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

Approves Alzheimer drug despite objections from science advisory panel & statisticians.
=============

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.

===========

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

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s