The pink pill is here. Who wants It?

  19 October 2015    Read: 1098
The pink pill is here. Who wants It?
Erica Palim trembled as she stood before a microphone at a packed hearing in June at the U.S. Food and Drug Administration in Gaithersburg, Md. For the first time, she was about to tell the world what it felt like to lose all desire to have sex. For years, she`d kept quiet, because the Georgetown-trained securities lawyer, mother of four and fixture in her Bethesda neighborhood, is a private woman.
And because, let`s be frank, talking honestly about one`s sex life just isn`t something most Americans do. Lie about it? Yes.

Uncomfortably change the subject? Yes. See it everywhere, steamy and hot in movies, TV shows and glossy magazine ads? Yes. But talk candidly about how much, how good, how often you`re in the mood, or why you`re not? No. Often not with one`s partners, and, for women, research shows, often not even with their doctors.

All morning, Palim had listened to a parade of mostly women, arguing about sex and whether this advisory panel should recommend FDA approval for the first-ever "female Viagra."

The real Viagra boosts blood flow to the genitals, making the hydraulics work better for men and thus treating erectile dysfunction, the most common male sexual problem, affecting about half over age 40. The drug under discussion, flibanserin, works on the brain. It jolts neurotransmitters to rekindle the flagging flames of a woman`s desire to remedy a condition called hypoactive sexual desire disorder. It is the most common sexual dysfunction for women and afflicts about one in every 10.

No one asked Palim to come to the hearing. No drug company paid her travel expenses. But she had heard low desire dismissed one too many times as just all in a woman`s head.

"I have never had another sexual partner besides my husband, and we have always had a very active sexual life," Palim began in a quiet voice, speaking of her husband of 25 years. Petite, dressed conservatively in a classic black pantsuit, her black hair pulled into a sleek ponytail, she told the panel how she and her husband met at college on her freshman orientation weekend and married on her graduation weekend. How he`d nursed her through six months of chemotherapy and radiation treatments after she found out she had aggressive breast cancer at age 24. Even through the cancer treatments that ravaged her body, even when she`d lost all her hair, the sex was good. And it stayed good through the pregnancies and births of their four children.

So when what she`d always considered a healthy sex drive simply vanished, and what had felt like a gift that she shared with her husband lost all meaning because she felt nothing, she became despondent. She felt old and thought she might be going crazy. Her doctors told her there was nothing to be done.

Women deserve better, she told the committee, her voice rising. "How is it possible that the medical community could so actively treat sexual dysfunction in a man - Who in this country has not heard or seen an ad for Viagra? - but completely ignore the same symptoms in women? Let alone treat those symptoms?" she asked. "What kind of message does that send - that a man`s sex life is important but a woman`s sex life isn`t?"

In August, after an 18-to-6 panel recommendation, the FDA approved flibanserin for premenopausal women with warnings about side effects. Days after the decision, a Canadian company bought the drug`s maker, Sprout Pharmaceuticals, for $1 billion. The drug, marketed as Addyi, was expected to hit the market like a bomb Oct. 17.

A month`s supply is expected to cost about the same as a month`s supply of Viagra, about $400, or for those with health insurance, the cost of a co-pay, Sprout officials said. They could not offer estimates of how many women are likely to try Addyi.

In the clinical trials, flibanserin worked for about half of the women who took it. On average, women on the drug reported having one more sexually satisfying event per month than women taking a sugar pill. Critics said that meant the pill was only a "mediocre aphrodisiac." Supporters argued it`s not how much sex but how much a woman wants it that matters. "We`re not aiming to move someone to want sex all of the time," Sprout chief executive Cindy Whitehead said. "We don`t want hypersexuality. We`re aiming to bring her back into normal range."

Critics call hypoactive sexual desire disorder a creation of the drug industry and contend that low libido is really mismatched sex drives, that monogamy is boring, or that sex is just bad - one survey of U.S. heterosexual couples found 75 percent of the men always climaxed during sex, compared with 29 percent of the women, one of the largest "orgasm gender gaps" in the world. The solution isn`t a drug, they argue. It`s another glass of wine. Or more chocolate. But questions like these raised at the hearing and throughout the nearly 20-year quest for a little pink pill still hang uncomfortably in the air. What is normal? Is it "natural" for men to desire sex, but not women, or not as much? What sparks desire? If the spark dies, is it something that popping a pill can - or even should - reignite?

The lawn in front of Erica and Mark Palim`s Bethesda home is littered with soccer balls, a pink jump rope and a rope swing, and near the minivan a ping-pong table stands at the ready in the driveway for their four children, ages 10 to 18. Sitting on their sunny screened-in back porch, drinking a morning cup of coffee together, the couple said that through the years, sex was something they both looked forward to, even in the joyful mayhem and exhaustion of working and raising a young family.

"That`s part of what carries over the next day with a loving spouse and keeps you connected," Erica said. "Sex is an important part of a wonderful relationship. A part of a full life."

After Erica`s breast cancer diagnosis, and with her genetics - she tested positive for the BRCA1 gene associated with higher rates of breast and ovarian cancer - her doctors wanted her to have her children quickly, and once her family was complete, they wanted her to have her ovaries removed.

So, a few months after giving birth to their fourth child, Palim underwent an oophorectomy. Her doctors warned her that without ovaries to produce estrogen, she`d undergo "surgical menopause" and could experience vaginal dryness and painful sex.

What they didn`t tell her is that the ovaries also produce testosterone, without which she may never want to have sex again.

From the first moments after surgery, Palim didn`t feel like herself. She became stooped, depressed and fearful, and routine tasks easily overwhelmed her. "She was like an old woman," said Mark Palim, a PhD economist who was raised in Belgium. Once, Erica became completely undone trying to figure out what to pack for their daughter`s Girl Scouts camping trip. And she lost all desire to have sex.

She worried it was all in her head and sought out a psychiatrist, who suggested anti-anxiety drugs. Her doctors said that other than lubricants, they had nothing for her. She kept trying to want Mark. "But it was impossible. When we kissed, or he touched me, it was like trying to start an engine: You turn the key and nothing happens. The battery is dead," she explained.

"I still loved him. But I was crying inside every time we had sex. I kept thinking, `Maybe this is what it feels like to have sex with a prostitute.` "

She turned to her husband and asked, "Could you tell?"

"Yes," he said.

"You could?"

"Yes," he paused. "I was sad for you. And sad for me."

As Erica sank into deeper depression, Mark began to read medical journals about testosterone treatments in Europe and Canada for women with low desire. Then, Erica found that one of the leading doctors using that treatment, James Simon, was in Washington.

Her other doctors tried to warn her away from testosterone. "My oncologist said, `If you use testosterone, you`re going to grow a penis in your vagina," Palim said. And, in truth, once women start taking testosterone, facial hair can start to grow, their voices can become lower and they can break out in acne. Simon has seen a clitoris swell to the size of a thumb.

Those more extreme side effects may be because there is no FDA-approved testosterone treatment for women. The FDA has twice rejected such treatments. Now, 2 million women with low libido, like Erica, are receiving off-label prescriptions. So getting the dosage right is still a matter of trial and error.

Many doctors say falling hormone levels and a flagging libido are simply natural parts of aging. "So is tooth decay. So is osteoporosis, nearsightedness and hemorrhoids," Simon responded. "We don`t accept them as okay. We have treatments for all those natural conditions. Why not this extraordinarily common condition, a woman`s loss of sexual desire?"

Simon put Palim on a regimen of hormone replacement that she continues to this day that includes an estrogen patch, progesterone pills and a tiny drop of testosterone cream that she applies near her vagina every other day.

Within two weeks, Erica`s anxiety diminished. That delicious warm flood of longing coursed again through her body when Mark touched her. She felt returned to life. But what if she`d never found Simon? Or if the hormones hadn`t worked? What if, like many of the women who testified before the FDA over the years, she had no idea why her sex drive disappeared? Women needed treatment options, she said. That`s why she decided to break her silence. "Just because we don`t fully understand this, just because we don`t have a cure for it, doesn`t mean it doesn`t exist," she said.

The pink pill is as much a symbol of ignorance as it is of progress. Science is only just beginning to understand the complex alchemy that triggers a woman`s desire.

The hormone testosterone, scientists say, makes desire for men a fairly straightforward affair. The more testosterone, the more sexual thoughts and fantasies, the more erections. Erectile dysfunction is all about blood flow.

As with men, Viagra increases blood flow to a woman`s genitals. But it does little to fan passion, which prompted manufacturer Pfizer to abandon studying the drug for use in women in 2004, after eight years of work.

For FDA approval, sexual dysfunction drugs for men and women must show a statistically significant increase in "sexually satisfying events" over placebo. For male dysfunction, that`s easy. Men with erections have more sex than men who don`t. But what has long confounded clinical trials for desire drugs like flibanserin is this: Women with low desire still have sex. Sometimes lots of it. They just don`t want it. So how can you tell if a desire drug is working?

Adding to the confusion, ideas about "normal" female sex drive throughout history have had more to do with prevailing social norms than with science.

The ancient Greeks thought women were naturally the randier sex. The prophet Muhammad`s son-in-law declared that, of the 10 parts of desire, nine accrued to women. And early Christian leaders blamed women`s lustfulness on the original temptress, Eve. A woman`s unbridled sexual desire was something to contain in chastity belts, behind veils and within the bonds of marriage.

That view changed entirely in the buttoned-up Victorian era. Doctors began writing that women were "naturally" passive and passionless and "merely endure" the sexual advances of men. Scientists began theorizing that men evolved to be sexually adventurous to spread their seed into the next generation, and that women mated reluctantly and sought a stable partner to ensure they and their children survived - a view that has only recently been challenged.

To cut through the centuries of mythology and taboo, Meredith Chivers, a sex researcher at Queen`s University in Ontario, Canada, studies human sex drive. She invites men and women to her lab, connects them to equipment that measures blood flow to the genitals and monitors vital signs, then shows them erotic films. She also asks them to rate how turned on they feel.

Men`s heads and bodies tend to be in tune. What gay and straight men reported aroused them - videos of men with women, and women with women for straight men, and men with men for gay men - lined up squarely with the blood flow the instruments picked up.

Gay women reported being aroused by the videos of women with women. Straight women reported being aroused by videos of men with women. But the instruments told an entirely different story: All the women were turned on by just about everything: men with women, women with women, men with men, even copulating apes.

So if Chivers`s research indicates women do indeed have strong and indiscriminate sex drives, why do some women lose the urge? Could it be biological: that the wiring gets tangled? Could it psychological: the message that good girls don`t and bad girls do? Could it be social: the notion that women may be more inclined for sex if they weren`t so resentful or tired doing two to three times as much housework and child care as men? Would a pill help? Research suggests Yes. Yes. Yes. And Maybe.

Desire requires a very particular firing of neurotransmitters in the brain: a rush of dopamine for pleasure-seeking and reward, norepinephrine for arousal and oxytocin for bonding. Not too much serotonin, the elusive signal of well-being that antidepressants seek to boost but winds up putting the brakes on sexual desire.

Flibanserin, which has to be taken daily, boosts dopamine and inhibits serotonin. Other libido-boosting drugs being developed involve different brain chemicals. One, which has to be injected just before sex, tinkers with receptors for hormones associated with skin pigmentation. It was first developed as a sunless tanning drug until researchers noticed it also caused spontaneous erections. Robert Peter Millar, a South African neuroendocrinologist, is trying to develop a drug that mimics a neuropeptide, called gonadotropin-releasing hormone, that helps regulate reproductive behavior - i.e., the desire for sex. "By stimulating this one molecule in the brain," he said, researchers have been able to gin up the libido in some primates, musk shrews and iguanas, male and female, and at the same time suppress their appetite.

Although developing a drug is still far off, the British press have already dubbed it the "skinny sex pill."

While the drugs may boost libido, they can`t answer the question that has plagued Palim: Is hypoactive sexual desire disorder real? For that, researchers at Stanford University have found brain differences on functional magnetic resonance imaging exams between women diagnosed with the disorder and women with healthy sex drives. Dutch researcher Gert Holstege is one the few to attempt to peer into women`s brains to see what low libido looks like and whether the disorder exists. Holstege recruited about a dozen married or partnered women ages 20 to 45 who`d been diagnosed with low desire disorder and a dozen women who had not. He put them in a PET scanner to track blood flow. For 21/2 hours, he showed them snippets of two-minute films: One about whales and the ocean, to capture a sexually neutral brain state; then he showed clips from romantic and pornographic films.

The results startled him. As the women with healthy desire viewed romantic or erotic clips, nearly the entire left side of the brain`s prefrontal cortex, the part that governs thinking, planning and organizing, became less active. Parts of the more intuitive and emotional right side of the brain lit up, showing the women had become caught up in the moment. For women with a desire disorder, the left side busily continued to whir.

For healthy women, as they watched romantic and sensual clips, the orbito-frontal cortex, which is thought to tell the brain what`s important to pay attention to for survival, was also engaged, Holstege said. For women with low desire disorder, it was disengaged. He sees the scans as proof that "low desire is a real biological phenomenon."

"It was unbelievable," Holstege said. "For the healthy women, they were so interested emotionally in what they saw that they weren`t thinking about anything else. That didn`t happen with the women with low desire. Their brains seemed not to be involved in what they saw at all. It was as if they were still thinking, `What do I have to buy at the grocery store tomorrow?` "

Suzy Olds, a biomedical engineering professor in the Chicago area and mother of two, knows what it feels like to, during an overture from her husband, suddenly start thinking about a carpool she forgot. "That kills desire, all that clutter in the brain," she said.

When she worried about her disappearing sex drive nearly a decade ago, her doctor told her she needed not a pill, but porn. Watching helped but made her feel ashamed. So she and her husband started their own video production company, After Nine Tonight, to make "tasteful, super-soft porn" films, such as "Staycation," about Simone and Will`s surprise sexy date. The films last no more than 15 minutes and are designed to help busy women get in the mood.

On her website, Olds also includes Quickies, educational videos about women`s low libido, with such titles as "Is Resentment Toward Your Husband Killing Your Sex Drive?" "We Hardly Have Sex Anymore. Is Our Marriage in Trouble?" and "How to Get Your Wife in the Mood." They provide helpful hints such as longer hugs before work, text messages during the day, "or even unloading the dishwasher without being asked." Said Olds, "Sex isn`t a priority for women when they have so much else going on." Then she quickly excused herself to rush from work to pick up her son at hockey practice.

While Olds has never tried flibanserin and isn`t sure it would work for her, Cara, 45, an executive who lives in Southern Maryland, said she wants to be first to get a prescription. Cara, who didn`t want her full name used because of the "stigma of being thought of as a sexual woman," was one of 11,000 women who took part in the flibanserin clinical trials. She once had a powerful and hungry sex drive that inexplicably turned off in her 30s.

To kick it in gear again, she tried herbs, supplements, expensive drinks, date nights, bed picnics and afternoons in hotel rooms with her husband. She sought out sex therapists and experimented with sex toys, lubricants and pornography. Nothing worked. "I was just servicing him," she said. Flibanserin changed that.

When the FDA approved the drug in August, she and her husband shared a bottle of champagne. "We`re really excited," she said, "like we just planned our honeymoon."

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