The benefits of hormone replacement therapy (HRT) for women who take it within 10 years of menopause outweigh the risks, according to study reviews.

HRT was found to reduce the incidence of heart disease, fractures and ongoing menopausal symptoms.

The study reviews published by the International Menopause Society further challenge the interim conclusion of the Million Women Study (MWS) ten years ago that HRT is too dangerous.

The increased risks of breast cancer, stroke and heart disease suggested by the MWS have since been disproved by retrospective analysis of its data.

HRT, which replaces oestrogen and progesterone in post-menopausal women, has improved the health and fitness of millions of patients.

The MWS findings led to HRT being largely abandoned – but later analysis found the study was methodologically flawed and the risks related mainly to women who started taking HRT long after the menopause.

The new reviews conclude that a ‘window of opportunity’ exists for HRT if it is started within 10 years of menopause or before age 60.

The therapy has been shown to significantly reduce the risks of osteoporosis, heart disease and colorectal cancer, while only slightly increasing the risks of embolism and stroke.

HRT is more effective than statins or aspirin in overall effect on mortality, the reviews concluded.

Investigator JoAnn Manson of Harvard Medical School commented: “HRT is not appropriate for every woman, but it may be appropriate for many women.”

Bioscience holds out the prospect of medical breakthroughs that can transform our lives – but it has to contend with traditional fears about ‘interfering with nature’. Maxine Vaccine asks whether fear itself might not be the greatest danger.

Everybody’s talking about biotechnology and its implications for medicine. Even the UK Government, hardly the brightest light on the Christmas tree, recently identified stratified medicine as a crucial area for medical innovation. The idea that drugs can be tailored to the specific genetic characteristics of a patient group is powerful and opens up a new vision of ‘personalised medicine’.

But with that comes the familiar fear among doctors and patients that the new therapies are ‘interfering with nature’. It’s a fear that runs through the history of medicine. Before the invention of the microscope, some doctors who argued that diseases could be spread by ‘germs’ were hounded out of their profession. Body fluids are ‘natural’ – how could they possibly pose a danger? The argument ‘it’s not natural’ has been used against hygiene, antiseptics, antibiotics, vaccines, transplants, transfusions, hormonal treatments...

But that’s all long in the past, you might say. These days we’re enlightened, we have evidence, we don’t listen to superstition. Well... maybe. Back in 1998 a doctor fabricated evidence that the MMR vaccine caused autism. He has now been convicted of fraud, but thousands of doctors believed him. Only this year, a critical analysis of the Million Woman Study by scientists who are not clinicians concluded that it had failed to prove a causal link between hormone replacement therapy (HRT) and increased risk of breast cancer – a causal link that had been broadly accepted by the medical profession across Europe and the USA, despite the persistent voices of a sceptical minority.

Is it just possible that where biopharmaceuticals are concerned, a significant proportion of clinicians are primed to believe scare stories because, at a deep level, they suspect that such therapies are ‘against nature’? Where HRT was concerned, after all, many thousands of women had been enabled to continue successful midlife careers without being nudged by the menopause and its traumatic sequels into early retirement. How could that be right?

Many people – and doctors are not only not immune to this, they may be more prone to it than patients – are driven by an uncritical reverence for ‘nature’s way’ to fear and resist the changes we can make to our own lives as our scientific knowledge develops. The recent decision of a European court to deny patents to medical therapies developed from stem cell research shows that the power of fear is still sometimes greater than the will to heal.

Of course there are valid fears about potential harm arising from science and technology. But the danger lies in the abuse of scientific knowledge for purposes of exploitation and social control. Where valid questions need to be asked about the ethics of medical science, those are not questions about the dangers of scientific knowledge. They are questions about us.

A major observational study that was widely accepted as proof that hormone replacement therapy (HRT) increases the risk of breast cancer has been challenged following a new review of the evidence.

The Million Women Study (MWS), which has driven a major drop in the number of menopausal and post-menopausal women being prescribed HRT, did not prove a causal link between HRT and breast cancer and its conclusions were ‘biologically implausible’, the review found.

The British Medical Journal (BMJ) recently claimed the reduction in prescription of HRT had reduced the incidence of breast cancer in the UK – so the review will give many GPs pause for thought.

The MWS analysed new cases of breast cancer arising in women who reported for breast screening in the UK between 1966 and 2001. It concluded that HRT increased the risk of fatal breast cancer by 22%.

The impact of the MWS on NHS prescribing and public perception has been drastic, with some clinicians demanding the banning of HRT while others have argued strongly for its retention as a treatment option for osteoporosis.

The review, published in the Journal of Family Planning and Reproductive Health Care (a BMJ Group journal) used scientific criteria to review the findings of the MWS and highlighted a number of flaws in the study’s design, including:

• Cancers detected in the first few months of the study would have been present beforehand, but these participants were not excluded.

• The use of study participants already reporting for breast screening would have increased the participation of HRT users (and non-HRT users) already aware of potential breast cancer symptoms.

• In a later MWS report, follow-up data on HRT use was not available for over 50% of the study participants.

In addition, the review argued that a 22% increase in the risk of fatal breast cancer due to HRT within the short time frame of the study was “biologically implausible”.

“The name ‘Million Women Study’ implies an authority beyond criticism or refutation. Yet the validity of any study is dependent on the quality of its design, execution, analysis and interpretation,” said the review authors.

The “problems and uncertainties” of the MWS as an observational study meant that its evidence was “unreliable”, they concluded, and so “the only effect of its massive size would have been to confer spurious statistical authority to doubtful findings.”

Diabetes care specialist Novo Nordisk has launched a new type of insulin pen in the UK that allows injection at the touch of a button.

The FlexTouch disposable prefilled insulin pen is available with Novo Nordisk’s rapid-acting insulin analogue NovoRapid (insulin aspart).

The design of FlexTouch includes a spring that allows any insulin dose (from 1 to 80 units) to be injected by pressing a button.

In a survey, 3 out of 4 healthcare professionals rated FlexTouch as ‘very easy’ to use for injection of 20 units.

The device is prefilled with 300 units of NovoRapid insulin. The dose is adjustable in 1 unit increments up to 80 units.

Debbie Hicks, Nurse Consultant, Diabetes, Enfield Community Services BEH-MHT, commented: “This new device really does offer potential advantages to patients. Everyone benefits when the pen is simple and easy to use – patients, doctors and nurses educating the patients.

“It is really important that we continue to give our patients options in the way their treatment is delivered, so that this becomes as little an interruption to their life as we can make it.”

“We are very proud to make FlexTouch available to UK patients, as it is designed to benefit both patients living with diabetes and the healthcare professionals who are treating them,” said Viggo Birch, Managing Director of Novo Nordisk.

Based in in Denmark, Novo Nordisk is a global company that specialises in diabetes care, haemophilia care, growth hormone therapy and hormone replacement therapy.

The FlexTouch was granted approval by the European Commission in July 2011.