01:00 AM EDT on Tuesday, September 21, 2004

SAN DIEGO

COUNTERFEIT medications have been identified in virtually every country. Last month, the U.S. Food and Drug Administration confirmed that a number of drugs purchased by U.S. citizens in Mexico were counterfeit, and issued a warning that the influx of bogus medicines into the United States represented a means by which terrorists could attack Americans.

Internet drug sales, sometimes with advertisements using Canadian and U.S. flags but selling drugs from other countries, have contributed to the problem. Unsuspecting patients who have taken counterfeit drugs purchased online have not received the benefit of treatment. Some have been harmed -- and a number killed.

Up to 20 percent of the drugs sold in some industrialized countries and up to a staggering 60 percent sold in developing countries might be counterfeit. This is not a problem limited to Third World countries; phony medications have recently made dramatic inroads in industrialized nations, including the United States.

Counterfeit drugs encompass almost 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 ingredients, which prevents the patient from being effectively treated, or, even worse, they have the wrong ingredients, which can hurt the patient.

Some of these counterfeit medications contain water laced with bacteria, creating a significant risk of life-threatening infection, particularly for those with weakened immune systems, such as AIDS and cancer patients, and the elderly.

Counterfeit medications abound because of the usual reason: money. While it is difficult to obtain exact figures, it is estimated that counterfeit-drug sales worldwide represent at least $32 billion annually. Perhaps not so obvious is that much of the fake production comes from Latin America, traditionally the source of such illegal drugs as cocaine and heroin.

In an unanticipated result of Latin American countries' cracking down on illegal-drug production, counterfeit medications have become more lucrative than illegal drugs. They are cheap to make and easy to sell to unsuspecting pharmacies, hospitals and government health agencies, because they appear legal. They can be sold domestically and for export, where they can be resold "legitimately." Or they can be sold on the black market, at much lower prices.

These activities prey upon the poor, who cannot afford drugs from traditional outlets, or on unsuspecting patients. And, while a drug lord in America can be imprisoned for 10 to 15 years for illegal-drug production, he may be out on bail within a few days, and in the end serve only six months in prison, for producing fake medicines.

These conditions have resulted in a significant increase in counterfeit-medicine production and sales from Latin America.

Solutions include using technology to monitor drug authenticity, stronger drug-regulation laws, and greater international collaboration. However, implementing these efforts is years away.

Both the Food and Drug Administration and the World Health Orgnization recommend doing a better job of educating consumers about the risk of counterfeit medications.

Consumers should suspect any medicines that do not come from such traditional outlets as well-established pharmacies, particularly if they are purchased on the Internet. Moreover, consumers should always note whether the drugs they are taking have a different effect from what they have previously experienced, and if so, immediately report them to their health-care providers.

Drug providers should be educated about the possibility of counterfeit medications, and be encouraged to suspect new suppliers with significantly cheaper prices. The providers should also warn patients about the potential for counterfeit medicines and encourage them to report medication effects different from what they have previously experienced.

Finally, providers and patients should work closely with law-enforcement personnel to monitor drug supplies and possible counterfeit medications.

Legitimately produced and distributed drugs save lives, reduce suffering, and improve quality of life. But these benefits accrue only if the drugs sold are what their sellers claim them to be. Consumers, providers and governments around the world must work together to ensure that the benefits of drugs go to those who need them -- not to terrorists or drug lords who seek to exploit the sick and vulnerable for their own nefarious gains.

Bryan A. Liang is a professor at California Western School of Law in San Diego, where he is executive director of the Institute of Health Law Studies.