Morning Briefing
Summaries of health policy coverage from major news organizations
Retractions Of 2 Major Drug Studies Heighten Fears Research Is Being Rushed During Crisis
The studies, published in renowned scientific journals, produced astounding results and altered the course of research into the coronavirus pandemic. One undercut President Trump鈥檚 claim that certain antimalarial drugs cure Covid-19, the illness caused by the virus, concluding that the medications in fact were dangerous to patients. The other found that some blood pressure drugs did not increase the risk of Covid-19 and might even be protective. Both studies were led by a professor at Harvard, and both depended on a huge international database of patient medical records that few experts had ever heard of. But on Thursday, the studies were retracted by the scientific journals in which they had appeared, The New England Journal of Medicine and The Lancet, because the authors could not verify the data on which the results depended. (Rabin and Gabler, 6/4)
The paper, published in the journal the Lancet last month, concluded that hydroxychloroquine, taken either alone or with an antibiotic, to treat patients with COVID-19 was of no benefit and actually increased a patient's risk of dying. The publication of the study prompted the World Health Organization (WHO) to halt its own study of hydroxychloroquine. The WHO has now resumed the trial. The Lancet paper analyzed data, purported to be from COVID-19 patients in more than 600 hospitals around the world. The data were collected by a private company called Surgisphere, whose founder, Sapan Desai, is a co-author on the study. (Greenhalgh, 6/4)
鈥淲e can no longer vouch for the veracity of the primary data sources,鈥 Mandeep Mehra of Brigham and Women鈥檚 Hospital, Frank Ruschitzka of University Hospital Zurich, and Amit Patel of University of Utah said in a statement issued by the Lancet. 鈥淒ue to this unfortunate development, the authors request that the paper be retracted.鈥 (Joseph, 6/4)
Even though the Lancet report was not a rigorous test, the observational study had huge impact because of its size, reportedly involving more than 96,000 patients and 671 hospitals on six continents. Its conclusion that the drugs were tied to a higher risk of death and heart problems in people hospitalized with COVID-19 led the World Health Organization to temporarily stop use of hydroxychloroquine in a study it is leading, and for French officials to stop allowing its use in hospitals there. Earlier this week, WHO said experts who reviewed safety information decided that its study could resume. (Marchione, 6/5)
Three of the Lancet paper鈥檚 authors said they decided to retract the paper after Surgisphere refused to share the full data set as part of a review triggered by concerns raised by outside researchers. The Lancet published a correction to the study on May 29. 鈥淲e always aspire to perform our research in accordance with the highest ethical and professional guidelines,鈥 the authors, Drs. Mehra, Patel and Frank Ruschitzka said in a statement. 鈥淲e can never forget the responsibility we have as researchers to scrupulously ensure that we rely on data sources that adhere to our high standards. Based on this development, we can no longer vouch for the veracity of the primary data sources.鈥 (Hopkins and Gold, 6/4)
In their retraction, Drs. Mandeep Mehra, Frank Ruschitzka and Amit Patel wrote that, after concerns were raised about the data and analyses conducted by Surgisphere and its founder, Sapan Desai, a co-author of the study, they launched a third-party peer review with Desai's consent. They aimed to confirm "the completeness of the database, and to replicate the analyses presented in the paper." "Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis as such transfer would violate client agreements and confidentiality requirements. As such, our reviewers were not able to conduct an independent and private peer review and therefore notified us of their withdrawal from the peer-review process," the three researchers wrote. (Gumbrecht and Fox, 6/4)
The retractions raised concerns in the medical and scientific community that researchers and even prestigious medical journals are lowering their standards in a rush to publish during the pandemic. 鈥淚鈥檓 concerned that the usual standards, both at the level of the journals and at the level of authors and faculty rushing to get high-impact work published, has meant that our usual standards have fallen,鈥 said Steven Joffe, a medical ethicist at the University of Pennsylvania. (McGinley, 6/4)
The quick retractions of two prominent studies could undermine the public's 鈥 and politicians' 鈥 trust of scientific research during a pandemic when knowledge is rapidly evolving and accumulating, said Jennifer Kates, director of global health policy at the Kaiser Family Foundation. "Some will question scientific findings, in an environment where misinformation and distrust of information is already a problem," she said. (Tahir, 6/4)
The anti-malarial drug has been controversial in part due to support from Trump, as well as implications of the study published in British journal The Lancet last month, which led several COVID-19 studies to be halted. The three authors said Surgisphere, the company that provided the data, would not transfer the dataset for an independent review and they 鈥渃an no longer vouch for the veracity of the primary data sources.鈥 (Erman, 6/4)
Newly compiled prescription data shows that President Trump鈥檚 decision to take an antimalarial drug to ward off the coronavirus did not inspire many Americans to do the same, reflecting the fast-changing landscape surrounding the virus and efforts to treat it. First-time prescriptions ticked up by only several hundred the day after Mr. Trump mentioned at a White House event on May 18 that, as a preventive measure, he was taking one of two antimalarial drugs he had touted, according to nationwide data analyzed by The New York Times. (Gabler and Keller, 6/4)
Scientists are resuming COVID-19 trials of the now world-famous drug hydroxychloroquine, as confusion continues to reign about the anti-malarial hailed by U.S. President Donald Trump as a potential 鈥済ame-changer鈥 in fighting the pandemic. (Kelland and Smout, 6/4)
A group of conservative U.S. doctors has sued the Food and Drug Administration for limiting use of the malaria drug hydroxychloroquine for COVID-19, arguing that the therapy should be made widely available to fight the pandemic. (Martell and Erman, 6/4)