NAMS Meeting Opens with Kerfuffle over Women's Sexual Enhancement

— Society's founder jabs panelists for overselling no-evidence elixirs

MedicalToday

SAN DIEGO -- The number and variety of love potions that claim to boost or restore the sex lives of women drives behavioral psychologist Sheryl Kingsberg, PhD, just a little bit crazy.

For example, "sex mints, sex dust, sex chocolate, horny goat weed, aphrodisiac granola, musk, products," all with scant evidence of benefit, said Kingsberg, president of the North American Menopause Society, during the start of the organization's 4-day here. She posted photos of more than a dozen such products on the conference monitor.

The label she pointed to on one appears to ensure "more satisfying love-making, more intense orgasms, more energy and stamina, improved memory and concentration, less food cravings, so you lose weight too. It has everything," she said.

"I don't know where the double-blind placebo controlled trial is yet, but they can put anything they want in their marketing as an unregulated dietary supplement," as long as they carry the FDA-required small print caveat, that the products are not intended to cure or prevent disease.

"Our patients are spending their hard-earned money and risking their health on these products. You think, 'not my patients' ... but how many have you had this conversation with? 'That pill they advertise all the time on TV? I'm not sure what it is, but I want it.'"

You name it, it's there for your patients, she said, adding that sales will bring what one survey estimated at $37 billion in "sexual wellness" global sales by 2022. At one point during her talk, she called a variety of such products "OTC snake oils versus what is evidence-based."

Kingsberg, chief of behavioral medicine at University Hospitals Cleveland Medical Center, is a specialist in the treatment of HSDD, or hypoactive sexual desire disorder, defined as lack of motivation for sexual activity, reduced or absent spontaneous desire. It's pervasive -- affecting a lot of women in myriad ways far beyond the bedroom, she said.

She referenced of 300 women showing that 69% said that HSDD impacted their body image and the way they saw themselves, 51% said it reduced their self-confidence, 66% said they felt less connected to their partner, and one third said it impaired their communication and made them worry that their partner might cheat on them.

"This is not trivial," Kingsberg said. "We want these aphrodisiacs, and yet we have only one." She pointed to what she called "cultural vilification" by a medical industry that has accused outspoken women like herself and organizations like NAMS of "overpathologizing ... trying to find a disease to fit a drug."

To her point, there are at least 26 pharmaceutical products with FDA approval for male sexual dysfunction, but just one for women, flibanserin, sold as Addyi. And it is indicated only for those who have not yet reached menopause.

Her message to clinicians in attendance, and especially those who do not have sexuality specialty practices, is to make sure they raise the issue of sexual health, or sexual healing, within their practices, even if it's tough to find the time to start those delicate conversations: "We want our patients talking about these problems," she said.

More Tension and Criticism

The conference's opening day was not without additional tension and criticism leveled at some of the panelists.

Irwin Goldstein, MD, IF, director of sexual medicine at Alvarado Hospital here, said he has seen remarkable benefits in most of his patients who used flibanserin.

Susan Kellogg-Spadt, PhD, CRNP, IF, FCST, CSC, director of Female Sexual Medicine at Drexel University College of Medicine in Philadelphia, extolled dozens of products from lubricants to stimulation devices for improving sexual satisfaction.

One outspoken critic of their talks was Wulf Utian, MD, PhD, NAMS founder and former executive director. He was the first to stand up during a question-and-answer period to publicly protest what he saw as some panelists' unjustified promotion of certain drugs and other products without evidence of benefit.

"I am concerned about the potential of endorsing products with really minimal evidence," said Utian, now professor emeritus at Case Western Reserve University in Cleveland.

"Flibanserin is barely better than placebo. It's an expensive product. It has potential side effects. And I worry about us selling too much to patients," he said.

Goldstein shot back tersely from the dais: "You're wrong. I'm sorry. It's basically 60% effective ... I use a lot of the product. I have amazing results."

Utien responded that Goldstein appeared to be speaking about patients in Goldstein's own practice rather than results from clinical trials. "There's a lot of psychotherapy going on ... and then you add a product ... but how effective were they really?"

Said Goldstein: "Looking at the actual trials, it is very effective."

Asked during the break to elaborate on his concerns, Utian was more specific. He questioned Goldstein's "statement that flibanserin was highly effective and was like a magic potion and his patients loved it when I know that the data says maybe they get one extra [orgasm] per month."

He also questioned a drug when its initial cost was nearly $1,000 a month or $30 per tablet, although the company website now the drug at no more than $99 a month for people without insurance and $25 for those with coverage.

Utian also criticized Kellogg-Spadt, for showing "a number of slides with different lubricants and gadgets and so on, and virtually there's no data on any one of those things. She said all my patients love this, and my patients love that. That's not science data. That's narrative ... pretty flimsy to be actively making recommendations."

Among some of the products she spoke highly of were the hormonal agents prasterone (Intarosa) and ospemifine (Osphena), a cannabinoid product named Foria, and the borage seed oil product Zestra.

Kellogg-Spadt, who also touted flibanserin in her talk, said that the drug's product insert says patients should see efficacy after 8 weeks. "You're not having someone on this for 2 years, saying, 'Oh it's going to work any day now.' I look for signals at 2 to 3 months, and if I don't get one, consider stopping. So, thank you for your comment."

Disclosures

Kingsberg disclosed having financial relationships with AMAG, Daré, Duchesney, Emotional Brain, Endoceutics, GTx, IVIX, Lupin, Materna, Palatin Technologies, Pfizer, Sprout, Strategic Science Technologies, TherapeuticsMD, Viveve, and Valeant.

Goldstein disclosed financial relationships with Valeant, AbbVie, Marius, Endoceutics, and Palatin.

Spadt disclosed financial relationships with Aytu, Amag, and Duchesnay.