Highly priced cancer drugs get rushed approvals despite poor trial methodology and little effect on the longevity of patients, cautions York University Professor Dr Joel Lexchin in the School of Health Policy and Management. "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," suggests Lexchin. "Drug agencies like the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA) don't actually look at whether people live longer."
Lexchin and co-author Donald Light, a professor in the School of Osteopathic Medicine, Rowan University, New Jersey, note in their study that 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.
The accelerated approval and shortened review times also make it a smooth sail for cancer drugs. Lexchin cites earlier research reviewing solid cancer drugs within 10 years of EMA approval to point out that these drugs improved survival by just over a month.
"Similarly 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," he says adding, "Also, only 42% met the American Society of Clinical Oncology Cancer Research Committee's criteria for meaningful results for patients."
The authors observe that pharma companies are having an easy ride with the European and US regulators, who are allowing them to test cancer drugs using surrogate measures instead of survival and other patient-centred measures.
[link url="http://ekaweb01.eurekalert.org/pub_releases/2015-05/yu-cda050715.php"]York University material[/link]
[link url="http://news.yorku.ca/files/Light-Lexchin-Cancer-drugs.pdf"]British Medical Journal editorial[/link]