Partner Mary Inman Speaks about Research Fraud with Science Whistleblower Dr. Elisabeth Bik at the HCCA’s Research Compliance Conference
On June 16, 2021, Constantine Cannon partner Mary Inman spoke at the Health Care Compliance Association’s (HCCA) Research Compliance Conference on the topic of ‘The Vital Role of Whistleblower Scientists in Exposing Fraudulent Research During the Pandemic.’ Mary was joined by co-panelist Dr. Elisabeth Bik, the Founder and Editor of the Science Integrity Digest, a blog about scientific integrity aimed at exposing discrepancies in and manipulation of data in academic publications. Last year, Dr. Bik was thrust into the spotlight, assuming the role of a prominent science whistleblower, for her work raising concerns about the integrity of a March 2020 paper by French scientists that promoted hydroxychloroquine for treating COVID-19, which was cited by former President Donald Trump.
Mary distinguished Dr. Bik as part of a new breed of whistleblowers — the whistleblower outsider looking in. Mary explained that while the prototypical whistleblower is the company insider who uncovers wrongdoing by their employer while working within a company structure and who dares to highlight a risk internally and/or to a government enforcement authority, such as the U.S. Department of Justice (DOJ) or the U.S. Securities and Exchange Commission (SEC). Dr. Bik, on the other hand, is self-employed and purposefully extricated herself from the perception of conflicts generated by working for a particular company or research institution and thereby is able with her research to look dispassionately at data published in journals at the peer review stage to detect instances of research fraud, including fabrication of data, falsification of data and plagiarism.
Although Dr. Bik is a whistleblower outsider, she unfortunately still has suffered the same types of retaliation for speaking out as much of her whistleblower insider peers. Dr. Bik said she has “earned an army of trolls and enemies who are always asking me, ‘Who is paying you?’” and has even been sued by the French scientists whose hydroxychloroquine research she criticized. Mary commended Dr. Bik’s whistleblower activism by stressing the signal her work sends to organizations, creating pressure on researchers to address compliance issues and improve staff training, as well as the creation of and conformity with a clear code of ethics. Dr. Bik’s work also has the effect of encouraging greater levels of transparency in the publication of academic research. Most importantly, such organizations should not sit back and wait for a member of staff to file a complaint internally, nor wait for an external individual like Dr. Bik to publicly expose their wrongdoings, but instead must take proactive steps to comply with the law.
Dr. Bik discussed the unusual pressure COVID-19 has placed on academic publishing houses, where rushed research is being funded and reported to a much greater extent, leading to what Dr. Bik described as “a time of haste and panic” in the academic publishing industry which undoubtedly has led to greater levels of fraudulent research, including data manipulation and falsification of test results.
Remarkably, Dr. Bik’s work has resulted in the retraction of 498 academic research papers. Despite this, she contends the majority of the papers she has flagged have not been corrected, creating a worrying precedent for researchers and readers hoping to derive and rely upon information from these papers. Due to the niche environment in which academic publishers operate, it is all too easy for them to turn a blind eye to scientific fraud and instead prioritize their publishing quotas. The rise in research fraud whistleblowers is one of the few deterrents to such conduct, with science whistleblowers providing prosecutors and regulators a handy roadmap to the wrongdoing. Mary noted that if fraud occurs in research funded by the U.S. government, such as research grants from the National Institutes of Health (NIH) and the National Science Foundation (NSF), whistleblowers are empowered under the federal False Claims Act to launch a lawsuit in the government’s name complaining of such research fraud. Mary cited a 2019 case involving Duke University, in which whistleblower Joseph Thomas, a fellow Duke researcher, filed a FCA lawsuit alleging a Duke scientist had submitted falsified research on federal grants from the NIH and Environmental Protection Agency. The Government joined the whistleblower’s case and settled it for $112.5M, $33M of which was awarded to the whistleblower.
The talk concluded with Mary and Dr. Bik highlighting the importance of organizations heeding whistleblowers’ warnings, whether internal or external to the organization. This involves actively listening to and addressing whistleblower concerns rather than dismissing them or seeking to divert attention from the wrongdoing by impugning the whistleblower messenger and ignoring the whistleblower’s message. When asked, Mary remarked that an institution should not respond differently if the complainant whistleblower is an outsider because “what whistleblowers are doing, whether they’re inside or outside, they’re bringing in information that hopefully will trigger an investigation by [the organization].”
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