Feb. 15, 2012 -- Cancer patients are furious that a counterfeit version of the drug Avastin has landed in U.S. clinics.
Avastin, which is made by the California-based company Genentech, is used in combination with chemotherapy to treat cancers of the colon, brain, kidneys and lungs. But the counterfeit lacks the tumor-starving ingredient some patients need to survive.
"It's an outrage," said Diane Barraza, 48, who takes Avastin for stage IV colon cancer. "For a company to sell this drug, put it in our blood, it's an outrage."
The U.S. Food and Drug Administration announced Tuesday that 19 clinics in California, Texas and Illinois may have purchased the phony Avastin from Quality Specialty Products, an "unapproved" foreign supplier also known as Montana Health Care Solutions. The counterfeit vials are labeled "Avastin" but indicate "Roche" as the manufacturer. Roche is the parent company of Genentech.
"The counterfeit contains no Avastin, no generic Avastin, no active ingredient whatsoever," Genentech spokesman Ed Lang told ABC News. Lang said the contents of the vials are still under investigation.
For patients like Barraza, a fake cancer drug would be the cruelest con.
"To sit in the chemo chair and watch that stuff drop into my veins," said an emotional Barraza, who lives in Fullerton, Calif., with her 6-year-old daughter. "It's all I've got. And it might just be water?"
Avastin is expensive, costing upwards of $650 for a small vial. But Montana Health Care Solutions sold the counterfeit vial for $480, according to one of the clinics -- a cost savings of 25 percent.
"Obviously it makes good business sense to try to get the drug at a reduced cost," said Dr. Jack Jacoub, a medical oncologist at Orange Coast Memorial Medical Center in Fountain Valley, Calif. "But when you start to get drug pricing that's markedly different from that of the standard distributor, it should raise a red flag."
Only four U.S. distributors are authorized to sell Avastin to doctor's offices; another four can sell the drug wholesale to hospitals. Montana Health Care Solutions is not an authorized Avastin distributor. Jacoub, who treats Barraza, said his clinic buys Avastin in bulk from an approved distributor for $593.20.
Montana Health Care Solutions claimed to be based in Belgrade, Mont. But the company's recently disconnected phone number has a New Brunswick, Canada, area code. It's unknown whether Montana Health Care Solutions knew the Avastin was counterfeit. They also sold other cancer drugs, including Neulasta and Faslodex, at a significantly discounted price.
The FDA was alerted to the possible counterfeit in December 2011 by the Medicines and Healthcare Products Regulatory Agency in the U.K., according to Genentech's Lang. In a Feb. 10 letter, the agency urged the 19 clinics known to have purchased through unapproved distributors to "retain and secure" any unused drugs. The counterfeit Avastin vials have the lot numbers B86017, B6011, B6010, and the labels are slightly different.
Counterfeit or illegally imported drugs are rare in the U.S. but not unheard of. In 2008, heparin (a blood thinner) imported from China killed 81 Americans.
"Counterfeit drug makers have reached a level of sophistication where the real and fake products look almost identical," said Peter Pitts, president of the Center for Medicine in the Public Interest and former associate commissioner for the FDA. Pitts estimated that counterfeit drugs generated $75 billion in 2010, a figure expected to grow by 20 percent annually. "It's a low risk, high reward proposition. It's almost a perfect crime -- people aren't getting the drugs they need and they end up dying."
For Barraza, who will have four more Avastin treatments over the next two months, the thought of criminals profiting from her disease is sickening.
"I wish they could understand what it feels like to be a cancer patient, to take a drug and to suffer," she said. "I'd do anything to stay alive, but I need the right medication."