Can women trust the drugs only ever tested on men?

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Susan Jamison was 16 when she had a full-blown seizure at school. It had never happened before, though for weeks she'd been getting bad headaches.

A neurologist diagnosed epilepsy and prescribed her a high dose of sodium valproate — four 500mg pills a day. The drug was considered effective and safe for preventing seizures. It worked for Susan, who is now 53: she has taken it ever since.

Sodium valproate is prescribed in the UK under various brand names — Susan takes one called Epilim — and works by blocking nerve activity in the brain involved in seizures. 

For some patients, it is the only medicine that works. It is also prescribed for bipolar disorder and as a last-resort treatment to prevent migraines.

Can women trust the drugs only ever tested on men? Incredibly, that's the case for many of the most popular treatments on the market

Can women trust the drugs only ever tested on men? Incredibly, that's the case for many of the most popular treatments on the market

For Susan, sodium valproate sounds like a success story. But the pharmacy assistant and mother of three says the drug left all her children, who are now aged 22, 24 and 26, with serious learning disabilities, psychological problems and physical defects — one child so seriously that she will never lead an independent life.

Susan was never warned that this could happen if she took the drug while becoming pregnant — even though by the time she had her first child, scientists had known of the danger for years. As many as 20,000 other children in the UK may have been similarly afflicted.

'I wasn't told anything about birth abnormalities, when it was first prescribed or after. I only noticed it made me less able to concentrate on lessons,' says Susan, who lives in Belfast.

In fact, although the drug was widely prescribed (and is still given to some 27,000 women in the UK each year), when sodium valproate was launched in 1963 it had not been tested specifically on women, let alone pregnant ones.

Extraordinarily, this has also been the case for an untold number of other drugs, as even today women are typically often excluded from trials of the very drugs they will ultimately take.

This has created absurd situations. In the early Sixties, a trial to see if oestrogen supplements would protect postmenopausal women from heart disease enrolled 8,341 men and no women.

Heartache: Susan Jamison with children (from left) Joe, Caroline and Anna

Heartache: Susan Jamison with children (from left) Joe, Caroline and Anna

Valium, that 'mother's little helper', was never originally tested on women. But in a 2016 study in the Journal of Depression and Anxiety, Brazilian researchers revealed that the menstrual cycle may significantly alter Valium's effectiveness depending on the time of the month — and may even render it useless.

And before U.S. regulators agreed to license the controversial 'female Viagra' drug Addyi in 2015, they asked for a study to see if it was safe when taken with alcohol. 

The drug's sponsor conducted a test of 25 people — 23 of whom were men. That was doubly absurd, because women are known to be more prone to the effects of alcohol, even when it's not mixed with a sex drug.

It is not just treatments. One recent U.S. study of how obesity affected breast and uterine cancer enrolled not one woman.

Researchers prefer males  

Why are male bodies preferred? The basic reason is that women's monthly cycles cause hormonal fluctuations which can complicate the results of the clinical drug tests required before any new medicine is approved for use. 

Researchers and pharmaceutical companies prefer men's bodies, as they are far more straightforward.

Moreover, women of childbearing age (and pregnant women) have traditionally been excluded from drug-safety trials for fear that foetuses may be harmed. 

Instead, drugs have gone on the market in what is effectively a giant random trial, in which hard evidence of harm to children may later emerge — and perhaps not be taken seriously, or ignored or covered up.

This practice has caused untold harm to women and their families.

When Susan gave birth to her first child, Caroline, in 1992, it was immediately apparent that something might be wrong.

'She was born with a strange facial look,' Susan recalls. 'Her ears were small and her eyes looked far apart. 

'The paediatrician looked at her and asked if I had been taking sodium valproate. I answered 'yes' but nothing more was said. I thought it was a passing query about whether I was taking my epilepsy medication and thought no more about it.'

Caroline was very slow to develop, only starting to walk after 19 months. Her speech was also much delayed. In fact, her deep-set features, developmental delay and subsequent autism were classic signs of foetal valproate syndrome (FVS). 

It was first identified in 1984, the year that neurophysiologists at Birmingham's Aston University reported how the drug could cause spina bifida in babies, among other abnormalities.

Clinicians working there warned all women of the risks and told them to stop taking the drug a month before trying to conceive. But the warning did not spread among clinicians or women patients, who, ignorant of the risks, continued conceiving while on the drug. Susan was among them.

Her second child, Anna, was born in 1994.

'She turned out to be the worst affected, with low intelligence, ADHD and dyspraxia,' says Susan. 'Anna developed Asperger's syndrome and had to go to a special needs school.

Decades of 'sexist' drug trials 

 VALIUM

'Mother's little helper' was not tested on women before it originally came on the market, but recent trials have found it can be rendered useless by changes in the menstrual cycle.

ADDYI

A study to test the interaction between alcohol and so-called female Viagra enrolled 23 men and just two women.

THALIDOMIDE

The original birth scandal drug was never tested in pregnant women before it went on sale in 1957 for morning sickness. It was found in 1962 to catastrophically disrupt foetal development.

DIETHYLSTILBESTROL (DES)

This synthetic form of oestrogen was widely prescribed to pregnant women between 1938 and 1971 to prevent miscarriage. It was later found to be ineffective — and In 1971 was found to raise the risk of specific cancers in women.

TAMIFLU

Research in 2011 suggested pregnant women clear the drug from their bodies faster, so expectant mothers may have received too-low doses.

'She is now 24 and will never be able to live independently. She has an emotional age of four and will always need care, which I provide.'

Again, no one ever said Susan's epilepsy drug was the cause. 'The doctors just asked if there were any similar problems in my family. There weren't,' she says.

In 1994 she became pregnant with her youngest, Joseph. He was born premature at 31 weeks, which Susan believes is also linked to Epilim. He was in intensive care for a month with breathing trouble.

Joseph is now 22 and works for a chain store. 'He has ADHD and dyslexia. His behaviour can be challenging, he can find life bleak and lonely,' says Susan. 'But he has a high IQ of 139 and is great with computers and musical instruments. What might he have done with his talents were it not for his birth problems?'

For years, Susan wondered why her children had been affected in this way. The penny only dropped in February last year, when her pharmacy received leaflets explaining how Jeremy Hunt, the then Health Secretary, was launching the Independent Medicines and Medical Devices Safety Review into how the NHS had responded to birth damage caused by sodium valproate.

Studies show babies born to mothers who have taken the drug during pregnancy have a 10 per cent chance of having a physical birth defect and a 40 per cent chance of having learning and developmental problems.

Tragically, sodium valproate is not an isolated case.

Maya Dusenbery, a U.S. journalist who has investigated these failings in a book entitled Doing Harm, says the bias against women in medical research is all-pervading.

'It starts at the most basic biomedical research, where investigators overwhelmingly use male cells and male animals in pre-clinical studies,' she writes. 

'It continues throughout the clinical research process, where women remain under-represented, analysis of differences in response to drugs between genders is rare and women's differing hormonal states and cycles are usually ignored entirely.'

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