Flaw in the ointment

by This email address is being protected from spam bots, you need Javascript enabled to view it on Wednesday, 01 August 2007

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At worst, counterfeit medications can kill. At best, they won't cure. Medical Times reports on the illegal trade that is costing lives.

Conveniently for a trade based on an under-the-counter culture, counterfeit drug trading has traditionally enjoyed a relatively low profile in the Middle East.
Despite being almost as lucrative as narcotic trading - global sales of counterfeit medications are expected to reach US$75 billion by 2010 - fake prescription drugs have received nothing like the attention.

There is no question about it; some pharmacists are complicit. They receive these products for very low prices and they make huge profits.

The announcement last month, however, that Dubai Customs had seized AED5 million worth of fake Plavix has splashed the spectre of counterfeit trading across the front pages of the region's newspapers. More importantly, it has confirmed that counterfeiters have the Middle East firmly in their sights as a target market, making it a problem we can no longer afford to ignore.

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"Counterfeiting is a developing world phenomenon," says Guy Willis, director of communications for the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). Viagra, Lipitor, Plavix - all popular and expensive drugs that are regularly prescribed - are prime targets for counterfeiters. While phony products may look like the real thing, right down to the blister packs and packaging, they typically contain few, if any, active ingredients or excipients and are potentially poisonous.

"Our losses are huge," admits Dr Ahmed El Hakim, director of external affairs at Pfizer Middle East, the manufacturer of Viagra.

Willis estimates that fake prescription drugs make up 10% of the pharmaceutical trade in the Middle East, although OECD figures suggest the number could be higher. While the full scope of the problem is obscured, in 2004, the chief of Lebanon's National Health Commission (NHC), Ismail Sakaria, admitted that up to 35% of pharmaceuticals available in the Lebanese market are fakes.

Industry experts agree that for those dabbling in counterfeit trading, the United Arab Emirates is strategically attractive as a transit point for the Asian market.

"The UAE is a transient location because of the Jebel Ali free zone," explains El Hakim. Raids held last month, he says, uncovered stores of counterfeit Viagra destined for exportation to Saudi Arabia.

"It (the free zone) plays a role in the spread of counterfeit medicines across the region. We need to close this loophole with the UAE government."

Figures from the European Commission, released last month, revealed the UAE as the second biggest source of counterfeit medications seized at EU borders. Dubai's Plavix heist is another case in point. "There were 20,000 boxes of Plavix, but it was for exportation," confirms a spokesperson for Sanofi Aventis.

The pharmaceutical industry has repeatedly been accused of a paucity of warnings on fake drugs, for fear of panicking patients and rocking confidence in their brands.

Now, in the face of a burgeoning global industry, such reticence is taking a back seat. "Does the industry shout it from the rooftops?" asks Willis, "No. We don't want to panic people. But they should be made aware that the industry takes the problem very seriously."

Yet lost profits and tarnished images are hardly the only casualties of counterfeiting. Beyond duping manufacturers and purchasers, counterfeit medications pose a serious health risk to patients. The reported 192,000 people in China that died over the course of 2001 after taking fake drugs are testament to the risks of bogus medication. And while not all fake drugs will kill, they won't cure either.

"For you to receive a counterfeit drug that has the correct active ingredient, with an excipient that will do no harm - the chances of getting a counterfeit like that are very slim," stresses Willis. "On the other end of the scale, these counterfeits can be poisonous."

But countries preparing to battle the trend have a fight on their hands, says Harvey Bale, IFPMA's director general. "As long as the cost per unit of a counterfeit is lower than the street price of the real thing, there will be counterfeits," he said in an interview with New Scientist.

Certainly, money drives trade on both sides of the purchasing equation. Pill-peddlers are attracted by the massive profits and comparatively light penalties of counterfeiting, while patients who can't afford the real deal will readily purchase cheaper black-market ‘alternatives'. Sanofi's spokesperson points to a recent case in China, where a counterfeiter was convicted of handling 500,000 fake Plavix tablets. "He received a six-month sentence," he says, "Yet he may have made up to $4 million."

Similarly, he adds, while the 20,000 boxes of Plavix were actually seized by Dubai Customs six months ago, legal proceedings have yet to be set in motion.

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