Pharmaceutical giant GlaxoSmithKline Plc has been making news in recent days over issues with its blockbuster antidepressant medication Paxil and allegations the drug is linked to birth defects when taken by pregnant women. Worse, new claims are emerging of a cover-up in which Glaxo knew of the dangerous side effects, but buried the information.
In one of two ongoing cases being heard, the family of William Seale—who died in 2004 allegedly as a result of heart defects caused by Paxil, said Fierce Pharma—is suing Glaxo. William’s mother was taking Paxil when pregnant with William and the family alleges that Glaxo knew of Paxil’s risks, yet attempted to have researchers position results to benefit the company and avoid legal actions, said Fierce Pharma.
Now, reports Fierce Pharma, a judge has mandated Glaxo provide emails between it and researchers who were looking into the Paxil-birth defect connection. U.S. District Judge Nancy Gertner in Boston ruled “the plaintiffs are entitled to correspondence and documents between anyone at Slone and GSK about the study, its scope” and methodology, quoted Fierce Pharma, citing Bloomberg. Glaxo has been trying to stop the family from viewing communications, including emails between it and researchers from Boston University’s Slone Epidemiology Center, said Fierce Pharma. Researchers Allen Mitchell and Carol Louik have been ordered to provide emails exchanged between Glaxo, including those between firm executives just prior to when Paxil trial results were given to the New England Journal of Medicine, said Fierce Pharma.
This week we also wrote that, according to Philly.com, a plaintiff’s attorney in a second Paxil lawsuit claimed Glaxo ignored information that the antidepressant caused birth defects. The lawyer represents a mother who claims her three-year-old son is suffering from cardiac issues because she took Paxil while pregnant. The boy has undergone some cardiac surgeries and is expected to have to undergo at least one more operation. The lawsuit is the first Paxil birth defect case to go to trial
These are just two of some 600 similar lawsuits pending against Glaxo.
According to the Food & Drug Administration (FDA), in late 2005 it sent an alert to physicians about early studies suggesting Paxil could be a contributor to heart defects in babies when taken by expectant mothers in the first trimester, said Bloomberg.com, previously. Glaxo received reports of 50 miscarriages or intrauterine deaths by 1997, with its own scientists describing the amount of cases as an “alarming finding,” words omitted in the final report provided to the FDA, despite that it was mandated to include such information, reported Philly.com, citing the plaintiff attorney.
Worse, Bonnie Rossello, an executive at Glaxo, wrote in a 1997 memo that should animal studies be conducted, the drug maker could “bury” any negative findings, added Philly.com.