57% of the anticancer agents authorized by the EU were launched without demonstrating any effect

More than half of cancer drugs approved by the European Union between 2009 and 2013 did not provide evidence to improve the survival or quality of life of patients.

A study of the 'British Medical Journal' is very critical of the policy of approval of drugs to treat cancer in the European Union. In the 2009-2013 period, 57% of marketing authorizations for cancer treatments were done without sufficient evidence.

This situation, as pointed out by the team of specialists in public health at King's College London who have participated in the research, "can harm patients and cause a significant waste of public resources", in addition to "raising serious doubts about current mechanisms of drug regulation. "

Studies to approve a drug require a methodology that demonstrates a positive effect on several parameters. In the case of anticancer agents, the most important criteria are the increase in life expectancy or, in the case of chronic patients or those with palliative care, that improve the quality of life.

These points to be fulfilled, according to the authors, are sometimes replaced by alterative criteria that show "improvements in biological activity, but that does not have a greater survival". This substitution was highlighted by two studies, published in 2014 and 2015, which showed that the positive results in the new criteria did not imply the improvements established in the original criteria.

The aim of the new study is to point out that this practice of substitution of parameters is greater than desired, since the European Medicines Agency (EMA) approves them in more than half of the cases using what in the study they call "indirect criteria of assessment".

In the five years, 48 ​​new agents against cancer were approved by the European Health Authority, used in 68 different drugs, which require specific individual studies.

However, 39 of them received the green light from the European regulator without demonstrating an improvement with respect to existing treatments in quality of life or in survival, criteria that the EMA considers to be the most important. In some of these cases, according to British scientists, the results were "often marginal".

"The European Union should rethink the extent to which they approve anti-cancer drugs based on substitution criteria," the authors point out in their study.