Opinion-Editorial: Medicating the male orgasm
www.commonground.ca
December 2005
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.

http://www.cbc.ca/ideas/features/patients/