30% of countries have little or no regulation to effectively combat #fakemeds
© Lilly, Machine used to make counterfeit tablets – Bogota, Colombia, November 2011
As Advisor on Lilly’s Global Product Protection Technical Team, Mike Dalton oversees technical personnel who conduct authentication testing of samples of suspected counterfeit medicines. The Global Product Protection Technical Team serves as one piece of an integrated network of experts inside and outside of Lilly work as a cohesive unit to stop pharmaceutical counterfeiting.
Each suspected counterfeit medicine tells a story. It can tell you about where counterfeiting originates, where they are distributed around the globe, what patient populations and therapeutic drug classes are targeted, and where these counterfeited products may end up. Suspect samples come from a variety of sources such as proactive internal investigations by Lilly, external investigations by governments and law enforcement agencies, and product complaints reported by consumers and healthcare providers. Regardless of where they come from, every sample that we receive and test has the potential to harm patients.
Counterfeiters will prey on any patient population or disease state where there is money to be made. They will also go through great lengths to make their products look like the authentic packaging and products. The global scope of the counterfeit drug trade has grown from lifestyle drugs such as erectile dysfunction medications, but also to life-saving medications like cancer and diabetes drugs. Unsuspecting patients, in many cases, cannot tell the difference just by looking at these counterfeits. It is only when patients take these counterfeits that they may realize they are not authentic, and by that time – it’s too late. This is why I take my job so seriously.
From time to time, I am called on to testify in a court of law about data and conclusions generated by Lilly experts who authenticate suspected counterfeit samples. During these trials I have a unique opportunity to see the face of the individuals involved with manufacturing and/or distributing these counterfeited products. Though I know there is a lot more work that needs to be done to protect patients from these criminal networks, I feel a great sense of accomplishment when the testimony that I give results in a successful conviction. These convictions demonstrate the commitment that pharmaceutical companies and government agencies are making to protect patients. Each conviction sends a message that this crime against patients will not be tolerated.
At Lilly, the patients who take our medicines are at the heart of everything we do. There are many highly-skilled individuals within our company who have devoted much of their careers to fighting pharmaceutical counterfeiting – people from Quality, Manufacturing, Security, Legal, Corporate Affairs, Patient Safety, Medical, Regulatory Affairs, and many other areas. I am but a small part of Lilly’s overall anti-counterfeiting cross-functional team; however, I do feel a great sense of pride in the work we do that ultimately results in protecting those who trust in the red “Lilly”.