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A notable rallying cry that emerged early during the Covid-19 pandemic was “flatten the curve.” It reflected the reality that hospitals lacked the resources, knowledge, and therapies to accommodate everyone in need.

Nearly 18 months later, the situation around the globe is different. Clinicians have a better understanding of how to prevent Covid-19, and how treat people with severe cases of it. Vaccines have brought much-needed relief.

But the picture is now being complicated by the emergence of substandard and falsified Covid-19 vaccines and medical products, which are becoming increasingly pervasive.

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Counterfeit vaccines and medicines, which include substandard and falsified products, can undermine the efforts to control the pandemic. These products can’t prevent or treat Covid-19, thus contributing to its spread. People developing Covid-19 after getting counterfeit vaccines would erode trust in vaccination and contribute to vaccine hesitancy. Substandard and falsified drugs and vaccines could lead to a proliferation of variants of concern and ultimately lead to resistance down the road.

Counterfeit medicines aren’t new to Covid-19. The World Health Organization, which has tracked them for several years, once called them “substandard/spurious/falsely-labelled/falsified/counterfeit medical products.” The WHO estimates that 1 in 10 medical products in low- and middle-income countries is falsified or substandard, causing huge personal and public health tolls are huge. The economic burden is as much as $200 billion a year.

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Now that “flatten the curve” is no longer the focus in many parts of the U.S. and in other countries, we believe it should be replaced by “steepen the gradient.” The gradient being the slope of the curve indicating the total number of people who are vaccinated. The steeper the slope, the faster people are being vaccinated.

The frantic chase for vaccines and therapeutics has been characterized in the media as the “Vaccine Hunger Games.” The shortage of vaccines and medicines, and the potential for harm from counterfeit ones, have already taken hold of the popular imagination, much as it did in the 1949 movie “The Third Man,” based on the novella by Graham Greene about Harry Lime, a smuggler of fake penicillin in post-war Vienna. In early March this year, talk show host Jimmy Kimmel aired a skit with Sacha Baron-Cohen portraying himself as an unauthorized peddler of Covid vaccines, suggesting the issues that lay ahead in ensuring strict quality control.

The potential of counterfeit vaccines and medicines for immediate harm to the individual is fairly clear. By not preventing or curing an ailment, a counterfeit therapy could lead to a worse course, or even death. At the societal level, fake medicines or vaccines could lead to infectious outbreaks and increased spread as infected individuals stop social distancing and adhering to other precautions because they wrongly assume they are protected.

While resistance to a particular therapeutic is a natural evolutionary process, human activities can expedite the proliferation of drug-resistant pathogens. In the case of antibiotics, overprescription, improper use, and poor adherence contribute to the development of antibiotic resistance. Less well-studied is the role of substandard and falsified therapeutics, though there is emerging evidence linking the use of substandard and falsified medicines to antibiotic resistance.

The dynamics of resistance (within and between hosts) can be understood in the light of mathematical models that describe the epidemiology and evolution of microbial populations. In a network-based approach, researchers are able to demonstrate that the presence of a fake drug can increase the level and duration of resistance. Hence the need to steepen the gradient of quality vaccines to overcome this resistance.

While the development of resistance to vaccines and therapeutics by SARS-CoV-2, the virus that causes Covid-19, is a real concern, substandard and falsified products affect public health efforts in ways that go beyond resistance. The presence of counterfeit vaccines could lead to an individual getting a fake vaccine for their second shot, giving the SARS-CoV-2 virus a chance to multiply and mutate in the host. Fake therapeutics could lead to repeat outbreaks in regions thought to have the disease under control.

Substandard and falsified products are also likely to disproportionately affect socioeconomically disadvantaged communities and countries in which the regulatory framework is weak. The erosion of trust in the system, among people in the regions where quality and fake medicines get mixed up, can have long-range implications for millions of people.

In tackling the issue of substandard and falsified vaccines and therapies in the battle against Covid-19, data regarding drug resistance may offer some policy insights. The regions of the world most plagued by antibiotic resistance match up quite well with regions where the problem of substandard and falsified therapeutics is acute. But this information could also be turned around and used as a surveillance and predictive tool: In regions of the world where new strains are routinely emerging, it may be worthwhile to investigate if they are being plagued by substandard or falsified therapeutics. Quick action in these places could save lives and contain the more lethal variants.

Studies of criminogenesis indicate that there are a variety of human-mediated factors that cause peddlers of counterfeit medicines to move into certain regions. Being human-mediated means they can often be counteracted through policy changes and effective enforcement of those policies.

With social media and the dark web, the speed and extent of the spread of fake medicines is frightening and may be even faster than the speed at which a mutant strain arrives in a community.

If left unchecked, the annual death rate due to antimicrobial resistance could swell twentyfold, from approximately 700,000 today to more than 10 million by 2050. A significant portion of these deaths could be averted through greater recognition by the scientific community, awareness from the society at large, and action from policymakers to confront the problem of substandard and falsified therapeutics head-on.

It is critical to strengthen and harmonize international cooperation in the creation of surveillance networks for detecting and containing the spread of fake vaccines and drugs. This will require adopting common policy definitions and standards, enhancing the ability to share information across surveillance networks and enforcement agencies, and strengthening existing coordination structures. Also needed is the development of innovative epidemiological and microbiological methods for better surveillance, data collection and faster identification of drug resistant pathogens.

The graph below shows the total number of “discovery incidents” — discrete events triggered by the discovery of counterfeit, illegally diverted, or stolen materials — more than doubled between 2014 and 2020. Instead of interpreting this increase as a symptom of a problem growing unchecked, we prefer to take the glass-half-full view and see it as an encouraging sign that the world has woken up to the problem of substandard and falsified therapeutics and is working to address it.

Patrick Skerrett / STAT Source: Pharmaceutical Security Institute

There is a real danger that the presence of counterfeit vaccines and medicines will allow Covid-19 to become endemic, a near-permanent and potentially overwhelming disease, especially in low- and middle-income countries. What we need now is to steepen the gradient and ensure equitable access to quality therapeutics, because it is good public health policy and morally the right thing to do.

Muhammad H. Zaman is a professor of biomedical engineering at Boston University. Ravi Sundaram is a professor of computer science in the Khoury College of Computer Sciences at Northeastern University in Boston. Walter Gabriel is a post-graduate research associate at the Yale School of Medicine. They are part of a multi-institution consortium to study counterfeit and substandard medical products. The authors would like thank their colleagues Nikos Passas, Mansoor Amiji, and Ioannis Kakadiaris for their input and guidance.

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