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.