Reanalysis Of Data Concludes Paroxetine Is Not Safe, Effective For Teens.

The New York Times (9/17, A20, Carey, Subscription Publication) reports that in 2001, GlaxoSmithKline “published a study showing that the antidepressant Paxil [paroxetine] was safe and effective for teenagers.” Yesterday, however, the BMJ “posted a new analysis of the same data concluding that the opposite is true.”

Reuters (9/17, Kelland) reports that the British Medical Journal criticized GlaxoSmithKline for providing delayed access to critical data from a clinical trial of paroxetine showing that the medication can cause an increased risk of suicide in adolescents. BMJ associate editor Peter Moshi, of the University of Maryland School of Pharmacy, argues in a recent re-analysis that GSK should have provided the data in 2001, while GSK claims that its disclosure of the data now displays its commitment to transparency.

The Washington Post (9/17, Bernstein, Cha) reports in “Health & Science” that “using 77,000 pages of previously unavailable documents, a team of researchers concluded that paroxetine…was no more effective than a placebo and considerably more dangerous than the original study indicated.” While “similar criticism of what is known as ‘Study 329’ began within a year of its publication,” yesterday’s “reappraisal…may be the most thorough yet.”

Related Links:

— “Antidepressant Paxil Is Unsafe for Teenagers, New Analysis Says,” Benedict Carey, New York Times, September 16, 2015.

Posted in In The News.