Terrorism and Viagra?

Shocking. Horrifying. Eye opening. These words crossed our minds as we left the 2nd Annual San Diego Health Policy Conference, which was sponsored by the Institute of Health Law Studies at the California Western School of Law.

The all-day seminar commenced with several distinguished speakers: Bryan Liang, MD, PhD, and JD, the executive director and professor of law at the Institute of Health Law Studies; the assistant director of the counterterrorism division of the FBI; the head of the Pharmaceutical Security Institute; an investigative reporter; a special agent with Immigration and Customs of the Department of Homeland Security; a representative of Global Security at Pfizer; and, finally, the CEO of the UK Centre for Mental Health.

The topic of discussion at the event was counterfeiting — no, not money, but drugs; specifically, medicinal drugs sold over the Internet.

As the key note speakers explained, these counterfeit medicines have become a more profitable and lucrative industry than narcotics. The current penalties for these criminals, if caught, are very light as opposed to those pertaining to illegal d rugs (ranging anywhere from six months to one year). There have been reports that profits from the counterfeit-medicines trade have been linked to organized crime and terrorist groups, including Hezbollah.

How do these fake drugs get into the market place and to the unwary consumer? As Dr. Liang explained, the Internet “allows virtually unreachable illicit sales (of drugs) using international criminal cooperation.”

In San Diego alone, there have been numerous seizures and arrests of individuals involved in this trade. Recently, misbranded Indian (the country of India) pharmaceuticals, worth more than $20 million, were seized from several San Diego warehouses. In 2004, $40 million in counterfeit Viagra was seized at a San Diego warehouse. These drugs were destined for Tijuana pharmacies, which would have been eventually sold them to U.S., Mexican, and other international consumers.

The Pharmaceutical Security Institute reported during the conference that in a recent sting operation they discovered a ‘small’ operation involving the manufacture of counterfeit drugs. The equipment seized created 200,000 tablets in five hours; all told, this resulted in the shipment of 1.3 million phony tablets in a mere 6.5 days of illegal operations. In this ‘small’ criminal endeavor, twenty branded products were discovered to have been manufactured; they matched in color, size and shape to the original medicine so perfectly that, to the average consumer, it would have been nearly impossible to detect any difference. Unfortunately for the unknowing purchaser, there were no active pharmaceutical ingredients found.

How do these drugs get into the hands of U.S. consumers? The answer: cruise ship passengers, international malls, pharmacies in Mexico and Canada, and, of course, the Internet.

The therapeutic category which is most often copied, stolen or diverted is that for genitourinary medicines (e.g., Viagra), followed by antibiotics and CNS/mental health drugs. Not only are the actual products fabricated with no active ingredient (ingredients range from starch to paper to dry wall compounds), but the packaging is printed to perfectly match the original.

Perhaps the most frightening statistic was presented by the Fraud Prevention Institute. In accordance with the FDA/U.S. Customs, FPI agrees that the Internet and the International drug imports are comprised of approximately 88% counterfeit products, and should be avoided at all costs. Many of these drugs were destined for wholesale distributors and retail pharmacies to be dispensed to the general public.

Why should we, as healthcare practitioners, be concerned about this alarming trend? It’s quite simple: we do not want our patients to suffer needlessly, or, at worse, die from medicines which are prescribed to help them. Keep in mind that these counterfeit drugs not only result in the ingestion of fraudulent ingredients, but they also deprive their recipients of physician-prescribed medication!

In 2005, Kunio Mikuriya from the World Customs Organization stated: “The fastest growing patient safety threat from counterfeit medicines is through online sales to individual patients.”

What can we do? Simple. Educate our patients about the risks of buying online medicines from pharmacies in cities in Europe, Canada, Mexico, and other international destinations. If they suspect their medicines are not providing the desired effects, they should report the finding immediately so as to prevent other consumers from purchasing the counterfeit drugs. There is no doubt there are some online outlets which are legitimate, but as Jim Thomson, CEO of the UK Centre for Mental Health explained, “… many more are not.” Sadly, because of a complex chain of ‘secondary purchases’ by U.S.-based pharmacies (even major-league pharmacies will often purchase medicines from the lowest bidder), even local drug stores and American Internet pharmacy organizations may be unwitting partners in the criminal enterprise of counterfeit drugs.

Thus, doctors beware!