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In a statement issued this week, the U.S. Food and Drug Administration (FDA) announced a renewed commitment to its drug safety system. Based on recommendations from a report by the Institute of Medicine (IOM), the agency outlined a series of immediate steps to ensure their safety procedures are as robust as they need to be.

“Our ongoing assessment of the drug and medical product safety system has affirmed that it is essential that our processes and scientific methods keep pace with the rapid evolution of science, technology and the health care system,” said Dr. Andrew C. von Eschenbach, commissioner of the FDA. “The extensive input we have received from stakeholders has proven invaluable as we transform the drug and medical product safety system and continue to fulfill our mission to protect and promote the public health.”
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According to journalists at the BBC, GlaxoSmithKline intentionally distorted and covered up damaging information about their antidepressant Seroxat and its link to an increased risk of suicide in children. Researchers for the BBC documentary series Panorama obtained three critical documents suggesting that the company had conducted trials proving the drug was unsafe, but failed to accurately disclose that information. (Seroxat is a brand name for paroxetine, a selective serotonin reuptake inhibitor (SSRI) class of antidepressant marketed in the U.S. as Paxil.)

The BBC’s website reports: “GSK’s biggest clinical trial of Seroxat on children was held in the U.S. in the 1990s and called Study 329. Child psychiatrist Dr. Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329. In 2002, he also gave a talk on childhood depression at a medical conference sponsored by GSK. He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates.”
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Pharmaceutical giant Wyeth was ordered by a Pennsylvania state jury to pay $1.5 million in compensatory damages to an Arkansas woman and her husband who held the company’s hormone replacement therapy (HRT) drug Prempro responsible for the woman’s breast cancer. Citing conduct by Wyeth that was “malicious, wanton, willful, or oppressive, or showed reckless indifference,” the jury has also begun deliberating on possible punitive damages to be tacked on. However, Judge Myrna Field ruled Tuesday that the company should not be held responsible for punitive damages a decision that may be overturned in the appeals process.

Mary Daniel, 60, of Hot Springs, Arkansas, began taking Prempro, a drug that combines estrogen and progestin, to treat the symptoms of menopause. Daniel started her therapy in late 1999 and was diagnosed with breast cancer in July of 2001. Her attorneys argued that Wyeth had known for decades about Prempro’s breast-cancer risk factor in postmenopausal women, but acted negligently by failing to provide adequate warnings or conduct sufficient testing.
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