Cardiology

A Food and Drug Administration advisory panel unanimously rejected a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women receiving concomitant estrogen therapy.

The vote by the Advisory Committee for Reproductive Health Drugs is not binding, but the FDA regularly convenes expert panels prior to making regulatory decisions and typically follows their advice.

Representatives from Proctor & Gamble Pharmaceuticals had presented data in support of Intrinsa, a 28-cm²-matrix transdermal system containing 8.4 mg testosterone that delivers approximately 300 mcg/day systemically when worn on the abdomen and changed twice weekly. Proctor & Gamble documents provided to the FDA claimed that 17% to 30% of the 10 million surgically post-menopausal women in the United States have hypoactive sexual desire disorder.

Steve Nissen, MD, medical director of the Cardiovascular Coordinating Center, vice chairman of the department of cardiology at the Cleveland Clinic Foundation and editorial board member of Cardiology Today’s Non-Invasive Imaging section, was on the panel as a voting consultant.

“It was clearly the right decision,” Nissen told Cardiology Today. “When you give hormone therapy to women, we’ve now learned from several big studies in the Women’s Health Initiative, you can have profound effects on global health, particularly cardiovascular health.”

Nissen said that nothing in the safety database for Intrinsa suggested a trend, but with only 487 patients and a mean treatment time of about 24 weeks the database was inadequate. “It was much too little,” Nissen said. “Particularly when the therapy is known to have some cardiovascular risks associated with it.”

Furthermore, safety must be judged in the context of efficacy, which Nissen called “pretty marginal,” at one additional satisfying sexual experience per month.

C. Noel Bairey Merz, MD, director of the Preventive and Rehabilitative Cardiac Center at Cedars Sinai Medical Center and editorial board member of Cardiology Today’s Preventive Cardiology section, said quality-of-life questions could not be easily dismissed.

“I would be careful about dismissing well-being in women as somehow less important than other things that we do for quality of life all the time,” Bairey Merz told Cardiology Today. “We do bypass all the time for quality of life because people don’t like feeling chest pain when they walk up a flight of stairs. So is sex and libido in a woman less a quality-of-life issue than a man who is having chest pain?”

Although she declined to explicitly endorse or criticize the panel decision, Bairey Merz suggested that the panel’s call for a safety study might have been an overreaction.

“What if they had required this of Viagra?” Bairey Merz said, adding that an expectation of perfect safety from any drug therapy is unrealistic and patients are capable of making decisions once informed of the risk. Women are still taking estrogen even as the risks have gained greater publicity because they have decided the benefits outweigh them, Bairey Merz said.

“We seem to require a higher level of scrutiny for women to get their libido back, and I do not see it as fair and equal treatment,” Bairey-Merz said. “If someone tells a man that if he pops Viagra he’s got a one in 10,000 chance of having a heart attack, he says ‘give me the pill, I’ll die with my boots on.” – by Jeremy Moore