Another blow to pharma legitimacy (IMHO)
 

OK, now I've heard it all. Listening to the radio I heard an ad for a new drug that has not only barrelled right through the FDA approval process (while scores of PWP suffer daily, waiting for approval of duodopa in this country) but is now being actively marketed for, drum roll, NOT any of the horrible conditions millions are and have been suffering for decades with, but, yes, apparently this is an epidemic we never knew about:

Shift Disorder Syndrome.

You read that right. If you work nights, or off hours, this new drug can help you overcome that pesky circadian rhythm and stay focused and alert all through the shift. There are, of course, side effects. Huge ones. In fact, the disclaimer of side effects took longer for the broadcaster to read through than the spiel for the drug itself.

And some wonder why so many have such little faith in the pharmacuetical industry.

Men with sexual dysfunction apparently suffer moree...
 

Oh, it gets better...shortly after I learned of Duodopa trials here, I ran across a blog entry on a vibrator for men in the shape of a hand. It was FDA "approved" in like six weeks!! As they say "rubber-stamped" and you'll love the rationale: other devices like it were already in use!!! Hellloooo Bureuacrats...can't the same be said of the pump infusion system?

Well, actually, it wasn't that fast....
 

I believe the drug is Nuvigil.

Nuvigil (armodafinil) is a long-acting version of a previously-approved drug, modafinil. Nuvigil is prescribed for people with excessive sleepiness caused by narcolepsy, shift work sleep disorder, use of breathing devices, or obstructive sleep apnea/hypopnea syndrome.

A quick Google search indicates that Nuvigil was not pushed through the FDA approval process. It was approved by the FDA after over 2.5 years of review, discussion, and follow-up. By contrast, the average approval period by the FDA for a new drug application is 12.5 months.

I mention all this not because I am personally interested in Nuvigil. I'm not. I mention this because I come to this forum to read what I consider to be usually well-researched and thoughtful discussions of issues that affect the PD community. I believe these discussions help us deepen our understanding of PD and the challenges facing our community and, in turn, make us better advocates for better research, heathcare, and treatment options.

I completely understand the frustration surrounding our limited drug options. I'm a PWP myself. But I don't think we advance our cause by making statements that are not fact-based and we lose ground when we trivialize the treatments that are available for those with other serious conditions.

Thanks for reading.

I swear they are inventing disorders to create markets. People have suffered from working weird hours forever. The reason the drug got through is not because it is useful, but because it is profitable. Hate to think of people operating machinery on such things. Often drugs like these can also cause the things they are supposed to prevent. And there is nothing wrong with the person that living with normal hours would not prevent. It like taking a person, stressing them, and then giving them something to take away the stress.....

Sorry if it's not appropriate to say it. That is how it appears to me.....

That's just it
 

That was pretty much the point, thank you. I hate to think of how much effort was spent on this "disorder" when so many are suffering with long-recognized and legitimate diseases. I can only imagine what disease/disorder/syndrome will come out next.

me too drugs and medicalizing behaviors/conditions
 

developing isomers of a successful drug which has come off patent is
the tactic used by all of pharma. these are all "me too" drugs, and this new drug for "shift disorders" differs how?
"...Provigil is a racemic drug, meaning it contains a mixture of two different versions of the same molecule, which each have a slightly different effect. Nuvigil contains only one version of the molecule...

Effects Common to Both
Provigil and Nuvigil are stimulant medications, with arousal effects similar to amphetamines. While it is known that both drugs affect several different neurotransmitters, the exact mechanism by which they induce wakefulness is not understood.

Differences in Effect
According to the manufacturer, the primary difference between Provigil and Nuvigil is that Nuvigil has a longer half-life, meaning it remains in the blood longer. The actual difference in half-life between the two drugs is not specified. No other differences are noted...



Read more: The Difference Between Nuvigil & Modafinil | eHow.com http://www.ehow.com/facts_5595693_di...odafinil.html#


Thus the new drug has a longer half life, but not long enough to be noted by the company? this pharma company spent lots of time and $$$ getting this "new improved" drug to be approved by the FDA. In addition, the company has medicalized sleepiness in night workers, branding the symptom "shift disorder", greatly expanding the population to whom the company can sell the drug. ALL these are common tactics used by pharma.
If interested, read Marcia Angell's book "the truth about the drug companies" or Merrill Goozner's book "the $800 million pill" or Robert Whitaker's book, "the anatomy of an epidemic"
A balanced article presenting both sides of the question:
http://www.sciencebase.com/science-b...alization.html

yes, narcolepsy is a real disorder--but "night shift disorder"? that's NOT narcolepsy, but it sure extends the numbers of people to whom this company can sell its "new improved" now still under patent drug.