Archive for June 24th, 2021

FDA: “Following the science & the data is over-rated.”

June 24, 2021

Approves Alzheimer drug despite objections from science advisory panel & statisticians.
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OK, the FDA didn’t explicitly say that following the science & the data is over-rated.

Nor did it explicitly say: “Do as we say, not as we do.”

But…

Last week, the FDA approved aducanumab — Biogen’s controversial new Alzheimer’s drug.

But, according to the WSJ, the FDA did so despite doubts about the therapy’s effectiveness.

Specifically. the FDA’s drug biostatistics office concluded that “substantial evidence of effectiveness had not been provided in the application.”

Accordingly, the FDA’s scientific advisory panel recommended against approval of the drug, “questioning whether  it provides any benefit at all.”

But, the FDA ignored the panel’s advice and approved the drug any way.

So, several of the panel members resigned, calling the decision  “probably the worst drug approval decision in recent U.S. history.”

Ouch.

More gently, critics say the FDA “ignored the scientific standards it typically holds drugmakers.”

So much for following the science and the data.

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For the record, given my family’s medical history, I’m rooting for Alzheimer-attacking drugs … and I’m a strong proponent of “right to try”.

So, I’m ok with the FDA’s decision.

But, I’m getting tired of elite pontificators telling me to follow elusive, unsettled  science … and, very tired of lying political-scientists