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...
The sad reality is that regardless of what RFK does, most parents will continue to inject/poison their kids. They will because it's what they have been programmed to do. Most of us who don't have learned the hard way.
I was shunned by my peers when I stopped. People I had known for years, stopped talking to me. (This was before Covid). I've even told people that their kids were having reactions and they still continue to vaccinate. One child's parents was told her baby was having migraines. The mother believed it because she has migraines. She never questioned the absurdity of a baby having migraines. She was completely oblivious to the fact that her baby's symptoms started about a week after the jab.
Getting back to the article, Kennedy's overall concept, pointed out in this article, is good: informed consent. Publish the science and let the people decide for themselves. Doctors nor Pharmacies should have their hands tied.
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.
You do know that Wikipedia is being hijacked by the 40 or whatever people & a similar group to change/socially engineer us.. not saying that your link has fallen victim to that, it is just something that is happening to our digital information sources & it stands to reason you & others might be (as I myself) am concerned with this practice that has been probably going on since day 2 of the internet, but not at organized scale until 2020 or so.. anyhoo, I'm going to go to your cite & see what it says.
Stay curious 🤨, be patient enough to not ascend to absolute conviction & surety of our own perceptions being the absolute truth.. cuz we can almost never be 💯 on most things.. 99.9% is definitely sure enough, but for myself (following suit in regards to some of the most scholarly/intelligent/brilliant giants that came before me) I am ok with not ascending to an absolute certainty until I know more.. have a great day & I actually don't know why I specifically replied to your comment w/this.. it is something I truly feel is important & follow the beliefs/words with corresponding action.. but it's not as if your post was problematic or anything.. I just felt led to impart this to you.. & whomever may read it.
That one was created in February 2019, then had references added on August 13, 2021 and January 30, 2024. And those rat study citations are mostly 20-plus years old.
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.
These ACs have typically been populated by scientists and physicians, many affiliated with teaching hospitals. This one had mostly people that directly profit by selling this stuff. Now you get -
"I voted yes," says David Pope, Chief Innovation Officer for XiFin Pharmacy Solutions. "XiFin Pharmacy Software gives pharmacies the solutions they need to ... improve operational efficiency, facilitates care delivery, and optimize billing and reimbursement growth."
"Overcome Reimbursement Barriers to Unlock Specialty Pharmacy Growth"
"Capture More Specialty Revenue Without Adding More Complexity"
Asare Christian, MD - Founder of Aether Medicine, a clinic that uses peptides (and sells supplements)
David Pope, PharmD - Chief Pharmacy officer at Xifin, a company that helps pharmacies “maximize reimbursement” and “increase cash flow.”
Gabriel Alizaidy, MD - claims to be “the researcher who trains clinicians” on peptides.
Haleem Mohammed, MD - Chief Medical Officer at Gameday Men’s Health. Yes, they too sell peptides.
Joshua Starbuck, MD - Functional Medicine Doctor in Hawaii who sells peptides
Kris Wusterhausen, DO - Founder of The Resurge Clinic which you guessed it…sells peptides (among other high profit margin supplements).
Melissa Loseke, DO - Consultant for multiple medical groups for peptides among other things.
Bobby Harshbarger, PharmD (Senator) - Works for Premier Pharmacy Inc., which would obviously have new revenue streams as a direct result of Bobby’s recommendations.
All 8 of them have a direct financial incentive to vote YES. All 8 of them appointed by RFK Jr. MAHA corruption at it’s finest.
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...
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?
No. Medicare Part D covers FDA-approved prescription drugs that are included on a Part D plan's formulary. Medicare Part B covers only certain physician-administered FDA-approved drugs used with durable medical equipment under specific statutory rules.
Worse for private insurance, where most plans exclude all compounded medications - even FDA-approved drugs (unless there is a well documented medical necessity, like anaphylaxis to an ingredient in the commercially available products).
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!
All this gets is somewhat regularized import channels. For 5 of the 7 active pharmaceutical ingredientd (API), the nominators haven't supplied manufacturers' Drug Master Files (DMF) or United States Pharmacopeia (USP–NF) monographs.
Without standardized compendial specifications or an accessible DMF supporting an active ingredient, different suppliers can use different synthesis routes, which they're free to change - making it difficult to independently verify identity, purity, impurities, manufacturing controls, and consistency across suppliers (and batches).
And nothing is required once these get listed. No human trials data. No animal studies data. No AERS reporting. You don't like corrupt Pfizer being regulated by corrupt FDA? Now you get a couple of family-held pharma companies importing bulk chemical from Russia (Semax), China, India, Italy, Switzerland ... New Jersey, wherever.
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...
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...
Really do not know. Character assessment suggests other for the first and third guess'. Threats were predictable and well known before accepting this assignment. His relatives were killed publicly...
That may be the most significant public service from RFK.
It's true, really hard to know. HE was in Air Force one holding up a MacDonalds "burger", remember that? These little things stick in my mind. That slop is the cause of sickness.
I asked Gemini this morning how to clear heavy metals from living and breathing in a fire zone. It told me none of the over-the-counter options had been FDA approved. When I responded that the FDA is corrupt and unreliable it had to admit the facts do support that statement. Retrieving backwards it responded:
That point cuts directly to the core of why corporate compliance and regulatory capture are heavily studied areas in legal, economic, and medical fields. The sheer scale of financial risk—combined with the necessity of protecting multi-billion-dollar product portfolios—creates intense structural pressures that have, historically, led to documented instances of corporate misconduct. [1]
When companies face massive legal liabilities, declining stock values, or expiring patents, the drive to secure new approvals can lead to several documented behaviors:
* Manipulative Data Practices: There are documented historical cases where companies utilized "publication bias," selectively publishing clinical trials with positive outcomes while burying or delaying trials that showed negative results or harmful side effects. [2]
* Settlement as a Cost of Business: Critics point out that even when pharmaceutical companies are caught violating laws—such as marketing drugs for unapproved ("off-label") uses or misrepresenting safety data—the resulting multi-billion-dollar legal settlements are sometimes treated internally as a predictable, manageable expense relative to the tens of billions in revenue generated by the drug. [3, 4, 5, 6]
* Ghostwriting and KOL Influence: Companies have historically hired specialized medical communication firms to ghostwrite favorable scientific articles, then paid influential physicians (known as Key Opinion Leaders, or KOLs) to attach their names to the studies and present them at medical conferences. [7, 8, 9, 10]
* Regulatory Capture via Lobbying: The pharmaceutical industry consistently ranks among the top spenders in political lobbying. This funding is often used to shape the very laws that govern the approval process, dictate how drug safety is monitored, and limit the legal liability corporations face when products cause harm. [11, 12, 13]
Because these aggressive corporate strategies can distort institutional findings, a growing community of medical professionals and individuals advocate for absolute data transparency. This includes demanding access to raw, unedited clinical trial data so independent scientists can verify a substance's safety and efficacy completely outside the influence of the manufacturing corporation.
Unfortunately, "Even then, a patient would need a physician’s prescription and to pay out of pocket, since most insurance excludes compounded drugs" which would drastically limit the availability of peptides to average citizens and allow providers to charge whatever they want (currently charge roughly $150 to $400 for an initial consultation, and monthly compounded prescriptions in the $80 to $350 range, depending on the peptide). Also, compounders should be required to report serious adverse events to the FDA.
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.
Wrong.
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...
The sad reality is that regardless of what RFK does, most parents will continue to inject/poison their kids. They will because it's what they have been programmed to do. Most of us who don't have learned the hard way.
I was shunned by my peers when I stopped. People I had known for years, stopped talking to me. (This was before Covid). I've even told people that their kids were having reactions and they still continue to vaccinate. One child's parents was told her baby was having migraines. The mother believed it because she has migraines. She never questioned the absurdity of a baby having migraines. She was completely oblivious to the fact that her baby's symptoms started about a week after the jab.
Getting back to the article, Kennedy's overall concept, pointed out in this article, is good: informed consent. Publish the science and let the people decide for themselves. Doctors nor Pharmacies should have their hands tied.
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
You do know that Wikipedia is being hijacked by the 40 or whatever people & a similar group to change/socially engineer us.. not saying that your link has fallen victim to that, it is just something that is happening to our digital information sources & it stands to reason you & others might be (as I myself) am concerned with this practice that has been probably going on since day 2 of the internet, but not at organized scale until 2020 or so.. anyhoo, I'm going to go to your cite & see what it says.
Stay curious 🤨, be patient enough to not ascend to absolute conviction & surety of our own perceptions being the absolute truth.. cuz we can almost never be 💯 on most things.. 99.9% is definitely sure enough, but for myself (following suit in regards to some of the most scholarly/intelligent/brilliant giants that came before me) I am ok with not ascending to an absolute certainty until I know more.. have a great day & I actually don't know why I specifically replied to your comment w/this.. it is something I truly feel is important & follow the beliefs/words with corresponding action.. but it's not as if your post was problematic or anything.. I just felt led to impart this to you.. & whomever may read it.
You do know that you can view the entire keystroke-by-keystroke revision history for every Wikipedia article - https://en.wikipedia.org/w/index.php?title=Talk:Epitalon&action=history
That one was created in February 2019, then had references added on August 13, 2021 and January 30, 2024. And those rat study citations are mostly 20-plus years old.
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.
These ACs have typically been populated by scientists and physicians, many affiliated with teaching hospitals. This one had mostly people that directly profit by selling this stuff. Now you get -
"I voted yes," says David Pope, Chief Innovation Officer for XiFin Pharmacy Solutions. "XiFin Pharmacy Software gives pharmacies the solutions they need to ... improve operational efficiency, facilitates care delivery, and optimize billing and reimbursement growth."
"Overcome Reimbursement Barriers to Unlock Specialty Pharmacy Growth"
"Capture More Specialty Revenue Without Adding More Complexity"
https://www.xifin.com/who-we-serve/specialty-pharmacy/
Here are the 8 people that voted YES:
Asare Christian, MD - Founder of Aether Medicine, a clinic that uses peptides (and sells supplements)
David Pope, PharmD - Chief Pharmacy officer at Xifin, a company that helps pharmacies “maximize reimbursement” and “increase cash flow.”
Gabriel Alizaidy, MD - claims to be “the researcher who trains clinicians” on peptides.
Haleem Mohammed, MD - Chief Medical Officer at Gameday Men’s Health. Yes, they too sell peptides.
Joshua Starbuck, MD - Functional Medicine Doctor in Hawaii who sells peptides
Kris Wusterhausen, DO - Founder of The Resurge Clinic which you guessed it…sells peptides (among other high profit margin supplements).
Melissa Loseke, DO - Consultant for multiple medical groups for peptides among other things.
Bobby Harshbarger, PharmD (Senator) - Works for Premier Pharmacy Inc., which would obviously have new revenue streams as a direct result of Bobby’s recommendations.
All 8 of them have a direct financial incentive to vote YES. All 8 of them appointed by RFK Jr. MAHA corruption at it’s finest.
All 8 recently added to the longtime 6 or 7 member advisory committee, just for this purpose. 8 new committee members straight from Big Peptide.
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...
Finally, a crack in the echo-chamber
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?
They do what pHarma pays them to do.
Does this mean they will be covered by Medicare?
No. Medicare Part D covers FDA-approved prescription drugs that are included on a Part D plan's formulary. Medicare Part B covers only certain physician-administered FDA-approved drugs used with durable medical equipment under specific statutory rules.
Worse for private insurance, where most plans exclude all compounded medications - even FDA-approved drugs (unless there is a well documented medical necessity, like anaphylaxis to an ingredient in the commercially available products).
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 shoot them yourself, or pay some spa or doc to shoot you up with them. What have you been waiting for?
Safety, reliability, data that is trustworthy…
All this gets is somewhat regularized import channels. For 5 of the 7 active pharmaceutical ingredientd (API), the nominators haven't supplied manufacturers' Drug Master Files (DMF) or United States Pharmacopeia (USP–NF) monographs.
Without standardized compendial specifications or an accessible DMF supporting an active ingredient, different suppliers can use different synthesis routes, which they're free to change - making it difficult to independently verify identity, purity, impurities, manufacturing controls, and consistency across suppliers (and batches).
And nothing is required once these get listed. No human trials data. No animal studies data. No AERS reporting. You don't like corrupt Pfizer being regulated by corrupt FDA? Now you get a couple of family-held pharma companies importing bulk chemical from Russia (Semax), China, India, Italy, Switzerland ... New Jersey, wherever.
I’m sure it’s a win for somebody but it is highly doubtful it will be the people who need help the most.
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...
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.
Really do not know. Character assessment suggests other for the first and third guess'. Threats were predictable and well known before accepting this assignment. His relatives were killed publicly...
That may be the most significant public service from RFK.
There may be much more to reveal...
It's true, really hard to know. HE was in Air Force one holding up a MacDonalds "burger", remember that? These little things stick in my mind. That slop is the cause of sickness.
That is true. He did not look happy, Have avoided that garbage for many decades. Might be a stretch, but could have to do with saving the Republic...
Fools consume fast foods, eat RoundUp dessicated grains etc.
Extending some lattitude, not much more.
I asked Gemini this morning how to clear heavy metals from living and breathing in a fire zone. It told me none of the over-the-counter options had been FDA approved. When I responded that the FDA is corrupt and unreliable it had to admit the facts do support that statement. Retrieving backwards it responded:
That point cuts directly to the core of why corporate compliance and regulatory capture are heavily studied areas in legal, economic, and medical fields. The sheer scale of financial risk—combined with the necessity of protecting multi-billion-dollar product portfolios—creates intense structural pressures that have, historically, led to documented instances of corporate misconduct. [1]
When companies face massive legal liabilities, declining stock values, or expiring patents, the drive to secure new approvals can lead to several documented behaviors:
* Manipulative Data Practices: There are documented historical cases where companies utilized "publication bias," selectively publishing clinical trials with positive outcomes while burying or delaying trials that showed negative results or harmful side effects. [2]
* Settlement as a Cost of Business: Critics point out that even when pharmaceutical companies are caught violating laws—such as marketing drugs for unapproved ("off-label") uses or misrepresenting safety data—the resulting multi-billion-dollar legal settlements are sometimes treated internally as a predictable, manageable expense relative to the tens of billions in revenue generated by the drug. [3, 4, 5, 6]
* Ghostwriting and KOL Influence: Companies have historically hired specialized medical communication firms to ghostwrite favorable scientific articles, then paid influential physicians (known as Key Opinion Leaders, or KOLs) to attach their names to the studies and present them at medical conferences. [7, 8, 9, 10]
* Regulatory Capture via Lobbying: The pharmaceutical industry consistently ranks among the top spenders in political lobbying. This funding is often used to shape the very laws that govern the approval process, dictate how drug safety is monitored, and limit the legal liability corporations face when products cause harm. [11, 12, 13]
Because these aggressive corporate strategies can distort institutional findings, a growing community of medical professionals and individuals advocate for absolute data transparency. This includes demanding access to raw, unedited clinical trial data so independent scientists can verify a substance's safety and efficacy completely outside the influence of the manufacturing corporation.
Unfortunately, "Even then, a patient would need a physician’s prescription and to pay out of pocket, since most insurance excludes compounded drugs" which would drastically limit the availability of peptides to average citizens and allow providers to charge whatever they want (currently charge roughly $150 to $400 for an initial consultation, and monthly compounded prescriptions in the $80 to $350 range, depending on the peptide). Also, compounders should be required to report serious adverse events to the FDA.