Counterfeit anti-cancer drug Avastin raises concerns

By Dr. Ananya Mandal, MDFeb 15 2012

The market is flooded with a counterfeit version of cancer drug Avastin worry doctors and patients. Injectable drugs have become increasingly attractive to counterfeiters, in part because they often fetch a higher price than regular pills.

The U.S. Food and Drug Administration said this week it notified 19 oncology practices they had purchased drugs from a supplier not approved by the agency, including a counterfeit version of Roche Holding AG's, Avastin, that did not contain the multibillion-dollar drug's active ingredient, bevacizumab. The FDA and Roche's Genentech division said on Wednesday they were still investigating how widely the fake medicine was distributed. They do not know how many patients might have been affected, or if anyone was harmed.

The FDA said the drugs came from an overseas supplier called Quality Specialty Products, which does business in the United States with a distributor identified as Montana Healthcare Solutions. Connie Jung of the FDA's Office of Drug Security said it was possible more practices could be involved. “Clinics need to know who they're buying their medicines from, they need to make sure they're buying them from legitimate sources, licensed sources in the United States,” she said.

Most of the doctors' offices contacted by the FDA are located in southern California, with one practice in Chicago and another in Corpus Christi, Texas. Several said they were scouring their inventories to see if they had any of the fake medicine and would monitor patients for any problems.

A list of expensive biotech medicines offered by Montana Healthcare Solutions and obtained by Reuters priced Avastin 400 mg vials for under $1900, compared with the nearly $2400 that Genentech charges in the United States. It listed Avastin under its Turkish brand name Altuzan. The list offered “lower-priced European alternatives” of products from Amgen Inc, Eli Lilly and Co, Celgene Corp and Novartis AG. The company did not return telephone calls by Reuters Health or e-mails seeking comment.

The FDA said it first found out about the bogus Avastin in late December after the UK Medicines and Healthcare Products Regulatory Agency alerted U.S. officials and Roche about the problem. Roche confirmed via testing earlier this week that the Avastin was fake, the FDA said. Genentech said it is monitoring side effect reports for any spike in safety issues that might arise from the fake Avastin.

“What we've seen is that there are active efforts underway by persons to specifically target clinics and doctors,” said Tom Kubic, president of the Pharmaceutical Security Institute, a non-profit, industry-supported organization that collects information on counterfeit medicines. “We're well beyond the traditional counterfeit medicines we've seen in certain therapeutic categories,” Kubic said, citing phony versions of erectile dysfunction drugs such as Pfizer Inc's Viagra.

Counterfeiters “are going after anything and everything, from patented to non-patented, expensive to inexpensive,” said John Clark, Pfizer's chief security officer. Last year, counterfeit Viagra accounted for 85% of the seized fake Pfizer drugs, down from a high of 95% when counterfeiting emerged as a serious threat in the late 1990s. Hugh Pullen, associate director for European government affairs at Eli Lilly & Co., said the faking of such products is a “growing phenomenon” and something Lilly is “looking at very closely.”

Britain's Medicines and Healthcare Products Regulatory Agency said it found that 41 out of 167 packs of counterfeit Avastin the British drug wholesaler bought from its Danish counterpart already had been sold to the U.S. The agency quarantined the packs that remained at the British company.

Last year Europe adopted legislation requiring each pack of drugs to carry a unique serial number. When the legislation comes into force in 2016, pharmacists and hospitals will be required to scan the bar code to ensure the product is legitimate.

Many drug makers have taken their own steps to curb counterfeiting. Pfizer has a global security team including former U.S. Federal Bureau of Investigation and Turkish narcotics agents, Hong Kong police and U.K. law-enforcement personnel to conduct undercover purchases and do other investigations. It shares the results with authorities in various countries.