New, expensive cancer drugs may be of little use: Study

Are newer anticancer drugs better, as manufacturers often claim? Research conducted by UK scientists on 48 drugs approved in Europe between 2009 and 2013, some of them available in India also, shows no clear evidence to prove this.

One anti-cancer drug can be used for multiple conditions. The 48 new drugs approved in Europe between 2009 and 2013 were meant for 68 cancer indications.

When researchers from King's College London and the London School of Economics recently evaluated their efficacy , they found 39 (57%) of them had no supporting evidence for better survival or quality of life when they entered the market.

At a minimum of 3.3 years after market entry, the study published by them in British Medical Journal (BMJ) reveals, there was still no conclusive evidence that 33 of these 39 cancer drugs either extended or improved quality of life.

Dr Ashok Vaid, chairman of medical oncology and haematology at Medanta, told TOI that newer drugs are introduced at exorbitantly higher prices but results are often not proportionally better."In a country like India, prescribing newer cancer drugs with lack of evidence is useless. We try to stick to the older ones in such cases," he said.

Dr Vinod Raina, who heads the medical oncology , haematology and BMT division at Gurgaon's Fortis Memorial Research Institute (FMRI) added: "Every year, many new drugs are launched and marketed. Companies often create a lot of hype around their proclaimed benefits. It is for a clinician to weigh the cost vs benefit to the patient".

According to Dr Vinay Prasad, assistant professor of medicine at the Oregon Health and Science University , a similar study found that between 2008 and 2012 the US Food and Drug Administration (FDA) approved most uses of cancer drugs without evidence of survival or improved quality of life (67%, 3654). "Among the 36 such approvals, only five (14%) uses were shown later to improve survival compared with existing treatments or placebo after a median of 4.4 years on the market," says Prasad, in an editorial released by BMJ.

He calls for `rigorous testing against the best standard of care in randomized trials powered to rule in or rule out a clinically meaningful difference in patient-centred outcomes in a representative population' and says `the use of uncontrolled study designs or surrogate endpoints should be the exception not the rule.' Dr Raina said better survival and quality of life used to be the benchmark for approval of newer drugs till about a decade ago. But then, he added, the regulating agencies like US FDA felt results were taking longer to produce and patients were not able to benefit from the drug development. Therefore, it was decided to approve life-saving drugs based on surrogate outcomes like tumour reduction or progression free survival in rare circumstances.

"Scientifically , this is a good decision. But economically it may not be as prudent because patients often have to pay much higher price for the newer drugs," he said.

The 48 cancer drugs approved in Europe between 2009 and 2013 were meant for 68 indications: 17 for haematological malignancies and 51 for treatment of solid tumours.

Haematological malignancies include chronic myeloid leukaemia, multiple myeloma and chronic lymphocytic leukaemia. Solid tumours included cancer of the breast, lung, bowel, and prostate.

Most drugs (6168, 90%) were approved for use in noncurative setting or where disease could not be cured. Doctors said if the new drugs couldn't increase patient's survival significantly what was the benefit for spending large sums on expensive drugs when cheaper ones were available.

"It's criminal on the part of regulatory authorities to approve such drugs. Patients often demand from doctors to prescribe them with the hope of better survival. But if the results are correct, they may end up remaining in misery , healthwise and financially ," said a doctor. A report on the `Economic burden of cancer at tertiary care public hospitals', conducted on 432 patients who visited AIIMS between October 2006 and December 2007, substantiates this.



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