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Lilly speaks out on New York Times article

Eli Lilly issues a strongly worded objection to an article in The New York Times based on a study published in The New England Journal of Medicine

US-based Eli Lilly has issued a strongly worded objection to an article in The New York Times (NYT) based on a study published in The New England Journal of Medicine (NEJM).

Written by a team of researchers from several universities and medical centres, the NYT analysis, titled "Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy," found that 31 per cent of studies on antidepressants submitted to the FDA by drug manufacturers between 1987 and 2004 were never published, and that the large majority of unpublished studies contained unfavourable results.

The article, headlined "Antidepressant studies unpublished," informed readers that "the makers of antidepressants like Prozac and Paxil never published the results of about a third of the drug trials that they conducted to win government approval, misleading doctors and consumers about the drugs' true effectiveness."

However, the suggestion that companies intentionally misled the public may be open to question. The authors of the NEJM study were careful to note that the publication bias could have resulted "from a failure to submit manuscripts on the part of authors and sponsors, from decisions by journal editors and reviewers not to publish, or both."

In its statement, Lilly takes issue with other aspects of the newspaper's presentation of the research. "Not only was the NYT story inaccurate when it comes to Prozac - the NEJM article didn't identify a single Prozac study as unpublished, but it also likely created a strong false impression with readers that Lilly suppresses data," the company said.

"The authors of the NEJM article decided not to count studies as ëpublished' if the manuscript included data from two or more studies," Lilly's statement explains. "While this methodology might be suitable for an academic discussion, it's clearly not the appropriate standard for determining whether a company has been transparent in disclosing its data."

The company argues that two Cymbalta studies identified in the NEJM article as being unpublished "have, in fact, been published in peer-reviewed journals." The studies appeared in 2002 in Psychopharmacology Bulletin and in 2003 in The Primary Care Companion Journal of Clinical Psychiatry, according to the firm. They were also presented at medical meetings and posted on the firm's online clinical trials registry, Lilly said.

The company's statement implies that the NYT did not perform due diligence in researching the article, asserting that Lilly would have offered the information about the articles' publication history to the newspaper "if only they had called and asked."

The Times did interview Alan Goldhammer, deputy vice-president for regulatory affairs at Pharmaceutical Research and Manufacturers of America, who pointed out that the NEJM study was based on data from before 2004 and added that "since then we've put to rest the myth that companies have anything to hide."

This latest flare-up between Lilly and the NYT comes about a year after the company publicly challenged a front-page article charging that its sales representatives promoted the antipsychotic drug Zyprexa for unapproved uses.

In responding to that article, Lilly denied the off-label promotions and deplored "the illegal release of select confidential documents," which it said were presented out of context in the newspaper. In September 2007, the company received USD 100,000 as part of a legal settlement with the doctor who leaked the documents to the NYT.

27th January 2008

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