Thread by @DoctorTro

🚨 THREAD 🚨

Discussing how science and regulatory process has been hijacked …

People often asked me, “Doc, can you give us example of the regulatory system being messed up…”

1/

These questions are often hard to answer without a long story, but this morning’s email from the AMA makes it easy.

Backstory: Two section heads from the FDA resigned because the administration put political pressure to approve the Pfizer vaccine for adolescents.

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The administration disbanded the VRBPAC, which is the advisory committee where doctors discuss the data and make a recommendation for or against approval.

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This process was bypassed for the approval for adolescents/boosters, and after these high-profile resignations and news articles outlining these issues, the FDA brought back the VRBPAC for the <5 year olds.

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The meeting for <5 year olds is scheduled for mid February.

TODAY, the AMA, in an email, released CPT codes for the off-label use of a pediatric vaccine, that has not yet gone to VRBPAC, or received approval yet, and of note this age group even had a FAILED 2-dose trial…

5/

meaning at this point “the science” doesn’t support it’s use in this population…

And yes “the science” is basically recommending it & preparing for it

This is NOT appropriate procedure or policy. In fact it’s unacceptable. We have advisory committee meetings for a reason.

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But the AMA is basically promoting off-label use PRIOR to any basic regulatory processes. It is wrong.

This isn’t about medicine, science or data anymore…

This is about expanding a label and protecting the industry.

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Yes, I’m otherwise vaccinated, yes so are my kids, yes I recommend the COVID vaccine to many of my patients…

This ain’t right

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