Over the past 30 years, regulatory initiatives have allowed new drugs to be marketed earlier, on the basis of weaker evidence. These initiatives are claimed to benefit patients and public health by fast-tracking new medicines to patients in need, with the assurance that full evidence on efficacy and safety can be collected after drugs are launched on the market and being prescribed to patients.

However, extensive research by King’s academic and Reader in Global Health and Social Medicine, Dr Courtney Davis, found that this wasn’t the case. As such, Davis came out with one clear recommendation to solve the problem – regulators must raise the standards needed to approve medicines.

Enhancing cancer drug regulation

Part of the research looked at the regulation of new cancer drugs, the single largest category of new drug approvals in Europe and the US.

The analysis, undertaken between 2009 and 2013, showed that at the point of approval, most of the drugs lacked evidence that they would either extend survival or improve the quality of the patient’s life. It also showed that the follow-up studies required by medicines regulators once drugs were on the market rarely gather the evidence to resolve these key uncertainties.

The World Health Organization (WHO) used this vital information when putting together their Essential Medicines List – a list of the most efficacious, safe and cost-effective medicines for priority conditions. The working group behind this list stated that “overall survival [was] the main eligibility criterion of a medicine proposed for EML listing.”

A WHO expert advisor also explained that Davis’ research “has been pivotal in drawing attention to the often marginal and uncertain benefits offered by many new cancer drugs relative to their price”.

Empowering advocacy groups and patient activists

Beyond influencing international policy on cancer drugs, Courtney Davis has worked to create a more inclusive and transparent conversation around medicines.

Davis has worked closely with advocacy groups and consumer health organisations to help them effectively scrutinise policymaking and regulatory bodies so they can pursue better outcomes for patients. She’s also worked with patient activists in the UK to help them engage more effectively with politicians and decision-makers.

As a result, advocates are now putting more focus on the importance of regulatory standards for generating robust and patient-relevant evidence.

One example where this data has made a real difference is through Just Treatment, a patient-led campaign group. Just Treatment were able to use Davis’s research to influence the Labour Party ahead of the general election in 2019, who used the group’s proposals to create a paper called ‘Medicines for Many’.

Although Labour didn’t win the general election, this was a step in the right direction to ensuring that patients are accessing medicines and treatments that are safe, effective and worthy of the ‘breakthrough’ status they’re given.