MD, PhD, FMedSci, FSB, FRCP, FRCPEd

medical ethics

George Lewith has died on 17 March, aged 67. He was one of the most productive researchers of alternative medicine in the UK; specifically he was interested in acupuncture. If you search this blog, you find several posts that mention him or are entirely dedicated to his work. Undeniably, my own views and research were often very much at odds with those of Lewith.

Wikipedia informs us that Lewith graduated from Trinity College, Cambridge in medicine and biochemistry.  He then went on to Westminster Medical School to complete his clinical studies and began working clinically in 1974. In 1977 Lewith became a member of the Royal College of Physicians. Then, in 1980, he became a member of the Royal College of General Practitioners and, later in 1999, was elected a fellow of the Royal College of Physicians.

He was a Professor of Health Research in the Department of Primary Care at the University of Southampton and a director of the International Society for Complementary Medicine Research. Lewith has obtained a significant number of institutional peer reviewed fellowships at doctoral and post-doctoral level and has been principal investigator or collaborator in research grants totally over £5 million during the last decade.

Between 1980 and 2010, Lewith was a partner at the Centre for Complementary and Integrated Medicine, a private practice providing complementary treatments with clinics in London and Southampton.

A tribute by the British Acupuncture Council is poignant, in my view: “George was a friend not only to all of the acupuncture profession, be it traditional, medical or physiotherapist – he was a member of all three professional bodies – but to the whole of complementary medicine. As well as being a research leader he was also politically savvy, working tirelessly up front and behind the scenes to try to bring acupuncture and CAM further into the mainstream. Nobody did more.”

I find it poignant because it hints at the many differences I (and many others) had with Lewith during the last 25 years that I knew him. George was foremost a proponent of acupuncture. His 1985 book – the first of many – advocated treating many internal diseases with acupuncture!

George did not strike me as someone who had the ability or even the ambition to use science for finding the truth and for falsifying hypotheses; in my view, he employed it to confirm his almost evangelic belief. In the pursuit of this all-important aim he did indeed spend a lot of time and energy pulling strings, including on the political level. George was undoubtedly successful but the question has to be asked to what extent this was due to his tireless work ‘behind the scenes’.

In my view, George was a typical example of someone who first and foremost was an advocate and a researcher second. During my time in Exeter, I have met numerous co-workers who had the same problem. Almost without exception, I found that it is impossible to turn such a person into a decent scientist. The advocacy of alternative medicine always got in the way of objectivity and rationality, qualities that are, of course, essential for good science.

George’s very first publication on acupuncture was a ‘letter to the editor’ published in the BMJ. In it, he announced that he is planning to conduct a trial of acupuncture and stated that “acupuncture will be compared to an equally magical placebo”. Yes, George always had the ability to make me laugh; and this is why I will miss him.

The love-affair of many nurses with complementary medicine is well-known. We have discussed it many times on this blog – see for instance here, here and here. Yet the reasons for it remain somewhat mysterious, I find. Therefore I was interested to see a new paper on the subject.

The aim of this ‘meta-synthesis‘ was to review, critically, appraise and synthesize the existing qualitative research to develop a new, more substantial interpretation of nurses’ attitudes regarding the, use of complementary therapies by patients. Fifteen articles were included in the review.

Five themes emerged from the data relating to nurses’ attitude towards complementary therapies:

  1. the strengths and weaknesses of conventional medicine;
  2. complementary therapies as a way to enhance nursing practice;
  3. patient empowerment and patient-centeredness;
  4. cultural barriers and enablers to integration;
  5. structural barriers and enablers to integration.

Nurses’ support for complementary therapies, the authors of this article claim, is not an attempt to challenge mainstream medicine but rather an endeavour to improve the quality of care available to patients. There are, however, a number of barriers to nurses’ support including institutional culture and clinical context, as well as time and knowledge limitations.

The authors concluded that some nurses promote complementary therapies as an opportunity to personalise care and practice in a humanistic way. Yet, nurses have very limited education in this field and a lack of professional frameworks to assist them. The nursing profession needs to consider how to address current deficiencies in meeting the growing use of complementary therapies by patients.

In my view, there are two most remarkable misunderstandings here:

  1. While it is undoubtedly laudable that nurses “endeavour to improve the quality of care available to patients”, it has to be said that such an endeavour does not require complementary medicine. Are they implying that with conventional medicine the quality of care cannot be improved?
  2. I fail to understand why the lack of good evidential support for most complementary therapies did not emerge as a prominent theme. Are nurses not concerned about the (lack of) evidence that underpins their actions?

THE HINKLEY TIMES is quickly becoming my favourite newspaper. Yesterday they published an article about my old friend Tredinnick. I cannot resist showing you a few excerpts from it:

START OF EXCERPTS

Alternative therapy advocate, David Tredinnick has called for greater self reliance as a way of reducing pressures on the NHS. Speaking on the BBC’s regional Sunday Politics Show he suggested people should take more responsibility for their own health, rather than relying on struggling services. He highlighted homeopathy as a way of treating ailments at home and said self-help could cut unnecessary trips to the GP. He also said people could avoid illness by not being overweight and taking exercise…During debate on the show about the current ‘crisis’ in health and social care he said: “There are systems such as homeopathic remedies. Try it yourself before going to the doctor.”

Mr Tredinnick has always stood by his personal preferences for traditional therapies despite others disparaging his views. His recent remarks have sparked a response from Lib Dem Parliamentary spokesman Michael Mullaney. He said in the wake of the NHS facing cuts and closures, Mr Tredinnick was yet again showing he was out of touch. He added: “It’s dangerous for Mr Tredinnick, who is not properly medically trained, to use his platform as an MP to tell ill people to treat themselves with homeopathy, a treatment for which there is no medical proof that it works. He should stop talking about his quack theories and do his job representing the people of Hinckley and Bosworth, or otherwise he should resign as MP for he is totally failing to do his job of representing local people.”

END OF EXCERPTS

Yes, there is no doubt in my mind: if the public would ever take Tredinnick seriously when he talks about quackery, our health would be in danger. Therefore, it must be seen as most fortunate that hardly anyone does take him seriously. And here are a few reasons why this is so:

David Tredinnick: not again! Alternative medicine saves lives?!?

Tory MP David Tredinnick: “perhaps the worst example of scientific illiteracy in government.” But is he also a liar?

David Tredinnick: perhaps the worst example of scientific illiteracy in government?

Personally, I would very much regret if he resigned – there would be so much less to laugh about in the realm of alternative medicine!

Aromatherapy is popular and pleasant – but does it have real health effects? The last time I tried to find an answer to this question was in 2012. At that time, our systematic review concluded that “the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.” But 5 years can be a long time in research, and more up-to-date information would perhaps be helpful.

This systematic review of 2017 aimed to provide an analysis of the clinical evidence on the efficacy of aromatherapy specifically for depressive symptoms on any type of patients. The authors searched 5 databases for relevant studies Outcome measures included scales measuring depressive symptoms levels. Twelve randomized controlled trials (RCTs) were included. Aromatherapy was administered by inhalation (5 studies) or massage (7 studies). Seven RCTs showed improvement in depressive symptoms. The quality of half of the studies was low, and the administration protocols varied considerably among the studies. Different assessment tools were employed in the studies. In 6 of the RCTs, aromatherapy was compared to no intervention.

Despite these caveats, the authors concluded that aromatherapy showed potential to be used as an effective therapeutic option for the relief of depressive symptoms in a wide variety of subjects. Particularly, aromatherapy massage showed to have more beneficial effects than inhalation aromatherapy.

Apart from the poor English, this paper is irritating because of the almost total lack of critical input. Given that half of the trials were of poor quality (only one was given the full points on the quality scale) and many totally failed to control for placebo-effects, I think that calling aromatherapy an effective therapeutic option for the relief of depressive symptoms is simply not warranted. In fact, it is highly misleading and, given the fact that depression is a life-threatening condition, it seems unethical and dangerous.

Considering these facts, my conclusion remains that “the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition, including depression.”

On 13 March, the UK Charity Commission published the following announcement:

This consultation is about the Commission’s approach to deciding whether an organisation which uses or promotes CAM therapies is a charity. For an organisation to be charitable, its purposes must be exclusively charitable. Some purposes relate to health and to relieve the needs of the elderly and disabled.

We are seeking views on:

  • the level and nature of evidence to support CAM
  • conflicting and inconsistent evidence
  • alternative therapies and the risk of harm
  • palliative alternative therapy

Last year, lawyers wrote to the Charity Commission on behalf of the Good Thinking Society suggesting that, if the commission refused to revoke the charitable status of organisations that promote homeopathy, it could be subject to a judicial review. The commission responded by announcing their review which will be completed by 1 July 2017.

Charities must meet a “public benefit test”. This means that they must be able to provide evidence that the work they do benefits the public as a whole. Therefore the consultation will have to determine what nature of evidence is required to demonstrate that a CAM-promoting charity provides this benefit.

In a press release, the Charity Commission stated that it will consider what to do in the face of “conflicting or inconsistent” evidence of a treatment’s effectiveness, and whether it should approach “complementary” treatments, intended to work alongside conventional medicine, differently from “alternative” treatments intended to replace it. In my view, however, this distinction is problematic and often impossible. Depending on the clinical situation, almost any given alternative therapy can be used both as a complementary and as an alternative treatment. Some advocates seem to cleverly promote their therapy as complementary (because this is seen as more acceptable), but clearly employ it as an alternative. The dividing line is often far too blurred for this distinction to be practical, and I have therefore long given up making it.

John Maton, the commission’s head of charitable status, said “Our consultation is not about whether complementary and alternative therapies and medicines are ‘good’ or ‘bad’, but about what level of evidence we should require when making assessments about an organisation’s charitable status.” Personally, I am not sure what this means. It sounds suspiciously soft and opens all sorts of escape routes for even the most outright quackery, I fear.

Michael Marshall of the Good Thinking Society said “We are pleased to see the Charity Commission making progress on their review. Too often we have seen little effective action to protect the public from charities whose very purpose is the promotion of potentially dangerous quackery. However, the real progress will come when the commission considers the clear evidence that complementary and alternative medicine organisations currently afforded charitable status often offer therapies that are completely ineffective or even potentially harm the public. We hope that this review leads to a policy to remove such misleading charities from the register.”

On this blog, I have occasionally reported about charities promoting quackery (for instance here, here and here) and pointed out that such activities cannot ever benefit the public. On the contrary, they are a danger to public health and bring many good charities into disrepute. I would therefore encourage everyone to use this unique occasion to write to the Charity Commission and make their views felt.

 

The notorious tendency of pharmacist to behave like shop-keepers when it comes to the sale of bogus remedies has been the subject of this blog many times before. In my view, this is an important subject, and I will therefore continue to report about it.

On the website of the AUSTRALIAN JOURNAL OF PHARMACY (AJP), we find interesting new data on Australian pharmacists’ love affair with bogus alternative medicine. The AJP recently ran a poll asking readers: “Do you stock Complementary Medicines (CMs) in your pharmacy?” The results of this little survey so far show that 54% of all participating pharmacists say they stock CMs, including homeopathic products. About a quarter (28%) of respondents stock CMs but not homeopathic products. And 9% said they “only stock evidence-based CMs”. Three percent completely refuse to stock CMs, while 2% stock them but with clear in-store labels saying that they may not work. One person stated they stock CMs but have recently decided to no longer do so.

The President of the Pharmaceutical Society of Australia (PSA) Joe Demarte commented on these findings: “The latest survey results, showing over 40% of pharmacists are adhering to PSA’s Code of Ethics on complementary medicines, are very encouraging… However it’s disappointing that some pharmacists are still stocking homeopathy products, which are not supported by PSA’s Code of Ethics or our Position Statement on Complementary Medicines… Irrespective of the products stocked in a pharmacy, the important thing is when discussing the use of complementary medicines with consumers, pharmacists must ensure that consumers are provided with the best available information about the current evidence for efficacy, as well as information on any potential side effects, drug interactions and risks of harm… It’s important for pharmacists to provide a fair, honest and balanced view of the current evidence available on all complementary medicines,” Demarte added.

NSW pharmacist Ian Carr, who is a member of the Friends of Science in Medicine group, commented that many pharmacists may not have much choice when it comes to stocking complementary and alternative medicines. “CMs policy is not being filtered through the professional assessment of the pharmacist… It’s basically a business deal with the franchise, and as a pharmacist taking on a franchise you’ve basically got to sign those rights away about what you get to sell. Some of the chains offer basically everything that is available, no questions asked. As an independent pharmacist I am able to make my own decisions about what to stock… We’ve got a ‘de-facto’ corporatisation happening with marketing groups and franchises, and I’m concerned the government will look at this trend and ask, why are we not deregulating the industry to reflect the apparent reality of pharmacy today? We’re only playing into the hands of people who want deregulation… We should be telling people in no uncertain terms that if something is on the shelf it doesn’t mean it’s been assessed or approved by the TGA… There is no doubt that there has been a long-term relationship between the supplement industry and pharmacy. But it was also a few decades ago that researchers started applying the concept of evidence-based medicine to healthcare generally. That should have been the point where we said, ‘we’re not just going to be a conduit for your products without questioning their basis in evidence’. That’s where we lost the plot. The question now is: where do we draw that line? I’m really trying to say to my fellow pharmacists: Please let us reassess the unquestioning support of the CM industry, or we’ll all be tarred with the same brush. I and many others are concerned about – and fighting for – the reputation of the pharmacy profession.”

A BMC Complementary and Alternative Medicine survey by researchers from Alfred Hospital in Melbourne found that 92% thought pharmacists should provide safety information about CMs, while 93% thought it important for pharmacists to be knowledgeable about CMs. This shows a huge divide between what is happening in Australian pharmacy on the one side and ethical demands or public opinion on the other side. What is more, there is little reason to believe that the situation in other countries is fundamentally different.

And did you notice this little gem in the comments above?  “…over 40% of pharmacists are adhering to PSA’s Code of Ethics…” – the PSA president finds this ‘VERY ENCOURAGING’.

When I saw this, I almost fell off my chair!

Does the president know that this means that 60% of his members are violating their own code of ethics?

Is that truly VERY ENCOURAGING, I ask myself.

My answer is no, this is VERY WORRYING.

 

The anti-vaccination attitudes of alternative practitioners such as chiropractors, homeopaths and naturopaths are well documented and have been commented upon repeatedly here. But most of these clinicians are non-doctors; they have not been anywhere near a medical school, and one might therefore almost excuse them for their ignorance and uneducated stance towards immunisations. As many real physicians have recently taken to practicing alternative therapies under the banner of ‘integrated medicine’, one may well ask: what do these doctors think about vaccinations?

This study tried to answer the question by evaluating the attitudes and practices regarding vaccination of members of the American Board of Integrative and Holistic Medicine (ABIHM). Prospective participants were 1419 diplomats of the ABIHM. The survey assessed members’ (1) use of and confidence in the vaccination recommendations of the Centers for Disease Control and Prevention (CDC) and of medical-specialty associations, (2) confidence in the manufacturing safety of vaccines and in manufacturer’s surveillance of adverse events, and (3) attitudes toward vaccination mandates. The questionnaire included 33 items, with 5 open-ended questions that provided a space for comments.

The survey was completed by 290 of 1419 diplomats (20%). Its findings showed a diversity of opinions in many vaccination issues. Integrative medicine physicians were less likely to administer vaccinations than physicians in traditional allopathic medicine. Among the 44% who provide vaccinations, 35% used alternative schedules regularly. Integrative medicine physicians showed a greater support of vaccination choice, were less concerned about maintaining herd immunity, and were less supportive of school, day care, and employment mandates. Toxic chemical and viral contaminants were of greater concern to a higher percentage of integrative medicine physicians. Integrative medicine physicians were also more likely to accept a connection between vaccinations and both autism and other chronic diseases. Overall, there was dissatisfaction with the Vaccine Adverse Event Reporting System as well as the vaccination recommendations of the CDC and their primary specialty.

The authors concluded that significant variations in the vaccination attitudes and practices of integrative medicine physicians. This survey provides benchmark data for future surveys of this growing specialty and other practitioners. It is important for public health leaders and the vaccination industry to be aware that integrative medicine physicians have vaccination attitudes and practices that differ from the guidelines of the CDC and the Advisory Council on Immunization Practices.

Now we know!

Physicians practicing integrative medicine (the 80% who did not respond to the survey were most likely even worse) not only use and promote much quackery, they also tend to endanger public health by their bizarre, irrational and irresponsible attitudes towards vaccination.

From bad to worse!

Yes, I am afraid it is Dana Ullman again!

On the last post, he commented: “If you actually think that homeopathic medicines will KILL people, then, we all must assume that you think that conventional medicines create MASS MURDERS.”

In my view, this is a sad comment indeed. It reveals that a homeopath who has, after all, been in the business for decades has really very little idea about what makes an intervention a potentially good or a bad treatment.

Is it its efficacy?

No!

Is it its safety?

No!

IT IS THE RATIO OF THE TWO!!!

For the Ullmans of this world, I provide two very simple examples:

  1. One could prevent a common cold effectively with interferon. Why don’t we do this routinely? Because the benefit would not out-weigh its harm.
  2. We all know that chemotherapy can have terrible adverse effects. Why do we nevertheless use it for cancer? Because the benefits of saving a life out-weigh all the significant harm chemotherapy might do.

The conclusion is simple: to be useful, a therapy must demonstrably generate more good than harm. If there is no effectiveness, the risk/benefit balance can never be positive, even if the risks are relatively small. But risk/benefit balance can still be favourable, even if the therapy causes considerable harm.

This hardly is rocket science, is it? But the Ullmans of this world do refuse to get it, and that is sad, in my view. This ignorance is the basis for the fundamentally misguided advice they issue to their patients day in, day out.

What is more, the Ullmans of this world stubbornly deny that anyone can do significant harm with homeopathic remedies; they evidently think that homeopathy cannot kill patients. Yet they are evidently wrong.

Whenever the simple rules of risk/benefit are ignored, even apparently harmless treatments, like highly diluted homeopathic remedies, can – and sadly will – kill patients.

I suspect that the Ullmans of this world are still in closed-minded denial about this point. Let me therefore quote a few of my own posts where cases of ‘death by homeopathy’ have been mentioned:

I fear that the Ullmans of this world will still not be convinced. Perhaps a look at this website might do the trick? No, probably not – changing one’s mind vis a vis facts requires intelligence. They will carry on claiming that, in comparison, “conventional medicines creates MASS MURDERS”.

And this is where we go full circle and I start again explaining about the balance of risk and benefit…

GIVE ME STRENGTH!!!

We have discussed the risks of (chiropractic) spinal manipulation more often than I care to remember. The reason for this is simple: it is an important subject; making sure that as many consumers know about it will save lives, I am sure. Therefore, any new paper on the subject is likely to be reported on this blog.

Objective of this review was to identify characteristics of 1) patients, 2) practitioners, 3) treatment process and 4) adverse events (AE) occurring after cervical spinal manipulation (CSM) or cervical mobilization. Systematic searches were performed in 6 electronic databases. Of the initial 1043 studies, 144 studies were included.

They reported 227 cases. 117 cases described male patients with a mean age of 45 (SD 12) and a mean age of 39 (SD 11) for females. Most patients were treated by chiropractors (66%) followed by non-clinicians (5%), osteopaths (5%), physiotherapists (3%) and other medical professions. Manipulation was reported in 95% of the cases (mobilisations only in 1.7%), and neck pain was the most frequent indication.

Cervical arterial dissection (CAD) was reported in 57% of the cases and 46% had immediate onset symptoms; in 2% onset of symptoms took for more than two weeks. Other complications were disc rupture, spinal cord swelling and thrombus. The most frequently reported symptoms included disturbance of voluntary control of movement, pain, paresis and visual disturbances.

In most of the reports, patient characteristics were described poorly. No clear patient profile, related to the risk of AE after CSM, could be extracted. However, women seem more at risk for CAD.

The authors concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AE using standardized terminology.

I do not want to repeat what I have stated in previous posts on this subject. So,let me just ask this simple question: IF THERE WERE A DRUG MARKTED FOR NECK PAIN BUT NOT SUPPORTED BY GOOD EVIDENCE FOR EFFICACY, DO YOU THINK IT WOULD BE ON THE MARKET AFTER 227 CASES OF SEVERE ADVERSE EFFECTS HAD BEEN DESCRIBED?

I think the answer is NO!

If we then consider the huge degree of under-reporting in this area which might bring the true figure up by one or even two dimensions, we must ask: WHY IS CERVICAL MANIPULATION STILL USED?

A recent article in the Guardian revealed that about one third of Australian pharmacists are recommending alternative medicines with little-to-no evidence for their efficacy, including useless homeopathic products and potentially harmful herbal products.

For this survey of 240 Australian pharmacies, mystery shoppers were sent in to speak to a pharmacist at the prescription dispensing counter and ask for advice about feeling stressed. The results show that three per cent of the pharmacists recommended homeopathic products, despite a comprehensive review of all existing studies on homeopathy finding that there is no evidence they work in treating any condition and that ‘people who choose homeopathy may put their health at risk if they reject or delay treatments’. Twenty-six percent of all pharmacists recommended Bach flower remedies to relieve stress. A comprehensive review of all existing studies on Bach flower remedies found no difference between the remedies and placebos. Fifty-nine per cent of people were just told the complementary and alternative product recommended to them worked, and 24% were told the product was scientifically proven, without any evidence being provided to them.

Asked about these findings, Dr Ken Harvey, a prominent Australian expert, said they demonstrated that some pharmacists were failing in their professional duty to consumers. “Pharmacists are giving crazy advice, and it is dangerous in some cases,” he said. “My view is that pharmacists, if they are going to sell these products, need to have a big shining sign over the shelves of the complementary and alternative medicine section that says ‘these products have not been assessed by the government regulators to see if they work, please talk to pharmacist’.Pharamacists are giving poor advice and they clearly have a conflict of interest,” Harvey said.

If you had hoped that in other countries pharmacists behave more responsibly, I must disappoint you. The information available shows that, when it comes to alternative medicine, pharmacists across the globe act much more like shop-keepers than like health care professionals. They are in the habit of putting profit before their duty to abide by the rules of evidence-based practice. And, in doing do, they violate their own ethical codes so regularly that I ask myself why they bothered to even implement one.

On this blog I have written so often about this issue that one could come to the conclusion that I have a bee under my bonnet:

The truth, however, is not that I am the victim of a bee.

The truth is that this is a very important public health issue.

The truth is that pharmacists show little signs of even trying to get to grips with it.

The truth is that pharmacists who sell bogus medicines put profit before professional ethics.

The truth is that such behaviour is not that of health care professionals but that of shop-keepers.

The truth is that I intend to carry on reminding these pharmacists that they are behaving like charlatans.

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