Fake Avastin was shipped by accident, Danish distributor says
February 21st, 2012 // 1:33 pm @ jmpickett
Danish drug distributor CareMed said it was an unwitting link in the journey of fake cancer medicine Avastin from Switzerland to Britain, in the latest twist in a saga that began when the counterfeit drugs surfaced in the United States last year.
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The fake version of the multi-billion dollar Roche drug had been traced back as far as Egypt before entering a complex supply chain that ended in California.
CareMed told Reuters on Friday it had sourced the drug from fully licensed Swiss distributor Hadicon, and the 167 vials of Avastin 400mg were sold from a transit warehouse in Switzerland directly to a transit warehouse in Britain.
Hadicon was also identified to Reuters as handler of the fake batch by Britain’s medicines regulator but the company is yet to confirm its role.
“We did not investigate the packages and the vials,” CareMed managing director Casper Tingkaer told Reuters in an emailed response to questions.
“In fact under our distribution license — for patient safety reasons — as a distributor, we are not even entitled to open the packages and check that, for example, batch numbers of the vials correspond to the batch numbers of the packages.”
The discovery of the fake medicine, which does not contain the active ingredient bevacizumab, highlights the growing problem of counterfeit drugs.
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“This is a global industry problem, in particular we have now seen that falsified products have found a way into the validated supply chain,” Tingkaer said.
CareMed sold the drugs to a “highly valued and experienced customer” in Britain, which informed it at the end of November that the batch numbers on the vials did not match the packages.
Tingkaer said the company immediately launched an investigation and told the Danish Medicines Agency, which contacted its counterpart in Britain.
The Danish Medicines Agency said that the Danish wholesale company had acted correctly.
Britain then informed Roche, which gets about $6 billion a year from Avastin sales globally, and the U.S. Food and Drug Administration.
Tingkaer said CareMed demanded documentation from Zug-based Hadicon but added the Swiss company did not supply the papers.
Hadicon said it was still not sure it was part of the supply chain that shipped the fake Avastin.
“We have no confirmation of evidence that the goods are definitely from us,” chief executive Klaus-Rainer Toedter said.
Regulator Swissmedic would not confirm Hadicon’s involvement, but said the fake drug was not sold in the country and it believed it was only stored in a Swiss warehouse.
A Swissmedic spokeswoman said it looked as if the distributor had no knowledge that the drugs were fake, a view echoed by Britain’s Medicines and Healthcare Products Regulatory Agency.
“There is no suggestion (CareMed and Hadicon) knew it was counterfeit,” a MHRA spokesman said.
Roche, which does not make Avastin in Egypt, said it was working with the FDA in the United States to stop the source of the counterfeit drugs.
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“Is anyone making the casing of Avastin here and exporting it illegally?” said Yousef Ehab, the head of the company’s operations in Egypt. “I do not know and would like to since this is something of great concern.”
Fake medicines are a particular problem in emerging markets, where up to 30 percent of drugs might be counterfeit, the European Parliament said last year.
MEP Marisa Matias said at the time that falsified medicines were “silent killers” and the absence of a legal framework encouraged counterfeiting, an organized crime.
Europe is introducing a series of measures to clamp down on fake medicines over the next three years, including authentication stamps on packaging.
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