Compounded HRT and obesity have been linked to an increase in uterine cancer. Picture: Thinkstock
Compounded HRT and obesity have been linked to an increase in uterine cancer. Picture: Thinkstock

‘Natural’ therapies linked to cancer

THOUSANDS of Aussie mothers and grandmothers are falling victim to a secret rise in uterine cancer with the number of cases of the deadly disease tripling in recent decades - and compounding chemists using women as human guinea pigs are partly to blame.

Medicos have warned the increasing use of untested and unregulated compound chemist hormone replacement therapies have been linked to the rise in the cancer.

The number of new cases of uterine cancer diagnosed increased from 942 in 1982 to an estimated 2861 in 2017 and the epidemic is claiming around 450 lives a year.

The increase is also due to the fallout of Australia's growing obesity crisis with doctors warning weight gain is a key risk factor for the cancer.

The incidence of the cancer has leapt from 14 cases per 100,000 women in 1982 to 19 per 100,000 women in 2013.

Uterine cancer on the rise. Picture: iStock
Uterine cancer on the rise. Picture: iStock

Professor Neville Hacker director of gynaecological cancer at the Royal Hospital for Women says about half the rise in uterine cancer rates is due to the epidemic of obesity.

"Fat cells produce oestrogen and that stimulates the uterus and brings premalignant changes called endometrial hyperplasia," he said.

But he has also treated around a dozen cases of uterine cancer linked to hormone replacement products produced by compound chemists.

In 2007, Professor Hacker was one of three doctors who reported cases of uterine cancer linked to compound chemist HRT in the Medical Journal of Australia.

That paper reported on a 71-year-old, a 59-year-old and a 54-year-old woman, all non-diabetic, who developed cancer after using the unregulated compounded products.

"Women should be advised to avoid bioidentical HRT, and those who continue to use it should receive regular endometrial surveillance," the paper warned.

Medical regulators have done nothing to check the safety of compounded HRT treatments. Picture: Supplied.
Medical regulators have done nothing to check the safety of compounded HRT treatments. Picture: Supplied.

Despite the warning, medical regulators have done nothing to check the safety of compounded HRT treatments and, concerningly, were unaware of adverse events linked to the products.

The Commonwealth Department of Health said its database of adverse events "does not contain any reports of uterine cancer in association with hormone replacement therapy (HRT) medicines that have been extemporaneously compounded".

However, when News Corp searched the database it found six adverse events reports linked to compounded progesterone, including three cases of endometrial (uterine) cancer, three cases of vaginal haemorrhage, one case of breast cancer and one case of endometrial hyperplasia (precancerous thickening of uterine tissue).

The nation's medicines watchdog the Therapeutic Goods Administration told News Corp compounded medicines are exempted from safety and efficacy rules that apply to medicines produced by big pharmaceutical companies.

Compounded medicines are meant to meet quality and sterility standards and require a prescription, but it is unclear whether any safety and sterility checks are ever carried out.

Compounded products are exempt from safety and efficacy rules. Picture: Supplied
Compounded products are exempt from safety and efficacy rules. Picture: Supplied

Menopause expert Professor John Eden says women should be wary about compounded products.

"The corner chemist can make anything without any testing or quality control and there is no way of ascertaining whether each dose is the same, is it safe and does it do what it says," he said.

"That is why you get disasters from time to time."

He estimates a third of women using HRT are using the untested HRT products that can cost $150 a month. It would be tens of thousands of women, he said.

"A lot of women think they are on a herb, but when you point out they are real hormones many are shocked," he said.

Pharmacist and pharmaceutical company boss Michael Buckley is deeply concerned about the rise in uterine cancer cases, his business makes a testosterone product that competes with compound chemist products and he has taken court action against chemists making compound testosterone in defiance of the rules.

NSW Health says the link between custom compounded hormone therapy and uterine cancer is unclear.

"There is concern that compounded products are not tested in the same way as conventional pharmaceutical products and there is no proof that the progesterone contained in compounded products is absorbed or is in large enough quantities to reduce the risk of oestrogen-driven uterine cancer," it told News Corp.

"Both the Royal Australian and New Zealand College of Obstetricians and Gynaecologists and the American College of Obstetricians and Gynaecologists state that compounded bioidentical hormones have not been proven to be safe," a spokeswoman for NSW Health said.

"Additionally, the US Endocrine Society, the Australasian Menopause Society, and Endocrine Society of Australia advise against their use."

Key medical bodies warn against using compound HRT. Picture: iStock
Key medical bodies warn against using compound HRT. Picture: iStock

Queensland's health department says compounded bioidentical hormone products are restricted drugs (Schedule 4 medicines) and must be prescribed by a doctor.

"Pharmacists are expected to compound medicines in accordance with the Pharmacy Board of Australia Guidelines.

"The monitoring of adverse events is co-ordinated and addressed Australia wide, if Queensland Health was notified of a product linked to cancer, we would work with the Therapeutic Goods Administration (TGA) to ensure an appropriate response and necessary action".

A spokewoman for Victoria's Minister for Health Jill Hennessy said "There are a range of factors which appear to put some women at greater risk of uterine cancer, but sadly, the exact cause is not yet known."

"If patients have concerns about the products they've been prescribed, they can make complaints directly to the Pharmacy Board, AHPRA, or also - in Victoria - to the Health Complaints Commissioner."

The exact cause of uterine cancer is unknown says Victoria’s Minister for Health, Jill Hennessy. Picture: Getty Images
The exact cause of uterine cancer is unknown says Victoria’s Minister for Health, Jill Hennessy. Picture: Getty Images

A spokesman for the Pharmacy Board of Australia said in order to minimise the risks associated with compounded medicines, the Board developed extensive guidelines in 2015.

The guidelines say evidence to support a decision to compound a medicine must be obtained from reputable reference texts international pharmacopoeial standards, or peer reviewed journals, and must not be based on testimonials and impressions.

The Board said it was unable to comment about whether it had received any complaints about compounded medicines links to cancer or whether it carried out audits to check their safety.

Shortly after News Corp began making inquiries about compounded hormone products the medical defence insurer for pharmacists Pharmaceutical Defence limited, owned by the Pharmacy Guild of Australia, issued a warning to chemists " to be familiar with the Pharmacy Board of Australia's (PBA) Guidelines on the Compounding of Medicines published in March 2015"

"The compounding landscape is evolving and represents a particularly high regulatory concern at the present time" the insurance company warned.



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