Re: LDN funding for trials?

[Guest guest]

In case you missed it:http://www.nytimes.com/aponline/national/AP-MS-Drug.html------------------------------------------------------------------------March 1, 2006Studies Find Withdrawn MS Drug Effective By THE ASSOCIATED PRESSFiled at 11:43 p.m. ETNEW YORK (AP) -- A promising multiple sclerosis drug that was suspended from the market because three people developed a rare brain disease now appears relatively safe and quite effective, three studies found.The research in Thursday's New England Journal of Medicine comes days before government hearings on whether to allow sales of the drug, Tysabri, to resume.Tysabri (pronounced ty-SAH-bree) was withdrawn a year ago by Biogen Idec Inc. and Elan Corp. PLC, only months after it had been approved. The Food and Drug Administration last month agreed to allow testing to

resume after the company said no more cases of the brain disease had emerged.The new studies found that Tysabri alone or with standard interferon treatment cut the rate of relapse 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 studies ''confirm that this drug is a significant advance for MS treatment,'' said Dr. Allan H. Ropper of Boston's Caritas St. 's Medical Center, who wrote an editorial in the journal.Multiple sclerosis, a disease of the central nervous system, afflicts about 350,000 Americans and is more common among women than men. There is no cure and the cause is unknown. Symptoms include trouble seeing and walking. The most common form causes periodic flare-ups of symptoms.Tysabri was highly anticipated because it works in a different way than existing drugs, which offer only

modest help. It blocks destructive immune cells from leaving the bloodstream and entering the brain to inflame and damage nerve tissue.Patients clamored for the drug when it went on sale, with about 7,000 getting treatment in the first three months.Then a woman who had gotten Tysabri and interferon for three years died of the brain disease, progressive multifocal leukoencephalopathy, or PML, and a second participant contracted it. Sales of the drug were suspended and tests halted.A Crohn's disease patient in a Tysabri test for the painful bowel disorder also died of the brain ailment, which is caused by a common virus that is usually dormant. It is most often seen in those with weak immune systems, such as AIDS patients.An independent committee that included National Institutes of Health scientists reported in the journal that a review found no other cases of the brain infection in other study volunteers.

They put the odds of getting PML at 1 in 1,000.In one study of 942 people, nearly twice as many on a dummy treatment got worse over two years. The Tysabri group had 68 percent fewer relapses.In the second study of 1,171, the rate of relapse was cut in half when Tysabri was added to interferon. A quarter more patients got worse on interferon alone.The researchers have received fees or support from the makers of Tysabri and include Biogen Idec employees.The lead researchers said they will soon resume testing Tysabri and would give it to the neediest patients if it went back on the market.''I think it's up to the doctor, together with the patient, to decide whether to use it,'' said the Cleveland Clinic's Dr. Rudick, who led the combination study.^------On the Net:New England Journal: http://www.nejm.orgNational MS Society: http://www.nmss.orgRuss Miles <milesruss@...> wrote: I have to agree with Gigi on this one. For What? So they ( the traditional medicine men) can find some reason to take an effective , low cost, RX off the market? Bet on it!

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[Guest guest]

In case you missed it:http://www.nytimes.com/aponline/national/AP-MS-Drug.html------------------------------------------------------------------------March 1, 2006Studies Find Withdrawn MS Drug Effective By THE ASSOCIATED PRESSFiled at 11:43 p.m. ETNEW YORK (AP) -- A promising multiple sclerosis drug that was suspended from the market because three people developed a rare brain disease now appears relatively safe and quite effective, three studies found.The research in Thursday's New England Journal of Medicine comes days before government hearings on whether to allow sales of the drug, Tysabri, to resume.Tysabri (pronounced ty-SAH-bree) was withdrawn a year ago by Biogen Idec Inc. and Elan Corp. PLC, only months after it had been approved. The Food and Drug Administration last month agreed to allow testing to

resume after the company said no more cases of the brain disease had emerged.The new studies found that Tysabri alone or with standard interferon treatment cut the rate of relapse 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 studies ''confirm that this drug is a significant advance for MS treatment,'' said Dr. Allan H. Ropper of Boston's Caritas St. 's Medical Center, who wrote an editorial in the journal.Multiple sclerosis, a disease of the central nervous system, afflicts about 350,000 Americans and is more common among women than men. There is no cure and the cause is unknown. Symptoms include trouble seeing and walking. The most common form causes periodic flare-ups of symptoms.Tysabri was highly anticipated because it works in a different way than existing drugs, which offer only

modest help. It blocks destructive immune cells from leaving the bloodstream and entering the brain to inflame and damage nerve tissue.Patients clamored for the drug when it went on sale, with about 7,000 getting treatment in the first three months.Then a woman who had gotten Tysabri and interferon for three years died of the brain disease, progressive multifocal leukoencephalopathy, or PML, and a second participant contracted it. Sales of the drug were suspended and tests halted.A Crohn's disease patient in a Tysabri test for the painful bowel disorder also died of the brain ailment, which is caused by a common virus that is usually dormant. It is most often seen in those with weak immune systems, such as AIDS patients.An independent committee that included National Institutes of Health scientists reported in the journal that a review found no other cases of the brain infection in other study volunteers.

They put the odds of getting PML at 1 in 1,000.In one study of 942 people, nearly twice as many on a dummy treatment got worse over two years. The Tysabri group had 68 percent fewer relapses.In the second study of 1,171, the rate of relapse was cut in half when Tysabri was added to interferon. A quarter more patients got worse on interferon alone.The researchers have received fees or support from the makers of Tysabri and include Biogen Idec employees.The lead researchers said they will soon resume testing Tysabri and would give it to the neediest patients if it went back on the market.''I think it's up to the doctor, together with the patient, to decide whether to use it,'' said the Cleveland Clinic's Dr. Rudick, who led the combination study.^------On the Net:New England Journal: http://www.nejm.orgNational MS Society: http://www.nmss.orgRuss Miles <milesruss@...> wrote: I have to agree with Gigi on this one. For What? So they ( the traditional medicine men) can find some reason to take an effective , low cost, RX off the market? Bet on it!

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[Guest guest]

Thank you Mike for the up-date I'll post this on the " Activist

Issues " secton involving Tysabri in http://MilesBooks.com.lol

~Hugs~ Russ:))

I have to agree with Gigi on

this one. For What? So they ( the traditional medicine men) can find

some reason to take an effective , low cost, RX off the market? Bet

on it!

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> Use Photomail to share photos without annoying attachments.

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