Elixir of youth or cancer risk?

"After one day on bioidentical estrogen, I felt the veil lift. After three days, the sky was bluer, my brain was no longer fuzzy" ... Oprah Winfrey's endorsement.

A decade ago Gary Aaron was offering hope to Australian men suffering from sexual dysfunction through Jack Vaisman's chain of impotence clinics. But when an international study came out in 2002 linking synthetic hormone replacement therapy to breast cancer, Dr Aaron saw a gap in the market for women's health.

The 46-year-old South African-born medical entrepreneur established Menopause Institute of Australia in 2003, offering fearful women ''natural'' HRT which promised not to pose the same risks as the synthetic version. Like his previous employer's Advanced Medical Institute, of longer-lasting-sex fame, Dr Aaron's Menopause Institute offered patients a safe and effective alternative to drugs promoted by the pharmacuetical giants.

Dr Aaron disowned Vaisman some years ago. He also abandoned the name, the Menopause Institute of Australia, after running foul of the Australian Competition and Consumer Commission, which took the company to court over deceptive and misleading conduct in 2006.

But six weeks after that court finding, the business was relaunched as the Australian Menopause Centre, offering the same products, albeit marketed more cautiously.

Medical concerns about natural HRT remain, with doctors saying it is untested, not approved by the Therapeutic Goods Administration (TGA) and may lead to cancer.

A University of NSW endocrinologist, Associate Professor John Eden, has published an article in the Medical Journal of Australia, drawing a link between uterine cancer and the use of natural hormone replacement therapy, also referred to as bioidentical HRT. He has expressed his views to the TGA to no avail.

But the treatment has fans in high places, including television host Oprah Winfrey and actress Suzanne Somers. Dr Aaron believes it has the potential to be an elixir of youth.

While natural HRT has been around for 20 years, it only became popular in Australia about a decade ago, fuelled by anxiety about synthetic HRT caused by the now largely discounted Women's Health Initiative study, which showed it posed an increased risk of breast cancer.

Claiming that natural HRT would reduce the risk of cancer, heart disease and Alzheimer's and protect against osteoporosis and low libido, business boomed at the Menopause Institute of Australia in the early 2000s. Patients did not even need to visit the institute's Belmore clinic, though that was the preferred option. They could get a consultation over the phone before being prescribed a treatment handmade by a compounding pharmacist to suit their individual needs.

''They make it sound like it's the best thing since sliced bread,'' Associate Professor Eden said, ''because they use words like natural and say it's adjusted to suit your body. It all sounds really good. But the bottom line is there is no quality control, there are no safety studies and … no testing of any sort.''

Dr Eden said about a quarter of Australian women on HRT were using the natural version.

The Menopause Institute was one of the first clinics to promote the treatment, made predominantly from wild yams.

While women responded well to the institute's marketing, the Australian Competition and Consumer Commission pursued the company over deceptive and misleading conduct charges in the Federal Court in 2006.

The Menopause Institute admitted misleading and deceiving its customers about the safety and effectiveness of its program as part of the court settlement. The ACCC alleged it made numerous misleading representations including that natural HRT reduces the risk of cancer, heart disease and Alzheimer's disease and is without dangerous side effects.

The ACCC chairman, Graeme Samuel, said it ''may have exposed their patients to serious risks''.

However, Dr Aaron continued his business under the new name of the Australian Menopause Centre.

While still offering the same treatments, Dr Aaron told The Sun-Herald: ''Since then the Menopause Centre has been very focused on ensuring whatever is advertised, whatever appears on the website, is vetted by the appropriate people and is correct and not unsubstantiated.

''It was a very important lesson that I have learned. In any practice, in any business, you need to behave ethically. If you are doing something unethical, you must change your ways or pay the price. It was a very good lesson for us.''

This view was one of the reasons he parted ways with Jack Vaisman, whose company, the Advanced Medical Institute, is facing court proceedings brought by the ACCC.

''I am extremely fortunate to have no longer any ties with him because he has had some doctors who have had to face the music quite badly with him,'' Dr Aaron said. ''I am glad that seven or eight years ago we went our different ways. He's an entrepreneur that knows no boundaries and I think that's wrong.

''When the ACCC investigated our marketing practices, it drew up the boundaries quite clearly for me and made me aware that you cannot cross these boundaries no matter what.

''Unfortunately Jack Vaisman chooses to ignore them often and do the things that he feels are necessary to build his business.''

Dr Aaron realises his medical techniques have critics. The Australiasian Menopause Society is scathing of bioidentical HRT, saying it is ''no more safe than any other prescribed hormone therapy''.

Dr Eden believes the treatments can lead to uterine cancer if prepared incorrectly and used over a long period. ''That's why we're now seeing a clutch of cases of cancer and that makes me very concerned,'' he said.

A spokeswoman for the TGA said medicines made by compounding pharmacists were not subject to the Therapeutic Goods Act.

Professor Henry Burger, chairman of the research committee at the Jean Hailes Foundation for Women's Health, describes the TGA's inaction on bioidentical treatments as ''a scandal''.

''These treatments can make women sick. It's an unregulated situation. This claim that you can tell how much of each hormone an individual woman needs for treatment is absolute balderdash.''

Dr Aaron shrugs off the criticism, saying it is fuelled by self-interested doctors and pharmaceutical companies. ''There is literature now confirming the benefit of bioidentical over the synthetic,'' he said. ''A lot of antagonists are really going quiet; we're not hearing very much at all.''

Oprah Winfrey gave the treatment a ringing endorsement in her self-titled magazine in 2009. ''After one day on bioidentical oestrogen, I felt the veil lift. After three days, the sky was bluer, my brain was no longer fuzzy, my memory was sharper.''