New FDA head needs to examine the accelerated approval program

SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. More than $170 million of this spending was for products voluntarily withdrawn by their manufacturers after clinical trials showed that they did not improve overall survival in people with various types of cancer.

The FDA’s “accelerated approval” program expedites the evaluation process for new treatments so that patients can have access to them sooner.

The analysis focused on Medicare Part B and Part D spending — which covers outpatient medical care and prescription drugs, respectively, — in 2017, 2018 and 2019, the researchers said.

It focused on four medications, according to the researchers: atezolizumab, which is sold under the brand name Tecentriq; durvalumab, or Drazalex; nivolumab, or Opdivo; and pembrolizumab, or Keytruda.

All four had received accelerated approval to treat historically challenging forms of cancer, but the recommended indications, or the diseases they could treat, were later changed after clinical trials found they failed to improve overall survival.


A separate analysis by the same research team, also published Monday by JAMA Internal Medicine, found that in 2018, nearly 60% of cancer patients with private insurance nationally received an oral targeted treatment that did not lead to improved overall survival in clinical trials.

Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 billion, with more than half of that devoted to products that did not provide a “documented overall survival benefit” in clinical trials.

This is another example of just how screwed up our healthcare system really is. That money is gone without any clinical benefit and the executives at those drug companies received compensation because of those sales.