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Old 07-19-2013, 10:56 PM
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lab rat lab rat is offline
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Join Date: Oct 2012
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Default I think the FDA suggested a delayed start trial

Quote:
Originally Posted by reverett123 View Post
Reading WebMD's coverage of the Azilect study is a bit underwhelming.

"How can that be proved? C. Warren Olanow, MD, of Mount Sinai School of Medicine, New York, and colleagues tried a daring study. They enrolled 1,176 patients with early, untreated Parkinson's disease in a two-phase study.

In the first phase, half the patients got Azilect at doses of either 1 milligram or 2 milligrams a day. The other half got a placebo. But it would be unethical to withhold an effective treatment for long, so after 36 weeks, the placebo patients started getting Azilect, too.

If all the patients were doing equally well after 72 weeks, one could conclude that Azilect simply treats the symptoms of Parkinson's disease. But if those who started treatment earlier were still doing better at that time, then any difference should be because of the slowing of Parkinson's disease itself.

It's a daring study because so much can go wrong with a study design like this. The study went as planned, but the results were unexpected.

Early treatment at the 1 milligram dose of Azilect did seem to slow Parkinson's disease. But early treatment at the 2 milligram dose did not.

"It is difficult to explain why the two doses did not provide similar results," Olanow and colleagues note.

Although they conclude that the 1 milligram dose of Azilect may very well slow Parkinson's disease, "the study results must be interpreted with caution."

The study findings appear in the Sept. 24 issue of The New England Journal of Medicine. The study was funded by Teva Pharmaceuticals, which makes Azilect. Olanow and some of his colleagues report receiving consulting and/or lecture fees from Teva and other pharmaceutical companies."
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OK. First, note that it was a "daring" study. So much so that they had to tell you twice. And it was interesting that even though 2 mg failed to impress, half that may have had an effect. But that is hard to say since they were so excited by the micro-response that they scrubbed the control group half-way through since they could not ethically withhold such a wonder drug any longer lest the wonder become invisible. Uh-huh. "With caution" indeed. In fact the results would be much more visible if you were being paid by Teva to look.

Search the forum for Olanow and you will find things like his heading a group of neuros who patented the use of mucuna pruriens for PD thus bottling up research on it. Selective amnesia about consulting fees in a South African case about manganese poisoning ("Ohh! That $3,000,000 your honor!"). And similar tripe.
In reading the transcripts of the FDA panel that was asked to approve Azilect as a disease modifier for PD, I think there was agreement that it was the FDA's idea to use a delayed start to prove disease modification.

In the end the FDA voted 17-0 against approval as a PD disease modifier.

PS --
Congratulations on your promotion to GRAND MAGNATE -- the check is in the mail.
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Bogusia (07-20-2013), reverett123 (07-20-2013)