Clinical Trials of New Drug Shows Promise for Relapsing-Remitting MS

Written by Anthony Hardie, 91outcomes.com

(91outcomes.com) - Results of two new clinical trials published in the September 20, 2012 edition of the prestigious New England Journal of Medicine show great promise for the relapsing-remitting form of multiple sclerosis (MS).  MS is suspected to be more prevalent among Gulf War veterans than others.

One study of the MS drug by Dr. Ralph Gold et al found that:

BG-12 (dimethyl fumarate) was shown to have antiinflammatory and cytoprotective properties in preclinical experiments and to result in significant reductions in disease activity on magnetic resonance imaging (MRI) in a phase 2, placebo-controlled study involving patients with relapsing–remitting multiple sclerosis.  ....and significantly reduced the proportion of patients who had a relapse, the annualized relapse rate, the rate of disability progression, and the number of lesions on MRI. 

Another study examining safety, efficacy and dosage of BG-12 by Dr. Robert Fox et al found that:

In patients with relapsing–remitting multiple sclerosis, BG-12 (at both doses) and glatiramer acetate significantly reduced relapse rates and improved neuroradiologic outcomes relative to placebo.

The randomized, double-blinded, placebo controlled Phase 3 studies are the "gold standard" of medical research.

In 2008, Congress passed a mandate that the U.S. Department of Veterans Affairs (VA) contract with the Institute of Medicine (IOM) to conduct a study to determine the rates of MS in Gulf War, OIF, and OEF veterans.

To date, however, VA officials continue to violate the law mandating this contracted study with IOM, including Dr. Victoria J. Davey, Ph.D., M.P.H., R.N., head of the VA's Office of Public Health that is responsible for such contracts with IOM.  

In June, the Congressionally chartered Research Advisory Committee on Gulf War Veterans' Illnesses (RAC) issued a "no confidence" report regarding VA's handling of Gulf War Illness research, based in part on VA's lawbreaking with regards to its failure to implement the law regarding the statutorily mandated MS study. (1)

The RAC noted in its report, "Thus, four years after the passage of this legislation, it is still unknown whether Gulf War service is associated with an elevated risk of multiple sclerosis."


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(1) Report of the Research Advisory Committee on Gulf War Veterans' Illnesses , June 19, 2012; Appendix E.  Retrieved from the Internet 9/19/2012: http://www.va.gov/RAC-GWVI/docs/Committee_Documents/CommitteeDocJune2012.pdf.