Biogen Idec, Elan facing suits over MS drug side effects

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Biogen Idec, Elan facing suits over MS drug side effects

Postby MSUK » Tue Sep 10, 2013 12:50 am

Despite living with multiple sclerosis since 1997, Kimberley A. Yout kept a busy schedule, working full time as a money manager for a Boston bank and modeling in her spare time.

That changed on Aug. 28 of last year when Yout, 45, was diagnosed with a rare brain infection that developed as a side effect of Tysabri, a drug she took for six years to keep her MS in check. Yout’s speech became slurred, her gait unsteady, and her future uncertain.

“I was a very successful businesswoman,” said Yout, who lives in Hanover. “Today, I can’t even balance my checkbook, I can’t use an ATM, I can’t see out of one eye. I had to move back in with my mother. I’ve lost my independence. I’ve lost everything.”

Now, she is suing the two companies that marketed Tysabri — Biogen Idec Inc. of Weston and the Irish drug maker Elan Pharmaceuticals Inc. — in Middlesex Superior Court in Woburn. Her complaint, filed Friday, alleges they failed to adequately warn patients of the risks some face from prolonged use of Tysabri..... Read More - http://www.ms-uk.org/index.cfm/tysabri
MS-UK - http://www.ms-uk.org/
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Re: Biogen Idec, Elan facing suits over MS drug side effects

Postby HarryZ » Tue Sep 10, 2013 6:29 am

I guess it's not surprising to see this kind of lawsuit when looking at the constant and increasing number of PML cases that are taking place. But cases such as this often take years to settle and Biogen's lawyers will stretch it out as long as they can. Out-of-court settlements as well often take place after all is said and done.

But looking at the big picture, Tysabri's income to Biogen brought in $ 1.6 billion in 2012 alone!! Do you really think that Biogen is the slightest bit worried about a lawsuit involving a few million dollars? Trying to prove that a patient was not adequately warned about the dangers of Tysabri is going to be one huge task for the patient's legal team. While some docs do spend the time and properly discuss a drug like Tysabri with their patient, others can't write the rx fast enough, especially if there is an "incentive" there.

And the overall stress that this case is going to bring to the patient won't help either.

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Re: Biogen Idec, Elan facing suits over MS drug side effects

Postby cheerleader » Tue Sep 10, 2013 1:27 pm

Here's the link to the article in the Boston Globe, which states---


http://www.bostonglobe.com/business/201 ... story.html


The lawsuit is one of at least a half-dozen pending in Massachusetts and federal courts in three other states. In each case, plaintiffs are seeking more than $1 million in punitive damages from Biogen Idec and Elan on behalf of patients or their families. After taking Tysabri, the patients developed progressive multifocal leukoencephalopathy, known as PML, an infection of the brain’s white matter that can cause death or severe disability.


The woman who was interviewed was doing well with her MS. Diagnosed with MS in 1997, she was still working and active--a "successful business woman" UNTIL she took Tysabri and contracted PML. We have to wonder if Tysabri was sold to her, even though her MS was relatively calm, to keep her from "future progression." I hear from people around the world who had mild MS, with little symptoms, who were sold Tysabri as the best bet for them to prevent future disability. Well, obviously, this was not true.

We have to get the real facts out there, to newly diagnosed and those who are being given the hard sell.
tysabri-antegren-or-natalizumab-f11/topic22315.html

cheer
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Re: Biogen Idec, Elan facing suits over MS drug side effects

Postby HarryZ » Wed Sep 11, 2013 4:01 am

We take PML very seriously,” Niazi-Sai said. “And we’re doing everything we can to educate doctors and patients on the benefits of Tysabri and also the risks. Tysabri is extremely effective for MS, but it’s got to be the right choice for patients in consultation with their physicians.


I guess Biogen didn't take PML very seriously when the first two cases of PML were discovered just as it was given initial approval by the FDA. They waited about a week before announcing the problem and temporarily withdrawing the drug from the market!! I guess the upper execs needed this time to sell off their stock and make millions!

Biogen's marketing and sales people have spent the last several years minimizing PML's associated danger with Tysabri. Yet we now see how the problem continues to escalate with the number of PML cases rising month after month. But with the immense revenue generation of Tysabri, Biogen will continue the current course. You wonder, though, just how bad it will have to get before the FDA steps in and halts the drug's use.

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Re: Biogen Idec, Elan facing suits over MS drug side effects

Postby DougL » Wed Sep 11, 2013 4:57 am

We take PML very seriously,” Niazi-Sai said. “And we’re doing everything we can to educate doctors and patients on the benefits of Tysabri and also the risks. Tysabri is extremely effective for MS, but it’s got to be the right choice for patients in consultation with their physicians.
yes i agree - very effective for MS.

you get a new condition that makes you forget all about your MS.
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Re: Biogen Idec, Elan facing suits over MS drug side effects

Postby SarahLonglands » Thu Sep 12, 2013 9:16 am

yes i agree - very effective for MS.

you get a new condition that makes you forget all about your MS.


Now, that is horribly funny!!

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An Itinerary in Light and Shadow Completed Dr Charles Stratton / Dr David Wheldon abx regime for aggressive secondary progressive MS in June 2007, after four years. Still improving with no relapses since starting. Can't run but can paint all day.
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Re: Biogen Idec, Elan facing suits over MS drug side effects

Postby jerrygallow » Sun Sep 22, 2013 12:34 pm

When I first started tysabri in 2007, my doctor told me there had been only a four cases of PML deaths. He said two of them were Crohns patients and the other two were doing more than one therapy at a time. He said if you get PML, it's just like an MS relapse. If you don't take Tysabri, you will continue to have that disability anyway.

Then several years pass and I decide to google it. Wow, there are something like 500 hundred cases of PML and about 100 deaths. I stopped the drug one year ago. But I can see how there is a lawsuit there. I found their old literature that I was given in 07, and it backs up what my doctor said. It really really underplayed the risk.

When they learned of the significant ongoing risk, they didn't bother to notify their patients, even though they could easily have done so through their Touch program and their constant calling campaigns. They could easily have warned their patients. But 50-60k per year per person is too big of a cash cow to risk.

I hope those suffering recover millions. It would still be very cheap for Biogen to write every family with a death a 5 million dollar check. They would still be making billions. So why should they change?
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Re: Biogen Idec, Elan facing suits over MS drug side effects

Postby aredmosquito » Sun Sep 22, 2013 5:24 pm

I was only DXed in March and my neuro tried to hawk Tysabri to me. My solution? Found a new neuro.

I refuse to use Ty until I have exhausted my other options. PML scares the crap outta me.
Symptoms as far back as 2007
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