US revokes emergency use of malaria drugs vs. coronavirus

THE UPPER 50'S. EMILY: THANK YOU. WE'VE GETTING INSIGHT ON THE CORONAVIRUS PANDEMIC FROM THE EXPERTS IN BOSTON. WE'RE JOINED BY DR. HELEN BOUCHER. SHE IS CHIEF OF GEOGRAPHIC MEDICINE AND INFECTIOUS DISEASES AT TUFTS MEDICAL CENTER. LET'S TALK ABOUT HYDROXYCHLOROQUINE. THE PRESIDENT SAYS HE'S USING IT IN AN ATTEMPT TO PREVENT COVID-19 INFECTION, DESPITE THE FDA SAYING IT COULD BE DANGEROUS AND ISN'T PROVEN TO FIGHT THE VIRUS. WHAT ARE SOME OF THE RISKS OF TAKE IT TO PREVENT COVID-1 >> IT'S NICE TO BE WITH YOU AND HYDROXY CHLOROQUINE CAN BE TOXIC TO THE HARD HEART AND THAT'S ONE OF THE THINGS THESE RENTS SO WE'RE NOT RECOMMENDING IT FOR TREATMENT OR PREVENTION OF THE DISEASE AT THIS TIME. EMILY: IT'S REALLY ONLY IN CLINICAL TRIALS OR IN HOSPITAL SETTINGS AT THE POINT. >> CORRECT, AND WE RECOMMEND ONLY USING IT IN THE SETTING OF A CLINICAL TRIAL. EMILY: LET'S TALK ABOUT THE VACCINE. CAMBRIDGE-BASED MODERNA AND THE NATIONAL INSTITUTES OF HEALTH RESULTS FROM THEIR COVID-19 VACCINE TRIAL. THEY SAID PARTICIPANTS ARE DEVELOPING NECESSARY ANTIBODIES AGAINST THE VIRUS. BUT THEY ONLY TESTED 8 OF THOUGHTS ON THOSE EARLY RESULT >> WELL, THESE ARE EARLY RESULTS AND IT WAS A SMALL, WE CALL PHASE ONE TRIAL AND IT'S ENCOURAGING TO SEE THAT THE ANTI-BODIES WERE DEVELOPED AS PREDICTED AND HOMED BUT IT'S IMPORTANT TO EMPHASIZE THAT IT'S VERY EARLY. WE NEED TO SEE SEVERAL MORE STEPS AND A LOT MORE PATIENTS TREATED SAFELY AND SUCCESSFULLY BECAUSE THIS BECOMES AVAILABLE TO OUR PATIENT. EMILY: AND THAT'S WHY THE TIMELINE OF THESE VACCINES OUFPBLE TAKES YEAR. >> THAT'S RIGHT AND THIS IS MOVING AT LIGHTNING SPEED. IT WAS 65 DAYS BETWEEN THE SIGNATURE ANYIFYING OF THE VIRUS AND THE PROCESSING OF THE VACCINE. THAT'S A RECORD BUT THERE ARE MANY STEPS TO GETTING A SAFELY AND EFFECTIVE VACCINE AND WE THINK IT WILL BE CLOSE TO A YEAR ONE COLINLY. EMILY: DO WE KNOW WHAT THE BENEFIT IS YET OF HAVING ANTIBODIES TO COVID-19? DOES IT MEAN A PERSON IS IMMUNE? >> WE BELIEVE THAT ANT BODES -- ANTI-BODIES MEAN THE PERSON HAS BEEN EXPOSED TO THE VIRUS. WOULD BE PROTECTED IN THAT CASE AND IF SO HOW LONG IT WOUL

U.S. regulators on Monday revoked emergency authorization for malaria drugs promoted by President Donald Trump for treating COVID-19 amid growing evidence they don’t work and could cause deadly side effects.The Food and Drug Administration said the drugs hydroxychloroquine and chloroquine are unlikely to be effective in treating the coronavirus. Citing reports of heart complications, the FDA said the drugs' unproven benefits “do not outweigh the known and potential risks.”The decades-old drugs, also prescribed for lupus and rheumatoid arthritis, can cause heart rhythm problems, severely low blood pressure and muscle or nerve damage.The 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 drugs are still available for alternate uses, so U.S. doctors could still prescribe them for COVID-19 — a practice known as off-label prescribing.Dr. Steven Nissen, a Cleveland Clinic researcher who has been a frequent FDA adviser, agreed with the decision and said he would not have granted emergency access in the first place.“There has never been any high-quality evidence suggesting that hyrdoxychloroquine is effective” for treating or preventing coronavirus infection, he said, but there is evidence of serious side effects.On Thursday, a National Institutes of Health panel of experts revised its recommendations to specifically recommend against the drug’s use except in formal studies, and “that, I’m sure, had influence on the FDA,” Nissen said.The actions by FDA and NIH send a clear signal to health professionals against prescribing the drugs for coronavirus.Trump aggressively pushed the drug beginning in the first weeks of the outbreak and stunned medical professionals when he revealed he took the drug preemptively against infection.Tens of thousands of people tried the drug after Trump touted it in briefings and interviews, saying, “What have you got to lose?” The nation’s top infectious disease expert, Dr. Anthony Fauci, warned, “I like to prove things first.” Weak studies further polarized views of hydroxychloroquine. No large, rigorous studies have found the drugs safe or effective for preventing or treating COVID-19. And a string of recent studies made clear they could do more harm than good.The FDA granted emergency use of the drugs for coronavirus patients in late March at the same time the U.S. government accepted 30 million doses of hydroxychloroquine and chloroquine that had been donated by two foreign drug manufacturers. Millions of those doses were shipped to U.S. hospitals to treat patient who weren’t enrolled in clinical trials.But the FDA previously warned doctors that it had seen reports of dangerous side effects and heart problems reported to poison control centers and other health systems.The agency said Monday it revoked the authorization in consultation with the Biomedical Advanced Research and Development Authority, or BARDA, which had requested the emergency use.

WASHINGTON —

The Food and Drug Administration said the drugs hydroxychloroquine and chloroquine are unlikely to be effective in treating the coronavirus. Citing reports of heart complications, the FDA said the drugs' unproven benefits “do not outweigh the known and potential risks.”

The decades-old drugs, also prescribed for lupus and rheumatoid arthritis, can cause heart rhythm problems, severely low blood pressure and muscle or nerve damage.

The 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 drugs are still available for alternate uses, so U.S. doctors could still prescribe them for COVID-19 — a practice known as off-label prescribing.

Dr. Steven Nissen, a Cleveland Clinic researcher who has been a frequent FDA adviser, agreed with the decision and said he would not have granted emergency access in the first place.

“There has never been any high-quality evidence suggesting that hyrdoxychloroquine is effective” for treating or preventing coronavirus infection, he said, but there is evidence of serious side effects.

On Thursday, a National Institutes of Health panel of experts revised its recommendations to specifically recommend against the drug’s use except in formal studies, and “that, I’m sure, had influence on the FDA,” Nissen said.

The actions by FDA and NIH send a clear signal to health professionals against prescribing the drugs for coronavirus.

Trump aggressively pushed the drug beginning in the first weeks of the outbreak and stunned medical professionals when he revealed he took the drug preemptively against infection.

Tens of thousands of people tried the drug after Trump touted it in briefings and interviews, saying, “What have you got to lose?” The nation’s top infectious disease expert, Dr. Anthony Fauci, warned, “I like to prove things first.” Weak studies further polarized views of hydroxychloroquine.

No large, rigorous studies have found the drugs safe or effective for preventing or treating COVID-19. And a string of recent studies made clear they could do more harm than good.

The FDA granted emergency use of the drugs for coronavirus patients in late March at the same time the U.S. government accepted 30 million doses of hydroxychloroquine and chloroquine that had been donated by two foreign drug manufacturers. Millions of those doses were shipped to U.S. hospitals to treat patient who weren’t enrolled in clinical trials.

But the FDA previously warned doctors that it had seen reports of dangerous side effects and heart problems reported to poison control centers and other health systems.

The agency said Monday it revoked the authorization in consultation with the Biomedical Advanced Research and Development Authority, or BARDA, which had requested the emergency use.

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