Artemisia infusions: correcting the records was difficult
This story is about Artemisia and two very "interesting" (or should I say infamous) studies.
1/ Well, read this paper: "Artemisia annua and Artemisia afra tea infusions vs. artesunate-amodiaquine (ASAQ) in treating Plasmodium falciparum malaria in a large scale, double blind, randomized clinical trial." by Munyangi J, et al. in Phytomedicine. Please look at table 4. Please look at the number of adverse events (number of subjects).
2/ Now please look at this paper: "Effect of Artemisia annua and Artemisia afra tea infusions on schistosomiasis in a large clinical trial." by Munyangi J, et al. in Phytomedicine. 2018. Please have a look at table S1. Please look at the number of adverse events (number of subjects).
In both tables there is an unusual pattern of adverse events with numbers that are almost all multiple of five. This is suspect of data fabrication. Some colleagues have therefore written two letters (letter 1 and letter 2) to the editor of the journal, Phytomedicine (publisher = Elsevier, Impact factor = 4.268). As you will see, there were sufficient warnings to retract these two papers at the speed of light. Here is a small quote to give you a taste of the letters : "TableS1 contains many adverse effect frequencies that are multiples of five, with 17 multiples of five for 21 non-zero frequencies, according to a binomial distribution, the probability of 17 or more multiples of five for 21 frequencies occurring by chance is approximatively 3.4×10−9"
There are also some concerns about the ethical approval of the two studies (e.g. the two different studies have the same number of approval and there were issues with the date of approval).
As no appropriate action (retraction of the papers) was done, a third letter was sent to request explicitly for a retraction. I was also signatory of this letter. We attached the database in the submission of this letter to document the problems with the database. These data were indeed shared with our group by the American author for a re-analysis (she sent excel files).
Indeed, when looking at the databases a lot of lines corresponding to patients seemed to have been copy/pasted (e.g. a series of patients had the exact same temperature at different time points / idem for parasitemias etc.). This was not possible and demonstrated major issues with the data quality process (at worst data fabrication, at best no quality control). Anyway, no reliable conclusion could be drawn from such a dataset.
When we called to retract the two papers, one of the colleagues was threatened by lawyers (concerning copyright of the database). We were no longer able to share the database with the editor. However, the authors showed one of their database to journalists covering there research. One can see that some lines are repeated in one of the database (see video, after 31 seconds, video acceded: 08/07/2020). One can easily see the copy/pasted pattern of each line.
Then, the editor temporary removed the two letters to the editor that were sent by my colleagues. One shortly reappeared but the second one was withdrawn for long. The retraction notice of this letter only stated : "The publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated."
But nothing happened for a long time. Until, a series of tweets (the content was almost the same as in this blog post) and the fact that Retraction Watch started to investigate the case. Please read the Story at Retraction Watch as it is worth it. It is a very nice piece of investigation and nicely details all the story.
Then we learned that the two studies will be retracted and that the comments will reappear soon. "Andrew Davis, the communications director for Elsevier, [...] said the two papers by Munyangi and colleagues will be retracted next week and that the letter to the editor would be reinstated. The notice will read, in part: “This article has been retracted at the request of the Editor-in-Chief. Concerns have been raised about the timely approval of the Ethics Committee for the study presented by this article, the consent of the trial participants to publish their data as well as the reliability of the data included in the article.” “The authors were not able to provide reasonable explanations and the Editor-in-Chief decided to retract the article.”
In summary, after nearly 2 years, 3 letters to the editor, nothing happened. After some tweets and some media coverage, we saw the appropriate reaction of the editor/publisher. Can one explain why a tweet is much more effective than a letter to the editor to correct the records? Is it worrying or inspiring ?