FDA Pushing to "Ban" All Compounded Hormones FDA Pushing to "Ban" All Compounded Hormones

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Thread: FDA Pushing to "Ban" All Compounded Hormones

  1. #1
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    Default FDA Pushing to "Ban" All Compounded Hormones

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    After putting hormones like hCG in the Difficult to Compound List, the FDA is now pushing to add all other hormones commonly used in HRT/TRT treatment. This will effectively put many compounding pharmacies and HRT clinics out of business and make HRT/TRT prohibitively expensive for countless people. It will also push many toward the black market, which is much riskier than compounded pharmacy products.

    Another fine move in the interest of public health...Mother@#%&$!


    FDA is Trying To Ban Compounded TRT : moreplatesmoredates

    Tell Congress & FDA: Protect People’s Access to Hormone Therapies

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  3. #3
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    The most likely grounds to protest this approach is that it is discriminatory to the gender diverse and impedes their rights to reflect the gender they actually are instead of the physical one they were born with.

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    What do you want to bet that the ban will affect only testosterone and not estrogen replacement?

  5. #5
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    Incredible. What's sad is that it doesn't even matter who is elected or not. These agencies act on their own accord. The "study" that is being used to justify this was commissioned by the FDA several years ago. By NASEM, from the description:

    "In light of the fast-growing popularity of cBHT preparations, the clinical utility of these compounded preparations is a substantial public health concern for various stakeholders, including medical practitioners, patients, health advocacy organizations, and federal and state public health agencies. This report examines the clinical utility and uses of cBHT drug preparations and reviews the available evidence that would support marketing claims of the safety and effectiveness of cBHT preparations. It also assesses whether the available evidence suggests that these preparations have clinical utility and safety profiles warranting their clinical use and identifies patient populations that might benefit from cBHT preparations in lieu of FDA-approved BHT."

    These clowns concluded there was no clinical utility and it's a public health concern because of a "lack of rigorous evidence...from well-designed or properly controlled clinical studies." Never mind the thousands (millions?) of individuals living better lives, or the fact that no one has ever died from reasonable HRT treatment. Straight out of the "a million anecdotes isn't data" school of idiocy.


    The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use | The National Academies Press

    National Academies of Science, Engineering, and Medicine (NASEM) Study on the Clinical Utility of Treating Patients with Compounded “Bioidentical” Hormone Therapy | FDA

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    I know next to nothing about the pharmacological industry so I could be talking out of my ass here. It looks like HCG was put on the list in 2020, but I can still get it at my HRT clinic if I want it. I assume this would be the same way, just that the hormones (biologics, I believe) will no longer be able to be compounded. I don't get HCG, but I do know they always give it as a separate shot to the testosterone.

    I'll never assume the government won't do something, but what does the guy who got his nuts shot off in Iraq do if they ban testosterone? What about the guy who had both testicles removed due to cancer? What about accident victims? There are enough people out there missing their testicles, believe it or not, that this would completely fuck them up.

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    This is an incredibly dumb question but what is a the difference, if there is one, between "compounded bioidentical hormones" and, say, test cypionate from Upjohn or Watson or whoever? Are they the same thing?

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    Quote Originally Posted by dalan View Post
    This is an incredibly dumb question but what is a the difference, if there is one, between "compounded bioidentical hormones" and, say, test cypionate from Upjohn or Watson or whoever? Are they the same thing?
    They are the same thing. Testosterone cypionate is incredibly cheap to make, and banning the custom compounding of the hormones shifts the profits back to Upjohn/Watson et al, where they obviously belong.

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    Quote Originally Posted by Mark Rippetoe View Post
    They are the same thing. Testosterone cypionate is incredibly cheap to make, and banning the custom compounding of the hormones shifts the profits back to Upjohn/Watson et al, where they obviously belong.
    Ah, I understand what's going on now. Thanks.

  10. #10
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    AAPS is not a professional organization of doctors, but a tiny litigious conspiracy promoter. Not my idea of a good source of facts.

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