beth israel deaconess medical center a harvard medical school teaching hospital

  • Contact BIDMC
  • Maps & Directions
  • Other Locations
  • Careers at BIDMC
  • Smaller Larger

Find a Doctor

Request an Appointment

Smaller Larger

Cancer Drugs May be Approved Even if Not Effective

Posted 12/8/2016

Posted in

  This is really upsetting. Really and truly upsetting. This report from Reuters indicates that cancer drugs that have been approved though a special sped-up process may stay approved even if later studies find that they are less effective than existing treatments. We are all aware of the reasons for these occasional quick approvals; if something is available that appears to be possibly helpful to very ill people without other options, it is tough to hold it back.

  Should you find this an interesting ethical question, there is plenty to read about it. The two sides are basically as stated: someone who is dying and learns of a new medication that may extend life should be able to try it even before it has moved through the normal channels. The countering argument is that sometimes these medications turn out not be to be helpful, that they can be extremely expensive and contribute to our sky-rocketing healthcare costs, and that interfering in the regular approval process undermines our entire system of review and data based medicine.

  Here is the article. I would love to hear your thoughts.

Cancer drugs may remain approved despite lack of benefit

- In the United States, cancer drugs are sometimes approved through sped-up
processes - and they often stay approved even if later studies show them to be inferior to other options or
even worse than doing nothing, a new study found.
Researchers evaluated studies done on 18 cancer drugs approved between 2008 and 2012 by the U.S.
Food and Drug Administration (FDA). None of the drugs had been found to prolong life, and only one had enough evidence to say it improved quality of life. Yet, all but one retained its approval status.

"We were shocked to find that these drugs don’t save lives and don’t improve quality of lives," said lead
author Diana Zuckerman, who is president of the National Center for Health Research and the Cancer
Prevention and Treatment Fund in Washington, D.C.
To ensure a cancer treatment's safety and quickly get it to market, the FDA sometimes approves a drug if it
meets "surrogate" research goals instead of the gold-standard endpoints the agency usually looks for.
Surrogate endpoints - like tumor shrinkage and time until the disease progresses - don't take as many
years to document as those used in the traditional approval process, so the drug can get on the market
"We don't really know if people live longer or improve based on those outcomes," said Dr. Vinay Prasad, of
the Oregon Health and Sciences University in Portland. In a 2015 study, Prasad and colleagues found that
36 cancer drugs were approved by the FDA between 2008 and 2012 based on those early endpoints.
Of those 36 approved drugs, 18 did not help patients live longer, later studies showed.

Read more:


Add your comment