Studies Find Withdrawn MS Drug Effective
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Rating
Studies Find Withdrawn MS Drug Effective
Our Review Summary
This article discusses the results of three studies which led to the re-introduction of the multiple sclerosis drug, Tysabri, withdrawn last spring due to the occurrence of serious adverse events. The story provides no meaningful context such as the variable progression of the disease or the size of the chance it will progress to the point of disbility. The patient quotes in the piece present the view this drug is desired by patients who have experienced its benefit, notwithstanding the potential harms. However, these are a subset of patients experiencing the more severe spectrum of disease symptoms. Selection of this particular set of patient quotes sets an unbalanced tone for the article. Although the new data do highlight the rare occurrence of the brain disease PML associated with the use of this drug, it failed to mention the possibility that PML occurs only after longer-term use than was followed in these studies. As multiple sclerosis is a chronic disease, an expectation of longer-term use is a real factor for inclusion in decision making about the use of this medication and is deserving of mention.
Criteria
Not Satisfactory
Failed to mention costs. Although researchers are quoted as saying they would ‘give it to the neediest patient if it went back on the market’ it is unclear whether this means that they would give it to the poorest patients or whether they would prescribe it to those most at risk of MS relapse.
Not Satisfactory
Baseline rates of relapse were not presented.
Not Satisfactory
The possibility of progressive multifocal leukoencephalophaty was raised; no other potential side effects associated with Tsyabri treatment were mentioned. The vignettes provided imply that the drug improves clincial status rather than preventing relapses.
Satisfactory
Presented the barest details of three studies in the New England Journal of Medicine on Tysabri; one a randomized clinical trial (RCT) comparing Tysabri with placebo; a second RCT comparing Tysabri with or without interferon; and the third, a retrospective examination of the incidence for the brain disease PML in individuals treated with Tysabri for MS, Crohn’s disease or rheumatoid arthritis. This article opens with a statement about safety outcomes in the three articles discussed, though the longer term follow-up needed to reach this conclusion for the use of a medication to treat a chronic condition is still absent.
Not Satisfactory
Presented estimate for the number of Americans with MS (350,000), with the notion that there is no cure and no known cause. However the story does not adequately discuss the probability that MS remains stable, has rare worsenings, the frequency of attacks, or how often it progresses to the point of disability.
Satisfactory
Mentions that researchers have received fees or support from the marketers of Tysabri. Did not specifically mention that the data from the first paper were analyzed by the makers of the drug.
Not Satisfactory
Mention made of interferon treatment as standard in the context of trial comparison with Tysabri. No mention made of other FDA approved medications for treatment, including steroids.
Not Satisfactory
Mention is made of recent FDA approval for testing. The FDA has lifted the hold on trials with this drug. Article was not clear that for now, Tysabri is only FDA approved for MS patients participating in clinical trial. This medication is not more widely available due to previous association with adverse outcomes.
Satisfactory
Article reports on new studies using Tysabri (natalizumab) as a treatment for multiple sclerosis(MS) and indicates that this drug had been on the market but been pulled due to serious adverse events.
Satisfactory
There is no evidence that this story relied solely or largely on a news release.
Total Score: 4 of 10 Satisfactory
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