Clarifying The Hormone Replacement Therapy Situation

03/18/2010 05:12 am ET | Updated Nov 17, 2011

On November 23, 2009 two juries awarded verdicts totaling $113 million in favor of two women who got breast cancer by taking Premarin and/or Prempro, HRT drugs known to cause cancer, strokes and heart attacks since 2002.

There are more than 10,000 cases awaiting trials in a major class action suit from women who took Premarin and Prempro who are believed to have gotten breast cancer from the use of these drugs. Somehow, the media is not spending much ink covering these law suits or their outcomes.

Since the entire area of HRT or hormone replacement therapy is so fraught with controversy and confusion, I believe this to be a great opportunity to shed some clarity on the area. Let's put things into perspective by presenting a few highly important facts that affect at least 40 million of us women today:

1. In 2002, (seven and a half years ago), the Women's Health Initiative, a study conducted (by a coalition of National Institutes of Health, Wyeth and dozens of US Academic Medical Centers) on more than 16,000 women proved beyond the shadow of a doubt that the leading menopause hormone treatment, Premarin and Prempro were highly dangerous drugs. They increased the risk of breast cancer, heart attack and strokes significantly as compared to placebo or women who did not take those particular drugs.

2. Today, in 2009 (7 1/2 years later), those same drugs are still on the market and physicians are prescribing them with the same impunity they did since their massive launch in 1965 when Dr. Wilson published the book "Feminine Forever" paid for in its entirety with money from Wyeth-Ayerst (the pharmaceutical company that manufactures Premarin and Prempro)

3. Premarin and Prempro made 2 billion dollars for their manufacturers in 2002. They now make 500 million and the marketing campaign to doctors is heating up again. No wonder your doctor knows nothing about bioidentical hormones as safe and efficacious alternatives to Premarin and Prempro.

4. After the WHI fiasco, millions of women were taken off Premarin and Prempro by their physicians and told they should never use HRT since it causes cancer, heart attacks and strokes.

5. Within a few months, the same millions of women started feeling awful ( hot flashes, night sweats, insomnia, fatigue, itchiness, loss of sex drive, etc.) and were given antidepressants by their conventional physicians instead of the beleaguered drugs.

6. By 2004, NAMS (North American Menopause Society) and ACOG (American College of Obstetrics and Gynecology), the medical groups that provide the guidelines for treatments of women in menopause for conventional physicians, reinstated Premarin and Prempro as the hormone drugs of choice for the treatment of menopausal symptoms in lower doses for a limited amount of time.

7. No study was ever conducted to prove safety or efficacy for these new guidelines.

8. Bioidentical hormones were not part of the Women's Health Initiative. They were not studied in the Women's Health Initiative although they were on the market at least 20 years before the arrival of Premarin and Prempro. In fact, human estrogen and progesterone were used in the 1930s and 1940s to treat menopausal symptoms with no negative reported side-effects in more than sufficiently vast and credible medical literature.

9. In 2007 when Suzanne Somers published her second book singing praises to bioidentical hormones and how they made her life better, the president of NAMS, Wolf Utian, stated on national TV that bioidentical hormones did not really exist but were a "marketing term" In fact, many conventional medical publications echoed the fact that there was no such thing as bioidentical hormones.

10. In the NAMS 2008 guidelines for physicians bioidentical hormones are identified along with the conjugated equine estrogens ( Premarin) but there appears to be much confusion surrounding them. While bioidentical hormones are identical to the hormones the woman's body makes, no mention of that fact is made in the publication. There is also no mention of the fact that different molecules of hormones act differently in the human body. Hence, bunching Premarin, Prempro and bioidentical hormones together only serves to further confuse the doctors. The confusion is later made worse by statements that most bioidentical hormones are made by compounding pharmacies who are unreliable and use saliva testing to determine dosages. These statements are untrue and unclear leaving physicians with the best intention unable to correctly distinguish facts from rhetoric. To date, most physicians who prescribe commercially available FDA approved bioidentical hormones aren't even aware they are prescribing bioidenticals.

11. In white papers published in Postgraduate Medicine, Medical Clinics, Life Extension Foundation and other highly respected medical publications hundreds of studies over the course of more than 40 years reporting safety and efficacy of bioidentical hormones over conjugated equine estrogens (Premarin and Prempro) can easily be found by turning to the extensive bibliographies of these articles.

12. The excuse that there isn't enough data to support safety of bioidenticals as well as the excuse that they are only available in compounded forms is no longer a tenable excuse. It has only served to set back women's health by decades.

Physicians, academic institutions and medical schools must learn and teach the option of bioidentical hormones and offer them to every woman who wants to take them and Premarin and Prempro should no longer be used.

Women must become informed and no longer allow doctors who are poorly informed to intimidate them or bully them into either taking Premarin/Prempro or antidepressants.

While the class action suit against Premarin/Prempro continues, let's use the honest and true information we have accumulated to protect ourselves from harmful drugs. In the midst of the growing debate over the new guidelines for mammography let us pause and acknowledge the potential injury and stop continuing the damage caused by Premarin and Prempro and stop taking these drugs proven to cause breast cancer. Maybe then, we can look at the mammography debate with fresh eyes.