By: Sarah Boseley
Campaign funded by treatment manufacturer could mislead women before official menopause guidance is released, some scientists fear
A PR campaign to promote the use of hormone replacement therapy in women is under way before official guidance on how to treat the menopause is released, causing some scientists concern that the cancer dangers of the drugs will be underplayed.
The campaign, run by the Weber Shandwick agency and funded by a drug manufacturer that provides the treatment, has already put out a survey saying women are unnecessarily worried about the risks of HRT. It is preparing a further release about the attitudes of GPs to prescribing the drugs.
Guidance on treating the menopause is due to be released by the National Institute for Health and Care Excellence (Nice) next Thursday. It is likely to say there are risks as well as benefits to taking HRT, but cancer scientists fear the warning may be drowned out and the guidance taken as an endorsement of use of the drugs in most women with menopausal symptoms.
Prof Valerie Beral, an Oxford epidemiologist who leads the Million Women study, which linked HRT to breast and ovarian cancer, fears that women will be misled into thinking the drugs are completely safe.
“About one million UK women are currently using hormones for the menopause,” she said. “Among them about 10,000 extra breast cancers are estimated to occur in the next 10 years (40,000 in total, instead of 30,000 if the women had not used the hormones). Also about 1,000 extra ovarian cancers are estimated to occur among them in the next 10 years (6,000 in total).”
Cancer specialists say the Nice committee is dominated by gynaecologists who are members of the British Menopause Society (BMS), which has tended to take a favourable view of HRT and clashed with the cancer scientists in the past. The Oxford scientists have approached the UK drug regulator with their concerns.
Jane Green, professor of epidemiology at Oxford University, said she and her colleagues did not want an “us and them” battle with gynaecologists who advocate greater use of HRT, which would further confuse women. “The thing that makes me so angry about all this is that the message that goes out is [that] nobody can agree. We are squabbling among ourselves. But we do know some facts and that it is complex,” she said.
The first salvo in the Weber Shandwock campaign came two weeks ago when a minor piece of unpublished research presented at a fertility conference in Baltimore, USA, was picked up and turned into front-page stories by UK newspapers. The reports said it proved HRT was harmless and that a generation of women had needlessly suffered by avoid ing the drug for fear it would cause cancer. “It’s official: HRT is NOT a danger to women as experts conclusively dismiss worries over safety,” ran the headline in the Mirror. The Guardian also ran a version of the story.
Dr Nick Panay, a consultant gynaecologist and former chair of BMS who is on the Nice guidance committee, was quoted as welcoming the news, saying: “We believe that the right HRT preparation, in the right woman, has low overall risks and has significant benefits. Too many women are being denied hormone therapy that might benefit from it.”
However, Panay told the Guardian that his comments had been taken out of context and that he had not read the fine detail of the study. “I was asked to discuss the menopause, hormone therapy and the directions in which we were going in general. I did not make a comment about the data from the study,” he said. .
The BMS posted a favourable view of the findings on its website. “An American study out today [18 Oct] confirms the safety of HRT, with beneficial effects being shown in women who continued taking HRT for many years,” it said.
“The study followed up women who took HRT and compared various outcomes with those in women not taking HRT. While the number of women was small in both groups, this study adds further to studies over recent years that have shown that, when used appropriately, HRT provides more benefits than risks.
“Menopause management should be individualised and should include consideration of diet and lifestyle changes but HRT should also be considered as a safe option.”
Cancer Research UK, however, issued a statement saying it was “deeply concerned for women’s health amid headlines that taking hormone replacement therapy is safe”.
The study presenting a positive case for the use of HRT was by no means comprehensive, drawing on the experience of just 80 women who had been taking the drugs and had not suffered from cancer or any other side-effects. But the evidence that breast and ovarian cancer risks rise with HRT was the result of two far-reaching studies by the Women’s Health Initiative in the US and the Million Women study at Oxford, which is funded by the cancer charity.
Dr Lila Nachtigall, author of the research, condemned the “ridiculous” coverage in the British press. She said the study had been about body composition, looking at where women accumulated fat if they put on weight during their course of HRT, and not cancer. She found it interesting that none had developed cancer, but “we made it very clear it was not a study. It was just an observation,” she said.
Weber Shandwick launched its own survey about women’s fear of HRT to coincide with Nachtigall’s presentation in Baltimore. “We were speaking to a few people we knew here and got wind of the fact there was this study,” said an account executive. “[The stories that ran in the press] really put the issue back on the agenda. There’s been this lost decade of women who haven’t taken HRT because of the studies that came out in the 60s. We’re hoping with the Nice guidance that will change and people will see it as a safer option.”
Its survey of just over 1,000 women was funded by Mylan Pharmaceuticals, which has recently bought Abbott’s generic drugs business, a supplier of HRT in Europe. Women “could be suffering needlessly,” said the release. “A staggering 85% of women are avoiding HRT which could alleviate the most common daily symptoms associated with the menopause.”
Women could enjoy a better sex life on HRT, it implied, quoting the psychologist Susan Quilliam who said: “Women in their 50s are the original baby boomer generation who led the sexual revolution. We are now seeing a record number of divorces with an increasing number of women in this age group returning to dating, so it’s a shame that just one in six has a better sex life now than they did in their 20s, with just one in three maintaining their ‘lust for life’.”
Julian De Gabriele, head of medical affairs at Mylan UK, drew the link with the new Nice guidance. “The new guidelines will inform and reassure women who are seeking a solution for their menopausal symptoms. We urge women to explore their treatment options, which should be tailored to individual symptoms and needs, so that they have more control over how they feel during the menopause, and can enjoy life without limits,” he said.
The BMS comprises medical professionals, mostly gynaecologists, and is funded by membership fees. A number of the Nice guidance committee members belong to it, including the chair of the guidance committee and one of the lay members, who is the BMS chief executive.
Nice said in a statement that it recruited as widely as possible to its guidance committees through open, competitive advertising. It “appoints members from the NHS, academia and industry as well as lay members with an understanding of patient and public perspectives on healthcare issues. All of our guidance is also subject to public consultation and we actively seek the views of healthcare professionals, patient groups and national organisations independent of the guideline development group which effectively minimises the risk of undue influence to any guideline.”
Some of the committee members, including Panay, reported having received funding from pharmaceutical companies for consultancy, speaking or research.
Menopausal symptoms include hot flushes, interrupted sleep and mood swings . Doctors agree that HRT resolves the problems. Panay said the gynaecologists were not at odds with the cancer epidemiologists, and that the most important thing was that women and doctors were aware of the options. “Ultimately what we all want is for women to have the information to make balanced choices and optimise their health in the future,” he said.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.