I have been watching the NMSS site for an offical response to the study. I sent an email again asking when that would be available. The paper is still not available but it was email to me. So this is it in its entirety and provided by : National Multiple Sclerosis Society, Professional Resource Center
Paper Questions Efficacy of Some MS Drugs
May 9, 2008
A recently published paper* reviews results from pivotal, phase 3 clinical trials that led to the approval of the disease-modifying therapies now available for relapsing forms of multiple sclerosis.
The paper makes direct comparisons between the results of the various trials, recalculating available data, and suggests varying degrees of effectiveness between the drugs, depending on the endpoints applied. One of their findings was that in some of the comparative measures, some of the drugs were not significantly better than inactive placebo.
There is abundant proof, published in peer-reviewed journals, that the approved disease-modifying therapies for MS are significantly better than the inactive placebos against which they were tested. Building evidence also suggests that they not only impact relapses but also may slow the progression of disease.
Well-designed, placebo-controlled studies that are done for extended periods of time have represented the gold standard for evaluation of new drugs. Most statisticians believe that it is very difficult to combine and compare results from different studies, as was done for this article. Problems with this type of analysis include the fact that each study used different patient populations (with differences in their recent relapse experience, age, time from disease onset, and many other variables), different outcome measures, different timeframes of study, and even different definitions of relapses and disease progression.
At the recent American Academy of Neurology meeting in Chicago this spring, a statistician (Dr. Gary Cutter, University of Alabama) looked at this very issue and concluded that one cannot make valid comparisons between treatment effects among studies with different baseline risks or populations.
Although direct head-to-head studies could represent a better way of comparing treatments, currently no well-controlled, double-blind, head-to-head phase III studies comparing the current first line drugs approved by the FDA have been performed.
The paper was supported from funds from EMD Serono, and several of the authors work at EMD Serono or Pfizer Inc.; these companies are co-marketers of one of the drugs involved in the current comparison.
*MS Freedman, B Hughes, DD Mikol, R Bennett, B Cuffel, V Divan, N LaVallee, A AL-Sabbagh “Efficacy of Disease-Modifying Therapies in Relapsing Remitting Multiple Sclerosis: A Systematic Comparison” European Neurology (2008;60:1-11).