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Egyptian middleman bought fake Avastin from Turkey

Fake versions of the multibillion-dollar cancer drug Avastin were purchased in Turkey before being traded by middlemen across the Middle East and Europe to the United States, an Egyptian businessman involved said on Tuesday.

Milad Kamal Ayad, who works on commission for Egyptian firm SAWA, told Reuters he sourced 167 packets of Avastin from Turkey, via a Syrian businessman also based in Egypt, for Swiss-based Hadicon AG.

The drug, found to be counterfeit, eventually reached clinics in California, Texas and Illinois. It contained no life extending medicine or any other biotech drug, Roche said on Monday, but instead contained salt, starch and a variety of chemicals.

The case involving Roche's top-selling cancer treatments has underscored how even expensive injectable medicines, not just pills like Viagra and Lipitor, are at risk from criminal counterfeiters.

It also shows how difficult it is to trace the source of such counterfeits as they pass from one supplier to another.

"Via SAWA, I bought these items from a Syrian. Of course, I didn't know they were counterfeit copies," Ayad said, speaking in a meeting at the Reuters bureau in Cairo where he described the deal.

He said that a sample packet of the drug he was shown by the Syrian appeared to be original.

Phony Avastin has been found in the region previously. Roche said on Friday that fake versions of Avastin were discovered in Syria in 2009.

In the latest case, the U.S. distributor, known as Montana Healthcare Solutions, listed Avastin along with its Turkish name Altuzan on an order form obtained by Reuters.

Zug-based Hadicon said it had dealt with SAWA to source the drug. The Swiss firm provided Reuters an address in Cairo, although no company by SAWA's name was based there. It also supplied a mobile number without a name. The phone belonged to Ayad.

Ayad, who said SAWA was owned and run by another Egyptian businessman now abroad, said he sourced the drug for Hadicon via Syrian businessman Mohamed Fakkas el-Beid, who he said is based in the Egyptian Mediterranean port city of Alexandria. Ayad provided a copy of the Syrian's national identification card.

Ayad showed a handwritten document bearing Fakkas el-Beid's name as the seller and Ayad as the buyer of the Avastin in a deal last year. The document said the drug was sourced from Istanbul, Turkey, though no company or other agent was named.

It bore a fingerprint of Fakkas el-Beid in place of a signature because Kamal said the Syrian could not write. Ayad said he drew up the document with Fakkas el-Beid after learning the drug was fake. He said he did not have original invoices.

Ayad said his Syrian contact had not given him any details about the Turkish source. During the meeting with Reuters, Ayad telephoned Fakkas el-Beid to request further details but his counterpart did not give him any. Calls by Reuters made separately to the Syrian's mobile were not answered.

It was not clear if the fake drug originated in Turkey.

Roche said there had been a number of other "individual cases" of counterfeit Avastin in the past few years, including a previously reported incident in Shanghai in 2010.

Ayad said he paid half the cost upfront for the consignment to the Syrian and the rest when Hadicon confirmed receipt. Subsequently, Hadicon called Ayad requesting their money be returned after the drug was found to be fake. Ayad said he was still pushing Fakkas el-Beid for the cash.

The phony Avastin was sold by Hadicon to Danish drug distributor CareMed, which shipped it on directly to Britain's River East Supplies, according to Danish and British regulators.

An Egyptian Health Ministry official earlier said no company by the name SAWA was registered with the ministry to import or export drugs. Ayad said SAWA had a more general license to trade and said the shipment of drugs never entered Egypt.

Roche in Egypt said there was only one official distributor for Avastin, Egydrug, a unit of a state-owned holding company.

Every shipment of Avastin or any other drug entering Egypt needs a Health Ministry license and is then subject to analysis before release, Yousef Ehab, Roche general manager in Egypt, told Reuters. Batches are also tracked after that, he added.

In addition, Ehab said contracts to import the drug include a clause preventing re-export, unless there are exceptional circumstances with a good reason. Even then, approval is needed from both Roche and the ministry, Ehab added.

Ehab said Roche was working with its customers and hospitals to ensure no counterfeit Avastin drugs were in use in Egypt.

According to Roche, Counterfeit versions of the cancer drug Avastin contained salt, starch and a variety of chemicals, but none of the life extending medicine or any other biotech drug. And that British health regulators sent it a small number of vials of the counterfeit Avastin to it for analysis.

Roche analyzed three of the vials and found that they contained none of the injectable cancer medicine's active ingredient or any protein or biologic drug, the company said.

What it did find in one or more of the three bogus vials it tested was salt, starch, citrate, isopropanol, propandiol, t-butanol, benzoic acid, di-fluorinated benzene, acetone and phthalate moiety.

The contents of the tested vials varied and Roche said it was not able to determine if the compounds or the levels of them would cause harmful or pathological effects.

"The counterfeit product is not safe or effective and should not be used," Roche said in a statement.

The counterfeit Avastin has so far been traced back to Egypt. It passed from there through legitimate distributors in Switzerland, Denmark and Britain before landing in the United States, where U.S. health regulators said it was being sold by shady distributors under investigation for peddling medicines not approved for sale in the United States.

Reuters
 2012-03-01  |  04:04:01   
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