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>Countering Counterfeits >Pfizer employs a global security force of more than 40 >investigatiors to hlep crack down on fake >pharmaceuticals, which now make up nearly 8 percent of >sales worldwide. > >‘In the beginning with Viagra, it was usually a crude, >lousy looking tablet. But in six months or so, it >looked very real.' Pfizer senior research scientist >John Thomas, below, on counterfeit pharmaceuticals > >Pfizer scientist Amy Drew scrapes a sample from a >counterfeit Lipitor tablet in the company's Groton >laboratories. > > >"In the beginning with Viagra, it was usually a crude, >lousy looking tablet. But in six months sor so, it >looked very real." >Pfizer senior research scientist John Thomas, on >counterfeit pharmaceuticals. > >By ANTHONY CRONIN >Day Staff Writer >Published on 1/2/2005 > >The bottle of Pfizer's Lipitor cholesterol drug looked >legitimate. At least to the average eye. But to those >who work in Pfizer Inc.'s forensics laboratory in >Groton, it was anything but. > >It was a drug counterfeit, just one of the many fake >medications that the high-tech laboratory ferrets out >in its continuing battle to quell a growing global >problem. > >“It has no active ingredient,” said John Thomas, a >senior research scientist who has 25 years of >experience with Pfizer, including the past six focused >solely on the forensics team investigating counterfeit >pharmaceuticals. The bogus drug, which came in a round >container rather than the more squarish >Pfizer-approved container, likely came from Mexico, >Thomas said, one of many countries that have been >identified as having counterfeiting labs. > >“There's always been counterfeiting,” Thomas said, >“but it used to be small and disorganized.” > >Today, that's hardly true. Industry estimates say that >at least 8 percent of the world's pharmaceutical >supply is beset with counterfeiters. Because >counterfeiting is a lucrative and relatively low-risk >criminal activity, it is growing. Pharmaceutical >industry experts say that penalties are still >relatively light for those who counterfeit, which the >industry is pushing to have strengthened. > >“I'm afraid that it's relatively simple for a person >with some level of sophistication to mix materials >that pack together,” said Dr. Joseph Hammang, director >of science policy and public affairs for Pfizer. He >said it is not difficult to colorize or stamp bogus >pills. > >Besides the obvious costs to a giant pharmaceutical >company like Pfizer, which last year had sales in >excess of $45 billion, these bogus drugs also harm >those who take them, who assume they are deriving the >same medicinal effect as the real drug, when they >often are getting none. In some cases, the drugs can >cause harm from toxic ingredients or from the lack of >proper dosages, meaning the patient can become more >ill before the bogus drugs are discovered. > >At Pfizer, the job of countering the counterfeiters is >a constant fight. Since 1996, its global security >force has grown from less than 10 to more than 40, >with offices in New York, London and China. > >China is considered a major source of counterfeit >drugs that are marketed throughout the world. >Counterfeit Pfizer drugs have also been found in >nearly every European Union country as well as a host >of other countries. > >Counterfeiting of Viagra, Pfizer's drug for male >impotence, took off in the late '90s. “Most of it has >been Viagra,” said Thomas, although the world's >best-selling drug Lipitor has also been a favorite of >the knock-off artists. “In the beginning with Viagra, >it was usually a crude, lousy looking tablet. But in >six months or so, it looked very real,” he said. > >Pfizer investigators say that increased enforcement >has resulted in more seizures of counterfeit Viagra >tablets. The number of bogus “little blue pills” >dropped from more than 1.8 million in 2002 to 760,000 >in 2003. But during that same time period, the number >of bogus Norvasc tablets, a Pfizer product used to >treat high blood pressure, ballooned from less than >4,000 tablets to more than 1.5 million. It's not >untypical, say those in the industry, for >counterfeiters to move on to another drug when >enforcement is increased. > >••• > >Inside Pfizer's forensics lab in a one-story, >nondescript building on its sprawling research campus >in Groton, Thomas and three other trained scientists >are, in effect, Pfizer's anti-counterfeiting cops. >They work in tandem with Pfizer's specially trained >global security force and federal agencies, most >notably the federal Food and Drug Administration's >Office of Criminal Investigation, to find those who >are manufacturing fake Pfizer drugs with improper drug >formulations. In most cases, there are no >formulations, and the bogus drugs are full of talc, >gypsum (derived from wallboard) or lactose, which is >milk sugar. > >The team uses a variety of computers and high-tech >pharmaceutical equipment that can detect the >components of a drug, real or fake, and display its >characteristics onto computer screens. With a quick >keystroke or two, the scientists can compare the fake >drug's components with the real formulation. The >computers can also show what the bogus ingredients >are, as well. > >And it's a never-ending quest. Thomas and his >associate, Amy Drew, a Pfizer scientist, point to >boxes worth of pharmaceuticals that have arrived at >the lab from other countries, part of routine surveys >by Pfizer of drugs that can be bought globally. Some >are the real thing; others are fakes of various shapes >and composition. The one thing the team can usually >count on when they open up the boxes is that they'll >find counterfeit drugs, sometimes copious amounts. > >Counterfeit drugs usually don't have deadly >ingredients, dubbed a “dead man pill,” but a variety >of harmful ingredients have been found as part of the >testing process, including lead paint and boric acid. >Drugs can be isolated in lab in the event there are >toxic or harmful ingredients. > >Counterfeiting is less of a problem within the U.S. >borders because of its heightened regulatory >environment and increasing focus on counterfeit drugs >by the FDA and the Department of Health and Human >Services. In addition, the Federal Bureau of >Investigation has been involved in the issue of >counterfeit drugs and investigators have found >connections between the counterfeiting of popular >drugs and organized crime. > >The FDA in 2003 established a high-level >counterfeiting drug task force but the agency has said >that there will be no magic bullet to cure the >problem. Counterfeiters, FDA officials have said, >continue to evolve rapidly, shifting their operations >and methods. During the 1990s, the agency was involved >in five counterfeit investigations. Since 2000, it >estimates it's involved in more than 20 full-scale >investigations a year. > >••• > >As the Internet becomes a growing alternative to >purchase pharmaceuticals, the concern grows over >patients being duped into paying for what is >essentially a bottle of talc pills because they were >trying to buy cheaper pharmaceuticals. > >“Counterfeiting of medicines is becoming a larger >worldwide problem,” Hammang said. “For us, like any >other industry, we want to make sure our products that >our patients buy are the real thing so we have to go >to great lengths to make sure our products on the >shelves in the pharmacy are the real thing.” > >He said that the industry, and Pfizer, is working on a >variety of anti-counterfeiting measures, from >increasing enforcement penalties to better tracking of >legitimate pharmaceutical products and special product >packaging to deter counterfeiters. > >“The biggest fear,” Hammang said, “is when our >medicines leave the hands of our manufacturing plants >and possibly end up in places where they can be >manipulated or tampered with.” > >This past November, Pfizer announced that it would put >tiny radio frequency identification tags on bottles of >Viagra to combat its popularity among counterfeiters. >The radio tags, already a popular item in the >retailing world, operate similar to the bar codes >found on food packaging scanned at supermarket >counters. The small computer chips provide detailed >tracking of an item, including drug shipments, and are >also used to verify the authenticity of the goods. > >“That's the kind of technology we're moving towards,” >he says, to help lessen the grip of counterfeiting on >the global pharmaceutical industry.

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