MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

fraud

TODAY IS ‘WORLD HOMEOPATHY DAY!!!

Let’s celebrate it by looking at the latest ‘cutting edge’ research on the world’s most commercially successful homeopathic remedy, Oscillococcinum®, a preparation of duck organs that are so highly diluted that not one molecule per universe is present in the end-product. It is therefore surprising to read that this new investigation finds it to be effective.

According to its authors, the goal of this controlled observational study was “to investigate the role of the homeopathic medicine in preventing respiratory tract infections (RTIs)”. The ‘study’ was not actually a study but a retrospective analysis of patients’ medical records. It examined 459 patients who were referred to a respiratory diseases specialist in Italy. Subjects who had taken any form of flu vaccine or any other type of vaccine (immuno-stimulants, bacterial lysates, or similar) were excluded from the study.  248 patients were treated with the homeopathic medicine, while 211 were, according to one statement by the authors, not treated. The latter group was deemed to be the control group. All patients were followed-up for at least 1 year, and up to a maximum of 10 years.

A significant reduction in the frequency of onset of RTIs was found in both the homeopathic medicine and untreated groups. The reduction in the mean number of RTI episodes during the period of observation vs. the year before inclusion in the study was significantly greater in the homeopathic-treated group than in untreated patients (-4.76 ± 1.45 vs. -3.36 ± 1.30; p = 0.001). The beneficial effect of the homeopathic medicine was not significantly related to gender, age, smoking habits or concomitant respiratory diseases when compared to the effect observed in untreated patients. The number of infections during the follow-up period is plotted in the graph.

40248_2016_49_Fig1_HTML

The authors concluded that these results suggest that homeopathic medicine may have a positive effect in preventing RTIs. However, randomized studies are needed before any firm conclusion can be reached.

This could well be the worst study of homeopathy, an area where there is no shortage of poor research, that I have seen for a long time. Here are some of its most obvious problems:

  • The aim was to investigate the role of homeopathic medicine – why then do the authors draw conclusions about its effectiveness?
  • The ‘control group’ was not ‘not treated’ as the authors claim, but these patients were prescribed the homeopathic remedy and did not comply. They were neither untreated – most would have self-medicated something else) nor a proper control group. This is what the authors state about it: “The physician initially instructed all 459 patients to take 1 dose of homeopathic medicine…A total of 211 patients were found to be non-compliant (i.e., they did not take the homeopathic medicine as recommended by the medical doctor), and these formed the control group.”
  • Why were vaccinated patients excluded? This would skew the sample towards anti-vaxers who tend to be homeopathy-fans.
  • A follow-up between 1 and 10 years? Are they serious? The authors tell us that “a total of 21 (4.6 %) patients ended the follow-up before 2012…” Did all the others die of homeopathic over-dose?
  • Before the start of the ‘study’, patients had more than 5 infections per year. This is way beyond the normal average of 1-2.
  • The authors inform us that “the primary outcome measure for assessing the effectiveness of the preventive treatment with homeopathic medicine was the reduction in the average number of RTI episodes per year versus the year before inclusion in the study.” This begs the question as to how the primary endpoint was assessed. The answer is by asking the patients or phoning them. This method is wide open to recall-bias and therefore not suited as a primary outcome measure.

My favourite alternative explanation for the reported findings – and there are many that have nothing to do with homeopathy – goes like this: some patients did not comply because their condition did not respond to homeopathy. These were the ones who were, on average, more severely ill. They needed something better than a homeopathic placebo and they therefore became the ‘control group’. As the differed systematically from the verum group, it would be most extraordinary, if they did not show different findings during follow-up.

So, is there nothing interesting here at all?

Not really…hold on, here is something: “The corresponding author thanks the Scientific Department of Laboratories Boiron S.r.l. (Milan, Italy) for funding the independent statistical analysis made at the Department of Medical and Surgical Sciences of the Alma Mater Studiorum-University of Bologna (Bologna, Italy).”

BOIRON SEEMS TO DECIDE ON FUNDING AFTER HOMEOPATHICALLY DILUTING SCIENTIFIC RIGOR AND COMMON SENSE.

One argument I hear over and over again; it could be called ‘the fallacy of the benign placebo’ and goes like this:

  • Alright, I accept that the evidence for xy isn’t brilliant.
  • I might even accept it is a pure placebo therapy.
  • But that is not important.
  • What counts is that it helps suffering patients.
  • Who cares about the mechanism?
  • As long as a therapy can be shown to be helpful, we should use it!

I am sure you agree, this fallacy is extremely common. What is more, it is damn difficult to argue against. Whatever I used to counter, people would look at me in disbelief thinking: those scientists really sit in their ivory towers and haven’t got a clue about the real issues.

In my frustration of not getting through to many people, I have now thought of THE TELLING TALE OF THE PLACEBO BANKER.

Allow me to explain:

Imagine you are in real difficulties. You lost your job, your wife is ill, your children need feeding, the bills are stacking up – in a word, you need a loan to survive the next few months until things are sorted out.

Luckily, you know a very nice chap who is in charge of your local bank and who has a reputation of trying his utmost to help clients in need. So, you make an appointment and see him. He listens attentively and shows compassion for your situation. He gives you all the time to explain things in full detail and then re-assures you that there is hope: he will help you! At the end of the consultation you leave his office feeling well and optimistic. You even have in your hands a tidy amount of money that will get you through this bad patch. All is fine…because you have seen a real banker who knows his job in such situations consists mainly of two things:

  1. be kind, listen with empathy and give assurance that makes customers feel good,
  2. give the necessary credit.
The real banker is, of course, akin to the real physician who must:
  1. show compassion and empathy,
  2. prescribe an effective treatment.

Now, imagine you are in dire straights again. This time you go to a different banker, someone who has the reputation to be even kinder and more ‘holistic’. The consultation proceeds much as the last one. The banker listens, offers help and shows compassion. If anything, this new chap is even better at this task. He is more understanding than the last one, he even explains why you got into difficulties, and he has a full hour just to talk with you. Consequently, you feel really good about the whole thing, and you are happy as he gives you an envelope full of money that will assist you solving your current problems. You go home and feel great…until, three days later, you need to pay your first bill, open the envelope and discover that it contains plenty of notes, but they are all Monopoly money. You discover that you have become the victim of THE PLACEBO BANKER.

The placebo banker is, of course, akin to the placebo therapist who can do little more than:

  1. show compassion and empathy,
  2. dish out placebos.

I know, the analogy is not perfect but is explains the fallacy a bit, I hope.

Placebo therapist, such as homeopaths, energy healers, etc., give you their time, compassion, empathy – and that’s why their patients often feel better. They also give you their placebos which do very little and, if they do anything at all, the effect does neither last nor cure the disease. To argue that this limited effect justifies the quackery is like pretending THE PLACEBO BANKER does a good job.

Good banking consists of courteous behaviour and adequate financial assistance.

Good medicine consists of compassion and effective treatments.

If one of the two essential elements is missing, neither the banking nor the medicine can be good or ethical.

‘Megalomania’ of a clinician is (for the purpose of this blog-post) defined as a practitioner claiming to cure everything. It seems to me that this dangerous condition is endemic in the realm of alternative medicine, and particularly in chiropractic. Perhaps they catch it at chiro school, I don’t know, but an awful lot of them seem to suffer from it.

We all had to get used to this fact, and there is nothing remarkable about it anymore. But recently I came across a website where an extraordinarily severe case is being disclosed. Let me share some of the text (including its grammatical and other errors) with you:

How many of the 10,000 patients Dr. Del Monte has – upon whom he has performed one million spinal adjustments – with his hands – healed themselves?

The woman who could not get pregnant. Doctors told her she would never conceive.

She came to Dr. Del Monte, got adjustments and soon after, somehow – she got pregnant and gave birth to a healthy child.

The person with the brain tumor that went away. Science can’t prove it – no more than you can X- Ray for a headache and prove it. Maybe he would have healed his tumor without spinal adjustments.

The two year old that couldn’t speak who suddenly opened her mouth and babbled one hour after her first adjustment.

Asthmatics, bedwetters, people in pain, their back and neck, indigestion, earaches.

Cured.

People set for surgery because they couldn’t bear the pain – who went to Dr. Del Monte and never met the surgeons’ knife.

Dr. Del Monte is an apostle – and I use the word advisedly – for chiropractic is not religion – although its founder D.D. Palmer thought of making it a religion – because it seems to unleash God’s healing power.

Chiropractic can open up impossible doors, unlock the door to free-flowing, “Innate Intelligence” – the natural tendency of the body to seek and maintain a condition of balance or equilibrium.

You don’t believe in Innate Intelligence?

One chiropractor explained it this way: “At the moment of your conception, 23 chromosomes from your mother and 23 chromosomes from your father combined to form one cell, the unique ‘You’.

“Barely the size of a pinhead, that one cell began to divide into what is now an estimated 80 quadrillion cells that make up your body. This process is driven by something – call it an Innate Intelligence, an inborn wisdom, which knows how tall you will be, the length of your fingers, where your nose should be on your face, and where your vital organs belong.

“This Innate Intelligence stays with you after you are born and guides every function of your body until your last breath of life.

“The master control system for this is your nervous system which consists of your brain, spinal cord and nerves that go to every cell, tissue and organ. Nerves control your heartbeat, respiration, hormone balance, digestion, immune system, muscle contraction and every other function that is necessary for you to live.

“Your Innate Intelligence is ‘wise’ to the importance of this system. Fully encased in bone, your skull protects your brain and your spinal column protects your spinal cord.”

While no chiropractor can guarantee that your Innate Intelligence will self cure any specific symptoms or diseases, they can guarantee that when your body is free of nerve interference it will work better.

Some have regained eyesight.

Several threw away their canes.

You will often hear people say, when they leave Dr. Del Monte’s office “My back is so much better, I can stand up straight; My migraines are gone; My blood pressure is down; My heartburn is gone; Menstrual cramping went away; My digestion is better; I haven’t had a cold in years.”

Dr. Del Monte explains: “Anything that could be effected by the nervous system can be improved by chiropractic manipulation, and the nervous system controls and coordinates almost every function of the body.

“Why would you mask the symptoms with drugs, when you could allow your own body to heal?”

“Sick cells makes sick tissues which make sick organs. Then there are sick people. Symptoms are the last to show up. If the spine is healthy, the body needs no help in healing. It does the healing.”

The main procedure is “spinal manipulation,” or “adjustments” which restore mobility by applying force into joints that became restricted – as a result of injury — caused by a traumatic event or through repetitive stresses – causing inflammation, pain, and diminished function.

Manipulation, or adjustment of the joint and tissues, alleviates pain and muscle tightness, and allows tissues to heal.

“It should be tried first ahead of drugs and surgery,” Dr. Del Monte says.

The focus is therefore on spotting and curing “vertebral subluxations”, said to be the cause of many diseases. Sometimes chiropractic assumes the sole cause of an individual’s health problems are subluxations.

These subluxations, commonly caused by birth trauma, childhood falls, accidents and all types of stress, reduce the function of the areas supplied by these nerves.

Nerve pressure can affect areas that are directly supplied by those nerves: muscles, bladder, prostate or heart; they can affect the entire body because of the relationship that each cell, organ and system share…

The list of ailments Dr. Del Monte has seen his patients cured of – self healed – are nearly endless: Bowel/bladder problems, chronic colds, allergies, ringing in the ears, earaches, bed wetting, sciatica, colds, fevers…

“So many times people come in with a cold or fever. We see an almost instant response- within hours. It’s not like you are waiting days.

“Ninety percent of the time patients get favorable results. Rarely does a patient go to a Chiropractor and say ‘it didn’t work for me’…

“I don’t need a referral. I don’t need a script. People do refer patients here, but I am primary healthcare. They don’t have to go through their medical doctor. They just come and see me. They just call the office, “ said Dr. Del Monte.

END OF QUOTE

THE ONLY CONDITION THAT CHIROPRACTIC MANIPULATION CANNOT CURE IS MEGALOMANIA!

On a good day, I can heartily laugh at this sort of thing (of which this article is merely one of hundreds of example available on the Internet). On a not so good day, however, I ask myself questions:

  • Where does such idiocy come from?
  • Do chiropractors ever learn anything about medical ethics?
  • Why is this chiropractor still allowed to practice?
  • What happens to the poor patients who fall for it?
  • Why is nobody stopping it?
  • Where are the protests of chiropractors who boast of being reformed and evidence-based?

Recently, I came across the ‘Clinical Practice Guidelines on the Use of Integrative Therapies as Supportive Care in Patients Treated for Breast Cancer’ published by the ‘Society for Integrative Oncology (SIO) Guidelines Working Group’. The mission of the SIO is to “advance evidence-based, comprehensive, integrative healthcare to improve the lives of people affected by cancer. The SIO has consistently encouraged rigorous scientific evaluation of both pre-clinical and clinical science, while advocating for the transformation of oncology care to integrate evidence-based complementary approaches. The vision of SIO is to have research inform the true integration of complementary modalities into oncology care, so that evidence-based complementary care is accessible and part of standard cancer care for all patients across the cancer continuum. As an interdisciplinary and inter-professional society, SIO is uniquely poised to lead the “bench to bedside” efforts in integrative cancer care.”

The aim of the ‘Clinical Practice Guidelines’ was to “inform clinicians and patients about the evidence supporting or discouraging the use of specific complementary and integrative therapies for defined outcomes during and beyond breast cancer treatment, including symptom management.”

This sounds like a most laudable aim. Therefore I studied the document carefully and was surprised to read their conclusions: “Specific integrative therapies can be recommended as evidence-based supportive care options during breast cancer treatment.”

How can this be? On this blog, we have repeatedly seen evidence to suggest that integrative medicine is little more than the admission of quackery into evidence-based healthcare. This got me wondering how their conclusion had been reached, and I checked the document even closer.

On the surface, it seemed well-made. A team of researchers first defined the treatments they wanted to look at, then they searched for RCTs, evaluated their quality, extracted their results, combined them into an overall verdict and wrote the whole thing up. In a word, they conducted what seems a proper systematic review.

Based on the findings of their review, they then issued recommendations which I thought were baffling in several respects. Let me just focus on three of the SIO’s recommendations dealing with acupuncture:

  1. “Acupuncture can be considered for treating anxiety concurrent with ongoing fatigue…” [only RCT (1) cited in support]
  2. “Acupuncture can be considered for improving depressive symptoms in women suffering from hot flashes…” [RCTs (1 and 2) cited in support] 
  3. “Acupuncture can be considered for treating anxiety concurrent with ongoing fatigue…” [only RCT (1) cited in support]
One or two studies as a basis for far-reaching guidelines? Yes, that would normally be a concern! But, at closer scrutiny, my worries about these recommendation turn out to be much more serious than this.

The actual RCT (1) cited in support of all three recommendations stated that the authors “randomly assigned 75 patients to usual care and 227 patients to acupuncture plus usual care…” As we have discussed often before on this blog and elsewhere, such a ‘A+B versus B study design’ will never generate a negative result, does not control for placebo-effects and is certainly not a valid test for the effectiveness of the treatment in question. Nevertheless, the authors of this study concluded that: “Acupuncture is an effective intervention for managing the symptom of cancer-related fatigue and improving patients’ quality of life.”

RCT (2) cited in support of recommendation number 2 seems to be a citation error; the study in question is not an acupuncture-trial and does not back the statement in question. I suspect they meant to cite their reference number 87 (instead of 88). This trial is an equivalence study where 50 patients were randomly assigned to receive 12 weeks of acupuncture (n = 25) or venlafaxine (n = 25) treatment for cancer-related hot flushes. Its results indicate that the two treatments generated the similar results. As the two therapies could also have been equally ineffective, it is impossible, in my view, to conclude that acupuncture is effective.

Finally, RCT (1) does in no way support recommendation number two. Yet RCT (1) and RCT (2) were both cited in support of this recommendation.

I have not systematically checked any other claims made in this document, but I get the impression that many other recommendations made here are based on similarly ‘liberal’ interpretations of the evidence. How can the ‘Society for Integrative Oncology’ use such dodgy pseudo-science for formulating potentially far-reaching guidelines?

I know none of the authors (Heather Greenlee, Lynda G. Balneaves, Linda E. Carlson, Misha Cohen, Gary Deng, Dawn Hershman, Matthew Mumber, Jane Perlmutter, Dugald Seely, Ananda Sen, Suzanna M. Zick, Debu Tripathy) of the document personally. They made the following collective statement about their conflicts of interest: “There are no financial conflicts of interest to disclose. We note that some authors have conducted/authored some of the studies included in the review.” I am a little puzzled to hear that they have no financial conflicts of interest (do not most of them earn their living by practising integrative medicine? Yes they do! The article informs us that: “A multidisciplinary panel of experts in oncology and integrative medicine was assembled to prepare these clinical practice guidelines. Panel members have expertise in medical oncology, radiation oncology, nursing, psychology, naturopathic medicine, traditional Chinese medicine, acupuncture, epidemiology, biostatistics, and patient advocacy.”). I also suspect they have other, potentially much stronger conflicts of interest. They belong to a group of people who seem to religiously believe in the largely nonsensical concept of integrative medicine. Integrating unproven treatments into healthcare must affect its quality in much the same way as the integration of cow pie into apple pie would affect the taste of the latter.

After considering all this carefully, I cannot help wondering whether these ‘Clinical Practice Guidelines’ by the ‘Society for Integrative Oncology’ are just full of honest errors or whether they amount to fraud and scientific misconduct.

WHATEVER THE ANSWER, THE GUIDELINES MUST BE RETRACTED, IF THIS SOCIETY WANTS TO AVOID LOSING ALL CREDIBILITY.

In recent blogs, I have written much about acupuncture and particularly about the unscientific notions of traditional acupuncturists. I was therefore surprised to see that a UK charity is teaming up with traditional acupuncturists in an exercise that looks as though it is designed to mislead the public.

The website of ‘Anxiety UK’ informs us that this charity and the British Acupuncture Council (BAcC) have launched a ‘pilot project’ which will see members of Anxiety UK being able to access traditional acupuncture through this new partnership. Throughout the pilot project, they proudly proclaim, data will be collected to “determine the effectiveness of traditional acupuncture for treating those living with anxiety and anxiety based depression.”

This, they believe, will enable both parties to continue to build a body of evidence to measure the success rate of this type of treatment. Anxiety UK’s Chief Executive Nicky Lidbetter said: “This is an exciting project and will provide us with valuable data and outcomes for those members who take part in the pilot and allow us to assess the benefits of extending the pilot to a regular service for those living with anxiety. “We know anecdotally that many people find complementary therapies used to support conventional care can provide enormous benefit, although it should be remembered they are used in addition to and not instead of seeking medical advice from a doctor or taking prescribed medication. This supports our strategic aim to ensure that we continue to make therapies and services that are of benefit to those with anxiety and anxiety based depression, accessible.”

And what is wrong with that, you might ask.

What is NOT wrong with it, would be my response.

To start with, traditional acupuncture relies of obsolete assumptions like yin and yang, meridians, energy flow, acupuncture points etc. They have one thing in common: they fly in the face of science and evidence. But this might just be a triviality. More important is, I believe, the fact that a pilot project cannot determine the effectiveness of a therapy. Therefore the whole exercise smells very much like a promotional activity for pure quackery.

And what about the hint in the direction of anecdotal evidence in support of the study? Are they not able to do a simple Medline search? Because, if they had done one, they would have found a plethora of articles on the subject. Most of them show that there are plenty of studies but their majority is too flawed to draw firm conclusions.

A review by someone who certainly cannot be accused of being biased against alternative medicine, for instance, informs us that “trials in depression, anxiety disorders and short-term acute anxiety have been conducted but acupuncture interventions employed in trials vary as do the controls against which these are compared. Many trials also suffer from small sample sizes. Consequently, it has not proved possible to accurately assess the effectiveness of acupuncture for these conditions or the relative effectiveness of different treatment regimens. The results of studies showing similar effects of needling at specific and non-specific points have further complicated the interpretation of results. In addition to measuring clinical response, several clinical studies have assessed changes in levels of neurotransmitters and other biological response modifiers in an attempt to elucidate the specific biological actions of acupuncture. The findings offer some preliminary data requiring further investigation.”

Elsewhere, the same author, together with other pro-acupuncture researchers, wrote this: “Positive findings are reported for acupuncture in the treatment of generalised anxiety disorder or anxiety neurosis but there is currently insufficient research evidence for firm conclusions to be drawn. No trials of acupuncture for other anxiety disorders were located. There is some limited evidence in favour of auricular acupuncture in perioperative anxiety. Overall, the promising findings indicate that further research is warranted in the form of well designed, adequately powered studies.”

What does this mean in the context of the charity’s project?

I think, it tells us that acupuncture for anxiety is not exactly the most promising approach to further investigate. Even in the realm of alternative medicine, there are several interventions which are supported by more encouraging evidence. And even if one disagrees with this statement, one cannot possibly disagree with the fact that more flimsy research is not required. If we do need more studies, they must be rigorous and not promotion thinly disguised as science.

I guess the ultimate question here is one of ethics. Do charities not have an ethical and moral duty to spend our donations wisely and productively? When does such ill-conceived pseudo-research cross the line to become offensive or even fraudulent?

The Nobel laureate Venkatraman Ramakrishnan recently called homeopathy ‘bogus’. “They (homeopaths) take arsenic compounds and dilute it to such an extent that just a molecule is left. It will not make any effect on you. Your tap water has more arsenic. No one in chemistry believes in homeopathy. It works because of placebo effect,” he was quoted saying.

But what does he know about homeopathy? This was the angry question of homeopaths around the world when the Nobel laureate’s views became international headlines.

Nothing! Exclaimed the furious homeopaths with one voice.

If we want to get an informed opinion, we a true expert.

The Queen’s homeopath Dr Fisher? No, he has been known to tell untruths.

Doctor Michael Dixon, the adviser to Prince Charles who recently defended homeopathy? No, he is not even a homeopath.

Dana Ullman, the voice of US homeopathy? Heavens, he is a homeopath but not one who is known to be objective.

Alan Schmukler perhaps? He too seems to have difficulties with critical thinking.

Perhaps we need to ask an experienced and successful homeopath like doctor Akshay Batra; someone with both feet on the ground who knows about the coal face of health care today. He recently spoke out for the virtues of homeopathy explaining that it is based on the ingenious idea that ‘like cures like: “For example if you are suffering from constant watering eyes, you will be given allium cepa which comes from onions, something that causes eyes to water. Homeopathy works like a vaccine”. Dr Batra claims that the failure of allopathy (mainstream medicine) is causing the present boom in homeopathy. “With the amount of deaths taking place due to allopathic medicine and its side effects, we can see people resorting to homeopathy,” he said. “Certain children using asthma inhalers suffer from growth issues or develop unusual facial hair. Homeopathy avoids that and uses a natural remedy that treats the root cause,” he added.

The top issues treated with homeopathy, according to Dr Batra, are hair and skin problems. “A lot of ailments today effecting hair and skin are because of internal diseases. Hair loss in women has become very prevalent and can be due to cystic ovaries, low iron levels or hormonal imbalance due to thyroid,” explained Dr Batra. “We find the root cause and treat that, since hair loss could just be a symptom and we need to treat the ailment permanently. Allopathic medicines just give you a quick fix, and not treat the root cause, while we give a more long term, complete solution,” he added. Homeopathy is mind and body medicine: “A lot of people today are under pressure and stress. Homeopathic treatment also helps in relieving tension hence treating the patient as a whole,” said Dr Batra.

I bet you now wonder who is this fabulous expert and homeopath, doctor Batra.

He has been mentioned on this blog before, namely when he opened the first London branch of his chain of homeopathic clinics claiming that homeopathy could effectively treat the following conditions:

Yes, Dr Akshay Batra is the managing director and chairman of Dr Batra’s Homeopathic Clinic, an enterprise that is currently establishing clinics across the globe.

And now we understand, I think, why the Nobel laureate and the homeopathy expert have slightly different views on the subject.

Who would you believe, I wonder?

What a question, you might say. And you would be right, it’s a most awkward one, so much so that I cannot answer it for myself.

I NEED YOUR HELP.

Here is the story:

Ten years ago, with the help of S Lejeune and an EU grant, my team conducted a Cochrane review of Laertrile. To do the ‘ground work’, we hired an Italian research assistant, S Milazzo, who was supervised mainly by my research fellow Katja Schmidt. Consequently, the review was published under the names of all main contributors: Milazzo, Ernst, Lejeune, Schmidt.

In 2011, an update was due for which the help of Dr Markus Horneber, the head of a German research team investigating alt med in relation to cancer, was recruited. By then, Milazzo and Schmidt had left my unit and, with my consent, Horneber, Milazzo and Schmidt took charge of the review. I was then sent a draft of their update and did a revision of it which consisted mostly in checking the facts and making linguistic changes. The article was then published under the following authorship: Milazzo S, Ernst E, Lejeune S, Boehm K, Horneber M (Katja had married meanwhile, so Boehm and Schmidt are the same person).

A few days ago, I noticed that a further update had been published in 2015. Amazingly, I had not been told, asked to contribute, or informed that my name as co-author had been scrapped. The authors of the new update are simply Milazzo and Horneber (the latter being the senior author). Katja Boehm had apparently indicated that she did no longer want to be involved; I am not sure what happened to Lejeune.

I know Markus Horneber since donkey’s years and had co-authored several other papers with him in the past, so I (admittedly miffed about my discovery) sent him an email and asked him whether he did not consider this behaviour to amount to plagiarism. His reply was, in my view, unhelpful in explaining why I had not been asked to get involved and Horneber asked me to withdraw the allegation of plagiarism (which I had not even made) – or else he would take legal action (this was the moment when I got truly suspicious).

Next, I contacted the responsible editor at the Cochrane Collaboration, not least because Horneber had claimed that she had condoned the disputed change of authorship. Her reply confirmed that “excluding previous authors without giving them a chance to comment is not normal Cochrane policy” and that she did, in fact, not condone the omission of my name from the list of co-authors.

The question that I am asking myself (not for the first time, I am afraid – a similar, arguably worse case has been described in the comments section of this post) is the following: IS THIS A CASE OF PLAGIARISM OR NOT? In the name of honesty, transparency and science, it requires an answer, I think.

Even after contemplating it for several days, I seem to be unable to find a conclusive response. On the one hand, I did clearly not contribute to the latest (2015) update and should therefore not be a co-author. On the other hand, I feel that I should have been asked to contribute, in which case I would certainly have done so and remained a co-author.

For a fuller understanding of this case, I here copy the various sections of the abstracts of the 2011 update (marked OLD) and the 2015 update without my co-authorship (marked NEW):

 

OLD

Laetrile is the name for a semi-synthetic compound which is chemically related to amygdalin, a cyanogenic glycoside from the kernels of apricots and various other species of the genus Prunus. Laetrile and amygdalin are promoted under various names for the treatment of cancer although there is no evidence for its efficacy. Due to possible cyanide poisoning, laetrile can be dangerous.

NEW

Laetrile is the name for a semi-synthetic compound which is chemically related to amygdalin, a cyanogenic glycoside from the kernels of apricots and various other species of the genus Prunus. Laetrile and amygdalin are promoted under various names for the treatment of cancer although there is no evidence for its efficacy. Due to possible cyanide poisoning, laetrile can be dangerous.

OBJECTIVES:

OLD

To assess the alleged anti-cancer effect and possible adverse effects of laetrile and amygdalin.

NEW

To assess the alleged anti-cancer effect and possible adverse effects of laetrile and amygdalin.

SEARCH METHODS:

OLD

We searched the following databases: CENTRAL (2011, Issue 1); MEDLINE (1951-2011); EMBASE (1980-2011); AMED; Scirus; CancerLit; CINAHL (all from 1982-2011); CAMbase (from 1998-2011); the MetaRegister; the National Research Register; and our own files. We examined reference lists of included studies and review articles and we contacted experts in the field for knowledge of additional studies. We did not impose any restrictions of timer or language.

NEW

We searched the following databases: CENTRAL (2014, Issue 9); MEDLINE (1951-2014); EMBASE (1980-2014); AMED; Scirus; CINAHL (all from 1982-2015); CAMbase (from 1998-2015); the MetaRegister; the National Research Register; and our own files. We examined reference lists of included studies and review articles and we contacted experts in the field for knowledge of additional studies. We did not impose any restrictions of timer or language.

SELECTION CRITERIA:

OLD

Randomized controlled trials (RCTs) and quasi-RCTs.

NEW

Randomized controlled trials (RCTs) and quasi-RCTs.

DATA COLLECTION AND ANALYSIS:

OLD

We searched eight databases and two registers for studies testing laetrile or amygdalin for the treatment of cancer. Two review authors screened and assessed articles for inclusion criteria.

NEW

We searched eight databases and two registers for studies testing laetrile or amygdalin for the treatment of cancer. Two review authors screened and assessed articles for inclusion criteria.

MAIN RESULTS:

OLD

We located over 200 references, 63 were evaluated in the original review and an additional 6 in this update. However, we did not identify any studies that met our inclusion criteria.

NEW

We located over 200 references, 63 were evaluated in the original review, 6 in the 2011 and none in this update. However, we did not identify any studies that met our inclusion criteria.

AUTHORS’ CONCLUSIONS:

OLD

The claims that laetrile or amygdalin have beneficial effects for cancer patients are not currently supported by sound clinical data. There is a considerable risk of serious adverse effects from cyanide poisoning after laetrile or amygdalin, especially after oral ingestion. The risk-benefit balance of laetrile or amygdalin as a treatment for cancer is therefore unambiguously negative.

NEW

The claims that laetrile or amygdalin have beneficial effects for cancer patients are not currently supported by sound clinical data. There is a considerable risk of serious adverse effects from cyanide poisoning after laetrile or amygdalin, especially after oral ingestion. The risk-benefit balance of laetrile or amygdalin as a treatment for cancer is therefore unambiguously negative.

END OF ABSTRACT

I HOPE THAT YOU, THE READER OF THIS POST, ARE NOW ABLE TO TELL ME:

HAVE I BEEN PLAGIARISED?

P S

After the response from the Cochrane editor, I asked Horneber whether he wanted to make a further comment because I was thinking to blog about this. So far, I have not received a reply.

Researching and reporting shocking stories like this one can only make me more enemies, I know. Yet I do think they need to be told; if we cannot learn from history, what hope is there?

I first became aware of Sigmund Rascher‘s work when I was studying the effects of temperature on blood rheology at the University of Munich. I then leant of Rascher’s unspeakably cruel experiments on exposing humans to extreme hypothermia in the Dachau concentration camp. Many of his ‘volunteers’ had lost their lives, and the SS-doctor Rascher later became the symbol of a ‘Nazi doctor from hell’. In 1990, R L Berger aptly described Rascher and his sadistic pseudo-science in his NEJM article:

“Sigmund Rascher was born in 1909. He started his medical studies in 1930 and joined both the Nazi party and the storm troopers (the SA) three years later. After a volunteer internship, Rascher served for three years as an unpaid surgical assistant. He was barred temporarily from the University of Munich for suspected Communist sympathies. In 1939, the young doctor denounced his physician father, joined the SS, and was inducted into the Luftwaffe. A liaison with and eventual marriage to Nini Diehl, a widow 15 years his senior who was a one-time cabaret singer but also the former secretary and possibly mistress of the Reichsführer, gained Rascher direct access to Himmler. A strange partnership evolved between the junior medical officer and one of the highest officials of the Third Reich. One week after their first meeting, Rascher presented a “Report on the Development and Solution to Some of the Reichsführer’s Assigned Tasks During a Discussion Held on April 24, 1939.” The title of this paper foretold the character of the ensuing relationship between the two men. Because of Rascher’s servile and ingratiating approach to Himmler, his “connections were so strong that practically every superior trembled in fear of the intriguing Rascher who consequently held a position of enormous power.

Rascher’s short investigative career included a leading role in the infamous high-altitude experiments on humans at Dachau, which resulted in 70 to 80 deaths. He was also involved in testing a plant extract as a cure for cancer. The genesis of this project illustrates Rascher’s style and influence. Professor Blome, the deputy health minister and plenipotentiary for cancer research, favored testing the extract in mice. Rascher insisted on experiments in humans. Himmler sided with Rascher. A Human Cancer Testing Station was set up at Dachau. The deputy health minister collaborated on the project, held approximately 20 meetings with Rascher, and visited the junior officer at Dachau several times.

Another of Rascher’s major research efforts focused on the introduction of a pectin-based preparation, Polygal, to promote blood clotting. He predicted that the prophylactic use of Polygal tablets would reduce bleeding from wounds sustained in combat or during surgical procedures. The agent was also recommended for the control of spontaneous gastrointestinal and pulmonary hemorrhages. Combat wounds were simulated by the amputation of the viable extremities of camp prisoners without anesthesia or by shooting the prisoners through the neck and chest.

Rascher also claimed that oral premedication with Polygal minimized bleeding during major surgical procedures, rendering hemostatic clips or ligatures unnecessary and shortening operating times. He published an enthusiastic article about his clinical experience with Polygal, without specifying the nature of some of the trials in humans. The paper concluded, “The tests of this medicine ‘Polygal 10’ showed no failures under the most varied circumstances.” Rascher also formed a company to manufacture Polygal and used prisoners to work in the factory. A prisoner who was later liberated testified that Rascher’s enthusiasm for Polygal’s antiinfectious properties was probably sparked by news of the introduction of penicillin by the Allies and by his eagerness to reap fame and receive the award established for inventing a German equivalent. He initiated experiments in humans apparently without any preliminary laboratory testing. In one experiment, pus was injected into the legs of prisoners. The experimental group was given Polygal. The controls received no treatment. Information filtered to Dr. Kurt Plotner, Rascher’s physician rival, that the controls were given large, deep subcutaneous inoculations, whereas the victims in the experiments received smaller volumes of pus injected intracutaneously. Plotner reportedly investigated the matter and discovered that the Polygal used was saline colored with a fluorescent dye.

The frequent references to Rascher in top-level documents indicate that this junior medical officer attracted extraordinary attention from Germany’s highest officials. His work was reported even to Hitler, who was pleased with the accounts. Rascher was not well regarded in professional circles, however, and his superiors repeatedly expressed reservations about his performance. In one encounter, Professor Karl Gebhardt, a general in the SS and Himmler’s personal physician, told Rascher in connection with his experiments on hypothermia through exposure to cold air that “the report was unscientific; if a student of the second term dared submit a treatise of the kind [Gebhardt] would throw him out.” Despite Himmler’s strong support, Rascher was rejected for faculty positions at several universities. A book by German scientists on the accomplishments of German aviation medicine during the war devoted an entire chapter to hypothermia but failed to mention Rascher’s name or his work.”

For those who can stomach the sickening tale, a very detailed biography of Rascher is available here.

I had hoped to never hear of this monster of a man again – yet, more recently, I came across Rascher in the context of alternative medicine. Rascher had been brought up in Rudolf Steiner’s anthroposophical tradition, and his very first ‘research’ project was on a alternantive blood test developed in anthroposophy.

A close friend of Rascher, the anthroposoph and chemist Ehrenfried Pfeiffer had developed a bizarre diagnostic method using copper chloride crystallization of blood and other materials. This copper chloride biocrystallization (CCBC) became the subject of Rascher’s dissertation in Munich. Rascher first tried the CCBC for diagnosing pregnancies and later for detecting early cancer (incidentally, he conducted this work in the very same building where I worked for many years, about half a century later). The CCBC involves a visual evaluation of copper crystals which form with blood or other fluids; the method is, of course, wide open to interpretation. Bizarrely, the CCBC is still used by some anthroposophical or homeopathic doctors today – see, for instance, this recent article or this website, this website or this website which explains:

“Hierbei werden einige Tropfen Blut mit Kupferchlorid in einer Klimakammer zur Kristallisation gebracht.
Jahrzehntelange Erfahrung ermöglicht eine ganz frühe Hinweisdiagnostik sowohl für alle Funktionsschwächen der Organe, auch z.B. der Drüsen, als auch für eine Krebserkrankung. Diese kann oft so früh erkannt werden, daß sie sich mit keiner anderen Methode sichern läßt.” My translation: “A few drops of blood are brought to crystallisation with copper chloride in a climate chamber. Decades of experience allow a very early diagnosis of all functional weaknesses of the organs and glands as well as of cancer. Cancer can often be detected earlier than with any other method.”

The reference to ‘decades of experience’ is more than ironic because the evidence suggesting that the CCBC might be valid originates from Rascher’s work in the 1930s; to the best of my knowledge no other ‘validation’ of the CCBC has ever become available. With his initial thesis, Rascher had produced amazingly positive results and subsequently lobbied to get an official research grant for testing the CCBC’s usefulness in cancer diagnosis. Intriguingly, he had to disguise the CCBC’s connection to anthroposophy; even though taken by most other alternative medicines, the Nazis had banned the Steiner cult.

Most but not all of Rascher’s research was conducted in the Dachau concentration camp where in 1941 a research unit was established in ‘block 5’ which, according to Rascher’s biographer, Sigfried Baer, contained his department and a homeopathic research unit led by Hanno von Weyherns and Rudolf Brachtel (1909-1988). I found the following relevant comment about von Weyherns: “Zu Jahresbeginn 1941 wurde in der Krankenabteilung eine Versuchsstation eingerichtet, in der 114 registrierte Tuberkulosekranke homöopathisch behandelt wurden. Leitender Arzt war von Weyherns. Er erprobte im Februar biochemische Mittel an Häftlingen.” My translation: At the beginning of 1941, an experimental unit was established in the sick-quarters in which 114 patients with TB were treated homeopathically. The chief physician was von Weyherns. In February, he tested Schuessler Salts [a derivative of homeopathy still popular in Germany today] on prisoners.

Today, all experts believe Rascher’s results, even those on CCBC, to be fraudulent. Rascher seems to have been not merely an over-ambitious yet mediocre physician turned sadistic slaughterer of innocent prisoners, he also was a serial falsifier of research data. It is likely that his fraudulent thesis on the anthroposophic blood test set him off on a life-long career of consummate research misconduct.

Before the end of the Third Reich, Rascher lost the support of Himmler and was imprisoned for a string of offences which were largely unrelated to his ‘research’. He was eventually brought back to the place of his worst atrocities, the concentration camp in Dachau. Days before the liberation of the camp by the US forces, Rascher was executed under somewhat mysterious circumstances. In my view, the CCBC should have vanished with him.

Recently I have focussed several posts on well-known homeopaths and proponents of homeopathy; they include 6 prominent defenders of this therapy:

Dr Peter Fisher, the Queen’s homeopath,

Dr Michael Dixon, GP, chair of the NHS Alliance, the College of Medicine  and holder of many other posts,

Prof Michael Frass, intensive care physician at the University of Vienna,

Christian Boiron, general manager of Boiron, the world’s largest homeopathic manufacturer,

Christophe Merville, lead pharmacist at Boiron,

Dana Ullman, US homeopath and entrepreneur.

This inevitably begs the question what these people might have in common. After some consideration, I think, there are the following common denominators (you might see others; if so, please let me know):

  1. Most have conflicts of interest, yet try to hide this fact as best as they can, a circumstance which could be seen as less than honest.
  2. Most are quick of accusing critics of homeopathy of dishonesty and harbour conspiracy theories of various kinds.
  3. Most seem unable to think critically.
  4. They never criticise each other, not even for demonstrably wrong remarks or actions.
  5. Most use fallacious arguments regularly.
  6. Most rely on cherry-picking their evidence.
  7. Most display anti-scientific tendencies, yet rely on ‘cutting edge science’ as soon as they can interpret it in favour of homeopathy.
  8. They seem to be unable to learn in the light of new evidence.
  9. They seem never able to change their mind about things related to homeopathy.
  10. This gives them a distinct flair of fanaticism and arrogance.
  11. Most seem to have an odd attitude towards medical ethics.
  12. Most try to mislead the public by claiming things which are evidently not true.

The last point is, in my view, the most striking, important and disturbing issue. I ask myself what reasons these individuals have to tell untruths and whether ‘telling untruths’ is the same as ‘telling lies’. The first part of this question seems to be answered by the fact that most have powerful conflicts of interest; that is to say their livelihood depends on misleading the public about homeopathy. But are they lying or telling untruths?

This is a potentially important difference, I think.

An untruth is a statement which is false. By contrast, a lie is a false statement made with deliberate intent to deceive. So, are the untruths issued by the above-named homeopaths lies or untruths?

I would not dare to decide on the answer of this question…but hope my readers have some suggestions.

Anyone who has looked into the discussions around homeopathy for more than 10 minutes will have come across Dana Ullman (DU). Some 15 years ago, I had the pleasure to meet him in person during a conference in Boston. After the brief chat, I asked a UK homeopath who this bizarre person was. “Oh Dana!” he replied “Dana is alright.”

But is he? Let’s have a look at the evidence.

There are very few papers by DU listed in Medline, and most of these articles are simply opinion pieces. The opinions DU expresses there (or anywhere else) are usually not supported by good evidence; some of them are even outright dangerous. Here are a few quotes:

“…homeopathic care is cost effective…”

“…homeopathic medicines are effective…”

“…homeopathic medicine may play a useful role as an adjunctive and/or alternative therapy [for HIV infections]”

“[There are]…significant effects of homeopathic treatment in allergic patients.”

Occasionally, DU writes little essays full of utter nonsense, logical fallacies and falsehoods for HUFFPOST where he is nevertheless characterised in glowing terms: Dana Ullman, M.P.H. (Masters in Public Health, U.C. Berkeley), CCH (Certification in Classical Homeopathy) is “homeopathic.com” and is widely recognized as the foremost spokesperson for homeopathic medicine in the U.S.

Wikipedia, however, is more critical and cites the opinion of a judge who was presiding over a class action against a US homeopathic producer in which DU had been called as an expert witness: The Defendant presented the testimony of Gregory Dana Ullman who is a homeopathic practitioner. He outlined the theory of homeopathic treatment and presented his opinion as to the value and effectiveness of homeopathic remedies. The Court found Mr. Ullman’s testimony to be not credible. Mr. Ullman’s bias in favor of homeopathy and against conventional medicine was readily apparent from his testimony. He admitted that he was not an impartial expert but rather is a passionate advocate of homeopathy. He posted on Twitter that he views conventional medicine as witchcraft. He opined that conventional medical science cannot be trusted…Mr. Ullman’s testimony was unhelpful in understanding the purported efficacy of the ingredients of SnoreStop to reduce the symptoms of snoring. Although he is familiar with the theory of homeopathic treatment, his opinions regarding its effectiveness was unsupported and biased. The Court gave no weight to his testimony.

The Encyclopedia of Americam Loons is even more poignant and describes DU as: A master of cognitive dissonance and memory bias, Ullman seems clinically unable to grasp the possibility that he may be wrong. Combined with a lack of understanding of science or medicine – and the possession of certain marketing skills – what we end up with is rather insidious.

Anyone who has debated with DU will have to concur with the claim that he fails to understand science or medicine. If you don’t believe me, please read his recent comments on the post about Prof Frass on this blog where he excels in producing one fallacy after the next (if he were on a mission to give homeopathy a bad name, he would be doing a sterling job!).

Despite all this abysmal ignorance, DU has one undisputed and outstanding talent: the knack of getting on people’s nerves and thus driving rational thinkers to distraction. In this way he even managed to be headlined as an ‘idiot‘!

I find it tempting to agree with the many experts who have called him an idiot, a moron or a laughing stock but, for now, I will resist that temptation. On the contrary, I want point out that he is much more cunning and clever than we give him credit for: after all, he runs a thriving business and lives off the nonsense he produces. To my mind, this is not idiotic; devious and unethical surely, but not idiotic nor laughable!

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