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Saturday, April 1, 2017

5 Things to Know About the New MS Medication: Ocrevus (TM) (Ocrelizumab)


                                                                  
  
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Ocrevus (ocrelizumab) for Primary Progressive and Relapsing MS 
Ocrevus will be used for treating primary progressive MS. 
In clinical trials, Ocrevus was found to slow the progress of disability in primary progressive multiple sclerosis (PPMS), which accounts for approximately 10 percent of MS patients.
Ocrevus will also be used for treating relapsing MS patients. 
Ocrevus was found to slow disease activity in more patients taking the drug compared to those who were taking Rebif.
Ocrevus targets myelin-attacking B-cells. 
Ocrevus is an anti-CD20 monoclonal antibody which works by targeting the mature B-cells which contribute to demyelination and damage to nerve cells. Most MS medications currently available work by targeting T-cells. This is one of the only medications that attacks these specific B-cells.
The outcome of the clinical trials. 
More than 1,600 MS patients participated in clinical trials for Ocrevus and 94 percent of participants had fewer brain lesions during the 96 weeks of treatment.
There was little increased risk of infection. 
The clinical trials for Ocrevus also found that while patients taking the drug did have a slightly increased risk of common colds and flu, they had no significant increased risk of other infections when compared to patients taking the alternative medication, Rebif.
Read more from MultipleSclerosisNewsToday



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Friday, March 31, 2017

Aaron Boster, MD Discusses How OCRELIZUMAB works in MS


                                                                  
  



Dr.Boster explains how OCRELIZUMAB works in #MS

Learn more from here: https://www.ocrevus.com/ 
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Ocrelizumab and Risk for Infections


                                                                  
  


Published on Feb 25, 2017
Dr. Daniel Kantor talks with Dr. Kottil Rammohan, Professor of Neurology at the University of Miami School of Medicine about Ocrelizumab and the risk for infections.

 Click above. Listen to Learn


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Thursday, March 30, 2017

When You Have MS, You Can’t Live Without …


                                                                  
  
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Written by Kareem Yasin | Published on March 30, 2017



Multiple sclerosis, or MS, affects about 2.3 million people worldwide. Living with the condition can present a host of challenges. Luckily, no matter what you’re going through, there’s usually a person, activity, personal mantra, or even a product to help give you the support or motivation to keep going.

We asked you: when you have MS, what’s one thing you can’t live without?
ms
“Hope. I couldn’t live without hope. Although I don’t foresee what many would consider a 'cure' for MS in my lifetime, that doesn’t mean that I do not have hope for that cure. Mostly, it's a hope that ours is the last generation to live without a cure for multiple sclerosis. But here's the thing: Hope without a plan is just a dream. I suppose what I really couldn't live without is the knowledge that some of the brightest, some of the most dedicated, and some of the most compassionate researchers of our age are working to end this damnable disease. There is a plan. They are the plan. So my hope is not just an empty dream."
Continue reading the article by clicking here and see if you can find any familiar people's names... 

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MS Voices: What Triggers Your Sensory Overload?


                                                                  
  
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Written by Kareem Yasin
Medically Reviewed by Deborah Weatherspoon, PhD, RN, CRNA, COI on March 15, 2017



Many people with multiple sclerosis (MS) have symptoms that aren’t talked about very much. One of these is sensory overload. When surrounded by too much noise, exposed to too many visual stimuli, or put in new or loud environments, many people with MS report experiencing confusion, fatigue, and pain.

Sometimes, sensory overload is related to myoclonus, a stimulus-sensitive symptom that can cause involuntary jerking of muscles.
We asked our MS community on Facebook what their triggers for sensory overload are. Read on to see what they said.

Noise

ms voices
“Noise in closed areas, such as parties, classrooms, malls, stores, etc. As long as I can leave the environment, I will be OK.” — Esther D., living with MS
“Noise! I can feel like my head is collapsing.” — Rhonda L., living with MS
“Noise of any sort. My cat meowing at me can freak me out at times." — Amy M., living with MS
“Someone chewing crunchy stuff.” — Deanna L., living with MS
“I get overwhelmed with too much background noise, especially if someone is trying to talk to me. And with two small kids, there is always background noise!” — Brandi M., living with MS
CONTINUE from Healthline



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Wednesday, March 29, 2017

OCREVUS information


                                                                  
  OCREVUS multiple sclerosis logo

NOW APPROVED



 


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Press Release: Genentech’s OCREVUS (ocrelizumab) for people with relapsing or primary progressive forms of multiple sclerosis (MS)


                                                                  
  
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Tuesday 03.28.17 - 8:33pm ET

The FDA approved Genentech’s OCREVUSTM (ocrelizumab) for people with relapsing or primary progressive forms of multiple sclerosis (MS). This is the first and only approved treatment for primary progressive MS (PPMS), which is one of the most disabling forms of MS.

OCREVUS is an important new treatment option for people with relapsing forms of multiple sclerosis (RMS) demonstrating superior efficacy on the three major markers of disease activity compared with Rebif®.

Key findings from the two Phase III RMS and one Phase III PPMS studies are included below and additional information is in the press release. As a reminder, results from these three Phase III studies were recently published in the January 19, 2017 issue of the New England Journal of Medicine (NEJM).
·       A large Phase III study, OCREVUS significantly slowed disability progression and reduced signs of disease activity in the brain compared with placebo in people with PPMS. 
·       Two large Phase III clinical studies showed that when compared to interferon beta-1a (Rebif®) in people with RMS, OCREVUS reduced relapses by nearly half, was better at slowing disability progression and suppressed signs of disease activity in the brain over two years. 

OCREVUS represents a different scientific approach to treating MS. It is a first-in-class medicine that targets CD20-positive B cells, a type of immune cell that plays a central role in the disease.



FDA Approves Genentech’s OCREVUS™ (Ocrelizumab) For Relapsing and Primary Progressive Forms of Multiple Sclerosis

·       First and only approved disease-modifying therapy for primary progressive form of multiple sclerosis (PPMS) – one of the most disabling forms of multiple sclerosis (MS)
·       An important new treatment option for people with relapsing forms of multiple sclerosis (RMS) demonstrating superior efficacy on the three major markers of disease activity compared with Rebif®
·       A favorable benefit-risk profile demonstrated in three large Phase III studies with a diverse patient population, including those early in the disease

South San Francisco, CA -- March 28, 2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved OCREVUS™ (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. The majority of people with MS have a relapsing form or primary progressive MS at diagnosis.

“The FDA’s approval of OCREVUS is the beginning of a new era for the MS community and represents a significant scientific advance with this first-in-class B cell targeted therapy,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Until now, no FDA-approved treatment has been available to the primary progressive MS community, and some people with relapsing forms of MS continue to experience disease activity and disability progression despite available therapies. We believe OCREVUS, given every six months, has the potential to change the disease course for people with MS, and we are committed to helping those who can benefit gain access to our medicine.”

In two identical RMS Phase III studies (OPERA I and OPERA II), OCREVUS demonstrated superior efficacy on the three major markers of disease activity by reducing relapses per year by nearly half, slowing the worsening of disability and significantly reducing MRI lesions compared with Rebif® (high-dose interferon beta-1a) over the two-year controlled treatment period. A similar proportion of people in the OCREVUS group experienced a low rate of serious adverse events and serious infections compared with people in the high-dose interferon beta-1a group in the RMS studies.

In a separate PPMS Phase III study (ORATORIO), OCREVUS was the first and only treatment to significantly slow disability progression and reduce signs of disease activity in the brain (MRI lesions) compared with placebo with a median follow-up of three years. A similar proportion of people in the OCREVUS group experienced adverse events and a low rate of serious adverse events compared with people in the placebo group in the PPMS study.

The most common side effects associated with OCREVUS in all Phase III studies included infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity. Results from these three Phase III studies were recently published in the January 19, 2017 issue of the New England Journal of Medicine (NEJM).

“This is an exciting day for everyone touched by MS, a disease that strikes in the prime of a person’s life when she or he may be starting a career or family,” said June Halper, MSN, APN-C, MSCN, FAAN, chief executive officer at the Consortium for MS Centers. “We have eagerly awaited the FDA approval of OCREVUS because it not only offers a new, highly efficacious treatment option for people with relapsing multiple sclerosis, but it is also the first disease-modifying therapy indicated for primary progressive multiple sclerosis, a highly disabling type of this chronic disease. For many people living with MS, this FDA approval is a source of hope.”

OCREVUS will be available to people in the U.S. within two weeks. Genentech is committed to helping people access the medicines they are prescribed and will be offering comprehensive services for people prescribed OCREVUS to help minimize barriers to access and reimbursement. Patients can call 1-844-OCREVUS for more information. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or http://www.Genentech-Access.com.

The OCREVUS Marketing Authorization Application (MAA) has also been validated by the European Medicines Agency (EMA) and is currently under review.

About the OPERA I and OPERA II studies in relapsing forms of MS

OPERA I and OPERA II are Phase III, randomized, double-blind, double-dummy, global multi-center studies evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months) compared with interferon beta-1a (44 mcg administered by subcutaneous injection three times per week) in 1,656 people with relapsing forms of MS. In these studies, relapsing MS (RMS) was defined as relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS) with relapses.

About the ORATORIO study in primary progressive MS

ORATORIO is a Phase III, randomized, double-blind, global multi-center study evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months; given as two 300 mg infusions two weeks apart) compared with placebo in 732 people with PPMS. The blinded treatment period of the ORATORIO study continued until all patients had received at least 120 weeks of either OCREVUS or placebo and a predefined number of confirmed disability progression (CDP) events was reached overall in the study.

A summary of the data from the OPERA I, OPERA II and ORATORIO studies that support this approval is below.

Key data in RMS patients treated with OCREVUS showed:

A 46 percent and 47 percent relative reduction in the annualized relapse rate (ARR) compared with interferon beta-1a over the two-year period in OPERA I and OPERA II, respectively (p < 0.0001 and p < 0.0001).
A 40 percent relative risk reduction in confirmed disability progression (CDP) sustained for 12 weeks compared with interferon beta-1a in a pooled analysis of OPERA I and OPERA II, as measured by the Expanded Disability Status Scale (EDSS) (p=0.0006).
A 94 percent and 95 percent relative reduction in the total number of T1 gadolinium-enhancing lesions compared with interferon beta-1a in OPERA I and OPERA II, respectively (p < 0.0001 and p < 0.0001).
A 77 percent and 83 percent relative reduction in the total number of new and/or enlarging T2 lesions compared with interferon beta-1a in OPERA I and OPERA II, respectively (p < 0.0001 and p < 0.0001).
Key data in PPMS patients treated with OCREVUS showed:

A 24 percent relative risk reduction in CDP sustained for at least 12 weeks compared with placebo, as measured by the EDSS (p=0.0321).
A -0.39 cm3 mean change in volume of brain hyperintense T2 lesions compared with a 0.79 cm3 mean change in volume of placebo-treated patients over 120 weeks (p < 0.0001).
A 25 percent relative risk reduction in the proportion of patients with 20 percent worsening of the timed 25-foot walk confirmed at 12 weeks.
The most common side effects associated with OCREVUS in all Phase III studies were infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity. Potential serious side effects may include infusion reactions, infections and malignancies where only routine screening is required based on age and medical history.

About multiple sclerosis

Multiple sclerosis (MS) is a chronic disease that affects an estimated 400,000 people in the U.S., for which there is currently no cure. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the brain, spinal cord and optic nerves, causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including muscle weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with MS experience their first symptom between 20 and 40 years of age, making the disease the leading cause of non-traumatic disability in younger adults. 

Relapsing-remitting MS (RRMS) is the most common form of the disease and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Approximately 85 percent of people with MS are initially diagnosed with RRMS. The majority of people who are diagnosed with RRMS will eventually transition to secondary progressive MS (SPMS), in which they experience steadily worsening disability over time. Relapsing forms of MS (RMS) include people with RRMS and people with SPMS who continue to experience relapses. Primary progressive MS (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15 percent of people with MS are diagnosed with the primary progressive form of the disease. Until now, there have been no FDA-approved treatments for PPMS.

People with all forms of MS experience disease activity – inflammation in the nervous system and permanent loss of nerve cells in the brain – even when their clinical symptoms aren’t apparent or don’t appear to be getting worse. An important goal of treating MS is to reduce disease activity as soon as possible to slow how quickly a person’s disability progresses. Despite available disease-modifying treatments (DMTs), some people with RMS continue to experience disease activity and disability progression.

About OCREVUS™ (ocrelizumab)

OCREVUS is a humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved.

OCREVUS is administered by intravenous infusion every six months. The first dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.

OCREVUS U.S. Indication

OCREVUS is a prescription medicine used to treat adults with relapsing or primary progressive forms of multiple sclerosis.

It is not known if OCREVUS is safe or effective in children.

Important Safety Information

Who should not receive OCREVUS?

Do not receive OCREVUS if you are a patient that has an active hepatitis B virus (HBV) infection. Do not receive OCREVUS if you are a patient that has had a life threatening allergic reaction to OCREVUS. Patients should tell their healthcare provider if they have had an allergic reaction to OCREVUS or any of its ingredients in the past.

What is the most important information about OCREVUS?

OCREVUS can cause serious side effects, including:

Infusion Reaction: OCREVUS can cause infusion reactions that can be serious and require a patient to be hospitalized. A patient will be monitored during the infusion and for at least 1 hour after each infusion of OCREVUS for signs and symptoms of an infusion reaction. Patients should tell their healthcare provider or nurse if they get any of these symptoms: itchy skin, rash, hives, tiredness, coughing or wheezing, trouble breathing, throat irritation or pain, feeling faint, fever, redness on the face (flushing), nausea, headache, swelling of the throat, dizziness, shortness of breath, fatigue, fast heart beat.
These infusion reactions can happen for up to 24 hours after the infusion. It is important that patients call their healthcare provider right away if they get any of the signs or symptoms listed above after each infusion. If a patient gets infusion reactions, the healthcare provider may need to stop or slow down the rate of the infusion.


Infection:
OCREVUS increases a patient’s risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Patients should tell their healthcare provider if they have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or signs of herpes (such as cold sores, shingles, or genital sores). These signs can happen during treatment or after a patient has received their last dose of OCREVUS. If a patient has an active infection, their healthcare provider should delay treatment with OCREVUS until the infection is gone.
Progressive Multifocal Leukoencephalopathy (PML): Although no cases have been seen with OCREVUS treatment, PML may happen with OCREVUS. PML is a rare brain infection that usually leads to death or severe disability. Patients should tell their healthcare provider right away if they have any new or worsening neurologic signs or symptoms. These may include problems with thinking, balance, eyesight, weakness on one side of the body, strength, or using arms or legs.
Hepatitis B virus (HBV) reactivation: Before starting treatment with OCREVUS, a patient’s healthcare provider will do blood tests to check for hepatitis B viral infection. If a patient has ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with OCREVUS. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. A healthcare provider will monitor a patient if they are at risk for hepatitis B virus reactivation during treatment and after they stop receiving OCREVUS.
Weakened immune system: OCREVUS taken before or after other medicines that weaken the immune system could increase a patient’s risk of getting infections.
Before receiving OCREVUS, patients should tell their healthcare provider about all of their medical conditions, including if they:

have ever taken, take, or plan to take medicines that affect the immune system, or other treatments for MS.
have ever had hepatitis B or are a carrier of the hepatitis B virus.
have had a recent vaccination or are scheduled to receive any vaccinations. A patient should receive any required vaccines at least 6 weeks before they start treatment with OCREVUS. A patient should not receive certain vaccines (called ‘live’ or ‘live attenuated’ vaccines) while being treated with OCREVUS and until their healthcare provider tells them that their immune system is no longer weakened.
are pregnant, think that they might be pregnant, or plan to become pregnant. It is not known if OCREVUS will harm an unborn baby. Patients should use birth control (contraception) during treatment with OCREVUS and for 6 months after the last infusion of OCREVUS.
are breastfeeding or plan to breastfeed. It is not known if OCREVUS passes into the breast milk. Patients should talk to their healthcare provider about the best way to feed their baby if the patient takes OCREVUS.
What are possible side effects of OCREVUS?

OCREVUS may cause serious side effects, including:

Risk of cancers (malignancies) including breast cancer. Patients should follow their healthcare provider’s recommendations about standard screening guidelines for breast cancer.
Most common side effects include infusion reactions and infections.

These are not all the possible side effects of OCREVUS.

Patients should call their doctor for medical advice about side effects. Side effects may also be reported to the FDA at 1-800-FDA-1088.

For more information, go to http://www.OCREVUS.com or call 1-844-627-3887.

For additional safety information, please see the full Prescribing Information and Medication Guide.

About Genentech in neuroscience

Neuroscience is a major focus of research and development at Genentech and Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease and autism.

About Genentech

Founded 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.



All trademarks used or mentioned in this release are protected by law. Rebif is a registered trademark of Merck KGaA and EMD Serono, Inc.





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Tuesday, March 28, 2017

The Detriment of Unsolicited Advice Regarding MS and Chronic Illness


                                                                  
  
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BY TERESA WRIGHT-JOHNSON 

I am sure many of us have had instances where someone “offered” their advice on what is the best way to manage our illnesses. They are not medical professionals and many of them don’t suffer from the disease themselves. They present their beliefs as scientific dogma, often referring to something they have read or  heard and have formed an opinion about.

I have had people ask why I choose to take traditional MS medication as opposed to holistic or natural therapy. Their opinion is emboldened by their belief that the approved therapies for MS damage the body over time, that they are a conglomerate of pharmaceutical companies, insurance companies and medical professionals for financial gain, and they do not guarantee the disease will not progress. My response is that nothing is guaranteed.

I have been told, as if I am uninformed, that MS is an inflammatory disease. A few have declared that reducing the inflammation in my body will “cure” my disease. That is not the case. While there is a multitude of evidence to support that symptoms of MS can be reduced and/or alleviated by eating foods that reduce inflammation, I have not yet seen any empirical evidence to prove that belief.

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Monday, March 27, 2017

Cannabidiol (CBD) Processing and information


For information on this CBD Supplement
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CBD might help you to reduce pain from Spasticity


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Dedicated Handicapped Parking is About Availability, Not Cost


                                                                  
  
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Written By: Paula Hardin

Being disabled by MS does not have many advantages. One — free city street parking in California — is likely to end soon. In the rush to garner parking revenue, though, the lack of concurrent discussion about providing dedicated handicapped parking (DHP) is troubling. The widespread abuse damages accessibility for disabled people, including those of us with MS.
Ignorant people too often do not comprehend that not all disabled people are in wheelchairs. When discussing how to stop abusers, they characterize the “worthy” handicapped as “wheelchair-bound” or “severely disabled.”
We don’t need any stinking disability police!
The abusers might look just like someone with MS. I hop out of my car and carry my books into the library and don’t LOOK disabled. In reality, without the DHP, sometimes I would not be able to go in the library at all. My problem is not solved with free parking. My problem will be solved only with DHP.

They are going to regret giving me that parking ticket

My new role as a disability rights activist was triggered by getting a parking ticket. I discussed my ongoing parking battles in another column as well.
That parking ticket made me think about disability and parking and city streets. Post-ticket, it seemed obvious to me that if parking lots were required to provide dedicated handicapped parking, so should city streets.
And a judge determined cities must provide dedicated handicapped street parking! Furthermore, the ruling held that this requirement must be met near medical care facilities, such as the one where I received my first ticket.
Read complete article by clicking here





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Integrative Medicine for MS: an Interview with Dr. Bowling


                                                                  
  
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making a difference
When you live with multiple sclerosis you search for ways to manage your disease. You turn to doctors who inevitably prescribe one of the many FDA-approved medications, but sometimes that’s not enough. To complete the picture of seeking better health, you need to also look outside the box of traditional medicine. That’s where integrative medicine comes in.
According to Duke Integrative Medicine, here are the principles of integrative medicine:
  • “The patient and practitioner are partners in the healing process.
  • All factors that influence health, wellness, and disease are taken into consideration, including body, mind, spirit, and community.
  • Providers use all healing sciences to facilitate the body’s innate healing response.
  • Effective interventions that are natural and less invasive are used whenever possible.
  • Good medicine is based in good science. It is inquiry-driven and open to new paradigms.
  • Alongside the concept of treatment, the broader concepts of health promotion and the prevention of illness are paramount.
  • The care is personalized to best address the individual’s unique conditions, needs, and circumstances. Practitioners of integrative medicine exemplify its principles and commit themselves to self-exploration and self-development.”
Sometime after my 1986 diagnosis, I began hearing about a doctor who was not only an internationally renowned neurologist and MS specialist, but also a leading authority on complementary and alternative medicine (CAM) for MS patients. I was intrigued, so I went to the library to learn more about this fascinating and new (to me) branch of medicine, and also the doctor I was hearing so much about.
His name is Dr. Allen Bowling, and the Colorado-based doctor is spreading the word about CAM for the MS community. His newest book, “Optimal Health with Multiple Sclerosis: A Guide to Integrating Lifestyle, Alternative, and Conventional Medicine,” is based on his decades of research, writing, and caring about the MS community. I use it as a guide for healthy living.  

At the 2016 Consortium of Multiple Sclerosis Center’s annual meeting, I attended a symposium focusing on lifestyle factors where Dr. Bowling presented his topic, “Expanding the MS Toolkit: Integrating Lifestyle Factors and Unconventional Medicine Into MS Clinical Care.”  

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