Healthy Skepticism Library item: 444

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Whalen J.
Glaxo Releases Studies on Drug For Depression
The Wall Street Journal 2004 Jun 16

Full text:

Responding to New York Attorney General Eliot Spitzer’s accusations of fraud and secrecy, pharmaceuticals company GlaxoSmithKline PLC published reams of data — some previously unavailable to the public — on the effects of the antidepressant Paxil in children.

The nine studies, released late Monday, largely show the drug to be no more effective than a placebo in treating depression in children. Four of the studies note that a small percentage of children developed suicidal thoughts or attempted suicide while being treated with Paxil that appeared at a higher rate than they did when taking a placebo.

Glaxo said it already had disclosed all the data to medical regulators last year and summarized it for physicians in a letter last month. But it said it is posting the trial data on its Web site in the interest of transparency.

Along with the data, Glaxo released a bibliography showing it had disclosed some of the trial data in various forms over the years. Most of the data had been presented in abbreviated form on posters at medical conferences. The bibliography also noted five articles that had been published about the data in the Journal of the American Academy of Child and Adolescent Psychiatry.

Independent experts said they needed more time to review the thousands of pages of data posted on the Web site before concluding whether they contain any significant information not previously disclosed.

Two weeks ago, Mr. Spitzer filed a lawsuit in New York state court accusing Glaxo of exaggerating Paxil’s effectiveness and suppressing data that show its dangerous side effects in children. The suit pointed to an internal Glaxo memo that stated it would be “commercially unacceptable” to publish data indicating poor results in treating children with the drug.

Glaxo has declined to comment on the specifics in the lawsuit, but denies hiding or distorting any data.

On Monday, Mr. Spitzer called Glaxo’s decision to publish the data “a positive first step toward changing a dangerous industry practice.”

Paxil isn’t approved for use in children, and Glaxo says it has never promoted the drug for such use. But because doctors are able to prescribe approved drugs at their discretion, hundreds of thousands of children have taken Paxil in recent years.

Overall, the nine trials showed 2.4% of patients taking Paxil experienced adverse side effects “possibly related to suicidal behavior,” compared with 1.1% taking the placebo, Glaxo said in a letter it says it circulated to physicians last month, before the Spitzer suit was filed June 2. That rate grew to 3.4% for Paxil users and 1.2% for placebo users when a 30-day period following the end of treatment was included.

But the trials don’t clearly state whether Paxil can be blamed. Two of the trials said the suicidal thoughts were “unrelated or probably unrelated” to Paxil. The other two studies don’t specify whether Paxil was at fault.

Some of the studies posted on Glaxo’s site also showed Paxil to be effective at treating obsessive compulsive disorder and social anxiety disorder in children.