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FDA issues warning about counterfeit cancer drug

octal/Flickr

In February 2011, the FDA issued a warning about vials of a popular cancer drug called Avastin that turned out to be fake, according to a CBS News investigative report.

The only FDA-approved Avastin that is allowed to be sold in the U.S. is manufactured domestically by Genetech. Five million vials of Avastin were sold in the U.S. in 2011.

The counterfeit Avastin was manufactured outside the U.S. in an unknown location, and was sold by Montana Healthcare Solutions (MHS), a company located in the Barbados, CBS found.

MHS sold the counterfeit Avastin for just under $2,000 for 400-milligram vials, $400 less than the manufacturer’s price.

Tom Haughton was responsible for bringing the drugs into the US. He runs several businesses in the pharmaceutical industry, including MHS and 3,000 website domain names.

The drugs were then sold through a complicated web of companies owned by Houghton in the U.K., Denmark, Switzerland, Turkey and Cairo, according to CBS sources.

I have nothing to hide,” Houghton said when interviewed by CBS News about bringing counterfeit drugs into the U.S. “The businesses that I have are ethical, safe and legal.” When pressed further by CBS, Houghton admitted he was “not sure what the U.S. laws are.”

“It’s my fault that my company sold this product,” Haughton said. “But I’m telling you we sourced it from the controlled and regulated EU supply chain that millions of people trust every day.”

A source close to a federal investigation told CBS News that Houghton’s involvement in bringing the counterfeit drugs into the U.S. is a key part of the investigation.

CBS also learned that Tom Houghton is one of the leading suppliers of Canadadrugs.com,  the “largest and most trusted” online Canadian pharmacy, who alleges that they had nothing to do with the fake Avastin being sold in the U.S. Furthermore, Canada Drugs says that Tom Houghton is “one of [their] trusted partners.”

Regardless, the U.S. Food and Drug Administration says that it is illegal for pharmacies based in Canada or other countries to ship prescription drugs into the U.S.

“Canada Drugs is not licensed in any of the U.S. states,” Carmen Catizone, executive director of the National Association of Boards of Pharmacy, said. “They are violating state law every time they ship a package into the U.S. to a U.S. patient.”

Catizone also noted that “no drugs that are being shipped via the Internet to U.S. consumers from these websites we’ve identified actually come from Canada or have actually been approved by Health Canada.”

The FDA has sent letters to 19 medical practices, saying they may have purchased the counterfeit drug which contained no active ingredient, containing mainly salt and starch.

“We use Avastin in combination with other chemotherapy,” Dr. James Speyer, head of the NYU Langone Cancer Center said. “In some these colon, lung and renal cancers, it significantly changes the rate of response and may change survival.”

“Counterfeit drugs is a huge problem in the United States,” Catizone said. “The estimates are that $75 billion worth of sales of counterfeit drugs occur annually.”

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