Turns out, fake Avastin not only wasn't Avastin, but wasn't a biotech drug at all. After analyzing vials of the recently unearthed counterfeit, Roche ($RHHBY) says it found a host of chemicals, along with salt and starch, but none of Avastin's active ingredient, and no traces of any sort of biotech drug.
The chemicals that were in the mix include benzoic acid, acetone, propandiol, and a phthalate compound, Reuters reports. Levels of the chemicals varied from vial to vial, Roche said, so the company couldn't determine whether the chemicals were present in concentrations that could harm people. Still, as a Genentech unit spokeswoman told The Wall Street Journal: "It should be assumed all these compounds are potentially unsafe."
As The Lancet points out, the Avastin fakery isn't the first episode of cancer-treatment counterfeiting this year. Back in January, FDA warned doctors about companies promoting direct-to-clinic sales of drugs, saying they could be fakes.
And the counterfeit drugs discovered could be just the tip of an iceberg, as global supply chains bring fakes out of the developing world, where they've been concentrated in the past, and into established markets. The International Journal of Clinical Practice warns that increasing numbers of fakes are getting into legitimate supply chains, and global sales of fake meds doubled from 2005 to 2010, to $75 billion.
The Lancet is calling for stronger anti-counterfeiting laws, plus stronger regulatory oversight and enforcement. The journal also backs "a binding, international standard for criminalizing the manufacture and distribution" of fake drugs--and not just one agreed upon by European officials, but a treaty initiated by the World Health Organization.
- see the news from Reuters
- get more from The Lancet
- read the post at PharmTech Talk
- here's more from the WSJ