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Aug29

Most New Cancer Drugs Don't Improve Survival or Quality of Life 

Prof.Dr.Dram,profdrram@gmail.com,Gastro Intestinal,Liver Hiv,Hepatitis and sex diseases expert 7838059592,9434143550


On every alternative day a new anticancer medicine is announced to ease the life of cancer patient from the view of quality and quantity of Life.few are very costly unaffordable to many,most are claimed that they are less toxic and better effective for patient survival and better life but The majority of new oncology drugs that were approved by the European Medicines Agency (EMA) from 2009 to 2013 entered the market without clear evidence that they improved survival or quality of life, according to a new report  in the BMJ.During this period, the EMA approved the use of 48 cancer drugs for 68 indications.Of these 68 indications, 39 (57%) approvals were made on the basis of a surrogate endpoint in the absence of evidence of a survival benefit or an improvement in quality of life.

                At a median of follow-up of 5.4 years in the postmarketing period, only 35 (51%) drugs showed a significant improvement in survival or quality of life, as compared with other therapeutic options, placebo, or as add-on treatment.For 33 (49%) of the drugs, there continues to be uncertainty as to whether they extend survival or improve quality of life.

                "When expensive drugs that lack clinically meaningful benefits are approved and reimbursed within publicly funded healthcare systems, individual patients may be harmed, important resources wasted, and the delivery of equitable and affordable care is undermined," write the authors, led by Courtney Davis, PhD, a senior lecturer from the Department of Global Health and Social Medicine, King's College London, United Kingdom.

               In an accompanying editorial, Vinay Prasad, MD, an assistant professor of medicine at Oregon Health and Science University, Portland, points to his own recent research, in which similar findings were reported for cancer drugs approved by the US Food and Drug Administration (FDA).His study found that the FDA is now heavily relying on surrogate markers of effectiveness. Between 2008 and 2012, the FDA approved most uses of cancer drugs without evidence of survival or improved quality of life (67%, 36/54).

                    During a median follow-up period of 4.4 years, only five of those 36 drugs were found to improve overall survival in randomized trials.Dr Prasad, who has established a reputation as something of a whistle-blower, has spoken out about physicians with financial conflicts of interest, as well as escalating drug prices and approved therapies that have been overly hyped or that offer very modest benefits.

                He emphasizes three important factors that have helped to characterize the current regulatory climate.

 

The first is that when drugs do offer survival advantages, the gains are often marginal.Second is that the small benefits that are seen often occur in trials that are conducted in unrepresentative patient populations ― patients who are younger and who have fewer comorbidities than physicians would generally be treating in real-world clinical practice.e.



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