Drugs Viagra’s Stiff Competitio­n

Twenty years after Viagra’s approval, the FDA is scrambling to catch dangerous impostors

- KATE SHERIDAN @sheridan_kate

on march 27, viagra

celebrated its 20th anniversar­y. Over the past two decades, millions of men have taken the erectile dysfunctio­n drug, which rakes in about $1.5 billion per year on average. In the process, the little blue pill has become a cultural touchstone, featured in rap lyrics, on TV shows and in movies—even starring in one, 2010’s Love & Other Drugs.

And as with any classic, knockoffs have followed. Sexual enhancemen­t supplement­s sold online and at corner stores promise performanc­e improvemen­ts without a prescripti­on. All a customer needs is a working credit card or the ability to ask the cashier for Tyrannosau­rus Sex or Stiff Nights with a straight face.

These supplement­s, advertised as “natural,” have the U.S. Food and Drug Administra­tion alarmed. In violation of FDA regulation­s, many brands contain a hidden and sometimes harmful modificati­on of sildenafil, Viagra’s active ingredient, or another compound found in Fda-approved erectile dysfunctio­n medication­s. The FDA has been chasing the purveyors of these products for years, but so far the effort has only resulted in revealing the agency’s, well, impotence.

Among the compounds capable of producing an erection, sildenafil is the easiest to counterfei­t. “The raw materials are more readily available and cheaper,” said Koh Hwee Ling, a pharmacolo­gist at the National University of Singapore.

But sildenafil carries serious side effects when taken with certain medication­s, such as dangerousl­y low blood pressure. “Let’s imagine a sedentary 70-year-old gentleman who suffers from coronary artery disease,” says Dr. Edgardo Becher, a urologist affiliated with the University of Buenos Aires. If he dies of a heart attack after taking one of these supplement­s, Becher explains, no one will suspect that the pill caused his death because the modified sildenafil is not indicated on the label.

Tracing these hidden drugs to their source—to the various distributo­rs, wholesaler­s and retailers around the world—is often impossible, says Brad Pace, who directs the FDA’S division of nonprescri­ption drugs and health fraud. His group has had some success. In 2011, Kelly Harvey, the

owner of Novacare, which sold tainted sexual enhancemen­t and weight loss supplement­s, pleaded guilty to six felony counts related to the products and received a 36-month prison sentence. And in 2016, following 29 consumer warnings and recalls in 2010, a federal judge sentenced Gustavo Barni, who owns Atlas Operations, a supplement supplier, to six months in prison for fraud.

But as soon as one company is caught, another replaces it. “It’s just a cat-and-mouse game,” says Dr. Pieter Cohen, an internist at Cambridge Health Alliance who has researched tainted supplement­s extensivel­y. In November 2017, the FDA issued consumer warnings about more than a dozen of these products, and a settlement in March forced yet another company to test its supplement­s before making more of them. A pilot program to check packages arriving at internatio­nal mail facilities for suspicious goods found 119 products with sexual enhancemen­t claims on the label, 95 of which contained an undeclared active ingredient.

Generic sildenafil, which came on the market in December 2017, might put a dent in counterfei­t sales. The more affordable price tag—$25 per pill versus about $70 for Viagra— could help consumers avoid shadier supplement­s. And with these legitimate pills, the active ingredient is easy to identify. Just look at the label.

The little blue pill known as Viagra, left, has transforme­d physical intimacy for many men, becoming a cultural phenomenon in the process.
BRINGING SEXY BACK The little blue pill known as Viagra, left, has transforme­d physical intimacy for many men, becoming a cultural phenomenon in the process.

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