Trump to nominate RFK Jr. as Health and Human Services secretary

[wing2000]

What kind of word salad is this?

What part do you not understand?

Is the US-UK traded deal subject to "EU Law"?

 

[Aryeh Jay]

What part do you not understand?

Is the US-UK traded deal subject to "EU Law"?

LM-NO-P

 

[Laodicean60]

Is the US-UK traded deal subject to "EU Law"?

.

Brits be warned....don't buy our overly processed "food").

I assumed you knew that many of the banned substances in EU law are widely held by the UK. Guess I thought you were smarter, my bad.

 

[wing2000]

.

I assumed you knew that many of the banned substances in EU law are widely held by the UK. Guess I thought you were smarter, my bad.

Why the snark?

 

[wing2000]

btw, it appears the UK set's it's own food import rules since BREXIT.....

https://commonslibrary.parliament.uk/new-customs-rules-for-trade-with-the-eu/

 

[Laodicean60]

Why the snark?

Is the US-UK traded deal subject to "EU Law"? (Brits be warned....don't buy our overly processed "food").

Because I thought you were being snarkish, too, because we were talking about food. So I can't be like the rest of you?

 

[Fantine]

I'm curious. Does it also disgust you to see pharmaceutical companies profiteering from people's illnesses?

Because we don't have universal healthcare, you mean?
Our prices are high because our politicians are bought off by lobbyists and allow it to happen.

 

[RocksInMyHead]

That gave me the idea to cross eggplant and tomato, again, both nightshades. That way you would only need one vegetable to make eggplant parmesean.

Jay, you're a genius. Better patent that idea quick.

 

[probinson]

Because we don't have universal healthcare, you mean?
Our prices are high because our politicians are bought off by lobbyists and allow it to happen.

I'm talking about pharmaceutical companies that push drugs that provide no benefit at astronomical prices while our regulatory agencies sit on their thumbs, complicity approving said drugs even when their advisory committees don't agree.

Let's look at Aducanumab, the drug the FDA approved for Alzheimer's that resulted in members of the FDA advisory board resigning in protest over its approval. Nevertheless, the FDA approved this drug with NO EVIDENCE of its effectiveness with a price tag of just FIFTY-SIX THOUSAND DOLLARS PER YEAR.

The maker of this drug, Biogen, which was alleged to have an "inappropriately close relationship" with the FDA was offering this drug with no evidence of benefit for $56K, not only taking people's money who were desperate for help but perhaps even more cruelly, offering them a false hope.

Doctors Remain Divided Over First Drug to Treat Alzheimer’s, But Patients Are Eager to Try It

The FDA approved Biogen's Aduhelm (aducanumab), the first treatment for Alzheimer's Disease—but it won’t be easy for patients to get it.

time.com

Does that "disgust" you?

 

[Fantine]

I'm talking about pharmaceutical companies that push drugs that provide no benefit at astronomical prices while our regulatory agencies sit on their thumbs, complicity approving said drugs even when their advisory committees don't agree.

Let's look at Aducanumab, the drug the FDA approved for Alzheimer's that resulted in members of the FDA advisory board resigning in protest over its approval. Nevertheless, the FDA approved this drug with NO EVIDENCE of its effectiveness with a price tag of just FIFTY-SIX THOUSAND DOLLARS PER YEAR.

The maker of this drug, Biogen, which was alleged to have an "inappropriately close relationship" with the FDA was offering this drug with no evidence of benefit for $56K, not only taking people's money who were desperate for help but perhaps even more cruelly, offering them a false hope.

Doctors Remain Divided Over First Drug to Treat Alzheimer’s, But Patients Are Eager to Try It

The FDA approved Biogen's Aduhelm (aducanumab), the first treatment for Alzheimer's Disease—but it won’t be easy for patients to get it.

time.com

Does that "disgust" you?

It works when diagnosed early.
And can save $150K a year in nursing home care.

 

[probinson]

It works when diagnosed early.

Do you really believe that? I mean, 10 of the 11 members of the advisory panel said there was not enough evidence to approve.

Aducanumab was approved by the FDA despite the fact that 10 of the 11 members of an advisory committee of independent experts the agency convened for guidance voted that there was not enough evidence to justify approval.​

10 out of 11 members of the advisory committee of independent experts said there was not enough evidence to justify the approval, yet the FDA approved it anyway, clearing the way for Biogen to charge $56K for a false hope. FYI, the drug has since been pulled from the market.

You sure do seem selective about the things that "disgust" you. You'd think a pharmaceutical company profiteering off the desperation of people with Alzheimer's would rise to the level of "disgust". But then again, perhaps your disgust is reserved solely for those with which you have a political animus.

And can save $150K a year in nursing home care.

Do you have a source for this claim?

 

[probinson]

The evidence to support Aducanumab’s clinical effectiveness is marginal at best, and may boil down to a statistical fluke at worst.1 Many have raised alarm over its approval, especially concerns over its hefty price tag: upwards of $50,000 per patient annually.2–4 Even with the FDA’s recent backtracking, adjusting the labeling of Aducanumab to limit to only people with mild cognitive impairment and mild dementia, many millions of people will still be eligible. Costs to Medicare, taxpayers, and patients could range in the tens of billions of dollars. Meanwhile, Medicare and Medicaid do not reimburse for health care delivery programs and non-pharmacological interventions with long track records of improving the quality of life for people living with dementia and their caregivers. Instead of spending money on a drug that offers only false hope, the healthcare system should pay for care that alleviates suffering. To do otherwise is an ethical failure.​

​

Instead of Wasting Money on Aducanumab, Pay for Programs Proven to Help People Living with Dementia - PMC

pmc.ncbi.nlm.nih.gov

​

 

[Fantine]

I have a sibling in a nursing home in NY due to physical illness.
And my friend's son is an FDA scientist working on Alzheimers meds. They were both very positive.
Why not let the rich be an additional test group? They can afford the price of $50K and get additional stats on effectivess before insurers approve.

 

[Hans Blaster]

I grew heirloom tomatoes that were ok for transport. San Marzano.

I tried "paste" tomatoes once, but they were a waste of space. I can do whatever I want with "slicers".

I heard someone crossed tobacco with tomatoes, both are nightshades. Taste horrible but you can't stop eatting them.

Mmm, Tomacco. The hard part is getting the plutonium.

That gave me the idea to cross eggplant and tomato, again, both nightshades. That way you would only need one vegetable to make eggplant parmesean.

We tried growing eggplant once when I was a kid. Halfway through the first meal, my mom said we didn't have to finish it.

 

[probinson]

I have a sibling in a nursing home in NY due to physical illness.
And my friend's son is an FDA scientist working on Alzheimers meds. They were both very positive.

About what? The evidence of benefit was non-existent. The surrogate endpoint was never proven to show any benefit. 10 of the 11 people on the advisory committee voted NOT to approve the drug because of a lack of evidence and the 11th voted "uncertain". 3 of the advisory committed members resigned in protest. One of them wrote this scathing letter in his resignation:

I am hereby resigning from the FDA's Peripheral and Central Nervous System Advisory Committee. I was honored to have served the Committee since 2015 because I believed in the value of Advisory Committees to provide a way for outside experts to provide science-based guidance to the agency on its drug approval decisions. But after my experience on this Advisory Committee for both the eteplirsen and now the aducanumab discussions, it is clear to me that FDA is not presently capable of adequately integrating the Committee's scientific recommendations into its approval decisions.​

​

With eteplirsen, the AdComm and FDA's own scientific staff reported that there was no convincing evidence that the drug worked; both groups were overruled by FDA leadership, which approved the drug based on considerations (including concerns about the sponsor's finances) that were not part of the Advisory Committee's discussions. This week, the aducanumab decision by FDA administrators was probably the worst drug approval decision in recent U.S. history. At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug's effect on brain amyloid was likely to help patients with Alzheimer's disease. But this pivotal question was not discussed at the Advisory Committee meeting, and its premise was specifically excluded from discussion, as the FDA said: "We're not using the amyloid as a surrogate for efficacy." At our public meeting, concerns about trial data from one of the FDA's own reviewers were not given adequate time for discussion, and some of the questions FDA asked the Committee to answer were worded in a way that seemed slanted to yield responses that would favor the drug's approval.​

​

For both eteplirsen and aducanumab, the decisions by FDA administrators to ignore the Advisory Committee's clear recommendations led to their approval of two highly problematic drugs that offered little evidence that they would meaningfully benefit patients suffering from these devastating conditions. This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system. For these reasons, I feel I can no longer make a useful contribution as a member of this Advisory Committee. The aducanumab and eteplirsen debacles demonstrate that the agency needs to reassess its decision-making processes, including how drug candidates are selected for AdComm review, which questions are put to the Committee and how those questions are worded, how anecdotal patient experience with drugs is presented to the committee, and how Committee recommendations are used (or ignored) by FDA officials. When clear AdComm recommendations against a drug are overruled by FDA administrators, as occurred in both these instances, the agency owes it to the nation to provide a detailed justification.​

​

In the future, reforms in these areas could allow outside experts to be better able to provide meaningful input into the FDA approval process. Should this occur, I would look forward to the possibility of rejoining a committee if and when it becomes clear that our input as experts will be fairly sought and help support appropriate decision-making that is truly in patients' best interests.​

Notwithstanding the opinion of your sibling and your friend's son, this drug approval (and subsequent removal from the market) is a huge stain on the FDA's credibility. When a third of your independent advisory committee resigns in protest, perhaps it's best to pay attention.

 

[Aryeh Jay]

I tried "paste" tomatoes once, but they were a waste of space. I can do whatever I want with "slicers".

I just don't like all the seeds.

Mmm, Tomacco. The hard part is getting the plutonium.

Curses! I would have gotten away with it too if it hadn't been for that meddling Hans!

 

[DaisyDay]

We tried growing eggplant once when I was a kid. Halfway through the first meal, my mom said we didn't have to finish it.

Eggplant will absorb the flavor of whatever it is cooked with, like a sponge.

 

[Fantine]

About what? The evidence of benefit was non-existent. The surrogate endpoint was never proven to show any benefit. 10 of the 11 people on the advisory committee voted NOT to approve the drug because of a lack of evidence and the 11th voted "uncertain". 3 of the advisory committed members resigned in protest. One of them wrote this scathing letter in his resignation:

I am hereby resigning from the FDA's Peripheral and Central Nervous System Advisory Committee. I was honored to have served the Committee since 2015 because I believed in the value of Advisory Committees to provide a way for outside experts to provide science-based guidance to the agency on its drug approval decisions. But after my experience on this Advisory Committee for both the eteplirsen and now the aducanumab discussions, it is clear to me that FDA is not presently capable of adequately integrating the Committee's scientific recommendations into its approval decisions.​

​

With eteplirsen, the AdComm and FDA's own scientific staff reported that there was no convincing evidence that the drug worked; both groups were overruled by FDA leadership, which approved the drug based on considerations (including concerns about the sponsor's finances) that were not part of the Advisory Committee's discussions. This week, the aducanumab decision by FDA administrators was probably the worst drug approval decision in recent U.S. history. At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug's effect on brain amyloid was likely to help patients with Alzheimer's disease. But this pivotal question was not discussed at the Advisory Committee meeting, and its premise was specifically excluded from discussion, as the FDA said: "We're not using the amyloid as a surrogate for efficacy." At our public meeting, concerns about trial data from one of the FDA's own reviewers were not given adequate time for discussion, and some of the questions FDA asked the Committee to answer were worded in a way that seemed slanted to yield responses that would favor the drug's approval.​

​

For both eteplirsen and aducanumab, the decisions by FDA administrators to ignore the Advisory Committee's clear recommendations led to their approval of two highly problematic drugs that offered little evidence that they would meaningfully benefit patients suffering from these devastating conditions. This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system. For these reasons, I feel I can no longer make a useful contribution as a member of this Advisory Committee. The aducanumab and eteplirsen debacles demonstrate that the agency needs to reassess its decision-making processes, including how drug candidates are selected for AdComm review, which questions are put to the Committee and how those questions are worded, how anecdotal patient experience with drugs is presented to the committee, and how Committee recommendations are used (or ignored) by FDA officials. When clear AdComm recommendations against a drug are overruled by FDA administrators, as occurred in both these instances, the agency owes it to the nation to provide a detailed justification.​

​

In the future, reforms in these areas could allow outside experts to be better able to provide meaningful input into the FDA approval process. Should this occur, I would look forward to the possibility of rejoining a committee if and when it becomes clear that our input as experts will be fairly sought and help support appropriate decision-making that is truly in patients' best interests.​

Notwithstanding the opinion of your sibling and your friend's son, this drug approval (and subsequent removal from the market) is a huge stain on the FDA's credibility. When a third of your independent advisory committee resigns in protest, perhaps it's best to pay attention.

I certainly hope you agree that the worst, very worst, absolutely worst possible solution to this one premature approval of a drug that had not been fully tested is dismantling the FDA, CDC, and NIH.

And that the worst, very worst, absolutely worst people to lead in the crusade to distmantle these agencies are RFK, Jr. and the motley crew of unqualified profiteering hucksters Trump is recommending to the Senate.

 

[probinson]

I certainly hope you agree that the worst, very worst, absolutely worst possible solution to this one premature approval of a drug that had not been fully tested is dismantling the FDA, CDC, and NIH.

Reform is badly needed.

You're kidding yourself if you think this is the only problem in the FDA.

Instead of looking at everything through your political lens, try considering the expert opinion of the advisory committee member who resigned in protest, stating, "...it is clear to me that FDA is not presently capable of adequately integrating the Committee's scientific recommendations into its approval decisions..."

 

[essentialsaltes]

The new nominee is RFK Jr associate Casey Means, a 'wellness influencer' with "impeccable MAHA credentials", who also shills dietary supplements.

She trained as a surgeon at Stanford University [but did not complete her residency] but has built an online following by criticizing the medical establishment and promoting natural foods and lifestyle changes to reverse obesity, diabetes and other chronic diseases.

[Her brother Calley has another role at HHS, calling for the removal of fluoride and reducing SNAP benefits.]

Kennedy's former running mate during his presidential run, Nicole Shanahan, said on the social media platform X that she had "been promised" that neither of "these siblings would be working under HHS or in an appointment." Others who have been supporters of Trump and Kennedy have also voiced their displeasure with Means, in part because she's not been vocal enough against vaccines.

The backlash even inspired Kennedy to come to her defense.

--

The surgeon general must be appointed from the Commissioned Corps of the U.S. Public Health Service and have "specialized training or significant experience in public health programs," according to the statute.

Medical license issue​

It's possible Means' inactive medical license may hold up her nomination.

The nominee can be appointed to the corps first and then to surgeon general, but being in the corps requires having an active license.