Side effects? Who cares?

■Cometriq, a $10,000-a-month drug for metastatic thyroid cancer that has no proven survival benefit and was linked to four deaths during testing. It received a black box warning for causing holes and bleeding in the gastrointestinal system.

■Iclusig, a $9,200-a-month leukemia drug that also has not been shown to lengthen lives. The FDA required a black box warning because clots formed in at least 27% of patients leading to possible heart attacks and strokes, potentially fatal heart failure and potentially fatal liver failure.

■Ixempra, a $7,600-a-month drug that improved the scans of advanced breast cancer patients for about a month and a half, but carried a warning for severe liver toxicity and a type of potentially fatal infection.

Critics say using surrogate measures to determine if a drug should be approved can backfire. Surrogates can mask complications that work against survival or quality of life, said Richard Deyo, a professor of evidence-based medicine at Oregon Health and Science University.

"Maybe you live a month longer with a new drug but you are having horrible symptoms or horrible quality of life in the meantime," said Deyo, author of "Hope or Hype: The Obsession with Medical Advances and the High Cost of False Promises."

"Patients would want to know that."

And much more...

http://www.jsonline.com/watchdog/watchdogreports/some-drugs-approved-despite-minimal-benefits-severe-side-effects-b99359283z1-280438692.html