More disturbing was the lack of evidence that the drugs would extend the life of the patients. "At a minimum of 3.3 years after market entry, there was still no conclusive evidence that these drugs either extended or improved life for most cancer indications. When there were survival gains over existing treatment options or placebo, they were often marginal." Or, meaningless in many cases, the study found.

As with quality of life, extended survival as an outcome was often not examined by pre-approval testing. The authors found that "only 18 of the 68 (26%) were supported by a pivotal study powered to evaluate overall survival as the primary outcome."

The authors concluded that, while the drugs once released to the public in all likelihood did no damage to patients, 57 percent of them neither extended the patient's life nor patient quality of life. Given that these are perhaps the two most common patient expectations of new drugs, the researchers politely but firmly took the approval system to task.

"When expensive drugs that lack clinically meaningful benefits are approved and paid for within publicly funded health care systems, individual patients can be harmed, important societal resources wasted, and the delivery of equitable and affordable care undermined," the study concluded.