Not one FDA expert voted to approve new Alzheimer’s drug, but it was approved anyway
The Food and Drug Administration (FDA) recently approved a new Alzheimer’s drug even though their expert review panel rejected the fraudulent end points that were used to promote the drug’s “efficacy!” Even though the three-member panel voted unanimously against the drug, the agency overruled their expert scientific analysis and approved the new drug anyway, opting to rely on a separate measure promoted by the drug company itself. In protest, the three FDA advisors resigned from their positions, leaving bare the FDA’s compromised state and scientific fraud.
The FDA no longer functions as an effective drug regulator, nor do they properly scrutinize medical fraud. With thousands of people dying after covid vaccines, it has become glaringly obvious that a protective and law-abiding FDA does NOT exist any longer. The FDA won’t revoke the emergency use authorization for these bioweapon delivery systems, and are therefore complicit in crimes against humanity.
FDA sets “dangerous precedent” disregarding their own scientific panel
One of the men who opposed the new drug was Dr. Aaron Kesselheim, director of Brigham and Women’s Hospital Program on Regulation, Therapeutics and Law. He said the approval of the drug Adulhelm sets “a dangerous precedent” on the type of evidence an Alzheimer’s therapy would need in order to gain FDA approval. He warned that the FDA abandoned the science and allowed the drug company to “turn around and at the last minute seek [accelerated approval] when their primary clinical endpoints in their trials don’t reach the level needed for [traditional] FDA approval.”
The new drug promotes an untested theory that amyloid plaque treatments can reverse Alzheimer’s. Jason Karlawish, a geriatrician and co-director of the Penn Memory Center in Philadelphia, Pennsylvania says the amyloid plaque reduction hypothesis has been studied for decades but no science has proven that these reductions improve cognition of Alzheimer’s patients. “Desperation should drive the funding of science, not drive the way we interpret the science,” Karlawish says.
Despite the controversy, Big Pharma’s mainstream media was already prepared to market the new drug, with hope-filled headlines for Alzheimer’s patients. Behind the scenes, however, this hope is based on fraudulent clinical endpoints, much like the clinical studies for the new covid vaccines, which also used fraudulent clinical endpoints and misleading interpretation of the data.
FDA approves new drugs based on correlations, not substantial scientific evidence
George Perry, a neurobiologist at the University of Texas at San Antonio, said “This is going to set the research community back 10–20 years,” because it will discourage drug developers from focusing on treatments that actually affect cognition in a profound way. The neurologists argue that demonstration of amyloid-lowering activity should not be the gold standard to win regulatory approval for new Alzheimer’s drugs. This is similar to the FDA’s emergency use approval for covid vaccines which is based on fraudulent diagnostic criteria and relies on chance and false correlations, with no comparison of the actual symptoms caused by the vaccines compared to any symptoms following positive PCR tests.
Another member of FDA’s expert panel, neurologist J. Perlmutter, decided to quit the committee “due to this ruling by FDA without further discussing with our advisory committee.” Mayo Clinic neurologist David Knopman followed suit, giving the FDA his letter of resignation. He said Biogen’s Aduhelm “was probably the worst drug approval decision in recent U.S. history.” Knopman, Perlmutter and Kesselheim were ahead of the curve last November, studying the Biogen’s fraud. Because they had previously exposed the drug’s fraudulent trial results and published a paper on the drug’s flaws in JAMA, the FDA recused Knopman from having any authority on the matter. The FDA now over-rules its own scientific panel and helps these drug company’s falsely market their fraudulent products.