Thursday, November 10, 2016

Expensive new cancer drugs have little effect on survival of many cancers

BMJ: Despite considerable investment and innovation, new cancer  drugs approved in the past 10 years may have little effect on  survival in adults with cancer, raising a number of concerns,  argues an expert in The BMJ today . Peter Wise, a former consultant at  Charing Cross Hospital in  London, says spending an annual six figure sum to prolong life  by a few weeks or months “may be inappropriate” for many  patients. In 2015, global sales of cancer drugs were around  $110bn (£85bn; €95bn) . He calls for stricter drug approval criteria and improved consent  processes “to achieve ethical treatment and reduce cancer costs."
” Cancer survival has improved in recent decades, he explains. In  the US, for example, five year relative survival in adults with  solid cancer increa sed from 49% in to 68% over 40 years . But how much of the improvement in cancer survival can we  attribute to new drugs, he asks? Other factors are more likely to  have been responsible. Many new drugs approved in the last  decade prolonged life by just one to two months . “The approval of drugs with such small survival benefits raises  ethical questions, including whether recipients are aware of the  drugs’ limited benefits, whether the high cost: benefit ratios are  justified, and whether trials are providin g the right information,”  writes Wise, whose major interests lie in the ethical elements of  medical research and care . He draws attention to limitations of cancer drug trials, such as  the use of surrogate endpoints that allow earlier approval of new  drug s, but are not always true indicators of survival benefit. And  he warns that the marginal responses in clinical trials may not  even apply to the majority of patients treated outside trials . He is hopeful that the recent integration of the Cancer Drugs  Fu

nd into the National Institute of Health and Care Excellence  (NICE) in England might make it possible to monitor the “real  world benefit” of these drugs . He also raises concern over the US Food and Drug  Administration (FDA)'s  accelerated and “breakthrou gh” category  which, he says, compounds the risk of premature approval on  limited evidence . “The low bar of approval for these expensive drugs ignores the  ethical principle of fairness and equity,” he writes. “By promoting  marginally better treatment of p oorly responsive cancers it  diverts valuable resources that might be better employed for  other health needs, within and outside cancer care. ” A lack of fully informed consent for cancer treatment is also a  concern, often leading to misinformed patients w ith unrealistic  expectations, he adds . “Good cancer care demands empowerment of patients with  accurate, impartial information followed by genuinely informed  consent in both the clinical trial and therapeutic settings,” he  writes. “Ethical impediments to  sound practice need to be  addressed and corrected. ” “Above all, the threshold for approval of new and existing cancer  drugs needs to be raised  - using more meaningful disease  specific criteria of risk - benefit and cost - benefit,” he concludes .