AHDA HeadNotes

The FDA Must Remember Migraine

In response to the FDA request for comments on the patient-focused drug development initiative, the AHDA proposed that Migraine and Related Disorders be included as a disease area for the focused attention of a public meeting. In a letter to the FDA, Bob Shapiro advised that migraine meets and exceeds the five criteria outlined by FDA for inclusion in the initiative. To help our voice be heard go to the website at the end of this blog and help us make our case.

This week, the Food and Drug Administration (FDA) is holding a public meeting related to FDA's patient-focused drug development initiative. The initiative is being conducted to fulfill FDA performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). This effort provides for a more systematic approach under PDUFA V for obtaining patient perspective on the disease severity and the currently available treatments. FDA is publishing a preliminary list of nominated disease areas for the patient-focused drug development initiative and the criteria used for nomination. So far Migraine and Related Disorders is NOT included.

Those disease areas initially nominated as a starting point to develop the list of 20 for this program are:

1. Pulmonary arterial hypertension.
2. Heart failure.
3. Primary glomerular diseases.
4. Narcolepsy.
5. Huntington's Disease.
6. Depression.
7. Autism.
8. Peripheral neuropathy.
9. Fibromyalgia.
10. Obesity.
11. Nocturia.
12. Chronic fatigue syndrome.
13. Irritable bowel syndrome.
14. Inflammatory bowel disease.
15. Alopecia areata.
16. Diabetic ulcers.
17. Female sexual dysfunction.
18. Interstitial cystitis/painful bladder syndrome.
19. Fracture healing.
20. Diabetic foot infections.
21. Hepatitis C.
22. HIV.
23. Patients who have experienced an organ transplant.
24. Sickle cell disease.
25. Chronic graft versus host disease.
26. Amyloidosis.
27. Aplastic anemia.
28. Melanoma.
29. Lung cancer.
30. Cancer and young patients.
31. Cancer treatment in pregnancy.
32. Cancer and sexual dysfunction.
33. Cancer and depression.
34. Clotting disorders (e.g., hemophilia A (factor VIII deficiency) and von Willebrand disease).
35. Thrombotic disorders (e.g., antithrombin deficiency and protein C deficiency).
36. Primary humoral immune deficiencies (e.g., common variable immune deficiency).
37. Neurologic disorders treated with immune globulins (e.g., chronic inflammatory demyelinating polyneuropathy).
38. Hereditary angioedema.
39. Alpha-1 antitrypsin deficiency.

As you can see, very few diseases with more impact on a population basis than migraine and headache are on the list. It is unlikely that any disease on this list is as underfunded by NIH and the US government as migraine.

A final list of 20 disease areas will be selected for inclusion in this five-year pilot program. Then, quarterly, over the next five years, FDA will meet with stakeholders — patients, caregivers, physicians, and others — with an interest in one of the 20 disease areas for an in-depth review of the needs related to treatment, the current state of treatments, disease burden, the human side of living with the disease, and other issues of possible relevance to reviewing treatments that may come before the FDA for review. It's truly an interesting and potentially very valuable program. There’s an excellent summary of the background in Volume 77, Number 185 of the Federal Register.

Teri Robert will be representing The Alliance for Headache Disorders Advocacy and the American Headache and Migraine Association at a meeting in Washington this week. She will really be representing all persons with migraine and cluster headache.

We need to make sure our voice is heard!  There is an opportunity for public comment before Nov 1.  Please go online at http://www.regulations.gov/?source=govdelivery#!documentDetail;D=FDA-2012-N-0967-0001

Written comments are due by November 1, 2012.

Thank you,
William B. Young; MD, FAHS, FAAN
Jefferson Headache Center; Philadelphia, Pennsylvania
Vice President, Alliance for Headache Disorders Advocacy

Teri Robert, PhD
Patient Educator and Advocate
Secretary, Alliance for Headache Disorders Advocacy

Congressional Hearing on Migraine and Headache - Help Wanted!

Advocates from the Alliance for Headache Disorders Advocacy (AHDA) are busily preparing to attend Headache on the Hill on the 27th of this month and hand deliver the petition urging Congress to hold a hearing on the impact of Migraine and other headache disorders.

For some reason the petition is not getting the signatures it should be - the signatures we know it could get. Thinking about it, I have to wonder if there's some confusion about the petition or what a Congressional hearing could accomplish.

That has led me to create a FAQ of sorts about the petition and a Congressional hearing in hopes that it will answer any questions you may have and address any reservations you may have about the petition...

Question: "But Snopes.com and others say online petitions are bogus!"

Answer: Actually, Snopes doesn't say that. In reality, some online petitions are worthless, and some are scams.

This particular petition is legitimate and legal. In addition, it doesn't stop online. Advocates for the AHDA will be hand delivering it to members of Congress during our Headache on the Hill event on March 27, 2012.

Question: Why should we want Congress to hold a hearing about the impact of Migraine disease and other headache disorders?

Answer: Whether we look at the general public or at members of Congress specifically, Migraine and other headache disorders are still terribly misunderstood and surrounded by myths and stigma. At a hearing, patients, advocates, and health care professionals would have the opportunity to testify before a Congressional committee. These "witnesses" would share factual data such as statistics and share comments and stories that have been shared through the current AHDA petition. But more than that, some of these witnesses would be patients who would testify about what Migraine and other headache disorders have done to their lives and the lives of their families.

Question: What would a better understanding in Congress accomplish?

Answer: Short-term, a better understanding in Congress must be accomplished before we'll see any significant increase in federal funding for Migraine and headache research funding.

We depend on pharmaceutical companies to develop new medications. The problem with that when it comes to Migraine and headache medications is the difficulty with developing medications for diseases and conditions when scientists don't yet understand them well. Pharmaceutical companies develop medications. They don't do the kind of basic disease research that's yet to be done into the cause and pathophysiology of Migraine and other headache disorders.

Longer-term, increased research funding can lead to better treatments. At this time, there are no treatments on the market that were originally developed for the prevention of Migraine and headache. This must change.

Also, we would hope that a better understanding in Congress would help lead to a better understanding among federal agencies and the general public, including employers.

Question/Comment: "I'm busy and don't have time for this."

Answer: Everyone has time for this. It's a simple matter of following the link then entering your name, address, and email address. It can be done in one minute, literally.

Question: What's done with my personal information I enter when I sign the petition

Answer: It goes into a database on a secure server. Only two officers of the AHDA have access to that information. Each Congressional office will receive a list of only the people in their districts who signed the petition. For Senators, of course, that will mean the whole state. For members of the house, that will mean only their own Congressional district.

We NEVER share or sell our data or our mailing list, not even with the organizations that are members of the AHDA. We may email you in the future when there's action to be taken, but that is the only email you will receive as a result of signing the petition. We take your privacy very seriously, as seriously as we take our own.

Question/Comment: But the country is already in a financial mess!

Answer: We realize that. At this point, we're asking for a Congressional hearing. Do we also want an increase in research funding? Certainly, we do, and we absolutely understand. But please hear me on this. At this point in time, when it comes to federal funding for medical research, there is no correlation between the amount of funding and disease burden. By disease burden, I don't just mean the number of people who have a disease or condition. I mean the total burden of it -- how many people it affects, how severely it impacts people, the economic cost of the disease, the social cost of the disease, and more. In previous years, when we've gone to Congress asking for increased research funding, we've also talked to them about there needing to be a better correlation between funding and disease burden so that the federal funding for research is allocated in a manner that is most beneficial.

Question: Who can and should sign the petition. Do you have to have Migraines or headaches? Do you have to live in the U.S.?

Answer: We'd love to see as many signatures of U.S. citizens over the age of 18 as possible. No, you don't have to have Migraines or headaches. Yes, you do need to be a U.S. citizen. If you're not a U.S. citizen, you can still help by sharing the link with your family and friends in the U.S. and asking them to sign the petition.

If you had questions or were reluctant to sign the petition, does that help? I hope so.

It's not too late to sign the petition.

Other ways to help:

• Share this post on your Facebook page.
• Tweet this post.
• Email everyone in your address book about the petition.

There's also a one-page flyer you can download and share with others via email or by printing and giving it to them. It even has a QR (quick response) code on it that can be read by apps on many smart phones. When read in those apps, it goes directly to the petition page so people can sign it. Download the flyer.

Thank you!

 

 

Teri Robert
Secretary, Alliance for Headache Disorders Advocacy

A Third Space for Migraine Patients

by William B. Young, MD:

When my daughter was about to go to college, I happened to see a patient who had just gotten her master’s in college counseling.  I asked for one piece of advice for my daughter.  She answered that based on the literature, the kids who have only classes and dorm activities were much less likely to be well adjusted and successful than the kids who participated in at least one other activity.  It didn’t matter what that third activity was, just as long as it involved something that was meaningful to them.  Whatever it was, it was tremendously protective against stress and social isolation.  For my daughter it was synchronized skating, and when she dropped out in her sophomore year because of scheduling conflicts, she became much more stressed and unhappy.

It recently occurred to me that this is a good model for everyone, really, but especially for chronic migraine patients.  Migraine disease is so consuming, and has such an impact on family and work relations, that finding this third-space sanctuary becomes an ever more critical inoculation against becoming overwhelmed.  One of my patients who has severe chronic migraine that at times leaves her unable to work, would sing in synagogue.  I thought that this was not the wisest thing for someone with a migraine, and she admitted it could temporarily worsen her migraine.  She pointed out that it was only for 1 hour a week and this is what she loved to do, and she could pull it together in trade for the joy and sense of normalcy it gave her.  By the way, she is now headache-free, got another degree, and is teaching and working.

I think that finding a good third space can be very hard for a person with bad migraine, but that finding something is truly important. I think it works best when it requires interacting with people outside of work or home and consumes someone in such a way that it becomes very hard to focus on pain.  I don’t think it needs that much time, and if an hour a week is all you can find, that is fine, if you have found a true sanctuary. Find something, try it on and if it doesn’t fit, keep trying until you find something meaningful. Fight for one tiny, special activity that takes you away from the places in your life that the pain resides. Keeping a seed of contented normalcy somewhere in one’s world is critical, and provides hope in the darkest times.

I say these things, and I believe them.  But I really don’t have any scientific evidence to prove them.  Persons with diabetes are supported, based on scientific evidence, with services like dietary consults, and encouraged to exercise.  Surely persons with severe migraine disease deserve scientific study of social strategies that help, and then support to get them. The Alliance for Headache Disorders Advocacy is dedicating to doing these things.

by Sarah Gomez, PsyD:

Migraine patients often come into my office and talk about how their lives have significantly changed due to their frequent pain. They discuss feeling that their world has been taken from them, how they used to do so much more, generally feeling a myriad of emotions in regard to their disease.  They mention anger and frustration at their decreased capacity to function, sadness and loss about missing social and family gatherings, feeling misunderstood and often guilty about their inability to participate in activities, and frequent dissatisfaction about the state of their lives. They worry about when the next migraine will come, how much pain may be expected, and what associated symptoms may arise. By and large, migraine sufferers are often consumed by feeling completely out of control of their own lives, experiencing the migraine as the entity in power.

Time and again, the migraine experience has the capacity to greatly diminish joy and happiness is in one’s life.  Additionally, depression and anxiety are common to migraine sufferers, making it doubly challenging to hang on to anything wonderful, bright, and good in life.  The pain and isolation that migraines produce commonly rob migraine sufferers of the things they enjoy most.  This is tremendously taxing; managing both the symptoms that migraines bring with them, as well as what they take away is exhausting. In psychotherapy we spend a lot of time processing this complex experience, as well as exploring ways to counteract the clutches of the disease.

My suggestion, as a psychologist and echoing the sentiments of the college counselor, is to keep up with something that brings you joy.  In appropriate moderation, do something that you love.  Try to keep the migraines out of one small aspect of your life.  See if you can identify and nurture a third space that is yours alone.  Granted, the pain may come, or be exacerbated by your activity, as the patient above described, but the price may be worth paying. To own something, to take something back in your life, to exert a sense of control over the obstinate migraine may provide a payoff that’s twofold. You are in charge of yourself for that moment in time, and secondly, joy enters back in your life! It sounds almost too simple, I know. However, recent research suggests, and my experience supports, this is often a major step for many patients toward feeling some sense of normalcy again. Increasing the sense that you can do something may make a world of difference. Over time, patients who become dedicated to this concept seem to develop and maintain migraine health better than others.  Of course, finding a third space isn’t a quick fix or a surefire way to reduce the pain, but it’s a little taste of the life you’re striving for. 

Little research has been done on social and psychological factors that have the ability to aid and hinder the migraine experience.  It is imperative for patients to feel that they have some tangible way to be involved and manage their health aside from simply taking a prescribed medication. The Alliance for Headache Disorders Advocacy supports this approach and is dedicated to working toward further understanding of these methods.

William B. Young, MD and Sarah Gomez, PsyD
Jefferson Headache Center; Philadelphia, Pennsylvania