death
We had to deal with Hongchi Xiao several times before:
- Slapping therapy? No thanks!
- China Power and Influence
- Slapping therapy: therapist arrested and charged with manslaughter by gross negligence
Slapping therapy is based on the notion that slapping patients at certain points of their body has positive therapeutic effects. Hongchi Xiao, a Chinese-born investment banker, popularised this SCAM which, he claims, is based on the principles of Traditional Chinese Medicine. It is also known as ‘Paida’—in Chinese, this means ‘to slap your body’. The therapy involves slapping the body surface with a view of stimulating the flow of ‘chi’, the vital energy postulated in Traditional Chinese Medicine. Slapping therapists believe that this ritual restores health and eliminates toxins. They also claim that the bruises which patients tend to develop after the treatment are the visible signs of toxins coming to the surface. Hongchi Xiao advocates slapping as “self-healing method” that should be continued until the skin starts looking bruised. He and his follows conduct workshops and sell books teaching the public which advocate slapping therapy as a panacea, a cure-all. The assumptions of slapping therapy fly in the face of science and are thus not plausible. There is not a single clinical trial testing whether slapping therapy is effective. It must therefore be categorised as unproven.
Now it has been reported that Hongchi Xiao has been sentenced to 10 years in prison for the death of a 71-year-old diabetic woman who stopped taking insulin during one of his workshops.
Hongchi Xiao, 61, was convicted of manslaughter by gross negligence for failing to get medical help for Danielle Carr-Gomm as she howled in pain and frothed at the mouth during the fourth day of a workshop in October 2016. The Californian healer promoted paida lajin therapy which entails getting patients to slap themselves repeatedly to release “poisonous waste” from the body. The technique has its roots in Chinese medicine and has no scientific basis and patients often end up with bruises, bleeding — or worse.
Xiao had extradited from Australia, where he had been convicted of manslaughter after a 6-year-old boy died when his parents withdrew his insulin medication after attending one of his workshops in Sydney. “I consider you dangerous even though you do not share the characteristics of most other dangerous offenders,” Justice Robert Bright said during sentencing at Winchester Crown Court. “You knew from late in the afternoon of day one of the fact that Danielle Carr-Gomm had stopped taking her insulin. Furthermore, you made it clear to her you supported this.” Bright added Xiao only made a “token effort” to get Carr-Gomm to take her insulin once it was too late and had shown no sign of remorse as he even continued to promote paida lajin in prison.
Carr-Gomm was diagnosed with type 1 diabetes in 1999 and was desperate to find a cure that didn’t involve injecting herself with needles, her son, Matthew, said. She sought out alternative treatments and had attended a previous workshop by Xiao in Bulgaria a few months before her death in which she also became seriously ill after ceasing her medication. However, she recorded a video testimonial, calling Xiao a “messenger sent by God” who was “starting a revolution to put the power back in the hands of the people to cure themselves and to change the whole system of healthcare.”
Xiao had congratulated Carr-Gomm when she told other participants at the English retreat that she had stopped taking her insulin. By day three, Carr-Gomm was “vomiting, tired and weak, and by the evening she was howling in pain and unable to respond to questions,” prosecutor Duncan Atkinson said.
A chef who wanted to call an ambulance said she deferred to those with holistic healing experience. “Those who had received and accepted the defendant’s teachings misinterpreted Mrs. Carr-Gomm’s condition as a healing crisis,” Atkinson said.
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A healing crisis?
A crisis of collective stupidity, I’d say!
If you live in the UK, you could not possibly escape the discussion about the ‘Assisted Dying Bill’ which passed yesterday’s vote in the House of Commons (MPs have voted by 330 to 275 in favour of legalising voluntary assisted suicide). Once the bill passed all the further parliamentary hurdles – which might take several years – it will allow terminally ill adults who are
- expected to die within six months,
- of sound mind and capable of managing their own affairs
to seek help from specialised doctors to end their own life.
After listening to many debates about the bill, I still I have serious concerns about it. Here are just a few:
- Palliative care in the UK is often very poor. It was argued that the bill will be an incentive to improve it. But what, if this is wishful thinking? What if palliative care deteriorates to a point where it becomes an incentive to suicide? What if the bill should even turn out to be a reason for not directing maximum efforts towards improving palliative care?
- How sure can we be that an individual patient is going to die within the next six months? Lawmakers might believe that predicting the time someone has left to live is a more or less exact science. Doctors (should) know that it is not.
- How certain can we be that a patient is of sound mind and capable of managing their own affairs? By definition, we are dealing with very ill patients whose mind might be clouded, for example, by the effects of drugs or pain or both. Lawmakers might think that it is clear-cut to establish whether an individual patient is compos mentis, but doctors know that this is often not the case.
- In many religions, suicide is a sin. I am not a religious person, but many of the MPs who voted for the bill are or pretend to be. Passing a law that enables members of the public to commit what in the eyes of many lawmakers must be a deadly sin seems problematic.
In summary, I feel the ‘Assisted Dying Bill’ is a mistake for today; it might even be a very grave mistake for a future time, if we have a government that is irresponsible, neglects palliative care even more than we do today and views the bill as an opportunity to reduce our expenditure on pensions.
The alleged harm of Covid-vaccinations is a topic that still leads to misunderstandings, perhaps nowhere more than in the realm of so-called alternative medicine. Therefore, this paper seems relevant.
The first dose of COVID-19 vaccines led to an overall reduction in cardiovascular events, and in rare cases, cardiovascular complications. There is less information about the effect of second and booster doses on cardiovascular diseases. Using longitudinal health records from 45.7 million adults in England between December 2020 and January 2022, this study compared the incidence of thrombotic and cardiovascular complications up to 26 weeks after first, second and booster doses of brands and combinations of COVID-19 vaccines used during the UK vaccination program with the incidence before or without the corresponding vaccination.
The incidence of common arterial thrombotic events (mainly acute myocardial infarction and ischaemic stroke) was generally lower after each vaccine dose, brand and combination. Similarly, the incidence of common venous thrombotic events, (mainly pulmonary embolism and lower limb deep venous thrombosis) was lower after vaccination. There was a higher incidence of previously reported rare harms after vaccination: vaccine-induced thrombotic thrombocytopenia after first ChAdOx1 vaccination, and myocarditis and pericarditis after first, second and transiently after booster mRNA vaccination (BNT-162b2 and mRNA-1273).
The authors concluded that these findings support the wide uptake of future COVID-19 vaccination programs.
The authors stress that their study has several limitations.
- First, residual confounding, including that linked to delayed vaccination in high-risk individuals, may persist despite extensive adjustments for available covariates. We were able to identify some, but not all people who were clinically vulnerable (and hence might have been eligible for earlier vaccination): for example, younger adults in long-stay settings could not be reliably identified.
- Second, we did not adjust for potential confounding by time-varying post-baseline factors that may have influenced receipt of vaccination and the outcomes of interest: for example, development of respiratory symptoms or being admitted into hospital leading to postponement of vaccination. Such confounding may explain estimated lower hazard ratios soon after vaccination.
- Third, ascertainment of some outcomes may have been influenced by public announcements from regulatory agencies, such as the European Medicines Agency Pharmacovigilance Risk Assessment Committee announcement or the CDC announcement on myocarditis. This was addressed in sensitivity analyses for myocarditis and pericarditis, censoring follow-up at the time of public announcements of these adverse effects of vaccination, although the shorter follow-up times and corresponding smaller numbers of events in the restricted analyses meant that aHRs were estimated with reduced precision.
- Fourth, outcomes may be underreported, particularly from people in nursing homes or among those with severe health conditions, due to diagnostic challenges; also, routine electronic health records, not intended for research, may under-ascertain less severe, non-hospitalised events. Both forms of potential underreporting, however, are expected to be uncommon for hospitalised thrombotic events.
- Fifth, we restricted follow-up to 26 weeks after vaccination to prevent an influence of subsequent vaccinations on estimated associations and limit the impact of delayed vaccination on our findings. Horne et al. demonstrated selection bias in estimated HRs for non-COVID-19 death arising from deferred next-dose vaccination in people with a recent confirmed COVID-19 diagnosis or in poor health.
- Sixth, we did not address long-term safety of vaccination, or the impact of subsequent booster doses.
Nonetheless, this study offers reassurance regarding the cardiovascular safety of COVID-19 vaccines, with lower incidence of common cardiovascular events outweighing the higher incidence of their known rare cardiovascular complications. No novel cardiovascular complications or new associations with subsequent doses were found. These findings support the wide uptake of future COVID-19 vaccination programs. The authors express their hope that this evidence addresses public concerns, supporting continued trust and participation in vaccination programs and adherence to public health guidelines.
Will the evidence convince the notorious anti-vaxers that regularly comment on my blog?
I very much doubt it – not because of the limitations of the study but because of the fact that anti-vaxers seem to be immune to any evidence that is out of line with their beliefs and conspiracy theories.
While medical experts across the world have expressed dismay at Trump’s appointment of Robert Kennedy, the ‘International chiropractors Association’ has just published this remarkable note:
Donald J. Trump made it official that he was nominating Robert F. Kennedy, Jr. to serve as the Secretary of Health and Human Services. Secretary-designee Kennedy has spent his entire career championing the health of the nation through education, advocacy, research and when needed litigation.
Among his many accomplishments are protecting the environment with Riverkeeper and the Natural Resources Defense Council His work at Riverkeeper succeeded in setting long-term environmental legal standards. Kennedy won legal battles against large corporate polluters. He became an adjunct professor of environmental law at Pace University School of Law in 1986 and founded the Pace’s Environmental Litigation Clinic which he co-directed for a decade.
It would be in the Pace Law Review that the landmark paper, “Unanswered Questions from the Vaccine Injury Compensation Program: A Review of Compensated Cases of Vaccine-Induced Brain Injury” (https://digitalcommons.pace.edu/cgi/viewcontent.cgi?article=1681&context=pelr) would be published in 2011.
Kennedy became laser focused on the autism epidemic while giving lectures on the dangers of mercury in fish, he was repeatedly approached by the mothers of children born healthy who regressed into autism after suffering adverse reactions from childhood vaccines, including their concern about the mercury-based preservative, thimerosal, being used in vaccines including the Hepatitis B vaccine given at birth. Kennedy’s approach to the issue was the same as it always, looking at the science. He assembled a team who gathered all the science and reviewed the issues with him. This resulted in the publication of the book, Thimerosal: Let the Science Speak
The Evidence Supporting the Immediate Removal of Mercury—a Known Neurotoxin—from Vaccines.
After establishing and leading the nonprofit Children’s Health Defense, last year Kennedy stepped back from the organization to throw his hat in the ring to be President. Becoming the embodiment of his uncle John F. Kennedy’s famous quote, “Ask not what your country can do for you, but what you can do for your country!”, Kennedy reached out to President Trump to form an alliance to focus on the crisis of chronic disease in the United States, and suspended his campaign to focus on the Make American Healthy Again (MAHA) Initiative.
ICA President, Dr. Selina Sigafoose Jackson, who is currently in Brazil promoting the protection of chiropractic as a separate and distinct profession stated, “Many ICA members have been supporters of Robert F. Kennedy, Jr.’s philanthropic activities and are all in on the MAHA Initiative. The Mission, Vision, and Values of the ICA align with the stated goals of the MAHA Initiative. We stand ready to provide policy proposals and experts to serve as advisors to the incoming Administration and to Secretary Kennedy upon his swearing in.”
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Perhaps I am permitted to contrast this with some health-related truths about Robert F. Kennedy, Jr. (my apologies, if the list is incomplete – please add to it by posting further important issues):
- Robert F. Kennedy, Jr. has, since about 20 years, been a leading figure of the anti-vaccine movement.
- During the epidemic, he pushed the conspiracy theory that “the quarantine” was used as cover to install 5G cell phone networks.
- He claimed that “one out of every six American women has so much mercury in her womb that her children are at risk for a grim inventory of diseases, including autism, blindness, mental retardation and heart, liver and kidney disease.”
- He wrote that, “while people were dying at the rate of 10,000 patients a week, Dr. Fauci declared that hydroxychloroquine should only be used as part of a clinical trial. For the first time in American history, a government official was overruling the medical judgment of thousands of treating physicians, and ordering doctors to stop practicing medicine as they saw fit.”
- He pushed the conspiracy theory that COVID-19 had been “ethnically targeted” to spare Ashkenazi Jews and Chinese people.”
- He claimed in a 2023 podcast interview that “There’s no vaccine that is safe and effective”.
- In a 2021 podcast, he urged people to “resist” CDC guidelines on when kids should get vaccines.
- He founded Children’s Health Defense’ that spreads fear and mistrust in science. One chiropractic group in California had donated $500,000 to this organisation.
- In 2019, he visited Samoa where he became partly responsible for an outbreak of measles, which made 5,700 people sick and killed 83 of them.
- He called mercury-containing vaccines aimed at children a holocaust. In 2015, he compared the horrors committed against Jews to the effects of vaccines on children. “They get the shot, that night they have a fever of a hundred and three, they go to sleep, and three months later their brain is gone. This is a holocaust, what this is doing to our country.”
- He repeatedly alleged that exposure to chemicals — “endocrine disruptors” — is causing gender dysphoria in children and contributing to a rise in LGBTQ-youth. According to him, endocrine disruptors are “chemicals that interfere with the body’s hormones and are commonly found in pesticides and plastic.”
- He stated “Telling people to “trust the experts” is either naive or manipulative—or both.”
- He plans to stop water fluoridation.
- He slammed the FDA’s “suppression” of raw milk.
- He said that a worm ate part of his brain which led to long-lasting “brain fog.”
- He has a 14-year-long history of abusing heroin from the age of 15. The police once arrested him for possession; he then faced up to two years in jail for the felony but was sentenced to two years probation after pleading guilty.
- He stated: “WiFi radiation … does all kinds of bad things, including causing cancer…cell phone tumors behind the ear.”
- He claimed that rates of autism have increased even though “there has been no change in diagnosis and no change in screening either.” Yet, both have changed significantly.
- He wrote: (Fauci’s) “obsequious subservience to the Big Ag, Big Food, and pharmaceutical companies has left our children drowning in a toxic soup of pesticide residues, corn syrup, and processed foods, while also serving as pincushions for 69 mandated vaccine doses by age 18—none of them properly safety tested.”
- He stated that cancer rates are skyrocketing in the young and the old – a statement that is evidently untrue.
- He authored a viral post on X: “FDA’s war on public health is about to end. This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma. If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags.”
- He has also aligned himself with special interests groups such as anti-vaccine chiropractors.
- He stated categorically: “You cannot trust medical advice from medical professionals.”
- He said he’s going to put a pause on infectious diseases research for 8 years.
- He promoted the unfounded theory that the CIA killed his uncle, former President John F. Kennedy.
- He linked school shootings to the increased prescription of antidepressants.
- An evaluation of verified Twitter accounts from 2021, found Kennedy’s personal Twitter account to be the top “superspreader” of vaccine misinformation on Twitter, responsible for 13% of all reshares of misinformation, more than three times the second most-retweeted account.
PS
Let me finish with a true statement: The World Health Organization has estimated that global immunization efforts have saved at least 154 million lives in the past 50 years.
The BMJ just published an article entitled “Disinformation enabled Donald Trump’s second term and is a crisis for democracies everywhere“. Please allow me to show you a few excerpts from this paper:
Donald Trump did not win the 2020 election, but asserting that he did became a prerequisite for Republicans standing for nomination to Congress or the Senate to win their primaries. An entire party became a vehicle for disinformation. Trump did win the 2024 presidential election, and key to that victory was building on the success of that lie. If you control enough of the information ecosystem, truth no longer matters…
… Readers of The BMJ will recall the huge amounts of misinformation (wrong or misleading content that is unknowingly shared) and disinformation (false content that is deliberately spread) during the covid-19 pandemic, some generated or amplified by politicians. This reduced vaccine uptake, promoted ineffective treatments, and encouraged attacks on health workers. In the past, factually incorrect statements might have had only local consequences, but a lie can now circle the world in seconds. Yet the speed in which disinformation can spread is only part of the problem…
… Part of Musk’s reason for buying Twitter was to influence the social discourse. And influence he did—by using his enormous platform (203 million followers) to endorse Trump, spread disinformation about voter fraud and deep fakes of Kamala Harris, and amplify conspiracy theories about everything from vaccines to race replacement theory to misogyny. Musk’s platform is effective: his endorsement of Trump coincided with Republican leaning posts being algorithmically favoured over Democrat leaning posts. A more mundane example: after Musk published three non-evidence based posts on X that favoured one medication over another, sales of the former rose by 18% while the other fell by 11%. …
The warning signs are clear for democracies around the world. Firstly, governments must regulate social media companies more rigorously. Brazil’s victorious dispute with X shows what is possible, and a major battle between the European Commission and Musk is under way. Beyond that, we must grapple with how to hold the world’s richest people to account when they directly interfere with national and international politics.
Secondly, public health agencies must create robust surveillance systems for infodemics just as they have for epidemics. They must monitor the emergence of disinformation and counter it or, ideally, anticipate and counter (pre-bunk) it among vulnerable audiences (and build population resilience). Independent organisations that are countering disinformation are already being deliberately targeted (https://counterhate.com/). And we must accelerate research on “inoculating” people against the algorithms and content that attempt to radicalise them.
Finally, politicians and the public health community must not be afraid of calling out disinformation, and we must all support and applaud them in doing so. And moving beyond responding to false rhetoric, we must also get on the front foot and create compelling counter narratives of a better politics that can support a kinder, more inclusive, and socially just world.
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I’d like to thank the authors (Martin McKee, professor of European public health, Christina Pagel, professor of operational research, and Kent Buse, co-founder of ‘Global Health) for their courage to speak out and stand up for the truth. I am in full agreement with them and encourage all my readers to study their excellent paper in full.
We all tend to believe that natural means harmless. Sadly this notion is far from true. The Korea Adverse Event Reporting System (KAERS) compiles spontaneously reported adverse event data for medicinal products including herbal medicines. This study analyzed adverse event data specifically related to herbal medicine products from the KAERS database.
Individual case safety reports (ICSRs) encompassing 84 types of herbal medicine products, identified by item codes from 2012 to 2021, were extracted from the KAERS database. Descriptive statistics were employed to analyze the characteristics of the extracted reports, and adverse event information was systematically categorized and analyzed based on the MedDRA System Organ Class and preferred term classification.
In total, 1,054 ICSRs were extracted, with some documenting multiple adverse events in a single ICSR, resulting in 1,629 extracted adverse events. When categorized by the MedDRA System Organ Class, gastrointestinal disorders were the most prevalent (28.7%), followed by skin and subcutaneous tissue disorders (20.1%). Based on the preferred terms, the most frequently reported adverse events were:
- diarrhea (5.8%),
- urticaria (5.3%),
- pruritus (4.7%),
- rash (4.4%),
- abdominal discomfort (4.2%).
The most frequently reported herbal medicines were:
- Bangpungtongseong-san (297 cases),
- Kyeongok-go (144 cases),
- Eunkyo-san (108 cases).
The authors conclused that spontaneously reported adverse events associated with herbal medicine products were systematically documented using the KAERS database. This study, which focused on voluntarily reported adverse reactions, underscores the need for additional research to estimate the incidence rate of adverse events and assess causality.
The authors also noted that serious adverse events, including death, life-threatening conditions, initial or prolonged hospitalization, and other importantmedical events, were individually evaluated for each reported adverse event. Out of the 1,054 ICSRs, 48 (4.6%) included one or more serious adverse events (four ICSRs were identified with duplicate labels spanning two serious adverse event categories). Further, among the 1,629 adverse events, 99 (6.1%) were identified as serious adverse events. Two cases of death were reported, with causality categorized as unknown or unlikely. Regarding life-threatening conditions, three cases of dyspnea, nausea, and dizziness have been reported, all of which resulted in recovery. Thirty-one cases of initial or prolonged hospitalization have been reported. Among the adverse events associated with hospitalization (51 events in total, considering the multiple events reported in one ICSR with hospitalization), the most frequent were:
- increased aspartate amino transferase and alanineaminotransferase levels (7 case seach),
- dyspnea (3 cases),
- liver function test abnormality (2 cases),
- nausea (2 cases),
- rash (2 cases).
Sixteen cases of other important medical events were reported, and among 43 related events, dyspnea (5 cases), angioedema (4 cases), urticaria (4 cases), anaphylactic reaction (3 cases), chest discomfort (2 cases), and dizziness (2 cases) were reported.
Yes, the ‘natural equals harmless’ fallacy is very widespread. It certainly is an excellent advertising gimmick. However, as this study demonstrates very clearly, it is as fallacious as it is dangerous.
During the past years, I have had multiple COVID vaccinations (5, if I remember correctly). Not once did I experience an adverse reation, and evidently, I did not die either!
This, however, if you remember, was vociferously predicted by many anti-vaxers many of them staunch advocates of so-called alternative medicine and several keen contributors to the comments section of my blog. Some anti-vaxers claimed that all vaccinated people would die within months; others said that not all but many or most of us would die. Therefore, they insisted, excess mortality would sky-rocket.
None of this happened!
Not only did excess mortality of the vaccinated population not increase, in the UK and US, it even fell slightly – as the graph below clearly shows.
So, the anti-vaxers were wrong!
Do they admit it?
No!
Do they apologise for scaring many and deterring thousands from getting vaccinated?
No!
Is it time they did?
Yes!
While the evidence base on web-based cancer misinformation continues to develop, relatively little is known about the extent of such information on the world’s largest e-commerce website, Amazon. Multiple media reports indicate that Amazon may host on its platform questionable cancer-related products for sale, such as books on purported cancer cures. This context suggests an urgent need to evaluate Amazon.com for cancer misinformation.
This study sought to
- (1) examine to what extent are misleading cancer cure books for sale on Amazon.com’
- (2) determine how cancer cure books on Amazon.com provide misleading cancer information.
The investigators searched “cancer cure” on Amazon.com and retrieved the top 1000 English-language book search results. They reviewed the books’ descriptions and titles to determine whether the books provided misleading cancer cure or treatment information. They considered a book to be misleading if it suggested scientifically unsupported cancer treatment approaches to cure or meaningfully treat cancer. Among books coded as misleading, they conducted an inductive latent thematic analysis to determine the informational value the books sought to offer.
Nearly half (494/1000, 49.4%) of the sampled “cancer cure” books for sale on Amazon.com appeared to contain misleading cancer treatment and cure information. Overall, 17 (51.5%) out of 33 Amazon.com results pages had 50% or more of the books coded as misleading. The first search result page had the highest percentage of misleading books (23/33, 69.7%). Misleading books (n=494) contained eight themes:
- (1) claims of efficacious cancer cure strategies (n=451, 91.3%),
- (2) oversimplifying cancer and cancer treatment (n=194, 39.3%),
- (3) falsely justifying ineffective treatments as science based (n=189, 38.3%),
- (4) discrediting conventional cancer treatments (n=169, 34.2%),
- (5) finding the true cause of cancer (n=133, 26.9%),
- (6) homogenizing cancer (n=132, 26.7%),
- (7) discovery of new cancer treatments (n=119, 24.1%),
- (8) cancer cure suppression (n=82, 16.6%).
The authors concluded that the results demonstrate that misleading cancer cure books are for sale, visible, and prevalent on Amazon.com, with prominence in initial search hits. These misleading books for sale on Amazon can be conceived of as forming part of a wider, cross-platform, web-based information environment in which misleading cancer cures are often given prominence. Our results suggest that greater enforcement is needed from Amazon and that cancer-focused organizations should engage in preemptive misinformation debunking.
This is an excellent paper that is long overdue. The plethora of dangerous books on so-called alternative medicine (SCAM) targeted at lay people is nothing short of a scandal. It was high time that we expose it, because it kills vulnerable patients. It is difficult, if not impossible, to quantify the damage done by such books but I am sure it runs in the thousands.
I have been aware of this scandal for a long time, in fact, it was the main motivation for publishing my own book on the subject. Obviously, it is not much more than a drop in the ocean.
Tragically, this scandal is not confined to just cancer. It relates to all potentially serious conditions. What could be more despicable and unethical than earning money through making desperately ill patients suffer? As the authors point out, Amazon urgently needs to address this problem. Failing this, Amazon should be legally held responsible, in my view.
‘ARS TECHNICA’ recently reported that the maker of a homeopathic nasal spray is refusing to recall its product after the Food and Drug Administration (FDA) found evidence of dangerous microbial contamination.
On 18 September 2024, the FDA therefore warned consumers to immediately stop using ‘SnoreStop nasal spray‘—made by Green Pharmaceuticals—because it may contain microbes that, when sprayed directly into nasal cavities, can cause life-threatening infections:
FDA is warning consumers and health care professionals not to use SnoreStop Nasal Spray, distributed by Green Pharmaceuticals Inc., Camarillo, Calif., because it may have microbial contamination. SnoreStop Nasal Spray was previously sold on the company’s website and other sites.
The use of microbially contaminated nasal spray can potentially lead to infection, which can be life threatening in certain patient populations, such as immune-compromised individuals. This unapproved product is marketed for children beginning at age 5 and adults with unproven claims that it opens air passages and relieves congestion.
Consumers who use SnoreStop should contact their health care professional with questions.
FDA recommended Green Pharmaceuticals recall their SnoreStop Nasal Spray product on Aug. 13 and Sept. 12, 2024. The agency reiterated its recall recommendation multiple times during this time. To date, the company has not taken action to recall this potentially dangerous product from the market.
FDA inspected Green Pharmaceuticals facility in April 2024 and uncovered laboratory test results that reported significant microbial contamination in SnoreStop Nasal Spray lot number 2460. FDA investigators found evidence that some products in this lot had been repackaged and distributed to customers for use as single units and in kits.
Following FDA’s inspection, on Aug. 8, 2024, Green Pharmaceutical destroyed the remaining SnoreStop Nasal Spray from lot 2460 and other products the company had on-hand. Green Pharmaceuticals subsequently stopped selling nasal spray products on their website. However, the agency is concerned that consumers may have purchased contaminated SnoreStop.
Previously, FDA issued a warning letter to Green Pharmaceuticals on Dec. 16, 2022, for distributing unapproved drugs and lack of quality controls over the products they sell. Additionally, the company voluntarily recalled one lot of SnoreStop NasoSpray on June 9, 2022, after FDA testing found the product contained microbial contamination identified as Providencia rettgeri. SnoreStop NasoSpray was renamed as SnoreStop Nasal Spray following this recall.
FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of any medication to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178
‘ARS TECHNICA’ reported that, instead of discarding the batch, the FDA inspectors found evidence that Green Pharmaceuticals had repackaged some of the contaminated lot and distributed it as single spray bottles or as part of a starter kit.
This isn’t new territory for the company. In 2022, Green Pharmaceuticals got warnings from the FDA and issued a recall due to microbial contamination in its SnoreStop nasal spray. In June 2022, the FDA held a conference with the company over findings of bacteria and fungi in the spray. Some of the results suggested high levels of microbial contamination. “The individual sample results varied between 420 and up to 6,200 colony forming units (CFU)/mL for total aerobic microbial count… and between 30 and up to 3,800 CFU/mL for total yeast and mold counts,” the FDA reported in a December 2022 warning letter sent after the fact.
The FDA noted finding the specific bacterial pathogen Providencia rettgeri, an opportunistic germ that can lurk in health care settings. It’s most often linked to urinary tract infections, but it can also cause pneumonia, brain and spinal cord infections, heart infections, and wound and bloodstream infections in vulnerable people, according to a 2018 review.
“The high bioburden in conjunction with the route of administration with this drug product poses a high risk of harm to vulnerable patients, including children,” the FDA wrote in its warning letter. Green Pharmaceuticals recalled SnoreStop in June 2022, after its meeting with the FDA.
Aside from the gross microbial contamination, the FDA also noted in its letter that SnoreStop appears to be an unapproved new drug, illegally claiming to treat a disease without FDA approval. SnoreStop is said to contain dilutions of: nux vomica (a natural source of strychnine), belladonna (deadly nightshade), Ephedra vulgaris (a source of the drug ephedrine), hydrastis canadensis (a toxic herb), Kali Bichromicum (potassium dichromate, which is considered toxic and carcinogenic), Teucrium marum (similar to catnip), and Histaminum hydrochloricum (Histamine dihydrochloride).
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There is, of course, no evidence that any of these ingredients – in any dilution or potency – can make people stop snoring.
Soon after taking power in 1933, the Nazis introduced a program of involuntary sterilisation of those German citizens who they considered unworthy of reproduction. These were predominantly, but not exclusively, people afflicted with heridetary diseases. The declared aim was to sanitize the German gene pool. Involuntary sterilisation was legalized through the ‘law for the prevention of genetically diseased offspring’ (Gesetz zur Verhuetung erbkranken Nachwuchs) as early as July 14, 1933. The law provided that handicapped individuals were to be identified, examined by a jury of experts who had to write an experts’ report, and subsequently sterilized.
In order to implement the law, a large number of new health authorities had to be established. By 1935, approximately 220 hereditary health courts and 30 higher hereditary health courts had thus been set up. Each court relied on the expertise of two physicians and one district judge. Throughout Germany, doctors were required to register with these courts every known case of hereditary illness. This included patients suffering from genetic blindness and deafness, manic depression, schizophrenia, epilepsy, congenital feeble-mindedness, Huntington’s chorea, and alcoholism. The doctors who carried out the sterilisations were paid 10 Reichsmark per case for their services.
The most common methods of sterilization were vasectomy for men and ligation of ovarian tubes for women. Around 6 000 patients, mostly women, died as a result of these operations. Because such methods sterilisations required a lengthy post-operative recovery time, the Nazis started looking for more economical methods of sterilisation. New options were thus tested on camp prisoners at Auschwitz and at Ravensbrück. For instance, experimental drugs were tried, carbon dioxide was injected and X-rays were administered. Another option that was considered was herbal medicine.
In October 1941, Adolf Pokorny, an Austrian dermatologist, wrote to Himmler. ‘Driven by the idea that the enemy must not only be defeated, but destroyed’, he suggested carrying out sterilisation experiments with the South American plant Caladium seguinum. Pokorny drew Himmler’s attention to a publication by Madaus, which suggested that the sap of the hogweed caused permanent sterility in animals:
‘If it were possible … to produce a drug that produces undetected sterilisation in humans in a relatively short time, we would have an effective weapon at our disposal. The very idea that the three million Bolsheviks currently in German captivity could be sterilised so that they would be available as workers, but excluded from reproduction, opens up far-reaching prospects.’
In order not to jeopardise the research in this regard, Pokorny recommended that plant cultivation be started soon and that Madaus be prohibited from publishing further papers on this subject so that the ‘enemy’ would not be made aware of these plans. Himmler who was easily impressed by quacks of all types instructed Oswald Pohl and Ernst-Robert Grawitz to follow up Pokorny’s tips and contact Madaus so that he could check ‘the possibility of experiments on criminals who would have to be sterilised in and of themselves’.
In the spring of 1942, the SS contacted the Madaus company. Gerhard Madaus, the company’s boss, had died shortly beforehand and his successor pledged to maintain secrecy about the effects of the plant. A chemist from IG Farben asserted that sterilisation might be possible. In October 1942, the SS placed an order for extracts to be used in human experiments. Ultimately, however, no such trials took place. There were several reasons for this:
- the plant did not thrive in the European climate,
- the Madaus company did not have enough glasshouses for growing the plant,
- attempts to synthesise the plant’s ingredients failed.
After the war, Himmler committed suicide, Oswald was sentenced to death and executed, Grawitz killed himself and his family, and Pokorny was put on trial in the famous ‘Nuremberg Doctors Tribunal‘. He defended himself by arguing that he had all along been aware of the ineffectiveness of Caladium seguinum and that he had wanted to dissuade Himmler from using tried and tested methods of sterilisation with his proposal. The court did not accept his argument, but nevertheless acquitted him:
‘We are not impressed by the defence which the accused has put forward, and it is difficult to believe that he was guided by the noble motives which he states when he wrote the letter. Rather, we are inclined to believe that Pokorny wrote the letter for entirely different and more personal reasons. […] In Pokorny’s case, the prosecution has not succeeded in proving his guilt. As outrageous and base as the suggestions in this letter are, there is not the slightest evidence that any steps were ever taken to apply them through human experimentation. We therefore declare that the accused must be acquitted, not because of, but in spite of the defence he has put forward.’
Porkorny was thus released from prison; his fate thereafter is not known.
