Monday, April 28, 2014

Sleepy Days, Updated

On Day 19 (two weeks after my last Lemtrada dose) I began to feel very sleepy. This sleepiness was different from the fatigue I am used to with MS. I actually took a nap in the middle of the morning after sleeping 9 hours the night before.

I did swim that night (Friday) but I was so tired Saturday that I didn't swim (rare for me- if the weather permits, I love to swim). I had to push myself to swim on Sunday. Today I am a bit better, not as sleepy- more like the MS fatigue I am accustomed to.

So- Why?

I think I might have stumbled upon my answer while talking with my sister Sunday afternoon. She said it sounded to her like how she felt during her two pregnancies as her body was using energy to make more cells than usual. (I have never been pregnant).

We postulate together that this sleepiness may be related to the increased activity of building new WBC and other immune components that were wiped away with the Lemtrada treatment. This is only our guess but it 'sounds right'.

She encouraged me to blog about it- so that others might know to expect this in their Post-Lemtrada weeks. So here it is. I don't really know what it means- but it is the reality of the past few days.

Confirmation

My dad sent this email commenting on this blog- I guess I come by this reaction 'honestly' (genetically)

"Subject: Pregnant make you Tired? Yes.

Read your blog.  Just so you know, when your mom got pregnant she went into hibernation.  Especially with your brother.  She would drag herself home from teaching, eat a little dinner and go directly to bed. Really up set poor FB (our German Sheppard, short for Financial Burden- he was a Christmas gift).  He would go to her bed and then come up to me and whine.  He Got over it after a week or two but for me it was like being a bachelor for nine months. "

I love my family and appreciate the support from all of you!

Update 5/1/14
This fatigue has been compounding day to day. Previous to this week I could feel each swim was easier and I was building endurance with each workout. But this week I seemed to be slipping backward in the fatigue department more and more each day. Instead of feeling better after each evening swim it became a great effort just to finish my regular swim. 

Yesterday was my birthday, so I decided to take the whole day off (I can hear all the people cheering who are always telling me to slow down- you know who you are!). I didn't log in to work from home, I didn't clean or cook. I didn't even fold laundry! I read, took care of our 'boys' (4 chihuahuas) and generally rested. 

Today I feel much improved. I think most of this recovery is about listening to your body each day. Do what you can, but don't push yourself. We all know this as people living with MS but a reminder from our body- or a friend- is a welcome wake-up call. 



Saturday, April 26, 2014

Week 3, Pleasant Surprizes

I have been home for two weeks- one week resting and this week I went back to work- full time! (I work from home, but still didn't think I would be working full days so soon).

Acknowledging things that aren't happening

You know when you have a headache, take Motrin and then don't really realize the moment the headache went away- just a few hours later, someone will ask- hows that headache?, and suddenly you realize it has resolved?

A similar thing happened to me this week. In the past years I have been experiencing 4 annoying but tolerable minor symptoms:

Numbness/Tingling in my toes- this sometimes kept me up at night and was very unpleasant

Random muscle spams causing my limbs to "jump"- no rhyme or reason to the onset or resolution

A continuous muscle twitch on the inside my left ankle between the ankle bone and heel- very annoying, nothing seemed to resolve this, although tried many things. This would also keep me awake.

Sudden retraction of my toes toward the sole of my foot- Very painful and required me to actually pull and hold my toes in the opposite direction for this to resolve and sometimes that did not work.

I realized yesterday that I have experienced NONE of these symptoms since Day 1 of Lemtrada infusion! Not even a hint at these. I think it is important to 'take stock' and give thanks for the blessings in life that you weren't even praying for! What a blessing this therapy has been already.

How the Week Went

Last week I reported 'boundless energy' after a week of convalescence and had just started to swim last Friday. Well I found something to do with that energy and its isn't so boundless anymore!

Exercise

I was able to swim on 6 of the last 8 days. And all these were 'full swims'- I have an exercise routine that takes about 40 minutes and on every occasional did all 100 laps. I could also tell yesterday that my endurance is increasing, as I need to take fewer breaths between strokes. I am very thankful my husband built me a lap pool with solar heating or I would not be swimming this early. Recently the pool temps have been in the low 90- actually a bit hot for a work out, but good.

Helping out around the house
For many years, I am sad to report, I have not been that useful in the household chores. I could do small things but never for great amounts of time. This week I decided to take my lunch break and tackle one area of the house at a time- the kitchen, the living room, laundry- My goal is to honor and acknowledge all the work my husband has been doing for us both over the past few years when things got bad. So when he gets home every day there is a pleasant surprise waiting form him- household work that doesn't need to be done.

Those things pretty much used up my 'boundless energy' but I fell wonderful being able to do them. I fully expect my capacity to increase in the coming weeks and months and look forward to helping out even more. Being sequestered so I don't catch any disease has actually worked in my favor- allowing me to start small with the energy expenditure in a targeted way. When I am able to start going out in public I will have the energy to do so!


One Opportunistic Infection

This week I experienced what is called an "opportunistic infection"- a common pathogen is able to gain ground and cause problems because of my decreased immune state. If I was not immune compromised due to Lemtrada this would not have happened.

Oral Candidiasis

On Saturday evening last week (so I had been home a week) I noticed a 'fissue' or gap in tissue on the left side of my lips at the crease. The area was red and slightly painful. This could have either been an atypical presentation of a cold sore or a fungal infection common to babies (who also have a suppressed immune system).

I had anticipated this problem and had Nystatin Oral Solution (available by Rx) on hand. I continuously swabbed the area for about 3-4 hours until I went to bed. The area was resolved the next morning with no other problems confirming this was a yeast (fungal) infection.

I recommend having Nystatin Oral on hand. The yeast that causes this infection is on everyone's body- very common- but does not cause problems because our immune system keeps it in check. I was fortunate to have the Nystatin on hand to treat immediately. If I had to wait to see a doctor it would have worsened and been more difficult to treat.

Goals for Next Week

Get Labs!!! This one I am especially excited about. They are not due until 5/5 but I am going to have them done 5/2 because Fridays are easier for me- the office is closed. This will be my first lab draw post therapy and I am very interested to see where my WBCs and T and B Lymphocyte levels are.

Swim Every Day. Sometimes the weather doesn't allow this but with a pool just out the back door (thanks again to my wonderful husband) I am able to sneak in around bad weather and swim most days.

Continue to Clean the House. I have a list of small jobs I want to get accomplished on my lunch hour so I will tackle those this week. I have also been routinely helping with dinner prep and clean up- something I was not able to do in the past after a full days work. I am so thankful to my care-giver husband, and I still rely on him a lot, but I want to do more so he can do less and the household still runs smoothly.


Turn 40. This one is the easiest of the goals. Time kinda takes care of this one. On Wednesday I will be 40 but I am feeling much younger with all these new activities. Thankfully I cant really celebrate the dreaded 40 due to the home-boundness. I will still have to start getting mammograms now... but I am keenly aware that my life is on an upswing this birthday- and so thankful for it!

I wish to thank everyone for their prayers during this time- especially the travel. I was very worried about catching something on the plane or in the airports and that didnt happen. One of my husband's co-workers came down with a stomach bug this week but he took precautions (no hello kiss upon his return, but directly into the shower). We both dodged that bullet.

I know I would not been where I am with the help and prayers of so many people- more than I can thank here. Please know that I appreciate all you have done on my behalf and I have really felt blessed going through this process.

Love to all!

Friday, April 18, 2014

Week 2, Home and Better than Normal

I returned home Saturday 4/12 with a lot of fatigue and jet lag. The journey was smooth except for the transition through Frankfurt. This airport's layout and confusion would not be tolerated by the domestic US population. I would advise avoiding this airport for international travel.

On Sunday-Tuesday I took to bed for most of the day. I was tired, jet lagged and still experiencing lower leg swelling from the steroids. Steroids also give me a fever/chills experience (not actually running a temperature) that lasts until the exogenous steroids are out of my body and my own adrenal glands take over the task of endogenous steroid production.

Wednesday I was a bit better an logged into my office from home to work a few hours. Just two hours seemed taxing (sitting at a computer) and I returned to bed.

Thursday & Friday were much better as my edema and fever/chills symptoms of the steroids resolved.

I am doing really well overall. I just have to remember not to jump up & overdue things or I get easily fatigued & a bit nauseous. But I think this is me not taking my own convalescence serious enough. 

I can tell this therapy is going to turn back the clock on my fatigue. I am already seeing glimpses of that- in that I think- "I will jump up & do that", see above for consequence- but I think this is a Great development. Before this month I wasn't even thinking about extending myself. I joked with my husband today about how far that MS clock will get turned back- 2012, 2010? I'm ready to step in my own 'way back' machine- into a life with less fatigue!

We are both still strangely jet lagged. My wake up time went from 8:30 prior to the trip to 6:00- and I feel refreshed, maybe this is part Lemtrada too. 

My preferred exercise is swimming in our lap pool but so far the weather is not cooperating- colder nights than usual and cloudy days that dont allow the solar heating to work. Hopefully I will be swimming daily in 1-2 days. I can't wait to see how that feels! 

Even today I think I feel better than when I was on Tysabri at the beginning of the year- and I really liked taking Tysabri. my titer and months on therapy were just too high a risk for me. Now I have to sort out fatigue from lazy- and push myself to get the rest of my house in order!

I really am feeling & believing in new beginnings here. Every day brings new energy and new hope!

Sunday, April 13, 2014

Travel Tips

#1- Bring your own favorite pillow! For the plane, hotel and infusion. European pillows are thin and not very supportive. Only one improvement I would make is to have brought extra pillowcases to exchange them out for fresh ones.

Avoid Frankfurt Airport
If at all possible avoid using the Frankfurt Airport- it is very disorganized, under construction and dirty. You have to go through security several times. Also most of the planes do not park at a gate, rather on the tarmack and you are bused (or if first class, taken by private car) to the main terminal.

Instead, try to make your transition through Canada or the UK, then direct Dresden from there. Changing plans in an English speaking airport must be easier. The Dresden airport is a breeze- you just pick up your bags and walk through the doors say "I have nothing to declare" instead of "I have items to be declared". after walking through door #1 you walk directly to your cab- easy.

If you do go through Frankfurt- call ahead for a wheelchair (even if you dont think you need it) but also remind your flight attendants that their should be one waiting for you. This will help you immensely through Frankfurt. You will go though immigration at Frankfurt but not pick up your bags until Dresden, where you 'go through' customs- just the door.

Hotel:
In Dresden I would highly recommend Swissotel: http://www.swissotel.com/hotels/dresden/ Everyone speaks English- we found Julia the most helpful. The hotel is very close to a US experience. You do not need a hairdryer- its provided and mine ran 'hot' if I tried to use it, so I just used theirs. You have a microfridge in your room but will have to ask for ice in the lobby. Customary toiletries are also provided along with a coffee pot and tea pot.

Sign up (for free) to their rewards club and internet is free your entire stay via wireless. This was helpful. We did not even try to get a local pre-paid phone or other internet. The clinic staff check their emails often so if I wanted to contact them after hours (I never had any emergency) I just sent an email- ie- we might be 15min late tomorrow, etc.

The hotel is also within 'MS' walking distance of many nice restaurants, shopping (including supermarkets) and the trains. I can send you some of our favorite food spots.

The Trains
Ava and her husband took cabs to the clinic every day but my husband and I decided we wanted to try the electric trains and really enjoyed using them. It is a short walk from the hotel to the main area where all the trains converge. You hop on train 12 and it drops you off in about 15 min right in front of the clinic. We used them for dinner excursions as well.

Converters & power cords
I would definitely recommend bringing about 6 outlet converters and 2 or so extension cords (that split into 3 extra outlets at the end) to plug in all your 'i' devices.

Comfort at the Infusion Center
The infusion room is nothing like you will have experienced in Tysabri like centers. We each had a narrow bed in the same small office (actually Dr. Ziemssen's personal office). A few times it felt like close quarters when we had visitors but overall it was nice to be near Ava & talk about how we each were doing. Teresa, our nurse, was with us all the time.

Ava and I did switch beds daily so that our IV arm on the outside was switched everyday. Our husbands went out daily to get us a light lunch from about 3-4 places that are very close by. I never visited these establishments because Ava and I would be hooked up this whole time. It is definitely nice to have someone who can run this errand for you- the food was fresh and good.

Please email me directly if you are considering some of these options and I can go into great detail- I just wanted to provide an overview here.

Home at Last, last few symptoms

We arrived home Saturday, just bush tired- even my husband, so its not just the MS.

A few strange observations:
The puncture sites for all the IV access are 'different' from what I have experienced with blood draws or Tysabri infusions. The access points appear almost as a bite mark- just a simple hole with no surrounding redness. I treated all of them with antibiotic ointment and bandaids and they seem to be improving. The strange non-healing appearance is probably based on the lack of immune cells, but this is only a guess.

Bloody nose/sore throat
Yesterday after returning home I experience bloody discharge from my nose. I attribute this to the dry air in flight as well as the drying effect of steroids.

I began to experience a slight sore throat the last 2 days in Dresden. This was Much worse following my first night at home. This also can have the same cause as above. Also- I have a history of chronic sore throats. So this may be specific to me.

The Taper
Tapering the steroids was a good idea. I am not having too many withdrawl side effects there. Here was my regimen:
1gm/day x 3 days- this is the protocol
Thursday 500mg IV
Friday 250mg IV
Saturday 100mg given before checking out as an IM- Intramuscular injection (anyone could do the same with an oral dose)

I had some adrenal pain (glands that sit on top of the kidneys and normally produce the steroids your body needs) on the plane but I found a heating pad on my back last night and today took care of the rest of the discomfort.

I slept well but woke a bit early. Today is completely a 'veg' day with nothing on my to-do list!

Friday, April 11, 2014

Update on Countries 4/11/14, final Dresden thoughts

Just heard today that Mexico is still not infusing and their grasp of the protocol sounds shaky at best.

Canada is also not yet ready.

The next infusion dates in Dresden will start in May. Easter is a four day weekend here- Friday & Monday off, hence the May dates.

Treatment is finished & my husband & I had a nice upscale Mediterranean dinner and are already tucked into bed & packed. Dresden has been a great experience, tiring but so very successful- all the side effects I was worried about- rash, headache, nausea- never really materialized. Honestly this surprised me. I expected things to be harder.

I am super tired but that is usual. I can't wait to get from Dresden to Frankfurt tomorrow & step on that non-stop flight back home!

Thank you to everyone for their support and encouragement- and most of all your prayers. I could feel the comfort of so many hands reaching out to support me through this- from Teresa's very tangible nursing care to the metaphoric ones coming from you at home.

I am so excited to see what these next few months hold- I have a goal to meet Dr. Ziemssen in Boston at the ECTRIMs conference in September where he will be speaking. So in the next 5 months I am anxious to do my part to improve & show him the success he brought about by opening his heart & clinic & taking a chance to treat a patient he had never met!

And we are done!

Today was our best day yet- and not just because it was our last day. As our bodies eliminated all the cells that were destroyed on Monday we felt tired on Tuesday and Wednesday. Thursday was better but today we felt almost normal.

As a result of the medication I became slightly hypertensive and Ava became hypotensive. Neither was a problem and both are expected. We just joked that we should average our BP #s and then we would be perfect.

I definitely saw improvements in Ava's mobility over the week although she downplayed the change- it was very apparent to me. I have not had any pain issues this week, some fatigue, and it is really too soon to know about my cognitive changes.

It is very surreal to think we made this long trip, took this drastic step and now are so Very Hopeful about our future. Dr. Ziemssen recommends an MRI in approximately 6 months and would like us to keep him informed of our lab progress.

Today a psychologist- Dr. Kern- came to speak to us about alternative therapies for MS. She informed us that even if MS patients are not depressed they seem to benefit by taking SSRIs (type of antidepressant, Prozac is an example) on the oligodendrocyte level (these are the cells that produce myelin). Melatonin is also recommended to aid in sleep when the mylein is being produced.

She further discussed "Oxidative Stress"- this occurs naturally in all mitochondria (a part inside each body cell) but in MS patients (and others, such a parkinsons) the patient does not seem to be able to clear the byproducts of cellular energy and growth. She recommended 4 dietary supplements (Vitamin E & C, Selenium, L-glutathione) to help with this- along with exercise & a healthy diet.

She also recommended finding a US psychologist trained in 'mindfulness'- a type of centering therapy that leads to less stress. This therapy was invented in the US and she informed us this should be easy to find in all of our metropolitan areas. I have articles on all of these topics and will post them when I get home & scan them.

This talk was very impressive to me- to see someone so excited about looking beyond simply the model of MS as an autoimmune process- to look at other issues in our bodies that we can take different actions against and improve our overall health.

Again I stress how impressive this clinic in Dresden truly is. Please understand that although the cost of the medication is high, the clinic makes nearly nothing on providing treatment to you. Some other centers are more expensive but Dr. Ziemssen is entirely patient focused and wanted to make the treatment as financially feasible as possible. Every person we worked with bent over backward to help with our stay.

I believe it was a bit of a stress to incorporate our care into their already busy clinic schedule but they never let on this was any kind of imposition. I am so impressed with the German people as a whole. I feel so welcomed and loved here. I have a new appreciation for my German friends & their beautiful country!

Please send any questions or comments you may have. Going forward I plan to post at least every 4 weeks to update the progress of my labs (first draw set for 5/2). If anything happens before then I will post that as well.

Best of Luck to you in your journey to conquer MS- I feel Ava and I have made great strides in that direction this week!

PS- Last night I was on television here and tomorrow I will be in the local paper. They dub all non-German voices on TV and the article will be in German so I didn't post those here.

Thursday, April 10, 2014

Info from Stephen, husband of Ava

Stephen responded to a joint conversation he and I are having with Helen in the US. She is trying to decide where to get Lemtrada and what pre-testing she is most comfortable with. She is Tyabri experienced with a positive titer. She knows she needs an MRI to rule out PML but is curious if a lumbar puncture (spinal tap) is also necessary. I heard Dr. Ziemssen tell us this news but Stephen summarizes it well here.

Stephen writes: 
I think many of your questions are similar to those I had, which unfortunately there are not definite answers to yet. Ava's EDSS is 7-7.5, and she has had this now for greater than 20 years, most of which were without therapy. This treatment had poor results in the early trials in SPMS and PPMS in the early 90s (read the excellent long history of Campath online), which is why they have so fastidiously focused on RRMS. That said, a few SPMS patients did make it into various trials, and a few found benefit, so we are here on a leap of faith. 

Emma here- I too believe it is a leap of faith, but one grounded in fact. Please keep in mind that your international doctor is taking the same leap of faith- he does not know you or know how informed you are- please take the time to study the drug, speak with your US neurologist and understand the strict monitoring required of you if you decide to proceed with Lemtrada.

As for long term monitoring- per Dr. Ziemssen: 

The peak of ITP (see previous post for explanation, this a a bleeding disorder) is after 2nd year, decreasing thereafter.

The peak of thyroid (bell-shaped curve) is after 3rd year (assuming annual dosing), decreasing to baseline by year 5. 

Longer term results are wholly anecdotal, and it is likely all early adopters will serve as guinea pigs for later users, and will be monitored for longer than necessary for safety concerns until we have harder end points on when baseline risk is achieved ( if ever). In fact there is a current US clinical trial that continues to monitor Lemtrada treated patients long term.

We asked Ziemssen, and he will continue to monitor his patients for time being (some of his patients are at the 5 year mark), until further data is available. Also, anecdotally, he is a big fan of laquinomod, which is not yet approved.  He would like to share in the monitoring of our labs from afar. Emma plans to send hers every 4 weeks.

Most recently Ava was on Tecfidera. We asked him about continuing on the Tecfidera now post Lemtrada, and he has advised giving the Tecfidera for at least 6 months, and more preferably a year before restarting Tec, unless breakthrough is intolerable. We plan to hault the Tecfidera at this time.

As for PML, he has seen more of PML than most (80 cases here in Germany), so I trust that when he says an MRI is sufficient to rule out PML in Tysabri treated patients I believe he is correct (a lumbar puncture LP or spinal tap is not necessary). Of note, no cases of Lemtrada-induced PML have been reported. Furthermore, I am unaware of any reports of MRI negative PML cases being diagnosed from LP. 

As for the therapy, I think the premed poly pharmacy, while necessary for preventing the infusion reactions, is likely at least in part to blame for the definite drowsiness we are witnessing this week in both Emma and Ava. But sleeping through the treatment and taking it easy in the evenings makes this completely manageable.

Dr. Ziemssen gave us these our daily oral meds:
Clairitin 10mg twice daily
Zantac 300mg twice a day
Acyclovir 200mg twice a day

We take these at the hotel before departing for the clinic.

At the clinic:
We are first given our Solumedrol
Then 2-500mg Tylenol
Then 12mg Lemtrada
Then a saline flush to run the remaining Lemtrada that is in the IV line with a short post-dose observation period

Emma added
Toradol 30mg intramuscular daily at the hotel as a pain preventive
Motrin for headache on the first day
Emma and Ava also used hard candies (cinnamon, butterscotch and strawberry) for the metallic taste that come with steriod infusion- we didnt need it every day but it was nice to have on hand.

Stephen discussed the clinical trial in place for Clemastine 4mg twice daily for remyelination. Clemastine is an old drug, with the brand name Tavist. It comes in 1.38mg/pill (or close to that) so you take 3 twice daily. It is sedating but if the clinical trial results bear out we will be targeting our oligodendrocytes to remyelinate our axons- therefore actually repairing our nerve function. So I have added this to my regimen this week (Stephen was gracious enough to provide me with some). 

I am determined to beat this MS and return to a more active and healthy lifestyle. My wish is that you all can find your path in this direction. 

Many Blessings!

Day 4- Still Going Well

Ava and I are 80% done- just tomorrow's dose and we are finished with our MS treatment for the whole YEAR!

I cannot put into words what an amazing experience this has been in Dresden. Before I came I did my research on Lemtrada and knew this was the route I wanted to take- the data on the strength of the medication was strong and I had to change my current therapy.

In investigating my options for foreign treatment centers, I could not have hoped for such a fine clinic. The staff are VERY knowledgeable and professional. Dr. Ziemssen (pronounced Zim-son) is an expert in his field. This week he flew to Frankfurt to consult with a clinic there infusing their first patient. His clinic is also running several clinical trials around Lemtrada therapy, sleep therapy in MS and cognitive issues.

Dr. Ziemssen also has a great bed-side manner. He is jovial and fun loving. His nurse, Teresa, is fluent in English and just a joy to spend the day with. She is very efficient and caring. She is working on a project of her own for the center, funded by Genzyme- it is a computer based monitoring system for Lemtrada infusion and follow up. She fields calls all day long from other German doctors about providing Lemtrada and the follow up required.

This clinic in Dresden is really Ground Zero for top quality MS care- and especially for Lemtrada!

The computer monitoring program Teresa works with is complete and is being released to centers throughout the world (at no cost) to help in the monitoring of patients during and post Lemtrada. Teresa helps work out the bugs in the system and teach other providers how to use the program.

For me personally today was very tiring. The infusion went well- I took 500mg of IV steroids and Ava took 1000mg (1gm) today. But the tiring part was the TV crew who showed up to interview me- I was up & down, walking the hallway, being interviewed, in shots with Teresa monitoring my IV, in shots with my husband discussing treatment, talking with Dr. Ziemssen about the next steps and a final few walks in the hall way ending with a joint discussion with my husband about why we chose Dresden and what our experience has been.

I was glad to do this for the hospital, it is the least I can do to thank them for the excellent care- but all the extra activity and long days are really taking a toll.

Tonight Dr. Ziemssen is takings us all out to a castle for dinner- Teresa as well. It will be hard to say goodbye to these people. They have become so vital in changing my future with MS. Dr. Ziemssen will be at the ECTRIMS conference in Boston Sept 10-13. I would like to travel to see him at that time to show him how improved I really am!

Ava and I never did develop a rash or any other side effects. Dr. Ziemssen told me today that we were past that window- if these things were to happen they would have already started. So tomorrow's infusions should go by without a hitch. I am hoping to sleep through the day, return to the hotel and pack as we need to leave the hotel at 7am Saturday to return home.

Please contact Dr. Ziemssen if you are interested in Lemtrada. He isa very busy man but does attempt to answer all emails. Please understand that it is difficult for him to decide to take a case when he has never met the patient. The more information you can provide and the more knowledgeable you are on the drug, its side effects and the monitoring required (see other pages on this blog for this information) the easier it is for him to make a decision on whether to take your case. I was told today 5 additional US patients have signed up to come to Dresden in the coming weeks.

Mexico might be cheaper (still don't know the situation there) but for my money and for such an important drug- I am convinced Dresden is the place to be treated.

Wednesday, April 9, 2014

Day 3- 60% there!

Today was a busy, hectic day. Ava had the drowsiness I had yesterday and good for her to sleep through all the visits we received! I wish it was my day to sleep, but that was yesterday for me.

This morning Teresa (our nurse and close friend) told us her 3 year old little girl was sick and she had to leave early. We sure did miss her but we hope her daughter gets better soon. Ava and I are both on an antibiotic and antiviral so I think we will be covered if this was something contagious- Teresa wanted to take her to the pediatrician to make sure we couldn't catch anything.

Dr. Ziemssen brought he Darling 9 month old baby girl Jetta to visit us today. She is a beautiful child with deep blue eyes and a healthy pale complexion. Her eyes lit up with joy when he make faces with her. She loved for him to play with her toes. Such a beautiful girl!

A local representative from Genzyme (the company that makes the medication) was in today. He was very interested in the patient's perspective of taking the medication. He wanted to use our patient experiences to help explain to other doctors in the area about the medication and how it is tolerated by patients.

He was very interested if we thought the required labs every 4 weeks for 5 years would be burdensome. I assured him it was much more convenient for me to drive 10 minutes for labs that took about 10 minuets than drive 1 hour to my infusion center for my previous drug, wait two hours for the infusion and drive 1 hour back.

We also discussed how medical treatment is different in the US vs. socialized medicine in Europe- basically that in the US patients are presented with options along with the pros and cons of each and then choose the best option for them. In Europe the model is very different- more paternalistic- the patient does what the doctor says and is not so interested in exploring other options. It was a lively discussion. He left for a few hours but returned later with more questions.

In the meantime the local newspaper and a representative from the University Newspaper came in to interview me- they wanted to know the history of my disease and how I came to chose treatment in Dresden. Dr. Ziemssen's experience and competence lead me to make this choice and Ava came because her husband saw my posting on an MS forum and asked me for the contact information here so Ava could come as well.

They had a professional photographer from the paper who took all sorts of shots with me- on the bed, in the hall, with my husband and with Dr. Ziemssen. They are going to try to get me copies of all the articles in English. They also were very interested in the web address of this blog for more background information. Tomorrow the TV people come and we do it all over again. Ava does not want to be interviewed so I am 'up to bat' again.

All this activity raised my blood pressure a bit but again neither of us had any side effects from the Lemtrada today. I think my drowsiness yesterday and Ava's today is more about our bodies clearing out all the dead immune cells that have been pillaged over the last few days. Both of us woke early in the morning (me at 2:30 and her at 4:00) and we couldn't get back to sleep. This is likely due to the hyper state high dose steroids can put you in.

Ava's mobility and gait have improved dramatically. This is also likely the steroids. She has elected to stay on 1gm for the final two days. Thursday I will take 500mg and Friday I will take 250mg to step down the high dose. The high dose shuts down our bodies own natural production of this steroid so slowly coming down (called tapering) allows our bodies to slowly recognize the need to start making its own steroid again- that transition can be painful and rough, tapering helps.

We had no headache, fever or rash- even though we started our Tylenol dose late today with all the visits and confusion. I hope we can avoid the rash all together by staying on steroids throughout (the regular protocol calls for this to be our last day of steroids with no tapering or extension- but as medical people we made special requests of Dr. Ziemssen those are being honored). We just love working with Teresa and Dr. Ziemssen- he is jovial, honest and collaborative. He really cares about his patients. We learned today that he gave up his personal office so that the two of us could be in the same room for the infusion. He is a very special person and very humble. He would never have told us this himself.

Nothing but good news to report from here. Dresden is a beautiful city and the people are very nice. The train system makes it easy to get from the hotel to the clinic in about 15 min and is very inexpensive. There are MANY restaurants within walking distance of our hotel- bakeries and shopping too. Germans buy bread every day- everything is so fresh here. It is Asparagus season and every dining experience has been top notch.

My infusion ended a bit early today so my husband and I took a tour of the city, part by tram and part on foot. It was a beautiful day to be out and about- so glad for this opportunity and looking forward to a future where I "have MS" and "MS doesn't have me!"

We sure feel blessed and thank everyone who has offered prayers on our behalf- they are SURELY working, we feel them and know this experience would not be going as smoothly without those prayers and the wonderful doctors and nurses in Dresden!

Please if you are thinking about going to another country, or even another EU city- please consider Dresden. The care you will receive here is truly top notch. I know of one US other patient who will be coming the first week of June. I am sure she will have a wonderful experience as well.

Many blessings to all!

Tuesday, April 8, 2014

Question from Blog: Criteria for acceptance

This question was posed to the blog: 


How did the neurologist in Germany qualify you for this treatment? Was it enough to have an MS diagnosis? Or did he have certain constraints? For example, age range, duration of disease, EDSS score, failed treatments, etc. In short, what criteria did he use to determine that you and Ava are good candidates for this treatment? Thanks for taking us along, as always! 

I can speak best for myself on these issues. About the only thing I can say about how Ava is differnt is our presenting symptoms- mine include cognitive decline, extreme fatigue and pain. Hers are quite different- mostly mobility issues. We have each been diagnosed over 10 years,

He did not ask to speak to my US doctor- but he does know my doctor personally. He did take the patients word on symptoms, tmt, etc. This may be because both Ava and I have medical backgrounds ourselves we knew the drug's potential, its side effects and the strict monitoring required. We voiced our commitment to a minimum 5 year follow up in the US as we knew this was key to our overall health. Please education yourself on these topics- all this information can be found in other posts on this blog.

I think this would bode well for any patient who wanted treatment because between us we cover the main MS symptoms but neither of us has them all. Your foreign doctor also must be Positive that you have an MS diagnosis. As is well known, MS can be the great 'imitator'- appearing to be one neurological disorder but being quite another. Lemtrada is a serious medicine and no patient should take the unecssary risks of treatment without a positive MS diagnosis- your US neurologist diagnosis is key here, in addition to extensive medical history, including your treatment history & reason each drug was started and stopped.

I sent a standard form letter about my diagnosis and a few relevant documents- most recent labs, JCV Ab titer, and report from last MRI.

When Dr. Ziemssen said he would be willing to consider providing Lemtrada I sent all of the medical data I had- every office visit (my neuro always gave me copies and so I scanned those in), every MRI report, & all relevant data I had and I answered a few of his questions. He did ask my EDSS score but I did not know it.

The information I sent included my own overview of treatments taken and why I was switched. I had this data already, I just typed it in one long word document.

The decision really came when we spoke on the phone. We talked about my main symptoms and especially my JCV titer. I felt the conversation was collaborative- we discussed what was reasonable for a wash out period- I would be just over 8 weeks off Tysabri. He asked for an MRI to look for PML activity- there was none. He also wanted me to be tested for HIV, Hep C, & Hep B. We discussed testing for TB but as a nurse I am tested for this frequently and have had no contacts that would put me at risk. He was ok with not testing for this. Some providers out there want a LP (lumbar puncture, or spinal tap) in addition to MRI for PML testing- he did not think this was necessary. (this last topic is covered extensively on Stephen's blog page posted 4/10/14)

At this time Lemtrada is not being used first line in Germany. Primarily because the diagnosis of MS must be clear before considering a medication that requires such extensive follow up. I do not think this would be a decision a foreign doctor could make without seeing you many times in person. So it would not be feasible to treat with Lemtrada first line with a foreign doctor.

Foreign doctors and Gemzyme, the manufacturer, are taking a risk on all the patients treated outside the US. The main sticking point is the importance of follow up and long term follow up- if you are NOT willing to have labs drawn every 4 weeks for 5+ years then do not take this route. Ultimately it is up to you back in the US to follow through with this- Genmzyne, your foreign doctor and you personally need to make this commitment to long tern follow up.

Dr. Ziemssen has continued to be very easy going, pleasant, and accommodating. The clinic is very flexible and the nurse who is with you all day is Wonderful! very helpful through the treatment but also helping our husbands find suitable places for lunch and short walks.

I cannot say enough about this experience. I feel very secure in my care here and am VERY glad I chose Dresden. I think it is even better here than in the bigger German cities- the care is VERY personalized and the city is beautiful. All shopping and restaurants are within short walking distance. The trams are quiet and smooth (electric) and very easy to get to from the hotel we booked.

The hotel is professional and comfortable. The staff all speak English and work with you in negotiating travel around town.

I can post a separate posting on travel and restaurant tips for anyone interested, just send me an email or comment on the blog and I can answer those.

Day 2 Went Great!

Day 2 got off to a bit of a slow start as we tried to figure out how to ride the train to the infusion center. That didn't work out and we walked back to the hotel to take a taxi. I hate arriving anywhere late but Teresa, the infusion nurse was very gracious about it.

Greg left after about 20 minutes and explored Dresden and at least on Beer Garden. That was great for me because I slept through most of the 6 hours and feel much better.

One of the new oral meds I take twice a day (that may actually restore the myelin that my immune system is eating away, causing damage)  makes me really tired. It is still in clinical trials but is an old antihistamine- Tavist (Clemestine 1.38mg 3 every AM and PM) with very few side effects- apart from the fatigue which will diminish over time.

So I slept most of the time- which was Great!

I had no side effects today- I drank over 2 liters of water which I think will help to clear the dead WBCs. Ava is also improving. She has some physical disabilities (mine are cognitive, fatigue & pain). Her gait was much improved after only one dose! I think she is also feeling better overall.

So no Headache, nausea (Ava had yesterday) and no dizziness.

Premeds for me:
Acyclovir 200mg (standard to protocol)
Toradol 30mg IM
Tylenol 1000mg

Additional meds during the infusion, just to ward off any headache before it happened:
Motrin 800mg
Tylenol 1000mg

They did not take any blood for the clinical trial on Interleukin 6 today. They will take more blood on Wednesday and Friday. We will get the results of this in 3 weeks- emailed to us.

I am very grateful to the staff for their personalized care and compassion. Today a different physician started my IV and got it the first try! I have no bruising from yesterday's IV site- I have become a 'hard stick' so this has impressed me- and is a lot less painful that multiple attempts.

2 Days down, Three to go!

Please let me know if you have any questions.

Please hit the G+ button below this post if you liked the information.

We Love our Dresden Care Team!

I cannot tell you how fortunate Ava and I feel to be treated by such a competent staff in such a friendly manner. All 4 of us are 'medical' people- Ava, me, her husband and mine- we all agree that the staff here are the best providers we know and we wish we could steal them all back to the states!

The clinic staff welcomes your emails and will answer any questions specific to your case as time permits.

Dr. Tjalf Ziemssen (pronounced Zimpson- like simpson in the US with a Z)
Heads the Clinic. He is a jovial fellow with a British sense of humor. He is always bright and optimistic during his drop-ins to check on us. We are all planning a celebration dinner last this week that will include his wife and possibly Teresa's husband
E-Mail: Tjalf.Ziemssen@uniklinikum-dresden.de
Tel.: +49-351-458-4465

FAX: +49-351-458-5717

Tereas Lehmann is the nurse that did all of our monitoring and care. She even took our husbands on a tour of the surrounding area so they would know where to pick up our tasty lunch. She is very competence in her care. We are her only patients this week.

Katija Thomas is the doctor who is preforming the clinical trial on interlukin reaction. I do not have a contact for her but she is very nice and started both our IVs with no problems.

Alexander Dachel is the Manager of International Patient Services. He will help you in paying for the medication as well as recommendations for local hotels, restaurants, trolly routes, etc.
Email: Alexander.Dachsel@uniklinikum-dresden.de


Of course we wish the FDA would approve Lemtrada before our next round is due, 

But if they dont, all the long travel is completely worth the trip to be in such competent hands.


Answer to a Question about the Steroid part of the protocol)

Question: 

How does this experience compares to 5 days in the hospital on steroids. 

Way worse? About the same? Or not even close to the same experience. 

I have not had 5 days of 1gm IV Solumedrol since diagnosis August 2003- only with home health ocassionally, so I cant speak to the special circumstance of dealing with the hassle of going through that system.

Back then steroids were much easier on my body- both during and after. When possible I try to get away with only 3 days + taper.

Recently it seems the trend is for neuros to put us on 3-5 days for an exacerbation with NO taper to follow. Even with 3 days and taper coming off steriods is incredibly painful- I get adrenal pain (pain above the kidneys but below the shoulder blades on your back. I cannot lean on any chair, get a hug or even stretch to reach something without a lot of pain.

I also have a general malaise, extreme lower leg edema and then a night sweat type conversion several days to 1 week after steroids when by body seems to convert from relying on external steroids and my adrenal glands get back to supplying the much small amount I need on a daily basis. 

This is the reason I have chosen to request the taper mentioned in the Day 1 post. Ava has decided to get a full 5 days of sisterhoods here and taper at home.  

So to answer your questions: 

The infusion of steroids has never been the hard part for me. Coming off steriods, which is next week's job is something I am not looking forward to. 

Ava and I agreed that the first day went well- minor headache that came & went for me. Her headache was not as bad but she did have some GI upset that may have been related to taking pills on an empty stomach. 

We were told we might have extra fatigue due to the death of all our white blood cells and the body working overtime to pick up and dispose of all those dead soldiers- but you may have had the experience that steroids initially give you a boost in energy. 

For me this was the case and I rested a bit at the hotel did some minor shopping (water mostly- you have to drink lots of water with this therapy- 2-3 liters at least/dy- think of the amount of liquid is an a 2 liter of coke in the states- and your goal is more than that each day), rested a bit and then we out to dinner at a Tapas place with my husband and Ava's husband. Ava chose room service and an early night.

To Sum up

I would say day 1 of the steroids + Lemtrada was not that much different than Day I of steroids without Lemtrada. Both of us were a bit tired but this is a difficult journey with the travel, dealing with foreign travel, jet lag- I cannot say the fatiuge (and mine was mild) can all the the fault of Lemtrada.

Please continue to send questions and I will answer any you have.


The evening of Day 1, a bit of fun

For dinner we stayed out a bit late but had wonderful conversation. In the area we re staying it is beautiful and rich with history. My husband- at my insistence is going to check out at least on beer garden today while we are being infused. 

He is also going to investigate all the best sites and then take me and my limited energy to the best ones :)

More later, I hope this answered your question

Monday, April 7, 2014

Good News for Lemtrada's potential approval in the US

Dr. Zisemmen brought us a Press Release today from Genzyme (the company that makes Lemtrada).

They are not going to appeal the denial in December 2013- rather they announced today that following constructive discussions with the FDA they plan to resubmit Lemtrada for US approval in the second quarter of this year (April to June timeline).

The Press Release did not indicate how long the process might be to approval.

They are seeking approval of Lemtrada "for the treatment of relapsing forms of MS". The re-submission will provide information to specifically address issues previously noted by the FDA in its December 27th 'Complete Response Letter'- ie the denial.

Good news for all US patients the wait will probably be long but it will be coming and maybe our insurance companies will pick up part of this tab!!

Good Luck to everyone!

Day One went smooth

I awoke this morning with that 'new place' thought of 'where am I'- When I did realized where I was and what was going to happen today I was so excited, thinking today is the the day, it is finally here!

Ava, the women who is here for treatment the same week with me, and I got to the clinic this morning at 9, it was supposed to be 8, but jet lag took a little bit of a toll :) We pre-premedicated with Ranitidine (an H2, histamine blocker), tylenol and Valtrex (an antiviral). I also took 25mg of Benadryl (low dose) and Toradol 30mg by IM injection for pain/inflammation.

After our IV port was established blood was drawn to look at our IL-6 (interleukin 6) level. This is part of an internal Clinical Trail being run by the MS clinic here. Blood was drawn on both of us 3 times today. We will have additional blood draws this week and the results will be given to us.

The first hour we were given 1gm IV steroids. We both tolerated that well. I brought hard candies along to mitigate the metallic taste you get with high dose steroids.  Everything went very smoothly. Both of our IV sites were accessed on the first try and the four of us and our nurse Teresa struck up a conversation that lasted the better part of 3 hours.

We took more Benadryl 50mg this time, to mitigate any rash that might develop. We send our husbands out for lunch- sandwiches, salads and homemade soup. Everything was very good. Then we sent everyone away so we could rest.

We cat-napped for a few hours while the boys went on a walk-about of Dresden. In the afternoon I developed a minor headache and took some Tylenol, Motrin and one Hydrocodone 7.5mg. Ana did not get a headache until much later and hers was so mild as to rank only a 1 on and 1-10 scale. Mine was about a 5. She developed very minor upper GI upset, with no change in bowel habits. This passed on its own without medical intervention.

After the Lemtrada infusion we both felt a little tired and dizzy when we first got up for a bathroom break but otherwise we were just fine. We too a taxi back to the hotel to rest before dinner.

We are all staying at the Swissotel (no H) in Dresden. It is centrally located and about a 10 min cab ride to the clinic. The facilities are modern (private bath in room) and the bedding was very comfortable. All the hotel staff speak English and are accommodating. They may have a free breakfast but we didnt go- our bodies still a bit jet lagged and we are not hungry at the usual times.

The clinic staff is Amazing- better than any doctors or nurses we have encourntered in the states. Both Ava and I wish Dr. Ziemssen (pronouced Zim-son, like the American Simpson with a Z) would move to the US and be our neurologist :) Teresa, out nurse was very courteous and competent. Katija, is another doctor who was in an out getting the blood for the clinical trial.

We had a wonderful and very easy day. I wish more people had this opportunity!

Later in the week we will be interviewed by the local newspaper and TV station. They decided Ava wold do the newspaper interview and I would do the TV- so that the two stories would have great publicity.

Please let me know by personal email or a blog comment here if you have any questions or want more information on a part of our treatment. We are happy to oblige and answer any questions.

Each of the next 4 days will be the same for time of treatment (total of about 5 hours + 1 hour monitoring after drug is infused). Ava has asked to have 1gm of Steroids every day (more than the protocol calls for). I plan to have 1gm for 3 days, then 500mg on day 4 and 250mg on day 5 (also a slight departure from protocol to allow for tapering). I will then give myself 100mg IM the day of departure.

Today was sunny and beautiful in Dresden. We hope your day was wonderful as well!

Please hit the G+ icon at the bottom of this post so Google knows how many people are following this blog.

Thanks!

Sunday, April 6, 2014

In Germany, Met with Doctor

We arrived in Germany today. The travel being hard but thankfully fairly uneventful.

We met our doctor this evening and discussed the treatment ahead. He provided us (a friend is here getting Lemtrada the same week as me) with the acyclovir for prophylaxis as well as an Zantac 300mg (H2 blocker) & Claritin for the rash that is prevalent with the infusion.

Tomorrow we will have approximately 6 hours of infusions beginning at 9am. We will get 1gm IV steriods prior to Lemtrada. He will monitor us for the two main side effects of headache and rash. We will also have a CBC drawn tomorrow and on the last day of treatment to check our white cell count that will be near 300 at the end of this week.

He did alay our fears about just how susceptible we will be after infusion- no masks are required at the airport but we still have to steer clean of other contacts for 2-3 months. Ava (the woman being infused with me) has taken 2 months off work. I work from home so I might go back to work in a limited capacity sooner.

Our first lab draw at home will be 4 weeks from tomorrow, so May 4th. We can alter this time a bit so I will have mine drawn on 5/1 because I don't work Fridays so it is just easier for me.

Our doctor is very optimistic about our prognosis and expects us both to regain some function.

I will write more tomorrow on how Day 1 goes!

Saturday, April 5, 2014

Coming to Mexico soon!

Mexico is getting prepared to begin Lemtrada infusions in the first week of May.

My friend Helen is investigating the options in Mexico right now.  I will update this page as she gets more specifics on sites and cost.

It is Saturday 4/5 and I am off to Germany today after a pilot strike at Lufthansa delayed our flight two days. I will meet with my doctor Sunday afternoon & begin infusions on Monday. Another American couple is traveling today as well and we will meet them tomorrow. If I have her permission I will include her experience as well as my own, once this treatment gets underway.

Thank you to everyone who has liked this blog (by clicking the G+ below each posting). The word is getting out! The FDA may think they can hold us back. But No Way. Were Americans- by land or by sea or by air we will make the medical decisions that our best for us- the government has no right making those decisions for us!!

Wednesday, April 2, 2014

Making Traveling Easier

Wheelchair assistance- Request It!


You should be able to request wheelchair assistance in advance through your airline. they will have a wheelchair waiting for you at check in and at each transition point during your journey. Even if you dont use an assistive devices on a regular basis. using a wheelchair in airports really cuts down on the fatigue and stress.

TSA Cares- Use It!


Our beloved TSA does have a 'caring side'. All airports should have a handicap line that is quicker than the usual wait. Your travel companions can join you in this line. If you dont see a line just ask the first TSA person you see for a "Passanger Support Specialist".

You do not have to have a body scan if you are not steady enough to stand with your hands above your head. You can request to walk through a metal detector or be pat down (this has happen to me several times and is more an inconvenience to the TSA than to me!). The pat down can take place in your wheelchair (sitting) or standing next to your chair holding on. Your travel companion can help you stand.

They will also check the chair if you have one- but you dont need to worry about that step.

Make it Official

You can download a printable Medical Card for TSA purposes here:

http://www.tsa.gov/sites/default/files/publications/disability_notification_cards_0.pdf

You do not have to fill out the medical condition, you can leave that blank. I added MS to mine.

You can also let the TSA know ahead of your flight that you are coming and will need a Passenger Support Specialist by going here:

http://www.tsa.gov/traveler-information/travelers-disabilities-and-medical-conditions

TSA Cares hotline is 1-855-787-2227
They are very helpful on the phone

Safe and Stress Free (or at least reduced stress) Travels to all!