Cancer drugs get an easy ride with regulators, study says

Despite little gains for patients and high price tags, pharma enjoys shortened review times for cancer drugs, according to two professors

Photo by: Reuters
Photo by: Reuters

Updated Jul 28, 2015

A recent article, asking “Why do cancer drugs get such an easy ride?” argues that “rushed approvals result in a poor deal for both patients and cancer research.”

Two professors, Donald W Light from York University School of Health Policy and Management and Joel Lexchin from Rowan University School of Osteopathic Medicine suggest that cancer drugs with high price tags are approved hastily despite having little effect on the survival of patients.

“We don’t have a lot of questions on [these] drugs because they’re slam dunks. It’s not if we’re going to approve them. It’s how fast we’re going to approve them,” quotes the article from US Food and Drug Administration (FDA) to support their argument. 

Article also cites a previous study reviewing cancer drugs approved in the last decade, showing these only caused patients to survive only for one month longer.

“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,” Light and Lexchin write.

The article mentions names two easy rides pharma receives from the US and EU regulators other than the “easy ride from regulators for drugs that usually offer few significant benefits for patients.”

“A second easy ride comes from regulators creating more ways to shorten review times… A third easy ride comes from European and US regulators allowing companies to test cancer drugs using surrogate measures instead of survival and other patient centered measures.”

Two researchers point out that a possible solution depends on patients and their doctors becoming more demanding.  

“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,” study says.

“Drug agencies like the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) don’t actually look at whether people live longer.”

TRTWorld and agencies