The whistleblower complaint, unsealed January 20 and reported by Bloomberg BNA (02/01/12), alleges Forest Pharmaceuticals paid a principal researcher involved in a study of Celexa, another SSRI antidepressant. Lexapro is a second generation of Celexa. According to the whistleblower, the alleged violations of the False Claims Act occurred during the STAR*D (Sequenced Treatment to Relieve Depression) study, which received funding from the National Institute of Mental Health.
The allegations were made by H. Edmund Pigott, who claims that bias in the STAR*D trial favored Celexa, and that bias was allegedly the result of kickbacks and bribes. Furthermore, he alleged, as a result of those bribes, researchers overstated the effectiveness of Celexa, leading to an increase in sales of both Celexa and Lexapro. The STAR*D trial was designed to study the effectiveness of different treatments for people with major depression, but included Celexa, even though Celexa was the least prescribed SSRI antidepressant.
READ MORE LEXAPRO BIRTH DEFECT LEGAL NEWS
The study involved an analysis of the birth registry data from babies born between 1996 and 2007 in Sweden, Iceland, Denmark, Finland and Norway. According to WebMD (1/12/12), researchers also found that mothers who were hospitalized for a psychiatric disorder but were not using SSRIs during pregnancy also had an increased risk of delivering a baby with PPHN.
Babies born with PPHN do not adapt to breathing outside the womb and may suffer from a lack of oxygen circulating through their blood flow. This can cause organ failure and death. Babies who survive PPHN sometimes require multiple surgeries and extended hospital stays.