Michael Levy, head of pharmacovigilance at Bayer Pharma and Bayer Consumer Health, makes a compelling case for the critical role of pharmacovigilance in ensuring ensuring patient safety and future-proofing the global pharma industry amidst the rush to develop and repurpose treatments and vaccines for COVID-19.
The COVID-19 virus overtook the world this year, claiming over a million lives and causing widespread economic disruption and societal unrest. We find ourselves living out the pages of the next generation’s history books: a global pandemic whose effects will last long after the outbreaks of disease are mitigated. Facing the challenges of COVID-19, the world is pushing for quick answers from a research system that is not built for speed. So, how is the industry rising to these challenges and keeping patients safe?
There are three therapeutic approaches to addressing novel infectious diseases: develop and offer new treatments, develop and offer a vaccine, or repurpose existing treatments.
Although hopes are pinned on a vaccine, historically, the lead time from lab to human has been a decade or more. New treatments take a similar amount of time to reach patients, and by design, do not prevent infections, which is why a vaccine is seen as the magic bullet that can return life to normal. However, in the face of the pandemic that has brought so much disruption to our lives, the world isn’t prepared to wait that long.
By repurposing or expanding the indications of drugs that are already approved, or are in the late stages of clinical trials, as potential treatments of COVID-19 and associated sequelae, we may be able to develop effective options for clinical use far faster than a vaccine. So, while we wait for an effective vaccine that can be manufactured at the scale required to make an impact, the more drugs that we test, the more likely we are to find something that works. From anticoagulants targeting thrombotic events in COVID-19 patients to multiple sclerosis treatments that regulate the immune response, research approaches are extremely diverse. The pharmaceutical industry is joining forces with the global community to fight the virus, providing scientific expertise and resources in the search for an effective treatment.
Worldwide, there are more than 2,000 studies ongoing, testing existing drugs to fight the many ways the virus can cause harm. Pharmacovigilance plays a critical role in reviewing any such study initiatives or investigator-initiated research because there is no guarantee that a drug approved for another condition will be equally safe for the treatment of COVID-19, particularly if dose and regimen differ. So, surveillance of the safety of these drugs in the COVID-19 treatment setting is an obvious priority – monitoring, assessing benefit-risk profiles and detailed reporting of all adverse events related to this kind of off-label use of medicines is vital to protecting public safety. It additionally helps to ensure that the impact of COVID-19 does not alter the benefit-risk or safety profile of drugs in their established indications.
Given the uncertainty and volatility caused by the pandemic, pharmacovigilance remains a pillar of stability with scientifically-driven benefit-risk analyses which protect patients and populations. For example, many viewed the recent pause of the Oxford COVID-19 vaccine trial after an adverse event as a disappointing delay. But, in reality, the delay demonstrated that pharmacovigilance safeguards are more important than ever, especially when innovation and clinical development are moving at unprecedented speeds.
Pharmacovigilance has the processes, technologies and mandate to steady the ship against the storm and prepare the pharmaceutical industry for the future, which may be even more volatile than the current situation. By diligently monitoring how existing treatments are being tested in new indications and in different settings, pharmacovigilance can analyze the data and provide information to health authorities so that they can promptly amend national treatment protocols. Further, by supporting cooperation between industry, academia, governments and health authorities, potentially safe and effective treatments can be identified and rolled out to patients as quickly as possible.
Although pharmacovigilance data use and processes generally remain the same, there’s an intensified demand for quick and effective risk assessment given the vast scale and justifiable urgency with which we tackle the virus. To this end, the timely review of incoming data and real-time signal detection is crucial in continuously providing important safety information that healthcare providers need. To meet these challenges, pharmacovigilance has had to adapt.
First, those working in pharmacovigilance have increased cross-functional cooperation with colleagues from other areas of expertise to cope with the dynamics and speed that the industry needs to identify insights. In a working environment that looks very different from a year ago, pharmacovigilance has also become even more predictive, protective and proactive in its decision making. Furthermore, pharmacovigilance leaders must remain dedicated to keeping their employees engaged and vigilant to preserve business continuity and build resilience in a highly dynamic environment.
Secondly, the industry is capitalizing on technology to keep effective oversight of the ever-evolving situation. AI technology can find complex connections within the enormous quantities of incoming data from the use of existing drugs in new indications. As a result, the process of data evaluation and documentation that is reported to health agencies can be far faster. By enabling the efficient identification of valuable real-time insights, hidden patterns and correlations from the sheer volume of complex data available, AI can support informed and reliable strategic decisions for patient care. So, as well as proving the value-added case of a drug treatment, pharmacovigilance ensures that decisions are evidence-based, not hope-based, in the rush to find an effective treatment for COVID-19. At Bayer, we are already employing Artificial Intelligence (AI) technology to fulfil our purpose of “Science for a Better Life”, to protect patient safety and make our contribution to identifying more precise, targeted treatments to fight the COVID-19 pandemic and future challenges.
However, to continue rising to the challenges of COVID-19 and future public health events, global pharmacovigilance needs to further adapt in the following ways:
- Increase the implementation of technologies to improve assessment of complex, real-time data.
- Improve sharing and partnering within pharmacovigilance communities and engage more cross-functionally to increase understanding of the safety and efficacy of drugs.
- Further increase collaboration with health authorities and bring even more clarity to the field by sharing knowledge and insight.
The COVID-19 pandemic has resulted in unprecedented global challenges and pressure on researchers to find answers. Given the understandable urgency with which we tackle these challenges, we cannot afford to lose sight of patient safety as a quid pro quo for a speedy solution. More than ever, pharmacovigilance experts have a crucial role to play in establishing how our expertise, knowledge and methodologies can help protect patient safety globally.