New York Times Op/Ed: Are You Buying Illicit Drugs?

In a New York Times Op/Ed published on March 31st, author Katherine Eban and Aaron Graham, former DEA Agent write about the recent pharmaceutical thefts and how this trend is made possible by “our haphazardly regulated pharmaceutical supply chain and the dangerous gray market that intersects it.”

According to the Op/Ed, “As soon as medicines leave manufacturers' loading docks, they enter a market teeming with middlemen, many legitimate, but some not. The drugs may move through a dozen hands, through small secondary wholesalers and repackagers. With so many middlemen involved, thieves can easily unload stolen drugs, which may be resold to pharmacies and hospitals and dispensed."

Ms. Eban and Mr. Graham then go onto detail to describe some of the more egregious recent incidents of pharmaceutical theft, diversion and counterfeiting.

Ultimately Ms. Eban and Mr. Graham conclude that the most effective way to deal with this growing epidemic which threatens the healthcare of consumers everywhere is through technologies that Track and Trace drugs throughout the supply chain. While Track and Trace technologies are important, they are limited in their effectiveness in that they were initially designed and implemented as inventory management tools. Basically these tools tell the supply chain where the box has been.

We at Secure Pharma Chain Blog believe that while it is important to know where the drug has been, ultimately knowing what is inside the box properly protects both the supply chain and the consumer. Track and Trace technologies require a comprehensive and complex, daisy chain of data flow while Authentication Technologies like XStream Systems’ XT250 can tell you what is inside the box and if it is safe to consume without maintaining an elaborate transaction pedigree.

The best solution is a multi-layered approach of a variety of solutions that thwart the opportunity for criminal organizations to profit from their deadly activities.

To learn more about authentication solutions, visit: http://www.xstreamsystems.net/.

To read the New York Times Op/Ed, visit: http://www.nytimes.com/2010/04/01/opinion/01eban.html?scp=1&sq=%2b%22Food+and+Drug+Administration%22&st=nyt.

ZERO IS THE RIGHT NUMBER!

By: Pat Earl, V. P. Business Development, XStream Systems, Inc.

If you had a chance to speak with Katherine Eban, Author of DANGEROUS DOSES, a Rhodes Scholar and a notable speaker these days on the safety of pharmaceuticals in the U.S., I know she would respond “we need to do more because counterfeit, diverted and adulterated drugs are still a real threat to America’s public safety.”

Today, I had the privilege to catch up with Katherine at her home in New York and ask her what her thoughts were on the vulnerabilities of the American drug supply.

Since Katherine released her best seller book in early 2005, the nation’s largest manufacturers and distributors have taken major steps to make the path a pharmaceutical takes from the manufacturer to the patient much safer. The FDA and the State Regulatory Agencies have developed standards for Supply Chain Security that includes identification, tracking, tracing, authentication and validation. As we look today, February 2009, four years have passed since she stunned the pharmaceutical industry and the American public with the chilling reality that criminal counterfeiters and scammers were contaminating the American drug supply. But the story has not ended here.

Globalization of the manufacturing processes has increased the opportunities for drug counterfeiting, drug diversion and other intentional acts that can adversely affect drug quality and safety. I shared with Katherine some of the observations that have stuck with me in my travels to visit some of the largest players in the distribution channel. There appears to be a complacency that pushes the responsibility to ensure that the product is not a fake up the chain.

Wholesalers draft policies to only buy from manufacturers or their sole distributors of record. Large chains and pharmacy benefit managers rely on the contracts that state their suppliers only buy from manufacturers and so on down the line. It’s obvious that there is a very real need for anyone receiving the drugs to be able to validate the path the drug has taken and to verify its authentication. What we are experiencing at all levels is …see no evil, hear no evil, speak no evil – so everything is fine and the problem is fixed.

In the conclusion of Dangerous Doses, Katherine reported that she was asked: “How would you define success when it comes to the problem of counterfeit medicine. What lower-percentage chance of getting such drugs should we be aiming for?” Her answer then was the same as it still is today. “There is only one answer to that question: ZERO.”

There is no such thing as a partial solution to the problem of counterfeit medicine.” Authentication of pharmaceuticals can be accomplished in a quick and easy fashion. Each drug has a unique formulation and therefore a unique molecular structure fingerprint that can be matched against that true standard to validate that the medicine in the package is not a fake, but is, indeed, the real deal.