2013 North American Education Program

Making Treatment & Lifestyle Decisions: Thinking About Benefits & Risks

Presenter’s Packet

Frequently Asked Questions

August, 2013


Welcome to the 2013 North American Education Program (NAEP) — Making Treatment & Lifestyle Decisions: Thinking About Benefits & Risks. We appreciate your taking the time to be a part of this important educational opportunity. To help with any questions that may arise, a list of frequently asked questions (FAQs) related to the subjects discussed in the DVD and program booklet was developed. In addition, discussion questions are provided to facilitate conversation with your group after watching the DVD.

These questions are not all-inclusive. If asked a question that is outside the scope of the presentation or that you or the presenter does not have an answer to, you can refer the person to an MS Navigator at 1-800-344-4867 or her or his healthcare team. If you’re considering bringing in a speaker, we encourage you to invite a neurologist, MS certified nurse or social worker knowledgeable about MS.

We want to thank Bayer HealthCare; EMD Serono; Genentech; Genzyme, a Sanofi company; Novartis; Teva Neuroscience and Questcor Pharmaceuticals, Inc. for providing generous educational grants to make this program possible.

Program Background

The National MS Society, in partnership with the MS Society of Canada, is pleased to bring you Making Treatment & Lifestyle Decisions: Thinking About Benefits & Risks. Our program this year focuses on the factors that influence people with MS, as well as their physicians and family members, as they consider their treatment and lifestyle options.

We are pleased to have the following doctors and researchers as the program’s presenters:

Deborah M. Miller, PhD, LISW

Mellen Center for MS, Cleveland Clinic

Amit Bar-Or, MD, CM, FRCPC

Professor, Neuro-immunology

Director, Experimental Therapeutics Program

Scientific Director, Clinical Research Unit

Montreal Neurologic Institute, McGill University

Robert Fox, MD

Mellen Center for MS, Cleveland Clinic

Marie Namey, APRN

Mellen Center for MS, Cleveland Clinic

Program Outcome Measurement

Each year the National MS Society strives to provide educational programming that is relevant and of interest to people living with MS. As a self-help group leader, your feedback, and that of your group, is vital. We want to know what is important in your lives and what you consider to be critical programming. Please provide your feedback on this and future NAEP programming by completing our short online survey at www.surveymonkey.com/s/GFDXCG7 or completing one of the surveys we’ve enclosed for participants. Please mail all completed surveys from group members to:

National MS Society
Heather Webb Jones
Broadway Station
900 S. Broadway, 2nd Floor
Denver, CO 80209


The National MS Society has an extensive library of resources about MS, including publications about treatment options, symptom management, and the day to day challenges of living with the disease. For more information please contact the National MS Society at 1-800-344-4867 (1-800 FIGHT MS) or visit nationalMSsociety.org and go to the About MS or Living with MS sections.

Frequently Asked Questions (FAQs) commitment

How has treating MS changed in the last 20 years?

In the past 20 years, our understanding of multiple sclerosis has expanded tremendously—and so have our choices. As recently as the early 1990s, we had no effective treatments for MS. Now, thanks to ongoing research, we know more about the origins of the disease, its triggering factors, and the wide variations in symptom type, frequency and intensity. What’s more, we now have many treatment options to modify disease activity for people with relapsing forms of MS and better address symptom management.

What factors need to be taken into consideration when making treatment decisions?

When considering a specific therapy we must decide how much risk we’re comfortable with. In addition, we must weigh numerous other factors, such as: our willingness to participate in careful screening and ongoing monitoring of our health, our ability to tolerate different kinds of side effects, and the convenience of one treatment method over another

How has the information age impacted medical decision making?

There was a time when we simply relied on doctors to make such decisions for us. They told us what the best treatment was for our condition, and we accepted that verdict. Now, many of us expect to take a greater role in our healthcare decisions, partnering with our medical team and advocating for our needs. We are more aware about what we want and don’t want out of our care. This dialogue leads to greater adherence to treatment decisions and that awareness is easier to achieve because of the vast amount of information now available.

How do emerging therapies differ from more established treatment options?

Because these medications have not been taken by as many people or for as many years as the earlier therapies, we have less data on them. We don’t know how people with more complicated health profiles will respond to them, or if very rare side effects will emerge after a period of time.

Injectable medications have been available the longest and because of that we have the most research and the most clinical experience with them. We know that on the whole, they are very safe, though they are generally thought to be only partially effective at limiting relapses. All are considered first-line treatments, meaning that the FDA has approved them for use in MS without requiring or recommending that other medications be tried first.

What sources of information are usually considered when making medical decisions?

·  Scientific data, including clinical studies

·  The media, including online blogs and social media

·  Input from friends and family

·  Healthcare professionals

How do doctors analyze the benefits and risks of medications with their patients?

There’s no single “right” amount of risk, and no “right” medication, but it is important to be comfortable with our decision so that we stick with the treatment and get the best possible result. Consider your job, family, social life, hobbies and anything else that’s important to you —and think through the impact that each risk or benefit would have in each of these realms— now and into the future.

Our healthcare team can also help you build the skills necessary to wade through the vast amounts of information, and make confident decisions. They can help us assess the likelihood of various risks given our individual characteristics, and can also help us put some risks in perspective.

Because the decision-making process is more complex now, because there are more medications that we can use to treat MS, and there are certainly concerns about the risk-benefit ratio, there should be more communication between us and our healthcare providers.

How does ones tolerance for risk, and that of their family, affect medical decisions?

What feels like a safe bet for one person may feel reckless to another. Even though the choice is ultimately up to us, family members may also bring up considerations or pressures that might not be top-of-mind for us. By discussing these concerns, family members can often agree on a plan that feels comfortable to everyone.

Does a person’s disease condition impact how tolerant they are of risk?

People vary widely in their tolerance for risk. If we’ve experienced active MS that causes problems we may gravitate toward a treatment that packs a bigger punch up -front. We may be more willing to take certain risks associated with that treatment—whether those are side effects or tolerability issues because we understand the importance of limiting new relapses. If we are doing very well with our MS overall, and a treatment is suggested that might limit relapses—so it’s a kind of an investment in your future because we are very, very functional—we may be less willing to take risks to decrease new injury

How do you weigh the risks of adverse events from a therapy compared to the risks of not taking a disease modifying therapy?

Sometimes, we get very focused on the potential risk and lose track of the purpose of a disease modifying therapy—to prevent relapses, progressive disability, scars and injury to the brain and spinal cord. We get very focused on the side effects and lose track of the bigger picture.

What should someone with MS think about when considering a switch in disease modifying therapies (DMT)?

Medical professionals advise us not to change therapies just because a new DMT becomes available. In certain cases, switching therapies can carry additional risks. In some instances, physicians will recommend a “washout” period to ensure that the first medication is out of our system before the new treatment is started; this prevents complications that could occur from two therapies being active at the same time.

What are doctors looking for out of a treatment?

It’s important for us to understand the goals of different therapies. There are three facets of treating their MS. One is treating active inflammation, typically with IV steroids.

The second is disease modifying therapies. They aim to prevent relapses, prevent lesions on the MRI, and prevent progressive disability over time. It’s not restorative. We’re not going to feel better. It’s not something we’re going to notice. It’s meant to be preventative. Doctors look at it from a relapse and lesions on the MRI perspective.

The third is the symptoms.

How does that compare with the expectations someone with MS has about their chosen treatment option?

While doctors look at disease modifying treatments from a functional point of view, i.e. relapses and lesions on the MRI, we look at from a quality of life perspective- Can I go to the soccer game? Can I go to work? Can I do what I want to do at home? It’s important that both recognize the different views. It’s important for doctors to recognize that we want to function. It’s important that we recognize the doctor wants to keep the lesions off of the MRI because that’s what’s going to keep us functioning over the long term. It needs to be a balance of those two views.

What treatment options are available for someone with primary progressive MS?

For those of us who live with progressive MS, the treatment options are much more limited. Virtually every DMT approved for relapsing-remitting MS has been tried (or is currently undergoing clinical trial) for progressive MS, but most haven’t proved effective in people who are not experiencing relapses.

In the meantime, physicians focus on providing therapies that can improve the symptoms and day-to-day functioning of people with progressive MS

Why is it taking so long to find an effective disease modifying therapy for people living with primary progressive MS?

Clinical trials for progressive MS are very challenging. Trials in relapsing-remitting MS often rely on counting relapses or using MRI scans to detect immune activity. Because there are no relapses to count, these strategies do not work for progressive MS. Instead, researchers need to study very large groups of people over very long periods of time to identify when progression occurs (or when an experimental therapy halts progression). These are very, very difficult studies to do. There is no easy way to identify progression. Researchers believe one way to measure progression is through brain atrophy; worsening of physical disability is another possible sign. But more definitive answers are needed.

Why is treating symptoms important?

Symptoms are what really affect quality of life over time. Symptom management can be critical for a person who experiences such symptoms on a daily basis as fatigue, problems with bladder control, numbness, tingling or a variety of other symptoms. Symptomatic treatment can be quite effective.

Why is it important to make decisions regarding disease modifying therapies and complementary/alternative (CAM) therapies with your healthcare team?

Most healthcare providers will not discourage us from pursuing other forms of CAM—as long as they are not damaging to our health or cost too much. Healthcare providers do want to know about all treatments we are pursuing so they can help to balance them with medications. Some CAM treatments may influence the way that our disease-modifying therapies or other prescriptions affect us. And it’s important for our clinician to know what steps we’re taking to really manage our illness. It’s important not to rely on CAM as a replacement for MS disease-modifying medication. Many of these treatments can feel nourishing and healthful, but they don’t undergo the same rigorous study of efficacy and safety as approved medications.

Are complementary and alternative therapies proven in the same way FDA approved therapies are?

The data about CAM therapies is not as robust so we don’t have that exact knowledge about the risks and benefits of some of these interventions. CAM therapies don’t undergo the same rigorous study of efficacy and safety as FDA approved medications.

What are basic nutritional guidelines for healthy living with MS?

A healthy diet is important for everyone. We now know that good dietary habits can prevent heart disease, stroke, diabetes and perhaps some types of cancer. Just like everyone else, we can be at risk for these other conditions, and should eat well to minimize these risks.

Healthcare professionals generally recommend a Mediterranean-style diet, with an abundance of lean protein—found in poultry, fish, beans and soy products—as well as healthy, unsaturated fats like those in olive oil, and lots of fruits and vegetables. The fiber in the fruits and vegetables can be especially helpful in managing constipation, which often occurs with MS. What’s good for the heart is good for MS.

Why is research on nutritional approaches or diets challenging?

It’s challenging to carry out an organized trial that relates to people’s diet because people don’t always stick to diets.

What is research showing in terms of Vitamin D?

Researchers in France noted that low levels of vitamin D seem to trigger a similar disease in mice. Numerous studies have shown a direct association between how near to the equator people live and their exposure to the sun. That in turn affects their vitamin D levels, which seems to correlate to their risk of developing MS. Those with the lowest levels appear more likely to develop the disease.