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Glaxo Withheld Paxil Birth-Defect Data, Witness Says

GlaxoSmithKline Plc, the world’s second-biggest drugmaker, withheld birth-defect data tied to its antidepressant drug Paxil from physicians as the number of reports grew, a psychiatrist testified.

Doctors seeking information about birth defects linked to Paxil originally got the total numbers of side-effect reports about the issue from Glaxo, Dr. David Healy, a professor at Cardiff University in Wales, told a Pennsylvania jury today. He’s testifying on behalf of a family suing over a child born with heart defects allegedly caused by the drug.


“When the numbers on birth defects was quite small, the company gave us the actual numbers,” Healy, a psychiatrist, said. As the numbers climbed in the mid-1990s, “then all we could get were percentages,” he said.

The state-court trial in Philadelphia is the first of more than 600 cases alleging London-based Glaxo knew Paxil caused birth defects and hid those risks to pump up profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxo’s total revenue.

The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Lyam’s mother, Michelle David, blames Paxil for causing life-threatening heart defects in her 3-year-old son.

Paxil Testing
Glaxo’s lawyer told jurors yesterday the London-based drugmaker isn’t liable for Lyam’s heart defects and acted responsibly in testing Paxil and updating safety information.

The company’s provision for legal and other non-tax disputes as of June 30 was 1.7 billion pounds ($2.8 billion), the company said in a July 22 regulatory filing that didn’t mention the Paxil litigation.

“We do not disclose our legal reserves for any specific litigation matter,” Glaxo spokesman Kevin Colgan said earlier this month.

Lawyers for Kilker allege Glaxo mounted a marketing campaign in the mid-1990’s to persuade doctors to write more Paxil prescriptions for pregnant women dealing with anxiety. The campaign came while the drugmaker was withholding information about birth-defect reports from doctors, the family contends.

‘Superior Safety’
Healy said Glaxo executives pointed to a 1996 safety study of a competing drug to show no antidepressant was shown “to have superior safety to Paxil for use in pregnancy,” according to internal company records.

In another memo, Healy pointed out Glaxo executive Bonnie Rossello suggested the company’s sales force should spend time in doctor meetings denigrating competing antidepressants to buttress Paxil sales.

The idea was to “distract the competition by enhancing the noise about their weaknesses so they spend more time explaining why it isn’t so and less time” promoting their drugs, Rossello said in a memo Healy read to jurors.

The company also used ghost-written articles in medical journals to help market Paxil to pregnant women, Healy said. Drugmakers sometimes pay companies to ghostwrite favorable studies of their medicines and then hire doctors to put their names on the journal articles.

Healy, who once served on a Glaxo advisory board, said doctors are sometimes paid as much as $2,000 for lending their names to such articles.

Glaxo’s American depositary receipts, each representing two ordinary shares, rose 20 cents to $38.96 in New York Stock Exchange composite trading at 3:46 p.m. Glaxo rose 5 pence to 1,176 pence in London.

The case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania (Philadelphia).

If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous and defective drugs, bad products, or toxic injury etc then please contact the Fort Worth Texas Defective Drugs Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.

The Dr. Shezad Malik Law is currently evaluating and accepting Paxil Birth Defects cases.

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