FDA Finds Medical Device Recalls Nearly Doubled In 10 Years
The Wall Street Journal says a report to be released today will spotlight the increasing number of problems.
The Wall Street Journal: Medical Device Recalls Nearly Doubled In A Decade
Recalls of defective medical devices nearly doubled in the decade from 2003 through 2012, according to a Food and Drug Administration report due Friday. The total number of recalls rose to 1,190 in 2012, up from 604 in 2003. There was a sharp increase in recalls where the defective product carried a reasonable probability of death. In 2012, there were 57 of these so-called Class I recalls, up from seven in 2003 (Burton, 3/21).
Also, the Journal looks at the dilemma for patients when the government wants to end some studies.
The Wall Street Journal: Hard Choices In Pursuit Of Rare-Disease Cures
Late last year, the National Institute on Aging, which is part of NIH, said a long-running observational study of fibromuscular dysplasia and four other rare diseases was no longer collecting data or enrolling patients, and that the study's goals had been met. Sufferers, arguing that fibromuscular dysplasia's cause or cure still isn't known, mobilized. ... The fight to continue the study exemplifies tensions that often arise between researchers and patients over which efforts yield the most valuable science. ... Both NIH and the Food and Drug Administration have said such studies are a critical early step toward drug development. But the studies are expensive and don't always lead to new trials (Marcus, 3/20).