Pfizer CSI: Big pharma team tracks down and identifies counterfeit drugs

In In The News by Barbara Jacoby

LLH network pressFrom: MedCity News

Wearing a white lab coat and nitrile gloves, Pfizer Inc. scientist Amy Callanan places a small blue tablet into a handheld machine that silently reads the chemical signature of the pill by measuring its response to vibrations.

The TruScan machine, used regularly by a team of three technicians at Pfizer’s counterfeit-drug testing lab on the pharmaceutical firm’s campus off Eastern Point Road, within minutes is able to determine that the Viagra-branded tablet is fake.

“The signature doesn’t match,” said Callanan, a senior scientist at Pfizer’s Intellectual Property Forensics Laboratory.

Sniffing out counterfeit drugs is an almost daily occurrence at the Groton labs, where Pfizer analyzes suspect branded products from North, Central and South America as well as the Caribbean. Other Pfizer labs in England and China, with slightly larger staffs, analyze suspicious drugs from the rest of the world, where most of the counterfeit manufacturing is being done.

“The ultimate goal is to find the manufacturer,” said Brian Donnelly, director of global security compliance for Pfizer and a former FBI agent with a background in pharmaceuticals.

New York-based Pfizer, as one of the largest drug companies in the world, has been particularly active in tracking counterfeit drugs. It’s an illicit trade that likely costs the company millions of dollars a year, but Pfizer spokesman Chris Loder said the concerns go way beyond lost money.

“If someone gets sick, that’s going to hurt our reputation,” he said. “What drives this for us is patient safety.”

The extent of the problem is staggering.

According to updated numbers, 5.1 million doses of counterfeit Pfizer products have been seized by authorities around the world through the first three quarters of this year. That’s more than 34 percent higher than for the same period a year ago.

While a few years ago 25 Pfizer products were subject to counterfeiting, today at least 65 company brands are on the radar of loosely knit criminal networks around the globe, the company said.

For the first time since Pfizer began compiling records, the cholesterol medicine Lipitor this year has surpassed the erectile dysfunction pill Viagra as the company’s most counterfeited medicine in the Asia Pacific region. Globally so far this year, Viagra is still the most counterfeited medicine, but only by a slim margin over Lipitor.

Fake Pfizer products circle the globe, having been discovered in at least 106 countries.

“It’s not just handbags anymore,” Donnelly said of counterfeits. “It is very serious because you put it in your body.”

Some of the most dangerous ingredients Callanan has found in knockoff drugs include car wax, floor wax and printer ink for coloring. The material from Sheetrock is a common ingredient, since it helps hold the pills together.

One of the worst cases that the counterfeit-drug unit in Groton has investigated involved the deaths of five people in Canada who were sold the fake blood-pressure medication Norvasc by a pharmacist in Hamilton, Ontario. The patients died because the fake medicine had no active ingredients and their conditions were not properly controlled, Donnelly said.

“We’re seeing the counterfeiters are going after the brand names,” he added.

Many of the knockoff drugs have active pharmaceutical ingredients — but often they are the wrong chemical compounds for the condition they are targeting. Even drugs with the right ingredients can sometimes have doses that are too high or, perhaps even worse, too low, which can lead strains of some diseases such as malaria and TB to develop resistance to the remedies.

Donnelly said most of the Pfizer contractors and personnel working to counteract counterfeit drugs come from a background in law enforcement or security around the world. Pfizer aids in tracking down counterfeiters using conventional investigative methods, then usually hands off its information to law enforcement agencies within individual countries.

“We’re almost like Pfizer CSI,” Donnelly said with a smile, referring to the television show whose acronym stands for Crime Scene Investigation.

A storage room in the Groton campus is piled high with boxes of “Cold Case Files” that might help solve counterfeiting mysteries years down the road. Donnelly remembers one case, involving a fugitive who was rearrested, in which Pfizer found evidence from more than 10 years earlier to help gain a conviction.

Just like law enforcement officers, Donnelly and Callanan are frequently asked to testify about counterfeiting cases, usually involving how they determined a given product was counterfeit or talking about intellectual property protection and trademarking. And, just like police, Pfizer must be careful to safeguard suspect products and diligently record their chain of custody to establish that the products weren’t lost or tampered with.

It started with Viagra

Knockoff drugs didn’t reach large proportions until the advent of Viagra in the late 1990s, Pfizer officials said. Viagra was a drug that men wanted but were often embarrassed to request from a doctor. At the same time, the Internet came to the fore, enhancing the ability of counterfeit drug manufacturers to sell their products.

“To some extent, it’s the perfect storm,” Donnelly said.

Pfizer usually starts an investigation by ordering drugs from suspect websites that purport to sell Viagra or other Pfizer remedies. The orders are then taken to the lab for analysis. If the analysis shows they are fake, a deeper probe will ensue.

The problem, said Donnelly, is that investigations usually show that criminals selling knockoff drugs have tentacles all over the world.

“It’s disorganized organized crime,” he said.

Websites might originate in Eastern Europe, but payments often go through Uzbekistan, a former Soviet satellite in central Asia. Illegal generic drugs usually come from India, but brand-name knockoffs more likely will be traced to Chinese manufacturers. And to make the investigation even more complex, suppliers often ship counterfeits in small batches to someone in the United States, who then fulfills orders through the U.S. mail, ensuring less scrutiny.

“This is unlike a drug cartel,” Donnelly said. “This is much more fluid than that.”

Making it trickier, different countries have different laws dealing with counterfeit drugs, Donnelly said, and many jurisdictions don’t deal with it harshly. Still, he estimates that Pfizer aids with 50 to 60 convictions every year around the globe.

Donnelly said other major drug firms, such as Eli Lilly & Co., maker of Viagra competitor Cialis, are equally active.

“We are always trading information back and forth,” he said. “Seizure follows market share. It’s kind of funny, but it makes sense because it’s a business.”

The World Health Organization, in a 2010 report on counterfeit drugs that cited estimates supplied by the U.S.-based Center for Medicine in the Public Interest, said counterfeit drugs were likely a $75 billion business worldwide. It cited raids during 2009 in Asia, Europe and the Middle East that each netted tens of millions of counterfeit prescription medicines.

“Results from this string of law enforcement operations around the world are slowly building a profile of the trade that shocks even regulators familiar with the issue,” the WHO said in a periodic bulletin. “Health experts believe such operations have only scratched the surface of a flourishing industry in counterfeit medicines that poses a growing threat to public health.”

Risky online purchases

Pfizer spokesman Loder said the illegal manufacturing sites are often in small apartments, nondescript buildings or even two-car garages, making detection for law enforcement agencies difficult. The sanitary conditions of some of these operations are deplorable, he added.

Pfizer officials said consumers can generally avoid counterfeit drugs by filling prescriptions at their local pharmacies. The problems come, they said, when patients trying to save a few dollars or avoid embarrassment turn to the Internet.

One study late last year that focused on online sales of Viagra indicated that up to three-quarters of the products received from nearly two dozen sites were counterfeit, reported. Earlier this year, an analysis by the National Association of Boards of Pharmacy indicated that 97 percent of online prescription sites were either operating illegally or were failing to abide by pharmacy laws or standards.

“There’s little disagreement about the significant dangers posed by taking fake Viagra and the fact that those purchasing it seem blissfully unaware of the risks they’re taking,” Forbes contributor Melanie Haiken said.

Callanan demonstrated in the Pfizer lab how consumers could tip both Viagra packaging as well as the pill itself and see it change from blue to purple, an indication that the product is authentic. Other products in the lab, such as ChapStick, also are easily detectable to authorities, Donnelly said, sometimes based initially on the very familiar lot numbers that are consistently used and rarely vary.

“It doesn’t seem like they’re out to fool us; they’re out to fool the purchasers,” Donnelly said.

While Pfizer has focused on counterfeit drugs over the past few years, Donnelly said the company recently expanded its investigations to include so-called “natural” or “herbal” products often found in gas stations and convenience stores with names such as “Man-up” and “Libigrow” along with pitches indicating they were meant as male sexual-performance enhancers.

A survey of stores in two metropolitan areas of the Southeast, Loder said, indicated that about 80 percent of these products were synthetic compounds very similar to Viagra, though they did not list the active ingredients on product labels and none of the drugs had gone through any regulatory scrutiny.

Callanan said some of these ingredients were just a few molecules away from sildenafil, the generic name of Viagra, and have caused men painful and life-changing complications.

“When you alter a molecule, you can change how well it works in the body,” she said. “There’s the potential of putting too much in.”

Loder said Pfizer’s findings were referred to the U.S. Food and Drug Administration, which regulates the sale and marketing of pharmaceuticals.

Pfizer’s active probes along a variety of fronts all around the globe certainly has the attention of criminal networks dealing in counterfeit drugs. And Pfizer’s counterfeiting-detection lab in Groton has been featured in a variety of high-profile television investigations, including CBS’s “60 Minutes.”

But the story Donnelly likes best came during a taped police investigation of a drug counterfeiter who, while challenging the identity of the wired undercover officer, gave the best indication Pfizer Global Security personnel were making a difference in their campaign to stamp out fake drugs.

“Are you a cop?” he asked, then paused. “Are you one of those Pfizer investigators?”