Court to FDA: Stop Playing Doctor: The Fifth Circuit revives a lawsuit over advice against taking ivermectin for Covid; The Real Data Behind the New COVID Vaccines the White House is Pushing, and other C-Virus related stories

Photo: Ted S. Warren/Associated Press

WSJ: Court to FDA: Stop Playing Doctor:

The Fifth Circuit revives a lawsuit over advice against taking ivermectin for Covid

The Food and Drug Administration regulates pharmaceuticals, but it has no business playing doctor and giving you medical advice. That’s the message of a Sept. 1 ruling from the Fifth U.S. Circuit Court of Appeals, which strikes a blow against the public-health excesses of the Covid-19 pandemic and in support of the physician-patient relationship.

The decision reversed a district court’s dismissal of an action by three physicians who alleged the FDA overstepped its authority by issuing medical advice. That lawsuit will now proceed.

The physician-plaintiffs had prescribed the human version of the antiparasitic drug ivermectin to Covid-19 patients. The doctors claimed that six FDA informational releases—which the court dubbed the “posts”—interfered with physicians’ “ability to exercise professional medical judgment in practicing medicine” by advising Covid-19 patients not to use ivermectin.

The physicians also alleged the posts resulted in harms to their reputations. One was referred to state medical boards for prescribing ivermectin, and the referrals included copies of the FDA’s posts. Another lost her hospital admitting privileges. The third lost medical school and hospital positions.

The physicians argued that the FDA posts were ultra vires—beyond the agency’s legal power or authority—under the Administrative Procedure Act and the Food, Drug and Cosmetic Act. The appellate court agreed: “FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine” and that nothing in the law’s plain text “authorizes FDA to issue medical advice or recommendations.”

The physicians claimed the right to prescribe an approved drug off-label—for a use different than that approved and labeled by the FDA. Off-label use accounts for about a fifth of all prescriptions. Existing medications are often repurposed because their safety profiles are already established. Repurposing was common early in the pandemic when no treatments or vaccines were available. --->READ MORE HERE

NY POST: The real data behind the new COVID vaccines the White House is pushing:

What if I told you one in 50 people who took a new medication had a “medically attended adverse event” and the manufacturer refused to disclose what exactly the complication was — would you take it?

And what if the theoretical benefit was only transient, lasting about three months, after which your susceptibility goes back to baseline?

And what if we told you the Food and Drug Administration cleared it without any human-outcomes data and European regulators are not universally recommending it as the Centers for Disease Control and Prevention is?

That’s what we know about the new COVID vaccine the Biden administration is firmly recommending for every American 6 months old and up.

The push is so hard that former White House COVID coordinator Dr. Ashish Jha and CDC head Mandy Cohen are making unsupported claims the new vaccine reduces hospitalizations. long COVID and the likelihood you will spread COVID.

None of those claims has a shred of scientific support.

In fact, if the manufacturers said that, they could be fined for making false marketing claims beyond an FDA-approved indication.

The questions surrounding Moderna’s new COVID vaccine approved this week are still looming.

Pfizer’s version, approved this week as well, also has zero efficacy data and has not been tested on humans at all. We only have data about antibody production from 10 mice.

The FDA, or Moderna (frankly, it’s hard to tell the difference sometimes), should disclose what happened to the patient who took the new vaccine and had a complication that required medical attention.

The public has a right to know. --->READ MORE HERE

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