Thread by @eturnermd1

“In recent years, under steady pressure from the pharmaceutical industry and the patient groups it funds, the F.D.A. has progressively lowered its standards of effectiveness and safety required for drug approvals.” via @nytopinion ⁦@akesselheim⁩ nytimes.com/2021/06/15/opi…

“…reached a low point last week when the F.D.A. approved aducanumab, a treatment for Alzheimer’s disease that has not been convincingly shown to work and can cause brain swelling and hemorrhage.”

“more than half of new drugs are now approved based on what’s called surrogate endpoints — changes in the body measured by lab tests that may not reflect clinical benefit — rather than requiring that the drug affect how a person feels, functions or survives.”

“an outside advisory committee for the agency was nearly unanimous in its ruling that the drug had failed to show strong evidence that it worked.”

“Committee members were also concerned about the drug’s safety, since about a third of patients taking a higher dose had evidence of brain swelling.”

“One of us, @akesselheim, was a member of that committee and has resigned as a result of the F.D.A.’s inexcusable decision to approve the drug anyway.”

“It unexpectedly approved the drug based on a theory that it could affect amyloid protein levels in the brain…Many investigational drugs have targeted amyloid levels without affecting the progression of this terrible disease.”

“Even worse, although aducanumab was tested only in patients with mild disease, the F.D.A. inexplicably approved it for use in any person with Alzheimer’s, regardless of severity.”

“It enters the market now as a monthly intravenous infusion with a $56,000 price tag and the need for regular M.R.I. scans to monitor for the possible brain swelling it can cause.”

“Now that the bar has been lowered, other companies are likely to seek similar pathways to approval.”

“If pressure from drugmakers and their lobbyists compels F.D.A. administrators to continue to loosen their standards, we need a new organization to review drug approvals and make evidence-based assessments of their clinical impact, as other countries do.”

Excellent piece by @akesselheim & Jerry Avorn in @nytimes, which I have extensively quoted from in this thread.

We similarly saw the @US_FDA bending over backwards in various ways to approve #esketamine #Spravato for treatment-resistant depression in March 2019.

Each time the @US_FDA lowers the bar for approval, it seems to embolden them to try to outdo themselves the next time and lower the bar even further.