Patients Sue Biogen over PML from Tysabri
 

From today's Boston Globe:

http://www.bostonglobe.com/business/...QoK/story.html

ANN

PML is a bigger fear for me than even MS. That's why I won't take the DMD's offered to MS patients. I guess I'm choosing what I consider the lesser of two evils even though I consider MS a pretty big evil.

Kitty,

I agree w you. I am more afraid of PML than worsening MS. I hope I don't have to choose.

I know Rituxan and Tysabri (both monoclonal antibodies) can cause PML. It hasn't occurred w the original DMD's: Avonex, Betaseron, Copaxone or Rebif.

ANN

I hope they win their suits. IMO, they should and the families who
lost their loved ones to PML due to TY, as well!!!

I hope some day they either find a vaccine for this virus or a cure for PML that leaves no damage. That way people can benefit from the drug without living in constant fear. The anxiety I suffered before I knew I was JC virus negative was absolutely awful.

I firmly believe that people have the right to take what ever they want to but they must be ADEQUATELY informed about all risks.

Now that people know if they are positive or negative they can make better decisions (not perfect ones) but given the rising number of cases you would think Biogen/doctors would not allow positive JC virus people to take the drug at all. But we know they love the $$$.

Those are absolutely heartbreaking stories. :(

I know a woman who has been on Ty for more than 3 yrs:eek:
She knows the inherent risks, but feels so much better on it that she'd rather take the risk than deteriorate, which was occuring before taking Ty.

I'm worried about all of these new immunosuppressants. IMO it's playing with fire...

Debbie,

I know someone who is near the end of her 4th year of Ty. And, she is JC positive. Her thinking, and I can't say she is wrong, is that she couldn't function -wasn't at all stable- until she went on Ty.

Her MD is watching her "closely."

Scares the heck out of me but she is OK w it. She can't, she says, go back to how she was. I am surprised that her doc is Ok w it.

ANN

Yep, that's the same for me - JC+, on Tysabri for more than four years now. My neuro doesn't seem especially nervous about it. I do the six month MRI thing.

It has been really good for me - Beta was not good at all in the end, though it worked ok for the first eight years, and I have brain stem, mid and lower spinal cord lesions that affect the left side of my body. To be really honest (and I sound like a doom-sayer) - I think it is only a matter of time before more stuff comes out about the other relatively new oral treatments that are around now.

They are all heavy artillery. My husband is starting to suggest I try maybe going back to one of the Interferons - at least they have a fairly long and proven safety record and don't have the big monsters that others do.

It is largely risk vs. benefits and I think we as consumers of these medications should be aware of and willing to accept the risks if we are going to take them.

Personally death is the least of my worries since getting this horrific diagnosis. :(

Sounds like myself, where Ty is concerned. Another, deciding factor for me, was reading about the rebound effect of coming off Ty. I didn't like the fact that studies, at least when I was making my decision, didn't go past two years. I don't like the idea of spending half the day, at the hospital to take the infusion.

I'll take my chances, considering how many years in remission, compared to how many weeks of flare ups, I've had, in 13 years time.

Thanks for sharing this article.

The woman I know is also JC+...the MS center she goes to is infamous for pushing Tysabri-I know several people who go there, and they're all on it. A neighbor, who was recently dxd, is also on it and is also J+. I couldn't believe my ears...

IMHO no DMD is 100% safe. I was on Copaxone, and I look like the moon with so many craters. So it's a question of quality of life...you take your chances, hold your nose and jump in...

Sounds like a frivolous lawsuit. Or they should be suing their doctor for prescribing a medication when s/he did not take advantage of the very available info. WE all knew about it. There's no excuse for a doctor not to. I believe by the time the people in the story filed their lawsuit, Tysabri had already been taken off the market and put back on. That info was not hidden from anyone.

Well, I certainly could never say that I am not informed - and for those who aren't - why not? The information is out there. I don't believe there has been any conspiracy of silence about this.

At first there was!!!:mad:

Yes - you are right Sally, I imagine there was a lot of stuff going on before the initial withdrawal of the drug - and in the early stages thereafter. I guess it probably only became common knowledge after the problem became to unwieldy to hush up (as lots of these things do). For those people who were affected, then they deserve everything they can get. I am just saying that for people like me, I know the risk profile (or at least I think I do :eek:).

It has a black box warning,right? Does that mean that patients who agree to take it have to sign a waiver?

Meds with a black box warning only require documentation that the prescriber reviewed the target, risks, benefits and alternatives with the patient. Any prudent prescriber makes very certain to cover this clearly both to be fair to the patient and also cover their license.

Debbie, since this drug is given IV, I'm not sure the patient sees the Black Box. They certainly should know from materials they get and a discussion w their MD.

Hi Jules! Cross-post.
ANN

But my thoughts are whenever a new medication comes to market, especially with a disease as tricky as MS and when you are fiddling around with immune systems, it is fair to expect the consumers are fairly well versed on the possible risks of a brand new medication having dangerous side effects as time wears on.

I am so thankful and my heart breaks for those brave souls who try drugs early on and are the ones who pave the way for others however I do not think it is a matter of malpractice on any level unless there were indications during the trials that were covered up.

These kind of lawsuits scare me because I believe they hinder future trials of new medications.

Just curious.....did they have you sign a release before taking Tysbri? I think "their" lawyers will still have a hard time fighting this lawsuit. Judges don't take kindly to this stuff and go for the deep pockets. If enough people are negatively affected, we will soon see a class action suit since its the lawyers that seem to really benefit from these suits.

Unfortunately I can tell you that I have been prescribed 2 drugs with black box warnings for different conditions. The drugs are Cipro (antibiotic) and Elidel cream (for dermatitis). The doctor said absolutely NOTHING. :( There are more black box drugs out there then you think.

My friend just told me that her healthy co-worker can hardly walk and has to use a cane after taking Cipro because she got a ruptured tendon.

I wish doctors were more on top of things so people can make informed decisions about pharmaceutical meds.

Over 30 years ago a severe reaction to some medication for peritonitis had my doctors hurrying around because it damaged my liver.
The surgeon told me then that before I take anything ever again, to have my CBC & especially my liver enzymes tested, and then tested within a week after taking it, and then regularly every in 2-4 weeks while taking it for the first couple of months.

Can't tell you how often I have refused medications because the attending physician refuses to order this testing. If I am giving consideration to taking a medication, I request the repeating lab requisition before the MD writes the script.

Since spring of this year, I have basically been 'excused' from the care of my current MS neuro specialist because of me making this a requirement of trying an off lable use of a medication that he is doing a study on.
I got the sense that his main concern was that if it was found to have an adverse effect on what he calls 'atypical liver hypersensitivity", that it might have messed up his over-all test results.

It is possible that some drug companies & MDs don't mention possible side effects of meds for similar reasons.

With love, Erika

Wow....this has been a very informative thread...Cipro is off my list!

Great idea to get all the info about a new med being added to our often long list of meds we take.

thanks all!!

Cipro, avelox, and another antibiotic in the same class (I think it begins with a L) can all cause the same tendon problems. I just remembered the other drug is levaquin. My sister has had ongoing Achilles issues after being put on levaquin several times for sinus infections. She eventually had sinus surgery. I had to take my mom to the ER when she was on avelox because the pain in her legs was so bad. It says right on the warning to exercise caution in prescribing it to the elderly.

I'm allergic to Cipro, so it and it's evil brothers are out for me.
I say that we should tell our health care prof.,you are allergic
to any med with a black box or bad reputation...DO NOT
PRESCRIBE!!!!:D

Well, there is some good news if you like to eat chicken and turkey Sally.

Did you know that Cipro was regularly fed to chickens and turkeys that were destined for your plate until 2005?

Who knows what medications livestock are routinely being fed these days, but it seems reasonable to conclude that those who are allergic to certain medications may have reactions to consuming meat or dairy products from animals that have been medicated with what they are allergic to.

Years ago when we had a small organic dairy, we sometimes did need to use antibiotics on the cows and goats that developed mastitis or abcesses. Of course the affected animals were then isolated from the herd and their milk was dumped; but I wouldn't be so sure that is the case in larger operations.

Agricultural Use of Antibiotics Prompts Human Health Concerns
http://www.medscape.com/viewarticle/520518

With love, Erika

Great Erika, thanks. They are bound to poison us one way or
the other, aren't they.:rolleyes::mad::rolleyes::mad::rolleyes::mad: