Choices in Menopause
Now Playing: "Freedom," by Richie Havens
Topic: Women's Health
FDA Asserts New Policy to Restrict Women’s Access to Bioidentical Hormones
Agency Warns Pharmacies Not to Compound Commonly Prescribed Hormone Treatments, Use the Term “Bio-identical” MISSOURI CITY, Texas – In a series of warning letters to compounding pharmacies across the country, the Food and Drug Administration (FDA) has asserted a policy that would deny hundreds of thousands of women access to many commonly compounded bioidentical hormones, substituting its judgment for that of doctors. Wyeth Pharmaceuticals, the number one manufacturer of synthetic hormone products, petitioned the FDA to do so in October 2005. More than 70,000 doctors, patients, and pharmacists filed comments with the FDA opposing Wyeth’s petition, the vast majority of whom opposed the petition.
“Under this policy, patients will suffer while Wyeth profits,” said L.D. King, executive director of the International Academy of Compounding Pharmacists (IACP). “Thousands of doctors are making patient-by-patient decisions that compounded hormones are medically appropriate, sometimes because Wyeth’s products are found to be ineffective or produce side effects. This is a decision that should be left to doctors.”
In the letters, the FDA states that it will “halt” compounding of medications containing estriol, an estrogen produced by the human body. Estriol is one of the most widely prescribed hormones and is regularly compounded with other bio-identical hormones pursuant to doctors’ prescriptions for women suffering from symptoms of menopause. Like many commonly prescribed drugs, estriol has a monograph from the U.S. Pharmacopeia (USP), but is not a component of an FDA-approved drug. When it passed the FDA Modernization Act in 1997, Congress clearly indicated that drugs with a USP monograph could be compounded.
The FDA also stated in its letters that pharmacies may not use the term “bio-identical” to characterize compounded hormone therapies, even though the chemicals used in such compounds are chemically identical to what is produced by the human body.
Furthermore, manufacturers of drugs containing the same bio-identical hormones commonly use the term to characterize their products. The chemical structure of these drugs is indisputable.
Pharmacy compounding is a long-standing, state-regulated and medically vital practice. Millions of Americans have unique health needs that off-the-shelf prescription medicines cannot meet. For them, customized, compounded medications prescribed or ordered by licensed physicians or veterinarians and mixed safely by trained, licensed compounding pharmacists are the only way to better health.
To file opposition to the the FDA's complaint, please visit www.savemymedicine.org. With a few clicks you can personalize a form letter and send your message to your members of Congress, your U.S. Representative and Andrew Von Eschenbach, M.D., of the FDA. Please act now to "choose women's health over Wyeth's wealth!"
FOR IMMEDIATE RELEASE FOR MORE INFORMATION
January 9, 2008 Joshua Wenderoff
To read what I've previously written about bio-identical hormones, CLICK HERE.
Who should tell us as women that we have to use synthetic or nothing...after they've ripped out our organs?
I'm fighting right now to save mine.
This is a personal issue for me. My first choice is to NOT have surgery...and I've pretty much decided I won't. I believe with my whole heart that I can get through this time in my life (men-o-pause...ick!)...with my organis intact. I actually had one doctor say to me when I was 50, that I was done having children so when did I want to schedule my surgery for....WHAT?!
Recently I had a big lesson...I almost put myself in a dangerous position regarding my health. I had been experiencing problems, and I dealt with them naturally with good success for some time, but then I wore myself down working from the time I woke up before dawn, until I dropped way late at night, with no recreation or rest. I also became inconsistent in my use of herbs and nutrition as well. I'm here to tell you, that doesn't work!
It's so easy sometimes to assume that because we KNOW something we're DOING it. I've noticed on and off throughout my life that such is not always the case. It may be due to circumstances, or finances, or complacancy, or forgetfulness...or thinking we're beyond all that now. But to achieve proper results there must be action in the proper direction...or rather in my case, I needed some rest.
Sooooooo.....I had a crisis that almost killed me, but with God and the help of the medical doctors I'm fine. It was very difficult for me to surrender myself to their care, but I was glad they were there at the time. I needed a transfusion. I hemorrhaged is what happened to me, and I lost 2/3 of my blood.
So I went through some hospital drama...don't get me wrong, I was very glad for the blood. But my oh my the things they did that were absolutely totally wrong! I won't get into it all, but I ended up calling the Patients Rights Advocate, and also the manager of the unit that I was on.
A lot of what happened boils down to this, in my opinion...I should have been in Intensive Care, but I was "just" a Medicare case. (In the defense of Medicare, though...I was allowed to stay for five days. Shoot! Mammograms and so many other intensely serious procedures don't even get that! Most of them don't even get to stay over night! I think that's a terrible thing.)
Anyways....they were unprepared for someone like me on their floor, and it's lucky I got out alive! God was with me, though. Doctor after doctor and nurse after nurse kept saying they'd never seen anyone concious before with as little bit of blood left as I had, but yet when I called the ambulance to come and get me, I had been out mowing the lawn! Hahaha! THAT'S how determined I was to keep working! Ha Ha! Actually, that's a testiment to God's power to keep someone even as stubborn as me alive.
What did I learn? A LOT! I have to DO it and DO it and KEEP DOING IT for as long as I am alive! There's never a time to stop taking care of our health, and it's never good to push, push, push all the time with no rest.
So that's what I'm doing now. I'm resting and eating REALLY good foods (my good friend Brenda filled my fridge up for me!)...and I'm taking my herbs like I should. I've got a really good formula that I made myself that I'm taking...I call it Figlyvimins...It's a whole food all around complete fiber, glyconutrient, vitamin, mineral blend...Fabulous, fabulous stuff. I wish I could put it on the market, but wow does the FDA present some horrendous hoops to go through. (As evidenced from what's written above!!!) I'm also taking some really good products from Nature's Sunshine
, like cayenne to keep down the bleeding, chlorophyll to build up my blood, enzymes of course as always, and flax seed, plus some herbs to balance my hormones and to clean the uterus out. There are some other things I'm using, too, like some wonderful local raw bee pollen I got, for some added support in keeping me strong and to give lots of extra nutrients to me.
And I'm resting. Resting. Resssssssssssssting! It's been so long I'm having to retrain myself! Relaxing baths with essential oils and h2o2..
watching the same episodes of "Friends" over and over because it's the only thing there is to watch since I haven't had TV for years (workaholic type thinking again)...but wow! I discovered I REALLY enjoy watching that show! Again and again and again! (You know how the pendulum swings! Yep! Workaholic turned potato right there on the couch! Hahaha!)
So I'm recovering, and the herbs and the rest are doing their work. I'm finding I'm sleeping a LOT. I'm catching up for years of it lost. The hardest part, though, is writing this entry, but I think it's something I need to write.
In doing the work that I do, a lot of people look up to me, and that's fine...I kind of like it sometimes! But I can't like it toooo much or else I'll get in trouble, so I always try to periodically remind everyone in a public way that I'm VERY human and quite a bit subject to fallibilities and wow...does that make me humble to say!
There are those, too, who do NOT look up to me In fact, there are quite a few who think I'm the most ridiculous, scatter-brained, opinionated twit that they've ever known in their life...or something like that, I've gathered from a few over the years. It's equally as hard to write something like this knowing that perhaps they will read what I'm saying, but that's part of what is keeping me humble, too. (And heck! Who am I kidding?! Ha ha! Why would they want to read anything written by someone they considered as nit-witted as what they think me to be, so they're probably not reading this! Hahahaha!)
Ahem...the point is...well, there are many points I'm trying to make. One of them is that if anyone who IS reading this has wondered where I've been at, I've been recovering from a quiet intense round of ignorance and the arrogance to behave as if my whole world depended upon my own efforts, forgetting to make adequate use of the gifts of herbs, rest, food and a few other things. I guess I forgot to let go and let God.
Another point I'm trying to make is that it is MY choice how I want to take care of my body, and I should have the right to make whatever kind of choices it is that I'm wishing to make. In my particular case, I am choosing to do what I teach and what I do with every other health condition with which I'm faced--I am choosing to cleanse, nourish and balance my system to health! It's what I believe and what's ALWAYS worked for me in the past, and it's working this time as well....I just stopped working on it for what seemed like only a minute, because I was too busy working myself to death. I had been making excellent progress for most of the way, and then I just slipped at the end, but I'm doing fabulous now, considering I was in critical condition two weeks ago. And I'm doing it all without drugs. That is MY choice to make!
In conclusion, please think about the choices each and every one of us make regarding our health. Some women can't wait to have everything removed, and that's fine...that's THEIR choice...not mine, but it's theirs and they should be allowed. Other women are presented no other choice, and that's sad. I think ALL women should be presented choices, but the truth is that people really don't know. The old ways are thought to be outdated, but they should still be a CHOICE, don't you think? Anymore it's harder and harder for people to even have any true idea of the true extent of the choices they have. Traditional ways have been pushed to the side....ways used for THOUSANDS of years.
I believe with all of my heart that every person should have the FREEDOM to choose whatever it is that they want when it comes to their health. Whether to go the traditional route or to make the most of what modern medicine has, or whether they should do a comfortable combination of both.
So why should the FDA outlaw the manufacture and even the termonology of bio-identical hormones? I'm praying I don't have my organs removed, but gee whiz....if they take them out (which I repeat! Is NOT what I'm aiming to let happen to me! That is and should remain my choice to make, unless of course Life has other plans, but we'll see. I believe strongly not only in the power of herbs, but also in the power of prayer and I am speaking the Truth of Life into my body each day and invoking the power of God!)
Anywayyyyyyyyyys.....IF something should ever happen and I would ever lose my uterus AND ovaries to the very competent surgeon I pray God would give me in such a case....I would not be able to produce my own hormones anymore and so I'd have to use SOMETHING to do the work that hormones do...so why not use hormones which are virtually identical...they're still artificial but they're the closest thing we've made in that way. Only God, of course, can make a REAL hormone, and so that's why I'm trying real hard to keep what produces mine. But in their absence I'd want something close, and bio-identical is as close as we've been able to get. It should be OUR choice what to use....why should we be forced to use synthetic or go without? It's not right!!!!!!
Even if this doesn't concern you...it does! Even men and children are affected by this, because when freedom begins to erode for one, it begins to erode for us all. DON'T LET THEM TAKE OUR CHOICES AWAY! Please join me in demanding our freedom and the right to manage our personal health in the way we see fit!
Mary Jo Eshelman, ND, CTN, CNHP, D.D.
Holistic Education and Research Unlimited...
The information presented is the author's personal and professional opinion, and is intended for educational purposes only. Nothing printed here is designed to take the place of a physician's advice. If you are experiencing problems with your health, it is recommended that you consult with a licensed health care professional. All Natural HealthWorks! is not responsible for any damages or ill-effects resulting from the information presented herein, nor do we make any recommendations regarding your health. We are simply here as a resource for you in making your own choices for your health yourself.