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Phakes and the Cancer Fight

Friday, March 2, 2012

It is quite likely that some of the fake oncology products found in significant amounts in the Middle East have made their way into Europe and the United States. Here’s what to do to stop it.

Two weeks ago, counterfeits of the key cancer drug Avastin were discovered in the U.S. market. The fact that we still do not know who made the fakes highlights the complexity of drug supply chains and the ease with which fakes can slip into them. And while the United States generally has safe drugs, there are risks; for the unluckiest Americans, death is the result.

We know that the importers, wholesalers, and other traders along the chain probably had no idea that the Avastin was fake. The fakes contained solvents, other inappropriate chemicals, and none of the correct active ingredient, and would not have treated patients. According to the UK drug regulator, the drugs probably were made in Egypt or Turkey. Given the recent history of the fake drug trade, that would make sense.

Fake oncology drugs are prevalent across the Middle East, where there are many ways to fake a drug and even more ways to introduce it into the market.

Fakes will continue to get into the system until all nations improve their monitoring of the criminals making them.

In Egypt in 2009, a gang of criminals bribed hospital staff to give them real, used drug packaging—old vials of a bone cancer medication. The gang then simply refilled the vials with a watery substance that looked like the near colorless liquid of the real drug.

A careful examination of the rubber stoppers in these vials showed two tiny pin-pricks—one made by the syringe of the doctor withdrawing the real drug, the second made by the gang adding the bogus liquid to the vial. Each vial was worth over $1,000; the gang sold thousands of them to unsuspecting drug traders. It is unknown how many reached the market.

In addition to the fake bone-cancer medicines, Egyptian authorities recently discovered enough fake breast cancer medicines to “treat” many thousands of patients in Cairo, other oncology centers in Alexandria, and possibly elsewhere. The volume of fakes was more than half the entire annual Egyptian demand for the real versions of these drugs. On realizing how much trade they had lost to the fake-drug network, one Western drug company representative told me that “our number one competitor was the fake [version of our own brand].”

Unfortunately, this Egyptian success at targeting fake breast cancer drugs was an anomaly rather than the result of tightly controlled distribution systems. The then-president's wife, Suzanne Mubarak, suffered from breast cancer and was active in breast cancer charities. High-level support encouraged the appointment of General Mostafa Amr, the former head of the narcotics bureau, to increase understanding of the network and learn how to shut it down.

But with the demise of the Mubarak regime, and with larger issues of governance for new Egyptian authorities to address, monitoring of smugglers and fake drug producers has collapsed.

Fake oncology drugs are prevalent across the Middle East, where there are many ways to fake a drug and even more ways to introduce it into the market.

The same is true in other parts of the Middle East, notably Syria and, to a lesser extent, Jordan and Turkey. Turkey was supposed to implement a track-and-trace system for drugs passing through their pharmacies in 2009, but has repeatedly delayed its launch. All the while fake drugs slip through the system.

In one haul I saw in customs offices in Damascus, Syria in 2009, over four tons of fake drugs were recovered, including counterfeits of over 60 Western brands. Those drugs were all impounded and likely destroyed, but since the Arab Spring more and more fakes are turning up again.

And so it is quite likely that some of the fake oncology products found in significant amounts in the Middle East made their way into Europe and the United States. The counterfeit Avastin was traded by wholesalers in Switzerland, Denmark, and the United Kingdom before landing in the United States.

One of the European wholesalers involved in trading the fake Avastin, Denmark's CareMed ApS, told the Wall Street Journal that it was making changes to its procurement and other systems “on the orders of Denmark's medical regulator.”

Avastin's manufacturer, the Swiss company Roche, sent out warnings to doctors and patient groups in the United States as soon as it knew about the fakes. And it is not yet clear if the drugs were actually given to patients or have harmed anyone. The FDA is investigating and asking for help from at least 19 medical practices, mainly in California, that might have received the bogus Avastin.

With the demise of the Mubarak regime, and with larger issues of governance for new Egyptian authorities to address, monitoring of smugglers and fake drug producers has collapsed.

A thorough investigation of all intermediaries is no doubt warranted and may unearth sloppy procurement practices. But fakes will continue to get into the system until all nations improve their monitoring of the criminals making them. Wholesalers and other traders are always looking for a good deal and smart counterfeiters know how to price and present their fakes to make the deal look legitimate and appetizing, but not too good to be true.

As yet, there is no international treaty or law banning the trade in fake products, and most countries in the Middle East do not have the requisite domestic laws in place. This makes it hard to attack the early parts of any bogus supply chain. Even if British or U.S. authorities discover who made the fake Avastin, they will not be able to prosecute them and will be reliant on Middle Eastern authorities to conduct any prosecution.

Negotiating a global treaty against fake drugs would encourage Middle Eastern nations and other countries to develop better laws. In addition, a treaty could allow for universal jurisdiction, enabling willing nations to prosecute malefactors anywhere in the world. This is the case with currency counterfeiters, and it could be with fake drug traders—it is time it was, because every year more and more lives are lost to fake drugs.

Roger Bate is a fellow at the American Enterprise Institute and author of Phake: The Deadly World of Falsified and Substandard Medicines, published next month by Rowman and Littlefield.

FURTHER READING: Bate also writes “Blood Diamonds Are Mugabe’s Best Friend,” “Time for a Fake-Drugs Treaty,” and “The Hidden Danger of Fake and Substandard Medicines.” Along with Richard Tren, Bate coauthors “A Lethal Subsidy” and “Africans Tell the UN to Buzz Off.” Scott Gottlieb discusses “Big Pharma's New Business Model.”

Image by Rob Green / Bergman Group

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