Modern medicines have revolutionized the way doctors treat patients, increased life expectancy, and, for many, improved the quality of life. Pharmaceuticals are a multi-billion dollar business, and criminal elements are trying to cash in with often-deadly consequences. VOA Jim Bertel takes a closer look at the growing problem of counterfeit drugs.
The World Health Organization calls counterfeit drugs the silent epidemic, preying on the sick and denying patients therapies that can alleviate suffering and save lives.
Counterfeit drugs -- like counterfeit money -- are difficult for even the most highly trained medical professionals to distinguish from the real thing.
"They look the same, the packaging is the same, the bottle is the same, the texture of the pill can even be similar" said Randall Lutter, an Associate Commissioner at the U.S. Food and Drug Administration, the government agency charged with safeguarding medicines in the United States, and Co-Chairs the FDA's Counterfeit Drug Task Force. He says the criminal elements behind fake drugs are motivated by one thing.
"Money. Somebody is making money off of selling the counterfeit drug. And as a result of that economic incentive, somebody's making money at the expense of the patient's pocketbook, but more importantly at the expense of the patient's health."
The WHO estimates 10 percent of pharmaceuticals worldwide are fake. In wealthier countries the most frequently counterfeited drugs are expensive lifestyle medicines such as allergy medications. In the developing world, counterfeiters target drugs used to treat life-threatening conditions like malaria.
The risks to the unsuspecting patient are great: Fake drugs offer little or no medicinal benefit or, in the most extreme cases, prove deadly. "But since deceit is involved you can never tell if it is going to be a little pain, if it is going to be no effect, or if it is going to kill you" said James Class. who is with the Pharmaceutical Research and Manufacturers Association.
He is also Executive Director of the Partnership for Safe Medicine, an international coalition committed to protecting the public from counterfeit medicines. He says since these counterfeit drugs flow through the black market it is difficult to trace their source. But most experts agree criminals in India and China are behind much of the fake drug trade. Class says China has taken steps to rein in these illegal activities, but India may not be regulating its export drug industry.
"There has been a number of outspoken advocates, especially Nigerian Health regulator Dora Akunyili, who believe the main problem is that India allows exported drugs, drugs that are designed for export, to leave the country without going through a regulatory system.
A number of developing countries have taken steps to combat counterfeit drugs, including Uganda, which set up strict rules for the importation of medicine.
Apollo Muhairwe, Executive Secretary of Uganda's National Drug Authority, says his agency is charged with ensuring only safe, quality medicines are available in his country. "We do this through drug registration, through inspecting sites, through quality control at the laboratory and also at the ports of entry."
But without global regulation and enforcement, the safety and quality of medicines in many developing countries cannot be guaranteed. The World Health Organization has created an international task force to try to coordinate various efforts around the world. But with counterfeiters utilizing increasingly sophisticated technology, many experts believe it will be difficult to stop counterfeiters from exploiting the ill.