Beyond ‘Bikini Medicine’

“Bikini Medicine.” What on earth is that? It is the mistaken belief that women’s health only differs from men’s in the parts of the body that a bikini would cover. Of course, reproductive and breast health is very important, but what about the rest of a woman’s body?

When you are thinking about your work in medicines, devices, medtech, patient programs, or clinical trials, how often do you think differently about men and women’s “whole body” physiology?

Until recently, neither did we. Like most people out there, we were unconsciously working within the deep-seated, societal belief that women are essentially men with different reproductive organs. Of course, this is nonsense and makes no sense when you take a conscious, scientific perspective. We all know that every cell in a woman’s body is different to a man’s because women have two XX chromosomes. But strangely, that doesn’t provoke us to ask sex-based questions about medical solutions.

Evidence tells us that women and men can experience many diseases differently and at different rates. In her book “The XX Brain,” leading neuroscientist Lisa Mosconi said: 

• “Women are twice as likely to have anxiety and depression as men.
• Women are over three times more likely than men to be diagnosed with an autoimmune disorder, including those that attack the brain, like multiple sclerosis.
• Women are up to four times more likely to suffer from migraines and headaches than men.
• Women are more prone than men to develop meningiomas, the most common brain tumors.
• Strokes kill more women than men.”

As if this is not bad enough, Mosconi goes on to explain that, looking further through the neuroscience lens, Alzheimer’s is the biggest threat to women’s health; two out of every three Alzheimer’s patients are women. Women in their 60s are about twice as likely to develop Alzheimer’s as they are to develop breast cancer. Yet Alzheimer’s is not labeled as a women’s health issue.

Pioneering women are calling to us all to recognize that diseases can present differently in men and women. The classic example is in cardiovascular medicine where only one in eight women experience a “Hollywood Heart Attack,” with chest clutching and crushing pain down the left arm. Over 70 percent of women having a heart attack show flu-like symptoms without any chest pain.

Today, scientists are required to recruit both men and women for research. But that wasn’t always the case. For decades after the thalidomide scandal, research was overwhelmingly conducted on male cells, male mice, and male patients. This supplied medicine with data that discounted 51 percent of the population. “Normal” meant “male.” 

According to Mosconi, important indicators of sex differentials today are often statistically removed from studies. Mosconi says: “In order to look at men and women independently, studies would need twice the number of patients, twice the time and twice the money. Many scientists have no other option than to keep removing gender from the equation, supressing its undeniable impact on study outcomes.” Hmmm. This feels very uncomfortable.

But there is an upside. We have chatted with members of Women in Pharma who design clinical studies; people have told us it is well within the capabilities of our amazing industry to be more ambitious in clinical study design and analysis.

Women in Pharma is encouraging you to look beyond Bikini Medicine. As inspiration, let’s look at estrogen in a different way. The neuroscience lens shows estrogen as the “master regulator” of the brain, with many functions beyond reproduction, such as energy regulation, neuro-protection, mood, endorphins, and cardiovascular management. The effect of estrogen in women and testosterone in men means that our brains have different levels of neurotransmitters, different cellular make ups, and different connectivity in some regions. If the “master regulator” of the brain is different, surely other things are different too. 

There is also evidence about differing drug effects. Most famously, men and women taking the same doses of the sleeping pill zolpidem have dramatically different reactions. Women are more likely to sleepwalk, sleep eat, and even sleep drive. Women reach maximum blood levels of this drug at much lower doses than men. When this came to light, the FDA halved the recommended dose for women, but for the previous 20 years women had been compromised by overmedication.

Whatever your sex or gender, Women in Pharma is challenging you to ask:

• Does the disease I work on affect men and women differently?
• How will we bring this knowledge into our study designs and outcomes?
• Are there any barriers to recruiting enough men and women to trials to power analysis of sex differences in drug performance?
• Could sex-based post-hoc analyses of large trials tell us more about the performance of existing drugs?
• Are we asking how the menstrual cycle, hormonal contraception, or the menopause affect the performance of our drug?

In an era of personalized medicine, your findings might better serve women and men. Imagine the possibilities. What if:

• Underperformance in women drags down results for a drug that works brilliantly in men?
• You found your drug had safety signals for women, but not for men?
• Your medicine had low efficacy in men and so it was denied to women for whom it transformed lives?

We call on men and women in pharma, biotech, medtech, and beyond, to ask themselves: “What do those XX chromosomes in every cell in a women’s body really mean for medicine?”