Little Lyam Kilker’s mother Michelle David had no idea that the antidepressant drug Paxil she was taking when she found out she was pregnant would cause a life-threatening heart defect in her baby boy. She didn’t know this because the drug’s manufacturer, GlaxoSmithKline, didn’t bother to share birth defect warnings that they allegedly had known about for decades.

Lyam’s mother now claims that Glaxo, the world’s second biggest drug company, withheld information from both consumers and regulators about the risk of birth defects, and failed to properly test Paxil.  Her Pennsylvania court case is the first of hundreds of lawsuits alleging that Glaxo knew Paxil caused birth defects, but deliberately hid those risks to increase profits. * See update below

Coincidentally, Paxil is just one of countless drugs whose sales were boosted by medical journal articles that were actually written by industry-paid medical ghostwriters.

According to an internal Glaxo memo written in April 2000, the ironically-named CASPPER ghostwriting program was designed to “strengthen the product positioning and overcome competitive issues”.

It was a unique twist on garden-variety ghostwriting fraud, because it used Glaxo’s huge drug sales force to convince private practice physicians on their routes to lend their names to Glaxo-written articles for journal submission – articles that downplayed Paxil’s association with serious side effects such as suicide and birth defects.

At the time, Paxil was competing with rival antidepressant blockbusters like Eli Lilly’s Prozac and Pfizer’s Zoloft. According to GlaxoSmithKline, about 25% of its Paxil users were women of childbearing age, between 18 and 45. Paxil has since lost its patent protection and now competes against cheaper generic versions of the drug.

Paxil was approved for use in 1992, and generated about $942 million in sales last year. Glaxo originally purchased the compound sold as Paxil from a Danish company that had done animal studies showing young rats had died after taking low doses of the drug, according to preliminary court statements.

And as far back as 1980, one of the company’s scientists noted in internal documents that information in the rat studies suggested Paxil “could be” a cause of birth defects.

Still, the drugmaker refused for almost 20 years to do studies on why the young rats died.

In a 1997 company memo, Glaxo executive Bonnie Rossello suggested burying negative research results on Paxil. She wrote this in a memo about her company’s options if forced to conduct animal studies on the drug:

“If neg(ative) results, can bury…”

Her memo was read during opening statements in the Pennsylvania trial.

In a 1998 internal review by Glaxo of all reports of side effects tied to Paxil, company officials found “an alarmingly high number” of birth defect reports. Even with those concerns, the report was never turned over to the FDA, and the “alarming” language was deleted from the report.

This was two years before Glaxo drug reps launched the CASPPER medical ghostwriting campaign targeted at family physicians.

In 2001, three years after that “alarming” internal review, Glaxo employees wrote about a patient taking Paxil who had undergone an abortion after learning about severe birth defects in the fetus. Glaxo knew of the woman’s experience with Paxil because she had e-mailed the company directly seeking information on studies done about Paxil’s links to birth defects, said Jane Nieman, former Glaxo director of global clinical safety at the time. The woman’s e-mail read:

“If there is a chance that this might hurt or affect the baby, I want to know up front and I will somehow stop taking it for the time being. Please contact me as soon as possible. Please don’t forget about me.” 

Ms. Nieman acknowledged a note in the company’s own database that the aborted fetus’ heart defects were likely linked to the woman’s Paxil use. The woman, whose identity was withheld by Glaxo, said she’d been taking Paxil for anxiety when she found out she was pregnant, Ms. Neiman said. The woman had praised Paxil as a “miracle drug” that provided relief from panic attacks, the executive added.

It wasn’t until after the FDA ordered Glaxo and other makers of antidepressants in 2003 to do more safety studies on their products that Glaxo officials publicly acknowledged that Paxil increases the risk of birth defects.  That was two years after the Paxil-induced abortion, and five full years after the “alarming” internal review of birth defect risks.

Lawyers in the Lyam Kilker court case allege that Glaxo had mounted a marketing campaign to persuade doctors to write more Paxil prescriptions for pregnant women dealing with anxiety. The drugmaker undertook that campaign while withholding information about birth defect reports from both doctors and regulators.

* NEWS UPDATE –  After deliberating for seven hours, a state court jury in Philadelphia found on October 13, 2009 that GlaxoSmithKline failed to properly warn doctors and pregnant women about risks associated with its blockbuster antidepressant Paxil. The jury awarded $2.5 million in damages to the family of Lyam Kilker, who was born with heart defects after his mother took Paxil during her pregnancy.

Tuesday’s award in court may pale in comparison to the $942 million in sales that Paxil generated for Glaxo last year, but the trial was closely watched as a test of Glaxo’s vulnerability. The company released a statement saying it disagreed with the verdict and would appeal:

“While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition.”

Ironically, jurors polled about what had swayed their decision told the media:

“The fact that GSK never adequately studied their own drug was a big deal. The animal testing they did showed that they had a potential problem, and they didn’t follow up with adequate studies on animals or humans.”

The company reportedly settled over 800 Paxil birth defects lawsuits for approximately $1 billion in July 2010. Tom Kline, a plaintiffs’ attorney with Kline & Specter, said that it appears that the Kilker trial was a “cathartic event” that influenced the course of the litigation.

Pharmaceutical companies have “economic and reputational incentives” to turn away from litigation, Kline said:

“Pharmaceutical companies think in terms of billions of dollars, and settling cases en masse doesn’t break their bottom line and must be weighed against the impact on their reputation with the public – including the federal Food and Drug Administration and health care professionals – with every case that goes to trial.”

Read more about the drug Paxil in the book Side Effects: A Prosecutor, a Whistleblower, and a Best Selling Antidepressant on Trial by Pulitzer Prize-nominated health journalist Alison Bass.