Leading Medical Journals Express Concerns Over Flaws In Studies On Malaria Drugs, Heart Medicine

The New York Times: Scientists Question Medical Data Used In Second Coronavirus Study
Since the outbreak began, researchers have rushed to publish research about the new coronavirus spreading swiftly through the world. On Tuesday, for the second time in recent days, a group of scientists has questioned the data used in studies in two prominent medical journals. A group of scientists who raised questions last week about a study in The Lancet about the use of antimalarial drugs in coronavirus patients have now objected to another paper about blood pressure medicines in the New England Journal of Medicine, which was published by some of the same authors and relied on the same data registry. (Rabin, 6/2)

The Associated Press: Concerns Mount About Two Studies On Drugs For Coronavirus
The New England Journal of Medicine issued an “ expression of concern ” Tuesday on a study it published May 1 that suggested widely used blood pressure medicines were not raising the risk of death for people with COVID-19. The study relied on a database with health records from hundreds of hospitals around the world. “Substantive concerns” have been raised about the quality of the information, and the journal has asked the authors to provide evidence it’s reliable, the editors wrote. (Marchione, 6/2)

Reuters: Study Panning Anti-Malaria Drug Trump Took Against COVID Faces New Questions
Nearly 150 doctors signed an open letter to the Lancet last week calling the article’s conclusions into question and asking to make public the peer review comments that preceded publication. “This is not some sideshow or minor issue,” said Dr. Walid Gellad, a professor at University of Pittsburgh’s medical school, who was not a signatory of the letter but has been critical of the study. (Erman, 6/2)

The Hill: Medical Journal Says Concerns Raised Over Massive Hydroxychloroquine Study 
The study found that the drugs were not only largely ineffective at treating or preventing the virus but also linked to a higher risk of death. The study relied on an analysis of a database with medical records from patients across 671 hospitals rather than a comprehensive randomized trial. (Weixel, 6/2)

Stat: Top Journals Raise Concerns About Data In Two Studies Related To Covid-19
The concerns, which have built over the past several days on social media, highlight larger issues with using big databases to draw conclusions about medicines, an approach that has been gaining rigor in the era of big data. Experts warn that conducting such studies properly is far more difficult than it appears. “This is not for the faint of heart,” said Harlan Krumholz, director of the Center for Outcomes Research and Evaluation at Yale New Haven Hospital. “This is not just a matter of dial-a-study when you get access to data. Well-done studies are based on understanding the provenance of the data and making sure what you are doing is reasonable. There is good science to be done with big databases, but there are also major mistakes to be made. The question is: What happened here?” (Herper and Joseph, 6/2)

Reuters: Trump And Bolsonaro Discussed Research Effort On Using Hydroxychloroquine To Fight Coronavirus, White House Says
U.S. President Donald Trump and Brazilian President Jair Bolsonaro discussed a joint research effort on using the anti-malarial drug hydroxychloroquine as both a prophylaxis and treatment for the coronavirus, the White House said on Tuesday. Trump and Bolsonaro “expressed their mutual appreciation for the longstanding collaboration on health issues between the two countries,” the White House said, discussing the U.S. delivery of 2 million doses of the controversial drug to Brazil and “a joint research effort to help further evaluate the safety and efficacy of hydroxychloroquine for both prophylaxis and the early treatment of the coronavirus.” (6/2)

In other pharmaceutical news —

The Wall Street Journal: Heart Drugs Show Promise With Covid-19 Complications
Spurred by promising early findings, researchers are investigating whether drugs currently approved to treat heart disease can also prevent or reduce complications from Covid-19 and help hospitalized patients recover sooner. Treatments being evaluated include blood-pressure drugs, blood thinners, statins, antiplatelets and a drug to lower triglycerides. Results from the studies, some of which could come as early as this summer, could offer doctors a new array of drugs to treat patients infected with the coronavirus. (Hopkins and McKay, 6/2)

Reuters: Gilead's Next Step On Coronavirus: Inhaled Remdesivir, Other Easier-To-Use Versions
Gilead Sciences Inc is developing easier-to-administer versions of its antiviral treatment remdesivir for COVID-19 that could be used outside of hospitals, including ones that can be inhaled, after trials showed moderate effectiveness for the drug given by infusion. (Beasley, 6/2)