Research into homeopathy: data falsification, fabrication and manipulation

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Edzard Ernsthttps://edzardernst.com/
Edzard Ernst is Emeritus Professor of Complementary Medicine at the Peninsula School of Medicine, University of Exeter. He is the author of ten books on complementary and alternative medicine.

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We all know that homeopathy is a placebo therapy: its assumptions fly in the face of science, its remedies are normally devoid of active ingredients, and the evidence from clinical trials is uniformly negative. After the UK and France, now even Germany, homeopathy’s home country, agrees with this position. The 128th ‘German Medical Assembly’ recently declared that:

“the use of homeopathy … is not an option that is compatible with rational medicine, the requirement for the best possible treatment and an appropriate understanding of medical responsibility and medical ethics”.

But such arguments fail to deter homeopaths. They argue that there are plenty of clinical trials of homeopathy that arrived at positive conclusions. And to be fair, they are not even entirely wrong. There have been several studies that did imply that homeopathy works beyond placebo.  

How come? Why do some studies of homeopathy show positive results? The obvious answer is because these studies are not rigorous; they are not randomised, or not double blind, or not placebo-controlled, for instance. But this assumption might also not be entirely true.

In 2020, Frass et al published a trial that seemed to prove it wrong. This randomised, placebo-controlled, double-blind study showed that the quality of life of cancer patients improved significantly with homeopathy compared to placebo. In addition, survival was significantly longer in the homeopathy group versus placebo and control.

When it was first published, this study was celebrated by homeopaths, while it raised many skeptics’ eyebrows. The trial seemed rigorous, was published in a highly reputed journal, and was conducted by well-known experts. Its lead author, Michael Frass, was a respected professor at the Vienna Medical School (the institution to which I too once belonged).

When I first read his paper, I was nevertheless suspicious, not least because I had previously found that Frass (whom I have never met in person) had published no less than 12 studies of homeopathy all of which arrived at positive conclusions. This had long led me to the conclusion that there must be something wrong with Frass’ research.

I was therefore not surprised that, soon after the publication of Frass’ new trial, an in-depth analysis by Norbert Aust and Viktor Weisshäupl disclosed several important inconsistencies. They eventually prompted complaints to both the journal, Oncologist, and the Vienna Medical School about suspected scientific misconduct. The Medical School then referred the case to the Austrian Agency for Scientific Integrity. The agency took their time, but recently, more that 3 years after the Frass study was published, they made available the final on-line summary of their assessment; here is my translation of part of this document:

After establishing sufficient suspicion of various violations of good scientific practice, the Commission declared itself responsible and initiated proceedings. In the course of this, the principal investigator was given the opportunity to submit a written statement and to provide the Commission for Research Integrity Annual Report 2022 material that would help to clarify the facts of the case, which the accused submitted in large quantities.

In a very complex, comprehensive investigation, which required, among other things, the on-site inspection of original documents, the Commission was able to substantiate the suspicion of data falsification, fabrication and manipulation. In a final statement, the study director, who no longer works for the university in question, and the numerous co-authors were informed in detail about the course and results of the commission’s investigation and informed of the recommendations to the university and journal. 

The Commission recommended that the university concerned should consider investigating its own responsibilities and act accordingly, and that the publication should be withdrawn as a matter of urgency. The journal responsible for the publication was asked to withdraw the publication on the basis of the findings of the investigation.

Unfortunately, the scandal does not end here. Despite the Agency’s urgent call to the journal to withdraw the fabricated study, this has still not happened. Merely an ‘expression of concern’ has been added to the paper on Medline. It has been up for many months and reads as follows:

This is an Expression of Concern regarding: Michael Frass, Peter Lechleitner, Christa Gründling, Claudia Pirker, Erwin Grasmuk-Siegl, Julian Domayer, Maximilian Hochmair, Katharina Gaertner, Cornelia Duscheck, Ilse Muchitsch, Christine Marosi, Michael Schumacher, Sabine Zöchbauer-Müller, Raj K. Manchanda, Andrea Schrott, Otto Burghuber, 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, Volume 25, Issue 12, December 2020, Pages e1930–e1955, https://doi.org/10.1002/onco.13548

In August 2022, the journal editors received credible information from the Austrian Agency for Research Integrity about potential data falsification and data manipulation in this article. While The Oncologist editorial team investigates and communicates with the corresponding author, the editors are publishing this Expression of Concern to alert readers that, pending the outcome and review of a full investigation, the research results presented may not be reliable.

Consequently vulnerable cancer patients might still be misled by the fake findings of Frass and colleagues.

The sorry story of Frass and his research illustrates some of the fundamental problems with research into homeopathy in particular, and alternative medicine in general. Sadly, scientific fraud is not uncommon in medicine. In conventional medicine, financial interests are often the driving force. This situation is very different in the field of alternative medicine, where ideological conflicts dominate.

To put it into a nutshell: researchers in this field tend to initiate studies primarily because they want to prove that their favourite therapy is effective. By not honestly testing their hypotheses, but dishonestly trying to prove them, they abuse research. This enables people like Frass to publish one positive result for homeopathy after another. On my blog, I summarise this growing group of people in the satirically named ‘ALTERNATIVE MEDICINE HALL OF FAME‘. It currently includes 24 (pseudo)scientists, 6 of whom specialise in researching homeopathy.

This could all be quite amusing but, of course, it is also very serious. Scientific fraud causes considerable damage. In the case of the Frass study, we even have to ask ourselves how many people’s lives it has shortened. Therefore, we should look for ways to minimise this phenomenon.

This would certainly not be an easy task, and there is no patent remedy for achieving it. In the field of alternative medicine, I have long advocated that researchers like Michael Frass, who produce nothing but implausible results that mislead us all, should be barred from receiving public research funding. This, one might hope, would stop at least some of the chronically deluded pseudoscientists of alternative medicine.

This is a revised and extended version of an article published in the Skeptical Inquirer, Data Falsification, Fabrication, and Manipulation by a Prominent Homeopath.

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