First appeared in Associated Press
The discovery that a fake version of the widely used cancermedicine Avastin is circulating in the United States is raising new fears thatthe multibillion-dollar drug-counterfeiting trade is increasingly makinginroads in the U.S.
The criminal practice has largely been relegated to poorcountries with lax regulations. But with more medicines and drug ingredientsfor sale in the U.S. being manufactured overseas, American authorities areafraid more counterfeits will find their way into this country, puttingpatients’ lives at risk.
The Avastin discovery follows other recent instances in theU.S. of counterfeiting, involving such drugs as Viagra, the cholesterolmedicine Lipitor and the weight-loss pill Alli.
“We do know there are counterfeits continuing to tryand make their way onto the U.S. supply chain,” said Connie Jung, anassociate director in the Food and Drug Administration’s office of drugsecurity.
The FDA announced Tuesday it is investigating fake vials ofAvastin that were sold to at least 19 doctors and clinics, including 16 sitesin California, two in Texas and one in Chicago. Tests showed the vials did notcontain the active ingredient in Avastin, which is given intravenously inhospitals, clinics and doctors’ offices to treat several types of cancer.
The contents of the vials are still being analyzed, and theFDA said it has not received any reports of patients who were harmed.
FDA officials said the counterfeit Avastin was imported fromBritain and distributed by Volunteer Distribution, a wholesaler based inGainesboro, Tenn. British regulators notified the FDA about the products inDecember, but the agency didn’t confirm they were fake until last week.
The FDA gave assurances Wednesday that the U.S. remains oneof the most secure pharmaceutical markets in the world. But the news sentcancer doctors scrambling to check their records.
Mary Mathias, a nurse who orders drugs for one doctor on theFDA list – Dr. Phillip L. Chatham in Granada Hills, Calif., – said they hadstopped using the company in question at least a year ago.
Because Avastin treatments are spaced one to two weeksapart, it is not likely that someone would get more than one infusion from thesame vial. And because these are people facing a life-threatening disease, itis hard to say whether missing one treatment with the real drug wouldcompromise their care.
Gauging harm from a counterfeit cancer treatment is nearlyimpossible, said Dr. Robert C. Young, former president of the Fox Chase CancerCenter in Philadelphia and now a consultant to cancer centers.
A colon cancer patient, for example, might receive 18 to 20Avastin infusions over six months. Missing one dose seems unlikely to have adramatic effect on survival odds, but it’s not provable either way becausecancer’s course and a patient’s response to treatment are not predictable, hesaid.
Counterfeits have traditionally been more of a concern indeveloping regions like Asia and Latin America, where as many as 30 percent ofdrugs sold are fake, according to the World Health Organization. The groupestimates just 1 percent of drugs dispensed in the U.S. and other developednations are fake.
But incidents of counterfeiting reported by drugmakers haveincreased steadily over the decade to more than 1,700 worldwide last year,though only 6 percent of those were in the U.S. There are few reliableestimates on the value of the global counterfeit drug trade, though most placeit in the tens of billions.
Counterfeiting has become more prevalent as pharmaceuticalsupply chains increasingly stretch across continents. Over 80 percent of theactive ingredients used in U.S. pharmaceuticals are now manufactured overseas,according to a recent congressional report, and experts say this has made iteasier to move counterfeit products into this country.
“With today’s transportation networks, it’s no longer astretch to move these materials from a source in Pakistan or India to theU.S.” said Tom Kubic, president of Pharmaceutical Security Institute, atrade association set up by two dozen pharmaceutical companies.
In 2005, federal prosecutors indicted 11 employees of aMissouri business on charges of conspiring to sell $ 42 million in counterfeitLipitor. It was manufactured in Costa Rica and illegally imported to the U.S.,where it was sold to wholesalers.
Industry experts also say a combination of big profits andlow penalties has made drug counterfeiting an increasingly attractive businessfor criminals in the U.S. and abroad.
A single vial of Avastin sells for $ 2,400, and the drug hadnearly $ 2.7 billion in U.S. sales last year, while the sentence for drugcounterfeiting in the United States is about three years in prison. Thatcompares with 15 years for counterfeiting money.
John Clark, head of global security for Pfizer Inc., saidcounterfeiters can make several million dollars quickly and, if they’re caught,get off with as little as six months in jail. He also said counterfeiters canset 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’sworth a gamble,” Clark said.
Clark said Pfizer’s anti-counterfeiting team around theworld has seen a number of fake vaccines and biologic drugs sold in developingcountries, not just pill-based drugs.
“They’re getting much more sophisticated,” oftengetting ahold of legitimate vials that had held such medicines, from patients,trash cans or recycling operations, and then filling them with oil or water.