Viagra for Children?

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The Food and Drug Administration (FDA) will decide later this week whether or not to approve a version of Viagra for use in treating children afflicted with a rare lung disease. The active ingredient in Viagra, a chemical called sildenafil, works by blocking an enzyme that regulates blood flow which in turn might help children by controlling blood pressure.

That sildenafil could be used to control severe pulmonary hypertension in children has been known since around 2002, after the FDA asked Viagra’s manufacturer, Pfizer, to study the drug’s effectiveness in children with lung disease. It took eight years for the drug to come up for FDA approval.

The delay was at least in part because childhood pulmonary arterial hypertension is so rare—affecting about 600 people each year—that the drug wasn’t considered cost-effective enough to test and develop.

However there’s an interesting twist: Pfizer isn’t offering a pediatric version of its best-selling erectile dysfunction drug out of the goodness of its little corporate heart. If approved, the company would sell the drug in exchange for a six-month extension on its Viagra patent.

The company sold nearly $2 billion worth of Viagra last year, so a six-month extension would likely create an additional $1 billion in profit before the patent expires in 2012 and cheaper generic alternatives are made available.

Presumably Pfizer could have offered the drug to sick children years ago, but decided to wait until now to move forward with it. So was this a cynical quid pro quo? Childhood pulmonary arterial hypertension is certainly a real disease, and according to doctors the drug seems to be both effective and well-tolerated by patients. And it’s a sweet deal for Pfizer as well.

If approved the agreement would be an economic and public relations coup for the pharmaceutical giant, which just last year was fined a record $2.3 billion to resolve criminal and civil complaints about illegal marketing. The cost of providing a children’s form of Viagra would be a pittance compared to the profits that Pfizer would reap.

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