’ and believe it is a task worth doing.
This is a question which I have asked myself more often than I care to remember. The reason is probably that, in alternative medicine, I feel surrounded by so much dodgy research that I simply cannot avoid asking it.
In particular, the co-called ‘pragmatic’ trials which are so much ‘en vogue’ at present are, in my view, a reason for concern. Take a study of cancer patients, for instance, where one group is randomized to get the usual treatments and care, while the experimental group receives the same and several alternative treatments in addition. These treatments are carefully selected to be agreeable and pleasant; each patient can choose the ones he/she likes best, always had wanted to try, or has heard many good things about. The outcome measure of our fictitious study would, of course, be some subjective parameter such as quality of life.
In this set-up, the patients in our experimental group thus have high expectations, are delighted to get something extra, even more happy to get it for free, receive plenty of attention and lots of empathy, care, time, attention etc. By contrast, our poor patients in the control group would be a bit miffed to have drawn the ‘short straw’ and receive none of this.
What result do we expect?
Will the quality of life after all this be equal in both groups?
Will it be better in the miffed controls?
Or will it be higher in those lucky ones who got all this extra pampering?
I don’t think I need to answer these questions; the answers are too obvious and too trivial.
But the real and relevant question is the following, I think: IS SUCH A TRIAL JUST SILLY AND MEANINGLESS OR IS IT UNETHICAL?
I would argue the latter!
Why?
Because the results of the study are clearly known before the first patient had even been recruited. This means that the trial was not necessary; the money, time and effort has been wasted. Crucially, patients have been misled into thinking that they give their time, co-operation, patience etc. because there is a question of sufficient importance to be answered.
But, in truth, there is no question at all!
Perhaps you believe that nobody in their right mind would design, fund and conduct such a daft trial. If so, you assumed wrongly. Such studies are currently being published by the dozen. Here is the abstract of the most recent one I could find:
The aim of this study was to evaluate the effectiveness of an additional, individualized, multi-component complementary medicine treatment offered to breast cancer patients at the Merano Hospital (South Tyrol) on health-related quality of life compared to patients receiving usual care only. A randomized pragmatic trial with two parallel arms was performed. Women with confirmed diagnoses of breast cancer were randomized (stratified by usual care treatment) to receive individualized complementary medicine (CM group) or usual care alone (usual care group). Both groups were allowed to use conventional treatment for breast cancer. Primary endpoint was the breast cancer-related quality of life FACT-B score at 6 months. For statistical analysis, we used analysis of covariance (with factors treatment, stratum, and baseline FACT-B score) and imputed missing FACT-B scores at 6 months with regression-based multiple imputation. A total of 275 patients were randomized between April 2011 and March 2012 to the CM group (n = 136, 56.3 ± 10.9 years of age) or the usual care group (n = 139, 56.0 ± 11.0). After 6 months from randomization, adjusted means for health-related quality of life were higher in the CM group (FACT-B score 107.9; 95 % CI 104.1-111.7) compared to the usual care group (102.2; 98.5-105.9) with an adjusted FACT-B score difference between groups of 5.7 (2.6-8.7, p < 0.001). Thus, an additional individualized and complex complementary medicine intervention improved quality of life of breast cancer patients compared to usual care alone. Further studies evaluating specific effects of treatment components should follow to optimize the treatment of breast cancer patients.
The key sentence in this abstract is, of course: complementary medicine intervention improved quality of life of breast cancer patients… It provides the explanation as to why these trials are so popular with alternative medicine researchers: they are not real research but they are quite simply promotion! The next step would be to put a few of those pseudo-scientific trials together and claim that there is solid proof that integrating alternative treatments into conventional health care produces better results. At that stage, few people will bother asking whether this is really due to the treatments in questioning or to the additional attention, pampering etc.
My question is ARE SUCH TRIALS ETHICAL?
I would very much appreciate your opinion.
In the world of homeopathy, the truth is often much weirder than fiction. Take this recent article, for instance; it was published by the famous lay homeopath Alan Schmukler in the current issue of ‘HOMEOPATHY 4 EVERYONE’.
Before you read the text in question, it might be relevant to explain who Schmukler is: he attended Temple University, where he added humanistic psychology to his passions. After graduating Summa Cum Laude, Phi Beta Kappa and President’s Scholar, he spent several years doing workshops in human relations. Alan also studied respiratory therapy and worked for three years at Einstein Hospital in Philadelphia. Those thousands of hours in the intensive care and emergency rooms taught him both the strengths and limitations of conventional medicine. Schmukler learned about homeopathy in 1991 when he felt he had been cured of an infection with Hepar sulph. He later founded the Homeopathic Study Group of Metropolitan Philadelphia, giving free lectures and hosting the areas best homeopaths to teach. He also helped found and edit Homeopathy News and Views, a popular culture newsletter on homeopathy. He taught homeopathy for Temple University’s Adult Programs, and has been either studying, writing, lecturing or consulting on homeopathy since 1991. He wrote Homeopathy An A to Z home Handbook, which is now available in five languages. Alan Schmukler has been practicing homeopathy for more than two decades and is Chief Editor of Hpathy.com and of Homeopathy4Everyone. He says that his work as Editor is one of his most rewarding experiences.
Now, brace yourself, here is the promised text/satire (in bold); I promise, I did not change a single word:
EIGHT REASONS TO VACCINATE YOUR CHILD
- Your child is deficient in Mercury, Aluminum, Formaldehyde, viruses, foreign DNA or other ingredients proven to cause neurological damage.
- Your child has an excess of healthy, functioning brain cells.
- You need more cash. The National Vaccine Injury Compensation program has paid out 2.8 billion dollars to parents of children injured or killed by vaccines.
- You and your husband are feeling alienated and you need a crisis to bring you together.
- You believe that pharmaceutical conglomerates which earn billions from vaccines are more credible than consumer groups.
- You think thousands of parents who report that their children became autistic two weeks after vaccination are lying.
- You don’t see a problem in logic when the government tells you that vaccines work, but that vaccinated children can catch diseases from unvaccinated children.
- You think the government should dictate which healing methods you and your children are allowed to use.
Funny? No!
Bad taste? Very much so!
Barmy? I think so!
Dangerous? Yes!
Irresponsible? Most certainly!
Unethical? Yes!
Characteristic for lay homeopathy? Possibly!
These days, I spend much of my time in France (my wife is French), and one striking thing about this country is the popularity of homeopathy. For instance, it is hard to find a pharmacy where the pharmacist does not approach you trying to sell you a homeopathic remedy for your health problem. But, of course, this is all far too anecdotal. The question therefore is, are there any reliable data on France’s usage of homeopathy?
The answer is YES: the aim of this new paper was to analyse data on medicines, prescribers and patients for homeopathic prescriptions that are reimbursed by French national health insurance.
The French national health insurance databases were used to analyse prescriptions of reimbursed homeopathic drugs or preparations in the overall French population, during the period July 2011-June 2012.
The results show that a total of 6,705,420 patients received at least one reimbursement for a homeopathic preparation during the 12-month period. This number equates to 10.2% of the French population, with a predominance in females (68%) and a peak frequency observed in children aged 0-4 years (18%). About one third of patients had only one reimbursement, and one half of patients had three or more reimbursements.
The cost of all homeopathic treatments prescribed during the 12-month period was approximately €279 million (based on the retail price). The observed mean reimbursement rate was 34%. This cost corresponded to nearly €98 million for the French national health insurance and amounted to 0.3% of France’s total drug bill. The most commonly prescribed stock was ‘Arnica montana’, followed by ‘Influenzinum’, Ignatia amara’ and ‘Gelsemium sempervirens’.
A total of 120,110 healthcare professionals (HCPs) prescribed at least one homeopathic drug or preparation. They represented 43.5% of the overall population of HCPs, nearly 95% of general practitioners, dermatologists and pediatricians, and 75% of midwives. Homeopathy accounted for 5% of the total number of drug units prescribed by HCPs. Conventional medicines were co-prescribed with 55% of homeopathic prescriptions.
From these data, the authors concluded that many HCPs occasionally prescribe reimbursed homeopathic preparations, representing however a small percentage of reimbursements compared to allopathic medicines. About 10% of the French population, particularly young children and women, received at least one homeopathic preparation during the year. In more than one half of cases, reimbursed homeopathic preparations are prescribed in combination with allopathic medicines.
So, my impression that homeopathy is much more popular in France than elsewhere was not entirely correct. Like in most other countries, it is used by a minority; but this minority is fairly vocal and gets plenty of press coverage. When discussing homeopathy with friends in France, I have regularly discovered that they have very little understanding about what homeopathy is truly about; they seem to favour it because it is heavily advertised as a harmless solution to benign health problems. In no other country have I seen regular TV commercials for homeopathy! The ones who earn by far the most from this is, of course, the pharmacist – in France, homeopathic products can only be found in pharmacies!
Seen from this angle, the French usage of homeopathy is a triumph of profit over reason: the two most popular preparations (Arnica and Influenzinum) are not just not evidence-based (like all other homeopathic remedies), they have been shown in systematic reviews not to work better than placebos.
The founder of Johrei Healing (JH), Mokichi Okada, believed that “all human beings have toxins in their physical bodies. Some are inherited, others are acquired by ingesting medicines, food additives, unnatural food, unclean air, most drugs, etc. all of these contain chemicals which cannot be used by the body and are treated as poisons…….. Illness is no more than the body’s way of purifying itself to regain health…… The more we resist illness by taking suppressive medications, the harder and more built up the toxins become…… If we do not allow the toxins to be eliminated from the body, we will suffer more, and have more difficult purification…..on the other hand, if we allow illness to take its course by letting the toxins become naturally eliminated from our bodies, we will be healthier.”
Johrei healers channel light or energy or warmth etc. into the patient’s or recipient’s body in order to stimulate well-being and healing. Sounds wacky? Yes!
Still, at one stage my team conducted research into all sorts of wacky healing practices (detailed reasons and study designs can be found in my recent book ‘A SCIENTIST IN WONDERLAND‘). Despite the wackiness, we even conducted a study of JH. Dr Michael Dixon, who was closely collaborating with us at the time, had persuaded me that it would be reasonable to do such a study. He brought some Japanese JH-gurus to my department to discuss the possibility, and (to my utter amazement) they were happy to pay £ 70 000 into the university’s research accounts for a small pilot study. I made sure that all the necessary ethical safe-guards were in place, and eventually we all agreed to design and conduct a study. Here is the abstract of the paper published once the results were available and written up.
“Johrei is a form of spiritual healing comprising “energy channelling” and light massage given either by a trained healer or, after some basic training, by anyone. This pilot trial aimed to identify any potential benefits of family-based Johrei practice in childhood eczema and for general health and to establish the feasibility of a subsequent randomised controlled trial. Volunteer families of 3-5 individuals, including at least one child with eczema were recruited to an uncontrolled pilot trial lasting 12 months. Parents were trained in Johrei healing and then practised at home with their family. Participants kept diaries and provided questionnaire data at baseline, 3,6 and 12 months. Eczema symptoms were scored at the same intervals. Scepticism about Johrei is presently an obstacle to recruitment and retention of a representative sample in a clinical trial, and to its potential use in general practice. The frequency and quality of practise at home by families may be insufficient to bring about the putative health benefits. Initial improvements in eczema symptoms and diary recorded illness, could not be separated from seasonal factors and other potential confounders. There were no improvements on other outcomes measuring general health and psychological wellbeing of family members.”
Our findings were hugely disappointing for the JH-gurus, of course, but we did insist on our right to publish them. Dr Dixon was not involved in the day to day running of our trial, nor in evaluating its results, nor in writing up the paper. He nevertheless showed a keen interest in the matter, kept in contact with the Japanese sponsors, and arranged regular meetings to discuss our progress. It was at one of those gatherings when he mentioned that he was about to fly to Japan to give a progress report to the JH organisation that had financed the study. My team felt this was odd (not least because, at this point, the study was far from finished) and we were slightly irritated by this interference.
When Dixon had returned from Japan, we asked him how the meeting had been. He said the JH sponsors had received him extremely well and had appreciated his presentation of our preliminary findings. As an ‘aside’, he mentioned something quite extraordinary: he, his wife and his three kids had all flown business class paid for by the sponsors of our trial. This, we all felt, was an overt abuse of potential research funds, unethical and totally out of line with academic behaviour. Recently, I found this fascinating clip on youtube, and I wonder whether it was filmed when Dr Dixon visited Japan on that occasion. One does get the impression that the Johrei organisation is not short of money.
A few months later, I duly reported this story to my dean, Prof Tooke, who was about to get involved with Dr Dixon in connection with a postgraduate course on integrated medicine for our medical school (more about this episode here or in my book). He agreed with me that such a thing was a most regrettable violation of academic and ethical standards. To my great surprise, he then asked me not to tell anybody about it. Today I feel very little loyalty to either of these two people and have therefore decided to publish my account – which, by the way, is fully documented as I have kept all relevant records and a detailed diary (in case anyone should feel like speaking to libel lawyers).
