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By Tom Cushing

Call Alice ...

Uploaded: Aug 28, 2015

With apologies to Grace Slick:

One pill makes him larger, and
One pill lights your spark.
But the promises Big Pharma gives you,
Too-o-oo often miss the mark ? *

Newsflash: the FDA has given its regulatory blessing to the 'Addyi' pill, the so-called 'female Viagra' -- or, as one wag put it, "finally, a cure for the common headache."

Except it's neither.

Now, I don't mean to be insensitive to anybody's sexual tribulations -- 'tis said that sex is a lot like oxygen -- not a huge deal unless it's in short supply. In bygone days, sufferers of such romantic hypoxia might have included a lot of gasping married folk, but somebody called Ashley Madison seems to have solved that problem for untold millions (not all by herself, of course, and her 32 million clients are apparently no longer 'untold').

What I want to curmudge here are various phenomena associated with these preciously pink oblong pills.

First, the term 'female Viagra' -- it's inaccurate. Those several related, male-oriented pharmaceuticals operate on a strictly, uh, mechanical level. They deal with plumbing and its obstructions, and leave libido to the imagination where it belongs, as well as all those free sites on the web. I'm told. Think of them as a kind of Drano that is supposed to work in four hours or fewer. Addyi, by contrast, apparently acts on biochemical balances in the brain -- particularly the mix of dopamine and serotonin.

That difference is likely to perpetuate the claim that absent ardor is all in the head of the female partner. Haven't we had enough of that sort of misogyny, "wherever" in a woman's body it's directed? That it's somehow her 'fault' she doesn't feel like tripping the dark fantastic?

Conversely, there's all those ill-humored adversarials who find evidence of systemic bias in the late arrival on the scene of this particular concoction. Finally, Big Pharma gets around to women, they say, before thinking much about it -- if this was a male problem, a solution would've been found long ago ? oh wait. Sexual dysfunction is not either party's individual problem; it's a couples thing -- two to tango, regardless of whether folks are standing or prone.

Then there's the warning that daily-use Addyi does not play nice with alcohol. Per the FDA approval announcement: "Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies," continued Dr. Woodcock (You're kidding, right FDA? No?) "Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment."

The announcement continues: 'Addyi can cause severely low blood pressure (hypotension) and loss of consciousness (syncope). These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines that interfere with the breakdown of Addyi in the body. Because of the alcohol interaction, the use of alcohol is contraindicated while taking Addyi. Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi.'

So, mixing this chemical with alcohol renders women unconscious? Sadly, there's already a pill for that, colloquially called 'roofies.' Do we really need to add another weapon to the abuse arsenal of placekickers and other sexual predators?

Further, the alcohol interaction study relied-on by the FDA was a sample of twenty-five people ? 23 of whom were men. According to researcher Lori Brotto, quoted in New York magazine: "Gender differences in the metabolism and toxicity of alcohol are well known, and women are more susceptible to toxicity effects than are men, As such, I think the negative interactions between Addyi and alcohol found in the safety study are understated, and in women taking Addyi, I would expect the mixing to be more devastating." Remember that girl who drank you under the table in college? (I do, sort of.) Well, she's not typical.

Finally, there's the ultimate question of does Addyi really work? The first thing to note is that it took three dates with the FDA approvers, along with an extensive lobbying campaign directed at the agency (which may have included candy and flowers), to score the regulators' blessing. Courtship, it seems, is just never easy. Next, the third-date data showed an average of about one more satisfying sexual event per month, slightly more than women taking a placebo. No word on unsatisfying events.

Fully half the drugged women expressed satisfaction with the pill, which seems like a strikingly good outcome -- at least until you compare it to the 40% of the placebo group who also expressed similar satisfaction with their confection. Further, in one trial, although the event tally went north, there was no significant daily desire effect. So the quality of the interactions was better, but the libido itself remained mired, in between 'events.' Significant side effects bothered more than one in five trialists.

So, is this pill much good? Not really. And will this pill succeed? Absolutely -- this is America, after all, where our healthcare mantra is "why prevent it, when you can cure it with a pill?" So confident is somebody, that Sprout Pharmaceuticals, the start-up that achieved FDA approval, was immediately sold to a larger company, for a cool $Billion. Will it be cost-effective? I don't have pricing data, but it's safe to conclude that it'll cost more than placebo sugar pills. A LOT more. And cost-effective vs. other interventions like couples therapy? Entirely unknown.

So where does that leave us? My strictly amateur, unscientific position is that the human brain of both sexes is the primary seat of sexual desire and promoter of its performance. And I have it on excellent authority and experience that the best thing partners can do to augment their 'satisfying sexual events' tally is to be kind to each other.

As explained to me recently, and borne-out in my own clinical trial: "the sexiest thing a man can do is ? housework. "

* What ? should I have adapted Jagger and Richards' "Mother's Little Helper?"