US Pharm. 2010;35(12):3. 

Now that the hoopla and celebrations over the midterm election results are quickly fading, Congress, with its newly elected members, will soon have to get down to the serious and daunting tasks of fixing the economy, reducing unemployment, exploring defense spending, and paying more attention to health care in the United States. While the provisions of the original health care bill will continue to be hotly debated, there is another health care crisis in the U.S. and other countries that has been growing exponentially for more than a quarter of a century and that seems to get little or no political attention.

According to the World Health Organization (WHO), the appearance of counterfeit medicines in international commerce was first mentioned as a problem at a WHO conference in Kenya in 1985. The proliferation of fake drugs is so widespread that no organization or business analyst can accurately predict the value of this trade to the counterfeiters or the number of lives it has affected; but by some estimates, 10% of all global drug sales are counterfeit, with some observers saying the total could be as high as 25%. And fake drugs put some $75 billion into the pockets of their distributors. While the pundits may argue over the actual figures, one thing virtually all of them agree on is that the widespread use of the Internet is the fuel powering the enormous growth in the distribution of counterfeit drugs worldwide. The WHO estimates that 50% of all medicines sold online are counterfeit. According to the Pharmaceutical Security Institute, last year nearly 1,700 incidents of counterfeit drugs were reported, triple the number in 2004.

The counterfeiters apparently spare no therapeutic category. The WHO reports that 60% of all the counterfeit drugs are manufactured to treat the most popular therapeutic categories, including antibiotics, hormones, analgesics, steroids, and antihistamines. Most recently, counterfeit drugs have popped up in very unlikely products as well. For example, the FDA recently reported that counterfeiters have infiltrated the surgical mesh market. Surgical mesh is used to reinforce soft tissue during surgery. And this past summer, the FDA warned about fraudulent Tamiflu sold over the Internet as “generic tamiflu.” In this particular scam, the product did not contain Tamiflu's active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin. And as if that were not enough, earlier this year the FDA issued a warning about a counterfeit version of the OTC weight-loss product Alli 60-mg capsules (120-count refill pack). A favorite arena for selling this particular product was online auction sites.

To put the profitability of fake drugs into perspective, an associate director for global security at Pfizer in Europe reports that the profit margin from counterfeit Viagra is some 10 times higher than that of the street drug heroin. A former FBI agent is quoted as saying, “Instead of punching out ecstasy tablets, counterfeiters can reload pill-producing machinery and make Lipitor.” At a recent drug seizure in Istanbul, investigators nabbed 700,000 fake Viagra pills alongside 51 kg of heroin.

It is estimated that the number of lives taken by counterfeit drugs could be as high as a million worldwide. For this reason, it is incumbent on pharmacists to continue warning their patients about the risks of buying drugs on the Internet and to be vigilant about checking the credibility of their suppliers. Fake drugs are real and are not going away anytime soon. 

To comment on this article, contact