Glaxo Executive’s Memo Suggested Burying Drug Studies (Update4)

An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced at a trial.

“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of a child born with heart defects.

The Philadelphia trial is the first of more than 600 cases alleging that 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. Kilker’s mother, Michelle David, blames Paxil for causing life-threatening heart defects in her 3-year-old son.

Glaxo officials urged scientists to withhold information about Paxil’s risks from a paper laying out the company’s “core safety philosophy” for the drug, said Sean Tracey, a lawyer for Kilker and David, in his opening statement in the trial.

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GlaxoSmithKline to Defend Paxil in Birth-Defect Case (Update1)

GlaxoSmithKline Plc, the world’s second-biggest drugmaker, begins a trial in Philadelphia next week in what may be a test case for more than 600 lawsuits over claims its antidepressant drug Paxil causes birth defects.

Patients and their parents claim internal company documents produced for trial show Glaxo failed to warn about the risks of Paxil until forced to do so in 2005 by the U.S. Food and Drug Administration. In a trial set for Sept. 14, Michelle David blames the drug for causing life-threatening heart defects in her son Lyam Kilker, 3.

The London-based company faces two more such trials a month from October through January in state court in Philadelphia. The first group will show both sides how the rest of the lawsuits may fare, said David Logan, dean and professor of law at Roger Williams University in Bristol, Rhode Island.

“These cases are sort of like the canary in the coal mine,” Logan said in a phone interview. “The early cases set the parameters for any global settlement negotiations.”

Paxil, approved by the FDA in 1992, generated about $942 million in sales last year, 2.1 percent of the total for the company. Glaxo has settled other Paxil-related cases, including a suit brought by the New York Attorney General’s office accusing the company of withholding safety data about the antidepressant.

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Antidepressant treatment may reduce male fertility

Treatment with paroxetine (Paxil), which belongs to the selective serotonin reuptake inhibitor (SSRI) class of antidepressant drugs, increases DNA fragmentation in sperm, according to research presented today at the 64th annual meeting of the American Society for Reproductive Medicine in San Francisco.

Although the study did not directly evaluate male fertility, the five-fold increase in the number of men who developed abnormal sperm DNA while being treated with paroxetine is "troubling" and "suggests an adverse effect on fertility," co-investigator Dr. Cigdem Tanrikut, from Harvard Medical School in Boston, told Reuters Health.

In a clinical trial she described as "the first study to assess the impact of an SSRI on semen parameters in healthy men," 35 men took paroxetine for 5 weeks. The drug was administered in once-daily doses of 10 mg the first week, 20 mg in the second week, 30 mg the third and fourth week, and 20 mg in the fifth week.

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GlaxoSmithKline faces US scrutiny over Paxil suicide link

GlaxoSmithKline (GSK), the UK's largest drug maker, is facing new scrutiny in America in the wake of a British government inquiry that found the company withheld data on the suicide risk of an antidepressant.

A US senator today asked the food and drug administration (FDA), the agency that regulates American pharmaceuticals, to follow its UK counterpart in probing whether GSK concealed clinical trial evidence.

"If the company engaged in this behaviour in the UK, then I want to make sure that the same didn't happen here in the US," Grassley said.

"The FDA should investigate this question thoroughly and be forthcoming about its findings."

The drug in question - Paxil, marketed in the UK as Seroxat - has been the subject of suicide warnings since 2003, when the British government told doctors not to prescribe it to young adults. A warning to that effect was added to its US labels in 2006.

In responding to the UK conclusion that GSK failed to inform authorities of Paxil's suicide risk, Grassley quoted the Guardian's report on imminent British legislation requiring drug companies to promptly publicise clinical trial data.

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Requiem for the Paxilated

Prozac was introduced by Eli Lilly to the US market in January 1988. Zoloft and Paxil followed in 1991 and 1992, respectively. Some 45,000 reports of adverse reactions to Prozac have been filed with the FDA. These include reports of about 2500 deaths, with the large majority linked to suicide or violence.

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Antidepressants most prescribed drugs in U.S.

Dr. Ronald Dworkin tells the story of a woman who didn't like the way her husband was handling the family finances. She wanted to start keeping the books herself but didn't want to insult her husband.

Antidepressants such as Paxil, Prozac and Lexapro are among America's most-prescribed drugs.

The doctor suggested she try an antidepressant to make herself feel better.

She got the antidepressant, and she did feel better, said Dr. Dworkin, who told the story in his book "Artificial Unhappiness: The Dark Side of the New Happy Class." But in the meantime, Dworkin says, the woman's husband led the family into financial ruin.

"Doctors are now medicating unhappiness," said Dworkin. "Too many people take drugs when they really need to be making changes in their lives."

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Antidepressant studies find low birth-defect risk

Use of antidepressants by pregnant women doesn't significantly increase the risk of birth defects, with rare exceptions, two studies found.

The overall risk of having a child with a defect increased by less than 1 percent in women on the drugs, including Pfizer Inc.'s Zoloft, GlaxoSmithKline PLC's Paxil and Forest Laboratories Inc.'s Celexa, according to research published today in The New England Journal of Medicine.

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