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Ocrevus

Most of you have probably heard that the FDA recently approved ocrelizumab (Ocrevus) for treatment of RRMS and for primary progressive MS. This drug is an infusion, given 2 weeks apart initially and every 6 months thereafter.

In the research trials the safety profile has been very good. No cases of JCV infection (PML) have been reported. Infusion reactions may occur but can usually be managed. It is a longer infusion than Tysabri or solumedrol and may take the better part of a day.

The first patients that we will try to start on this are ones currently on Tysabri who are JCV carriers.

The timetable for actually starting the drug is not clear. Reimbursement and insurance issues are yet to be ironed out. Nevertheless we hope to begin using it within a few weeks.

It will take time to get everyone switched so please be patient. This is a serious drug, with serious effects on the immune system, and an office visit will be needed for everyone prior to starting.

There has been some unrealistic media hype about this. Clearly it seems to be an effective drug but it does not reverse disability that a person already has, and will not be the best choice for everyone. Think of it as another good arrow in the quiver.

MS Update 10/16

I apologize for the hiatus but there have not really been any major developments recently.

One new drug, daclizumab, has been approved by the FDA for RRMS. This is a once a month subcutaneous injection, brand name Zinbryta. It has some rather serious side effects including skin reactions, liver disease which can be severe, swollen glands, and other autoimmune disorders. It is not yet in widespread use and its place in our arsenal of MS drugs is not yet clear. It is generally reserved for patients who have tried and failed a couple of other drugs.

Ongoing studies on Tysabri safety in patients who carry the JC (John Cunningham) virus continue to suggest that extended interval dosing - from every 5 to every 8 weeks - is still effective from the MS standpoint and may offer some protection from PML. The study is ongoing.

Disappointing news from ECTIMS in London - the anti-LINGO drug trial was negative. These drugs were hoped to help with remyelination

Rumor has it that ocrelizumab (Ocrevus) may be approved by the FDA in December. The exciting feature of this drug is that it seems to protect against progression in patients with primary or secondary progressive MS. It also is very effective for relapse prevention. It is a type of drug called a B-cell depleter, and is closely related to rituximab which itself is often used, off-label, for MS.

Ocrevus is given as an intravenous infusion in the office once every 6 months. SIde effects have been mild in the trials and so far there have been no cases of JC virus related problems. Questions do remain about cost (likely high), insurance coverage, etc. Much will depend upon the FDA's wording of the approval.

And the best news of all -- Dr Ingrid Loma-Miller, fellowship-trained MS doc for adults and kids, will be joining me full time in January. As many of you know, she has a real passion for caring for people with MS and related disorders and I am very excited to have her coming on board! She also has a special interest and expertise in women's issues in MS including pregnancy & fertility

Diet & MS

Today I'm happy to welcome Renee Scott Walker, PA, to the blog. Renee has recently been researching diets for MS and here are her findings. Thanks Renee! DIET AND MULTIPLE SCLEROSIS There are many times that my patients ask what is the best diet for MS? My response is typically, there is no one good diet for MS. Diets are like MS medications. You never know which is going to be a good fit for you. You have to try something and see how you feel. I recently gave a talk at the National MS Society MS Live Well, Live Fully conference in Virginia Beach about nutrition and MS. I looked into several diets that possibly helps individuals with MS. Listed below are summaries about some of the diets that are argued to help individuals with MS. DISCLAIMER: The diets listed below are not the only diets that can help with MS. Also, it is not to say that these are the only diets to try. If you know of another diet out there that has worked well, let me know. From experience, the MS community is one of the most knowledgeable and pro-active groups out there! We call all learn things from one another. If you are interested in learning more specifically about any of the diets listed below, go to your local book store and check out the books shown below. BEFORE STARTING A NEW DIET PLEASE CONSULT WITH YOUR HEALTHCARE PROVIDER FOR GUIDANCE. The Paleo Diet The Paleo diet is based on the theory that humans are not designed to handle the current diet. The goal is to eat like our ancestors ate in a hunter-gatherer lifestyle. There are 7 keys to the Paleo Diet 1. Eat a relatively high amount of animal protein compared to that in the typical American diet 2. Eat fewer carbohydrates than most modern diets recommend, but eat lots of good carbohydrates– from fruits and vegetables, not from grains, starch tubers, or refined sugars 3. Eat a large amount of fiber from non-starchy fruits and vegetables 4. Eat a moderate amount of fat, with more good (monounsaturated and polyunsaturated) fats than bad (trans and certain saturated)fats, and nearly equal amounts of omega 3 and omega 6 fats 5. Eat foods with a high potassium content and a low sodium content 6. Eat a diet with a net alkaline (basic) load 7. Eat foods rich in plant phytochemials (biologically active compounds found in plants), vitamins, minerals, and antioxidants Rules are as follows: • Eat all the lean meats, fish, and seafood you can eat • Eat all the fruits and non-starchy vegetables you can eat • Avoid cereals (Barley, corn, oats, quinoa, rice, rye, wheat) • Avoid legumes (beans, peas, lentils, peanut butter) • Avoid dairy product's (milk, butter, cheese, yogurt) • Avoid processed foods There are some reports that this diet can improve fatigue in progressive MS patients. Drawbacks to the diet are that you may not get enough vitamin D or B vitamins. Supplementation is recommended if you are deficient in those vitamins. The Wahls Protocol Dr. Terry Wahls is a physician who was diagnosed with multiple sclerosis in 2000. Within three years of diagnosis, Dr. Wahls was so disabled that she required a power wheelchair. Dr. Wahls decided to research brain biology and autoimmune disease. She changed the way she obtained her nutrients using a "nutrient-rich paleo diet." Over time this approach resulted in a reversal of her disabilities. The Wahls Protocol focuses on the function of the mitochondria. Mitochondria are the powerhouse of most cells. They produce energy for your body. Well functioning mitochondria helps the body function efficiently and properly. There are three phases of the Wahls Protocol. –Phase One - Wahls diet Eat nine cups of fruits and vegetables every day –Three cups tightly packed raw or cooked leafy greens, like kale, collards, chard, Asian greens, and lettuces –Three cups deeply colored vegetables and fruits, such as berries, tomatoes, beets, carrots, and winter squash –Three cups sulfur-rich vegetables, including broccoli, cabbage, asparagus, Brussels sprouts, turnips, radishes, onions, and garlic Cut out all gluten and dairy products –Approved grains includes: corn, millet, oats, potato flour, quinoa, rice –Approved dairy includes: almond, coconut, hazelnut, rice, soy milk Eat high-quality protein Try to use organic, grass-fed, or wild-caught foods. –Phase Two- Wahls Paleo This is more strict than phase one • Reduce all non-gluten grains, legumes, and potatoes to just two servings per week. • Add seaweed or algae along with organ meats to your diet • Add fermented foods, soaked seeds and nuts, and more raw foods –Phase Three - Wahls Paleo Plus This is the most restrictive phase • Eliminate ALL grains, legumes, and potatoes • Consume at least 6 cups of vegetables, divide evenly between greens, color, and sulfur vegetables • Reduce cooked starch vegetables and fruits • Add coconut oil and full-fat coconut milk • Eat just twice per day and fast twelve to sixteen hours every night The Starch Solution (Dr. McDougall diet) Dr. John McDougall suffered a stroke at the age of 19. This sparked his interest in medicine. During his practice of medicine, he noted that patients did not improve as anticipated. This drove Dr. McDougall to see if there were ways to improve health outside of traditional medications. He looked into food and found that starches may be the answer. The diet is a low-fat high carbohydrate, moderate sodium, vegan diet. Its goal is to center the food on your plate around starches, adding color and flavor with non-starchy vegetables and fruits Foods to enjoy: • Starchy vegetables • Whole grains • Pastas • Beans • Rice or nut milk • Brown rice • Nut based yogurts Foods to avoid: • Meat • Poultry • Fish • Dairy • Eggs • Vegetable oils • Processed or packaged foods Drawbacks to the Starch Solution include deficiencies in: • Vitamin B12 • Vitamin D • Omega fatty acids • Calcium The Swank Diet Dr. Roy Swank was a physician who was one of the first physicians to look at diet as it relates to MS. In 1948 he started treating individuals with MS with his diet. He studied patients taking this diet and found that overall, his patients had better outcomes than individuals not on his diet. This diet essentially is a low fat diet for patients with MS. It focuses on reducing both unsaturated and saturated fats. Rules are as follows: • You will eat no red meat for the first year. This includes dark meat of chicken and turkey • Following the first year, 3 ounces of red meat will be allowed once per week. The eating of red meat is discouraged except on special occasions • Dairy products containing 1 percent butterfat or more will be eliminated • All processed foods containing saturated fat will be eliminated As stated earlier, this is just a sampling of diets that could potentially help those with multiple sclerosis. If anyone out there has tried one of these and noticed significant improvement, let us know. We would love to hear about your success!! • •

ECTRIMS/2015

The biggest news from the recent ECTRIMS conference in Spain was the data about the new drug called ocrelizumab. This is a type of drug know as a B-cell depleter, meaning that it targets B-cell lymphocytes. Many of our existing treatments target T-cells, a different type of lymphocyte, so this is a fairly dramatic new step. In general, B-cells fight infection by producing antibodies, while T-cells attack invaders, bacteria, viruses, etc, directly.

The new drug is similar to a drug called rituximab, (Rituxan), which seems to be effective for MS but which is not FDA approved for MS, for reasons which are financial and political, not medical.

The new drug is a monoclonal antibody, and is given intravenously every 6 months. So far the side effects have been very mild. PML has been very rare with rituximab, and no cases have been seen so far with ocrelizumab. Most importantly it seems very effective at reducing relapses and new MRI activity, much better than interferon. It also seems to slow the progression of progressive MS, which is very exciting since the only other drug shown to do that is novantrone, which has serious side effects.

So will ocrelizumab be the next big thing? it’s possible, but obviously it’s early days, but stay tuned. Genentech plans to submit it to the FDA for approval in early 2016, so if all goes well it could be approved as early as the end of 2016.

Other research showed that most patients, about 70%, treated with alemtuzumab (Lemtrada) had no further relapses or worsening of disability for up to 4 years after treatment, which is certainly encouraging.

Finally there was a very interesting study with minocycline, an antibiotic with a good established safety record, showing that it slowed the progression of patients with the very early, CIS form of MS to full blown MS. We shall see.

Health Insurance

Toady I am happy to welcome Wendy VanFossen, CPA to the blog. Maany of you know her from her role coordinating Tysabri benefits. She has long experience with heath insurance issues and i’m happy to have her share some of her insights today.

It’s that time of year again when many people have to make a decision about their health insurance. If you have MS, it’s especially important that you fully understand the benefits and costs of your policy and how to compare policies if you have the choice. Before you even start looking at the details of each policy, call your MS doctor’s office to be sure they accept all of the insurances you are considering. If you still have several policies to consider, you need to compare the premiums, deductibles, copays, maximum out of pocket limits and prescription coverage.

Let’s start with some easy to understand definitions:

Premium – the monthly amount you will have to pay to have health insurance.

Deductible – the amount of your medical bills you will have to pay before your insurance will pay for anything. You will hear the phrase “after you have met your deductible” frequently. This means that if the deductible is $500, once you have paid out $500, this is the amount your insurance will cover.

Copay – the amount you will be responsible for (after you have met your deductible). This may be a percentage or a set amount. Be aware that many times there is a different amount for your primary care doctor and a specialist.

Maximum out of pocket (OOP) – this is the maximum amount you will be responsible to pay during the plan year. Be sure you know what your plan year is. Most often it is January – December, but it may be different. The maximum will include the deductible and any copays. Once this amount has been met, you will not have to pay any more copays during that plan year. For some plans, this includes prescriptions but most of them don’t have a maximum for prescriptions.

Prescription coverage – this is how your prescription medications will be covered and how much it will cost you to get a prescription filled. A plan may require you to use a mail order pharmacy.

Referrals – Some insurance policies require you to get an insurance referral from your primary care physician(PCP) before you can see a specialist. This is your responsibility so be sure you know if the insurance you are considering requires this and if it’s something you want to be bothered with. Most importantly, if you chose a plan that requires a referral, you will have to choose a PCP that participates in that plan. If this is a new PCP for you, you will have to see that physician for a visit before they will issue any referrals.

The next step is for you to think about how you use your insurance. If you have MS, you are most likely on at least one, if not several, expensive medications. Depending on your treatment, you may also need frequent MRI’s, infusions, lab work, etc. All of these items can add up really fast and need to be considered when evaluating the total cost of your insurance. Also consider how often you go to other doctors and if you frequently need home health or other medical services. If you have access to your insurance statements, take a look at them to make sure you’re not forgetting anything. This will also give you a good idea of the cost of different services so you can calculate percentages if necessary.

Use all of this information to try to estimate your copays and out of pocket costs for a year for each plan, remembering to cap the amount at the maximum OOP. Next add in the yearly premium. This will give you the total cost and allow you to compare the available plans. Many times there is a significant difference in premiums and only a slight difference in the OOP. If you’re likely to reach the maximum, then go with the cheaper premium. If you don’t use your insurance very often, you may want to go with a high deductible plan and save on the premiums. You just need to be prepared for a large bill if you need unexpected medical care. If you use your insurance a lot, it may save you money to pay the higher premium and have lower copays and OOP.

If you are still confused, talk to the insurance carrier, your employer or your physician’s insurance office. Your physician’s office cannot tell you which plan to choose but can help explain how the different plans work and let you know their experiences with each one.

Wendy VanFossen, CPA

PML with Oral MS Drugs

In recent months there has been one case of PML reported with each of two oral MS drugs, Tecfidera and Gilenya. There have been other reported cases occurring after changing from Tysabri to oral drugs, but those cases have been attributed to the prior Tysabri.

The Tecfidera patient had been on the drug for nearly 5 years and had run a very low lymphocyte count (a type of white blood cell) for much of that time. JC virus status prior to the PML had not been tested. This patient subsequently died.

The Gilenya patient had been on the drug for about 4 years. PML was diagnosed by MRI and confirmed with JC virus in the spinal fluid. Gilenya was stopped and the patient is reported to be doing well.

I should emphasize that these are very rare occurrences, but they do emphasize the need for careful surveillance of all patients on immune therapy. There is no need to stop taking Gilenya or Tecfidera but we will continue to monitor all patients on these drugs carefully.

Welcome Renee Scott Walker, PA-C

All of us here at MSCT are very happy to welcome the addition of Renee Scott Walker, PA-C, to our team. Ms. Walker is a certified MS health professional, having spent the past 6 years working with MS patients at the local Sentara hospitals. She received her Physician's Assistant degree at EVMS.

I hope many of you will get to meet Ms Walker in the upcoming months. We are thrilled to have her on board!

Lemtrada Approved

Last month the US FDA approved the use of alemtuzumab (Lemtrada) for relapsing forms of MS. This comes a year after they had declined to approve the drug, primarily for safety concerns. It has already been approved in 40 other countries.

Lemtrada is a monoclonal antibody directed at CD52 T&B white blood cells. It has been available in the past as second line treatment for chronic lymphocytic leukemia.

This drug will generally be available only to patients who have failed at least 2 other MS medications. There will be restricted distribution system called Lemtrada REMS - Risk Evaluation and Mitigation Strategy.

For MS it is given as a 12mg infusion over 5 consecutive days in year one, then on 3 consecutive days a year later. Whether further treatment will generally be required is not known with certainty, but the biological effects are long lived.

Side effects can be significant. Infusion reactions can be serious, and cases of thyroid inflammation, thyroid cancer, and platelet (bleeding) disorders may occur.

In clinical trials, Lemtrada has been shown superior to interferon in reduction of relapse rates , and reduced accumulation of disability in one of 2 studies. Like most MS drugs, it has not been tested head to head with any other competitors.

It is way too early to tell where this drug will fit in the MS armamentarium, but it is always good to have more choices. I will continue to keep you posted.

Tecfidera & PML

Biogen Idec has recently reported that a patient taking Tecfidera for MS has died of PML. This is a rare viral disease of the brain caused by activation of the JC (John Cunningham) virus, which is normally a harmless virus carried by over half of the population.

We do not have all the details of this case, but the patient had apparently been on Tecfidera for about 4&1/2 years and had run a persistently low lymphocyte (a type of white blood cell) count. We don't know the age or sex of the patient, or what dose they were taking.

At this point our center will continue to monitor all patients on Tecfidera carefully, with regular checks of white blood counts and MRI scans as needed. Patients who do run persistently low white blood counts might be candidates to switch therapies.

It is important to realize that this is a single isolated event among many thousands of patients taking Tecfidera. There is no need to panic, and I do not recommend stopping the medicine without checking with your doctor.

I will update you about this as new information is available

ACTRIMS/ECTRIMS

Kathy & I have just returned from the MS Boston meeting of ACTRIMS & ECTRIMS, the American & European Committees on Treatment and Research In MS. I also attended a conference on NMO sponsored by the Guthy-Jackson Foundation.

There were no huge breakthroughs this time, but some interesting research all the same.

Stem Cells: 2 studies were presented about stem cell trials. In one case the cells were given intravenously and in the other they were given intrathecally (into the spinal fluid space, by spinal tap). These were both preliminary studies designed to assess safety. In both studies the treatments were safe & well tolerated but so far there have been no signs of benefit. Early days.

Epidemiology: Low salt diet has been found to be helpful in MS. Also, smokers with MS tend to progress their disability more rapidly than non-smokers, so if you need any more incentive to quit, here it is. Smokers on Tysabri are also 2&1/2 times more likely to develop anti-Tysabri antibodies, which then neutralize the Tysabri.

Treatments, etc: Daclizumab, a monthly SQ injection, was showed to reduce the annual relapse rate by 45%, in the range with the current oral drugs. Not clear yet whether or not this will be approved by FDA.

There has been new research on NMO showing that some patients have different antibodies, called MOG, instead of NMO antibodies. These patients have somewhat different clinical findings, usually less severe.

The generic form of Copaxone was shown to be just as effective as the brand. This is important since it might lead to cheaper treatments among the biological medications. Look for the drug companies to fight this.

Plegridy, a new interferon preparation

Just recently the FDA approved Plegridy, or pegylated interferon, for patients with relapsing MS. This is a drug similar to Betaseron and Rebif/Avonex but adjusted so that is a sustained release preparation.

Plegridy will be given only once every 2 weeks, subcutaneous (small needle), with injector. Effectiveness and side effects probably not too different from other interferons - convenience and fewer injections are the main benefits.

Not quite ready to prescribe but soon. Best candidates for this are patients stable on other interferons already.

Research Update

I was able to attend the American Academy of Neurology annual meeting this past May in Philadelphia. Several items of interest, in no particular order:

1) Lemtrada (see previous post) will be re-examined by the FDA. This was the result of a lot of pressure from the MS community, patients, doctors, and organizations. I don't know the timetable but keep your eyes on this blog.

2) a new drug with promise for women with MS called Estriol. This is a type of estrogen normally secreted in the body during the third trimester of pregnancy, which happens to be when women are least likely to suffer MS relapses. When added to Copaxone, it reduced the number of MS relapses compared to another group on Copaxone alone. Safety was good in this trial. It is not available yet in US.

2) Pegylated interferon is likely to be approved soon. This is beta-interferon 1-alpha, similar to Avonex or Rebif, but chemically altered so that it can be given only once every 2 weeks. It will also be a subcutaneous shot, not intramuscular.

3) A monoclonal antibody known as Ofatumumab, which is used for some leukemias, has shown good results in RRMS. It's similar to Rituxan which we use for NMO, a disease related to MS, and occasionally for MS itself when all else fails.

4) There is evidence that high dose Lipitor (atorvastatin) may retard the progression of progressive MS. Other similar statin drugs have not been tested but if this is confirmed it would be a big breakthrough. The tested dose was high, 80 mg/day, which can be associated with muscle weakness and pain.

5) Another drug called laquinimod, which was not terribly effective against relapses, does seem to prevent progression and may get another look.

6) Smoking increases progression rate among patients with progressive MS. So quit, already!

Lemtrada Update

As many of you have heard, the FDA has recently failed to approve Lemtrada as a treatment for MS. The following article in the Wall Street Journal summarizes the feelings of many in the MS community including most MS specialists:

The FDA Nixes a Pathbreaking Drug for MS

Christopher DeMuth Sr. And

Christopher DeMuth Jr.

Jan. 16, 2014 7:12 p.m. ET Thirty developed nations have approved Lemtrada. The U.S. refusal to do so shows the need for regulatory reform.Alemtuzumab is used today as an intravenous treatment for a form of leukemia. But 20 years of research centered at Cambridge University also has shown that the action of this drug—depleting immune cells that become misdirected and attack one's own body—is effective in treating multiple sclerosis.

We are invested in Lemtrada through a partnership that one of us manages—and we still think the investment will do well. European authorities have called Lemtrada a "step change" in treating MS, and it will promptly become an important therapy at the intermediate"relapsing-remitting" stage of the disease. This is the stage when patients still have periods of normal life before permanent brain and nerve damage sets in.

It was sickening to watch the FDA deny an obviously effective and important therapy to those afflicted with a terrible disease. For as long as the decision stands, much needless suffering will result (and much needless foreign travel). The agency's action is also a vivid example of the serious problems besetting U.S. drug regulation.

The primary reason FDA reviewers gave for rejecting Lemtrada was that the studies demonstrating the drug's efficacy did not conform to the agency's standard requirement of double-blind, placebo-controlled drug trials—where some patients, unbeknownst to themselves and their doctors, receive placebo treatments. There are excellent reasons for the standard approach, but only up to a point. Lemtrada and many established MS treatments have immediate side effects, such as nausea and headaches, that are well known to doctors and patients. A double-blind trial would not really be blind. Patients on a placebo would promptly discover that they were the "controls," and many would decline to participate further—scrambling the statistical comparison with patients receiving real treatments.

The Lemtrada investigators therefore designed "active control" trials that matched it against a leading MS therapy (a branded version of beta interferon) that would be its primary clinical alternative. The trials found that Lemtrada patients relapsed into active MS symptoms at rates 50% lower than patients taking the alternative. These results were buttressed by MRI and other objective measures that found, for example, highly significant reductions in brain atrophy and new brain lesions.

FDA officials turned their backs on these powerful results. Drug regulators inhabit a complex world that mixes strong political pressures, abstract questions of biological science and statistical inference, and practical trade-offs between the benefits and risks of new therapies. In these circumstances, the agency elevated the double-blind, placebo-controlled trial to the level of dogma. It simplifies the reviewers' work and reduces the need to make case-by-case judgments about an appropriate trial design. Most of all, it leaves the agency with wide discretion, at the end of years of development and evidence, to say "no" or "tell us more."

For Lemtrada, the FDA reviewers announced that the trials were not "adequate and well-controlled." They are now demanding another round of trials, with somewhat different procedures, that would take years and cost at least $100 million. Given the magnitude of the results of the already completed trials, the additional trials could add nothing to answering the regulatory question of whether Lemtrada is suitable for clinical use against MS.

The Lemtrada application was one of a growing number of cases where progress in biological science is upsetting FDA doctrine. The drug was developed through decades of "clinical science" that combines scientific method with continuously recalibrated clinical treatments. The research, conducted by world-leading academic neuroscientists, encountered and solved many biological and clinical puzzles along the way, enlarging scientific understanding of MS's underlying mechanisms.

By the time alemtuzumab entered regulatory review, its properties and effectiveness in treating relapsing-remitting stage MS were already well understood. In rejecting a therapy widely known to be highly effective, the agency's reviewers were sending a defiant message to the medical community: The advance of biological research and development must conform to FDA institutional prerogatives rather than the other way around.

FDA reviewers raised an additional concern. Lemtrada, they said, presents serious health risks to patients that may exceed its health benefits. Lemtrada treats aberrations in the immune system, and that intervention does present risks, mainly of thyroid and blood disorders. But the risks of the drug are well known from the Cambridge research and from a decade of clinical use, in much higher doses, treating leukemia. In almost all cases when the disorders do appear, they are much less severe and more easily treated than MS itself.

There is no reason to deny doctors and patients the choice of Lemtrada over other therapies that have risks of their own. For many with MS, the choice will be an easy one—as the fervent petitions of MS patients and advocacy groups during the FDA review attest.

Lemtrada is administered just twice—in one-week intravenous regimens, one year apart—compared with established therapies that are administered continuously on a monthly, weekly or daily basis. And a significant number of Lemtrada patients find themselves free of MS debilities after just the first session. These are enormous benefits. Yet at a public meeting in November, one FDA reviewer warned an agency advisory committee that because Lemtrada patients would have less need to see their physicians constantly, it could be more difficult for physicians and the FDA to monitor them.

This objection is revealing. At some point, regulatory command-and-control needs to make room for the welfare of patients and the skills and professionalism of their doctors.

If Lemtrada does no more than postpone progressive, irreversible paralysis for a few years, permitting patients to live normal lives, that is a great blessing even if some of them fall off the FDA grid. But the therapy is also slowing the progression of the disease—some patients have remained free of clinical disease activity for up to 14 years.

With experience and learning, these successes may point the way to averting MS damage to the central nervous system at the earliest, asymptomatic stages. Medical progress is iterative; it must be free to pursue the logic of the problem at hand at each incremental step.

The cascade of Lemtrada approvals outside the U.S. demonstrates that vigilant public regulation can adapt to, and make use of, modern biological science. It should be adopted here. FDA reform will not be achieved in a single decision, but it will certainly require decisions, and correcting the stark mistake made about Lemtrada would be an excellent step in the right direction.

Messrs. DeMuth are, respectively, a distinguished fellow at Hudson Institute and a managing partner of Rangeley Capital LP. Rangeley Capital invests in a Lemtrada-specific security that is publicly traded.

Welcome Dr. Ingrid Loma-Miller

I have the great pleasure to announce that Dr. Ingrid Loma-Miller will be joining me at the MSCT beginning October 9. Dr. Loma-Miller is a board-certified pediatric neurologist at CHKD who has also completed a Fellowship in MS at the University of Pittsburgh, so that she is fully trained to see both children and adults with MS. She is actually the first and only Fellowship-trained MS doctor in the Tidewater area. She has a special interest in women's health issues in MS as well, including pregnancy and MS.

Dr. Loma-Miller will be seeing patients one day a week at the MSCT, on Wednesdays as it now stands. I think she will be a terrrific addition to our team and I know that you will enjoy meeting her.

Tecfidera Side Effects

Now that we have started quite a few patients on Tecfidera we have found that the side effects we are seeing are a little different from what we expected.

Some patients do get flushing, and it may involve lots of areas of the body, not only the face. Taking a baby aspirin and Zyrtec about an hour before the Tecfidera may cut down on the flushing, but it often disappears on its own after a week or two, sometimes sooner.

The bigger problem has been GI related - nausea, vomiting, cramping, and diarrhea. To help with this we and others around the country have found that a medication called Robinul, an antispasmodic, can help, usually 1/2 to 1 mg an hour before the Tecfidera. There is also a different starting schedule which may help if you are just beginnning. Remember that the Tecfidera does not work well if taken only once a day.

Please call the office if you need help with any of these side effects.

NMSS Recognition

I am very happy to announce that our center, the MS Center of Tidewater, has been officially designated as a Partner in MS Care-Center of Comprehensive Care by the National Multiple Sclerosis Society.

This is a very prestigious designation, and we join the James Q. Miller Center at UVA as one of only two such centers in Virginia.

To become a Partner in MS Care-Comprehensive Care Center we had to demonstrate superior capability in and/or access to all facets of MS care. These included neurological expertise, certified MS nursing care, an infusion center, psychological evaluation and support, and easy access to many other specialties and disciplines.

Many thanks to our team - Kathy, Jamie, Wendy, Shantate, Janet, and Christina, for all their hard word to make this possible. Also thanks to Robyn at the Hampton Roads Chapter of the NMSS for helping us navigate all the paperwork, and to everyone at the national office who evaluated us.

We are proud to work together with the National MS Society toward our shared goal of making the world free of MS.

BG-12 (Tecfidera) Approved

As expected, the FDA today approved dimethyl fumarate (aka BG-12), to be marketed as Tecfidera. As with most of the other drugs for MS, it has been approved only for the relapsing-remitting type of MS.

We will be meeting with the company, Biogen Idec, soon and will try to obtain details on the rollout.

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