About The times. (Gainesville, Ga.) 1972-current | View Entire Issue (May 23, 2020)
8A Weekend Edition - May 23-24, 2020 The Times, Gainesville, Georgia | gainesvilletimes.com POLITICS Study adds doubt to malaria drugs for COVID-19 RAFIQ MAQB00LI Associated Press A chemist holds a pack of hydroxychloroquine tablets, Tuesday, May 19, in Mumbai, India. A Friday, May 22 report in the journal Lancet shows malaria drugs pushed by U.S. President Donald Trump as treatments for the coronavirus not only did not help but were tied to a greater risk of death and heart rhythm problems in a study of nearly 100,000 patients around the world. BY MARILYNN MARCHI0NE Associated Press Malaria drugs pushed by President Donald Trump as treatments for the coro navirus did not help and were tied to a greater risk of death and heart rhythm problems in a new study of nearly 100,000 patients around the world. Friday’s report in the journal Lancet is not a rig orous test of hydroxychloro quine or chloroquine, but it is by far the largest look at their use in real world set tings, spanning 671 hospitals on six continents. “Not only is there no ben efit, but we saw a very con sistent signal of harm,” said one study leader, Dr. Man- deep Mehra, a heart special ist at Brigham and Women’s Hospital in Boston. Researchers estimate that the death rate attrib utable to use of the drugs, with or without an antibi otic such as azithromycin, is roughly 13% versus 9% for patients not taking them. The risk of developing a serious heart rhythm prob lem is more than five times greater. Even though it is only observational, the size and scope of the study gives it a lot of impact, said Dr. David Aronoff, infectious diseases chief at Vanderbilt Univer sity Medical Center. “It really does give us some degree of confidence that we are unlikely to see major benefits from these drugs in the treat ment of COVID-19 and pos sibly harm,” said Aronoff, who was not involved in the research. Trump repeatedly has pushed the malaria drugs, and has said he is taking hydroxychloroquine to try to prevent infection or mini mize symptoms from the coronavirus. The drugs are approved for treating lupus and rheu matoid arthritis and for preventing and treating malaria, but no large rigor ous tests have found them safe or effective for pre venting or treating COVID- 19. People sick enough to be hospitalized with the coro navirus are not the same as healthy people taking the drugs in other situations, so safety cannot be assumed from prior use, Mehra said. These drugs also have potentially serious side effects. The Food and Drug Administration has warned against taking hydroxychlo roquine with antibiotics and has said the malaria drug should only be used for coro navirus in formal studies. Lacking results from stricter tests, “one needs to look at real-world evidence” to gauge safety or effec tiveness, Mehra said. The results on these patients, from a long-established global research database, are “as real world as a data base can get,” he said. His study looked at nearly 15,000 people with COVID- 19 getting one of the malaria drugs with or without one of the suggested antibiot ics and more than 81,000 patients getting none of those medications. In all, 1,868 took chloro quine alone, 3,783 took that plus an antibiotic, 3,016 took hydroxychloroquine alone and 6,221 took that plus an antibiotic. About 9% of patients taking none of the drugs died in the hospital, versus 16% on chloroquine, 18% on hydroxychloroquine, 22% on chloroquine plus an antibiotic, and 24% on hydroxychloroquine plus an antibiotic. After taking into account age, smoking, various health conditions and other fac tors that affect survival, researchers estimate that use of the drugs may have contributed to 34% to 45% of the excess risk of death they observed. About 8% of those taking hydroxychloroquine and an antibiotic developed a heart rhythm problem vs. 0.3% of the patients not taking any of the drugs in the study. More of these problems were seen with the other drugs, too. The results suggest these drugs are “not useful and may be harmful” in people hospitalized with COVID-19, professor Christian Funck- Brentano, of the Sorbonne University in Paris, wrote in a commentary published by the journal. He had no role in the study. Experiments underway now to test these drugs in a strict manner “need to be completed and should not be stopped prematurely,” Aronoff said. Even though the Lancet study was large, observa tional look-backs like this “cannot control for every possible factor that may be responsible for observed results,” he said. FBI director orders internal review of Flynn investigation BY ERIC TUCKER Associated Press WASHINGTON - FBI Director Christopher Wray has ordered an internal review into pos sible misconduct in the investigation of former Trump administration national security adviser Michael Flynn, the bureau said Friday. The after-action review will examine whether any current employees engaged in misconduct during the course of the investigation and evaluate whether any improvements in FBI policies and procedures need to be made. In announcing the review, the FBI, a frequent target of President Donald Trump’s wrath, is stepping into a case that has become a ral lying cry for Trump supporters — and doing so right as the Justice Department pushes back against criticism that its recent decision to dismiss the prosection was a politically moti vated effort to do Trump’s bidding. The announcement adds to the internal scru tiny over one of special counsel Robert Mueller’s signature prosecutions during his investigation into ties between Russia and Trump’s 2016 presidential campaign. It underscores how a case that was seemingly resolved by Flynn’s 2017 guilty plea has instead given way to a protracted, politically charged debate about FBI and Justice Department tac tics during that investigation and the Russia probe more broadly. The unusual review will be led by the bureau’s Inspection Division, which conducts inter nal investigations into potential employee misconduct. Trump has recently been sharply critical of the FBI, and suggested earlier this month that Wray’s fate as direc tor could be in limbo. An FBI offi cial said Friday that the review had been contemplated for some time and that the FBI has cooper ated with multiple Russia-related internal inquiries. Although the FBI does not have authority on its own to bring a criminal prosecution, the after action review will look at whether any current employees engaged in misconduct deserving of dis cipline. The division cannot take disciplinary action against for mer employees. It is not clear how many officials involved in the Flynn investiga tion remain with the FBI. Several prominent officials — including former Director James Comey, former Deputy Director Andrew McCabe and former agent Peter Strzok, who interviewed Flynn — have either been fired or have otherwise left the bureau. The FBI did not say what sort of potential misconduct it was looking for in the investigation of Flynn, who pleaded guilty to lying to agents about conversations with the Russian ambassador during the presidential transition period. But the case has long been a subject of outrage for Trump and his allies, who have alleged that Flynn was effectively set up to lie when the FBI questioned him at the White House in Janu ary 2017. Those concerns were given new life earlier this month when the Justice Department moved to dismiss the case and identi fied a series of what it says were problems in the way Flynn was investigated. The department’s motion to dis miss alleged that agents had insuf ficient basis to interview Flynn in the first place, especially since the FBI was prepared earlier in the month to close out its investi gation into Flynn after finding no crime. 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