The Guardian (USA)

Manufactur­ers struggle to keep up with soaring demand for HRT

- Joanna Partridge

It’s a position that most businesses would love to find themselves in: booming demand for their products.

But soaring requests for hormone replacemen­t therapy (HRT) among British women going through menopause have seen some manufactur­ers fail to keep up, leading to months of supply shortages and stories of women struggling to sleep or work effectivel­y after being unable to obtain their prescripti­ons.

Several HRT drug providers describe it as the “Davina effect”: the documentar­y Davina McCall: Sex, Myths and the Menopause, fronted by the TV presenter, which was first broadcast on Channel 4 in May 2021, sparking an immediate surge in demand.

Yet almost a year later, this shows no signs of abating. Demand for HRT products surged by 30% in the month after the broadcast, according to Theramex, a global pharmaceut­ical company focused on women’s health.

Orders continued to grow through the year, climbing by 130% during the second half of 2021, according to Tina Backhouse, UK country manager for women’s health at Theramex.

Millions of women go through the menopause each year, and many experience a range of symptoms, which can be severe, including anxiety, low mood, hot flushes and difficulti­es sleeping.

“As an industry we didn’t have any warning of [the documentar­y],” Backhouse said. Theramex subsequent­ly increased manufactur­ing of its HRT products, which are made in Germany, but this is continuall­y under review.

“Every month we are looking at it and putting it up again. I thought at the worst we’d have nine to 12 months of safety stock in the warehouse and that is not the case. But we are bringing in enough.”

However, the company, owned by private equity firms PAI Partners and Carlyle, said ramping up production has required significan­t investment, so has not immediatel­y led to higher profits.

“It is expensive to increase production capacity. You’ve got to take a leap of faith,” Backhouse added. “It’s not like ordering a load of groceries for next week, [the manufactur­ers] have to source raw materials.”

HRT shortages in previous years have been blamed on manufactur­ing and supply chain problems, however the industry says lack of availabili­ty in recent months stems from growing numbers of women requesting the products.

The number of prescripti­ons for HRT in England has doubled in the past five years to more than 500,000 a month. As a result, some products have not been available for periods of time.

Earlier in April, the British Menopause Society warned members and doctors of noticeable ongoing shortages of Oestrogel, a gel that contains the hormone oestrogen and is applied to the skin.

Its manufactur­er, Besins Healthcare, said it had been experienci­ng “continuing extraordin­ary demand” for the gel in the UK.

The privately owned, Brusselshe­adquartere­d firm said in a statement it regretted “the continuing situation regarding insufficie­nt supplies of Oestrogel into the UK”.

Despite delivering almost double

the amount of the gel – which is produced in France and Belgium – to the UK between January and April, compared with the same period in 2021, the company acknowledg­ed supplies were sometimes “insufficie­nt”.

“Besins are acutely aware of the impact this situation is having on patients and understand that they are worried about fulfilling their prescripti­on,” the company said, advising any concerned patients to speak to their doctor or pharmacist.

Besins said it plans to further increase its production, so it can supply more product to the UK in the longer term.

HRT gels or patches that are applied to the skin are prescribed more frequently, according to Dr Paula Briggs, chair elect of the British Menopause Society, and a consultant in sexual and reproducti­ve health, because they do not increase the user’s risk of developing blood clots. Although the risk is small, this can be a side-effect of HRT tablets.

Producers of HRT rarely join forces because of commercial sensitivit­ies, even at a time of shortages.

Some hope the government’s appointmen­t of an ‘HRT tsar’ to tackle lack of availabili­ty will bring about more joined-up thinking and collaborat­ion within the industry.

“At the moment it feels like menopause management is celebrity-driven, and the clinical focus is not as it should be,” said Briggs. “Whoever is appointed needs to have involvemen­t with national organisati­ons and be in collaborat­ion with the royal colleges.”

Briggs is also calling for availabili­ty of HRT products to be standardis­ed across the regions and nations of the UK, regardless of whether they are prescribed at GP surgeries or hospitals, to ensure patients can access replacemen­t drugs if their usual prescripti­on isn’t available.

HRT producers are not expecting demand to reduce anytime soon. Studies have suggested that between 13% to 14% of UK women are prescribed

HRT, despite the fact that an estimated 80% experience some menopausal symptoms.

“I think that in the UK lots of very powerful women in politics and the media have all hit menopausal age at the same time and are using their platform to discuss that,” Backhouse said.

TV producers have confirmed McCall’s latest documentar­y on the menopause will be broadcast in early May. HRT suppliers are braced for demand to rocket once again.

 ?? Photograph: Steve Parsons/PA ?? Davina McCall with (front row, from left) Dr Louise Newson, Mariella Frostrup, MP Carolyn Harris and Penny Lancaster at a protest over HRT prescripti­on charges.
Photograph: Steve Parsons/PA Davina McCall with (front row, from left) Dr Louise Newson, Mariella Frostrup, MP Carolyn Harris and Penny Lancaster at a protest over HRT prescripti­on charges.

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