The editors at The Catalyst recently asked John P. Clark, Vice President and Chief Security Officer, Pfizer Inc., a few questions about being on the front line in the battle against foreign counterfeit medicines. John provided a snapshot of the risks patients could face if the closed U.S. drug supply system were to open up. I urge you take a close look at all the pictures provided by Pfizer Inc. - counterfeit medicines are often made in dirty foreign manufacturing sites that look like this.
[caption id="attachment_2322" align="alignleft" width="150" caption="Photo credit: Pfizer"]
[/caption] How has your background in law enforcement prepared you for your role at Pfizer as Chief Security Officer and Vice President of Global Security?
During my 28 years in federal law enforcement, I worked in three federal agencies - U.S. Border Patrol, U.S. Customs, Immigration and Customs Enforcement (ICE) - under three departments within the Executive Branch - Justice, Treasury and DHS - in five cities. As Deputy Assistant Secretary at ICE, I managed an agency of approximately 20,000, and was responsible for global smuggling investigations (Office of Investigations), physical security at federal facilities (Federal Protective Service), coordinating ICE enforcement operations (Office of International Affairs), protecting air passengers (Federal Air Marshal Service), and collecting and analyzing data from ICE operations (Office of Intelligence). The wide variety of those assignments provided me with invaluable experience and aligns well with my responsibilities as Pfizer's Chief Security Officer, where I am responsible for global anti-counterfeiting, the safety of Pfizer's colleagues and facilities, and mitigating the threat that counterfeit medicines pose to patients. My Pfizer team has dedicated members - including experienced investigators, analysts and experts in physical security and crisis management - that, in my view, is the gold standard for a corporate security department. [caption id="attachment_2324" align="alignright" width="150" caption="Photo credit: Pfizer"]
[/caption] Have you seen a dramatic increase in the illicit trade of counterfeit medicines over the years? If so, what do you think is causing the upward trend?
We have seen an increase in the number of countries in which counterfeit Pfizer medicines have been confirmed - 105 as of March 31, 2012. What was once seen as a problem limited to lifestyle medicines is now recognized as a threat from which no therapeutic area is immune. In fact, we have confirmed the presence of more than 60 Pfizer medicines. We have seen an even more dramatic increase in the number of countries in which counterfeits have breached legitimate supply chains - on pharmacy shelves and dispensed to patients. As of March 31, 2012, we have confirmed counterfeit versions of 23 Pfizer medicines in 56 countries. Pharmaceutical counterfeiting is a low risk, high profit criminal enterprise that attracts entrepreneurs and organized criminals. We have seen those who have previously trafficked in narcotics and firearms turn to counterfeiting medicines because they can earn more money and face much lighter penalties even if caught and convicted. Advances in technology have made it easier for those who counterfeit our medicines to make very convincing copies, often making it virtually impossible to tell the difference between the counterfeit and authentic medicine without a full chemical analysis. [caption id="attachment_2323" align="alignleft" width="150" caption="Photo credit: Pfizer"]
[/caption] Can you give an example of a counterfeiting case that really illustrates the threat that we're facing?
The case of Kevin Xu is an excellent example of how counterfeit medicines can breach even the most highly regulated pharmaceutical supply chain. Xu was the target of simultaneous undercover investigations by US ICE, Pfizer and another PhRMA member company. During conversations with the undercovers he boasted that he was able to produce medicines to meet the demands of his customers, as well as packaging for specific markets into which they intended to sell his counterfeit. Xu boasted of having the ability to breach legitimate supply chains, a boast that was confirmed by authorities who linked him to the May 2007 recalls of major products from the legitimate supply chain in the U.K. [caption id="attachment_2321" align="alignright" width="150" caption="Photo credit: Pfizer"]
[/caption] How real is the counterfeit medicine threat in the U.S.?
While the U.S. regulatory system is often help us as the gold standard, we are not immune from the threat posed by counterfeit medicines, as evidenced by the introduction of a counterfeit cholesterol-lowering medicine in 2003 and a counterfeit cancer therapy in 2012. The greatest risk to U.S. patients, however, is to those patients who purchase medicines from unlicensed, unregistered internet pharmacies, who place themselves at risk of receiving a counterfeit product. The real danger in order medicines over the Internet is the complete lack of transparency as to the true location of the "pharmacy" from which you placed the order and the source... and authenticity... of the medicines they dispense. While medicines can safely be purchased from those pharmacies that are licensed and registered - such as those with the National Association of Boards of Pharmacy's VIPPS certification - the vast majority are no more than convincing "shells." Furthermore, the World Health Organization has estimated that consumers who order medicines from "rogue" online pharmacies - those that conceal their true location and the source of their medicines - have a 50% chance of receiving a counterfeit medicine. [caption id="attachment_2320" align="alignleft" width="150" caption="Photo credit: Pfizer"]
[/caption] What about in other countries around the world with weak regulatory systems?
The threat that counterfeit medicines pose to patient health and safety is much greater in those countries with weak regulatory systems. Do you think the closed U.S. drug supply system is helping to safeguard American patients from the counterfeit medicine epidemic?
Yes. Because a "closed" system, such as that currently in place in the U.S., provides transparency of the supply chain, it affords patients the greatest level of protection from counterfeit medicines. As recent events have shown, it is when those involved in the distribution of medicines go outside of that well-established chain that counterfeits breach our supply chain. [caption id="attachment_2319" align="alignright" width="150" caption="Photo credit: Pfizer"]
[/caption] Many people think that "Canadian" online pharmacy sites are safe to purchase medicines. Do you think this is the case?
No. Many rogue websites - those that conceal their true location and the source of their medicines - place a maple leaf on their website hoping to trick patients into believing that the medicines they will receive come from Canada, which has a strong regulatory system. The RxNorth case is an excellent example, however, of how easily patients can be fooled. Although patients who visited the website thought they were ordering safe and effective medicines from Canada, the medicines they received were counterfeits manufactured in China and shipped through various countries to disguise their true source. Some of the counterfeits had inadequate levels of the active pharmaceutical ingredient; others were laced with heavy metals. U.S. patients can order medicines safely on line by ordering from an online pharmacy that bears the NABP's VIPPS certification. Some policymakers want to open up the closed U.S. drug supply to foreign drugs. Do you think this is a good idea?
No. We should not place the health and safety of U.S. patients in the hands of those with weaker regulatory systems. A secure supply chain, one in which there is complete transparency between manufacturer and patient is critical. The more times a medicine changes hands between the manufacturer and the patient, the greater the likelihood that a counterfeit could be introduced into our supply chain and dispensed to an unsuspecting patient.