Campaign Mounts to Curb Counterfeit Drugs

Import controls and risk strategies aim to promote quality and spur new drug development.
Sep 02, 2012
Volume 36, Issue 9

Jill Wechsler
Drug counterfeiting has become big business for international criminals, lured by easy profits and relatively low risk of prosecution and penalties. Analysts calculate that counterfeit drugs cause 100,000 deaths worldwide each year and provide approximately $75 billion in revenue for illegal operators. Distribution of phony medicines has become such a global public health threat that it made the agenda of the Group of Eight (G8) world leaders at their May 2012 annual meeting. G8's concluding declaration supported exchange of information on rogue Internet pharmacy sites and on methods to combat counterfeit medical products.

The Chinese government is looking to counter its reputation as the lead global source of fake and adulterated medicines by cracking down on counterfeiters of drugs and healthcare products. In a raid last month, some 18,000 law officers detained nearly 2000 suspects and seized approximately $182 million in illegal remedies for diabetes, high blood pressure, cancer, and other conditions. Unfortunately, a similar effort in 2011 led to the arrest of 114 suspects and seizure of $30 million in bogus products, but that apparently did not deter the counterfeiters.

An EU report on customs enforcement in 2011 states that medicines accounted for the most (i.e., 24%) of detained articles. The document notes that counterfeit drug enforcement units broke up rings in Spain and the UK and uncovered fake HIV medications and unauthorized asthma drug inhalers. Counterfeiters no longer focus just on "lifestyle" drugs for erectile dysfunction and weight-loss, but market medicines for a range of serious conditions.

More opportunities

Despite more active anticounterfeiting efforts, shortages of key medicines in the US and Europe have created new opportunities for illicit traders, while ever-longer manufacturer supply chains open the door to diversion and theft. In the past two years, FDA has uncovered Internet sales of counterfeit Abbott pain medicine Vicodin, fake Phentermine tablets, and a phony version of the "morning after pill" called Evital.

In May, FDA warned consumers and health professionals that Internet operators were selling counterfeit versions of Teva Pharmaceutical's Adderall (amphetamine and dextroamphetamine). Severe shortages of the short-acting treatment for attention deficit hyperactivity disorder prompted patients to seek new sources, but many of these products either lack active ingredient or contain dangerous substances.

Patients and physicians also are attracted to unknown suppliers by lower prices, as seen in the wave of counterfeit Avastin (bevacizumab), Roche's cancer therapy, which was purchased by dozens of US oncologists. FDA continued to uncover sales of the counterfeit product, in some cases under Avastin's Turkish brand name, Altuzan, despite widely published warnings in February that the phony vials lacked the key active ingredient. FDA has sent letters to more than 70 doctors and clinics in 28 states warning against purchasing the illegal product and launched a major investigation of alleged distributor Canada Drugs and other parties (1). Several online pharmacy operators were arrested, along with importers and distributors.

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