Almost two thirds (57%) of cancer drugs authorised by the European Medicines Agency (EMA) between 2003 and 2009 came onto the market without any clear evidence they improved the quality or quantity of patients’ lives, according to research from King’s College London and the London School of Economics and Political Science (LSE), published in the BMJ today.
The research team, led byDr Courtney Davis (GHSM, King’s College London), Dr Ajay Aggarwal (from the Institute of Cancer Policy at King’s) and Dr Huseyin Naci (LSE), and funded by Health Action International, found most cancer drugs are approved by the EMA using only surrogate measures which, although indicators, are not strong predictors of survival – whether living longer or feeling better.
Dr Courtney Davis, a medical and political sociologist in the Department of Global Health and Social Medicine at King’s College London who led the team said: ‘We evaluated the evidence base for all new drugs entering the market over a 5 year period and found that the majority came onto the market without clear evidence that they improved patients’ survival or quality of life. A large number of people are undergoing treatment for cancer and little new information is available to guide patients and their treating clinicians regarding drug effectiveness. When expensive drugs that lack robust evidence of clinical benefit are approved and reimbursed within publicly funded healthcare systems, individual patients may be harmed and public funds wasted. ’
This low level for authorisation means a significant number of cancer drugs, available on the European market and often promoted as ‘breakthrough therapies’, have no actual demonstrable benefit over existing treatment options or placebo. This leads to false hope and exposure to unnecessary drug toxicity for some patients as well as being a significant waste of important resources and funding.
The team also found that even after a median follow-up of five years, almost half of the drugs (49%) still showed no quality or quantity of life benefit and of those that did, these benefits were judged to be clinically insignificant around 50% of the time.
As a result of these findings, the researchers are calling on the EMA to increase its evidence bar for the market authorisation of new drugs.
Notes to Editors:
For more information or interview requests with Dr Courtney Davis please contact Claire Gilby, PR Manager (Arts & Sciences), on 020 7848 3092 or firstname.lastname@example.org.
There are a number of study limitations to this research including incomplete and variable reporting of results from the EMA and the scientific literature leading to possible overestimation of the proportion of drugs that offer survival or quality of life benefits. The appropriateness of clinical trial design was not considered and the team did not take account of negative studies for the same drug-indication, so the findings do not reflect the totality of the evidence base for a specific authorised indications.
Dr Courtney Davis is also the Director of the MSc in Medicine, Health and Public Policy at King’s College London. Applications for the programme are open for entry September 2018. For more information about the MSc see here: