FDA Admits Role of Politics In Safety Case
The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.
The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.
But after receiving what an FDA report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Sens. Robert Menendez and Frank R. Lautenberg and Reps. Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.
All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they acted appropriately and were not influenced by the money.
Hyatts In Boston Area Face Protests after Layoffs
Hyatt Hotels is facing a wave of anger and protests as a result of its decision to lay off 98 members of its housekeeping staff at three Boston area hotels and replace them with lower paid workers.
Upset by the layoffs, Gov. Deval Patrick of Massachusetts has called on state employees to boycott Hyatt hotels unless the company reinstates the workers.
The housekeepers generally earned $14 to $16 an hour with health benefits, while their replacements, union and Hyatt officials say, are being paid around $8 an hour without health benefits. Hyatt said it was “very disappointed” by Patrick’s boycott threat, saying it endangers the jobs of 600 Hyatt employees in the Boston area.
“The difficult decision to outsource the housekeeping function at our Boston properties was made in response to the unprecedented economic challenges those hotels are facing in the current business environment,” Hyatt said in a statement. “A precipitous drop in revenues at our Boston hotels has made major cost-cutting measures necessary.”
Experts Awed by Anglo-Saxon Treasure Found by Man with Metal Detector
For the jobless man living on welfare who made the find in an English farmer’s field two months ago, it was the stuff of dreams: a hoard of early Anglo-Saxon treasure, probably dating from the seventh century and including more than 1,500 pieces of intricately worked gold and silver whose craftsmanship and historical significance left archaeologists awestruck.
When the discovery was announced Thursday, experts described it as one of the most important in British archaeological history.
The new trove includes gold items weighing 11 pounds, and 5.5 pounds of silver. Tentatively identified by some experts as bounty from one of the wars that racked Middle England in the seventh and eighth centuries, they included sword pommels and dagger hilts, scabbard bosses and helmet cheekpieces, Christian crosses and figures of animals, eagles and fish.
Archaeologists initially estimate the value of the trove at 1 million pounds — about $1.6 million — but say it could be many times that.