Counterfeit Drugs: A $75 Billion Trade

Samples of pills — some legitimate medications, others counterfeit — line the counter in a lab at the Pfizer complex in Groton.

On the other side of the counter, Pfizer senior scientist Amy Callanan pours a “homeopathic remedy” that promises to boost virility from a test tube into a beaker. The beaker fills with a cloudy white substance.

“Well, that’s definitely not an herbal,” she said. “It’s some sort of synthetic substance.”

Pfizer’s Intellectual Property Forensic Lab is where a small group of scientists spends its days sorting out the real from the fake.

The staggering abundance of counterfeit drugs makes for a $75 billion industry. The amount of fake medications has been increasing by about 13 per cent each year, according to the Centre for Medicine in the Public Interest.

The U.S. Department of Homeland Security seized more than 1 million counterfeit pills in fiscal year 2010, according to Robert Rutt, acting director of the Intellectual Property Rights Coordination Centre, which coordinates major law enforcement agencies’ anti-counterfeiting efforts. In just a one-week period in October, an international cooperative effort involving IPR, INTERPOL, the World Health Organization and other agencies seized more than 1 million illicit and counterfeit pills.

More than simply cheating consumers, said Patrick Ford, senior director of global security for Pfizer, counterfeit drugs put them in danger.

Although some of the cruder counterfeits are detectable with the naked eye — the colour is a little off or the embossed lettering differs from the original — it’s not hard to make a decent-looking fake. Ford points to two batches of pills. One is Cytotec, an ulcer medicine; the other is a counterfeiter’s version of it.

“If I were to put this in a pile, I’d never know the difference,” he said. “I keep them separate so that I can tell them apart.”

What looks like an exact duplicate, though, could be made of very different ingredients and created in unsanitary conditions.

“You don’t have to be a doctor, you don’t have to be a scientist,” he said. “You can be your average run-of-the-mill criminal and make a good-looking product. They’ll colour it and stamp it out and emboss it. As long as it looks good, that’s all they care about.”

What do they colour it with? “We’ve seen road paint.”

China produces the most counterfeit drugs, Ford said, but those coming out of Russia are among the most sophisticated. “There are a lot of academics there who are looking for work.”

Ford said that Viagra is the most counterfeited of Pfizer’s drugs. Lipitor is another popular target, and was the subject of one of the worst counterfeiting cases. In 2003, 18 million tablets entered the supply chain; consumers were buying them at pharmacies.

“The legitimate chain was breached,” Ford said. “From the counterfeiters’ perspective, that’s the jackpot.”

Zoloft, Celebrex and Diflucan are a few more of the 44 Pfizer products that the company knows to have been counterfeited.

Because the fake drugs can fool even Pfizer employees, most of the detective work is done in the lab, by scientists like Callanan and John W. Thomas, the lab’s team leader.

Samples of possible counterfeits are brought to the lab and stored in a security cage, where they’re photographed and catalogued. Then they’re analysed with an infrared spectrometer, a device that sends frequencies through the samples. How a sample absorbs those frequencies depends on what chemicals are in it.

A graph on a computer monitor a few feet away tells the scientists if the chemical make-up deviates from the chemical signature of the original drug. By the time a sample gets to this point, it usually turns out to be fake. Most of the pills are ordered from websites that bear the tell-tale signs of shady dealings, Ford said.

“If they don’t ask for a prescription, you’ll almost definitely get something bogus,” he said.

Even when they use the same chemicals to make the drug, detecting the fake isn’t difficult. Where pharmaceutical manufacturers have precise measurements, counterfeiters aren’t so exacting.

“It’s one scoop today, two scoops tomorrow,” Ford said. “It will have too much or too little or the wrong active ingredient.”

Once they determine that a drug is not the real McCoy, the scientists go about trying to figure out what exactly is in it.

“You see all sorts of things,” Thomas said. They received a batch of fake Norvasc, the medicine for high blood pressure, which was made entirely of talcum powder. Boric acid, used to kill cockroaches, has been found in many of the fake drugs; Gypsum, used to make drywall, is another common ingredient. Sometimes brick dust shows up in the analyses.

“Really, there are so many different counterfeiters, they take whatever’s handy, and they end up putting that in the tablets,” Thomas said. “They’re certainly not ethical manufacturers.”

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