big pharma
The British doctor and outspoken anti-vaxer Aseem Malhotra has featured several times on this blog, e.g.:
- UK Cardiologist Dr. Aseem Malhotra receives a well-deserved award
- Dr Aseem Malhotra and Dr Steven James: candour and complacency
Now, there has been a potentially important new development in his story. The Good Law Project recently announced the following:
During the pandemic, we depended on doctors telling us how we could protect ourselves and our loved ones. We trusted their advice would be based on the most reliable and up-to-date research.
But when the British cardiologist Dr Aseem Malhotra went on television, or posted to his hundreds of thousands of followers on social media, he repeatedly claimed the vaccine was ineffective and posed a greater threat than Covid, causing “horrific unprecedented harms including sudden cardiac death” – suggestions refuted by medical experts and branded false by factcheckers.
The General Medical Council is responsible for regulating doctors in the UK and investigating those whose conduct falls short of the required standards. Despite the clear risk to public health of vaccine misinformation, it has so far refused to launch an investigation into Malhotra’s public pronouncements, originally saying that they “don’t consider that the comments or posts made by the doctor call his fitness to practice into question…” and subsequently upholding that decision after a number of doctors challenged it.
Good Law Project is supporting a doctor who is taking the regulator to the High Court over their failure to investigate whether Malhotra has breached standards. The judicial review has now been given permission to proceed by the High Court, which held that it raises an “issue of general public importance” as to how the GMC exercises its functions.
According to the claimant, Dr Matt Kneale, medical professionals “should not be using their professional status to promote harmful misinformation”.
“When doctors repeatedly say things that are incorrect, misleading and put people’s health at risk – for example by encouraging them to refuse a vaccine – the GMC must hold them to account,” Kneale said.
For the Good Law Project Executive Director, Jo Maugham, the regulator’s failure to investigate doctors spreading misinformation forms part of a wider pattern.
“What we have learned from both the pandemic inquiry and the calamitous economic consequences of Brexit,” Maugham explained, “is quite how serious are the consequences of deciding, as Michael Gove did, that we have ‘had enough of experts’.”
The council may prefer to avoid becoming embroiled in a controversy over free speech, he continued, but “its primary obligation is to protect the public – and it’s really hard to see how its stance delivers on that objective.”
Dr Malhotra is far from the only proponent of vaccine misinformation in the UK. Open Democracy revealed that anti-lockdown MPs, including Tufton Street’s Steve Baker, took large donations from a secretive group called The Recovery Alliance, which has been linked with a fake grassroots organisation that campaigned against the vaccine.
We’re working to stop misinformation from going unchallenged, and to make sure that regulators like the General Medical Council hold dangerous doctors who make unfounded claims accountable.
By helping to fund this case, you’ll be fighting for trust in the medical profession and to make sure public safety is doctors’ first priority. Any support you can give will help us make positive change.
____________________
The ‘Good Law Project’?
Who are they?
Good Law Project is a not for profit campaign organisation that uses the law for a better world. We know that the law, in the right hands, can be a fair and decent force for good. It is a practical tool for positive change and can make amazing things happen. We are proud to be primarily funded by members of the public, which keeps us fiercely independent. We want to inspire hope in difficult times by showing that you can make a difference, with the backing of good law. Our mission is to use the law to hold power to account, protect the environment, and ensure no one is left behind. You can learn more about our organisation and achievements in 2022-23 in our annual report.
You might even decide to support this splendid organization!
I hope you do.
Guest post by Ken McLeod
Readers will recall that Barbara O’Neill is an Australian health crank, completely unqualified in anything, who is subject of a Permanent Prohibition Order issued by the New South Wales Health Care Complaints Commission, (HCCC),[1] preventing her from engaging in any health-related activity, including ‘health education,’ in Australia. The NSW Public Health Act 2010 provides that it is an offence for a person to provide ‘health education’ in contravention of a prohibition order, with a fine of $60,500 AUD ($38,151 USD, 36251 Euros) for an individual or imprisonment for 3 years, or both, or $121,000 AUD for a corporation.
For jurisdictional reasons that Order does not apply outside Australia and for several years she been touring the world giving health education lectures. The latest was a lecture tour of Ireland.[2] Despite the thorough debunking of her fruitloop beliefs by the HCCC,[3] she has maintained them and continues to give the ‘health education’ that was so dangerous that it led to the Prohibition Order in Australia.
Her Irish ‘health education’ lectures were live-streamed to people in Australia who paid the 20 Euro fee, and one was recorded by us.[4]
A transcript was made and is available online.[5] Her statements were analysed and some comments are made as follows. Alas, we didn’t have time to take a deep dive of her lecture to find the best references, but the following shows that an amateur with limited time and resources can prove that she does not know what she is talking about and that her advice is dangerous, even life-threatening.
It is up to the health regulators and immigration authorities in each country to act on her activities there, but so far none outside Australia have done so.
So a quick analysis of her ‘lecture’ in Dublin on 27 September 2023 shows that O’Neill has learned nothing from her experience with the HCCC. Some comments:
1. O’Neill and her husband, after the Prohibition Order was issued, changed the name of their facility from ‘Misty Mountain Health Retreat’ to ‘Misty Mountain Lifestyle Retreat’ to avoid the jurisdiction of the HCCC. However on four occasions in her lecture O’Neill referred to it as a ‘health retreat.’ 00:07:23 , 00:15:48, 01:30:04, 01:40:16.
2. At 00:12:53 O’Neill claims that the Amish don’t get autism. That is false, as explained by AP Factcheck. [6]
3. At 00:12:54 O’Neill claims that the Amish, ‘They don’t vaccinate their Children. Did you know that they don’t vaccinate their Children and yet they don’t get autism Very rare. Maybe 1%. And often that’s because of chemical exposure. There is always a reason. So why are vaccinations causing autism? Well, it’s neurotoxins, the neurotoxins. ‘
False; Amish do vaccinate their children. [7] However, studies have documented cases of autism, diabetes and cancer among the Amish, albeit at lower rates in some cases than the broader population and for reasons that are unrelated to their vaccination status. These reasons include the cultural norms and customs that may be playing a role in the reporting style of caregivers. [8] O’Neill is engaging in cherry-picking on a grand scale here.
4. At 00:13:37 O’Neill claims that ‘there are still two more neurotoxins’ (In vaccines.) Because children are still autistic. There’s formaldehyde, and there is aluminium, both neurotoxins.’
This is scaremongering disinformation. The CDC says ‘Formaldehyde is diluted during the vaccine manufacturing process, but residual quantities of formaldehyde may be found in some current vaccines. The amount of formaldehyde present in some vaccines is so small compared to the concentration that occurs naturally in the body that it does not pose a safety concern.’ As for aluminium, the CDC says ‘Ingredients like aluminum salt help boost the body’s response to the vaccine.’ The CDC says that both are safe. [9]
5. At 00:15:01 O’Neill claims ‘did you know that the milk in the supermarket if you give that to a newborn baby cow, that cow will die?’
I can find no reference supporting that and I suggest that it is pure fantasy.
6. At 00:18:29 O’Neill claims that ‘parents discover that they put their trust in the princes and vaccinated their child. Now their child has epilepsy. Now their child has autism.’
This is misleading panic-mongering that is a misrepresentation of the science. The Royal Australian College of General Practitioners says ‘Seizures and status epilepticus can occur within 14 days following administration of inactivated and live-attenuated vaccines. These vaccine-proximate seizures can undermine parental confidence in vaccine safety and affect further vaccination decisions. Vaccine-proximate status epilepticus (VP-SE) is uncommon but may be the first manifestation of genetic developmental epileptic encephalopathies, including Dravet syndrome.’ So ‘epilepsy’ may be first encountered [10] following vaccination but the root cause is genetic.
7. At 00:20:27 O’Neill says that she would like to suggest that no child would be vaccinated, because the fact is, our body was designed to heal itself.
This is pure crazy antivax propaganda, unsupported by the facts.
8. At 00:22:01 O’Neill claims ‘skin cancer has only been around in about the last 80 years, and you know what they’re finding today? That vitamin D deficiency is a big contributing back factor to skin cancer’.
The first claim is false; the science shows that skin cancers have been around ‘since the beginning of time.’ [11]
As for the second claim, the research published at the US National Library of Medicine shows that O’Neill’s advice is dangerous. ‘It is, therefore, preferable and safer to obtain adequate levels of vitamin D through diet than through sun exposure. In fact, it is currently accepted that dietary and supplemental vitamin D is functionally identical to that produced after UV exposure, being more reliable and quantifiable (the risks of keeping high levels of vitamin D have not been extensively studied) source of this vitamin.’ And ‘Neither natural nor artificial sun exposure should be encouraged as the main source of vitamin D.’ [12]
9. At 00:23:18 O’Neill disputes claims that ‘cholesterol causes heart disease. Well, it’s been going for 40 years now, and it still hasn’t proven that. But you know what? It has proven that people with high cholesterol levels don’t get Alzheimer’s.’
O’Neill’s first claim points to the conflicting research as revealed by the Cochrane Collaboration. [13] As for her second claim, the research does not justify her claim that it is ’proven.’ The evidence is conflicting and as the Alzheimer’s Society of the UK say, ‘More research is needed to better understand this relationship and what it can tell us.’ [14] O’Neill’s conviction is not based on evidence.
10. At 00:34:41 O’Neill said that at Dublin airport ‘about 10 days ago,’ she was approached by a man who asked ‘Are you the Australian doctor? And I smiled.’
O’Neill did not correct him and allowed him to be duped into believing she is a real doctor. Despite having no qualifications in anything O’Neill has used the honorific title ‘Dr’ many times in social media,[15] so it is no surprise that he assumed she was a doctor. I can’t help but be confused by her use of the ‘Dr.’ Throughout her lectures she denigrates real doctors, and then tries to boost her credibility by adopting the title.
11. At 00:35:21 she claimed that with ‘epigenetics, you can actually turn your genes on or off.’…. ‘So Michael effectively turned those genes off with castor oil. Castor is very effective for for cataracts. Put it in your eye, one lady said. Is it safe? Does anyone ever ask that of the doctor? Is that drug safe? Then the people have been putting cholesterol in their eyes for centuries. It’s safe.’
Bollocks! As Consumer Lab says ‘Although eye drops containing castor oil may help improve symptoms of dry eye and blepharitis, there is currently no compelling evidence that applying castor oil to the eye can diminish cataracts.’ [16] And there is no evidence that Michael turned the genes off.
12. At 00:40:08 she refers to a woman who recently had a stroke. She says
‘… because she had a stroke, she was put on the protocol she was on put on statins. Cholesterol lowering medication with clear arteries. How much sense does that make? You don’t have. You don’t have to be a rocket scientist to work this out. Trust in your gut feeling trust in this incredible body that God has given you. Her blood was no longer thick. Her arteries are open now. And so she came to our retreat and I said, Well, I can’t tell you what to do. And I have no authority over your medication. Only you, and go. You and your doctor do. But this is what I would do. I would stop the blood thinning medication immediately because that aspirin causes brain bleeds, eye bleeds and stomach bleeds. Got that? And I would stop the statin drugs because that the side effect of statin drugs is Alzheimer’s dementia, uh, memory loss, muscle wasting. And they’ve just added another one, which is breast cancer, because all our sex hormones are made from cholesterols.’
O’Neill told a woman who had suffered a stroke to stop taking her life-saving medication! These medications are prescribed by highly qualified medical specialists based on the research. As the UK Stroke Association says, ‘Blood-thinning medications reduce your risk of stroke by helping to prevent blood clots from forming. You might be prescribed them after a transient ischaemic attack (TIA) or a stroke caused by a blockage (an ischaemic stroke, or clot).’[17] It is clear that O’Neill, who has no qualifications in anything, does not know what she is talking about.
As for her claim that the side effects of statins is breast cancer, the research shows the opposite. ‘While statins do not affect the incidence of most cancers, they do exert significant benefits on recurrence and survival in many cancer types, including breast cancer.’ [18]
13. At 42:48 O’Neill claims ‘If you are on cholesterol lowering medication and many have been deceived….’ As above, it is O’Neill who is doing the deceiving.
14. At 45:09 O’Neill claims that ‘If you stop your cholesterol lowering medication, there will be a side effect. Your memory will return. Your muscles will get stronger. Any little appearances of Alzheimer’s will start to ease.’
As above, the available research does not show that.
15. At 48:57 O’Neill claims ‘Why did they put fluoride in water? The claim was to harden the teeth. Has it hardened the teeth? Not at all. Has it reduced tooth decay? Not at all.’ And ‘But that fluoride is very hard on the kidneys, very hard on the liver.’
The research here is overwhelming; as the CDC says: ‘The CDC named community water fluoridation one of 10 great public health achievements of the 20th century.
‘Many research studies have proven the safety and benefits of fluoridated water. For 75 years people in the United States have been drinking water with added fluoride and enjoying the benefits of better dental health.
‘Drinking fluoridated water keeps teeth strong and reduces cavities (also called tooth decay) by about 25% in children and adults.’
As for O’Neill’s claim that fluoride is very hard on the kidneys, very hard on the liver,’ the research is inconclusive, and in fact the reverse may be true. Research shows ‘Fluoride exposure may contribute to complex changes in kidney and liver related parameters among U.S. adolescents. As the study is cross-sectional, reverse causality cannot be ruled out; therefore, altered kidney and/or liver function may impact bodily fluoride absorption and metabolic processes.’ So the science does not support O’Neill’s certainty.
16. At 48:57 O’Neill claims that ‘all body symptoms and body diseases and shows how dehydrating has a huge factor.’ O’Neill gives no evidence to support that huge claim.
17. At 01:00:20 O’Neill claims that a woman told her ‘I had the vaccine. Now I’ve got clots. Barbara, I had the vaccine. I can’t. I cannot even remember all the diseases that are arising. Have you noticed? And so many people were blackmailed into that vaccine.’ And ‘Is that (COVID19) a crisis? it’s not a crisis at all. And yet we’re seeing so many problems arising.’
O’Neill is dreadfully wrong here. COVID 19 was a crisis. How else would we describe a pandemic that is known to have killed at least 6,961,014 deaths, as reported to the WHO? [19] And what are the problems that we are seeing arising? Outside her imagination, that is.
18. At 01:00:20 O’Neill claims that ‘one man said, Show me the safety studies. They gave him three pages of blank paper. No safety studies, no safety studies at all.’ (On vaccines). And ‘drugs never cure disease.’ And a few lines later, again, ‘Drugs never cure disease.’
The allegation that ‘They (doctors) gave him three pages of blank paper’, is just so deranged. No doctor would do that because there are thousands of studies of vaccine safety.
O’Neill’s claim that there are no safety studies on vaccines is hopelessly wrong and dishonest. It’s one of the many anti-vax lies circulating on the internet, so beloved by the gullible. As the Australian Dept of Health and Aged Care say, ‘Research and testing is an essential part of developing safe and effective vaccines. In Australia, every vaccine must pass strict safety testing before the Therapeutic Goods Administration (TGA) will register it for use. Before vaccines become available to the public, they are tested on thousands of people who take part in large clinical trials.’ [20] It took me a few seconds on the internet to find an interesting research paper on HPV vaccines, including a section on safety. [21] O’Neill could do that so the inevitable conclusion is that she set out to deceive. As for ‘drugs never cure disease,’ that is so bizarre, so whacky, so deluded, that it almost not worth challenging. But I will anyway; medical professionals have seen drugs work billions of times, and I can testify that I was saved from a life-threatening illness due to cephalexin.
19. At 01:10:49 O’Neill claims ‘some (medications) can be stopped immediately, like your statin drugs and your blood thinners. Yeah, what do you take instead of statin drugs? Well, there’s no need, because cholesterol is not a problem.’
O’Neill’s advice here is life-threatening rubbish. As the Mayo Clinic says ‘Abruptly stopping an anticoagulant can increase your risk of a stroke.’ [22] As for her advice on cholesterol, see above.
20. At 01:15:39 O’Neill claims that there was ‘No diabetes on the planet til sugar was well established.’ And lack of nose-breathing causes ‘Chronic fatigue syndrome. There’s one cause; it’s lack of oxygen at the cellular level.’
Humans have gathered sugar since we first became homo sapiens and diabetes has always been a problem for us and other animals.
As for her claim that lack of nose-breathing causes ‘Chronic fatigue syndrome;’ the Mayo Clinic says ‘The cause of ME/CFS is unknown, although there are many theories. Experts believe it might be triggered by a combination of factors.’ They go on to list many possible causes but lack of nose-breathing is not one of them.[23]
21. At 01:26:08 O’Neill claims that a researcher ‘…. could turn cancer cells on and off by the amount of animal, pro and animal protein that he was giving’ and liver cancer could be prevented by ‘a simple diet and cancer weights were very low low compared to the city again, with that high meat diet….’ There is some truth in this, but it does not justify O’Neill’s other advice to avoid prescribed medications.
22. At 01:49:26 O’Neill claims ‘if someone has a rash and they put cortisone on it, what happens to the rash? It’s gone, but But it comes back in about another week. Is that right? Twice as bad.’ And ‘No drug can heal cancer. The body and the body alone when it’s given the right conditions can cause cancer to be conquered in the body.’ And ‘A fever is nothing to fear.’
O’Neill’s claim that ‘No drug can heal cancer’ is demonstrably wrong. Life expectancy following cancer treatment has improved vastly over the decades, largely due to better detection and prescribed medications. As the US National Cancer Institute (NCI) estimates, ‘due to improved detection and treatment, deaths have dropped 41 percent from 1989 to 2018, according to the ACS.’ [24]
As for O’Neill’s claim that ‘a fever is nothing to fear,’ the Victorian Dept of Health says ‘High fever (about 41.5°C or more) is extremely dangerous and could trigger convulsions.’ [25]
23. At 01:53:47 O’Neill claims that drug therapy is not working.
What does O’Neill mean by that? Does she mean that prescribed medication does not work? If she is repeating her earlier claim that ‘drugs never cure disease?’ I repeat my earlier rebuttal. That is so bizarre, so whacky, so deluded, that it almost not worth challenging. But I will anyway; medical professionals have seen drugs work billions of times, and I can testify that I was saved from a life-threatening illness due to cephalexin.
I’ll finish the analysis here because you have suffered enough.
Readers everywhere now have rock-solid evidence that should be presented to their national health regulators, showing that O’Neill, as the HCCC put it, ‘poses a risk to the health and safety of members of the public’ and therefore ‘should be permanently prohibited from providing any health services, whether in a paid or voluntary capacity.’ And you have rock-solid evidence that should be presented to venue managers who have allowed O’Neill to present life-threatening ‘education’ to the public on their premises, asking them to cancel the booking. It’s not hard; it was done in Ireland by members of the public. That led to cancellation of the booking, and a rush by O’Neill’s supporters to find a new venue.
References
1 https://www.hccc.nsw.gov.au/decisions-orders/public-statements-and-warnings/public-statement-and-statement-of-decision-in-relation-to-in-relation-to-mrs-barbara-o-neill
2 https://www.independent.ie/irish-news/controversial-wellness-coach-barbara-oneill-set-to-host-talk-in-ireland-this-month/a1781099169.html
3 https://www.hccc.nsw.gov.au/ArticleDocuments/216/Statement%20of%20Decision%20-%20Mrs%20Barbara%20ONeill.pdf.aspx
4 The video is available at https://rumble.com/v3lt611-barbara-oneill-positive-life-event-27th-september.html and a backup is available at https://www.dropbox.com/scl/fi/vqe9plhgjijunvl22kvb6/Barbara-ONeill-Positive-Life-Event-27th-September.mp4?rlkey=1kjyi9jdl8kfdp8kcdf1p4xba&dl=0
5 https://www.dropbox.com/scl/fi/csl95hg7gomr318nygotx/TRANSCRIPT-BARBARA-O-NEILL-POSITIVE-LIFE-EVENT-DUBLIN-27-SEPT-2023.pdf?rlkey=z2d5uh59fwagzdfdk30hvpauy&dl=0
6 https://apnews.com/article/fact-check-amish-covid-vaccines-cancer-diabetes-autism-356029928165
7 https://apnews.com/article/fact-check-amish-covid-vaccines-cancer-diabetes-autism-356029928165
8https://www.researchgate.net/publication/268144514_Prevalence_Rates_of_Autism_Spectrum_Disorders_Among_the_Old_Order_Amish
9 https://www.cdc.gov/vaccines/vac-gen/additives.htm
10 https://www1.racgp.org.au/ajgp/2020/october/seizures-following-vaccination-in-children
11 https://www.usatoday.com/story/news/factcheck/2023/08/03/false-claim-skin-cancer-has-only-been-around-for-60-years-fact-check/70515019007/
12 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8709188/
13 https://s4be.cochrane.org/blog/2018/07/02/cholesterol-and-heart-disease-whats-the-evidence/
14 https://www.alzheimers.org.uk/about-dementia/risk-factors-and-prevention/cholesterol-and-dementia
15 https://www.facebook.com/people/Dr-Barbara-ONeill/100093111507726/
16 https://www.consumerlab.com/answers/castor-oil-eye-drops-for-cataracts/castor-oil-cataracts/
17 https://www.stroke.org.uk/resources/blood-thinning-medication-and-stroke
18 https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-018-1066-z#author-information
19 https://covid19.who.int/
20 https://www.health.gov.au/are-vaccines-safe
21 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7565290/
22 https://connect.mayoclinic.org/blog/take-charge-healthy-aging/newsfeed-post/know-the-warning-signs-of-blood-thinner-complications/
23 https://www.mayoclinic.org/diseases-conditions/chronic-fatigue-syndrome/symptoms-causes/syc-20360490
24 https://www.healthline.com/health/breast-cancer/survival-facts-statistics#breast-cancer-stages
25 https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/fever#bhc-content
Vaccine hesitancy has become a threat to public health, especially as it is a phenomenon that has also been observed among healthcare professionals.
In this study, an international team of researchers analyzed the relationship between endorsement of so-called alternative medicine (SCAM) and vaccination attitudes and behaviors among healthcare professionals, using a cross-sectional sample of physicians with vaccination responsibilities from four European countries:
- Germany,
- Finland,
- Portugal,
- France.
In total the sample amounted to 2,787 physicians.
The results suggest that, in all the participating countries, SCAM endorsement is associated with lower frequency of vaccine recommendation, lower self-vaccination rates, and being more open to patients delaying vaccination, with these relationships being mediated by distrust in vaccines. A latent profile analysis revealed that a profile characterized by higher-than-average SCAM endorsement and lower-than-average confidence and recommendation of vaccines occurs, to some degree, among 19% of the total sample, although these percentages varied from one country to another:
- 24% in Germany,
- 18% in France,
- 10% in Finland,
- 6% in Portugal.
These results constitute a call to consider health care professionals’ attitudes toward SCAM as a factor that could hinder the implementation of immunization campaigns.
The authors also point out that the link between SCAM endorsement and negative attitudes toward vaccines has been documented in previous research among the general public. A systematic review, which categorized arguments against vaccines retrieved from peer-reviewed articles and debunking texts published by international fact checking agencies, identified a category of arguments largely based on alternative health beliefs related to SCAM. This category was the third most common in the scientific and fact-checking literature. Furthermore, in a British study, anti-vaccination arguments related to SCAM were also among the most endorsed arguments by individuals. These results suggest that SCAM beliefs play an important role in individuals’ justification of their hesitant attitudes toward vaccines for both adults and children. Analyses of samples from the Australian, Finnish, American, and Spanish general populations found that positive attitudes toward SCAM were related to negative attitudes toward vaccines. In a recent large-scale study in 18 European countries, parental consultation with homeopaths was associated with higher vaccine hesitancy than consultation with pediatricians or nurses. Moreover, a systematic review found that SCAM use tended to be positively associated with lower childhood immunization. Similar findings were reported also from the US and Australia.
There are several potential causes for the observed relationship between vaccine hesitancy and SCAM. Since SCAM use occurs more frequently at the poles of the disease spectrum (i.e., in cases of minor or life-threatening illness), SCAM use has been identified as a marker of both misperception of risk and frustration with regular healthcare (e.g., negative prognosis or lack of remission of symptoms). Accordingly, SCAM-related health conceptions could be motivating healthcare practitioners (HCPs) to be more reluctant to recommend and receive vaccinations both for illnesses that are perceived as minor and in cases of severe clinical pictures. There are also reasons related to the potential alignment between SCAM and the ideology or worldview of the HCP, such as their distrust in “Big Pharma” or a general disregard for scientific knowledge. Along the same lines, it has been shown that the main reasons for their preference for SCAM included a greater affinity between SCAM, their do-it-yourself approach to health care, and their sympathy for natural and allegedly harm-free products in contrast to medications marketed by pharmaceutical companies, which were perceived as ineffective, “toxic” and “adulterating.”
Besides these implicit reasons, some SCAM traditions are theoretically incompatible with vaccination and portrayed as a valid, or even superior, alternative to scientific knowledge. A quantitative study found that pro-SCAM and anti-vaccination attitudes both reflect beliefs contrary to basic scientific knowledge, such as “an imbalance between energy currents lies behind many illnesses” and “an illness should be treated with a medicine that has properties similar to those of the illness.” An example of these SCAM-related beliefs that contradict the theoretical basis of vaccinations is “homeopathic immunization” through so-called “nosodes” – orally administered extreme dilutions of infectious agents. Similarly, Rudolf Steiner and Ryke Geerd Hamer, promoters of anthroposophic medicine and ‘German New Medicine’, respectively, have sown doubts about vaccinations based on their conceptions of the etiology and treatment of diseases. Consequently, strong science denial and vaccine hesitancy can be found within these communities, and outbreaks of vaccine-preventable diseases, such as measles and whooping cough, have been reported in educational centers linked to anthroposophy.
PS
This project has received funding from the European Union’s Horizon 2020 research and innovation programme.
The US ‘Public Citizen‘ is an American non-profit, progressive consumer rights advocacy group, and think tank based in Washington, D.C. They recently published an article entitled “FDA Guidance on Homeopathic Drugs: An Ongoing Public Health Failure“. Here are a few excerpts:
In December 2022, the U.S. Food and Drug Administration (FDA) issued new guidance on homeopathic drug products. The guidance states that the agency now “intends to apply a risk-based enforcement approach to the manufacturing, distribution and marketing of homeopathic drug products.”
Under this new risk-based approach, the agency plans to target its enforcement actions against homeopathic drug products marketed without FDA approval that fall within the following limited categories:
- products with reports of injury that, after evaluation, raise potential safety concerns
- products containing or purportedly containing ingredients associated with potentially significant safety concerns (for example, infectious agents or controlled substances)
- products that are not administered orally or topically (for example, injectable drug products and ophthalmic drug products)
- products intended to be used to prevent or treat serious or life-threatening diseases
- products for vulnerable populations, such as immunocompromised individuals, infants and the elderly
- products with significant quality issues (for example, products that are contaminated with foreign materials or objectionable microorganisms)
But this new FDA guidance fails to adequately address the public health threat posed by the agency’s decades-long permissive approach to these illegal drug products.
Under FDA regulations, prescription and over-the-counter (OTC) homeopathic products are considered drugs and are supposed to be subject to the same review and approval requirements as all other prescription and OTC medications. However, under a flawed enforcement policy issued in 1988, the FDA has allowed these drug products to be marketed in the U.S. without agency review or approval. Thus, all products labeled as homeopathic are being marketed without the FDA having evaluated their safety, effectiveness or quality…
… there is no plausible physiologic or medical basis to support the theory underlying homeopathy, nor is there evidence from well-designed, rigorous clinical trials showing that homeopathic drugs are safe and effective.
The FDA should declare unequivocally that all unapproved homeopathic drug products are illegal and direct all manufacturers to immediately remove such products from the market. In the meantime, as we have recommended for many years, consumers should not use homeopathic products. At best, the products are a waste of money, given the lack of any evidence that they are effective. At worst, they could cause serious harm because of the lack of FDA oversight to ensure safety.
_____________________
I fully agree with these sentiments. The harm caused by homeopathy is considerable and multi-facetted. Many previous posts have discudded these problems, e.g.:
- Nine cases of severe homeopathy-induced liver injuries
- Another death by homeopathy
- HOMEOPATHY – “It is not just irresponsible, it’s downright dangerous.”
- Adverse effects of homeopathy and aggravations at NAFKAM
- Homeopathy: it’s time to stop the double standards
- Homeopathy can cause serious harm – and finally, the NHS England has realised it
- Vidatox, homeopathy’s answer to cancer or outright fraud?
- Another child has died because of homeopathy
- Doctor homeopaths violate fundamental rules of ethics when practising homeopathy
- ‘Best homeopathy doctor in Delhi’ offers treatment for HIV/AIDS
- DIY-Homeopathy: how to kill your entire family
- The risks of homeopathy?
- The FDA has warned 4 manufacturers of unapproved injectable homeopathic drugs
- Is this the crown of the Corona-idiocy? Nosodes In Prevention And Management Of COVID -19
- The FDA has sent more warning letters to homeopathic manufacturers
- Walmart is being sued for selling homeopathic products
- Homoeopathic remedies may be safe, but do all homeopaths merit this attribute?
- Recommending homeoprophylaxis is unethical, irresponsible and possibly even criminal
- FDA: homeopathic teething remedies were toxic
- “Homeoprophylaxis, the homeopathic vaccine alternative, prevents disease through nosodes.”
- A truly dangerous homeopath
- The scandalous attitude of some homeopaths and their supporters towards immunisations
- Oh yes, let’s have homeopaths as primary care practitioners! But only in a parallel universe,please.
Having warned about the dangers of homeopathy for decades, I feel it is high time for regulators across the world to take appropriate action.
It has been reported, at the German Medical Congress (DÄT) a year ago, that it was decided to delete the additional title of homeopathy from the model further training regulations of the German Medical Association. And Federal Health Minister Karl Lauterbach (SPD) tweeted applause: “Homeopathy has no place in modern medicine.”
Now the ‘ Bundesverband der Pharmaziestudierenden in Deutschland’ (BPhD), the German Pharmacists Organization, even goes a few steps further. The position paper distinguishes between evidence-based medicine (EBM) and unproven therapeutic methods. According to the BPhD, these include homeopathy, but also anthroposophy, traditional Chinese medicine, and traditional medicines.
Among other things, the BPhD is disturbed by the way homeopathy presents itself as an alternative, because an alternative means “a choice between two equally suitable possibilities” to achieve a goal, and this is not the case. Compared to evidence-based medicine (EBM), homeopathy is a “constructed, illusory concept” and “the principles of homeopathic teachings and principles” are to be rejected as “unscientific”. According to the BPhD, a designation as “alternative” for advertising purposes should no longer be allowed.
They would also like to see a demarcation from naturopathy; the clear distinction between homeopathy and phytopharmacy has been lacking up to now. The advertising attribute “natural” should therefore also be banned in order to prevent equalization in advertising, the position paper states.
Like doctors, pharmacy students point to the lack of proof of efficacy beyond the placebo effect. According to the BPhD, the dogma WER HEILT HAT RECHT, “he who heals is right” would “disregard all processes that work towards healing and glorify the result”. The “gold standard” of EBM – randomized, double-blind studies with placebo control – should in future also have to be fulfilled by homeopathic medicines, experience reports are not sufficient, it continues.
Homeopathic medicines are only registered as medicinal products without indication, which requires neither proof of efficacy nor clinical studies. The BPhD, therefore, demands that a warning be placed on the preparations that they have “no proven efficacy beyond the placebo effect”. Up to now, without this warning, patients have been “deceived about the efficacy”, and there is an “urgent need for detailed public information and counseling on homeopathy since its unjustified reputation poses a danger of not seeking treatment”. The BPhD also demands that the status of homeopathic medicines is withdrawn and that the pharmacy obligation for the preparations is abolished…
“In the health professions, no trivialization of unproven therapeutic procedures should be tolerated, as inadequate counseling or ignorance poses a danger to patients,” the BPhD said.
_________________________
When I first read this article – I translated and shortened it for those who cannot read German- I was truly dazzled. These are the suggestions that I have been making for around 20 years now, not specifically for Germany but for pharmacists in general. For many years, the Germans seemed the least likely to agree with me. But now they seem to be ahead of everyone else in Europe!
How come?
I suspect and hope that our recent initiative might have something to do with it.
Let’s hope that the pharmacists of other countries follow the German example.
In response to yesterday’s post, I received a lengthy comment from ‘Stan’. Several readers have already commented on it. Therefore, I can make my arguments short. In this post, will repeat Stan’s points each followed by my comments (in bold). Here we go:
Seven Reasons Homœopathy is Not Placebo Effect
Sorry, Stan, but your heading is not proper English; I have therefore changed it for the title of this post.
1. Homeopathic remedies work on babies, animals, plants and people in a coma. Biodynamic farmers use homeopathic remedies to repel pests and treat plant diseases. Some organic ranchers rely on homeopathic remedies to treat their herds. Some “placebo by proxy” effect has been shown for children but its doubtful that it could be shown for a herd of cattle or crops in a field. Farmers can’t rely on wishful thinking to stay in business.
As discussed ad nauseam on this blog, homeopathic remedies do not work on babies or animals better than placebos. I don’t know of any studies with “people in a coma” (if you do, Stan, please let me know). The fact that ranchers rely on homeopathy is hilarious but does not prove anything.
2. The correct curative remedy will initially cause a worsening of the condition being cured if it is given in too strong (i.e. too dilute) a dose. A placebo might only cause a temporary improvement of the condition being treated; certainly not an aggravation.
The ‘homeopathic aggravation’ is a myth created by homeopaths. It disappears if we try to systematically research it; see here, for instance.
3. One can do a “proving” of an unknown homeopathic remedy by taking it repeatedly over several days and it will temporarily cause symptoms that one has never experienced previously – symptoms it will cure in a sick person. This is a repeatable scientific experiment used to determine the scope of a new remedy, or confirm the effects of an already proven remedy. A placebo might possibly have an effect if the individual taking it has been “prepared” by being told what they are taking but it likely wouldnt match previously recorded symptoms in the literature.
Homeopathic provings are rubbish and not reproducible when done rigorously; see here.
4. One can treat simple acute (self-limiting) conditions (e.g. minor burns, minor injuries, insect bites, etc.) and see unusually rapid cures with homeopathic remedies. A placebo might only cause a temporary improvement of the condition being treated while taken. Placebos have been found mostly effective in conditions with a strong psychological component like pain.
You mean like using Arnica for cuts and bruises? Sadly, it does not work.
5. One can get homeopathic treatment for long term chronic (non self-limiting) conditions and see a deep lasting cure, as has been documented clinically for a couple centuries. A placebo might only cause a temporary partial improvement of the condition being treated while the placebo is being taken.
You mean like asthma, eczema, or insomnia?
6. There is over 200 years worth of extensive documentation from around the world, of the clinical successes of homeopathy for both acute and chronic conditions of all types. As Dr Hahn has said you have throw out 90% of the evidence to conclude that homeopathy doesnt work. The Sheng et al meta-analysis in 2005 Lancet that was supposedly the death knell of homeopathy used only 8 studies, excluding hundreds of others. Unsurprisingly homeopathy was found wanting. So-called Skeptics see what they want to see in the science. There is relatively little documentation of placebo usage. A few recent studies have been done showing the limited temporary benefits of placebos.
What Hahn wrote is understandably liked by homeopaths but it nevertheless is BS. If you don’t trust me, please rely on independent bodies from across the world.
7. Homeopathic remedies have been shown to have a very weak electromagnetic signature and contain some nano-particles. Some believe this explains their mechanism. An exciting new potential field of research is the subtle cell signalling that has been found to direct the development of stem cells. Scientists have created double-headed planeria worms and this trait has been found to be inherited by their offspring without any change in the genes or epigenetics. Until now we had no idea how a single fertilized ovum could evolve into a complex creature that is bilateral and has multiple cell types. It is possible that the very subtle electromagnetic signature or some other unknown effect of homeopathic remedies is effecting this subtle cell signalling.
The homeopathic nano-myth is nonsense. And so is the rest of your assumptions.
Every conventional drug has “side effects” that match the symptoms for which it is indicated! Aspirin can cause headaches and fever, ritalin can cause hyperactive effects, radiation can cause cancer. Conventional doctors are just practicing bad homeopathy. They are prescribing Partially similar medicines. If their drugs were homeopathic (i.e. similar) to the patients symptoms on all levels they would be curative. Radiation sometimes does cure cancer instead of just suppressing it per usual.
Even if this were true, what would it prove? Certainly not that homeopathy works!
Dr Hahneman did forbid mixing homeopathy and conventional medicine. In his day doctors commonly used extensive blood letting and extreme doses of mercury. Its not Quite as bad now.
You evidently did not read Hahnemann’s writings.
Just because we dont know how extremely dilute homeopathic remedies work, doesn’t discount that they Do work. Homeopathy seems to fly in the face of Known science. In no way is it irrational or unscientific. There are lots of phenomena in the universe that cant be explained yet, like dark energy and dark matter effects and even consciousness!
Not knowing how a treatment works has not stopped science to test whether it works (e.g. Aspirin). In the case of homeopathy, the results of these endeavors were not positive.
The assumption that the moon is made of cheese also flies in the face of science; do you perhaps think that this makes it true?
The actions of homeopathy can and have been well-explained: they are due to placebo effects.
________________________
Stan, thank you for this entertaining exercise. But, next time, please remember to supply evidence for your statements.
According to a German court ruling, the homeopathic remedy Meditonsin for colds may no longer be advertised with certain statements. The Higher Regional Court in Hamm, Germany made it clear that it shares the opinion of the Regional Court in Dortmund, which had sentenced the marketing company to desist from making statements such as “rapid and reliable reduction of the intensity of the typical cold symptoms”. Such statements falsely generate the impression that therapeutic success can be expected with certainty. The court made it clear that the company’s appeal against the previous ruling was unlikely to be successful. The company subsequently withdrew its appeal today – and the judgment is now legally binding.
The lawsuit filed by a consumer organization was thus successful. It had criticized several statements as unfair and inadmissible advertising. The Dortmund court shared this view in September 2022 – and according to the spokesman, the Higher Regional Court in Hamm now followed the argumentation of the lower court.
The statements that
- “good efficacy and tolerability were once again impressively confirmed by a pharmacy-based observational study”,
- and “all cold complaints showed a clear improvement in the course of the disease”,
were deemed to be misleading advertising. They must therefore be omitted, the ruling stated.
Meditonsin is currently being advertised as follows:
For support of the immune system at the first signs of a cold to help the body build up the defense against pathogens effectively.
In addition, conditions are made more difficult for the intruders – through an effective medicine: the well-known Meditonsin® supports your defenses and naturally fights the onset of inflammation of the ears, nose and throat with pure homeopathic ingredients.
If applied early and correctly, Meditonsin® helps to ensure that the typical unpleasant symptoms have no chance to develop. Because Meditonsin® is particularly well tolerated and protects the organism, it is for both adults and children alike – a family medicine in the best sense.
Meditonsin contains two homeopathic ingredients in the D5 and one in the D8 dilution. To the best of my knowledge, there is no sound evidence that the remedy is effective for anything.
Turnera diffusa, known as damiana is a shrub native to southern Texas in the United States, Central America, Mexico, South America, and the Caribbean that produces small, aromatic flowers. Damiana is an ingredient in a traditional Mexican liqueur, which is sometimes used in lieu of triple sec in margaritas. Damiana was included in several 19th-century patent medicines, such as Pemberton’s French Wine Coca. The leaves were omitted from that product’s non-alcoholic counterpart, Coca-Cola.
In folklore, the plant was believed to be an aphrodisiac. I looked for evidence from clinical trials but was unable to find any. However, that does not seem to bother PharmaSGP GmbH which produces a drug called Neradin.
The German advertisement of Neradin tells us that:
Bei sexueller Schwäche wie Erektionsstörungen können auch traditionelle Mittel helfen – ohne die Nebenwirkungen mancher chemischer Potenzmittel. Das pflanzliche Arzneimittel Neradin® nutzt dazu erfolgreich Wirkstoffe der mexikanischen Heilpflanze Damiana (Turnera Diffusa).
Die Vorteile von Neradin® auf einen Blick: Fördert die Potenz des Mannes bei sexueller Schwäche
I translated this into English:
Traditional remedies can also help with sexual weakness such as erectile dysfunction – without the side effects of some chemical sexual enhancers. The herbal medicine Neradin® successfully uses active ingredients from the Mexican medicinal plant Damiana (Turnera Diffusa).
The advantages of Neradin® at a glance: Promotes male potency in case of sexual weakness
The patient information leaflet states that “Niradin is a homeopathic drug” and “one tablet Niradin contains 100mg Turnera Diffusa Trit. D4”.
English language sites concur:
Neradin is a homeopathic medicine. Homeopathy is understood as a regulatory therapy for acute and chronic diseases. The areas of application are derived from the homeopathic drug pictures. The following indications are authorised for this medicinal product: Discomfort caused by sexual weakness
So, what we seem to have here is the following:
- A pharma firm that advertises a homeopathic product as a herbal drug.
- A homeopathic remedy that is based on a plant for which there is not a jot of evidence.
- If there were evidence that the plant helps against erectile dysfunction, its homeopathic dilution would, according to the homeopathic ‘like cures like’ axiom, bring about erectile dysfunction.
- A dilution (1:10000) that is too low to have any effect, even if it were made of Viagra.
Am I the only one to think that something is not quite right here?
But don’t let it spoil your HAPPY VALENTINE!
It has been reported that a German consumer association, the ‘Verbraucherzentrale NRW’, has first cautioned the manufacturer MEDICE Arzneimittel Pütter GmbH & Co. and then sued them for misleading advertising statements. The advertisement in question gave the wrong impression that their homeopathic remedy MEDITONSIN would:
- for certain generate a health improvement,
- have no side effects,
- be superior to “chemical-synthetic drugs”.
The study used by the manufacturer in support of such claims was not convincing according to the Regional Court of Dortmund. The results of a “large-scale study with more than 1,000 patients” presented a pie chart indicating that 90% of the patients were satisfied or very satisfied with the effect of Meditonsin. However, this was only based on a “pharmacy-based observational study” with little scientific validity, as pointed out by the consumer association. Despite the lack of evidence, the manufacturer claimed that their study “once again impressively confirms the good efficacy and tolerability of Meditonsin® Drops”. The Regional Court of Dortmund disagreed with the manufacturer and agreed with the reasoning of the consumer association.
“It is not permitted to advertise with statements that give the false impression that a successful treatment can be expected with certainty, as suggested by the advertising for Meditonsin Drops,” emphasizes Gesa Schölgens, head of “Faktencheck Gesundheitswerbung,” a joint project of the consumer centers of North Rhine-Westphalia and Rhineland-Palatinate. According to German law, this is prohibited. In addition, the Regional Court of Dortmund considered consumers to be misled by the advertising because the false impression was created that no harmful side effects are to be expected when Meditonsin Drops are taken. The package insert of the drug lists several side effects, according to which there could even be an initial worsening of symptoms after taking the drug.
The claim of advantages of the “natural remedy” represented by the manufacturer in comparison with “chemical-synthetic medicaments, which merely suppress the symptoms”, was also deemed to be inadmissible. Such comparative advertising is inadmissible.
__________________________________
This ruling is, I think, interesting in several ways. The marketing claims of so-called alternative medicine (SCAM) products seem all too often not within the limits of the laws. One can therefore hope that this case might inspire many more legal cases against the inadmissible advertising of SCAMs.
The U.S. Food and Drug Administration issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease or related conditions, such as atherosclerosis, stroke or heart failure, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is urging consumers not to use these or similar products because they have not been evaluated by the FDA to be safe or effective for their intended use and may be harmful.
The warning letters were issued to:
- Essential Elements (Scale Media Inc.);
- Calroy Health Sciences LLC;
- Iwi;
- BergaMet North America LLC;
- Healthy Trends Worldwide LLC (Golden After 50);
- Chambers’ Apothecary;
- Anabolic Laboratories, LLC.
“Given that cardiovascular disease is the leading cause of death in the U.S., it’s important that the FDA protect the public from products and companies that make unlawful claims to treat it. Dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease and related conditions could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments from qualified health care providers,” said Cara Welch, Ph.D., director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. “We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that could put their health at risk.”
Under the FD&C Act, products intended to diagnose, cure, treat, mitigate or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements. Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters announced today are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.
The FDA advises consumers to talk to their doctor, pharmacist or other health care provider before deciding to purchase or use any dietary supplement or drug. Some supplements might interact with medicines or other supplements. Health care providers will work with patients to determine which treatment is the best option for their condition.
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 encourages health care providers and consumers to report any adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.
The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or provide their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.
