Monday, October 31, 2011

Cutting-Edge Strategies to Control Cognitive Issues

Day 6 at ECTRIMS: Managing cognitive function is an important part of your well-being and personal health while living with MS. Learn more about the important research being done in this area.

Thursday, October 27, 2011

Medicare open enrollment period has begun: Beneficiaries have more benefits, better choices, lower costs

Kris Erickson

The Center for Medicare & Medicaid Services is encouraging people with Medicare and their families to begin reviewing drug and health plan coverage options for 2012 to take advantage of the increased benefits, improved choices and lower costs that are available. The Medicare Open Enrollment Period – which began earlier this year on Saturday, October 15 – has been expanded to seven weeks and will end on December 7th. This will give people more time to compare and find the best plan to meet their unique needs.

Beginning today, seniors and people with disabilities can review the 2012 quality ratings for Medicare Advantage health plans (Part C) and prescription drug plans (Part D) for the upcoming year.

Resources for Medicare Beneficiaries

People with Medicare coverage, their families, and other trusted representatives can review and compare current plan coverage with new plan offerings, using many resources, including:
  • Medicare’s website, where they can get a personalized comparison of costs and coverage of the plans available in their area. The popular Medicare Plan Finder tool has been enhanced for an efficient review of plan choices. Spanish Open Enrollment information is available.
  • The 2012 Medicare & You handbook. It is also accessible at online here, and has been mailed to the homes of people with Medicare.
  • The Medicare & You 2012 handbook in Spanish can be found here.
  • Counseling assistance from an MS Navigator at 1-800-344-4867.
People with Medicare who have limited income and resources may qualify for Extra Help paying for their prescription drug costs. There is no cost to apply for Extra Help, also called the low-income subsidy. Medicare beneficiaries, family members, trusted counselors or caregivers can apply online on Social Security’s Website or by calling Social Security at 1-800-772-1213 (TTY 1-800-325-0778) to find out more.

Are you having trouble navigating Medicare – or health insurance in general? Our MS Navigators are trained to assist you in finding the best plan to meet your needs. Call 1-800-344-4867 to speak with an MS Navigator.

Tuesday, October 25, 2011

No one should have to face MS alone

For people affected by MS, finding answers and making decisions means having the right information at the right time. That’s what an MS Navigator provides — answers to your questions and access to information about all of the options available to you.

In the online world there is information everywhere, but it can be quite a challenge to find what you’re looking for when you need it. MS Navigators have the resources to provide you with the latest about MS including:
  • What you need to know when newly diagnosed
  • Treatment options and symptom management strategies
  • Accessing optimal health care
  • Meeting workplace challenges
  • Understanding benefits such as health insurance
  • Facing financial challenges and planning for the future
  • Facing caregiver challenges
  • Finding help in the home
  • Managing life changes
  • Locating resources in your community.

MS Navigators have information on national resources, and those that are available right in your area. They can help you:
  • Deal with a crisis
  • Connect with others living with MS
  • Find what you need to maintain independence
  • Access comprehensive educational programs and more.

Our MS Navigators are here to respond to your unique needs. Whether you are a person with MS, a family member or concerned about someone with MS, the National MS Society is your partner — helping you find the information and resources you need.

Call 1-800-344-4867 to speak directly to a navigator. Or pose your questions in the comments field below, and check back in to the Society blog in the days and months to come as we address your questions through our “Ask an MS Navigator” column.

Saturday, October 22, 2011

Biomarkers to guide MS therapy: Moving from "sledgehammer" to "scalpel"


Every 2 years the Multiple Sclerosis International Federation awards The Charcot Award for Lifetime Achievement in MS Research. This year the award was given to Larry Steinman, Professor of Neurology at Stanford University. He was chosen, in part, for a series of studies looking at molecules involved in disease that led to Tysabri. I was lucky enough to be at ECTRIMS 2011 and see Dr. Steinman accept his award. I have to admit to becoming a little emotional when Dr. Steinman took the podium and said, "Though I'm deeply honored, let's have the real celebration when the disease is something we can see only in the rear view mirror." He is currently working on a DNA vaccine for MS, as well as finding biomarkers to guide therapy, which he discussed in his talk. I will attempt to paraphrase and summarize Dr. Steinman's presentation on biomarkers.

A "biomarker" is something in our body – for instance, a certain cell, hormone or something on our DNA – that could give clues about a disease or if a treatment is working. We could use the drugs that we have better and develop more specific drugs for MS if we could find out exactly what a person's immune system is responding to. We could then isolate the cells that are targeting the myelin and shut them off.

There are starting to be success stories in using biomarkers to guide treatment.

A couple of years ago, it was discovered that people with neuromyelitis optica (NMO), another autoimmune disease that is similar to MS, had high levels of IL-17 (Interleukin-17, a protein made in the immune system) in their spinal fluid. There are several papers in the literature that show that if you give people with NMO interferons (namely Betaseron and Avonex), they get worse.

This led researchers to wonder if people with MS who had high levels of IL-17 would not be good candidates for interferon-based medicine. Sure enough, preliminary data indicated that about half of the people with MS who have high levels of IL-17 may be "non-responders" to interferon-based disease-modifying therapy (DMT).

While it would be great to have a test that would tell you a definite "yes" or "no" to determine if an interferon DMT would work, larger studies failed to get a solid correlation. At this point, testing for IL-17 only works for 10% of people (those "outliers" with very high levels of IL-17), indicating that interferon treatment in these people has very little chance of working. However, this information would be valuable to know for those 10%. Dr. Steinman thinks that we are still at least five years away from having a licensed test to determine drug choice.

One big success in using biomarkers to guide therapy, however, is the anti-JCV antibody test to determine risk of PML in people who are considering starting (or continue taking) Tysabri. If this test is positive, the risk of PML in someone on Tysabri is one in several hundred. However, if the test is negative, the risk is miniscule.

However, biomarkers are not just to tell us what existing medications will work best. If we can find out exactly what a person's immune system is responding to, we could isolate the cells that are targeting the myelin. We could then create drugs to target just those cells.

At this point, we still do not know exactly what the immune response is in MS. Therefore, we have a "sledgehammer" approach, as many of our drugs involve modulating or deleting a large part of the immune system. By taking this approach, we impede one of the primary jobs of the immune system – preventing infection, and maybe even cancer.

Ideally, it would be better to find a treatment that "nicked" the specific part of the immune system that was causing the problem. If we could figure out which cells were involved in MS, that is, identify them as "biomarkers," we could make a more specific therapy that targeted just these cells – a "scalpel," rather than our current "sledgehammer." Eventually, we might be able to get so specific in identifying these cells and figuring out things like appropriate levels and relationships to other immune cells that we may even have different treatments for different people.

Dr. Steinman pointed out that we are making progress with neuromyelitis optica (NMO). We understand NMO better, and understand that aquaporin 4 (a protein in the brain and spinal cord) is the main antigen. It has been shown that blocking immune response to aquaporin 4 reduces NMO lesions. Dr. Steinman says that we need to put more effort into understanding these diseases that we have a better grasp of, as this will give us necessary clues to figuring out MS targets for treatment.

I'll paraphrase one presenter at ECTRIMS 2011 who talked about a "MS treatment Utopia" that would allow our neurologists to tell us exactly what kind of MS we had, what treatment would be best, how well it was working and exactly what to change to if it stopped working. Sounds like the next best thing to a cure.

This is my last blog from the ECTRIMS 2011 conference in Amsterdam. Thank you for reading these blogs. My goal was to bring you to the conference with me by giving you some highlights of the research presented. I will continue discussing more research findings on my site,, for many months to come. Check it out.

Keep coming back to this blog of the National MS Society. The Society is committed to keeping people with MS in the conversation and this is one way to get those of us with MS talking to scientists, researchers, doctors and each other.

Take care of yourselves, my friends.

Breaking News: Zeroing In On Risk Factors For MS

Vitamin D Deficiency, smoking and the Epstein Barr Virus are three environment risk factors that have been studied as potential triggers for MS. Learn more from Day 5 at ECTRIMS.

Where is the PPMS research at ECTRIMS 2011?


When I wrote that I was coming to ECTRIMS 2011 to report on the most current MS treatment and research on the disease, I got several e-mails and blog comments from people with primary progressive MS (PPMS), who were anxious to hear what treatment was in development for them. My friends, I wish I had better – indeed, any – news to report. At this conference, there was no research presented about developments in treatment of PPMS.

Why the huge disparity in research activity around treatment for relapsing-remitting MS (RRMS) and PPMS? Of course, the first thing that comes to mind is that PPMS treatment has much less potential for huge profit than a successful RRMS drug, due to the fact that only 10 to 15% of people with MS have PPMS, with the vast majority having RRMS.
I won't lie to you – the bottom line is definitely a factor. However, there are other big challenges to running trials to test medications specifically for PPMS, though. Many of these have to do with designing a study that would give any meaningful results. Remembering that virtually every clinical trial is complicated by difficulties in recruitment, follow-up, unexpected side effects, adherence, etc., which makes any clinical trial a huge and expensive undertaking. Even for a motivated group of researchers, any of the characteristics of PPMS as a disease and the population with PPMS make trials even more daunting.
Disability: Many studies require people to be ambulatory (able to walk) in order to be included in a study. This is so that the effect of the study drug on walking ability, energy level and other physical abilities can be studied by having people walk a certain distance within a certain time. In this way, researchers can use scores on the Expanded Disability Status Scale (EDSS) as an outcome measure. Many people with PPMS are no longer ambulatory.
Age: People with PPMS tend to be older, meaning that they often have additional age-related health problems, such as cardiac issues, diabetes, high blood pressure, vision problems and others. This makes it more difficult to determine which disease (MS or one of the other ones) is causing or contributing to disability. It also makes it difficult to determine which symptoms are side effects from the study drug and which are due to underlying health problems. In addition, people with other conditions may need to take other medications, which would exclude them from the study, as interactions between medications would not be known or could interfere with results.

Side Effects: It may be harder for people with PPMS to tolerate side effects from the study drug, both due to MS-related symptoms, other health issues and age.

PPMS Is Unpredictable: PPMS behaves differently in different people — some people experience a very quick progression to disability and others progress very slowly, often experiencing “plateaus” of several months or even years where symptoms remain stable. This variability makes it very difficult for researchers to compare placebo groups to treatment groups.

People whose PPMS progresses very slowly may have to be eliminated from the study so that researchers could figure out if the drug is doing anything (otherwise the study would have to continue for many years). That would leave only the people with quickly-progressing PPMS, though, which would also not be a good test of a drug, as these cases may not be representative of all (or even most) cases of PPMS.

Basic Research is Being Done: All of these points are just to illustrate why research on PPMS treatment is very difficult. However, this does not mean that scientists are ignoring PPMS. There are some studies in very early stages, many still in animal models, exploring treatments that regenerate and rebuild myelin and lost axons, as well as studies on DNA and other biomarkers that will eventually guide treatment.
In addition, researchers are starting to explore different technology, such as triple-dose gadolinium, and more powerful MRI scans to learn more about the effects of PPMS that have been difficult to assess until recently. I would have loved nothing more than to bring news to you about a "breakthrough" in treating PPMS, hopes are that these developments will eventually help in the search for effective therapies for people with PPMS.

Friday, October 21, 2011

Memorizing stories to help with cognitive dysfunction


Many people with MS will relate to the statement "MS hits each person where it hurts the most." By this, I mean that we seem to develop symptoms that limit our ability to do what we love the most.

I can certainly tell you that in my case, MS did not steal my ability to win marathons or sing opera. The "punch in the gut" MS symptom that I experienced (and continue to struggle with) is cognitive dysfunction. At my worst, I was unable to read complicated text or keep up with fast-moving conversations. It certainly made life at the academic institution where I was on faculty nearly impossible. These days, I am doing better – I have learned how to compensate for this symptom in many ways.

Over half of people with MS have cognitive issues, including problems with short-term memory, executing functioning, word-finding, and speed of information processing. Much work is being done in this area. Dr. Ralph Benedict, Professor of Neurology at SUNY Buffalo, says that much research is being done around cognitive impairment, including work on: attempts to treat cognitive impairment, risk factors (why do some people have it and others not), changes in physiology, how to measure cognitive impairment.

Two approaches to treatment of cognitive dysfunction are being studied: 1) rehabilitation and 2) treatment using medication.

One group is working on a rehabilitation approach called the modified Story Memory Technique, which has been shown to improve short-term memory in people with MS. This approach is comprised of 8 sessions of 30-90 minutes long, 2 sessions per week. During these sessions, people work with a therapist or psychologist on memory techniques. The modified Story Memory Technique teaches skills around using context and imagery to facilitate learning.

During some sessions, the patients are shown a written story. Many of the key words are written in all capital letters and the story focuses on images. An example that I have seen used is: Mr. Jones PULLED a fresh APPLE from a TREE.

Patients are asked to retell the story that they have read to the therapists. They then work with the therapist, who gives them tips to remember the story better. This exercise is repeated twice in each of the first four sessions with the same story – the goal being to recognize imagery and use it in recounting a situation that occurred or a story that was heard.

During the next couple of sessions, a list of words is given to the patients who are taught to make a story out of them to better memorize them. In the final sessions, the patient and the therapist work together on ways to apply these techniques in their lives.

This technique has been shown to have an impact on cognitive function in three studies, reports Dr. John DeLuca.

Two of these studies have been shown to improve measures on cognitive tests, comparing treatment with this technique to a placebo. Interestingly, the treatment effect was maintained for some time after the treatment ended and continued to improve during 5 follow-up tests.

The other study looked at changes in brain activity on a functional MRI scan after treatment and found greater activation in many parts of the brain when people performed a memory task.

"At this time, it is time to take this data and start designing a program to help our patients using these techniques," says Dr. DeLuca. He also said he thinks that 8 to 10 sessions will not be enough, but that booster sessions will be required, which is currently being studied.

Day 4 at ECTRIMS: Recent findings related to CCSVI

CCSVI research: Why are the results so different?


There are many components to a "good" experiment - not just that a researcher gets the results that he or she wants, showing that their hypothesis was valid with statistical significance. A very important part of scientific "success" is that the experiment is reproducible, meaning that a scientist anywhere who followed the protocol exactly should be fairly certain to get the same results (or at least very close).

Trying to establish a correlation between chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS) has been a huge scientific mess, with results ranging from 0% correlation of the presence of CCSVI in people with MS to 100% of people with MS having these deformities or "stenosis" of the veins that drain blood from the brain. A presentation by Dr. Doepp pointed out that CCSVI results were often difficult to reproduce in the same patient, even using the same imaging equipment and techniques.

This difference in the correlations found by different scientists indicates that there is a problem with the way the test is being done in various people in various places. Using different types of imaging technology on different sections of the veins can easily give vastly different results in the research. Other factors can also come into play.

According to Robert Fox, of the Mellen Clinic of the Cleveland Clinic, one easily-overlooked challenge in getting an accurate image of the veins in people with MS is hydration. Because many people with MS have bladder dysfunction that either leads to incontinence or urgency, they may be chronically dehydrated, as they reduce fluid intake to avoid accidents. I have also read of people whose results were considered "invalid" or "unusable" because their head was tilted a couple degrees in the wrong direction.

Dr. Fox and his research group found a way around the measurement error that can be introduced with these advanced imaging technologies and patient behavior – he took a real look at the veins of people that had died and donated their bodies to research.

The group "harvested" the internal jugular (IJV), subclavian, brachiocephalic, and azygous (AZY) veins from 7 people with MS and 6 people without MS. These veins were prepared by injecting them with silicone, then cut open and mounted for examination. They defined "stenosis" as a reduction of more than 50% of the inner diameter of the veins, as compared to a normal region in the same vein.

The group found a variety of abnormalities in the veins they examined which could have affected blood flow. However, these abnormalities were found in both people with MS and the people without MS (4 of 7 MS patients and 3 of 6 controls). However, there were differences in the valves and other structures, like flaps or membranes, within the veins in more of the people with MS (6 out of 7) than in the people without MS (2 out of 6), all of which could impair blood flow. These structures could very well create a stenosis (blockage) without there being a difference in thickness of vein walls.

This tells us two things: 1) these abnormal structures are very delicate, meaning some of these abnormalities would probably be missed with certain imaging techniques, such as magnetic resonance venography, indicating that Doppler ultrasound might be better; 2) we need to look at more than just the thickness of the vein walls, as there may be abnormalities inside the veins that could provide an important part of the puzzle.

Choosing and staying on MS therapy: What are people doing and why?


Everyone has their own journey with multiple sclerosis (MS). One part of life with MS involves treatment.

At some point, we all have to make a decision about initiating treatment with disease-modifying therapy (DMT) or a decision to not use therapy at all. For most people living with MS, decisions around treatment, both disease-modifying therapies and symptom management approaches, can be emotionally-charged and filled with ambivalence.

Many considerations go into treatment decisions, not just how effective the meds are, but lifestyle factors, costs, doctor's opinion, injection frequency and other things specific to an individual's life and values.

Once a therapy is selected, there is the matter of adherence – taking treatment as prescribed and staying on it. This comes with its own challenges as we try to adapt to using these drugs in a real-life setting, coping with needle anxiety, unpleasant side effects, timing issues and other aspects of fitting these meds into our lives. Often, we have a hard time reconciling the images of happy people in the marketing materials that came with these medications with our own situation.

One US study looked at what happens to people in terms of treatment initiation and continuation after diagnosis with MS.

Here is what they found:
  • 30% of people started an interferon (Rebif, Betaseron, Avonex) an average of over 5 months after diagnosis
  • 16% started Copaxone an average of over 6 months of diagnosis
  • 4% started something else (Tysabri, mitoxantrone, IVIG) a year and a half after diagnosis
  • Nearly 50% of people in the database had not started any disease-modifying therapy four years after treatment

What happened to the people that started? About half of the people who initiated therapy stayed on it for all four years, although about 10% of people switched to another disease-modifying therapy. Interestingly, half of the people that discontinued their DMTs said they would restart the drug.

Another study also looked at persistence with treatment (how long they stayed on medication) once people started and found that, on average, people stayed on the first DMT that they were prescribed for 2.9 years before switching or quitting treatment altogether.

That tells us what happened around the treatments that people selected and how long they stayed on them. However, why do people continue or stop therapy? One UK group looked at people who started "high-dose, high-frequency" interferon (aka Rebif) to see what they did and why.

They found that 68% of people had "no concerns" before they started therapy. However, 24% discontinued therapy by the end of the 4.5-year study period, the most common reason being that they "felt unwell" on this therapy. Interestingly, people who felt uninformed about the treatment before they started were more likely to discontinue treatment (and discontinue it sooner) than those who felt "informed."

What I can take away from this is that it really serves us well to research our medications. That will tell us what to expect, so that we can prepare better.

For some tips on how to do this, read my article on some ideas on learning more about your meds:

Thursday, October 20, 2011

Exposure to disease-modifying therapy during pregnancy: How worried should we be?


Many women, myself included, upon finding out that they are pregnant, experience about 90 seconds of pure joy before beginning to inventory every single thing that we ate, drank, inhaled or injected from the moment of conception. We all worry that we may have put something in our bodies that would somehow harm our babies.

Most of the disease-modifying therapies (Avonex, Betaseron, Rebif, Tysabri, Gilenya) fall into FDA pregnancy category C, with the exception of Copaxone, which is a category B medication.

Category C drugs carry the following warning: "Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks."

In other words, according to this categorization, it is probably not considered a good idea to use these drugs during pregnancy. Indeed none of the disease-modifying therapies are approved for use during pregnancy. Most neurologists have their patients with MS discontinue their disease-modifying therapies (DMTs) about a month before they begin trying to conceive. If a woman conceives while taking one of these medications, she is told to stop taking it immediately. All of these precautions are to protect the unborn baby.

However, there is a difference between mega-doses given to lab animals and what happens in real life when women take the drugs.

A couple of presentations at the ECTRIMS 2011 conference examine what actually happens to babies when there is brief exposure to these drugs prior to conception and during early pregnancy. The answer so far seems pretty clear: not much happens at all.

One group conducted a meta-analysis looking at 12 different studies where a total of 1105 pregnant women with MS were exposed to interferon therapy (Rebif, Avonex or Betaseron). In 10 of these studies, there was no evidence of an increase in miscarriage or birth defects in exposed pregnancies. In only one of the studies, there was a much higher rate of miscarriage in the group that was exposed (39%) than there was in the control group (5%) – for reference, the average miscarriage rate in the general population is between 15 and 20%. Another of the studies involving with what was considered an inadequate number of women found that 12.5% of pregnancies exposed to interferons prior to conception developed birth defects.

Another study from Latin America followed 43 pregnancies involving "long-term" exposure (defined as at least 8 weeks of continuous exposure) to Copaxone (24), interferons (16), IVIG (2) and Solu-Medrol (1). Again, there was no difference in miscarriage or birth defect rates between the exposed group and a control group of 78 women with MS who were not exposed to DMTs during pregnancy.

Data from the Tysabri Pregnancy Exposure Registry is also failing to show a correlation between exposure to Tysabri and adverse pregnancy outcomes. It should be noted, however, that "exposure" in this case is defined as getting a dose of Tysabri within the 90 days before becoming pregnant and not necessarily receiving Tysabri after conception.

Interestingly, all studies except the Tysabri data did show a slightly lower birth weight in babies who had been exposed to DMTs, but still within a normal range.

Bear in mind that these studies focused on the babies of women who used a therapy very early, before they even knew they were pregnant, and that the vast majority were taken off their meds when their pregnancy was discovered. So it’s hard to draw conclusions about what the outcomes might be if babies were exposed to these medications throughout the pregnancy. Since it’s unlikely that anyone will do a study that tests these risks full term, all we have to go on are these accidental exposures.

So, where does this information get us? At the very least, it seems to tell us that accidental exposure to your MS DMTs before you know you are pregnant should be nothing to worry about, so take that off your list of stressors.

I hope that this issue will be carefully considered and weighed in the future, so that docs and patients can be given clear direction based on real life evidence. Of course, all treatment decisions before, during and after pregnancy are to be made in conjunction with the doctor that is treating your MS and your OB/GYN.

Fewer relapses as we age


During my first relapse, I remember asking my neurologist lots of questions, including what my future held in terms of relapses, based on what he had seen.

He was honest with me, saying that he didn't know and making some joke about his crystal ball being lost. Of course, I was a little emotional about the whole thing, being in the middle of a course of Solu-Medrol, which left me shaky and anxious. I wanted to know what the likelihood was that I would have relapses more frequently as time went by. I just wanted to prepare myself and my loved ones for what the future held in terms of relapses.

It was an impossible question, I now realize, especially since I wanted a very specific answer about my own situation. However, data is becoming available that might give us clues as to how relapse patterns shift as we age.

One group from the UK, has systematically looked at the relapse pattern among 1534 patients and the findings are fascinating:
  • People age 29 and younger had the most relapses, with an annualized relapse rate of 0.49 – this translates into one relapse every two years. The frequency of relapses dropped as people got older, and people older than 60 only had .06 relapses per year. To quantify this number, think of this as 6% chance of having a relapse in a given year or one relapse every 16 years. * 
  • People tended to have many more relapses early in their disease (or sooner after diagnosis) than those who had the disease for a longer time. 
  • Women had more relapses than men.
Interestingly, the researchers asked people to fill out surveys about their relapses and then compared them to medical records. It turns out that older people tended to overestimate the number of relapses that they had, while the younger people accurately reported relapses.

So, what does this mean in real life? The authors of the study say that "treatments which are directed towards relapse reduction are likely to be most effective if targeted at those patients under the age of 30 and their impact will reduce rapidly with age and disease duration."

This does NOT mean, of course, that those of us over 30 should consider stopping our disease-modifying therapy. Remember, these are rates that apply to a large study population, averaged out among many people, so they can't really tell us specifically about our own situation. However, what this data may provide, especially when combined with other factors, is another piece in the puzzle of selecting the right treatment for the right person as we move into the era of "personalized medicine" for MS.

* I was unable to determine if part of the reason for this drop in number of relapses had to do with a number of people moving into secondary progressive MS as they aged and lived with the disease longer. Once people are classified as having secondary progressive MS, they typically experience far fewer relapses, if any.

Using DNA to Unlock MS’ Mysteries

Imagine a world where you could be diagnosed with MS before ever having any first symptoms.  Biomarkers are the map of who you are and scientists are identifying important elements to help create a personalized treatment plan for you.

Have you ever fallen?


Raise your hand if you've fallen. I bet you didn't have to think long to come up with that answer. Most of us cannot remember what we ate for dinner yesterday without thinking about it a little while, but, boy, those falls are permanently imprinted on our memory and often come to mind at unexpected moments like other embarrassing situations that we have endured.

Most MS symptoms can be covered up. Bladder accidents can usually be hidden. If you have problems with your speech, you can simply participate in conversation with one-word answers. People with tremor often keep their hands clasped when not using them. However, a fall is public and obvious. And humiliating. If it happens when one is alone, it can be scary.

Falls separate us from "healthy" people in a very literal way. We are completely alone in that moment when we hit the floor, no matter who we were standing with seconds before. As we struggle to get up, our first instinct is to reassure everyone, including ourselves, that the fall was "no big deal," that we are "just fine."

However, often we are not "just fine." Among adults with MS who experience difficulty walking, 60% report that they have fallen. These are usually not isolated incidents, either – typically those who have experienced falls report having fallen about three times in the prior six months. Beyond psychological and emotional impact of falls, there is a very real physical danger, as one-third of the people who report falling say that a fall resulted in an injury.

This data comes out of a study presented at ECTRIMS 2011 by Dr. Nicolas LaRocca, Vice President for Health Care Delivery and Policy Research at the National MS Society. The survey, entitled, "The Frequency and Impact of Walking Impairment in MS," shines a light on a subject that often gets overlooked by researchers and docs, and often goes unmentioned by patients. In fact, although the majority of people with MS report difficulty walking or maintaining balance, 40% of people discuss this symptom with their doctor "rarely" or "never."

According to the survey findings, younger people with MS are less likely to bring up their walking difficulties with their doctor - on average, people with MS aged 41 or younger who do discuss trouble walking with their doctor initiate the conversation only 46% of the time, compared to 54% of people who are 61 or over.

As a person living with MS myself, I can imagine some of the reasons for this. Maybe people are afraid that their docs will immediately decree that they need an assistive device, when the patient may not be ready for such a move. Perhaps there are other symptoms that are bothering them more at the moment. Maybe they are waiting for the doctor to start this difficult conversation or perhaps they are too intimidated to bring it up.

However, it is important to discuss walking or balance issues with your doc, especially if you have fallen or afraid that you might. There are many things that can be done to address these difficulties. As Dr. LaRocca stated in his presentation, "The basic activities that constitute life are seriously disrupted by difficulties walking." If there is a way to reduce unnecessary stress and challenges around this symptom, we owe it to ourselves to look into our options.

No time to waste on drugs that aren't working: Determining who is a "non-responder" early in the game


When we start our disease-modifying therapy, it is with the hopes that it is going to stop (or at least drastically reduce) our MS relapses and/or progression of disease. For some of us, a certain therapy works and for others it doesn't.

However, since MS is a chronic disease that is extremely unpredictable, we often don't know if our DMTs are working or not. Unlike an antibiotic prescribed for a bacterial infection (where a blood test and clinical symptoms can pretty clearly determine if the infection is cured or not), the determination is usually made for DMT efficacy when the drugs are decidedly not effective against our MS – in other words, we have relapses, accumulate disability and show worsening MRI results while we are still taking the drugs. At a certain point, we are classified as "non-responders" to that drug and switched to another medication.

However, this may not happen quickly and we may be taking a treatment that is not effective for many years before the determination is made that it has not been working for us. Not only have we unnecessarily incurred expenses and injected ourselves, we have also potentially wasted time that we could have been on treatment that would have actually slowed down the MS.

Dr. Mar Tintoré, of Barcelona, Spain, in her presentation, "Detecting Therapeutic Response Using Early Clinical Signs and MRI," followed a group of patients for 2 years to find out if they could proactively identify "non-responders" to therapy.

They found that if an MRI taken at 12 months after starting treatment showed 2 or more active lesions, then that person was 8.3 times more likely to be a non-responder.

Moreover, the people on DMTs who had 2 or more new or enlarging lesions after 2 years of therapy had significantly more disability. The researchers found that if people on therapy are having at least 2 of the 3 signs of disease activity (relapses, more disability or MRI activity) after 12 months of treatment, they will continue to have these things and disability will accumulate.

Likewise, an Italian study, presented by Dr. Romeo, looked at MRI scan taken within 6 to 12 months of initiating treatment and found that the presence of more than 2 active lesions within that time meant that the person was more than 4 times as likely to be a "non-responder." In this study, non-responder was defined as a person who showed at least a 1.5 increase on the EDSS within 5 years.

What does this mean? Considering this data, it seems logical that a protocol would be developed whereby people starting a certain disease-modifying therapy receive an MRI within a year of initiation. If a certain level of activity is seen, serious consideration should be given to switching the person to a different DMT. However, according to Dr. Tintoré, at the moment, if a patient is completely stable clinically, but shows MRI activity, treatment is NOT changed.

Many new drugs are coming down the pipeline, which will soon be available to patients and docs. As Dr. Tintore states: "It is our responsibility to decide early which patients are good responders to medications."  She continued, "We need to standardize our definition, as the group of non-responders can be as low as 7% or as high as 45% in the same group of patients, depending on the definition of non-responder that we use." According to Dr. TintorĂ©, the ultimate goal is to find the right treatment for each of our patients. Amen to that.

Wednesday, October 19, 2011

Advances in Using Stem Cells as a Treatment for MS


It is true that the term "stem cells" immediately has people thinking about those stem cells that are derived from fetuses or embryos – the topic of much discussion and controversy. However, much exciting work is being done on stem cells that can be taken from adults – either donors or the transplant recipient themselves.

Three presentations at ECTRIMS 2011 looked at current research on stem cells and the potential to be used as therapy for MS.

Until the late 1990s, stem cell research and theories around MS focused on only one thing – the idea that stem cells could be used to repair damaged cells that were no longer functioning. To date, researchers have not been able to produce damaged neurons with stem cells. However, about 10 years ago, it was discovered that stem cells can be used a different way – to create a "new" immune system for people with MS, one that does not attack the myelin.

The most progress in looking at the effect of stem cells in humans with MS (as opposed to experimental mice models) has been made on hematopoietic stem cells. This research was presented by Mark Freedman, MD from the Ottawa Hospital Research Institute at ECTRIMS 2011.

Hematopoietic stem cells (HSC) are taken from adult bone marrow and blood. They can also come from umbilical cord blood. They are multipotent, meaning they can turn into only a small number of different cell types. HSC are quite rare, making up less than .1% of bone marrow cells. These cells act as the foundation for the immune response.
Basically, the way that HSC can be used to treat MS are to "reconstitute" the immune system. The steps of treatment with HSC are:
  1. Bone marrow is harvested from the patient. 
  2. The HSCs are separated out from the other cells in the bone marrow. This is very important, as this also removes the pathogenic T cells that are thought to cause MS. 
  3. The HSC are multiplied in vitro (outside of the body). 
  4. Meanwhile, the patient's immune system is completely destroyed using chemotherapy. 
  5. The HSC are then transplanted back into the patient. 
  6. The HSC works to completely rebuild the immune system. However, the "new" immune system does not contain pathogenic T cells.
Dr. Freedman presented data from the Canadian MS Bone and Marrow Transplant study, which was conducted in 26 patients with very aggressive MS. These patients were on no therapy. Here is what happened:
  • None of the participants experienced relapses and no new lesions were detected.
  • Ten patients stabilized, meaning they showed no clinical progression, however they did not regain function.
  • Nine patients recovered much of their lost function. These were the ones who had been diagnosed most recently.
  • However, 7 patients continued to progress in terms of disability. Researchers think that timing of this kind of stem cell therapy is crucial and that to be effective, treatment cannot wait until there is too much damage.

The European Bone Marrow Transplant Registry is currently following people who got stem cell transplants in other places. It is estimated that about 50 people with MS are getting this kind of stem cell treatment every year.
  • A majority of these patients stabilized
  • Mortality started around 5 percent, but is now down to 1.3% of people treated this way.
  • People less than 40 years old and those who had the disease less than 5 years did best. 

The International Bone Marrow Transplant Study Group is initiating a clinical trial following this conference. This trial will randomize people to the best therapy in their country vs. HSC (bone marrow transplant). Look for exciting details about this study in upcoming months.