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GlaxoSmithKline Plc rejected allegations that it concealed safety information about its diabetes drug Avandia or acted inappropriately in marketing it, saying a U.S. Senate staff report was inaccurate and incomplete.
The company diligently studied the drug’s safety and effectiveness, and communicated its findings to governments, regulators, scientists and doctors, London-based Glaxo said in a statement.
A jury has awarded a woman $23.4 million in a civil judgment against Ford Motor Co. for a 2007 freeway accident that left her a quadriplegic.
Cynthia Castillo lost control of her 1997 Ford Explorer when the tread separated from her left-rear tire as she drove on the freeway.
Her attorney, Brian Brandt, said the SUV veered off the freeway and rolled three times down an embankment, leaving her legs and most of her body paralyzed. Flaws in the vehicle’s design caused it to lose control when the tire tread separates, Brandt said.
An Idaho Springs man was awarded $18.5 million for catastrophic injuries he suffered when a driver drunk on alcohol and high on marijuana left a mountain road and slammed into him as he was changing the oil on his wife’s car in their driveway.
Clear Creek District Court Judge Granger assessed the award against the driver, Kevin Ruszkowski, 24; the owner of the Jeep, Randall Guy; and Guy’s son, Justin Guy, 20, who had allowed Ruszkowski to drive the vehicle.
Paul Savage, 46, who was injured, was head waiter at the Alpenglow Stube at Keystone at the time.
Ruszkowski had no license because his driving privileges had either been suspended or revoked for prior driving misconduct.
Read more: http://www.denverpost.com/news/ci_14419648#ixzz0gN2hsQw2
The pressure on Toyota Motor Corp. intensified as the company disclosed subpoenas from a federal grand jury and the Securities and Exchange Commission related to sudden acceleration in its cars, while the leaders of a congressional panel accused Toyota of misleading the public about safety problems.
The House Energy and Commerce Committee, in an 11-page letter, previewed issues its members likely will raise at a hearing Tuesday. The letter criticized Toyota for resisting the possibility that electronic defects could be responsible for the reports of unintended acceleration.
The Food and Drug Administration, under fire from a new Senate report questioning the safety of GlaxoSmithKline PLC’s diabetes drug Avandia, told doctors that patients taking the medicine should stay on it unless their doctors say otherwise.
Rep. Rosa DeLauro (D., Conn.), the chairwoman of the House appropriations panel that controls the FDA’s budget, said: “I strongly urge the FDA to remove Avandia from the market until a truly independent, science-based advisory panel can evaluate the safety and effectiveness of the drug.”
A pedestrian wearing a hooded jacket has been killed by a commuter train in Dallas.
The woman walked into a Trinity Railway Express train, which links Dallas and Fort Worth and carries about 10,000 passengers daily, during afternoon rush hour Monday.
Three years ago, Dr.Nissen, a cardiologist at the Cleveland Clinic, conducted a landmark study that suggested that the best-selling diabetes drug Avandia raised the risk of heart attacks. The study led to a Congressional inquiry, stringent safety warnings, a sharp drop in the drug’s sales of GlaxoSmithKline, Avandia’s maker.
The battle between Dr. Nissen and GlaxoSmithKline was waged from afar in news releases and published papers. But on May 10, 2007, 11 days before Dr. Nissen’s study was published in The New England Journal of Medicine, he and four company executives met face to face in a private meeting whose details have not been disclosed until now.
Tobacco smoke contamination lingering on furniture, clothes and other surfaces, dubbed thirdhand smoke, may react with indoor air chemicals to form potential cancer-causing substances, a study found.
After exposing a piece of paper to smoke, researchers found the sheet had levels of newly formed carcinogens that were 10 times higher after three hours in the presence of an indoor air chemical called nitrous acid commonly emitted by household appliances or cigarette smoke. That means people may face a risk from indoor tobacco smoke in a way that’s never been recognized before, said one of the study’s authors, Lara Gundel.
The maker of Poligrip denture cream will stop making formulas containing zinc amid lawsuits claiming years of excessive use caused neurological damage and blood problems in consumers, allegedly crippling some.
GlaxoSmithKline will stop making and marketing Super Poligrip Original, Ultra Fresh and Extra Care products in the U.S. The company plans to reformulate the creams without zinc.
Confidential studies by Food and Drug Administration officials recommend that GlaxoSmithKline’s Avandia, a diabetes medicine, get pulled from the market because it is linked to heart attacks.
The studies, released as part of a report on Avandia by staff of Senate Finance Committee members Chuck Grassley (R., Iowa) and Max Baucus (D., Mont.), also say any head-to-head trial where patients get Avandia and Takeda Pharmaceutical Co.’s diabetes medicine Actos would be “unethical and exploitative.” GlaxoSmithKline is currently sponsoring a study, called TIDE, where patients get either Avandia, Actos or other medicines.
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