Stats and Facts for Commenting to FDA About Migraine
Yesterday, I told you about an incredible opportunity to share information about living with Migraines and other headache disorders with the FDA. If you missed that post, check out FDA Wants to Hear from Us About Migraines.
Today, I thought I'd share some facts and stats that you can use if you'd like to add some to your comments:
- Migraine and other headache disorders are the most prevalent neurological disorders, affecting more than 90% of all Americans.
- Migraine alone affects more than 37 million Americans of all ages.
- Four percent of Americans experience headache pain more than four hours per day for more than 15 days per month. That's more than 12.5 million Americans.
- Migraine affects people of all ages from very young children to the elderly.
- According to a World Health Organization (WHO) analysis, a severe Migraine attack is as debilitating as quadriplegia.
- Based on a sample of Americans, suicide attempts are three times more likely in individuals with Migraine with aura compared to those with no Migraine, whether or not major depression is also present.
- More than 1,400 more American women with Migraine with aura die annually from cardiovascular diseases compared to women who do not have Migraine.
- Migraine disproportionately affects women, impacting three times as many women as men.
- ALL of the available Migraine abortive medications - the triptans and ergotamines - carry warnings that they should not be used by people with a history of or high risk factors for heart or stroke issues.
- There are NO medications on the market for Migraine prevention that were originally developed for Migraine. All the medications in use are hand-me-down drugs developed for other conditions.
- Cluster headache is as prevalent as multiple sclerosis, and cluster headache attacks are among the most severe pain conditions known.
- There are NO medications on the market that were originally developed for cluster headache; not for acute treatment of attacks OR prevention. Not one.
FDA used several criteria to develop the preliminary list of potential disease areas. They request that when proposing additional disease areas for consideration, we describe how we applied the identified criteria in making recommendations for additional disease areas to consider. These criteria include the following:
- 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.
I fully realize how difficult it can be not to get very emotional when preparing comments such as these, but please — address the criteria. Do share your experience, but please try to keep your comments relatively short, and don't get too emotional. We need to come across as determined. Short, concise, and succinct is best.
If you want to read more about the upcoming public meeting and why FDA is seeking public comment, you can find more information in FDA Wants to Hear from Us About Migraines.
If you're ready to comment, 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!
Let's make a difference!
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