Sunday, October 28, 2012

Action Needed (by 11/1/12): Comment to FDA About Migraine

The FDA is in the process of compiling a list of 20 diseases to receive intense focus as part of a five-year pilot program. The FDA will hold quarterly meetings with stakeholders (patients, doctors, caregivers, etc.) to try to understand the current state of each disease from all angles.

Migraine Disease (and headache disorders) was not included in the preliminary list of possible diseases.

Patient advocate and educator Teri Robert attended the public meeting on October 25, and had a chance to speak for 2 minutes. It's impossible to share the severity and impact of Migraine Disease in a mere 2 minutes. Fortunately, though, the FDA wants to hear from us, the citizens, before they make a final decision. We must do our part by submitting our comments online (I'll include the criteria the FDA is using to choose the final 20 diseases, so that you can allow them to guide you in your comments - see below).

Here is patient advocate Ellen Schnakenberg's call to action:
We desperately need your comment TODAY! 
It has begun. Teri Robert is right this moment in the FDA discussion, standing up for the 37 million of us who suffer Migraine Disease, and the countless others with one or more of the other over 300 headache disorders that are being ignored, most likely as a result of the pervasive stigma which has turned so many heads away from us. Very few of you have taken the time to sign the FDA comments that we so desperately need.
You need not be a headache patient to do this!
This week is sooooo very important, and I am counting on YOU to take 5 minutes out of your day to literally change the lives of millions. Teri, Diana and I have had your back for years. This week I need you to have ours. All I am asking for is a few minutes of your time...
Step 1: Read Teri's article here which tells what the FDA wants you to say.
Step 2: Read Diana's post here which tells what the FDA wants you to say.
Step 3: Write a short comment to the FDA panel that will be choosing the 20 diseases and disorders that will receive their time. Do this in a word document or note, but not on the FDA site yet. This is so you can perfect it by going back through the two articles to be sure you have hit on at least some of the points necessary.
Step 4: Go to the FDA link and post your response, either directly there, or if it's longer than 2000 characters it may be sent as a document.
*** Comments must be submitted BY November 1, 2012 ***
Step 5: Post this on your Facebook page and beg and plead for your friends and family to help too.
37 million Migraineurs are counting on you. Peeing at night was put on this list over Headache disorders or Migraine, which have been stated by the World Health Organization as more debilitating than quadriplegia. Whadda you have to say about that?
These are the criteria the FDA is using to choose the final 20 diseases. Please keep these factors in mind in writing your comments to the FDA:
  • Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living;
  • Disease areas that reflect a range of severity;
  • Disease areas for which aspects of the disease are not formally captured in clinical trials;
  • Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly);
  • Disease areas that represent a broad range in terms of size of the affected population; or
  • Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives.
Other tips for writing your comments:
  • Prepare your comments in advance before you go to the FDA submission page. This will allow you to spell check, proofread and perfect your arguments and wording.
  • Balance your personal story with the big picture of the impact and burden of Migraine disease.
  • Try not to be overly emotional. Stick to the facts.
  • Utilize this up-to-date list of facts about Migraine and other headache disorders: Stats and Facts About Migraine.
  • Don't forget to consider the FDA's decision criteria (listed above).
  • Be as concise as possible.
*** And, if your comment is longer than 2000 characters, save it as a document and send it to them by clicking the document button on the FDA comment page.

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