"HORMONE REPLACEMENT THERAPY"
TO BE OR NOT TO BE - IS THAT THE QUESTION?
One would certainly think so if the media is to be believed at face value.
"More than 16,000 women participating in a major clinical trial (the Women's Health Initiative) were ordered to stop
taking hormone medication this week after tests revealed that the 6 million other American women taking the drugs were at risk" trumpeted ABC News.com.
This study was recruited between 1993 and 1998 and was supposed to produce the information we all needed and
wanted - a double blind prospective analysis that would finally give us definitive answers as to benefits versus risks related to estrogen and progesterone replacement therapy for peri- and post menopausal women.
Unfortunately, as I have complained ever since the study started, the estrogen chosen for use was Premarin (Pregnant Mare's Urine) taken orally, and the progesterone was Provera, a synthetic progestin quite different from real progesterone.
These choices of medication were no accident. The pharmaceutical manufacturers were extremely anxious that their brands of estrogen and progesterone be used. Think of the free publicity, the huge potential for increased sales if the study results confirmed more benefit than risk using these two products.
First, a little history is in order.
In 1942, Premarin was approved and came on the market in the United States. Real human estrogen (estradiol) had not yet been isolated or manufactured. In the mid 1960's, Dr. Robert Wilson, a private practitioner in New York, wrote a book which he called Feminine Forever. The pharmaceutical company with the patent on Premarin immediately realized that the concept of hormone replacement therapy using their drug would be a financial bonanza if they could sell that idea to American women. They promoted the book into a national best seller and began to reap the financial reward (2 billion dollars per year at present).
The Premarin juggernaut had been born.
It steamed along as sales gradually increased, until an article appeared in the "New England Journal of Medicine" in the early 1980's reporting on estrogen use (Premarin, of course) and the risk of heart disease. This article, derived from data in the Harvard Nurses Study, claimed a marked increase in the risk of heart attack in estrogen users. Subsequent reports from around the world showed the opposite.
No one - then or now - compared dos-age, route of administration, or blood estrogen levels. In 1992, a French endocrinologist,"Dr. Bruno des Lignieres", brought the question of "route of administration of the estrogen" and "first pass through the liver" effect to the fore. See "Special Bulletin" which I wrote in March 1992. His concept, however, was largely ignored, especially in this country. Premarin continued to be the estrogen of choice in the U.S. and the drug used almost exclusively for research studies. It is still currently the second most prescribed drug of any kind in America.
In 1998, Dr. Gerald Friede at the Cooper Clinic undertook a study of my patients, who were on non-oral estradiol hormone replacement, and compared them to other patients on oral or no hormone replacement. The results of his study are detailed in my "Special Bulletin" May 1998.
Monitoring "estrogen replacement", which is crucial, is summarized and explained in my article of the same name, which is available, as are the others, in my office. Should you be on hormone replacement therapy done correctly with non-oral human estradiol and real human progesterone, monitored with periodic blood levels? YES! Do the benefits largely outweigh the risks? YES! Should Premarin be taken off the market? Probably.
Should a prospective double blind study using non-oral estradiol be undertaken in this country?Absolutely! Will it happen? Almost certainly not, since no drug company has any financial incentive to do so, and government funding for research is almost impossible to obtain at this time.
