It has been reported that the US Insurer ‘State Farm’ is fighting a fraudulent scheme that has been exploiting New Jersey’s personal injury protection (PIP) benefits law since 2014. The insurer is seeking to recover $2.6 million in what it claims are fraudulent auto injury claims and a declaratory judgment that it need not pay any further claims submitted by the providers involved in the alleged scheme.
State Farm’s suit accuses 12 chiropractic and spine clinics and doctors of fraud, unjust enrichment, and violations of the New Jersey Insurance Fraud Prevention Act. The insurer alleges these providers used a “predetermined protocol” for all patients and a patient referral system for services that were either not performed or were not medically necessary for the individual patients. Instead, the services were carried out to enrich the defendants by exploiting the patients’ eligibility for PIP benefits, according to the complaint.
The suit accuses the providers of failing to legitimately evaluate patients to determine the true nature of their injuries and of reporting the same or similar findings for all patients to justify a predetermined course of treatment that was substantially the same for all patients. Part of the “predetermined protocol” for patients with soft-tissue injuries of the neck and back consisted of
- hot and cold packs,
- chiropractic manipulations,
- mechanical traction,
- physical medicine and rehabilitation,
- and manual therapy.
These treatments were administered to almost every patient on almost every visit, regardless of each patient’s unique circumstances and needs, according to the complaint. The chiropractors are also accused of referring patients to diagnostic clinics, some allegedly illegally owned by the chiropractors, for an “unnecessary and predetermined course of pain management and invasive treatments” including injections. State Farm says they would submit false documentation for each case representing that the treatments were legitimately performed and medically necessary.
The 80-page complaint details case after case where the patient’s responses to questions and tests were the same or similar, allegedly serving as a “pretext to justify” the chiropractors’ wide range of treatments. The defendants in the complaint filed in U.S. District Court for New Jersey are:
- Tri-County Chiropractic and Rehabilitation Center,
- Robert Matturro, D.C.,
- Advanced Spine and Pain Management,
- Varinder Dhillon, M.D.,
- Nicholas Rosania, D.C.,
- Bloomfield UAI,
- Dov Rand, M.D.,
- Primary Medical Services,
- Louis J. Citarelli, M.D.,
- Chiro Health Center P.C.,
- Marc Matturro, D.C.
- Marco Tartaglia, M.D.
This story made me wonder: which of the listed treatments
- hot and cold packs,
- chiropractic manipulations,
- mechanical traction,
- physical medicine and rehabilitation,
- and manual therapy
would ever be indicated for patients with soft-tissue injuries of the neck and back? Or more specifically, are chiropractic manipulations indicated or contra-indicated for such problems following a car accident? I fail to see any sound evidence that they are effective. If I am correct, should insurance companies not sue all chiropractors who routinely use manipulations for such cases? If the answer is YES, the sum of 2.6 million might need to be increased by several orders of magnitude.
All healthcare professionals have an ethical obligation to be truthful and act in the best interest of the patient by adhering to the best available evidence. Providing false or misleading information to patients or consumers is thus a breach of medical ethics. In Canada, the authorities have started taking action against nurses that violate these ethical principles.
- A nurse has been suspended for asking a co-worker to create fake vaccine records.
Now it has been reported that a former registered nurse in West Kelowna has been suspended for four weeks after giving a vulnerable client anti-vaccine information and recommending “alternative pseudoscience” treatments.
According to the terms of a consent agreement posted on the B.C. College of Nurses and Midwives site, Carole Garfield was under investigation for actions that happened in September 2021. The college claims that Garfield contacted the client when she was off duty, using her personal mobile phone and email to give information against the COVID-19 vaccine and recommending so-called alternative medicine (SCAM). The exact nature of the “pseudoscience modalities” Garfield recommended to the client was not listed in the college’s notice.
Garfield’s nursing licence was cancelled back in April, according to the college’s registry. It’s unclear how exactly the four-week suspension will be applied. In addition to her month-long suspension and a public reprimand, Garfield is not allowed to be the sole nurse on duty for six months. She will also be given education about ethics, boundaries, and client confidentiality, as well as the province’s professional nursing standards. “The inquiry committee is satisfied that the terms will protect the public,” read a statement from the college.
In my view, it is high time for professional bodies to act against healthcare professionals who issue misleading information to their patients. In the realm of so-called alternative medicine (SCAM), issuing false or misleading information is extremely common and causes untold harm. Such harm would be largely preventable if the professional bodies in charge would start acting responsibly in the best interest of patients. It is high time that they follow the Canadian example!
The Center for Inquiry (CFI) is a charitable nonprofit organization dedicated to defending science and critical thinking. CFI’s vision is a world in which evidence, science, and compassion—rather than superstition, pseudoscience, or prejudice—guide public policy.
It has been reported that the CFI, through its Office of Consumer Protection from Pseudoscience, warned Amazon.com that the marketing and sale of unapproved homeopathic drugs betrays consumers’ trust and runs afoul of federal law. In a letter sent to the world’s largest online retailer, attorneys for CFI charged that Amazon has legal and moral obligations to end its trade in the prohibited items and urged the company to immediately cease the sale of unapproved drugs marketed as medicine for babies, infants, and children.
In Amazon’s Health Care Products department, a search for “homeopathic” returns more than 10,000 product results–each claiming to treat a host of health issues, ranging from “nerve pain” and “fever” to “surgical wounds” and “fibroids and ovarian cysts.” Marketed with names such as “Boiron RhinAllergy Kids” and “Hyland’s 4Kids Pain Relief,” many items are explicitly sold as medicine for children. However, not one homeopathic drug has been approved by the Food and Drug Administration (FDA) as required by the federal Food, Drug & Cosmetic Act.
“Amazon built its business and public reputation on assurances it prioritizes consumer trust above all else,” says CFI Vice President and General Counsel Nick Little. “It’s impossible to be ‘Earth’s most customer-centric company’ while aggressively promoting thousands of snake oil products to parents. If Amazon truly wants to put its customers first, the company should be protecting them from sellers of sham treatments and faux medicine, not profiting from it.”
The FDA recently issued a warning letter to Amazon over the platform’s prohibited sale of mole and skin tag removal products that lack FDA approval. CFI makes clear that the same prohibitions apply to homeopathic drugs sold on Amazon.com. The letter also highlights deceptive marketing practices used to sell the products, noting that the industry’s own figures found 85 percent of those who purchased a brand of homeopathic product were not aware the item was actually homeopathic.
“Amazon recently announced partnerships to help crack-down on phony wrestling memorabilia,” Little notes. “We think protecting children against harmful homeopathic drugs is a bit more deserving of the company’s attention and hope Amazon accepts our offer to help identify these particularly problematic products for removal.”
You can read CFI’s letter to Amazon here.
Le Figaro reported that France’s medical appointment booking service ‘Doctolib’ is being accused of promoting so-called alternative medicine (SCAM) on its platform. “Measures will be taken soon. Several options are on the table, we do not exclude anything,” announced Doctolib after declaring during the day on its Twitter account the immediate suspension of some profiles.
Health professionals and patients have been criticizing the platform for allowing its users to make appointments with practitioners claiming to be naturopaths and some offering dangerous quackery. Naturopathy is not recognized in France and is sometimes considered to be linked to charlatanism.
A member of the office for the control of conspiracies, Tristan Mendès France, had found a practitioner promoting urine therapy via Doctolib. “The presence of these individuals on a service that puts patients and health professionals in touch with each other gives them totally unjustified credit and endorsement,” stated a Twitter account aimed at informing “about the dangers of certain pseudo-alternatives in terms of health and nutrition”.
Amongst the questioned profiles were the naturopaths Thierry Casasnovas and Irène Grosjean, two influential personalities in the naturopathic world who are discredited in the health world. “We would like to point out that it is impossible for a patient to make an [appointment] on Doctolib in a practitioner not referenced by the Ministry of Health, without having expressly sought to do so,” Doctolib defended its position stating that it would proceed to checks on practitioners “whose actions would be dangerous or condemnable by law” and who would have been the subject of complaints on social media.
97%” of practitioners signed up with Doctolib are registered with the Ministry of Health,” the company claimed. According to Doctolib, only 3% of its practitioners are therefore from the realm of SCAM: sophrologists, hypnotherapists, naturopaths. In France, these practitioners are not regulated and do not have the status of health professional, but they are nevertheless legal. The appointments made on Doctolib with such practitioners represent “0.3% of the totality” of the volume recorded on the platform.
The CEO of Doctolib, Stanislas Niox-Chateau, said that he was responding to a request from patients and refused to position his site as a simple directory of the Ministry of Health: “The demand is there. It is not up to us to say whether these activities are effective or useful. They are legal, so we have no reason to prevent practitioners from being listed on our site.”
As so often in the realm of SCAM, the dispute seems to be one between ethical/moral responsibilities and commercial interests of the parties involved.
An article in THE TIMES seems worth mentioning. Here are some excerpts:
… Maternity care at Nottingham University Hospitals NHS Trust (NUH) is the subject of an inquiry, prompted by dozens of baby deaths. More than 450 families have now come forward to take part in the review, led by the expert midwife Donna Ockenden. The trust now faces further scrutiny over its use of aromatherapy, after experts branded guidelines at the trust “shocking” and not backed by evidence. Several bereaved families have said they recall aromatherapy being heavily promoted at the trust’s maternity units.
It is being prosecuted over the death of baby Wynter Andrews just 23 minutes after she was born in September 2019. Her mother Sarah Andrews wrote on Twitter that she remembered aromatherapy being seen as “the answer to everything”. Internal guidelines, first highlighted by the maternity commentator Catherine Roy, suggest using essential oils if the placenta does not follow the baby out of the womb quickly enough… the NUH guidelines say aromatherapy can help expel the placenta, and suggest midwives ask women to inhale oils such as clary sage, jasmine, lavender or basil, while applying others as an abdominal compress. They also describe the oils as “extremely effective for the prevention of and, in some cases, the treatment of infection”. The guidelines also suggest essential oils to help women suffering from cystitis, or as a compress on a caesarean section wound. Nice guidelines for those situations do not recommend aromatherapy…
The NUH adds frankincense “may calm hysteria” and is “recommended in situations of maternal panic”. Roy said: “It is shocking that dangerous advice seemed to have been approved by a team of healthcare professionals at NUH. There is a high tolerance for pseudoscience in NHS maternity care … and it needs to stop. Women deserve high quality care, not dangerous quackery.” …
The journalist who wrote the article also asked me for a comment, and I emailed her this quote: “Aromatherapy is little more than a bit of pampering; no doubt it is enjoyable but it is not an effective therapy for anything. To use it in medical emergencies seems irresponsible to say the least.” The Times evidently decided not to include my thoughts.
Having now read the article, I checked again and failed to find good evidence for aromatherapy for any of the mentioned conditions. However, I did find an article and an announcement both of which are quite worrying, in my view:
Aromatherapy is often misunderstood and consequently somewhat marginalized. Because of a basic misinterpretation, the integration of aromatherapy into UK hospitals is not moving forward as quickly as it might. Aromatherapy in UK is primarily aimed at enhancing patient care or improving patient satisfaction, and it is frequently mixed with massage. Little focus is given to the real clinical potential, except for a few pockets such as the Micap/South Manchester University initiative which led to a Phase 1 clinical trial into the effects of aromatherapy on infection carried out in the Burns Unit of Wythenshawe Hospital. This article discusses the expansion of aromatherapy within the US and follows 10 years of developing protocols and policies that led to pilot studies on radiation burns, chemo-induced nausea, slow-healing wounds, Alzheimers and end-of-life agitation. The article poses two questions: should nursing take aromatherapy more seriously and do nurses really need 60 hours of massage to use aromatherapy as part of nursing practice?
My own views on aromatherapy are expressed in our now not entirely up-to-date review:
Aromatherapy is the therapeutic use of essential oil from herbs, flowers, and other plants. The aim of this overview was to provide an overview of systematic reviews evaluating the effectiveness of aromatherapy. We searched 12 electronic databases and our departmental files without restrictions of time or language. The methodological quality of all systematic reviews was evaluated independently by two authors. Of 201 potentially relevant publications, 10 met our inclusion criteria. Most of the systematic reviews were of poor methodological quality. The clinical subject areas were hypertension, depression, anxiety, pain relief, and dementia. For none of the conditions was the evidence convincing. Several SRs of aromatherapy have recently been published. Due to a number of caveats, the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.
In this context, it might also be worth mentioning that we warned about the frequent usage of quackery in midwifery years ago. Here is our systematic review of 2012 published in a leading midwifery journal:
Background: in recent years, several surveys have suggested that many midwives use some form of complementary/alternative therapy (CAT), often without the knowledge of obstetricians.
Objective: to systematically review all surveys of CAT use by midwives.
Search strategy: six electronic databases were searched using text terms and MeSH for CAT and midwifery.
Selection criteria: surveys were included if they reported quantitative data on the prevalence of CAT use by midwives.
Data collection and analysis: full-text articles of all relevant surveys were obtained. Data were extracted according to pre-defined criteria.
Main results: 19 surveys met the inclusion criteria. Most were recent and from the USA. Prevalence data varied but were usually high, often close to 100%. Much use of CATs does not seem to be supported by strong evidence for efficacy.
Conclusion: most midwives seem to use CATs. As not all CATs are without risks, the issue should be debated openly.
I am tired of saying ‘I TOLD YOU SO!’ but nevertheless find it a pity that our warning remained (yet again) unheeded!
Warning: Exceptionally, this post is not on so-called alternative medicine but on a different scam.
The current issue of the BMJ carries an editorial that is worth quoting on my blog, I think. I have never made a secret of the fact that I am against Brexit. In fact, I re-took German nationality because of it. Therefore, I am in agreement with Kamran Abbasi, the BMJ editor and author of the editorial. Here are what I consider the two most important paragraphs from his article:
… In the absence of public debate and meaningful data six years after the UK’s Brexit referendum, we asked Richard Vize to examine the effects of Brexit on health and care (doi:10.1136/bmj.o1870).20 The news isn’t all bad, although there isn’t much good. Brexit hasn’t brought about a cut in NHS funding but did fail to deliver the £350m weekly windfall that Boris Johnson and others promised. The European Working Time Directive remains in place, and the predicted “stampede” of European doctors leaving the NHS hasn’t happened. But the impacts on social care and lower paid staff are harming delivery of care in an increasingly multidisciplinary service.
Health technology, life science industries, and research, where integration with Europe was greatest and benefits most obvious, are being damaged. Promises to cut red tape have created new complexities and been tarnished by suspect procurement practices at the height of the pandemic (doi:10.1136/bmj.o1893).21 Perhaps the most damning legacy of Brexit, however, is the state of unreadiness it created for a pandemic that required utmost readiness. Whether or not you agree Brexit was the right decision, you should at least agree that it is a decision worthy of question, analysis, and redoubled effort if the signs are good and possibly even reversal if the damage is too great.
This quote probably makes more sense if one also reads the paper referenced in its 2nd link. So, please allow me to quote from this article as well:
… In a highly critical report, the Commons Public Account Committee accuses the Department of Health and Social Care of “woefully inadequate record keeping” and failing to meet basic requirements to publicly report ministers’ external meetings or deal with potential conflicts of interest when awarding testing contracts to the company.
The committee said that large gaps in the document trail meant it was impossible to say the contracts were awarded properly in the way that would be expected, even allowing for the exceptional circumstances and accelerated processes in place at the time. The first contract, for £132m, was awarded at the height of the covid pandemic in March 2020, when the department had suspended the normal requirements for competition between suppliers in the award of government contracts.
The report noted that officials were aware of contacts between Matt Hancock, the then health and social care secretary, and Owen Paterson, a Conservative MP and paid consultant for Randox, and of hospitality that Hancock received from Randox’s founder Peter Fitzgerald in 2019, but failed to identify any conflicts of interest before awarding the first contract.
The department set up a “VIP lane,” through which suppliers put forward by officials, MPs, ministers, or Number 10 would be given priority. Suppliers coming through priority routes were awarded £6bn out of the total £7.9bn of testing contracts awarded between May 2020 and March 2021, the committee noted…
This is by no means all, and I do encourage you to read these articles in full. Once you have, you might ask yourself as I do:
Has Britain become a banana republic?
For many years, Dr. Natalie Grams-Nobmann provided evidence-based medical information on social media – including on homeopathy, other forms of so-called alternative medicine, and more recently the COVID pandemic. These activities deservedly earned her plenty of praise but sadly they also made her the target of intolerant, occasionally aggressive people who disagree with the evidence. As I mentioned in yesterday’s post, Natalie has recently deleted her Twitter account. To explain her decision, she gave an interview to Marc Zimmer, MDR AKTUELL. With Natalie’s permission, I have translated sections of it and re-publish them here:
Q: What do you think about the case of your Austrian colleague?
A: The case has affected and frightened me terribly. I followed Kellermayr’s work and everything that came afterward. It is simply a terrible example of how little protection one has as a doctor or vaccination educator on social media. It also is a terrible example of how this “hate” does not stay in the realm of social media but spills over into real life. And that we have nothing to counter this “hate”.
Q: You yourself have also drawn consequences and deleted your Twitter account. Can you explain this step?
A: After seven years of vaccination education and medical education on social media, I thought I couldn’t take it anymore. I can’t stand looking into this hell where people celebrate the death of another human being, the suicide of another human being – and see that as an admission of guilt of this really threatened and persecuted doctor and rise above it like that. I think that when even the death of a human being is no longer free of gloating and hatred, then ideology is above everything. I didn’t know how to deal with it anymore. And, of course, it also scared me. I think my death would be celebrated in the same way, and I find that terribly frightening in human terms.
Q: To what extent have you experienced threats so far?
A: … I’ve experienced an incredible amount of different forms of hate – be it threats, insults, slander, or persecution. This has also spilled over into real life for me. I have sometimes given lectures under police protection. I am very glad that it is still sensible to wear a mask in public spaces… I think that in some cases it really is a life-threatening fear that you have to endure when you speak out on social or other media about vaccination protection or about protective measures. A lot of what you hear has to be reported and followed up. It is not the case that the internet is a lawless space or that my inbox simply has to swallow every insult in the world…
Q: You mentioned the platforms. What about politics? Do you feel supported enough by it and by the authorities?
A: No, not at all and that was certainly the case with the Austrian colleague. In desperation and panic, people turn to the police, and of course, there are individual female officers who react in an excellent way. But I have also heard things like: “Well, then don’t go out in public. Why do you do that? You’re doing it voluntarily, so you have to put up with it”. Or they say that it’s freedom of expression, that everyone is allowed to say anything… If no more discourse is possible, what am I supposed to do? I would like to be able to ensure that I remain objective, that I provide information and do not insult anyone. At the moment I simply don’t see myself in a position to do that because of the many threats.
Q: What do you wish from politics?
A: I would like politicians to draw the right conclusions from this: not just those who shout the loudest must be listened to. The ones who are silenced should be heard as well.
This “silencing” that I have been following throughout the pandemic is a terrible thing. The best and most factual discussants are disappearing more and more from the platforms. I haven’t insulted or threatened or unobjectively excoriated anyone in all my time on social media. Of course, you are allowed to make a joke or use satire. But you’re not allowed to put another person down. And the very people who have always managed to remain objective – despite the well-known strains during the pandemic – are now leaving and this should alarm us all.
I do, of course, understand and respect Natalie’s decisions. Nevertheless, I am sad that she is partly withdrawing from public life. I feel that, in these difficult times, we need everyone who can contribute to more responsible information for the public. We must try to balance irrationality with rationality. Natalie is particularly gifted in doing just that (she is much more gentle and empathetic in the face of adversity than I, for instance). My hope, therefore, is that things improve, hatred recedes, and she is able to return to public life soon. Regardless of what she decides, I wish her well.
I have often called out unreliable or fraudulent research in the realm of Traditional Chinese Medicine (TCM). I think it is important to do so because the abundance of scientific misconduct is such that it has become a danger to public health. Today, I present yet another example:
This recent review claimed to summarize the evidence on TCM in treating MI, the clinical evaluations of TCM in treating male infertility (MI), and the molecular mechanisms of TCM effects. I was alerted to the fact that the authors cite a paper on acupuncture that I had co-authored. Here is the section in question from the review:
Acupuncture is one of the therapeutic techniques that are part of TCM. Acupuncture is a non-invasive technique and is regarded as free of risk if performed by trained personnel . One of the advantages of acupuncture was that the incidence of adverse effects was substantially lower than that of many drugs or other accepted . Acupuncture has been used in the treatment of male and female infertility and in assisted reproductive technology treatments for many years. A total of 100 patients with MI who met the diagnostic criteria were randomly divided into two groups . Half of the patients received acupuncture treatment, and the other half received placebo acupuncture. After 10 weeks treatment, acupuncture successfully improved the indicators of the semen, including the spermatozoa survival rate, b-level activity rate, sperm density, sperm activity rate. A total of 28 infertile patients with severe oligoasthenozoospermia received acupuncture according to the principles of acupuncture and 29 infertile patients received placebo acupuncture. A significantly higher percentage of motile sperm (World Health Organization categories A-C), but no effect on sperm concentration, was found after acupuncture compared with placebo acupuncture . Of the 279 cases of male sterility treated by the combination of acupuncture, pilose antler essence injection to acupoints and oral administration of Chinese materia medica, 142 cases (47.8%) were cured, 81 cases (27.3%) markedly effective, 53 cases (17.8%) effective and 21 cases (7.1%) ineffective . The therapeutic effect of the combination of these three treatments was satisfactory.
Emerging evidence has shown that cell-cell interactions between testicular cells, in particular at the Sertoli cell-cell and Sertoli-germ cell interface, are crucial to support spermatogenesis. The unique ultrastructures that support cell-cell interactions in the testis are the basal ES (ectoplasmic specialization) and the apical ES. The basal ES is found between adjacent Sertoli cells near the basement membrane that also constitute the blood-testis barrier (BTB). The apical ES is restrictively expressed at the Sertoli-spermatid contact site in the apical (adluminal) compartment of the seminiferous epithelium. These ultrastructures are present in both rodent and human testes, but the majority of studies found in the literature were done in rodent testes. As such, our discussion herein, unless otherwise specified, is focused on studies in testes of adult rats. Studies have shown that the testicular cell-cell interactions crucial to support spermatogenesis are mediated through distinctive signaling proteins and pathways, most notably involving FAK, Akt1/2 and Cdc42 GTPase. Thus, manipulation of some of these signaling proteins, such as FAK, through the use of phosphomimetic mutants for overexpression in Sertoli cell epithelium in vitro or in the testis in vivo, making FAK either constitutively active or inactive, we can modify the outcome of spermatogenesis. For instance, using the toxicant-induced Sertoli cell or testis injury in rats as study models, we can either block or rescue toxicant-induced infertility through overexpression of p-FAK-Y397 or p-FAK-Y407 (and their mutants), including the use of specific activator(s) of the involved signaling proteins against pAkt1/2. These findings thus illustrate that a potential therapeutic approach can be developed to manage toxicant-induced male reproductive dysfunction. In this review, we critically evaluate these recent findings, highlighting the direction for future investigations by bringing the laboratory-based research through a translation path to clinical investigations.
This paper does not relate to the statement it is meant to support by the review authors.
The review by Qin et al (1) includes 5 trials none of which should have been included in a quality metaanalysis as the methodology was unconvincing: In the trial by Alraek et al., patients were randomised to receive either acupuncture or no treatment. This means that no attempt was made to control for the effects of placebo or extra attention. Therefore, this study does not demonstrate an effect of acupuncture as the outcome could be due to non-specific effects unrelated with this therapy. By contrast, the trial by Aune et al. did attempt to control for placebo effects by using a sham control group. Sham acupuncture was given using six needles superficially inserted in the calves, thighs or abdomen outside known acupuncture points or meridians. Needles were not manipulated in the sham group. Sham or placebo controls have the purpose of rendering patients unaware of whether they receive the real or the sham treatment. The method used here cannot achieve this aim; patients would be easily able to tell which intervention they received. In other words, this study also did not adequately control for placebo effects. The remaining three trials are all not Medline-listed, authored by Chinese investigators and published in inaccessible journals. This should disqualify them from inclusion as they were unverifiable by the peer review process. According to the published table, they were equivalence trials of acupuncture versus antibiotics with a sample size around 30. This means they are grossly underpowered and thus unable to generate reliable results. Unless BJOG peer reviewers could see the primary articles, or be provided with translations from Chinese, the systematic review should not have been accepted. The “many eyes of science” requires transparency, testing, challenge and verification. Although in the past, inconclusive results of acupuncture have not been thought to be due to Chinese influence (2), it has been noted that virtually all recent published acupuncture trials are “positive” (3), raising questions of publication and other biases. Our colleagues are under tremendous pressure to publish, but we do them no favours by effectively lowering the standard of scientific peer review. Elite journals too have an obligation to train and reiterate about publication ethics and sound scientific writing (4). As none of the primary studies convincingly demonstrated that acupuncture is an effective therapy for recurrent urinary tract infections, no positive conclusion was warranted. Although Qin et al. did state that the risk of bias of the included trials was generally high or unclear (1), the BJOG nevertheless allowed them to turn massive uncertainty into relatively firm, positive conclusions in the abstract (“Acupuncture appeared to be beneficial for treatment and prophylaxis of rUTIs”) and tweetable abstract (“This review found that acupuncture may improve treatment and prevent recurrence of urinary tract infection in women”), thus leading to excited media headlines that inevitably mislead the public. ‘May’ is a weasel word which should be avoided as it is unfalsifiable (for example, pigs do not fly but they ‘may’ fly in the future). The definite, straightforward conclusion must be “There is no good evidence to support the use of acupuncture for the treatment and prophylaxis of recurrent UTIs”. It is not acceptable to give international credibility to an implausible modality that no objective, independent high-quality review has found effective beyond placebo (5). The dampening accompanying mini-commentary (6) does not undo the damage.
The review should be withdrawn while the primary papers are translated for peer reviewers to examine, the above limitations discussed in the text, and the positive ‘spin’ in conclusions corrected. These improvements would consolidate the researchers’ probity and justify the accolade of BJOG publication.
Our letter to the editor does not bear any relation to the statement it is meant to support by the review authors.
In this first prospective, randomized, single-blind, placebo-controlled study, 28 infertile patients with severe oligoasthenozoospermia received acupuncture according to the principles of traditional Chinese medicine (TCM) and 29 infertile patients received placebo acupuncture. A significantly higher percentage of motile sperm (World Health Organization categories A–C), but no effect on sperm concentration, was found after acupuncture compared with placebo acupuncture.
This small study is far from convincing and does not lend itself to far-reaching conclusions
Of the 279 cases of male sterility treated by the combination of acupuncture, pilose antler
essence injection to acupoints and oral administration of Chinese materia medica, 142
cases (47.8%) were cured, 81 cases (27.3%) markedly effective, 53 cases (17.8%) effective
and 21 cases (7.1%) ineffective. The therapeutic effect of the combination of these three
treatments was satisfactory.
This study had no control group and used two different therapies. Therefore, it does not allow any conclusion about the effectiveness of acupuncture.
Perhaps you feel that these errors are trivial. But I would disagree. The review authors’ praise of acupuncture for MI is misplaced and will mislead the public. There are plenty of reviews on the subject, and those that are not overtly biased arrive at conclusions like these:
- The current evidence on acupuncture for oligoasthenozoospermia is inadequate to draw a solid conclusion due to the poor methodological quality. Rigorous full-scale RCTs are needed to validate the therapeutic efficacy and safety of acupuncture in treating oligoasthenozoospermia.
- The current evidence showing that acupuncture might improve poor semen quality is insufficient because of the small number of studies, inadequacy of procedures and/or insufficient information for semen analysis, high levels of heterogeneity, high risk of bias, and poor quality of reporting. Further large, well-designed RCTs are required.
So, how did this sloppy review come about?
Its authors are affiliated to the TCM Regulating Metabolic Diseases Key Laboratory of Sichuan Province, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China, and the Tea Research Institute, Sichuan Academy of Agricultural Sciences, Chengdu 610066, China. A footnote tells us that their review was supported by the National Natural Science Foundation of China [No. 81973647] and the Xinglin scholar discipline promotion talent program of Chengdu University of traditional Chinese medicine [No. BSH2021018]. This sounds respectable enough.
The journal that published the review is ‘Pharmacological Research – Modern Chinese Medicine‘. Its stated aims are as follows: The journal publishes articles reporting on advances in our comprehension of mechanism and safety in experimental pharmacology and clinical efficacy and safety of pharmacologically active substances, including compound prescriptions, utilized in Traditional Chinese Medicine applying modern scientific research methods. Studies reporting also on the mechanisms of actions of the active substance(s) investigated are encouraged.
The editors in chief of the journal are Guan-Hua Du, PhD, China Academy of Chinese Medical Sciences Institute of Chinese Materia Medica, Beijing, China and Emilio Clementi, M.Mus, MD, PhD, University of Milan, Milan, Italy. No doubt, these are respectable scientists. And because they are, they should make sure that what they publish is correct – a criterion this recent review clearly does not meet.
I had totally forgotten this amusing little episode: According to THE GUARDIAN, Jacob Rees-Mogg (JRM) once tweeted that I should be locked up in the Tower of London!
If you are not from the UK, you may not know this Member of Parliament. So, let me explain.
JRM is the MP for North East Somerset and currently the ‘Minister for Brexit Opportunities and Government Efficiency’. His personal net worth is estimated to be well over £100 million. I probably don’t need to add much more about JRM; there is plenty about him on the Internet and on social media, for instance, this little gem:
Some of JRM’s medically relevant voting records are revealing:
- He voted against raising welfare benefits five times in 2013.
- He voted against higher benefits over long periods for those unable to work as a result of an illness or disability: 14 votes over 5 years.
- Between 2012-2016, he voted 52 times to reduce the spending on welfare benefits.
- He voted to exempt pubs and clubs where food is not served from the smoking ban in October 2010.
- He voted against a law to make private vehicles smoke-free if a child is present.
- He voted against allowing terminally ill people to be given assistance in ending their lives.
Wikipedia mentions that Rees-Mogg is against abortion in all circumstances, stating: “life begins at the point of conception. With same-sex marriage, that is something that people are doing for themselves. With abortion, that is what people are doing to the unborn child.” In September 2017, he expressed “a great sadness” on hearing about how online retailers had reduced pricing of emergency contraception.
In October 2017, it was reported that Somerset Capital Management, of which Rees-Mogg was a partner, had invested £5m in Kalbe Farma, a company that produces and markets misoprostol pills designed to treat stomach ulcers but widely used in illegal abortions in Indonesia. Rees-Mogg defended the investment by arguing that the company in question “obeys Indonesian law so it’s a legitimate investment and there’s no hypocrisy. The law in Indonesia would satisfy the Vatican”. Several days later, it was reported that the same company also held shares in FDC, a company that sold drugs used as part of legal abortions in India. Somerset Capital Management subsequently sold the shares it had held in FDC. Rees-Mogg said: “I am glad to say it’s a stock that we no longer hold. I would not try to defend investing in companies that did things I believe are morally wrong”.
In a nutshell, JRM seems to stand for pretty much everything that I am against. But that is no reason to send me to the Tower of London. So, what exactly was JRM referring to when he wanted me locked up?
The Guardian article explains: At a press conference to mark his retirement [Ernst] agreed with a Daily Mail reporter’s suggestion that the Prince of Wales is a “snake-oil salesman”. In the living room of his house in Suffolk he unpacks the label with the precision on which he prides himself. “He’s a man, he owns a firm that sells this stuff, and I have no qualms at all defending the notion that a tincture of dandelion and artichoke [Duchy Herbals detox remedy] doesn’t do anything to detoxify your body and therefore it is a snake oil.” Far from regretting the choice of words and the controversy it has generated, he appears to relish it.
Looking back at all this bizarre story, I am surprised that JRM did not advocate chopping my head off in the Tower of London. He must have been in a benevolent mood that day!
The interest in the medicinal properties of honey is lively. A recent review, for instance, concluded that honey is a safe natural substance, effective in the inhibition of bacterial growth and the treatment of a broad range of wound types, including burns, scratches, diabetic boils (Skin abscesses associated with diabetic), malignancies, leprosy, fistulas, leg ulcers, traumatic boils, cervical and varicose ulcers, amputation, burst abdominal wounds, septic and surgical wounds, cracked nipples, and wounds in the abdominal wall. Honey comprises a wide variety of active compounds, including flavonoids, phenolic acid, organic acids, enzymes, and vitamins, that may act to improve the wound healing process. Tissue-engineered scaffolds have recently attracted a great deal of attention, and various scaffold fabrication techniques are being researched.
But there is also reason to be cautious. The U.S. Food and Drug Administration (FDA) posted warning letters to four companies for illegally selling honey-based products that may pose a significant health risk to consumers. The FDA’s laboratory testing found that product samples contained active drug ingredients not listed on the product labels, including the active drug ingredients found in Cialis (tadalafil) and Viagra (sildenafil), which are FDA approved drugs used to treat men with erectile dysfunction. Sildenafil and tadalafil are restricted to use under the supervision of a licensed health care professional. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
“Tainted honey-based products like these are dangerous because consumers are likely unaware of the risks associated with the hidden prescription drug ingredients in these products and how they may interact with other drugs and supplements they may take,” said FDA Associate Commissioner for Regulatory Affairs Judy McMeekin, Pharm.D., “Products marketed with unidentified ingredients may be dangerous and, in some cases, deadly to consumers. We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that put their health at risk, and instead seek effective, FDA-approved treatments.”
Today’s warning letters outline how companies violated federal law by selling active drug ingredients in products marketed as foods, like honey, and by making unauthorized claims that their products treat disease or improve health. These products are promoted and sold for sexual enhancement on various websites and online marketplaces, and possibly in some retail stores.
The warning letters were issued to:
- Thirstyrun LLC (also known as US Royal Honey LLC),
- MKS Enterprise LLC,
- 1am USA Incorporated dba Pleasure Products USA
Companies marketing food products containing tadalafil and/or sildenafil violate federal law. Some of the products cited in the warning letters are also unapproved new drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and they lack FDA approval. In some cases, product claims reference diseases that can only be diagnosed or treated under medical supervision. Additionally, some products cited in the warning letters are represented as dietary supplements even though tadalafil and sildenafil products are excluded from the dietary supplement definition.
The FDA has requested responses from the companies within 15 working days stating how they will address these issues or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
Consumers using or considering using any over-the-counter product marketed for sexual enhancement should talk to a health care professional first, as some ingredients may interact with medications or dietary supplements. The FDA’s health fraud products database can help consumers identify nearly 1,000 of these potentially dangerous products.
The FDA previously warned consumers about more than 10 honey-based products containing hidden drug ingredients. The FDA’s laboratory testing found that product samples contained undeclared active ingredients, including sildenafil and tadalafil. The agency also previously warned consumers to avoid products with hidden drug ingredients sold through Amazon, eBay, Walmart and other retailers. The FDA is committed to protecting consumers by identifying and removing these potentially dangerous products from the market and urges stores, websites, and online marketplaces to stop selling these products.
If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA also encourages health care providers and consumers to report adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.