Medical journals raise concerns over data from Covid-19 studies
On Tuesday, the New England Journal of Medicine published an “expression of concern” about a study released by the journal on May 1 that looked at the use of heart drugs called ACE inhibitors in coronavirus patients.
Two prestigious medical journals said they have significant concerns about a database that was used to look at how older drugs, including an antimalarial drug promoted by President Donald Trump, may work in the treatment of Covid-19.
On Tuesday, the New England Journal of Medicine published an “expression of concern” about a study released by the journal on May 1 that looked at the use of heart drugs called ACE inhibitors in coronavirus patients. Later Tuesday the Lancet, a nearly 200-year-old U.K. medical journal, issued its own similar warning about a May 22 trial that examined treating Covid-19 patients with the malaria drug hydroxychloroquine.
Both studies relied on data from a firm called Surgisphere Corp., which says it aggregates information from medical records around the globe. Last week, more than 200 scientists signed a letter to the Lancet asking for greater transparency regarding the hospitals where patients’ medical records came from and the method of analysis, along with other issues.
The use of hydroxychloroquine has become a charged political issue because of Trump’s support, and several studies -- including the Lancet article -- have raised safety worries about the pills in Covid-19 patients. The data concerns raised by the two prestigious journals are likely to muddy the waters further about the drug and whether it might be an effective treatment or method to prevent infection.
“Important scientific questions have been raised about data reported in the paper,” the Lancet editors wrote. Results of an independent audit of the validity of the data are expected “very shortly,” the editors said, adding that they would provide an update as soon as they received more information.
In its separate note, the New England Journal of Medicine said that “substantive concerns have been raised about the quality of the information in that database.” The study showed that people who take the heart drugs don’t face higher risks from Covid-19.
“We have asked the authors to provide evidence that the data are reliable,” the journal said. “In the interim and for the benefit of our readers, we are publishing this Expression of Concern about the reliability of their conclusions.”
Sapan Desai, Surgisphere’s chief executive officer and one of the authors on both papers, said the firm would have an outside group audit the data used in the Lancet study, and would give the authors of the New England Journal paper access to the underlying information so they can review its accuracy.
“I am confident Surgisphere is able to address the concerns of NEJM, the Lancet and the broader scientific community,” Desai said in an emailed statement. “Surgisphere stands behind the integrity of our studies.”
Mandeep Mehra, the lead author of both papers and the medical director of Brigham and Women’s Hospital Heart and Vascular Center in Boston, said the researchers who aren’t affiliated with Surgisphere initiated their own independent reviews of the data used in both papers after learning about the accuracy concerns. The auditors leading those reviews will provide their findings to the journals and the researchers, independent of Surgisphere, Mehra said in a statement.
Hydroxychloroquine is under investigation in a number of international trials. Safety concerns raised by the Lancet study led many researchers to curtail testing of the drug, including in an international trial coordinated by the World Health Organization.
The Lancet study used data from Surgisphere that consolidates medical records from around the globe.
Surgisphere, based in Chicago, has said it has agreements with hospitals, countries and governments that prevent it from sharing more of its data. The company takes data security and privacy very seriously, according to a statement about the Lancet study on Surgisphere’s website.
While the issue is still being studied, the New England Journal referred its readers to two other papers on the topic of ACE inhibitors and coronavirus.