A new study examining the effectiveness of new cancer drugs claims that the majority of them show no clear evidence of improving a patient’s life.
An analysis of five years’ worth of new approved cancer drugs has cast considerable doubt on their effectiveness and ability to improve a patient’s quality of life.
The study – conducted by researchers from King’s College London and the London School of Economics – looked at all of the latest cancer drugs approved by the European Medicines Agency (EMA) between 2009 and 2013.
In a paper published to The BMJ, the researchers claim that of 68 cancer indications approved during this period, 57pc (39) were given the go-ahead with no evidence that they extended survival or improved the quality of patients’ lives.
It added that after a median of five years on the market, only an additional eight drug indications had given any improvement.
Out of the 68 drugs approved by the EMA, the study claims that the actual number of beneficial drugs amounted to 35 (51pc) over existing treatments or placebos, while the remaining 33 (49pc) were left uncertain as to their benefits.
Limitations to study
The researchers in their paper said of the findings: “When expensive drugs that lack clinically meaningful benefits are approved and paid for within publicly funded healthcare systems, individual patients can be harmed, important societal resources wasted, and the delivery of equitable and affordable care undermined.”
However, they admitted that there are several limitations to their study that would require further research.
Among them was examples of considerable variation in the reporting of quality of life benefits and the fact they did not consider the appropriateness of clinical design means that they may have overestimated the benefits offered by some of the drugs in their sample.
Despite this, the team said their findings raise the possibility that regulatory evidence standards “are failing to incentivise drug development that best meets the needs of patients, clinicians, and healthcare systems”.
‘Cycle of weak evidence and uncertainty continues’
Last month, the EMA convened its first meeting to discuss a streamlined drug authorisation process across Europe.
The purpose of the meeting, the EMA said, was to speed up patients’ access to and cost for new medications by eliminating inefficiencies from clinical trials to regulators and on into public use.
Dr Deborah Cohen, associate editor at The BMJ, pointed out in an accompanying piece examples of methodological problems with trials that the EMA had either failed to identify or overlooked, including trial design, conduct, analysis and reporting.
“The fact that so many of the new drugs on the market lack good evidence that they improve patient outcomes puts governments in a difficult position when it comes to deciding which treatments to fund,” she said.
“But regulatory sanctioning of a comparator that lacks robust evidence of efficacy, means the cycle of weak evidence and uncertainty continues.”