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The Food and Drug Administration (FDA) on Friday warned against the use of hydroxychloroquine or the closely related chloroquine for COVID-19 outside of hospitals or clinical trials. The drugs, approved decades ago for several uses, including the treatment of malaria, have shown promise in small studies and in hospitals for treating COVID-19 but other studies have suggested harmful side effects or no evidence they work against the new disease. The FDA said in the warning that it was aware of reports of heart rhythm problems seen in some patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with...

The U.S. Food and Drug Administration is warning doctors against prescribing a malaria drug widely touted by President Donald Trump for treating the new coronavirus outside of hospitals or research settings. In an alert Friday, regulators flagged reports of serious side effects and death among patients taking hydroxychloroquine and the related drug chloroquine. The drugs, also prescribed for lupus, can cause a number of side effects, including heart rhythm problems, severely low blood pressure and muscle or nerve damage.

As the lockdown continues across the world, pharmaceutical companies are accelerating their efforts to provide a vaccine to prevent the spread of the virus. Unfortunately, Moderna, the company which has gained prominence in news headlines for developing Mrna-1273 vaccine to fight the disease, uses cells of aborted babies. Although alternatives exist which could be considered morally acceptable, they are not getting as much coverage as Moderna’s vaccine work. Suspicions about the vaccine were raised after checking Moderna’s patents and in particular, the use of the Spike (S) protein. The idea behind using this Spike protein in a vaccine with messenger...

Christine Blasey Ford takes a break in her testimony before the Senate Judiciary Committee, Thursday, Sept. 27, 2018 on Capitol Hill in Washington. Lawyers seated are Debra Katz and Michael Bromwich. (Saul Loeb/ Pool Image via AP) It’s almost like The New York Times is nothing but a partisan gossip rag.Yesterday, a story was put out by Maggie Haberman that made a rather convenient claim that just so happened to reinforce every media narrative. Namely, that an FDA official named Rick Bright was fired for selflessly sounding the alarm on the supposed vast dangers of hydroxychloroquine. Breaking News: A doctor who...

A “glaring scientific breakdown” at the CDC’s main laboratory was behind the federal agency’s failure to quickly make a coronavirus test kit... One of the three test components became contaminated because the way the Centers for Disease Control and Prevention laboratory put the kits together violated sound manufacturing practices... cross contamination because the chemical mixtures were put together into testing kits in a lab space that was also dealing with synthetic coronavirus material. The Food and Drug Administration also concluded the CDC violated its own laboratory standards,

The Food and Drug Administration has approved the first at-home test for the coronavirus. It's made by LabCorp, that said due to limited quantities, it will first be made available to healthcare workers and first responders... The FDA approval is not a "general authorization for at-home collection of patient samples" and only applies to the LabCorp testing kit. Right now, the kits are available in Maryland, New Jersey, New York and Rhode Island.

The Food and Drug Administration (FDA) on Tuesday announced that is authorizing the first coronavirus test that allows patients to collect samples at home themselves. The FDA said the emergency authorization would make coronavirus testing easier and smoother by allowing some patients to collect their test samples without having to leave home. The patients, after using the nasal swab, would then mail the sample to LabCorp, the company that makes the test, to be tested. “With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” FDA Commissioner...

The FDA has authorized the first diagnostic test with a home collection option for COVID-19, the disease caused by coronavirus. In a statement released Tuesday, the FDA said that it had reissued an Emergency Use Authorization for LabCorp to COVID-19 RT-PCR Test to permit testing of samples that were self-collected by patients at home using LabCorp's Pixel by LabCorp COVID-19 Test home collection kit. "Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options," said FDA Commissioner Dr. Stephen Hahn.

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...

The surge of interest in testing for the COVID-19 pathogen has led to some innovative tests and test strategies, including at-home tests. However, the FDA has indicated that it is wary of both at-home testing and specimen collection in other than supervised settings, a policy that is meeting with criticism from some quarters, but not all. Everlywell Inc., of Austin, Texas, had announced March 18 that it had a test kit available for shipment that would have permitted at-home collection of samples that could have been analyzed via telehealth. The company indicated it had 30,000 such kits available, but the...

The Food and Drug Administration (FDA) is under fire for being too slow to approve at-home tests in the coronavirus crisis. Earlier this month, the agency announced it would allow labs to sell tests, and apply for emergency approval 15 days later. Several companies jumped to offer their tests in a use-at-home format, and some even began selling them. Most of the tests were to be taken by an individual at home, and then would be mailed to an approved lab for analysis – a process already used for many medical tests. But on March 20, the FDA updated their...

MADISON (WKOW) -- Sen. Ron Johnson (R-WI) has organized a letter from physicians to push President Donald Trump to increase access to the Malaris drug Hydroxychloroquine. In his letter, he urges the President to remove restrictions that would allow patients to try the drug early in the course of their COVID-19 diagnosis. The first request is for the President to remove FDA Emergency Use Authorization restriction that states hydroxychloroquine (HCQ) and chloroquine (CQ) from the Strategic National Stockpile are only approved "for certain hospitalized patients. " Johnson also requests in the letter that President Trump issues an executive order to...

The CDC designed a flawed test for COVID-19, then took weeks to figure out a fix so state and local labs could use it. New York still doesn’t trust the test’s accuracy. As the highly infectious coronavirus jumped from China to country after country in January and February, the U.S. Centers for Disease Control and Prevention lost valuable weeks that could have been used to track its possible spread in the United States because it insisted upon devising its own test. The federal agency shunned the World Health Organization test guidelines used by other countries and set out to create...

"The failure to conduct early and wide testing left politicians ignorant of basic facts about the COVID-19 epidemic. Public officials across the United States are flying blind against the COVID-19 epidemic. Because of a government-engineered testing fiasco, they do not know how fast the virus is spreading, how many people have been infected by it, how many will die as a result, or how many have developed immunity to it. The failure to implement early and wide testing, which was caused by a combination of short-sightedness, ineptitude, and bureaucratic intransigence, left politicians scrambling to avoid a hospital crisis by imposing...

QUEENS, New York — On Sunday night, March 15, I started feeling achy. By Monday night, I was achy all over. However, on Tuesday, I felt better, as I did all day Wednesday. On Thursday night, March 19, the aches returned. On Friday, I was sick: I had a fever, ached all over, was extremely lethargic, and lost my appetite. That weekend, as I collapsed on my couch, President Donald J. Trump told journalists that he thought an anti-malaria drug called hydroxychloroquine might be a promising treatment against COVID-19. “I’m not saying it will, but I think that people may...

Dr. Stephen McColgan, chief medical officer at California-based Vivera Pharmaceuticals, told "Tucker Carlson Tonight" Wednesday that his company's rapid coronavirus antibody test is ready to be deployed, but is being held up by "red tape" at the Food and Drug Administration (FDA). "We have a rapid antibody test. And the key to this is, this is part of the solution to the crisis," McColgan said. "It identifies patients that have immunity and it identifies people that can give plasma [to] critically ill patients. "It was developed in Germany," McColgan said. "Germany has the lowest mortality from COVID-19 globally at this...

DENVER (CBS4)– Colorado Congresswoman Diana DeGette wants the FDA to look into the hoarding of drugs used to treat coronavirus. She said the prescriptions for hydroxychloroquine can take away the drugs from those who really need them. Hydroxychloroquine has been touted by President Donald Trump as a treatment for COVID-19 patients. There is a dispute among medical professionals about the effectiveness of the drug for coronavirus. Using it for coronavirus has also resulted in a huge demand and shortage.

This gem from the AP last night was posted here: https://apnews.com/a04cb47fc2fd9dff61118e5086aabb0e One doesn’t realize the absolute ignorance of our media until they report on an area where one has expertise. You also realize the degree to which the media relies on the public’s ignorance. The conflation of FDA approval of an expanded use of an approved drug or drugs and efficacy for that expanded or new use in the above article is astounding. Everyday, a physician somewhere prescribes a drug for a use for which it was not originally approved. Everyday. But just because the drug is not approved for...

A fight broke out in the White House Situation Room over the weekend between Dr. Anthony Fauci and another member of President Trump’s coronavirus task force, with the exchange getting so intense that Vice President Mike Pence and others were left trying to calm down the country’s trade czar, according to a report. The argument, which Axios reports took place Saturday afternoon, ensued when FDA Commissioner Stephen Hahn brought up the topic of hydroxychloroquine, the malaria drug Trump believes could help fight the virus. White House trade adviser Peter Navarro then stood up and distributed reading materials on what he...