“It is health that is real wealth and not pieces of gold and silver”
Mahatma Gandhi
I recently made a discovery that affects us all and it’s something I, and probably most of us, have never thought about. And that is the gender gap in clinical trials – an area where discrimination is running rampant.
A week ago I attended a medical conference, sponsored by Johns Hopkins Center for Women’s Health, Sex and Gender Differences, in West Palm Beach. Now, I think of myself as a rather informed person, especially on issues concerning women, but…
Even though I had known that, for many decades, the scientific community equated “normal” with “male”, I had no idea that the drugs you and I are taking might never have been tested on women.
Did you know that the lack of clinical trial data for women means we don’t fully understand if drugs are as safe and effective in women as they are in men? As a result, in many cases, women taking a drug have had to learn about its efficacy or safety the hard way. Between 1997 and 2001, eight of ten FDA-approved drugs pulled from the market due to “unacceptable health risks” were found to be more harmful to women than to men. I didn’t.
Did you know estrogen was first tested among men in the 1940s? I didn’t.
Did you know that many years ago in the U.S., researchers investigating the possible interactions between libido-boosting drug flibanserin — known as “female Viagra” — and alcohol, used a study group of 25 participants -twenty-three were men. I didn’t.
Did you know that in Canada it isn’t law to include women in clinical trials? I didn’t.
It wasn’t until 1977 that the U.S. & Canada recognized the need to even consider the opposite sex. In 2013, Health Canada issued a new guidance document on who should be included – unfortunately it is still not mandatory to have female representation.
Cardiovascular disease and Alzheimer’s are the two biggest threats to us girls as we age yet they are still male centric.
Cardiovascular disease is the number one killer of U.S. women, and it affects men and women differently at every level, including symptoms, risk factors and outcomes. But only one third of cardiovascular clinical trial subjects are female and only 31% of cardiovascular clinical trials that include women report results by sex.
Two thirds of the 5.1 million people currently suffering from Alzheimer’s are women, and a woman’s overall lifetime risk of developing Alzheimer’s is almost twice that of a man. The prevailing thinking in the field is that this is simply because women live longer. But Alzheimer’s researchers have just begun looking past the assumption, and early discoveries indicate that the impact of hormonal changes at menopause and sex differences in gene expression may be involved as well
What I’ve written about are just a few of the gaps -- the same trends play out across the spectrum of health research. I had to ask myself how, in 2018, did we end up in a place when there is so much data pointing to how different sex differences are in health and disease yet there’s not more attention to this across all fields of medicine?
At the health Conference, the key note speaker, Immunologist. Dr. Sabra Klein, co-director of John Hopkin’s Women’s Centre, whose research focuses on evaluating the effects of genetics and hormones on immune responses to viral infections, summed it up perfectly asking the question does equal mean same? Is it that to protect women equally as men in medicine, must we be treated differently?
She concluded her talk with a call to action – advocacy. “It’s up to each and every one of us to do something about this.”
My journey as an advocate started that moment. Stay tuned. I have a big idea.