Protect rights to bioidentical compounded hormones, act by 4/4

Discussion in 'Fibromyalgia Main Forum' started by mbofov, Mar 21, 2006.

  1. mbofov

    mbofov Active Member

    Pjsmonster submitted a post last month re a petition submitted by Wyeth Corporation to the FDA which would severely restrict our ability to obtain bio-identical hormones from compounding pharmacies. Wyeth is the maker of Premarin, made from pregnant horses’ urine, which was shown to have dangerous side effects in a major HRT study a few years ago. Wyeth is now trying to stop women from obtaining natural hormones from compounding pharmacies.

    This is a reminder that April 4th is the deadline to submit comments to the FDA asking them to reject Wyeth’s petition. You can submit comments on-line, by mail, or via fax, the information is below, but it’s very important to do this. They need 20,000 comments by April 4th to defeat Wyeth’s petition.

    To file a comment on line, go to www.fda.gov/ohrms/dockets and click on “Submit Electronic Comments”. Then go to docket no. 2005P-0411 to submit your comment. The dockets are NOT in numeric order, there are 149 of them, but no. 2005P-0411 is about the 5th one down on the page which contains dockets 121 to 135.

    Here is a sample form which my compounding pharmacy sent to me, which you can use to submit your comments.

    VIA FAX: (301) 827-6870

    Division of Dockets Management
    Food and Drug Administration
    5630 Fishers Lane, Room 1061 (HFA-305)
    Rockville, MD 20852

    Re: Docket 2005P-0411 (it’s important to include the docket number)

    Dear Sir or Madam:

    My name is ________________ and I have been taking bio-identical hormones for __________(length of time). It has been a tremendous benefit to me as it alleviates ________________________.

    I consult with my physician, who prescribes bio-identical hormones specifically for me, and my pharmacist prepares them. Without this medication, ___________________________
    __________________________________________________________________________
    (describe how you would suffer or your life would be more difficult without the medication)

    The benefit of bio-identical hormone replacement therapy is that it is designed for me and I am concerned that Wyeth’s petition (Docket #2005P-0411) would limit the ability of my physician and pharmacist to keep prescribing and preparing these individualized doses for me. The FDA should reject Wyeth’s petition.

    Sincerely,

    ___________________(name)
    _____________________(city), _____________(state)


    Here’s the comment I submitted:

    I have been taking bio-identical hormones for 3 years. They help alleviate insomnia, mood swings and hot flashes. They have greatly helped improve my quality of life. My doctor prescribes bio-identical hormones specifically for me, and my pharmacist prepares them.

    I deliberately chose not to take Premarin, made by Wyeth Corporation, because Premarin is made from pregnant horses’ urine. It contains hormones for pregnant horses and was implicated in many undesirable side effects in the major HRT study a few years ago. Unfortunately, research regarding bio-identical hormones was omitted from that study.

    I and millions of other women deserve to choose what we put into our bodies. I don’t think it’s coincidental that Wyeth, the maker of Premarin, is trying to limit my access to natural, bio-identical hormones. I’m sure they have suffered monetary losses since the HRT study came out, and they are now trying to recoup their losses by hurting women further, by denying them access to natural hormones. Wyeth exhibited no such concern for our health when they pushed pregnant horse hormones on women for decades.

    I urge you to reject Wyeth’s petition (Docket #2005P-0411) because it would limit the ability of my doctor and pharmacist to prescribe and prepare individualized doses of natural hormones for me. I much prefer to take my chances with natural, bio-identical hormones, than those derived from pregnant horses’ urine. Wyeth has no right to deny me that choice.


    So, send your comments ASAP!

    Mary
    [This Message was Edited on 03/22/2006]
  2. I just really don't have much faith in it, as my compounding pharmacy sent a letter with my beef liver & B1(thiamine) injections, that explains why they've been *forced* to put preservatives in some of their vitamins & other products now.

    It also explains that the FDA took them to court in January 2001 (again) and lost, but, continues to try to take control of the few compounding pharmacies that exist. It's 5 years later...I'm glad, but suprised it hasn't happened, yet. The pharmacy I get my injections from must be small, I would think they would update the letter a bit?

    I just started those shots last Tuesday, (B1 only, daily, intramuscular, for MS. I mix the beef liver in 4/7 days a week starting *next* Tuesday) I know that if they DO work, I sure as heck don't want someone taking over all of a sudden and deciding I could no longer HAVE those shots!

    Good luck y'all, I sure hope that you don't lose your right to have your bio-identical hormones, that is just wrong, wrong, wrong!!!!!!!! Not to mention REDICULOUS! What does that leave you!? and WHERE does it leave you!? GRRR!


    Best of luck! ((((((((((Hugs)))))))))))


    Laura
  3. findmind

    findmind New Member

    Mary....

    Don't take em, but you and drs should decide who does get to take them..

    Will do, immmediately!

    Thanks.

    findmind
  4. bettydroop

    bettydroop New Member

    this together Mary. Would it matter if I have JUST started them- I mean as far as how to make the statements on the form? It says how it has CHANGED MY life but I havent noticed a difference yet. OF COURSE this makes me SOOOO angry that this is even a possibility. I am so pissed, I cant believe it! OK. I know getting mad doesnt get you anywhere, thats why I wanna DO something.

    OK. So to sum up: Are you looking for people that HAVE had a trial run with this stuff and they KNOW what they are talking about? Like I said, I havent been on it enough to really give an opinion at this point, although I am almost positive this is going to be extremely helpful for me, probably after a few months, that is.

    To bad there isnt a place to make comments regarding how much you want to cuss someone out lol, or tell them that this is AMERICA people!! How can this be happening. I guess we might as well (they think) just lay down and let them steam roll over people , tell em what THEY should do, what they should take, and what money they are gonna MAKE$$$$> After all, it IS all about the money. Period. They dont care about anyone, are they doing this cause they say it is for our own good(dont know why that would be) I mean WHATS THE PROBLEM???? Oh yeah I forgot. They are losing BIG money right now.

    Sorry. just had to.

    Ps. Does anyone know what their excuse is...? Why we shouldnt be able to obtain these things? What arguement could they possibly have?
  5. mbofov

    mbofov Active Member

    You can send a comment, anyone can, just say that you want the right to choose what you put in your body and that you and your doctor have decided that this is the best thing for you. You can also say that you think bio-identical hormones are safer than pregnant horse hormones.

    I think Wyeth is arguing that compounded hormones aren't subject to rigorous testing or something, I'm not sure what, but all I know is they didn't care anything about this until all the dangers of Premarin were found.

    Wyeth doesn't care about our health; otherwise they would stop giving women pregnant horse hormones.

    Mary
  6. mbofov

    mbofov Active Member

    I have to go out of town for about 6 days and won't be on-line so would appreciate it if people would keep bumping this, it's too important to be forgotten - thanks!

    Mary