evidence
It’s again the season for nine lessons, I suppose. So, on the occasion of Christmas Eve, let me rephrase the nine lessons I once gave (with my tongue firmly lodged in my cheek) to those who want to make a pseudo-scientific career in so-called alternative medicine (SCAM) research.
- Throw yourself into qualitative research. For instance, focus groups are a safe bet. They are not difficult to do: you gather 5 -10 people, let them express their opinions, record them, extract from the diversity of views what you recognize as your own opinion and call it a ‘common theme’, and write the whole thing up, and – BINGO! – you have a publication. The beauty of this approach is manifold:
-
- you can repeat this exercise ad nauseam until your publication list is of respectable length;
- there are plenty of SCAM journals that will publish your articles;
- you can manipulate your findings at will;
- you will never produce a paper that displeases the likes of King Charles;
- you might even increase your chances of obtaining funding for future research.
- Conduct surveys. They are very popular and highly respected/publishable projects in SCAM. Do not get deterred by the fact that thousands of similar investigations are already available. If, for instance, there already is one describing the SCAM usage by leg-amputated policemen in North Devon, you can conduct a survey of leg-amputated policemen in North Devon with a medical history of diabetes. As long as you conclude that your participants used a lot of SCAMs, were very satisfied with it, did not experience any adverse effects, thought it was value for money, and would recommend it to their neighbour, you have secured another publication in a SCAM journal.
- In case this does not appeal to you, how about taking a sociological, anthropological or psychological approach? How about studying, for example, the differences in worldviews, the different belief systems, the different ways of knowing, the different concepts about illness, the different expectations, the unique spiritual dimensions, the amazing views on holism – all in different cultures, settings or countries? Invariably, you must, of course, conclude that one truth is at least as good as the next. This will make you popular with all the post-modernists who use SCAM as a playground for enlarging their publication lists. This approach also has the advantage to allow you to travel extensively and generally have a good time.
- If, eventually, your boss demands that you start doing what (in his narrow mind) constitutes ‘real science’, do not despair! There are plenty of possibilities to remain true to your pseudo-scientific principles. Study the safety of your favourite SCAM with a survey of its users. You simply evaluate their experiences and opinions regarding adverse effects. But be careful, you are on thin ice here; you don’t want to upset anyone by generating alarming findings. Make sure your sample is small enough for a false negative result, and that all participants are well-pleased with their SCAM. This might be merely a question of selecting your patients wisely. The main thing is that your conclusions do not reveal any risks.
- If your boss insists you tackle the daunting issue of SCAM’s efficacy, you must find patients who happened to have recovered spectacularly well from a life-threatening disease after receiving your favourite form of SCAM. Once you have identified such a person, you detail her experience and publish this as a ‘case report’. It requires a little skill to brush over the fact that the patient also had lots of conventional treatments, or that her diagnosis was never properly verified. As a pseudo-scientist, you will have to learn how to discretely make such details vanish so that, in the final paper, they are no longer recognisable.
- Your boss might eventually point out that case reports are not really very conclusive. The antidote to this argument is simple: you do a large case series along the same lines. Here you can even show off your excellent statistical skills by calculating the statistical significance of the difference between the severity of the condition before the treatment and the one after it. As long as this reveals marked improvements, ignores all the many other factors involved in the outcome and concludes that these changes are the result of the treatment, all should be tickety-boo.
- Your boss might one day insist you conduct what he narrow-mindedly calls a ‘proper’ study; in other words, you might be forced to bite the bullet and learn how to do an RCT. As your particular SCAM is not really effective, this could lead to serious embarrassment in the form of a negative result, something that must be avoided at all costs. I, therefore, recommend you join for a few months a research group that has a proven track record in doing RCTs of utterly useless treatments without ever failing to conclude that it is highly effective. In other words, join a member of my ALTERNATIVE MEDICINE HALL OF FAME. They will teach you how to incorporate all the right design features into your study without the slightest risk of generating a negative result. A particularly popular solution is to conduct a ‘pragmatic’ trial that never fails to produce anything but cheerfully positive findings.
- But even the most cunningly designed study of your SCAM might one day deliver a negative result. In such a case, I recommend taking your data and running as many different statistical tests as you can find; chances are that one of them will produce something vaguely positive. If even this method fails (and it hardly ever does), you can always focus your paper on the fact that, in your study, not a single patient died. Who would be able to dispute that this is a positive outcome?
- Now that you have grown into an experienced pseudo-scientist who has published several misleading papers, you may want to publish irrefutable evidence of your SCAM. For this purpose run the same RCT over again, and again, and again. Eventually, you want a meta-analysis of all RCTs ever published (see examples here and here). As you are the only person who conducted studies on the SCAM in question, this should be quite easy: you pool the data of all your dodgy trials and, bob’s your uncle: a nice little summary of the totality of the data that shows beyond doubt that your SCAM works and is safe.
The purpose of this review was to
- identify and map the available evidence regarding the effectiveness and harms of spinal manipulation and mobilisation for infants, children and adolescents with a broad range of conditions;
- identify and synthesise policies, regulations, position statements and practice guidelines informing their clinical use.
Two reviewers independently screened and selected the studies, extracted key findings and assessed the methodological quality of included papers. A descriptive synthesis of reported findings was undertaken using a level-of-evidence approach.
Eighty-seven articles were included. Their methodological quality varied. Spinal manipulation and mobilisation are being utilised clinically by a variety of health professionals to manage paediatric populations with 
- adolescent idiopathic scoliosis (AIS),
- asthma,
- attention deficit hyperactivity disorder (ADHD),
- autism spectrum disorder (ASD),
- back/neck pain,
- breastfeeding difficulties,
- cerebral palsy (CP),
- dysfunctional voiding,
- excessive crying,
- headaches,
- infantile colic,
- kinetic imbalances due to suboccipital strain (KISS),
- nocturnal enuresis,
- otitis media,
- torticollis,
- plagiocephaly.
The descriptive synthesis revealed: no evidence to explicitly support the effectiveness of spinal manipulation or mobilisation for any condition in paediatric populations. Mild transient symptoms were commonly described in randomised controlled trials and on occasion, moderate-to-severe adverse events were reported in systematic reviews of randomised controlled trials and other lower-quality studies. There was strong to very strong evidence for ‘no significant effect’ of spinal manipulation for managing
- asthma (pulmonary function),
- headache,
- nocturnal enuresis.
There was inconclusive or insufficient evidence for all other conditions explored. There is insufficient evidence to draw conclusions regarding spinal mobilisation to treat paediatric populations with any condition.
The authors concluded that, whilst some individual high-quality studies demonstrate positive results for some conditions, our descriptive synthesis of the collective findings does not provide support for spinal manipulation or mobilisation in paediatric populations for any condition. Increased reporting of adverse events is required to determine true risks. Randomised controlled trials examining effectiveness of spinal manipulation and mobilisation in paediatric populations are warranted.
Perhaps the most important findings of this review relate to safety. They confirm (yet again) that there is only limited reporting of adverse events in this body of research. Six reviews, eight RCTs and five other studies made no mention of adverse events or harms associated with spinal manipulation. This, in my view, amounts to scientific misconduct. Four systematic reviews focused specifically on adverse events and harms. They revealed that adverse events ranged from mild to severe and even death.
In terms of therapeutic benefit, the review confirms the findings from the previous research, e.g.:
- Green et al (Green S, McDonald S, Murano M, Miyoung C, Brennan S. Systematic review of spinal manipulation in children: review prepared by Cochrane Australia for Safer Care Victoria. Melbourne, Victoria: Victorian Government 2019. p. 1–67.) explored the effectiveness and safety of spinal manipulation and showed that spinal manipulation should – due to a lack of evidence and potential risk of harm – be recommended as a treatment of headache, asthma, otitis media, cerebral palsy, hyperactivity disorders or torticollis.
- Cote et al showed that evidence is lacking to support the use of spinal manipulation to treat non-musculoskeletal disorders.
In terms of risk/benefit balance, the conclusion could thus not be clearer: no matter whether chiropractors, osteopaths, physiotherapists, or any other healthcare professionals propose to manipulate the spine of your child, DON’T LET THEM DO IT!
This Cochrane review assessed the effectiveness and safety of oral homeopathic medicinal products compared with placebo or conventional therapy to prevent and treat acute respiratory tract infections (ARTIs) in children.
The researchers included double‐blind randomized clinical trials (RCTs) or double‐blind cluster‐RCTs comparing oral homeopathy medicinal products with placebo or self‐selected conventional treatments to prevent or treat ARTIs in children aged 0 to 16 years.
In this 2022 update, the researchers identified three new RCTs involving 251 children, for a total of 11 included RCTs with 1813 children receiving oral homeopathic medicinal products or a control treatment for ARTIs. All studies focused on upper respiratory tract infections (URTIs), with only one study including some lower respiratory tract infections (LRTIs). Six RCTs examined the effect on URTI recovery, and five RCTs investigated the effect on preventing URTIs after one to four months of treatment. Two treatment and three prevention studies involved homeopaths individualizing treatment. The other studies used predetermined, non-individualized remedies. All studies involved highly diluted homeopathic medicinal products, with dilutions ranging from 1 x 10‐4 to 1 x 10‐200.
Several limitations to the included studies were identified, in particular methodological inconsistencies and high attrition rates, failure to conduct intention‐to‐treat analysis, selective reporting, and apparent protocol deviations. Three studies were classified as at high risk of bias in at least one domain, and many studies had additional domains with unclear risk of bias. Four studies received funding from homeopathy manufacturers; one study support from a non‐government organization; two studies government support; one study was co‐sponsored by a university; and three studies did not report funding support.
The authors concluded that the “pooling of five prevention and six treatment studies did not show any consistent benefit of homeopathic medicinal products compared to placebo on ARTI recurrence or cure rates in children. We assessed the certainty of the evidence as low to very low for the majority of outcomes. We found no evidence to support the efficacy of homeopathic medicinal products for ARTIs in children. Adverse events were poorly reported, and we could not draw conclusions regarding safety.”
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These findings are hardly surprising. Will they change the behavior of homeopaths who feel that
- children respond particularly well to homeopathy,
- ARTIs are conditions for which homeopathy is particularly effective?
I would not hold my breath!
The INDY and many other news outlets reported that the British Tory MP, Andrew Bridgen, has called on prime minister Rishi Sunak to suspend mRNA covid vaccines after alleging they are “not safe, not effective and not necessary”.
During Wednesday’s PMQs (13 December), Bridgen stated that “since the rollout in the UK of the BioNTech-Pfizer mRNA vaccine, we have had almost half a million reports of adverse effects from the public”, a message he later reiterated on Twitter.
Posting a snippet from his debate, Bridgen tweeted: “Almost half a million yellow card reports of adverse effects following administration of the Biotech Pfizer mRNA vaccine in the UK alone! Answers are desperately needed. #completelyunprecedented”.
Bridgen also claimed that a leading figure in the British Heart Foundation is suppressing evidence that the Covid vaccines cause heart damage, even sending non-disclosure agreements to his research team.
Facebook flagged his post with a notice urging users to ensure that they share “reliable information.” It included two links to “continue sharing” or “get vaccine info.”
The scandals Bridgen has been involved in seem too numerous to mention (e.g. violation of parliamentary standards, homophobic remarks, antisemitic statements). Here is just one of the most recent:
A Leicestershire MP has been ordered to pay £800,000 and been evicted from his five bedroom home by a judge following a legal dispute involving the family vegetable business. It is currently unknown where Andrew Bridgen, Conservative MP for North West Leicestershire, lives after being given final deadline of August 24 to vacate the premises in Coleorton, near Coalville.
The 57-year-old was branded “dishonest” by a High Court judge in March – who ruled that Bridgen “lied” under oath. Judge Brian Rawlings said he was so dishonest that nothing he said about the dispute with AB Produce, a vegetable and potato supplier based in Measham, could be taken at face value.
Bridgen was also said to have behaved in an “abusive”, “arrogant” and “aggressive” way during the dispute, in which he has spent years suing the firm. A later judgment in June, reported by the Times on Sunday, forced the MP to vacate the £1.5 million-valued property owned by AB Produce that he has lived in since 2015…
For a fact check on Bridgeon’s vaccine claims, see here. And below are a few reactions from Twitter users to Bridgen’s Covid proctophsia:
First a High Court judge says Tory MP, Andrew Bridgen, lied under oath, then he evicts him from his home and orders him to pay £800,000 now Facebook flags his posts as Covid misinformation. How’s your week going?
Andrew Bridgen MP now promoting Dr David Cartland, a man who aligns himself with claims that Freemasons rule the world; that Covid doesn’t exist; and that medical doctors who don’t share his views should be executed (screenshots H/T
Andrew Bridgen MP now promoting Dr David Cartland, a man who aligns himself with claims that Freemasons rule the world; that Covid doesn’t exist; and that medical doctors who don’t share his views should be executed.
This Andrew Bridgen? ‘A Conservative MP lied under oath, behaved in an abusive, arrogant and aggressive way, and was so dishonest that his claims about a multimillion-pound family dispute could not be taken at face value, a high court judge has ruled.’
Proper tinfoil-hat stuff from Andrew Bridgen, suggesting Covid vaccines are unsafe, misrepresenting data, and implying some sort of conspiracy between ‘Big Pharma’ and MHRA.
Our ‘Memorandum Integrative Medicine‘ seems to be causing ripples. A German website that claims to aim at informing consumers objectively posted a rebuttal. Here is my translation (together with comments by myself inserted via reference numbers in brackets and added below):
With drastic words and narrow-mindedness bordering on ideology (1), the Münster Circle, an association of opponents to complementary therapies such as homeopathy (2), takes issue with the treatment concept of integrative medicine in a memorandum (3). By integrative medicine physicians understand the combination of doctor-led medicine and doctor-led complementary medicine to a meaningful total concept with the goal of reducing side effects and to treating patients individually and optimally (4). Integrative medicine focuses primarily on chronic diseases, where conventional acute medicine often reaches its limits (5)In the memorandum of the Münsteraner Kreis, general practitioner Dr. Claudia Novak criticizes integrative medicine as “guru-like self-dramatization” (6) by physicians and therapists, which undermines evidence-based medicine and leads to a deterioration in patient care. She is joined by Prof. Dr. Edzard Ernst, Professor Emeritus of Alternative Medicine, who has changed from Paul to Saul with regard to homeopathy (7) and is leading a veritable media campaign against proponents of treatment procedures that have not been able to prove their evidence in randomized placebo-controlled studies (8). The professor ignores the fact that this involves a large number of drugs that are used as a matter of course in everyday medicine (9) – for example, beta-blockers or other cardiological drugs (10). “Like the devil fears the holy water” (11), the Münsteraner Kreis seems to fear the concept of integrative medicine (12). The vehemence coupled with fear with which they warn against the treatment concept makes one sit up and take notice (13). “As an experienced gynecologist who has successfully worked with biological medicine as an adjunct in his practice for decades, I can only shake my head at such narrow-mindedness”, points out Fred-Holger Ludwig, MD (14). Science does not set limits for itself, but the plurality of methods is immanent (15). “Why doesn’t Prof. Ernst actually give up his professorial title for alternative medicine? That would have to be the logical consequence of its overloud criticism of established treatment concepts from homeopathy to to integrative medicine”, questions Dr. Ludwig (16).
The concept of integrative medicine is about infiltrating alternative procedures into medicine, claim the critics of the concept, without mentioning that many naturopathic procedures have been used for centuries with good results (17) and that healthcare research gives them top marks (18). “Incidentally, the scientists among the representatives of the Münster Circle should know that it is difficult to capture individualized treatment concepts with the standardized procedures of randomized, placebo-controlled studies (19). Anyone who declares the highest level of evidence to be the criterion for approval makes medicine impossible and deprives patients in oncology or with rare diseases, for example, of chances of successful treatment (20). Even there, drugs are used that cannot be based on high evidence, tested in placebo-controlled studies, because the number of cases is too low (21),” notes Dr. Ludwig .
- Ideology? Evidence is not ideology, in my view.
- We are an association of multidisciplinary experts advocating a level playing field with sound evidence in all areas of healthcare.
- The actual memorandum is not linked in this text; does the author not want his readers to form the own opinion?
- In our memorandum, we offer various definitions of integrative medicine (IM), none of which is remotely similar to this one.
- No, IM is usually being promoted in a much wider sense.
- This term does not appear in our memorandum.
- I am not aware that I changed from Paul to Saul with regard to homeopathy; I know that I was led mostly by the evidence.
- I feel flattered but don’t think that my humble work is a ‘media campaign’.
- True, I do not pretend to understand all areas of medicine and tend to be silent in the ones that I lack up-to-date expertise.
- Is he really saying that beta-blockers are not evidence-based?
- The holy water comparison from a homeopath, who arguably makes a living from dishing out ‘holy water’, made me laugh!
- It is most revealing, I think, that he thinks our motivation is fear.
- Splendid!
- FHL is the author of the article, and it is thus charmingly naive that he cites himself in this way
- I somehow doubt that he understands what he is expressing here.
- I find this rather a bizarre idea but I’ll think about it.
- Argumentum ad traditionem.
- Those that get ‘top marks’ belong to evidence-based medicine and not to IM.
- Here the author reveals that he does not understand the RCT methodology and even fails to know the trial evidence on homeopathy – RCTs of individualised homeopathy are possible and have been published (e.g. this one).
- If he really believes this, I fear for his patients.
- Pity that he does not provide an example.
To understand FHL better, it is worth knowing that he claims to treat cancer patients with conventional and homeopathic medicine. He states that this approach reduces side effects – without providing evidence, of course.
Altogether, FHL does not dispute a single fact or argument from our memorandum. In fact, I get the impression that he never actually read it. To me, it feels as though he merely read an article ABOUT the document. In any case, his critique is revealing and important, in my view. It demonstrates that there are no good arguments to defend IM.
So, thank you FHL!
Like traditional acupuncture, “cosmetic acupuncture” involves the insertion of needles into the skin. Also called facial rejuvenation acupuncture, cosmetic acupuncture is believed to stimulate collagen and therefore reduce the look of wrinkles. They also claim that cosmetic acupuncture rejuvenates your skin by improving your overall energy and is a great addition to your overall wellness routine – at least, this is what enthusiasts want us to believe. 
No surprise then that many consumers give cosmetic acupuncture a try. But what, if after paying for a session, you don’t notice any difference? What, if you even look worse than before?
Impossible?
Not at all! One of the few studies on the subject showed that about half of the clients complained of blotchiness and hyperpigmented spots.
Cosmetic acupuncturists are well prepared for this argument and claim that the treatment will take longer to show any results: “Most cosmetic acupuncture treatments are meant to be taken in a series, generally in a group of 10,” says DiLibero. “The effects of acupuncture are cumulative, so follow-up appointments are recommended.”
And what does the evidence tell us about the effectiveness of cosmetic acupuncture?
One study showed “promising results as a therapy for facial elasticity”. Another one “showed clinical potential for facial wrinkles and laxity.”
That’s great!
No, it isn’t; the studies were published in 3rd class journals and did not even have control groups. Sorry, but I don’t call this evidence. In fact, the type of study that merits the term has not emerged. In other words, cosmetic acupuncture is a swindle!
But at least cosmetic acupuncture is not harmful.
Wrong!
- It will cost you a lot of money because the therapist will persuade you that you need 10 treatment sessions or more.
- It can cause blotchiness and hyperpigmented spots, as mentioned above.
- It has been reported to cause extensive facial sclerosing lipogranulomatosis.
So, you want to improve your looks?
I am not sure what therapies work for this purpose. But I do know that cosmetic acupuncture isn’t one of them.
Psychics make big promises. Here is just one example:
All the questions that you’re longing to find the answers to are now just a Reading away.Want to know when
you’ll find love? Just ask. Want to know which way your career is heading? Just say the word. Want to know what opportunities are around the corner for you? Just go ahead and find out.
At The Circle, you’ll have access to the very best Psychic Readers in the country at your fingertips, whenever you need to understand your life better. With regular Psychic Readings, you will experience better love lives, stronger relationships, more successful careers, and much more personal fulfillment.
The Circle is the UK’s most trusted Psychic Reading service, and for very good reason. Since 1997 we’ve performed millions of Readings and have helped many customers like you on their life journey.
How come then that a psychic could not predict the following?
The US Attorney’s Office has announced that Michael Paul Guzman, 42, was sentenced to 38 months in prison, and Samantha Stevens, 51, was sentenced to 30 months in prison by U.S. District Judge Darrin P. Gayles for orchestrating a fortune-telling fraud scheme and money laundering.
According to court documents, Stevens was portraying herself as a psychic/fortune teller in 2012 when she met a victim in Miami. Stevens gained the victim’s trust and convinced her that a curse had been placed on her and her family. Stevens claimed she needed to perform rituals on large sums of money in order to lift the curse. Failure to do so—the victim was led to believe—would result in harm to her and her family.
Stevens and Guzman spent the victim’s money on vehicles, property, and casino gambling. The relationship between Stevens and the victim lasted several years. During this time, the victim was persuaded to give up more than $3 million. The scheme came to an end in 2016 when Stevens cut off communication with the victim after she no longer could pay for the rituals. Once Stevens severed the relationship, the victim contacted federal law enforcement.
Stevens argued in court that the ceremonies she performed were an expression of her religion and the client “received exactly what she bargained for.”
_______________________________
This is not the first time self-proclaimed psychics have been sentenced to prison in Florida. In 2020, a woman and her daughter were sentenced for “defrauding two victims with their spiritual scams” and in 2019, a woman was reportedly sentenced to more than three years in prison for a “fortune telling” fraud scheme. In 2014, a South Florida woman who claimed to be a psychic with the ability to positively influence terminal cancer was sentenced to three years and nine months in prison.
Didier Raoult, the French scientist who became well-known for his controversial stance on hydroxychloroquine for treating COVID-19, has featured on this blog before (see here, here, and here). Less well-known is the fact that he has attracted controversy before. In 2006, Raoult and 4 co-authors were banned for one year from publishing in the journals of the American Society for Microbiology (ASM), after a reviewer for Infection and Immunity discovered that four figures from the revised manuscript of a paper about a mouse model for typhus were identical to figures from the originally submitted manuscript, even though they were supposed to represent a different experiment. In response, Raoult “resigned from the editorial board of two other ASM journals, canceled his membership in the American Academy of Microbiology, ASM’s honorific leadership group, and banned his lab from submitting to ASM journals”. In response to Science covering the story in 2012, he stated that, “I did not manage the paper and did not even check the last version”. The paper was subsequently published in a different journal.
Now, the publisher PLOS is marking nearly 50 articles by Didier Raoult, with expressions of concern while it investigates potential research ethics violations in the work. PLOS has been looking into more than 100 articles by Raoult and determined that the issues in 49 of the papers, including reuse of ethics approval reference numbers, warrant expressions of concern while the publisher continues its inquiry.
In August of 2021, Elisabeth Bik wrote on her blog about a series of 17 articles from IHU-Méditerranée Infection that described different studies involving homeless people in Marseille over a decade, but all listed the same institutional ethics approval number. Bik and other commenters on PubPeer have identified ethical concerns in many other papers, including others in large groups of papers with the same ethical approval numbers. Subsequently, Bik has received harassment and legal threats from Raoult.
David Knutson, senior manager of communications for PLOS, sent ‘Retraction Watch’ this statement:
PLOS is issuing interim Expressions of Concerns for 49 articles that are linked to researchers affiliated with IHU-Méditerranée Infection (Marseille, France) and/or the Aix-Marseille University, as part of an ongoing case that involves more than 100 articles in total. Many of the papers in this case include controversial scientist Didier Raoult as a co-author.
Several whistleblowers raised concerns about articles from this institute, including that several ethics approval reference numbers have been reused in many articles. Our investigation, which has been ongoing for more than a year, confirmed ethics approval reuse and also uncovered other issues including:
- highly prolific authorship (a rate that would equate to nearly 1 article every 3 days for one or more individuals), which calls into question whether PLOS’ authorship criteria have been met
- undeclared COIs with pharmaceutical companies
To date, PLOS has completed a detailed initial assessment of 108 articles in total and concluded that 49 warrant an interim Expression of Concern due to the nature of the concerns identified. We’ll be following up with the authors of all articles of concern in accordance with COPE guidance and PLOS policies, but we anticipate it will require at least another year to complete this work.
Raoult is a coauthor on 48 of the 49 papers in question. This summer, Raoult retired as director of IHU-Méditerranée Infection, the hospital and research institution in Marseille that he had overseen since 2011, following an inspection by the French National Agency for the Safety of Medicines and Health Products (ANSM) that found “serious shortcomings and non-compliances with the regulations for research involving the human person” at IHU-Méditerranée Infection and another Marseille hospital. ANSM imposed sanctions on IHU-Méditerranée Infection, including suspending a research study and placing any new research involving people under supervision, and called for a criminal investigation. Other regulators have also urged Marseille’s prosecutor to investigate “serious malfunctions” at the research institution.
Pierre-Edouard Fournier, the new director of IHU-Méditerranée Infection, issued a statement on September 7th that said he had “ensured that all clinical trials in progress relating to research involving the human person (RIPH) were suspended pending the regularization of the situation.” Also in September, the American Society for Microbiology placed expressions of concern on 6 of Raoult’s papers in two of its journals, citing “a ‘scientific misconduct investigation’ by the University of Aix Marseille,” where the researcher also has an affiliation.
___________________________
Christian Lehman predicted on my blog that ” If Covid19 settles in the long-term, he [Raoult] will not be able to escape a minutely detailed autopsy of his statements and his actions. And the result will be devastating.” It seems he was correct.
Max Gerson is well-known to experts in so-called alternative medicine (SCAM). After all, he invented the famous alternative cancer regimen, the Gerson therapy (previously discussed here, here, and here). Not that this treatment works – in fact, it is not just ineffective but also dangerous – but it has prominent promoters, not least King Charles III
. As I say, Gerson is well known for his cancer quackery. What hardly anyone knows is that, before he dabbled in cancer, he invented an entirely different medicine.
Max was born as the 3rd of 9 siblings into a Jewish family on October 18, 1881. They lived in Wongrowitz, a part of Poland that at the time belonged to Germany. Max went to school in his hometown and studied medicine in Breslau (Wrocław, now Poland), Wuerzburg, Berlin, and Freiburg. In 1909, he graduated from the University of Freiburg and began practicing medicine at age 28 in Breslau. During WWI, Gerson worked as a surgeon in a military hospital in Breslau and was awarded the ’Iron Cross’ for his service. In 1916, he married Gretchen Hope; the two had three daughters and stayed together until his death.
In 1918, the Gerson family moved to Bielefeld (Germany), and Max specialized in internal medicine as well as neurology. During this period, Gerson developed an anti-inflammatory drug combination and made contact with a local pharmaceutical firm, ‘ASTA Medica’. On the occasion of the firm’s recent 100th jubilee, a German newspaper reported: “The company did business with the well-known Bielefeld physician and inventor Dr. Max Gerson. At the time, he owned the prescription and trademark for a painkiller called Quadronal. Dr. Gerson became a silent partner.”[1] Remarkably, Gerson who published >50 papers (most in German) seems to have no publication on Quadronal.
In his biography of Gerson, Howard Straus (Max’s grandson), explained that Max Gerson did, in fact, develop not just Quadronal for ASTA but also another drug, Quadronox, which however was not as successful as Quadronal. Crucially, Straus makes it very clear that the drug company defrauded Gerson and “never paid a penny to him or his family, nor honored his early ownership of the shares in the company”.[2]
When I was a young clinician in Germany, Quadronal was still quite popular, and I prescribed it regularly. It had been unquestionably the main success for the multi-million firm, ASTA. Today, it is less in use or even no longer available (I am not sure, perhaps someone can fill me in). Gerson’s second drug, Quadronox, seems to have disappeared a long time ago.
I find this story interesting and potentially relevant to the history of Max Gerson. His time in Bielefeld ended when he fled the Nazis (many of his family were killed during the Holocaust). Eventually, Max, his wife, and their three daughters ended up in New York where Gerson tried to establish his anti-cancer regimen. He became fiercely anti-pharma, and many of his followers even claim that he died by being poisoned by the medico-pharmaceutical establishment which allegedly was afraid that his ‘highly successful’ cancer therapy would put them out of business. It is hard to resist the temptation of suspecting a connection between Gerson’s pharma-phobia and the unfair treatment Max received from ASTA in Bielefeld.
Obviously, my knowledge about all this is incomplete, and I would love to hear from people who know more about it.
[1] ASTA-Erfolgsgeschichte startet vor 100 Jahren (westfalen-blatt.de)
[2] Dr. Max Gerson Healing the Hopeless: Amazon.co.uk: Straus, Howard: 9780976018612: Books
The American Heart Association has issued a statement outlining research on so-called alternative medicine (SCAM) for heart failure. They found some SCAMs that work, some that don’t work, and some that are harmful.
Alternative therapies that may benefit people with heart failure include:
- Omega-3 polyunsaturated fatty acids (PUFA, fish oil) have the strongest evidence among complementary and alternative agents for clinical benefit in people with heart failure and may be used safely, in moderation, in consultation with their health care team. Omega-3 PUFA is associated with a lower risk of developing heart failure and, for those who already have heart failure, improvements in the heart’s pumping ability. There appears to be a dose-related increase in atrial fibrillation (an irregular heart rhythm), so doses of 4 grams or more should be avoided.
- Yoga and Tai Chi, in addition to standard treatment, may help improve exercise tolerance and quality of life and decrease blood pressure.
Meanwhile, some therapies were found to have harmful effects, such as interactions with common heart failure medications and changes in heart contraction, blood pressure, electrolytes and fluid levels:
- While low blood levels of vitamin D are associated with worse heart failure outcomes, supplementation hasn’t shown benefit and may be harmful when taken with heart failure medications such as digoxin, calcium channel blockers and diuretics.
- The herbal supplement blue cohosh, from the root of a flowering plant found in hardwood forests, might cause a fast heart rate called tachycardia, high blood pressure, chest pain and may increase blood glucose. It may also decrease the effect of medications taken to treat high blood pressure and Type 2 diabetes.
- Lily of the valley, the root, stems and flower of which are used in supplements, has long been used in mild heart failure because it contains active chemicals similar to, but less potent than, the heart failure medicine digoxin. It may be harmful when taken with digoxin by causing very low potassium levels, a condition known as hypokalemia. Lily of the valley also may cause irregular heartbeat, confusion and tiredness.
Other therapies have been shown as ineffective based on current data, or have mixed findings, highlighting the importance of patients having a discussion with a health care professional about any non-prescribed treatments:
- Routine thiamine supplementation isn’t shown to be effective for heart failure treatment unless someone has this specific nutrient deficiency.
- Research on alcohol varies, with some data showing that drinking low-to-moderate amounts (1 to 2 drinks per day) is associated with preventing heart failure, while habitual drinking or intake of higher amounts is toxic to the heart muscle and known to contribute to heart failure.
- There are mixed findings about vitamin E. It may have some benefit in reducing the risk of heart failure with preserved ejection fraction, a type of heart failure in which the left ventricle is unable to properly fill with blood between heartbeats. However, it has also been associated with an increased risk of hospitalization in people with heart failure.
- Co-Q10, or coenzyme Q10, is an antioxidant found in small amounts in organ meats, oily fish and soybean oil, and commonly taken as a dietary supplement. Small studies show it may help improve heart failure class, symptoms and quality of life, however, it may interact with blood pressure lowering and anti-clotting medicines. Larger trials are needed to better understand its effects.
- Hawthorn, a flowering shrub, has been shown in some studies to increase exercise tolerance and improve heart failure symptoms such as fatigue. Yet it also has the potential to worsen heart failure, and there is conflicting research about whether it interacts with digoxin.
“Overall, more quality research and well-powered randomized controlled trials are needed to better understand the risks and benefits of complementary and alternative medicine therapies for people with heart failure,” said Chow. “This scientific statement provides critical information to health care professionals who treat people with heart failure and may be used as a resource for consumers about the potential benefit and harm associated with complementary and alternative medicine products.”
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No doubt, this assessment is a laudable attempt to inform patients responsibly. Personally, I am always a bit skeptical about such broad statements. SCAM encompasses some 400 different therapies, and I doubt that these can all be assessed in one single overview.
It is not difficult to find SCAMs that seem to have not been considered. Take this systematic review, for instance. It included 24 RCTs (n = 1314 participants) of 9 different mind-body interventions (MBI) types: Tai Chi (n = 7), yoga (n = 4), relaxation (n = 4), meditation (n = 2), acupuncture (n = 2), biofeedback (n = 2), stress management (n = 1), Pilates (n = 1), and reflexology (n = 1). Most (n = 22, 95.8%) reported small-to-moderate improvements in quality of life (14/14 studies), exercise capacity (8/9 studies), depression (5/5 studies), anxiety and fatigue (4/4 studies), blood pressure (3/5 studies), heart rate (5/6 studies), heart rate variability (7/9 studies), and B-type natriuretic peptide (3/4 studies). Studies ranged from 4 minutes to 26 weeks and group sizes ranged from 8 to 65 patients per study arm.
The authors concluded that, although wide variability exists in the types and delivery, RCTs of MBIs have demonstrated small-to-moderate positive effects on HF patients’ objective and subjective outcomes. Future research should examine the mechanisms by which different MBIs exert their effects.
Or take this systematic review of 38 RCTs of oral TCM remedies. The majority of the included trials were assessed to be of high clinical heterogeneity and poor methodological quality. The main results of the meta-analysis showed improvement in total MLHFQ score when oral Chinese herbal medicine plus conventional medical treatment (CMT) compared with CMT with or without placebo [MD = -5.71 (-7.07, -4.36), p < 0.01].
The authors concluded that there is some encouraging evidence of oral Chinese herbal medicine combined with CMT for the improvement of QoL in CHF patients. However, the evidence remains weak due to the small sample size, high clinical heterogeneity, and poor methodological quality of the included trials. Further, large sample size and well-designed trials are needed.
Don’t get me wrong: I am not saying that TCM remedies are a viable option – in fact, I very much doubt it – but I am saying that attempts to provide comprehensive overviews of all SCAMs are problematic, and that incomplete overviews are just that: incomplete.
