Quick Approval of High Cost Cancer Drugs Don't Benefit Patients
Study warns that drug reviewers don't look at long term survival of patients.
Study warns that drug reviewers don’t look at long term survival of patients.
Costly cancer drugs that are rushed through the approval process have little impact on the long term survival of patients, according to a recent study.
Conducted by York University Professor Dr. Joel Lexchin of the School of Health Policy and Management, the study finds that these drugs receive quick approvals despite poor methodology and limited effect on the longevity of patients.
"Patients and their doctors should demand that regulators require pharma companies to provide clear evidence of clinical effectiveness of the drugs, resulting from rigorous methodology," Dr. Lexchin said in a press release. "Drug agencies like the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) don't actually look at whether people live longer."
The researchers noted that the accelerated approval process and shortened review times also provide few challenges for cancer medications. The researchers cited prior research that indicates a review of solid cancer drugs within 10 years of EMA approval show these drugs improved survival by just over a month.
"Similarly 71 drugs approved by the FDA from 2002 to 2014 for solid tumors have resulted in median gains in progression-free and overall survival of only 2.5 and 2.1 months, respectively," Dr. Lexchin said. "Also, only 42% met the American Society of Clinical Oncology Cancer Research Committee's criteria for meaningful results for patients."