Internet-marketed medication purporting to be a generic form of the phosphodiesterase type-5 inhibitor Viagra (sildenafil citrate) is likely to be neither generic nor Viagra but instead is an expertly packaged mix of materials such as paint, insecticides, rat poisons, boric acid, and gypsum, according to a study presented at the AUA annual meeting in Atlanta.
"The patent for sildenafil 25, 50, and 100 mg for treatment of erectile dysfunction is still in effect. There is no such thing as generic Viagra for erectile dysfunction, but it is illegally advertised as such all over the Internet," said senior author Irwin Goldstein, MD, director of sexual medicine at Alvarado Hospital, San Diego and clinical professor of surgery at the University of California at San Diego. (A Urology Times Google search of the term 'generic Viagra' yielded more than 50 million hits.)
The ready availability of counterfeit Viagra masquerading as a generic product and the apparent eagerness of consumers to acquire inexpensive drugs during a recession is a real and growing health problem, Dr. Goldstein told Urology Times.
He noted several harms that could be associated with the drugs. The agents, produced and packaged to look exactly like their legitimate counterparts, are often contaminated with health-threatening agents such as boric acid and rat poison. Deaths and serious illnesses have been reported from use of these counterfeit agents. The counterfeit Viagra pills provide little to no clinical benefits when clinical benefits may indeed be needed. In addition, erectile dysfunction can be a symptom of underlying disease that continues to be undiagnosed and untreated as long as men are self-medicating.
The pills, some of which may contain lower doses of some active ingredients, are ingested without instruction. PDE-5 inhibitors are contraindicated in men taking nitrates, but the warning never appears on or in counterfeit Viagra packaging.
"The conditions under which these drugs are made are unbelievable. The contents of a specific drug may well depend upon what was being made earlier that day," Dr. Goldstein said, noting that the drugs have been found to be compounded in filth-encrusted bathrooms, basements, and construction sites where concrete mixers that churn plaster by day are used to mix counterfeit drugs at night.
The study, whose data were acquired by Pfizer Global Security, looked at Viagra purchased from 22 Web sites during 4 days in March 2011. The pills cost as little as $3.28 and as much as $33. (The average prescription dose of Viagra costs around $20.) None of the Web sites required a prescription. Postal origins of the pills included Hong Kong, the U.S., Canada, China, and India.
Although chemical analysis showed the vast majority (80%) of the pills to be counterfeit, some 15% were found to be authentic Pfizer product and 4% had formulations close to the parent sildenafil molecule. On spectral analysis, the active pharmaceutical ingredients in the counterfeit medications ranged from 30% to 50% of that claimed on the packaging.
Dr. Goldstein explains that Pfizer Global Security is an entity created by the drug company to chase down and identify organizations that are marketing the phony agents. Counterfeit drugs constitute a substantial and growing cost to the pharmaceutical industry, and the U.S. Drug Enforcement Agency has been unable thus far to resolve the problem. Viagra is not the only drug to be counterfeited, but it is one that attracts a lot of attention from the buying public and is also one that is likely to be perceived as relatively safe by the public, according to Dr. Goldstein.
"Another side of this problem is the niche occupied by so-called herbal medications which are sold as a means of enhancing sexual function. Sildenafil, like many pharmaceutical products, is easy to make. These people are adding counterfeit Viagra to their 'natural' products without telling the public.
"It is paradoxical. When you order Viagra [online], you don't get real sildenafil in correct doses and get many other products, such as gypsum and rat poison, that you do not want. When you order horny goat weed (a Chinese herb), you might actually be getting some sildenafil, even though this is not found on the label, so if you are taking nitrates you will not be warned," Dr. Goldstein said.
Pfizer has posted several YouTube videos regarding counterfeit Viagra (http://www.youtube.com/user/VIAGRA/). In one of them, interviewee Richard Boscovich of Microsoft's Digital Crimes Unit explains that purchasers of counterfeit drugs can be harmed in more ways than one. Not only do they get worthless and/or dangerous drugs, but also they are often giving their credit card numbers, names, e-mail addresses, telephone numbers, and a wealth of other personal information to individuals known to be criminals.