The majority of cancer drugs approved in Europe in recent years entered the market “without clear evidence that they improved survival or quality of life for patients”, according to a UK study published today.
Even where drugs did show survival gains over existing treatments, these were often marginal, the results published in the British Medical Journal indicate.
Dr Robert O’Connor, the Irish Cancer Society’s (ICS) head of research, said he supported the findings, adding that better validation and approval systems needed to be in place in Ireland, given cancer trends and demands on the health service.
The UK study found that many of the drugs were approved on the basis of indirect measures. These do not always reliably predict whether a patient will live longer or feel better, raising serious questions about the current standards of drug regulation.
The researchers, based at King’s College London and the London School of Economics, concluded: “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.”
The team analysed reports on cancer approvals by the European Medicines Agency between 2009 and 2013.
Of 68 “cancer indications” (ie, drugs that can be used to treat a particular disease) approved during this period, 39 (57 per cent) came on to the market without evidence that they extended survival or improved the quality of patients’ lives. Only 35 (51 per cent) had shown a survival or quality of life gain over existing treatments or placebo in the following five years. For 33 drugs (49 per cent), uncertainty remains over whether they extend survival or improve quality of life.
Dr O’Connor said he was familiar with the work of the authors, who had raised “very valid issues” that were going to increasingly impact on society. This was against a backdrop of rising drug costs and pressure on health services. In Ireland’s case, cancer rates are predicted to double over the next 25 years and with an ageing population, cases would be concentrated in older people.
He accepted science had brought tremendous advances with reduced mortality and survival rates improving by 1 per cent a year, and that people wanted every possible care available. But there was a particular difficulty with drugs used in immunotherapy, he said, such as those used in the treatment of lung cancer and skin melanomas, which in the past were difficult to treat and had poor success rates.
With new drug treatments, “they come with very significant costs, and we don’t know who will benefit”.
Some people see tumours disappearing, while data shows others not benefiting and in some cases, people’s condition deteriorates. “The necessary tools are not properly developed to fully evaluate these drugs,” Dr O’Connor said.
He cited the case of a melanoma drug, where in one out of two cases patients might get a couple of extra months survival, while more that 50 per cent experienced toxic effects, from a treatment costing up to €150,000 a year.
