The FDA often fast-tracks approval for chemotherapy drugs. That helps get life-saving new cancer treatments to patients as soon as studies prove that it can shrink a tumor or slow down the cancer’s progression.

Those “surrogate” research goals enable smaller, faster, cheaper clinical trials — but they do not prove the drug helps patients live longer or better lives.

In a study published in JAMA Internal Medicine, researchers looked at follow-up data on 36 cancer drugs that were approved by the FDA based on “surrogate” endpoints between 2008 and 2012.

The results were not good — 50% (18 drugs) definitely did not help patients live longer, and 17 of those did not improve quality of life. Only 5 were proven to extend survival. The remaining 13 had no public follow-up data.

The estimated annual costs of the 18 ineffective cancer drugs ranged from around $20,000 for rituximab to $170,000 for cabozantinib. All but five of them had annual costs exceeding $100,000.

The most expensive drug — cabozantinib — did not improve patient survival and also worsened quality of life compared to a placebo, the researchers discovered.

“What’s happening is we are flooding the market with medical products that don’t work very well, or we don’t know whether they work,” says lead author Dr. Diana Zuckerman of the National Center for Health Research.

She was talking about parts of the 21st Century Cures Act that would expand the use of “surrogate” endpoints to get more drugs approved.

The FDA does require follow-up studies to prove that fast-tracked medications actually benefit patients and improve survival. However, even when follow-up studies prove that these drugs do not work, the FDA rarely revokes approval, the researchers said.

Former FDA Commissioner Mark McClellan told NPR, “A lot of follow-up studies have not been performed or have not been performed well because we don’t have good systems in place to learn about drugs once they are on the market.”

Source: Quality of Life, Overall Survival, and Costs of Cancer Drugs Approved Based on Surrogate Endpoints — JAMA Internal Medicine (November 2016)

Posted by Elizabeth Bradley

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