Researcher Made False Statements Regarding Strattera Trial in Kids
An Australian researcher wrongly told a university ethics committee that Eli Lilly's Strattera did not have a black box warning label in an application for a trial of the drug in children.
At the same time, an Eli Lilly employee was paid to work on the study as an investigator even though parents of children enrolled in the study were told it was "independent" of the drug company.
The story was broken by The Weekend Australian. Strattera has had a black box warning since 2005. Yet in an application for the study, Associate Professor Heather Jenkins, the researcher at Curtin University who led the trial, told the ethics panel:
"Since the study has been approved, there has been some publications related to the rare occurrence of suicidal ideation in some patients who were taking Strattera," Professor Jenkins told the ethics committee. "This initially led to a black-box warning from the FDA, which was subsequently revoked following further investigations."That was wrong. Plus, Australia's drug authorities had also applied their strongest warning to the drug at the time. The drug carries a risk of suicidal thoughts in users.
Jenkins told parents:
"Eli Lilly has signed an agreement with Curtin University of Technology that confirms that the university investigators are completely independent of their company. This means that Eli Lilly Australia has not influenced the design of the study."But a Lilly exec was in on the study:
The documents show that a drug company employee was paid to work on the study as an investigator who would "contribute to the overall conduct of the study through advice on design and implementation". In an email from Eli Lilly's director of corporate affairs and health economics to Professor Jenkins in 2002 during the set-up phase of the project, he wrote: "We (Eli Lilly) would like the opportunity for our clinical research physician to look at the proposed protocol in more depth. We have some initial thoughts regarding a couple of additional instruments that may be worth including."Interestingly, both Lilly and the University fought the release of the documents.
- BNET's previous coverage of Lilly's legal troubles:
- More Zyprexa Trouble for Lilly as Insurers Want Money Too
- In Zyprexa Settlement, Lilly Fritters Away 7.2 Percent of Revenues
- How Eli Lilly Waved Goodbye to $3.1 Billion
- FDA to Allow "Off-Label" Unapproved Drug Promotion
- FDA: J&J's Risperdal and Lilly's Zyprexa Are Over-Used in Kids