:Random thoughts from a Renegade Mom:
Friday, March 10, 2006FDA Panel Backs Return Of MS Drug
"A promising drug for multiple sclerosis should be returned to the market despite questions about a rare brain disease, scientific advisers told the government Wednesday, even as they continued to grapple with just who should be allowed to use it.
This is a very interesting case. The Drug, Tysabri, was taken off the market because several patients came down with a very rare and potentially fatal brain infection, PML. The Manufacturers pulled the drug from the markers voluntarily after two patients died after being on the market for just four months.
This particular drug was VERY successful in treating MS and the patients stood behind the drug, saying with a progressive illness such as MS patients should be the one to make the call about the risk.
patients testified to the FDA Panel pleading for the drug to be put back on the market.
"I am at the end of my road, in terms of what I can take. I want it to be my choice," said Barbara Crooks, 48, shortly before testifying. She and her husband, David, traveled from the Pittsburgh area to speak.
The risk? Perhaps one in every 1,000, eventually will get the often-fatal virus believed to cause PML.
The benefit? Current drug treatment reduces relapse by 1/3 this new drug by 2/3.
Three studies recently published by the New England Journal of Medicine found that Tysabri alone or with standard interferon treatment cut the rate of relapse in MS patients by as much as two-thirds after two years and reduced the number of people whose MS got worse, compared to those on a dummy treatment or interferon alone.
"The two-thirds reduction in relapse rate cannot be ignored. It is a striking result," said Dr. Richard Rudick, a neurologist at the Cleveland Clinic who appeared before the panel on behalf of Biogen.
I think the FDA made the right call on this one. With progressive, debilitating illnesses patients should have more of a choice!
Gina froze in time on 7:14 AM [ | ]
"NASA's Cassini spacecraft might have discovered water geysers on one of Saturn's moons, raising the possibility that conditions favorable for life in our solar system are more common than once was thought."
One of the things that is baffling scientist is how the water near the pole's surface is kept liquid. They believe there is a heat source in the core of the moon.
Gina froze in time on 7:01 AM [ | ]
Tuesday, March 07, 2006
I'm having a bad day and am not up to blogging.
After losing my keys in Costco and having to spend 3 hours there with a 2 and 4 yr old. My loving husband took me out to eat, against my will!!! In the parking lot I smashed my hand on the door of the car. The kids were their usual horrible selves, and the meal was not at all relaxing. The only highlight was the drink I had! Ya for liquor!!!
Well we got home and a beeline for the door so I can put the kids to bed, and guess what????
I left my keys at the restaurant!
I think I'm going to bed right now!
Gina froze in time on 7:42 PM [ | ]
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The chaotic life of a (exausted) mother of 2 little mosters, I mean children. These are my thoughts on life and the world around me, so I can talk about things other than diapers! Current news, health and women's issues.
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