The last sentence says it all...

Nic 57/15


On Thu, Sep 24, 2009 at 7:28 AM, mschild <[log in to unmask]> wrote:

> It is worth reading to the very end
> Maryse
>
>
>
> The drug, rasagiline (Azilect), was approved in 2006 by the U.S. Food and
> Drug
> Administration on the basis of studies showing that it reduced Parkinson's
> symptoms such as trembling and slowed motion. The new study, reported in
> the
> Sept. 24 issue of the New England Journal of Medicine, was designed to
> determine whether the drug also acts on the underlying nerve deterioration
> that causes the disease.
>
> "In our heart, what we are hoping for is neuroprotection," said study
> author
> Dr. C. Warren Olanow, a professor of neurology and neuroscience at Mount
> Sinai
> School of Medicine, in New York City.
>
> To distinguish the effect on symptoms from the hoped-for effect on the
> underlying disease, "we used a totally new study design, to see if it is
> disease-modifying," Olanow explained.
>
> The study enlisted 1,176 people with previously untreated Parkinson's
> disease
> who were seen at medical centers around the world. At the start, half took
> daily doses of either 1 milligram or 2 milligrams of rasagiline for 36
> weeks,
> while the other half took a placebo. After that, all the participants took
> either 1 milligram or 2 milligrams of rasagiline for another 36 weeks.
>
> A complex system to measure the treatment effects showed an apparent
> improvement in the participants who took the 1-milligram doses but not in
> those taking the 2-milligram doses.
>
> "It did something to affect the course of the disease," Olanow said. "We
> don't
> know why, but we are entitled to speculate."
>
> His speculation is based on a detailed study of the 25 percent of
> participants
> who showed the greatest benefit. "What I think is right is that the higher
> dose
> had a greater effect on symptoms than the lower dose, so that masked our
> ability to detect its effect on disease progression," Olanow said. "We
> thought
> that this floor effect was why we couldn't see a difference."
>
> Olanow was enthusiastic about the results. "This doesn't prove
> unequivocally
> that it [rasagiline] is neuroprotective, but there is no other rational
> explanation for the results," he said. "This is good news for Parkinson's
> patients."
>
> Asked if he would prescribe the drug for that reason, Olanow said, "Yes, I
> would personally prescribe it."
>
> A much more skeptical response came from Dr. William J. Weiner, chair of
> neurology at the University of Maryland, who took part in the study.
>
> "The authors were very careful in the paper not to indicate that they had
> shown neuroprotection," Weiner said. "The tone of the article itself is
> moderate."
>
> The methods used to determine trial results need scrutiny, he said. "They
> used
> a lot of very fancy mathematical models, some of which had not been used
> before," Weiner said. "Most neurologists wouldn't understand the
> mathematical
> models they used. Research neurologists don't deal with equations about the
> slope of curves."
>
> And the end results were not impressive, he maintained. "The difference
> reported in the study is less than two points on a scale that has 150
> points,"
> Weiner said.
>
> The reason why the lower dose worked, and the higher one didn't? "It simply
> could be luck," he said.
>
> While rasagiline can provide benefits in reducing symptoms of early
> Parkinson's
> disease, Weiner said he was worried that "patients will be given what I
> believe to be false hopes" by the new study.
>
> "It has mild symptomatic effects, but I do not prescribe this drug for
> neuroprotection and this study doesn't convince me to do that," Weiner
> said.
>
> Several of the study authors have received consulting or lecturing fees
> from
> pharmaceutical companies, including Teva, the maker of Azilect.
>
>
>
> http://health.usnews.com/articles/health/healthday/2009/09/23/new-parkinsons-
> drug-draws-mixed-reviews.html<http://health.usnews.com/articles/health/healthday/2009/09/23/new-parkinsons-%0Adrug-draws-mixed-reviews.html>
>
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