US judge slams pharma regulator for rubbishing drug ivermectin

The world’s most powerful drug regulator has been humiliated after a US federal court ruled it was out of bounds in telling Americans they were not a “horse” so should not take the drug ivermectin – an anti-parasitic medication whose inventors won the Nobel Prize for medicine in 2015 – to treat Covid-19.

The US federal appeals court in Louisiana on Friday (Saturday AEST) ruled the Food and Drug Administration erred in a tweet that went viral in August 2021, saying “You are not a horse. You are not a cow. Seriously, y’all. Stop it”, in response to reports, later debunked, that Americans were overdosing by taking the drug as an alternative to Covid vaccines.

“FDA is not a physician. It has authority to inform, announce, and apprise – but not to endorse, denounce, or advise,” judge Don Willett wrote for the appeals court. “The doctors have plausibly alleged that FDA’s posts fell on the wrong side of the line between telling about and telling to,” the judge concluded, referring to three doctors who had sued the FDA for, in effect, stymieing their ability to prescribe ivermectin to their patients.

Mary Bowden, one of the plaintiffs, claimed her ability to prescribe ivermectin for patients had been undermined by the FDA’s social media posts, which caused some pharmacies to withhold the drug, in addition to reputational damage caused.

“I’ve treated over 6000 Covid patients now and found ivermectin not only effective but also extremely safe,” she told The Australian in an interview.

Throughout the pandemic an aggressive war emerged between some doctors and pharmaceutical regulators over the utility of two off-patent drugs, ivermectin and hydroxychloroquine, which some observational studies had shown to be effective if prescribed early in the onset of Covid-19 symptoms.

In January the US federal court blocked California from enforcing a new state law that would have punished doctors for giving advice contrary to the government public health and pharmaceutical regulators.

“There are a number of significant public health risks associated with taking ivermectin in an attempt to prevent Covid-19 infection rather than getting vaccinated,” Australia’s Therapeutic Goods Administration said in September 2021, as it banned Australian doctors from prescribing the drug.

Dr Bowden suspected institutional resistance to ivermectin for Covid-19, in the US and other developed nations including Australia, stemmed from a desire to encourage take-up of next-generation vaccine technology.

“If they had a safe, effective treatment, that would be an obstacle to getting the vaccine out, which really is too big to fail, just too much money and ego involved,” she said.

It has been reported that US law prevented the granting of Emergency Use Authorisation for then new Covid-19 vaccines, which have generated more than $US110bn in revenue for the three US pharmaceutical giants if existing prophylactic treatments were already available.

Robert Clancy, a retired University of Newcastle professor of immunology, told The Australian it was “nonsense to say ivermectin didn’t work”. “It was panned because it would have stopped the FDA and TGA from legally allowing the Covid-19 vaccines,” he posited.

In 2021, America’s top podcaster, Joe Rogan, and CNN butted heads over the drug after the latter accused Rogan, who said he had taken the drug via a prescription from his doctor, had consumed “horse dewormer”.

The TGA in May reversed its 2021 ban on prescribing ivermectin for Covid-19, claiming “sufficient evidence the safety risks to individuals and public health” was “low”.

However, the TGA does not endorse off-label prescribing of ivermectin for the treatment or prevention of COVID-19.

Asked if drugs such as ivermectin were more effective than the Covid-19 vaccines, Dr Bowden said “hands down, the medications”. “That’s what prompted my scepticism to begin with: I was seeing a lot of patients coming in who had been vaccinated, and they were just as sick if not sicker than the patients that were not vaccinated.”

https://www.theaustralian.com.au/world/us-judge-slams-pharma-regulator-for-rubbishing-drug-ivermectin/news-story/b0a97b6f280eb007e4db3e5fa20e2cdc

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Why Won't COVID Lockdown Artists Admit They Were Wrong?

COVID mania just won't go away. The deadly strains of the virus have been gone for two years now, and yet the recent outbreak of a mild flu-like variant is again stoking panic on the Left.

Nearly 100 universities are requiring masks this fall.

Lionsgate movie studios in Los Angeles and Atlanta-based Morris Brown College recently stated they are reinstating not just mask mandates but social distancing measures and contact tracing.

CNN, which led the panic in 2020 and 2021 -- causing manic school, restaurant and business shutdowns and vaccine mandates -- recently put out a headline on its website that encouraged its readers not to go outside without a mask on. Really? The latest evidence finds this is less dangerous than a normal flu virus and tracking data suggest that the wave has already peaked.

What's even more disturbing here is that the leftist medical community and the media aren't renouncing their calls for mitigation strategies that were catastrophically wrong in the panic era of 2020 and 2021 -- but instead calling for more of these assaults on freedom in the future.

It is one thing for well-meaning medical experts to have disagreed about how to best combat a once-in-a-half-century deadly virus. We didn't know exactly what we were dealing with. But now we know with concrete scientific evidence that most mandates and lockdowns had a small impact on the spread of the virus and on fatalities. It turns out there was almost no difference in death rates in states with strict lockdowns and no lockdowns at all. The same is true of cross-country evidence.

Healthy children were never at risk from COVID (something we knew early on), so shutting down schools for one or two years was a sop to the teachers unions but a disaster for this generation of kids. Test scores are the worst in 30 years.

Before the pandemic, only 15% of public school students were chronically absent -- more than 18 or more days a year.

Stanford University education professor Thomas Dee's data shows an estimated 6.5 million additional students are now chronically absent. In Connecticut and Massachusetts, chronic absenteeism remains double its pre-pandemic rate.

But polls show that Democrats -- even those who are highly educated -- generally still support the lockdowns that were mandated. These are the same people who lecture about "following the science." The most comprehensive study by experts at Johns Hopkins University found death rates from lockdowns were reduced by 0.1 percent. But how many people died from the isolation of lockdowns, delayed health screening from cancer, the increase in drug overdoses?

Biden's vaccine mandates only made Americans more resistant to get pricked. They backfired.

Worst of all, Anthony Fauci, who remains a hero of the Left, recently not only refused to admit the errors of his advice but said the "lockdown was absolutely justified."

Why does this bizarre rewrite of recent history matter? Because the fearmongering Left can't wait to install new lockdowns every time we have a new flu virus and health scare. They've even started putting out feelers for occasional climate change economic shutdowns.

Those who love freedom must strenuously resist this coming tyranny.

https://townhall.com/columnists/stephenmoore/2023/08/29/why-wont-covid-lockdown-artists-admit-they-were-wrong-n2627693

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Back in Masks?

Dr. Jill Biden has COVID with “mild symptoms,” and though Joe Biden tested negative, he’s in a mask, despite both of them being stuck full of shots and boosters. Anthony “The Science” Fauci is on CNN extolling the efficacy of masks. Did we fall in a time warp and end up in 2021 again? Is Biden’s pandemic presidency ever going to be over?

Not if Democrats once again use COVID to rig the election with bulk-mail ballots.

The truth, of course, is that COVID is now endemic, not a pandemic. It’s going to be around for a while in whatever mutated form happens to spread this week. Most people now think of it as a mild or sometimes bad cold. But some people want more panic.

White House Press Secretary Karine Jean-Pierre promises the 80-year-old Biden is “not experiencing any symptoms,” but he “will be masking while indoors and around people, in alignment with CDC guidance.”

Or not.

Those CDC guidelines stipulate that people should test, wear masks, and self-isolate after exposure, “regardless of your vaccination status or if you have had a previous infection.” The guidelines were last updated in August 2022. Biden didn’t follow the CDC, even while presenting the Medal of Honor to 81-year-old Larry Taylor and then immediately fleeing the room, so why should anyone else?

“We are in a very good position to deal with COVID-19 in the fall,” Jean-Pierre added, “and we’re going to continue to listen to the experts as we move forward.”

Ah, the “experts.” Those would be the same experts who politicized a virus and wrecked our economy over it.

Speaking of those “experts,” the 82-year-old Fauci says he’s “concerned that people will not abide by recommendations.” Lavishly retired but still making appearances on CNN, Fauci opined, “I would hope that if we get to the point that the volume of cases is such and organizations like the CDC recommends — CDC does not mandate anything — recommends that people wear masks, I would hope that people abide by that recommendation and take into account the risks to themselves and their families.”

Oh don’t worry, Tony. We’re taking things into account and know exactly where you can stick those recommendations.

After he patronized the American people with his sanctimony, Fauci continued talking out of both sides of his mouth about masks. CNN’s Michael Smerconish challenged Fauci to explain the huge Cochran Review study of randomized tests earlier this year that concluded, “Wearing masks in the community probably makes little or no difference.” Just as all the experts knew back in early 2020 before politics took the place of science.

“When you’re talking about the effect on the pandemic as a whole, the data is less strong,” Fauci sputtered. “But when you talk about an individual basis of someone protecting themselves … there’s no doubt that there’s many studies that show that there is an advantage [to masks].” Whatever, dude.

This is the same guy who in March 2020 said, “There’s no reason to be walking around with a mask.” That was before he told us it was “common sense” to wear not one mask but two.

Fauci’s “credibility is entirely shot,” said Stanford epidemiologist Jay Bhattacharya back in 2021. “He’s been all over the place on masks.”

Masks aren’t all, either. Fauci lied about that little matter of U.S. taxpayer funding for gain-of-function research at the Wuhan lab that leaked COVID into the world. More evidence that he knew of that funding back in 2020 before spending years denying it just came to light this week. Can we get a lockdown of Fauci?

Meanwhile, the same people who want to help kids change their gender want those kids to mask up in schools again. Because science, or something.

Maybe Fauci wouldn’t be “concerned” about people ignoring medical advice if anything the “experts” said made any sense at all anymore.

https://patriotpost.us/articles/100239-back-in-masks-2023-09-06

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) 

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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