The vote is a win for HHS Secretary Kennedy and MAHA, opening a path for compounding pharmacies to prepare BPC-157, TB-500 and four other popular peptides by prescription.
Yeah and parents are injecting/poisoning their kids with vaccines that have gone through less study than peptides. peptides should be the least of our concerns.
No, this is not a win. That is because the peptides are synthetic, thus the province of Big P and the Medical Cartel. Peptides are another term for amino acids that in turn are the building blocks of proteins. Synthetic peptides are thus drugs.
It is but a play by Pharma to capitalize and train hordes of clueless people of the inherant dangers. Sec Kennedy has errored in this fundamental concept.
Have not performed cost analysis, do not need to...
They were just voted. Nothing has been "cleared," because that's an inapplicable regulatory term. This was always expected, given the committee of "peptide" importers, distributors and sellers.
Several of the 7 nominated BDSs aren't even well characterized. As in, there's uncertainty about the exact chemical identity, stability, degradation products, or pharmacology, making it impossible to assess the risk-benefit profiles. “BPC-157” comes as BPC-157-acetate, BPC-157 base, BPC-157-arginate, BPC-157-trifluoroacetate, etc. Could be any or all.
Concerns with adding BPC-157, AOD-9604, Epithalon, and the other nominated "peptides" to the 503A Bulk Drug Substances List include;
Quality/manufacturing concerns: Peptides are chemically complex, and ensuring purity, identity, potency, and freedom from contaminants can be challenging. Variability in manufacturing is bad, and especially bad for injectables.
These drugs have no human data from prospective controlled studies, most having only been studied in animals, or a few obscure publications out of India, China or Russia. Immunogenicity, carcinogenicity, reproductive toxicology studies? Not even in animals.
Efficacy evidence is sparse, inconclusive or absent. Nothing beyond concierge “health and wellness practitioners’” anecdotes.
Potential immunogenicity and unknown long-term risks: Peptides may trigger immune responses or have unforeseen long-term effects, particularly when there is little clinical experience.
For BPC-157 specifically, FDA concerns;
Human safety data are very limited. There are unresolved questions about potential effects on angiogenesis (blood vessel formation), cell growth, and tumor biology, immunogenicity, reproductive effects and more
No approved drug containing BPC-157 anywhere in the world. In Russia it's an oral dietary supplement.
Peptides are good but without the basic 5, you wind up fighting an uphill battle. The basic 5 are: Magnesium, Liposomal Vitamin C (in large doses), B-Complex, D3 and separate K2-MK7 and Omega 3 krill Oil.
No, this is not a win. That is because the peptides are synthetic, thus the province of Big P and the Medical Cartel. Peptides are another term for amino acids that in turn are the building blocks of proteins. Synthetic peptides are thus drugs.
It is but a play by Pharma to capitalize and train hordes of clueless people of the inherant dangers. Sec Kennedy has errored in this fundamental concept.
Have not performed cost analysis, do not need to...
Thank you Robert-F Kennedy Jr, HHS Secretary for this Interesting approvals process considering big Pharma-profit's ongoing grip on government & medicine. This approval of 6 of 7 Peptides is excellent.
"Let food be thy medicine" Hippocrates (460-370 BC) hopefully will lead to a greater evaluation, record-keeping & approval system for humanity to move back into its most successful botanical & life-style medicines, which, along with whole-lifestyle-health practices kept our indigenous ancestors healthy for 100s of 1000s of years. Few in the public & less professionals, ever knew how we could ever get this far past the iron-grip of Standard-Oil's circa 1900 AD Rockefeller imposed patented refined petrochemical 'iatrogenic' (Physician & medical system caused illness & death) prescription & dearth of record-keeping on Adverse-Events & Death.
PROPOSAL FOR RE-IMPLEMENTING ALL HUMANITY'S WORLDWIDE INDIGENOUS MEDICAL & WHOLE LIFE RECORD-KEEPING SYSTEM
Bottom-up Cultural process of reporting Adverse Events, Deaths as well as Positive Physiology & Life Enhancing experiences was traditionally structured by all humanity's worldwide 'indigenous' (Latin 'self-generating') ancestors is in intimate, intergenerational, female-male, interdisciplinary, critical-mass, economies-of-scale 'Fractals' ('Fraction, multiplier, building-block, where-the-part-contains-the-whole').
Example: Alex Haley in his 1960s book 'Roots' describes the personal & family record-keeping role of his ancestral west African 'Griots', who within each 'Multihome-Dwelling-Complex' (eg. Longhouse-apartment, Pueblo-townhouse & Kanata-village'). Records reflected each individual, family & community's whole life experience over a couple of thousand years. Alex Haley found that the Griots of his peoples could recall the name & events of his ancestor Kunta-Kinte before he had been enslaved & brought to America >120 years previously. These memory records were kept orally in mnemonic song, rhyme & previously before Africa's long 7000 years of colonial invasion on versions of the Graphic Character Writing Hieroglyphics. Each village, region, nation, continent & hemisphere, united expertise & record-keeping from the bottom-up
Indigenous data mathematical 'community' (L. 'com' = 'together' + 'munus' = 'gift-or-service') bottom-up culture is different from top-down 'exogenous' (Latin 'other-generated') inappropriately scaled institutions
Each person & each community are unique in terms of having many 1000s of unique personal, genetic, exposures or environmental condition or factors, so top-down administration of mandated so-called 'medicine' is never appropriate. ONE-SIZE DOESN'T FIT ALL
All humanity's worldwide ancestral heritage of many 10s of 1000s of years of peace & prosperity under the 'GREAT-GOOD-WAY-OF-KINDNESS' aka 'GREAT-LAW-OF-PEACE' aka 'CONSTITUTION'. Knowing our ancient indigenous strength can help folks implement a positive transcendent path for themselves today. The Great-good-way is based in individual & collective cultural peace. On Turtle-Island the 'Haudenosaunee' (Iroquois 'People of the extended-rafters' aka 'Welcome') 6 Nation Confederacy for example call this 'Kaianere'kowa'. Central America the Maya refer to Kindness as 'In Lakesh' (I am another you. You are another me). In the Amazon, Aymara, Jamamadi, Apurina nations refer to Kindness as Maloka = 'Longhouse' + 'Aini' (Quechua) 'economy', Indigenous Celtic-Slavic Europe refer to the 'System of 100s' for their longhouse & other housing economies. In southern Africa, Nguni people refer to 'Ubuntu' meaning 'Human Kindness'. Eastern Europe Serbs & Croatians refer to 'Zadruga' meaning 'economy of friends', India as 'Swadeshi' (Hindi = 'indigenous' aka 'self-sufficiency'), China's character for 'money' refers to the ancient indigenous 'Bei' or 'Cowrie Shell', Korea as 'Chaebol' & Japan as 'Keiretsu' referring to 'Family Economy'.
WORLDWIDE INDIGENOUS HERITAGE OF PEACE & PROSPERITY. Eg. TURTLE-ISLAND (North America)'s ~110 nations joined into ~25 Confederacies held Council at all levels, in all domains in what’s referred to as the 'Kaianere'kowa from Haudenosaunee 5 Nation Confederacy meaning: 'Great-good-way-of-kindness' aka 'Great-law-of-Peace' aka 'Constitution' as a continental & hemispheric system of relations. Represented in worldwide CIRCLE-of-LIFE Https://sites.google.com/site/indigenecommunity/a-home/3-indigenous-circle-of-life
3 MAIN PILLARS:
1) ~100 (50-150) person Multihome-Dwelling-Complexes (eg. Longhouse-apartment, Pueblo-townhouse & Kanata-village) enable people to specialize in Circular Collective ‘Domestic’ (mostly women) 'Economies' (Greek 'oikos' = 'home' + 'namein' = 'care-&-nurture') providing the very best essential goods & services with people we know & are known-by. Industry & Commerce (mostly men) are considered as supportive Subsets to the primary Domestic. 70% of people live in the Multihome-Dwelling-Complex today. Indigenous law & constitution centres distributed decentralized human agency, power & democracy in the worldwide Multihome. 20% of Multihome-(apartment, townhouse & village) dwellers today, are extended-families living intentionally with privacy & in proximity for social & economic collaboration, contributing 2 trillion $/year of the most individually appropriate goods, services, sharing & caring/year to N America (Turtle-Island). https://sites.google.com/site/indigenecommunity/c-relational-economy/1-extending-our-welcome-participatory-multihome-cohousing
3) TIME-BASED EQUIVALENCY ACCOUNTING on the STRING-SHELL VALUE SYSTEM. All humanity's worldwide 'indigenous' (Latin 'self-generating') ancestors organized in Cultural 'Fractals' ('fraction, multiplier, building-block, where-the-part-contains-the-whole'). Intimate, intergenerational, female-male, interdisciplinary, critical-mass, economies-of-scale. In-order-to understand real 'money', one must study & research all humanity's once worldwide time-based accounting upon the String-shell Value System (eg. Wampum on Turtle-Island/N. America, Quipu in S. America & Cowrie-shell in once indigenous Celtic-Slavic Europe, Asia, Africa, Australia & all islands). String-shell integrates: a) 'Capital' (L 'cap' = 'head' = 'collective-intelligence' from contribution, experience, expertise & decision-making-acumen). b) ‘Currency’ ('flow' as in recognition & empowerment from diverse stakeholders), c) 'Condolence' = 'social-security' for all conditions, d) Collegial 'education' (L. 'educare' = 'to-lead-forth-from-within') Credit, e) time-math-management Communication, f) professional Costume for identification of essential goods & service expertise & more. Https://sites.google.com/site/indigenecommunity/c-relational-economy
This is an interesting statement: “ They also noted that approved drugs already exist to treat the conditions for which these peptides were proposed.” I have to wonder if any of these people have any personal experience with the disease processes they make that claim for!? I have multiple autoimmune conditions including adhesive arachnoiditis and, if they believe that there is ANYTHING that makes it better, they are not just ill informed but (IMHO) willfully ignorant! Peptides are assuredly the new frontier but God knows, it is time for innovation because the pharmaceutical industrial complex has created/allowed an entire nation of sick, struggling people who are largely incapable of even maintaining the status quo, let alone having the “better life than mine” their parents thought they were giving them!
No, this is not a win. That is because the peptides are synthetic, thus the province of Big P and the Medical Cartel. Peptides are another term for amino acids that in turn are the building blocks of proteins. Synthetic peptides are thus drugs.
It is but a play by Pharma to capitalize and train hordes of clueless people of the inherant dangers. Sec Kennedy has errored in this fundamental concept.
Have not performed cost analysis, do not need to...
It seems as though the FDA is in the habit of sabotaging studies on products that they don't want approved and falsifying studies on products they do want approved. Is that in their job description?
This AC was just a performance. Nothing has been cleared; these drug importers and sellers haven't 'overruled' anyone. They voted to add some of their chemicals to the BDSL. bobby will be the overruler.
GLP-1 drugs like Ozempic, Mounjaro and Wegovy are approved peptides. Insulins for diabetes are peptides.
Human Growth Hormone is an approved peptide - Bobby wants the similar but unstudied (outside rodents) peptides sermorelin and ipamorelin added to the 503(a) Bulk Drug Substances List.
Epitalon is the only nominated chemical that's had any actual human research - 3 or 4 small Russian studies over 20 years ago, totalling <300 subjects. Significantly increased WBC telomere length.
A governmental agency is now overseeing peptides? Now I see why they inserted him, to push the exact opposite in a deception. Who the F know what's in peptides. You believe the FDA? You're sunk.
No, this is not a win. That is because the peptides are synthetic, thus the province of Big P and the Medical Cartel. Peptides are another term for amino acids that in turn are the building blocks of proteins. Synthetic peptides are thus drugs.
It is but a play by Pharma to capitalize and train hordes of clueless people of the inherant dangers. Sec Kennedy has errored in this fundamental concept.
Have not performed cost analysis, do not need to...
Yeah and parents are injecting/poisoning their kids with vaccines that have gone through less study than peptides. peptides should be the least of our concerns.
No, this is not a win. That is because the peptides are synthetic, thus the province of Big P and the Medical Cartel. Peptides are another term for amino acids that in turn are the building blocks of proteins. Synthetic peptides are thus drugs.
It is but a play by Pharma to capitalize and train hordes of clueless people of the inherant dangers. Sec Kennedy has errored in this fundamental concept.
Have not performed cost analysis, do not need to...
Wrong.
They were just voted. Nothing has been "cleared," because that's an inapplicable regulatory term. This was always expected, given the committee of "peptide" importers, distributors and sellers.
Several of the 7 nominated BDSs aren't even well characterized. As in, there's uncertainty about the exact chemical identity, stability, degradation products, or pharmacology, making it impossible to assess the risk-benefit profiles. “BPC-157” comes as BPC-157-acetate, BPC-157 base, BPC-157-arginate, BPC-157-trifluoroacetate, etc. Could be any or all.
Concerns with adding BPC-157, AOD-9604, Epithalon, and the other nominated "peptides" to the 503A Bulk Drug Substances List include;
Quality/manufacturing concerns: Peptides are chemically complex, and ensuring purity, identity, potency, and freedom from contaminants can be challenging. Variability in manufacturing is bad, and especially bad for injectables.
These drugs have no human data from prospective controlled studies, most having only been studied in animals, or a few obscure publications out of India, China or Russia. Immunogenicity, carcinogenicity, reproductive toxicology studies? Not even in animals.
Efficacy evidence is sparse, inconclusive or absent. Nothing beyond concierge “health and wellness practitioners’” anecdotes.
Potential immunogenicity and unknown long-term risks: Peptides may trigger immune responses or have unforeseen long-term effects, particularly when there is little clinical experience.
For BPC-157 specifically, FDA concerns;
Human safety data are very limited. There are unresolved questions about potential effects on angiogenesis (blood vessel formation), cell growth, and tumor biology, immunogenicity, reproductive effects and more
No approved drug containing BPC-157 anywhere in the world. In Russia it's an oral dietary supplement.
Peptides are good but without the basic 5, you wind up fighting an uphill battle. The basic 5 are: Magnesium, Liposomal Vitamin C (in large doses), B-Complex, D3 and separate K2-MK7 and Omega 3 krill Oil.
No, this is not a win. That is because the peptides are synthetic, thus the province of Big P and the Medical Cartel. Peptides are another term for amino acids that in turn are the building blocks of proteins. Synthetic peptides are thus drugs.
It is but a play by Pharma to capitalize and train hordes of clueless people of the inherant dangers. Sec Kennedy has errored in this fundamental concept.
Have not performed cost analysis, do not need to...
Thank you Robert-F Kennedy Jr, HHS Secretary for this Interesting approvals process considering big Pharma-profit's ongoing grip on government & medicine. This approval of 6 of 7 Peptides is excellent.
"Let food be thy medicine" Hippocrates (460-370 BC) hopefully will lead to a greater evaluation, record-keeping & approval system for humanity to move back into its most successful botanical & life-style medicines, which, along with whole-lifestyle-health practices kept our indigenous ancestors healthy for 100s of 1000s of years. Few in the public & less professionals, ever knew how we could ever get this far past the iron-grip of Standard-Oil's circa 1900 AD Rockefeller imposed patented refined petrochemical 'iatrogenic' (Physician & medical system caused illness & death) prescription & dearth of record-keeping on Adverse-Events & Death.
PROPOSAL FOR RE-IMPLEMENTING ALL HUMANITY'S WORLDWIDE INDIGENOUS MEDICAL & WHOLE LIFE RECORD-KEEPING SYSTEM
Institutionalized medicine worships artifice, doesn’t follow Natural Holistic Science or Health. Https://sites.google.com/site/indigenecommunity/d-participatory-structure/6-holistic-science
False Reductionist Science doesn't appreciate interdisciplinary knowledge at every level, particularly those of intimate observation, first hand. Https://sites.google.com/site/indigenecommunity/a-home/9-undoing-false-science
Bottom-up Cultural process of reporting Adverse Events, Deaths as well as Positive Physiology & Life Enhancing experiences was traditionally structured by all humanity's worldwide 'indigenous' (Latin 'self-generating') ancestors is in intimate, intergenerational, female-male, interdisciplinary, critical-mass, economies-of-scale 'Fractals' ('Fraction, multiplier, building-block, where-the-part-contains-the-whole').
Example: Alex Haley in his 1960s book 'Roots' describes the personal & family record-keeping role of his ancestral west African 'Griots', who within each 'Multihome-Dwelling-Complex' (eg. Longhouse-apartment, Pueblo-townhouse & Kanata-village'). Records reflected each individual, family & community's whole life experience over a couple of thousand years. Alex Haley found that the Griots of his peoples could recall the name & events of his ancestor Kunta-Kinte before he had been enslaved & brought to America >120 years previously. These memory records were kept orally in mnemonic song, rhyme & previously before Africa's long 7000 years of colonial invasion on versions of the Graphic Character Writing Hieroglyphics. Each village, region, nation, continent & hemisphere, united expertise & record-keeping from the bottom-up
Indigenous data mathematical 'community' (L. 'com' = 'together' + 'munus' = 'gift-or-service') bottom-up culture is different from top-down 'exogenous' (Latin 'other-generated') inappropriately scaled institutions
Each person & each community are unique in terms of having many 1000s of unique personal, genetic, exposures or environmental condition or factors, so top-down administration of mandated so-called 'medicine' is never appropriate. ONE-SIZE DOESN'T FIT ALL
All humanity's worldwide ancestral heritage of many 10s of 1000s of years of peace & prosperity under the 'GREAT-GOOD-WAY-OF-KINDNESS' aka 'GREAT-LAW-OF-PEACE' aka 'CONSTITUTION'. Knowing our ancient indigenous strength can help folks implement a positive transcendent path for themselves today. The Great-good-way is based in individual & collective cultural peace. On Turtle-Island the 'Haudenosaunee' (Iroquois 'People of the extended-rafters' aka 'Welcome') 6 Nation Confederacy for example call this 'Kaianere'kowa'. Central America the Maya refer to Kindness as 'In Lakesh' (I am another you. You are another me). In the Amazon, Aymara, Jamamadi, Apurina nations refer to Kindness as Maloka = 'Longhouse' + 'Aini' (Quechua) 'economy', Indigenous Celtic-Slavic Europe refer to the 'System of 100s' for their longhouse & other housing economies. In southern Africa, Nguni people refer to 'Ubuntu' meaning 'Human Kindness'. Eastern Europe Serbs & Croatians refer to 'Zadruga' meaning 'economy of friends', India as 'Swadeshi' (Hindi = 'indigenous' aka 'self-sufficiency'), China's character for 'money' refers to the ancient indigenous 'Bei' or 'Cowrie Shell', Korea as 'Chaebol' & Japan as 'Keiretsu' referring to 'Family Economy'.
WORLDWIDE INDIGENOUS HERITAGE OF PEACE & PROSPERITY. Eg. TURTLE-ISLAND (North America)'s ~110 nations joined into ~25 Confederacies held Council at all levels, in all domains in what’s referred to as the 'Kaianere'kowa from Haudenosaunee 5 Nation Confederacy meaning: 'Great-good-way-of-kindness' aka 'Great-law-of-Peace' aka 'Constitution' as a continental & hemispheric system of relations. Represented in worldwide CIRCLE-of-LIFE Https://sites.google.com/site/indigenecommunity/a-home/3-indigenous-circle-of-life
3 MAIN PILLARS:
1) ~100 (50-150) person Multihome-Dwelling-Complexes (eg. Longhouse-apartment, Pueblo-townhouse & Kanata-village) enable people to specialize in Circular Collective ‘Domestic’ (mostly women) 'Economies' (Greek 'oikos' = 'home' + 'namein' = 'care-&-nurture') providing the very best essential goods & services with people we know & are known-by. Industry & Commerce (mostly men) are considered as supportive Subsets to the primary Domestic. 70% of people live in the Multihome-Dwelling-Complex today. Indigenous law & constitution centres distributed decentralized human agency, power & democracy in the worldwide Multihome. 20% of Multihome-(apartment, townhouse & village) dwellers today, are extended-families living intentionally with privacy & in proximity for social & economic collaboration, contributing 2 trillion $/year of the most individually appropriate goods, services, sharing & caring/year to N America (Turtle-Island). https://sites.google.com/site/indigenecommunity/c-relational-economy/1-extending-our-welcome-participatory-multihome-cohousing
2) COUNCIL-PROCESS as Both-sides-now, Equal-time, Recorded & Published Dialogues COMMUNICATE such-as formally through COUNCIL PROCESS for creating understanding, Constructive Agreements, Contract delineation & for Conflict Resolution. Https://sites.google.com/site/indigenecommunity/d-participatory-structure/1-both-sides-now-equal-time-recorded-dialogues
3) TIME-BASED EQUIVALENCY ACCOUNTING on the STRING-SHELL VALUE SYSTEM. All humanity's worldwide 'indigenous' (Latin 'self-generating') ancestors organized in Cultural 'Fractals' ('fraction, multiplier, building-block, where-the-part-contains-the-whole'). Intimate, intergenerational, female-male, interdisciplinary, critical-mass, economies-of-scale. In-order-to understand real 'money', one must study & research all humanity's once worldwide time-based accounting upon the String-shell Value System (eg. Wampum on Turtle-Island/N. America, Quipu in S. America & Cowrie-shell in once indigenous Celtic-Slavic Europe, Asia, Africa, Australia & all islands). String-shell integrates: a) 'Capital' (L 'cap' = 'head' = 'collective-intelligence' from contribution, experience, expertise & decision-making-acumen). b) ‘Currency’ ('flow' as in recognition & empowerment from diverse stakeholders), c) 'Condolence' = 'social-security' for all conditions, d) Collegial 'education' (L. 'educare' = 'to-lead-forth-from-within') Credit, e) time-math-management Communication, f) professional Costume for identification of essential goods & service expertise & more. Https://sites.google.com/site/indigenecommunity/c-relational-economy
This is an interesting statement: “ They also noted that approved drugs already exist to treat the conditions for which these peptides were proposed.” I have to wonder if any of these people have any personal experience with the disease processes they make that claim for!? I have multiple autoimmune conditions including adhesive arachnoiditis and, if they believe that there is ANYTHING that makes it better, they are not just ill informed but (IMHO) willfully ignorant! Peptides are assuredly the new frontier but God knows, it is time for innovation because the pharmaceutical industrial complex has created/allowed an entire nation of sick, struggling people who are largely incapable of even maintaining the status quo, let alone having the “better life than mine” their parents thought they were giving them!
You can already buy these online and get physicians and spas to shoot you up with them. What have you been waiting for?
No, this is not a win. That is because the peptides are synthetic, thus the province of Big P and the Medical Cartel. Peptides are another term for amino acids that in turn are the building blocks of proteins. Synthetic peptides are thus drugs.
It is but a play by Pharma to capitalize and train hordes of clueless people of the inherant dangers. Sec Kennedy has errored in this fundamental concept.
Have not performed cost analysis, do not need to...
It seems as though the FDA is in the habit of sabotaging studies on products that they don't want approved and falsifying studies on products they do want approved. Is that in their job description?
This AC was just a performance. Nothing has been cleared; these drug importers and sellers haven't 'overruled' anyone. They voted to add some of their chemicals to the BDSL. bobby will be the overruler.
GLP-1 drugs like Ozempic, Mounjaro and Wegovy are approved peptides. Insulins for diabetes are peptides.
Human Growth Hormone is an approved peptide - Bobby wants the similar but unstudied (outside rodents) peptides sermorelin and ipamorelin added to the 503(a) Bulk Drug Substances List.
Epitalon is the only nominated chemical that's had any actual human research - 3 or 4 small Russian studies over 20 years ago, totalling <300 subjects. Significantly increased WBC telomere length.
https://en.wikipedia.org/wiki/Epitalon?wprov=sfla1
A governmental agency is now overseeing peptides? Now I see why they inserted him, to push the exact opposite in a deception. Who the F know what's in peptides. You believe the FDA? You're sunk.
No, this is not a win. That is because the peptides are synthetic, thus the province of Big P and the Medical Cartel. Peptides are another term for amino acids that in turn are the building blocks of proteins. Synthetic peptides are thus drugs.
It is but a play by Pharma to capitalize and train hordes of clueless people of the inherant dangers. Sec Kennedy has errored in this fundamental concept.
Have not performed cost analysis, do not need to...
Exactly. Kennedy is also paid, under threat, or a useful idiot. I'm not entirely sure.