A paper that claimed to show a homeopathic intervention improved quality of life and survival for people with advanced lung cancer has received an extensive correction two years after a research integrity watchdog asked the journal to retract the article over concerns about manipulated data, Retraction Watch has learned.
The two scientists who sounded the alarm on the paper are not satisfied with the correction, they told us.
The article, “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,” appeared in The Oncologist in November 2020. Michael Frass, the lead author of the paper, is a homeopathic practitioner who was working at the Medical University of Vienna, at the time the work was published.
The paper has been cited 18 times, according to Clarivate’s Web of Science, and was included in a German medical organization’s guideline about complementary treatment for cancer patients. Many homeopathy organizations posted about the study on X as evidence of the approach’s benefit, helping propel the article to the top 5% of all research articles for which Altmetric, a publication data company, has tracked online attention.
The article also attracted the notice of Norbert Aust, a retired mechanical engineer who started the Homeopathy Information Network in Germany, and Viktor Weisshäupl, a retired anesthesiologist now working on the Initiative for Scientific Medicine in Austria. The pair undertook an analysis of the study protocols and data posted to ClinicalTrials.gov.
They found several differences between the initial registration posted in January 2012, a protocol dated January 2011 but uploaded in July 2019, and the published paper. These differences included the number of participants, study arms, exclusion criteria, follow-up time, and cancer types included in the study. Aust and Weisshäupl also noted the study protocol said the software the authors used to analyze their data was a version not yet available in 2011.
“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,” Aust and Weisshäupl wrote in a description of their findings on Edzard Ernst’s blog in June 2021.
According to another article Aust and Weisshäupl published in Skeptical Inquirer in 2023, the pair reported their findings to the Medical University Vienna, which referred the matter to the Austrian Agency for Scientific Integrity.
In a report dated September 2022 and obtained by Retraction Watch, the Austrian watchdog said its investigation “found numerous manipulations,” and asked The Oncologist’s editor in chief Susan Bates to retract the article.
Among the findings:
- “The presentation of the study as double-blind placebo controlled is untrue.”
- “Substantial” changes to the study protocol while it was running, including to the primary endpoint, that were not mentioned in the publication, “suggestive of data manipulation.”
- “Many patients were excluded post-hoc, which is suggestive of data manipulation.”
- “Fully implausible” survival data, “compatible with selective deletion of records.”
- “The patients in the homeopathy group report a quality of life that is much higher than that of the general population known from other surveys. For patients with stage four non-small cell lung cancer this is highly implausible.”
The Oncologist published an expression of concern in October 2022 citing “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,” the notice stated.
On Tuesday, the journal published an extensive correction to the article, stating:
Additional details not included in the original publication have since been provided by the authors and reviewed by the editors to clarify these concerns. These omissions do not affect the results of this study.
Frass told us he and his team were “pleased that after a profound and thorough investigation by The Oncologist it has now been proven that the paper is correct. The Commission’s allegations are unsubstantiated and completely unfounded.” He provided a diagram he and a friend made which he said showed “all allegations could be refuted adequately.”
Along with the correction, the journal published an editorial by Bates and another editor describing how The Oncologist published the paper in a section dedicated to the results of clinical trials that might not otherwise be posted. It concluded:
The Oncologist and its CTR section hope that—by turning to the laboratory to determine whether any fraction of a homeopathic remedy holds a thread of promise—science identifies what is in these mixtures and that, in turn, potential anticancer compounds are then developed through conventional pathways.
We reached out to Bates for comment, and received the following response from a spokesperson for Oxford University Press, the journal’s publisher:
In 2022 The Oncologist received a letter about “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” from the Commission for Research Integrity of the Austrian Agency for Research Integrity (OeAWI) and the journal issued an expression of concern. The journal has since conducted a thorough investigation and based on guidelines from the Committee on Publication Ethics (COPE), determined that a correction is the appropriate response to the concerns raised. The accompanying editorial provides further context. The correction and editorial are the journal’s full response.
The correction doesn’t address the issues Aust, Weisshäupl, and the Austrian Agency for Scientific Integrity found with the study, Aust told us.
“They explain some trifles,” he said, “but the elephant in the room is not mentioned.” He also wondered why a letter to the editor he and Weisshäupl submitted in 2021 had not been published.
The editorial’s question of whether some components in the homeopathic intervention could be therapeutic “is completely irrelevant,” Aust said.
“If some results are obtained by data manipulation and falsification, then it is pointless to argue if there might have been some effect by the preparations that were administered,” he said. “The data are not valid and it is wrong, unethical and might cause harm for patients if they stay published like solid outcomes of some rigorous trial.”
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Did Aust publish his letter anywhere?