By Erik Boetto and Davide Golinelli.
Frauds and misconduct have been common in the history of science. A well-known example is that of former-doctor A.J. Wakefield, who published a study in 1998 reporting the association between measles, mumps, and rubella vaccination and a syndrome of autism in children. Only in 2011 was it proven that Wakefield heavily manipulated the research data and forged false ethical approval to depict a false association between vaccines and autism, which would have granted him significant personal economical returns through the involvement in a lawsuit against manufacturers of the measles-mumps-rubella (MMR) vaccine.
This was not only a deliberate fraud, but also one of the biggest scientific scams in recent history. Using words from a 2011s BMJ editorial, still true to this day: “the damage to public health continues, fueled by unbalanced media reporting and an ineffective response from government, researchers, journals, and the medical profession[…]”.
This quote, unfortunately, also perfectly fit a much more recent series of events, concerning three studies on COVID-19 that have shaken up the scientific community in the last months. The three studies, which shared a group of three co-authors, addressed the use of ACE inhibitors (in The New England Journal of Medicine), hydroxychloroquine (on The Lancet) and ivermectin for treatment of COVID-19. The first two two have since been proven to be fraudulent and retracted; however, the third one was still only a preprint, which was not retracted but simply removed from the online repository where it was uploaded.
Other than the authors, these three studies shared the same source for their data: a small private data analysis company, Surgisphere, owned by one of the co-authors, and which claimed to have access to data on thousands of patients and hundreds of hospitals from six continents. The first suspicions of the authenticity of the data were raised by the readers of the journals, which were then forced to investigate, only to be faced with the harsh truth: the data had not just been manipulated by the authors, it was pretty much made up.
How could these fraudulent studies have passed the peer-review process of two of the most influential and prestigious medical research journals?
It seems that the current standards for the peer-review process may not be enough. One of the journals that were directly involved in the Surgisphere scandal,The Lancet, seems to be taking seriously the mission of establishing better, safer and stricter policies of peer-review. One of the most important changes will be the requirement to share data for all studies, and not only for clinical trials: the Surgisphere study on hydroxychloroquine was a retrospective study, therefore access to research data was not mandatory. Other changes will include the involvement of statistics and data science experts for studies with large data sets, and the use of explicit questions for reviewers on whether they have concerns about the integrity or ethics of the paper they are reviewing. This is a good start, but unlikely to be enough.
Lack of scientific integrity, data manipulation and dubious ethics are issues that also concern the sector of translational research. “Stealth research”, as defined by John P. A. Ioannidis, is a term used for touted biomedical innovation happening outside the peer-review literature in a confusing mix of “possibly brilliant ideas, aggressive corporate announcements, and mass media hype.”
One of the most striking examples is that of Theranos, a medical diagnosis start‐up company valued at more than $9 billion in 2013, a so-called “unicorn” (a term used to refer to venture capital‐backed companies with valuations over $1 billion). Theranos had not published any peer‐reviewed papers, but made claims that its technology would “disrupt medicine”, at least until the founder and CEO, the former president, and the company itself were charged with “massive fraud” by the US Securities and Exchange Commission in 2018.
It may be time to completely review the process of knowledge and evidence creation, starting from the scientific literature itself, but also spreading this change to other stakeholders in the context of scientific research.
This pandemic may be the final push needed to start this long overdue change process, by reinforcing the current system but also by the adoption of innovative tools and technologies.
Authors of the associated paper:
Erik Boetto, Davide Golinelli, Gherardo Carullo, Maria Pia Fantini
Erik Boetto, Department of Biomedical and Neuromotor Sciences (DIBINEM), Alma Mater Studiorum, University of Bologna.
Davide Golinelli, Department of Biomedical and Neuromotor Sciences (DIBINEM), Alma Mater Studiorum, University of Bologna.
Gherardo Carullo, Department of Italian and Supranational Public Law, University of Milan, Italy.
Maria Pia Fantini, Department of Biomedical and Neuromotor Sciences (DIBINEM), Alma Mater Studiorum, University of Bologna.
Competing interests: None declared