I am a little bit leery about putting out my anecdotal and unscientific feeling on how this drug is working. I would hate to improperly influence somebody. It is only N of one, and an intuitive measure. I do think that I am fairly immune from the placebo effect. I also think that I am not overly pessimistic. I give it my best thought and logic. I have decided to log my unsubstantiated opinion in the hope that it will be helpful to others. I think that this anecdotal evidence is better than nothing.
If others would like to share their experiences, I will be glad to read them with a healthy dose of skepticism, as you should have as you read mine.
LOG of how I feel it is working:
(updated Feb 2018, and thus, old) My progression since mid 2016 (diagnosed in late 2016) has felt remarkably steady. My upper body is pretty good, but walking, even with a walker is pretty much out now. I can go very short distances with much difficulty. I do almost all of my movement in an electric wheelchair. (on in red, off in black)
- 11-16-2017 I started infusions of Radicava for 14 days.
- My neck and shoulder muscles during this time were annoyingly stiff and sore. I didn’t think of any link at the time as I continue to push myself physically and do a lot with my upper body (neck though?). Soreness and stiffness lasted until early December, after the infusion cycle was over.
- During infusion cycle I noticed that I felt a little more tired and needed more sleep. (this was not profound or provable)
- The progression during this time did not seem to slow down. I almost felt like it sped up. My wife, who bikes with me, had the same feeling. This of course does not prove anything. N of one, and intuitive feelings. Possibilities of error in our assessment are: 1) I am just paying more attention (I try to account for this) (I am constantly pushing myself in sporting type activities so my intuitive feeling has some good measuring) 2) Any additional loss is more apparent as you get closer to the limit of being able to do things. 3) Perhaps I am confusing temporary weakness due to drug side effects with progression. 4) It would have just been the same or worse without the medication.
- 11-29 Last infusion of first round.
- 11-30 Start of 14 days off.
- I wasn’t really paying attention, but my soreness and stiffness during the off period went away.
- 12-14 Started the second cycle of infusions.
- 12-16 I noticed that my neck and shoulder muscles were getting stiff and sore again. It was at this moment that I had realized that the stiffness had gone away in the previous week or two.
- 12-17 I feel mild tiredness and weakness. Just don’t feel quite as well as a few days ago. I think I’ll take a knap.
- 12-19 I have noticed that the fasciculations in my arms has mostly disappeared. A little less in the legs. The first positive indication! I needed something to want to continue the treatment long term. The soreness in my neck and shoulders is no worse.
- 12-23 Last infusion of second round.
- 12-24 Neck and shoulder muscles still sore, perhaps slightly more so.
- 12-26 Neck and shoulders no longer sore but still a little stiff.
- 12-29 Neck and shoulders no longer sore or stiff, despite a bad cold.
- 1-5-2018 Decline seems slow and steady. Similar to before. Slower? Perhaps, I can’t really tell.
- 1-6 Fasciculations seem to be slightly more than when on the infusion cycle. Feels similar to before the start of Radicava.
- 1-11 Start of 3rd cycle of Radicava.
- 1-14 I feel that weakness has noticeably increased in the last few days. My decline had appeared to have slowed towards the end of my recent off period. It is my guess that temporary muscle weakness, along with some soreness, is a side effect of this drug. IS THIS NOTICED BY OTHERS? Neck and shoulders are slightly stiff again, but only slightly. (I hope it’s only temporary weakness)
- 1-16 Unlike the previous two cycles, I generally feel fine this time. Arms now feel tired and warn out, but perhaps has nothing to do with the medication.
- 1-18 Two days of med left. The amount of fasciculations has definitely decreased since the start of the med cycle. This was noticed on the previous two cycles also. Does less fasciculations mean slower progression? I can’t tell. The amount of progression of weakness definitely keeps marching on. Is Radicava working? Inconclusive.
- 1-31 In the off med period, progression in my legs has continued slowly. It somehow does not feel quite as quick as when I’m on the medication cycle. Fasciculations has gotten worse in my arms over the last few days. The soreness and stiffness in my neck and shoulders is gone. All of this is a repeat of the previous 3 cycles.
- 2-12 Start of taking Radicava for the fourth cycle (slight delay due to vacation, but still in line with the program). My progression has continued slowly but steadily during the off period. I am on a pace to were it takes about one week to be able to tell a slight, but certain, decline from the week before. I can not tell at all if the drug is helping, hurting or doing nothing at all.
- 2-19 Almost done with round 4. Unlike all the previous cycles, I do not have the stiffness and soreness in my neck and shoulders. Also unlike previous cycles, I had a disturbing bout of fasciculations in my arms recently. It may not be useful, this trying to judge the effectiveness of the medication on a cycle by cycle time frame. I’ll keep trying though because there is no way to tell how my progression would have been had I not been on the medication. It was my hope to be able to spot recurring trends during the cycles, while on and off the medication. All in all, still no way to tell if I am better with or without this treatment. No overall slowing that I can tell.
- 2-23 Today was my once every 3 month clinic visit at SLU hospital. According to their numbers, I am progressing just slightly slower than average expectations. The main doctor reiterated her faith in the drug and that a cycle by cycle self evaluation is not scientific or expected to be useful. I agree with this for the most part. I am still going to continue my assessments as they might possibly prove to be useful, even if not yet shown to be.
- 3-7 Though the progression isn’t stopping, it seems slow and the fasciculations (twitching) has been less lately. I got the flu many days ago but am feeling on the mend.
- 3-12 Started day one of Round 5 of Radicava. (ten days of infusions)
- 3-13 Started having a lot of fasciculations in me legs, where it had been pretty quite in the week before.
- 3-16 Things seem to change faster when I’m on the medication. Not so pronounced to say that I am positive beyond any reasonable doubt, but this is now the fifth time.
- 3-21-2018 Last infusion of the fifth cycle. Unlike cycles two and three, the twitching has not diminished by the end. The decline in the last week has been definite, though not huge. Faster than the average in my opinion, which has left me scrambling to try and find some way to make a smart decision about whether or not to continue in the future. I feel slightly sore and stiff in my neck, but not bad at all.
- 3-23-2018 In scrambling to gather new data on the drug, I reached out to the physicians at my ALS clinic. This is where we stand on Radicava information: “No new information about the study besides what we have before the medicine was launched. Some studies looking at different aspects may be starting over time.” I am thankful for the answers and their candor.
- 3-26 Fasciculations have diminished some in the last couple of days, but not gone completely by any means. Self transferring from wheelchair to other chairs is getting tough.
- 3-31 No change in twitching since 3-26.
- 4-2 Twitching is fairly light, but not completely gone. I don’t feel that progression has stopped, but not faster than average over the last week or so.
- 4-5 The twitching in my legs has increased and is significant, but not quite the storm that started on 3-13.
- 4-7 The twitching is fairly calm now. The progression of my weakness has definitely not stopped on this off cycle, but not faster than average. There does seem to be a correlation between the amount of fasciculations and progression. This is probably something that is well known one way or another by the doctors.
- 4-9 Start of cycle #6. Twitching at the start is light. The port is not getting a blood draw and is working slowly. They tried to clear it with chemicals later this day. That did not seem to make any difference. We are going to just go with it. There is an elevated concern of infection with a port with no blood return.
- 4-11 So far, there has been no particularly noticeable increase in twitching from just before the start of this cycle. This is unlike the last cycle. The explosion just after the start of the last cycle is something that gave me much concern over this drug.
- 4-13 Twitching has increased some, but is not at peak levels. Difficulty getting to a standing, knees locked position from my wheelchair is nearing the edge of possibility. Mussels are just starting to get a little stiff and sore. This soreness is the one thing that has been consistent and repeated for all 6 cycles. All else is a bit muddled and hard to know for sure.
- 4-17 I was hoping that I could make this as scientific as possible. Obviously, this is not. Perhaps, rather than giving a self assessment of my progression rate, I should have just measured and posted my abilities, day by day. That would have been tricky, time consuming and hard to decipher, however. What I would say is, I am generally less happy about the take away of my abilities towards the end of the ten days of taking the medication than I am towards the end of the 18 days off the medication. Obviously, one (including me) would think that my happiness is so influenced by the act of taking the meds. I would say, however, that with my port, self administering the drug has turned out to be an easy routine that is not particularly unpleasant, as I read the morning paper, etc.
- 4-18 Last day of infusion for cycle #6. I have now been on Radicava for the length of the Japanese study. The future for me lies beyond the data set, for better or for worse, who knows.
- 4-20 Progression continuing same as before. Some twitching.
- 4-24 Fasciculations (twitching) has diminished and is very light. Difficult to make an assessment on progression rate on this short of a timescale. I am weak enough to be concerned about my independence.
- 4-27 Fascicutions are still on the light side, but the progression is continuing at a pace that is similar to any other. My knee buckled trying to stand out of my wheelchair, and I fell. Just standing, while holding on with legs locked is now a bit of a scary endeavor. I would say that when comparing on cycles and off cycles, on feels a bit more negative, but it is all rather inconclusive.
- 5-2 Planning on starting cycle #7 this coming Monday. If the progression feels faster than during this off period, it may be my last… but that is what I said last time.
- 5-7 Starting round 7. I am now going beyond the time frame of the original study. Port is working but very slow with a lot of back pressure when flushing. I am able to get the infusion done by leaving the flow controller at full open. Fasciculations are fairly light, as they have been the for the whole off cycle.
- 5-9 The fasciculations are getting a bit stronger. The port worked incredibly slow, taking many ours to complete the infusion this morning. Option Care ordered the chemicals to clear clotting, but it turned out that re-accessing the port with a new needle in a slightly different location completely fixed it, instead.
- 5-10 The strength of the fasciculations has most definitely increased in the last day. Although it is a difficult task to gauge progression on a two week schedule, it is not difficult to gauge the strength of fasciculations. After a positive direction for the first two cycles, all subsequent cycles have seen the strength of the fasciculations increase very noticeably a few days in to infusions. I must do more investigation into the known correlation of the two.
- 5-13 I fear that I may have found my answer on the correlation between fasciculations and progression. The progression in the last few days has been alarming. It has put me into a panic. My ability to stand out of the electric wheelchair (thus independence) is about gone. Of course this was inevitable, but the last few days has seen a fast and obvious change. It’s hard to know for sure what would be happening without the infusions, but my feeling is that this medication is now not helping me.
- 5-13 I AM SUSPENDING INFUSIONS (4 left in this cycle). I may restart if I can get some more positive evidence or feelings about it. This is a hard decision for me. I am anything but sure if I am doing the right thing. I very much want and wanted it to work, despite my skeptical nature.
- 5-14 Fasciculations has gotten a little less strong, but not gone. Upon doing much research and contacting the Clinical Educator for the drug, and the drug company itself, and reassurance from my doctor that fasciculations and progression rate is NOT directly correlated, I am probably going to start back up. I should still be pretty close to keeping with the proscribed schedule. Also a big factor in the decision to restart is my finding, through various professionals, that relatively few people are actually quitting the drug, or of the opinion that it is making them worse.
- 5-15 I have started back up to finish my cycle. Future cycles are still to be decided on.
- OK, let’s explore some possible reasons for my worrisome assessment: 1) I could be having negative feelings due to some preconceived prejudice against the drug (I personally don’t think so). 2) I could subconsciously be looking for something to blame my progression on, something that I could jettison in order to save myself (I personally don’t think so). 3) It could be random variation five times in a row. (There is a one in one-hundred twenty eight chance of five heads, or tails, in a row) 4) This drug has a stated side effect of “gait disturbance”. Even the doctors have not given me a good definition of what “gait disturbance” is. Perhaps the gait disturbance that they are referring to is caused by weakening of the legs, and possibly I have that side effect. (this would be plausible) 5) A stated possible cause of “benign fasciculations” is coffee. Perhaps I guzzle down more coffee than usual while sitting for my infusions (I somewhat doubt this is the cause, but possible) 6) The drug really is causing me trouble. (I take the statement from two independent medical groups in St. Louis, that others are generally not reporting this, as significant evidence that it may not be causing any harm) 7) I am just plane mistaken in my assessments. (don’t feel like it, but who knows.
- 5-18 Last infusion of cycle 7.
- 5-20 Fasciculations are less. Progression is continuing. If I accept that there is no direct correlation between fasciculations and rate of progression, then my negative feelings about this drug are lessened. The last couple of weeks have been disappointing. Progression rate has been strong.
- 5-27 I had my once every 3 month meeting at my clinic on Friday. My progression rate is about average for this disease. The vast majority of patients there, including the doctors, are feeling that Radicava has been positive. It looks like there is only a very, very low percentage giving up on it. This is enough positive evidence, new to me, for me to most likely continue my treatment. My next cycle is due to start in about a week. My fasciculations are firing at an average rate for me at this time.
- 6-3 Why am I continuing the medication? I am as scientifically thinking a person as anyone I know. My feelings have not been good, but I recognize that feelings are swayed by so much and who knows what would have happened otherwise (hence, the on cycle off cycle thinking). The limited scientific data is still on the positive side and nothing has changed about that. That is the frustrating part, 6 1/2 years from study start and 3 1/2 from study completion, and little new data. On the 18 days off the medication, the fasciculations continue, but at a very noticeably lower intensity. Of this, I am quite certain, even though it might likely be meaningless. Progression in the last week or so has seemed slow to not noticeable.
- 6-4 Start of infusions for cycle # 8.
- 6-6 Magnitude of fasciculations in my legs has increased, but that may be meaningless.
- 6-8 I’m starting to feel a little foolish in this endeavor in that I can’t produce anything that is at all definitive, and it comes across like I am simply complaining. My recent thought was to just stop thinking about it and just continue with the meds. I would like to quit worrying about it but in the last couple of days, I feel that transferring into my car has gotten noticeably more difficult (it was already difficult so the smallest amount extra is a problem). Fasciculations have calmed to normal levels.
- 6-13 Last infusion of round 8. Decline over the last ten days has been noticeable. To sum up how the fasciculations go: Off cycle, they are more consistent and continuous, but barely noticeable in intensity. In other words, more constant, but low intensity. On cycle, the fasciculations might occasionally totally disappear, but the amplitude, when it does fire, is much greater. In other words, less consistent, but stronger.
- 6-14 My decline over the last week has been very disappointing, even scary, fastest decline yet. In the couple of weeks prior, I had gotten happier, with the feeling that progression had halted and things were staying the same for a while. I sound like I’m just a complainer, but what the hell is going on man? I keep being told that cycle by cycle observation can’t tell you anything. How do they know that? What scientific study is that statement based on? I do want this to work, but I keep getting hit with this unsubstantiated problem, or feeling that my decline is accelerated when I’m taking the medication. View this paragraph through to lens that I am a little upset.
- 6-20 The amplitude, or strength of the fasciculations is less now. I would say fairly calm but not gone. I recently got a new van with a lowered flour and automatic ramp for me to drive my electric wheelchair into. I got it in the nick of time as the manual ramp in my regular minivan was quickly getting scary dangerous with my legs only being useful with knees locked and recently weak back and core muscles. I’m not thinking about the medication much now in the off cycle. That is very nice. That is also a possible influence on my feelings. I probably think about it more while taking it, which is possibly unfair to the drug, but also a negative side effect in its own right.
- 6-22 I had four occurrences of high amplitude fasciculations in one leg.
- 6-23 Decline is definitely marching on. Off cycle, or on cycle as of late.
- 6-26 Well, it’s that time again. Time to decide on whether or not to continue with my next round of Radicava infusions. My purpose for this blog was to log my experience, in order to not waste an opportunity to possibly learn or discover something. What have I discovered? Fasciculations are positively stronger a few days into infusions. After that, nothing definitive, provable or for certain. I do have an unhappy and desperate feeling about my decline, more often during the infusion process (several days delayed on both ends). At this time, I am more inclined to trust the science and attempt to discount my feelings. Are most drugs tested by just one study, and if the result is positive, that’s it, we’re done? They say that they stopped the testing for humanitarian reasons. Does that mean that no further blind studies are possible? Does the manufacturer have any financial incentive to pure more money into it and possibly upset the apple cart?
- 6-27 I think that desperation (I don’t actually feel that desperate) tends to make you want to do something. You never hear people say “don’t just do something, stand there!” Often times, standing there is the correct move. I wonder if I am falling prey to this natural human trait. I think that likely, I am.
- 7-1 Decline over the last 18 days has definitely not stopped. I am on the struggle buss to remain independent but still making it work. Has the decline been faster or slower than during the ten day infusion cycle? Difficult to tell. I would not say faster. Ten days on seems equal to 18 days off but so hard to tell. Fasciculations continue but seem less and their amplitude is less.
- 7-2 Starting round 9 of infusions.
- 7-4 Fasciculations are stronger now. They were never completely gone, but a few days ago, they were weak enough to easily ignore. There is no ignoring them right now. As I have been told, this may have nothing to do with rate of progression, but something is different while taking infusions. PS, happy 4th, beer me.
- 7-5 Fasciculations are calmer by the end of today, much like a few days ago.
- 7-7 Unhappiness due to the perception of quickening progression, has increased. I deaccessed the port to take a few days off due to a weekend vacation and unhappiness about the last few days. Always the tug of war between science based evidence and negative personal perception.
- 7-13 Five doses are still in the box. I am just plane happier when I am not taking the drug, and fasciculations are less. Fasciculations are light now. I suppose that I am making my decision by procrastinating now. I have been completely compliant with the schedule up until now.
- 7-17 There is a likeliness that our brains equate the strong twitching with rate of progression. I try to keep this in mind, but can you really? It’s not as if the fasciculations completely go away when off cycle. It’s not as if I can be sure that progression is any quicker when on the medication. Far from it, quicker progression is a just feeling that I have, with no proof worthy of directing others. I don’t want anyone else to make a major decision based on my feelings of progression rate. I have become aware that the downside of taking the medication extends beyond the hassle of infusions. I have been lucky, and it has gone well for me, but keeping the dressing attached and the port clean in these hot humid conditions, has been tenuous at best. The only other ALS patient that I know personally, spent time in the hospital with a blood infection. Accessed port has kept me from doing things on rare occasions.
- 7-29 Though fasciculations are less powerful, progression is still marching on in this off cycle. Despite my best effort, I realize that my assessment of the drug by comparing on cycle and off cycle has reached no reliable conclusions. Always on the fence but I feel that it would be illogical to let my feelings overrule the sample done with the scientific method. I have decided to continue treatment for now. It is more likely than not that Radicava is doing it’s job and slowing the progression. There just is no way to tell. I will also probably post less in the future, unless I learn something new. This is for two reasons. I don’t want to waste everyone’s time with speculation that could be influenced by emotions caused by increased twitching. I also have become aware that MT Pharma is reading this blog and has contacted my doctor and clinic about what I write here. I don’t know what to think about that.
- I do appreciate the research efforts of the companies, doctors and patients in the struggle to understand and cure diseases. I realize that there is always much trial and error. My frustrations are thus: Despite more than 3 ½ years passing since the conclusion of the one positive sample of 68 patients on Radicava in Japan, I have heard of no concerted effort to corroborate the findings. When I talked to the representatives for Radicava, they gave me no new useful information, but alarmingly, they did give me a sales job. They informed me that ‘no, it was a much bigger study than that, it involved more than 300 patients but most were disqualified for various reasons before starting the double blind study’. C’mon man! You could say that the study involved 7 billion people but most were disqualified because they didn’t have ALS. It’s still just 68 patients on the drug. I did not feel that this sales job looked good for the process.
- The one double blind study only lasted 6 months. I have now been on the drug for 9 plus months. The drug company seems surprisingly willing to extrapolate out the results. Something that provides a benefit for sixth months is not necessarily going to provide a benefit indefinitely. The drug company holds that anything that is not proven in a double blind study is not worth much, yet seems not to start any new ones, and is happy to extrapolate the results well past the length of the one study.
- 7-30 Start of round 10 of Radicava infusions.
- 8-6 Only after 7 or 8 days has fasciculations grown a little stronger, and only slightly at that. Rate of progression is not changing in any knowable fashion.
- 8-8 Last infusion of round 10. I am now having much difficulty transferring as my arms are weakening a lot, seemingly a bit more quickly over the last few days. This has been coming for some time but the last few days is putting me over the edge. The fasciculations in my arms has increased in the last few days. There have been almost no fasciculations in my legs, which is probably due to the fact that my legs are almost completely gone now. If I don’t grab them and move them with my hands, they aren’t moving. I must sound like the biggest whiner and a very unappreciative person. My problem is that my feeling is that the takeaway over the last few days has nearly equaled the takeaway over the previous 23 days of off period. I realize that my methods and feelings are unreliable, but that’s the way it is.
- 8-22 Fourteen days since the end of infusions and my ability has not changed much since then. I know decline is continuing, but at a slow enough pace, one can kind of ignore. Fasciculations are now mostly in my arms and core now (used to be legs). They are somewhat constant, but rather light.
- 9-3 This off period has been longer than usual (26 days off) due to a vacation to Alaska. I need complete assistance getting on and off the plane with an isle wheelchair provided by the airline. I am sure that progression is not stopping, but I can not perceive any significant change in the last few weeks. Fascicualations are light and only rarely noticed.
- 9-4 Start of round 11. getting closer to one year of infusions. Being that this has been an unusually long off period, coupled with the progression feeling slow to not existent lately, and fasciculations definitely being light, this cycle might provide me better insight for my decision.
- 9-9 Same old, same old. Fasciculations have increased, though not at all extreme. Things just feel just a little faster now. Is that clear to me? No. A trip to Alaska towards the end of the off period was a challenge, but we were able to get it done. Getting dressed on my own is recently getting nearly impossible. Of course this was coming either way but not that much changed in the few weeks prior. All just vague feelings with no data.
- 9-10 Fasciculations are going strong now. Arms and now chest muscles.
- 9-11 Last night, the fasciculations in my right chest muscle was so strong last that I had a hard time sleeping. The chest is new for me. The decline is slowly making it’s way around my body. Always fasciculations first, then that particular muscle slowly goes dead. I suppose that it is hard to mentally disconnect the two.
- 9-13 Last day of infusions for the 11th cycle/month. Fasciculations have calmed down now to fairly normal levels.
- 9-21 Fascicualation in my upper arms has been average to slightly above average over the last week. Self transferring from chairs is very difficult and tricky. My opinion on the drug is inconclusive at this time. It always has been, I’m just a little more ambivalent now.
- 10-1-2018 Start of my 12th round of infusions. 12 rounds! wow time flies. Fasciculations are fairly light at this time.
- 10-8 Fasciculations in my arms have been stronger over the last few days. My arms also feel tired and a little sore from doing transfers. No noteworthy changes other than that. The comment recently left on this blog has peaked my interest. This is something worth looking into.
- 10-10 Last infusion of the 12th cycle.
- 10-11 The last week has seen a noticeable slide and life without help is no longer possible. I am not blaming the progress of the disease on the medication. Many cycles, but not every cycle, a noticeable amount of progression seems to occur nearing, and just after, the end of the infusions.
- 10-17 Fasciculations had been calming down in the last few days but last night and this morning saw a medium strength burst of them. There is always a number of days delay in the changes from on cycle to off cycle. This is 6 and seven days out though.
- 10-19 Reasonably calm fasciculations.
- 10-23 My slide in progression in my arms over the last few days has been noticeable. I usually do not notice this increased rate at this point in the off cycle. This is the kind of increased rate that I usually seem to notice towards the end of the ten days of taking infusions.
- 10-25 Trying to decide whether to continue taking Radicava infusions continues to be a struggle. There is still a lack of new scientifically collected data. Should I just get over it that the drug company, MT Pharma, is not providing any new study information? What is the financial incentive for them to hurry? The drug is approved. At this point, from a purely business point of view, further study only poses a risk. We must keep in mind that large drug companies are subject to all pressures of success as the rest of us.
- 10-28 Progression is continuing but it is slow. Fasciculations are light yet existent.
- 10-29 Start of Round 13 of Radicava infusions. It was such a toss up as to whether or not to continue. The tendency is always ‘give it one more try’.
- 11-2-2018 My personal trial of Radicava has come to an end. The factors affecting my decision are:
- My own personal misgivings of how the drug was affecting me (I kept trying to push this aside because I am generally a fact based person, but most cycles kept bringing me back to this).
- I recently learned that there actually was a trial of Radicava in Japan, years before ‘the trial’. That first trial did NOT return positive results.
- I recently learned that while the people in ‘the trial’ that were on Radicava did a little better than the placebo group, both groups did worse than would have been expected. (it is possible that getting infusions of any kind are not good for ALS)
- I mistakenly made the assumption that MT Pharma must be performing new studies on Radicava, and I have been complaining that they were not moving fast enough. I recently learned that MT Pharma is not performing any new trials on Radicava and probably never will. It’s been approved.
- I have learned that some top clinics are no longer prescribing it.
- I will continue to log my post medication experiences on occasion, when I think that there is anything noteworthy.
- 11-14 The strength of fasciculations are a little more consistent while off the medication. They range from light to a little worse than medium in strength. Not much has changed since ending infusions. Progression rate feels about the same. It certainly is not stopping, of course. It’s mentally a little more pleasant for me to not be thinking about it and trying to decide any more.
- 11-18 My arms are weakening at a rate that is not any slower than before. Change is noticeable over the time span of one week. This is pretty consistent with the past.
- 11-21 Because of my weakening arms, I have crossed new milestones over the last week or two. I can no longer get in or out of bed by myself, transfer off the toilet myself or dress myself (unless I put up an exhaustive fight). Has the rate of decline increased since discontinuing Radicava? Perhaps, difficult to say.
- 11-30 Well, I’ve screwed up the experiment. Not that it that it was much of an experiment to start with. Since progression has been at least as fast, if not faster recently, I decided to use my six remaining doses, starting on the 26th. When one is lacking good information, you do the best you can. I think that my opinions and assessments are as accurate as humanly possible, but I have not come up with anything worth swaying others. I gave it my fairest assessment though. I’ll keep my log going for what it’s worth.
- 12-13 Fasciculations are extremely light to non existent, and have been for a while. Progression is continuing at a steady rate, perhaps every bit as fast as before, perhaps even faster. Who knows. The only thing I know for sure (reasonably) is that Radicava increases fasciculations.
- 1-3-19 Progression is continuing at least as fast as before. It could even be faster, difficult to say. Makes one wonder if I made a mistake, but there is no way to tell.
- 1-27-19 My feelings on Radicava have become much more muted now that I am not getting 1) stuck by needles and getting courses of daily infusions, and 2) Not asking, and thus hitting a brick wall, about any new data on the effectiveness on the drug. I would say that my progression since quitting is at least as fast (sometimes I wonder if it’s faster) than when I was on it. I even wonder if it would be wise to start back up. Therefore, I would not count my one experience as any kind of proof, or even evidence, either way. My frustration is still the same subject; Thousands and thousands of patients on it for well over a year, at hundreds of millions of dollars to insurance companies, and not a peep from the drug company. My expectation now is that there never will be. It’s disappointing to think that all new data will have to come from others. In my search for new study news on Radicava, I found something due out soon. Doctors following a group of 20 patients in Iran. This, strangely, made me laugh.
- 3-19-19 On March 8, I had my, once every three month, ALS clinic visit. At each visit they do a questioner about life task functioning, called the ALSFRS. My scores through time have been:
- January 20, 2017………… 45
- February 23, 2018……… 38
- May 25, 2018………………. 35
- September 14, 2018…… 32
- December 14, 2018……. 32
- March 8, 2019……………..31
- June 14, 2019………………28
- september 13, 2019…….27
- December 13, 2019……..17
- February 28, 2020……….16
- 6-8-19 My arms continue to weaken. My grip is fairly good, but I can’t reach out very far. Speech is good. Breathing is weak but seems rather unchanged from a few months ago. Again, progression feels rather consistent in pace. I need complete assistance when not in my wheelchair.
- 6-14-19 Once every three month ALS clinic visit. ALSFRS score, 28.
- 9-13-19. Once every three months ALS clinic visit Alsfrs score, 27. Although it feels like the decline is more than just one point
- 12-13-19. By far the fastest drop yet. 17 on alsfrs, 32% lung function.
- 2-28-20. Alsfr score 16. Respitory tharopist did not feel it good or necessary to measure lung function anymore.
- 9-27-2020 Well, I’m still here. I do need twenty -four hour care though. I have no idea whether Rodicava was helping me or whether I would be better or worse Off now had I not stopped taking it one year and ten months ago. What I do know is this: for the last year and ten months I have not had to spend many mornings waiting for an iv bag to finish dripping into my recently accessed port.
My Opinion of Radicava At This Time:
I do not know whether this drug works or does not work. Do not take any of my observations as proof of anything, pro or con. I feel that it is clear that this is not a wonder drug that will save you. To be fair, it was never marketed that way. I do feel like some of the excitement that many were caught up in at first may have been overdone. I appreciate MT Pharma for developing and giving us this option. I very much encourage them to continue looking and sincerely wish them the best of luck.
I realize that medical progress is slow and trials take a long time. I see that it is a daunting task, especially for a treatment resistant disease such as this. The trouble with a fast regulatory approval, as this drug received, is that you have many thousands of people getting regular intravenous infusions, with all the troubles that infusions cause, for the remainder of their lives. We should be pretty clear that there is a benefit before subjecting people to this. First, do no harm.
Following is a recent paper published October 29, 2018, from Canada. It is worth considering.
Health Insurance: I just had a new lesson in health insurance. For decades we have payed for good health insurance. For many years now, it’s been with United Healthcare. We have a small family business and good insurance is important to us. Turns out, however, if you get something long term and serious, one can not keep their company coverage. If you can’t work, you can’t stay on your company plan, that’s the law, even if you are willing to keep paying your premiums. You can continue paying for your plan under the COBRA rules, but after 18 months that’s done and the insurance company can tell you “don’t let the door hit you in the ass on the way out”. I suppose I can start looking into the Obama care exchange, not what I wanted. I wonder how many Americans know about this.
My Struggle To Get Knowledge To Make Good Decisions: (old) It may seem like I am criticizing Radicava. That is not my intention. I was cautiously skeptical at first, before it became available. Just before I started the medication, I became very excited and hopeful that I will respond extremely well and that progression will slow to a trickle. I can be an optimist and have high hopes just like anyone else. Seven months later, that optimism has evaporated. The only question now is, would I have progressed even faster without it? Unknown. The smart money would bet on taking it, which I am continuing to do. My intention is to try to figure out the effectiveness so that I can decide whether to continue. The data seems extremely thin and I am getting absolutely zero information from anything post original Japanese study. It does not appear that any scientific data has been released, or perhaps even collected, since the original study. I suppose I want answers too soon, but 6 months, or years, is a hell of a long time to be getting infusions and not have any handle on whether it’s helping, hurting, or doing nothing at all. I would not be so conflicted if my unsubstantiated feeling of it’s effectiveness was better.
They say that they don’t know how this drug works. It’s all based on the one small blind study. Therefore, below is the chart of the results of that study from inside the sealed box of medication. It is worth looking at closely.
Has anyone else noticed unexplained sore and stiff muscles during treatment cycles?
The first cycle was done with peripheral IV’s. They always flushed well with the saline. The medication started well, especially on the first day the IV was installed. Then, during the hour long infusion, it would slow down.
By about the third day of the IV, the saline flush would be OK, medication would start, but by the end of what is supposed to be an hour long infusion, I would have the bag up at the ceiling and be massaging the arm and vein to get it complete. The vein would feel stiff and tight as if it were swelling shut. Days later, there were no residual effects to the IV site.
Now I have a “traditional” port for the second cycle and beyond. Infusions with the port went well. With some retaping, I was able to leave the port accessed for the whole 10 day cycle, thus having only one needle insertion. I diligently did not get it wet. Showers are overrated.