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

prevention

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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.

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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.

It has been reported that two London councils have written to parents to warn that children who are not vaccinated against measles may need to self-isolate for 21 days if a classmate is infected with the disease. It comes after modelling by the UK Health Security Agency (UKHSA) warned that up to 160,000 cases could occur in the capital alone as a result of low vaccination rates. Just three-quarters of London children have received the two required doses of the MMR jab, which protects against measles. This is 10 per cent lower than the national average.

Barnet Council wrote to parents on July 20 warning that any unvaccinated child identified as a close contact of a measles case could be asked to self-isolate for up to 21 days. “Measles is of serious concern in London due to low childhood vaccination rates. Currently we are seeing an increase in measles cases circulating in neighbouring London boroughs, so now is a good time to check that your child’s MMR vaccination – which not only protects your child against measles but also mumps and rubella – is up to date,” the letter reads. “Children who are vaccinated do not need to be excluded from school or childcare,” the letter added.

Neighbouring Haringey Council also warned that children without both MMR doses may be asked to quarantine for 21 days. Just over two-thirds (67.9 per cent) of children in the area had received both doses by the age of five. The councils stated that they had sent the letters based on guidance by the UKHSA, but the agency said that headteachers should consider “excluding” unvaccinated pupils who become infected with measles rather than instructing them to self-isolate.

Data published by the UKHSA showed that 128 cases of measles were recorded between January 1 and June 30 this year, compared to 54 cases in the whole of 2022. Two-thirds of the cases were detected in London. The agency have said that there is a high risk of cases linked to overseas travel leading to outbreaks in specific population groups such as young people and under-vaccinated communities.

Dr Vanessa Saliba, a consultant epidemiologist at UKHSA, said: “When there are measles cases or outbreaks in nurseries or schools, the UKHSA health protection team will assess the situation, together with the school and other local partners, and provide advice for staff and pupils. “Those who are not up to date with their MMR vaccinations will be asked to catch up urgently to help stop the outbreak and minimise disruption in schools.”

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Measles is a significant concern with approximately 10 million people infected annually causing over 100,000 deaths worldwide. In the US before use of the measles vaccine, there were estimated to be 3 to 4 million people infected with measles annually, causing 400 to 500 deaths. Complications of measles include otitis media, diarrhea, pneumonia, and acute encephalitis. Measles is a leading cause of blindness in the developing world, especially in those who are vitamin A deficient. Malnourished children with measles are also at higher risk of developing noma (or cancrum oris), a rapidly progressive gangrenous infection of the mouth and face. Most deaths due to measles are caused by pneumonia, diarrhea, or neurological complications in young children, severely malnourished or immunocompromised individuals, and pregnant women. A rare sequela of measles is subacute sclerosing panencephalitis.

Back in 2003, we investigated what advice UK homeopaths, chiropractors and general practitioners give on measles, mumps and rubella vaccination programme (MMR) vaccination via the Internet. Online referral directories listing e-mail addresses of UK homeopaths, chiropractors and general practitioners and private websites were visited. All addresses thus located received a letter of a (fictitious) patient asking for advice about the MMR vaccination. After sending a follow-up letter explaining the nature and aim of this project and offering the option of withdrawal, 26% of all respondents withdrew their answers. Homeopaths yielded a final response rate (53%, n = 77) compared to chiropractors (32%, n = 16). GPs unanimously refused to give advice over the Internet. No homeopath and only one chiropractor advised in favour of the MMR vaccination. Two homeopaths and three chiropractors indirectly advised in favour of MMR. More chiropractors than homeopaths displayed a positive attitude towards the MMR vaccination.  We concluded that some complementary and alternative medicine providers have a negative attitude towards immunisation and means of changing this should be considered.

The problem is by no means confined to the UK. German researchers, for instance, showed that belief in homeopathy and other parental attitudes indicating lack of knowledge about the importance of vaccinations significantly influenced an early immunisation. Moreover, being a German homeopath has been independently associated with lower own vaccination behavior. Data from France paint a similar picture.

Some homeopaths, of course, claim that ‘homeopathic vaccinations’ are effective and preferable. My advice is: DON’T BELIEVE THESE CHARLATANS! A recent study demonstrated that homeopathic vaccines do not evoke antibody responses and produce a response that is similar to placebo. In contrast, conventional vaccines provide a robust antibody response in the majority of those vaccinated.

Many community pharmacies in Switzerland provide so-called alternative medicine (SCAM) approaches in addition to providing biomedical services, and a few pharmacies specialise in SCAM. A common perception is that SCAM providers are sceptical towards, or opposed to, vaccination.

The key  objectives of this study were to examine the potential roles of biomedically oriented and SCAM-specialised pharmacists regarding vaccine counselling and to better understand the association between vaccine hesitancy and SCAM. The researchers thus conducted semistructured, qualitative interviews. Transcripts were coded and analysed using thematic analysis. Interview questions were related to:

  • type of pharmaceutical care practised,
  • views on SCAM and biomedicine,
  • perspectives on vaccination,
  • descriptions of vaccination consultations in community pharmacies,
  • and views on vaccination rates.

Qualitative interviews in three language regions of Switzerland (German, French and Italian). A total of 18 pharmacists (N=11 biomedically oriented, N=7  SCAM specialised) were invited.

Pharmacist participants expressed generally positive attitudes towards vaccination. Biomedically oriented pharmacists mainly advised customers to follow official vaccination recommendations but rarely counselled vaccine-hesitant customers. SCAM-specialised pharmacists were not as enthusiastic advocates of the Swiss vaccination recommendations as the biomedically oriented pharmacists. Rather, they considered that each customer should receive individualised, nuanced vaccination advice so that customers can reach their own decisions. SCAM-specialised pharmacists described how mothers in particular preferred getting a second opinion when they felt insufficiently advised by biomedically oriented paediatricians.

The authors concluded that vaccination counselling in community pharmacies represents an additional option to customers who have unmet vaccination consultation needs and who seek reassurance from healthcare professionals (HCPs) other than physicians. By providing individualised vaccination counselling to vaccine-hesitant customers, SCAM-specialised pharmacists are likely meeting specific needs of vaccine-hesitant customers. As such, research and implementation efforts should more systematically involve pharmacists as important actors in vaccination provision. SCAM-specialised pharmacists particularly should not be neglected as they are important HCPs who counsel vaccine-hesitant customers.

I must say that I find these conclusions odd, perhaps even wrong. Here are my reasons:

  • Pharmacists are well-trained healthcare professionals.
  • As such, they have ethical obligations towards their customers.
  • These obligations include behaving in a way that is optimal for the health of their customers and follows the rules of evidence-based practice.
  • This includes explaining to vaccine-hesitant customers why the recommended vaccinations make sense and advising them to follow the official vaccination guidelines.
  • SCAM-specialised pharmacist should ask themselves whether offering SCAM is in line with their ethical obligation to provide optimal care and advice to their customers.

I fear that this paper suggests that SCAM-specialised pharmacists might be a danger to the health of their customers. If that is confirmed, they should consider re-training, in my view.

Swedish researchers examined the relationship between cognitive ability and prompt COVID-19 vaccination using individual-level data on more than 700,000 individuals in Sweden.

The analyses were based on individual-level data from several administrative registers in Sweden. The study population consisted of all men and women who enlisted for military service in Sweden between 1979 and 1997. During this period, enlistment was mandatory for men the year they turned 18 or 19. Women could not enlist for military service before 1980 but were then allowed to do so on a voluntary basis.

The study population thus covered almost the entire population of Swedish men born between 1962 and 1979, in total 750,381, as well as the sample of women who enlisted during the period of 1980–1997, in total 2703. In addressing the role of confounders, the researchers analyzed the sub-sample of 6750 twin brothers (3375 twin-pairs) in the enlistment records (identified by shared biological mother and year and month of birth).

The results show a strong positive association between cognitive ability and swift vaccination, which remained even after controlling for confounding variables with a twin-design. Consistent with this, the researchers showed that simplifying the vaccination decision through pre-booked vaccination appointments alleviates almost all of the inequality in vaccination behavior.

The authors concluded that the complexity of the vaccination decision may make it difficult for individuals with lower cognitive abilities to understand the benefits of vaccination.

On this blog, we have repeatedly discussed similar or related findings, e.g.:

I know, it would be politically incorrect, unkind, unhelpful, etc. but is anyone not tempted to simplify the issue by assuming that people who are against (COVID) vaccinations are intellectually challenged?

The KFF provides reliable, accurate, and non-partisan information to help inform health policy in the US. The KFF has just released its ‘Health Misinformation Tracking Poll Pilot‘ examining the public’s media use and trust in sources of health information and measuring the reach of specific false and inaccurate claims surrounding three health-related topics: COVID-19 and vaccines, reproductive health, and gun violence. It makes grimm reading indeed. Here are but a few excerpts pertaining to health/vaccination:

Health misinformation is widespread in the US with 96% of adults saying they have heard at least one of the ten items of health-related misinformation asked about in the survey. The most widespread misinformation items included in the survey were related to COVID-19 and vaccines, including that the COVID-19 vaccines have caused thousands of deaths in otherwise healthy people (65% say they have heard or read this) and that the MMR vaccines have been proven to cause autism in children (65%).

Regardless of whether they have heard or read specific items of misinformation, the survey also asked people whether they think each claim is definitely true, probably true, probably false, or definitely false. For most of the misinformation items included in the survey, between one-fifth and one-third of the public say they are “definitely” or “probably true.” The most frequently heard claims are related to COVID-19 and vaccines.

Uncertainty is high when it comes to health misinformation. While fewer than one in five adults say each of the misinformation claims examined in the survey are “definitely true,” larger shares are open to believing them, saying they are “probably true.” Many lean towards the correct answer but also express uncertainty, saying each claim is “probably false.” Fewer tend to be certain that each claim is false, with the exception of the claim that more people have died from the COVID-19 vaccines than from the virus itself, which nearly half the public (47%) recognizes as definitely false.

Across the five COVID-19 and vaccine related misinformation items, adults without a college degree are more likely than college graduates to say these claims are definitely or probably true. Notably, Black adults are at least ten percentage points more likely than White adults to believe some items of vaccine misinformation, including that the COVID-19 vaccines have caused thousands of sudden deaths in otherwise healthy people, and that the MMR vaccines have been proven to cause autism in children. Black (29%) and Hispanic (24%) adults are both more likely than White adults (17%) to say that the false claim that “more people have died from the COVID-19 vaccine than have died from the COVID-19 virus” is definitely or probably true. Those who identify as Republicans or lean towards the Republican Party and pure independents stand out as being more likely than Democratic leaning adults to say each of these items is probably or definitely true. Across community types, rural residents are more likely than their urban and suburban counterparts to say that some false claims related to COVID vaccines are probably or definitely true, including that the vaccines have been proven to cause infertility and that more people have died from the vaccine than from the virus.

Educational attainment appears to play a particularly important role when it comes to susceptibility to COVID-19 and vaccine misinformation. Six in ten adults with college degrees say none of the five false COVID-19 and vaccine claims are probably or definitely true, compared to less than four in ten adults without a degree. Concerningly, about one in five rural residents (19%), adults with a high school education or less (18%), Black adults (18%), Republicans (20%), and independents (18%) say four or five of the false COVID-19 and vaccine misinformation items included in the survey are probably or definitely true.

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If you have followed some of the comments on this blog, you might find it hard to be surprised!

I do encourage you to read the full article.

This study aimed to clarify the psychological mechanism by which individuals accept health misinformation from social media and how health misperceptions affect subsequent unhealthy behavior in the context of dewormer use.

An online survey was conducted with 307 South Korean adults exposed to dewormer use information on social media. The positive association between the respondents’ uncertainty about their health and factual misbeliefs about dewormer use was moderated by their pre-existing attitude toward so-called alternative medicine (SCAM) vs. standard treatments, suggesting that individuals who are uncertain but more favorable toward SCAM tend to accept factual misbeliefs more easily. Individuals’ uncertainty about their health and treatment for the health management was positively associated with conspiracy beliefs. Factual misbeliefs were the key mediator in the association between the interaction of uncertainty and pre-existing attitude toward SCAM vs. standard treatments and dewormer-taking intention.

 

Image result for misinformation, cartoon

This is a subject that we have discussed many times before. See, for instance, here:

In my view, it is hugely important. Consumers who are uncertain, easily misled, convinced that ‘the establishment’ is against them, or prone to other conspiracy theories tend to be the ones that also fall easily for the lies of SCAM promoters. Indeed, I have previously suggested that SCAM itself is a conspiracy theory in disguise. Anyone who has been following the comment sections on this blog will find more evidence for this theory than he had ever needed, I fear.

It is clear to me that misinformation undermines not just evidence-based medicine but – much more dangerous -rationality in general. It would be thus urgent to do something about it.

But what?

In my view, the answer is to promote critical thinking. This, of course, is what I am aiming at with my blog. But my effort is merely a drop in the ocean. What we need is a systematic promotion of critial thinking on a much larger scale. It has to start at school and should be followed through to post-graduate education and beyond.

Such a strategy would require a very broad backing, not least on the political levels. And this is where the concept runs into insurmountable difficulties: politcians might not want us to be critical thinkers! This could enable the public to realize what often dismally poor jobs they might be up to.

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, and France (total N = 2,787).

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: 23.72% in Germany, 17.83% in France, 9.77% in Finland, and 5.86% in Portugal.

The authors concluded that these results constitute a call to consider health care professionals’ attitudes toward SCAM as a factor that could hinder the implementation of immunization campaigns.

In my view, this is a very important paper. It shows what we on this blog have discussed often before: there is an association between SCAM and vaccination hesitancy. The big question is: what is the nature of this association. There are several possibilities:

  1. It could be coincidental. I think this is most unlikely; too many entirely different investigations have shown a link.
  2. It could mean that people start endorsing SCAM because they are critical about vaccination.
  3. It could be that people are critical about vaccination because they are proponents of SCAM.
  4. Finally, it could be that some people have a mind-set that renders them simultaneously hesitant about vaccination and fans of SCAM.

This study, like most of the other investigationson this subject, was not desighned to find out which possibility is most likely. I suspect that the latter two explanations apply both to some extend. The authors of this study argue that that, “from a theoretical point of view, this situation may be explicable by reasons that are both implicit (i.e., CAM would fit better with certain worldviews and ideological standpoints that conflict with the epistemology and values that underlies scientific knowledge) and explicit (i.e., some CAM techniques are doctrinally opposed to the use of vaccines). Although we have outlined these potential explanations for the observed relationships, more research is needed to better understand the underlying mechanisms”.

 

I like skeptics; they have taught me a lot, and I am thankful for it.

At the same time, they occasionally irritate me when they comment on so-called alternative medicine (SCAM).

Why? Because, when they comment on SCAM, they are not rarely wrong or at least not quite correct.

I am referring to the typical scenario where a skeptic discusses a form of SCAM and explains that there is no evidence on it. Such statements are almost invariably false. There is evidence on almost all forms of SCAM; it may not be positive but it exists. To make statements to the contrary is demonstrably wrong.

Let’s assume that a skeptic discusses CUPPING (I am referring to an actual video that I recently watched). He explains its history, how it’s done, that there is no plausible mode of action, and that there is NO evidence on it.Pregnant Man Cartoons and Comics - funny pictures from CartoonStock

This is not correct!

In fact, there is a substantial body of evidence in terms of clinical trials and even systematic reviews (if you search this blog, you will find quite a bit; if you go on Medline, you’ll find even more). And there is some evidence about cupping’s possible mode of action.

Don’t get me wrong:

  • I am not a fan of cupping,
  • in fact, cupping is merely an example – I could have chosen almost any other SCAM,
  • I am certainly not defending therapists who practice cupping,
  • the evidence is far from convincing.

All that I am trying to say is this:

When you comment on a SCAM (or anything else), it is worth checking the evidence. More often than not, you will then find that there is quite a lot of evidence. You might conclude that:

  • the evidence is poor quality,
  • the evidence is negative,
  • the evidence is suspect,
  • etc., etc.

So, please comment accordingly. Just saying THERE IS NO EVIDENCE is not just wrong, it is irritating, because it gives the SCAM promoters the occasion to rightly point out that skeptics are just badly informed. And that surely is worth preventing!

 

This article entitled: Keeping Medical Science Trustworthy: The Threat by Predatory Journals caught my attention.

Many scientific journals have started to ask article processes costs from authors. This development has created a new category of journals of which the business model is totally or predominantly based on financial contributions by its authors. Such journals have become known as predatory journals. The financial contributions that they ask are not necessarily lower than those asked by high-quality journals although they offer less:

  • there is commonly no real review,
  • texts are not edited,
  • there are commonly no printed editions.

The lack of serious reviews might make predatory journals attractive particularly to authors of low-quality (or even fraudulent) manuscripts.

The authors of this paper suggest that numerous journals, some of which may predatory, attract manuscripts by approaching authors of articles in high-quality journals. They conclude that publication of articles in such journals contaminates the medical literature and undermines the trustworthiness of science and medicine. Any involvement in such journals (as an author, reviewer or editor) should therefore be discouraged.

The ironic thing here is that the paper was published by a journal that itelf is, in my view, borderline, to say the least. But let me nonetheless contribute a recent, personal experience on this issue.

About 2 weeks ago, I received an invitation to join the editorial board of a general medicine journal that I had never heard of. I looked it up and found that it had a decent impact factor and a long list of international members of the board. But then I found that the journal charged around $ 1 500 for each submission. I was told that this is to cover the cost of the review process.

I then decided to write to the editor thanking her for the kind invitation. I also asked her how much the journal would pay its reviewers for reviewing submissions. I received a polite answer explaining that the amount was $ 00.00. My response was to politely decline the invitation to join the editorial board and to urge the journal editor to make it clear from the outset that the fees charged to authors did NOT go to the reviewers.For many years now, I have taken a very dim view on predatory journals. Sadly, in the realm of so-called alternative medicine (SCAM), there currently are dozens of such publications. I believe their danger in polluting the medical literature is hard to over-estimate. I think they ought to be stopped. One way of doing this is refusing to co-operate with them in any way.

 

This short news report appeared on X [formerly Twitter]:Short-haired blonde woman on a stage speaking into a headset microphone, wearing an animal stripe jacket with a bare lightbulb and draped cloth behind her

The Ohio State Medical Board just approved the indefinite suspension Dr. Sherri Tenpenny’s medical license, an osteopathic physician and longtime figure in the anti-vaccine movement. The board got around 350 complaints into her behavior, but that’s not why she’s being suspended.

As this could easily be unreliable, I looked for confirmations … and found several, for instance, this one:

An Ohio physician who sparked widespread ridicule in 2021 after spreading bizarre COVID-19 vaccine conspiracies to the House Health Committee by claiming the jabs magnetize their hosts and “interface” with cell towers had her medical license indefinitely suspended Wednesday. Anti-vaccine spreader Sherri Tenpenny sparked a firestorm in June, 2021 after making the comments, which saw 350 complaints sent to the State Medical Board. According to Cleveland.com, the board’s decision was not based on the comments, rather on procedural grounds, citing Tenpenny’s refusal to cooperate with investigators during the inquiry. “Dr. Tenpenny, neither you nor any doctor licensed by this board is above the law, and you must comply with the investigation,” said Dr. Jonathan Feibel, an orthopedic surgeon and medical board member, according to the outlet. “You have not done so, and therefore, until you do, your license will be suspended.” A lawyer for Tenpenny, Tom Renz, described the investigation as a form of “harassment” on her “free speech rights.” Tenpenny did not speak after the announcement, however Renz declared, “This appears very much like a lynch mob.”

Who is Sherry Tenpenny? Here is what Wiki tells us about her:

Sherri J. Tenpenny is an American anti-vaccination activist and conspiracy theorist who promulgates the disproven hypothesis that vaccines cause autism.[1] An osteopathic physician, she is the author of four books opposing vaccination. A 2015 lecture tour of Australia was canceled due to a public outcry over her views on vaccination, which oppose established scientific consensus. A 2021 Center for Countering Digital Hate analysis concluded that Tenpenny is among the top twelve people spreading COVID-19 misinformation and pseudoscientific anti-vaccine misinformation on social media platforms. She has falsely asserted that the vaccines magnetize people and connect them with cellphone towers…

The story is puzzling, in my view. The biggest question for me is this:

Why only now?

She should have been suspended years ago!

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