Tysabri, monoclocal antibiody for MS,,

[Laurellynne]

What is the name of your state? North Carolina

Tysabri had been fast tracked to treat Multiple Scleoris due to it's glowing clinical trials. Shortly after general participants of the IV montly dosage had began, it was discovered that three patients in the clinical trial had contracted a rare brain wasting disease, called PML caused from the JCVirus.

Having had a progressive course of Multiple Sclerosis I was already on steroids and a chemotherapy drug, Novantrone. We felt that Tysabri may be of huge benefit to slow my disability. I had to have a port/cath inserted as my viens viable but concerns that they would give out down the round as Tysabri IV infusion is for the life of the MSer. Feb. 2005 I received my first and only infusion of Tysabri. The drug was pulled from the market 13 days later. Obviously I was and still am frightened that due to the massive immunosuppresion drugs in my body, that the addition of Tysabri may well create this horrible disease called primary multifocal leukonencephalapathy. This disease has been discovered in AIDS most recently.

Obviously I've lost trust in Biogen and Elan due to the fact that their own scientist did not discovere these three patients in a timely matter. As a matter of fact two patients are dead, one MSer and one Chron's patient and had to be exhumed to determine the true cause of their deaths. The MS patient was young with mild symptoms and the clinical doctors missed the diagnosis.

My questions: Can I sue inorder to recoup some of the cost of the surgery for the port/cather. I would not have had it placed in otherwise. It is however having to be flushed every 4-6 weeks(expensive for life of the port) and has been used for steroids and Novantrone (Mitoxantrone) chemo on a few occassions. But I would not have had the surgery for the part had I been aware that Tysabri would be leaving the market place, as I had planned on using that drug every 28 days for the rest of my life

Next: There was very fishy timing on the removal of Tysabri by Biogen timewise. Some reports indicate that Biogen was alerted to the potential for this horrible disease (PML) the first week of Februaury and did not pull it till the end of Feb. Plus the maket timing showed massive sell off by the head honchos during this sesitive time period. WOuld the SEC not be interested in the chairman and other honchos selling millions of their dollars. This drug was suppose to be blockbuster for their company and I guess they were trying to grab as much money as possible and sell before the losses were too high.

Third, I was assured by Biogen the drug would be $2300 every 28 days, induction to be done in a onocology set up. My god when I received my first bill it was $4900, $4600 for the drug only! I do not have this in writing, but numberous telehone calls to my insurer and to Medicare (a seconday insurer for me) agreed as to the $2300 dollar figure, I also saw the $2300 in newspaper articles and hints from Biogen that it would be very competitively priced as they were going up against one of their own MS drugs (probably didn't want to canabilize those sales) it posted in a few medical pamphlets and releases. I have to pay20% of the $4600 figure and frankly can not afford it. Even at $2300, not sure how long we could have held up financially.

ANy chance that I have a legitimite lawsuit to recoup moneies lost from the port/cath surgery (which by the way trigged a huge exacerbation and had to receive steroids to help reduce the inflammation from the attack) and what about anxiety and the stopping of the current protocal of Novantrone that I was on. Frankly I'm disgusted with the whole thing and have to return to using the chemo based drug.

FOrgive my rambaling...THank you , Lauellynne

[rmet4nzkx]

Originally Posted by Laurellynne

What is the name of your state? North Carolina

Tysabri had been fast tracked to treat Multiple Scleoris due to it's glowing clinical trials. Shortly after general participants of the IV montly dosage had began, it was discovered that three patients in the clinical trial had contracted a rare brain wasting disease, called PML caused from the JCVirus.

Having had a progressive course of Multiple Sclerosis I was already on steroids and a chemotherapy drug, Novantrone. We felt that Tysabri may be of huge benefit to slow my disability. I had to have a port/cath inserted as my viens viable but concerns that they would give out down the round as Tysabri IV infusion is for the life of the MSer. Feb. 2005 I received my first and only infusion of Tysabri. The drug was pulled from the market 13 days later. Obviously I was and still am frightened that due to the massive immunosuppresion drugs in my body, that the addition of Tysabri may well create this horrible disease called primary multifocal leukonencephalapathy. This disease has been discovered in AIDS most recently.

Obviously I've lost trust in Biogen and Elan due to the fact that their own scientist did not discovere these three patients in a timely matter. As a matter of fact two patients are dead, one MSer and one Chron's patient and had to be exhumed to determine the true cause of their deaths. The MS patient was young with mild symptoms and the clinical doctors missed the diagnosis.

My questions: Can I sue inorder to recoup some of the cost of the surgery for the port/cather. I would not have had it placed in otherwise. It is however having to be flushed every 4-6 weeks(expensive for life of the port) and has been used for steroids and Novantrone (Mitoxantrone) chemo on a few occassions. But I would not have had the surgery for the part had I been aware that Tysabri would be leaving the market place, as I had planned on using that drug every 28 days for the rest of my life

Next: There was very fishy timing on the removal of Tysabri by Biogen timewise. Some reports indicate that Biogen was alerted to the potential for this horrible disease (PML) the first week of Februaury and did not pull it till the end of Feb. Plus the maket timing showed massive sell off by the head honchos during this sesitive time period. WOuld the SEC not be interested in the chairman and other honchos selling millions of their dollars. This drug was suppose to be blockbuster for their company and I guess they were trying to grab as much money as possible and sell before the losses were too high.

Third, I was assured by Biogen the drug would be $2300 every 28 days, induction to be done in a onocology set up. My god when I received my first bill it was $4900, $4600 for the drug only! I do not have this in writing, but numberous telehone calls to my insurer and to Medicare (a seconday insurer for me) agreed as to the $2300 dollar figure, I also saw the $2300 in newspaper articles and hints from Biogen that it would be very competitively priced as they were going up against one of their own MS drugs (probably didn't want to canabilize those sales) it posted in a few medical pamphlets and releases. I have to pay20% of the $4600 figure and frankly can not afford it. Even at $2300, not sure how long we could have held up financially.

ANy chance that I have a legitimite lawsuit to recoup moneies lost from the port/cath surgery (which by the way trigged a huge exacerbation and had to receive steroids to help reduce the inflammation from the attack) and what about anxiety and the stopping of the current protocal of Novantrone that I was on. Frankly I'm disgusted with the whole thing and have to return to using the chemo based drug.

FOrgive my rambaling...THank you , Lauellynne

You may certainly call one of the law firms posting on the internet who can evaluate your case to see if your issues qualify as injuries, just search with the words "Tysabri & PML" and one should come right up along with a lot of information and the FDA letter found in the following links. [url]http://www.fda.gov/cder/drug/advisory/natalizumab.htm[/url]
[url]http://www.fda.gov/cder/drug/infopage/natalizumab/natalizumabQA_2_2005.htm[/url]
[url]http://www.nationalmssociety.org/Research-2005Feb28.asp[/url]

Were you also taking Avonex? To date the only cases of PML were in patients taking both Avonex and Tysabri. THere are simply not enough answers yet. Remember Tysabri received accelerated approvial because in the first tests it proved to have excellent results in combination with Avonex, thus the usually longer trials were continued while it was released for use by an eager patient population while the post market release research continued. PML occurs in persons with compromised immune systems AND the symptoms are very similar to MS, do you see where this could be leading? They are not sure if it is the drug Tysabri alone or in combination with Avonex or another reason, perhaps the patients who contracted PML really had PML all the time? The data is still being studied, the withdrawl is voluntary. The FDA was notified late in the afternoon 2-18-5 of the deaths due to PML. WHen did you have your infussion?

As to the port, If you had had to have infussion therapy for a long time or for life, then you would have needed a port as infussion therapy without a port is not pleasant at all BTDT and you have used it, so I don't think you can recoup the cost but you can try as you may also try to negotiate the cost of the therapy you did receive, I can't say that you will or won't recoup your out of pocket costs. If you are on medicare don't they cover the infussion therapy?

Call and get an evaluation of your case and update us later.