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discusses the results of three studies which led to the re-introduction of the multiple sclerosis drug, Tysabri, withdrawn last spring due to the occurrence of serious adverse events.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.
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.
Baseline rates of relapse were not presented.
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.
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.
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.
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.
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.
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.
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.
There is no evidence that this story relied solely or largely on a news release.
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like