Report: Fake Drugs a Growing International Threat

(April 7) -- At one of Beijing's ubiquitous 24-hour pharmacies, an entire display is dedicated to medication for male virility. Behind the counter, a woman in a nurse's uniform unlocks a case to pull out a box of Viagra.

In a blue package labeled with Pfizer's logo, the drugs seem benign at first glance. But the side of the package carries an indication that the contents might not really hail from a reputable drug-maker: "LONG-LASTING ERECTION" is printed in block letters, a telling sign that this Viagra is -- like most drugs sold by these retailers -- counterfeit.

It's one of dozens of examples cited by the authors of a new report on phony drugs in this week's issue of Nature Medicine. In a series of nine essays, perspectives from around the world illustrate that counterfeiting is on the rise and already taking a costly -- and deadly -- toll.

Roxanne Khamsi, the editor who compiled the research, told AOL News that the situation has become "a veritable arms race," adding, "It's time to take a closer look at this problem."

Phony drugs aren't necessarily ineffective; some are manufactured with less than the recommended dose of an active ingredient. Others, however, are essentially medication-free tablets, often containing hazardous ingredients, in packaging designed to resemble the real thing.

The problem is so severe across sub-Saharan Africa that 30 percent of drugs are thought to be counterfeit, according to the World Health Organization. That includes drugs to treat potentially life-threatening illnesses, such as malaria, as well as so-called "lifestyle drugs" like Viagra. African counterfeiters usually tamper with drug packages, replacing valuable medicine with cassava root, and then reselling the ineffective products.

In Uganda, a phony version of the antimalarial drug Metakelfin can cost 4,000 Ugandan shillings per dose, according to the report. That's two U.S dollars, in a country where the average income per person is merely $340 a year.

An estimate generated by the World Bank suggests that in an African country of 20 million people, 800,000 of an annual 4 million malarial treatments are phony -- and kill 4,000 children each year.

In some African countries, governments are trying to clamp down on counterfeiters. But efforts to protect intellectual property (brand-name drugs) can also limit the sale of generic alternatives -- making life-saving medicine nearly impossible for locals to access.

"Intellectual property [law] is a two-edged sword; you protect investors, but people will lose access to medicine," Ugandan human health lawyer Mulumba Moses said in the report.

Developing countries are especially vulnerable to counterfeiting, because so few are able to pay full price for medication. But the problem also persists across Asia, the United States and much of Europe: Over 100 countries reported incidents of fake drug sales in 2007, according to a study by the Pharmaceutical Security Institute.

Reports of drug counterfeiting in the U.S are sporadic, but Khamsi cautions that American consumers ought to be wary. "The problem here is nothing like it is elsewhere," she said. "But wherever there's a drug, there's a risk of a fake."

No matter where drug counterfeiting is happening, those responsible are quickly adapting to new safeguards. Phony drug-makers have managed to reproduce hologram seals and often lace the fakes with some active ingredients to pass chemical-based detection tests.

"There's a lot of innovation out there, but counterfeiters are going to keep catching up," Khamsi said.

In Ghana, officials are testing a text-message system to protect consumers. Medication packages include a "scratch off" bar, much like a lotto ticket, that reveals a unique code. Sending it in via text message allows customers to confirm that the drug is legitimate.

But the burgeoning impact of the Internet continues to complicate the problem. Drug purveyors can establish a Web hub and need nothing more than a credit card number -- no prescription -- to dole out inexpensive, counterfeit medications anywhere in the world.

It's an added twist that has many experts calling for the globalization of anti-counterfeiting efforts.

"We need multilateral agreements that have real strength and utility. These should foster cooperation among inspectors and law enforcement agencies to share information on a slew of components," Marv Shepherd, president of the Partnership for Safe Medicines, writes in the Nature Medicine report.

The WHO has taken one step in that direction, with the establishment in 2006 of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). But the move to coordinate international efforts has been stalled by questions of syntax: Countries still can't agree on what constitutes "counterfeit," "substandard" or simply "generic."

Ongoing disagreements have led some countries, including the U.S., to initiate their own policies. Proposed legislation here would force drug-makers to report any signs of suspicious activity. Right now, it's optional, and manufacturers often don't want to sour public perception of their products.

But Khamsi insists that without worldwide cooperation, counterfeit drugs will continue to circulate.

"What we're talking about now is a global market," she said. "Unfortunately, that means a single country just can't solve the problem on their own."