Fight Over ‘Female Viagra’ That’s Been Raging For Years Pits Scientists Against Feminists

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February 24th, 2015

A pharmaceutical company hoping to develop the female version of Viagra resubmitted its drug for the Food and Drug Administration’s review on Tuesday — representing the latest major development in a years long fight that has pitted scientists against feminists.

This week marks the third time that Sprout Pharmaceuticals has sought FDA approval of flibanserin, a drug that aims to address sexual dysfunction in women. As the Associated Press reports, Sprout’s fight to get its female libido drug on the market “illustrates the complicated politics and unresolved science surrounding women’s sexuality.”

According to a frequently-cited number from a 1999 study in the Journal of the American Medical Association, more than 40 percent of U.S. women suffer from some type of sexual dissatisfaction. That’s what flibanserin wants to address. The medication is frequently referred to as the “little pink pill,” since it hopes to provide a female counterbalance to Viagra’s “little blue pill” that was first approved in 1998.

But FDA officials have so far declined to approve flibanserin for mass production because of concerns over its side effects, like levels of dizziness and drowsiness that could impair driving. Experts have also suggested that it isn’t effective enough to justify its potential risks. Critics, meanwhile, have accused the agency of gender bias, saying there are already more than 20 drugs on the market to treat male sexual dysfunction and the FDA’sreluctance to approve a drug for women suggests an implicit discomfortwith women taking control over their sexuality.

“We live in a culture that has historically discounted the importance of sexual pleasure and sexual desire for women,” Terry O’Neill, the president of the National Organization for Women, told NPR this week. “And I fear that it’s that cultural attitude that men’s sexual health is extremely important, but women’s sexual health is not so important. That’s the cultural attitude that I want to be sure the FDA has not, maybe unconsciously, imported into its deliberative process.”

Last year, along with several women’s health nonprofit groups, Sprout Pharmaceuticals launched a high-profile advocacy campaign — Even the Score — to push back on FDA officials in explicitly feminist terms. O’Neill is one of the partners in that effort.

Even the Score has been circulating a petition declaring that “treatments for women’s sexual dysfunction seem to be held to a different standard for approval at the FDA.” Several U.S. lawmakers — including Reps. Debbie Wasserman Schultz (D-FL) and Louise Slaughter (D-NY) — have added their voices to the criticism, writing a letter to the FDA urging the agency to use “careful review employing the same standards of consideration given to the approved drugs for men in your risk/benefit analysis.”

People on the other side of the issue disagree, saying that it’s unnecessary and potentially even irresponsible to market a drug that claims to help women who are struggling with low libidos. Some behavioral health experts argue that women’s sexuality is too complex to be regulated with a pill, and the pharmaceutical industry is more interested in its own profits than in finding real solutions to nuanced sexual health issues.

“There’s really been a move toward medicalizing normal human experience,” Adriane Fugh-Berman, a Georgetown University professor who studies the influence of drug companies’ marketing practices on the medical profession, told NPR. “And while there are certainly some women who have very troublesome symptoms of low libido, it’s not at all clear that medication is a good answer for them.”

But proponents of the “pink pill” say that there’s been a concerted effort to downplay the number of women struggling with sexual dissatisfaction, even though there’s some evidence that it’s linked to issues with the neurotransmitters dopamine and norepinephrine. According to a recent review of the research published in the Atlantic, several studies have found that women diagnosed with Hypoactive Sexual Desire Disorder (HSDD) — women who have an “emotionally distressing” lack of arousal — have different brain activity, compared to the women who don’t have that disorder, when they’re shown sexually explicit images.

The FDA, which has been headed by a woman for the past six years, has repeatedly denied any gender bias in the agency’s decisions about flibanserin. It has also taken some steps to address the ongoing criticism in this area. This past fall, the FDA held a two-day conference dedicated to the issues standing in the way of a drug treatment for female sexual dysfunction.

But the debate isn’t likely to die down anytime soon. As part of its media push around the decision to resubmit flibanserin, officials at Sprout Pharmaceuticals have beenconnectingmembers of the media with women who say that they’re struggled with the consequences of sexual dysfunction, and desperately need their own version of Viagra.

“It’s got to be men making these decisions,” one of those women, Cara, who participated in a trial to test out flibanserin, told Marie Claire. “If it were women, this thing would’ve been on the market years ago.”

‘No research to link sex education to pornography’

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February 17th, 2015

 There is no research linking sex education and pornography but “explicit” sex education could actually stimulate teenagers and excite them to know more, according to experts.

This is the opinion of psychologists following the statement made yesterday by PAS Ulama wing information chief Datuk Dr Mohd Khairuddin Aman Razali at-Takiri, who said the government’s plan to introduce sex education in secondary school next year would cause youths to watch pornography.

He proposed “Islamic sex education” and teaching of abstinence instead.

The PAS cleric made the comment after Women, Family and Community Development Minister Datuk Seri Rohani Karim’s said a new syllabus will be introduced for boys aged 16 years and above next year to increase awareness on reproductive and social health topics.

Universiti Putra Malaysia Social Science and Development senior lecturer, Dr Hanina Hamsan, said she was not aware of what the new syllabus looked like but she imagined it would be “visual”.

“We might actually stimulate them (teenagers) by showing them pictures and graphic examples,” she said. “At this age, teenagers’ biological and sexual functions are active, so teaching them sex education could make them more curious to know more and explore themselves.”

She said sex education could be implemented depending on the content of syllabus and the target groups.

“If it is teaching sexual health. then go ahead. However, if it is more towards sex, we have to be careful. Some teenagers from rural areas are naive about sex, so exposing them could spark their curiosity.”

Universiti Kebangsaan Malaysia Faculty of Social Sciences and Humanities senior lecturer and developmental psychologist, Dr Suzana Mohd Hoesni, echoed this view, saying “too explicit” sex education, such as in the United States – where students are shown how to put on a condom, could encourage teenagers to try it out.

“It depends on the context and how the syllabus will be taught,” she said.

However, sex education proponents and sexual health experts believe PAS’s statement is outright ludicrous.

“Why would he connect sex education with pornography?” Federation of Reproductive Health Association Malaysia programme services head Lim Hwei Mian said.

“Recently, an article stated Terengganu had the highest number of porn viewers in the country, so this goes on without proper sex education anyway.

“Therefore, what is the justification for making the statement?”

Lim said sex education teached young people about biology and reproductive health system, and empowering young girls to learn to say no, and not how to have sex.

“we need comprehensive sec education because we need to give young people the correct information.

“Then they will make the right decision and know the consequences of their actions,” she said.

Sex educator June Low asked Mohd Khairuddin to provide peer-reviewed evidence that teens will not watch porn if they are taught Islamic sex education. She also said abstinence-only sex education had been proven not to work time and time again.

Malaysian Association for Adolescent Health secretary Dr Kamarudin Ahmad believes sex education is important because if we did not teach proper sex education, teenagers will look for it elsewhere, such as through the Internet and peer groups, which are dangerous.

However, he said the ministry should consider starting sex education at an earlier age such as pre-school.

“If the ministry would go ahead with the new syllabus for teenagers, they should focus on the implementation and also train the teachers, so that the delivery will be effective.”

Female Libido Pill Fires Up Debate About Women And Sex

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February 17th, 2015

For 15 years, Carla Price and her husband’s sex life was great. But then things began to change.

“Before, I would want to have sex,” says Price, who is 50 and lives in central Missouri. “But over the years my sexual desire has just dwindled to nothing.”

Price has no idea why. She’s healthy. She’s not really stressed out about anything. And she’s still totally crazy about her husband.

“It’s not that our relationship got boring,” Price says. “Because it’s actually the opposite — we became closer as we got older together.”

But her lack of interest in sex almost wrecked their marriage.

“It did get to the point where my husband thought that perhaps we just needed to divorce,” she says.

Women like Price, who see their decreasing sex drive as a problem, are at the center of an intense, emotional debate that’s been raging for years over whether the Food and Drug Administration should approve the first drug that claims to boost a woman’s libido.

NPR reached Price through Sprout Pharmaceuticals Inc., the company that makes the drug.

“Men have a number of treatment options for sexual dysfunction, says Cindy Whitehead, Sprout’s CEO. “We haven’t yet gotten to one for women’s most common dysfunction.”

“Up until now,” she says, “the treatment paradigm for women with sexual dysfunction has essentially been: Let’s take a drug that works in men and let’s see if it works in women.”

None of them did. But Sprout’s drug, flibanserin, takes a totally different approach than, say, Viagra. Instead of increasing blood flow to the genitals, flibanserin affects a different part of the body: the brain.

Flibanserin shifts the balance of three key brain chemicals, Whitehead says. The drug, she says, increases “excitatory factors for sex” — dopamine and norepinephrine — and decreases serotonin, which can dampen the sex drive.

But there’s a lot of skepticism about flibanserin. The FDA has rejected it twice, saying there wasn’t much evidence it works. The agency also questioned the drug’s safety, especially with long-term, daily use.

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“The combination of … not very robust effectiveness, and the fact that the safety profile had not been really characterized very well at all made us reach that conclusion, that it really wasn’t ready for approval,” says Sandra Kweder, deputy director of the FDA’s Office of New Drugs.

The company acknowledges flibanserin can have side effects, including sleepiness, nausea and dizziness. And there are no results yet, Sprout says, on whether the drug might interfere with the helpful action of Zoloft, Prozac or other SSRI antidepressants, which are thought to work primarily by boosting levels of serotonin in the brain.

But Whitehead argues that flibanserin is safe and says the company’s studies show it can help many women.

“We increase their desire by 53 percent,” she says of study participants. “We decrease their distress by 29 percent, and then they doubled their number of satisfying sexual events.”

Whitehead argues the FDA is holding flibanserin to a higher standard than it uses to evaluate drugs for men. And some women’s rights advocates worry that might be true.

“We live in a culture that has historically discounted the importance of sexual pleasure and sexual desire for women,” says Terry O’Neill, president of the National Organization for Women. “And I fear that it’s that cultural attitude that men’s sexual health is extremely important, but women’s sexual health is not so important. That’s the cultural attitude that I want to be sure the FDA has not, maybe unconsciously, imported into its deliberative process.”

The FDA denies any bias.

“We have taken those concerns very seriously and we think the accusation is truly misplaced,” Kweder says.

Many other women’s health advocates agree with the agency’s caution.

“It doesn’t seem to work very well, if at all, and it’s got some safety concerns that are troubling and haven’t been fully explored,” says Cindy Pearson of the National Women’s Health Network. “So we felt very comfortable saying to the FDA, ‘You know, women want attention, but they want drugs that work. And this doesn’t seem to be one of them.’ ”

Others argue that the campaign for flibanserin is oversimplifying female sexuality. And many women (and men) who experience a waning libido at midlife don’t see it as a problem.

“The misrepresentation that everybody should be having it — needs to have it, wants to have it, has a problem if they don’t have it — is to change, really, what sexuality isinto more of a medical thing,” says Leonore Tiefer, a psychologist at New York University. “I think that’s a terrible direction for knowledge, for understanding, for society.”

Some say Sprout’s campaign is part of a bigger trend by the pharmaceutical industry to turn everything into a disease that needs a pill.

“There’s really been a move toward medicalizing normal human experience,” saysAdriane Fugh-Berman, who studies drug companies at Georgetown University. “And while there are certainly some women who have very troublesome symptoms of low libido, it’s not at all clear that medication is a good answer for them.”

A low libido may be a symptom of fluctuating hormones or of some health problem that needs attention. Some women may just be in a bad relationship. For others, therapy might be the answer.

Carla Price says she would like to try flibanserin. Marriage counseling and a hormonal cream have helped, she says. But not enough.

“Even though it’s better, it’s not perfect,” she says. “I would gladly take risks of side effects to keep my marriage and my relationship.”

Sprout says the company plans to submit some new studies soon that it hopes will finally convince the FDA to approve the first drug to boost a woman’s libido.

A shout-out to International Condom Day

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February 12th, 2015

Saturday not only happens to be Valentine’s Day but International Condom Day, as well. Though the latter holiday may not be as well known, it is definitely just as important to recognize. – See more at: http://www.chieftain.com/life/3291781-120/health-tips-condoms-condom#sthash.IIA0dc7N.dpuf

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International Condom Day reminds us that we can protect ourselves and our partners from sexually transmitted diseases (STDs) and unplanned pregnancy by using condoms. Condoms are inexpensive and readily available, and they are the only form of contraception that can help protect its users from STD such as:

Gonorrhea

Chlamydia

HIV

With such high rates of STDs and unplanned pregnancy in , it is even more important individuals are responsible when engaging in sexual activity. Condoms also can also help protect against STDs that can be transmitted through anal and oral sex. Remember, using a condom means safe and responsible sex that protects you and your partner — not just on Valentine’s Day, but all year long.

Take control of your sexual health: Be smart. Be safe. Be healthy.

- See more at: http://www.chieftain.com/life/3291781-120/health-tips-condoms-condom#sthash.IIA0dc7N.dpuf

Doctors’ assumptions on sex heighten lesbians’ cervical cancer risk: study

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February 12th, 2015

(Reuters) – Lesbians may be at higher risk of cervical cancer because they get fewer screenings than heterosexual women, due partly to doctors’ sometimes incorrect assumptions about their sexual history, University of Washington researchers said on Tuesday.

Although nearly all cases of cervical cancer are attributable to a human papillomavirus, or HPV, infection, healthcare providers often do not encourage lesbian patients to get regular HPV screenings, the researchers found.

That is because the disease is most commonly transmitted during heterosexual sex and doctors may wrongly assume lesbians have only had sex with other women, despite studies that have found most lesbians and their partners have had sex with men, researchers said.

A lack of testing can also occur at times because lesbians lack insurance or do not always have a need for pregnancy prevention checkups, or may not want to share their sexual orientation with doctors, the researchers said.

“If we are serious about reducing the rates of cervical cancer in lesbians, an unbiased health assessment by a provider must ask the question: ‘Do you have sex with men, women or both?’” University of Washington School of Nursing professor Joachim Voss said in a statement.

Voss and Lindsay Waterman, an adult nurse practitioner at the Seattle-based university, analyzed medical literature and studies, including Pap screen rates, between 2000 and 2013, published in last month’s Nurse Practitioner journal.

“Ob-gyns should provide the same comprehensive gynecologic health care to lesbians and bisexual women as they do to heterosexual women, including Pap tests,” the American College of Obstetricians and Gynecologists has said.

Researchers were unable to quantify the overall rates of cervical cancer among lesbians compared with heterosexual women because cancer patients are not typically asked their sexual orientation, Voss said.

Screening every three years can detect abnormal cervical cells and pre-cancerous lesions in women ages 21 to 65, but lesbians are screened at rates 5 percent to 18 percent lower than heterosexual women because of the perceived lack of risk exposure, the researchers said.

HPV can be transmitted between women partners through both skin-to-skin contact and contact with sex toys.

Nearly eight of every 100,000 U.S. women are diagnosed with cervical cancer annually, the researchers said.

(Reporting by Eric M. Johnson in Seattle; Editing by Cynthia Johnston and Peter Cooney)