It has been reported that ‘Boots the Chemist’ have filed several legal complaints against The Guardian in relation to articles published by the paper in relation to its April 2016 investigation. The Guardian articles in question alleged that Boots, the UK’s largest pharmacy chain, had placed undue pressure on its pharmacists to perform medicines use reviews so that it could claim the maximum payments possible from the NHS. In other words, The Guardian implied that Boots was trying to get more money from our NHS than might have been due.
Personally, I am always uneasy when I hear that someone takes legal action on such matters. I think that legal complaints of such a nature can turn out to be counter-productive, both in general and in this particular instance.
There could be several reasons. For instance, such actions might give someone the idea of filing complaints against Boots. I am sure it is not difficult to find reasons for that.
In the realm of alternative medicine, for example, someone might question whether selling homeopathic remedies in Boot’s section ‘pharmacy and health’ is not misleading. These remedies might be seen by a naïve customer as masquerading as medicines. As readers of this blog know all too well, they do not, in fact, contain anything (other than lactose) that has any pharmacological activity. Therefore Boots should best market them in the category of ‘confectionary’.
One might even suspect that Boots are fully aware of all this. After all, a spokesperson for the company stated years ago during a parliamentary inquiry: “I have no evidence to suggest that they [homeopathic remedies sold by Boots] are efficacious …”
And it is also not the first time that Boots have been challenged for selling products they know to be placebos. This is what The Guardian reported in 2008 about the issue: “Ernst accuses the company [Boots] of breaching ethical guidelines drawn up by the Royal Pharmaceutical Society of Great Britain, by failing to tell customers that its homeopathic medicines contain no active ingredients and are ineffective in clinical trials.”
A similar void of evidence also applies to Boot’s wide range of Bach Flower Remedies and aromatherapy oils.
Or am I wrong?
Perhaps Boots want to post links to the evidence in the comment section below?
I am always keen to learn and only too happy to change my mind in view of new, compelling evidence!
Boots also sell a very wide range of herbal medicines, and here the situation is quite different: herbal medicines actually contain molecules that might have pharmacological effects, i. e. they might heal or might harm you. And many of these products imply indications for which they should be taken. I will pick just one example to explain: HERBAL SLIM AID.
Yes, you are absolutely correct – this product is (according to its name) not for gaining weight, it’s for reducing it. Each coated tablet contains 45 mg of extract (as dry extract) from Bladderwrack thallus (Fucus vesiculosus L.) (5:1) (equivalent to 225 mg of Fucus) Extraction solvent: water, ,30 mg Dandelion Root (Taraxacum officinale Weber ex Wigg), 27 mg of extract (as dry extract) from Boldo leaf (Peumus boldus Molina) (4-6:1) (equivalent to 108-162 mg of Boldo leaf) Extraction solvent: Methanol 70% v/v, 10 mg Butternut Bark (Juglans cinerea L.).
Now, I thought I know quite a bit about herbal slimming aids, after all, we had a research focus on this topic for several years and have published about a dozen papers on the subject. But oddly, I cannot remember that this mixture of herbs has been shown to reduce body weight.
Perhaps Boots want to post evidence for the efficacy and safety of this product as well?
I certainly hope so, and I would instantly withdraw any hint of a suspicion that Boots are selling unproven or disproven medicines.
Where is all this going?
I have to admit that am not entirely sure myself.
I suppose all I wanted to express was that it might be unwise to throw stones when one is sitting in a glass-house – a cliché, I know, but it’s true nevertheless.
CONFLICTS OF INTEREST:
None [except I don’t like those who easily take legal action against others]
Turmeric (Curcuma longa) is a truly fascinating plant with plenty of therapeutic potential. It belongs to the ginger family, Zingiberaceae and is native to southern Asia. Its main active ingredients are curcumin (diferuloylmethane) and the related compounds, demethoxycurcumin and bis-demethoxycurcumin (curcuminoids) which are secondary metabolites. Turmeric has been used extensively in Ayurvedic medicine and has a variety of pharmacologic properties including antioxidant, analgesic, anti-inflammatory, and antiseptic activities.
In the often weird world of alternative medicine, turmeric is currently being heavily hyped as the new panacea. Take this website, for instance; it promotes turmeric for just about any ailment known to mankind. Here is a short excerpt to give you a flavour (pun intended, turmeric is, of course, a main ingredient in many curries):
It comes at a surprise to a lot of people that herbs can be highly effective, if not more effective, than conventional medications …
To date, turmeric is one of the top researched plants. It was involved in more than 5,600 peer-reviewed and published biomedical studies. In one research project that extended over a five year period, it was found that turmeric could potentially be used in preventive and therapeutic applications. It was also noted that it has 175 beneficial effects for psychological health…
The 14 Medications it Mimics
Or should we say the 14 medications that mimic turmeric, since turmeric has been around much longer than any chemical prescription drug. Here’s a quick look at some of them:
- Lipitor: This is a cholesterol drug that is used to reduce inflammation and oxidative stress inside of patients suffering from type 2 diabetes. When the curcuminoid component inside of turmeric is properly prepared, it can offer the same effects (according to a study published in 2008).
- Prozac: This is an antidepressant that has been overused throughout the past decade. In a study published back in 2011, turmeric was shown to offer beneficial effects that helped to reduce depressive behaviors (using animal models).
- Aspirin: This is a blood thinner and pain relief drug. In a study done in 1986, it was found that turmeric has similar affects, which makes it a candidate for patients that are susceptible to vascular thrombosis and arthritis.
- Metformin: This is a drug that treats diabetes. It is used to activate AMPK (to increase uptake of glucose) and helps to suppress the liver’s production of glucose. In a study published in 2009, it was found that curcumin was 500 to 100,000 times more effective at activating AMPK ad ACC.
- Anti-Inflammatory Drugs: This includes medications like ibuprofen, aspirin and dexamethasone, which are designed to reduce inflammation. Again, in 2004, it was proven that curcumin was an effective alternative option to these chemical drugs.
- Oxaliplatin: This is a chemotherapy drug. A study done in 2007 showed that curcumin is very similar to the drug, acting as an antiproliferative agent in colorectal cell lines.
- Corticosteroids: This is a steroid medication, which is used to treat inflammatory eye diseases. In 1999, it was found that curcumin was effective at managing this chronic condition. Then in 2008, curcumin was used in an animal model that proved it could also aid in therapy used to protect patients from lung transplantation-associated injuries by “deactivating” inflammatory genes.
Turmeric Fights Drug-Resistant Cancers… it’s been shown that curcumin can battle against cancers that are resistant to chemotherapy and radiation…
END OF QUOTE
As I said, turmeric is fascinating and promising, but such hype is clearly counter-productive and dangerous. As so often, the reality is much more sobering than the fantasy of uncritical quacks. Research is currently very active and has produced a host of interesting findings. Here are the conclusions (+links) of a few, recent reviews:
Overall, there is early evidence that turmeric/curcumin products and supplements, both oral and topical, may provide therapeutic benefits for skin health. However, currently published studies are limited and further studies will be essential to better evaluate efficacy and the mechanisms involved.
While statistical significant differences in outcomes were reported in a majority of studies, the small magnitude of effect and presence of major study limitations hinder application of these results.
The highlighted studies in the review provide evidence of the ability of curcumin to reduce the body’s natural response to cutaneous wounds such as inflammation and oxidation. The recent literature on the wound healing properties of curcumin also provides evidence for its ability to enhance granulation tissue formation, collagen deposition, tissue remodeling and wound contraction. It has become evident that optimizing the topical application of curcumin through altering its formulation is essential to ensure the maximum therapeutical effects of curcumin on skin wounds.
What emerges from a critical reading of the evidence is that turmeric has potential in several different areas. Generally speaking, clinical trials are still thin on the ground, not of sufficient rigor and therefore not conclusive. In other words, it is far too early to state or imply that we all should rush to the next health food store and buy the supplements.
On the contrary, at this stage, I would even warn people not to be seduced by the unprofessional hype and wait until we know more – much more. There might be risks associated with ingesting turmeric at high doses over long periods of time. And there are fundamental open questions about oral intake. One recent review cautioned: …its extremely low oral bioavailability hampers its application as therapeutic agent.
WATCH THIS SPACE!
The ACUPUNCTURE NOW FOUNDATION (ANF) have recently published a document that is worth drawing your attention to. But first I should perhaps explain who the ANF are. They state that “The Acupuncture Now Foundation (ANF) was founded in 2014 by a diverse group of people from around the world who were concerned about common misunderstandings regarding acupuncture and wanted to help acupuncture reach its full potential. Our goal is to become recognized as a leader in the collection and dissemination of unbiased and authoritative information about all aspects of the practice of acupuncture.”
This, I have to admit, sounds like music to my ears! So, I studied the document in some detail – and the music quickly turned into musac.
The document which they call a ‘white paper’ promises ‘a review of the research’. Reading even just the very first sentence, my initial enthusiasm turned into bewilderment: “It is now widely accepted across health care disciplines throughout the world that acupuncture can be effective in treating such painful conditions as migraine headaches, and low back, neck and knee pain, as well as a range of painful musculoskeletal conditions.” Any review of research that starts with such a deeply uncritical and overtly promotional statement, must be peculiar (quite apart from the fact that the ANF do not seem to appreciate that back and neck pain are musculoskeletal by nature).
As I read on, my amazement grew into bewilderment. Allow me to present a few further statements from this review (together with a link to the article provided by the ANF in support and a very brief comment by myself) which I found more than a little over-optimistic, far-fetched or plainly wrong:
“Male fertility, especially sperm production and motility, has also been shown to improve with acupuncture. In a recent animal study, electro-acupuncture was found to enhance germ cell proliferation. This action is believed to facilitate the recovery of sperm production (spermatogenesis) and may restore normal semen parameters in subfertile patients.”
The article supplied as evidence for this statement refers to an animal experiment using a model where sperm are exposed to heat. This has almost no bearing on the clinical situation in humans and does not lend itself to any clinical conclusions regarding the treatment of sub-fertile men.
“In a recent meta-analysis, researchers concluded that the efficacy of acupuncture as a stand-alone therapy was comparable to antidepressants in improving clinical response and alleviating symptom severity of major depressive disorder (MDD). Also, acupuncture was superior to antidepressants and waitlist controls in improving both response and symptom severity of post-traumatic stress disorder (PTSD). The incidence of adverse events with acupuncture was significantly lower than antidepressants.”
The review provided as evidence is wide open to bias; it was criticised thus: “the authors’ findings did not reflect the evidence presented and limitations in study numbers, sample sizes and study pooling, particularly in some subgroup analyses, suggested that the conclusions are not reliable”. Moreover, we need to know that by no means all reviews of the subject confirm this positive conclusion, for instance, this, this, or this one; all of the latter reviews are more up-to-date than the one provided by ANF. Crucially, a Cochrane review concluded that “the evidence is inconclusive to allow us to make any recommendations for depression-specific acupuncture”.
“A randomized controlled trial of acupuncture and counseling for patients presenting with depression, after having consulted their general practitioner in primary care, showed that both interventions were associated with significantly reduced depression at three months when compared to usual care alone.”
We have discussed the trial in question on this blog. It follows the infamous ‘A+B versus B’ design which cannot possibly produce a negative result.
Now, please re-read the first paragraph of this post; but be careful not to fall off your chair laughing.
There would be more (much more) to criticise in the ANF report but, I think, these examples are ENOUGH!
Let me finish by quoting from the ANF’s view on the future as cited in their new ‘white paper’: “Looking ahead, it is clear that acupuncture is poised to make significant inroads into conventional medicine. It has the potential to become a part of every hospital’s standard of care and, in fact, this is already starting to take place not only in the U.S., but internationally. The treatment is a cost-effective and safe method of relieving pain in emergency rooms, during in-patient stays and after surgery. It can lessen post-operative nausea, constipation and urinary difficulties, and have a positive impact on conditions like hypertension, anxiety and insomnia…
Driven by popular demand and a growing body of scientific evidence, acupuncture is beginning to be taken seriously by mainstream conventional medicine, which is incorporating it into holistic health programs for the good of patients and the future of health care. In order for this transition to take place most effectively, misunderstandings about acupuncture need to be addressed. We hope this white paper has helped to clarify some of those misunderstandings and encourage anyone with questions to contact the Acupuncture Now Foundation.”
My question is short and simple: IGNORANCE OR FRAUD?
Yes, yes, yes, I know: we have too few women in our ‘ALT MED HALL OF FAME’. This is not because I have anything against them (quite the contrary) but, in alternative medicine research, the boys by far outnumber the girls, I am afraid.
You do remember, of course, you has previously been admitted to this austere club of excellence; only two women so far. Here is the current list of members to remind you:
David Peters (osteopathy, homeopathy, UK)
Nicola Robinson (TCM, UK)
Peter Fisher (homeopathy, UK)
Simon Mills (herbal medicine, UK)
Gustav Dobos (various, Germany)
Claudia Witt (homeopathy, Germany and Switzerland)
George Lewith (acupuncture, UK)
John Licciardone (osteopathy, US)
If you study the list carefully, you will also notice that, until now, I have totally ignored the chiropractic profession. This is a truly embarrassing omission! When it comes to excellence in research, who could possibly bypass our friends, the chiropractors?
Today we are going to correct these mistakes. Specifically, we are going to increase the number of women by 50% (adding one more to the previous two) and, at the same time, admit a deserving chiropractor to the ALT MED HALL OF FAME.
Cheryl Hawk is currently the Executive Director of Northwest Center for Lifestyle and Functional Medicine, University of Western States, Portland, USA. Previously she worked as Director of Clinical Research at the Logan University College of Chiropractic, Chesterfield, USA, and prior to that she was employed at various other institutions. Since many years she has been a shining light of chiropractic research. She is certainly not ‘small fry’ when it comes to the promotion of chiropractic.
Cheryl seems to prefer surveys as a research tool over clinical trials, and it was therefore not always easy to identify those of her 67 Medline-listed articles that reported some kind of evaluation of the value of chiropractic. Here are, as always, the 10 most recent papers where I could extract something like a data-based conclusion (in bold) from the abstract.
Hawk C, Schneider MJ, Vallone S, Hewitt EG.
J Manipulative Physiol Ther. 2016 Mar-Apr;39(3):158-68
All of the seed statements in this best practices document achieved a high level of consensus and thus represent a general framework for what constitutes an evidence-based and reasonable approach to the chiropractic management of infants, children, and adolescents.
Clinical Practice Guideline: Chiropractic Care for Low Back Pain.
Globe G, Farabaugh RJ, Hawk C, Morris CE, Baker G, Whalen WM, Walters S, Kaeser M, Dehen M, Augat T.
J Manipulative Physiol Ther. 2016 Jan;39(1):1-22
The evidence supports that doctors of chiropractic are well suited to diagnose, treat, co-manage, and manage the treatment of patients with low back pain disorders.
Ndetan H, Hawk C, Sekhon VK, Chiusano M.
J Evid Based Complementary Altern Med. 2016 Apr;21(2):138-42.
The odds ratio for perceiving being helped by a chiropractor was 4.36 (95% CI, 1.17-16.31) for respondents aged 65 years or older; 9.5 (95% CI, 7.92-11.40) for respondents reporting head or neck trauma; and 13.78 (95% CI, 5.59-33.99) for those reporting neurological or muscular conditions as the cause of their balance or dizziness.
Schneider MJ, Evans R, Haas M, Leach M, Hawk C, Long C, Cramer GD, Walters O, Vihstadt C, Terhorst L.
Chiropr Man Therap. 2015 May 4;23:16.
American chiropractors appear similar to chiropractors in other countries, and other health professionals regarding their favorable attitudes towards EBP, while expressing barriers related to EBP skills such as research relevance and lack of time. This suggests that the design of future EBP educational interventions should capitalize on the growing body of EBP implementation research developing in other health disciplines. This will likely include broadening the approach beyond a sole focus on EBP education, and taking a multilevel approach that also targets professional, organizational and health policy domains.
Chiropractic identity, role and future: a survey of North American chiropractic students.
Gliedt JA, Hawk C, Anderson M, Ahmad K, Bunn D, Cambron J, Gleberzon B, Hart J, Kizhakkeveettil A, Perle SM, Ramcharan M, Sullivan S, Zhang L.
Chiropr Man Therap. 2015 Feb 2;23(1):4
The chiropractic students in this study showed a preference for participating in mainstream health care, report an exposure to evidence-based practice, and desire to hold to traditional chiropractic theories and practices. The majority of students would like to see an emphasis on correction of vertebral subluxation, while a larger percent found it is important to learn about evidence-based practice. These two key points may seem contradictory, suggesting cognitive dissonance. Or perhaps some students want to hold on to traditional theory (e.g., subluxation-centered practice) while recognizing the need for further research to fully explore these theories. Further research on this topic is needed.
Twist E, Lawrence DJ, Salsbury SA, Hawk C.
Chiropr Man Therap. 2014 Dec 10;22(1):40
These results strongly suggest that chiropractic clinical researchers are not developing ICDs at a readability level congruent with the national average acceptable level. The low number of elements in some of the informed consent documents raises concern that not all research participants were fully informed when given the informed consent, and it may suggest that some documents may not be in compliance with federal requirements. Risk varies among institutions and even within institutions for the same intervention.
Hawk C, Kaeser MA, Beavers DV.
J Chiropr Educ. 2013 Fall;27(2):135-40.
This active learning exercise appeared to be a feasible way to introduce tobacco counseling into the curriculum.
Hawk C, Schneider M, Evans MW Jr, Redwood D.
J Manipulative Physiol Ther. 2012 Sep;35(7):556-67
This living document provides a general framework for an evidence-based approach to chiropractic wellness care.
Ndetan H, Evans MW Jr, Hawk C, Walker C.
J Altern Complement Med. 2012 Apr;18(4):347-53.
C/OM is primarily used for back and neck pain, which is increasing in prevalence in children. Teens are more likely to use it than are younger children.
Dougherty PE, Hawk C, Weiner DK, Gleberzon B, Andrew K, Killinger L.
Chiropr Man Therap. 2012 Feb 21;20(1):3.
Given the utilization of chiropractic services by the older adult, it is imperative that providers be familiar with the evidence for and the prudent use of different management strategies for older adults.
I am pleased to say that Prof Hawk gave me no problems at all; her case is clear: she is a champion of using research as a means for promoting chiropractic, has published many papers in this vein, clearly prefers the journals of chiropractic that nobody other than chiropractors ever access, and has an impeccable track record when it comes to avoiding negative conclusions which could harm chiropractic in any way.
Very well done indeed!
WELCOME, PROF HAWK, TO THE ‘ALT MED HALL OF FAME’.
You have to excuse me, if I keep coming back to this theme: so-called ‘alternative cancer cures’ are truly dangerous. I have tried to explain this already many times, for instance here, here and here. And it is by no means just alternative therapists who make a living of such quackery. Sadly qualified medical doctors are often involved as well. As to prove my point, here is a tragic story that broke yesterday:
Former Miss New Hampshire, Rachel Petz Dowd, lost her battle with cancer on Sunday 12 June 2016 — a battle she fought publicly through personal writings in a blog in hopes of helping others on a similar journey toward healing. The singer/songwriter and mother of three from Auburn died about a month after traveling to Mexico for an aggressive form of alternative cancer treatment. She turned 47 last week. Dowd was diagnosed with stage 2 triple negative breast cancer in May 2014. The diagnosis led her to create a blog called “Rachel’s Healing” to document what she hoped would be a journey back to health. “I hope my readers can gain something from my journey and that they find their own personal way to combat this disease impacting too many women today,” she wrote. Dowd used the blog to share her experiences with traditional and natural medicine during her cancer fight.
On 5/3/16 Mrs Dowd wrote on her blog: “Well after some careful consideration and looking at different clinics and hospitals we’ve made a decision. Will be going to the CMN Hospital on the Yuma, Arizona border*. For 28 days of treatments. It’s not a day clinic but a full hospital servicing over the past 30 years. There’s a special wing dedicated to alternative cancer care and the treatment list is impressive. Many treatments that are not available in this country. We feel this would be the best course of care daily for 28 days and then at the end of the 4 weeks I intend my immune system to be back on-line. I will be doing a stem cell boost of my bone marrow the last week. I know of a women, Shannon Knight, from The Truth About Cancer documentary, who had stage 4 metastasized into locations of her bones and her lungs and she came out of there completely cured. Her oncologist said it was nothing short of a miracle, but she said no it was just clean hard work! She said no it was just clean the hard, aggressive treatments that only attack cancer, boost and prime your immune system, become a whole, healthy being once again:) It is possible and I am planning on being one of the exceptions like Shannon!”
- The hospital is across the US border in Mexico; it is run by medically qualified personnel.
The hospital [“CMN Hospital’s facility is only 14 blocks away once you cross the border to begin your alternative cancer treatment”] has a website where they tell a somewhat confusing story about their treatment plans; here is a short but telling excerpt:
“CMN’s protocols are individualized and comprehensive. You will benefit from oxidative therapies, IV minerals selenium and bicarbonate IV vitamins such as vitamin B-17 and IV vitamin C. Far infrared and others including MAHT, Cold Laser Therapy, Hyperbaric Oxygen Therapy and Ozone Therapy are a daily part of your protocol. Ultraviolet Blood Irradiation is effective in destroying pathogens in your blood and slows the growth of cancer cell growth. CMN’s Stem cell therapy and Dendritic cell therapy are just two of the advanced cancer treatments applied to patients.”
IV Vitamin C If large amounts of vitamin C are presented to cancer cells, large amounts will be absorbed. In these unusually large concentrations, the antioxidant vitamin C will start behaving as a pro-oxidant as it interacts with intracellular copper and iron. This chemical interaction produces small amounts of hydrogen peroxide. Because cancer cells are relatively low in an intracellular anti-oxidant enzyme called catalase, the high dose vitamin C induction of peroxide will continue to build up until it eventually lyses the cancer cell from the inside out!
IV Vitamin B17 / Laetrile Also known as amygdaline, Vitamin B-17 is a molecule made up of four parts: -2 parts Glucose -1 part Benzaldahyde-1 part Hydrogen Cyanide. Laetrile is found in at least 1200 different plants, including apricots, peaches, apple seeds, lentils, cashews, brown rice, millet, and alfalfa. Commercial preparations of laetrile are obtained from the kernels of apricots, peaches and bitter almonds. The body requires an enzyme called beta-glucosidase in order to process laetrile and release the cyanide. Studies have shown that cancer cells contain more of this enzyme than normal cells, which allows for a higher release of cyanide at tumor sites. Another enzyme known as rhodanese is important in this process. Normal healthy cells contain rhodanese which protects them from the activated cyanide. Most cancer cells are deficient in this enzyme, leaving them vulnerable to the poison. Tumor destruction begins once the cyanide is released within the malignancies, meaning laetrile therapy is selectively toxic to cancer cells while remaining non-toxic to normal cells.
Essiac Tea / Order Original Essiac Tea Essiac, given its name by Rene Caisse (“caisse” spelt backwards), consists of four main herbs that grow in the wilderness of Ontario, Canada. The original formula is believed to have its roots from the native Canadian Ojibway Indians. The four main herbs that make up Essiac are Burdock Root, Slippery Elm Inner Bark, Sheep Sorrel and Indian Rhubarb Root. Essiac tea helps release toxins that build up in fat and tissues into the blood stream where they can be filtered and excreted by the liver and kidneys. Cleaning the body of toxins and impurities frees up the immune system to focus on killing cancer cells and protecting the body.
I think I will abstain from further comments, firstly because I want to avoid getting sued by these people and secondly because it seems all too depressingly obvious.
Seasonal allergic rhinitis (hay fever) is a common condition which can considerably reduce the quality of life of sufferers. Homeopathy is often advocated – but does it work?
A new study was meant to be an “assessment of the clinical effectiveness of homeopathic remedies in the alleviation of hay fever symptoms in a typical clinical setting.”
The investigator performed a ‘clinical observational study’ of eight patients from his private practice using Measure Yourself Medical Outcome Profile (MYMOP) self-evaluation questionnaires at baseline and again after two weeks and 4 weeks of individualized homeopathic treatment which was given as an add-on to conventional treatments.
The average MYMOP scores for the eyes, nose, activity and wellbeing had improved significantly after two and 4 weeks of homeopathic treatment. The overall average MYMOP profile score at baseline was 3.83 (standard deviation, SD, 0.78). After 14 and 28 days of treatment the average score had fallen to 1.14 (SD, 0.36; P<0.001) and 1.06 (SD, 0.25; P<0.001) respectively.
The author concluded as follows: Individualized homeopathic treatment was associated with significant alleviation of hay fever symptoms, enabling the reduction in use of conventional treatment. The results presented in this study can be considered as a step towards a pilot pragmatic study that would use more robust outcome measures and include a larger number of patients prescribed a single or a multiple homeopathic prescription on an individualized basis.
It is hard to name the things that are most offensively wrong here; the choice is too large. Let me just list three points:
- The study design is not matched to the research question.
- The implication that homeopathy had anything to do with the observed outcome is unwarranted.
- The conclusion that the results might lend themselves to develop a pilot study is meaningless.
The question whether homeopathy is an effective therapy for hay fever has been tested before, even in RCTs. It seems therefore mysterious why one needs to revert to tiny observational studies in order to plan a pilot, and even less for an assessment of effectiveness.
There are few conditions which are more time-dependent than hay fever. Any attempt of testing the effectiveness of medical interventions without a control group seems therefore not just questionable but wasteful. Clinical studies absorb resources; even if the author was happy to waste his time, he should not assume that he can freely waste the time, effort and availability of his patients.
Two final points, if I may:
- An observational study of homeopathy for hay-fever without a control group might be utterly useless but it is still an investigation that requires certain things. As far as I can see, this study did not even have ethics approval nor is there a mention of informed consent. Strictly speaking, this makes it an unethical study.
- If we allow research of this nature to take place and be published, we give clinical research a bad name and undermine the confidence of the public in science.
I am puzzled how such a paper could pass peer review and how an Elsevier journal could even consider publishing it.
The question whether pharmacists should sell unproven alternative medicines will not go away. On this blog, we have discussed it repeatedly, for instance here, here and here. The Australian Journal of Pharmacy’s latest poll shows that readers have their suspicions about the validity of naturopathic medicines, with a whopping 544 voters choosing the option, “No, there’s no evidence they work” at the time of writing.
This constitutes 65% of readers who took part in the poll. A significant minority – 193 readers, with 23% of the vote – said that pharmacies should stock these medicines as they are legitimate products. Five per cent said that while they questioned their efficacy, pharmacy should stock them; and 3% said they were unsure, but the public wanted them.
Taree pharmacist and member of Friends in Science and Medicine Ian Carr, who has spoken to the AJP several times in the last couple of weeks as debate has continued about the subject of naturopathy in pharmacy, said he was surprised and pleased at the strength of the No vote. “I looked at [the poll] on the first day, and there was definitely a majority saying these things have no evidence, but there was still above 30% saying yes, they were legitimate products,” Carr told the AJP. “That’s been dwarfed by a lot of people who’ve looked in, and it’s interesting to have that many people vote. “I’m glad that it seems to be becoming recognised that there’s a need for the evidence base in these things, and the difference between having a naturopathic product or supplement on the shelf, and having somebody there charging for their time, as a naturopath, dispensing advice without knowing the patient’s background and without an intervention by a registered pharmacist.” He encouraged pharmacists concerned about the validity of naturopathy to consider what products and services they offer.
Where naturopaths are used, they should at least be expected to keep a record of products and advice dispensed, he says, similar to protocols around blood pressure and blood glucose monitoring. “If there’s going to be an insistence that naturopaths remain, that’s the way I’d like to see it: that the pharmacy has good records and oversight of what they’re doing. I think, given our connection to the PBS and the fact that we as pharmacists are looking for a more serious role as part of the health care team generally, and having a more active and integrative role, we would be silly to fritter it away on peripheries like naturopathy. I personally see the opportunities in evidence-based medicine and what flows from that, rather than trying to make up dollars. We’re more likely to lose control of pharmacy if we don’t guard it jealousy.”
One of the suppliers of CAM products to pharmacies responded to the article by stating the following:
“The complementary and alternative medicine (CAMs) sector and its role in healthcare management continues to be hotly debated by the media. Rather than dissuade this debate, we actively encourage this discussion, as it shines a light on many issues which need to be addressed. Of priority is the point that not all complementary and alternative medicine products are equal. As in many media articles, an incredibly wide spectrum of products are grouped under the label of ‘CAMs’. Products with specific clinical evidence, high-quality manufacturing processes and transparency on the sourcing of ingredients are not clearly identified from products without these qualities. Consumers and healthcare professionals are unable to distinguish this difference due to a lack of clear labelling. We agree with calls for CAMs products to be more thoroughly assessed, beyond being simply classified as ‘safe’. Healthcare professionals and consumers deserve this information and are indeed asking for it. Consumers are aware of the impact of their choices and that their demand drives industry change. History is littered with recent examples where consumer awareness has changed the marketplace for the better. Consumer-driven change in the CAMs industry IS possible, it just needs to be supported. The Australian CAMs industry needs to increase healthcare professional and consumer education on the importance of evidence-based CAM products; on what ‘evidence-based’ means and what this difference delivers… Healthcare professionals are key to helping their patients understand that not all CAMs or natural medicine products are equal… It takes time to change the way people see CAMs and natural medicines – but it is of inherent value for the consumer. Something, we believe, is integral to the future of the industry.”
The arguments are clearest, if we focus on a specific type of alternative medicine and spell out what precisely we are talking about. The one that comes to mind is, of course, homeopathy. In my view, there is no good reason why pharmacists should sell homeopathic remedies. It is comforting to know that the Chief Scientist of the UK Royal Pharmaceutical Society, Professor Jayne Lawrence, agrees; she stated about a year ago that “the public have a right to expect pharmacists and other health professionals to be open and honest about the effectiveness and limitations of treatments. Surely it is now the time for pharmacists to cast homeopathy from the shelves and focus on scientifically based treatments backed by clear clinical evidence.”
And what has changed since?
Nothing, as far as I can see – but please correct me, if I am wrong.
I think it is important that we remind the community pharmacists everywhere that they have their very own codes of ethics and that they need to adhere to them. If they don’t, they tacitly agree that they are not really healthcare professionals but mere shop-keepers.
I am editor in chief of a journal called FACT. It has a large editorial board, and I am always on the look-out for people who might be a good, productive and colourful addition to it. On 3 June, I sent an invitation to Mel Koppelman, who is by now well known to regular readers of this blog. Here is a copy:
can I ask you a question?
would you consider joining the ed-board of FACT [as you mentioned it in one of your comments, I assume you know this journal – but you are wrong in implying that it has anything to do with the pharmaceutical or any other industry]? if you agree, we would expect you to write 2-3 ‘summaries/commentaries’ per year. in return you get a free subscription and, of course, can submit other articles.
no, this is not a joke or a set-up. I like to have the full spectrum of opinion/expertise on my ed-board, and I do think you understand science quite well. our opinions differ but that’s what I think is good for the journal.
think about it – please.
On 6 June, she replied as follows:
Great to hear from you, I hope you enjoyed your weekend.
Thank you very much for the kind offer, it’s something I would consider. I certainly have no problem with, and in fact embrace, people who have different opinions and views from my own, so long as I feel that they have integrity in their approach.
Just a few questions / comments:
1) Regarding FACT’s affiliations, what I said in my comment was that it was a publication of the Royal Pharmaceutical Society. According to Wiley’s website, Focus on Alternative and Complementary Medicine is copyright by Royal Pharmaceutical Society. It’s also listed on the Pharmaceutical Press website.
Are you telling me that’s incorrect? That I’m “wrong” in saying there’s a relationship? I obviously need to understand the nature of the publication whose editorial board I’m considering joining. Very confusing that you as editor say there’s no relationship to the RPS and yet they claim copyright over your publication. Incidentally, is FACT self-sufficient, earning all of its income from subscriptions? Or does any financial support come from the publishers?
2) As enticing as a free subscription to FACT is, I have access to more high quality peer-reviewed reading material than I could enjoy in many lifetimes. Because my skills seem to be in high demand and because I already spend 10-20 hours per week doing unpaid volunteer work, any additional projects that I take on at this time would need to be financially compensated. I understand that this may be a deal-breaker.
3) While I have no issue with you having different views when it comes to medical research, in order to choose to work with your publication, it’s important to me that it’s run by people with a high level of academic integrity and put patient welfare at the forefront of it’s agenda.
In March, you came out in public support of the NICE draft guidelines. You were quoted in the Guardian as saying: “It is good to see that Nice have now caught up with the evidence. Neither spinal manipulation nor acupuncture are supported by good science when it comes to treating low back pain.”
Following this, it was brought to your attention that the recommendations were contrary to best evidence and that the conclusions were unsupportable. While you have the option of following this up to make sure that the record reflects best evidence, you have indicated that you have no interest in evaluating the situation and possibly admitting an error. This behaviour is concerning from the perspective of academic integrity, particularly when it directly leads to increased human suffering (policy in several countries has already been changed based on the draft), and I would be worried that by joining your board I could be associated with such unethical behaviour.
Perhaps if I understood better your position, which seems to be to ignore the situation, not follow up on the concerns raised, and leave your comments uncorrected even though they may be inaccurate and backing guidelines that cause harm to patients, that might allay certain reservations.
Anyways, these are my initial thoughts. I hope you have an opportunity to enjoy the beautiful weather, and I look forward to hearing from you.
At that stage, I began to fear that I had made a mistake. But, giving her the benefit of the doubt, I swallowed my pride and replied as politely as I could to her concerns which, in my view, were odd, to say the least. This is what I wrote on 7 June:
Thank you for your reply to my invitation. Let me address your points in turn:
- I said that FACT has nothing to do with the pharma industry which is true [when you state that “you as editor say there’s no relationship to the RPS” – it suggests to me that you did not read my email properly]. In their own words, the RPS is “the professional membership body for pharmacists and pharmacy in Great Britain and an internationally renowned publisher of medicines information.” [http://www.rpharms.com/home/about-us.asp] They have a similar status as the Royal Colleges. In the 2 decades that I am running the journal, there has been not a single instance of interference of any kind. We use them simply as an excellent publishing house. And yes, FACT is to the best of my knowledge self-sufficient and survives without funds from 3rd parties.
- I am delighted to hear that your skills are in demand.
- I have stated my position regarding the draft NICE guideline ad nauseam: I prefer to wait until I see their next version of the draft before I make further comments on it. In my view, this is both reasonable and honourable. If you disagree, I can do little about it other than expressing my sincere regrets.
I hope these brief clarifications are helpful for you to arrive at a decision.
On 8 June, I received Mel’s reply:
How interesting! Is he trying to ‘keep his enemies closer’ or am I being too skeptical? He has recognised your talents and dedication and intellect so he is not altogether stupid after all! I eagerly await his response to your reply.
Those who have studied with Ernst say that he’s a genuine chap and misunderstood – which I know is almost unimaginable given his behaviour – but we always have to allow for the possibility that we have misjudged people however remote! Also, people can turn – especially when they get older and near retirement. Alternatively he may just fancy you!…
Mel Koppelman Really enjoying hearing y’all’s thoughts on this. I just want to say that If I had thought that the chances of me being able to create positive change by joining FACT were high, I would have tempered the tone of my reply. But the simple fact that EE can’t even be factual or forthright about whose journal it is suggests an irreparable break with reality. And surely there’s an issue (academic? ethical? legal?) with recruiting someone to your board and denying an industry tie when there is one? Not to mention that if the RSP does fund his journal, he’s been lying about his conflicts of interest. Is that someone I want to spend time adding value to that could be spent with family, patients, time in nature or really making positive change by supporting the ANF? I’ll be interested to read his reply if there is one and especially how he responds regarding the relationship between FACT and RSP. Will keep y’all posted.
John McDonald Healthy skepticism! Healthy journal! And it’s 99% fact-free!
I hope that you find these exchanges as amusing as I did – but are they important? Perhaps not exactly, but revealing certainly. They shed some light on the mind-set of acupuncturists and perhaps other alternative practitioners as well. Let me try to explain.
What struck me first was the degree of suspicion, even outright hostility from the acupuncturists. I had made it quite clear that I was asking Mel to join my Editorial-Board because of her views which vastly differ from mine. In science, differences of opinions and backgrounds can be stimulating and often generate progress. That is not something that seems to be wanted by alternative practitioners; they do not seem to tolerate criticism, different perspectives or views. One cannot help asking to what degree this attitude is immature or even dogmatic.
The next thing that baffled me was the speed with which conclusions are jumped upon. Everyone seemed to be instantly convinced that I was via my journal FACT in the pocket of the pharmaceutical industry. Nobody even bothered to look up what the Royal Pharmaceutical Society truly stand for and to verify that they do NOT represent ‘BIG PHARMA’. This blindness to the possibility of being wrong confirms my fear that alternative therapists are guided by strong beliefs which must not be questioned and are hard to influence, even with facts that take less than a minute to research.
And then there are, of course, the personal attacks which came quick, thick and fast. Its authors might think that such attacks get under my skin. If so, they are mistaken: if anything, they amuse me! I have long been of the opinion that they are important victories of reason. When an acupuncturist went as far as diagnosing me as being borderline psychopathic, I almost fell off my chair laughing! To me, this remark (which has emerged several times before) is emblematic, as it suggests several things at once:
- The author is obviously rude
- He/she is incompetent, even stupid
- He/she lacks empathy – after all, one would expect from a healthcare professional to show some understanding, if I were truly ill! And if not, one would expect more respect towards mentally ill patients.
- But, of course, he/she did not mean it like that; he/she merely meant to insult me. And employing mental health issues for this purpose shows a remarkable lack of professionalism, in my view.
Am I making too much of all this? Perhaps – sorry, I am almost done.
But first I need to briefly address Mel’s doubts about my integrity. She can, of course, question what she likes as often as she wants. My point is that repeating nonsensical arguments ad nauseam does not render then sensical.
Finally, there is Mel’s public claim that I have been lying about my conflict of interests. To me, it suggests a degree of desperation, perhaps even fanaticism, that is only surpassed by her inability to apologize after the truth had become undeniable even to her.
I know that there are some people who would have sued for libel.
For that I find all this far too hilarious.
We tend to trust charities; many of us donate to charities; we think highly of the work they do and the advice they issue. And why shouldn’t we? After all, a ‘charity’ is ‘an institution or organization set up to provide help, money, etc, to those in need’. Not a hint at anything remotely sinister here – charities are good!
Except, of course, those that are not so good!
By ‘not so good’ I mean charities that misinform the public to a point where they might even endanger our health, well-being and savings. Yes, I am speaking of those charities that promote unproven or disproven alternative therapies – and unfortunately, there are many of those around today.
Our recent letter in the SUNDAY TIMES, tried to alert the public to this problem and to the fact that the UK regulator seems to be failing to do much about it. A Charity Commission spokesman, in turn, replied that his organisation had received the letter and would respond formally to it:
“The Commission is required to register organisations as charities which are established for exclusively charitable purposes for the public benefit,” he said. “Charitable purposes for the advancement of health include conventional methods as well as complementary, alternative or holistic methods which are concerned with healing mind, body and spirit in the alleviation of symptoms and the cure of illness. Those organisations dealing with complementary and alternative medicines must be able to demonstrate that they are capable of promoting health otherwise they will not be for the public benefit.
“The Commission is the registrar and regulator of charities however it is not the authority in the efficacy of any and every non-traditional medical treatment. These are issues of substantial debate with a variety of opinions. Each case is considered on its merits based on the evidence available. To be charitable there needs to be sufficient evidence of the efficacy of the method to be used. The Commission must further be assured that any potential harm that might be said to arise does not outweigh the benefit identified by the method.
“The Commission expects charities to provide information that is factually accurate with legitimate evidence.”
But is the information provided by all charities factually accurate?
Take, for instance, YES TO LIFE! Have a good look and then decide for yourself.
On their website they state: “We provide support, information and financial assistance to those with cancer seeking to pursue approaches that are currently unavailable on the NHS. We also run a series of educational seminars and workshops which are aimed at the general public who want to know more and practitioners working with people who have cancer.”
The website informs us about many alternative therapies and directly or indirectly promote them for the curative or supportive treatment of cancer. I have chosen 5 of them and copied the respective summaries as published by YES TO LIFE. My main selection criterion was having done some research myself on the modality in question. Here are the 5 cancer treatments which I selected; the text from YES TO LIFE is in bold, and that of my published research is in normal print with a link to the published paper:
Carctol is a relatively inexpensive product, specifically formulated to assist cells with damaged respiration, it is also a powerful antioxidant that targets free radicals, the cause of much cellular damage. It also acts to detoxify the system.
Often given intravenously as part of a programme of Metabolic Therapy, Laetrile is a non-toxic extract of apricot kernels. The claimed mechanism of action that is broken down by enzymes found in cancer cells. Hydrogen cyanide, one of the products of this reaction then has a local toxic effect on the cells.
The claims that laetrile or amygdalin have beneficial effects for cancer patients are not currently supported by sound clinical data. There is a considerable risk of serious adverse effects from cyanide poisoning after laetrile or amygdalin, especially after oral ingestion. The risk-benefit balance of laetrile or amygdalin as a treatment for cancer is therefore unambiguously negative.
Mistletoe therapy was developed as an adjunct to cancer treatment in Switzerland in 1917-20, in the collaboration between Dr I Wegman MD and Dr Rudolf Steiner PhD (1861-1925). Mistletoe extracts are typically administered by subcutaneous injection, often over many years. Mistletoe treatment improves quality of life, supports patients during recommended conventional cancer treatments and some studies show survival benefit. It is safe and has no adverse interactions with conventional cancer treatments.
None of the methodologically stronger trials exhibited efficacy in terms of quality of life, survival or other outcome measures. Rigorous trials of mistletoe extracts fail to demonstrate efficacy of this therapy.
A type of low toxicity chemotherapy derived from a combination of two known cytotoxic drugs that are of little use individually, as the doses required for effective anticancer action are too high to be tolerated. However the combination is effective at far lower doses, with few side effects.
The data from randomised clinical trials suggest Ukrain to have potential as an anticancer drug. However, numerous caveats prevent a positive conclusion, and independent rigorous studies are urgently needed. [To judge the validity of this last treatment, I also recommend reading a previous post of mine.]
Finally, it might be informative to see who the individuals behind YES TO LIFE are. I invite you to have a look at their list of medical advisors which, I think, speaks for itself. It includes, for instance, Dr Michael Dixon of whom we have heard before on this blog, for instance, here, here and here.
Say no more!
The subject of placebo is a complex but fascinating one, particularly for those interested in alternative medicine. Most sceptics believe that alternative therapies rely heavily, if not entirely, on the placebo effect. Some alternative practitioners, when unable to produce convincing evidence that their treatment is effective, seem to have now settled to admitting that their therapy works (mostly or entirely) via a placebo effect. They the hasten to add that this is perfectly fine, because it is just an explanation as to how it works – a mechanism of action, in other words. Causing benefit via a placebo effect still means, they insist, that their therapy is effective.
In a previous post, I have tried to demonstrate that this belief is erroneous and where the notion comes from. It originates, I believe, from a mistaken definition of ‘effectiveness’: for many alternative practitioners ‘effectiveness’ encompasses the specific plus the non-specific (e. g. placebo) effects of their therapy. In real medicine, ‘effectiveness’ is the degree to which a treatment works under real life conditions.
The ‘alternative’ definition is, of course, incorrect but alternative practitioners stubbornly refuse to acknowledge this fact. Here are just two reasons why it cannot be right:
- If it were correct, it would be hardly conceivable to think of a treatment that is NOT effective. Applied with empathy and compassion, virtually all treatments – however devoid of specific effects – will produce a placebo effect. Thus they will all be effective, and the term would be superfluous because ‘treatment’ would automatically mean ‘effective’. An ineffective treatment would, in other words, be a contradiction in terms.
- If it were correct, any pharmaceutical or devices company could legally market ineffective drugs or gadgets and rightly claim (or even prove) that they are effective. Any such therapy could very easily be shown to generate a placebo-effect under the right circumstances; and as long as this is the case, it would be certifiably effective.
I do sympathise with alt med enthusiasts who find this hard or even impossible to accept. They see almost every day how their placebo-therapy benefits their patients. (It seems worth remembering that not just the placebo phenomenon but several other factors are involved in such outcomes – take, for instance, the natural history of the disease and the regression towards the mean.) And they might think that my arguments are nothing but a devious attempt do away with the beneficial power of the placebo.
The truth, however, is that nobody wants to do anything of the sort; we all want to help patients as much as possible, and that does, of course, include the use of the placebo effect. In clinical practice, we usually want to maximise the placebo effect where possible. But for this goal, we do not require placebo therapies. If we administer a specifically effective therapy with compassion, we undoubtedly also generate a placebo response. In addition, our patients would benefit from the specific effects of the prescribed therapy. Both elements are essential for an optimal therapeutic response, and I don’t know any conventional healthcare professionals who do not aim at this optimal outcome.
Giving just placebos will not normally generate an optimal outcome, and therefore it cannot truly be in the interest of the patient. It is also ethically problematic because it usually entails a degree of deception of the patient. Moreover, placebo effects are unreliable and usually of short duration. Foremost, they do not normally cure a disease; they may alleviate symptoms but they almost never tackle their causes. These characteristics hardly make placebos an acceptable choice for routine clinical practice.
The bottom line is clear and simple: a drug that is not better than placebo can only be classified as being ineffective. The same applies to all non-drug therapies. Double standards are not acceptable in healthcare. And the demonstration of a placebo effect does not turn an ineffective therapy into an effective one.
I know that many alternative practitioners do not agree with this line of thought – so, let’s hear their counter-arguments.