News about and from Cellcept makers
 

http://www.newsinferno.com/archives/3370

and the official notice

http://www.rocheusa.com/products/cel...ML_May2008.pdf

I see NO notice of the FDA requiring a black label, a TOUCH-like program or any of the other hoops that Tysabri has had to put in place. That doesn't mean it isn't coming...but makes me wonder WHY, with ALL the drugs out there on the market now that have been associated with PML, natalizumab continues to be singled out after TWO years on the market without a SINGLE case of PML.

Underdeveloped pocket-padding skills.:icon_rolleyes:

I wonder if imuran carries a similar risk?

Unless things have changed recently, CellCept is not an approved drug for MS. It may be being used off-label, but it is not scientifically proven or FDA approved for MS. As far as I know, there have been only a few studies of CellCept with MS, and with very few participants.

CellCept is a chemotherapy, which is used to ward off organ transplant rejection. There are KNOWN risks with CellCept, or any of this type of drug, and EVERY doctor (and patient) is aware of those risks. Chemo is always reserved for "no other choice" patients . . .

There is huge risks associated to organ transplant, with or without the drugs those patients have to take . . . and death is the only other option to getting a transplant. That is not the case with MS as we are probably as likely to live just as long without ANY drugs.

Tysabri was intended to be marketed as a MS drug, and not only that, but the "most effective MS drug there is out there" (although studies show that to be not true, now). PwMS, ie. those of us who raised a stink about Tysabri coming back on the market, were afraid that patients were not going to be given the opportunity to make an informed decision, if the information about risks wasn't provided in a formalized manner. Of course back then, no one knew for sure that it was the combination of Tysabri with Avonex that might have been the "cause" of PML. We still don't know that, and we don't know the long-term effects of Tysabri.

They needed this period, and perhaps longer, to test the waters with Tysabri. I imagine that once there is a confidence that PML and other opportunistic infections are not a big threat, they may consider stopping the TOUCH program. No doubt Biogen is working at this as we speak. :D

Someone I know from another forum, who used CellCept, just passed on yesterday. :(

Cherie

Links please?

Whether Cellcept is approved for MS or not, it IS being used for MS. It has been used in MS for longer than 3 years, since it was one of the meds that my neuro recommended back in 2005 when Tysabri was withdrawn from the market. Other drugs used in MS have also been associated with PML, including Imuran, Rituxan, Methotrexate and others. Even interferons have been associated with PML. That information is contained within the FDA AERS site and can be searched on FDAble site.

http://www.fdable.com/main/search?al...gs&new_query=1

That makes it worth discussing in an MS forum, so we will all have the information to make an informed decision.

Cherie, is this the member of BT, who just died of Cirrosis of the Liver (thought to be caused by long term use of Beta)??

You made it sound as though she died because of cellcept.:eek:

Thanks for the link. I'm having difficulty trying to figure out how to sort on that site, perhaps that it because I am not a member. I'm unable to determine how many people are suspected to have died from the interferons (or any other drug) and PML, but I was aware of a few cases a couple of years ago. At that point, many, many thousands of people had been on these drugs though, over several years.

I adamantly disagree that there is no difference.

A FDA approved drug, developed for a specific non-life-threatening condition, should have a higher standard to live up to then a risky drug that a few aggressive doctors and risk-taking patients are willing to try off-label out of desperation.

These drugs are approved/not approved for a particular medical condition, and we should be able to have a sense that safety due diligence has been done BEFORE a drug is put on the market . . . at least for its intended purpose. What happens after that, in this day and age, seems to be (unfortunately??) mostly up to the doctors and patients.

For instance, it seems Tysabri is being rx’d to most anybody now, even though that was not the intended purpose of this drug. It was supposed to be reserved for people who had proven to have extremely progressive RR, and/or where they’ve failed on other MS approved therapies. That isn’t the only demographic using it now though . . . but to be honest, I had little doubt that would happen once it hit the market. That is one of the reasons I argued to have a program such as TOUCH when Tysabri came out.

Of course we are going back over two years now, when we were unable to look back at 30,000 patients and say “without a single case of PML”. Why something was decided “once upon a time”, dredges up the reasons that people fought for this program initially . . . which may or may not apply any longer, to this or to any other drug.

Going back in time though . . . the PML scare was not uncovered until AFTER Tysabri was fast-tracked on the market, and the Biogen execs had cashed out a boatload of shares on the drug (which lost them a lot of credibility). No one, not even Biogen, had any idea if Tysabri alone could cause the PML, especially since one of the people in the Crohns/Tysabri trial who died from PML was on monotherapy at the time he took Tysabri. We knew he had been on immunosuppressants PREVIOUSLY, but we didn’t know how much/what kind of immunosuppressants combined with Tysabri, might cause PML to occur. Personally, I wanted to be sure there was a formalized program, such as TOUCH, so people would be informed of this, and other known and unknown risks.

It’s not just Tysabri, Cellcept, Rituxan, Methotrexate, etc. that are considered potentially dangerous drugs, and it’s not just people with MS who are trying off-label drugs for their condition. This brings to mind the broader question of whether unapproved/off-label drugs (CellCept, Rituxan, Neurotin, etc.) should be permitted to be rx’d by doctors . . . but I don’t think you are meaning to debate that question with your posting?

While it is understandable why we do not have head-to-head trials on these meds, one has to wonder why they don’t at least have the same criteria for recruiting and measuring the effectiveness of a drug intended for the same patient-base. However, this recent study used “evidence-based medicine principles” to compare them . . .

Efficacy of disease-modifying therapies in relapsing remitting multiple sclerosis: a systematic comparison.

Freedman MS, Hughes B, Mikol DD, Bennett R, Cuffel B, Divan V, LaVallee N, Al-Sabbagh A.

Department of Medicine (Neurology), University of Ottawa, Ottawa, Ontario, Canada. mfreedman@ottawahospital.on.ca

The treatment of relapsing-remitting multiple sclerosis (RRMS) has become more effective over the last decade with the advent of the currently available disease-modifying therapies (DMTs). Pivotal clinical studies differ in many characteristics, such that cross-comparisons of relative risk reductions are of limited value and can be misleading.

Our objective was to compare the clinical efficacy of currently approved first-line DMTs in patients with RRMS, applying an evidence-based medicine approach. We reviewed all phase III pivotal trials of DMTs. Six clinical trials of Avonex, Betaseron, Copaxone, Rebif and Tysabri in patients with RRMS were identified for analysis. Only randomized, placebo-controlled, double-blind studies were included. The clinical efficacy endpoints compared were: proportion of relapse-free patients at 1 and 2 years; annualized relapse rate at 2 years; proportion of progression-free patients at 2 years, and proportion of patients free of gadolinium-enhancing lesions at 1 year or 9 months.

Based on these analyses, Betaseron, Rebif, and Tysabri show comparable effects, whereas for several endpoints Avonex or Copaxone did not significantly differ from placebo. In the absence of head-to-head studies for all products used to treat RRMS, it still may be possible to compare treatment effects by applying evidence-based medicine principles. (c) 2008 S. Karger AG, Basel.

PMID: 18437041 [PubMed - in process]
http://neurotalk.psychcentral.com/thread47948.html

I'm not sure of your point, because anyone who knows me, knows I have ALWAYS been one to offer up alternative views and to encourage others to do so the same on the forums. :confused:

It is extremely refreshing to have a forum, such as this one, that allow people freedom of speech . . . trust me, there are some out there (usually sponsored by the pharma companies and MS associations), that are known to shut down conversations/posters that are not 100% supportive of “their” agenda.

Cherie

I didn’t mean to imply that Sally . . . this thread about CellCept was posted on the day I found out about her death, so the topic reminded me of that announcement.

They have no idea of what cased the cirrohsis (hmmm... how would they categorize this death in that databank RW posted?), but what we do know is that she used a lot of aggressive MS treatments.

She was on Beta for 14 yrs, but it was while she was on Novantrone that they discovered a “damaged” liver. For that reason, they discontinued her last few potential dosages of Novantrone, but she continued on with Beta. Next they introduced CellCept into the cocktail, then when things got out of whack WORSE, they stopped just the Beta.

She was still RRMS, 54 yrs old, and only had MS since the early 90’s. She was not severely affected by her MS, still walked, drove, etc., so she may have had many more years ahead of her before the MS caused severe disability. However, she clearly had a very aggressive doctor . . . and personally I think she paid the price for his "experimentation". That’s what scares me about trusting doctors to make good decisions for us, and the reason I want people to be fully INFORMED of the risks they are taking.

We lost a good lady. :(

Cherie

UT Southwestern medical school in Dallas has been running clinical studies using Cellcept in combination with Avonex.

I have a friend who has been on Cellcept now for 8 years because of a rare autoimmune blood disorder. She was on her death bed (no joke) and this was the only thing that saved her life (courtesy of European doctors who figured out what to give her to save her). Anyhow, she was recently told by the doc. in the US that she now has to go off of Cellcept because she has been on it for too long. Apparently your body can only handle so much of the drug before it is at too great a risk for lymphoma, cancers, and all sorts of other nasty things. I did not know PML was a risk. Interesting....