The fight against counterfeit drugs
March 13, 2011 — 60 Minutes' nine-month investigation of counterfeit prescription drugs reveals how the dangerous and sometimes deadly fakes get into the nation's drug pipeline. Dr. Sanjay Gupta reports.
Counterfeiting medicines is on the rise in the United States and around the globe, putting patients at risk.
Counterfeit medicines are dangerous by their very nature – they are not produced under safe manufacturing conditions and they are not inspected by the regulatory authorities. Therefore, it is impossible for consumers to know what ingredients these products actually contain.
In recent years we have seen a spike in counterfeit medicines in the legitimate medicine supply chain. While the United States is fortunate to have a pharmaceutical distribution system that is generally considered to be among the safest in the world, new cases of counterfeit medicines are emerging every day and Pfizer is not exempt from being targeted.
“Counterfeit medicines pose a serious threat to patient health and safety. Patients who unknowingly purchase counterfeit medicines are denied the therapeutic benefit of the medicines their doctors have prescribed. Counterfeits pose a further risk because they may contain ingredients that are actually harmful. At Pfizer there is no higher priority than ensuring that every patient who purchases a Pfizer medicine receives an authentic product, one that is both safe and effective.” – John Clark, Vice President and Chief Security Officer, Pfizer Global Security
Even in countries generally considered "safe," such as Canada, the United States, and many of the European Union, counterfeit medicines have entered the legitimate supply chain, including counterfeit Lipitor®, Norvasc®, Viagra®, Zithromax®, and Celebrex®. During 2010, authorities from 53 countries seized almost 8.4 million tablets, capsules and vials of counterfeit Pfizer medicines. Many of the raids resulted from leads developed by Pfizer Global Security.
A number of factors have contributed to this rise in criminal counterfeiting activity. Included among them are the growing involvement in the medicine supply chain of under-regulated wholesalers and repackagers, the proliferation of internet pharmacies, advancements in technology that make it easier for criminals to make counterfeit medicines, the increased importation of medicines from Canada and other countries, and the relatively small risk and penalty faced by counterfeiters.
Pfizer believes that there is no higher priority than ensuring that consumers have safe and effective medicines. To realize this goal, both industry and regulators must work cooperatively around the globe to fight counterfeiting and secure the integrity of the pharmaceutical supply chain.
Pfizer has a team of experts who constantly assess new and existing technologies to identify those that will make it more difficult for those who counterfeit our medicines to make convincing copies, and for patients and healthcare providers to distinguish authentic from counterfeit Pfizer medicines.
“The research shows that [the problem of] counterfeiting of medicines is on the increase, and it's a substantial one. Globally we estimate the business is worth in excess of $35 billion a year and we predict that at a growth rate of between 12-16%, it will reach a value of $75 billion by 2010.” – Peter Pitts, Director of the Center for Medicine in the Public Interest
Recognizing that there is no “catch-all” solution, Pfizer is working closely with the U.S. Food and Drug Administration (FDA) and other regulatory authorities to ensure that pharmaceutical companies have the resources they need to implement the anti-counterfeiting technologies that work most effectively for their products. Pfizer is working collaboratively with wholesalers, pharmacies, customs offices worldwide, and law enforcement agencies to increase inspection coverage, monitor distribution channels, and improve surveillance of distributors and repackagers.
Pfizer has also created a diversified international team to rapidly address product integrity issues as they arise and work proactively to stop them from occurring. The team has focused on putting into place business practices designed to protect patient health, increase cooperation with law enforcement agencies to prosecute counterfeiters, and promote public policy that will help eliminate counterfeiting.
Addressing this rising threat requires a sophisticated, coordinated, and united response. Pfizer recognizes that in addition to its own initiatives, partnerships must be forged across government agencies, the health care community, patients, and third-party stakeholders, to ensure that patients have a safe supply of medicines and that justice is served to those who put patients' lives at risk.
We ask you to join us as a partner in this fight to protect patient safety.
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