MD, PhD, FMedSci, FSB, FRCP, FRCPEd

ethics

When someone has completed a scientific project, it is customary to publish it ['unpublished science is no science', someone once told me many years ago]. To do so, he needs to write it up and submit it to a scientific journal. The editor of this journal will then submit it to a process called ‘peer review’.

What does ‘peer review’ entail? Well, it means that 2-3 experts are asked to critically assess the paper in question, make suggestions as to how it can be improved and submit a recommendation as to whether or not the article deserves to be published.

Peer review has many pitfalls but, so far, nobody has come up with a solution that is convincingly better. Many scientists are under pressure to publish ['publish or perish'], and therefore some people resort to cheating. A most spectacular case of fraudulent peer review has been reported recently in this press release:

SAGE statement on Journal of Vibration and Control

London, UK (08 July 2014) – SAGE announces the retraction of 60 articles implicated in a peer review and citation ring at the Journal of Vibration and Control (JVC). The full extent of the peer review ring has been uncovered following a 14 month SAGE-led investigation, and centres on the strongly suspected misconduct of Peter Chen, formerly of National Pingtung University of Education, Taiwan (NPUE) and possibly other authors at this institution.

In 2013 the then Editor-in-Chief of JVC, Professor Ali H. Nayfeh,and SAGE became aware of a potential peer review ring involving assumed and fabricated identities used to manipulate the online submission system SAGE Track powered by ScholarOne Manuscripts™. Immediate action was taken to prevent JVC from being exploited further, and a complex investigation throughout 2013 and 2014 was undertaken with the full cooperation of Professor Nayfeh and subsequently NPUE.

In total 60 articles have been retracted from JVC after evidence led to at least one author or reviewer being implicated in the peer review ring. Now that the investigation is complete, and the authors have been notified of the findings, we are in a position to make this statement.

While investigating the JVC papers submitted and reviewed by Peter Chen, it was discovered that the author had created various aliases on SAGE Track, providing different email addresses to set up more than one account. Consequently, SAGE scrutinised further the co-authors of and reviewers selected for Peter Chen’s papers, these names appeared to form part of a peer review ring. The investigation also revealed that on at least one occasion, the author Peter Chen reviewed his own paper under one of the aliases he had created.

Unbelievable? Perhaps, but sadly it is true; some scientists seem to be criminally ingenious when it comes to getting their dodgy articles into peer-reviewed journals.

And what does this have to do with ALTERNATIVE MEDICINE, you may well ask. The Journal of Vibration and Control is not even medical and certainly would never consider publishing articles on alternative medicine. Such papers go to one of the many [I estimate more that 1000] journals that cover either alternative medicine in general or any of the modalities that fall under this wide umbrella. Most of these journals, of course, pride themselves with being peer-reviewed – and, at least nominally, that is correct.

I have been on the editorial board of most of the more important journals in alternative medicine, and I cannot help thinking that their peer review process is not all that dissimilar from the fraudulent scheme set up by Peter Chen and disclosed above. What happens in alternative medicine is roughly as follows:

  • a researcher submits a paper for publication,
  • the editor sends it out for peer review,
  • the peer reviewers are either those suggested by the original author or members of the editorial board of the journal,
  • in either case, the reviewers are more than likely to be uncritical and recommend publication,
  • in the end, peer review turns out to be a farcical window dressing exercise with no consequence,
  • thus even very poor research and pseudo-research are being published abundantly.

The editorial boards of journals of alternative medicine tend to be devoid of experts who are critical about the subject at hand. If you think that I am exaggerating, have a look at the editorial board members of ‘HOMEOPATHY’ (or any other journal of alternative medicine) and tell me who might qualify as a critic of homeopathy. When the editor, Peter Fisher, recently fired me from his board because he felt I had tarnished the image of homeopathy, this panel lost the only person who understood the subject matter and, at the same time, was critical about it (the fact that the website still lists me as an editorial board member is merely a reflection of how slow things are in the world of homeopathy: Fisher fired me more than a year ago).

The point I am trying to make is simple: peer review is never a perfect method but when it is set up to be deliberately uncritical, it cannot possibly fulfil its function to prevent the publication of dodgy research. In this case, the quality of the science will be inadequate and generate false-positive messages that mislead the public.

My 2008 evaluation of chiropractic concluded that the concepts of chiropractic are not based on solid science and its therapeutic value has not been demonstrated beyond reasonable doubt. It also pointed out that the advice of chiropractors often is dangerous and not in the best interest of the patient: many chiropractors have a very disturbed attitude towards immunisation: anti-vaccination attitudes till abound within the chiropractic profession. Despite a growing body of evidence about the safety and efficacy of vaccination, many chiropractors do not believe in vaccination, will not recommend it to their patients, and place emphasis on risk rather than benefit.

In case you wonder where this odd behaviour comes from, you best look into the history of chiropractic. D. D. Palmer, the magnetic healer who ‘invented’ chiropractic about 120 years ago, left no doubt about his profound disgust for immunisation: “It is the very height of absurdity to strive to ‘protect’ any person from smallpox and other malady by inoculating them with a filthy animal poison… No one will ever pollute the blood of any member of my family unless he cares to walk over my dead body… ” (D. D. Palmer, 1910)

D. D. Palmer’s son, B. J. Palmer (after literally walking [actually it was driving] over his father’s body)  provided a much more detailed explanation for chiropractors’ rejection of immunisation: “Chiropractors have found in every disease that is supposed to be contagious, a cause in the spine. In the spinal column we will find a subluxation that corresponds to every type of disease… If we had one hundred cases of small-pox, I can prove to you, in one, you will find a subluxation and you will find the same condition in the other ninety-nine. I adjust one and return his function to normal… There is no contagious disease… There is no infection…The idea of poisoning healthy people with vaccine virus… is irrational. People make a great ado if exposed to a contagious disease, but they submit to being inoculated with rotten pus, which if it takes, is warranted to give them a disease” (B. J. Palmer, 1909)

Such sentiments and opinions are still prevalent in the chiropractic profession – but today they are expressed in a far less abrupt, more politically correct language: The International Chiropractors Association recognizes that the use of vaccines is not without risk. The ICA supports each individual’s right to select his or her own health care and to be made aware of the possible adverse effects of vaccines upon a human body. In accordance with such principles and based upon the individual’s right to freedom of choice, the ICA is opposed to compulsory programs which infringe upon such rights. The International Chiropractors Association is supportive of a conscience clause or waiver in compulsory vaccination laws, providing an elective course of action for all regarding immunization, thereby allowing patients freedom of choice in matters affecting their bodies and health.

Not all chiropractors share such opinions. The chiropractic profession is currently divided over the issue of immunisation. Some chiropractors now realise that immunisations have been one of the most successful interventions ever for public health. Many others, however, do still vehemently adhere to the gospel of the Palmers.  Statements like the following abound:

Vaccines. What are we taught? That vaccines came on the scene just in time to save civilization from the ravages of infectious diseases. That vaccines are scientifically formulated to confer immunity to certain diseases; that they are safe and effective. That if we stop vaccinating, epidemics will return…And then one day you’ll be shocked to discover that … your “medical” point of view is unscientific, according to many of the world’s top researchers and scientists. That many state and national legislatures all over the world are now passing laws to exclude compulsory vaccines….

Our original blood was good enough. What a thing to say about one of the most sublime substances in the universe. Our original professional philosophy was also good enough. What a thing to say about the most evolved healing concept since we crawled out of the ocean. Perhaps we can arrive at a position of profound gratitude if we could finally appreciate the identity, the oneness, the nobility of an uncontaminated unrestricted nervous system and an inviolate bloodstream. In such a place, is not the chiropractic position on vaccines self-evident, crystal clear, and as plain as the sun in the sky?

Yes, I do agree: the position of far too many chiropractors is ‘crystal clear’ – unfortunately it is also dangerously wrong.

A remarkable article about homeopathy and immunisation entitled THE IMMUNISATION DILEMMA came to my attention recently. Its abstract promised: “evidence quantifying the effectiveness of vaccination and HP (homeoprophylaxis) will be examined. New international research describing and analysing HP interventions will be reported. An evidence-based conclusion will be reached.”

Sounds interesting? Let’s see what the article really offers. Here is the relevant text:

…evidence does exist to support claims regarding the effectiveness of homeopathic immunisation is undeniable.

I was first invited to visit Cuba in December 2008 to present at an international conference hosted by the Finlay Institute, which is a W. H. O.-accredited vaccine manufacturer. The Cubans described their use of HP to control an outbreak of leptospirosis (Weilʼs syndrome – a potentially fatal, water-born bacterial disease) in 2007 among the residents of the three eastern provinces which were most severely damaged by a severe hurricane – over 2.2 million people [7]. 2008 was an even worse year involving three hurricanes, and the countryʼs food production was only just recovering at the time of the conference. The HP program had been repeated in 2008, but data was not available at the conference regarding that intervention.

I revisited Cuba in 2010 and 2012, each time to work with the leader of the HP interventions, Dr. Bracho, to analyse the data available. Dr. Bracho is not a homeopath; he is a published and internationally recognised expert in the manufacture of vaccine adjuvants. He worked in Australia at Flinders University during 2004 with a team trying to develop an antimalarial vaccine.

In 2012 we accessed the raw leptospirosis surveillance data, comprising weekly reports from 15 provinces over 9 years (2000 to 2008) reporting 21 variables. This yielded a matrix with 147 420 possible entries. This included data concerning possible confounders, such as vaccination and chemoprophylaxis, which allowed a careful examination of possible distorting effects. With the permission of the Cubans, I brought this data back to Australia and it is being examined by mathematicians at an Australian university to see what other information can be extracted. Clearly, there is objective data supporting claims regarding the effectiveness of HP.

The 2008 result was remarkable, and could only be explained by the effectiveness of the HP intervention. Whilst the three hurricanes caused immense damage throughout the country it was again worse in the east, yet the three homeopathically immunised provinces experienced a negligible increase in cases whilst the rest of the country showed significant increases until the dry season in January 2009 [8].

This is but one example – there are many more. It is cited to show that there is significant data available, and that orthodox scientists and doctors have driven the HP interventions, in the Cuban case. Many people internationally now know this, so once again claims by orthodox authorities that there is no evidence merely serves to show that either the authorities are making uninformed/unscientific statements, or that they are aware but are intentionally withholding information. Either way, confidence is destroyed and leads to groups of people questioning what they are told…

Final Conclusions

The attacks against homeopathy in general and HP in particular will almost certainly continue. If we can achieve a significant level of agreement then we would be able to answer challenges to HP with a single, cohesive, evidence-based, and generally united response. This would be a significant improvement to the existing situation.

 

Reference 7 is the following article: Bracho G, Varela E, Fernández R et al. Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control. Homeopathy 2010; 99: 156-166. The crucial bit if this paper are as follows:

A homeoprophylactic formulation was prepared from dilutions of four circulating strains of Leptospirosis. This formulation was administered orally to 2.3 million persons at high risk in an epidemic in a region affected by natural disasters. The data from surveillance were used to measure the impact of the intervention by comparing with historical trends and non-intervention regions.

After the homeoprophylactic intervention a significant decrease of the disease incidence was observed in the intervention regions. No such modifications were observed in non-intervention regions. In the intervention region the incidence of Leptospirosis fell below the historic median. This observation was independent of rainfall.

The homeoprophylactic approach was associated with a large reduction of disease incidence and control of the epidemic. The results suggest the use of HP as a feasible tool for epidemic control, further research is warranted.

The paper thus describes little more than an observational study. It shows that one region was less affected than another. I think it is quite clear that this could have many reasons which are unrelated to the homeopathic immunisation. Even the authors are cautious and speak in their conclusions not of a causal effect but of an “association”.

The 2012 data cited in the text remains unpublished; until it is available for public scrutiny, it is impossible to confirm that it is sound and meaningful.

Reference 8 refers to this article: Golden I, Bracho G. Adaptability of homœoprophylaxis in endemic, epidemic and stable background conditions. Homœopathic Links 2009; 22: 211-213. I have no access to this paper (if someone does, please fill us in) but, judging from both its title and the way it is described in the text, it does not seem to show reliable data about the efficacy of homeopathic immunisation.

So, is it true that “evidence does exist to support claims regarding the effectiveness of homeopathic immunisation”?

I do not think so!

Immunisation is by no means a trivial matter; wrong decisions in this area have the potential to cost the lives of millions. Therefore proofs of efficacy need to be published in peer-reviewed journals of high standing. These findings need then be criticised, replicated and re-criticised and re-replicated. Only when there is a wide consensus about the efficacy/safety or lack of efficacy/safety of a new form of immunisation, can it be generally accepted and implemented into clinical practice.

The current consensus about homeopathic immunisation is that it is nothing less than dangerous phantasy. Those who promote this quackery should be publicly exposed as charlatans of the worst kind.

Yesterday, BBC NEWS published the following interesting text about a BBC4 broadcast entitled ‘THE ROYAL ACTIVIST’ aired on the same day:

Prince Charles has been a well-known supporter of complementary medicine. According to a… former Labour cabinet minister, Peter Hain, it was a topic they shared an interest in.

“He had been constantly frustrated at his inability to persuade any health ministers anywhere that that was a good idea, and so he, as he once described it to me, found me unique from this point of view, in being somebody that actually agreed with him on this, and might want to deliver it.”
Mr Hain added: “When I was Secretary of State for Northern Ireland in 2005-7, he was delighted when I told him that since I was running the place I could more or less do what I wanted to do.***
“I was able to introduce a trial for complementary medicine on the NHS, and it had spectacularly good results, that people’s well-being and health was vastly improved.

“And when he learnt about this he was really enthusiastic and tried to persuade the Welsh government to do the same thing and the government in Whitehall to do the same thing for England, but not successfully,” added Mr Hain.

*** obviously there is no homeopathic remedy for megalomania (but that’s a different story)

Oh really?

A TRIAL?

SPECTACULARLY GOOD RESULTS?

NO KIDDING?

Let’s have a look at the ‘trial’ and its results. An easily accessible report provides the following details about it:

From February 2007 to February 2008, Get Well UK ran the UK’s first government-backed complementary therapy pilot. Sixteen practitioners provided treatments including acupuncture, osteopathy and aromatherapy, to more than 700 patients at two GP practices in Belfast and Derry.   

The BBC made an hour long documentary following our trials and tribulations, which was broadcast on BBC1 NI on 5 May 2008.

Following the successful completion of the pilot, the results were analysed by Social and Market Research and recommendations were made to the Health Minister

Aims and Objectives 

The aim of the project was to pilot services integrating complementary medicine into existing primary care services in Northern Ireland. Get Well UK provided this pilot project for the Department for Health, Social Services and Public Safety (DHSSPS) during 2007.

The objectives were:

  • To measure the health outcomes of the service and monitor health improvements.
  • To redress inequalities in access to complementary medicine by providing therapies through the NHS, allowing access regardless of income.
  • To contribute to best practise in the field of delivering complementary therapies through primary care.
  • To provide work for suitably skilled and qualified practitioners.
  • To increase patient satisfaction with quick access to expert care.
  • To help patients learn skills to improve and retain their health.
  • To free up GP time to work with other patients.
  • To deliver the programme for 700 patients.

Results 

The results of the pilot were analysed by Social and Market Research, who produced this report.

The findings can be summarised as follows: 

Following the pilot, 80% of patients reported an improvement in their symptoms, 64% took less time off work and 55% reduced their use of painkillers.

In the pilot, 713 patients with a range of ages and demographic backgrounds and either physical or mental health conditions were referred to various complementary and alternative medicine (CAM) therapies via nine GP practices in Belfast and Londonderry. Patients assessed their own health and wellbeing pre and post therapy and GPs and CAM practitioners also rated patients’ responses to treatment and the overall effectiveness of the scheme.

Health improvement
• 81% of patients reported an improvement in their physical health
• 79% reported an improvement in their mental health
• 84% of patients linked an improvement in their health and wellbeing directly to their CAM treatment
• In 65% of patient cases, GPs documented a health improvement, correlating closely to patient-reported improvements
• 94% of patients said they would recommend CAM to another patient with their condition
• 87% of patient indicated a desire to continue with their CAM treatment

Painkillers and medication
• Half of GPs reported prescribing less medication and all reported that patients had indicated to them that they needed less
• 62% of patients reported suffering from less pain
• 55% reported using less painkillers following treatment
• Patients using medication reduced from 75% before treatment to 61% after treatment
• 44% of those taking medication before treatment had reduced their use afterwards

Health service and social benefits
• 24% of patients who used health services prior to treatment (i.e. primary and secondary care, accident and emergency) reported using the services less after treatment
• 65% of GPs reported seeing the patient less following the CAM referral
• Half of GPs said the scheme had reduced their workload and 17% reported a financial saving for their practice
• Half of GPs said their patients were using secondary care services less.

Impressed? Well, in case you are, please consider this:

  • there was no control group
  • therefore it is not possible to attribute any of the outcomes to the alternative therapies offered
  • they could have been due to placebo-effects
  • or to the natural history of the disease
  • or to regression towards the mean
  • or to social desirability
  • or to many other factors which are unrelated to the alternative treatments provided
  • most outcome measures were not objectively verified
  • the patients were self-selected
  • they would all have had conventional treatments in parallel
  • this ‘trial’ was of such poor quality that its findings were never published in a peer-reviewed journal
  • this was not a ‘trial’ but a ‘pilot study’
  • pilot studies are not normally for measuring outcomes but for testing the feasibility of a proper trial
  • the research expertise of the investigators was close to zero
  • the scientific community merely had pitiful smiles for this ‘trial’ when it was published
  • neither Northern Ireland nor any other region implemented the programme despite its “spectacularly good results”.

So, is the whole ‘trial’ story an utterly irrelevant old hat?

Certainly not! Its true significance does not lie in the fact that a few amateurs are trying to push bogus treatments into the NHS via the flimsiest pseudo-research of the century. The true significance, I think, is that it shows how Prince Charles, once again, oversteps the boundaries of his constitutional role.

Arnold Relman has died aged 91. He was a great personality, served for many years as editor-in-chief of ‘The New England Journal of Medicine’ and was professor of medicine and social medicine at Harvard Medical School. He also was an brilliantly outspoken critic of alternative medicine, and I therefore believe that he deserves to be remembered here. The following excerpts are from an article he wrote in 1998 about Andrew Weil, America’s foremost guru of alternative medicine; I have taken the liberty of extracting a few paragraphs which deal with alternative medicine in general terms.

Until now, alternative medicine has generally been rejected by medical scientists and educators, and by most practicing physicians. The reasons are many, but the most important reason is the difference in mentality between the alternative practitioners and the medical establishment. The leaders of the establishment believe in the scientific method, and in the rule of evidence, and in the laws of physics, chemistry, and biology upon which the modern view of nature is based. Alternative practitioners either do not seem to care about science or explicitly reject its premises. Their methods are often based on notions totally at odds with science, common sense, and modern conceptions of the structure and the function of the human body. In advancing their claims, they do not appear to recognize the need for objective evidence, asserting that the intuitions and the personal beliefs of patients and healers are all that is needed to validate their methods. One might have expected such thinking to alienate most people in a technologically advanced society such as ours; but the alternative medicine movement, and the popularity of gurus such as Weil, are growing rapidly…

That people usually “get better,” that most relatively minor diseases heal spontaneously or seem to improve with simple common remedies, is hardly news. Every physician, indeed every grandmother, knows that. Yet before we accept Weil’s contention that serious illnesses such as “bone cancer,” “Parkinson’s disease,” or “scleroderma” are similarly curable, or respond to alternative healing methods, we need at least to have some convincing medical evidence that the patients whom he reports in these testimonials did indeed suffer from these diseases, and that they were really improved or healed. The perplexity is not that Weil is using “anecdotes” as proof, but that we don’t know whether the anecdotes are true.

Anecdotal evidence is often used in the conventional medical literature to suggest the effectiveness of treatment that has not yet been tested by formal clinical trials. In fact, much of the mainstream professional literature in medicine consists of case reports — “anecdotes,” of a kind. The crucial difference between those case reports and the testimonials that abound in Weil’s books (and throughout the literature of alternative medicine) is that the case reports in the mainstream literature are almost always meticulously documented with objective data to establish the diagnosis and to verify what happened, whereas the testimonials cited by alternative medicine practitioners usually are not. Weil almost never gives any objective data to support his claims. Almost everything is simply hearsay and personal opinion.

To the best of my knowledge, Weil himself has published nothing in the peer-reviewed medical literature to document objectively his personal experiences with allegedly cured patients or to verify his claims for the effectiveness of any of the unorthodox remedies he uses. He is not alone in this respect. Few proponents of alternative medicine have so far published clinical reports that would stand the rigorous scientific scrutiny given to studies of traditional medical treatments published in the serious medical journals. Alternative medicine is still a field rich in undocumented claims and anecdotes and relatively lacking in credible scientific reports…

… Thus Weil can believe in miraculous cures even while claiming to be rational and scientific, because he thinks that quantum theory supports his views.

Yet the leading physicists of our time do not accept such an interpretation of quantum theory. They do not believe quantum theory says anything about the role of human consciousness in the physical world. They see quantum laws as simply a useful mathematical formulation for describing subatomic phenomena that are not adequately handled by classical physical theory, although the latter remains quite satisfactory for the analysis of physical events at the macro-level. Steven Weinberg has observed that “quantum mechanics has been overwhelmingly important to physics, but I cannot find any messages for human life in quantum mechanics that are different in any important way from those of Newtonian physics.” And overriding all discussions of the meaning of quantum physics is the fundamental fact that quantum theory, like all other scientific law, is only valid to the extent that it predicts and accords with the evidence provided by observation and objective measurement. Richard Feynman said it quite simply: “Observation is the ultimate and final judge of the truth of an idea.” Feynman also pointed out that scientific observations need to be objective, reproducible, and, in a sense, public — that is, available to all interested scientists who wish to check the observations for themselves.

Surely almost all scientists would agree with Feynman that, regardless of what theory of nature we wish to espouse, we cannot escape the obligation to support our claims with objective evidence. All theories must conform to the facts or be discarded. So, if Weil cannot produce credible evidence to validate the miraculous cures that he claims for the healing powers of the mind, and if he does not support with objective data the claims he and others make for the effectiveness of alternative healing methods, he cannot presume to wear the mantle of science, and his appeal to quantum theory cannot help him.

Some apologists for alternative medicine have argued that since their healing methods are based on a “paradigm” different from that of traditional medicine, traditional standards of evidence do not apply. Weil sometimes seems to agree with that view, as when he talks about “stoned thinking” and the “ambivalent” nature of reality, but more recently — as he seeks to integrate alternative with allopathic medicine — he seems to acknowledge the need for objective evidence. This, at least, is how I would interpret one of his most recent and ambitious publishing ventures, the editorship of the new quarterly journal Integrative Medicine***.

Integrative Medicine describes itself as a “peer-reviewed journal … committed to gathering evidence for the safety and efficacy of all approaches to health according to the highest standards of scientific research, while remaining open to new paradigms and honoring the healing power of nature.” The Associate Editors and Editorial Board include prominent names in both alternative medicine and allopathic medicine, who presumably support that mission. Yet the first two issues will disappoint those who were looking for original clinical research based on new, objective data. Perhaps subsequent issues will be different, but in any case it is hard to understand the need for Weil’s new journal if he truly intends to hold manuscripts to accepted scientific standards: there already exist many leading peer-reviewed medical journals that will review research studies of alternative healing methods on their merits. During the past decade or so, only a few such studies have passed rigorous review and have been published in first-rate journals. Recently, more studies have been published, but very few of them report significant clinical effects. And that is pretty much where matters now stand. Despite much avowed interest in research on alternative medicine and increased investment in support of such research, the evidentiary underpinnings of unconventional healing methods are still largely lacking…

The alternative medicine movement has been around for a long time, but it was eclipsed during most of this century by the success of medical science. Now there is growing public disenchantment with the cost and the impersonality of modern medical care, as well as concern about medical mistakes and the complications and side-effects of pharmaceuticals and other forms of medical treatment. For their part, physicians have allowed the public to perceive them as uninterested in personal problems, as inaccessible to their patients except when carrying out technical procedures and surgical operations. The “doctor knows best” attitude, which dominated patient-doctor relations during most of the century, has in recent decades given way to a more activist, consumer-oriented view of the patient’s role. Moreover, many other licensed health-care professionals, such as nurse-practitioners, psychotherapists, pharmacists, and chiropractors, are providing services once exclusively reserved to allopathic physicians.

The net result of all these developments has been a weakening of the hegemony that allopathic medicine once exercised over the health care system, and a growing interest by the public in exploring other healing approaches. The authority of allopathic medicine is also being challenged by a swelling current of mysticism and anti-scientism that runs deep through our culture. Even as the number and the complexity of urgent technological and scientific issues facing contemporary society increase, there seems to be a growing public distrust of the scientific outlook and a reawakening of interest in mysticism and spiritualism.

All this obscurantism has given powerful impetus to the alternative medicine movement, with its emphasis on the power of mind over matter. And so consumer demand for alternative remedies is rising, as is public and private financial support for their study and clinical use. It is no wonder that practicing physicians, the academic medical establishment, and the National Institutes of Health are all finding reasons to pay more attention to the alternative medicine movement. Indeed, it is becoming politically incorrect for the movement’s critics to express their skepticism too strongly in public…

There is no doubt that modern medicine as it is now practiced needs to improve its relations with patients, and that some of the criticisms leveled against it by people such as Weil — and by many more within the medical establishment itself — are valid. There also can be no doubt that a few of the “natural” medicines and healing methods now being used by practitioners of alternative medicine will prove, after testing, to be safe and effective. This, after all, has been the way in which many important therapeutic agents and treatments have found their way into standard medical practice in the past. Mainstream medicine should continue to be open to the testing of selected unconventional treatments. In keeping an open mind, however, the medical establishment in this country must not lose its scientific compass or weaken its commitment to rational thought and the rule of evidence.

There are not two kinds of medicine, one conventional and the other unconventional, that can be practiced jointly in a new kind of “integrative medicine.” Nor, as Andrew Weil and his friends also would have us believe, are there two kinds of thinking, or two ways to find out which treatments work and which do not. In the best kind of medical practice, all proposed treatments must be tested objectively. In the end, there will only be treatments that pass that test and those that do not, those that are proven worthwhile and those that are not. Can there be any reasonable “alternative”?

 

*** the journal only existed for a short period of time

‘THE HINKLEY TIMES’ is not a paper that I read often, I have to admit – but maybe I should! It was there that I found the following remarkable article:

Bosworth MP David Tredinnick has asked questions in the House of Commons about the growing problem of antibiotic resistance within hospitals, suggesting herbal remedies could be answer.

The Tory MP, who has a keen interest in alternative medicine particularly herbal curatives, asked Jeremy Hunt, Secretary of State for Health, whether the problem was being discussed at the very top level.

He said: “Does my right honourable friend agree that a critical problem that A and E units will face in the future is antibiotic resistance? Is he aware that the science and technology committee, of which I am a member, has been looking at this issue and it also interests the health committee, of which I am also a member? Can he assure me that he is talking to the Prime Minister about how to stimulate new antibiotic research, and will he also remember that nature has its own remedies, such as tea tree oil?”

In reply Mr Hunt said: “My honourable friend is right about the seriousness of the issue of antimicrobial resistance. Some 25,000 people die in Europe every year as a result of the failure of antibiotics – more than die in road traffic accidents. I raised the issue at the World Health Assembly and I have discussed it closely with the Prime Minister.”

David Tredinnick is no stranger to strange ideas. Wikipedia (yes I know, many people do not like it as a source) sums it up quite succinctly:

He is a supporter of complementary and alternative medicine (CAM). He has made supportive comments in Parliament on homeopathy, despite continued lack of evidence of its effectiveness. He has supported chiropractic and mentioned the influence of the Moon on blood clotting. In this same debate he characterised scientists as “racially prejudiced”. He has tabled several early day motions in support of homeopathy’s continued funding on the National Health Service.Tredinnick’s views continue to cause amused disbelief in some quarters and a spokesman for the Royal College of Surgeons of England said they would “laugh their heads off” at the suggestion they could not operate at the full moon.

At the 2010 general election, in addition to candidates from the two main parties, Tredinnick was opposed by New Scientist journalist Dr. Michael Brooks who objected to “Tredinnick’s outspoken promotion of complementary and alternative medicine.”During a hustings debate called by Brooks to “highlight the scientific literacy of the UK’s elected representatives” Brooks claimed that Tredinnick regarded homeopathy as a suitable treatment for Malaria and HIV, which Tredinnick did not deny. Tredinnick in turn argued that “alternative treatments are incredibly good value for money” and stated his belief that randomised controlled trials are not effective at evaluating very dilute preparations.

In March 2013 Tredinnick was ridiculed as “nonsensical” by the government’s outgoing chief scientist, Sir John Beddington, who said the MP had fallen for the “Galileo fallacy” (Galileo was laughed at but was right, therefore since I am laughed at I must be right).

In July 2013 Tredinnick sponsored an EDM congratulating a farmer on his decision to use homeopathy with what were claimed to be positive results.The motion was supported by one other MP but the British veterinary association says there is no evidence of any benefit.

Tredinnick is a supporter of astrology especially the use of it in medical practice.In November 2009, he spoke at a meeting organised by the Astrological Association of Great Britain, where he related his personal experience of astrology and illness, advocating that astrology be integrated into the NHS.

Tredinnick’s appointment to the Health committee in June 2010 was criticised in two science reports in the Guardian. Martin Robbins said his appointment was “an extremely disturbing development” even though “Tredinnick is a figure unlikely to be taken seriously by policymakers” whilst Nature‘s Adam Rutherford described Tredinnick as “misinformed about a great many things” and said that “giving [him] influence on medical policy ..is a bad move.”The Telegraph writer Ian Douglas also described it as “a problem.”

His appointment to the Science and technology committee also drew criticism. Andy McSmith in the Independent, cited his views that homeopathy could cure HIV, TB, malaria, urinary infections, diarrhoea, skin eruptions, diabetes, epilepsy, eye infections, intestinal parasites, cancer, and gangrene amongst others and quoted Imran Khan, head of the Campaign for Science and Engineering, as saying that “someone with such incredibly odd views is not helpful”. Tom Whipple in the Times said his appointment caused despair,whilst Elizabeth Gibney in the Times Higher Education quoted the Skeptical Voter website as saying that Tredinnick is “perhaps the worst example of scientific illiteracy in government”…

In 2009 Tredinnick attempted to claim the £125 cost of attending a course on “intimate relationships” through his Parliamentary expenses. He was also found to have used expenses to purchase astrology software, claiming it was for a debate on alternative medicine.

Compared to some of theses bizarre activities, the notion that herbal remedies might provide the solution for antibiotic resistance seems almost reasonable and clever.

ALMOST!!!

Tredinnick does not seem to know that:

  • many antibiotics originate from plants or other natural substances,
  • several large pharmaceutical companies are feverishly looking for more such substances from plants,
  • most plants do actually contain substances which have antibiotic activity,
  • however, most cannot be used as medicines, for instance, because they are far too toxic (tea tree oil is a good example for this),
  • once a pure compound has been isolated from a plant and is used therapeutically, it ceases to be herbal medicine (which is defined as the use of full plant extracts),
  • it is thus unlikely that full plant extracts, i. e. herbal medicine, will ever provide a solution to antibiotic resistance.

I have little doubt that Tredinnick will continue to mislead parliament and the public with his nonsensical views about alternative medicine. And even if it might have no effect whatsoever, I will continue to point out just how nonsensical they are.

Some time ago, I published a post entitled HOW TO BECOME A CHARLATAN. This prompted ‘THE NORWEGIAN ACADEMY OF SCIENCE AND LETTERS’ to invite me to give a lecture on the subject, a great honour, I am sure. Consequently, I have thought about this somewhat unusual subject quite a lot.

Obviously, my thoughts come from the perspective of someone who has researched alternative medicine for many years. Pseudoscientists seem to love alternative medicine and proponents of alternative medicine love pseudoscience. As a result, alternative medicine is densely populated by pseudoscientists.

But what is the characteristic of pseudoscience? Reflecting on this question, I found not one but several hallmarks (and for each of them, there are many posts on this blog which provide further explanations):

Based on these 12 hallmarks, one could create a simple score which indicates the likelihood of the presence of pseudoscience. In other words, it might be useful to consider pseudoscience in terms of a sliding scale. Some things in alternative medicine can be just a bit pseudoscientific, others quite a lot, while others again are hopelessly so.

The issue of pseudoscience is by no means just academic; it is very real problem and has many important, practical implications. The most important one probably is that, in health care (and other areas as well), pseudoscience can be harmful, even to the point that it costs lives of vulnerable patients who believe that everything masquerading as science can be relied upon.

In the early 1920s, a French physician thought he had discovered the virus that caused the Spanish flu. It oscillated under his microscope, and he thus called it oscillococcus. Not only did it cause the flu, in the opinion of his discoverer, but it was also responsible for a whole host of other diseases, including cancer. In fact, the virus does not exist, or at least nobody ever confirmed it existed, but that fact did not stop our good doctor to make a homeopathic remedy from it which he thought would cure all these diseases. His remedy, Oscillococcinum, is made from the liver and heart of a duck because the imaginative inventor believed that the fictitious virus was present in these organs of this animal.

To understand all this fully, one needs to know that the duck organs are so highly diluted that no molecule of the duck is present in the remedy. It is sold in the C200 potency. This means that one part of organ extract is diluted 1: 10 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 (a note to Boiron’s legal team: I had a hell of a time getting all these zeros right; in case, I got it wrong after all, it is an honest error – please do not sue me for it!). The dilution is so extreme that it amounts to a single molecule per a multitude of universes.

Given these facts it seems unlikely that the remedy has any effects on human health which go beyond those of a placebo. Let’s see what the current Cochrane review says about its effectiveness: There is insufficient good evidence to enable robust conclusions to be made about Oscillococcinum(®) in the prevention or treatment of influenza and influenza-like illness. Our findings do not rule out the possibility that Oscillococcinum(®) could have a clinically useful treatment effect but, given the low quality of the eligible studies, the evidence is not compelling. There was no evidence of clinically important harms due to Oscillococcinum(®).

Considering that the first author of this review works for the British Homeopathic Association and the senior author is the homeopath of the Queen, this seems a pretty clear statement, don’t you think?

Regardless of the scientific evidence, Oscillococcinum made of ‘Anas Barbariae Hepatis et Cordis Extractum‘, as it is officially called, became a homeopathic best-seller. In the US alone Boiron, the manufacturer, is said to sell US$ 15 m per year of this product. Not only that, in France, where the remedy is a popular medicine sold in virtually all pharmacies and often recommended as soon as you walk into a pharmacy, it is hard to find anyone who does not swear by the ‘potentized‘ duck or is willing to discuss its merits critically.

The amazing duck, it seems, has turned into a ‘holy cow’.

If we search on ‘Medline’ for ‘complementary alternative medicine’ (CAM), we currently get about 13000 hits. A little graph on the side of the page demonstrates that, during the last 4 years, the number of articles on this subject has grown exponentially.

Surely, this must be very good news: such intense research activity will soon tell us exactly which alternative treatments work for which conditions and which don’t.

I beg to differ. Let me explain why.

The same ‘Medline’ search informs us that the majority of the recent articles were published in an open access journal called ‘Evidence-Based Complementary and Alternative Medicine’ (eCAM). For example, of the 80 most recent articles listed in Medline (on 26/5/2014), 53 came from that journal. The publication frequency of eCAM and its increase in recent years beggars belief: in 2011, they published just over 500 articles which is already a high number, but, in 2012, the figure had risen to >800, and in 2013 it was >1300 (the equivalent 2013 figure for the BMJ/BMJ Open by comparison is 4, and that for another alt med journal, e.g. Forsch Komplement, is 10)

How do they do it? How can eCAM be so dominant in publishing alt med research? The trick seems to be fairly simple.

Let’s assume you are an alt med researcher and you have an article that you would like to see published. Once you submit it to eCAM, your paper is sent to one of the ~150 members of the editorial board. These people are almost all strong proponents of alternative medicine; critics are a true rarity in this group. At this stage, you are able to suggest the peer reviewers for your submission (all who ever accepted this task are listed on the website; they amount to several thousand!), and it seems that, with the vast majority of submissions, the authors’ suggestions are being followed.

It goes without saying that most researchers suggest colleagues for peer reviewing who are not going to reject their work (the motto seems to be “if you pass my paper, I will pass yours). Therefore even faily flimsy bits of research pass this peer review process and get quickly published online in eCAM.

This process explains a lot, I think: 1) the extraordinarily high number of articles published 2) why currently more than 50% of all alt med research originate from eCAM 3) why so much of it is utter rubbish.

Even the mere titles of some of the articles might demonstrate my point. A few examples have to suffice:

  • Color distribution differences in the tongue in sleep disorder
  • Wen-dan decoction improves negative emotions in sleep-deprived rats by regulating orexin-a and leptin expression.
  • Yiqi Huoxue Recipe Improves Heart Function through Inhibiting Apoptosis Related to Endoplasmic Reticulum Stress in Myocardial Infarction Model of Rats.
  • Protective Effects of Bu-Shen-Huo-Xue Formula against 5/6 Nephrectomy-Induced Chronic Renal Failure in Rats
  • Effects and Mechanisms of Complementary and Alternative Medicine during the Reproductive Process
  • Evidence-based medicinal plants for modern chronic diseases
  • Transforming Pain into Beauty: On Art, Healing, and Care for the Spirit

This system of uncritical peer review and fast online publication seems to suit many of the people involved in this process: the journal’s owners are laughing all the way to the bank; there is a publication charge of US$ 2000 per article, and, in 2013, the income of eCAM must therefore have been well over US$2 000 000. The researchers are equally delighted; they get even their flimsiest papers published (remember: ‘publish or perish’!). And the evangelic believers in alternative medicine are pleased because they can now claim that their field is highly research-active and that there is plenty of evidence to support the use of this or that therapy.

But there are others who are not served well by eCAM habit of publishing irrelevant, low quality articles:

  • professionals who would like to advance health care and want to see reliable evidence as to which treatments work and which don’t,
  • the public who, in one way or another, pay for all this and might assume that published research tends to be relevant and reliable,
  • the patients who have given their time to researchers in the hope that their gift will improve health care,
  • ill individuals who hope that alternative treatments might relieve their suffering,
  • politicians who rely on research to be reliable in order to arrive at the right decisions.

Come to think of it, the vast majority of people should be less than enchanted with eCAM and similar journals.

Auricular acupuncture (AA), according to the ‘COLLEGE OF AURICULAR ACUPUNCTURE’, has its origins in Modern Europe. In 1957 Dr. Paul Nogier, a neurologist from Lyons in France, observed a locum doctor treating sciatica by cauterizing an area of the ear. This prompted extensive research culminating in the development of the somatopic correspondence of specific parts of the body to the ear based upon the concept of an inverted foetus. Dr. Nogier believed that pain and other symptoms in the body could be alleviated by needling, massaging or electronically stimulating the corresponding region of the ear. Auricular Acupuncture is a specialized complementary therapy where acupuncture points on the outer ear are treated, using either needles or acupunctoscopes (electrical location and stimulation machines) to help relieve many chronic complaints. There are over 200 acupuncture points on the ear, each point named after an area of our anatomy. The outer ear acts like a switchboard to the brain. Each acupuncture point being treated, triggers electrical impulses from the ear via the brain, to the specific part of the body being treated.

Sounds odd? Well, that’s because it is odd!

But just because something is odd does not mean it is ineffective – so, what does the reliable evidence tell us? Here are some conclusions from systematic reviews:

The evidence that auricular acupuncture reduces postoperative pain is promising but not compelling.

The evidence for the effectiveness of AA for the symptomatic treatment of insomnia is limited.

The benefit of ear-acupressure for symptomatic relief of allergic rhinitis is unknown…

All of these analyses point out that the quality of the studies is usually very poor, and stress that more and better research is required. It is therefore interesting to note that a new study has just been published. Perhaps it could settle the question about the effectiveness of AA?

The aim of this study was 1) to evaluate whether auricular acupuncture effective for reducing health care provider stress and anxiety and 2) to determine, if auricular acupuncture impacts provider capacity for developing caring relationships with patients. Pre-intervention and post-intervention surveys were evaluated to see, if auricular acupuncture was associated with changes in State-Trait Anxiety Inventory (STAI), Professional Quality of Life, and Caring Ability Inventory scores. The results indicate that, compared with baseline, participants had a significant reduction in state anxiety (STAI), trait anxiety (STAI), burnout, and secondary traumatic stress scores (Professional Quality of Life). Significant increases were noted in courage and patience, two dimensions of the Caring Ability Inventory.

From these findings, the authors conclude that auricular acupuncture is an effective intervention for the relief of stress/anxiety in providers and supports heightened capacity for caring.

Sounds odd again? Yes, because it is odd!

I would argue that a study of any controversial therapy that has already been tested repeatedly in poor quality trials must have sufficient scientific rigor to advance the field of inquiry. If it does not fulfil this criterion, it is quite simply not ethical. The new study does not even have a control group; we can therefore not begin to tell whether the observed outcomes were due to non-specific effects, the natural history of the condition or regression towards the mean (to mention but a few of the possible sources of bias). To conclude that AA is ‘an effective intervention’ is therefore utterly barmy.

All of this could be entirely trivial and inconsequential. I am afraid, however, that it is not. Alternative medicine is littered with such unethically flawed research conducted by naïve and clueless pseudo-scientists who arrive at outrageous conclusions. This relentless flow of false-positive findings misleads consumers, health care professionals, decision makers and everyone else to draw the wrong conclusions about bogus therapies. And, in the end, this sort of thing even does a grave disfavour to any branch of alternative medicine that might have some degree of respectability.

IT IS HIGH TIME THAT THIS NONSENSE STOPS! IT BORDERS ON SCIENTIFIC MISCONDUCT.

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