RFK Jr, HHs & Public Health News | Measles outbreak, etc.
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Several things but biggest driver was a significant outbreak among Orthodox Jews in NYC (Brooklyn) who refuse vaccinations on religious grounds. Mostly little kids got sick and a big push to get over 90% MMR vaccinations rates ultimately succeeded.
This graph is weird. What the hell happened in 2019??
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A Trump Administration?
This graph is weird. What the hell happened in 2019??
He’s such a loon.
Lots of good Kennedys. Little Robert Kennedy is a loon by his own efforts.
I know. Just saying he must have been screwed up by his dad getting killed and couldn't handle the whole Kennedy name. He definitely has a few screws loose.
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I tend to think it was his venturing into being an environmental advocate. In that sort of undertaking, it is very easy to see corporations as evil and unwilling to spend even a dime to save a multitude of lives. That sort of mind-set makes it easy to see conspiracies everywhere. Being an environmental advocate while maintaining a healthy and reality based understanding of corporate behavior is an extremely difficult balance to maintain. It's just easier to assume all corporations are run by evil persons seeking to outsouce all costs onto anyone without the means to resist. It's a tough area in which to maintain one's composure and objectivity. But it can be done. I have personally met people who simultanously advocated for protection of the environment without falling into the trap that everyone who isn't with you is both against you and evil.
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Received a communication from FDA asking us to limit the number of submissions for a particular product to 2 for the rest of the year. Submissions meaning data from studies that support updates to the prescribing information. This hasn’t ever happened in anyone’s recollection.
He was never an environmental advocate - it's pure mythmaking. He's a legal grifter at his core, and environmentalism was simply his grift of choice. It's worth a read to see how Kennedy isolated Robert Boyle, one of the great environmental writers of the 20th Century, out of the Hudson River Fisherman's Association that Boyle founded.
Can you translate this? Sounds as if you’re saying the FDA wants less frequent data from you to support something — some kind of pharmaceutical?
Are those submissions to the FDA currently on a regular cadence? Or sporadic as new data comes in and gets pushed out?
superrific
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In a related story, does anyone have a recollection of the FDA suddenly reducing its force by 50% or more?
These fucking idiots have no idea what they are doing.
superrific
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I think he's referring to stage 3 trials that occur after a medication is approved for use. The trials don't just stop: the medication is studied, in the field so to speak, to see if the data from earlier clinical trials is borne out, or if there are new problems that weren't uncovered earlier, or if there are potentially off-label uses to study.
One important function of these trials is to assess safety over a long period of time. When a drug is first evaluated for safety, the study lasts for a year, I think. The other poster has far more insight on that than I do. But whatever the time frame -- a year, two years, 6 months -- none of the initial studies can study 10-year health impacts, or 20 year health impacts.
It's not a regular process, in the sense that there are statutory deadlines or a set cadence, but it's regular in the sense that it happens frequently and the FDA used to welcome all additional data.
Sorry, wrote that between meetings fully in my regulator affairs mode. When a company gets a medication or vaccine approved, there are usually further studies planned throughout the life cycle. For example, company A has a chemotherapy that gets approved for use in patients with stage 4 disease, then wants to show that it I improves outcomes in patients with stage 3, or company B has a flu vaccine that is effective in adults and wants to use it in pediatric patients. Each expansion of the indication or population will require an additional study evaluating safety and efficacy for that specific case. Once the study is conducted, companies have to organize the data and submit everything to FDA for their evaluation. Companies can submit as many changes as they like- they’re charged a fee with each one, which is part of how FDA is funded.
For the product in question (you’ve almost certainly seen a commercial for it), we had four planned submissions over the second half of the year. FDA has asked us to limit it to two, which apparently is pretty unprecedented.