Stories
Slash Boxes
Comments

SoylentNews is people

posted by martyb on Friday June 05 2015, @11:55AM   Printer-friendly
from the just-getting-started dept.

A committee of advisers to the U.S. Food and Drug Administration (FDA) are meeting to consider whether the FDA should approve the first drug that aims to boost a woman's libido:

The FDA has twice before rejected the drug, called flibanserin, after previous advisory panels concluded there were questions about its safety and insufficient evidence that the drug was effective for women with low sex drives. Sprout Pharmaceuticals, which makes flibanserin, has submitted more research that the company hopes will finally convince the advisers and the agency the drug is ready for the market. The company's evidence includes a study it says shows women can safely drive after using the medication. One concern about the drug is that it can leave women drowsy the day after taking it, increasing the risks for accidents. "The review of flibanserin... represents a critical milestone for the millions of American women and couples who live with the distress of this life-impacting condition without a single approved medical treatment today," Cindy Whitehead, Sprout's CEO, said in a statement before the hearing began.

Flibanserin, which the company plans to sell under the brand name Addyi if approved, shifts the balance of three key brain chemicals, increasing dopamine and norepinephrine and decreasing serotonin.

The drug has long been the focus of an intense debate. The company and some advocacy groups, including the National Organization for Women and Even the Score, have suggested that the FDA is being sexist by holding the drug to a higher standard than drugs, such as Viagra and Cialis, for male sexual problems. The FDA denies those charges. In documents posted online in advance of the hearing, Hylton Joffe, director of the FDA's Division of Bone, Reproductive and Urologic Products, said that such claims "are misleading and inaccurate." "The FDA rejects claims of gender bias," Joffe wrote. "The FDA's regulatory decision for each product is based on an assessment of whether the benefits outweigh the risks, and does not take gender into consideration." Many women's health advocates agree with the agency's caution and remain opposed to the drug despite the company's new research.


Original Submission

 
This discussion has been archived. No new comments can be posted.
Display Options Threshold/Breakthrough Mark All as Read Mark All as Unread
The Fine Print: The following comments are owned by whoever posted them. We are not responsible for them in any way.
  • (Score: 3, Insightful) by bzipitidoo on Friday June 05 2015, @02:23PM

    by bzipitidoo (4388) on Friday June 05 2015, @02:23PM (#192543) Journal

    People are obsessed with magic pills to "cure" things that might not be problems at all, and might respond better to environmental factors. And Big Pharma eggs us on. As VLM touched on above, money is a powerful drug itself.

    Most people feel hornier when times are good. Depression doesn't always just happen, often there is good reason for it. Sometimes it is a chemical imbalance. But environmental and external factors often play a huge role. Pretty depressing to flunk a few classes and be told that you're a poor student and maybe you should consider quitting, resign yourself to the fact that you'll never amount to more than a ditch digger or garbage collector. Very depressing to be a soldier and see your buddies get cut down in a battle. Real cheap to be expected to just blot out the pain with happy pills, when it would have been so much better to have never had the war happen.

    Starting Score:    1  point
    Moderation   +1  
       Insightful=1, Total=1
    Extra 'Insightful' Modifier   0  
    Karma-Bonus Modifier   +1  

    Total Score:   3  
  • (Score: 0) by Anonymous Coward on Friday June 05 2015, @06:46PM

    by Anonymous Coward on Friday June 05 2015, @06:46PM (#192625)
    Yeah don't end up like the Black Knight, keep on saying it's just a flesh wound.

    I agree that depression is a disease. However some of the supposed treatments seem about as bad as the disease.

    It's a bit analogous to someone having a disease that makes them feel hungry all the time, and people treating them by:
    a) Feeding them all the time
    b) Zapping/cutting their brains in the hope that somehow their brain gets damaged enough in the right places that they stop feeling hungry all the time.
    c) Giving them drugs that stop them from feeling hungry at all.
    d) Giving them drugs so that they too foggy minded to feel hungry.