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Third member of FDA panel resigns over approval of Biogen Alzheimer's drug

49 点作者 AndrewBissell将近 4 年前

5 条评论

qzw将近 4 年前
For context, this is from November 2020:<p><a href="https:&#x2F;&#x2F;www.cnbc.com&#x2F;2020&#x2F;11&#x2F;06&#x2F;biogen-suffers-setback-after-alzheimers-drug-fails-to-win-support-from-fda-panel-.html" rel="nofollow">https:&#x2F;&#x2F;www.cnbc.com&#x2F;2020&#x2F;11&#x2F;06&#x2F;biogen-suffers-setback-after...</a><p>Patient advocacy groups were pushing for approval pretty strongly. From the article:<p><i>&gt;In a letter sent to the FDA ahead of the meeting, the Alzheimer’s Association said the publicly released data so far “justifies approval accompanied by a Phase 4 post-marketing surveillance study.”<p>“The alternative, requiring completion of an additional Phase 3 trial, would deny broad access up to four years while it is completed. A four-year delay is too long to wait for millions of Americans facing a progressive, fatal disease. A four-year delay is too long to wait for millions of American caregivers,” the organization said.</i><p>I have a family member who suffers from Alzheimer&#x27;s, and it&#x27;s a devastating disease. She&#x27;s progressed too far for this drug, whether it works or not. But I can understand the desire for all the patients&#x2F;families that still have some hope to have <i>something</i>, even if there&#x27;s only a small chance it would work. On the other hand, if the FDA begins approving drugs not backed up by data, then it opens up the flood gates for all kinds of snake oil. It&#x27;s a pretty tough call.
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andredz将近 4 年前
&quot;Three FDA Advisers Resign over Agency’s Approval of Alzheimer’s Drug&quot; <a href="https:&#x2F;&#x2F;news.ycombinator.com&#x2F;item?id=27468756" rel="nofollow">https:&#x2F;&#x2F;news.ycombinator.com&#x2F;item?id=27468756</a>
MattGaiser将近 4 年前
At a certain point even the most robust regulatory processes are going to give way to desperate searches for hope, no matter whether they make sense.<p>There hasn&#x27;t been a drug for this in 20 years.
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phnofive将近 4 年前
See also: <a href="https:&#x2F;&#x2F;news.ycombinator.com&#x2F;item?id=27468756" rel="nofollow">https:&#x2F;&#x2F;news.ycombinator.com&#x2F;item?id=27468756</a>
readonthegoapp将近 4 年前
Damn props to those folks for resigning<p>Too much regulatory capture with all our agencies<p>Sucks and is dangerous
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