1/ Great thread here by my old friend @CharlesBHolmes.
Regeneron's press release (not a study!) didn't comment on side-effects. With other monoclonal antibodies, side-effects have included fever, chills, weakness, headache, nausea, vomiting, diarrhea, low blood pressure, & rash.
2/ More severe side-effects may include: life-threatening anaphylaxis, cytokine release syndrome (also caused by COVID), cardiac toxicity, clotting dysfunction, immune-related effects, infections, autoimmunity, and off-target effects.
3/ The Regeneron monoclonal antibody cocktail is so new we don't yet have data on its side-effects. And it hasn't been tested in older patients, like the president.
4/ Yes, monoclonal antibodies are a promising approach for the treatment of COVID (more here: podcasts.apple.com/us/podcast/s1e…), but I find it perplexing that such an experimental drug with unknown risk profile would be given to the president.
5/ I also think it's strange that the decision to treat the president with monoclonal antibodies was made without consultation with an infectious disease specialist or members of the WH Coronavirus Taskforce, who are among the world's leading experts (e.g. Dr. Fauci).
6/ It's certainly possible that the president's decompensation and need for hospitalization could be due to the monoclonal antibody cocktail, but in the absence of information and transparency on the part of the WH, it's impossible to know.
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What’s changed isn’t the science. It’s the process.
Policy is increasingly announced by officials online & outside the usual evidence review, creating mixed messages for families.
on @CBSMornings with @edokeefe @TheKellyOGrady
2/ Normally, FDA reviews products, then CDC’s vaccine advisers (ACIP) publicly weigh evidence & vote.
CDC adopts guidance, which insurers & programs like Medicaid, the Children's Vaccine Program (CHIP), & Vaccines for Children follow.
That process has been corrupted.
3/ This season, the FDA narrowed COVID vaccine approvals:
🔹People 65+
🔹People 6m to 64y if they have at least one risk factor for severe COVID (including pregnancy)
Off-label use:
🔹Healthy people 6m to 64y in consultation with your doctor
The director was fired less than a month into her tenure, four senior leaders resigned in protest, & the agency is still reeling from a shooting at its Atlanta HQ.
on @CBSNews @FaceTheNation with @EdOKeefe
2/ These aren’t just headlines about “palace intrigue.”
What’s unraveling is the basic machinery that keeps Americans safe: vaccines, outbreak detection, lab guidance, and expert support for state health departments.
3/ Within hours of the firing of CDC Director Dr. Susan Monarez’s, 3 leaders—responsible for vaccine safety, respiratory diseases, & the chief medical officer role—resigned.
Earlier that week, CDC’s head of data systems also stepped down.
1/ After the shooting at CDC earlier this month, employees sent a blunt letter to HHS Secretary Robert F. Kennedy Jr.
They said that instead of standing with them, RFK Jr. is spreading conspiracy theories about the CDC & their work.
on @CBSEveningNews with @jdickerson
2/ They called this dangerous & made 3 requests:
🔹Stop spreading inaccurate health info
🔹Affirm CDC’s scientific integrity
🔹Guarantee safety of the HHS workforce
Because a major new U.K. clinical trial—the largest & longest yet—found that even “improved” UPFs can’t match the benefits of minimally processed meals. 🍎🥗