Pharma Sleight of Hand

Viagra By Mail!
Enhance Your Performance!
Only 99 Cents Per Tablet!

This is what most of us find in our spam baskets, usually written in pidgin English and from strange overseas ISPs. Viagra, as you probably know, is one of Pfizer’s all-time blockbusters, and remains under (very expensive) patent protection in the United States until 2019. Although its sales peaked in 2008, four years later it still earned the mother ship over $2B in global sales. Depending on the insurance/ copays/ deductibles my male readers might possess, a tablet of 50mg can cost upwards of $32 each.

[sidebar, overheard at one pharmacy window: “$32?!? No thanks. The missus sent me. Not worth it”]

So the above e-solicitation is obviously bogus, right?

Not exactly.

confiscated counterfeit blue gold

confiscated counterfeit blue gold

Viagra, patented first in the U.K. in 1996, came on the U.S. market two years later. Its active ingredient, sildenafil citrate, was originally investigated as an anti-hypertensive and treatment for angina pectoris. It acts by inhibiting cGMP-specific phosphodiesterase type 5, an enzyme that promotes degradation of cGMP… pretty boring stuff, unless you’re a biochemist. But it was only during clinical trials that its other, far more lucrative and now famous, physiologic effect was discovered. Now ubiquitous in late night comedians’ monologue punchlines, aging men (think Hugh Hefner, Bob Dole, Pelé) sing its praises, and a robust grey market has developed. Not a few marriages have been saved, and probably more destroyed, by its easy (albeit expensive) availability. It is said to be the most counterfeited drug anywhere. In short, Viagra’s pop culture notoriety has done for American – nay, world – sexuality in the 21st century what The Pill did for the Sexual Revolution back in the 1960s.

But it’s so damned pricey!

[sidebar: now working with the Veterans’ Administration, I’ve noticed that a majority of my male patients are prescribed Viagra by their primary care docs. However, the VA puts a strict limit on how many Vitamin Vs a patient can receive, likely because of cost. In case you’re wondering, Washington allows twelve tablets per 90 days. I’ve had more than one vet come to my office fuming, saying something to the effect of, “I served honorably for [x] years in [insert Third World hellhole]. And now Uncle Sam tells me that I can only get lucky* once a week?!?”]

[*“get lucky” is not the actual phrase used]

I have written before about off-label prescribing, the (perfectly legal and widely practiced) mechanism by which drugs approved for one indication can be used for whatever the prescriber wants, once the Rx is on the market. In a related vein, many medications were first envisioned for one role but quickly segued to other uses as clinical findings and needs dictated.

Thorazine was at first a veterinary anesthetic before it was an antipsychotic tranquilizer

Monoamine Oxidase Inhibitors were being applied to treat TB before their antidepressant effects were realized.

Minoxidil was used for hypertension and then was found to grow hair on bald scalps.

The moiety Bupropion has been marketed as both Wellbutrin (for depression) and Zyban (smoking cessation).

Fluoxetine is best known when prescribed as Prozac, another antidepressant, although it also is the active ingredient in Sarafem, for monthly pre-menstrual symptoms.

[sidebar: I remember a time when Wellbutrin and Prozac were on formulary, while Zyban and Sarafem were not. Easy to get around that, however… just prescribe the formulary agent for the non-formulary indication and everyone is happy except the accountants]

In short, if it’s FDA approved, on the market, and you have a medical license and can prescribe, go for it!

Why this is germane: Viagra for male erectile dysfunction loses its U.S. patent protection in 2019. But sildenafil, its active ingredient, has already been available to internists and pulmonologists as a generic for the treatment of pulmonary arterial hypertension since 2012. And as a generic, sildenafil’s cost has plummeted, now running about $1 per 20mg tablet (or $3 for three of them, roughly approximating the dose of sildenafil in a costly 50mg Viagra)

To make matters even more interesting, local pharmacies can usually order generic sildenafil with little effort, and will often mail these meds to one’s home if the doctor calls in a prescription and you provide a credit card number. These are not fly-by-night foreign mail order pharmacies. These are (licensed) pharmacies here in the US of A providing an accepted pharmaceutical for a recognized medical use – the treatment of pulmonary arterial hypertension.

Although seen in other illnesses as a related finding (e.g., pulmonary embolus, scleroderma, lupus), at a frequency of only 3 per million, idiopathic pulmonary arterial hypertension is a far less common condition than, say, middle aged erectile dysfunction.

So, with a wink from your doctor and pharmacist, what one does with the cheap sildenafil when it arrives with your electric bill and copy of TIME magazine is entirely up to you.

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[Copyright 2013 @ The Alienist’s Compendium]

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