Paxil flap spurs Glaxo to list drug trials

GlaxoSmithKline, facing complaints that it selectively disclosed results from pediatric trials of its popular antidepressant drug Paxil, said Friday that it planned to create a company Web site that would publicly list all clinical trials on its marketed drugs.

The company said that the Web site would include the results of all tests run on a drug before its approval for marketing as well as subsequent tests of that same medication for new uses or on new types of patients. The information would be listed after a drug was approved or after any subsequent tests were completed.

In recent months, Glaxo-SmithKline has found itself in a firestorm over the issue of drug test disclosure. This month, the New York state attorney general, Eliot Spitzer, sued the company, accusing it of misleading doctors by highlighting positive tests of Paxil in depressed youngsters while effectively burying trials that had negative findings.

Spitzer praised the company’s Web site decision Friday.

Drug regulators in both the United States and Britain are now trying to determine whether some antidepressants like Paxil might cause depressed children and adolescents to have increasing suicidal thoughts or to try to kill themselves.

Friday’s announcement by GlaxoSmithKline was not unexpected. This week, the company released on its Web site all the reports of tests of Paxil in children and adolescents suffering from psychological conditions like depression. Company officials also indicated at that time that they intended to expand that database to include other drugs.

A company spokeswoman said she did not know when the site would start operating but added that it would include a listing of drug trials for medication approved since 2000.

Provided by ArmMed Media
Revision date: July 9, 2011
Last revised: by David A. Scott, M.D.