At The Charlie Foundation, our greatest hope is that people achieve seizure freedom—be it through medications, surgery, cannibidiol, or diet therapy. The question we ask is why the esteemed authors of a recent SUDEP article would choose to censor nearly 100 years of published science, including two randomized controlled studies, indicating the Ketogenic Diet reduces seizures by at least 50% in half the people who try it, and eliminates seizures in 15-25%.In March, 2017 the American Academy of Neurology and the American Epilepsy Society published their SUDEP (Sudden Unexplained Death in Epilepsy) practice guidelines. They reported “with high confidence in evidence” that “SUDEP risk increases in association with increasing frequency of GTCS (generalized tonic clonic seizures).”GTCS, also know as grand mal seizures, are a hallmark ofmyoclonic astatic epilepsy(Doose Syndrome).According to the 2009 published Medical Consensus Guidelines for administering the Ketogenic Diet, “KD should be strongly considered after the failure of two or three medications regardless of age or gender…in the case ofmyoclonic astatic epilepsyit should be considered earlier.”Yet somehow the authors of the new practice guidelines fail to mention a word about diet therapy.The practice guidelines go on to say, “ …having frequent GTCS, and the absence of seizure freedom, are strongly associated with SUDEP.Again, the authors chose to disregard the overwhelming evidence that after the failure of two or three medications for most non-surgical candidates, the best way to reduce or eliminate seizure frequency--and hence reduce or eliminate the chance of SUDEP--is with a Ketogenic Diet Therapy.The cornerstone of health care is “evidence based medicine”-- in other words medicine that is based on science. We feel that to ignore Ketogenic Diet Therapies for medication-resistant epilepsy, especially while raising the specter of death, is unconscionable.
In March, 2017 The Educational Journal of the International League Against Epilepsy (ILAE) published a paper entitled: “SUDEP: what every neurologist should know”. In it they write:
“SUDEP risk increases with less well controlled epilepsy.”
“There are currently no established evidence based prevention strategies.”
Though the ILAE makes strong suggestions that medications and surgery may decrease chances of SUDEP, there is not a single mention of Ketogenic Therapies. This despite nearly a century of overwhelming data, including two randomized controlled studies, documenting that a Ketogenic Diet reduces seizures by at least 50% in 50% of the people who try it; and eliminates seizures completely in 15-25%.
According to the ILAE: “By far the greatest clinical risk factor for SUDEP is frequency of generalized tonic clonic seizures.” So, if you reduce tonic clonic seizures by 50% with diet, you reduce the chance of SUDEP by 50%. If you eliminate these seizures with diet, you eliminate the greatest risk factor for SUDEP.
Why then did the ILAE fail to mention the Ketogenic Diet?
It is noteworthy that in their disclaimers the authors of the ILAE paper disclose they receive benefits from pharmaceutical companies UCB, Eisai, Janssen, Lilly, Servier, Astra Zeneca and Neuro Sigma among others.
Please watch this video of Jeff Buchhalter MD PhD addressing an alternative point of view regarding the relationship between the Ketogenic Diet and SUDEP.
In addition to reviewing further articles on SUDEP, we’ll be posting a series of diet and nutrition topics with evidence of benefit for people with epilepsy. Stay tuned for the next post about how Vitamin D can improve seizure control.
The criteria for the FDA to approve a new anti-epileptic drug is merely that a medication must reduce seizures by 50% in 50% of the people who don’t drop out of the trial because of intolerance, non compliance, adverse affects, or other reasons. So lets crunch the numbers. Let’s say a new drug is tested on 100 people. Of that number lets say 20 people drop out of the study for whatever reason. That means that for the drug to get FDA approval there has to be seizure reduction of at least 50% in only 40 of the original 100 people who started the trial. There is no requirement for anything more than 50% reduction.
Compare that to Ketogenic Diets. For ninety plus years 66% of the people who try them, including those who stop because of non-compliance, adverse affects, etc. have seizure reduction of greater than 50% -- not to mention fewer drugs, improved cognition, and seizure freedom. In other words, of 100 new people who try a ketogenic therapy, 66 will improve.
That’s right. 75% better outcomes with ketogenic therapies than the next drug the FDA can approve.
Maybe that's why our logo has a smile!
Ironically, though the Ketogenic Diet is underutilized due largely to a dearth of keto dietitians, the argument could well be made that none of us would be reading this blog, and perhaps today the diet itself may have faded into extinction, were it not for one particular dietitian, Millicent Kelly RD. Along with Dr. John Freeman and Dr. Samuel Livingston, she became the dietitian at Johns Hopkins that quietly put so many hundreds of children on the ketogenic diet and kept the diet afloat while fighting a near perfect Western medicine storm of modern drugs, their simplicity of use, and their enormous profit margins.
Mrs. Kelly, as her patients came to call her, enrolled at Johns Hopkins after college graduation in 1948 to take a one-year course as a student dietitian. She formally retired in 1999. She learned the diet from Dr. Samuel Livingston, a Johns Hopkins pediatrician and a passionate advocate for the diet. In 1953 he published that of 304 patents he had put on the diet, 43% had complete seizure control and another 34% were markedly improved. (As a measure of how times have changed, Livingston not only would make follow-up house calls on his keto patients, he would frequently take a week at a time and travel from Baltimore to Texas, Florida, or Wyoming to see how they were doing). It was in this positive environment that Mrs. Kelly learned and then helped perfect the diet, one child at a time.
Two decades later, in 1973, though the keto dietary staff at Hopkins had shrunk to Mrs. Kelly and just a few other dietitians, Livingston wrote, “Since 1958 we have treated an additional 575 patients with the ketogenic diet regimen and the results with regard to seizure control were essentially the same as those reported earlier.” Yet the patient lists dwindled as new, easily prescribed drugs came along and overwhelmed the work intensive ketogenic diet.
It was about this time that Livingston retired and handed over the reins of the ketogenic diet program to John Freeman who, equally impressed with the diet’s success and challenged by the absence of medical acceptance in the face of modern drugs, found a way to keep the diet afloat--found a way within the Hopkins machinations to keep Mrs. Kelly helping fifteen to twenty sick kids per year stop having seizures with a diet and her gentle tenacity.
Decades passed. More new drugs were introduced. Other ketogenic diet centers began to fall by the wayside. One by one, the dietitians dropped out of the keto program leaving Dr. Freeman and Mrs. Kelly, along with Diana Pillas coordinator-counselor at Hopkins Pediatric Epilepsy Center, the lone slender threads that kept the ketogenic diet helping kids at Hopkins. By 1990, contract food services took over the keto nutrition at Hopkins complicating her work even more acutely. Later that year when Mrs. Kelly was demoted within the nutrition department, she went to Dr. Freeman to announce her retirement. Freeman, whose rebellious, persistent spirit is loved by all who know him, fully understood Mrs. Kelly’s importance to the very existence of the diet, and would have none of it. He found a way to keep her on board as Pediatric Dietary Consultant to Pediatric Neurology. Mercifully, she stayed.
In 1994 the ketogenic diet dramatically circumvented traditional medical information distribution routes, and awareness of its success went straight to millions of families through mainstream media focus. Public demand fueled an enormous resurgence of interest in the diet within the scientific and medical communities. It began to achieve a new foothold in epilepsy treatment and has begun to restore its rightful focus within the neurology community. Today, with over 200 ketogenic diet centers world wide, it is once again becoming a priority in the treatment of children and adults with difficult to control seizures, other neurological disorders, and certain cancers.
But one has to wonder where this story might have ended were it not for the Livingston/Kelly/ Freeman connection. What might have happened if Mrs. Kelly had simply gone away? So I asked her recently what kept her going through all those years of hard work, little pay, and even less recognition. “I thought it was my job,” she said. “I met some of the nicest people. Some of those mothers and fathers and families--what they had to endure. If I could do something, I had to.”
The Charlie Foundation
*Photo at left is of Charlie Abrahams and Tim Indermittee - 2 seizure free kids, circa 1996.
When Charlie started the Ketogenic Diet and his seizures went away so dramatically at the end of 1993, I asked Dr. Freeman from Johns Hopkins three questions.
1) Why did we have to find the diet on our own?
2) Why didn't any of the pediatric neurologists we saw tell us about the diet?
3) Why, even when we learned of the diet as a treatment option, did they try to talk us out of it?
Although I didn't fully grasp the dark implications of his answer at the time, here's what Dr. Freeman said, "The Ketogenic Diet will never become popular again if you try raise awareness through traditional means of medical communication (meetings, papers, etc.). If you want to help restore the diet's rightful place as an early treatment option for children with seizures you need to circumvent the medical community and go straight to the public with this information."
Dateline NBC found out about Charlie as we were making our introductory video to the ketogenic diet and came to film his story.
In anticipation of what Dr. Freeman called "the deluge" from the huge public demand that would occur when the diet was revealed to the world on a national level, he and the Charlie Foundation held a conference at which directors from seven other epilepsy centers from around the country came to Hopkins with their dietitians to learn about the diet. Nonetheless, the public demand from the broadcast caught the medical community largely flat footed. Dr. Freeman said that his clinic alone got over 5,000 calls during the week following the broadcast.
I also tried to read as many of the thousands of letters and requests for information we received at The Charlie Foundation. They were incredible: grateful for hope, angry about lost years, heartbroken over potential unnecessarily damaged lives.
But one letter stood out as a new direction to reach the public. It was dated 10/27/94 and was kind of a stream of consciousness from Connie Indermittee, a Chicago area mom who had seen Dateline the previous night. The program had triggered memories of her experiences and feelings from the mid 1970's when she found the ketogenic diet for her son, Tim. Though in many details it was uniquely dramatic, in essence it was the story of all the families who have had to battle through epilepsy's costs, stigma, medical resistance, and ineffective and debilitating drug treatments to find diet therapy.
I read her letter and made three phone calls.
The first was to Connie to ask if I could come visit.
The second was to Dr. Freeman to share the story. (Tim had started the diet at Hopkins also).
The third was to Meryl Streep, who had helped us with the introductory video, to ask, "What do you think?
Please take the time to read the letter below from Connie Indermittee which ultimately provided the plot for the movie "First Do No Harm", written and directed by Jim Abrahams. We wanted to share this very special letter beacuse Connie's story represents the story of EVERYONE who at one point, may of felt helpless as a parent to find a treatment that works for their child or loved one. Thank you Connie and the entire Indermittee family for continuing to inspire everyone to never give up.
See transcribed letter below handwritten letter.
In April 1978 my 3 year old son had 1 gran mal seizure. We took him to the hospital and all the tests proved nothing. In the next 7 months, we took him to 6 other hospitals, 21 doctors, and 38 drugs. He had between 150 and 200 seizures a DAY. He spent the last 2 1/2 months at Pres-St. Lukes in Chic (Chicago) in intensive care. He was scheduled for exploratory brain surgery. I was almost praying Tom would die instead of living the rest of his life as a grossly retarded person with this problem.
I must stop for a minute and tell you, as I write this chills run down my spine. This was a nightmare that you relived for me on Dateline. I was going crazy trying to (self) cure my son. I went to the U of I Library and read - for weeks - from the time they opened to closing.
I got a copy of Sam Livingston's book. I read the Ketogenic Diet. I called Baltimore, They told me to come right away -
I tried to take Tim out of the hospital. I realized I'd LOST the custody of him. They would not let me transfer him from Pres-St. Lukes to John Hopkins. I stole him from the hospital. I had the help of 2 others to pull it off. He was on Valium IV 24 hour plus 8 other drugs.
I knew he could die. They knew he could die. He was seizing every 1/2 to 3/4 hour.
We had an ambulance come in the middle of the night. (at shift change) Took him to a commercial flight to Baltimore. Pulled the IV so we could board- wasn’t sure if he'd live to see Baltimore. We arrived - went to Livingston clinic - went to J.H. Hos. - 3 days starvation - went on the Ketogenic diet. A pure miracle -.
Tim is 19. He has not seized since that trip to Baltimore. He is a smart beautiful boy. He attended 1 year of college. He's a lucky kid, like yours.
Since, I tried to tell people about this method of treatment. The doctors here in the Midwest would not even consider its use. They would not admit that this is the cure for children with multi seizure.
If I had to do this all over again - I don’t know if I could. It financially devastated us. My husband lost his job. My other 2 children were virtually abandoned by my husband and I. We begged Fed Land Bank not to take the farm from us. The neighbors helped by taking the other kids, filling the freezer with food and most of all their prayers.
I stayed at Notre Dame Convent in Baltimore, as I had not any money for a motel. I stayed in the cloister as that was the only place there was to stay. All the sisters prayed a miracle would happen. It did. The Ketogenic diet saved my son.
The hospital taught me how to administer the diet. They were great. they wrote all the costs off as they knew we were totally financially broke.
For 2 years I followed the diet with Tim. We found that to be very hard, but we did it.
I have shopping bags full of medical records that would blow your mind showing the various treatments. I had doctors telling me they exhausted every treatment known, so just take him home and live with him seizuring - with no hope for any future for Tim.
As I write this, my heart is skipping. I remember like yesterday the ordeal we went through. I wish that NO ONE, ever. I tried so hard to tell my story to Readers Digest, local and larger news - media, and they weren't interested. Think how many children could have been saved.
Please write me. I may be of help to you and the awareness of this treatment. Keep it in mind that no doctor ever - in Chicago- had ever "tried" this diet. I begged them. They would not. When the tribune writer realized that I was bashing some of the most thought of doctors in the Midwest - they canned the whole story. To this day the pediatrician who first took care of Tim does not believe that is what cured Tim's seizure problem.
I almost hate all doctors now. They almost killed my son.
By the way - how we got to fly to Baltimore - My neighbor was a doctor and a pilot. He arranged the flight - the ambulance - the escape from Pres. St. Luke's. He could have been fired from his airline and lost his license to practice medicine. The risk he took was huge - the results were worth it.
Again please let me know you received this. I now realize someone else went thru the ordeal of this size.
Please excuse this poorly written letter. I shake when I think of those days - I forgot to slow down while writing - but it's readable, so I'm sending it. I kept a daily journal during those days and you relived them last night.
Please send me the video. thxs-"
The Charlie Foundation was founded on the principle that the medical standard of care needs to be be a process of informed, joint decision making between a patient or caregiver, and his/her health care provider. We have the highest regard for the value and necessity of science. We have much less sympathy for the intervention of government in this process. What's more, science doesn't always lead the way. Frequently there is a painstaking period while science takes a great deal of time to substantiate or rule out what may be fact. Many don't have the luxury of that time. That's when factors such as anecdotal evidence and risk/benefit ratio need to be considered without government interference. That's where it appears we are with CBD today. If we had waited for a randomized controlled study to be published on the efficacy the ketogenic diet, Charlie would have been seventeen years, rather than 20 months old before he started the diet, and I don't know that we would still have him today. What's more, to paraphrase "first do no harm": "To pretend that multiple drug treatments for children with difficult to control epilepsy are science and then argue against CBD is the cruelest of double standards."
Jim Abrahams, The Charlie Foundation