20 March 2020 00:45
US President said, a drug currently used as an antimalarial, hydroxychloroquine would be made available almost immediately to treat coronavirus. According to the details, Trump, speaking at a news conference, pointed to efforts on Gilead Sciences Inc's experimental antiviral drug Remdesivir and the generic antimalarial drug hydroxychloroquine, saying he had called on the U.S. Food and Drug Administration to streamline its regulatory approval process. Trump said, "We have to remove every barrier or a lot of barriers that were unnecessary and they've done that to get the rapid deployment of safe, effective treatments and we think we have some good answers." FDA Commissioner Stephen Hahn carefully tempered the President's remarks regarding his team's work to develop treatments for coronavirus. He said, "The FDA is committed to continuing to provide regulatory flexibility and guidance, but let me make one thing clear: the FDA's responsibility to the American people is to ensure that products are safe and effective." Trump likened the FDA's approach to "Right to Try," an approach championed by conservatives and libertarians that allows for patients with fatal illnesses to be treated with unapproved therapies. The key difference between "Right to Try" and FDA's compassionate use is that doctors, patients and drug companies that participate don't need to get the FDA to approve the individual course of treatment.
The "Right to Try" law signed by Trump in May 2018 came after years of opposition by the pharmaceutical industry, which was afraid that more liberal distribution of experimental drugs outside of controlled clinical trials could result in lawsuits or make it harder to win FDA approval if a patient's condition did not improve or there were adverse side effects. But since it was implemented, there have been only a handful of instances of "Right to Try" being used, and most drug companies prefer to use the FDA's compassionate use process. And the "Right to Try" policy was intended by lawmakers as a last resort for patients with a rare, lethal disease. Hahn appeared to walk back the idea that "Right to Try" was the FDA's desired approach in this case, arguing that the FDA needed the patient use data to make an informed decision about whether the drugs would ultimately be safe and effective for the broader population. President Donald Trump announced a drug Thursday that could be used to treat the coronavirus, but some experts disputed its effectiveness.
Afterwards, in terms of adverse effects, at increased doses, it is possible that patients will have pain or fever, but it seems that the treatment is effective at lower doses, according to the Chinese data. Hydroxychloroquine was first tested in a laboratory setting for use against COVID-19 by Chinese Academy of Science researchers, who published their findings March 9. They found the drug to effectively kill the deadly virus. This week, French researchers released results from a preliminary trial using 36 COVID-19 patients. Twenty of the patients received 600 milligrams of hydroxychloroquine daily, and the remainder did not to act as a control group.
After six days, 70% of the patients who received the drug were considered cured, compared with only 12.5% of the control group, according to Newsweek. "The results have yet to be fully scrutinized, and of course, it is essential to conduct other, larger controlled trials to determine accurately the effectiveness of [the drug] as a treatment for COVID-19. FDA has NOT approved malaria drug chloroquine for COVID-19, an FDA spokesperson confirms to me referring me to @stevefda's remarks at the press conference — Anna Edney (@annaedney) March 19, 2020 Trump said in the news conference Thursday that "We're going to be able to make that drug available immediately" by prescription. "Normally the FDA would take a long time to approve something like that, and it's--it was approved very, very quickly and it's now approved by prescription," Trump said. However, conflicting reports from Bloomberg say the FDA says it hasn't been approved yet. "An FDA spokesperson said the drug had not been approved for use in Covid-19 patients. However, U.S. doctors are legally able to prescribe a drug for any illness or condition they think is medically appropriate." — Anna Edney, Bloomberg FDA Commissioner Stephen Hahn said the U.S. will use hydroxychloroquine first in a clinical, controlled trial. Experts still hold out hope that this old, inexpensive drug could be the answer to the coronavirus pandemic affecting hundreds of thousands globally. "If clinical data confirm the biological results, the novel coronavirus-associated disease will have become one of the simplest and cheapest to treat and prevent among infectious respiratory diseases," researchers in the March 9 lab study concluded. Support real journalism. Your subscription to the Atlanta Journal-Constitution funds in-depth reporting and investigations that keep you informed. Thank you for supporting real journalism. The Bank of England could barely wait more than a week before cutting interest rates again. The U.K. central bank, in a surprise and unscheduled meeting, opted to cut interest rates to 0.1% from 0.25%, having only cut them from 0.75% last week. The Bank of England said most of the bond purchases will be government securities. "Over recent days, and in common with a number of other advanced economy bond markets, conditions in the U.K. gilt market have deteriorated as investors have sought shorter-dated instruments that are closer substitutes for highly liquid central bank reserves. As a consequence, U.K. and global financial conditions have tightened," the Bank of England said in a move that echoed the European Central Bank's actions from Wednesday night. The cut also made history, dropping the rate to its lowest in the history of the Bank of England: The Bank of England also said its regularly scheduled monetary-policy meeting on March 25 will go ahead.