Is the FDA sexist?
That’s the latest debate to come out of the pharmaceutical market after the FDA refused approval of Flibanserin, a drug designed to treat sexual dysfunction in women.
Flibanserin, also known as the “little pink pill,” is essentially the female equivalent of Viagra. The drug addresses a condition known as hypoactive sexual desire disorder (HSDD) – one that some experts deny even exists. However, women struggling with the disorder and the practitioners that treat them say this condition is very, very real.
The condition is so real in fact, that Sprout Pharmaceuticals has dedicated years to developing and researching Flibanserin. The drug acts on key chemicals in the brain that are believed to be at the heart of HSDD. And, all that hard work is feeling a little futile since the FDA has denied approval, claiming the side effects of the drug outweigh the benefits. Researchers and experts balked at these claims, citing that the side effects are minimal – fatigue, anxiety and dizziness – especially when compared to the deadly side effects associated drugs that address male sexual dysfunction. Lisbeth Roy, D.O., a Fort Lauderdale physician who dedicates her practice to sexual wellness and rejuvenation, says, “There are 25 drugs on the market to treat male sexual dysfunction with side effects including stroke, heart and erections that last for hours. There are no drugs for women. Whether it’s mental or physical, sexual dysfunction is sexual dysfunction.”
In Sprout’s leading clinical study of 1,000 women, 50 percent of women taking the drug experienced improvement in sexual desire, with only 15 percent of those women experiencing side effects of dizziness, anxiety and sleepiness.
The FDA declined to comment on the drug for Nightline’s breaking story last week, but they underlined their commitment to “supporting the development of therapies for medical conditions related to female sexual dysfunction.” The response from doctors has been divided. Many side with FDA stating that the FDA’s rejection is valid – HSDD does not exist. Flibanserin is merely a solution to a fabricated problem.
Sprout refuses to give up and is pursuing two more clinical trials before reviews begin again next year. And, for the millions of women suffering from this “fabricated disorder,” as some experts claim, there are alternatives.
Doctors Studio in Fort Lauderdale, the sexual health practice owned and founded by Dr. Lisbeth Roy, sees women suffering from HSDD, vaginal dryness, inability to orgasm and painful sex. “If these problems aren’t real, then why do I have so many women in my office asking for help?” Dr. Roy isn’t waiting on Flibanserin to help her patients find relief. She is a leading expert and pioneer alongside Dr. Charles Runels in using platelet rich plasma to help the body heal itself. The O-Shot® is one such treatment that has riveted women across the nation, allowing them embrace the sexual side of themselves.
Patients who receive the O-Shot report results that included increased sexual desire and greater satisfaction in the bedroom. Dr. Roy couples the O-Shot with a total sexual wellness treatment plan that is tailored to meet the needs of each individual woman. “Sexual wellness has to be viewed and treated in a very distinct manner. That’s why so many physicians avoid the discussion with their patients. It’s requires personal attention and a very personal treatment plan. We can all be affected by similar conditions, but how we react to those conditions, mentally and physically – especially in the realm of sexual wellness - is as unique and individual as each patient. The O-Shot and even Flibanserin, upon approval, needs to be carefully administered under the care of a doctor, who is helping the patient work through all aspects of the issue.”