FDA Warns California Clinics of Fake Avastin

By Kamal Menghrajani

A counterfeit version of the cancer drug Avastin may have made its way into clinics here in California. The medicine is used to treat colon, lung, and other cancers, but several physicians may have unwittingly been giving patients a useless knock-off.

You may remember Avastin because it was considered a blockbuster drug for breast cancer treatment. That was until November of last year, when the Food and Drug Administration (FDA) pulled its approval for treating the disease. However, Avastin is still widely used for other types of cancer.

Earlier this month, the FDA sent letters to 19 doctors around the country warning that they may have fake Avastin. Sixteen of these physicians are here in California, all of them in Southern California.

The FDA says these clinics purchased the medicine from a foreign supplier under the names "Quality Specialty Products" or "Montana Health Care Solutions." Volunteer Distribution, a company based in Tennessee, funneled the fake vials out to clinics. The company was not licensed by drugmaker Genentech to provide Avastin, and some doctors’ offices were fooled.

“I think we’re all shaken up by it. This isn’t like Viagra – this is life and death when you’re dealing with cancer,” said Tracey Butler, Director of Operations for the Beverly Hills Cancer Center, which received the FDA warning. “We’re in this business so that we can find a cure for cancer, so to think that somebody out there would harm that, is very disturbing.”

Despite having had a past contract with Montana Health Care Solutions, Butler’s clinic did not have the counterfeit Avastin. “We looked through our stocks as soon as the FDA notified us about a month ago and we had nothing from them.”

Calls to Volunteer Distribution went unanswered. Nobody at the Gainesboro, Tennessee company answered the phone when we called.

Andrew Selesnick is a lawyer who represents one of the doctors who received a letter from the FDA. Until this incident, he told me, “I don’t think [doctors] looked at this as an issue to be concerned about, but now I think a lot of physicians are looking at their drug purchasing protocol in a different light.”

“It’s a low person who would replace a cancer-fighting drug with a counterfeit,” he added.

Genentech has been analyzing the counterfeits to determine what is in the vials. Charlotte Arnold, a spokesperson for the company said, “We do know that it doesn’t have the active ingredient for Avastin or any biologic effective for treating cancer,” she said. “We do know that there’s not anti-cancer medicine in there. … It’s not safe or effective and should not be used.”

She says counterfeiting may not be restricted to Avastin, as the FDA is currently investigating whether other fake anti-cancer drugs are circulating in the U.S. “The FDA issued a notice [PDF] in January that mentioned Rituxin and Herceptin, but there was no confirmed counterfeit, as there was in this case."