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

fraud

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On FACEBOOK I recently found this advertisement posted by ‘LifeCell Health’

Guys, weight loss starts at our gut. The reishi mushroom targets this key area of the body and promotes weight loss in a unique way, by changing our gut bacteria to digest food in a manner that improves weight loss and can even prevent weight gain. By combining 3 of the most researched mycological species on the planet, LifeCell Myco+ delivers a blend of weight loss mushrooms like no other: Improve gut health, speed up weight loss, enhance immune function, natural energy and more with our blend of Reishi, Turkey Tail, and Shiitake mushrooms. Each mushroom has been the subject of several in-vivo studies proving their efficacy when it comes to weight loss.

🍄Why Mushrooms Work.
✔️Reishi: Prevents weight gain by altering bacteria inside the digestive system
✔️Shiitake: Helps the body develop less fat by nourishing good gut bacteria.
✔️Turkey Tail: Reduces inflammation and helps prevent weight gain.

That sounded interesting, I thought, and I investigated a bit further. On the website of the firm, I found this text:

By combining 3 of the most researched mycological species on the planet, LifeCell Myco+ delivers an organic wellness formula unlike any other. Improve gut health, speed up weight loss, enhance immune function, natural energy and more with our blend of Reishi, Turkey Tail, and Shiitake mushrooms.

Keeping a healthy balance of beneficial bacteria in your gut is critical for maintaining a strong immune system. Your gut bacteria interact with immune cells and directly impact your immune response. Turkey tail mushrooms contain prebiotics, which help nourish these helpful bacteria. An 8-week study in 24 healthy people found that consuming 3,600 mg of PSP extracted from turkey tail mushrooms per day led to beneficial changes in gut bacteria and suppressed the growth of the possibly problematic E. coli and Shigella bacteria.

Next, I conducted a few Medline searches but was unable to find any trial data suggesting that any of the three mushrooms or their combination might reduce body weight. So, I wrote to the company:

Dear Madam/Sir

I am intrigued by your product MYCO +. Would you be kind enough to send me the studies showing that it can reduce body weight?

Many thanks

Edzard Ernst

What followed was a bizarre correspondence with several layers of administrators in the firm. They all said that I should discuss this with the next higher person. So, I asked myself up the hierarchy of LiveCell. The last email I received was this one:

Good morning Edzark,

Thank you for your email and I hope you are enjoying your day.

It is great to hear that you are interested in our LifeCell Myco.  I have forwarded your request for additional information and once received I will be sure to forward the information to you.

What do I conclude from this experience?

Apart from being unable to get my name right, the people responsible at ‘LifeCell Health’ seem also not able to send me the evidence I asked for. This, I fear, means that there is no such evidence which means the claims are unsubstantiated. Scientifically, this might amount to misconduct; legally, it could be fraudulent.

But I am, of course, no lawyer and therefore leave it to others to address the legal issues.

 

PS

If anyone happens to know of some evidence, please let me know and I will correct my post accordingly.

 

Two chiropractors conducted a retrospective review of publicly available data from the California Board of Chiropractic Examiners. Their aim was to determine categories of offense, experience, and gender of disciplined doctors of chiropractic (DC) in California and compare them with disciplined medical physicians in California.

Retrospective reviews of publicly available data from the California Board of Chiropractic Examiners.

The DC disciplinary categories, in descending order, were

  • fraud (44%),
  • sexual boundary issues (22%),
  • other offences (13%),
  • abuse of alcohol or drugs (10%),
  • negligence or incompetence (6%),
  • poor supervision (2%),
  • mental impairment (.3%).

The authors concluded that the professions differ in the major reasons for disciplinary actions. Two thirds (67%) of the doctors of chiropractic were disciplined for fraud and sexual boundary issues, compared with 59% for negligence and substance misuse for medical physicians. Additional study in each profession may reveal methods to identify causes and possible intervention for those who are at high risk.

The two authors of this paper should be congratulated for their courage to publish such a review. These figures seem shocking. But I think that in reality some of them might be far higher. Take the important matter of competence, for instance. If you consider it competent that chiropractors treat conditions other than back pain, you might arrive at the above-mentioned figure of 6%. If you consider this as incompetent, as I do, the figure might be one order of magnitude higher (for more on unprofessional conduct by chiropractors see here).

The abstract of the paper does not provide comparisons to the data related to the medical profession. Here they are; relative to doctors, chiropractors are:

  • 2x more likely to be involved in malpractice,
  • 9x more likely to be practising fraud,
  • 2x more likely to transgress sexual boundaries.

The frequency of fraud is particularly striking. Come to think of it, however, it is not all that amazing. I have said it before: chiropractic is in my view mostly about money.

Bernie Garrett is a professor of nursing at the University of British Columbia. He is being mentioned here because he has written a book entitled THE NEW ALCHEMISTS which deals (mostly) with so-called alternative medicine (SCAM). It is a well-written, informative, critical, and evidence-based text that I can recommend wholeheartedly. It will be available in the UK on 29 July but you can pre-order it already.

On Amazon, It is being advertised with the following words:

How to identify and see through deceptive and unethical health marketing practices Health scams come in all shapes and sizes-from the suppression of side-effects from prescription drugs to the unproven benefits of ‘traditional’ health practices-taking advantage of the human tendency to assume good intentions in others. So how do we avoid being deceived? Professor of Nursing, Bernie Garrett explores real-world examples of medical malpractice, pseudo and deceptive health science, dietary and celebrity health fads, deception in alternative medicine and problems with current healthcare regulation, ending with a simple health-scam detection kit. And he looks at how these practices and ineffective regulations affect our lives.

The book is written for the interested layperson. But I am sure that healthcare professionals will like it too, not least because it is fully referenced. Its aim is to inform and prevent consumers from being deceived and exploited by charlatans, an aim shared with this blog – while reading the book, I often got the impression that Bernie Garrett might be a regular reader of my blog.

This does not mean that I did not learn a lot from reading Bernie’s book. On the contrary, there was a lot that I did not know before and that is worth knowing. For instance, were you aware that you can earn a ‘Doctor of Naturopathic Medicine, Advanced Diploma’ or Reiki master qualification for $ 12.99 in a 6-hour online course (if you want to know where you’ll have to get Bernie’s book)?  Well, I didn’t.

Yes, I did enjoy reading this book, and I share Bernie’s views on SCAM. In his overall conclusions, he writes: “The sad truth is, many health fraudsters are highly skilled manipulators, and do not always end up being held to account for their crimes, and many continue to profit from them.” Because this is so, it is good to have another splendid book that will help us in our struggle to inform the public responsibly.

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?

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.

RNZ reported that New Zealand doctors spreading misinformation about Covid-19 may lose their job. Medical Council chair Dr Curtis Walker said a small number of doctors were peddling conspiracies. “It’s questioning the severity of Covid, it’s questioning the safety of vaccination, it’s questioning whether the whole thing is a conspiracy theory. You know you name it, this is what’s been put out there.”

The council has received 13 complaints about medical staff from the public this year – although that included instances of multiple complaints about the same doctor. It comes after it was reported last month that dozens of heath professions, including GPs, signed an open letter opposing the Pfizer vaccine.

Dr Walker said an independent body was investigating to decide if charges should be laid with the Health Practitioners Disciplinary Tribunal. Doctors have a professional duty to provide advice based on evidence, he said. “There’s a mountain of evidence out there of how effective and safe the Covid vaccine is. And we’ve already seen the alternative of unvaccinated populations where millions have died.” Walker said doctors were particularly respected members of the community and their opinions about health carried extra weight. Any found spreading misinformation could potentially lose their jobs and the right to practice medicine.

NZ Royal College of General Practitioners president Dr Samantha Murton said while people could choose not to get vaccinated there were serious consequences if the virus breached the borders. “If those vulnerable people are being given misinformation, they may choose to do something that’s really detrimental to their health. What worries me the most is the poorer people, the people who are at higher risk. If they’re getting this … misinformation then it’s potentially putting their lives in jeopardy.”

Kate Hannah, who researches misinformation at the University of Auckland, said anyone could be sucked in – including highly educated people such as doctors. Most misinformation originated overseas – with people here adapting it to target particular demographics, she said. “And in doing so it targets people’s lived experiences of things like racism in the health system or racism more broadly, or say women’s experiences of the health system where they may have experiences of previously not being listened to.”

Ways to spot misinformation included if someone was trying to sell you something; was asking for donations; or the information was presented to elicit an emotional reaction. “If it’s written in a way that makes you feel upset or scared, or nervous or fearful, you know that’s not normally how we convey good quality public health information. Good quality public health information should provide you with information and make you feel reassured and calm and like you can make good decisions.” Other red flags included asking for personal information or to sign up to receive regular updates – ways to separate you from your current community or sources of information, Hannah said. Covid conspiracies could act as as a gateway, exposing people to online communities espousing far right ideology, misogyny, racism and transphobia, she said.

__________________________

Willful misinformation about a serious health matter amounts to a violation of medical ethics. It, therefore, stands to reason that healthcare professionals who engage in such activities should be reprimanded. If that is so, it applies not just to COVID-19 but to any medical misinformation. Moreover, I should not just apply to doctors, but to all healthcare professionals.

If we do this systematically, it would mean that also providers of so-called alternative medicine (SCAM) might get struck off their professional register, if they make unsubstantiated claims in cases of serious illnesses.

Not realistic, you say?

Why not? After all, medical ethics cannot be bent to protect the interests of SCAM professionals.

WHAT DO YOU THINK?

On 7/10/2020, I discussed a study suggesting that homeopathy improves the quality of life and survival of cancer patients. Now, these data have been carefully scrutinized by a group of members of the „INH“ and „Initiative für Wissenschaftliche Medizin“.

By guest bloggers Norbert Aust and Viktor Weisshäupl

Abstract

The first impression of the results of the study on the adjunctive homeopathic treatment of patients with non-small cell lung cancer (NSCLC) is that of a seemingly rigorous trial with valid results. But a more thorough review yields different insights:

  • The methods and definitions were pre-determined in a protocol and seem to have been maintained up to the end. But the date given in the document pointing at some point in time before enrollment began is wrong and misleading: This protocol was first published by uploading it to the register only two months after data assessment was completed with outcomes presumably available.
  • The data initially saved to the register are not in agreement with the information given in the published paper: important definitions were subjected to considerable modifications while the study was underway. None of these modifications are mentioned in the paper, neither a rationale nor a comment of their impact on the results was provided.
  • Some of the modifications with presumably heavy impact on the results were introduced with the upload of the protocol only, that is two months after data collection was completed. These were (a) a massive extension of the exclusion criteria: the number increased from 1 during initial registration to 20 in the final paper. and (b) an equally massive reduction of the follow-up time for the primary endpoint from two years to 18 weeks.
  • The paper discloses no reason why the additional exclusion criteria were introduced. Their selection seems arbitrary without any apparent necessity arising from the trial itself.
  • The patients who did not meet the added criteria and were thus excluded are not mentioned in the publication. The CONSORT flow chart does not give information either of their number or of the point in time when they were excluded.
  • The survival curves of the placebo and verum groups show some aspects that arise if the inter-group difference was due to the exclusion of unfavorable data.
  • It is hard to imagine that, in this trial, the homeopathic preparations had strong effects on the patients’ health, while other rigorous studies or systematic reviews failed to notice such effects.

Altogether, it seems much more plausible to assume that the positive results were achieved by post hoc data manipulation, namely by omitting patients with unfavorable outcomes, than by rigorous and valid science. A retraction of the paper seems the only appropriate measure to avoid misleading the public. 

Introduction

Due to its outstanding results, the study about adjunct homeopathic treatment of non-small cell lung cancer patients was met among homeopaths with enthusiasm. However, in this article, we will show that the enthusiasm is unjustified because the results may not be based on a rigorous trial meeting established scientific criteria. Crucial definitions were modified, while the study was underway or even after data collection was completed. It stands to reason that this introduced bias in favor of homeopathy.

For this analysis, we considered the following sources of information :

  • the text of the published paper (link)
  • the data that were uploaded during registration (link)
  • the history of changes of the registered data (link)
  • the study protocol included in the registration (link)

As all of this information is readily available on the internet, it is easy to double-check our findings and verify our statements. We also submitted a letter to the editor of the Oncologist, the journal where the paper was published which has not yet been published (status 06-06-2021).

The study

At first glance, the study meets the requirements for reliable evidence.

  • There is a study protocol dated January 11, 2011, well before recruiting of participants started. It provides definitions that were used until the end.
  • The study was registered at ClinicalTrials.gov before recruiting started.
  • The methods of randomization and blinding are suitable to meet the requirements for a low risk of bias rating.
  • The presentation of the paper follows the principles set out in the CONSORT-Statement.
  • The paper was published in a peer-reviewed journal of some reputation.

The study yielded formidable results in favor of homeopathy: In the group that received the adjunctive homeopathic treatment, the quality of life improved continuously throughout the follow-up time, while the patients in the placebo group deteriorated. In addition, the median survival time was only about two-thirds compared to the patients in the homeopathy group. However, the impression of a valid study does not stand up to closer scrutiny when the history of changes is taken into account.

Changes in study parameters 

Between the initial registration and data upload in January 2012 (Link), shortly before recruiting started in February 2012, and the publication in October 2020, multiple changes in essential study parameters occurred:

Registration January 2012 Publication October 2020
Number of participants 600 150
Number of study arms 2 3
Number of exclusion criteria 1 20
Follow-up time for Quality of life 104 weeks (*) 18 weeks
Number of cancer types 3 1
(*) Derived from “Time Frame: 7 Years” minus the recruitment period of 5 years.

Note the drastic reduction in the follow-up time for quality of life by more than 80 % which was defined as the primary endpoint. Furthermore, note the substantial increase in the number of exclusion criteria. Both issues will be discussed in more detail below.

In contrast to the requirements for a rigorous and valid trial, these modifications are not mentioned in the published paper, and no rationale is given as to why they became necessary. As a consequence, the authors do not discuss the possible impact these modifications may have had on the results.

The study protocol 

A study protocol is available in the registration database. It was first uploaded on September 18, 2019, about two months after the end of data collection in July 2019 (Link). The document itself is dated January 11, 2011, which would place it about a year before the study was registered. However, this date is obviously wrong: there are substantial discrepancies between the parameters specified in the protocol and the data provided one year later during initial registration:

Protocol, allegedly January 2011 Registration January 2012
Number of participants 300 600
Number of study arms 3 2
Number of exclusion criteria 9 1
Follow-up time for Quality of life 18 weeks 104 weeks (*)
Number of cancer types 1 3
(*) Derived from “Time Frame: 7 Years” minus the recruitment period of 5 years.

We see no sensible explanation why the parameters given in the study protocol allegedly compiled in January 2011 are in line with the publication nine years later, but not with the registration only one year after the protocol was compiled. The only sensible conclusion seems to be that this protocol was not completed on the date indicated, but at a much later point in time, maybe just shortly before its upload (September 2019). This impression is corroborated by the information presented in the document that was not available on the date given: On page 10 the software package used in data analysis is referenced as “IBM SPSS statistics 25.0” while, at the beginning of 2011, when the protocol was allegedly compiled, the current version number of this package was 19 only.

A second clue: Also on page 10 there is a reference “(EORTC-QLQ-C30 remaining dimensions; SF-36; subjective well-being)25.” with the number 25 indicating some reference. And some references that is, but not in the protocol – this does not have any references – but in the published paper, where the 25 indicates a paper on the SF-36 questionnaire. So it stands to reason that the number in the protocol originates from some messed up copy and paste procedure from the draft of the paper. Which would indicate that the paper and the protocol were at least partially developed in parallel.

It seems therefore reasonable to assume, that the protocol was finished only shortly before it being uploaded in September 2019, that is two months after data collection was completed.

However, the obviously inaccurate date given in the protocol supports the impression that the study parameters were set a year before the study began and were consistently maintained during the course of the trial, which is not the case, as the above tables show.

Change in exclusion criteria 

The initial registration data list pregnancy as the only exclusion criterion. But with the upload of the protocol, which took place two months after data collection was completed, the number of exclusion criteria was increased to nine, only to be enlarged once again in the final publication to the final number of twenty. It is beyond any doubt that at least the final increase of eleven criteria took place after the data collected from the patients were available. But all this is neither disclosed in the final paper nor is there any rationale given for this action.

The patients excluded by the additional criteria never appear anywhere, they are not included in the CONSORT-flow-chart, Fig 3 in the study. It is obvious that some patients were excluded: What was the reason to define such an abundance of criteria, if they were not to be applied? As a consequence, the CONSORT diagram seems to be incomplete which would be in violation of the CONSORT statement.

Thus, an unknown number of patients seems to have been excluded from the study by criteria defined at a time after data collection was completed with outcomes available. After all, eleven of the exclusion criteria were established even after the protocol had been uploaded, at least those were established well after the patients’ results were available.

This raises the question of why these exclusion criteria were introduced. One would assume that an intervention to treat stage III and stage IV lung cancer patients should be effective under the conditions that are usually present in such patients. One would expect that patients somewhat advanced in age, like in this study, usually suffer from some health problems, regardless of their cancer condition. What is the sense of excluding patients with hematological, hepatic, or renal pathology, with coronary heart disease or rheumatism? Homeopathy is claimed to be able to treat comorbidities based on the assessment of symptoms independent of what disease they belong to. And this apparently was the idea at the start of the trial where only pregnancy was specified as an exclusion criterion, while it was understood that elderly patients to be enrolled in the study would suffer from some additional medical problems.

On the other hand, not all health conditions that are associated with advanced age were excluded. Diabetes, hypertension, gastrointestinal diseases, or COPD were no reason to exclude any patient from participation. Only very few of the criteria are somewhat self-explanatory as to why they were defined as exclusion criteria, e.g. if a patient was unwilling to give her informed consent.

Altogether, the assumption seems reasonable that more patients had participated in the trial than accounted for in the publication, and that an unknown number of them were excluded according to criteria that were not present until after data collection was completed. If so, a substantial bias was introduced.

Median survival time

Here, we will focus on the comparison between the homeopathy and placebo groups and leave aside the third group not receiving any additional treatment at all.

If the favorable result in survival really was established by dropping unfavorable data, this might be recognized in some characteristics of the survival curves. Therefore, we modeled this situation starting with two random distributions somewhat tweaked to resemble the typical shape of natural survival functions.

This graph shows the two distributions (n = 80) defined in the range of 0 to 200 as thin lines. Both are very similar to each other with median survival at 27 weeks. If 15 of the 20 patients with the shortest survival are dropped from the thin blue line this would result in the solid blue line (“Hom”). If, on the other hand, 15 out of 20 patients with the longest survival are dropped from the other distribution this would yield the solid red line (“Plac”).

The new functions show some characteristic properties:

  • In the red line, median survival drops by 8 weeks to 19 weeks.
  • In the blue line median survival rises by 12 Weeks to 39 weeks.
  • The difference between the two functions arises from of the first 12 weeks alone. With the blue line, 8 people died, with the red line 23 people died during the first 12 weeks. After week 12 up to week 80, the same number of fatalities occur in both groups (blue: 36, red: 37).

After week 80, the two functions start to converge, which is due to the fact that at some future point all the patients of both groups will be dead. The survival functions that are reported in the study show the same characteristics.

Assuming that homeopathy did not have any effect, both groups should show more or less identical survival functions. In the paper 10.1 months = 303 days is cited from literature as to be expected under conventional care, maybe with some margin to the better because the data that yielded this value of 10.1 months were more than six years old at the time of the trial. The survival functions allegedly found in the trial show:

  • Median survival time with the placebo group is reduced by 46 days compared to conventional care alone.
  • Median survival time with the homeopathy group is increased by 132 days compared to conventional care alone.
  • The advantage of homeopathy arises within the first 9 weeks alone, where only two patients died (out of 51) in the homeopathy group compared to 11 (out of 47) in the placebo group. After this initial phase, the groups developed in parallel: By the end of the two-year follow-up time an additional 26 patients died with homeopathy, and about the same, namely 25 patients died with placebo.

The inevitable convergence of both functions apparently started outside the two-year follow-up. In other words, the survival functions given in the study for placebo and homeopathy treatments show characteristics that match what you would be expected, if two very similar functions were manipulated by dropping unwanted results, i.e. “good” survival data from placebo and “bad” survival data from homeopathy functions. After week 9, the two functions develop parallel to each other, indicating a lack of effect of homeopathy even though the treatment continued until the death of the patient or the end of the study. However, with ongoing effective treatment, the functions should continue to diverge. It seems implausible that homeopathy should be effective on a short time basis only, with a sudden complete loss of effectiveness later on.

Reduction of observation time

Quality of life was defined as the primary endpoint. On initial registration, it was specified that patients should be observed for the entire seven-year duration of the study which, allowing for the recruitment period of five years, results in a follow-up time of two years or 104 weeks for each individual patient. According to the information provided in the study, this was indeed done: “Patients were followed up every nine weeks until death” (or until the end of the study, of course), and questionnaires were completed to determine the quality of life.

The reduction of follow-up time from 104 to 18 weeks was first introduced when the protocol was uploaded. So it is obvious that this substantial reduction occurred after data collection was completed and that data from more than 80 % of the originally defined follow-up were omitted.

Incomplete outcome reporting, especially when a larger scope was defined at the beginning of the study, is considered a source of substantial bias and a major shortcoming in clinical trials: Maybe patients initially experienced an improvement in their quality of life due to whatever effect – but what were the results after this initial phase? Why were they omitted? Perhaps because they got worse than in the placebo group? The long-term development would have been a vital aspect for the evaluation of efficacy – and the study originally was designed to evaluate such long-term effects. Yet, the authors’ conclusions on the quality of life – notably: the primary outcome criterion – are based on less than 20 % of the follow-up in which a positive effect may have occurred due to bias or by chance. To extrapolate from this short time to the total period is not justified and may be misleading. A detailed review of the quality of life results is meaningless: they do not disclose any long-term effects and they are subject to bias caused by the post hoc exclusion of patients anyway.

Study results

The overall evidence on the effectiveness of homeopathy is not encouraging. The quintessence of all systematic reviews that have looked at homeopathy as a whole is that some marginal effect may be found, if all studies are included in the review, regardless of their quality. But this result is questionable due to the generally low quality of the primary studies (Link, in German). However, when quality is taken into account, the systematic reviews do not produce robust evidence for any positive effect beyond placebo. In addition, no review could identify a single condition in which homeopathy is of well-established therapeutic benefit.

This study on NSCLC contradicts the long-established and often-confirmed evidence. During the follow-up time for the patients who actually received the prescribed homeopathic preparations, the quality of life improved steadily in all subscales – even down to the patients’ financial situation – whereas the opposite was observed in the placebo patients. In addition, the mean survival time was about two-thirds longer for the homeopathy patients than for the placebo group.

After 200 years of clinical research into homeopathy, it seems unlikely that such a powerful effect of homeopathy should not have been noticed before. Another scenario seems to be much more plausible:

  • The survival times of the placebo group were worse than the data from the literature. This could be due to the fact that patients with relatively good outcomes were excluded by the introduction of additional exclusion criteria.
  • The survival times of the homeopathy group were considerably better than expected. This could also be due to the additional exclusion criteria, in that patients with poor outcomes were excluded retrospectively.
  • The long time frame where the survival functions run in parallel from week 9 onwards until the end of the two years observation period indicates the lack of effect of the homeopathic treatment. The advantage occurring in the first nine weeks alone seems to be the result of unwanted data being dropped.
  • In the case of quality of life (after all, not a “hard” criterion, but based on information from the patients ), the advantage in survival would have initially created a positive effect for the homeopathy group. Then, reporting was discontinued, once the initial positive effects presumably caused by the selective omission of patients had ended.

In conclusion, it seems likely that the substantial modifications of crucial study parameters that occurred after the study had been started and results had become available biased the results in favor of homeopathy. Therefore, this study does not meet strict scientific standards that were established to exclude any confounding factors or biases. If our analysis is correct, the results of this study are invalid, and the authors’ conclusions are not justified. Retraction of this study seems to be appropriate.

Reference

[1] Frass M, Lechleitner P, Gründling C et al. Homeopathic Treatment as an Add-On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non-Small Cell Lung Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Three-Arm, Multicenter Study. The Oncologist 2020;25:e1930–e1955 https://theoncologist.onlinelibrary.wiley.com/doi/epdf/10.1002/onco.13548

Vaccinations lead to masturbation! This surprising claim comes from Zita Schwyter, a Swiss anti-vaxxer, and practitioner of so-called alternative medicine (SCAM). Is there any evidence for a link? The only evidence I could find seems to suggest that the causal link (if there is one) goes in the opposite direction: “Women engaging in mutual masturbation were nearly two times more likely to decline the free vaccine.

In her practice, Schwyter offers homeopathic treatments, hara massage, “vaccination consultations”, quantum medicine, ‘Matrix Energetics’, colon cleansing, and other SCAMs. Schwyter claims that vaccinations cause “vaccination disease” with symptoms such as sleep disorders, dyslexia, stuttering, autism, brain tumors, the tendency to masturbate, allergic reactions, cancer, swelling and redness at the injection site, or aching limbs. According to Zita Schwyter, chronic diseases and autoimmune diseases have only been on the rise since vaccination was introduced, and that, according to her fallacious thinking, implies a causal relationship.

On the website of her practice, Schwyter tells us that “Fühlen Sie sich in guten Händen und vertrauen Sie Ihre Gesundheit der ganzheitlichen Gemeinschaftspraxis vor Ort an. Ein professionelles Therapeutenteam mit einem fundierten Fachwissen, jahrelangen Ausbildungen und weitreichenden Erfahrungen erwartet Sie.”  (Feel in good hands and entrust your health to the holistic group practice on site. A professional team of therapists with in-depth expertise, years of training and extensive experience awaits you.) And elsewhere, she states that “Durch meine berufliche Laufbahn verstehe ich mich deshalb als kompetentes Bindeglied zwischen Schulmedizin und Naturheilkunde, spezialisiert auf dem Gebiet der Homöopathie. Die richtige Person also, die Ihre Beschwerden ganzheitlich erfassen, richtig interpretieren und Sie mit dem angemessenen Behandlungskonzept zu besserer Gesundheit führen kann.” (Through my professional career, I therefore see myself as a competent link between conventional medicine and naturopathy, specializing in the field of homeopathy. The right person, therefore, who can grasp your complaints holistically, interpret them correctly and lead you to better health with the appropriate treatment concept.)

Homeopathy, Schwyter claims on the same site, can effectively treat the following conditions:

  • Joint pain
  • Rheumatism
  • Gout
  • Allergies
  • Neurodermatitis,
  • Acne
  • Shingles
  • Asthma
  • Hay fever
  • Varicose veins
  • Reynauds syndrome
  • Gynecological diseases
  • Pregnancy pains
  • Migraine
  • Chronic headache
  • Diarrhea
  • Constipation
  • Chronic bowel inflammation
  • Epilepsy
  • Multiple sclerosis
  • Parkinson’s disease
  • High blood pressure
  • Dizziness
  • Diabetes mellitus
  • Metabolic disorders
  • Liver/gall bladder problems
  • Acute and chronic childhood diseases
  • Growth and development disorders in children
  • Susceptibility to infections
  • Flu
  • Otitis media
  • Coughing
  • Convalescence from acute diseases
  • Chronic injury sequelae
  • Sleep disorders
  • Learning difficulties
  • Exhaustion
  • Nervousness
  • Depression
  • Anxiety
  • Obsessive-compulsive disorders
  • Diseases resistant to conventional medicine
  • And much more

Call me a skeptic, but somehow, I doubt Schwyter’s competence, expertise, and professionalism. But I do admire her humor!

The UK ‘Advertising Standards Authority‘ (ASA) received a complaint about an advertisement that stated:

“Homeopathy is used throughout the world to keep healthy … People in the UK have been using it to successfully help with migraine, anxiety, chronic pain, woman’s [sic] health issues, depression, eczema, chronic fatigue, asthma, IBS, rheumatoid arthritis, and many other conditions”.

The ‘Good Thinking Society‘ had challenged whether:

  1. the ad discouraged essential treatment for conditions for which medical supervision should be sought, namely migraines, chronic pain, women’s health issues, depression, asthma, rheumatoid arthritis; and
  2. the claim “People in the UK have been using [homeopathy] to successfully help with anxiety, chronic pain … eczema, chronic fatigue syndrome … IBS” was misleading and could be substantiated.

The response of the ASA has just been published. Here are the key excerpts from the ASA’s assessment:

1. Upheld

The CAP Code required that marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis or treatment for such conditions unless that advice, diagnosis or treatment was conducted under the supervision of a suitably qualified medical professional. Among other conditions, the ad referred to “migraines”, “chronic pain”, “woman’s [sic] health issues”, “depression”, “asthma”, and “rheumatoid arthritis”, which we considered were conditions for which medical supervision should be sought, and therefore advice, diagnosis or treatment must be conducted under the supervision of a suitably qualified medical professional. We noted that the practice was run by a GMC-registered GP, who we considered was a suitably qualified health professional. However, the individual homeopaths were not registered and did not hold the same qualifications. Therefore, Homeopathy UK had not shown that all treatment and diagnoses conducted at the practice would be conducted under the supervision of a suitably qualified medical professional. Because Homeopathy UK had not supplied evidence that treatment would always be carried out by a suitably qualified health professional, and because reference to the conditions listed in the ad could discourage consumers from seeking essential treatment under the supervision of a suitably qualified health professional, we concluded that the ad had breached the Code.

On that point the ad breached CAP Code (Edition 12) rule 12.2 (Medicines, medical devices, health-related products and beauty products).

2. Upheld

We considered that consumers would understand the claim “People in the UK have been using [homeopathy] to successfully help with anxiety, chronic pain … eczema, chronic fatigue syndrome … IBS” to mean that homeopathy could be used to successfully treat those conditions … when we reviewed the evidence provided by Homeopathy UK, we considered that the studies provided did not meet the standard of evidence we required for the types of claims being made, both in terms of adequacy and relevance…

On that point the ad breached CAP Code (Edition) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1  (Medicines, medical devices, health-related products and beauty products).

Action

The ad must not appear again in the form complained about. We told Homeopathy UK to ensure their future marketing communications did not to refer to conditions for which advice should be sought from suitably qualified health professionals. We also told them to ensure they did not make claims for homeopathy unless they were supported with robust evidence.

_____________________________

Am I reading this correctly?

The ASA seems to be saying that homeopaths are not suitably qualified health professionals and, as no therapeutic claims are supported by robust evidence, that claims for homeopathy are improper.

You may not like it, but we do seem to live in the age of the ‘alternative truth’. It might necessitate reconsidering some of our definitions. A lie, for instance, was formerly defined as making an untrue statement with intent to deceive. Does that definition need to be revised in the age of the ‘alternative truth’?

Laura Kuenssberg, the political editor of the BBC, seems to think so. She recently published an interesting new definition of a lie: “… outright lying … is relatively rare. It is too easily found out. Only one senior politician still in the game has ever privately told me something that was utterly, entirely, and completely untrue.” She wrote this in an article about our PM, Boris Johnson who, by old standards, would probably qualify as a habitual liar. And as the BBC political editor cannot easily call him that, she conveniently moved the goal post and defined a lie to be something “utterly, entirely, and completely untrue”.

So, here we have it, the age of alternative truths has redefined the lie!

But I am not starting to write political rants – tempting though it often is – there is enough to rant about in so-called alternative medicine (SCAM). The questions I asked myself are these: how does SCAM measure up to the new Kuenssberg definition, and how gullible have we become?

Let’s play a little game to find out, shall we?

I provide 10 statements commonly used by the SCAM fraternity, and I ask you to consider which of them is “utterly, entirely, and completely untrue”.

  1. Chiropractic manipulations have been proven to do more good than harm.
  2. Acupuncture is effective for chronic pain.
  3. Homeopathy is supported by sound evidence.
  4. Homeopathic remedies act as nano-particles.
  5. Natural means safe.
  6. Integrative medicine is in the best interest of patients.
  7. Chiropractic subluxations do exist.
  8. Detox is a concept that makes sense.
  9. SCAM practitioners treat the root causes of disease.
  10. SCAM is cost-effective.

Next, please count the number of statements that are “utterly, entirely, and completely untrue”. This will give you a figure between 0 and 10. I propose that it can be used as a measure of gullibility.

I suggest the following grading:

  • 10 – 8 = not gullible
  • 7 – 5 = gullible
  • 4 – 2 = very gullible
  • 1 – 0 = dangerously gullible.

And here you have the ‘Edzard Ernst measure of gullibility’!

 

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