Are Bio-identical Hormones Safe?

I do agree that the public does want things fast and they dont like to wait for results. Maybe it isnt just the FDA's fault but they should have to do more indepth studies before putting a drug on the market to make sure they are safe and to find out the side effects and all. I dont care if people are yelling for them or not! No, maybe its not all the FDA's fault but if they dont have their hands in it so they can make money, it seems they try to shut the other sources down.

We all know that the FDA is in cahoots with the Big Pharma to make money off drugs that KILL! They do not care about what is safe for us to take, they are in it for the big bucks and that is all! They dont like women taking these others because they cant regulate them and make money off them. They are afraid of losing money is all ! It is a sad day when money is more important than the health and well being of people! I am outraged that they have so much influence over our rights as people...we have the right to choose how we take care of ourselves and what kind of treatments we want to have! The FDA needs to be revamped.

Any one who still believes that the FDA, as it is presently run, has the safety of women at heart...well, I got a bridge to sell you. The FDA is in bed with Big Pharma, and, make no mistake, it is Big Pharma (specifically Wyeth, that erstwhile and financially hurting pharmaceutical giant, that made all its big bucks poisoning women with synthetic HRT products) that objected to natural hormone sales cutting into its profits, NOT as this pandering article suggest, woman's groups or independent physicians.

It is common knowledge that bio-identical hormones cannot be patented because they are identical to the hormones our bodies produce naturally. There fore, the pharmaceutical companies will never make money on them. They DO, however, seem to have pushed Premarin, a poison that causes more problems than it helps. Women are NOT horses, and horse urine is not an option for me. Using natural progesterone cream helped me with a lifetime of hormone imbalance, including PMDD and post partum depression. I sought help for years and was only offered therapy or anti-depressants. Finally, after using this cream, I feel better. Melatonin also helps me sleep better than any xanax pill ever did, is not habit forming, and helps your immune function.It's a shame that bio-identicals are now being attacked when in Europe, studies have shown them to be safe and effective. Only in the USA, where most medical research is funded by the pharmaceutical companies, do we fight their availablity. I'm a fan of them, and I feel I should have that option. If you want to ban a drug, try banning Premarin, a known cause of breast and uterine cancer.

My sister-in-law was on the synthentic hormones for years and now at the age of 48 is diagnosed with breast cancer. I started having menopause sympthoms so bad it affected my personal and professional life. So I went to a doctor who took 5 minutes to listen to me and throughout the two years I was with him gave me three of the worst anti-depressants on the market. I gained lots of weight and was sick to my stomach all of the time and NOT EVEN DEPRESSED. I finally got off the FDA approved anti-depressants myself and started doing my own research. My doctor just pacified me and said all women have to go through this and it will get better. How does he know? He has never been at a meeting at work and got such bad hot flashes he wanted to throw up in front of everyone?
Finally, relief, at my local library. From the informatin I found there, I was able to find a very kind doctor who is a savior. She actually talked to me for TWO AND 1/2 HOURS. She took my blood work and I was on the biodentical hormone therapy within 3 weeks.
Guess what? I am feeling like my old self again. I am actually showing up to work and getting projects completed because I don't have to run to the bathroom several times and day to get sick. And everyone around me likes to be around me again because I am not biting their heads off when they look at me wrong. And best of all I am losing all of the weight I gained being on the anti-depressants. I would not wish the symptoms of menopause on anyone. People make fun of it and really do not know how bad it makes you feel. I lost TWO years of my life that is suppose to be the best part of life. I will stay on the biodenticals until my NEW doctor tells me otherwise. God bless the doctors who are working with women and actually take the time to LISTEN to them instead of rushing them out the door. One thing I don't get is how can a male doctor TRUELY know what we go through? I had such bad hot flashes I broke out in blisters. You can not know how bad that is until you actually have one yourself.

Once again Big Pharma is trying to take away a natural remedy that works ONLY becuase they can not make money off it. Do you see any studies quoting statistics of problems with bio-identicals? No? I didn't think so! And, they will never do any studies because they would never spend money to prove that something natural that they won't make money on actually WORKS! I tried everything before bio-identicals and NOTHING worked! In addition, most caused horrible side-affects! Thank God for bio-identicals! Big Pharma is all about money - NOT our health!

I am a 65 yrs old, and have taken bio-identical estrogen for 12 yrs. I aways had a problem with the hormone levels in my body as I did not menstruate normally even in my twenties. I was regulated with birth control pills, but when they were discontinued, I ceased menstruation in my thirties. I was told that I had the normal balance of hormones ( I had two children), but they were not triggering properly for menstruation.
When I hit (50), I felt like my life was over. I had insommnia, depression, hot flashes. urinary tract infections that persisted even with treatment, gastro problems, and everything in between.
My doctor first put me on Prempro which did alleviate my symptoms, but then gave me symptoms of it's own.
When he suggest the Tri-est HRT, my life changed completely. It is absolutely the best thing I ever did.
I am a firm believer that your body know what is good for it, and this had been the best for me.
This deal with the FDA is absolutely nothing but $$$$$$$$$$$$ for the Pharmaceutical companies who control this country.
Additonally, this would never happen to a drug that was helping men.
Let's fight back

I believe the issue is choice. Some believe that The FDA is simply protecting the finanial interest of Wyeth, while others believe that the FDA is an honest entity. I believe the best action would be to simply categorize bio-identical estrogen as a "supplement" and then let customers experiment, just like customers choose to do with any supplement. They can put the "non-FDA" approved labels on them. But, it seems to me that the FDA is indeed just looking out for the financial interest of key Pharma companies, which is why when a prescription substance harms thousands of people, the FDA is still hesitant to take it off the market, while supplements are quickly banned for unproven reasons, like effedra. Congress is now trying to ban the natural hormone DHEA, which is the only substance that has helped my depression and ADD symptoms: I tried all the synthetic prescription products, but they did not work as well as DHEA.

I think if we believe in "Freedom", that means the freedom of people to have choice over their health, not having an authoritarian government department dictate what each individual is allowed to choose.

I would suggest taking a look at the Life Extension Foundation for more information on what is the best policies for your health.

Regards.

I spent five years taking every kind of hormone replacement, working with mainstream doctors. The things they gave me caused me to have terrible acne, and they sent me to dermatologists who gave me medicines, both internal and external that interfered with the HRT. When I made complaint, they upped the doses of everything until I was spending all my disposable income and NOTHING worked. We're talking hundreds upon hundreds every month. I finally stopped it all, and was so uncomfortable, with vaginal dryness, I couldn't stand my life. I had to use over the counter remedies HOURLY, to survive. I went to an alternative integrative medicine clinic, in North Carolina, and in 16 months after trials, tests, and changes, I use bio-identical hormones, balanced to my body needs, and am comfortable and sexually functioning for over a year, now. I think these people and their work is a God send, and it is much less expensive than the traditional "care"which is a traditional nightmare! Please investigate these treatments with patients, instead of AMA rhetoric, before advising women to abandon alternatives that may the ONLY thing that can help them!
Sincerely,

Wyeth wants the FDA to stop compounding pharmacies from using the term bio-identical because their products are not bio-identical.

Estriol is produced in the placenta and its lack is indicative of a child with Downs Syndrome. It is unconscionable or ignorant for the FDA to make a decision that such a substance should not be available.

Since the following guideines by the FDA were published much research has been done on the bio-identicals however apparently no one has bothered to instigate changes to FDA's guidelines. I would judge that the FDA still thinks that all estrogen is identical to equine estrogen which apparently does not contain estriol.

http://www.fda.gov/cder/guidance/6932dft.pdf

Page 3

"Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman."

The HRT available from "Big Pharma" is made from mare's and other animals urine and other bodily fluids. Last I checked, I was not a mare. I would much rather go to my local compounding pharmacists and get a plant-based estriol product (which, by the way, IS approved by the FDA when used in other compounds.

People act as if compound pharmacies are doing the marketing. This article, books by doctors and patients like Suzanne Summers are the marketers. Compounding pharmacies don't have the finances to market the way big pharma does. Also, a compounding pharmacists does not ship hormones without a doctor's prescription. If I was a physician prescribing bio-identical hormones, I would be insulted by the recent actions by the FDA considering the fact that compounding pharmacies act on the physician's consent.

Premarin is FDA approved but 3 women who took it and developed breast cancer SUED AND WON a lawsuit against Wyeth (the drug maker and leading critic of bio-identical products). 134.5 million dollars later, Wyeth wants to make some of that money back. So much for "rigors of main stream testing". Check out this link
http://lawsuitsandjudgments.com/breast-cancer-survivors-win-lawsuit-against-drug-company-36.html#more-36

Premarin is FDA approved but 3 women who took it and developed breast cancer SUED AND WON a lawsuit against Wyeth (the drug maker and leading critic of bio-identical products). 134.5 million dollars later, Wyeth wants to make some of that money back. So much for "rigors of main stream testing". Check out this link
http://lawsuitsandjudgments.com/breast-cancer-survivors-win-lawsuit-against-drug-company-36.html#more-36