Ms. Carroll is a retired senior paralegal and consultant who enjoys freelance writing in her spare time.
Understanding Hormonal Balance
A woman's hormonal balance is a delicate thing. Her ovaries produce three different types of estrogen, as well as progesterone and testosterone. When the body fails to produce some or all of these hormones in sufficient levels, there can be serious health consequences such as infections, heart disease, blood clots and stroke, osteoporosis and cancer. The absence of hormones in a woman's body may be the result of menopause, a total hysterectomy, ovarian cysts, or other medical conditions. It is important, therefore, that women have hormone replacement therapy (HRT) or menopausal hormone therapy (MHT) available to them.
The Difference Between Hormone Replacement Therapy and Menopausal Hormone Therapy
There are two HRT or MHT options available to women in the United States: synthethic drugs and bio-identical drugs. Synthetic drugs are those which have been molecularly altered so they can be patented and sold by the pharmaceutical companies that develop them. This includes drugs like Prempro or Premarin. Premarin, for instance, is extracted from a pregnant mare’s urine, then altered. Bio-identical drugs such as Tri-Est are derived from nature such as ginseng, black cohosh, red clover, and other natural sources.
When complete HRT or MHT is necessary, it is important to consider all three types of estrogen. The three types of estrogen, Estriol, Estrone and Estradiol, play different but very important roles in the body. There are many websites which explain the three types of estrogen and their role in the body.
Estriol is important to the estrogen mix. This type of estrogen relieves menopausal symptoms and protects against heart disease and osteoporosis without any evidence that it increases the risk of breast or endometrial cancer. In fact, Estriol has been shown to have anti-cancer affects whereas the other two types of estrogen when used alone, have been shown to increase these risks.
Synthetic drugs such as Premarin and Prempro do not contain Estriol.
How the Women's Health Initiative Study Impacted Premarin
Millions of women have taken and may still be taking some form of Premarin. However, those numbers came down significantly after the negative results of the Women's Health Initiative study. The Women’s Health Initiative Study was a long-term research effort which attempted to study frequent causes of death and disability in post-menopausal women. The study included both synthetic estrogen and progestin in its clinical trials. However, the trials were actually STOPPED due to substantiated health risks associated with the synthetic drugs given to the study participants. It was clear that drugs like Premarin and Prempro were not preventing heart disease or cancer, but in fact, increasing the risks of these diseases and others. This necessitated that the WHI study be halted.
The WHI study offered overwhelming evidence that synthetic drugs are not doing what they need to be doing. Despite that fact, several U.S. Congressmen continue to sponsor or co-sponsor legislation that has the potential to take bio-identical drugs away from women. Large pharmaceutical companies like Wyeth are working in concert with the FDA to eliminate women's access to natural hormone alternatives, particularly Estriol. Premarin is one of Wyeth's largest selling drugs, and was the largest at one time. While it is clinically proven that synthetic hormones are harmful to women, drug companies like Wyeth choose to utilize their resources trying to lobby away women’s rights to bio-identical drugs, rather than developing safer and more effective synthetic drugs.
Review the WHI study and related studies here
- Effect of Hormone Therapy on Risk of Heart Disease May Vary by Age andYears Since Menopause, April 3
Legislative Attempts to Restrict Access to Bio-Identical Hormones
Legislative attempts to restrict access to bio-identical hormones or drugs are made every year. These efforts began as early as 2007 and 2008 and were then buried in a bill called the “Safe Drug Compounding Act.” With every new congressional session, the FDA and pharmaceutical companies put a new twist on their attempts to get their agenda passed. Similar legislation has been stifled ever since but the issue is not going away.
Does Congress have the right to legislate away your access to bio-identical hormones, particularly in lieu of the WHI? Big pharma and their lobby may just succeed if women don't remain proactive in the fight to protect their hormonal and overall rights to good health. Women should be free to choose whether they want natural hormone replacements or synthetic hormones after consulting with their health care providers and carefully weighing health risks against their personal and physical needs. Legislation such as the Safe Drug Compounding Act is merely designed to perpetuate the special interests of large pharmaceutical companies.
On a personal note, I wrote to my senators and representatives when the Act was introduced and opposed their legislation. Fortunately, a group of other Senators and Representatives introduced a separate resolution that deemed the FDA’s actions as “not in the public interest.” I also wrote to them and endorsed their legislation.
Every woman should stay apprised of this critical health care issue and write their legislators. There are several websites where you can state your opinion. As Act Now to Defend Safe Bio-Identical Hormones from FDA Ban, the FDA is now "stacking the deck" against them, even a decade after the Safe Drug Compounding Act tried to eliminate them.
Read the Women's Health Initiative, listen to Susanne Somers Youtube on the topic, and then read Hormone Replacement Therapy: Yes or No? I think after you've done these three things, you will find it not only enlightening but life altering.
- Update on medical and regulatory issues pertaining to compounded and FDA-approved drugs, including h
Track regulatory issues relating to HRT
keepitreal on August 06, 2015:
You taught me a ton in this hub- thank you.