In Europe, profiteers masquerading as pharmacists are selling unsafe, unregulated, mislabeled, repackaged, and commingled drugs to unsuspecting consumers, through a process known as parallel trade, or reimportation.
In August 2004, for example, counterfeit medicines were found in the legitimate British supply chain after a patient complained about a crumbling tablet. The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued an immediate alert. Days later, the MHRA had to issue another alert after a different counterfeit medicine was found in Britain’s legitimate supply chain.
Drug Sources Unknown
Last year, 140 million individual drug packages were parallel-imported (imported by a wholesaler, repackaged, and then exported) throughout the European Union, and each and every one was repackaged by a wholesaler.
“The increasing flow of counterfeit drugs represents a significant public health threat,” Dr. Scott Gottlieb, deputy commissioner for medical and scientific affairs for the U.S. Food and Drug Administration, said at a September 20 conference in Washington, DC sponsored by the Center for Medicines in the Public Interest (CMPI) and the Pacific Research Institute (PRI). “We must step up our efforts to safeguard the drug supply–we certainly should not weaken those controls.”
As a result of internal European Union trade, drugs purchased from a British pharmacy by an unknowing American consumer could come from EU nations such as Greece, Latvia, Poland, Malta, Cyprus, or Estonia. In fact, parallel traded (reimported) medicines account for about 20 percent of all prescriptions filled by British pharmacies.
“Anyone who institutionalizes this kind of activity at the state level by setting up or signing up to state-sponsored online pharmacy schemes, does not know where those drugs are coming from,” said Jim Thomson, CEO of the UK Centre for Mental Health, at the CMPI/PRI meeting. “They do not know that they are genuine, because some of them are coming from my country, and we don’t know,” he said.
Internet Ordering Easy, Dangerous
Thomson recounted the case of a young man in the UK who had schizophrenia and chose to treat himself. At one point, he was receiving 300 antidepressant pills a day through the mail, said Thomson. The 24-year-old tried 23 prescription drugs on his own before he overdosed.
Thomson and some of his Centre for Mental Health colleagues, masquerading as a single patient, successfully bought drugs online even though they did not have a prescription, and even though they admitted on a questionnaire that the fictional patient had a preexisting diabetic condition and had repeatedly self-harmed and attempted suicide. They were still able to order methadone over the Internet.
On September 8, 11 Chinese citizens and an American man were arrested in a counterfeit medicine scheme that spanned 11 countries and involved millions of dollars’ worth of fake drugs. Chinese police seized 440,000 fake pills in the eastern port city of Tianjin and two cities in central Henan province, and they arrested 11 men between August 1 and September 2 as a result of the investigation.
One American was involved in the illegal trafficking ring. Richard Cowley, a Washington state resident, was charged with importing and distributing counterfeit goods. The seized drugs, worth $4.3 million, included the male sexual dysfunction drugs Viagra, Cialis, and Levitra.
— Peter Pitts