Roche has made public some of the details in the recent case
involving counterfeit Avastin, including the convoluted route that
resulted in the cancer drug being inveigled into the US supply
Investigations by the US Food and Drug Administration (FDA) and other regulatory authorities around the world indicate that the fake material may have passed through Egypt, Turkey and wholesalers in Switzerland, Denmark and the UK before landing in the USA.
Egyptian company SAWA, Swiss wholesaler Hadicon AG, Danish wholesaler Caremed and River East Supplies of the UK have all been name checked in the investigation. In the latest instalment, the FDA says it is investigating whether Canadian Internet pharmacy CanadaDugs.com, based in Winnipeg, was also involved in distributing the counterfeit material.
The agency is looking into suggestions that at least some of the fake Avastin was handled by the Canadian pharmacy on its way into the US.
Last month Roche warned that fake Avastin had found its way into 19 clinics in the US - mainly in California and Texas - and had been administered to a number of patients (see Roche warns counterfeit Avastin now in US market).
The FDA is reportedly exploring suggestions that China may be the original source country for the material, although it has yet to make an official statement to that effect. Counterfeit Avastin used off-label to treat an eye condition was the subject of a major scandal at a state-run hospital last year.
Meanwhile, the Turkish Pharmacists Association (TEB) issued a statement (in Turkish) earlier this month insisting that the counterfeit Avastin could not have been passed through pharmacies in the national supply chain thanks to the recently-introduced ITS (drug monitoring system), which makes use of serial numbers to provide medicine traceability and reimbursement control.
Laced with solvents
Analysis of the material by scientists at Roche subsidiary Genentech indicate that the counterfeit Avastin did not contain the active ingredient bevacizumab, but was laced with salt, phthalates, starch and various solvents, including acetone, di-fluorinated benzene, t-butanol and isopropanol.
The companies say it is still not clear whether any patients have been harmed by the counterfeit material.
The case has sent shockwaves through the US as it exposes once again the vulnerabilities of medicine supply chains even in countries considered to be well-regulated.
Similar consternation greeted the news that fake cancer drugs, antipsychotics and cardiovascular medicines had penetrated the UK supply chain in 2007.