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02-29-2008, 12:40 PM
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#101 | |||
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Grand Magnate
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Given that this is the sticky for those people who are contemplating Tysabri might review, it's probably as good a place as any to store all NMSS warnings/bulletins that come out along the way (like this recent liver one).
I am aware of two other warnings that have come out previously: Research Bulletins Bulletins Archive Researchers Report that Stopping Tysabri Increased MRI-Detected Disease Activity in Some Patients, September 14, 2007 Researchers from one site involved in the pivotal studies of Tysabri® (natalizumab, Biogen Idec and Elan Pharmaceuticals) in relapsing forms of MS report that stopping the drug may lead to an increase in the number of new and enlarging lesions (areas of damage or disease activity) detected on magnetic resonance imaging scans. They compared before-treatment scans with scans from a 15-month period after 21 participants stopped taking the drug. No substantial increase of clinical activity, such as relapses, was noted. These findings of “rebound” activity occurring in a small sample of patients warrant confirmation in independent, larger groups of people before recommendations can be made concerning Tysabri administration. Drs. Machteld Vellinga, Chris Polman (VU University Medical Center, Amsterdam, the Netherlands) and colleagues report the findings in the online edition of the journal Neurology (published online September 12, 2007). Background: Tysabri was approved by the FDA for relapsing MS based on its ability to slow disability progression and reduce relapses in two pivotal clinical trials, called AFFIRM (which compared Tysabri alone to inactive placebo in 942 people with relapsing MS) and SENTINEL (which tested Tysabri plus interferon beta-1a or Tysabri plus placebo in 1171 people with relapsing MS). Detailed results were published in The New England Journal of Medicine 2006;354:899-910 and 2006;354:911-923). These studies were suspended when two cases of PML (progressive multifocal leukoencephalopathy, a rare and frequently fatal disease of the central nervous system) were diagnosed in those on combination therapy. One of those cases was fatal. A third case of PML, also fatal, was uncovered in another person who had taken Tysabri during a clinical trial for Crohn’s disease. “Rebound” findings: When dosing was suspended in these studies at the VU University Medical Center in Amsterdam, the neuroradiologist reviewing post-treatment MRI scans noticed an increase in lesions among participants. The team analyzed “T2” lesions, which show cumulative damage, from 21 people who had MRI scans of their brains taken before taking Tysabri and again within a 15-month interval after discontinuing the drug. Participants were divided into two groups: one group took the drug for an average of three years, and the other group took the drug for an average of two months. Their findings show that the total group of participants developed more than three times as many lesions in the 15-month period after discontinuing the drug than before they started taking it. This increase was mainly driven by those who took the drug for an average of two months, who experienced five times as many brain lesions after stopping the drug. Clinical relapses did not increase following suspension of the drug. These findings of “rebound” activity occurred in a small sample of patients, and warrant confirmation in independent, larger groups of people so that their potential significance to clinical practice in terms of the administration of Tysabri can be determined. http://www.nationalmssociety.org/sit...rch_2007sept14 Research Bulletins Bulletins Archive Two Cases of Melanoma (Skin Cancer) Reported in People Taking Tysabri for MS, February 7, 2008 Physicians in Boston have reported two cases of melanoma (skin cancer) that developed in women in their practice who were administered Tysabri® (natalizumab, Biogen Idec and Elan Pharmaceuticals) to treat their multiple sclerosis. John T. Mullen, MD, and two colleagues (Beth Israel Deaconess Hospital, Boston) reported the cases in the New England Journal of Medicine (2008;358[6]:647-8). The melanomas developed early in the course of treatment, but it cannot be confirmed from these case reports that Tysabri caused them. However, the authors advise against treating individuals with Tysabri when there is a personal or family history of melanoma or in patients with atypical moles or ocular nevus (spot at the back of the eye). Background: Tysabri is a laboratory-produced monoclonal antibody that is approved for patients with relapsing forms of MS to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations. It is designed to hamper movement of potentially damaging immune cells from the bloodstream, across the "blood-brain barrier" into the brain and spinal cord. Details: Dr. Mullen’s team reports that a 46-year-old woman developed a melanoma shortly after receiving her first dose of Tysabri, and an ocular nevus developed into a melanoma after several doses in a 45-year-old woman with a family history of melanoma . A case of melanoma also appeared in the AFFIRM study which involved 942 individuals with relapsing MS, who received either Tysabri or inactive placebo by intravenous infusions every four weeks for more than two years in a patient with a history of malignant melanoma. It cannot be confirmed from these reports that there is a causal link between Tysabri administration and the occurrence of melanoma. However, given these occurrences, the authors recommend that Tysabri not be administered to people with a history or family history of melanoma. “These reports raise concern and they underscore the importance of carefully tracking patients on powerful medications like Tysabri,” said Dr. John R. Richert, executive vice president of research and clinical programs at the National MS Society. “This drug is relatively new to the market, and as experience grows we are bound to learn more about its benefits as well as possible adverse events,” Dr. Richert added. http://www.nationalmssociety.org/sit...earch_2008feb7 Previous conversation here about this topic: http://neurotalk.psychcentral.com/sh...hlight=tysabri Cherie
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I am not a Neurologist, Physician, Nurse, or Hairdresser ... but I have learned that it is not such a great idea to give oneself a haircut after three margaritas
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02-29-2008, 01:00 PM
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#102 | |||
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Magnate
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Quote:
Not a study. It's a sampling. What other drugs were they on for treatment after Tysabri was withdrawn from market? Were they on any treatment at all? We don't know. Why not? Because it wasn't a SCIENTIFIC STUDY. Does this show that a national organization purported to be an organization to disseminate facts to MS patients is doing anything but re-publishing unscientific data based on a sampling?? YUP. Study #2 Not a study. Two letters from two doctors from the same neurology department at the same hospital, published in the letters section of the NEJM. Both patients had a family history of MM or actually HAD MM prior to being treated with Tysabri. First made public by a financial analyst before the magazine was even in mailboxes. Show me studies, show me science, don't throw me rumor, Cherie. While both of the articles you got from NMSS may turn out to be more, at this time there are NO substantiated scientific studies associated with either of them.
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I know the sound the river makes, by dawn, by night, by day. But can it stay me through tomorrows that find me far away? . I have this mental picture in my mind of you all, shaking bones and bells and charms, muttering prayers and voodoo curses, dancing around in a circle of salt, with leetle glasses and tiny bottles of cheer in the middle...myyyyyy friends! diagnosed 09/03/2004 scheduled to start Tysabri 03/05 Tysabri withdrawn from market 02/28/05 Copaxone 05/05-12/06 Tysabri returned to market 06/05/06 Found a new neuro 04/07 Tysabri 05/25/07-present Medical Marijuana legally 12/03/09 . Negative for JC virus antibodies! . I'm doing alright and making good grades, The future's so bright, I gotta wear shades! . |
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| "Thanks for this!" says: | SallyC (02-29-2008), tovaxin_lab_rat (02-29-2008) |
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02-29-2008, 01:48 PM
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#103 | |||
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In Remembrance
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I'm with RW on this. I don't think that every scare story that comes down the pike, should be entered here....Only the recognized relevent studies that have actually been recognized by the FDA and added to the Warning label.
So many things are said, but not all are directly attributed to Tysabri and shouldn't just be thrown in here, without proper explaination. Thanks, RW, for doing that. Cherie, we all appreciate your knowledge of such things, but please explain about scientific proof. Remember all the scare tactics from LDN naysayers???  .....All turned out NOT to be true. Thanks, 
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~Love, Sally . "The best way out is always through". Robert Frost ~If The World Didn't Suck, We Would All Fall Off~ |
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| "Thanks for this!" says: | Riverwild (03-03-2008) |
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02-29-2008, 02:11 PM
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#104 | |||
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Grand Magnate
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Often we hear about this information through the media as it occurs, and those "rumors" are still out there when people start researching their options. However, I think it makes sense to reference these concerns from a reasonably reliable source such as the NMSS. If there is ANY merit (or not) to the rumors, the NMSS will publicize what they think is necessary . . . and they have.
That is true of LDN as well. When I was looking at the various options, I went to the MSS sites to see what was written so that I could objectively evaluate this alternative option. There were no "scientific studies" to validate the concerns expressed about LDN . . . but I definitely considered the NMSS's perspective on the topic. I think this input is as important a consideration as "anecdotal evidence" about how someone's shot of the month went, or how they think they are doing better. Both pieces of information are valuable, when considering Tysabri (in this case) and/or any other alternative. Cherie
__________________
I am not a Neurologist, Physician, Nurse, or Hairdresser ... but I have learned that it is not such a great idea to give oneself a haircut after three margaritas
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| "Thanks for this!" says: | SallyC (02-29-2008) |
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02-29-2008, 04:10 PM
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#105 | |||
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Member
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I find this fascinating. I remember hearing about the increase in lesion bulletin - but kinda just kept moving on - and said, "well - all the more reason to stay on Tysabri if it works for me..."...  - note: i havent started it yet - I am waiting for the TOUCH people to get their acts together.Anyhow - I find this interesting: Their findings show that the total group of participants developed more than three times as many lesions in the 15-month period after discontinuing the drug than before they started taking it. This increase was mainly driven by those who took the drug for an average of two months, who experienced five times as many brain lesions after stopping the drug. Clinical relapses did not increase following suspension of the drug. If you REALLY read that part of the statement (that is - If I am reading it correctly - but you know, I have holes in my brain, so some days I'm more "off" than not!) - you see that the people MOST affected were the ones who ONLY took Tysabri for TWO months! - "this increase was mainly driven by those who took the drug for an average of two months" - Also - as RW said - this isn't scientific - and we don't know cause-and-effect here - and as MS is a DEGENERATIVE disease - it makes sense that after a year of suspending a treatment that more lesions were found - especially if we do not know if a new treatment was started after Ty stopped. We also don't know if by the time Ty was stopped if any of the people tested had changed classification from RRMS to something more progressive, that could account for the quicker increase in lesions. EVEN IF we can say that they are rebound lesions - then wouldn't we also have to argue that Ty prevented them from forming while on treatment - and so that those participants who were on Ty for three years - did not have an increase in lesions during treatment - and as we've heard reports from many people on Ty - one might be led to believe that in the years they were on Ty - that they had QUALITY of life - the Ty helped grant them that. ISN'T THAT THE POINT OF THE TREATMENT - at this point in time - as so far - no one has made any claim to be a cure for MS? Okay, so I admit - it does kinda suck that the increase of lesions after stopping treatment is so large and it is a little alarming! I am a supporter of the med - but I'm also not an ignoramus! LOL Will it stop me from taking Ty? No, probably not. If Ty works for me - would it make me very upset if they pull it from the market? YOU BET. Then we'd have to show the FDA that pulling it from the market does more harm than good. Alright, time for me to call TOUCH and see if they're getting my paperwork in order. Cherie - I am glad you posted the article - I believe in INFORMED CONSENT - buyer beware - know what you are getting into before you get in! ~Keri |
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02-29-2008, 04:20 PM
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#106 | |||
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Member
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Well, as someone who's seriously weighing the risk vs. benefit of all of the therapies currently available to me, I don't find this infomation particularly ...rumor-esque.
I'm a big proponent of the therapies available, no matter how frustrated I am sometimes. I had liver damage with Avonex and body dents by Copaxone; yet I STILL wouldn't take back my decisions to take those drugs when I did. As to the after market data on Tysabri, we're not talking about "studies" per se. There are no studies specifically designed (double blind w/placebo using control groups) to specifically measure how many people will develop or die from PML, malignant moles or suffer liver damage: those things just happened along the way. They're noted. They're documented. And they're significant enough that the FDA and the manufacturer of the drug communicated to doctors and patients that they happened . They're not sounding the fire alarm here, but they ain't just whistling Dixie, either. This is significant information. Why on earth would we not talk about these things? I have personal doubts about taking this drug. I don't have doubts about the people who've chosen to take this drug ...because I trust they're doing exactly the right thing for themselves ...but I do get a little frustrated that some of us are criticized for not being cheerleaders where this drug is concerned. My opinion is what it is. |
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02-29-2008, 08:39 PM
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#107 | ||
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Member
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RedP,
You are talking about a drug here that plays big time with one's immune system. It prevents certain parts of one's immune cells from crossing the blood-brain barrier and doing what they normally do. Now, for whatever reason, the patient has to stop taking Tysabri because the nasty side-effects can become life threatening. Now these immune system cells, after being prevented from doing their thing for a long period of time, start to go into the brain again. In reported cases, some patients are getting a huge increase in the number of brain lesions! All the MS drug trials hang their claim to fame that they reduce the number of these lesions. Now the drug they can't take anymore could possibly cause their MS to speed up tremendously. First it was stopping the drug resulting a large increase in lesions, then it was problems with melanoma and moles and now it's possible severe liver damage happening very quickly. Do you not think that Biogen may have rushed this drug out the door a bit too quickly??!! Here is a company (Biogen/Elan) that along with the FDA, rushed the approval process by one year. They combined it with Avonex in a trial BEFORE the drug was approved on its own. They published a part of their marketing plan on the internet, stating how many $ billions they would make and how huge a chunk of the MS drug market they would gain BEFORE the drug got approved. I just can't trust these people to be telling us what else they don't want us to know about Tysabri. Harry |
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03-01-2008, 10:54 AM
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#108 | |||
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Grand Magnate
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I think that you have to weigh the pros and cons with tysabri just as you do with any drug therapy. In my case I am allergic to interferons and had too many bad reactions to copaxone. (5 serious IPIRs in 4 1/2 months) So I decided to go on tysabri after alot of deliberation. I did not make this decision blindly. It is true that no one know the long term side effects of this drug. That is true of all new drug therapies. So I could wait a few more years, take nothing, and have my MS progress. Or I could try to get into a study where I may be taking a placebo and the drug being studied may also have potential problems associated with it. I know that tysabri is not the "silver bullet" but I
am willing to take the risk. Quality of life is more important to me. Oh, I have scheduled an appointment with a dermatologist for a full body mole check and I am planning to ask my neuro about bloodwork at my 4th tysabri appointment on Wednesday. I also am experiencing less fatigue and I am using my cane less. |
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03-01-2008, 01:57 PM
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#109 | |||
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In Remembrance
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Quote:
__________________
~Love, Sally . "The best way out is always through". Robert Frost ~If The World Didn't Suck, We Would All Fall Off~ |
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| "Thanks for this!" says: |
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03-01-2008, 07:16 PM
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#110 | |||
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Member
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Quote:
back at you. becca |
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| "Thanks for this!" says: | SallyC (03-01-2008) |
| Closed Thread |
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