Covid-19 Retractions Raise Concerns About Data

News in focus in South America, says Carlos Chaccour of the Barcelona Institute for Global Health in Spain, COVID-19 RETRACTIONS who is running a clinical trial of ivermectin and had raised questions about the preprint’s data. RAISE CONCERNS ABOUT Researchers testing hydroxychloroquine in clinical trials are worried that the Lancet find- DATA OVERSIGHT ings might make it harder for them to complete their research, despite the fact that the paper Studies relied on health-record analyses from firm has been retracted. “We’re hearing that people just aren’t interested in hydroxychloroquine,” that declined to share its raw data for an audit. says David Smith, an infectious-disease special- ist at the University of California, San Diego, By Heidi Ledford and who is helping to run a trial of the drug in people Richard Van Noorden with COVID-19 who have not been hospitalized. Most data on hydroxychloroquine in wo weeks after a high-profile paper COVID‑19 have come from in vitro studies in The Lancet1 reported that the anti or small clinical trials. On 5 June, however, malarial drug hydroxychloroquine researchers working on a large randomized might be dangerous to people with UK trial called RECOVERY announced that their COVID-19, three of its four authors data on more than 4,600 hospitalized people Tretracted the work because they were unable indicated that hydroxychloroquine didn’t to independently verify their data set, a reduce the risk of death, and that they were large proprietary collection of electronic stopping that arm of the trial. health records analysed by the US company It is not uncommon for studies that use Surgisphere. large data sets to be published without exter- On the same day, 4 June, the researchers nal scrutiny of the raw data, says Smith. But and other co-authors retracted a paper2 in an exception is when the paper is expected to The New England Journal of Medicine, for the have particularly high impact. In the Lancet

same reason. That study, published a month study, he says, it seems that extra-careful NARINDER NANU/AFP/GETTY ago, had looked at the impact of certain heart Hydroxychloroquine, an antimalarial drug. review was skipped. “We are desperate for medications on people with COVID-19, and knowledge, and maybe we’re skipping over found no safety concerns. Sapan Desai, the founder of Surgisphere some of our tried-and-true checks,” he says. Scientists say the affair raises serious and a co-author of the studies, declined to questions about how researchers and jour- comment to Nature on the retractions and on Ivermectin effect nals evaluate the data underlying papers concerns about the quality of the data behind Surgisphere’s ivermectin preprint might that they publish, and might complicate the the studies. have a longer life. The Peruvian government effort to trial drugs during the coronavirus After the Lancet study appeared, some included the drug in its national treatment pandemic. “This whole event is catastrophic regulators paused enrolment in clinical trials guidelines a few days after a white paper cited — it is problematic for the journals involved, it of hydroxychloroquine as a treatment for the SSRN preprint, Chaccour says. A week after is problematic for the integrity of science, it is COVID-19. The drug, which is cheap and easy that, Bolivia added ivermectin to its treatment problematic for medicine and it is problematic to administer, has been widely endorsed dur- guidelines, citing the situation in Peru. for the notion of clinical trials and evidence ing the pandemic, despite scant evidence of its Since Chaccour gave a talk about ivermectin generation,” says Ian Kerridge, a bioethicist at to the Peruvian Academy of Sciences, he says, the University of Sydney, Australia. “I no longer have confidence people regularly text him to say that they have Both papers relied on analysis of proprietary an infected family member and can get formula- data from electronic health records on tens in the origination and tions of ivermectin intended for use in animals, of thousands of people that were apparently veracity of the data, nor the not people. “They send me a photo of a veteri- gathered from hundreds of hospitals around findings they have led to.” nary formulation and ask me, ‘Would you mind the world by Surgisphere, which is based in telling me what dose we should use?’” he says. Chicago, Illinois. But even after critics raised “It is broadly available and people are broadly questions about the studies, the firm did not effectiveness. Some of the halted trials, includ- desperate and this could lead to misuse.” make its raw data available to third-party ing one led by the World Health Organization, Because the preprint was not published in auditors for validation. According to the are starting up again. a journal, there is no retraction mechanism Lancet retraction notice, Surgisphere was A third study authored by Desai, Mehra to limit its long reach, Chaccour worries. concerned that transferring the data would and others, which used Surgisphere data “Who retracts this ivermectin ghost in Latin violate “client agreements and confidentiality and reported finding a large reduction in America?” he says. “There’s no high-profile requirements”. COVID‑19 mortality when patients were journal saying this was wrong.” “Since we do not have the ability to verify given the anti-parasitic drug ivermectin, the primary data or primary data source, I no has disappeared from the social-sciences Additional reporting by Smriti Mallapaty and longer have confidence in the origination and preprint server SSRN, where it was posted in David Cyranoski veracity of the data, nor the findings they have April. Mehra told Nature that he removed it led to,” said Mandeep Mehra, a cardiologist because he “did not feel it was ready for peer 1. Mehra, M. R., Desai, S. S., Ruschitzka, F. & Patel, A. N. Lancet https://doi.org/10.1016/S0140-6736(20)31180-6 at Brigham and Women’s Hospital in Boston, review”. It was not published in a peer-re- (2020). Massachusetts, who was the lead author of viewed journal, but has nonetheless contrib- 2. Mehra, M. R., Desai, S. S., Kuy S., Henry, T. D. & Patel, A. N. both studies. uted to a surge in the popularity of ivermectin N. Engl. J. Med. https://10.1056/NEJMoa2007621 (2020).