The Illicit Sale of Medications for the Treatment of Erectile Dysfunction

Philip J. Dorsey, Jr; Wayne J.G. Hellstrom, MD, FACS

Disclosures

Medscape Urology 

In This Article

Counterfeit Medications: A Global Problem

The mass production of fake and substandard medications is a growing global problem with the potential for significant deleterious impact on the individuals who ingest them. In the United States alone, the number of FDA investigations of drug fraud in 2004 was almost 10 times the number in 2000.[6] Although the FDA estimates that the percentage of counterfeit medications in the legitimate distribution network in the United States is <1%, their report suggests that the industry is growing more organized and complex.[6] They describe counterfeiters as "well-organized criminal operations that seek to introduce finished drug products that may closely resemble legitimate medications yet may only contain inactive ingredients, incorrect ingredients, improper doses, subpotent or super-potent ingredients, or may be contaminated."[6]

Estimates of the scale of the global trade in counterfeit medications vary widely. According to the FDA, 6% to 10% of medicines sold worldwide are counterfeit.[7,8] Other published reports give estimates of counterfeit sales of approximately 15% of drugs sold in developed countries, and up to 50% in parts of Africa and Asia.[8] This would translate into annual sales exceeding US$35 billion worldwide.[8]

This growing market of counterfeit medications has resulted in an increasing number of deaths in the past 2 decades. Most notably, in Nigeria in 1990, cough mixture diluted with a poisonous solvent caused the death of 100 children, and in India in 1998, diethylene glycol poisoning led to the death of 30 children.

Counterfeit Medications in the US Drug Supply

It is estimated that counterfeit drug sales in the United States alone will reach $75 billion by 2010, up from $39 billion in 2005.[7] In the United States, counterfeiters generally target the most popular and expensive medications. These counterfeits are increasingly finding their way into the legitimate supply network.[8] For example, in May 2002, thousands of vials of Procrit (epoetin) (retail $2176.98 for 4 vials, 1 mL)[9] labeled as containing 40,000 units/mL were found to contain only 2000 units/mL. In 2003, the FDA discovered 3 lots of counterfeit Combivir (retail $371.14 for 30 pills).[9] In the same year, the discovery of counterfeit versions of Lipitor (retail $109 for 30 pills)[9] in the supply chain prompted the manufacturer to recall 200,000 containers of the medication to prevent the risk of patient exposure.

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