The Role of Pharmaceutical Medicine in Public Health Emergencies (PHEs)

Introduction

AB opened the meeting by highlighting that Pharmaceutical medicine is the medical specialty concerned with the research, development, and monitoring of new medicines. Pharmaceutical physicians are involved at every stage in the development of new medicines and vaccines: translating knowledge into new medicines; evaluating repurposed or new medicines in clinical trials; promoting the well-being of research participants; understanding the safety and efficacy profiles of medicines; and ensuring the soundness of medicines in their manufacturing, public health implementation, and use by physicians and patients.

This webinar series actively implements the FPM’s commitment to the four core principles (Knowledge, Skills, and Performance; Safety and Quality; Communication, Partnership and Teamwork and Maintaining Trust), while also examining the role they played in pharmaceutical medicine’s ethical response to the COVID-19 pandemic as well as the role they should play in future PHEs.

The aim of this first FPM EPC Webinar Series is to reflect on, and learn from the response of the pharmaceutical research community to recent epidemics and PHEs, in particular the COVID-19 pandemic.

AB- Has pharmaceutical medicine, as a discipline and practice, successfully contributed to COVID-19 pandemic? In what ways, yes? In what ways, no?

TH -Health sciences have had an enormous impact so far during the pandemic. This is very different to the earlier pandemics we have had in the last 20 years. Very different to H1N1 in terms of how it impacts the lungs. Similarly, different to SARS and MERS. This virus impacts blood vessels and causes thrombosis that can present late following discharge from hospital. Endothelial injury and thrombosis are important mechanisms in this disease that were not understood at the beginning of the pandemic

We are learning a lot to add to what we had already learnt from SARS and MERS, however, this global pandemic has been an extraordinary experience for all of us and there are likely to be more such PHEs over the next decade.

A large number of clinical studies were set up in a short space of time necessitating an enormous amount of work from Pharmacovigilance, regulatory groups and drug supply. Many are international studies and medical contribution is at the heart of the design of these studies.

In what ways no? As an industry we have not perhaps picked up the wider societal and population impact from prior pandemics and perhaps this made us too defensive in terms of our work. We have not assisted decision making within society as such. There have been relatively few studies in terms of avoidance of contamination, cleaning of surfaces, nosocomial infection where Pharmaceutical physicians could contribute

AB- How have patients been taken into consideration by pharmaceutical medicine during this pandemic? COVID-19 patients? Patients not affected by COVID-19 but whose needs are still real?

ABo considered four separate patient groups:

1. Those with COVID 19 – participating in COVID 19 studies

· When thinking about the design of the studies, given the amount of care that is needed, it is important to keep the studies simple i.e. to ensure we can capture only relevant endpoints but not disrupt usual care

2. Those in ongoing clinical studies at the time the pandemic started

· Many trials were disrupted. However, the regulatory authorities acted quickly and flexibly (e.g. patients being able to receive oncology treatments at home as opposed to in hospital etc.).

3. Patients without COVID but with other diseases

· This group such as rare disease patients or cancer patient have been left behind (more will be discussed in later webinars)

4. The rest of the population – what about the information we have been able to get and how we communicate information

· It is important to work with the media to ensure that the right messages are out there.

AB Has pharmaceutical medicine contributed to global cooperation in responding to the pandemic? How? And how not?

PW -We still have to supply medicines and devices in relation to other diseases

Supply chains have needed to be reworked e.g. anaesthetics have had a challenge due to ‘just in time delivery’. The industry has also done a lot of work with respect to testing by testing systems both from an epidemiological perspective and also in contributing to clinical testing.

Repurposing of a number of therapies e.g. with respect to complement, cytokines or coagulation. This has all had to be done in the context of a time when manufacturing and supply is also a challenge for pharma, as it is for other industries.

The other help is in assisting in the design of clinical trials – encouraging studies that have clear meaningful outcomes. Initially case series were published from China which helped us think about the disease and pathology. However, this did not help resolve whether a drug may be beneficial. Congratulations to Gilead Sciences and others for the development of remdesivir in a very short time window. This drug has shown promise in accelerating time to recovery and preventing downstream effects if given early enough.

Both PW and ABo mentioned their positive recent experiences with regulatory agencies both MHRA and FDA, having been very responsive during recent interactions. ABo recommended using common sense, when providing Agencies with information, to keep to simple key facts initially and not overloading them with too much information in the early stages

Questions from the delegates: Q Pharma and politics – how much should Pharma companies get involved?

ABo – if companies are seeing things happening in the world, they should be involved and should comment. There were so many ideas about treatments and non-treatments early in the pandemic that needed course correction early on. Poorly-designed, underpowered studies may have opportunity costs for patients in terms of limiting their access to therapies with greater likelihood of benefit. Pharma has a role to ensure this is corrected and information accurate. Pharmaceutical physicians in companies have a duty to ensure they above all else do no harm.

Q. Will Pharma be seen more positively following this pandemic?

PW– a lot will depend on the price of future treatments and vaccines. The ethical question remains whether we/anyone should make a profit from this crisis?

TH– much less concerned about the cost as opposed to the efficacy. The cost to society of this pandemic has been huge. TH believes pharma is being viewed in a different way but it is going to be difficult to make people believe medicines work e.g. in the context of partial efficacy. For context not everyone takes up the flu vaccination. Very important to better communicate relative benefit and risk. If we can communicate this, then this will really help us

In summary, AB concluded that with 227 potential COVID-19 treatments globally and 159 vaccines in different stages of development, significant amount of work is undergoing currently. Many of the topic raised during this opening webinar today will be discussed in more detail in the ensuing seven Webinars in this series. The second Webinar will take place on 17 June 2020 16:00 to 17:00 GMT+1 (London Time) with the theme: ‘Clinical Research and Development in PHEs: Therapeutics’. This webinar examines the way clinical research and development has addressed the needs for therapeutics in response to the COVID-19 pandemic.

AB thanked the FPM organisers, the meeting sponsors and panellists and encouraged all to attend the next webinar in the series.