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The Food and Drug Administration said on Monday that it was revoking emergency authorization of two malaria drugs to treat Covid-19 in hospitalized patients, saying that they are “unlikely to be effective” and could carry potential risks. The drugs, hydroxychloroquine and chloroquine, were heavily promoted by President Trump after a handful of small, poorly controlled studies suggested that they could work against the disease caused by the coronavirus. Mr. Trump said he took hydroxychloroquine after he had been exposed to two people who tested positive for the coronavirus. (Thomas, 6/15)

After reviewing new information from large clinical trials the agency now believes that the suggested dosing regimens "are unlikely to produce an antiviral effect," FDA chief scientist Denise Hinton said in a letter announcing the decision Critics have accused the agency of caving to political pressure when it authorized use of hydroxychloroquine and chloroquine in hospitalized Covid-19 patients in late March despite thin evidence. More recent randomized controlled trials have found the drugs do not benefit coronavirus patients, and doctors have reported that hydroxychloroquine can cause heart problems. (Owermohle, 6/15)

The FDA had authorized the antimalarial drugs in late March for hospitalized covid-19 patients after small studies indicated they might provide a benefit. But the decision quickly became a scientific flash point, with critics, including former FDA officials, calling the evidence scant and accusing the agency of buckling to political pressure from the White House. Several argued that what was at stake was larger than just the emergency approvals, in terms of the public’s ability to trust the federal response to the pandemic was based on the best available evidence. (McGinley and Johnson, 6/15)

Hydroxychloroquine’s anti-inflammatory and antiviral properties suggested it might help COVID-19 patients, and the FDA authorized its emergency use in March at the height of a pandemic for which there were no approved treatments. The early enthusiasm was partly based on laboratory experiments in which the drug appeared to neutralize the virus. Chloroquine, which is not approved for any use in the United States and has more side effects, has not fared any better in human clinical trials. (Beasley and Mishra, 6/15)

FDA’s move means that shipments of the drugs obtained by the federal government will no longer be distributed to state and local health authorities for use against the coronavirus. The decades-old drugs are still available for alternate FDA-approved uses, so U.S. doctors could still prescribe them for COVID-19 — a practice known as off-label prescribing. (Perrone, 6/15)

President Donald Trump said on Monday other countries had provided great reports on the effectiveness of malaria drug hydroxychloroquine for treatment of the deadly coronavirus, complaining that only U.S. agencies have failed to grasp its benefit. His remarks, delivered to reporters at the White House, came hours after the U.S. Food and Drug Administration revoked its emergency use authorization for hydroxychloroquine to treat COVID-19, despite Trump’s frequent praise of the drug’s usefulness for staving off the disease. (6/15)

Public health officials have cautioned for months that there is no compelling scientific evidence to support the use of hydroxychloroquine as a safe and effective way to prevent or to treat Covid-19. Still, dozens of clinical trials are under way around the world that researchers and physicians hope will provide answers about whether they are useful in fighting the virus. On June 5, researchers testing whether hydroxychloroquine helped hospitalized Covid-19 patients halted a roughly-4,500-subject U.K.-based study after a preliminary analysis showed the pill didn’t provide a benefit. (Burton and Hopkins, 6/15)

President Trump was an early and vocal champion of the drugs, and even declared in May that he was taking the drugs to prevent COVID-19.Hydroxychloroquine and chloroquine were initially designed as anti-malarial drugs and later shown to be useful in treating certain autoimmune disorders. Early on in the pandemic, some researchers thought the drugs might be useful in treating COVID-19. (Palca, 6/15)

"As we have done throughout the pandemic, the FDA continues to evaluate all of the emergency use authorizations issued and their related materials and will continue to make changes as appropriate based on emerging science and data," Dr. Patrizia Cavazzoni, acting director of the FDA's Center for Drug Evaluation and Research, said in a statement.(Edwards, 6/15)

The emergency permission granted by the agency last February that added the drugs to the federal stockpile and allowed them to be distributed to states for use against COVID-19 will end. “We’ve made clear throughout the public health emergency that our actions will be guided by science and that our decisions may evolve as we learn more about the SARS-CoV-2 virus, review the latest data, and consider the balance of risks versus benefits of treatments for COVID-19,” said Anand Shah, the agency’s deputy commissioner for medical and scientific affairs. (Ebbs, 6/15)

And though it seems to settle scientific questions about the drug — mounting evidence has already shown the drug is not effective at treating either patients already infected with Covid-19 or as a preventative treatment— it’s worth noting that there are still over 100 active and recruiting clinical trials meant to test hydroxychloroquine as a treatment for the disease caused by the novel coronavirus. The FDA warned that the drug is “unlikely to be effective in treating Covid-19,” and highlighted “serious side effects,” but the decision could have a lasting impact on public confidence in the agency and its independence. (Florko, 6/16)