According to these doctors the FDA said, at the time of the disciplining and still says on their web site as of this writing, that (see horse image right/below as well):
- The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals. Ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea.
- Currently available data do not show ivermectin is effective against COVID-19. Clinical trials assessing ivermectin tablets for the prevention or treatment of COVID-19 in people are ongoing.
- Taking large doses of ivermectin is dangerous.
- If your health care provider writes you an ivermectin prescription, fill it through a legitimate source such as a pharmacy, and take it exactly as prescribed.
- Never use medications intended for animals on yourself or other people. Animal ivermectin products are very different from those approved for humans. Use of animal ivermectin for the prevention or treatment of COVID-19 in humans is dangerous.
The FDA, according to the suit, also said a number of other similar things.
According to the doctor's lawyer on Epoch Times (link here):
 |
| From the linked FDA web page. |
“The FDA has made public statements on ivermectin that have been misleading and have raised unwarranted concern over a critical drug in preventing and treating COVID-19,” Marik told The Epoch Times. “To do this is to ignore both statutory limits on the FDA’s authority and the significant body of scientific evidence from peer-reviewed research.”
Fast forward to today. We are in Federal court. Here's what the FDA attorney's have to say (source here):
“The cited statements were not directives. They were not mandatory. They were recommendations [underline mine]. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin,” Isaac Belfer, one of the FDA.
Just a "recommendation" - right... What you "should do". That's a directive, not a request, especially when you are the biggest bully on the block...
How about this Mr. FDA for "consequences" of your "recommendations" (just a few of many):
(Note on the last one - it mentions the "FDA Warning" - hmmm - see how some interpret "should do" - I wonder what that exact warning was?)
Funny how, when under oath, things become a bit different clearer.
(Remember, we are following the science here...)
Jared Kelson, the plaintiffs attorney, told the court that informal claim “doesn’t explain the language they actually used: ‘Stop it. Stop it with the ivermectin.'”
The FDA’s posts, comments, and actions “clearly convey that this is not an acceptable way to treat these patients,” Kelson argued.
We also know the government, including the FDA, were in cahoots with Facebook and other big tech social media companies (see my post on this here).
Words and actions have consequences, Mr. FDA.
Today we also know, from situations like Honduras about which I reported here, that Ivermectin works in this context.
From this more recent Epoch Times article:
“Plaintiffs have also not shown that any of their claimed injuries are fairly traceable to defendants’ statements because their injuries were caused by independent third-party conduct that was not a predictable response to those statements,” Belfer, an FDA lawyer, said in response to Kelson.
Belfer noted that the FDA’s pages say people can use ivermectin if their health care provider prescribes it, argued the statements “did not bind the public or FDA, did not interpret any substantive rules, and did not set agency policy,” and said the FDA’s position could change in the future if new data become available.
“They also do not have legal consequences for anyone but simply provide nonbinding recommendations to consumers,” he said.
Just take a look at the FDA vaping media (see https://www.fda.gov/media/159410/download) and its consequences. No more vaping, period. Sure, the FDA is just "making a recommendation"... Destroying entire industries and increasing use of combustion tobacco - but no matter...
Attorney Kelson disagreed: “If the government is going to label ivermectin a horse medicine or a horse dewormer and promulgate the idea that it is only for animals, then the natural correlation is that doctors who prescribe it are horse doctors or quack doctors, which has played out,” he said. “That is enough of a harm to get into court,” or have the motion to dismiss rejected, he said.
“The government engaged in a singularly effective campaign here to malign a common drug that has been used for a very long time and has been dispensed in billions of doses. It’s one of the most famously safe drugs in the history of human medicine. And when people did exactly what the FDA said to ‘Stop it. Stop it with the ivermectin,’ I don’t understand how that would not be traceable back to the FDA,” Kelson said.
It will be interesting to see what the judge rules...
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