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

Congress Is Listening. Is NIH?

Tuesday your advocacy efforts paid off. As a result of past Headache on the Hill events and the on-line petition (almost 9000 signers so far), Congress has taken notice.

A hearing on Pain in America; Exploring Challenges to Relief was held Tuesday before the full Senate Health, Education, Labor, and Pensions Committee. At the hearing, Senator Bernie Sanders (VT) entered into the Congressional Record our written testimony on the impact of headache disorders. Take a look at the submitted testimony, including some of your comments, and listen to the hearing. The exposure provided by this hearing represents real progress in gaining congressional awareness of the disabling nature of headache disorders.

Congressional attention is crucial because the funding for headache research remains abysmal. The new numbers for NIH expenditures for ‘headaches’ and ‘migraine’ were posted on Monday. While NIH funding for headache research rose overall from $19M in FY10 to $21M in FY11, it is estimated to drop to $20M through FY13. Likewise, migraine research rose from $15M in FY10 to $16M in FY11, but is predicted to remain at that level through FY13. Where are the significant funded initiatives that were to emerge from the NIH planning workshop of 2010? Furthermore, the Department of Defense is not following-up their past funding of headache research with any new funding in FY12. Essentially research funding levels are static everywhere, where they ought to be doubling every two or three years to make up for decades of lost research opportunities.

So we still need your help now. We still seek a full airing of the state of headache disorders in devoted hearings before committees on both the Senate and House sides of Congress.

If you haven’t signed the petition already,

please sign the petiton now.

Please encourage others to do so too. Here's a URL that's easy to remember that will take you directly to a petition page: www.HeadacheAdvocacy.org/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.

Thanks very much.
Bob Shapiro

Migraine and Cluster Headache Care Threatened by Shortages

First there was the unintentional punch in the nose that Congress and the FDA gave to migraine patients when they threw isometheptene compounds (Midrin) off the market. Now, over the last year, things have gotten really tough for us headache doctors and for our patients trying to get safe, effective, non-opioid, non-barbiturate headache treatments. One by one some of our best meds have become scarce or completely unavailable.

Here's a list of medications we routinely use that are now scarce or completely unavailable:
 
Infusion Therapy-Outpatient/Inpatient

• Ativan/lorazepam IV
• Compazine/prochlorperazine IV
• Depacon/valproic acid IV
• DHE IV/IM
• Droperidol IV
• magnesium sulfate IV
• Phenergan/promethazine IV
• Reglan/metoclopramide IV
• Toradol/ketorolac IV
• Zofran/odansetron IV

Nerve Blocks/Other injections

• Bacteriostatic NaCl (saline) 0.9%
• Lidocaine 1% and 2%

Oral Drugs

• Indocin/indomethacin

I heard a scary story from a headache patient today. She was having trouble getting her DHE, so her pharmacy found some, but would not sell it to her unless she paid full retail price and did not go through insurance.

Here is what is going on. Basically there is a low profit margin on generic drugs in the US. Medicare legislation reimburses for injectable generics at no more than 6% above the average sales price paid during the preceding quarter for any generic drug. For this (and other) reason(s), generic profit margins are very low. So, for business reasons,  companies have purposefully kept inventories low and have not increased manufacturing. A series of natural disasters that took down drug manufacturing plants and FDA closings for manufacturing deficiencies have taken some plants off-line. The plants that remain are struggling to keep up production, and falling behind as demand continues. Scarce plant capacity may be allocated to chemotherapy or heart drugs at the expense of headache treatments.

I think headache patients are at particular risk. Because of a lack of research funding and, therefore, lack of new migraine drug development, we are mostly using older generic medications. Certainly nobody has been developing new IV migraine drugs for hospital and infusion center use. Many of the indications for which these old drugs were developed (they were never developed for migraine) have had newer drugs developed for this indication, while their use in headache was not supplemented by another drug. Finally, there is less of a movement to advocate for increased production of headache medicines compared to other types of medicine.

IV generics have been affected more than oral ones, and I am worried about the consequences. There is no way to know for sure, but I thought I had been seeing, gratefully, a slow move away from persons with migraine being given opioids (narcotics) in the emergency department, and an increased use of more effective non-narcotic options that don’t lead to medication overuse and occasionally addiction. In the last year, as these non-narcotic options have become unavailable, my sense is that this trend has been reversed. If it hasn’t, it soon will be as the shortages continue.  I know of no shortage of IV opioids, nor of oral opioids or barbiturate containing pills (Fioricet).

What if the generic IV shortages hit oral headache meds? Imagine for a moment a shortage of amitriptyline (Elavil), a very commonly prescribed generic migraine preventive. Suddenly a million Americans (I would not doubt the number is that high) switch to other drugs, with resultant withdrawal symptoms, irritability, insomnia, new side effects from the substitute medications, and a loss of headache control. All this would require urgent doctor visits, emergency visits for migraine status, and exacerbation of other pain disorders, like diabetic nerve pain. I can tell you from long experience, transitioning off amitriptyline to another preventive can be extremely tricky. You don’t want to stop cold turkey.  There is already a scary on and off shortage of indomethacin, a drug that is often the only thing that works for persons with several rare and very painful headache diseases like hemicrania continua and chronic paroxysmal hemicranias.

If headache drug development had kept pace with drug development in other areas, we would not be in this much of a pickle. The AHDA will continue to work for increased headache research and to increase awareness and find solutions for the problems of those with migraine, cluster headache, and other headache diseases.

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

Migraine and Headache Comments from the Petition

We're currently working toward Congressional hearings to bring out into the open the facts about Migraine and other headache disorders, including their resultant disability, stigma, suffering, inadequate treatments, and federal neglect.

When you sign the petition, you also have the opportunity to make a comment to go along with the petition. We've been reading these comments, and to say that we've been touched by them would be an understatement in the extreme.

This morning, without disclosing any names, we want to share some of those comments with you:

"17 years of constant headache...sudden onset...severe headache...headache every day since...I was 35 at the time...life changing"

"I have suffered from Migraine headaches for more than 26 years. Due to Migraines, I left active duty military, I have missed out on much of my daughters' lives growing up, I have placed un-due stress on my marriage and have been on full disability for the last four years. This is not living."

"I have a 7 year old daughter who suffers these horrible migraines every 2 weeks. We were told there isn't enough research being done on young children and migraines. We are crying for help.."

"i suffer from migraines and have over 10+ years--i have suffered a stroke from them--i also live with a migraine every day to some degree or other. i have days where i live on my couch away from my life. i have seen numerous drs no one can help me."

"Signing this with a migraine, hoping someone we elected will listen to us for a change."

"As someone who was given a diagnosis of an intractable, literally constant headache that will not respond to any curative treatment, I beg of you to help in any way you can."

"My father suffered from cluster migraines. In 1980, he chose to end his life at age 52 rather than live with these headaches any longer. 32 years later and there are still no good answers."

"my husband is a military soldier with ptsd, and migraines.. i myself have cluster migraines. Day to day life is rough to say the least."

"I have suffered with migraines since age five. I am now sixty-two. I have lost precious time from school, family/friends, and work due to this debilitating disorder. I have been told "it's all in your head", "just shake it off", and "it can't be that bad"! I have tried every new migraine drug that comes onto the market; many of these with terrible side effects. I have spent much time and money at doctor's offices and hospitals. I was promised by doctors that once I reached menopause my migraines would disappear. This did not happen in my case. I have also experienced mini strokes due to migraine, which are evident on imaging. I have come to the conclusion that I am a "lifer"! I strongly support this petition! A migraine induced stroke could end my life at any moment!"

"I was forced to seek social security disability at age 45 for migraine. I have now been on disability for over 18 years. I never realized my full potential in earnings nor did I really utilize my college education. Indeed, I was forced to declare bankiruptcy and will probably spend the remainder of my adult life on public assistance, food stamps and HUD housing assistance to augment my Social Security Disability income. The financial loss includes lost taxes on a professional income, loss because of bankruptcy and a loss to the Nation in public assistance to support me that includes almost 20 years of medical costs for migraine drugs at between $1200 - $2000 per month!"

"PLEASE, PLEASE, PLEASE increase funding for research and clinical trials to find the cause of CLUSTER HEADACHE attacks. Over the past 20 years, I have been to countless doctors and tried over 35 ineffective medications with horrible side effects. I just want to be able to live and enjoy life rather than dreading with fear my next CLUSTER HEADACHE attack."

"Migraine all day every day and they can't help me nobody understands..."

"I have not shut myself off from life, my head pain has shut life off from me. I would hate to see another person go through life as lonely and afraid as I am at this very moment."

"After suffering with migraines for the past 45 years I know how they touch so deeply your personal life, family life and work life....affecting each dramatically, though in different ways."

"It is necessary for an awareness of the debilitating, insidious nature of migraines. They steal ones life away. The dizziness, nausea, sensitivity to light and sound, fatigue, and of course the pain. The inability to make any plans. The destruction of relationships. It is the time for answers and solutions for all of us that suffer on a daily basis!"

"So many of us have to stop working and live on government aid because of headache disorder disabilities. With lack of education, funding for research, and new treatment options, we are have no other option than to continue living this way. Give the nation education, research funding, and new treatment options, and I guarantee that you will be shocked at how many Americans will benefit and be able to go back to work, thus paying back into the system. Help us so that we can help you."

"Many more people are suffering than anyone knows as you can't see it like if someone had a broken arm for example. Millions of us are suffering in silence and only more research will bring and end to our problems..."

We hope sharing these comments gives you a better view of why we're fighting for Congressional hearings, why AHDA advocates will be on the Hill on March 27 to personally present the petition to members of Congress.

If you've signed the petition, thank you. You've stepped forward to help the people who wrote those comments and millions of other people. If you haven't signed it, we hope you'll take just a minute to do so now. It's very quick and simple. Just follow the link and enter your first name, last name, email address, and ZIP code. Please be sure to enter your full name rather than initials so your signature will be counted.

One more thing you can do to help is to ask all your friends to sign the petition, whether they have Migraines or headaches or not. Send the link to everyone in your email address book, post it to your Facebook page, Tweet it, share it any way you can.

SIGN THE PETITION, PLEASE.

With our sincere thanks,
Bob Shapiro
Bill Young
Brad Klein
Teri Robert

Cincinnati Children's Awarded NIH Grant for Migraine Trial

Andrew Hershey, MD, PhD, and Scott Powers, PhD, who co-direct the Headache Center at Cincinnati Children's will be leading a five-year study to be conducted at up to 40 sites across the United States. The study will be funded by a $12 million grant from the National Institutes of Health. The AHDA asked the study team to talk about the grant here since it relates to AHDA activities to increase NIH research funding. Here are the points they chose to share with us...

(1)  How Research Comes Through the NIH:
Research is submitted to the National Institutes of Health (NIH) through many different institutes.  Not only are there a variety of institutes, but there are a variety of types of grants that one can pursue.  Research comes through the NIH through research training and fellowship grants (T award series), research project grants (R award series), research grant collaborative agreements (U award series), research program project or center grants (P award series), career development awards (K award series), and resource grants (various series of awards).  The opportunities are oftentimes limitless, while at the same time, a conundrum of where one should begin.  Depending on where an investigator is within their career and what the investigator is hoping to accomplish, the approach taken and grant type chosen will vary.

(2)  How Hard it is to get a Grant:
In the current economic climate, while the available funding money at times seems frozen, there is a plethora of pathways and many avenues of research presented through grant submissions.  The NIH is presented with thousands of promising grants each year by distinguished investigators and meritorious research teams.  Many of these grants go unfunded each year.  Earning a grant in today’s economic climate is a difficult task.  One with persistence, zeal, and a team of great supports would consider themselves lucky to reach the full-funding, finish line.  It is a sincere trial to earn grant funding.

(3)  How We Got this Grant:
This grant was originally submitted as an R01 research project in 2010.  With a promising score from the NINDS, we were asked to revise and re-submit as a U01 trial, a research grant collaborative agreement with the NINDS.  At least 3 years of thought and planning went into making this grant a reality.  During the planning stages, such efforts as attending Headache on the Hill in Washington, DC; consulting the top headache specialists in the nation; weekly conference calls between the data coordinating center and the clinical coordinating center; and team development and editing of documents helped to keep us in the running for a successful submission.  With the recommendation to revise and resubmit, we diligently worked to respond to reviewers and aim at perfecting our original submission.  We had an overall team meeting in Cincinnati connecting both the University of Iowa and the Cincinnati Children’s teams and tackled the grant reviewer’s responses one by one.  Following that productive, in-person, meeting, each team assisted one another in preparing our grant re-submissions.  The solid and well-concerted efforts within our teams and between our teams were of both promise and hopefulness.  We really believed in our finished product.  We had faith in the support and guidance of headache specialists across the nation.  Paramount was the sentiment that this trial was both necessary and urgent, a true need to help serve the millions of children and adolescents who suffer from headaches not only in the United States, but around the world.  The feedback from headache societies, groups, and specialists, even the NINDS, in their review of the initial grant submission, indicated this necessity.  Our goal was to develop a grant that would respond to this void in evidence-based practice.  Answering this call was the forefront of our work over the last three years.  We received this grant by working together between our teams, as well as with headache societies, groups, and specialists, even the NINDS, as we responded to their revision requests for this pivotal project.  We were honored to hear that the NINDS study section found merit in our refined approached to this international need to relieve headache and migraine pain in children and adolescents… a hope to help change the outcome and facilitate young headache suffers to develop into fully, functioning healthy adults; not missing out on work and life to deal with on-going migraine pain.

(4)  How Big this Grant is:
This grant is an 18 million dollar award ($12 million to the Clinical Coordinating Center at the Headache Center of Cincinnati Children’s Hospital Medical Center and $4 million to the Data Coordinating Center at the Clinical Trials Statistical and Data Management Center of the University of Iowa) from the National Institutes of Health, specifically the National Institute of Neurological Disorders and Stroke.  It will be the first grant of its kind; hoping to determine the best medication for preventing migraines in children and adolescents by comparing amitriptyline and topiramate (two medications often prescribed by headache specialists to prevent childhood migraine).  With this grant, over five years, Cincinnati Children’s Hospital will train and reach out to 40 research sites across the United States to help answer this question on a national front.  Overall, this study will involve 675 children and adolescents between the ages of 8 and 17.  With this grant comes the opportunity to lessen the $36 billion national economic impact of migraine, as more than six million children and adolescents suffer from migraine in the United States.

(5)  What this Grant may Accomplish:
This grant may elucidate which preventative medication works best to prevent migraine in children and adolescents.  It would not only lead to the development of an evidence-based treatment paradigm, but economic relief for society – generating a potential impact within schools, family life, and the overall growth and development of youth dealing with migraine.  Since the negative impact of having migraines on quality of life is similar to cancer, heart disease, and rheumatic disease within children, successful completion of this trial could profit today’s youth in many positive ways.  Amitriptyline and topiramate have long been used in adults, but there has been little research in children.  By comparing these preventative medications within this trial, headache specialists would have a better understanding of their (the medications) effectiveness in achieving relief of migraine pain in children and adolescents.

(6)  What this Grant could do for Headache Medicine and for Patients:
This pivotal project could provide a pathway for headache medicine in the treatment of migraine in children and adolescents.  Not to mention, the relief for patients and their families.  Some patients have a daily, continuous headache that never goes away.  If one or both of these preventative medications is found effective in preventing migraine headache, a significant burden would be lifted from the shoulders of this patient and their family.  Clinician’s world-wide would have an evidence-based approach in the treatment of pediatric migraine.

(7)  What Patients can do to get involved in this Grant:
Our greatest hope is that patients will get involved in this trial.  We will need 675 patients between the ages of 8 and 17 to complete this study.  Any patient suffering from at least 4 headaches per month is eligible for this research project.  There will be 40 sites across the United States where patients can go to be screened for enrollment.  If they meet the study criteria and agree to participate, we would be happy for them to be involved.  To be involved, they would need to keep a record of their headaches on a daily headache diary, take their study medication each day, answer check-in phone calls and/or come in for study visits (depending on the time-point in the study), and complete questionnaires at their visits.  Our overall goal is to get many patients who suffer from migraines across the various research sites within United States involved in this trial.

(8)  Receiving this Grant is a Big Step, Headache Still has a Way to Go – How to Bridge Funding Gap:
Bridging the funding gap is just as daunting a task as building that first, well-constructed bridge in history.  There are many great research ideas out there, but not all of them will appeal to the funding supporters.  Dollars are limited during this time period.  Ideas are many.  One major focus could be on gleaning which projects would have the most profound impact within the disease populations of society, what teams can develop a proven track record of conducting research within these populations of people, and how can the dollars be divvied out in such a way to support the success of study patients and their families, the progression of the careers of those conducting the trials, and the capabilities of the overall funding sources to thus support the greatest number research projects at any one block of time.  A healthy marriage of both economics and health care research could bridge this gap; however, as a body of scientists, no one wants to be floating down-river without toll to the other side.  Working as teams of scientists might make bridging this gap achievable and allow for an overall encompassing, solid research project, one of exceptional promise and fortitude to influence the health care community upon completion.  Writing economically-friendly grants will also leave funds in the coffers of institutes, societies, and funding bodies to serve other scientists and thus support on-going improvements within medical treatment, health care, the field of science itself, and most importantly, society overall.

Janelle R. Allen, MS,
Andrew D. Hershey, MD, PhD, FAHS,
and Scott W. Powers, PhD, ABPP, FAHS
on behalf of The CHAMP Study team (Childhood and Adolescent Migraine Prevention Study). 
MS Allen is a research coordinator, and Drs. Hershey and Powers are Co-Directors of the Headache Center at Cincinnati Children's Hospital.

Help Sustain Progress in Headache and Migraine Research

In May, 2010, the NIH held a planning workshop to develop strategies for headache research and to identify consensus areas for focused research. Now, 18 months later, the meeting proceedings and recommendations of the workshop have finally appeared in a report, “Opportunities and Priorities for Headache Research." A brief 2-page update attached to the report also details federal responses to date to the Workshop discussions and recommendations.

These responses include:

1. NIH funding of a large comparative effectiveness clinical trial to study pediatric migraine preventative medications. This trial addresses a major problem never before studied. (It will be the topic of an upcoming full HeadNotes entry.)
2. Sponsorship of five further meetings. Three workshops were devoted to pain conditions other than headache (chronic fatigue syndrome, TMJ, and vulvodynia). The fourth workshop, a 5-hour conference held last June 1st, was devoted to “Advancing Translational Headache Meeting”. The fifth workshop on grant opportunities and writing skills was also held in June at the American Headache Society Annual Meeting.
3. Announcement of the FDA “Analgesic Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION). This is a public-private partnership initiative to improve and expedite development of new analgesics.
4. Announcement of the “NIH Pain Consortium Centers of Excellence in Pain Education.”  This initiative is intended to develop curricular tools to facilitate pain education for health professionals at multiple levels of training. 
5. Announcement of an initiative to develop common data elements (CDEs) for standardization of data collection across clinical trials for headache disorders. This initiative is intended to permit greater ease of design, execution, and interpretation of clinical studies. 

These initiatives and developments are very welcome and represent significant progress towards improving the context and environment for performing research.

However, what is still lacking is a commitment by NIH, aside from the pediatric trial, to increase funding of actual research on headache disorders. More than sufficient concrete suggestions are contained in the workshop report to form the bases for NIH programs that are critical to jump-starting headache research and training. Where are the specifically funded initiatives (e.g. Request for Applications, Program Announcements) to follow-through on the outcomes of the workshop? A tremendous amount must be done and too few resources are currently devoted to the effort.

Furthermore, why did it take 18 months to issue the brief report from the May 2010 Workshop? Nothing in its contents explains why it could not have been available more than a year ago. Equally puzzling, the June 1st translational research workshop was almost 6 months ago and no report is available for that workshop either. When the data for 2011 NIH funding are released in February of next year, we will see whether the actions and inactions of the past year have appreciably changed the level of research funding for migraine and headache disorders.

In the meantime, we need to keep our concerns directly before our elected officials who have oversight of NIH.

We are seeking a congressional hearing, the very first of its kind, to air publically the facts about headache disorders, including their resultant disability, stigma, suffering, inadequate therapies, and federal neglect. We are asking you to sign a national on-line petition at this time.

We will present the signed petition to members of Congresss to urge them to hold such a hearing. Please sign the petition and ask everyone and anyone you know that cares about someone suffering with a disabling headache disorder to sign as well. Only with your help can we expect to have a congressional hearing scheduled and have the current state of inadequate research publically recognized and addressed.

Click here to sign the petition now.

Thank you very much in advance,
Bob Shapiro
President, Alliance for Headache Disorders Advocacy

Botox Games: Insurance Company Strategies to Make the Chronic Migraine Patient Lose

In late 2010, the FDA approved Botox for chronic Migraine. In February of this year, it became possible to code and get Botox paid for by Medicare, and insurance companies followed suit a few months later. But they did it reluctantly, and are doing everything they can to deny, delay, postpone, or otherwise impede chronic Migraine patients from getting the only FDA-approved treatment for their disease.

With traditional insurance companies, the criteria for qualifying for Botox are 1) – having chronic Migraine (more than 15 headache days per month), and 2) – failing 3 or more preventives in at least 2 classes (antidepressant, seizure medicine, or blood pressure medicine).

I know the criteria, and I don’t play games and submit patients I know don’t qualify. My patients are usually so overqualified for Botox they should have tried it last century. I have been collecting chronic Migraine patients for 20 years, and many have tried 20 or 30 preventives.

But, unfortunately, Botox is expensive. The drug itself runs about $1100 for the right amount of units, four times a year. So the insurance companies:

1. Require the doctor to fax tons of records, including all the clinical information from previous physicians, lab & blood tests, medications tried, all clinical information from our facility, and sometimes an additional letter of medical necessity. We send about a half-inch of medical records to most insurance companies.
2. Don’t read the faxed records. We summarize the record, and use the required verbiage: “The patient has chronic migraine. They have headaches more than15 days per months which are linked to Migraine (the exact wording of the FDA approval). They have failed adequate trials of these antidepressants, these seizure medicines, and these blood pressure medicines, all of which are proven to be effective against Migraine.” They still don’t read it!
3. Lose faxed material. (Our record is three consecutive lost faxes on the same patient.)
4. Require the same material faxed for each and every treatment, and require us to prove once again the patient still has chronic Migraine. This gives them an opportunity to once again not find the relevant information they were eventually able to find the last time, or lose the records again. If we have to get a patient re-authorized, we have to re-fax everything we previously faxed for the initial authorization, as well as any other recent office visit notes and/or Botox office visit notes with procedure notes.
5. Require us to show a percentage change in headache frequency or a reduction in number of hours of headache per month after two injection cycles. So a patient does not get to decide if he or she had meaningful headache improvement. If your daily headache goes from an 8/10 to 3/10, but you don’t have headache-free time, will this be good enough?
6. Jack up the co-pays. Everybody is experiencing increasing co-pays. Not only might the patient have a co-pay for the procedure itself, which is then added to the regular office visit co-pay, he or she might have a co-pay for the drug through the specialty pharmacy. But with Botox, this is taken to a new extreme. What insurance companies have done for other medical treatments was just practice for what many of them have done for Botox.
7. Delay decision until after the procedure. Some insurance companies won’t make the determination of whether you meet criteria until after the procedure has been performed. The insurance company not only wants to know how much our facility bills for the procedure, but how much we charge for the drug itself because, ultimately, we have to use our stock, which we have purchased, and bill for it. Imagine: “Have the procedure, and then we will let you know if we will pay or if you are on the hook for over a thousand dollars.”

Is there a vendetta by the insurance companies against chronic Migraine patients, because they are not worthy of an expensive treatment? I don’t know, but that is what it feels like to me.

I think part of the strategy is to make it unappealing to take care of headache patients. If the number of doctors willing to do this procedure is reduced, maybe insurance companies can increase their profits. The AHDA must defend the practice of headache medicine.

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

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

Representative Michele Bachmann Casts Light on the Neglected Burden of Migraine in America

Burlington, Vermont – July 20, 2011 - US Representative, and presidential candidate, Michele Bachmann reported yesterday that “I experience migraines that are easily controlled with medication," and that “…my ability to function effectively has never been impeded by migraines and will not affect my ability to serve as commander in chief.” Representative Bachmann’s reassuring remarks require no further clarification; several distinguished US presidents, including Ulysses Grant and probably Thomas Jefferson, suffered severe migraine attacks during their terms in office.

However, Representative Bachmann’s candid disclosures bring to public awareness the stark fact that, for millions of other Americans, migraine attacks can be severely disabling, as well as a compulsory undisclosed private matter due to the widespread stigmatization of the disorder.

This year nearly 1 in 5 Americans will experience some form of migraine attack, and 1 in 25 Americans will have headaches at least 15 days per month. Available migraine therapies are few in number and often limited in effectiveness and tolerability. Over the past 49 years, only one innovative drug, discovered and developed specifically for migraine treatment and given priority review by the FDA, has been approved for clinical use. Since breakthrough drugs are typically discovered by publicly funded research investigators, rather than within pharmaceutical company laboratories, it is alarming that US federally funded migraine research totaled only $15M in 2010. The World Health Organization estimates that migraine is responsible for more lost years of healthy life in the US than multiple sclerosis, epilepsy, ovarian cancer, and tuberculosis combined, yet these disorders received more than 45 times more research funding from the National Institutes of Health than migraine last year.

In light of the pivotal role for NIH funded research in the discovery of novel drugs, the Alliance for Headache Disorders Advocacy strongly urges Congress to prioritize marked increases in federal research funding to understand the causes of migraine and to discover novel effective treatments for it.

The Alliance for Headache Disorders Advocacy is comprised of ten not-for-profit national and regional member organizations advocating on behalf of patients with migraine and other headache disorders. http://www.allianceforheadacheadvocacy.org/

Contact:
Robert E. Shapiro, MD, PhD
robert.shapiro@uvm.edu