FDA allows Novartis to test hydroxychloroquine against COVID-19

The U.S. Food and Drug Administration (FDA) and Novartis have reached an agreement to allow the Swiss pharmaceutical company to proceed with a clinical trial of hydroxychloroquine for patients with COVID-19, the disease caused by the novel coronavirus. Novartis announced on Monday that it will begin enrollment for phase III of the clinical trial within the next few weeks and that the study will be conducted in more than a dozen U.S. labs. The trial is set to evaluate the anti-malaria drug, which President Trump has repeatedly touted as a potential "game changer" in the fight against COVID-19. Health officials have insisted, however, that not enough is known about the drug to determine its efficacy. The FDA last month issued an emergency-use authorization for hydroxychloroquine to be distributed and prescribed by doctors to COVID-19 patients when a clinical trial is not available.

The Novartis clinical trial will study the anti-malaria drug's effects on approximately 440 patients, the company said, adding that the drug supply would be provided by Sandoz, its generics and biosimilars division. “We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, head of global drug development and chief medical officer at Novartis. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”

Trump has repeatedly promoted hydroxychloroquine in recent weeks, even as health officials on the White House coronavirus task force stress that there is no scientific evidence the drug is effective in treating COVID-19. There is no cure for the virus, which has infected more than 2.4 million people worldwide. The announcement from Novartis follows the company's move to pledge 130 million tablets of hydroxychloroquine to supply global clinical research efforts focused on the drug. The Health and Human Services Department announced in March that it received 30 million doses.

https://thehill.com/policy/healthcare/493622-fda-allows-novartis-to-test-hydroxychloroquine-against-covid-19

Dr. Fauci urges caution about relying on coronavirus antibody tests

White House coronavirus task force member Dr. Anthony Fauci is urging caution about relying on coronavirus antibody tests to determine whether someone who has recovered from the illness is immune. Fauci said on “Good Morning America” that “we still have a way to go” with antibody, or serology, tests, which check for proteins in the immune system through a blood sample. The presence of proteins means a person was exposed to the coronavirus and developed antibodies against it, which may mean they have at least some immunity. Health officials suggested that tests could be used as a way to help determine when to reopen communities.

“The problem is that these are tests that need to be validated and calibrated, and many of the tests out there don’t do that. So even though you hear about companies flooding the market with these antibody tests, a lot of them are not validated,” Fauci said. “There’s an assumption — a reasonable assumption — that when you have an antibody that you are protected against reinfection, but that has not been proven for this particular virus. It’s true for other viruses,” he said. The director of the National Institute of Allergy and Infectious Diseases added that “we don’t know how long that protection, if it exists, lasts. Is it one month? Three months? Six months? A year? “So the assumption that with the tests that are out there, if you have an antibody positivity, you’re good to go — unless that test has been validated and you can show there’s a correlation between the antibody and protection, it is an assumption to say that this is something that we can work with,” Fauci said. “We still have a way to go with them,” he added.

Meanwhile, Fauci also said there would be no real economic recovery if the US doesn’t get coronavirus “under control.” “Clearly, this is something that is hurting from the standpoint of economics, from the standpoint of things that have nothing to do with the virus,” Fauci said when asked about protests that have erupted across the US amid shelter-in-place orders. “Unless we get the virus under control, the real recovery economically is not going to happen,” he told ABC’s George Stephanopoulos. “If you jump the gun and go into a situation where you have a big spike, you’re going to set yourself back,” Fauci continued. “So as painful as it is to go by the careful guidelines of gradually phasing into a reopening, it’s going to backfire.”

https://nypost.com/2020/04/20/facui-urges-caution-about-relying-on-coronavirus-antibody-tests/

Adam Schiff’s Dirty Impeachment Tactics Coming to Light

Rep. Adam Schiff spent months launching secret impeachment hearings, never thinking his conduct would be called into question. He is now caught in the crosshairs of a formidable government agent, Mr. Brendan Carr, Federal Communication Commissioner. The impeachment may be over, but Mr. Carr is formally investigating Rep. Schiff for violating privacy laws – more like obliterating ethical boundaries – by setting up his own surveillance state to target the president’s allies. Carr is currently uncovering the diabolical nature of the congressman’s “surveillance state.” At the time, Schiff resorted to such desperate measures because he didn’t have much of an impeachment case: Therefore, he issued secret subpoenas to phone carriers hoping to mine the private data of his political opponents, or in effect ransacking their private lives. The objective was to obtain and publish the calls of Trump’s allies.

Much to his delight, Schiff’s subpoenas to the phone carriers resulted in their turning over nearly 4,000 pages of confidential records, in the process violating their customers’ rights to data privacy. None of this has escaped the notice of the top gun at the FCC. Carr is proposing a $200 million fine against the phone carriers for failing to protect their customers who have a legitimate expectation of privacy.

The FCC commissioner, in reviewing the nearly 4,000 pages, had a very pointed question to ask as part of his investigative letter to the House Intelligence Committee (where Schiff serves as chairman). “Is Rep. Schiff continuing to issue secret subpoenas?” That translates to mean: Does the congressman plan to continue to run roughshod over the private lives of political opponents while employing abusive impeachment tactics? Before the FCC stepped in, Schiff had already performed much of his cloak-and-dagger work targeting some of the president’s most ardent supporters. Schiff’s committee took additional clandestine measures in issuing the subpoenas, even slapping a gag order on Republican leaders. Undoubtedly, those targeted by the congressman were blindsided by the process because they were deprived of their legal right to fight the surveillance requests. They included Rudy Giuliani, attorney for the president, Rep. Devin Nunes, ranking Republican on the Intelligence Committee, John Solomon, conservative journalist, and others. As part of the FCC investigation, Carr dropped a major bombshell, which most likely won’t make the news cycle on CNN or other leftist outlets. Carr lambasted Schiff for “exceeding his authority” by publishing call records that lack “any apparent nexus to the Committee’s legitimate work.” Some would argue this isn’t the first time Schiff has strayed from “legitimate work”. The congressman, now serving his 10th term in the House, has carved out a special role for himself as the “go to” Trump-hating politician devoting hundreds of hours to interviews with fawning reporters. It can almost be argued that his audience is the media, filtering everything the public should hear. What more can a politician ask for? Many of those fawning reporters interviewing Schiff about the impeachment proceedings were the very same talking heads who had heard the congressman impart an endless stream of salacious gossip and “credible” leaks to fuel the Russia-collusion hysteria.

https://www.americanthinker.com/articles/2020/04/adam_schiffs_dirty_impeachment_tactics_coming_to_light.html