Fight Over 'Little Pink Pill' Raises Sexism Questions

It’s called the “little pink pill,” a tiny tablet that could have a huge impact on treating female sexual dysfunction. If it’s approved, it would become the first drug of its kind on the market.

But that’s a big IF.

The drug Flibanserin is locked in a heated battle for approval from the U.S. Food and Drug Administration, raising controversial questions about why there are so many sexual enhancement drugs available for men and zero for women.

Cindy Whitehead, the founder and COO of Sprout Pharmaceuticals, a Raleigh, North Carolina-based company focused on producing only Flibanserin, has been fighting for FDA approval for the drug for three years.

“There are 25 approved drugs for some form of male sexual dysfunction, but still a great big zero for the most common form of FSD [female sexual dysfunction],” Whitehead said.

“No matter how or why we got here, we're here, and we've got to come up with a solution for it.”

Flibanserin is more than curing a weak libido. It’s specifically for treating Hypoactive Sexual Desire Disorder, or HSDD. Gynecologist and sexual health crusader Dr. Lauren Streicher explained that HSDD goes much deeper than just a low sex drive.

“[HSDD] is a very specific problem in a woman who doesn't think about sex, she doesn't fantasize, she doesn't desire sex,” Streicher said. “What makes it different is that it’s distressing to her. This has a negative impact on her. She’s worried about it, she’s frustrated.”

According to the International Journal of Women’s Health, as many as 1 in 10 women suffer from HSDD. While many doctors agree HSDD is a problem that should be addressed, there are no medical treatment options.

Whitehead believes Flibanserin is the solution to solving female sexual dysfunction, but said it’s not accurate to call the drug “female Viagra” because it doesn't work in the same way that Viagra does for men.

“Viagra is a blood-flow issue, a mechanical issue, and Flibanserin works on key chemicals in the brain,” she said.

Scientists have known for years that a woman’s most significant sexual organ is actually her brain, which is what makes female desire disorders so hard to treat.

Flibanserin is taken daily at bedtime, but it’s not a hormonal supplement. Instead, the pill manipulates certain chemicals in the brain to achieve desire.

To test it in clinical trials, Whitehead said it was important to find women who genuinely suffer from HSDD, and not just boredom.

“There's a diagnostic questionnaire that physicians go through, and they really can pretty quickly get to whether or not this is a relationship dynamic or something that's happening biologically,” she said.

Amanda Parrish said that’s exactly what she was facing. A mother of four from Nashville, Tenn., Parrish said she used to have a smoldering sex life with her husband, but over time, things cooled off. She said the problem wasn't with him, but with her.

“I felt like even though we were close and having a great relationship there was something that wasn't extremely gratifying,” Parrish said. “There was something just not there, so I was in search of something that would make that happen.”

Feeling pressure to be a so-called “wholesome soccer mom,” Parrish said she never discussed the issue with her friends but had a feeling she wasn't alone. “If you asked ten ladies on the street I think seven or eight would fess up that their sex life is not what they wanted it to be,” she said.

After filling out a questionnaire, Parrish found out she had symptoms of HSDD and was selected to participate in the Flibanserin clinical trials. She had to take the pills every day and keep a diary of her progress.

“The diary was very personal,” Parrish said. “Every morning it would go off and I would have to answer if I had sex, if I had initiated sex, if I had turned it down, if I had lubricated, if I had orgasmed. ... Within a couple weeks I began to notice a dramatic difference in the way I responded.”

Around 1,000 women participated in the clinical trials. According to Sprout Pharmaceutical’s results, on average, women taking Flibanserin doubled their number of so-called “satisfying sexual events” with taking the drug, and reported a 50 percent increase in sexual desire.

But about 15 percent of those women in the clinical trials dropped out because of side effects, including sleepiness, dizziness and anxiety, which Flibanserin proponents point out seem mild compared to the side effects listed in the now iconic Viagra commercials, such as nausea, diarrhea and the risk of erections lasting over four hours.

The FDA last rejected Flibanserin in December 2013, though Whitehead and Sprout Pharmaceuticals are appealing the FDA’s decision.

“We heard from the FDA in the simplest term, ‘no,’” Whitehead said. “What they basically said to us is in the risk-benefit evaluation. They felt that Flibanserin's effect was only modest, and, therefore, they didn't give us an approval.”

The FDA’s rejection of Flibanserin ignited a storm of controversy with many crying sexism. The government agency was bombarded with letters in support of the drug from prominent women’s groups and even a handful of congresswomen.

“There’s absolutely some sexism at play,” Streicher said. “No one is making this up. This is not a hallmark holiday that someone just decided to invent something in order to sell more of something.”

The FDA declined “Nightline’s” request for an interview about Flibanserin and declined to comment on the drug, but said in a statement that they are, “committed to supporting the development of therapies for medical conditions related to female sexual dysfunction” and denied allegations of gender bias. Read the FDA's full statement here.

Some doctors believe Flibanserin was rejected for a very simple reason: it’s an ineffective drug for a non-existent problem.

Dr. Adriane Fugh-Berman, a general practitioner and associate professor at Georgetown University Medical Center (GUMC), is also the director of the medical center’s research project PharmedOut, which analyzes the effects of pharmaceutical marketing on prescribing practices. She said the buzz created around Flibanserin is a “classic marketing technique” for new drugs.

“It’s not sexist for the FDA not to approve a drug that it doesn't believe is effective or safe,” Fugh-Berman said. “It’s a classic marketing technique to first create a problem, and then sell the solution, and that’s what’s going on here,”

“Of course sexual desire varies by person and it varies by phase of life, but that doesn't make it a disease,” she continued. “This is a drug with minimal effectiveness, if any, and it’s meant to be taken every day for a condition that is not of a disease.”

At the FDA’s request, Sprout Pharmaceuticals is running two more trials on Flibanserin before the agency brings it up for review again. If Sprout wins the appeal, Flibanserin could be available with a prescription as early as next year.

“I will be the first one waiting for my prescription,” Parrish said. “I believe that strongly in how it works and that women deserve an equal opportunity to enjoy and become equal members in their sex life as men have become with the products available.”

U.S. Food and Drug Administration's Full Statement to "Nightline":

The FDA is committed to supporting the development of therapies for medical conditions related to female sexual dysfunction. The agency has approved treatments for pain during sexual intercourse and vaginal dryness associated with menopause. Additionally, the FDA has also identified female sexual dysfunction as one of 20 disease areas of high priority and focused attention. The agency will be actively soliciting patients’ perspectives on their condition and its impact on daily life.

The FDA cannot discuss any drug that is still under regulatory consideration. The agency evaluates drugs based on science and strongly rejects claims of gender bias. Currently, the FDA continues to work with the company to determine whether the drug’s benefits could outweigh its risks. The FDA strives to protect and advance all important areas of women’s health, and the agency is committed to working with companies to develop safe and effective treatments for female sexual dysfunction.

Dr. Lauren Streicher Will Teach You to Love Sex Again

Female sexual dysfunction affects 40% women and 60% of postmenopausal women. The number one mistake is accretive sexual dysfunction as traditional.

What causes it?

Number one is low sexual desire. It should ensue to medication; it may be depression. It may start out that you’re having painful intercourse. Then after all you’re attending to have decreased libido, as a result of people don’t wish to try and do painful things.

What usually causes the pain?

Sometimes it’s endometriosis, and typically it’s vaginal dryness. If somebody doesn’t lubricate, that fairly often as a result of sexual hormones issues: menopause or birth control pills. Additionally you would like an good blood supply to the vagina in order to have normal lubrication, and women with diabetes and heart disease often have a decline in their blood supply in that area.

How does one fix it?

It may somewhat be if a lady uses the proper lubricant, she’s attending to be fine.

And if not?

Women are nervous concerning taking hormones. But local vaginal estrogen is safe for essentially everyone to use. We’re using this in women with breast cancer because the systemic absorption is so low that it doesn’t even increase their blood levels beyond the postmenopausal range.

Are there any recent breakthroughs that ladies ought to remember of?

There’s a tool known as InTone that reproduces what a pelvic floor therapist will. There are variety of latest product, like nonestrogen product for treatment of vaginal dryness that most women are not familiar with.

So typically a prescription is necessary?

Would you say to a man who couldn’t maintain an erection that he shouldn’t consider Viagra? Right now there are 25 drugs approved for male sexual health, and other than the vaginal dryness drugs, there are zero approved for female sexual health. That’s a real problem.

Any promising medicine within the pipeline?

Flibanserin has been shown in the medical literature to have an impact on female libido. It is going back to the FDA [for approval] in a couple of months. You say that most doctors are not up on these solutions. Why? Knowledge is highly variable depending upon where somebody trains. At Northwestern, sexual health is not a part of the residency. I’m trying to change that. It sadly all comes down to funding.

New Agent for Female Sexual Dysfunction Has Promise

The melanocortin-receptor-4-agonist bremelanotide seemed to cut back distress and increase satisfaction among premenopausal ladies with feminine sexual dysfunction, researchers rumored here.

In phase II clinical studies, a 1.75-mg hypodermic dose of the experimental bremelanotide result in a mean reduction of regarding 1.1 points in feminine Sexual Distress Scale-Desire/Arousal/Orgasm score compared with a mean reduction of regarding 0.6 points among placebo patients (P<0.001), said Sheryl Kingsberg, PhD, from Case Western Reserve University in Cleveland, and colleagues.

Combining the 1.25-mg dose and also the 1.75-mg dose, the reduction was regarding 0.9 points (P<0.01 versus placebo), Kingsberg unhappy at an advertisement presentation at the American College of Obstetricians and Gynecologists annual meeting.

"There aren't any approved medication for hypoactive sexual desire disorder in ladies," she told MedPage these days.

"Female sexual dysfunction could be a category of disorders that represent the foremost outstanding sexual disorders in ladies," she went on to clarify. "You could still have sex and it would be pleasurable, but it is about wanting sex."

In a companion study that specifically checked out hypoactive sexual desire disorder, David Portman, MD, director of the Columbus Center for Women's Health analysis in Ohio, said that treatment with bremelanotide resulted in ladies boosting the amount of satisfactory sexual events in a month.

The study by Kingsberg's cluster targeted on the analysis of how at-home, self-administered bremelanotide mitigated the strain hooked up to hypoactive sexual desire.

"The FDA needs that the treatment cut back stress on the feminine Sexual Distress Scale-Desire/Arousal/Orgasm," Kingsberg same. "We demonstrated a dose-dependent efficacy for bremelanotide to cut back the distress of feeling fazed by low sexual desire."

The 12-week study had 97 ladies who were randomised to received placebo, 87 ladies who were treated with a 0.75 mg dose of bremelanotide, that was a dose that wasn't more practical than placebo, 75e ladies who were treated with 0.25 mg of bremelanotide, and 74 ladies on a high dose of 0.75 mg. the ladies self-administered the drug on an as-needed basis.

Responder rates for satisfying sexual events were 37 for placebo, 38% for 0.75-mg dose, 48% for 1.25-mg dose, 55% for 1.75-mg dose, and 51 for one.25-mg and 0.75-mg pooled dose. Responder rates were 45%’ 49%, 60%, 69%, and 64%, severally, on the feminine Sexual Distress Scale-Desire/Arousal/Orgasm.

Patients taking bremelanotide reported more nausea, flushing, and headaches than those on placebo. About 5% of the placebo patients and 10% of the 1.75-mg dose of bremelanotide patients withdrew from the study because of adverse events, but the drug was generally well tolerated, Kingsberg said.

"Bremelanotide has finished its phase II studies and designs for phase III are now awaiting approval from the FDA," she said.

In the phase IIB, 24-week study by Portman's group, women self-administered the drug about 45 minutes prior to anticipate sexual activity. Of the 327 participants, the majority had either mixed hypoactive sexual desire disorder or female sexual arousal disorder with a primary diagnosis of hypoactive sexual desire disorder.

The mean change in sexual satisfying events with was increased by 0.3 events per month among the 76 placebo patients; by 0.7 events a month among the 62 women assigned to the 1.75-mg dose (P<0.05); and by 0.7 events per month in the 128 patients in the pooled 1.25-mg and 1.75-mg dose (P<0.05).

"In premenopausal hypoactive sexual desire disorder, subcutaneous bremelanotide yielded improvements across all key hypoactive sexual desire disorder measures with robust dose-dependence attaining statistical significance at 1.75 mg," the authors concluded.

Studies Say The Smaller Your Clitoris, The Bigger The Problem

New research published in the Journal of Sexual Medicine (the only kind of medicine) is implying that it might not be the size and shape of the boat that matters, but the size and shape of the dock. That metaphor makes little sense, but come on board anyway. What I mean is: when it comes to female orgasm, size matters - clitoral size that is.

The vagina scientists used MRIs to scan 30 women’s’ pelvises. Of those women in the very tiny sample, ten had reported rarely or never achieving orgasm despite their best sexual and masturbatory efforts, the rest had what The Daily Mail referred to as “a normal experience during sex.” I’m not sure what a normal sexual experience is, but using context clues, I figured it means they had orgasms regularly.

Here is what the researchers found: “Although adequate sexual function is complex, we document that clitoral size and location may be paramount in impacting sexual function, specifically orgasm.”

The clit may look like a little button nugget outside the body, but the whole clitoral complex is the boomerang shapes and extends into the body “and includes parts that are known as the body, crura, bulb and root.” The research implies that perhaps the smaller the distance between the whole clitoral-boomerang and the vagina makes orgasming more likely because the clitoris is more easily stimulated during vaginal intercourse. Basically, it could be that the smaller and farther and from the vagina, the less likely a lady is to come.

The team acknowledges that “these physical characteristics cannot be changed,” but that doesn’t mean progress isn’t being made, “understanding the physiology of the female sexual response advances knowledge.” Knowledge is good!

This discovery is pretty freaking cool for a number of reasons. Because it focuses on female parts for once, values female pleasure and could lead to treatments for women afflicted with anorgasmia, the inability to have an orgasm and other types of sexual dysfunction. This is progress, people. I see a future with no gods, no masters, and orgasms for everyone.

Source: http://www.blisstree.com/2014/02/21/sex-relationships/sex/clitoris-orgasm/#ixzz2uKnezVHR

Most Common Women Sexual Dysfunction

Women’s encountering intimate pain and issue is not a new fact and unlike men it is usually neglected. The word feminine intimate dysfunction is comparatively new, and it’s extremely avoided as well as totally different to explain either theoretical.

What is Intimate Dysfunction?

Intimate dysfunction refers to any issue throughout any part of the intimate response cycle that stops the individual or even couple from encountering intimate satisfaction. The intimate response cycle has 4 stages: excitement, plateau, coming and determination.

Most Frequent Intimate Dysfunction in Female

Inhibited intimate desire - This involves a decrease of intimate attraction. Many aspects will lead to a scarcity, hormonal changes, medical conditions and coverings (for example cancer and chemotherapy), depressive disorders, being pregnant, tension and also tiredness. Displeasure with regular intimate routines conjointly could lead to a decrease of enthusiasm for intercourse, as will style factors, like careers and therefore the care of kids.

Issues changing into Sexually Aroused - Incapability to grown to be sexually aroused are usually associated with loss of intimate require or desire. In different cases, the woman feels intense intimate desire however cannot become aroused.

Pain throughout intercourse - Pain throughout intercourse (dyspareunia) isn't uncommon. Like other intimate problems, it will cause a woman to reduce interest in intercourse.

The identification of female sexual dysfunction requires in-detailed medical therapy by doctor to get an in depth patient intimate wellness history that defines the dysfunction, recognizes signs and symptoms or contradictory medical or medical specialty problems, and psychosocial data.

Questionnaires or regular checkup and appointments with doctor can help to solve various women intimate issues.