GlaxoSmithKline Plc, the U.K.’s largest drugmaker, complied with all U.S. Food and Drug Administration regulations in testing and monitoring Paxil, according to a former employee for the agency.
Glaxo reported to the FDA on a regular basis and supplied animal toxicology studies that didn’t indicate the drug could cause birth defects, Judith Jones testified as an expert witness for the company. Jones spent eight years in the FDA’s post- marketing surveillance and drug safety group.
“The FDA was provided all of the reports that GlaxoSmithKline had received on a regular basis and they specifically did not identify a signal,” Jones told jurors in state court. “They provided all the necessary information to the FDA.”
Jones testified toward the end of the first trial over claims Paxil causes birth defects. Michelle David blames her Paxil use for her 3-year-old son’s life-threatening heart defects. She accuses the company of withholding information from consumers and regulators about the risk of birth defects and failing to properly test Paxil.
The trial is the first of more than 600 cases alleging Glaxo knew Paxil caused birth defects and hid those risks to increase profits.
Glaxo wasn’t aware of any potential teratogenic effects of the drug until the summer of 2005, Jones said. A teratogenic agent is one that causes malformations of an embryo or fetus.
In December 2005, the FDA told doctors preliminary studies suggested Paxil might contribute to heart defects in infants when taken in the first three months of pregnancy.
The FDA asked the company to update the label enclosed with the medicine, changing its birth-defect warning. Paxil’s label includes specific language from the agency concluding that that the drug is reasonably safe for human use at suggested dosages, Jones said. The current label is “reasonable and appropriate,” she said.
Jones’ testimony contradicts statements made by former FDA doctor Suzanne Parisian, who testified on behalf of David and her son, Lyam Kilker.
Parisian testified earlier in the case Glaxo never submitted internal documents showing its scientists were alarmed by a rising number of birth defects in pregnant women taking Paxil as early as 1997. An internal report showed there was a 13.3 percent rate of incidence for congenital abnormalities as of November 1997.
That figure doesn’t accurately reflect an estimate of incident rates since it’s unknown how many pregnant women were on Paxil at the time, Jones said.
“The 13 percent was a proportion of the cases they had in hand,” Jones told jurors.
Under cross-examination, Jones said Glaxo continued to investigate potential adverse effects associated with the drug well after it debuted on the market. She dismissed a March 1980 memo from Glaxo scientist John Baldwin that raised the possibility that Paxil could cause birth defects at higher dose levels.
Earlier this week, a pediatric cardiologist testifying for Glaxo told jurors that genetics is the most likely cause of the birth defect in Kilker.
Of known causes of birth defects, genetics account for as much as 25 percent, said H. Scott Baldwin, of the Vanderbilt University Medical Center. Still, research shows that an estimated 65 percent of the defects are attributed to unknown causes.
Baldwin acknowledged during questioning by Kilker’s lawyers that there’s no way to conclusively tell what caused Kilker’s heart defect.
“We do not know the gene that caused it,” Baldwin testified. “We know some things that didn’t cause it, but we don’t know the actual epidemiology of what did cause it.”
The case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania (Philadelphia).
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