Biogen’s Tysabri Causes Another Brain Infection
13 CommentsBy Ed Silverman // December 15th, 2008 // 4:13 pm
Yet again, the multiple-sclerosis medication has caused a serious brain infection, the same malady that prompted the drug to be withdrawn in 2005 for about a year. A German MS patient contracted PML, or progressive multifocal leukoencephalopthy, and remains hospitalized, according to a filing by Biogen with the Securities and Exchange Commission.
This is not good news for Biogen and its marketing partner, Elan, which have issued three previous statements this year about four other MS patients contracting PML after taking Tysabri (back story). Nonetheless, the drug has been used by about 35,500 patients as of September, and about 9,500 have taken the injection for at least 18 months, The Wall Street Journal notes.
Coincidentally, the disclosure comes just a few days after Novartis reported that an experimental MS pill cut annualized relapse rates by 38 to 52 percent in a study, depending on the dose, compared with treatment with Avonex, another Biogen MS drug. Moreover, one investor just called for the ouster of the Elan ceo over complaints that Tysabri marketing was botched (see here).
Ivan
Yawn!
Condor
So — Ivan, a brain infection bores you?
That’s strike two against you. . . I saw one of your otehr comments — you are in danger of being definitively labeled as a Kool-Aid drinker (with two cups of sugar).
Whatever, dude.
Namaste.
Nathan
Condor - So let me get this strait: You think that 2 brain infections (maybe this is the third?) out of ~35,000 users of this drug *IS* a big deal? (a drug that treats an absolutely devestating disease, by the way) I think you’re smoking crack!
-A coolaid drinker.
Condor
Um, Nathan — let’s get this straight (note spelling): I think feigning boredom (Ivan’s “yawn”) in response to someone else’s suffering. . . is a big deal.
So, to answer your question, Kool-Aid boy: Yes.
Namaste.
Nathan
Condor,
So you were commenting on Ivan’s lack of concern, not on the severity of the problem.
Ok, so let’s have a more reasoned discussion. What are you saying should happen in responce to these brain infections? 3 out of 35,000 is a pretty small percentage. MS is a pretty devestating degenerative disease. I would gladly accept a ~1 in 10,000 risk of a (non-fatal) infection with the hope that I might have another few years of quality life. Maybe you think about these issues differently. Please explain.
Thanks,
Kool-Aid boy
Bingo
Kool-Aid Boy,
Unfortunately, PML us usually NOT non-fatal in this population.
An NIH website reports that “For non-AIDS individuals with PML, the prognosis remains grim; the disease usually lasts for months and 80 percent die within the first 6 months, although spontaneous improvement has been reported. Those who survive PML can be left with severe neurological disabilities.”
Hardly worth a yawn, especially among those who have taken the drug.
Nathan
Bingo,
I agree that it’s hardly worth a yawn - but I disagree that this is any sort of a significant issue. If we were treating PMS, then I agree that a 0.01% risk of PML is an unacceptable. But MS? There really are no good treatment options for MS — a 1 in 10,000 risk of dying doesn’t sound so bad to me….
Bruce
Nathan
The risk of PML with Tysabri is 1in1000. There have been 3 confirmed cases in MS patients and 1in a crohns patient. I have worked with MS patients for three years and while they are desperate for something to cure them, a lot are not willing to risk death or a vegetative state for that cure.
Hi Ed. I am still around.
Nathan
Thanks Bruce - how is the risk 1 in 1000 when there have only been 4 confirmed cases but (according to Ed’s article) between 9700 and 35,000 people have taken the drug?
By the way, there are ~43,000 deaths by car accidents in the US every year. Our population (250 million) suggests that the “random” death rate is ~1 in 5000 people PER YEAR will be killed by a car accident. That is about the same risk that people with MS face by taking this drug. That’s hardly a risk in my mind…
Ivan
Condor
The yawn was in reply to yet another piece of sensationalist rubbish written by journalists that seemingly have a hidden agenda. So please do not try to play the emotional blackmail card. Nobody wants to see people suffer.
The irony of these, continued and often incorrect media pieces, serves only to muddy the waters for those people wanting to understand the real issues.
We do not want to read another manufactured ‘gutter press’ article aimed at damaging companies and stock prices and when we see such most of us sigh and, in my case, yawn!
Ivan
Ed Silverman
Dear Ivan,
With all due respect, I believe my three-paragraph post was rather straightforward and conveyed basic information about a drug that is widely used, offers a great deal of benefit for many patients, but unfortunately, has also a history of causing a problem for others - to the extent that Tysabri was briefly off the market. You know this much, though, yes?
In running this item, I was providing coverage of what turns out to be an ongoing story. If there are factual mistakes in my post, please point them out and I will correct them, assuming your own facts are accurate. However, I assure you there was no attempt to ‘damage companies and stock prices.’ There was no hidden agenda and, to be honest, I think your accusations are off base.
Perhaps you would prefer such episodes go unreported. You don’t say anything about your own agenda. But there are many reasons that such information should be reported, because there are people - regulators, doctors, patients and, yes, investors, among others - who do need to know.
Hope this helps,
ed
Lauren Roberts
Dear Mr. Silverman, please note that this patient that developed PML had a history of MS and prior disease modifying therapies, including beta-interferons…, these prior DMDs could have been Imuran/Azathioprine, CellCept, Remicade, Novantrone, etc.)
Those particular medications can last for years in the body even though the patient has discontinued them for quite some time.
Also, please note that the expert authors of the New England Journal of Medicine attribute PML to a diminished immune system, and not to Tysabri. See: http://tinyurl.com/2mhn82
So far, it has been determined that each patient which developed PML was severely immune suppressed prior to &/or during Tysabri therapy, thus developing PML.
There are currently over 46,000 patients that have been treated with Tysabri (according to statements made by Biogen)
I honestly believe that Tysabri has been given a bad rap…, the ABCRs efficacies only range from 29% to 34% [respectively], and Tysabri’s efficacy is 67% when it comes to preventing further relapses, slowing the disease process down and shows significant improvements with regard to function in some MS patients.
Tysabri is the only MS FDA approved medication which can make that claim.
Respectfully submitted,
Lauren Roberts (MS patient for 33 plus years & and Tysabri patient for more than two years)
Ed Silverman
Hi Lauren,
Thanks for your note. And please don’t misunderstand me - I’m not making any judgement about Tysrabi or its value to MS patients. I simply reported that another case of PML occurred and noted the context, which is that a few other cases were recently reported.
Again, I think Ivan was confusing the messenger with the message - the case arose and it was reported. I do not believe that writing about the exisnce of another case is the same thing as saying Tysabri is a bad drug. If I wanted to write that, I would have done so.
Hope this helps,
ed