Report on FDA Meeting - Last Call for Migraine Comments
Last week, I had the opportunity to address the need for Migraine treatments when I spoke at a public meeting related to the FDA's patient-focused drug development initiative.
It was a staggering responsibility to be speaking on behalf of more than 37 million Americans with Migraine disease, a responsibility that left me tossing and turning rather than sleeping the night before. Each speaker was allotted just two minutes to speak, and we had to begin by introducing ourselves. With so little time, I had to carefully choose what to say. I hit these points:
- There are more than 37 million Americans with Migraine disease.
- According to a World Health Organization analysis, Migraine is responsible for more lost years of healthy life in the U.S. annually than epilepsy, multiple sclerosis, ovarian cancer, and tuberculosis combined.
- Also according to that analysis, a severe Migraine attack is as debilitating as quadriplegia.
- Migraine disproportionately strikes women at a ratio of three to one.
- Migraine does not discriminate based on age. It strikes children too young to talk and tell us what's wrong, and it strikes the elderly. My oldest granddaughter had her first Migraine at two and a-half.
- There are no preventive or management medications on the market that were originally developed for Migraine. All we have are hand-me-down drugs.
- The abortive medications we have - triptans and ergotamines - are all contraindicated for patients with a history of or risk factors for stroke or coronary issues. All of them.
I then told them that I was submitting written comments that addressed their six criteria for selecting the 20 disease areas for the program, then thanked them for the program and for hearing me.
The written comments I referred to were drafted by Dr. Robert Shapiro, president of the Alliance for Headache Disorders Advocacy and sent out to a group of advocates, researchers, and interested doctors for comments. They were edited and polished, then signed by:
- Teri Robert, on behalf of the American Headache and Migraine Association
- Bray Patrick-Lake on behalf of the PFO Research Foundation
- Eileen Jones on behalf of Miles for Migraine Races
- Michael John Coleman on behalf of MAGNUM (National Migraine Association)
- Robert Wold on behalf of Clusterbusters
- Heather Zanitsch on behalf of Chronic Migraine Awareness
- Robert Shapiro, MD, PhD, on behalf of the Alliance for Headache Disorders Advocacy and the Headache Cooperative of New England
- Elizabeth Loder, MD, on behalf of the American Headache Society
- Roger Cady, MD, on behalf of the National Headache Foundation
- Bruce Sigsbee, MD, on behalf of the American Academy of Neurology
- Brian Kennedy, on behalf of the Alliance for Patient Access
- Robert Cowan, MD, on behalf of the Headache Cooperative of the Pacific
- Gretchen Tietjen, MD, on behalf of the Ohio Headache Association
- Cathy Glaser, on behalf of the Migraine Research Foundation
If you'd like to read these comments you can download a copy.
It was an honor to represent our community at that meeting, but that's not going to be enough to get Migraine and headache disorders added to the list of disease areas for this program. Don't get me wrong. It was important that we were represented, and it will definitely help, but it's not enough on its own. The submission of written comments is still vital.
Public comments are open until Thursday, November 1. Please, go to this page for the Prescription Drug User Fee Act Patient-Focused Drug Development Meeting and click the blue "Comment Now!" button near the top right corner of the page to comment. If you enter your comments into their box, there's a limit of 2,000 characters. If your comments are longer than that, you can go to step #3 and use the optional method of uploading your comments in a file. You don't need to fill in the Organization Name or Submitter's Representative sections, but if you want to, you can use American Headache and Migraine Association for the Organization and my name for the representative. If you do that, select Consumer Group for the Category.
If you need some solid facts and stats or the list of criteria FDA is using to select disease areas for this program, you can find them in my post Stats and Facts for Commenting to FDA About Migraine.
Please, submit your comments by November 1!
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