Why do cancer drugs get such an easy ride?

Unlike most other diseases, cancer instils a special fear and “is treated as an evil, invincible predator, not just a disease.” The ability of drug companies to charge very high prices, even when most approved cancer drugs provide little gain for patients, drives much of the research, as desperate patients lead some governments and private insurers to pay whatever companies charge. Officials within the US Food and Drug Administration are enthusiastic about new cancer drugs. Richard Pazdur, who oversees oncology activities for the FDA says that new cancer drugs are so effective that “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.” The methodological weaknesses in oncology trials do not support such enthusiasm. Researchers compared 8942 oncology clinical trials conducted between 2007 and 2010 with trials for other diseases. Trials for cancer drugs were 2.8 times more likely not to be randomised, 2.6 times more likely not to use a comparator (single arm), and 1.8 times more likely not to be blinded. Each undermines the validity of outcomes but reflects what regulators will allow. Less valid trials reflect an easy ride from regulators for drugs that usually offer few significant benefits for patients. A review of drugs for solid cancers approved by the EuropeanMedicines Agency (EMA) in its first 10 years found that, overall, new oncology drugs improved survival by a mean and median of 1.5 and 1.2 months, respectively. The 71 drugs approved by the FDA from 2002 to 2014 for solid tumours have resulted in median gains in progression-free and overall survival of only 2.5 and 2.1 months, respectively. Further, only 42%met criteria set by the American Society of Clinical Oncology Cancer Research Committee for meaningful results for patients. Accelerated approval and surrogate outcomes