FDA no longer requires informed consent | James Lyons-Weiler, PhD

REMINDER: The FDA has amended its regulations to "[allow] an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject..."🚨 (1/3)

CEO, scientist, author, and human rights advocate James Lyons-Weiler (@lifebiomedguru) describes for Wayne Rhode (@waynerohde) how an entry into the Federal Register published in December of 2023, dubbed "Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations," allows for scientists and physicians in the U.S. to experiment on people—including children—without their informed consent.

"Basically what this document talks about is whether or not you and I and our children, or grandchildren...have any say whatsoever [regarding] whether doctors can do experiments on you. [That is] include you in a clinical trial with your knowledge and consent," Lyons-Weiler says, referring to the "rule" entered in the Federal Register. The scientist notes that while "that might seem like it's impossible, that they would go this far and do this, because, hey, this is the United States of America," the principles of informed consent "are rapidly decaying like quicksand right at our feet..."

"What the language says is that your doctor can do it [experiment on you] if the doctors or a doctor has determined that, for you, there is minimal risk," Lyons-Weiler says. He notes, however, that "as we saw with COVID-19 vaccines, and other things, like COVID-19 drugs...where they got risk wrong, the ability of physicians and doctors that want to do the studies, or pharmaceutical scientists that want to do the studies, to assess risk early on, does not exist."

"They have no ability to assess risk," the scientist adds.

Lyons-Weiler goes on to note that "what a doctor can do [now] is call a pharmacist and say, 'I wanna change my patient's drugs—they used to be on drug A, now we're going to put them on drug B. But it's part of a clinical trial, so it has to be labeled like drug A.'" He adds that would mean that "you think you're taking drug A, but the doctor can give you a different drug entirely and you don't know what's in it, you don't know what it's made of, you don't know the risk profile. You have no information that it's even happening to you."

This would be true of pharmaceuticals as well as "vaccines."

"[I]t seems like the only logical thing that any thinking American can possibly do to protect themselves is to refuse any pharmaceutical product whatsoever, because you never know what you're going to get," Lyons-Weiler says. He adds that this language also means that "they've written themselves a pass to go ahead and experiment on...children without the parent knowing."

Incredibly (although perhaps not unexpectedly), Lyons-Weiler says that it was Anthony Fauci and his wife who decided to write a paper, published in 1986, that said "of the two people in the room making a decision about medical care for a patient, the person who has the most say over consent should be the doctor, because the doctor knows more than the patient." The scientist notes that "this is Fauci-ism to a T. It's paternalistic, it's anti-freedom, it's anti informed consent."

"[Fauci] and people like him are stripping away your rights to know what's going into your body," Lyons-Weiler adds.

SOURCE: https://x.com/SenseReceptor/status/1802775783343071491