Wednesday, September 12, 2007

Watchdog's U-turn on drug for MS patients
Scotsman - United Kingdom
Last year, the Scottish Medicines Consortium (SMC) said Tysabri was not cost-effective for use in the health service, leaving campaigners and patients ...
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Genmab reports encouraging preclinical data for ofatumumab
Trading Markets - Los Angeles,CA,USA
Genmab has reported that ofatumumab appeared more effective than rituximab at inducing complement dependent cytotoxicity, an immune system killing mechanism ...
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Novartis to boost payouts to shareholders
San Diego Union Tribune - United States
Novartis said it had completed enrolling patients for two pivotal Phase III studies of its experimental oral multiple sclerosis drug FTY720, which could be ...
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Football player's cooling treatment is experimental, but also tried for stroke, brain injury - NFL - Yahoo! Sports
By MARILYNN MARCHIONE, AP Medical Writer
September 12, 2007

Doctors are following the playbook in treating Buffalo Bills football player Kevin Everett's severe spinal cord injury except in one notable regard: pumping icy cold saline into his veins to try to prevent further damage.

Although the treatment is experimental, it is more science than science fiction, and also is being tried on stroke and brain injury patients.
"There are compelling reasons why one might want to try it" in a case like this said Dr. Gary Steinberg, chairman of neurosurgery at Stanford University. He had no role in Everett's case but has tested the body cooling treatment.

Everett's prognosis remains uncertain. His doctors were encouraged by signs on Tuesday that he could move his legs and arms -- a day after saying he stood little chance of making a full recovery. They also have said that his spinal cord was intact rather than severed -- a very good sign.

Doctors say that it is far too soon to know whether he will be left with any paralysis or its extent.

"Walking out of this hospital is not a realistic goal, but walking may be," Dr. Andrew Cappuccino, the team's orthopedic surgeon, said at a news conference in Buffalo on Wednesday.

That does not mean a return of his career, though, said Dr. Joseph Maroon, team neurosurgeon for the Pittsburgh Steelers and a University of Pittsburgh specialist who was consulted on Everett's case.

"If he ever does regain function, no neurosurgeon would ever permit him to play football," Maroon said.

Everett suffered a fracture and dislocation of his spinal cord in the neck area during a game Sunday night against the Denver Broncos. Watching it on television from home was Dr. W. Dalton Dietrich, scientific director for the Miami Project, a spinal cord program affiliated with the University of Miami Miller School of Medicine.

The program is among several in the United States that has led research into moderate hypothermia, or cooling the body a few degrees to try to limit swelling, inflammation and the cascade of events and chemicals that cause further damage after an initial neurological injury.

Dietrich sent an urgent e-mail to fellow neurosurgeon Dr. Barth Green, who knows Buffalo Bills owner Ralph Wilson.

Who did what next is unclear, but doctors say Everett received the experimental cooling therapy in the ambulance, even before X-rays and other tests could show the extent of his injury and the treatment he would need.

The goal of the treatment is "to cool the tissue a few degrees to reduce its need for oxygen and to reduce its metabolic rate" and limit secondary damage from chemicals the body releases after the initial injury, said Dr. Elad Levy, a University of Buffalo neurosurgeon who treated Everett.

On Monday, as Everett's temperature began to rise, doctors decided to try cooling his body again, using a slightly different system. This time, a hollow tube called a catheter was inserted into the femoral vein in the leg near the groin, and cold saline was circulated through the veins but not put directly into the bloodstream.

"We did this here at the University of Pittsburgh in the 70s," but with a different method of threading a catheter directly over the spinal cord, Maroon said. The treatment had to be done within three hours of injury to have any benefit and was extremely cumbersome, he said. For that and other reasons, it was largely abandoned until recently, when doctors have resumed testing it through different cooling methods for stroke and brain injury patients.

"Not a lot is known about it for spinal cord injury," said Steinberg at Stanford, where it mostly is done in some stroke and head injury cases under an experimental protocol.

Other aspects of Everett's care are more routine.

He received large intravenous doses of methylprednisolone, a steroid to limit inflammation and swelling, and had decompression surgery to relieve pressure on his spinal cord.

Doctors initially operated from the front of his neck, removing the injured disk and bone impinging on the spinal cord, and realigned it. They filled the space where the disk had been with a bone graft -- whether from a cadaver or his hip isn't known -- and put in a titanium plate to stabilize the neck area.

Surgeons then turned him over and operated from the back of his neck, fusing the vertebrae above and below the fracture, and putting in four screws and two small rods.

Long-term results from such operations can vary widely, said Maroon, the Steelers' surgeon who published a paper in the April issue of Journal of Neurosurgery on this topic. He has operated on about 30 athletes.

On Wednesday, Everett was successfully removed from the respirator though doctors say it could be a struggle to keep him breathing on his own. A stroke and blood clots in his legs are other possible complications they are trying to prevent.

He showed more ability to move his legs and a little more in his arms, but has no movement or function at all of his hands. He is getting nourishment from a feeding tube, and his mother is at his side.

"She understands that this is a life-changing event," and that "the story will change over months to years," said Dr. Kevin Gibbons, another University of Buffalo neurosurgeon who has been treating Everett.

On the Net:

Spinal cord center: http://www.themiamiproject.org/

Body cooling system: http://www.alsius.com/

http://sports.yahoo.com/nfl/news?slug=ap-everettinjury&prov=ap&type=lgns

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