News for the Multiple Sclerosis Community

Cochrane Review of Copaxone Says "No Effect"

The Cochrane reviews are systematic reviews of published data on various scientific topics. The most recent review was on the efficacy of Copaxone in MS and the conclusion they came to was:

Glatiramer acetate did not show any beneficial effect on the main outcome measures in MS, i.e. disease progression, and it does not substantially affect the risk of clinical relapses. Therefore its routine use in clinical practice is not currently supported.

Some more comments on this are found here. Interesting to have this come out so soon after they published their release talking about the 10 year results and how well people were doing.

Cochrane reviews exclude all studies which are not randomized and placebo controlled, so this may not be entirely fair. See this message on the Yahoo Low Dose Naltrexone board from aegis; I'll copy his message here for those who aren't members:
This Cochrane article was discussed with Teva last year. Teva had pointed out several shortcomings in the Cochrane review. Cochrane Reviews have excluded all studies which were not randomized and placebo controlled. Anyone familiar with Copa knows that the stinging and local redness cannot be imitated by a saline placebo. Therefore, it is impossible to have a proper placebo controlled study. Many good studies have been excluded from analysis, see below.

"Out of 103 references identified by the search strategy, 41 abstracts were provisionally selected to be read as full published papers. A further 24 were then excluded based on the following criteria: eight were uncontrolled open-label studies (Abramsky 1977; Bornstein 1982; Baumhefner 1988; Kott 1997; Meiner 1997; De Seze 2000; Duda 2000; Flechter 2002b), six reported on experimental investigations where only laboratory endpoints have been assessed (lymphocyte activity, cytokine outburst, uric acid increase) (Constantinescu 2000; Qin 2000; Brenner 2001; Chen 2001; Farina 2001; Karandikar 2002), four restricted the analysis to MRI parameters (Cohen 1995; Mancardi 1998; Wolinsky 2001; Sormani 2002), three were comparing glatiramer acetate and beta-interferons without any placebo group (Fusco 2001; Khan 2001; Flechter 2002a), one study considered pretreatment data a control for the treatment effect without randomising patient allocation as it is required in cross- over design (Miller 1998), one was a re-analysis of the US phase III study where neuropsychological test performance has been measured as the only clinical endpoint (Weinstein 1999) and the last one re- analysed the US phase III core trial introducing a peculiar summary measure of the total in-trial morbidity (Liu 2000). (See table of excluded studies)."

art's picture
Yeah, I've contacted Teva and they said they are formulating their response. I'll post it when I get it.