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My Submission To The Fda


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#1 Heidi L

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Posted 24 September 2013 - 11:16 AM

The FDA is having their "Patient Focused" drug meeting today.   Here is the information I wanted them to know-

 

Topic 1: Disease symptoms and daily impacts that matter most to patients
 
 
1. Of all the symptoms that you experience because of your condition, which 1-3 symptoms have the most significant impact on your life?
 
The depression. The soul-crushing life-destroying depression. The depression is worse than all the other symptoms combined. Narcolepsy doesn't kill you, it makes you want to die.
 
2. Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition?
 
I can't eat. That would be a pleasant experience to have again. I gave up even thinking about working or having children long ago. Right now I'm just hoping to live long enough to see you people get this right.
 
 
3. How have your symptoms changed over time?
The symptoms change constantly. Daily weekly yearly. They fluctuate with age and illness and diet. Sugar is a trigger. And gluten. And sinusitis. And periodontitis. And it gets cumulatively worse. To the point it's unbearable. And then you get DEMENTIA.  I have extensively documented the scientific literature regarding these symptoms and comorbid factors on my websites. zombieinstitute.net
 
Topic 2: Patients’ perspectives on current approaches to treating narcolepsy
 
1)What are you currently doing to help treat your condition or its symptoms?
a) What specific symptoms do your treatments address?
 
Gluten-Free Low-Carb Diet- for sleepiness, depression, cognitive impairment.
Oropharygial infection prevention- for anxiety, insomnia, obsession.
Caffeine and Nicotine- because my frontal cortex is fried.

B) How has your treatment regimen changed over time, and why?

This protocol changes constantly as I learn more about the orexin system and autoimmune disorders. 
 

2. How well does your current treatment regimen treat the most significant symptoms of your disease?


I AM ABLE TO NOT USE ANY PRESCRIPTION DRUGS FOR NARCOLEPSY.

a) How well do these therapies improve your ability to do specific activities that are important to you in your daily life?

The Gluten-free low carb diet works extremely well on the Hyperinsulinemia related symptoms. I no longer have sleep attacks, daytime sleepiness, depression or cognitive impairment.
The antimicrobial prophylaxis addresses the autoimmune effects of Streptococcal infection which is The Primary Cause of Narcolepsy. This is less effective as I have been chronically infected for my entire life without proper diagnosis.
The caffeine and nicotine make my research and thus my continuing existence possible.
 
B) How well have these treatments worked for you as your condition has changed over time?
 
Way better than the drugs my doctor prescribed.  It gave me my life back.
 
 
3. What are the most significant downsides to your current treatments, and how do they affect your daily life? 
 
Downsides? Metabolic dysfunction and recurring infections are truly annoying, but let's start with the fact that due to the insidious influence of the drug companies in the sleep medicine industry-  no “specialists” seem to be aware of the basic mechanisms of Narcolepsy.   They only offer stimulant drugs.   I can't talk to a doctor about this. That really interferes with my health care.
My daily life now revolves around finding and disseminating this crucial information to other narcoleptics.
 
 
4. Assuming there is no complete cure for your condition, what specific things would you look for in an ideal treatment for your condition?
 
Don't assume there's no cure.  We've already found some effective treatments, and we're working on preventing it altogether. Us. The Narcoleptic Patient Researchers who truly know what's at stake.
 

In the meantime- we really could use some proper Diet Information, Metformin and Antibiotics.  We really need to be able to think.   Thanks.

 

For more information on the orexin system and alternative methods of narcolepsy symtom control, please look me up.  Heidi Lindborg



#2 Ferret

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Posted 24 September 2013 - 02:40 PM

Way to go Heidi! I wasn't quite as blunt as you but I think they got the message. I, too, have survived the last twenty five years on caffeine and nicotine.

Please read my two responses to a recent enquiry about Provigil in this section.

I'd like to kick the FDA in the butt personally. Although I'm sure I can't blame them completely because they are overworked, overwhelmed and under funded.



#3 DeathRabbit

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Posted 24 September 2013 - 02:40 PM

@OP: I know you're frustrated, but that seemed more than a tad adversarial. Just something to keep in mind.



#4 kevers

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Posted 19 October 2013 - 05:25 PM

Way to go Heidi! I wasn't quite as blunt as you but I think they got the message. I, too, have survived the last twenty five years on caffeine and nicotine.

Please read my two responses to a recent enquiry about Provigil in this section.

I'd like to kick the FDA in the butt personally. Although I'm sure I can't blame them completely because they are overworked, overwhelmed and under funded.

 

more like corrupt



#5 moonlightmelody

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Posted 14 November 2013 - 12:50 PM

Hi, I'm interested  in the gluten free thing.  but i'm on xyrem right now.  what would happen if i "went into remission" while still taking xyrem?  you said dangerous but what does that mean?



#6 ironhands

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Posted 14 November 2013 - 01:06 PM

If you're on Xyrem, going gluten-free probably wouldn't help your sleep/wake cycle, but, it may give you more energy during the day.  I would highly recommend speaking to your doctor about it