RFK Jr, HHs & Public Health News | Measles outbreak, etc.

[superrific]

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?

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.

 

[nrsair]

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?

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.

 

[superrific]

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.

Are these additional trials labeled stage 3? I wasn't sure if there's a different category for post-approval studies. Don't think so, but don't know.

Note: I'm sure you know this better than me, but others might not be aware-- this is just for changes in the official labeling and prescription information, right? Drugs are used off-label all the time without supporting research, or at least high-quality supporting research, and they are generally allowed to be used that way. It's never been clear to me why that should be allowed, but I've taken meds off-label. My wife prescribes meds off-label (I think that most off-label use is in psychiatry but I could def be wrong about that).

 

[altmin]

In shocking news, vaccines prevent deaths.

not sure why modern society needs to keep re-learning it.

Calls for vaccine review after flu deaths surge

Campaigners blame a reduction in free vaccine eligibility for the highest death figures in four decades.

www.bbc.co.uk

 

[nrsair]

Are these additional trials labeled stage 3? I wasn't sure if there's a different category for post-approval studies. Don't think so, but don't know.

Note: I'm sure you know this better than me, but others might not be aware-- this is just for changes in the official labeling and prescription information, right? Drugs are used off-label all the time without supporting research, or at least high-quality supporting research, and they are generally allowed to be used that way. It's never been clear to me why that should be allowed, but I've taken meds off-label. My wife prescribes meds off-label (I think that most off-label use is in psychiatry but I could def be wrong about that).

Yep, trials for new uses of an approved drug are generally still phase 3. In rare cases with extremely compelling data or extenuating circumstances (like, say an imminent bird flu pandemic), a phase 1 or 2 study may suffice to update the official prescribing information. There are phase 4 trials as well, those are typically long-term surveillance trials for approved uses.

Your second point about off-label use is correct as well. From my (admittedly hazy) recollections of our pharmacy law class a decade ago, there aren’t any statutory limits governing prescribing, but the official position of the NC medical and pharmacy boards is that prescribing should be done within established medical practice and with the informed consent of the patient.

 

[Geisterfahrer]

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.

I think it’s the mountains of blow and steroids.

 

[8992Tiger]

I am an engineer, net even a scientist, and it pisses me off to no end to hear someone like him, who has ZERO training or experience in science, engineering, stats, etc., say something like, "All you really need to do is read some science." He's just like those dumb fucks on FB who said, "Do your own research" on Covid but barely passed general science in high school. He, and they, wouldn't recognize good research if it smacked them in the head with a 2X4. So yes, Mr. Kennedy, don't lecture me about science and I won't lecture you on the law or heroin addiction. God, the sooner these clowns are gone, the better, so they will "quit ruinin' my life!"

 

[nycfan]

I am an engineer, net even a scientist, and it pisses me off to no end to hear someone like him, who has ZERO training or experience in science, engineering, stats, etc., say something like, "All you really need to do is read some science." He's just like those dumb fucks on FB who said, "Do your own research" on Covid but barely passed general science in high school. He, and they, wouldn't recognize good research if it smacked them in the head with a 2X4. So yes, Mr. Kennedy, don't lecture me about science and I won't lecture you on the law or heroin addiction. God, the sooner these clowns are gone, the better, so they will "quit ruinin' my life!"

A lot of what RFK Jr is doing will empower a lot of his buddies in the trial bar to go after American pharma and food giants. I will be interesting to see how the Trump Admin responds when they have those giant companies complaining about Trump enabling copious class actions against them based on government promoted junk science brought to HHS by a member of the very trial bar they disdain.

 

[superrific]

Revealing that RFK's first entry in his bill of particulars is that autistic people won't pay taxes. Yep, the most important thing.

 

[superrific]

A lot of what RFK Jr is doing will empower a lot of his buddies in the trial bar to go after American pharma and food giants.

Really? I mean, they might try but I don't think courts are going to let junk peddlers pass Daubert just because there's a junk peddler at HHS. The lower courts, at least, are wise to these games and are not going to accept Trump's anti-science bullshit.

 

[dukeman92]

These fucking idiots have no idea what they are doing.

 

[Huh?]

I agree. I believe this is an inside job with the intent of creating discovery for the inevitable class-action lawsuits that follow.

 

[BlooVooDoo]

Really? I mean, they might try but I don't think courts are going to let junk peddlers pass Daubert just because there's a junk peddler at HHS. The lower courts, at least, are wise to these games and are not going to accept Trump's anti-science bullshit.

If HHS starts funding junk science, there are plenty of journals that will publish it (e.g. Hindawi) so the peer review criterion should be easier to meet.

 

[superrific]

If HHS starts funding junk science, there are plenty of journals that will publish it (e.g. Hindawi) so the peer review criterion should be easier to meet.

Assuming those journals count as legit peer review.

I don't think courts are going to be fooled by this nonsense.

 

[farce©]

My baseball playing, job holding, tax paying autistic son doesn't understand what the Secretary is talking about.

Since moving uptown, my wife and I have a new friend who is autistic. He is an actuary for an insurance company by day, and works at Spectrum Center as an usher by night. So he works two jobs and pays taxes, while living independently in an uptown apartment. I don’t know about baseball but he does play weekly in a co-ed kickball league. Also, you want him to be on your team if you’re playing music trivia.

 

[tarheelbillie]

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.

Ohhh...they know well what they're doing. Methods may be clumsy...yes; but, the plan is to shrink any benefits of government to middle class and below while allowing big business and wealthy to retain near 100% of profits.

 

[Calheel]

Assuming those journals count as legit peer review.

I don't think courts are going to be fooled by this nonsense.

When you've got Kacsmaryk and Cannon on the bench (and more of their ilk), don't be surprised when populist junk science starts to be admitted in some cases.

 

[duluoz]

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.

Great info, thanks. So the FDA is turning down more frequent data and associated fees they’d be owed.

Can you think of any efficiencies this new approach creates for them? For instance, maybe the cost and resources of the data ingest process become relatively inefficient the more often they have to run it. And maybe the fees as currently structured aren’t compensating for that.

Or something?

 

[nrsair]

https://finance.yahoo.com/news/novavax-slides-rfk-jr-casts-152014610.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAGGIbhZFlAqdFI6-3QZHRSJbIO7aLykzRb3FrPU0CZSG2VAD58evJuXF6fjWt3ZpdAmOwmcPTypqgVel4HL5yIlUK-saul8InH2hOKefvInhLlSkopTmsnxSlKcyEjtMfkbIT7lzFpsBt4_ada7dY5QPv6bJ9GfkTZN-aksrBb22

This has kind of flown under the radar. FDA hasn’t given a decision for Novavax’s COVID vaccine and the deadline has now passed. The published data looked good.

“In an interview with CBS News’ Jon Lapook, RFK Jr. attributed the delay to the vaccine’s single-antigen composition, which he said has never worked against respiratory diseases. “We’re looking at that vaccine, and it is a single-antigen vaccine. And, for respiratory illnesses, the single-antigen vaccines have never worked,” RFK Jr. said, adding that “we are actually shifting our priorities to multiple-antigen vaccines. And NIH is already working on a number of those.”

Single antigen vaccines have been proven to work in the context of the H1N1 pandemic, so he’s talking out of his ass per usual. And it’s interesting (concerning) that Novavax is the first target of the anti-vaccine efforts because it’s a traditional vaccine which has historically been what the MAGA crowd has pointed to as an alternative to the mRNA vaccines.

 

[nrsair]

Great info, thanks. So the FDA is turning down more frequent data and associated fees they’d be owed.

Can you think of any efficiencies this new approach creates for them? For instance, maybe the cost and resources of the data ingest process become relatively inefficient the more often they have to run it. And maybe the fees as currently structured aren’t compensating for that.

Or something?

I don’t have much insight into the internal workings of FDA but my suspicion given recent experience with previous submissions is that this is directly related to staffing. Typically when we submit the data package and related documents, FDA will conduct a preliminary review and then give us general timelines of when we can expect to receive questions from them, and then a deadline by which they need to approve or reject the changes. They normally start sending questions about a month in advance. With all the changes and chaos, we’ve been getting questions from them as late as just a week prior to the deadline, often very late in the evenings or over the weekends.