Monday 27 June 2022 10:36 PM Are women's lives at risk from drugs tested by men? trends now

Monday 27 June 2022 10:36 PM Are women's lives at risk from drugs tested by men? trends now
Monday 27 June 2022 10:36 PM Are women's lives at risk from drugs tested by men? trends now

Monday 27 June 2022 10:36 PM Are women's lives at risk from drugs tested by men? trends now

Using ‘male’ crash-test dummies to determine how men and women would fare in car accidents has been blamed for the dismal injury record for women on the roads.

Although men are more likely than women to be in a car crash, when women are involved in an accident on the road they are almost twice as likely to become trapped in a vehicle, according to a study of more than 70,000 people in the UK, published in the journal BMJ Open last month.

Alarmingly, previous studies in the U.S. have revealed that women are also 47 per cent more likely to be seriously injured than men, 71 per cent more likely to be moderately injured and 17 per cent more likely to die.

Yet for decades, only crash-test dummies representing a man around 5 ft 8 in tall and weighing 12 st were used in safety trials, and even now ‘female’ dummies are little more than a scaled-down version of the original, rather than an anatomically correct representation.

Hormone fluctuations throughout adulthood have also been cited historically as a reason for excluding women, as scientists argue this makes women more difficult to study

Hormone fluctuations throughout adulthood have also been cited historically as a reason for excluding women, as scientists argue this makes women more difficult to study

Generally speaking, women have smaller and less muscular bodies, with different sex hormones which make their ligaments more lax, leaving them more prone to certain injuries. It means, say scientists, that men are better protected than women when it comes to road safety.

And this is just one shocking example of the systemic bias women face when it comes to potentially life-saving research.

For decades, women have been either omitted entirely from the testing of new medicines or included only in small numbers.

Instead, as with the crash-test dummies, scientists have relied on data from studies carried out predominantly on men — typically the ‘reference man’, who is Caucasian, aged 25 to 30 and weighs 11 st — and applied them to women and people from other ethnic backgrounds.

Tsar to tackle inequalities costing women's lives 

Take heart disease — probably the worst-offending area. Although women make up 47 per cent of the 7.6 million people in the UK with heart disease, they accounted for just 28 per cent of participants in 500 key heart trials carried out between 1996 and 2015, according to a Canadian study, published in Circulation: Cardiovascular Quality and Outcomes in 2018.

This simple and very convenient approach — using male data for females — we now know undermines the way millions of women are treated for potentially life-threatening illnesses, such as heart disease and cancer.

For example, it is estimated that a woman having a heart attack has around a 50 per cent greater chance of misdiagnosis compared with a man, according to research by the University of Leeds in 2018.

Women are also less likely to receive potentially life-saving treatments for a heart attack in a timely manner, less likely to be admitted to a specialist heart ward and less likely to be prescribed drugs to help prevent a second heart attack.

As a result, it is estimated that 8,200 women in England and Wales died between 2002 and 2013 simply because they didn’t have the same care as men, the research found. In fact, Chris Gale, a consultant cardiologist who carried out this study, warned that this could be an underestimate, as not all heart attacks were recorded in the research.

These alarming statistics — and the low profile of other issues such as the menopause and female infertility — prompted the Government earlier this month to appoint Dame Lesley Regan, former president of the Royal College of Obstetricians and Gynaecologists, as its first Women’s Health Ambassador for England.

Her job will be to tackle the inequalities that are costing some women their lives.

‘This is an important opportunity to get it right for women and girls, and make a real difference . . . by addressing the inequalities that exist across society,’ she said.

For while our DNA may be 98 per cent identical, key biological differences between the sexes — from organ size to body composition — mean we are poles apart.

For example, men are on average taller and heavier, with greater muscle mass and, literally, thicker skins; while women’s bodies tend to be smaller, with 10 per cent more body fat and regulated by a different set of hormones.

These fundamental physiological differences mean they respond in different ways to medication.

For instance, it takes longer for a female body to clear drugs from its system because they become ‘trapped’ in its higher levels of body fat, and it processes them more slowly because the liver and kidneys are smaller.

This means that when a woman is prescribed a dose based on what works best for a man, they’re more at risk of adverse effects and, in some cases, need a different dose.

‘When it comes to prescribing drugs, a one-size-fits-all approach, based on male-dominated clinical trials, is not working and women are getting the short end of the stick,’ says Irving Zucker, a professor of psychology and integrative biology at the University of California, Berkeley.

In 2020, Professor Zucker carried out a review of more than 5,000 studies and found that when men and women are given the same dose of a drug, women experience side-effects such as nausea, heart problems, headaches and seizures nearly twice as often.

This is because, at the same dose, women had higher concentrations of the drug in their blood, and it took longer for the drug to be cleared from their bodies.

And the damning review — which was published in the journal Biology of Sex Differences — found that this was happening with more than 80 commonly prescribed medicines taken by millions of people in the UK every year.

They included antidepressants such as fluoxetine; painkillers such as morphine and oxycodone; and heart medication such as the beta-blocker propranolol, widely used on the NHS to treat high blood pressure, heart rhythm problems and even anxiety.

Professor Zucker called for dose reductions for women where there is evidence that taking the same amount as a man causes side-effects. Yet this rarely happens.

In 2013, U.S. medicines regulator the Food and Drug Administration (FDA) did just that for the sleeping pill zolpidem, once researchers found that after eight hours, the recommended 10mg dose resulted in 15 per cent of women still having enough of the drug in their system to leave them drowsy in the day, putting them at greater risk of road accidents. In men, however, the figure was only 3 per cent.

The FDA recommended the dose for women be reduced from 10mg to 5mg.

But this is a rare event. Indeed, the move proved controversial among some scientists and this reduction in dosage has not been introduced in the UK or elsewhere in the world.

Maternal deaths due to lack of data 

Meanwhile, the exclusion of women from clinical trials continues. In a recent example, pregnant women were not included in the initial Covid vaccine trials.

While this was understandable — given the hypothetical risk to babies in the womb — it had catastrophic consequences, according to Marian Knight, a professor of maternal and child population health at the University of Oxford.

‘With no data, when the vaccines secured an emergency licence they couldn’t be recommended for pregnant women — and that was

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