MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

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.:

Having warned about the dangers of homeopathy for decades, I feel it is high time for regulators across the world to take appropriate action.

23 Responses to Homeopathy: An Ongoing Public Health Failure

  • How can we take this seriously? None of them spoke to Dana to hear his rational and evidence-based views on the subject.

    His foaming lunacy would have offered the final concrete support for their conclusions.

  • “containing or purportedly containing” is interesting. Do homeopathic companies preparing Rhus tox 30C purport that it does, or does not, “contain” Rhus toxicodendron? They should be forced to say!

  • Dr. Edzard

    “An Ongoing Public Health Failure”

    Some REAL Public Health Failure.

    https://www.youtube.com/watch?v=F3StJGMs0Q4

    ““….there have been two waves of injury to the world the first has been the surge cov2 infection which preyed upon the frail and the elderly and then the second wave of injury now has been the covid-19 vaccines the role of the who appears to be adverse in both of these the role of the who appears to be operating within a biopharmaceutical complex a Syndicate a complicated Syndicate that has formed over time it includes the WHO, the United Nations the World Economic Forum, The Gates Foundation, Rockefeller Foundation, The Welcome trust, Gavi sepi, the Coalition for epidemic preparedness and Innovation that Gates Foundation in the Waf formed largely, the Department of State in the United States, the National Institutes of Health, the CDC, the FDA, the MHRA in the UK the TGA in Australia, Safra in South Africa, the EMA here in Europe, this grouping of non-governmental organizations with governmental Public Health agencies is operating as a unit they’re carefully coordinated and the impact has been adverse at the outset of the pandemic there was an investigation by The WHO on the origins of SARS cov2 that’s when the beginning of the cover-up began Rear Admiral Brett Gerard in the United States nominated three independent scientists to go to Wuhan and figure out what was going on
    we knew at that time and this has all come out in a Congressional hearing that Anthony Fauci Francis Collins Jeremy Farrar who was at the welcome trust who’s now the chief scientist at The WHO Christian Andersen at Scripps Edwin homes in Sydney Peter desicc at the ecohealth alliance they all conspired in January of 2020 to cover up what they knew that the virus was engineered in a joint U.S Chinese collaboration in the lab in Wuhan China and they deceived the world with 12 subsequent fraudulent papers in the peer-reviewed literature these were quarterbacked by Jeremy Farrar who is the chief scientist at the who this is all in the series of reports in the house Select Committee in the United States by the U.S Congress led by representative Brad wenstrup the who has played an adverse a role from the very beginning deceiving the world on the origins of the Sars Covid……….

    Worth listening to.

    You can also find out the injuries expected from the vaccine that you took and make sure you have the right insurance that covers each possibility.

    You still believe Homeopathy can be “Public Health Failure”?

    • once you have learnt that youtube videos are not evidence, perhaps you might then learn wich name is my surname

      • Edzard on Saturday 23 September 2023 at 17:47

        “…youtube videos are not evidence,..”

        You don’t like youtube or the message? Was the speaker in the video Dr. Peter A. McCullough, American cardiologist? At the “Health & Democracy, under WHO’s proposed rules, expert hearing? (https://www.americaoutloud.news/dr-mcculloughs-speech-at-the-european-parliament/)

        Below are the credentials of Dr. McCullough: (Source: Wikipedia)
        He earned a Bachelor of Science degree from Baylor University in 1984 and his Doctor of Medicine (MD) degree from the University of Texas Southwestern Medical Center in 1988. He completed his residency in internal medicine at the University of Washington in Seattle, a cardiology fellowship in 1991, and practiced internal medicine in Grayling, Michigan, for two years before enrolling in the University of Michigan School of Public Health, earning a Master of Public Health (MPH) degree in 1994.
        After receiving his MPH, McCullough was a cardiovascular fellow at William Beaumont Hospital in the Detroit metropolitan area until 1997. He then worked at the Henry Ford Heart and Vascular Institute in Detroit until 2000, served as section chief of cardiology of the University of Missouri–Kansas City School of Medicine, and returned to William Beaumont Hospital where he worked from 2002 to 2010. He spent the next four years as chief academic and scientific officer of the St. John Providence Health System, Detroit, before joining the Baylor University Medical Center in 2014. McCullough entered into a confidential separation agreement with Baylor Scott & White Medical Center in February 2021. In July, in response to his promotion of misinformation about COVID-19, Baylor sued McCullough to prevent him falsely claiming any current association with Baylor Health. On January 17, 2023, the 191st Judicial District Court of Dallas County, Texas dismissed the case. While details were not disclosed, according to The Texan, “voluntary dismissal of claims with prejudice are usually entered after a settlement agreement has been reached.”
        McCullough is a founder and current president of the Cardio Renal Society of America and co-editor-in-chief of Cardiorenal Medicine, the society’s journal, and also editor of Reviews in Cardiovascular Medicine. He has conducted several studies on running and heart disease, and co-described the term Phidippides cardiomyopathy, a heart condition found in some high endurance athletes. McCullough’s other research projects have included the relationship between heart disease and kidney disease and risk factors for heart disease. He is a member of the conservative advocacy group Association of American Physicians and Surgeons and has advocated for conspiracy theories promoted by the group.

        Does this make him a Cardiologist or a charlatan?

        Dr. McCullough refers to the study by Schmelling and colleagues from Denmark.
        https://www.researchgate.net/publication/369660342_Batch-dependent_safety_of_the_BNT162b2_mRNA_Covid-19_vaccine
        Danish Bombshell: Three Levels of Pfizer mRNA Vax Batches with Various Association to SAEs, Including Deaths (April 12, 2023)

        Dr. McCullough refers to the studies on adverse effects of vaccines: myocarditis, Cardiac Arrest, blood clots, hemorrhagic stroke, disabilities, sudden death at home in bed.

        https://onlinelibrary.wiley.com/doi/10.1002/iid3.807 “Adverse events following COVID-19 mRNA vaccines: A systematic review of cardiovascular complication, thrombosis, and thrombocytopenia”

        Results
        A total of 81 articles analyzed confirmed cardiovascular complications post-COVID-19 mRNA vaccines in 17,636 individuals and reported 284 deaths with any mRNA vaccine. Of 17,636 cardiovascular events with any mRNA vaccine, 17,192 were observed with the BNT162b2 (Pfizer−BioNTech) vaccine, 444 events with mRNA-1273 (Moderna). Thrombosis was frequently reported with any mRNA vaccine (n = 13,936), followed by stroke (n = 758), myocarditis (n = 511), myocardial infarction (n = 377), pulmonary embolism (n = 301), and arrhythmia (n = 254). Stratifying the results by vaccine type showed that thrombosis (80.8%) was common in the BNT162b2 cohort, while stroke (39.9%) was common with mRNA-1273 for any dose. The time between the vaccination dosage and the first symptom onset averaged 5.6 and 4.8 days with the mRNA-1273 vaccine and BNT162b2, respectively. The mRNA-1273 cohort reported 56 deaths compared to the 228 with BNT162b2, while the rest were discharged or transferred to the ICU.

        This is not from video. For achieving such level of death and illness and getting away with it, requires strong network and powerful people in the right places. That is what the Dr. states.
        Creating messages like Homeopathy : Public Health failure, is a façade to hide these failures or you are missing something?

        All doctors and studies referred here are from the area of “scientific medicine”.

    • @Krishna

      Wow…you just blew my mind with that video. I never thought there is such a huge network of bad actors convincing the public to get the vaccine. I did some research of my own and uncovered that the Earth is FLAT!! CAN YOU BELIEVE IT? HERE IS THE EVIDENCE:
      https://m.youtube.com/watch?v=xM9S4QiEHEY

    • @Krishna
      Your video touts former Doctor, current antiscientist Peter McCullough. The only lesson we can learn from him is that a fool with sciency titles is still a fool.

      • Björn Geir on Saturday 23 September 2023 at 23:57

        Why should a doctor, speaking about his experience be labeled “anti scientist”? Only because he speaks against the general perception and the pharmaceutical interests?

        Normally, labeling people with adjectives starts when logical responses are missing. Very common approach.

        • @Krishna

          Why should a doctor …

          McCullough is not a doctor any more.

          … speaking about his experience …

          McCullough does not speak from experience, but from misguided beliefs and delusions.

          … be labeled “anti scientist”?

          Because the lies and disinformation he spreads are not based on science and are not supported by facts or evidence. There is a very good reason why he has been stripped of his medical certifications: his medical judgement can no longer be trusted, which means that he is a danger to patients.

          And oh, when talking about financial interests: McCullough has sunk to the level of snake oil salesman. And he also makes a neat profit off is misguided followers on Substack.

          • Richard Rasker on Sunday 24 September 2023 at 19:25

            You missed this study link?

            https://onlinelibrary.wiley.com/doi/10.1002/iid3.807 “Adverse events following COVID-19 mRNA vaccines: A systematic review of cardiovascular complication, thrombosis, and thrombocytopenia”

            Results
            A total of 81 articles analyzed confirmed cardiovascular complications post-COVID-19 mRNA vaccines in 17,636 individuals and reported 284 deaths with any mRNA vaccine. Of 17,636 cardiovascular events with any mRNA vaccine, 17,192 were observed with the BNT162b2 (Pfizer−BioNTech) vaccine, 444 events with mRNA-1273 (Moderna). Thrombosis was frequently reported with any mRNA vaccine (n = 13,936), followed by stroke (n = 758), myocarditis (n = 511), myocardial infarction (n = 377), pulmonary embolism (n = 301), and arrhythmia (n = 254). Stratifying the results by vaccine type showed that thrombosis (80.8%) was common in the BNT162b2 cohort, while stroke (39.9%) was common with mRNA-1273 for any dose. The time between the vaccination dosage and the first symptom onset averaged 5.6 and 4.8 days with the mRNA-1273 vaccine and BNT162b2, respectively. The mRNA-1273 cohort reported 56 deaths compared to the 228 with BNT162b2, while the rest were discharged or transferred to the ICU.

            This is summary of the studies Dr. McCullough quoted in his deposition at the EU meet.

          • @Krishna
            You appear to be insufficiently educated to understand what you are linking to, so please allow me to enlighten you.

            The review you link to is titled “Adverse events following COVID-19 mRNA vaccines …” (emphasis added). It doesn’t say that all adverse events mentioned were caused by vaccination.
            Furthermore, this review appears to be mostly based on case studies, preprint studies and on studies involving VAERS and similar databases, all of which are de facto useless for establishing causality.
            Then there are the numbers themselves. The authors simply come up with aggregated counts of certain types of adverse events from the articles they reviewed. Not a word about relative risks or proper statistical analysis, or even what proportion of those AEs was obtained from VAERS etc.. For instance, they mention a total of 17,363 cardiovascular events following vaccination. But what total number of vaccinations are we talking about? Should we take the approximately 12 billion vaccinations administered worldwide so far? Then this shows that the vaccines are quite safe, with just one cardiovascular AE per 700,000 vaccinations – assuming that all AEs mentioned were actually caused by vaccination, which they are most definitely not. If the majority of those AEs was coming from studies based on e.g. VAERS data, then the real numbers are almost certainly much, much lower.

            In other words: this review that you are linking to and which McCullough is using to support his lies and FUD is pretty much useless. It basically just says how many reported cardiovascular events following vaccination they could find in other studies. It doesn’t say anything about actual risks or side effects of vaccination.

            About McCullough: the man is a liar and a fraud. His ‘studies’, articles and testimonies are inaccurate at best and total lies at worst. This is why the man has been stripped of his medical license and why no-one listens to him any more. Except of course a few antivaccine dimwits.

            Anyway, I’ll leave it at this, as your antivaccine nonsense is off-topic here (although it does of course illustrate how homeopaths and their followers tend to have misguided antivaccine sentiments).

          • In addition to Richard Rasker’s comment, here is just one of the plethora of problems I noticed:

            Yasmin, F, Najeeb, H, Naeem, U, et al.
            Adverse events following COVID-19 mRNA vaccines: A systematic review of cardiovascular complication, thrombosis, and thrombocytopenia.
            Immun Inflamm Dis. 2023; 11:e807
            DOI: 10.1002/iid3.807

            ST-elevation was the prevalent ECG finding with 0.6% in BNT162b2 (Pfizer−BioNTech) and 4.1% in mRNA-1273 (Moderna) vaccine groups.

            That finding is ridiculous because the error rate of ECG ST-elevation assessment is circa:
            • 15–20% type I  error (false positive);
            • 20–30% type II error (false negative).

          • Richard Rasker on Monday 25 September 2023 at 07:47

            “The review you link to is titled “Adverse events following COVID-19 mRNA vaccines …” (emphasis added). It doesn’t say that all adverse events mentioned were caused by vaccination……”

            If I understood correctly, you imply:
            1. The researchers studying “Adverse events following Covid vaccines” are grossly incompetent to include ALL adverse events- caused/not caused by vaccination thereby making the study meaningless? Is this the level of education and training received by researchers conducting studies in scientific medicine? Very inappropriate, would you say?
            2. Dr. McCullough was idiotic enough not to see through the gross anomalies in the studies pointed out by you and based his testimony on such erroneous reports while you could easily identify these failures? Very impressive. Did you write to the researchers of these studies about the shortcomings and hopefully save careers of many other doctors?

            Dr. McCullough was cleared to practice as a Cardiologist in 1992. “He worked at the Henry Ford Heart and Vascular Institute in Detroit until 2000, served as section chief of cardiology of the University of Missouri–Kansas City School of Medicine, and returned to William Beaumont Hospital where he worked from 2002 to 2010. He spent the next four years as chief academic and scientific officer of the St. John Providence Health System, Detroit, before joining the Baylor University Medical Center in 2014.’

            In your opinion. how did the scientific medical system allow such an incompetent and mediocre person, to study, practice cardiology and take responsible positions in different hospitals? Also can you estimate the number of dead patients he could be responsible for in the past 30 odd years of his working in this area? How are deaths of patients under such irresponsible doctors handled in the “scientific medical system?”

            Either these researchers and the Doctor are wrong or you have no clue what you are up to. I am positive it is YOU. (Now go back and read the study AGAIN: carefully.)

            “This is why the man has been stripped of his medical license.”

            Tell me something new. The Indian History is filled with numerous similar instances.

            In earlier times, the King would certify numerous chieftains in different areas of his kingdom to rule provinces in his name, implement his policies, collect funds so generated and send these funds to the central treasury. Implementing King’s policies was mandatory in each province. Any chief trying to make a change or speak against the King’s policy, was considered a threat to the system, had his position revoked, was physically dragged to the Capital, laid out in the open in the biggest market, where a trained elephant would crush the rebel’s head during a public display. The body of this ex-chief would lie in the market area as an example for other Chiefs. Many of these chiefs would realize that the policies were erroneous, but out of fear of getting their certificate revoked, would continue implementing the King’s policy.

            This was a standard protocol and is followed even today, (revoking the doctor’s medical license) minus the barbaric part of killing the doctor in the open market and leaving his body in the open as a message for other doctors.

          • Either these researchers and the Doctor are wrong or you have no clue what you are up to. I am positive it is YOU. (Now go back and read the study AGAIN: carefully.)

            @Krishna

            Richard Rasker and Pete Attkins pointed out to you exactly what is wrong with the study. I don’t think they need to go back and read the study.

            Richard Rasker said:

            It doesn’t say that all adverse events mentioned were caused by vaccination.
            Furthermore, this review appears to be mostly based on case studies, preprint studies and on studies involving VAERS and similar databases, all of which are de facto useless for establishing causality.
            Then there are the numbers themselves. The authors simply come up with aggregated counts of certain types of adverse events from the articles they reviewed. Not a word about relative risks or proper statistical analysis, or even what proportion of those AEs was obtained from VAERS etc.. For instance, they mention a total of 17,363 cardiovascular events following vaccination. But what total number of vaccinations are we talking about? Should we take the approximately 12 billion vaccinations administered worldwide so far? Then this shows that the vaccines are quite safe, with just one cardiovascular AE per 700,000 vaccinations – assuming that all AEs mentioned were actually caused by vaccination, which they are most definitely not. If the majority of those AEs was coming from studies based on e.g. VAERS data, then the real numbers are almost certainly much, much lower.

            Pete Attkins said:

            That finding is ridiculous because the error rate of ECG ST-elevation assessment is circa:
            • 15–20% type I error (false positive);
            • 20–30% type II error (false negative).

            Instead of refuting their arguments, you went on and on about McCullough’s background, his intelligence, and some random stories from history. You failed to come up with even a single valid argument and resorted to deflecting from the topic. I think you don’t understand the methodology (or lack thereof) of the paper that is being discussed. Mind you, this is the same paper you started waving around as proof against vaccinations. At this point I’d typically ask you to read the paper, but it wouldn’t be fair to you, because you are scientifically uneducated.

          • @Krishna
            Oh, the study results may be perfectly valid. They’re just meaningless. It’s like saying that 1 million people died in hospitals around the US, and that 1.7 million died in elderly homes. What does this tell us? Yep: nothing at all.

            McCullough was not always an idiot and fraud, but now he certainly is. There are more formerly reputable doctors/scientists like him who for some reason abandoned science and reason, and went down a rabbit hole of bad science, conspiracies and other nonsense. This sometimes even happens to Nobel prize winners, with for instance Luc Montaigner completely losing his mind and starting to dabble in homeopathy – something that normally only misguided and rather dumb people believe in.

            And yes, now that you ask: I always find it a shame when people start doing stupid things. If there’s one human trait that I value right after being nice and friendly, it’s intelligence. Note that intelligence is not by definition linked to a higher education or stuff like that; I’ve met quite intelligent house cleaners who not only knew what they were doing, but also took pride in their work – and I’ve also met highly educated yet very stupid, arrogant a**holes.

            So yes, I think McCullough is an idiot, but I also feel somewhat sorry for him. He clearly made some very bad choices, and I can’t imagine that he feels good about it.

          • And oh:

            Either these researchers and the ex-Doctor are wrong or you have no clue what you are up to.

            Ah yes, the ‘lone critic’ fallacy. Well, I’m not the only one who thinks that McCullough is telling lies and nonsense. Countless thousands of doctors and scientists think McCullough is a liar and a fraud.

            So to paraphrase your words:
            Either those countless thousands of doctors and scientists are all wrong, or McCullough has no clue what he is up to.

    • Peter McCullough again? Your “allies” @jim and @OldBob have already linked him here several times as “key witness” for their crude theories. McCullough’s statements are worth nothing and belong in the trash can.

      During the COVID-19 pandemic, McCullough has promoted misinformation about COVID-19, its treatments, and mRNA vaccines.
      […]
      In October 2022, the American Board of Internal Medicine recommended that McCullough’s board certification be revoked due to his promotion of misinformation about COVID-19 vaccines.

      https://en.wikipedia.org/wiki/Peter_A._McCullough

  • @Krishna
    I can’t really blame you for believing all that dumb nonsense you just posted – as believing in nonsensical things is in fact a professional requirement for homeopaths and homeopathy supporters. After all, you also believe that a bit of shaking can turn plain water into a medicine.

    But I am genuinely curious about one thing: why do you insist on posting your nonsensical stuff here of all places? No-one here is swallowing your whacky claims, and you only make yourself look silly.

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