Invisible Women: Data Bias in a World Designed for Men

Even if they are treated for their pain, women routinely have to wait longer than men to receive that treatment. A US analysis of 92,000 emergency-room visits between 1997 and 2004 found women had longer waiting times than men,76 and a study of adults who presented to a US urban emergency department between April 2004 and January 2005 found that while men and women presented with similar levels of pain, women were less likely to receive analgesia and women who did receive analgesia waited longer to receive it.77 A US Institute of Medicine publication on chronic pain released in 2011 suggested that not much has changed, reporting that women in pain face ‘delays in correct diagnosis, improper and unproven treatments’, and ‘neglect, dismissal and discrimination’ from the healthcare system.78 In Sweden a woman suffering from a heart attack will wait one hour longer than a man from the onset of pain to arrival at a hospital, will get lower priority when waiting for an ambulance, and will wait twenty minutes longer to be seen at the hospital.79

The reality that female bodies are simply not afforded the same level of medical attention as male bodies is often brushed aside with the riposte that, on average, women enjoy more years of life than men. But while it is true that female life expectancy remains a few years longer than male life expectancy (although that gap is narrowing as women’s lives have become less prescriptive and occupational safety in male-dominated jobs has become more stringent), there is evidence to suggest that the female mortality advantage isn’t exactly secure.

A 2013 paper that examined trends in US mortality rates from 1992-2006 in 3,140 counties reported that even as mortality decreased in most counties, female mortality increased in 42.8% of them.80 And while men’s years of good health have increased in line with their longevity, both women’s longevity and active years have increased at a much lower rate: thirty years of US health data showed that, while women live on average five years longer than men (in Europe it is 3.5 years81), those years are spent in ill health and disability.82

The result is that US women no longer have more active years than men,83 despite their longer lives, and while women account for 57% of US citizens aged over sixty-five, they make up 68% of those who need daily assistance.84 In 1982 both men and women who lived to eighty-five could expect two and half further years of active healthy life. For women, that figure hasn’t changed, but an eighty-five-year-old man alive now can expect to be active and healthy until he’s eighty-nine. The trend of increasing longevity and good health amongst men can also be found in Belgium85 and Japan.86 A WHO paper into women’s health in the EU reported that in 2013, ‘even in countries with some of the highest overall life expectancy in the Region, women spent almost 12 years of their life in ill health’.87 And, yes, it would be nice to have some sex-disaggregated data on why this is happening.

A particularly troubling side effect of Yentl syndrome is that when it comes to medical issues that mainly or only affect women, you can forget about including women in trials because here the research is often lacking altogether.

Premenstrual syndrome (PMS) is a collection of symptoms that can include among other things: mood swings, anxiety, breast tenderness, bloating, acne, headaches, stomach pain and sleep problems. PMS affects 90% of women, but is chronically under-studied: one research round-up found five times as many studies on erectile dysfunction than on PMS.88 And yet while a range of medication exists to treat erectile dysfunction89 there is very little available for women, to the extent that over 40% of women who have PMS don’t respond to treatments currently available. Sufferers are still sometimes treated with hysterectomies; in extreme cases, women have tried to kill themselves.90 But researchers are still being turned down for research grants on the basis that ‘PMS does not actually exist’.91

Period pain – dysmenorrhea – similarly affects up to 90% of women,92 and according to the American Academy of Family Physicians it affects the daily life of around one in five women.93The level of pain women experience on a monthly basis has been described as ‘almost as bad as a heart attack’.94 But despite how common it is and how bad the pain can be, there is precious little that doctors can or will do for you. A rare 2007 grant application for research into primary dysmenorrhea described its causes as ‘poorly understood’ and treatment options as ‘limited’.95 The prescription medications which are available have serious possible side effects and are by no means universally effective.

When I went to my (male) doctor about period pain that wakes me up at night and leaves me in a moaning foetal position in the daytime, he more or less laughed me out of the room. I haven’t bothered trying again. So imagine my joy when I read about a 2013 study that seemed to have found a cure. The ‘primary outcome’ of a double-blind, randomised, controlled trial of sildenafil citrate, was, ladies, you may want to sit down for this: ‘total pain relief over 4 consecutive hours’, with ‘no observed adverse effects’.96 Imagine.

Created in 1989, sildenafil citrate is the medical name for Viagra. In the early 1990s, the drug was being tested as a heart-disease medication.97 It turned out not to be great at that, but one thing participants did report was an increase in erections (yes, all the trial participants were men). Total erectile dysfunction affects between 5-15% of men depending on age,98 with about 40% of men experiencing it to some degree – and so naturally the researchers were keen to explore this alternative use for their drug. By 1996, sildenafil citrate had been patented in the US and by March 1998 it was approved by the FDA.99 A happy ending for men, then.

But what if the trial had included women? The outcome of the 2013 study is suggestive. The trial had to be stopped because the funding ran out, meaning the researchers did not meet their sample size and therefore could not confirm the primary hypothesis. They called for ‘larger studies of longer duration, likely multi-center’ to confirm their findings.

These studies have not happened. Dr Richard Legro, who led the study, told me he applied twice to the NIH for funding ‘to do a longer and larger study and also to compare sildenafil to the standard of care, a non-steroidal anti-inflammatory agent’. He was rejected both times. In each case, the grant ‘was deemed to be in the lower half of grants submitted’. It wasn’t even reviewed. Legro tells me that the comments he received ‘indicated that the reviewers did not see dysmenorrhea as a priority public health issue’. They also didn’t ‘fully understand clinical trial design of dysmenorrhea trials’. When I ask him if he thinks he will ever get funding, he says, ‘No. Men don’t care or understand dysmenorrhea. Give me an all-female review panel!’

The failure of pharmaceutical companies to step in here and capitalise on what is surely a gold-plated commercial opportunity may seem baffling, but it’s quite possibly just another data-gap problem. In an email, Legro told me that, for cost reasons, the pharma industry ‘doesn’t usually fund investigator-initiated projects’, particularly of drugs that are available generically. And this may be where the data gap comes in: there simply isn’t much research done on dysmenorrhea,100 which makes it difficult for pharma companies to know exactly how much money could be made on such a drug – and therefore makes it harder for them to decide to fund trials. Especially if the people making the decisions happen not to be women. Legro also suggested that pharma companies may not want to risk doing tests in women in case of negative findings that would endanger the use of sildenafil in men. In short, it seems that pharma companies may in fact not see this as a gold-plated commercial opportunity. And so women carry on being incapacitated by pain on a monthly basis.

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