Talk Cancer

Question:

- Hide quoted text — Show quoted text -Aleric wrote: > That’s true.  I was dx 6.5 years ago, so we’ve seen the same advancements as > far as available MS therapies.  However, I consider the all of the CRAB > drugs as one therapy. They are all about the same in terms of efficacy, so > the choice really comes down to lifestyle, side-effects, and things like > that. Therefore, the oft-quoted number of MS treatments available today > seems a bit misleading to me. Novantrone is different, but it is only > indicated for patients whose MS is very active or has reached a certain > stage.  I know I’m not a candidate for Novantrone at this point, so it’s not > an option.

i would separate copaxone from the interferons personally, but agree with you about the CRAB choice coming down to side effects and personal preferences. it’s occasionally frustrating for me when i see how much of the M.S. research being done is being done on already-existing therapies, whether combo trials or better packaging or whatever the case may be — but i understand (some of) the reasons it’s that way. being secondary progressive, once in a while i wish more options applied well to my own badself, but it seems more research really IS being done into SPMS, for which i’m glad. if tysabri had lived up to expectations, i’d have been glad for RRMS folks as well, because it sure did look like an ace relapse reducer, and i also feel bad for those who improved in the trials and those who were looking forward to starting tysabri after the initial FDA approval. i don’t get excited about the M.S. research often anymore — tysabri kind of sneaked through, then roared right on out the back. i was part of the second wave in the original betaseron ‘lottery,’ and the hooplah bordered on hysteria back in those days, among patients and neurologists alike. i was dx’d in 1990, and it was seroids and IVIG at the time, period, so there was huge excitement surrounding THE first new therapy approved for M.S. in — well, long before i was diagnosed, i reckon! now we’re all much more informed — sometimes to the point of being blase — and speak so casually about how the CRABs are only effective with RRMS, and only partially so at that. myself definitely included! at the same time, to the general public, every new study is a ‘BREAKTHROUGH!’ i don’t think i really have any point, other than ‘what a long, strange trip it’s been!"   rose

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Thank you Bob, Rob, A little reasurance really goes a long way. -Lucy

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hoW DID YOU HEAR THIS, I HAVE BEEN WAITING….

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"KKT" <sendme.nos…@hotpop.com> wrote in message

news:424cb987$1_2@newspeer2.tds.net… – Hide quoted text — Show quoted text -> Aleric wrote: >>>"Unlike the two MS patients identified in February, who took Tysabri in >>>combination with an older Biogen Idec MS drug, Avonex, the third case >>>involves a patient who suffered from Crohn’s disease and was taking >>>Tysabri alone as part of a different set of Crohn’s clinical trials." >> That’s a very good question.  I noticed that, also.  The Bloomberg.com >> piece that Jils posted did not elaborate on what the "immune-suppressing >> drugs" were taken for.  One might initially assume that it could’ve been >> for Crohn’s (an autoimmune condition that involving the inflammation of >> the bowels), but it could be for some other condition that wasn’t >> disclosed. The article didn’t say.   Of course, new drug trial protocols >> do not typically allow for the subject to take other drugs for the >> condition under study, for obvious reasons.  However, I do not know much >> about that particular Crohn’s study, or what the protocol was.  I suppose >> it is possible that the use of other drugs were allowed under certain >> circumstances. >> "The new case of PML was initially diagnosed as malignant astrocytoma, a >> kind of brain cancer. Biogen and Elan said they worked with the clinical >> investigator to re-evaluate the case as part of a safety review.  The >> patient had received eight doses of Tysabri over a period of 18 months, >> according to Biogen, and was also being treated with immune-system >> suppressing drugs." > I checked it out again … there seems to be conflicting reports. Of > course, most of the stuff I read was from the financial pages. Once I had > a "well, duh" moment, I went to Elan’s site and found this: > As part of this ongoing safety review, the companies, > in agreement with the clinical trial investigator, > reassessed the case. Following this additional > evaluation, the diagnosis is being reassessed as > PML. The patient had received 8 doses of TYSABRI > over an 18 month period and prior medication history > included multiple courses of immunosuppressant agents. > Elan and Biogen Idec’s comprehensive safety evaluation > concerning TYSABRI and any possible link to PML is > ongoing. The companies are reviewing clinical trial > data, working with investigators to evaluate the > approximately 3,000 patients in multiple sclerosis, > Crohn’s disease, and rheumatoid arthritis trials, and > working with PML and neurology experts. The results > of this safety evaluation will be discussed with > regulatory agencies to determine possible re-initiation > of dosing in clinical trials and future commercial > availability. > What I get from all this is that they were testing Tysabri on people with > Crohn’s disease and rheumatoid arthritis … and that the person who died > had been on immunosuppressant drugs some time prior to the Tysabri trials > [although that's not absolutely clear from what's written]. > I don’t think I’m going to be volunteering for clinical trial on this drug > any time soon …   > Kathie

Good catch.  The article you found provides a much more detailed and plausible explanation.   It makes much sense that she was no longer on the immunosuppressant drugs when she began the Tysabri. I guess one question might be, how long had it been between the time she stopped the immunosuppressants and started on the Tysabri?  I don’t know how long it takes after stopping some of those drugs before the immune system normalizes. So, whether or not that was a factor in this is probably still not known. Yes, they had been testing Tysabri in both RA and Crohn’s, as well as MS. I understand how you feel about clinical trials following something like this.  I’ve been a anxious these past few weeks being a ‘former participant’.  While I’m still officially enrolled,  obviously they aren’t dispensing the drug anymore, so there is not much going on except observation (just had *another* MRI last Friday).  Clearly, I had no idea that the stakes were quite this high when I signed the informed consent form.  I figured that if by chance, complications did arise (like infections),  they wouldn’t be serious and could be easily dealt with. Then, once the trial was over and everything looked good, this PML business comes out.   I’d never even  heard of PML before.  I think I know more than I care to know now! I think the MS clinicians, especially those who were principal investigators for the trials are stunned.  My Dr. (and a principal investigator for the trial)  told me last week,  that she was very surprised that PML occurred in those patients.  She said, that Tysabri only affected about 80% of the lymphocytes trafficking into CSF.  Some of the heavier duty MS therapies commonly used, i.e.chemo agents, affect the immune system much more profoundly.  I think it’s the unfortunate combination of Tysabri, perhaps Avonex, AND a particular individual’s immune system, that is perhaps compromised in some unknown way, that leads to the high risk of coming down with the PML condition.  If Tysabri ever does reappear on the market, it seems to me that they would have to develop a ways to both monitor and screen high risk patients for PML.  I have a feeling that will be a tall order. -Bob

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- Hide quoted text — Show quoted text -Aleric wrote: >>"Unlike the two MS patients identified in February, who took Tysabri in >>combination with an older Biogen Idec MS drug, Avonex, the third case >>involves a patient who suffered from Crohn’s disease and was taking >>Tysabri alone as part of a different set of Crohn’s clinical trials." > That’s a very good question.  I noticed that, also.  The Bloomberg.com piece > that Jils posted did not elaborate on what the "immune-suppressing drugs" > were taken for.  One might initially assume that it could’ve been for > Crohn’s (an autoimmune condition that involving the inflammation of the > bowels), but it could be for some other condition that wasn’t disclosed. > The article didn’t say.   Of course, new drug trial protocols do not > typically allow for the subject to take other drugs for the condition under > study, for obvious reasons.  However, I do not know much about that > particular Crohn’s study, or what the protocol was.  I suppose it is > possible that the use of other drugs were allowed under certain > circumstances. > "The new case of PML was initially diagnosed as malignant astrocytoma, a > kind of brain cancer. Biogen and Elan said they worked with the clinical > investigator to re-evaluate the case as part of a safety review.  The > patient had received eight doses of Tysabri over a period of 18 months, > according to Biogen, and was also being treated with immune-system > suppressing drugs."

I checked it out again … there seems to be conflicting reports. Of course, most of the stuff I read was from the financial pages. Once I had a "well, duh" moment, I went to Elan’s site and found this:         As part of this ongoing safety review, the companies,         in agreement with the clinical trial investigator,         reassessed the case. Following this additional         evaluation, the diagnosis is being reassessed as         PML. The patient had received 8 doses of TYSABRI         over an 18 month period and prior medication history         included multiple courses of immunosuppressant agents.         Elan and Biogen Idec’s comprehensive safety evaluation         concerning TYSABRI and any possible link to PML is         ongoing. The companies are reviewing clinical trial         data, working with investigators to evaluate the         approximately 3,000 patients in multiple sclerosis,         Crohn’s disease, and rheumatoid arthritis trials, and         working with PML and neurology experts. The results         of this safety evaluation will be discussed with         regulatory agencies to determine possible re-initiation         of dosing in clinical trials and future commercial         availability. What I get from all this is that they were testing Tysabri on people with Crohn’s disease and rheumatoid arthritis … and that the person who died had been on immunosuppressant drugs some time prior to the Tysabri trials [although that's not absolutely clear from what's written]. I don’t think I’m going to be volunteering for clinical trial on this drug any time soon …   Kathie

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"Bob (Aleric)" <sha…@bmwe30.net> wrote in message

news:1112383902.322558.242020@z14g2000cwz.googlegroups.com… – Hide quoted text — Show quoted text -> Lucy wrote: >> K, I’m scared now, I had one dose of Tysabri in February and I know > the >> chances of developing PML are slim but jeez, i can’t help being > scared, >> should i be taking rebif so soon after my Tysabri infusion?! > gahhh… > I believe they are recommending that you not take any other > immunomodulating MS drug for at least thirty days after stopping > Tysabri treatment, just be on the safe side. > If you haven’t, I wouldn’t lose any sleep over it. You will be fine. > -Bob

If youre not showing signs of it now, you never will.  Its a rare disease. Tysabri must block just enough WBC’s to allow the JC virus to spread enough to take over the CNS.  Stopping Tysabri allows, within a month, your WBC’s to once again cross the BBB and take care of business… like eating and digesting JC virus infected braincells.  Which is what they normally do and thats how they keep this disease in check.  Virtually all of us are infected with the JC virus, but our immune system wins the day and keeps it from causing problems.  Appearently Tysabri lowers the amount of WBC’s just enough to let it take over.  If you had PML, the incurabe progressive form of the infection, you would have known already.  If you dont have it now, youre fine. It seems Tysabri doesnt block immune cells who are targetting myelin, but instead, blocks most, if not all immune cells.  (not amount, just type)  So its not nearly specific enough.  Long ago I proposed creating a drug that blocked immune cells atuned to myelin basic protein from crossing the bbb. I wish they had done that, instead of going for the shotgun approach. It cant be that hard to develop a chemical that latches onto receptor sites of myelin atuned WBC’s making them to large to cross the bbb, or inefective in doing so.  Thats where the ultimate treatment lies.  PML is when the JC virus invades and uses astrocytes for reproduction.  The drug stopped enough immune cells from getting in there and eating those up.  Just talking out loud… Rob Rob

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- Hide quoted text — Show quoted text -Aleric wrote: >>I was thinking about it … weren’t those people diagnosed with PML >>while they were still on Tysabri? Presumably, once the drug leaves one’s >>system, the risk passes … is my logic OK on that? > Yes, that’s my understanding (on both counts). > I understand what you are saying about assessing one’s self.  However, my > assessment was corroborated by the EDSS tests they had me perform throughout > the trial.  I advanced one full point in the within > the last year.  This fact caused me to question my doctor as to whether she > thought that the combination therapy was working for me or not.  I also > asked her if she thought that advancing point on the EDSS was ‘acceptable’, > given my age, gender, MS history, the therapy, etc.  She said, that > "acceptable" was the wrong word to use and that she didn’t like it.  I > probably should have used a different term to describe what I was trying to > say, but I’m pretty sure she knew what I meant.   I still can’t express the > thought in a way the describes exactly what I mean.  In any case, I really > didn’t get a good answer from her anyway..

Do you mean "typical?" As in, "given all these things, is my condition what you would expect with this new drug?" – Hide quoted text — Show quoted text ->>I had hopes for Tysabri, too … based on anecdotal evidence. It’s >>disappointing … but there are a ton of new things on the horizon. Heck, >>there are 66% more drug therapies now as when I was diagnosed only 5 years >>ago … > That’s true.  I was dx 6.5 years ago, so we’ve seen the same advancements as > far as available MS therapies.  However, I consider the all of the CRAB > drugs as one therapy. They are all about the same in terms of efficacy, so > the choice really comes down to lifestyle, side-effects, and things like > that. Therefore, the oft-quoted number of MS treatments available today > seems a bit misleading to me. Novantrone is different, but it is only > indicated for patients whose MS is very active or has reached a certain > stage.  I know I’m not a candidate for Novantrone at this point, so it’s not > an option. > Tysabri was supposed to be the big step in MS therapy for this decade.  I’m > not sure that there will any more before 2010, but I’ve heard of two or > three that might come in before the decade is out (at least they are > scheduled to arrive by then, if they pass the trials, that is!)

Someone posted this a few weeks ago [I think I got it here}:         http://tinyurl.com/4o9qc         February 10, 2005         Daclizumab shows promise for treatment         By NewsRx.com         Daclizumab shows promise for the treatment of multiple         sclerosis. In a recent study, neurologists in the United         States "examined whether treatment with daclizumab, a         humanized monoclonal antibody specific for the interleukin-2         receptor alpha chain, was safe and efficacious in         relapsing-remitting and secondary progressive multiple         sclerosis patients." My doctor didn't know any more than was in the article and thought it would be a fair while before it was generally available. Kathie

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K, I'm scared now, I had one dose of Tysabri in February and I know the chances of developing PML are slim but jeez, i can't help being scared, should i be taking rebif so soon after my Tysabri infusion?!  gahhh...

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Lucy wrote: > K, I'm scared now, I had one dose of Tysabri in February and I know the > chances of developing PML are slim but jeez, i can't help being scared, > should i be taking rebif so soon after my Tysabri infusion?!

gahhh... I believe they are recommending that you not take any other immunomodulating MS drug for at least thirty days after stopping Tysabri treatment, just be on the safe side. If you haven't, I wouldn't lose any sleep over it. You will be fine. -Bob

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> I was thinking about it ... weren't those people diagnosed with PML > while they were still on Tysabri? Presumably, once the drug leaves one's > system, the risk passes ... is my logic OK on that?

Yes, that's my understanding (on both counts). - Hide quoted text -- Show quoted text ->> I will say, that in my case, it really didn't help as much as I had hoped >> it would.  I did experience some clinically measured progression during >> that time, so it will interesting to see what the data on progression >> looks like once it is released.  So far, the only data they have released >> relates to relapse rates. >> However, my own experience aside, I feel the disappointment many of my >> fellow MSers must feel having Tysabri pulled.  I've read many accounts >> where people starting Tysabri noticed improvement right away. So, they >> were very hopeful.   But, like most drugs, I think it would help some >> people more than others.  I may have been have been one of those >> 'non-responders'.  I really don't know.  I figure I'd be in the same >> place now if I had just taken the Avonex alone, like I was doing prior to >> the trial. > Yeah ... although I think it's hard for someone to accurately assess > his/her own progress. I'm just thinking about my MD's appointment > yesterday. I'm feeling like I'm getting worse, mainly because I'm not > walking as well. The doctor didn't see anything much he attributed to MS, > but thought that the difficulties in walking were due to arthritis ... my > self-assessment was totally off ...

I understand what you are saying about assessing one's self.  However, my assessment was corroborated by the EDSS tests they had me perform throughout the trial.  I advanced one full point in the within the last year.  This fact caused me to question my doctor as to whether she thought that the combination therapy was working for me or not.  I also asked her if she thought that advancing point on the EDSS was 'acceptable', given my age, gender, MS history, the therapy, etc.  She said, that "acceptable" was the wrong word to use and that she didn't like it.  I probably should have used a different term to describe what I was trying to say, but I'm pretty sure she knew what I meant.   I still can't express the thought in a way the describes exactly what I mean.  In any case, I really didn't get a good answer from her anyway.. > I had hopes for Tysabri, too ... based on anecdotal evidence. It's > disappointing ... but there are a ton of new things on the horizon. Heck, > there are 66% more drug therapies now as when I was diagnosed only 5 years > ago ...

That's true.  I was dx 6.5 years ago, so we've seen the same advancements as far as available MS therapies.  However, I consider the all of the CRAB drugs as one therapy. They are all about the same in terms of efficacy, so the choice really comes down to lifestyle, side-effects, and things like that. Therefore, the oft-quoted number of MS treatments available today seems a bit misleading to me. Novantrone is different, but it is only indicated for patients whose MS is very active or has reached a certain stage.  I know I'm not a candidate for Novantrone at this point, so it's not an option. Tysabri was supposed to be the big step in MS therapy for this decade.  I'm not sure that there will any more before 2010, but I've heard of two or three that might come in before the decade is out (at least they are scheduled to arrive by then, if they pass the trials, that is!) Bob

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Kathie wrote:

"> I am truly sorry to have made that comment. I didn't realize that > you were a participant and I would have been more tactful if I'd stopped > to think that someone might have this kind of concern ... I'm sorry. > Obviously, I didn't think at all ...

No apology necessary! I didn't take any offense or take your comment as insensitive at all! I don't seem much 'worse for the wear' following the combination Tysabri + Avonex treatment for 27 months. I will say, that in my case, it really didn't help as much as I had hoped it would.  I did experience some clinically measured progression during that time, so it will interesting to see what the data on progression looks like once it is released.  So far, the only data they have released relates to relapse rates. However, my own experience aside, I feel the disappointment many of my fellow MSers must feel having Tysabri pulled.  I've read many accounts where people starting Tysabri noticed improvement right away. So, they were very hopeful.   But, like most drugs, I think it would help some people more than others.  I may have been have been one of those 'non-responders'.  I really don't know.  I figure I'd be in the same place now if I had just taken the Avonex alone, like I was doing prior to the trial. --Bob

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Aleric wrote: >> I am truly sorry to have made that comment. I didn't realize that >>you were a participant and I would have been more tactful if I'd stopped >>to think that someone might have this kind of concern ... I'm sorry. >>Obviously, I didn't think at all ... > No apology necessary! I didn't take any offense or take your comment as > insensitive at all! > I don't seem much 'worse for the wear' following the combination Tysabri + > Avonex treatment for 27 months.

I was thinking about it ... weren't those people diagnosed with PML while they were still on Tysabri? Presumably, once the drug leaves one's system, the risk passes ... is my logic OK on that? > I will say, that in my case, it really didn't help as much as I had hoped it > would.  I did experience some clinically measured progression during that > time, so it will interesting to see what the data on progression looks like > once it is released.  So far, the only data they have released relates to > relapse rates. > However, my own experience aside, I feel the disappointment many of my > fellow MSers must feel having Tysabri pulled.  I've read many accounts where > people starting Tysabri noticed improvement right away. So, they were very > hopeful.   But, like most drugs, I think it would help some people more than > others.  I may have been have been one of those 'non-responders'.  I really > don't know.  I figure I'd be in the same place now if I had just taken the > Avonex alone, like I was doing prior to the trial.

Yeah ... although I think it's hard for someone to accurately assess his/her own progress. I'm just thinking about my MD's appointment yesterday. I'm feeling like I'm getting worse, mainly because I'm not walking as well. The doctor didn't see anything much he attributed to MS, but thought that the difficulties in walking were due to arthritis ... my self-assessment was totally off ... I had hopes for Tysabri, too ... based on anecdotal evidence. It's disappointing ... but there are a ton of new things on the horizon. Heck, there are 66% more drug therapies now as when I was diagnosed only 5 years ago ... KKT

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Aleric wrote: >>PML. The patient had received 8 doses of TYSABRI >>over an 18 month period and prior medication history >>included multiple courses of immunosuppressant agents.

<stuff deleted> - Hide quoted text -- Show quoted text ->>What I get from all this is that they were testing Tysabri on people with >>Crohn's disease and rheumatoid arthritis ... and that the person who died >>had been on immunosuppressant drugs some time prior to the Tysabri trials >>[although that's not absolutely clear from what's written]. >>I don’t think I’m going to be volunteering for clinical trial on this drug >>any time soon …   > Good catch.  The article you found provides a much more detailed and > plausible explanation.   It makes much sense that she was no longer on the > immunosuppressant drugs when she began the Tysabri. I guess one question > might be, how long had it been between the time she stopped the > immunosuppressants and started on the Tysabri?  I don’t know how long it > takes after stopping some of those drugs before the immune system > normalizes. So, whether or not that was a factor in this is probably still > not known.

Does anyone know? I’m not sure. > Yes, they had been testing Tysabri in both RA and Crohn’s, as well as MS. > I understand how you feel about clinical trials following something like > this.  I’ve been a anxious these past few weeks being a ‘former > participant’.  While I’m still officially enrolled,  obviously they aren’t

I am truly sorry to have made that comment. I didn’t realize that you were a participant and I would have been more tactful if I’d stopped to think that someone might have this kind of concern … I’m sorry. Obviously, I didn’t think at all … – Hide quoted text — Show quoted text -> dispensing the drug anymore, so there is not much going on except > observation (just had *another* MRI last Friday).  Clearly, I had no idea > that the stakes were quite this high when I signed the informed consent > form.  I figured that if by chance, complications did arise (like > infections),  they wouldn’t be serious and could be easily dealt with. > Then, once the trial was over and everything looked good, this PML business > comes out.   I’d never even  heard of PML before.  I think I know more than > I care to know now! > I think the MS clinicians, especially those who were principal investigators > for the trials are stunned.  My Dr. (and a principal investigator for the > trial)  told me last week,  that she was very surprised that PML occurred in > those patients.  She said, that Tysabri only affected about 80% of the > lymphocytes trafficking into CSF.  Some of the heavier duty MS therapies > commonly used, i.e.chemo agents, affect the immune system much more > profoundly.  I think it’s the unfortunate combination of Tysabri, perhaps > Avonex, AND a particular individual’s immune system, that is perhaps > compromised in some unknown way, that leads to the high risk of coming down > with the PML condition.  If Tysabri ever does reappear on the market, it > seems to me that they would have to develop a ways to both monitor and > screen high risk patients for PML.  I have a feeling that will be a tall > order.

You’re probably right. I’d be surprised to see the drug back on the market until and unless this is understood much better than it is now. Tysbari really seemed to have a very positive effect on some people, and I was truly hoping it would pan out … Kathie

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Duh.  I guess I shoould just look it up on the Intenet, but I came here first…. I THINK I heard that they are going to begin dispensing again.   OOOHHH  I have not been so excited since my first, or was it my second, (NO…It was my first…)  date… here is hoping… Eric

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check this: http://www.bloomberg.com/apps/news?pid=10000087&sid=aNBCb8yf0V7g&refe… – Hide quoted text — Show quoted text -Cropsey wrote: > Duh.  I guess I shoould just look it up on the Intenet, but I came here > first…. > I THINK I heard that they are going to begin dispensing again.   OOOHHH >  I have not been so excited since my first, or was it my second, > (NO…It was my first…)  date… > here is hoping… > Eric

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Cropsey wrote: > Duh.  I guess I shoould just look it up on the Intenet, but I came here > first…. > I THINK I heard that they are going to begin dispensing again. OOOHHH >  I have not been so excited since my first, or was it my second, > (NO…It was my first…)  date…

sorry, eric, the news you heard seems to indicate it’s LESS likely to go back on the market, rather than more likely. here’s one article (from my local paper) — http://www.signonsandiego.com/news/business/20050331-9999-1b31biogen…. another patient has died; and this person was in the crohn’s disease trials, rather than the M.S. trials, which means s/he was NOT on combo tysabri/avonex treatment, but tysabri alone. biogen’s and elan’s stocks aren’t just IN the toilet, they’re circling on their way down the drain. bright-side it, eric — you won’t have to worry about being diagnosed with something that’s guaranteed to kill you within months, so you’ll be around for the next breakthrough! rose

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> bright-side it, eric — you won’t have to worry about being diagnosed > with something that’s guaranteed to kill you within months, so you’ll > be around for the next breakthrough!

Rose, well-said and good attitude. Keep it up! Mike

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"rose" <rosedawn_sc…@yahoo.com> wrote in message

news:1112285363.637380.206870@g14g2000cwa.googlegroups.com… – Hide quoted text — Show quoted text -> Cropsey wrote: >> Duh.  I guess I shoould just look it up on the Intenet, but I came > here >> first…. >> I THINK I heard that they are going to begin dispensing again. > OOOHHH >>  I have not been so excited since my first, or was it my second, >> (NO…It was my first…)  date… > sorry, eric, the news you heard seems to indicate it’s LESS likely to > go back on the market, rather than more likely. > here’s one article (from my local paper) — > http://www.signonsandiego.com/news/business/20050331-9999-1b31biogen…. > another patient has died; and this person was in the crohn’s disease > trials, rather than the M.S. trials, which means s/he was NOT on combo > tysabri/avonex treatment, but tysabri alone. biogen’s and elan’s stocks > aren’t just IN the toilet, they’re circling on their way down the > drain. > bright-side it, eric — you won’t have to worry about being diagnosed > with something that’s guaranteed to kill you within months, so you’ll > be around for the next breakthrough! > rose

Additional details on this news:  This other patient passed away back in 2003.  She was a participant in one of the Crohn’s studies.  They thought it was a type brain cancer at the time, but have just recently determined that it was PML.  She had had only eight infusions of Tysabri.  However, I think the most important thing to point out is that she was also on some other immunosuppressant drug(s) along with the Tysabri. -Bob

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Aleric wrote: > Additional details on this news:  This other patient passed away back in > 2003.  She was a participant in one of the Crohn’s studies.  They thought it > was a type brain cancer at the time, but have just recently determined that > it was PML.  She had had only eight infusions of Tysabri.  However, I think > the most important thing to point out is that she was also on some other > immunosuppressant drug(s) along with the Tysabri.

Was she on immunosuppressants to combat the Crohn’s [Disclaimer: I know NOTHING about Crohn's]? Because the article specifically says: "Unlike the two MS patients identified in February, who took Tysabri in combination with an older Biogen Idec MS drug, Avonex, the third case involves a patient who suffered from Crohn’s disease and was taking Tysabri alone as part of a different set of Crohn’s clinical trials." KKT

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"KKT" <sendme.nos…@hotpop.com> wrote in message

news:424c5c67$1_3@newspeer2.tds.net… – Hide quoted text — Show quoted text -> Aleric wrote: >> Additional details on this news:  This other patient passed away back in >> 2003.  She was a participant in one of the Crohn’s studies.  They thought >> it was a type brain cancer at the time, but have just recently determined >> that it was PML.  She had had only eight infusions of Tysabri.  However, >> I think the most important thing to point out is that she was also on >> some other immunosuppressant drug(s) along with the Tysabri. > Was she on immunosuppressants to combat the Crohn’s [Disclaimer: I know > NOTHING about Crohn's]? Because the article specifically says: > "Unlike the two MS patients identified in February, who took Tysabri in > combination with an older Biogen Idec MS drug, Avonex, the third case > involves a patient who suffered from Crohn’s disease and was taking > Tysabri alone as part of a different set of Crohn’s clinical trials." > KKT

Hi Kathie. That’s a very good question.  I noticed that, also.  The Bloomberg.com piece that Jils posted did not elaborate on what the "immune-suppressing drugs" were taken for.  One might initially assume that it could’ve been for Crohn’s (an autoimmune condition that involving the inflammation of the bowels), but it could be for some other condition that wasn’t disclosed. The article didn’t say.   Of course, new drug trial protocols do not typically allow for the subject to take other drugs for the condition under study, for obvious reasons.  However, I do not know much about that particular Crohn’s study, or what the protocol was.  I suppose it is possible that the use of other drugs were allowed under certain circumstances. "The new case of PML was initially diagnosed as malignant astrocytoma, a kind of brain cancer. Biogen and Elan said they worked with the clinical investigator to re-evaluate the case as part of a safety review.  The patient had received eight doses of Tysabri over a period of 18 months, according to Biogen, and was also being treated with immune-system suppressing drugs." -Bob

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