Some 'misbranded drugs' turned up in Avastin probe came from Roche plant

Plant making drugs for foreign markets is not among Roche's FDA-approved facilities
Tools

At least some of the cancer drugs that have surfaced as part of an investigation into counterfeit Avastin were legitimate cancer drugs made by Roche ($RHHBY) but in a plant not overseen by the FDA. The disclosure comes in a plea deal cut by a Tennessee doctor and his business manager who acknowledged that they bought $2 million in misbranded drugs from a Canadian wholesaler to save money then charged federal health programs full price.

The FDA and FBI have been tracking down the products that clinics acquired from several companies associated with CanadaDrugs in Winnipeg, according to The Wall Street Journal. The probe picked up urgency early this year when it was discovered that some drugs labeled as Roche's Avastin were counterfeit, containing starch and salt but no active ingredients. The newspaper says 155 medical practices in 33 states have been given a heads up by the FDA that they bought unapproved drugs. Its says the practice of doctors buying drugs from outside sources picked up after Medicare in 2005 significantly reduced what it would pay doctors for the drugs, cutting their profits. 

Some of the drugs the clinics bought were made for foreign markets in plants not listed with the FDA. That was the case with some of the drugs bought by a Knoxville, TN, cancer clinic whose majority owner and office manager have pleaded guilty to charges of buying and using misbranded drugs. According to The Wall Street Journal, Dr. William Kincaid, one of the owners of the now defunct McLeod Cancer and Blood Center, recently fessed up as part of a plea agreement. Business manager Michael D.Combs entered a plea to a misdemeanor in September.

According to Comb's plea agreement, one of the drugs the center bought was rituximab, the foreign version of the cancer drug sold as Rituxan in the U.S. It was manufactured at a Roche plant in Switzerland, shipped to a distributor in India and then to the U.K. before being imported into the U.S. The plea agreement points out that the drug must be temperature-controlled during shipping. The Rituxan Roche sells in the U.S. is manufactured in a plant in Vacaville, CA.

Combs' plea agreement said the men bought the rituximab and other drugs, including Avastin, from Quality Specialty Products (QSP) and Montana Healthcare Solutions. The Wall Street Journal says QSP is owned by CanadaDrugs, which began as an online pharmacy. CanadaDrugs is owned by Kris Thorkelson and has been at odds with U.S. authorities for years for selling drugs in the U.S. The company has denied selling the counterfeit Avastin.

- read The Wall Street Journal's story (sub. req.)
- see Michael Combs' plea agreement (pdf)
- check out the DOJ release

Related Articles:
FDA shoots warning across bow of CanadaDrugs.com
Fake of Roche's Avastin shipped from Canadian supplier
Phony Avastin vials contained chemicals, but no drugs
Avastin alert likely to revive discussion of pharma-financed tracking system
FDA tries to teach consumers of Internet dangers