Warren Lammert Addresses FDA Panel on New Medical Device for Seizures

First I want to thank the FDA and the Panel for the opportunity to share my thoughts. I am the father of a 15 year old girl, Sylvie, who lives with uncontrolled epilepsy, a Co-Founder of the Epilepsy Therapy Project and epilepsy.com and now a Board Member of the Epilepsy Foundation. I have not received any compensation or travel support for my appearance today and my comments are solely my own. Sylvie had her first seizure at 9 months, a second seizure the same day and then later that evening an episode of status that lasted more than 30 minutes. And so Sylvie started on her first seizure drug, phenobarbital, and when that failed, on to another and another and quickly a cocktail of medicines that still failed to give her control of her seizures. Over the next fourteen years, Sylvie has gone on to try more than a dozen drugs and a range of drug cocktails and combinations, the ketogenic diet, and an implanted medical device (VNS Therapy^®) but still has found no answer for the daily waves of absence and myoclonic seizures she experiences. A few years into this journey, I learned that like Sylvie at least a third of those with epilepsy similarly had no therapy that could control their seizures and that the available drug therapies brought with them side effects including fatigue and cognitive slowing that are only acceptable against the terrible risks, including SUDEP, of ongoing seizures.

I wanted to try and change that reality for Sylvie and for others living with epilepsy. And so, in 2000, I helped start both epilepsy.com (a leading website for the epilepsy community) and the Epilepsy Therapy Project (ETP), whose mission is to accelerate ideas into therapies for people living with epilepsy. Now 10 years later, ETP has provided funding to a broad range of new pharmaceutical, device, diagnostic and dietary therapies in the epilepsy pipeline, often working in partnership with other leading Epilepsy Organizations and in particular the Epilepsy Foundation with whom ETP merged at the end of last year.

As a result of my involvement in ETP and work to advance new therapies, I became aware of NeuroPace and the RNS system and have closely followed its progress through its clinical trials. I have attended scientific sessions where the RNS clinical trial data has been presented, have read several publications reviewing the clinical trial data, and have discussed the results with leading epileptologists. I have also reviewed the executive summaries and other materials made available to the public relative to today's panel meeting. Patients using the RNS system saw a 38% reduction in disabling seizures during the blinded evaluation period, results which improved to better than 50% reductions at one and two years. Further, these patients showed improvement in mood and in many quality of life measures. There appear to be no safety and side-effect issues unknown already in deep brain stimulation and none of the side-effects common to drugs including cognitive issues, sedation, ataxia, memory, mood, or interactions with other drugs.

Epilepsy needs new, effective therapies. The RNS is one good option. Moreover, it is an approach that offers a new window on epilepsy, a path to progress in our understanding and treatment. All new therapies involve unknowns and risks, but these have to be weighed against the risks and too often devastating, even fatal reality of uncontrolled seizures. People with uncontrolled epilepsy, together with their families and doctors, deserve the opportunity to weigh the costs and risks of their epilepsy against the risks and promise of this new therapy which has been shown to be effective in appropriate clinical trials. While a number of new drugs have come to market in recent years, we have not made notable headway against the problem of uncontrolled seizures. And it has now been 15 years since a new device has been made available against epilepsy. A failure to approve would take away an important, now proven, new therapy option, and it would have a devastating impact on investment in other new device therapies. For the sake of Sylvie and all of those living with uncontrolled epilepsy, the RNS should be approved and made available as an important new option for therapy.