Women deserve better options when it comes to health care. That’s a pretty broad statement, but it’s also the underlying truth that compelled me to create my company EmpowHER.com. Why am I mentioning it now? This month the U.S. Food and Drug Administration (FDA) held a historic vote that has major consequences for women’s treatment options. And in my opinion, the result was not good.
After my complete hysterectomy at age 42, it took a lot of trial and error to get my life back on track. At that point I vowed to give women a resource to learn about their own health and a common voice, so they could be heard by the doctors and regulators who control our health care.
When I heard there were two non-hormonal drugs to treat hot flashes coming up for a vote by the FDA this month, it really struck a chord with me. This is an issue that primarily affects women. Men don’t have the estrogen fluctuations we have that cause hot flashes, so they don’t have to worry about bursting into flames during a presentation or getting up several times at night to change the sheets after another round of night sweats.
To find out how women feel about hot flashes and available treatments, I partnered with Kathy Kelley from HysterSisters.com to conduct a poll. Over 6,350 women responded with their experiences with hot flashes, what they do to treat them, and what they wish they could do. You can see more from the poll on HysterSisters.
Here’s a quick summary:
- 93 percent of the women who responded have hot flashes and three out of four rated them from moderate to severe.
- Most women who have hot flashes are embarrassed by them.
- More than half said their hot flashes have a negative impact on their lives.
- Most are concerned about taking the hormone estrogen to treat their symptoms.
- Most of the women who participated in the poll admitted they do nothing to treat their symptoms.
As Kathy said, “Often these women won’t take estrogen therapy or they can’t take estrogen therapy because of health conditions that preclude them from doing so. Their needs are currently not met, and they want additional treatment options.”
That brings us back to this month’s vote. There were two non-hormonal treatments for hot flashes presented to the FDA for approval on the same day. Both will probably be denied.
Advisors to the FDA spoke against the drugs made by Depomed and by Noven Pharmaceuticals, claiming the companies had not proven that their drugs work. They said the risks were not worth the benefits and recommended that the FDA not give approval to the drugs. Although the FDA does not have to accept the advisors’ recommendations, it usually follows their advice.
I’m not a scientist, so I can’t say whether the advisors were right or wrong. But as a health advocate, I can absolutely say this is not the response women are looking for. We have a serious, life-altering condition and we deserve an appropriate, safe treatment.
Kathy said it this way: “I am disappointed by the committee's decision to not recommend the products for approval, because I believe women deserve a non-estrogen, FDA approved medication for their hot flashes. Currently, women are prescribed these "off-label" non-estrogen medications for VMS if they cannot take estrogen. We will continue to see continued use of off-label prescriptions until a better option comes along.”
I was privileged to present the results of our online poll to the FDA at the hearing leading up to that vote. It wasn’t enough this time – but this isn’t the end. I believe we can create movement in the direction we want to go – toward solutions for our specific health concerns – when we join forces and present a united voice to the powers that be. I’m honored and thankful for the opportunities I have as a health advocate to help give women the voice they deserve.
Michelle King Robson (pronounced robe-son) is one of the nation's leading women's health and wellness advocates. She is the Founder, Chairperson and CEO of EmpowHER, one of the fastest-growing and largest social health companies dedicated exclusively to women's health and wellness. In 2011 EmpowHER reached more than 60 million women onsite and through syndication expects to reach more than 250 million in 2012.
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