from Hacker News

Biogen used an FDA back channel to win approval of its Alzheimer’s drug

by lighttower on 7/5/21, 2:53 AM with 39 comments

• by jmcgough on 7/5/21, 4:01 AM

  This is so messed up. Time and time again we've seen drugs that target amyloid beta fail to have any effect, and this one is no different.

  Not only were the studies inconclusive, but they were only of people with very mild Alzheimer's or even pre-alzheimers and yet the FDA is approving it for any patient with Alzheimer's.

  Just stealing billions of dollars from desperate people.

• by tima101 on 7/5/21, 3:53 AM

  So two large clinical studies concluded that this antibody drug does not work. Nevertheless, FDA approved drug and Biogen stock went up.

  Aren't we just a bunch of greedy monkeys?

  PS: Therapy costs $56,000/year. My question stands.

  PPS: Seems like Medicare will pay for it, so burden is on taxpayers.

• by ta988 on 7/5/21, 3:47 AM

  And people wonder why others wouldn't trust federal instances with health recommendations during the pandemic. This is exactly this kind of stories that undermine the trust in those institutions, and these effects ripple far away in the future...

• by KKKKkkkk1 on 7/5/21, 6:28 AM

  "Back channel" here seems like a euphemism for bribery.

• by fn-mote on 7/5/21, 3:36 AM

  Non-paywall link, seems to be the exact same article (see references to "STAT has learned ..." in the MSN-hosted article):

  https://www.msn.com/en-us/news/us/inside-e2-80-98project-ony...

  At the end: "This is an abridged version of a STAT special report." (It doesn't seem very abridged! To do more they would have to give dates of the meetings or something.)

• by bpodgursky on 7/5/21, 4:14 AM

  I get the qualms around this approval of a drug that very plausibly does not work, but I feel that too much ire is being directed at the FDA instead of at Medicare for paying for any approved drug. That's the core issue here — not that Biogen is allowed to sell the drug, but that public funds will be drained to pay for it.

  Yeah sure this might not work, but the FDA is reasonably confident it doesn't make things _worse_, and if it does actually work, there's immense potential for lives improved. Alzheimer's is truly a devastating blow to any family with a member who get it. So why not approve it? Bare minimum, we'll get more data.

• by hprotagonist on 7/5/21, 1:11 PM

  This is egregious.

  The reasonable way to kill this, by the way, is for Medicare to decline to reimburse for the drug. It’ll be approved, but it’ll be dead on arrival.

• by newbie789 on 7/5/21, 3:31 AM

  Is there a non-paywalled link for this?

• by vmception on 7/5/21, 3:32 AM

  hm, paywall and archive.is shows the wall too

  tl;dr, what's the backchannel and will this become an area of concern?