FDA Draft Guidance Published to Expedite Delivery of Drug Treatments in ME/CFS

[Firestormm]

Regulatory Focus News:

FDA Says Sponsors of Chronic Fatigue Syndrome Drugs can Rely on Patient-Reported Outcomes

10 March 2014

Draft guidance: HERE

Federal Register: HERE

By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has released a new draft guidance document intended to expedite the development of drugs to treat chronic fatigue syndrome (also known as myalgic encephalomyelitis)—a poorly understood condition that has recently been subject to significant interest by FDA regulators.

Background
Chronic fatigue syndrome (CFS) affects patients by causing severe, persistent and often debilitating fatigue. Little is known about the underlying causes of the condition, or even if it is a single condition or a group of related conditions. Despite numerous theories—including some that have since been discredited—there are no tests to determine its cause.

That leaves patients in something of a bind: The effects of CFS are real, but without an understanding of its underlying causes, researchers and manufacturers are unable to target potential or existing therapies to treat it.

That bind was put on display and amplified in February 2013, when FDA—following the advice of one of its advisory committee panels—did not recommend Hemispherx's Ampligen (rintalolimod), saying it needed additional clinical evidence and data before it could consider approving the drug.

But CFS patients are also the first to benefit from a special provision of the Food and Drug Administration Safety and Innovation Act (FDASIA), which calls for FDA to set up a "Patient-Focused Drug Development Initiative" to better take into account the views of patients during the regulatory review process.

"The human drug and biologic review process could benefit from a more systematic and expansive approach to obtaining input from patients who experience a particular disease or condition," FDA explained in a Federal Register posting announcing the program in September 2012.

In October 2012, FDA sat down with CFS patients in order to hear their views on the regulatory process, most notably including their tolerance for risk...

Read more: HERE

 

[Firestormm]

Comments on the guidance will be accepted by FDA through 10 May 2014.

 

[taniaaust1]

Im about to look at the link but

"Chronic fatigue syndrome (CFS) affects patients by causing severe, persistent and often debilitating fatigue"

***sigh*** when will gov depts get things right and stop saying this illness is only basically about fatigue by only putting that! A gov dept only saying this about our symptoms and how it affects, puts out a false impression of this illness, is so so wrong. It helps to perpentuatrate (have i got the word right).. the myths out there that this illness is just about being tired.

Isnt their something legal which could be done to stop gov depts from misleading people about this illness? Which the above comment does. Its not a balanced comment. Cant a demand be made for them to stop this misrpresentation? (its like saying cancer makes people fatigued but leaving out the rest of what that does.. cancer people wouldnt their illness to be so badly misrepresented so why do we and our associations allow this?). Gov depts should be setting a good example to not be misrepresenting illnesses. If its okay to misrepresent at that level, it then becomes okay for everyone else to misrepresent it.

We are long past the time of it being acceptable for a gov dept to explain this illness like they have here. They are being responsible for causing confusion between what is "chronic fatigue" to what is "chronic fatigue syndrome". We need to comment to them that this illness IS different to what is "chronic fatigue" which they have described here (could they be made to correct this?).

How are they going to sort out medications for us when they cant even get right what this illness is? It should read CFS is a severe, persistent, multi symptomed illness which also causes fatigue.. (if they just have to have that word there). I feel outraged every time I see the bullshit play down of this illness by ignoring that its far more then just an issue with fatigue. CHRONIC FATIGUE IS NOT CHRONIC FATIGUE SYNDROME.

I personally think this confusion is done purposely!!!! I know many will read their article and think great and progress forward and let what's annoyed me go.. but Gov depts are not showing they are serious about this illness until they are at least willing to stop falsely representing it!! and keeping the confusion already out there going on. Yes by this thing there could be some movement forward but I think its only cause they have been pushed/forced into having to do this. I wont believe other wise till I see them start to represent our illness truthfully.

 

[taniaaust1]

Someone needs to start a petition to the governments and medical orgs to stop falsely representing our illness as just being about fatigue when its a muti-symptom illness (in which one of its symptoms is fatigue). A lot of damage is being done by false representation being allowed and allowing CFS to be confused with CF.

(I just noticed that article is done by The Regulatory Affairs Professionals Society (RAPS) ..maybe people could email them nicely asking them to correct the description of CFS in that article so its not confusing CF with CFS as they are different things. Maybe they would correct it).

Contact RAPS Global Headquarters
Regulatory Affairs Professionals Society (RAPS)
5635 Fishers Lane, Suite 550
Rockville, Maryland 20852
P +1 301 770 2920 F +1 301 841 7956
Email: raps@raps.org

 

[Firestormm]

It was a news site, @taniaaust1 the words in my extract didn't come from any government department as far as I am aware.

 

[taniaaust1]

It was a news site, @taniaaust1 the words in my extract didn't come from any government department as far as I am aware.

yeah, thanks, Ive realised that now, my brain is a bit slow and struggling to comprehend things right.

I think the description they've used comes from some of those bad studies done in which they only used those with chronic fatigue rather then CFS (but then went and called it a CFS study). I see that precise description a lot, its been copied from somewhere (actually I still do wonder if it originally came from a gov website thou it could of been changed there by now but still being used wrongly all over the place).

 

[taniaaust1]

I emailed this news site requesting they correct this article. Unfortunately I spelt the word multi-symptom wrong and didnt notice before as I had a brain block **sighs** I try. (I hope they understand what that word is supposed to say, fancy spelling wrong the most important word in the whole email and I managed to spell it wrong in not one but both places in the email too (I hate doing advocacy by myself, I nearly always screw up my letters, letter will probably be less paid attention to due to my mistake).
"
To whom in concerns,

Im writing in regard to an very misleading description in one of your articles which actually describes another condition and not the one the article is about
http://www.raps.org/focus-online/ne...ndrome-drugs-can-rely-on-patient-reporte.aspx

In this article it states
"Chronic fatigue syndrome (CFS) affects patients by causing severe, persistent and often debilitating fatigue."
The description the author has given above actually describes the symptom known as "chronic fatigue" which appears in lots of different diseases rather then the illness known as CFS so gives an inaccurate representation of the disease.

CFS is a severe, persistent muti-symptom disorder in which debilitating fatigue features as well. Its the muti-symptom aspect of it which distinguishes it from the disorder just called chronic fatigue seen in other illnesses.
It would be good if this article can be corrected so it defines the right condition and isnt misleading and confusing people by giving a different defintion to what this illness is. Yes there are many different descriptions for this illness as the article notes but to have CFS a person has to have far more then just fatigue as a symptom or it isnt a CFS diagnoses no matter what CFS diagnoses definition one is using.

Yours Sincerely
Tania Selth.
'