OPINION | New cancer drugs: First safety, then quickly to patients
Promising treatments must become available quickly, but not at the expense of safety. And people who benefit from them need access, says Professor Maarten IJzerman of the University of Melbourne Centre for Cancer Research Cancer Health Services Research group, and University of Twente Techmed Center.
Europe assesses cancer drugs far too slowly, says Professor Carin Uyl-de Groot in Trouw (14 September). It is a provocative article in which she takes a stand against the bureaucracy and the staff shortage at the European Medicines Agency (EMA) as the cause of the slow approval of new medicines.
This is an interesting but debatable position, at a time when the U.S. Food and Drug Administration is under political pressure to quickly authorise a COVID-19 vaccine. Scientists in the US are rightly concerned.
In a recent study published in the New England Journal of Medicine, reduced mortality from lung cancer is attributed to a new generation of targeted drugs that have been authorised in the period from 2013 to 2016.
That's good news for anyone dealing with this terrible disease, and plea for making promising treatments available quickly. But the real question here is not how long it takes regulators to approve these drugs, but when and for whom the drugs are made available.
The time it takes to bring new drugs to patients, depends on the time between submission and obtaining market approval from the EMA and the time needed to obtain reimbursement in each individual country. The latter in particular causes the delay. In some European countries, and in Australia, it takes up to three years before new medicines are available. That is a problem, but not a good argument for a comparison with the US, where it is unclear who the drugs are available to after approval, and who will actually receive them.
Making new medicines available quickly should not come at the expense of safety either. This is complex, as shown in a study in the British Medical Journal (2017). For most cancer drugs approved between 2009 and 2013, there was insufficient evidence that they improved survival or quality of life. In a period when the authorization of these drugs is based on increasingly smaller or on single-arm studies, i.e. without a control group, we cannot compromise on the assessment of safety.
I would much rather argue in favour of using authorised medicines as effectively and quickly as possible based on personal genetic information and creating the financial conditions for this. Slow admission says more about the complexity of current oncology research than it does about bureaucracy.
This piece was first published in Trouw.