Wednesday, August 16, 2006

Dangerous "natural" remedies for women

Women are being urged to avoid so-called natural hormone replacement therapy because of health fears. Some women using the therapy, also known as bio-identical hormones, have suffered elevated hormone levels that could lead to excessive bleeding, increased risk of breast and uterine cancer and blood clots.

Dr John Eden, director of the Sydney Menopause Centre at Randwick's Royal Hospital for Women, said in the past year he had referred two cases of uterine cancer in patients who had been taking natural hormone replacement therapy, to the Therapeutic Goods Administration. Dr Eden said these "handmade hormones" were prepared by chemists - known as compounding chemists - without scrutiny. Although the process is legal, it is beyond the regulatory control of the TGA and state-based pharmacy boards. "There's a whole stack of women being treated out there with handmade hormones. It's untested hormone replacement therapy," he said. "Many women think they are getting a herbal treatment and are shocked to learn they are getting a hormone treatment."

One of the NHRT's major wholesalers, Professional Compounding Chemists of Australia, defended the practice, citing an exemption in the TGA Act that allows the preparation of medicines for individuals. The medication is usually made into troches, or lozenges, with the hormones absorbed through the lining of the mouth. NHRT contains the female hormones oestrogen and progesterone, sourced from yams or soy and synthesised in laboratories. However, NHRT can also include the male hormone testosterone, which has not been approved in Australia for use on women. Some compounds also include thyroid hormone, the little-understood sex steroid pregnenolone and a steroid called DHEA, which converts to testosterone and is banned from manufacture in Australia.

Dr Helena Teede, research director at Australia's leading women's health organisation, the Jean Hailes Foundation, said many women were unaware preparations were not approved by the TGA. "There has been very limited research into these preparations and women taking the compounds are essentially guinea pigs," she said.

A leading compounding chemist Richard Stenlake, in Bondi Junction, said he would welcome more regulation of the industry and there were discussions taking place about how it could be done. Mr Stenlake said he was one of the few compounding chemists with the expertise to do regular testing of NHRT preparations to make sure there was the correct dose of hormones. "There should be parameters put on compounding pharmacists that drug companies face," he said. "You have to make sure the dose prescribed by the doctor is the dose that goes out to the patient."

The PCCA defended the safety of the practice, citing an exemption in the TGA Act which allows the preparation of medicines for individuals. However, it acknowledged in a written statement there was no formal testing of the products. "Since compounded products are made on an individual basis according to the needs of a specific patient, it is not possible to test each product before supply to a patient without making the cost prohibitive. Many pharmacies do test samples of products that are made frequently," it said in the statement.


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