Earlier this spring, the United States Food and Drug Administration (FDA) approved the first ever drug to relieve the symptoms of postpartum depression. The FDA estimates that one in nine, and potentially one in five, new mothers suffer from postpartum depression, which interferes with essential bonding between mom and baby. The new drug, called SAGE-547, is cause for celebration. But it’s also an especially good moment to ponder the issue of gender-biased drug development.
What is postpartum depression? Think of everything you have heard or know about depression—mood swings, excessive crying, withdrawal from family and friends, exhaustion, irritability, fuzzy thinking, possibly wanting to die. Add a small creature (human baby) that needs you CONSTANTLY, arousing new fears of guilt, anxiety, being a bad mom and possibly thoughts of wanting to harm the baby or yourself. This is what it feels like.
Many changes happen after giving birth. Hormones are vacillating like mad; you are feeding yourself and the baby. And then there is sleep…. In her first year, my oldest daughter slept from 9:30 PM to 5:30 AM, but that included getting up two to four times a night to breastfeed. She also took a total of two 15-minute naps a day. Given the years of my own sleep deprivation, babies sleeping through the night and taking 2 or 3-hour naps still exemplify injustice to me.
What causes postpartum depression? It’s impossible to tell… because most clinical research has been conducted on men and (one could argue) men don’t get it.
Women have been historically underrepresented in clinical trials. Especially prior to 1980, biomedical researchers assumed that drug efficacy and side effects would be the same for males and females. Yet it is increasingly clear that women are not simply smaller versions of men and that drug metabolism can be very different between males and females. Welcome to gender-biased drug development, clinical trial gender inequity, and potentially dangerous morbidity for women.
Could the historical failure to provide equitable funding to women medical researchers lengthen the timeline toward the development of novel therapies specifically targeted for women? The UK-based British Medical Journal’s (BMJ) analysis of cancer research funding found that across all cancer research types, including breast and cervical cancer, male researchers are better funded than their female colleagues in the UK. “Men received more total investment in all disease themes than women,” the journal concluded. The effects of gender-biased research, pharmacology, and diagnosis are continuously uncovered. Cardiovascular disease is the number one killer of women and men, yet women are often dangerously misdiagnosed due to the differences in heart attack symptoms between men and women.
Still, what does this have to do with the new drug for postpartum depression? One drug industry analyst was clearly not impressed with the side effect profile of the drug, which was developed and tested by Sage Therapeutics. Paraphrasing the comedian Jerry Lawler while referring to the fact that some women fall unconscious during SAGE-547 treatment, the analyst quipped: “Why don’t you slip into something more comfortable… like a coma.” If that doesn’t give pause, consider that clinical trials are underway exploring the use of SAGE-547 to treat individuals experiencing prolonged seizures. Does this imply that SAGE-547 treatment is a strategy to generally depress the nervous system? If so, at what cost to women with postpartum depression? Because of the potential side effects, treatment with SAGE-547 requires hospitalization for 60 hours. And the drug costs $34,000 per treatment.
Then there’s the issue of access. Who will receive SAGE-547? A woman with good insurance who can leave a newborn for three days and has the wherewithal to convince the outside world and healthcare system that she needs help. Even writing off the poor, as Sage Therapeutics seems happy to do, how many 20 and 30-year olds (typical child-bearing age) will this apply to?
Finally, there is the issue of efficacy. Clinical tests of Sage-547 showed a strong placebo effect. Depression in women on the drug dropped by two-thirds, but a placebo treatment cut depression in half. Maybe this is not surprising given hormonal changes and sleep deprivation. Even hooked up to an IV, 60 hours of care and uninterrupted sleep would likely cheer up a lot of new moms.
Postpartum depression is more prevalent in countries with high income inequality, high maternal and infant mortality and a skewed work-life balance. Sound familiar? Yes, the new drug might alleviate a serious condition. But $34,000 in cold cash could right a lot of wrongs in a baby’s first year of life by providing much needed child care and other support to a new mom.
Susan Logan is a research scientist at New York University Langone Medical Center and a mom.