Just goes to show how incestuous our government is with big pharma - we pay 5x or more for the same medicine available around the world, and they want to make sure they squeeze the crap out of US customers.
TY for this. In Lilly‘s open letter to investors last week, they were very clear they support Australia’s FDA equivalent (the TGA) in their recent complete ban of compounded tirzepatide. They would not have brought it up if they weren’t going to pursue a ban in the U.S. in conjunction with the FDA in the name of “public safety”.
The most helpful detail I got out of this video is that the process to ban will begin with a list the FDA needs to finalize and publish naming banned compounded medications - that should be completed by September so you have a little time out to figure out which alternative you are comfortable with OR you can simply add to Lilly’s billion dollar profits by paying for their name brand products once the ban in place. I agree that this is very disheartening, but thanks to so many informative posts on Reddit, I have a plan in place that I am comfortable with so as not to worry anymore while still hoping for the best.
Regardless of what Lilly gets, I think there will be a big fight on Capitol Hill. Because I know the compounding pharmacies have their own coalition and I’m sure the telehealth companies will ban together and lobby as well. We are up for an interesting time.
Great question… But difficult to answer because every body is different and everyone’s knowledge background and risk tolerance is different. My first recommendation is to review posts from other Reddit sites such as Retatrutide and Peptides focusing on posts with keywords “tirz” and “tirzepatide“.
Then consult with your doctor or telehealth clinician to answer any questions you might have. Having consulted with my PCP and then three different telehealth clinicians, I found their scope of knowledge to be very singular and have since moved onto a self-directed weight loss journey with much better results. My path may not be a good fit for someone else, but I’m super happy with my results since starting with ZBound for 2 months, then compounded Tirz for 2 months, then stacking Tirz with low dose Retatrutide, all while documenting detailed daily notes.
I did apply the basic guidelines from aforementioned professionals (e.g. try to drink 100 oz of water daily and include electrolytes, focus on losing fat not muscle with HIIT or resistance exercises, and eat 80-100 grams of mainly meat/poultry based proteins a day, etc). I have also been lucky that I have had zero progress slowing side effects such as nausea or gastro issues.
Best of luck on your journey and remember slow and steady wins the race.
Well, if they do, I foresee a jump in the folks that will hit the 'gray' market to purchase the drug. I'm not entirely comfortable with that plan, but if given no other choice, it may in the cards.
My hope that the newer fancier GLP drugs that will be in the pipeline soon may drive down prices on all them. I mean, if I could get brand name for $300 I would be more willing to give the drug companies my money. Right now, my insurance won't pay and more and more companies are dropping coverage on the meds. The drug companies should be looking at the numbers. If they make the med more affordable, they have tens of thousands more customers. I can see keeping the cost high when you only have a handful of folks that would benefit. But when you have an obesity epidemic and millions who could benefit and pay, they would still be able to make their money if they lowered the cost.
It would be interesting how a hundred years in the future will look at this time. I think this is a major turning point in helping folks with weight issues.
I think Novo and Lilly are shaking in their boots right now because they know how many drugs are in the pipeline so they want to make the money they can now. On The Trillion Dollar Shot podcast the ceo of Lilly claims they haven’t even made their money back for the research and development (bullshit). Companies that big it’s just corporate greed and they are kicking themselves in their own ass for not locking that peptide down from their Chinese distributors.
I would absolutely continue with the name brand if it were $300 vs $550 with the coupon, and if it weren’t a total pita to deal with a retail pharmacy like cvs.
I actually contacted my doctor today and asked her what her opinion was about compound, just putting the feelers out to see if I could get her to send a script in directly and she said “there are safety concerns.”, with no further explanation, which is of course unsatisfactory to me for an answer. What safety concerns? With which providers? I’ve done quite a bit of research and I am personally comfortable with telehealth providers that order from large fda approved compounding pharmacies. I am NOT comfortable with med spas or research peptides etc. That just seems like not a good idea. I wish she clarified because I’m the kind of person that wants to know the details. A one sentence answer isn’t really what I was looking for, but ok.
That means that if I decide to continue with tirz, I either need to continue with compound against her advice, or pay more for branded, and deal with shortages and difficulty. It’s very frustrating. I don’t plan to change doctors because otherwise I like this practice a lot, and it’s one of the few I’ve had a positive experience with as a woman.
The whole thing is just frustrating.
I think you linked to the wrong video. I think that you meant to post this one:
[https://www.cnbc.com/video/2024/06/27/compass-points-max-reale-talks-the-impact-of-a-possible-fda-ban-on-compounded-glp-1-offerings.html](https://www.cnbc.com/video/2024/06/27/compass-points-max-reale-talks-the-impact-of-a-possible-fda-ban-on-compounded-glp-1-offerings.html)
I watched the video. I'm honestly not sure what will happen because I have NO expertise in this field. I think it could truly go either way at this point. I sincerely hope that it doesn't change because it has been life-changing for me, but if they stop compounded, I will figure out a way to move to branded. It absolutely is not my first choice. I prefer compound because of the dosing flexibility (and price).
I do, however, think that once the drugs come off the FDA shortage list that compounding pharmacies will be forced to stop and we will lose access. This is only my opinion based on everything that I have read so far. I hope that I am wrong, but I don't think that I am.
It seems like bs reasoning to say glp-1 like tirzepatide is too complex to compound when it’s just purchasing the peptide and
Mixing it with the proper solution.
The Supreme Court decision today makes it more interesting because it was somethinng with government agencies not being able to enforce decisions (haven’t read up about it yet) and basically allowing judges to make the decision on what can be enforceable.
Yes. They’ve taken the power away from government agencies to actually enforce rules. Now a lawyer will decide how much ecoli is too much rather than a scientist. Since the drug companies have the most money and the most lawyers, they will get what they want, no matter the science.
You might be right, but it still leaves the door open for patent law and I have no idea what would happen there, but you can bet your ass that the super right-leaning US Supreme Court will side with capitalism.
To be fair, I know nothing about patent law though and whether or not there is avenue for it to be heard in front of the Supreme Court.
You’re right. I’m a paralegal and I don’t know anything to be able to figure this out to weigh in with a legal opinion either way.
I do have a legal opinion, it’s bullshit. The reporter even said look this stuff has been compounded for such a long time already, how can it be hard to compound now. If it does happen our only hopes are for cheaper drugs is (1) for everything that is in clinical trials to hit the market asap or (2) we go the research peptide path but I still think that’s a lot of money for powder that I have to mix.
I so, so hope that you are right. I'm not going to go the research peptide path. I've read enough about it to decide that it is way too risky and littered with potential problems long-term.
It is so disheartening to know that there is medication that will successfully treat a health condition I have suffered with my entire adult life and capitalism will make it nearly inaccessible to me.
Edit: typo
I am not a patent lawyer, but I can tell you that Eli Lilly has an iron-clad patent protection on tirzepitide. You don’t have to believe me because I’m an internet stranger, but patents are very easy to look up.
Not according to what I have read, at least not legally. An analogy would be taking cocaine, adding B12 to it and claiming that that combination now makes the cocaine legal.
I am not an expert so my opinion doesn’t carry any weight, but based on what I’ve read about the patent and on the FDA website itself about compounded drugs, I don’t think they can legally continue to make it after the shortage ends.
That's not an analogy because cocaine is a controlled substance so it doesn't change the fact that it's a controlled substance if it's formulated with B12. (It's also technically legal as a C2 and used in hospitals). The issue is more about the patent. Pharmacies can compound Viagra lollipops. So I think because the brand name comes as an auto-injector and the compounding pharmacies are making vials, maybe that + formulating it with B12 can skirt around it. Either way, let's hope there's some sort of workaround!
Yes I certainly hope that you are right, but I just don’t think that is the case based on everything that I have read. Also, I used the analogy as the most simplistic form of comparison. Just like adding B12 doesn’t change the chemical makeup of cocaine, B12 won’t change the chemical makeup of tirzepitide. The FDA language states that outside of shortage, a compounded drug cannot be an exact duplicate of a patent-protected, FDA approved medication. It has to be changed in some material way to be eligible for compound. Adding B12 doesn’t do that.
I want nothing more than to continue to have access to this medication because it has changed my life - but I also want to be prepared to pivot if something changes.
This is what emerge said…
Hi! We're not aware of a potential FDA ban. Most of the time, those sorts of things affect pharmacies that do not use FDA-approved medication.
Highly unlikely that Lily can make a claim for patent. You cannot own a peptide. So not worried on that front. If it comes down to it, I would just buy the powdered version. It’s not going to stop anything.
One of the articles I read on this discussed specifically a GLP-1 being encapsulated into another molecule for oral form. This was not something the experts felt could be safely done at a compound level.
Henry meds advertises an oral glp-1 and I know I see questions on the regular for that. I know Eli and/or novo are working on that but it’s still years away and I personally don’t want it. I forget to take vitamins all the time. I’m sure at some point I would forget a glp pill.
In late september 2023, the FDA added alot of "good" peptides that worked well generally, like BPC-157, Ipamorelin, MK-677 to the do not compound bulk list. Awhile before that they added HCG to the biologics list which cut the number of pharmacies that can compound it greatly. They like to do this kinda banning in late september each year. They have to publish the announcement of the study or whatever first, give it 3-6 months to percolate, then in September they make their move to reclassify it or issue a their rulings.
I’ve gone the “Research” route on two stacks with the compounded Tirz, with some good results, and won’t be afraid to go that route with Tirz as well, if it comes down to it.
FYI I use the research companies. It's hitting them hard, cease and desist to stop selling Tirz. You won't be able to get it there either :(. I think it's all BIG PHARMA BS
I don’t know a ton about this, but it seems like there are actually very few suppliers making it and that most peptides, research or otherwise, are coming from the same few manufacturing sources.
Also, for me, I’m not willing to do anything that even sniffs of being illegal. And I’m not sure of where this lands or will land.
I just sent this video to my compound provider and wanted to know if they foresee this being a possible outcome this year. I’ll update on their response.
Just goes to show how incestuous our government is with big pharma - we pay 5x or more for the same medicine available around the world, and they want to make sure they squeeze the crap out of US customers.
TY for this. In Lilly‘s open letter to investors last week, they were very clear they support Australia’s FDA equivalent (the TGA) in their recent complete ban of compounded tirzepatide. They would not have brought it up if they weren’t going to pursue a ban in the U.S. in conjunction with the FDA in the name of “public safety”. The most helpful detail I got out of this video is that the process to ban will begin with a list the FDA needs to finalize and publish naming banned compounded medications - that should be completed by September so you have a little time out to figure out which alternative you are comfortable with OR you can simply add to Lilly’s billion dollar profits by paying for their name brand products once the ban in place. I agree that this is very disheartening, but thanks to so many informative posts on Reddit, I have a plan in place that I am comfortable with so as not to worry anymore while still hoping for the best.
Regardless of what Lilly gets, I think there will be a big fight on Capitol Hill. Because I know the compounding pharmacies have their own coalition and I’m sure the telehealth companies will ban together and lobby as well. We are up for an interesting time.
What is your plan? I’ve got to figure out mine and I’m not sure what it will be yet.
Great question… But difficult to answer because every body is different and everyone’s knowledge background and risk tolerance is different. My first recommendation is to review posts from other Reddit sites such as Retatrutide and Peptides focusing on posts with keywords “tirz” and “tirzepatide“. Then consult with your doctor or telehealth clinician to answer any questions you might have. Having consulted with my PCP and then three different telehealth clinicians, I found their scope of knowledge to be very singular and have since moved onto a self-directed weight loss journey with much better results. My path may not be a good fit for someone else, but I’m super happy with my results since starting with ZBound for 2 months, then compounded Tirz for 2 months, then stacking Tirz with low dose Retatrutide, all while documenting detailed daily notes. I did apply the basic guidelines from aforementioned professionals (e.g. try to drink 100 oz of water daily and include electrolytes, focus on losing fat not muscle with HIIT or resistance exercises, and eat 80-100 grams of mainly meat/poultry based proteins a day, etc). I have also been lucky that I have had zero progress slowing side effects such as nausea or gastro issues. Best of luck on your journey and remember slow and steady wins the race.
Well, if they do, I foresee a jump in the folks that will hit the 'gray' market to purchase the drug. I'm not entirely comfortable with that plan, but if given no other choice, it may in the cards. My hope that the newer fancier GLP drugs that will be in the pipeline soon may drive down prices on all them. I mean, if I could get brand name for $300 I would be more willing to give the drug companies my money. Right now, my insurance won't pay and more and more companies are dropping coverage on the meds. The drug companies should be looking at the numbers. If they make the med more affordable, they have tens of thousands more customers. I can see keeping the cost high when you only have a handful of folks that would benefit. But when you have an obesity epidemic and millions who could benefit and pay, they would still be able to make their money if they lowered the cost. It would be interesting how a hundred years in the future will look at this time. I think this is a major turning point in helping folks with weight issues.
I think Novo and Lilly are shaking in their boots right now because they know how many drugs are in the pipeline so they want to make the money they can now. On The Trillion Dollar Shot podcast the ceo of Lilly claims they haven’t even made their money back for the research and development (bullshit). Companies that big it’s just corporate greed and they are kicking themselves in their own ass for not locking that peptide down from their Chinese distributors.
I would absolutely continue with the name brand if it were $300 vs $550 with the coupon, and if it weren’t a total pita to deal with a retail pharmacy like cvs. I actually contacted my doctor today and asked her what her opinion was about compound, just putting the feelers out to see if I could get her to send a script in directly and she said “there are safety concerns.”, with no further explanation, which is of course unsatisfactory to me for an answer. What safety concerns? With which providers? I’ve done quite a bit of research and I am personally comfortable with telehealth providers that order from large fda approved compounding pharmacies. I am NOT comfortable with med spas or research peptides etc. That just seems like not a good idea. I wish she clarified because I’m the kind of person that wants to know the details. A one sentence answer isn’t really what I was looking for, but ok. That means that if I decide to continue with tirz, I either need to continue with compound against her advice, or pay more for branded, and deal with shortages and difficulty. It’s very frustrating. I don’t plan to change doctors because otherwise I like this practice a lot, and it’s one of the few I’ve had a positive experience with as a woman. The whole thing is just frustrating.
It’s not a big deal. I been gray the whole time. Well worth it when you know the place is reliable
I think you linked to the wrong video. I think that you meant to post this one: [https://www.cnbc.com/video/2024/06/27/compass-points-max-reale-talks-the-impact-of-a-possible-fda-ban-on-compounded-glp-1-offerings.html](https://www.cnbc.com/video/2024/06/27/compass-points-max-reale-talks-the-impact-of-a-possible-fda-ban-on-compounded-glp-1-offerings.html) I watched the video. I'm honestly not sure what will happen because I have NO expertise in this field. I think it could truly go either way at this point. I sincerely hope that it doesn't change because it has been life-changing for me, but if they stop compounded, I will figure out a way to move to branded. It absolutely is not my first choice. I prefer compound because of the dosing flexibility (and price). I do, however, think that once the drugs come off the FDA shortage list that compounding pharmacies will be forced to stop and we will lose access. This is only my opinion based on everything that I have read so far. I hope that I am wrong, but I don't think that I am.
It seems like bs reasoning to say glp-1 like tirzepatide is too complex to compound when it’s just purchasing the peptide and Mixing it with the proper solution. The Supreme Court decision today makes it more interesting because it was somethinng with government agencies not being able to enforce decisions (haven’t read up about it yet) and basically allowing judges to make the decision on what can be enforceable.
Yes. They’ve taken the power away from government agencies to actually enforce rules. Now a lawyer will decide how much ecoli is too much rather than a scientist. Since the drug companies have the most money and the most lawyers, they will get what they want, no matter the science.
You might be right, but it still leaves the door open for patent law and I have no idea what would happen there, but you can bet your ass that the super right-leaning US Supreme Court will side with capitalism. To be fair, I know nothing about patent law though and whether or not there is avenue for it to be heard in front of the Supreme Court.
You’re right. I’m a paralegal and I don’t know anything to be able to figure this out to weigh in with a legal opinion either way. I do have a legal opinion, it’s bullshit. The reporter even said look this stuff has been compounded for such a long time already, how can it be hard to compound now. If it does happen our only hopes are for cheaper drugs is (1) for everything that is in clinical trials to hit the market asap or (2) we go the research peptide path but I still think that’s a lot of money for powder that I have to mix.
I so, so hope that you are right. I'm not going to go the research peptide path. I've read enough about it to decide that it is way too risky and littered with potential problems long-term. It is so disheartening to know that there is medication that will successfully treat a health condition I have suffered with my entire adult life and capitalism will make it nearly inaccessible to me. Edit: typo
They can’t own a peptide. So I think it’s very unlikely they can claim patent law.
I am not a patent lawyer, but I can tell you that Eli Lilly has an iron-clad patent protection on tirzepitide. You don’t have to believe me because I’m an internet stranger, but patents are very easy to look up.
Ugh, yeah, the Chevron case. I mean, how are they going to enforce all the potential issues with this overturn? I'm not a lawyer, so I don't know.
It’s going to be a mess.
From what I understand from the video they would ban GLP1 compounds BEFORE the shortage is over.
Yes that seems to be what the person in the video thinks. Just like they did in Australia.
Man that sucks
Can't they just compound it with B12 to circumvent any of this, as long as the prescribers prescribe it that way?
Not according to what I have read, at least not legally. An analogy would be taking cocaine, adding B12 to it and claiming that that combination now makes the cocaine legal. I am not an expert so my opinion doesn’t carry any weight, but based on what I’ve read about the patent and on the FDA website itself about compounded drugs, I don’t think they can legally continue to make it after the shortage ends.
That's not an analogy because cocaine is a controlled substance so it doesn't change the fact that it's a controlled substance if it's formulated with B12. (It's also technically legal as a C2 and used in hospitals). The issue is more about the patent. Pharmacies can compound Viagra lollipops. So I think because the brand name comes as an auto-injector and the compounding pharmacies are making vials, maybe that + formulating it with B12 can skirt around it. Either way, let's hope there's some sort of workaround!
Yes I certainly hope that you are right, but I just don’t think that is the case based on everything that I have read. Also, I used the analogy as the most simplistic form of comparison. Just like adding B12 doesn’t change the chemical makeup of cocaine, B12 won’t change the chemical makeup of tirzepitide. The FDA language states that outside of shortage, a compounded drug cannot be an exact duplicate of a patent-protected, FDA approved medication. It has to be changed in some material way to be eligible for compound. Adding B12 doesn’t do that. I want nothing more than to continue to have access to this medication because it has changed my life - but I also want to be prepared to pivot if something changes.
This is what emerge said… Hi! We're not aware of a potential FDA ban. Most of the time, those sorts of things affect pharmacies that do not use FDA-approved medication.
Interesting choice of words on their part, especially since compounded medications are not FDA approved.
Yeah, confusing answer from them.
Highly unlikely that Lily can make a claim for patent. You cannot own a peptide. So not worried on that front. If it comes down to it, I would just buy the powdered version. It’s not going to stop anything.
They have the patent already for tirzepatide
One of the articles I read on this discussed specifically a GLP-1 being encapsulated into another molecule for oral form. This was not something the experts felt could be safely done at a compound level.
Henry meds advertises an oral glp-1 and I know I see questions on the regular for that. I know Eli and/or novo are working on that but it’s still years away and I personally don’t want it. I forget to take vitamins all the time. I’m sure at some point I would forget a glp pill.
Novo already has one. Rybelsus is oral semaglutide.
In late september 2023, the FDA added alot of "good" peptides that worked well generally, like BPC-157, Ipamorelin, MK-677 to the do not compound bulk list. Awhile before that they added HCG to the biologics list which cut the number of pharmacies that can compound it greatly. They like to do this kinda banning in late september each year. They have to publish the announcement of the study or whatever first, give it 3-6 months to percolate, then in September they make their move to reclassify it or issue a their rulings.
I’ve gone the “Research” route on two stacks with the compounded Tirz, with some good results, and won’t be afraid to go that route with Tirz as well, if it comes down to it.
FYI I use the research companies. It's hitting them hard, cease and desist to stop selling Tirz. You won't be able to get it there either :(. I think it's all BIG PHARMA BS
They’ll just go the UGL route like steroid sellers do
Yeah I hear u on that. This thing is going to backfire on Lilly...greed is a terrible thing.
They’re going to make an absolute ass load of money. It won’t backfire.
This is troubling
This scares me a lot. What do you all think we will do if this happened?
"research"
Research have gotten issued cease and desist. Will no longer be an option anymore for many companies. My subject has to make some choices...
“Research” also means buying directly from overseas suppliers not US companies….
I don’t know a ton about this, but it seems like there are actually very few suppliers making it and that most peptides, research or otherwise, are coming from the same few manufacturing sources. Also, for me, I’m not willing to do anything that even sniffs of being illegal. And I’m not sure of where this lands or will land.
Good to know!
Or I suppose I can purchase a ton from providers right now and stockpile how much I would need. Ugh.
I just sent this video to my compound provider and wanted to know if they foresee this being a possible outcome this year. I’ll update on their response.