3 ms·
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/in
by fn-mote 5y ago
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-onyx-e2-80-99-how-biogen-used-an-fda-back-channel-to-win-approval-of-its-polarizing-alzheimer-e2-80-99s-drug/ar-AALzzpL 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.)
- londons_explore 5y agoI would really like each FDA approval to come with a piece of text to be printed on the bottle along the lines of: "The FDA found this drug to improve quality of life Vs a placebo, p<0.005". And if, during use of the drug, that statement becomes no longer true, withdraw use for all new patients.
- Vecr 5y agoI'm not really sure that would be helpful, what does "improve quality of life" mean? The prescribing guide gives information about how the drug works (or how it's suspected/hoped to work), and it should have detailed information about side effects and benefits with percentages as seen in trials. It is first-party marketing material, so it has to be in agreement with verified data submitted to the FDA.
- refurb 5y agoHey that's a fantastic idea! Oh wait, the FDA has been doing exactly that for the past 70 years.
- deleted 5y ago[deleted]
- sanarothe 5y agoThanks I like STAT news but I just can't justify paying $300/year - And I know I'm not special enough to get my company to pay for it :)