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by Alan Cassels
As someone who frequently lectures on pharmaceutical issues, I learned very early that no discussion of prescription drugs is complete without at least one Viagra joke. “Did you hear the one about Viagra being marketed in liquid form? Now it’s truly possible for a man to pour himself a stiff one.”
Like Viagra, the next big drug for male sexual difficulties will be a windfall for standup comedy for years to come. You can say you heard it here first. Our thoughtful friends in the drug research labs are about to launch a pill to treat a new and growing condition that affects up to 40 percent of the male population. Yes, I’m talking about premature ejaculation (PE) the hottest new disease to hit the comedy stage. But just wait.
It seems the makers of this newest treatment for PE may have suffered a bit from premature enthusiasm in the eyes of drug regulators. Just last month, the US FDA told drug maker Johnson & Johnson that dapoxetine, its exciting, new, experimental premature ejaculation (PE) drug was “not approvable.” J&J maintained that dapoxetine “…increased intra-vaginal ejaculatory latency (IEL) time” better than a placebo, and pointed to two, 12-week, phase three, randomized, placebo-controlled studies involving about 2,600 men between the ages of 18 and 77. The FDA said there was insufficient data to prove the drug’s worth and sent the company back to the drawing board.
Ouch, that hurt. As J&J shares slid downward, the financial analysts scuttled back to their cubicles to revise the company’s now less than “shagarific” financial projections. More clinical trials are probably necessary, which can be costly. Undaunted, the company promised it would be back to try again, possibly next year. And it will have plenty of company.
Dapoxetine, you see, had the financial whiz boys mighty excited, because the potential PE market is not only massive, but also malleable. Could be that as many as 30 to 40 percent of us guys are “sufferers,” and in need of treatment. The market for erectile dysfunction drugs, made so popular by Pfizer’s “Riser” Viagra – Hugh Hefner’s suggestion for the drug’s street name – was tiny in comparison, affecting only 10 to 12 percent of the male population.
What is happening, of course, is little more than another crude incarnation of “selling sickness,” where drug makers invent a medical condition as a vehicle to tout their expensive, newly patented drugs that then sail in to the rescue.
So, even though it’s long been known that Prozac-like drugs delay ejaculation – not to mention they also dampen sexual interest – what is different here is the brazen way companies tap into the side effect of a chemical entity to create a brand new market. Loss of sexual interest and delayed orgasm in men are well-known side effects of the selective serotonin reuptake inhibitors (SSRIs), which include Paxil (paroxetine), Zoloft (sertraline), Prozac (fluoxetine) and Luvox, (fluvoxamine). Dapoxetine, which is not approved as an antidepressant, is basically one of this crowd.
Anecdotally, we’ve known about these side effects for years. One of my friends, who jokes about her overactive libido, tells me that one of the key features of her Zoloft, is that it “brings her back to normal,” in terms of how often she wants to shag her husband. Seems he’s not arguing, as her decreased sexual desire means he can get more done around the house. In one study of the sexual side effects of SSRIs, 58 percent of patients admitted to experiencing at least one of these side effects: decreased libido, delayed orgasm, delayed ejaculation, inability to ejaculate, or impotence.
But how can we ever define the “premature” in premature ejaculation? Let’s face it, there are likely some men, at the extreme end of the spectrum, who are a little trigger-happy, and whose guns go off before they can draw them from the holster. Those guys might indeed benefit from pharmaceutical enhancement, but can we fool ourselves that such treatment will be reserved for them alone?
Of course not. The marketing will be intense, with ads targeting every man in the world, regardless of their staying power. With marketing campaigns posing the question, “Wouldn’t you like to go a little longer?” who could say no?
The kicker, of course, is that only men will be asked that question. What about their partners? Maybe the concept of premature, be it 30 seconds, five minutes, or half an hour, rests in the eye of the beholder. And maybe what a guy thinks is premature may be just about right for his partner. Doesn’t matter. Already, several companies are queuing up to conduct clinical trials of their short-acting SSRI clones. Others are considering resurrecting older drugs to see if they may have some effect on ejaculation latency. Indeed, as the chemists work the labs, the marketers are creating a brave new world of PE advertising, because as every ad man knows, “You don’t sell the steak, you sell the sizzle.”
Dr. John Grantmyre, an urologist at Dalhousie University in Halifax has noted: “If you don’t like the erection ads, be prepared. Ejaculation is next.” According to Grantmyre, “Premature ejaculation is something that’s going to get hot in the coming years.”
So what’s a guy to do if he wants relief from this condition and a drug has yet to be approved? According to studies in this area, the main SSRIs available right now – paroxetine (Paxil), fluoxetine (Prozac), and sertraline (Zoloft) – have all been shown to delay ejaculation. But don’t expect your doctor to prescribe these drugs for that reason, as that would constitute “off-label” prescribing, a practice of prescribing drugs for uses not approved by the drug regulator. Evidence, not anecdote, is what should guide drug treatment, and “off label prescribing” is what we researchers call prescribing in an “evidence-free” zone.
At the end of the day, any man who wants to use an SSRI, for whatever reason, should do so with a high level of informed consent. Again, read everything you can from non-industry funded sources about the pros and cons of SSRIs. Be aware of the potential adverse side effects, such as withdrawal symptoms, and effects that span the range from common, but mildly annoying, to rare, but life altering. Know that there is a growing awareness that some people taking SSRIs may be at increased risk of suicide or suicidal ideation (suicidal thoughts).
It would be a shame if, in order to last a little longer in bed, you were led down a road that hastened your death.
Resources: worstpills.org is researched, written, and maintained by Public Citizen’s Health Research Group, a division of Public Citizen. Public Citizen is a nonprofit, nonpartisan public interest group founded in 1971 to represent consumer interests.
Alan Cassels is the co-author of Selling Sickness: How the World’s Largest Pharmaceutical Companies Are Turning Us All Into Patients and a drug policy researcher at the University of Victoria. He has spent most of the last 10 years studying how clinical research about prescription drugs is communicated to policy makers, prescribers, and consumers and has produced several full-length documentaries for CBC Ideas, including Manufacturing Patients, which deals with the subject of selling sickness.
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