by James Heywood
Update (March 7, 2008): PatientsLikeMe ALS Lithium Research released.
Does it work? 
On February 12th of this year, Proceedings of the National Academy of Sciences (one of the leading science journals) published a paper entitled — Lithium Delays Progression of Amyotrophic Lateral Sclerosis. After 10 years researching ALS, I believe it is fair to say this paper includes the most promising suggestive set of data from a clinical trial ever published. I say “suggestive” because there are many flaws with both the information presented and with the publication process itself. These flaws make it so that patients and their doctors are left trying to draw conclusions about the use of Lithium to treat ALS, without actually having any realistic confidence in the data or its meaning.
For a patient, there is genuine risk either way. Lithium is not a harmless drug, and, although it is widely used, it can have significant side effects if it is not monitored properly. In addition, the reality is that in several of the last clinical trials in ALS, including minocycline and topiramate, the patients in the treatment group did worse than those in the control group. So, fears about the risk of an unproven drug are well founded. However, there is also the risk of doing nothing. If the paper turns out to be even half true, the effect on the progression of the disease could be dramatic.
We also must consider the consequences of waiting for more information. For someone with a life expectancy of several years, the consequence is obvious. Unfortunately, the harsh reality is that the traditional medical research system will not provide any better data to patients for at least 2 years – that is, 6 months to start a trial, 15 months of evaluation, and 3 months to share the data. In fact, 2 years is being optimistic, if truth be told. History teaches us that it will most likely be much longer.
History also teaches us that patients sharing stories with each other will not answer the question alone. Chinese stem cells, herbal supplements, nutraceuticals — all have been discussed extensively on the internet with some claiming cures and some describing great harm; yet we have no definitive answer. Despite the thousands of postings, very little knowledge has advanced the treatment of ALS, and patients are still left unable to make effective treatment decisions.
We can and will do better
PatientsLikeMe was built to solve this problem and accelerate the transfer of knowledge about what works and what does not. Today, PatientsLikeMe has data on the progression and history of more than 1600 ALS patients – twice the number in the largest ALS trial in history. Even before the trial results were published, 50 patients worldwide who had elected to start taking lithium, in collaboration with their doctors, have been tracking their progression and blood levels on PatientslikeMe. This is more than twice the number of patients participating in the trial itself! We have data on historical forced vital capacity, the ALS Functional Rating scale, and a full symptom battery for most of the patients who have started, as well as for all the other non-lithium users in our system.
PatientsLikeMe is committed to solving this problem. We are collaborating with Humberto Macedo, a patient, and Karen Felzer, who’s father has ALS, to recruit all patients taking lithium. Together, with all the patients involved, we will run the first real-time, real-world, open and non-blinded, patient-driven trial. We believe we will have the power, within months, to begin answering the question of how much lithium modifies the progression of ALS. Unlike a blind placebo control trial, we are watching the use of this drug in the real world, and because of the number of patients and our system’s sophisticated data modeling, we can determine the significance of each reported change in each patient as he/she deviates from his/her predicted course. There are many risks to our approach, patient optimism, the placebo effect, uncertain quality, and many other variables will compromise our data. Despite these, and many other challenges, we remain committed to solving this problem.
Our Pledge to ALS Patients
We will use all our shared patients’ data to determine, to the highest predictive power possible, the effect of lithium on ALS patients in the real world. We will share that information in real time with all patients. We commit to displaying that information in a realistic manner that communicates the true confidence and uncertainties it contains. We will build a platform that allows patients, doctors and researchers the ability to drill down into all of the data in the system, to each and every data point, so that they can trust that our analysis is based on what really happened. We commit to engaging in an open and productive dialogue about our methods, so we can all learn to do this better – today and tomorrow.
What you need to do
Regardless of whether you take lithium or not, we need your data. The more patients that share their information, the more power we have to detect the effect of lithium, or any of the other 800 treatments in our system. We encourage all patients, including those who have chosen on their own in effective consultation with their doctor to take lithium, to join PatientsLikeMe and share your data with the world. We do not encourage any patient to start taking lithium. As noted above, all drugs have risks and, in general, ALS patients have experienced more harm than good trying experimental treatments. It is important to note that, either way, you help if you participate, because the more data we have, the more ability we have to answer the question of what’s working.
Realistic Hope
In the 9 years since my brother, Stephen, was diagnosed with ALS, we have been through so many cycles of hope and disappointment. We have tried treatments that turned out not to work, and we have tried treatments that were and remain unproven. Each time, we approach the data with a little more skepticism, as each time before it has been proven to be wrong. Someday a treatment will work. I hope and pray that lithium is the one, but I am realistic given the failures of the past. The realistic hope of PatientsLikeMe is that together we can accelerate the day when we know. We know most patients use PatientsLikeMe because they want to talk to someone like them and support their friends, they use PatientsLikeMe to share their insights; they use PatientsLikeMe, because, without question, we improve patients’ quality of life through the sharing of information. We value that greatly, but we also have higher goals, Today, we start achieving them. Today, we allow patients to begin to answer how to treat ALS, and that will help us answer it for all diseases.
Like so many others in the ALS community, I scour the news each day hoping my long-awaited miracle has been discovered. And though I’ve been disappointed countless times, the hope I feel with each new discovery is fresh and just as real as ever before. I’m going to talk to my doctor about lithium, and I encourage everyone to do the same. If your doctor hasn’t seen the study, you can download it from the Extra Hands for ALS website here: http://www.extrahands.org/lithiumpaper.pdf.
Many thanks to Jamie and everyone at PatientsLikeMe for providing this opportunity for us to talk with each other.
In my view, the above is extremely well thought out, unbiased and well written piece.
I think it’s excellent that Jamie posted this not only on the PLM ALS Forum but publicly on this blog. Well done Jamie.
Since this is in the public domain I cross-posted over at the ALSTDI Forum yesterday.
“Together, with all the patients involved, we will run the first real-time, real-world, open and non-blinded, patient-driven trial.” Clearly, there are unresolved issues with this approach that need to be addressed and Jamie details the commitment that PLM will make to solve them.
PLM continue to set new precedents which is most commendable.
My best wishes,
Graham
Graham Steel
Co-founder, CJD Alliance
Gram, Jack,
Thanks – there is much to do but I think the most important step is to be committed to doing it.
-jamie
I was at a conference at the Harvard Medical School on Wendsday the 20th. And they mentioned Lithium at the presentation, and how it slowed dow als. Keep up the good work, and find something that works (please) Gratefully, Ralph Costa
Hi Jamie
I am an ALS patientslikeme member. My Dr has suggested Lithium and I have been scared to try it out. I live in Zambia and am worried that I won’t be able to monitor my blood levels. I will keep informed and make a decision. Thanks for this
Jenny
Thanks for this, very well written and encouraging. I would like to read the study, but the above url no longer works. Is it available somewhere else?
Jamie,
Very well written piece and approach on Lithium. Thank you for all your efforts with Patientslikeme. You are a champion. The site has done me alot of good in many ways, but mostly has given me strength from the others.
Keep up the good work. I will try lithium as well.
Lynn Stewart (stewld)
http://www.extrahandsforals.org/mt/archives/000680.html
Extra Hands website article on Italian Lithium study.
My husband, a 58 year old retired h.s. teacher, was diagnosed in August of 2005. He is on Rilutek, taking IV Rocephin daily, and was just put on Lithium (150 mgs 2x a day for 2 weeks, and now 300 mgs. 2 x a day). I feel he seems better, but it’s hard to tell. He gets a blood test every week to make sure the Lithium level is safe.
A relative wants us to go to the Haverford Clinic in Pennsylvania, but I have read many discouraging things from ALS patients who have tried the protocol there.
my father is 54 he was diagnoised in nov 07. he is curredntly in the ceftriaxone study. i am in the process now of trying to get him on the lithium, so far i know the dr wants him to take it but he cant give it to him becuse hes already in a study. im trying to get it from his family dr, wish me luck
In the near future anyone will be able to take part of any scientific trial wherever it is. PLM System tool and our initial spreadsheet demonstrate this new way as a breakthrough.
Best,
Humberto
My Mom was recently diagnosed with Bulbar ALS. She is devastated and may not be allowed to be in the upcoming clinical trials if she doesn’t pull it together and take her meds and tube feeding as recommended by her doctor. She is severely depressed and I don’t know what to do to help her. She was a very young 73 year old until this happened and has lost her ability to swallow and speak. We are desperate to have some answers. She is excluded from most clinical trials due to the feeding tube. Any help would be appreciated.
I was told that I have ALS on March 13,2008.
I have contacted my Dr. and he has agreed to prescribe Lithium to me tomorrow.
Sincerely, A. Richard Dixon
It is good article Now I am taking Lithium I will let you know if it is helping me.
I have been on Lithium since June 24, 2008. I started out on 150mgs twice a day for two weeks and then went to 300mgs twice a day.
I have felt a little weak and I haven’t had much energy since I went up to the 300mgs twice a day. I don’t know if this is from the Lithium or somthing else. Have anyone else had these side effects?
Richard,
You can see the side effect profiles for about 150 ALS patients on lithium here on our research summary page. You might want to ask the question in the forum as well.
-jamie
http://www.patientslikeme.com/als_lithium/side_effects
I have ALS. I was diagnosed in May. I am in a wheelchair now and have little use of my hands, but I still can feed myself as long as my food has been cut up for me. I am a 67-year-old retired RN. I started the lithium trial yesterday and I’m hoping to see some good come out of it. I like short information pieces, and don’t like to be bogged down with lots of literature. My only question is how fast does ALS run? I have gone from a health to invalid since January 2008.
I would like to know, if the first ALS patients, that entered to the Patient, Lithium trial, have felt better or its disease, has been halted or slowed.
Please let me know, because i dont know what to do, if take Lithium or not,
Thank you very much for your help.
Luz Maria
I was diagnosed with ALS in June 08 .
Had a accitent 1 yar earlier ,suspected my right side was affected then by ALS .
Started taking Rilutec in September 08.
My Limbs are gratually getting weaker .
Like to hear more abaut the Litheum triels .
I am still very active .
I was diagnosed with Bulbar ALS in August, 2008. I had symptoms for 8mo. prior to diagnosis. I take Rilutek since Oct., 2008 and started in the Lithium Clinical Trial in Arizona just over 2 weeks ago. So far, I cannot tell if my disease progression has decreased. My speach is very poor and difficult for others to understand and my swallowing is also very difficult. I try to eat small cut-up portions or much softer foods and it is easier to drink thick liquids. I walk with a walker.
I am very interested in any information you come up with. Thanks for this website. Ken
lithium trail start at this time in the netherlands,
I was ask for this but only 50% get lithium en other
placebo,so I say no ,I start lithium for my self whit
control of the docter,and see the rest by patientslikeme.
My father started lithim trial yesterday with 300mgX2.
Will let you know in case any improvement
Around 1980 or 1981 i was diagnosed as having mood swings and placed on lithium carbonate. Around 1995 my new doctor took me off lithium.On july 2006 i was diagnosed with ALS . Has anyone else been on lithium for other reasons then taken off lithium and developed ALS.
Dear site founders & administrators, sorry for may be a very basic question: how it is possible to see the results of on going study with Lithium? (how many people say “it is helpful”, how many are not satisfied). This is very important for us now, as my mother was diagnosed an ALS recently…but the case is not an ordinary one..she has a chest cancer almost at the same time…
we are trying to take any chance: Considering Lithium therapy now.
many thanks for any feedback.
Regards,
Alex
Sorry, one more question:
did any one tried the traetment from:
http://tcmtreatment.com/
the say many promising things, but it sounds not really clear…any feedback wotld be highly appreciated..
Alex
Diagnosed with Bulbar palsy/Probable ALS last month. I will be starting on Rilutek next week and my doctor will start me on Lithium a month later. He wants to see if I have any side effects from the Rilutek first. Here is hoping for the best
my doctor will start me on lithium next wek too,
The PatientsLikeMe approach is incredibly exciting from a health communications perspective.
First, it breaks down the feeling of isolation that contributes to our experience of illness. (This alone is empowering.) Second, the PLM approach provides meaningful data visualization which really adds to the open community experience. Lastly, the front end was designed with ease-of-use in mind. These 3 traits position this product to be very helpful for clients seeking knowledge of symptoms and treatments.
You are empowering all of us (patients, editors and advocates) to tell a much more compelling story with this approach and I can easily imagine many more applications of the model.
been on rilutek 1 wk,had bulbar 2 yrs now beginning arm + leg weakness,can u take lithium and either of the antibiotics they are currently doing trials on,i go to dr at osu
Were lookin for hope that Lithium does provide a slowing effect of this desease. Can you provide the trial study results. I have a very close friend living in Bulgaria we are despreat to provide something that will actually help. Im currently reviewing the 125 research trial studies, hoping to find something. Is there a special type of lithium that I need to look for. How do we monitor the lithium in his system?
I went on 300 mg daily 3 weeks ago just incase it does slow progression. I hope and pray it does….we’ll see.
My 62years young wife was diagnosised with ALS in April 2009. She started on Rilutek in June 2009 and Lithium (150mg) twice/day…18 months later she is totally unable to use hands, legs, arms. She got a PEG in October 2010, since swallowing was soooo difficult. I would recommend getting the PEG early in the diagnosis because when breathing becomes an issue having the PEG surgery becomes can create complications. She was on Lithium for almost a year and really saw no changes other than fast progression (who knows, maybe the progression would have been even faster). The DR. told us to stop using lithium since there were conflicting results…in some cases accellerating the progression. At this point she needs devine intervention!
Hi!
My name is McKenna, and in July of this past year my Papa was diagnosed with ALS. The doctors didn’t know what to tell him; he was 74 and it wasn’t looking good. This past February he passed away because of fluid in his lungs; caused by ALS. I pray for a cure so no one else has to go through what my family went through, and I pray for those who do.
-McKenna