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 Michelle King Robson to create her company EmpowHER.com. 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 Michelle's opinion, the result was not good.
After her complete hysterectomy at age 42, it took a lot of trial and error to get her life back on track. At that point she 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 Michelle 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 her. This is an issue that primarily affects women. Men don’t have the estrogen fluctuations women 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, Michelle 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:
1. 93 percent of the women who responded have hot flashes and three out of four rated them from moderate to severe.
2. Most women who have hot flashes are embarrassed by them.
3. More than half said their hot flashes have a negative impact on their lives.
4. Most are concerned about taking the hormone estrogen to treat their symptoms.
5. 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 them 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.
Michelle, as a health advocate, can absolutely say this is not the response women are looking for. Women have a serious, life-altering condition and she feels they 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.”
Michelle was privileged to present the results of their 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. Michelle believes they can create movement in the direction they want to go – toward solutions for their specific health concerns – when they join forces and present a united voice to the powers that be. Michelle is honored and thankful for the opportunities she has 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.
SOURCE: Foxnews.com/health/2013
After her complete hysterectomy at age 42, it took a lot of trial and error to get her life back on track. At that point she 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 Michelle 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 her. This is an issue that primarily affects women. Men don’t have the estrogen fluctuations women 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, Michelle 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:
1. 93 percent of the women who responded have hot flashes and three out of four rated them from moderate to severe.
2. Most women who have hot flashes are embarrassed by them.
3. More than half said their hot flashes have a negative impact on their lives.
4. Most are concerned about taking the hormone estrogen to treat their symptoms.
5. 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 them 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.
Michelle, as a health advocate, can absolutely say this is not the response women are looking for. Women have a serious, life-altering condition and she feels they 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.”
Michelle was privileged to present the results of their 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. Michelle believes they can create movement in the direction they want to go – toward solutions for their specific health concerns – when they join forces and present a united voice to the powers that be. Michelle is honored and thankful for the opportunities she has 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.
SOURCE: Foxnews.com/health/2013
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