No Shortcuts to Health and Safety: The Threat of Counterfeit Drugs …

By Bryan A. Liang, MD, PhD
Professor of Law, California Western School of Law
Executive Director, Institute of Health Law Studies
Co-Director & Adjunct Associate Professor of Anesthesiology, San Diego Center for Patient Safety, University of California, San Diego School of Medicine

(Originally published in the San Diego County Bar Association’s publication, San Diego Lawyer Magazine)

Recently, the AMA (American Medical Association) House of Delegates approved of the importation of prescription drugs … given “appropriate safeguards.” In part, this announcement was supported by an AMA survey that found that roughly half of physicians support some form of drug importation and by concern regarding the high cost of medicines in the United States. Although supporting affordable medicines for patients is important, importation from Canada and other countries poses significant risks for patients: most importantly, counterfeit drugs and its negative sequelae.

Counterfeit medications have been identified in virtually every country in this hemisphere and around the world. Importantly for San Diego, the FDA confirmed that a number of drugs purchased by U.S. citizens in Mexico were counterfeit, and issued a warning that the influx of fake medicines into the United States represented a means by which terrorists could attack Americans.

Counterfeit drugs encompass virtually every category, including AIDS therapies, over-the-counter pain medications, antibiotics, insulin, cholesterol drugs, Viagra, cancer drugs, anti-arthritis medicines, cardiac drugs, and antihistamines. A vast majority of these fake medicines have no or low amounts of active ingredient or, even worse, have the wrong ingredients that can prove harmful. Indeed, some injectable counterfeit medications have been found to contain water laced with bacteria, creating a significant risk of life-threatening sepsis, particularly in immuno-compromised patients, such as those with AIDS, those undergoing chemotherapy, such as cancer patients, and the elderly.

The reason why counterfeit medications abound is simple: money. While it is difficult to obtain exact figures, it is estimated that counterfeit drug sales worldwide represent at least $32 billion annually — almost $88 million a day. Perhaps not so obvious is that much of the fake production comes from countries in Latin America, traditionally the source of illegal drugs such as cocaine and heroin. Because of significant efforts in these countries to control illegal drug production, which carry stiff prison terms, drug lords and others have shifted to producing counterfeit “legitimate” medicines, which are much cheaper to make and carry light penalties — with much higher profits and low downside risks.

Purchasing from Canada is not a panacea to avoiding fake drugs. Drugs from Canada, if not earmarked for Canadian citizens, are not subject to the country’s drug safety laws. As noted by a representative from Health Canada, Canada is becoming the world’s “drug post office box.” Shipments arrive in Canada from countries such as Belize, Pakistan, Romania, Bulgaria, Turkey, and Thailand, which have significant quality problems and are known sources of fake drugs; these drugs are en route to unsuspecting consumers who believe they are purchasing from Canadian sources that are subject to Canadian safety requirements and oversight.

Internet pharmacies are even worse. Unscrupulous businesses using Canadian and U.S. flags tout drugs on the World Wide Web with little or no connection to either country, ask virtually no medical information, require no prescription, and are willing to sell to anyone with a credit card.

The insidious danger for providers is that often patients who are vulnerable and victims of fake drugs are difficult to identify clinically. The art of medicine requires us to take into account potential side effects, progression of disease, and the fact that some therapies work better at some times than at others. Hence, the presence of a change in clinical characteristics of a patient may not imply in a clinician’s mind the presence of counterfeit medicines unless a high level of suspicion and vigilance is maintained. But, in a world of fake drugs, Internet pharmacies, and unscrupulous businesses, we must maintain that suspicion and educate our patients about it.

For the patients in this country, we need safe, affordable medicines, not imported medicines. A drug that is FDA approved, purchased from a licensed U.S. provider, and that is subject to U.S. safety laws and oversight is quite different from an imported drug with a questionable pedigree and unknown therapeutic content that is not subject to safety requirements. Affordable medicines is a laudable goal; but let us not be seduced by rhetoric that short cuts our patients’ health and safety.