Stimulating sexual science

In addressing Uncomfortably Numb last week, (“Biking to climax,” Jan. 15) we discussed exercise as a possible solution to anorgasmia. But as actual climax inducing devices go, you may have read about Dr. Stuart Meloy and his Orgasmatron. If you haven’t, here’s a primer: latimes.com/features/health/la-he-orside11feb11,1,7473561.story.

In his work treating chronic pain, Meloy discovered—in a thrilling set of circumstances you might read about in a gothic novel—that stimulating a specific area of the spinal cord induced orgasms in secondary anorgasmics, women who had previously been able to come but had lost the ability. Meloy is optimistic about the device’s potential to help carve out neural pathways over a longer period of time and assist even primary anorgasmics (women who have never orgasmed) in climaxing, though he has run into a few obstacles developing his device.

While the machine that he originally used to test his theories is FDA approved for treating chronic pain, it is not FDA approved to treat sexual dysfunction. Additionally, he says, “The existing equipment is so awfully expensive. I have resolved to become my own Edison and build a cheaper and more functional device.”

Meloy says primary anorgasmia is much more rare than secondary, and therefore has chosen to forge ahead with the latter group, including as a priority women who have suffered spinal chord injuries. Meloy admits that sympathetic funding is easier to secure for groups who have endured hardship and that they’re also “pretty strong lobbyists for their own interests.”

The pervasive belief that sexual pleasure is trivial doesn’t wash quite as well when you’re looking at women who have lost it in tragic circumstances. He will be including men in his tests as well, where the device has proven to stimulate erection. Male sexuality, it seems, is also considered a more imperative and fundable field of research, no doubt bolstered by the multibillion-dollar Viagra and friends industry.

Meloy now realizes his original target of two to three years won’t be reached; FDA approval for such a pioneering device will require many more years of tests for safety and efficacy. As Dr. Jim Pfaus says, “He would have to subject people to the implant procedure and do some kind of optimization procedure in his Phase I trials. He would have to gather safety data, with a specific eye to the implanted electrode entry area and any possibility of long-term infection.

“For Phase II studies, he would then have to give devices to women, or men for that matter, and do a ‘Stay-at-Home’ trial, in which the subjects would keep a diary of the use of the device and the effect it had on many aspects of their sexual function and quality of life. And those markers that the FDA would require the subjects to rate would have to go up considerably and significantly without a demonstrable increase in any risk factor before the FDA would allow Phase III studies. The FDA needs to find out beyond any shadow of a doubt that the drug works and that it doesn’t cause any untoward side effects. It would never approve a surgical procedure with indwelling electrodes, even for someone with intractable pain unless it was absolutely proven to be safe.”

Meloy is not easily discouraged though. “I intend to pursue this as far as I can,” he says, despite this not being the best time to seek out venture capital. And though according to him the people in Bush’s Food and Drug Administration were professional and accommodating, he does say, “We may get more favourable treatment under a new FDA.” Pfaus is hopeful in this regard. “All the Bush appointees to the FDA are evangelically opposed to medical procedures to treat ‘lifestyle’ problems,” he says. “I sincerely hope that the incoming president, who works out on a daily basis and understands how important ‘lifestyle’ variables are to health and wellbeing, will replenish the FDA with likeminded people.”

Meloy’s Web site on the topic, down for revamping, will be back up again, according to him, within a week. If you are interested in following his progress, it is here: nasfonline.com.

Got any questions for Sasha? E-MAIL: POULEDELUXE@YAHOO.COM