5 ms·

I won't presume your qualifications, but I'll just state my opinion: the people who are qualified to perform benefit risk assessments are the people writing pap

by Niksko 5y ago

I won't presume your qualifications, but I'll just state my opinion: the people who are qualified to perform benefit risk assessments are the people writing papers saying that the benefit risk assessment is favourable. You might be qualified to make that assessment. But you'd be in disagreement with most of your peers.

s1artibartfast 5y ago
This statement should give you pause when the FDA has rejected the risk benefit assessments of the qualified advisory committees. https://www.nbcnews.com/news/amp/rcna2074 https://www.nbcnews.com/news/amp/rcna2074 https://www.rollcall.com/2021/11/17/fda-to-sidestep-advisers-on-boosters-for-all-approval/ https://www.rollcall.com/2021/11/17/fda-to-sidestep-advisers...
- acdha 5y ago
  That was a narrow rejection based on incomplete evidence, as explained in the article. They were relying only on old U.S. data and still believed that the original 2 shots were adequate protection. This was in question at the time and subsequently there’s been a clear consensus that a booster is necessary at least until the original short timing is fixed, and, of course, that was before Omicron greatly increased the risk of exposure.
  - nradov 5y ago
    The original 2 shots still provide good protection. Whether that's "adequate" or not is entirely subjective and arbitrary.
  - s1artibartfast 5y ago
    I don't think that a post-hoc justification is sufficient here. Policy makers didn't have advance knowledge that the scientific experts didn't. It may have worked out in this case, but what about the next? In particular, I am concerned about the risk assessments for the <5 population. Or perhaps the next drug\therapy. Looking abroad, you will also find cases where expert panels found questionable risk/benefit for some groups and were overruled.
    - acdha 5y ago
      Most of what I said was available at the time (not Omicron, of course). The US agencies chose not to take non-US data seriously, similarly to when the CDC acted like Delta would magically stop at the border after it was causing huge problems in the UK & India.
raxxorrax 5y ago
I assume this is to peer pressure and other dynamics at this point. The benefit for young people is nearly not quantifiable.

by Niksko 5y ago

s1artibartfast 5y ago

This statement should give you pause when the FDA has rejected the risk benefit assessments of the qualified advisory committees. https://www.nbcnews.com/news/amp/rcna2074 https://www.nbcnews.com/news/amp/rcna2074 https://www.rollcall.com/2021/11/17/fda-to-sidestep-advisers-on-boosters-for-all-approval/ https://www.rollcall.com/2021/11/17/fda-to-sidestep-advisers...

acdha 5y ago
That was a narrow rejection based on incomplete evidence, as explained in the article. They were relying only on old U.S. data and still believed that the original 2 shots were adequate protection. This was in question at the time and subsequently there’s been a clear consensus that a booster is necessary at least until the original short timing is fixed, and, of course, that was before Omicron greatly increased the risk of exposure.
- nradov 5y ago
  The original 2 shots still provide good protection. Whether that's "adequate" or not is entirely subjective and arbitrary.
- s1artibartfast 5y ago
  I don't think that a post-hoc justification is sufficient here. Policy makers didn't have advance knowledge that the scientific experts didn't. It may have worked out in this case, but what about the next? In particular, I am concerned about the risk assessments for the <5 population. Or perhaps the next drug\therapy. Looking abroad, you will also find cases where expert panels found questionable risk/benefit for some groups and were overruled.
  - acdha 5y ago
    Most of what I said was available at the time (not Omicron, of course). The US agencies chose not to take non-US data seriously, similarly to when the CDC acted like Delta would magically stop at the border after it was causing huge problems in the UK & India.

raxxorrax 5y ago

I assume this is to peer pressure and other dynamics at this point. The benefit for young people is nearly not quantifiable.