PFO and Migraine: Patients Organize for More Research

There has been a great deal of conversation and debate about patent foramen ovale (PFO) and its role in Migraine. Patient advocate Bray Patrick-Lake reports on a new foundation formed by patients for patients and supported by leading experts in the field of PFO medicine.

PFO: A Medical Conundrum Can a Group of Patients Make a Difference?

Approximately one out of four adults has a heart flap that is left over from when they were in their mother’s womb. Medical specialists thought for decades that this flap, a patent foramen ovale or PFO, was an innocent remnant of the fetal heart design.

After several decades of mounting evidence it is firmly established that PFO is linked to strokes in adults of all ages and severe migraines. The evaluation and treatment of these patients remains a source of great debate and much uncertainty. A small group of patients, meeting on the internet, saw that the medical community was unable to provide patients with answers; and sometimes certain providers provided misinformation and biased opinion.  Many providers just said, “we don’t know.” The PFO Conundrum had transformed into PFO confusion and the patients decided something had to be done.

So started the organization of the PFO Research Foundation, or PRF. Their goals are to improve patient care and to ensure research into PFO is funded, leading to an advance in PFO science. Lofty goals are easy, but how to move a medical field forward that is stuck in a quagmire is not easy. What did this group of patients do?

First, they found medical experts who shared their frustration and asked them to provide advice. Unlike the medical device industry, PRF could not pay them consulting fees but asked them to volunteer and help them chart a pathway that could lead to scientific discovery and medical advancement. The medical experts listened to their stories as patients, saw many parallels to their own patients, and said, “Yes, we will help.”

PRF then decided that there were several hurdles creating the PFO Conundrum. First, the medical issues crossed specialty lines of the heart, the brain, and the blood. Individual specialties could not solve the Conundrum but a joint effort might. Second, there was a paucity of research funding to understand the underlying causes of these special strokes and severe migraines. Third, part of the confusion was the uncertainty of how to diagnosis and quantify the PFO flap and medical testing standards were needed. Next, medical devices had been designed to close the PFO in a non-surgical fashion but there were wide spectrums of medical opinion with a body of conflicting medical literature as to the value of these devices.  Thus, key players were saying “No” including the FDA, insurance companies, and the venture capitalists, who were starting to withdraw financial support for device development and the clinical trials to test these new treatments.

The patients in PRF said “Stop, don’t abandon us – these are serious and unsolved problems affecting tens of thousands of people in the prime years of their lives - let’s sit down as a group and chart a pathway to answers, to treatments, and to restoration of our health!”

Shortly after organizing PRF in April of 2010, these patients were working nights and weekends, stealing moments from their regular jobs and families to organize The PFO Summit.  On September 20, 2010 in Washington, DC these patients brought together the medical experts on PFO from around the world, the device companies, the FDA, NIH representatives from NHLBI and NINDS, AHRQ, CMS, and even the venture capitalists to share scientific information and brainstorm solutions to the PFO Conundrum. What happened during and after this unique all day meeting that was so action packed that it didn’t even break for lunch?

The story’s ending is not yet known but what is known is that multiple collaborative initiatives to address those hurdles have been started. Neurologists, cardiologists, and hematologists are brainstorming together. Guidelines on PFO diagnosis are being written. Patient educational material on PFO that is objective, authoritative, and practical is being drafted and research grants are being prepared.

PRF now moves forward after PFO Summit 2010 planning for its second Summit and hoping that the fire the patients have lit will not die. Visit www.pforesearch.org to learn more.

Bray Patrick-Lake
President and CEO
PFO Research Foundation

Comments

[Julie Lyon]

Awesome!!! So proud of this PFO group... HUGE thanks to Bray for all her hard work!!!!

[Bray Patrick-Lake]

Many thanks, Julie, but I'm not alone in this effort. We are fortunate to have a dedicated board of patients in addition to myself supporting the foundation.