Wall Street Journal 16/03/09
By ERIKA SCHWARTZ , KENT HOLTORF , and DAVID BROWNSTEIN
Mainstream medicine has been given a wake-up call on a matter critical to the health of 65 million women in the U.S. At issue are the options for treatment of menopause symptoms that cause significant health problems for women in mid-life as their bodies produce fewer hormones. It doesn’t seem like a complicated problem, given advances in medical science. Yet hormone- replacement therapy has become a textbook example of how special interests, a confused medical establishment, and opportunists can combine to complicate the issue and deny patients access to safe and effective treatments.
Until seven years ago, women going to conventional doctors were prescribed the FDA-approvedsynthetic hormone Premarin, derived from the urine of pregnant horses; Provera, a synthetic progestin; or Prempro, a combination of the two. Premarin was the bestselling drug in the U.S. in 2001, generating $2 billion a year for Wyeth.
In 1994 a study led by the National Institutes of Health called the Women’s Health Initiative (WHI) was started with the hope of establishing that Premarin and Provera would, beyond relieving menopause symptoms, protect aging women from heart attacks, strokes, osteoporosis and cancer.
On July 9, 2002, however, the WHI came to an abrupt halt. The study proved unequivocally that the drugs were unsafe and significant factors in increasing the risk of heart attacks, strokes and breast cancer in the more than 16,000 women studied.
This led doctors to take millions of women off Premarin, Prempro and Provera overnight. Predictably, these women started to feel horrible in the aftermath of the drugs’ sudden withdrawal, and their physicians told them there were no alternatives. Instead they prescribed antidepressants or birth control pills with shoddy results.
One year after this disaster, the American College of Obstetrics and Gynecology developed new guidelines that encouraged physicians to prescribe the same drugs in lower doses for shorter periods of time. Yet, and this is key, the safety of this “low dose option” was never proven scientifically.
Meanwhile, many conventional physicians have ignored the effectiveness of “bio-identical” or natural progesterone, which is formulated to be identical to the progesterone molecule that is produced by the human body.
There are 25 years of scientific research with hundreds of studies in the U.S. and Europe that have demonstrated that bio-identical hormones, estradiol and micronized progesterone, are equally or more effective than synthetics — and safer. Yet mainstream medicine has buried its head in the sand and refused to take these studies seriously.
While Europeans have long used bio-identicals, no commercially available bio-identical hormones existedin the U.S. until 1998, when a few pharmaceutical companies obtained FDA approval for an array of bio-identical estrogen preparations and one progesterone preparation. Unfortunately, due to drug companies running the medical profession by controlling what goesinto medical education, most doctors never get educated about bio-identical hormones or the way in which different hormone molecules work. With Premarin and Provera dominatingthe market, drug companies had no incentive to spread the word.
Today the distinction between bio-identical/natural progesterone and the synthetic progestin Provera remains widely misunderstood. Progesterone is used by fertility specialists to protect pregnancy, while medroxyprogesterone (Provera) is used in the morning after pill and in birth control pills to prevent pregnancy. Their actions are totally different and antithetical.
Sadly, seven years after the WHI study finding Premarin/Provera unsafe, the hormone- replacement debate can be summed up in three words: confusion, ignorance, misinformation. Meanwhile, millions of women have embraced bio-identicals, leaving their conventional physicians looking stubborn and foolish.
The medical establishment must stop kowtowing to drug companies and start serving women’s best interests — and that involves widely prescribing bio-identical hormones. This will lead to healthier, happier women and, in the long run, help reduce America’s skyrocketing health-carecosts.
Drs. Schwartz, Holtorf and Brownstein are founding members of the Bioidentical Hormone Initiative, a nonprofit group of physicians dedicated to patient and physician education (www.bio-identicalhormoneinitiative.org).