FDA Refuses To Change Anti-Ivermectin Statements After Court Ruling

Sunday, Sep 17, 2023 - 10:15 PM

Anti-ivermectin statements made by the FDA are not being changed, even after an appeals court ruled against the agency.

The U.S. Food and Drug Administration (FDA) is refusing to change its statements against ivermectin, even after a court said it acted outside of its authority when it told people to stop using it to treat COVID-19.

The U.S. appeals court said that the FDA's statements, including one telling people to "stop" using ivermectin as a COVID-19 treatment, went beyond the authority conferred on the agency by Congress. “FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine,” U.S. Circuit Judge Don Willett wrote in the Sept. 1 ruling.

Two weeks later, FDA social media posts and a key webpage remain unchanged: That includes an Aug. 21, 2021, Twitter post, on the social media site since renamed X, that hyperlinked to a FDA webpage and stated: "You are not a horse. You are not a cow. Seriously, y'all. Stop it." The page has not been updated either. It says people "should not use ivermectin to treat or prevent COVID-19."

The appeals court did not order the FDA to take any action and remanded the case to a lower court for consideration on standing. But Dr. Robert Apter, the lead plaintiff in the case that led to the ruling, said that the FDA should still take action.

"From an ethical point of view, the FDA has been told not to do what they are doing. They have an ethical and moral obligation to follow the court’s directive and stop giving advice against using effective repurposed drugs for early treatment of COVID," Dr. Apter told The Epoch Times in a message.

The FDA declined to comment. "The FDA does not comment on possible, pending, or ongoing litigation," a spokesperson told The Epoch Times via email.

In a statement after the ruling was handed down, the agency noted that ivermectin is approved by the FDA but for other uses. The FDA "has not authorized or approved ivermectin for use in preventing or treating COVID-19, nor has the agency stated that it is safe or effective for that use," the agency said…..

Ruling

• In the ruling, a U.S. Court of Appeals for the Fifth Circuit panel found in favor of Drs. Apter, Mary Talley Bowden, and Paul Marik, overturning a previous decision.

• The doctors sued the FDA in 2022 over its anti-ivermectin statements, arguing the agency was illegally interfering with their practice of medicine.

• While the Federal Food, Drug, and Cosmetic Act enables the FDA to inform consumers, it does not let the agency give medical advise, Jared Kelson, an attorney representing the doctors, told the panel during oral arguments.

U.S. District Judge Jeffrey Brown had ruled against the plaintiffs, finding the FDA acted within the authority conferred by the act.

The panel disagreed.

• "FDA never points to any authority that allows it to issue recommendations or give medical advice," Judge Willett wrote. “Nothing in the act’s plain text authorizes FDA to issue medical advice or recommendations,” he also said.

• "The decision is pretty clear that the FDA is not a physician, and that while it might have authority to inform the public, it can't endorse particular treatments or advise on how to approach any specific illness," Mr. Kelson told The Epoch Times.He declined to comment on whether the FDA should update its statements.

The appeals court decision trumps the previous ruling, but the panel also sent the case back to Judge Brown. The FDA had asked the appeals court to dismiss the case based on lack of standing. The court said it chose not to decide on the standing issue.

"We see greater wisdom in remanding for the district court to address standing and any other jurisdictional issues in the first instance," the panel said. "We express no view on those issues, and instead we trust their initial determination to the district court’s sound judgment."

That means Judge Brown will take up the case again, but that his ruling on standing could be overturned.

The government could also appeal the recent appeals court ruling. That appeal would go to the U.S. Supreme Court.The U.S. Department of Justice, which is representing the FDA, did not respond to a request for comment.

https://www.zerohedge.com/political/fda-refuses-change-anti-ivermectin-statements-after-court-ruling

NATO Fractures: In U-Turn, Poland Announces It Will No Longer Arm Ukraine

by Tyler Durden Wednesday, Sep 20, 2023 - 07:00 PMYES!

The dam is breaking on unified Western support for Ukraine, and the timing couldn't be worse for Zelensky, given tomorrow he's expected to meet with President Biden at the White House. On Wednesday evening there's monumental news out of Poland which could potentially change the entire course of the war

"Poland will no longer arm Ukraine to focus on its own defense," Polish prime minister Mateusz Morawiecki announced just hours after Warsaw summoned Ukraine's ambassador related to a fresh war of words and spat over blocked grain exports, according to the AFP. Warsaw has throughout more than a year-and-a-half of the Ukraine-Russia war been Kiev's staunchest and most outspoken supporter.

Will this massive and hugely significant about-face mark the beginning of the end? Are peace negotiations and ceding of territory in the Donbas inevitable at this point?

Within the last 48 hours relations between Poland and Ukraine quickly spiraled to their lowest point since the Russian invasion, and it's directly related to Warsaw joining a handful of EU countries which extended a grain export ban on Ukraine, amid continuing anger and outrage from Polish farmers who are suffering due to their country being flooded with cheap Ukrainian wheat.

Crucially, Poland will hold crucial parliamentary elections on Oct.15. The prior atmosphere of enthusiastic pro-Kiev rhetoric has drastically changed, now with comparisons likening Ukraine to a "drowning man". As The Associated Press explains:

Polish leaders have compared Ukraine to a drowning person hurting his helper and threatened to expand a ban on food products from the war-torn country. Meanwhile, Ukrainian President Volodymyr Zelenskyy suggested that EU allies that are prohibiting imports of his nation’s grain are helping Russia.

Now, Polish officials, who are trying to win parliamentary elections next month with help from farmers’ votes, are expressing dismay over some of Ukraine’s latest moves, including a World Trade Organization complaint over bans on Ukrainian grain from Poland and two other EU countries.

Poland’s elections are Oct. 15… https://t.co/DRwG37xGut — Mark MacKinnon (@markmackinnon) September 20, 2023

developing…

https://www.zerohedge.com/geopolitical/nato-fractures-u-turn-poland-announces-will-no-longer-arm-ukraine

20 Sep, 2023 19:35

UN must adapt to new world – Kremlin

The globe is undergoing dramatic changes and the organization must adjust to them, the President Putin's spokesman has said

The existing system of international law is floundering, while the modern world is plagued by an array of conflicts, Kremlin spokesman Dmitry Peskov has said. He made the remarks in an interview with RT Arabic on Wednesday, calling upon the UN to adapt to a changing world.

“It is evident that the world is currently undergoing dramatic tectonic changes. Changes are underway, this requires a certain adaptation on the part of the UN; first of all, of its main body – the Security Council,” Peskov said.

However, Peskov ruled out the possibility of creating a new international organization to replace the UN, stating that the international body’s tools should be “developed and honed” instead.

“It is too early to talk about this yet. Thus far, the main body is the UN, we have no other. And in the current situation, when the whole world is riddled with conflicts, when international law is trampled upon, and economic relations, the system of Bretton Woods relations are de facto collapsing, I don’t think we can say that we will be able to create some other system. This is simply impossible,” Peskov explained.

The Security Council currently consists of 15 members, ten of which serve two-year terms and cannot veto resolutions. Only five permanent members – the US, UK, China, France, and Russia – hold such power. Russia has advocated a more diverse Security Council for years, arguing that the body can be democratized only through increasing the representation of African, Asian, and Southern American states.

Recently, multiple world leaders and top officials have called for a reform of the UN Security Council, criticizing the institution as a dysfunctional one and lacking a fair representation of leading nations of the world. The issues confronting the council have been acknowledged by UN Secretary-General Antonio Guterres as well, who has said a reform is long overdue to better reflect the “realities of today’s world.”

(This is huge, I wonder if Russia and other countries have pointed out the corruption, human trafficking etc. to the UN leadership.)

https://www.rt.com/russia/583310-un-security-council-adapt/

20 Sep, 2023 14:21

==G7 believes (hopes) Ukraine conflict will last until end of decade – Bloomberg

Members of the group must plan financially to continue support for Kiev during the protracted conflict, a senior official said

The Russia-Ukraine conflict may extend for another six to seven years, according to a senior G7 official who spoke with Bloomberg. The official emphasized that Kiev's allies will confront various challenges as they endeavor to sustain their support for Ukraine.

In an article released on Tuesday, multiple officials, speaking on the condition of anonymity, indicated that the prolonged timeline resulted from Ukraine's much-heralded counteroffensive progressing slowly, which has led to “tempered expectations.”

Continuing to provide military and financial aid to Kiev for such a long conflict “won’t be easy,” said Czech Foreign Minister Jan Lipavsky. “It’ll put a lot of pressure on societies, on governments, through different elections in Europe,” he added, stressing that there has to be a “midterm strategy of long-term support to Ukraine.”

One top European official informed Bloomberg that even with the support provided, Ukraine will likely grapple with challenges stemming from insufficient Western weapons supplies and the escalating toll of manpower losses.

Regardless of this dire outlook, Kiev and its allies remain opposed to negotiations and are unwilling to accept any resolution that does not include the complete withdrawal of Russian troops from territories Ukraine claims as its own, the officials told the outlet.

Kiev, for its part, has consistently emphasized its unwillingness to make any territorial concessions to Russia as part of potential peace agreements. In an interview with CBS News on Sunday, Ukrainian President Vladimir Zelensky affirmed that despite the counteroffensive’s slow pace, Ukraine remains committed to it regardless of adverse weather conditions or other factors.

Ukraine initiated its offensive in June; however, territorial gains have proven elusive, with heavy casualties being the predominant outcome. According to Russian President Vladimir Putin, Ukraine has incurred substantial losses during this push, including over 71,000 troops, 543 tanks, and nearly 18,000 armored vehicles.

Last year, four former Ukrainian territories – the Donetsk and Lugansk People’s Republics and the Kherson and Zaporozhye Regions – voted to join Moscow after holding public referendums. Kiev and its allies have refused to recognize the votes, while Zelensky has signed a decree banning any negotiations with the current Russian leadership.

Moscow, meanwhile, has repeatedly said that it has not closed the door on negotiations with Kiev but has urged the Ukrainian leadership to recognize the “realities on the ground.”

(These greedy SOBs, they just want to destroy Russia and they like the money from war, so they are willing to submit their people to pain and suffering for a SHITHOLE country. The members of the G7 are the United States, Canada, the United Kingdom, France, Germany, Italy, and Japan. The leaders of the member countries meet periodically, mainly to discuss economic and monetary issues, though they also tackle political issues at times. The G7 was once called the G8, as it included Russia.)

https://www.rt.com/russia/583293-ukraine-conflict-g7-estimate/