Healthy Skepticism Library item: 13117

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

Goldstein S.
Glaxo escapes prosecution on Seroxat disclosure
MarketWatch 2008 Mar 6
http://www.marketwatch.com/news/story/glaxo-escapes-prosecution-depression-drug/story.aspx?guid=%7B3689F3DC-6EE8-4750-ADAC-B65AFFA63833%7D

Full text:

LONDON (MarketWatch) — Britain’s top drug regulator Thursday chided GlaxoSmithKline for not quickly releasing data on increased suicidal risk in patients under 18 who used its Seroxat antidepressant drug, but declined to press criminal charges.

After four years of investigation and poring over one million pages of evidence, the Medicines and Healthcare products Regulatory Agency said there wasn’t a “realistic” prospect that it could get a criminal conviction against GlaxoSmithKline.

The regulator said the law at the time — 2003 — wasn’t clear enough. In particular, the MHRA said the rules for disclosing data on drug use outside of its license were too muddy to win a prosecution.

Drugmakers seek “indications” for particular use — in Seroxat’s instance, for treating depression in adults — but often those drugs are prescribed legally for alternative uses, or so-called “off-label” use.

Up to 8,000 patients under 18 years of age were taking Seroxat — called Paxil in the U.S. — for depression, the regulator said.

Laws have subsequently been changed to require drugmakers to report adverse reactions in any clinical trial. However, these rules don’t apply outside of Europe, and most of Glaxo’s trials on Seroxat were conducted in the United States.

The MHRA said it will press for a law change in the U.K. and eventually Europe to force drugmakers to report adverse clinical data no matter where trials are conducted.

But the regulator did criticize GlaxoSmithKline in the report.

“I remain concerned that GSK could and should have reported this information earlier than they did,” Kent Woods, MHRA chief executive, said in a statement.

GlaxoSmithKline defended itself, pointing out — as the MHRA accepts — that the data linking increased suicidal risk to those under 18 comes from a study of the trials collectively and not from any one trial.

“When reviewed individually, none of these trials were considered by GSK or independent investigators to show a clinically meaningful increase in the rate of suicidal thinking or attempted suicide,” the company said.

“As has been confirmed by the MHRA in their conclusions, it was only when all the data became available, at the end of the research program, and were analyzed together … [that] an increased rate of suicidal thinking or attempted suicide [was] revealed in those pediatric patients taking Seroxat.”

Shares in the drugmaker fell 1.3% in London afternoon trade.

Seroxat and Paxil sales totaled 553 million pounds ($1.1 billion) last year, down 6% in constant-currencies terms.