Tag: FDA

CDC Downplayed News of Vax Myocarditis

Mary Pat Campbell

Link: https://checkyourwork.kelleykga.com/p/cdc-downplayed-news-of-vax-myocarditis

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Excerpt:

With the recent discovery that the CDC drafted — but never sent — a Health Alert in May 2021 about myocarditis after mRNA vaccination, I put together this timeline about vaccine myocarditis news and updates from government officials. I include a combination of documents from CDC and FDA, as well as what was covered in the mainstream media.

I think this timeline shows a pattern in which CDC & FDA failed to adequately investigate and inform the public about the risks of myocarditis early in the vaccine rollout. However, there was public acknowledgement by the CDC, as early as May 20, 2021, about a potential pattern of myocarditis after the 2nd dose of mRNA vaccines, particularly in young men.

On June 1, 2021, the CDC confirmed that they had identified a higher than expected signal of myocarditis for young men after mRNA vaccination, but that they still recommended Covid vaccination for everyone in this age group. Despite a lot more analysis and discussion of myocarditis after that, and a changing landscape with widespread natural immunity, the CDC & FDA position has changed very little since that time.

Author(s): Kelley in Georgia

Publication Date: 19 Jan 2024

Publication Site: Check your Work on substack

Social Media Is Fueling Enthusiasm for New Weight Loss Drugs. Are Regulators Watching?

Mary Pat Campbell

Link: https://kffhealthnews.org/news/article/social-media-is-fueling-enthusiasm-for-new-weight-loss-drugs-are-regulators-watching/

Excerpt:

Competition to claim a market that could be worth $100 billion a year for drugmakers alone has triggered a wave of advertising that has provoked the concern of regulators and doctors worldwide. But their tools for curbing the ads that go too far are limited — especially when it comes to social media. Regulatory systems are most interested in pharma’s claims, not necessarily those of doctors or their enthused patients.

Few drugs of this type are approved by the FDA for weight loss — they include Novo Nordisk’s Wegovy. But after shortages made that treatment harder to get, patients turned to other pharmaceuticals — like Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro — that are approved only for Type 2 diabetes. Those are often used off-label — though you wouldn’t hear that from many of their online boosters.

The drugs have shown promising clinical results, Jaisinghani and her peers emphasize. Patients can lose as much as 15% of their body weight. Novo Nordisk is sponsoring research to examine whether Wegovy causes reductions in the rate of heart attacks for patients with obesity.

The medications, though, come at a high price. Wegovy runs patients paying cash at least $1,305 a month in the Washington, D.C., area, according to a GoodRx search in late March. Insurers only sometimes cover the cost. And patients typically regain much of their lost weight after they stop taking it.

Author(s):Darius Tahir and Hannah Norman

Publication Date: 18 Apr 2023

Publication Site: KFF Health News

When Will The FDA Approve Paxlovid?

Mary Pat Campbell

Link: https://astralcodexten.substack.com/p/when-will-the-fda-approve-paxlovid

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For context: a recent study by Pfizer, the pharma company backing the drug, found Paxlovid decreased hospitalizations and deaths from COVID by a factor of ten, with no detectable side effects. It was so good that Pfizer, “in consultation with” the FDA, stopped the trial early because it would be unethical to continue denying Paxlovid to the control group. And on November 16, Pfizer officially submitted an approval request to the FDA, which the FDA is still considering.

As many people including Zvi, Alex, and Kelsey have noted, it’s pretty weird that the FDA agrees Paxlovid is so great that it’s unethical to study it further because it would be unconscionable to design a study with a no-Paxlovid control group – but also, the FDA has not approved Paxlovid, it remains illegal, and nobody is allowed to use it.

One would hope this is because the FDA plans to approve Paxlovid immediately. But the prediction market expects it to take six weeks – during which time we expect about 50,000 more Americans to die of COVID.

Perhaps there’s not enough evidence for the FDA to be sure Paxlovid works yet? But then why did they agree to stop the trial that was gathering the evidence? Or perhaps there’s enough evidence, but it takes a long time to process it? But then how come the prediction markets are already 90% sure what decision they’ll make?

Author(s): Scott Alexander

Publication Date: 22 Nov 2021

Publication Site: Astral Codex Ten

Federal law prohibits employers and others from requiring vaccination with a Covid-19 vaccine distributed under an EUA

Mary Pat Campbell
Federal law prohibits employers and others from requiring vaccination with a Covid-19 vaccine distributed under an EUA

Excerpt:

The same section of the Federal Food, Drug, and Cosmetic Act that authorizes the FDA to grant emergency use authorization also requires the secretary of Health and Human Services to “ensure that individuals to whom the product is administered are informed … of the option to accept or refuse administration of the product.”

Likewise, the FDA’s guidance on emergency use authorization of medical products requires the FDA to “ensure that recipients are informed to the extent practicable given the applicable circumstances … That they have the option to accept or refuse the EUA product …”

Author(s): Aaron Siri

Publication Date: 23 February 2021

Publication Site: Stat News

Myths of Vaccine Manufacturing

Mary Pat Campbell

Link: https://blogs.sciencemag.org/pipeline/archives/2021/02/02/myths-of-vaccine-manufacturing

Excerpt:

The first thing to understand is that these are not, of course, traditional vaccines. That’s why they came on so quickly. mRNA as a vaccine technology has been worked on for some twenty to twenty-five years now, from what I can see, and (as I never tire of mentioning) we’re very fortunate that it had worked out (and quite recently) several of its outstanding problems just before this pandemic hit. Five years ago we simply could not have gone from sequence to vaccine inside of a year. And I mean that “we” to mean both “we the biopharma industry” and “we the human race”.

At this point, let me briefly dispose of an even less well-founded take that’s been going around as well. I’ve seen a number of people say something like “We had the vaccine back in February! It only took until the end of the year to roll it out because of the FDA!” The main thing I’ll say about that idea is that no one who actually works on vaccines, in any capacity, has any time for that statement. Not all vaccine ideas work – we’re already seeing that with the current coronavirus, and if you’d like to talk to some folks about that, then I suggest you call up GlaxoSmithKline and Sanofi and ask them what happened to their initial candidate, and while you’re at it, call up Merck and ask them what happened to their two. Note that I have just named three of the largest, most experienced drug companies on the planet, all of whom have come up short. So no, we did not “have the vaccine” in February.

Author(s): Derek Lowe

Publication Date: 1 February 2021

Publication Site: Science Magazine