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

Edzard

This study assessed the effects of being born under the zodiac sign Pisces on mortality. For that purpose, a retrospective observational study was conducted of the data from 26 Scandinavian intensive care units between 2009 and 2011. Patients aged 18 years or older with severe sepsis and in need of fluid resuscitation were included from the Scandinavian Starch for Severe Sepsis/ Septic Shock (6S) trial. The main outcome measure was the 90-day mortality.

The researchers included all 798 patients in the study; 70 (9%) of them were born under the sign of Pisces. The primary outcome (death within 90 days) occurred in 25 patients (35.7%) in the Pisces group, compared with 348 patients (48%) in the non-Pisces group (relative risk, 0.75; 95% CI, 0.54-1.03; one-sided P = 0.03).

The authors concluded that in a multicentre randomised clinical trial of IV fluids, being born under the sign of Pisces was associated with a decreased risk of death. Our study shows that with convenient use of statistics and an enticing explanatory hypothesis, it is possible to achieve significant findings in post-hoc analyses of data from large trials.

This is an excellent paper! It showcases the sort of nonsense one can do with datasets, statistics, and post hoc hypotheses. The authors entitled their article “Gone fishing in a fluid trial”, and this title should ensure that there are not some astrology nutters who mistake correlation for causation

… I hope

… but, of course, I am an optimist.

I recently discussed the incredible paper by Walach et al. To remind you, here is its abstract again:

COVID-19 vaccines have had expedited reviews without sufficient safety data. We wanted to compare risks and benefits.

Method: We calculated the number needed to vaccinate (NNTV) from a large Israeli field study to prevent one death. We accessed the Adverse Drug Reactions (ADR) database of the European Medicines Agency and of the Dutch National Register (lareb.nl) to extract the number of cases reporting severe side effects and the number of cases
with fatal side effects.

Result: The NNTV is between 200–700 to prevent one case of COVID-19 for the mRNA vaccine marketed by Pfizer, while the NNTV to prevent one death is between 9000 and 50,000 (95% confidence interval), with 16,000 as a point estimate. The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations. For three deaths prevented by vaccination we have to accept two inflicted by vaccination.

Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy.

In my post, I pointed out that the analysis was deeply flawed and its conclusion ridiculous. Many other observers agreed, and several editorial board members of the journal, Vaccines, that unbelievably had published this junk resigned. Yesterday, the journal reacted by retracting the paper. Here is their statement:

The journal retracts the article, The Safety of COVID-19 Vaccinations—We Should Rethink the Policy.

Serious concerns were brought to the attention of the publisher regarding misinterpretation of data, leading to incorrect and distorted conclusions.

The article was evaluated by the Editor-in-Chief with the support of several Editorial Board Members. They found that the article contained several errors that fundamentally affect the interpretation of the findings.

These include, but are not limited to:

The data from the Lareb report (https://www.lareb.nl/coronameldingen) in The Netherlands were used to calculate the number of severe and fatal side effects per 100,000 vaccinations. Unfortunately, in the manuscript by Harald Walach et al. these data were incorrectly interpreted which led to erroneous conclusions. The data was presented as being causally related to adverse events by the authors. This is inaccurate. In The Netherlands, healthcare professionals and patients are invited to report suspicions of adverse events that may be associated with vaccination. For this type of reporting a causal relation between the event and the vaccine is not needed, therefore a reported event that occurred after vaccination is not necessarily attributable to vaccination. Thus, reporting of a death following vaccination does not imply that this is a vaccine-related event. There are several other inaccuracies in the paper by Harald Walach et al. one of which is that fatal cases were certified by medical specialists. It should be known that even this false claim does not imply causation, which the authors imply. Further, the authors have called the events ‘effects’ and ‘reactions’ when this is not established, and until causality is established they are ‘events’ that may or may not be caused by exposure to a vaccine. It does not matter what statistics one may apply, this is incorrect and misleading.

The authors were asked to respond to the claims, but were not able to do so satisfactorily. The authors were notified of the retraction and did not agree.

In my blog post about the paper, I wrote: Let’s hope the journal editor in chief (who failed miserably when publishing this idiocy) has the wisdom to retract it swiftly. I am glad that the retraction has been done quickly. This shows that the important self-cleansing process of science is working.

Two questions still remain to be answered:

  1. Were Walach et al just incompetent or did they wilfully try to mislead us?
  2. How much nonsense is Walach allowed to publish before he is finally stopped?

Boris Johnson has recently bent over backward in order to please the Indian PM, Narendra Mondi. Some even say that a trade agreement between the two countries was achieved at the cost of letting the Delta variant into the UK. Now it seems that political considerations are at the heart of the decision to lend official support to Indian traditional medicine in the UK. The ‘2030 Roadmap for India-UK future relations‘ is a policy document of the UK government. In it, we find that the UK government intends to:

  • Explore cooperation on research into Ayurveda and promote yoga in the UK.
  • Increase opportunities for generic medicine supply from India to the UK by seeking access for Indian pharma products to the NHS and recognition of Indian generic and Ayurvedic medicines that meet UK regulatory standards.

This clearly begs the question, are these plans good or bad for UK public health?

Ayurveda is a system of healthcare developed in India around the mid-first millennium BCE. Ayurvedic medicine involves a range of techniques, including meditation, physical exercises, nutrition, relaxation, massage, and medication. Ayurvedic medicine thrives for balance and claims that the suppression of natural urges leads to illness. Emphasis is placed on moderation. Ayurvedic medicines are extremely varied. They usually are mixtures of multiple ingredients and can consist of plants, animal products, and minerals. They often also contain toxic substances, such as heavy metals which are deliberately added in the ancient belief that they can have positive health effects. The truth, however, is that they can cause serious adverse effects.

Relatively few studies of Ayurvedic remedies exist and most are methodologically weak. A Cochrane review, for instance, concluded that” although there were significant glucose-lowering effects with the use of some herbal mixtures, due to methodological deficiencies and small sample sizes we are unable to draw any definite conclusions regarding their efficacy. Though no significant adverse events were reported, there is insufficient evidence at present to recommend the use of these interventions in routine clinical practice and further studies are needed.”

The efficacy of Ayurvedic remedies obviously depends on the exact nature of the ingredients. Generalizations are therefore problematic. Promising findings exist for a relatively small number of ingredients, including Boswellia, Frankincense, Andrographis paniculata.

Yoga has been defined in several different ways in the various Indian philosophical and religious traditions. From the perspective of alternative medicine, it is a practice of gentle stretching exercises, breathing control, meditation, and lifestyles. The aim is to strengthen prana, the vital force as understood in traditional Indian medicine. Thus, it is claimed to be helpful for most conditions affecting mankind. Most people who practice yoga in the West practise ‘Hatha yoga’, which includes postural exercises (asanas), breath control (pranayama), and meditation (dhyana). It is claimed that these techniques bring an individual to a state of perfect health, stillness, and heightened awareness. Other alleged benefits of regular yoga practice include suppleness, muscular strength, feelings of well-being, reduction of sympathetic drive, pain control, and longevity. Yogic breathing exercises are said to reduce muscular spasms, expand available lung capacity and thus alleviate the symptoms of asthma and other respiratory conditions.

There have been numerous clinical trials of various yoga techniques. They tend to suffer from poor study design and incomplete reporting. Their results are therefore not always reliable. Several systematic reviews have summarised the findings of these studies. An overview included 21 systematic reviews relating to a wide range of conditions. Nine systematic reviews arrived at positive conclusions, but many were associated with a high risk of bias. Unanimously positive evidence emerged only for depression and cardiovascular risk reduction (Ernst E, Lee MS: Focus on Alternative and Complementary Therapies Volume 15(4) December 2010 274–27).

Yoga is generally considered to be safe. However, the only large-scale survey specifically addressing the question of adverse effects found that approximately 30% of yoga class attendees had experienced some type of adverse event. Although the majority had mild symptoms, the survey results indicated that attendees with chronic diseases were more likely to experience adverse events associated with their disease. Therefore, special attention is necessary when yoga is introduced to patients with stress-related, chronic diseases. 

So, should we be pleased about the UK government’s plan to promote Ayurveda and yoga? In view of the mixed and inconclusive evidence, I feel that a cautious approach would be wise. Research into these subjects could be a good idea, particularly if it were aimed at finding out what the exact risks are. Whole-sale integration does, however, not seem prudent at this stage. In other words, let’s find out what generates more good than harm for which conditions and subsequently consider adopting those elements that fulfill this vital criterium.

The use of so-called alternative medicine (SCAM) is common among cancer patients and it may reflect the individual and societal beliefs on cancer therapy. This paper aimed to evaluate the trends of CAM use among patients with cancer between 2006 and 2018.

The researchers included 2 Cohorts of patients with cancer seen at the Oncology Department at King Abdulaziz Medical City of Ministry of National Guard Health Affairs, Riyadh, KSA, who were recruited for Cohort 1 between 2006 and 2008 and for Cohort 2 between 2016 and 2018. The study is a cross-sectional study obtaining demographic and clinical information and inquiring about the types of SCAM used, the reasons to use them and the perceived benefits. The researchers compared the changes in the patterns of SCAM use and other variables between the two cohorts.

A total of 1416 patients were included in the study, with 464 patients in Cohort 1 and 952 patients in Cohort 2. Patients in Cohort 2 used less SCAM (78.9%) than Cohort 1 (96.8%). Cohort 1 was more likely to use SCAM to treat cancer compared to Cohort 2 (84.4% vs. 73%, respectively, p < 0.0001,); while Cohort 2 used SCAM for symptom management such as pain control and improving appetite among others. Disclosure of SCAM use did not change significantly over time and remains low (31.6% in Cohort 1 and 35.7% for Cohort 2). However, physicians were more likely to express an opposing opinion against SCAM the use in Cohort 2 compared to Cohort 1 (48.7% vs. 19.1%, p < 0.001, respectively).

The authors concluded that there is a significant change in SCAM use among cancer patients over the decade, which reflects major societal and cultural changes in this population. Further studies and interventions are needed to improve the disclosure to physicians and to improve other aspects of care to these patients.

I think that these are interesting findings. Should both patients and conventional healthcare professionally truly become more sceptical about SCAM? It would be good, in my view, but can we be sure?

The answer is NO!

Firstly, we would need data from other countries (SCAM use is known to show marked national differences). Secondly, we would require more up-to-date evidence. The present paper has suggested that, within one decade, SCAM use can change. Therefore, it is only reasonable to assume that it has changed again since 2016/18.

My hope is that progress continues. And by progress, I mean that those forms of SCAM that are demonstrably useful in palliative and supportive cancer care are employed wisely, while all the many bogus alternative cancer ‘cures’ are rapidly falling by the wayside.

While working on yesterday’s post, I discovered another recent and remarkable article co-authored by Prof Harald Walach. It would surely be unforgivable not to show you the abstract:

The aim of this study is to explore experiences and perceived effects of the Rosary on issues around health and well-being, as well as on spirituality and religiosity. A qualitative study was conducted interviewing ten Roman Catholic German adults who regularly practiced the Rosary prayer. As a result of using a tangible prayer cord and from the rhythmic repetition of prayers, the participants described experiencing stability, peace and a contemplative connection with the Divine, with Mary as a guide and mediator before God. Praying the Rosary was described as helpful in coping with critical life events and in fostering an attitude of acceptance, humbleness and devotion.

The article impressed me so much that it prompted me to design a virtual study for which I borrowed Walach’s abstract. Here it is:

The aim of this study is to explore experiences and perceived effects of train-spotting on issues around health and well-being, as well as on spirituality. A qualitative study was conducted interviewing ten British adults who regularly practiced the art of train-spotting. As a result of using a tangible train-spotter diary and from the rhythmic repetition of the passing trains, the participants described experiencing stability, peace, and a contemplative connection with the Divine, with Mary as a guide and mediator before the almighty train-spotter in the sky. Train-spotting was described as helpful in coping with critical life events and in fostering an attitude of acceptance, humbleness, and devotion.

These virtual results are encouraging and encourage me to propose the hypothesis that Rosary use and train-spotting might be combined to create a new wellness program generating a maximum holistic effect. We are grateful to Walach et al for the inspiration and are currently applying for research funds to test our hypothesis in a controlled clinical trial.

 

Prof Harald Walach is well-known to regular readers of this blog (see, for instance, here, here, and here). Those who are aware of his work will know that he is not an expert in infectious diseases, epidemiology, virology, or vaccinations. This did not stop him to publish an analysis that questions the safety and rationale of the current COVID-19 vaccination programs. Here is the abstract:

COVID-19 vaccines have had expedited reviews without sufficient safety data. We wanted to compare risks and benefits.

Method: We calculated the number needed to vaccinate (NNTV) from a large Israeli field study to prevent one death. We accessed the Adverse Drug Reactions (ADR) database of the European Medicines Agency and of the Dutch National Register (lareb.nl) to extract the number of cases reporting severe side effects and the number of cases
with fatal side effects.

Result: The NNTV is between 200–700 to prevent one case of COVID-19 for the mRNA vaccine marketed by Pfizer, while the NNTV to prevent one death is between 9000 and 50,000 (95% confidence interval), with 16,000 as a point estimate. The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations. For three deaths prevented by vaccination we have to accept two inflicted by vaccination.

Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy.

I hesitate to comment because some could think that I have a personal grudge, as Walach propagated lies about me. And crucially, like he, I am not a vaccination expert. Yet, I feel I ought to point out that the data that form the basis of Walach’s calculations should not be used in this way for at least two reasons.

  1. Death after vaccination does not mean that this event was caused by the vaccine. For example, if someone had a fatal accident after vaccination, it would count as a vaccine incident according to Walach’s calculation.
  2. Vaccine effectiveness cannot be measured by calculating how many people must receive a vaccine to prevent one case of COVID-19 vaccination. Since vaccines have a protective effect on the community, this would be an outright miscalculation. The more people who receive a vaccine, the fewer people need to receive it to prevent a single case. This situation is the exact opposite of what Walach assumes in his paper.

Conclusion: amongst all his previous nonsense, Walach’s new publication stands out, I feel, as the most stupid and the most dangerous. The mistakes seem too obvious to not be deliberate. Let’s hope the journal editor in chief (who failed miserably when publishing this idiocy) has the wisdom to retract it swiftly. One of its editors already tweeted:

I have resigned from the Editorial Board of

following the publication of this article. It is grossly negligent and I can’t believe it passed peer-review. I hope it will be retracted.

And another ed-board member had this to say:

Some time ago, we published a systematic review of adverse effects of homeopathic remedies. It prompted a spade of angry letters to the editor essentially claiming that homeopathic are so dilute that they cannot possibly cause problems. But they can! And here is another case in point.

It has been reported that, in Germany, several patients suffered from adverse effects such as visual disturbances and dry mouth after taking a homeopathic atropine remedy purchased from a pharmacy.

A 56-year-old man experienced taste and visual disturbances and drowsiness about 15 minutes after taking 30 drops of a homeopathic solution prepared at the pharmacy. Two further patients also experienced increased symptoms of malaise, slurred speech, dry mouth, hypertension, and dizziness after taking the homeopathic product. In each case, the symptoms improved one to two days after discontinuation of intake. In one case, the effects were observed again after repeated intake.

The pharmacy prepared the homeopathic prescriptions on the prescription of a Heilpraktiker. For this purpose, the pharmacy first diluted an Atropinum sulfuricum D4 dilution in a ratio of 1:10. The diluted solution was then added to three other OTC homeopathics. The proportion of the diluted solution was 50 percent (M/M) in each case.

Laboratory analyses found an increased atropine content of up to a factor of 800 in all the solutions tested. It was determined that the pharmacy’s manufacturing process was not the cause of the problem. The steps taken to produce the homeopathic remedy were demonstrably correct.

Eventually, the company that supplied the atropine solution discovered a mix-up: what was declared to be a D4 dilution was in fact the mother tincture of atropine, i.e. undiluted substance. The pharmacist had therefore used the mother tincture instead of the D4 dilution to prepare the formulations.

The story shows that, unsurprisingly, the quality control of homeopathic remedies can be deficient. When this happens, remedies that should contain nothing suddenly contain something. It is, I think, indisputable that this has the potential to harm patients. And this leads me to the conclusions that:

  1. homeopathic remedies are dangerous when they contain nothing because they leave illness untreated;
  2. homeopathic remedies are dangerous when they contain something because they may poison patients.

 

Rudy Giuliani, the former mayor of New York and legal advisor of Donald Trump, is already facing a billion-dollar lawsuit for defamation. He also had his license to practice law revoked by the New York Bar Association for spreading lies about the 2020 election. I therefore can imagine that he needs some cheering up and could do with some good news.

Well, Rudy, here it is!

Giuliani has been given a very special award.

In recognition of his truly outstanding achievements in dishonesty and his contribution to disinformation, Rudy Giuliani is the winner of the Center for Inquiry’s first Full of Bull Award!

A rogue’s gallery of celebrity hucksters was drawn up who best represent the threat posed by the wholesale rejection of reality. Calling out these infamous purveyors of flimflam and nonsense, the Center for Inquiry asked the public to vote for who was the worst offender.

It could not have been an easy choice, but now the voters have spoken: 41.7 percent of voters chose Giuliani over these other superspreaders of the infodemic:

Why Giuliani? He really gave his all to rise above the field over the past year as a dedicated champion of bogus COVID-19 cures at the peak of a global pandemic and chief spreader of the highly dangerous Big Lie about the 2020 election. “America’s Mayor” no more, Giuliani has slid to the fringes of conspiracy theories and quack medicine, truly embodying what it takes to be an all-around Full of Bull champion.

At the time of reporting, no reaction of the awardee was available. Yet, we can be confident that Rudy will treasure the award above all other distinctions and that he will display it prominently in his office. The Center for Inquiry wants to thank everyone for voting and for being a part of the reality-based community, it intends to remain committed to taking on bull artists of all stripes.

Germany has long been the ‘Promised Land’ for so-called alternative medicine (SCAM). For many years, about two-thirds of the general population has been reported to be regular SCAM users. Now, this seems about to change. A recent survey found that only one-third of Germans believe that homeopathy works as well as conventional medicine. The verdict on SCAM as a whole is similar: Only 35 percent of respondents would like SCAM to play a role in healthcare in addition to modern medicine. The results originate from an extensive representative survey commissioned by the GWUP and carried out by the KANTAR Institute to sound out attitudes toward esotericism and pseudoscience. The figure below depicts percentage figures of the belief in (from left to right) homeopathy, integrated medicine, spiritual healing, electrosmog, dowsing, clairvoyance, psychokinesis, ghosts, astrology, extra-terrestrials, none mentioned.

“It is a good sign for health care if two-thirds of the population reject dubious cures. The experience from the pandemic shows that we can only fight diseases with science and modern medicine,” stated Amardeo Sarma, chairman of GWUP. “I am pleased with the result because it also underlines the impact of our educational work. I’m convinced that we’re helping people make important decisions, removing uncertainty and, not least, preventing suffering caused by incorrect treatments.”

“As a physician, I am pleased when more and more people are concerned with their health and critically question promises of healing,” said Dr. Natalie Grams. “For me, the declining approval of homeopathy means that it is worthwhile to publicly stand by science and not be muzzled by industry interests. Fewer homeopathics mean more good medicine for patients that really works.”

This sounds like good news indeed. Yet, I think, we need to be careful and avoid jumping to conclusions because prevalence surveys are often not as reliable as they seem.

1) They frequently lack a clear definition of what is being surveyed. There is no generally accepted definition of alternative medicine, and even if the researchers address specific therapies, they run into huge problems. Take integrated medicine, for instance – some see this as alternative medicine, while others would, of course, argue that it is the integration of social and health care. Or take homeopathy – many consumers confuse it with herbal medicine.

2) The questionnaires used for such surveys are rarely validated. Essentially, this means that we cannot be sure they evaluate what we think they evaluate. We all know that the way we formulate a question can determine the answer. There are many potential sources of bias here, and they are rarely taken into consideration. It is therefore not surprising that different surveys report different prevalences. In Indonesia, for instance, an increase in SCAM use has been reported associated with the pandemic.

3) The typical survey has a low response rate; sometimes the response rate is not even provided or remains unknown even to the investigators. This means we do not know how the majority of patients/consumers who received but did not fill the questionnaire would have answered. Often there is good reason to suspect that those who have a certain attitude did respond, while those with a different opinion did not. This self-selection process is likely to produce misleading findings.

4) The typical survey has a long list of questions and reports only those results that the investigators find interesting or pleasing. Such selective reporting can introduce a significant bias that may not be detectable for the reader of the report.

I am sure the new survey is not seriously affected by any of these drawbacks. After all, it is from the GWUP, the Society of the Scientific Study of Para-Sciences. If they are not able to do good science, who is?

In the UK, a new post-Brexit regulatory framework is being proposed for food supplements by the government. The nutraceutical sector is estimated to be worth £275bn globally and £4bn in the UK.  A new report claims that “science is starting to point the way to a new sector of nutritional products with increasingly explicable and/or verifiable medicinal benefits, which needs to be reflected in our regulatory framework.” Tory MP George Freeman, one of the authors of the report, was quoted saying:

“We are living through an extraordinary period of technological change – not just in life science but in host of sectors: from AI to robotics to agri-tech, nutraceuticals, nanotechnology, synthetic biology, biofuels, satellites and fusion energy. The UK is indeed a ‘science superpower’. But we have traditionally been woeful at commercialising here in the UK. There are many reasons. But, in recent years, the EU’s increasingly slow, bureaucratic and ‘precautionary’ approach – copied in Whitehall – has made the EU and the UK an increasingly poor place to commercialise new technology.”

If a product like a food or a herbal remedy makes ‘medicinal’ claims, it is currently regulated by the MHRA. If a product only makes general ‘health’ claims, it is regulated by the Department of Health and Social Care in England, by the FSA in Wales and Northern Ireland, and by Food Standards Scotland in Scotland. This ‘patchwork of regulators’ is bound to change as it is deemed to create additional costs and uncertainty for businesses who would like to see the relevant functions brought together in a central regulatory body and a clearer UK landscape.

In response to the task force’s report, PM Boris Johnson stated that bold and ambitious ideas such as these are needed to encourage growth and innovation:

“The Government, through our Better Regulation Committee, is already hard at work on reform of the UK’s regulatory framework. Your bold proposals provide a valuable template for this, illustrating the sheer level of ambitious thinking needed to usher in a new golden age of growth and innovation right across the UK. So we will give your report the detailed consideration it deserves, consult widely across industry and civil society, and publish a response as soon as is practicable.”

Am I the only one who feels more than a little uneasy about all this? I honestly do not see much new science that, according to the report, points to ‘verifiable medicinal benefits’ of food supplements or nutraceuticals. What the report does however point to, I fear, is that the UK government is about to deregulate quackery with a view to making some entrepreneurs wealthy snake oil salesmen at the cost of public health and wealth.

I hope I am mistaken.

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Archives
Categories