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BMJ: 'Lilly acted properly'

The British Medical Journal has officially apologised to Eli Lilly & Co for accusing it of hiding side effect data relating to antidepressant, Prozac.

The British Medical Journal (BMJ) has apologised officially to US pharmaceutical company Eli Lilly & Co and has withdrawn certain claims it made over the questionable disclosure of side effect data relating to antidepressant Prozac.

The journal, one of the country's most esteemed publications, alleged in an article published in early January that documentary evidence of what were described as ìtroubling side effectsî linked to Lilly's top-selling antidepressant, had ìgone missingî during a product liability lawsuit in 1994.

The evidence in question was later submitted to the BMJ by a source, who remains anonymous, and the journal in turn submitted it to America's Food and Drug Administration in what some saw as rather atypical behaviour for a publication of its type.

Following a complaint by Lilly, which said it was ìdisturbedî as the article in January ìinaccurately reported about Prozac and made negative references regarding [the] company's conductî, the BMJ conducted a deeper investigation and then retracted the claims.

ìAs a result of a detailed investigation, it is clear that these documents did not go missing. The BMJ is happy to set the record straight and to apologise to Eli Lilly,î it stated. Lilly accepted its apology.

However, despite acting editor Kamran Abbasi's proclamation that ìthe BMJ did not intend to suggest that Eli Lilly caused these documents to go missingî, he remains adamant that other parts of the article are accurate; notably, claims that Lilly was aware of Prozac's ìtroubling side effectsî in the 1980s, and hence the question over whether the alleged ìmissingî documents were submitted to the FDA at the appropriate time is still yet to be answered.

As part of the SSRI (selective serotonin reuptake inhibitor) class of antidepressant medications, Prozac bore a good deal of scrutiny in 2004 when a furore sprang up based on potential links to suicidal behaviour in juvenile patients on withdrawal of medication.

All companies marketing SSRIs were obliged by regulators to make immediate label changes, however GlaxoSmithKline, which makes Seroxat, seemed to bear the brunt of the pressure. Prozac is currently the only such drug approved by the FDA for treating children.

30th September 2008

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