Tuesday, July 13, 2010

advisory panel prepares to weigh the fate of the controversial diabetes drug.

The FDA panel of outside experts will discuss the data and hear from researchers, patients and public health advocates at the July 13-14 meeting before offering their advice, which could range from leaving the drug on the market and collecting more data to calling for its withdrawal.

But at least one expert witness for the plaintiffs, a Canadian cardiologist, said what he saw was so critical that he sought to testify before the FDA advisers this week. He did not indicate the nature of the documents.

In a letter to the FDA, McGill University's Allan Sniderman said he has "access to data that has not previously been available to any similar group" but is barred by a court protective order from discussing the documents he has seen.

"These data are, in my opinion, essential to review," he wrote last month.

Lawyers for patients who say they have been harmed by GlaxoSmithKline Plc's Avandia say critical data is still under wraps even as a U.S. advisory panel prepares to weigh the fate of the controversial diabetes drug.

The lawyers, who represent thousands of patients or family members suing the British drugmaker in multi-district federal litigation, say they have uncovered critical documents.

They are pushing the court to allow their release to both the U.S. Food and Drug Administration and the Senate Finance Committee, which has investigated Glaxo's handling of Avandia.

An FDA advisory panel is already wading through hundreds of pages of conflicting data and studies, and is due to meet for two days starting Tuesday on whether to recommend that Avandia be pulled off the market due to heart risks.

Avandia has been under fire since 2007 over concerns that it raises the risk of heart attack, stroke and death more than Takeda Pharmaceutical Co's rival diabetes pill Actos.

It is unclear what the court-sealed documents contain, but it raises questions about whether the FDA will be acting on Avandia without the benefit of all available information.

Friday, July 2, 2010

Three-Legged Dogs Aid in Robot Design

German researchers used high-tech infrared cameras to record the movements of dogs missing a fore limb or hind limb as they walked and ran on a treadmill. The tests revealed that the dogs used different coping methods, depending on which limb was missing.

Adjusting to a missing fore limb is more difficult for a dog than dealing with a missing hind limb, for example. Fore limb amputation requires the remaining limbs to undergo careful adaptation to coordinate with each other, a process called "gait compensation." In the case of a hind-limb amputation, the fore limbs continue to act as they normally would in a four-legged dog, so there is little or no compensation strategy.

The difference in compensation strategies may be due to the fact that a dog's fore limbs carry more body weight than the hind limbs.

The research is slated to be presented Thursday at the Society for Experimental Biology's annual meeting in Prague.