This editorial by Tim Mackey was published in STAT News on December 1, 2017. Tim K. Mackey, Ph.D., is an associate professor at the University of California, San Diego, School of Medicine; a fellow at the World Health Organization Collaborating Center for Governance, Accountability and Transparency in the Pharmaceutical Sector; director of Health Care Research and Policy at the University of California, San Diego, Extension; and director of the Global Health Policy Institute.
Are We Making Progress in the Fight Against Fake Medicines?
The World Health Organization report released this week showing that 1 in 10 medications in low- and middle-income countries are either substandard or falsified is alarming. The international trade in fake medicines, which rakes in billions of dollars a year, is estimated to harm hundreds of thousands of people every year. Yet this report belies a far more complex and large-scale global health challenge, one that the WHO is not equipped to tackle on its own.
I have spent nearly a decade researching the trade in fake medicines and know firsthand the limitations of trying to understand this dreadful problem. To estimate the size of the counterfeit medicine issue, the WHO turned to its Global Surveillance and Monitoring System, which was launched in July 2013. Although this system can help standardize reporting of counterfeit medicines, it relies on national regulatory authorities, which can limit what it captures.
Other monitors, such as the Counterfeiting Incident System provided by the Pharmaceutical Security Institute, a not-for-profit pharmaceutical security membership organization, have been collecting data from a variety of sources for more than a decade, including pharmaceutical companies and law enforcement agencies.
No surveillance system is perfect, especially when you are trying to quantify illegal activity that occurs across multiple jurisdictions. Research from my group, using Pharmaceutical Security Institute data from 2009 through 2011, identified a similar number of global counterfeit drug incidents (1,510 to be exact) as the WHO did, and a wide range of therapeutic classes, with anti-infective agents at the top of the list.
Yet there are differences in our analyses — likely the result of how the data are collected and who reports them — which may paint very different pictures of what drugs are being faked, what populations are being affected, and where public health and law enforcement officials should focus their efforts.
One case study we investigated, the 2012 infiltration of fake versions of the blockbuster anti-cancer drug bevacizumab (Avastin) into the U.S. drug supply chain, illustrates the challenges of detecting and protecting patients against fakes. The Food and Drug Administration sent nearly 1,000 warning notices to physicians and medical practices in 48 different states and two U.S. territories, informing them that they might have purchased fake versions of Avastin that had no active ingredient and were instead vials containing substances ranging from cornstarch to acetone.
Although about a dozen criminal prosecutions resulted from these fake medicines — none of which led to hefty jail time — we have no idea how many patients may have been given fake Avastin and died because of it.
Cancer patients are the perfect target for a fake medicine scheme: Their care is costly and their overall survival is low, meaning any failure in treatment may go undetected. In this case, even the most vigilant drug regulatory system, the FDA, was unable to proactively detect, prevent, or measure the impact of this fake medicine infiltration on patients.
Another case in point is the distribution of fake medicines via the internet. Open any search engine and type in “no prescription” followed by your drug name of choice and you will be flooded with links to online pharmacies that will sell you anything from erectile dysfunction drugs to antibiotics and cancer medications. Are these drugs genuine even though their pricing and packaging often make them suspicious? It’s hard to say, as few studies have assessed their actual quality and authenticity, though criminal prosecutions against these networks have revealed how the internet is used to traffic fake drugs.
Some drugs sold online are clearly dangerous, such as recent research from my group detecting websites that use social media to sell controlled substances, potentially fueling the national prescription drug crisis. The distribution of fake medicines through these alternative direct-to-consumer channels circumvents detection from national regulatory authorities, meaning we are getting an incomplete picture of the totality of the fake medicine problem.
The global trade in fake medicines is not monolithic. The challenges faced by individuals in low-income countries seeking anti-malarial drugs from their community pharmacies or the black market are different from the threats posed by counterfeit versions of fentanyl-laced pills sold by traffickers to satiate demand from people with opioid addictions in the United States. What they have in common is that trafficking falsified medicines is a crime against human health.
That fact brings the limitations of the WHO front and center: It has no enforcement powers and has been reticent to partner more broadly with other stakeholders on the issue. As a case in point, the WHO’s Member State Mechanism for combating substandard and falsified medical products is not inclusive and fails to adequate involve industry, academia, law enforcement, and civil society stakeholders, all of whom have an important role to play in the fight against fakes.
In the end, a statistic is only a statistic. The WHO’s numbers don’t provide new insight into the fake drug problem. The international community knows that fake drugs are a serious challenge to human health — and criminals know they can continue to profit from it.
Ongoing debate about access to medicines, intellectual property considerations, and drug affordability are important public conversations to have, but they are becoming an excuse for inaction in making real progress to address the clear and present dangers from fake medicines. Others have taken notice of the need to act — the Council of Europe is the home for the MEDICRIME Convention, the first international binding instrument that criminalizes counterfeiting of medical products.
What we need is sustained and coordinated action, strengthening law enforcement, legal and judicial capacity, and long-term investment in anti-counterfeiting measures, pharmacovigilance, and leveraging advances in digital technology such as blockchain and machine learning for supply chain data provenance and analysis. These efforts to enhance the resilience of the global drug supply chain must be carried out by inclusive and genuine partnerships, with the WHO leading from a public health standpoint and openly partnering with other international organizations, such as the United Nations Office of Drugs and Crime, the World Customs Organization, and Interpol, to engage all sectors that can help in the fight against fake medical products.
The WHO 1-in-10 headline, while alarming, reveals that much remains unknown, and that much work remains to be done.