More Than Half of Cancer Drugs Have No Effect on Patients

'There is a clear need to raise the bar for approving new cancer drugs, ' said Huseyin Naci of LSE.

The study, performed by researchers from the United Kingdom and Latvia, evaluated the availability of evidence on survival and quality of life benefits of drugs that had been approved by the EMA between 2009 and 2013.

Apart from dashing patient hopes, allowing unproven medicine onto the market also unnecessarily exposed people to toxicity inherent in all drugs, while inflating state pharmaceutical spending.

The research team analysed reports on cancer approvals by the European Medicines Agency (EMA) from 2009 to 2013.

The study was published online Thursday in the journal, BMJ. Well, it turns out many patients would be no better off taking a placebo.

Lead author of the study Dr Courtney Davis, a medical and political sociologist in the Department of Global Health and Social Medicine at King's College London, explained: "We evaluated the evidence base for all new drugs entering the market over a 5 year period and found that the majority came onto the market without clear evidence that they improved patients' survival or quality of life".

Since most cancer drugs cost about $100,000 per patient per year, it is not surprising that cancer is one of the most costly diseases to treat.

"The US Medicare programme is legally required to pay for any drug approved by the FDA without negotiation on price".

Furthermore, for those drugs that did show improvement in overall survival (24 out of 68, 35%), the benefits turned out to be limited, with a median of 2.7 months of life prolongation and a maximum of 5.8 months.

Even when drugs did show survival gains over existing treatments, the benefits were marginal, the study said. Questioned by AFP, the european medicines Agency has noted that they "extensively discussed the evidence supporting the anti-cancer drugs" and be open to any "new debate" on the subject.

Reactions of outside experts were mixed.

Of 23 indications whose survival benefit could be scored with the ESMO-MCBS tool, the benefit was judged to be clinically meaningful in less than half (48%). For the remaining 49% (33) there was uncertainty over whether the drugs extended survival or improved quality of life.

For Winette van der Graaf of The Institute of Cancer Research, the level of evidence required for drug efficacy "is very hard to obtain" in the case of rare cancers, "meaning that these patients would find it extremely difficult to gain access to new treatments", if regulators were less flexible.

In a linked editorial, Professor Vinay Prasad, of Oregon Health & Science University, said findings showed that the European Union system was "broken" and taking some decisions which were "absolutely unjustifiable".

Researchers said drugs were being passed for use across Europe on the basis of indirect measures - such as showing that medication had a biological effect on the body - rather than actual proof they could benefit patients.

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