Drug promoted by Trump as coronavirus ?game changer? increasingly linked to deaths

Several have called for the FDA to revoke its emergency use authorization, given hydroxychloroquine’s documented risks.“They should say, ‘We know there are harms, and until we know the benefits, let’s hold off,’ ” said Joseph Ross, a professor of medicine and public health at Yale University, who added that the original authorization may have been warranted but new evidence has emerged about the drug’s risks.“I’m surprised it hasn’t been revoked yet,” said Luciana Borio, who served as director for medical and biodefense preparedness of the National Security Council and was acting chief scientist at the FDA.Sign up for our Coronavirus Updates newsletter to track the outbreak. Health and Human Services Secretary Alex Azar attacked Bright on Thursday, saying “his allegations do not hold water.”In a recent interview, FDA Commissioner Stephen Hahn denied that he was pressured to authorize hydroxychloroquine: “I can assure you 100 percent that the president has never pressured me to make a decision regarding any regulatory aspect of the FDA’s work.”The FDA said in a statement Friday that it is continuing to evaluate its emergency use authorization for chloroquine and hydroxychloroquine, as it does with all such authorizations for drugs to ensure their continued safety.“In general, the FDA may revise or revoke an EUA under certain circumstances, including information related to linked or suspected adverse events, newly emerging data that may contribute to revision of the FDA’s initial conclusion that a product may be effective against the particular threat or a material change in the risk/benefit assessment based on evolving understanding of the disease or condition,” the statement said.Trump has continued to promote hydroxychloroquine without reservation while attacking those who question its effectiveness. “I think they should revoke the EUA because clearly based on the data it is no longer considered a treatment for covid.”Some doctors, including one in Texas who is also a Republican committeeman, have continued to give the drug to coronavirus patients — with mixed results.A study of Veterans Affairs patients hospitalized with the coronavirus found no benefit and higher death rates among those taking hydroxychloroquine, researchers said last month.More than 27 percent of patients treated with hydroxychloroquine died, and 22 percent of those treated with the combination therapy died, compared with an 11.4 percent death rate in those not treated with the drugs, the study said.Growing friction between White House, CDC hobbles pandemic responseThe National Institutes of Health announced Thursday that it had begun a clinical trial of 2,000 adults to determine if the combination of hydroxychloroquine and azithromycin — the cocktail touted by Trump — works as a therapeutic for those with coronavirus.“Although there is anecdotal evidence that hydroxychloroquine and azithromycin may benefit people with COVID-19, we need solid data from a large randomized, controlled clinical trial to determine whether this experimental treatment is safe and can improve clinical outcomes,” Anthony S. He has largely ignored scientific studies to pitch the drug without caveat.In a tweet shared 102,800 times and liked 384,800 times on March 21 Trump claimed that “HYDROXYCHLOROQUINE AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine.”He invited several recovered coronavirus patients to the White House last month, including some who said hydroxychloroquine saved their lives.From mid-March through early April, Trump touted the drug as a potential panacea while downplaying any potential risks.“The nice part is it’s been around for a long time, so we know that if things don’t go as planned, it’s not going to kill anybody,” he told reporters on March 19.The president’s associates, including Fox host Laura Ingraham and his personal attorney, Rudolph W.