CDEX in the news....
Government, industry work to find remedy for phony drugs
Originally published February 26, 2006
baltimoresun.com
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"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 five-year-old business, works with drugs in liquid and solid form, while ASD uses only solids, such as tablets.
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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 said it hopes to find a customer base for the system among Border Patrol agents, Homeland Security divisions and hospital pharmacists.
CDEX Chief Executive Officer 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.
'Not validated'
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 started, 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," Griffin said.
In a three-week period from December into January, Customs Border Patrol Agents in San Francisco, New York and Chicago confiscated 300 shipments of fake Tamiflu. That has lawmakers worried that terrorists could try to attack the country through its drug supply, using the threat of an avian flu pandemic as a chance to tamper with vaccinations and affect a large portion of the population.
"We simply cannot risk vaccinating Americans with counterfeited therapy," Rep. Mark Souder, a Republican from Indiana, told Congress last fall.
While a growing problem, counterfeit drugs are relatively rare in the United States, compared with estimates in other parts of the world. In China, up to 30 percent of drugs might 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.
Also, 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 activated the system, though it 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, but none is in place at neighborhood drugstores, 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 multimillion-dollar civil lawsuit against the distributors and pharmacies that handled the fake Epogen he took. They settled the suit this month, Turkewitz said, though he didn't offer details. He said, however, he was heartened by recent efforts to curb counterfeit drugs.
'Tim Fagan's Law'
Bills dubbed "Tim Fagan's Law" have been introduced in the New York state legislature. They would increase penalties for criminal counterfeiters and allow for a maximum sentence of life in prison.
Last year, the country's major drug wholesalers -- including Pennsylvania's AmerisourceBergen, which sold the phony Epogen to Fagan's CVS -- pledged to not 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," he said.
tricia.bishop@baltsun.com |
