RFK announces rescheduling of various peptides

[CNCCurrency]

A broken clock is right twice a day

Why would you care?

 

[ltjltj]

What are you talking about? Once rescheduled compounders will be able to make them again! You still need a script from a doctor.

Which is just like other drugs - so why don't peps need safety data at a minimum?

(efficacy? we can debate that but I'm very open to off-label use so much less concerned with demonstrated efficacy in this space than safety)

I don't know why peptide vs other forms of drugs should have a different panel approving them either.

Overall I'm very open to a process that evaluates drugs that have significant data, especially those already approved in other countries, without a sponsoring company pushing them through - this applies to a couple of the peps on the list, but not most. So, as I said above, let's see who ends up on this panel, and the safety justification for those that pass and get approved. It's still early.

 

[CNCCurrency]

Which is just like other drugs - so why don't peps need safety data at a minimum?

(efficacy? we can debate that but I'm very open to off-label use so much less concerned with demonstrated efficacy in this space than safety)

I don't know why peptide vs other forms of drugs should have a different panel approving them either.

Overall I'm very open to a process that evaluates drugs that have significant data, especially those already approved in other countries, without a sponsoring company pushing them through - this applies to a couple of the peps on the list, but not most. So, as I said above, let's see who ends up on this panel, and the safety justification for those that pass and get approved. It's still early.

I'm still unsure what your beef is? Where do you get your glp 1 and other peptides from now?

 

[staffn1]

There should be two categories, FDA approved and not FDA approved. Label it such and let people make up their own minds. Not FDA approved would include all the crazy energy shots, supplements, peptides, etc unless a company wanted to go the FDA route. Most people don't care. The government allows you to put extremely harmful things in your body (as long as you are over a certain age).

 

[CNCCurrency]

There should be two categories, FDA approved and not FDA approved. Label it such and let people make up their own minds. Not FDA approved would include all the crazy energy shots, supplements, peptides, etc unless a company wanted to go the FDA route. Most people don't care. The government allows you to put extremely harmful things in your body (as long as you are over a certain age).

 

[ltjltj]

I'm still unsure what your beef is? Where do you get your glp 1 and other peptides from now?

Are GLP-1s unapproved FDA drugs severely lacking safety data? No. (Reta is unapproved as of today, but certainly there is plenty of safety data). Suggesting that doctors prescribe some of the peps on the list despite the lack of safety data is also opening a giant can of malpractice worms.

As I said, I don't know how this'll play out - I suggested reasonable outcomes (approval path for drugs without corporate pushing that do have safety data), but blanket YOLO from the FDA is anathema to their mission.

Do you believe any compound a company develops should be available via compounding prior to having safety data? If not, why are peptides a special class of drugs that warrant skipping that safety step?

 

[CNCCurrency]

Are GLP-1s unapproved FDA drugs severely lacking safety data? No. (Reta is unapproved as of today, but certainly there is plenty of safety data). Suggesting that doctors prescribe some of the peps on the list despite the lack of safety data is also opening a giant can of malpractice worms.

As I said, I don't know how this'll play out - I suggested reasonable outcomes (approval path for drugs without corporate pushing that do have safety data), but blanket YOLO from the FDA is anathema to their mission.

Do you believe any compound a company develops should be available via compounding prior to having safety data? If not, why are peptides a special class of drugs that warrant skipping that safety step?

If the glp1 is not name brand then yes not they are not an fda approved drug. Ie compounded glp 1 are not fda approved.

 

[ltjltj]

If the glp1 is not name brand then yes not they are not an fda approved drug. Ie compounded glp 1 are not fda approved.

We're talking past each other. I think my point is clear regarding evidence of safety. If your argument is that there's no evidence of safety for compounded GLP-1, only pharma GLP-1 I'm going to agree to disagree on that distinction.

 

[CNCCurrency]

We're talking past each other. I think my point is clear regarding evidence of safety. If your argument is that there's no evidence of safety for compounded GLP-1, only pharma GLP-1 I'm going to agree to disagree on that distinction.

Same can be said for the peptides they want to reschedule. You never answered as to where you are getting yours from?

 

[ltjltj]

Same can be said for the peptides they want to reschedule. You never answered as to where you are getting yours from?

In absolutely no way can it be said for most of the peps on their list - which of those have a commercial FDA-approved equivalent? Which have notable safety data to back them up?

Sigh...

I'm not answering your question because it's irrelevant and a distraction. FWIW, I'm not comfortable personally injecting any compound that doesn't have safety data to back it up, which so far has kept me to compounds that are FDA approved (I'd extend that to something like Reta given the published data, but I haven't felt the need). So, my personal standard applies - I wouldn't take the compounds that I don't think the FDA should approve. I'm not personally concerned with the sourcing path for said compounds (commercial vs compound), and in the case of grey market I think that appropriate testing can manage that risk.

 

[CNCCurrency]

In absolutely no way can it be said for most of the peps on their list - which of those have a commercial FDA-approved equivalent? Which have notable safety data to back them up?

Sigh...

I'm not answering your question because it's irrelevant and a distraction. FWIW, I'm not comfortable personally injecting any compound that doesn't have safety data to back it up, which so far has kept me to compounds that are FDA approved (I'd extend that to something like Reta given the published data, but I haven't felt the need). So, my personal standard applies - I wouldn't take the compounds that I don't think the FDA should approve. I'm not personally concerned with the sourcing path for said compounds (commercial vs compound), and in the case of grey market I think that appropriate testing can manage that risk.

Well that definitely puts you in the minority on this forum.

 

[ltjltj]

Well that definitely puts you in the minority on this forum.

Which I'm 100% fine with! I'm actually not sure that's true, it's quite a leap to go from a well-studied drug to very poorly studied drugs just because they have similar chemical structures, but either way it seems pretty irrelevant. Are you saying that makes me not welcome or something?

 

[Jfrick11]

There is a ton of information you can read that will show you that big med companies do not have our best interests in mind. We definitely don’t need to get into that debate, but that much is true.

And if he is so horrible, then why is he doing so many things, like this, in the name of health? Someone objectively horrible wouldn’t do anything helpful.

Being critical of pharma is fair, but it’s not a reason to disregard science or evidence based practice.

In that tone.... the name of health” doesn’t mean evidence based or safe. And this isn’t just “a guy trying to help,” it’s someone with a pattern of promoting claims that conflict with established evidence, especially around public health.

That’s a credibility issue in a space where being wrong can actually harm people.

And peptides aren’t benign supplements, some have significant systemic effects and require real knowledge to use responsibly.

Because yes, some of these absolutely require a real understanding of:

dosing and half-life

downstream hormonal effects

interactions (especially anything touching GH/IGF-1, insulin sensitivity, immune modulation)

contraindications (kidney, liver, cancer risk, etc.)

Expanding access without that context isn’t automatically a good thing.

And just because I personally use peptides doesn’t mean I’m going to overlook someone’s lack of credibility or call them “good” because we loosely align on one idea.

 

[Ragnar]

When I originally joined this forum I was only comfortable injecting Tirzepatide because it was FDA approved as Zepbound and Mounjaro.

My comfort level has expanded to include Survo because it is far along in the process of approval.

I have more recently changed my views on some drugs that have undergone approval in Russia (Semanx, Selanx) because they have some clinical studies to back them up as well as ghk-cu and BPC. I have included the later two because obtaining FDA approval would require a financial incentive to undergo the required clinical trials. This will not occur if the peptide is not patentable and thus marketable so that Pharma can recuperate the investment and risk. This is just the way it is.

 

[Jfrick11]

There should be two categories, FDA approved and not FDA approved. Label it such and let people make up their own minds. Not FDA approved would include all the crazy energy shots, supplements, peptides, etc unless a company wanted to go the FDA route. Most people don't care. The government allows you to put extremely harmful things in your body (as long as you are over a certain age).

It sounds simple, but it ignores how risk actually works. “Not FDA approved” doesn’t tell people whether something is low risk or potentially harmful, it just lumps everything together. Most people don’t have the background to evaluate that difference.

And the consequences don’t stay individual. Complications, hospitalizations, and LONG term effects impact the healthcare system as a whole. That’s why public health doesn’t work as “label it and hope people figure it out.”

 

[Jfrick11]

If the glp1 is not name brand then yes not they are not an fda approved drug. Ie compounded glp 1 are not fda approved.

That’s a false equivalence.

Compounded GLP1s aren’t “FDAapproved products,” but the active drugs themselves are extensively studied and approved with well established safety profiles.

So it deosnt work to say....

“So they’re basically the same as unapproved, poorly studied peptides”

Big difference

 

[Jfrick11]

Well that definitely puts you in the minority on this forum.

Being an individual that does his/her/their own research and decides what's best for them?

Thats the forum I belong to I thought

 

[CNCCurrency]

That’s a false equivalence.

Compounded GLP1s aren’t “FDAapproved products,” but the active drugs themselves are extensively studied and approved with well established safety profiles.

So it deosnt work to say....

“So they’re basically the same as unapproved, poorly studied peptides”

Big difference

What? if its not name brand then they are not FDA approved. All compounded versions are made different and there for are not FDA approved.

A compounded drug might be appropriate if a patient’s medical need cannot be met by an FDA-approved drug, or the FDA-approved drug is not commercially available. However, compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed.

The agency has identified some areas of concern for compounded GLP-1 drugs. FDA is working with its state regulatory partners and will continue to communicate with compounders regarding these concerns.

 

[Jfrick11]

What? if its not name brand then they are not FDA approved. All compounded versions are made different and there for are not FDA approved.

A compounded drug might be appropriate if a patient’s medical need cannot be met by an FDA-approved drug, or the FDA-approved drug is not commercially available. However, compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed.

The agency has identified some areas of concern for compounded GLP-1 drugs. FDA is working with its state regulatory partners and will continue to communicate with compounders regarding these concerns.

You are arguing regulatory technicality.

I am arguing scientific reality …and those are not the same conversation.

You’re right that compounded drugs aren’t FDA approved as products. But that’s not the same as saying they aren’t based on well studied, FDA approved medications.

GLP1s have extensive clinical data and well established safety profiles.

Compounding usually changes d ifferent dose or concentration, d ifferent delivery form (liquid, sublingual, injection, cream), or removes or changes inactive ingredients (preservatives, fillers).

It does not change the active ingredient or the underlying evidence behind the drug itself.

That’s very different from peptides that don’t have that level of data at all.

And BTW.... the issue they're finding is mixing GLP1S w vitamin B12, which is another active compound. They've found it creates an entirely new molecule. They don't know if that's good or bad... Just that it's not the same. Compounding pharmacies use this to say "reduces nausea" in order to get around patents. So a game essentially so they can make these GLP1s.

 

[Calm Logic]

Being an individual that does his/her/their own research and decides what's best for them?

Thats the forum I belong to I thought

Exactly. And most of us who have GLPs in our freezers for 5-10+ years from now don't hoard the non-GLPs in the same way, if at all.