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Promising Migraine Preventive Drugs Target CGRP

Positive findings from two phase II clinical trials of promising migraine preventive medications were announced today (here’s the full press release). If these drugs make it to market, they’ll be the first developed specifically for migraine prevention.

These drugs are the first to test monoclonal antibodies for migraine prevention and both target the protein calcitonin gene-related peptide (CGRP). If those words are gibberish to you, here’s a brief introduction to CGRP and its role in migraine from James at Headache and Migraine News. (I intend to write an explanation at some point, but don’t currently have the mental ability.)

The first study included 163 people who had five to 14 days of migraine attacks each month. They either received a single IV dose of the drug, called ALD403, or a placebo*. After 24 weeks, those who received the drug had an average of 5.6 fewer migraine days a month (a 66% reduction) than before receiving the dose and 16% were migraine-free after 12 weeks. Those who received the placebo had 4.6 fewer days per month (a 52% decrease) and none were migraine-free. Side effects were the same for both groups.

The second study included 217 people who had migraine from four to 14 days per month. For 12 weeks, partipants received biweekly injections of the drug, LY2951742, or a placebo. After 12 weeks, those who received the drug had an average of 4.2 fewer migraine days a month (a 63% decrease), while those who received the placebo had 3 fewer migraine days a month (a 42% reduction). Participants who received the drug were more likely to have side effects than those who received the placebo. These side effects included pain at the injection site, upper respiratory tract infections and abdominal pain. Still, the drug was considered overall to be safe and well-tolerated.

Those are definitely good early results. More, larger studies are needed to confirm the findings.

Even more than the results, I’m struck by the positive, hopeful comments from two researchers involved in the studies, both highly regarded in the field:

“These results may potentially represent a new era in preventive therapy for migraine.” –Peter Goadsby, MD, PhD, UC San Francisco

“We’re cautiously optimistic that a new era of mechanism-based migraine prevention is beginning.” –David Dodick, MD, Mayo Clinic Arizona

While not effusive, these comments echo the optimistic, hopeful attitude I’ve heard countless headache specialists use when talking about CGRP drugs. I, too, am quite hopeful for these drugs.

*The placebo effect is way oversimplified as the power of positive thinking. The process is far more intricate that “you think it will work, so it does.” It’s another topic I’m planning a post on, but I don’t know when I’ll get to it. If you’re curious to learn more, Jerome Groopman’s book The Anatomy of Hope describes it well, and Placebo Effect Stronger Than We Thought? is a good article.

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Opioids (Narcotics) for Migraine & Headache Disorders: Two Specialists Weigh In

Opioids are highly controversial in the world of headache medicine. Beyond the obvious issues of dependence and addiction, there are risks specific to headache disorders. In this short video, two headache specialists address some of the issues, including:

  • Taking opioids more than eight times a month puts a person at risk for rebound headache (also called medication overuse headache or MOH).
  • Opioids can reduce the efficacy of other migraine medications, including abortives and preventives.
  • Migraine is an inflammatory condition. Opioids may increase inflammation, counteracting any migraine relief they might provide.
  • Opioids aren’t particularly effective for head pain to begin with. The receptors of the brain associated with head pain have few opioid receptors, so there’s not much for the opioids to work on.

This is a huge, controversial topic, but the more I learn about it, the more convinced I become that opioids should be of limited use in treating headache disorders. Opioids have a place, but that place is small and specific. They shouldn’t be a front line treatment, which they too frequently are.

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Tell Social Security to Include Headache Disorders in Disability Benefits: Take Action TODAY!

speak up for Social Security Disability benefits for headache disordersApplying for Social Security Disability benefits is a complicated battle for people with headache disorders. The process can last years and rulings often go against the patient. One reason for this is that the Social Security Administration’s official criteria to qualify for benefits does not include headache disorders as potentially disabling.

The Social Security Administration is currently revising the criteria for neurological disorders. Despite urging from several members of Congress and the Alliance for Headache Disorders Advocacy, the administration has said they will not include any headache disorders in the revised criteria. Without this inclusion, people who are disabled by headache disorders will continue having to fight for years and through numerous appeals for benefits they may not ultimately receive.

You have until April 28, 2014 to help change this. Write the Social Security Administration TODAY on the neurological revisions comment page. Submitting your comment directly to the administration is the most effective action you can take, but you can also voice your support by signing this petition. And please ask anyone you know who cares about someone who is disabled by a headache disorder to submit a comment to the administration.

Want to learn more? Read Speak Out for Migraine & Social Security Disability Today by patient advocate and lawyer Diana Lee.

Note: Be sure to leave your comment on the Social Security Administration’s website, not as a comment on this The Daily Headache post. While I always appreciate your comments, only those submitted through official government channels will count.

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On Suffering and Chronic Illness

While I don’t like to be called a migraine sufferer, What Suffering Does, a NY Times op-ed by David Brooks, resonated deeply with my experience of chronic illness.

There’s the awareness that despite desperately wishing for things to change, illness is not an issue of mind over matter:

[S]uffering gives people a more accurate sense of their own limitations, what they can control and cannot control. When people are thrust down into these deeper zones, they are forced to confront the fact they can’t determine what goes on there. Try as they might, they just can’t tell themselves to stop feeling pain, or to stop missing the one who has died or gone.

The recognition that loss of control doesn’t have to equal helplessness and that we do have control over how we respond to strife:

They are not masters of the situation, but neither are they helpless. They can’t determine the course of their pain, but they can participate in responding to it. They often feel an overwhelming moral responsibility to respond well to it… placing the hard experiences in a moral context and trying to redeem something bad by turning it into something sacred.

“Moral responsibility” and “turning it into something sacred” sound like they’d require grand gestures that are beyond the ability of someone with a debilitating chronic illness, but many of us turn our suffering into something sacred in the everyday. We do it by keeping others in our thoughts or prayers, by not judging someone whose behavior is changed by illness, by reassuring the friend who is new to chronic illness that she’s doing everything right, by telling the person who pays for prescription drugs out-of-pocket about drug discount cards and prescription assistance programs, and in millions of other ways.

The line from the op-ed that most spoke to me was,

Recovering from suffering is not like recovering from a disease. Many people don’t come out healed; they come out different.

By definition, chronic illness is not something a person heals from, but it certainly changes everyone who lives with it. It’s up to each one of us to decide what that change will look like in our own lives. I will never say chronic illness is a gift, but I do like who I’ve become because of it.

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Migraine & Pregnancy: 5 Must-Read Articles

Most pregnant women want to avoid all medications during pregnancy, but that’s not always practical with a health issue like migraine. Doing so can lead to other problems, like severe weight loss, that could be even more dangerous than taking certain medications. These must-read articles answer questions about migraine during pregnancy and breastfeeding, which medications are safe, weighing your migraine management options and more.

Migraine and Pregnancy
A brief overview migraine and pregnancy, this article from Beth Israel Deaconess Medical Center in Boston starts with advice for women considering becoming pregnant and answers common questions about migraine during pregnancy and while breastfeeding.

You Are Pregnant (or Planning to Have a Baby)
Is your migraine frequency or severity likely to change during pregnancy? Can having migraine attacks while pregnant harm your baby? The National Headache Foundation shares statistics and answers questions.

What To Expect With Pregnancy and Delivery
This excerpt from The Woman’s Migraine Toolkit provides detailed and easy-to-understand explanation how hormones during pregnancy and after delivery can impact migraine. (Diana Lee of Somebody Heal Me, who is expecting a baby in July, recommends this book.)

Expert Answer: How can I manage my migraines during pregnancy?
A headache specialist talks about the importance of creating a migraine treatment plan for use while pregnant, which medications are safe to use during pregnancy and what alternative treatments a pregnant woman can consider trying.

A Migraine Mama’s Advice on Balancing Medication Usage During Pregnancy and Breastfeeding
A chronic migraineur reconsidered her resolve to avoid all migraine medications during pregnancy after her migraines spiraled out of control and she lost 15 pounds before her first OB appointment. She describes the emotional wrangling of finding the balance between getting the treatment she needed without endangering the pregnancy.

And remember, your particular situation may be different than those addressed in any of these articles. Work with your doctors to find the safest, most effective treatment approach for you. Having migraine attacks while pregnant isn’t harmful, but they are a physically stressful event. Your body is already stressed enough with the changes of pregnancy, so it’s extra important to take good care of yourself and treat your migraines appropriately.