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Trump says White House “slashed red tape” to expand trials.

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Trump says White House “slashed red tape” to expand trials. by Kenyans247(m): Thu 19, March, 2020 10:20pm
As coronavirus cases soared in the United States and health care workers complained of shortages of critically-needed supplies, President Trump said Thursday that his administration had “slashed red tape” to expand trials for possible treatments but gave mixed signals about whether he would move to compel private industry to produce medical equipment.

With the development of a usable coronavirus vaccine at least a year off, Mr. Trump, surrounded at the White House by leading federal health officials, said that they had been working to swiftly expand trials of several antiviral therapies they hoped would prove effective against the coronavirus.

“I’ve directed the F.D.A. to eliminate outdated rules and bureaucracy so this work can proceed rapidly, quickly, and I mean fast,” said an enthusiastic Mr. Trump, who said that several drugs could turn out to be a “game changer,” before adding a note of caution: “and maybe not.”

Dr. Stephen Hahn, the Food and Drug Administration commissioner, gently tamped down some of Mr. Trump’s optimism, saying that while it was important for doctors to give hope, it was also important “not to provide false hope.”

“We need to make sure the sea of new treatments will get the right drug to the right patients at the right dosage at the right time,” Dr. Hahn said, citing the importance of establishing the safety and efficacy of possible treatments. “As an example we may have the right drug but may not be near appropriate dosage form right now and that may do more harm than good.”

There is no proven drug treatment for the new coronavirus, and doctors around the world have been desperately testing an array of medicines in the hopes of finding something that will help patients, especially those who are severely ill.During the briefing, the president and Dr. Hahn said that the F.D.A. had approved the use in coronavirus patients of the prescription drugs chloroquine and hydroxychloroquine, which have been used for malaria. There have not been clinical trials to determine whether those drugs actually work for the disease, and Dr. Hahn did not explain why the F.D.A. is supporting their use, nor he did explain whether today’s action was actually a formal approval of the drug for this new use.

Doctors in China and France have said there were indications they might help, and many hospitals in the United States had already begun using them. The drugs are inexpensive and relatively safe. Because they were already approved for other illnesses, doctors in the U.S. were free to use them in an “off-label” way based on their own judgment.

Dr. Hahn also said the F.D.A. was considering the use of “convalescent plasma,” meaning blood from people who have recovered from the disease, which contains antibodies against the coronavirus that might be able to help other patients fight the virus.

Mr. Trump and Dr. Hahn also said they planned to allow patients to gain access to an experimental drug, remdesivir, through a policy known as “compassionate use.” Compassionate use is typically used to grant access to not-yet-approved experimental drugs to give potentially lifesaving treatments to patients who might otherwise die.

When the president was asked if it was acceptable that there were such shortages of masks some health care workers were being urged to reuse them, he turned to Vice President Mike Pence. Mr. Pence said that there had been “a dramatic increase in production” in masks, but did not say when they would be in the hands of health care workers.

Mr. Trump gave mixed signals on whether he would use the Defense Production Act, which authorizes presidents to take extraordinary action to force American industry to ramp up production of critical equipment and supplies. In this case, the list could include ventilators, respirators and protective gear for health care workers.

When asked why he hadn’t yet compelled companies to do this — especially given the projected shortages of masks and lifesaving ventilators — the president first told reporters that governors were responsible for buying equipment for their states.“Nobody in their wildest dreams would have thought we would need tens of thousands of ventilators,” he said. But he said he would use the power if needed, before adding ambiguously, “You don’t know what we have done.”

Dr. Deborah Birx, the White House coronavirus response coordinator, said that a large backlog of pending tests would be released in the next two to three days.

She said that 50 percent of reported coronavirus cases in the United States have come from 10 counties, and praised health care workers for prioritizing available tests for people who show symptoms. She added that the number of positive results had increased as a result.

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