News of the Day ... in Perspective8/10/2004
FDA accused of concealing youth suicide risk of antidepressant drugs
Depending on how the data are analyzed, certain antidepressants may double the risk of suicide in children and adolescents, according to a new FDA-commissioned analysis by outside researchers at Columbia University. Conclusions depend on whether reports include suicidal ideation and episodes of self harm that are not necessarily suicidal.
In Britain, regulators have discouraged the use of certain drugs in children under the age of 18. In March, the U.S. FDA called on drug makers to beef up warnings to doctors about watching for increasing depression or suicidal thinking.
The rate of antidepressant prescriptions for children and adolescents tripled between the early 1990s and 2001. In 2002, an estimated 10.8 million prescriptions for antidepressants were dispensed for patients under the age of 18.
In June, New York State Attorney Eliot Spitzer sued GlaxoSmithKline, alleging that the company concealed findings in pediatric tests of paroxetine (Paxil) (Wall Street Journal, Aug. 5, 2004).
Spitzer cited studies showing that 6.5% of patients on Paxil displayed “emotional lability,” compared to 1.4% of those on placebo (June 11, 2004).
Spitzer has also targeted Forest Laboratories and Johnson & Johnson, seeking information about marketing practices, clinical trial results, and studies of off-label uses.
The AMA among others is calling for increased public disclosure of clinical trial results, including negative ones (NY Times, Aug. 4, 2004).
A congressional hearing into alleged concealment of harmful drug effects was cancelled after committee chairman James Greenwood (R-PA) signed a contract to serve as president of BIO (the Biotechnology Industry Organization) upon retirement.
New FDA warnings: www.fda.gov/cder/drug/antidepressants/default.htm
FDA informational site on pediatric drugs: www.fda.gov/cder/pediatrics
AAPS opposes Pediatric Rule forcing expanded use of pediatric test subjects: www.aapsonline.org/press/nrpedrule.htm.