Drug Approvals and FDA Denials
This week TEVA Pharmaceutical Inc announced that the FDA has approved the new 40mg/mL formulation of Copaxone (glatiramer acetate) designed to be injected subcutaneously three-times-a week. Although TEVA hopes to transition current daily Copaxone users to the new formula, the original 20mg/mL formula will continue to be available, even after it goes off patent in May 2014 and faces generic competition from Mylan Inc. The safety and efficacy of the longer-lasting dosing was demonstrated in the GALA study, results published in Annals of Neurology (Ann Neurol. 2013 Jun;73(6):705-13. doi: 10.1002/ana.23938. Epub 2013 Jun 28.) Copaxone is prescribed for the treatment of relapsing-remitting MS to reduce the number of clinical exacerbations; and for patients who have experienced a first clinical episode and have MRI features consistent with MS.
But not all decisions made by the FDA regarding MS disease-modifying drugs were positive. At the end of December, Genzyme, a subsidiary of Sanofi, failed to receive FDA approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of MS although it is already approved in the European Union, Canada, and Australia. Alemtuzumab is a humanized anti-CD52 monoclonal antibody that rapidly depletes CD52-expressing T- and B-lymphocytes from circulation which suppresses inflammation (J Clin Cell Immunol. 2013 Jul 8;4(4). pii: 1000152). It has been shown to be effective in reducing relapse rate and the accumulation of disability in 3 clinical trials involving more than 1700 MS patients, however it has also been associated with increased infection and development of new autoimmune disorders. A recently published review of the clinical trials appears in the International Journal of MS Care (Int J MS Care. 2013 Winter;15(4):159-68. doi: 10.7224/1537-2073.2013-004.) In anticipation of FDA approval of Lemtrada in MS, Genzyme pulled Campath (alemtuzumab) from the market in September 2012 to prevent off-label prescribing.
Risk of MS and Disease Progression
Alcohol consumption may actually protect against the development of MS.
The genetic or familial risk of developing MS may be lower than previously reported, according to a new study involving 28,161 MS patients representing an estimated 96% of the MS population in Sweden.
Low levels of serum vitamin D in newly-diagnosed MS patients is an early predictor of disease activity and progression, according to a new Harvard study published in JAMA Neurology.
MS Community Discussion Online and CCSVI
Discussions in any community setting can easily be driven by outspoken individuals or those highly devoted to the subject. It is no different in online health-related forums where patients go to connect with others, gather and share information, and learn from all variety of experiences and opinions. In a recent observational study, researchers used the largest Germany MS online forum as the database to analyze forum member debate about the controversial Chronic Cerebrospinal Venous Insufficiency (CCSVI) hypothesis (J Med Internet Res. 2014 Jan 14;16(1):e10. doi: 10.2196/jmir.2875).
Of 139,912 posts from 11,997 threads posted between January 2008 and August 2012, 8628 posts discussed or at least mentioned CCSVI. Researchers detected 31 posts which included hyperlinks pointing to CCSVI-related scientific publications. In contrast, 2829 different URLs were posted to the forum, most frequently referring to social media such as YouTube or Facebook.
Researchers identified a total of 6 different roles of hyperlink posters including Social Media Fans, Organization Followers, and Balanced Source Users. Apart from the large and nonspecific residual category of the "average user", several specific behavior patterns were identified, such as the small but relevant groups of CCSVI-Focused Responders or CCSVI Activators whose behavioral patterns played a core role in fueling the discussion about CCSVI.
Several studies investigating CCSVI have been published in the past 4 years. Robert Zivadinov and Chih-Ping Chung provide an excellent review of the science in "Potential involvement of the extracranial venous system in central nervous system disorders and aging" (BMC Med. 2013 Dec 17;11:260. doi: 10.1186/1741-7015-11-260) with an accompanying editorial, "Is there a link between the extracranial venous system and central nervous system pathology?" (BMC Med. 2013 Dec 17;11:259. doi: 10.1186/1741-7015-11-259). Another brief review of the CCSVI saga is presented in "Goodbye to all that: a short history of CCSVI" (Mult Scler. 2013 Oct;19(11):1425-7. doi: 10.1177/1352458513502400).
Lisa Emrich is a patient advocate, accomplished speaker, author of the award-winning blog Brass and Ivory: Life with MS and RA, and founder of the Carnival of MS Bloggers. Lisa uses her experience to educate patients, raise disease awareness, encourage self-advocacy, and support patient-centered research. Lisa frequently works with non-profit organizations and has brought the patient voice to health care conferences and meetings worldwide. Follow Lisa on Facebook, Twitter, and Pinterest.