MD, PhD, FMedSci, FSB, FRCP, FRCPEd

pseudo-science

1 2 3 25

This randomized, double-blind study evaluated the efficacy of a homeopathic treatment in preventing excessive weight gain during pregnancy in overweight or obese women who were suspected of having a common mental disorder. For the homeopathic group (n=62), 9 homeopathic remedies were pre-selected: (1) Pulsatilla nigricans, (2) Sepia succus, (3) Lycopodium clavatum, (4) sulphur, (5) Lachesis trigonocephalus, (6) Nux vomica, (7) Calcarea carbonica, (8) phosphorus; and (9) Conium maculatum. From those 9 drugs, one was prioritized for administration for each participant. After the first appointment, a re-selection or selection of a new, more appropriate drug occurred, using the list of preselected drugs. The dosage was 6 drops orally 2 ×/day, in the morning and at night, on 4 consecutive days each week, with an interval of 3 d between doses, up until the next appointment medical appointment. The control group (n=72) took placebos. Both groups also received a diet orientation.

Weight change during pregnancy was defined as the difference between the body mass index (BMI) at the initial evaluation and that recorded at the final evaluation, adjusted for 40 weeks of gestation. In addition, the APGAR index in the newborn  (a measure of the health of the baby) was evaluated. The mean variation between baseline BMI and BMI at week 40 of gestation was +4.95 kg/m2 in the control group and +5.05 kg/m2 in the homeopathy group. The difference between the two groups was not significant. APGAR 10 at 5 min (59.6% in the homeopathy group and 36.4% in the control group) was statistically significant (P = .016).

The authors concluded that homeopathy does not appear to prevent excessive body mass gain in pregnant women who are overweight or obese and suspected of having a common mental disorder. Homeopathy did not change the APGAR score to modified clinical attention at delivery room. However, the evidence observed at APGAR 10 at minute 5 suggests that  homeopathy had a modulating effect on the vitality of newborns, warranting further studies designed to investigate it.

I have seen many odd studies in my time, but this must be one of the oddest?

  • What is the rationale for assuming that homeopathy might affect body weight?
  • Why take pregnant women with a weight problem who were suspected of having a common mental disorder?
  • Why try to turn a clearly negative result into a finding that is (at least partly) positive?

The last point seems the most important one to me. The primary outcome measure of this study (weight gain) was clearly defined and was not affected by the therapy. Yet the authors feel it justified to add to their conclusions that homeopathy had a modulating effect on the vitality of newborns (almost certainly nothing but a chance finding).

Are they for real?

I suppose they are: they are real pseudo-scientific promoters of quackery!

You probably remember: the US Federal Trade Commission’s (FTC) has issued a statement announcing that unsupported claims for homeopathic remedies will be no longer allowed. Specifically, they said that, in future, homeopathic remedies have to be held to the same standard as other medicinal products. In other words, American companies must now have reliable scientific evidence for health-related claims that their products can treat specific conditions and illnesses.

Now the AMERICAN INSTITUTE OF HOMEOPATHY (AIH) has published a rebuttal. It is hilarious and embarrassing in equal measure. Here it is in full (I have only omitted their references – they can be seen in the linked original –  and added footnotes in bold square brackets with my very short comments):

START OF QUOTE

November 30, 2016

The American Institute of Homeopathy applauds the Federal Trade Commission’s (FTC) goal of protecting the American public from false advertising claims, but in a recent circumstance we believe the FTC has overstepped its jurisdictional bounds and promulgated false information in what appears to be a bid to restrict health care choices [1] available to the American public.

In Response to the recent Enforcement Policy Statement1 and a Consumer Information Blog,2 both issued by the FTC on November 15, 2016, the American Institute of Homeopathy registers our strong concern regarding the content of the following inaccurate statements:

  1. “Homeopathy… is based on the view that disease symptoms can be treated by minute doses of substances that produce similar symptoms…”

Homeopathy is not based on a “view” or an opinion. It is based on reliable, reproducible, clinically acquired, empiric evidence [2] gathered through two centuries of corroborated data, assisted by thousands of practitioners worldwide [3], demonstrating the actions of different medicinal substances in living systems, aka: the science of homeopathy. In fact, the homeopathic scientific community were pioneers of the modern scientific method including the widespread adoption of blinded and placebo controlled studies in 1885 [4], decades before conventional medicine.3

Homeopathy is not based on a theory or on conjecture, but on principles that have been confirmed by long-studied clinical data, meticulously gathered and analyzed over many years [5].

  1. “Many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance.”

While the dilution and succussion process of formulating homeopathic medicines does reduce the concentration (and the toxicity) of the original substances, detectable amounts of these materials remain quantifiable in the form of nanoparticles [6] dispersed throughout.4 Multiple independent laboratories, worldwide have confirmed that these nanoparticles persist,5 and that they are biologically active.6 Many other homeopathic products (particularly those sold OTC and described as “low potency”) have dilute amounts of the original substance [7] that remain chemically detectable by straightforward titration.

  1. “…homeopathic product claims are not based on modern scientific methods…”

This statement is false and misleading. The active ingredients within most OTC homeopathic products have hundreds or thousands of case reports from physicians who have used these medicines [8]. These reports of direct clinical experiences establish a collective, real-world dataset that demonstrates which conditions have been observed to respond to treatment. Such historical data is similar to the types of information used to demonstrate effectiveness for many conventional OTC medicines on the market today [9].

The Homeopathic Pharmacopeia Convention of the United States (HPCUS) maintains a formulary describing the appropriate manufacturing standards for homeopathic medicines [10]. Every homeopathic manufacturer member of the American Association of Homeopathic Pharmacists in good ethical standing complies with both manufacturing and labeling standards set by the HPCUS. Consumers should be cautious when using any products that are not distinguished by conformance with “HPUS” on the label.

  1. “…the case for efficacy is based solely on traditional homeopathic theories…”

This statement is false. Neither homeopathy nor homeopathic efficacy is based on any theories. Efficacy for various homeopathic medicines has been established by scientifically reproducible clinical empiric research evidence [11] and cured patient cases followed over many years [12]. Homeopathy is an evidence-based medical subspecialty rooted in patient care.

  1. “…there are no valid studies using current scientific methods showing the product’s efficacy.”

While this statement may have limited accuracy with respect to some OTC products, it is false and misleading with respect to most homeopathic medicines listed in the Homeopathic Pharmacopeia of the United States. Hundreds of state-of-the-art double-blinded, randomized, placebo-controlled studies, many in peer-reviewed journals, demonstrate the superior efficacy of homeopathic medicines in a wide range of conditions, including asthma,7 depression and anxiety,8 chronic illness,9 allergic rhinitis,10 hypertension,11 headaches/migraines,12 sepsis,13 mild traumatic brain injury,14 otitis media,15 cancer,16 and many other conditions [13]. The American Institute of Homeopathy maintains and continually updates an extensive database, available free to the public, with over 6,000 research articles [14].17

Multiple meta-analyses published in peer reviewed medical journals that conclude that homeopathic medicine effects are superior to placebo [15] and that additional study of this therapeutic system is warranted.18,19,20,21,22,23  To that end, we encourage the National Institutes of Health to reverse their current position of blocking funding for homeopathic trials.24

  1. “…marketing claims that such homeopathic products have a therapeutic effect lack a reasonable basis and are likely misleading…”

The conclusion of whether a product has a “reasonable basis” is entirely irrelevant if that product has demonstrable clinical effectiveness. The important question, when it comes to homeopathy, is whether it is effective in clinical settings, not whether it has a “reasonable basis” for how it works. The mechanism by which homeopathy works differs from conventional medicines [16], but this fact does not make these products “misleading”.

Several recent class-action lawsuits brought against homeopathic manufacturers confirm that marketing practices were neither deceptive nor misleading [17].25

The FTC’s inability to formulate a reasonable basis for why homeopathic medicines work should not enter into any governmental enforcement policy statement. The FTC is not a medical organization, lacks expertise in interpreting scientific research [18], and is not qualified to make any comment on the validity of any field of medicine. To be less misleading, the FTC should exclude opinions from its policy statements.

  1. “Homeopathy: Not backed by modern science”

Homeopathy, as a system of medicine, does not fall under the purview of the FTC. Therefore, the FTC has been reckless in expressing an opinion of this magnitude. In this situation, the FTC’s comments can only be construed as being prejudicially biased and intentionally discriminatory against homeopathy. Such statements cause unwarranted harm to public trust and damage to a respected traditional system of medicine in the United States [19].

The American Institute of Homeopathy strongly objects to the FTC’s characterization of the entire field of homeopathic medicine as being without scientific evidence of efficacy. These comments are unqualified and wholly lacking in merit. The release of this Enforcement Policy Statement serves only to align the FTC with several recently released scientifically fraudulent [20] reports by a variety of pseudoscientists [21] and lowers the credibility of this valued consumer protection agency.

This type of misinformation should be embarrassing to a government organization striving to be nonpartisan and objective. The FTC owes an apology to the American Institute of Homeopathy as well as the many consumer groups that look toward this agency for fair and accurate information.

END OF QUOTE

My comments:

1 In healthcare, choice must be restricted to treatments which demonstrably generate more good than harm.

2 The AIH seems to be unaware of the difference between the nature of evidence, anecdote and experience.

3 Fallacy – appeal to popularity.

4 The first randomized, placebo-controlled study of homeopathy was, in fact, published in 1835 – its results were negative.

5 Fallacy – appeal to tradition.

6 The nano-particle explanation of homeopathy is but a theory (at best).

7 Fallacy – appeal to tradition.

8 Fallacy – appeal to authority.

9 Really? Which ones? Examples would help, but I doubt they exist.

10 The proper manufacturing of nonsense must still result in nonsense.

11 See footnote number 2

12 Fallacy – appeal to tradition.

13 For all of these conditions, the totality of the reliable evidence fails to demonstrate efficacy.

14 In this context, only clinical trials are relevant, and their number is nowhere near 6,000.

15 Most of the independent systematic reviews fail to be positive.

16 The mechanism is well-known and is called ‘placebo-effect’.

17 Many class actions also went against the manufacturers of homeopathic preparations.

18 I assume they ‘bought in’ the necessary expertise.

19 Surely, the damage is only to the cash-flow of firms selling bogus products.

20 Really? Name the report you libel here or be quiet!

21 Name the individuals you attack in this way or be quiet!

I must say, I had fun reading this. In fact, I cannot remember having seen a document by an organisation of healthcare professionals which was so embarrassingly nonsensical that it becomes comedy gold. If one of my PhD students, for instance, had submitted such drivel, I would have had no choice but to fail him or her.

Having said that, I need to stress to the AIH:

FULL MARKS FOR AMUSEMENT!!!

 

WHAT DOCTORS DON’T TELL YOU (WDDTY) is probably the most vile publication I know. It systematically misleads its readers by alarming news about this or that conventional treatment, while relentlessly promoting pseudoscientific non-sense. This article , entitled “MMR can cause skin problems and ulcers if your immune system is compromised” is a good example (one of a multitude):

The MMR vaccine can cause serious adverse reactions, researchers have admitted this week. The rubella (German measles) component of the jab increases the risk of infection from the rubella virus itself, and can cause serious skin inflammation and ulcers in anyone whose immune system is compromised.

The risk is highest among people with primary immunodeficiency diseases (PIDD), chronic genetic disorders that cause the immune system to malfunction.

Although the risk for people with compromised immune systems has been known, and is even included in the package inserts supplied with the vaccine, it was theoretical, say researchers from the Children’s Hospital of Philadelphia, who say they have uncovered “genuine evidence of harm.”

The researchers analysed the health profile of 14 people—four adults and 10 children—who suffered some form of a PIDD. Seven of them still had the rubella virus in their tissues, suggesting that their immune systems were too weak to get rid of the virus in the vaccine. The virus can damage skin cells and cause ulcers, and makes the person more susceptible to the actual rubella virus, the researchers say.

People with a poor immune system already have compromised T-cells—which are responsible for clearing viral infections—and the MMR makes the problem worse.

END OF QUOTE

And what is wrong with this article?

The answer is quite a lot:

  1. The research seems to be about a very specific and rare condition, yet WDDTY seem to want to draw much more general conclusions.
  2. The research itself is not described in a way that it would be possible to evaluate.
  3. The sample size of what seems to have been a case-control study was tiny.
  4. The study is not properly cited for the reader to verify and check; for all we know, it might not even exist.
  5. I was not able to find the publication on Medline, based on the information given.

Collectively, these points render the article not just useless, in my view, but make it a prime example of unethical, unhelpful and irresponsible scaremongering.

 

Price Charles celebrates his 68th birthday today. Time to update the tribute which I dedicated to him on this occasion three years ago. Charles is, of course, one of the world’s most outspoken and influential proponent of alternative medicine and a notorious attacker of science. This is why he has featured on this blog with some regularity. His love affair with all things alternative started early in his life.

As a youngster, Charles went on a journey of ‘spiritual discovery’ into the wilderness of northern Kenya. His guru and guide was Laurens van der Post (later discovered to be a fraud and compulsive fantasist and to have fathered a child with a 14-year old girl entrusted to him during a sea voyage). Van der Post wanted to awake Charles’ mind and attune it to the ideas of Carl Jung’s ‘collective unconscious’ which allegedly unites us all through a common vital force. It is this belief in vitalism that provides the crucial link to alternative medicine: virtually every form of the otherwise highly diverse range of alternative therapies is based on the assumption that some sort of vital force or energy exists. Charles was so taken by van der Post that, after his death, he established an annual lecture in his honour.

Throughout the 1980s, Charles lobbied for the statutory regulation of chiropractors and osteopaths in the UK. In 1993, it finally became reality.

Osteopathy has strong Royal links: Prince Charles is the President of the GOsC; Princess Diana was the President of the GCRO; and Princess Anne is the patron of the British School of Osteopathy (statement dated 2011).

In 1982, Prince Charles was elected as President of the British Medical Association (BMA) and promptly challenged the medical orthodoxy by advocating alternative medicine. In a speech at his inaugural dinner as President, the Prince lectured the medics: ‘Through the centuries healing has been practised by folk healers who are guided by traditional wisdom which sees illness as a disorder of the whole person, involving not only the patient’s body, but his mind, his self-image, his dependence on the physical and social environment, as well as his relation to the cosmos.’ The BMA-officials were impressed – so much so that they ordered a full report on alternative medicine which promptly condemned this area as nonsense.

In 1993, Charles founded his lobby group that ended up being called the ‘Foundation for Integrated Health’ (FIH). It was closed down in 2010 amidst allegations of money laundering and fraud. Its chief executive, George Gray, was later convicted and went to jail. The FIH had repeatedly been economical with the truth.

In 2000, Charles wrote an open letter to The Times stating that…It makes good sense to evaluate complementary and alternative therapies. For one thing, since an estimated £1.6 billion is spent each year on them, then we want value for our money. The very popularity of the non-conventional approaches suggests that people are either dissatisfied with their orthodox treatment, or they find genuine relief in such therapies. Whatever the case, if they are proved to work, they should be made more widely available on the NHS…But there remains the cry from the medical establishment of “where’s the proof?” — and clinical trials of the calibre that science demands cost money…The truth is that funding in the UK for research into complementary medicine is pitiful…So where can funding come from?…Figures from the department of complementary medicine at the University of Exeter show that less than 8p out of every £100 of NHS funds for medical research was spent on complementary medicine. In 1998-99 the Medical Research Council spent no money on it at all, and in 1999 only 0.05 per cent of the total research budget of UK medical charities went to this area…

In 2001, Charles worked on plans to help build a model hospital of integrated medicine. It was to train doctors to combine conventional medicine and alternative treatments, such as homeopathy, Ayurvedic medicine and acupuncture, and was to have have up to 100 beds. The prince’s intervention marked the culmination of years of campaigning by him for the NHS to assign a greater role to alternative medicine. Teresa Hale, founder of the Hale Clinic in London, said: “Twenty-five years ago people said we were quacks. Now several branches, including homeopathy, acupuncture and osteopathy, have gained official recognition.” The proposed hospital, which was due to open in London in 2003 or early 2004, was to be overseen by Mosaraf Ali, who runs the Integrated Medical Centre (IMC) in London. But the hospital never materialised. This might be due to Mosaraf Ali falling in disrepute: Raj Bathija, 69 and from India, went for a massage at the clinic of Dr Mosaraf Ali and his brother Imran in 2005 after suffering from two strokes. However, he claims that shortly after the treatment, his legs became pale and discoloured. Four days afterwards, Mr Bathija was admitted to hospital, where he had to have both legs amputated below the knee due to a shortage of blood. According to Mr Bathija, Dr Ali and his brother were negligent in that they failed to diagnose his condition and neglected to advise him to go to hospital. His daughter Shibani said: “My father was in a wheelchair but was making progress with his walking. He hoped he might become a bit more independent. With the amputations, that’s all gone.”

In 2002, the The Royal London Homeopathic Hospital (today called the Royal London Hospital for Integrated Medicine (RLHIM)) received £18.5 million of NHS funds to pay for an extensive refurbishment and restoration of the grand Victorian building. It seems likely that Royal protection facilitated this action.

In 2003, Prince Charles’ FIH launched a five-year plan which outlined how to improve access to alternative therapies.

In 2004, Charles publicly supported the Gerson diet as a treatment for cancer and Prof Baum, one of the UK’s most eminent oncologists, was invited to respond in an open letter to the British Medical Journal: …Over the past 20 years I have treated thousands of patients with cancer and lost some dear friends and relatives to this dreaded disease…The power of my authority comes with knowledge built on 40 years of study and 25 years of active involvement in cancer research. Your power and authority rest on an accident of birth. I don’t begrudge you that authority but I do beg you to exercise your power with extreme caution when advising patients with life-threatening diseases to embrace unproven therapies.

In 2005, the ‘Smallwood-Report’ was published; it had been commissioned by Charles and paid for by Dame Shirley Porter to inform health ministers. It stated that up to 480 million pounds could be saved, if one in 10 family doctors offered homeopathy as an alternative to standard drugs for asthma. Savings of up to 3.5 billion pounds could be achieved by offering spinal manipulation rather than drugs to people with back pain. Because I had commented on this report, Prince Charles’ first private secretary asked my vice chancellor to investigate my activities; even though I was found to be not guilty of any wrong-doing, all local support stopped which eventually led to my early retirement. ITV later used this incident in a film entitled THE MEDDLING PRINCE.

In a 2006 speechPrince Charles told the World Health Organisation in Geneva that alternative medicine should have a more prominent place in health care and urged every country to come up with a plan to integrate conventional and alternative medicine into the mainstream. But British science struck back. Anticipating Prince Charles’s sermon in Geneva, 13 of Britain’s most eminent physicians and scientists wrote an “Open Letter” which expressed concern over “ways in which unproven or disproved treatments are being encouraged for general use in Britain’s National Health Service.” The signatories argued that “it would be highly irresponsible to embrace any medicine as though it were a matter of principle.”

In 2008The Times published my letter asking the FIH to withdraw two guides promoting “alternative medicine”, saying: “the majority of alternative therapies appear to be clinically ineffective, and many are downright dangerous.” A speaker for the FIH countered the criticism by stating: “We entirely reject the accusation that our online publication Complementary Healthcare: A Guide contains any misleading or inaccurate claims about the benefits of complementary therapies. On the contrary, it treats people as adults and takes a responsible approach by encouraging people to look at reliable sources of information… so that they can make informed decisions. The foundation does not promote complementary therapies.”

In 2009, the Prince held talks with the health Secretary to persuade him to introduce safeguards amid a crackdown by the EU that could prevent anyone who is not a registered health practitioner from selling remedies. This, it seems, was yet another example of Charles’ disregard of his constitutional role.

In the same year, Charles urged the government to protect alternative medicine because “we fear that we will see a black market in herbal products”, as Dr Michael Dixon, then medical director of Charles’ FIH, put it.

In 2009, the health secretary wrote to the prince suggesting a meeting on the possibility of a study on integrating complementary and conventional healthcare approaches in England. The prince had written to Burnham’s predecessor, Alan Johnson, to demand greater access to complementary therapies in the NHS alongside conventional medicine. The prince told him that “despite waves of invective over the years from parts of the medical and scientific establishment” he continued to lobby “because I cannot bear people suffering unnecessarily when a complementary approach could make a real difference”. He opposed “large and threatened cuts” in the funding of homeopathic hospitals and their possible closure. He complained that referrals to the Royal London homeopathic hospital were increasing “until what seems to amount to a recent ‘anti-homeopathic campaign’”. He warned against cuts despite “the fact that these homeopathic hospitals deal with many patients with real health problems who otherwise would require treatment elsewhere, often at greater expense”.

In 2009, the ‘College of Integrated Medicine’ (the name was only later changed to ‘College of Medicine’, see below) was to have a second base in India. An Indian spokesman commented: “The second campus of the Royal College will be in Bangalore. We have already proposed the setting up of an All India Institute of Integrated Medicine to the Union health ministry. At a meeting in London last week with Prince Charles, we finalized the project which will kick off in July 2010”.

In 2010, Charles publicly stated that he was proud to be perceived as ‘an enemy of the enlightenment’.

In 2010, ‘Republic’ filed an official complaint about FIH alleging that its trustees allowed the foundation’s staff to pursue a public “vendetta” against a prominent critic of the prince’s support for complementary medicines. It also suggested that the imminent closure of Ernst’s department may be partly down to the charity’s official complaint about him after he publicly attacked its draft guide to complementary medicines as “outrageous and deeply flawed”.

In 2010, former fellows of Charles’ disgraced FIH launched a new organisation, The College of Medicine’ supporting the use of integrated treatments in the NHS. One director of the college is Michael Dixon, a GP in Cullompton, formerly medical director of the Foundation for Integrated Health. My own analysis of the activities of the new college leaves little doubt that it is promoting quackery.

In 2010, Charles published his book HARMONY which is full of praise for even the most absurd forms of alternative therapies and even bogus diagnostic tests used by alternative practitioners.

In 2011, after the launch of Charles’ range of herbal tinctures, I had the audacity to publicly criticise Charles for selling the Duchy Herbals detox tincture.

In 2011, Charles forged a link between ‘The College of Medicine’ and an Indian holistic health centre (see also above). The collaboration was reported to include clinical training to European and Western doctors in ayurveda and homoeopathy and traditional forms of medicine to integrate them in their practice. The foundation stone for the extended campus of the Royal College known as the International Institution for Holistic and Integrated Medicine was laid by Dr Michael Dixon in collaboration with the Royal College of Medicine.

In 2012, Charles was nominated for ‘THE GOLDEN DUCK AWARD’ for his achievements in promoting quackery. However, Andrew Wakefield beat him to it; Charles certainly was a deserving runner-up.

In 2013, Charles called for society to embrace a broader and more complex concept of health. In his article he described a vision of health that includes the physical and social environment, education, agriculture and architecture.

In 2013, Charles’ Highgrove enterprise offered ‘baby-hampers’ for sale at £195 a piece and made a range of medicinal claims for the products it contained. As these claims were not supported by evidence, there is no way to classify them other than quackery.

By 2013, the ‘Association of Osteomyologists’ were seeking to become regulated by statute, with the help of Prince Charles as their patron. The chairman and founder of this organisation was knighted for services to alternative medicine.  Osteomyologists encourage the use of techniques including cranio-sacral therapy and claim that “we all know that Colleges, Institutions, and Medical Practitioners, are brain washed from the very outset into believing that their discipline is the only way to go.”

In November 2013, Charles invited alternative medicine proponents from across the world, including Dean Ornish, Michael Dixon, chair of College of Medicine, UK and Issac Mathai of Soukya Foundation, Bangalore, to India for a ‘brain storm’ and a subsequent conference on alternative medicine. The prince wanted the experts to collaborate and explore the possibilities of integrating different systems of medicines and to better the healthcare delivery globally, one of the organisers said.

In June 2014, BBC NEWS published the following 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. On this blog, I have pointed out that the research in question was fatally flawed and that Charles, once again, overstepped the boundaries of his constitutional role.

In 2015, two books were published which are relevant in this context. My memoir A SCIENTIST IN WONDERLAND recounts most of my dealings with Charles and his sycophants, including how an intervention from his first private secretary eventually led to the closure of my department. The book by Catherine Meyer CHARLES, THE HEART OF A KING is far less critical about our heir to the throne; it nevertheless severely criticises his stance on alternative medicine.

In October 2015, the Guardian obtained the infamous “black spider memos” which revealed that Charles had repeatedly lobbied politicians in favour of alternative medicine (see also above).

In 2016, speaking at a global leaders summit on antimicrobial resistance, Prince Charles warned that Britain faced a “potentially disastrous scenario” because of the “overuse and abuse” of antibiotics. The Prince explained that he had switched to organic farming on his estates because of the growing threat from antibiotic resistance and now treats his cattle with homeopathic remedies rather than conventional medication. “As some of you may be aware, this issue has been a long-standing and acute concern to me,” he told delegates from 20 countries “I have enormous sympathy for those engaged in the vital task of ensuring that, as the world population continues to increase unsustainably and travel becomes easier, antibiotics retain their availability to overcome disease… It must be incredibly frustrating to witness the fact that antibiotics have too often simply acted as a substitute for basic hygiene, or as it would seem, a way of placating a patient who has a viral infection or who actually needs little more than patience to allow a minor bacterial infection to resolve itself.”

CONCLUSIONS

It seems that, in recent years (and perhaps in view of soon becoming our King), the Prince has tried to keep a low profile in controversial areas such as alternative medicine. But, every now and then, his passion for quackery seems to get the better of him. The late Christopher Hitchens repeatedly wrote about this passion, and his comments are, in my view, unsurpassable:

We have known for a long time that Prince Charles’ empty sails are so rigged as to be swelled by any passing waft or breeze of crankiness and cant. He fell for the fake anthropologist Laurens van der Post. He was bowled over by the charms of homeopathic medicine. He has been believably reported as saying that plants do better if you talk to them in a soothing and encouraging way… The heir to the throne seems to possess the ability to surround himself—perhaps by some mysterious ultramagnetic force?—with every moon-faced spoon-bender, shrub-flatterer, and water-diviner within range.

HAPPY BIRTHDAY YOUR ROYAL HIGHNESS

On 25 and 26 May of this year I wrote two posts about an acupuncture trial that, in my view, was dodgy. To refresh your memory, here is the relevant part of the 2nd post:

This new study was designed as a randomized, sham-controlled trial of acupuncture for persistent allergic rhinitis in adults investigated possible modulation of mucosal immune responses. A total of 151 individuals were randomized into real and sham acupuncture groups (who received twice-weekly treatments for 8 weeks) and a no acupuncture group. Various cytokines, neurotrophins, proinflammatory neuropeptides, and immunoglobulins were measured in saliva or plasma from baseline to 4-week follow-up.

Statistically significant reduction in allergen specific IgE for house dust mite was seen only in the real acupuncture group. A mean (SE) statistically significant down-regulation was also seen in pro-inflammatory neuropeptide substance P (SP) 18 to 24 hours after the first treatment. No significant changes were seen in the other neuropeptides, neurotrophins, or cytokines tested. Nasal obstruction, nasal itch, sneezing, runny nose, eye itch, and unrefreshed sleep improved significantly in the real acupuncture group (post-nasal drip and sinus pain did not) and continued to improve up to 4-week follow-up.

The authors concluded that acupuncture modulated mucosal immune response in the upper airway in adults with persistent allergic rhinitis. This modulation appears to be associated with down-regulation of allergen specific IgE for house dust mite, which this study is the first to report. Improvements in nasal itch, eye itch, and sneezing after acupuncture are suggestive of down-regulation of transient receptor potential vanilloid 1.

…the trial itself raises a number of questions:

  1. Which was the primary outcome measure of this trial?
  2. What was the power of the study, and how was it calculated?
  3. For which outcome measures was the power calculated?
  4. How were the subjective endpoints quantified?
  5. Were validated instruments used for the subjective endpoints?
  6. What type of sham was used?
  7. Are the reported results the findings of comparisons between verum and sham, or verum and no acupuncture, or intra-group changes in the verum group?
  8. What other treatments did each group of patients receive?
  9. Does anyone really think that this trial shows that “acupuncture is a safe, effective and cost-effective treatment for allergic rhinitis”?

In the comments section, the author wrote: “after you have read the full text and answered most of your questions for yourself, it might then be a more appropriate time to engage in any meaningful discussion, if that is in fact your intent”, and I asked him to send me his paper. As he does not seem to have the intention to do so, I will answer the questions myself and encourage everyone to have a close look at the full paper [which I can supply on request].

  1. The myriad of lab tests were defined as primary outcome measures.
  2. Two sentences are offered, but they do not allow me to reconstruct how this was done.
  3. No details are provided.
  4. Most were quantified with a 3 point scale.
  5. Mostly not.
  6. Needle insertion at non-acupoints.
  7. The results are a mixture of inter- and intra-group differences.
  8. Patients were allowed to use conventional treatments and the frequency of this use was reported in patient diaries.
  9. I don’t think so.

So, here is my interpretation of this study:

  • It lacked power for many outcome measures, certainly the clinical ones.
  • There were hardly any differences between the real and the sham acupuncture group.
  • Most of the relevant results were based on intra-group changes, rather than comparing sham with real acupuncture, a fact, which is obfuscated in the abstract.
  • In a controlled trial fluctuations within one group must never be interpreted as caused by the treatment.
  • There were dozens of tests for statistical significance, and there seems to be no correction for multiple testing.
  • Thus the few significant results that emerged when comparing sham with real acupuncture might easily be false positives.
  • Patient-blinding seems questionable.
  • McDonald as the only therapist of the study might be suspected to have influenced his patients through verbal and non-verbal communications.

I am sure there are many more flaws, particularly in the stats, and I leave it to others to identify them. The ones I found are, however, already serious enough, in my view, to call for a withdrawal of this paper. Essentially, the authors seem to have presented a study with largely negative findings as a trial with positive results showing that acupuncture is an effective therapy for allergic rhinitis. Subsequently, McDonald went on social media to inflate his findings even more. One might easily ask: is this scientific misconduct or just poor science?

END OF QUOTE

This and the previous post created lots of discussion and comments. However, the question whether the study in question amounted to scientific misconduct was never satisfactorily resolved. Therefore, I decided to write to the editor of ‘Ann Allergy Asthma Immunol‘ where the trial had been published. He answered by saying I would need to file an official complaint for him to address the issue. On 13 June, I therefore sent him the following email:

Thank you for your letter of 3/6/2016 suggesting I make a formal complaint about the paper entitled ‘EFFECT OF ACUPUNCTURE ON HOUSE DUST MITE…’ [ Ann Allergy Asthma Immunol 2016] by McDonald et al. I herewith wish to file such a complaint.

The article in question reports an RCT of acupuncture for persistent allergic rhinitis. It followed a parallel group design with 3 groups receiving the following interventions:

1.       Acupuncture

2.       Sham-acupuncture

3.       No treatment

There was a plethora of outcome measures and time points on which they were measured. A broad range of parameters was defined as primary endpoints.

The conclusion reached by the authors essentially was that acupuncture affected several outcome measures in a positive sense, thus supporting the notion that acupuncture is efficacious [“Symptoms and quality of life improved significantly and were still continuing to improve 4 weeks after treatment ceased.”] This conclusion, however, is misleading and needs correcting.

The main reasons for this are as follows:

·         Despite the fact that the authors did many dozens of statistical tests for significance, they did not correct for this multiplicity of tests. Consequently, some or most of the significant results are likely to be false positive.

·         Many of the positive results of this paper were not obtained by comparing one group to another but by doing before/after comparisons within one group. This approach defies the principle of a controlled clinical trial. For doing intra-group comparisons, we obviously do not need any control group at all. The findings from intra-group comparisons are prominently reported in the paper, for instance in the abstract, giving the impression that they originate from inter-group comparisons. One has to read the paper very carefully to find that, when inter-group comparisons were conducted, their results did NOT confirm the findings from the reported intra-group comparisons. As this is the case for most of the symptomatic endpoints, the impression given is seriously misleading and needs urgent correction.

On the whole, the article is a masterpiece of obfuscation and misrepresentation of the actual data. I urge you to consider the harm than can be done by such a misleading publication. In my view, the best way to address this problem is to withdraw the article.

I look forward to your decision.

Regards

E Ernst

END OF QUOTE

I had to send several reminders but my most recent one prompted the following response dated 7/11/ 2016:

Dear Professor Ernst,
Thank you for your patience while we worked through the process of considering your complaints levied on the article entitled ‘EFFECT OF ACUPUNCTURE ON HOUSE DUST MITE…’ [ Ann Allergy Asthma Immunol 2016] by McDonald et al. I considered the points that you made in your previous letter, sought input from our editorial team (including our biostatistics editor) , our publisher and the authors themselves. I sent the the  charges ( point by point) anonymously to the authors and allowed them time to respond which they did. I had their responses reviewed by selected editors and , as a result of this process, have decided not to pursue any corrective or punitive action based upon the following :
 
  1. Our editorial team recognizes that this is not the best clinical trial we have published in the Annals of Allergy, Asthma and Immunology. However, neither is is the worst. As in most published research studies, there are always things that could have been done better to make it a stronger paper. Never-the-less, the criticism falls fall short of any sort of remedy that would include withdrawal of the manuscript.
  2. Regarding your accusation that the multiple positive endpoint resulted in the authors making specific therapeutic claims, our assessment is that no specific therapeutic claim was made but rather the authors maintained that the data support the value of acupuncture in improving symptoms and quality of life in patients with AR. We do not believe there was overreach in those statements.
  3. The authors’ stated intent was to show immune changes associated with clinical markers of improvement in the active acupuncture group compared to controls. The authors maintain (and our editors agree) that their data assessments were primarily based upon three statistical tests not “dozens” (as stated in your original letter of complaint).  The power analysis and sample size calculations were presented to us and deemed adequate , making the probability of a type I error quite low.
  4. The authors acknowledge in their paper that there could be limitations to their data interpretation based upon potential disparities between intra- and intergroup comparisons. The editors felt their transparency was adequately disclosed.
In summary, as editor-in-chief of the Annals of Allergy, Asthma and Immunology, I did not find sufficient merit in your charges to initiate any corrective or punitive action for this manuscript. I understand you will strongly disagree with this decision and I regret that. However, in the final analysis, my primary intent is to preserve the objectivity, fairness, and integrity of our journal and its review process. I believe I have accomplished that in this instance.
 
Sincerely
END OF QUOTE
This seems to settle the issue: the study in question does not involve scientific misconduct!
Or does it?
I would be grateful for the view of the readers of this post.

This press-release just came to my attention:

Today, with the stroke of his pen, Governor Tom Wolf adds Pennsylvania to the list of states that acknowledge the value of alternative healthcare from a qualified professional. Pennsylvania becomes the 21st U.S. jurisdiction to regulate naturopathic medicine. The new law HB516 regulates naturopathic doctors; ensuring patients can trust that their wellness professional holds a graduate degree from an accredited naturopathic medical school.

Heidi Weinhold, N.D. and Legislative Chair of the Pennsylvania Association of Naturopathic Physicians (PANP), says, “This is a historic day for naturopathic medicine. The governor’s approval will throw open the doors for more Pennsylvania students to choose this academic course of study. Then, they can return home from a four-year graduate program to set up a practice as a naturopathic doctor.”

The PANP members worked for the last 16 years with the state legislature to advance the much-needed recognition of this growing medical field. Their goal was to increase the credibility and minimize the confusion between professionals with an advance degree and the self-study practitioner. “Naturopathic professionals also seek to better coordinate and collaborate with medical professionals across the spectrum. We believe in integrative care, and this law gives us the stature we need to work N,” explains Dr. Weinhold.

Under the new law, the terms Naturopathic Doctor and ND will be reserved exclusively for those who have attended four-year, post-graduate level programs at institutions recognized by the United States Department of Education. “This protects the scope-of-work and title for graduates from an accredited N.D. program,” offers Dr. JoAnn Yanez, executive director of the Association of Accredited Naturopathic Colleges.

Naturopathic Doctors are currently practicing at Cancer Treatment Centers of America in Philadelphia, as well as the University of Pittsburgh Medical Centers, where they work side by side with medical doctors in an integrative setting. More patients could be served in this manner once naturopathic doctors are registered in this state. Both Penn State Hershey Medical Center and West Penn Allegheny General Hospital have indicated that they would hire Naturopathic Doctors if they were registered in the state.

“The PANP will be working over the next year on implementation of the legislation in order that NDs can begin to register with the Board of Medicine. A number of Representatives and Senators have encouraged us to come back to the legislature next session in order to expand the scope of this bill. We are very encouraged about the future of naturopathic medicine in Pennsylvania,” says Dr. Marie Winters, manager of the Naturopathic Medicine Department of the Cancer Treatment Centers of America and president of PANP.

The law will go into effect January 1, 2018.

Pennsylvania joins these other jurisdictions which regulate naturopathic medicine: Alaska, Arizona, California, Colorado, Connecticut, District of Columbia, Kansas, Maine, Maryland, Minnesota, Montana, New Hampshire, North Dakota, Oregon, Rhode Island, Utah, Vermont, Washington, Puerto Rico and U.S. Virgin Islands, and these provinces in Canada: Alberta, British Columbia, Manitoba, Ontario, Saskatchewan.

END OF QUOTE

Here are a few comments and issues that I find remarkable about this announcement:

  • Naturopaths are called ‘naturopathic doctors’, yet in the same sentence it is pointed out that they are ‘wellness professionals’. I am not sure what the latter, woolly term is supposed to mean – perhaps that naturopathy cannot effectively treat diseases?
  • The document speaks of ‘accredited naturopathic medical schools’. Has anyone checked the utter nonsense that is being taught there? The answer is yes, Britt Marie Hermes has, and her verdict is truly depressing and devastating.
  • Naturopaths instantly interpret the new regulation as a ‘governor’s approval’ and ‘recognition’. It shows why alternative practitioners want to be regulated: they foremost crave the APPROVAL and the RECOGNITION they clearly do not deserve.
  • Naturopaths believe in ‘integrative care’ – of course they do, because this is nothing but a ploy for smuggling quackery into evidence-based medicine (EBM).
  • Naturopaths want to be ‘peer-to-peer with other disciplines’ – but they are unable to show that their interventions generate more good than harm. This effectively is an attempt to place quackery on the same level as EBM.
  • Naturopaths already treat cancer patients in the state! Really? Do they use Laetrile, or homeopathy?
  • Naturopaths are portrayed as being a benefit to public health. Has anyone considered that the opposite might be the case? See for instance here and here.

Prince Charles’ views on health have repeatedly taken centre stage on this blog. And rightly so; they are often weird and wonderful. In 2013, for instance, I quoted them extensively:

Charles stands for…”the kind of care that integrates the best of new technology and current knowledge with ancient wisdom. More specifically, perhaps, it is an approach to care of the patient which includes mind, body and spirit and which maximizes the potential of conventional, lifestyle and complementary approaches in the process of healing”. Charles believes that conventional medicine aims “to treat the symptoms of disease” his vision of a post-modern medicine therefore is “actively to create health and to put the patient at the heart of this process by incorporating those core human elements of mind, body and spirit…This whole area of work – what I can only describe as an ‘integrated approach’ in the UK, or ‘integrative’ in the USA – takes what we know about appropriate conventional, lifestyle and complementary approaches and applies them to patients. I cannot help feeling that we need to be prepared to offer the patient the ‘best of all worlds’ according to a patient’s wishes, beliefs and needs“. Charles also points out that “health inequalities have lowered life-expectancy” in parts of the UK and suggests, if we “tackle some of these admittedly deep-seated problems, not only do you begin to witness improvements in health and other inequalities, but this can lead to improvements in the overall cost-efficiency and effectiveness of local services.

Sounds alright? Well – at least it is touching to see how he is concerned about inequalities in the UK!

But the royal and no doubt well-intended views need to be followed by royal actions. If not, such words might degenerate into royal BS. If Charles is so keen on giving us all THE BEST OF BOTH WORLDS, he should stop promoting outright quackery such as homeopathic remedies. They contain nothing but sugar! But that is one substance Charles seems to be rather fond of, regardless of the harm it can do in high doses to public health.

Recently, Prince Charles has been criticised by health campaigners for the high sugar content of his Duchy Organic ice cream. The Duchy Organic vanilla ice cream contains 14.5g of sugar per 100g, almost double the amount of Asda’s ‘smart price’ vanilla ice cream which has 7.9g sugar per 100g.  If that wasn’t enough of a blow to the Prince’s brand, the Asda ice cream is also much more affordable at 85p for two litres – compared with £3.49 for every 750ml tub of the Duchy Organic product. Charles’ Dutchy Originals products are sold by Waitrose, and a spokesman of the retailer said: “Waitrose Duchy Organic vanilla ice cream is an indulgent product which is not aimed at children.”

Indulgent like in ‘expensive’? So much for inequalities, Charles.

But let’s not go there; let’s be constructive; after all, the man is full of good will, isn’t he?

I recommend the R&D department of Dutchy Originals put their profits and Charles convictions to good use. Specifically, I suggest they start a research programme on the homeopathic cure for sugar-induced obesity. If Charles is correct, and LIKE CURES LIKE, the obesity epidemic in the UK should be treatable with the very cause of excess body weight. It follows that potentised sugar ought to be a cure for obesity.

I can see it now: DUTCHY ORIGINALS – ‘SUGAR C30’, £15.99 per 10g.

Stable angina is a symptom of coronary heart disease which, in turn, is amongst the most frequent causes of death in developed countries. It is an alarm bell to any responsible clinician and requires causal, often life-saving treatments of which we today have several options. The last thing a patient needs in this condition is ACUPUNCTURE, I would say.

Yet acupuncture is precisely the therapy such patients might be tempted to employ.

Why?

Because irresponsible or criminally naïve acupuncturists advertise it!

Take this website, for instance; it informs us that a meta-analysis of eight clinical trials conducted between 2000 and 2014 demonstrates the efficacy of acupuncture for the treatment of stable angina. In all eight clinical trials, patients treated with acupuncture experienced a greater rate of angina relief than those in the control group treated with conventional drug therapies (90.1% vs 75.7%)….

I imagine that this sounds very convincing to patients and I fear that many might opt for acupuncture instead of potentially invasive/unpleasant but life-saving intervention. The original meta-analysis to which the above promotion referred to is equally optimistic. Here is its abstract:

Angina pectoris is a common symptom imperiling patients’ life quality. The aim of this study is to evaluate the efficacy and safety of acupuncture for stable angina pectoris. Clinical randomized-controlled trials (RCTs) comparing the efficacy of acupuncture to conventional drugs in patients with stable angina pectoris were searched using the following database of PubMed, Medline, Wanfang and CNKI. Overall odds ratio (ORs) and weighted mean difference (MD) with their 95% confidence intervals (CI) were calculated by using fixed- or random-effect models depending on the heterogeneity of the included trials. Total 8 RCTs, including 640 angina pectoris cases with 372 patients received acupuncture therapy and 268 patients received conventional drugs, were included. Overall, our result showed that acupuncture significantly increased the clinical curative effects in the relief of angina symptoms (OR=2.89, 95% CI=1.87-4.47, P<0.00001) and improved the electrocardiography (OR=1.83, 95% CI=1.23-2.71, P=0.003), indicating that acupuncture therapy was superior to conventional drugs. Although there was no significant difference in overall effective rate relating reduction of nitroglycerin between two groups (OR=2.13, 95% CI=0.90-5.07, P=0.09), a significant reduction on nitroglycerin consumption in acupuncture group was found (MD=-0.44, 95% CI=-0.64, -0.24, P<0.0001). Furthermore, the time to onset of angina relief was longer for acupuncture therapy than for traditional medicines (MD=2.44, 95% CI=1.64-3.24, P<0.00001, min). No adverse effects associated with acupuncture therapy were found. Acupuncture may be an effective therapy for stable angina pectoris. More clinical trials are needed to systematically assess the role of acupuncture in angina pectoris.

In the discussion section of the full paper, the authors explain that their analysis has several weaknesses:

Several limitations were presented in this meta-analysis. Firstly, conventional drugs in control group were different, this may bring some deviation. Secondly, for outcome of the time to onset of angina relief with acupuncture, only one trial included. Thirdly, the result of some outcomes presented in different expression method such as nitroglycerin consumption. Fourthly, acupuncture combined with traditional medicines or other factors may play a role in angina pectoris.

However, this does not deter them to conclude on a positive note:

In conclusion, we found that acupuncture therapy was superior to the conventional drugs in increasing the clinical curative effects of angina relief, improving the electrocardiography, and reducing the nitroglycerin consumption, indicating that acupuncture therapy may be effective and safe for treating stable angina pectoris. However, further clinical trials are needed to systematically and comprehensively evaluate acupuncture therapy in angina pectoris.

So, why do I find this irresponsibly and dangerously misleading?

Here a just a few reasons why this meta-analysis should not be trusted:

  • There was no systematic attempt to evaluate the methodological rigor of the primary studies; any meta-analysis MUST include such an assessment, or else it is not worth the paper it was printed on.
  • The primary studies all look extremely weak; this means they are likely to be false-positive.
  • They often assessed not acupuncture alone but in combination with other treatments; consequently the findings cannot be attributed to acupuncture.
  • All the primary studies originate from China; we have seen previously (see here and here) that Chinese acupuncture trials deliver nothing but positive results which means that their results cannot be trusted: they are false-positive.

My conclusion: the authors, editors and reviewers responsible for this article should be ashamed; they committed or allowed scientific misconduct, mislead the public and endangered patients’ lives.

cufimrfweaarb0r

I found this on Twitter; fascinating isn’t it?

So much so, that I decided to run a quick ‘reality check’: are any of these claims based on anything resembling sound evidence?

Here we go:

IT HELPS BRING ABOUT RECOVERY

This is the sort of woolly language that quacks of any type seem to adore. Recovery of what? Perhaps recovery from delusion? No evidence for that, I am sure.

IT CAN REDUCE YOUR BLOOD PRESSURE

Yes, there are some studies on this topic. There is even a systematic review of the relevant trials; it was published by chiros in a chiro journal and it nevertheless concluded that there is currently a lack of low bias evidence to support the use of Spinal Manipulative Therapy as a therapy for the treatment of hypertension. Future investigations may clarify if SMT is effective for treating hypertension, either by itself or as an adjunctive therapy, and by which physiologic mechanism this occurs.

IT IMPROVES THE NERVOUS SYSTEM

Another woolly claim, if there ever was one. What does it mean? Nothing! Consequently, there also is no evidence to back it up.

BETTER POSTURE AND FLEXIBILITY

Chiros will probably claim that the exercises they sometimes recommend might lead to improvements in posture and flexibility of the musculoskeletal system. Even though there is not much good evidence for this, it might still be true. But chiropractic manipulations are unlikely to achieve these aims.

STRONG IMMUNE SYSTEM

There are some studies to imply that spinal manipulations stimulate the immune system. This is what I wrote about them previously: If we look at the actual research that might support such strange claims, we find that that it is scarce, flimsy and unconvincing. To the best of my knowledge, nobody has yet shown that people who receive regular chiropractic care are protected from conditions mediated via the immune system. Unless such a phenomenon can be demonstrated beyond reasonable doubt, we should be highly sceptical of the claim that chiropractic care stimulates the immune system and thus generates better health. In my view, regular chiropractic adjustments stimulate only one thing: the cash flow of the therapist.

LESS NEED FOR MEDICATIONS

This is one of the favourite claims of chiros. It is  supported by evidence showing that patients who see a chiropractor use less drugs than those who don’t. But that is due to chiros traditionally being anti-drug; they thus advise their patients not to take any drugs. Very different from claiming their patients need less medications, I’d say. In fact, it seems to me like saying people who regularly go to church pray more than those who don’t.

Why is any of this important?

Some might think that all of this is trivial, irrelevant and boring. I beg to differ.

It matters, I think, because such promotion and bogus claims are what consumers are constantly exposed to. Eventually, many will believe this nonsense, even if it is overtly wrong or stupid. What is being trumpeted loudly a thousand times might eventually be believed.

In other words, such advertisements are relevant because they shape the minds of the public. As responsible healthcare professionals, we ought to be aware of these campaigns and do what we can to correct the false impressions they generate.

I have warned you before to be sceptical about Chinese studies. This is what I posted on this blog more than 2 years ago, for instance:

Imagine an area of therapeutics where 100% of all findings of hypothesis-testing research are positive, i.e. come to the conclusion that the treatment in question is effective. Theoretically, this could mean that the therapy is a miracle cure which is useful for every single condition in every single setting. But sadly, there are no miracle cures. Therefore something must be badly and worryingly amiss with the research in an area that generates 100% positive results.

Acupuncture is such an area; we and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. In other words, one does not need to read the paper, one already knows that it is positive – even more extreme: one does not need to conduct the study, one already knows the result before the research has started. But you might not believe my research nor that of others. We might be chauvinist bastards who want to discredit Chinese science. In this case, you might perhaps believe Chinese researchers.

In this systematic review, all randomized controlled trials (RCTs) of acupuncture published in Chinese journals were identified by a team of Chinese scientists. A total of 840 RCTs were found, including 727 RCTs comparing acupuncture with conventional treatment, 51 RCTs with no treatment controls, and 62 RCTs with sham-acupuncture controls. Among theses 840 RCTs, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The percentages of RCTs concealment of the information on withdraws or sample size calculations were 43.7%, 5.9%, 4.9%, 9.9%, and 1.7% respectively.

The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.

END OF QUOTE

Now an even more compelling reason emerged for taking evidence from China with a pinch of salt:

A recent survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. Officials are now warning that further evidence malpractice could still emerge in the scandal.
According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations.

“Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Contract research organizations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”

A doctor at a top hospital in the northern city of Xian said the problem doesn’t lie with insufficient regulations governing clinical trials data, but with the failure to implement them. “There are national standards for clinical trials in the development of Western pharmaceuticals,” he said. “Clinical trials must be carried out in three phases, and they must be assessed at the very least for safety,” he said. “But I don’t know what happened here.”

Public safety problems in China aren’t limited to the pharmaceutical industry and the figure of 80 percent is unlikely to surprise many in a country where citizens routinely engage in the bulk-buying of overseas-made goods like infant formula powder. Guangdong-based rights activist Mai Ke said there is an all-pervasive culture of fakery across all products made in the country. “It’s not just the medicines,” Mai said. “In China, everything is fake, and if there’s a profit in pharmaceuticals, then someone’s going to fake them too.” He said the problem also extends to traditional Chinese medicines, which are widely used in conjunction with Western pharmaceuticals across the healthcare system.
“It’s just harder to regulate the fakes with traditional medicines than it is with Western pharmaceuticals, which have strict manufacturing guidelines,” he said.

According to Luo, academic ethics is an underdeveloped field in China, leading to an academic culture that is accepting of manipulation of data. “I don’t think that the 80 percent figure is overstated,” Luo said.

And what should we conclude from all this?

I find it very difficult to reach a verdict that does not sound hopelessly chauvinistic but feel that we have little choice but to distrust the evidence that originates from China. At the very minimum, I think, we must scrutinise it thoroughly; whenever it looks too good to be true, we ought to discard it as unreliable and await independent replications.

1 2 3 25
Recent Comments

Note that comments can now be edited for up to five minutes after they are first submitted.


Click here for a comprehensive list of recent comments.

Categories