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Exposing deception
(Baltimore Sun, The (KRT) Via Thomson Dialog NewsEdge) Feb. 26--Four years ago, when Timothy Fagan was 16 and struggling to recover from a nine-hour operation that had replaced his liver and left him severely anemic, doctors prescribed a weekly injectable drug called Epogen to boost his red blood cell count.
It nearly killed him.
"Several hours after each injection, my son woke up screaming in pain," Fagan's father told a Congressional committee last November. "Tim was doubled over crying, screaming 'Help me,' and I didn't know what to do."
His doctors too, were dumbfounded -- until the pharmacy called eight weeks later. It turned out that Fagan, who lived with his parents in Long Island, N.Y., and filled his prescription from a local CVS, had purchased a fake pharmaceutical with a label dangerously doctored to look like the real thing.
About one-tenth of all prescription drugs on the market today are counterfeit, taking in about $32 billion per year, according to the World Health Organization, the United Nations' specialized agency for health. The organization, which held an international meeting on the topic this month in Rome, expects those numbers to double by 2010.
As many as 3 million fake doses were seized in the United States in 2004, 30 times more than the amount grabbed in 2000, according legislators who've studied the issue.
With drug prices at an all-time high, consumers are increasingly turning to the Internet and mail-order operations in search of better deals. And, until recently, some drug wholesalers who sell to major chain pharmacies like CVS were looking for bargains through so-called secondary markets. Some of those discounted drugs were forgeries, which have become easier to make as technology has improved.
The increase in fraudulent distribution has led to recent laws in some states stiffening licensing standards for distributors. Pharmaceutical companies have joined to find a solution to protect their brands' reputations. And the U.S. Food and Drug Administration may also soon require that drugmakers adopt electronic trace and track technologies to keep tabs on their products, from start to finish.
"The drug supply in the United States is probably among the safest in the world, but any counterfeit incident is a concern to us, so we want to make sure that the U.S. drug supply chain is as safe and secure as it can be," said Ilisa B.G. Bernstein, the FDA's director of pharmacy affairs.
Earlier this month, the agency held a two-day meeting to look at ways to ensure drug authenticity through package tracking or authenticating a medication's chemical makeup.
Over the last few years, a handful of businesses have launched various "drug verification" systems that can be used to help ensure a bottle's label matches its contents.
QS/1 Data Systems, a South Carolina division of the J.M. Smith Corp., offers subscription access to a database of images that pharmacists can use to make sure the pill they have in hand looks as it should. Two other companies -- CDEX Inc. of Rockville and Analytical Spectral Devices Inc. (ASD) of Boulder, Colo. -- make products that test the chemical makeup of medications.
ASD's RxSpec system, launched in late 2004, shines a light on a drug, developing a "near-infrared chemical fingerprint," chief executive Dave Rzasa said, and compares it to a known library of such prints to make sure they match.
The device currently is used by high-output pharmacies, including the Veterans Administration's Consolidated Mail Outpatient Pharmacies. But the company is also developing smaller systems for use in individual drugstores.
Drug verification, which some estimate could be a $2-billion industry, grew after a Kansas City case five years ago when a pharmacist confessed to diluting four chemotherapy drugs dispensed to 34 patients so he could pocket the difference. He later amended his count to include more than 60 diluted drugs, but FBI officials believe the count is much greater, affecting 98,000 prescriptions issued through 400 doctors to about 4,200 patients.
"The [counterfeit cases] we're identifying are the tip of the iceberg. I don't think anyone really knows how big the submerged part of the iceberg is," said Jerry Blair, vice president of marketing and sales for CDEX.
His company's ValiMed system, the first commercialized product for the 5-year-old business, works with drugs in liquid and solid form while ASD uses solids, like tablets, only at this point.
ValiMed beams a high-energy source through a drug, exciting its electrons and releasing photons, which then leave an individual "spectral signature" that the machine can read. The company hopes to find a customer base for it among border patrol agents, Homeland Security divisions and hospital pharmacists.
CDEX Chief Executive James O. Griffin conducted a demonstration for a reporter at his Rockville offices last month with what appeared to be a package of the anti-viral Tamiflu. At least that's what the box said.
Griffin mixed the drug in a liquid solution and popped it into a ValiMed prototype that looked like a typewriter case. A light flashed, a clicking noise ensued and seconds later a female voice announced: "Not validated." A stoplight graphic appeared on a screen for good measure.
"It's a very simple interface," said Griffin.
In a three-week period from December through January, customs border patrol agents in San Francisco, New York and Chicago confiscated 300 shipments of fake Tamiflu. That has some lawmakers worried that terrorists could attempt to attack the country through its drug supply, using the threat of an avian flu pandemic as an opportunity to tamper with vaccinations and affect a large portion of the population.
"We simply cannot risk vaccinating Americans with counterfeited therapy," Rep. Mark E. Souder, a Republican from Indiana, told Congress last fall.
While a growing problem, counterfeit drugs are relatively rare in the United States, compared to estimates in other parts of the world. In China, up to 30 percent of drugs may be fakes and as many as half of Africa's antimalarials could be phony.
Fake drugs are not the only problem verification systems are trying to solve. The Institute of Medicine estimates that about 8,000 Americans are killed every year from medication mistakes; that is, from taking the wrong medication or mixing it with another improperly. And some worry about "impaired clinicians" -- those at risk for substance abuse -- stealing drugs and substituting something else in their place when returning them to cabinets.
The University of Maryland Medical Center plans to use CDEX's ValiMed system to verify the contents of drugs to be administered and make sure leftover medications have not been tampered with. The hospital has not yet activated the system, though plans to do so soon.
"We are focused on patient safety at UMMC, and the CDEX ValiMed product offers us an additional opportunity to validate the end products being dispensed from the pharmacy and to validate returned narcotics," Marc Summerfield, the center's pharmacy director, said in a statement.
About 10 hospitals throughout the country have either licensed or tested ValiMed systems, though none are in place at neighborhood drug stores, where such a system might have made a difference for Timothy Fagan.
He's now a 20-year-old college student doing "as well as can be expected" for a transplant patient, his Manhattan attorney Eric Turkewitz said.
Fagan and his family had filed a multi-million-dollar civil lawsuit against the distributors and pharmacies that handled the fake Epogen he wound up taking. They settled the suit this month, Turkewitz said, though he couldn't talk about the details. He said he was heartened by recent efforts to curb counterfeit drugs, though.
Bills dubbed "Tim Fagan's Law" have been introduced in the New York state legislature that would increase penalties for criminal counterfeiters and allow for a maximum sentence of life in prison. And last year, the country's major drug wholesalers -- including Pennsylvania's AmerisourceBergen, which sold the phony Epogen to Fagan's CVS -- pledged to no longer buy drugs from discount secondary markets.
"I think that change is certainly not just in the wind, but on its way," Turkewitz said. "It can never come soon enough. If counterfeit drugs can infiltrate the Fagan house, they can infiltrate your house and my house and the White House and everybody else's house."
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