The FDA and Provigil/Modafinil


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The FDA and Provigil/Modafinil

Postby bhall » Thu Sep 25, 2003 2:57 pm

Today on the Public Radio International show, Market Place, there is a story about the FDA approving Provigil (a.k.a. Modafinil) being approved for broader use as a legal stimulant.

"If FDA expands use of stay-awake drug Provigil, how will it affect the manufacturer?"

Listen on your local NPR station or go to http://www.marketplace.org tomorrow for an archive.
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Re: The FDA and Provigil/Modafinil

Postby Guest » Thu Sep 25, 2003 4:31 pm

So, shortly, Pro/Mo will end up over the counter and WADA (as it just did w/ ephedrine and caffeine) will declare it an innocuous substance that's no longer on the list. So, like the Rumanian gymnast cited in another thread today, Kellie White will end up stripped of medals/money but be innocent. But her case will be even worse. The gymanast's stuff was illegal when she took it, White's wasn't! Only so-declared after the fact. This is juicy stuff.
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Re: The FDA and Provigil/Modafinil

Postby MJD » Sat Oct 25, 2003 7:40 am

>Today on the Public Radio International show,
>Market Place, there is a story about the FDA
>approving Provigil (a.k.a. Modafinil) being
>approved for broader use as a legal stimulant.

...and now it's a buy:

"LAPPIN: Well, I have always, I always have something going in the biotech area, and one of the companies I like there is Cephalon. The stock is actually down a few dollars for this year, and they have a drug called PROVIGIL, which was approved a year or more ago for narcoleptics, people that just can’t stay away. And just in the last 10 days, PROVIGIL has been given an expanded label so that it can be used by people who work night shifts and so forth. They’ve done studies that the Three Mile Island accident happened because people were exhausted. And you know the circadian rhythms or whatever they call them that want us to be up during the day and sleeping at night are disrupted for night shift workers. And so that’s just one of many new opportunities for them to market, and I think that drug is going to grow to be a billion-dollar drug."

http://www.pbs.org/wsw/tvprogram/
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Re: The FDA and Provigil/Modafinil

Postby Guest » Sun Oct 26, 2003 8:51 am

Only one problem with this little tale: ephedrine and caffeine are both still on the banned list to some degree or other. Just because a drug becomes availible OTC doesn't mean it is legal for athletes to take.
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Re: The FDA and Provigil/Modafinil

Postby bhall » Sun Oct 26, 2003 10:19 am

In 2004 both caffeine and ephedrine are slated to come OFF the banned list. UCI, the internation cycling federation, is none too pleased with WADA's decision on this, especially regarding caffeine. Yet Modafinil will be added.

See the following-
http://www.wada-ama.org/docs/web/standa ... t_mods.pdf
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Re: The FDA and Provigil/Modafinil

Postby bhall » Mon Oct 27, 2003 6:24 am

Above I said "ephedrine", which should of course be pseudoephedrine NOT ephedrine. If you looked at the link above or have the November issue of the magazine (page 47 I *think*) you'd have known I was short the pseudo part. Sorry for any confusion.
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Re: The FDA and Provigil/Modafinil

Postby abinferno » Mon Oct 27, 2003 9:33 am

Well, as an athlete, I can honestly attest that no amount of caffeine will aid your performance in any measurable sense. Will NCAA adjust their banned list to match these changes? Somehow I doubt it.
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Re: The FDA and Provigil/Modafinil

Postby Pego » Mon Oct 27, 2003 10:14 am

<I can honestly attest that no amount of caffeine will aid your performance>

Nor does ephedrine or any other stimulant including illegal (except with the prescription) amphetamines. Just because you "feel full of energy" does not translate to a better performance.
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Re: The FDA and Provigil/Modafinil

Postby Guest » Mon Oct 27, 2003 10:55 am

>>Nor does ephedrine
>or any other stimulant including illegal (except
>with the prescription) amphetamines. Just because
>you "feel full of energy" does not translate to
>a better performance.>>

Which is what leads me to wonder if the IAAF didn't do a bit of a rush to judgement in the Modafinil case. Since it wasn't on the banned list before Paris, and it only took them a couple of days after it showed up to declare it illegal, clearly there has been ZERO done in the way of studies to see if it is in any way a performance-enhancer.

I've been told that the only reason that caffeine and pseudoephedrine ever showed up on the banned lists was because the testers started finding them frequently in tests. Rather than actually see if they were enhancers, they took the view of "well they're taking them, so we'd better ban them." And now, years later after punishing no end of people, they've done a 180 and decided they're OK.

Given that Modafinil is apparently on the fast track to going over the counter, will it be the same?

I'm all for stamping out drug use/abuse, but only if it's done in a logical fashion, not unscientific knee-jerk methodology.
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Re: The FDA and Provigil/Modafinil

Postby Guest » Mon Oct 27, 2003 11:08 am

>I'm all for stamping out drug
>use/abuse, but only if it's done in a logical
>fashion, not unscientific knee-jerk methodology.

Agreed but hasn't the army already proven that it can help guys kill people and break things?
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Re: The FDA and Provigil/Modafinil

Postby Guest » Mon Oct 27, 2003 11:15 am

<In 2004 both caffeine and ephedrine are slated to come OFF the banned list. UCI, the internation cycling federation, is none too pleased with WADA's decision on this, especially regarding caffeine.>

I believe caffeine has a proven positive effect in LONG events (over 2 hours). Something related to fat utilization I think. Probably why the cycling federation isn't happy, as many of their events are 3-6 hour affairs. For track athletes not much advantage unless in very high dose - then you may get the Jimmy leg and false start:)
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Re: The FDA and Provigil/Modafinil

Postby Guest » Mon Oct 27, 2003 11:57 am

Supposedly caffeine aids the switch over to burning fat once the carbs are used up. In theory, might help at the end of a marathon or in a 50K racewalk. My bet, however, is that the diuretic effects and (for many) stomach irritation large doses of caffeine can cause would cancel out any positive effects.

>I believe caffeine has a proven
>positive effect in LONG events (over 2 hours).
>Something related to fat utilization I think.
>Probably why the cycling federation isn't
>t happy, as many of their events are 3-6 hour
>affairs. For track athletes not much advantage
>unless in very high dose - then you may get the
>Jimmy leg and false start:)
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Re: The FDA and Provigil/Modafinil

Postby Pego » Mon Oct 27, 2003 2:38 pm

<Supposedly caffeine aids the switch over to burning fat once the carbs are used up>

No marathon runner nor the road cyclist (triathlete etc.) goes entirely on to burn fat. They all take all kinds of "power bars", almost exclusively carbohydrates. Where in the world is that caffeine effect?!
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Re: The FDA and Provigil/Modafinil

Postby Guest » Mon Oct 27, 2003 3:05 pm

Caffeine info. FYI

www.rice.edu/~jenky/sports/caffeine.html

Sorry if it doesn't show up as a link - I'm an illiterate on this damn computer machine thingy.
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Re: The FDA and Provigil/Modafinil

Postby Guest » Mon Oct 27, 2003 3:27 pm

>Caffeine info.
>FYI

Interesting summary, except it doesn't mention anything about the effects of caffeine on reaction time (which is the other reason I would expect people to use it in the sprints, aside from muscle twitch).

Anyone know something about that? I'm thinking that might be another use of modafinil, too. Heighten altertness and fine-tune reaction?
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Re: The FDA and Provigil/Modafinil

Postby Pego » Mon Oct 27, 2003 3:29 pm

<www.rice.edu/~jenky/sports/caffeine.html>

After reading the article, what I said before is confirmed. Caffeine helps metabolism of fat when NO continues supply of glucose is available. The caffeine containing drinks they used also contained glucose, so no new information surfaced.
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Re: The FDA and Provigil/Modafinil

Postby Guest » Mon Oct 27, 2003 4:48 pm

Did the Marketplace report >definitely< say it was going to be approved for over-the-counter sales?
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Re: The FDA and Provigil/Modafinil

Postby bhall » Mon Oct 27, 2003 9:21 pm

>Did the Marketplace report >definitely< say it
>was going to be approved for over-the-counter
>sales?

No. Report says *nothing* about over-the-counter. Only says that an FDA panel approved Provigil/Modafinil for treatment of a wider variety of problems. According to the report Provigil/Modafinil will still require a prescription from a doctor.
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Re: The FDA and Provigil/Modafinil

Postby DentyCracker » Tue Oct 28, 2003 3:08 am

With regard to caffeine it has significant diuretic activity, maybe it helps to clear the urine of banned substances, when taken with lots of water. I'll check to see whether that makes any sense, working on 1 hour's sleep here
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