WASHINGTON (AP) — The discovery that a fake version of the widely used cancer medicine Avastin is circulating in the United States is raising new fears that the multibillion-dollar drug-counterfeiting trade is increasingly making inroads here.
The practice has largely been relegated to poor countries with lax regulations.
But with more medicines and drug ingredients for sale in the United States being manufactured overseas, American authorities are afraid more counterfeits will find their way into this country, putting patients' lives at risk.
The Avastin discovery follows other recent instances in the United States of counterfeiting, involving such drugs as Viagra, the cholesterol medicine Lipitor and the weight-loss pill Alli.
"We do know there are counterfeits continuing to try and make their way onto the U.S. supply chain," said Connie Jung, an associate director in the Food and Drug Administration's office of drug security.
The FDA announced last week that it is investigating fake vials of Avastin that were sold to at least 19 doctors or clinics. Tests showed the vials did not contain the active ingredient in Avastin, which is given intravenously in hospitals, clinics and doctors' offices to treat several types of cancer.
The FDA gave assurances Wednesday that the United States remains one of the most secure pharmaceutical markets in the world. But the news sent cancer doctors scrambling to check their records.
A vial of Avastin could treat up to four people. But because the treatments are spaced one to two weeks apart, it is not likely that someone would get more than one infusion from the same vial. And because these are people facing a life-threatening disease, it is hard to say whether missing one treatment with the real drug would compromise their care.
Counterfeits have traditionally been more of a concern in developing regions such as Asia and Latin America, where as many as 30 percent of drugs sold are fake, according to the World Health Organization. The group estimates just 1 percent of drugs dispensed in the United States and other developed nations are fake.
Counterfeiting has become more prevalent as pharmaceutical supply chains increasingly stretch across continents. Over 80 percent of the active ingredients used in U.S. pharmaceuticals are now manufactured overseas, according to a recent congressional report, and experts say this has made it easier to move counterfeit products into this country.
Industry experts also say a combination of big profits and low penalties has made drug counterfeiting an increasingly attractive business for criminals in the United States and abroad.
John Clark, head of global security for Pfizer Inc., said counterfeiters can make several million dollars quickly and, if they are caught, get off with as little as six months in jail. He also said counterfeiters can set up an operation at a fairly low cost — perhaps $50,000, including about $20,000 for a pill press.
"It's a no-brainer for criminal organizations that it's worth a gamble," Clark said.
Copyright ©2012 Omaha World-Herald®. All rights reserved. This material may not be published, broadcast, rewritten, displayed or redistributed for any purpose without permission from the Omaha World-Herald.
