Tysabri Suspension - after shocks will be?

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

try advil

Postby batpere » Thu Apr 07, 2005 7:38 am

dannape wrote:Well, my best friend is right back to the flu like symptoms, after only one shot of Avonex...up all night, couldn't sleep, body aches, headaches, sick to her stomach...so i guess 1/2 a shot didn't help.


I had the body aches consistently for years while taking Tylenol.
Then someone recommended Advil so I tried that - works great.
I tried Aleve too for longer lasting relief, but that didn't do anything
for me. I think my neuro said there are also prescription pain
relievers if the over-the-counter ones aren't enough.
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Postby bedias » Thu Apr 07, 2005 6:55 pm

We were at the Neuro's last week. He said that he thought Tysabri would be back in the fall. This may have simply been conjecture on his part, I don't know. Hopefully, he is not just repeating what the salemen are telling him.
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Postby HarryZ » Thu Apr 07, 2005 9:58 pm

Peggy,

The comments that I have heard about Tysabri are that it will be quite some time before it comes back...if ever. There is a lot of speculation floating around and not until the scientists examine the the PML cases thoroughly will be get some accurate information.

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Biogen Idec says no changes yet at Oceanside plant

Postby better2gether » Fri Apr 08, 2005 11:18 am

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Biogen Idec says no changes yet at Oceanside plant

Thu Apr 7

Biogen Idec Inc. says it's business as usual at its new manufacturing plant in Oceanside, even though the drug to be made there was yanked off the market.

The company is continuing with preparations to begin making the drug Tysabri at the plant next year, said Jose Juves, a spokesman for Biogen Idec . The company is developing the drug with Elan Corp.

The multiple sclerosis drug was removed from use on Feb. 28 after it was linked to two cases of a rare and sometimes fatal brain disorder. So far, two patients that were given the drug during clinical trials have died.

Biogen Idec and Elan are evaluating more than 3,000 patients who took the drug during clinical trials and plan to release those findings later this year.

Roughly 500 people have been hired at the plant so far, approximately 380 of which are tied to the Tysabri project. The company had planned to hire another 75 employees next year.

While preparations are under way, Juves said the company is unlikely to hire the additional employees until the evaluation is complete.

"We're taking it one step at a time and the first step is to evaluate the data we have on Tysabri," Juves said. "It's too early to say" what will happen next.


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Re: Biogen Idec says no changes yet at Oceanside plant

Postby HarryZ » Fri Apr 08, 2005 1:30 pm

Better,

The multiple sclerosis drug was removed from use on Feb. 28 after it was linked to two cases of a rare and sometimes fatal brain disorder. So far, two patients that were given the drug during clinical trials have died.



Something isn't right here....there have three reported cases of PML...two in the MS trials and one in the Crohn's trial. Biogen states two deaths have resulted...do they mean the second person in the MS trial has died or are they referring to the second death as the Crohn's patient?

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Re: Biogen Idec says no changes yet at Oceanside plant

Postby HarryZ » Tue Apr 19, 2005 8:33 am

I have no way of confirming this latest information so you can call it rumor, innuendo or whatever you want but....further review of Tysabri trial patients has revealed 22 cases of melanomas!! I will attempt to try and get some kind of source verification.

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Postby garynuman » Tue Apr 19, 2005 9:56 am

Are you just reading what you see on the anonymous cafe pharma board or do you have another source of this rumor?
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Postby Arron » Tue Apr 19, 2005 11:40 am

hi Harry... the melanoma rumor may have come from the fact that patient #2 (the one who lived) had a history of melanoma:

"A 46-year-old male MS subject with a history of melanoma, allergies and
Bell's Palsy received 28 doses of TYSABRI in combination with AVONEX
as part of a company-sponsored clinical trial. His last dose of TYSABRI
was on 13 Dec 04. "

but certainly any additional information would be highly welcomed.
Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.
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Postby HarryZ » Tue Apr 19, 2005 1:12 pm

Two places....cafepharma and from a contact I have who heard it via another source....again, both unable to be verified.

I just started reading cafepharma last week and while some of the messages there can be quite vicious, I am told that a lot of the rumor that starts there ends up becoming very true. It's certainly an interesting place, to say the least!!

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Postby HarryZ » Sat Apr 30, 2005 1:18 pm

Depending on how much one believes what is said on Cafepharma, one person there posted today that additional information about the Tysabri patients who developed melanomas, will be forthcoming very soon....whatever that means.

Guess we'll just have to wait and see.

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Drug withdrawal a travesty for multiple sclerosis sufferers

Postby better2gether » Mon May 02, 2005 2:22 am

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Columns - May 2, 2005

Drug withdrawal a travesty for multiple sclerosis sufferers

By MICHAEL FUMENTO

THE YANKING from the market of both Vioxx and Bextra, members of a new generation of pain relievers called COX-2 inhibitors, has critics ripping raw flesh off the Food and Drug Administration. Inevitably, the agency and pharmaceutical companies are under intense pressure to over-scrutinize new drugs. But over-caution can also cause tremendous anguish, as multiple sclerosis sufferers using a recently pulled drug called Tysabri can attest.

Tysabri belongs to an incredibly promising new class of biotech drugs called monoclonal antibodies. Monoclonals have repeatedly shown an ability to slow or reverse diseases for which previously there had been nothing available but pain relievers and to be effective against multiple diseases.

Such appears to be the case with Tysabri, produced in partnership by Biogen Idec and Elan Pharmaceuticals and approved for MS in late November. About 400,000 people in this country have MS, in which the immune system attacks both the brain and spinal cord and causes a host of symptoms, including blindness, paralysis, and sometimes death.

There are other MS drugs, but none seems nearly as effective as as Tysabri or as well-tolerated. In fact, results released this month of two years of clinical trials showed a stunning 42 percent reduction in the risk of disability progression and an even more amazing 67 percent drop in clinical relapses.

In late clinical trials, Tysabri has also apparently been extremely effective against Crohn's disease, a severe bowel disorder. Additionally, it was also in human testing for rheumatoid arthritis. So it came as a stunning blow to the approximately 8,000 patients using the drug, as well as a long list of persons waiting to get prescriptions, when the ax fell.

The force behind that ax was a tiny virus that's extremely common but that the immune system keeps locked up. If unleashed, though, it causes an often-fatal disease of the central nervous system called progressive multifocal leukoencephalopathy. Unfortunately, two MS patients on Tysabri contracted the disease and one died. When the drug makers scoured their databases they found another PML death in a Crohn's patient. He also died.

It's possible that in suppressing the immune system's attack, Tysabri may have let loose the virus. But tremendously complicating matters is that all three patients were also on other immunosuppressive drugs at the time, leaving the real possibility that Tysabri alone is harmless. There are no known cases of PML in patients using only Tysabri, according to the FDA.

What's bizarre to Dr. Jeffrey Horstmyer, director of the MS Center at Mercy Hospital in Miami, is that less-effective MS drugs known to kill people have been used for years. "We allow Novantrone," he says, "and yet take Tysabri off the market." Novantrone's side effects can include heart failure and leukemia.

Likewise, all the drugs that slow the progression of rheumatoid arthritis carry FDA warning labels, and two have been implicated in several deaths. Yet sufferers practically worship the companies that make them.

"Tysabri is a great drug," says Horstmyer. "My patients . . . were delighted with the lack of side effects and its effectiveness." He adds they're "really ticked" that it's been pulled. In fact, New York Newsday headlined a recent story, "MS Patients Plead for a Recalled Medication," and the drug makers are being deluged with requests from desperate MS sufferers.

Horstmyer thinks the threat of lawsuits was primarily responsible for the drug being withdrawn, while the Competitive Enterprise Institute's Sam Kazman blames government.

"What we've apparently got is FDA reverting to its traditional operating mode of deadly over-caution," he says. "That plays well in both Congress and the press but it's murder on patients." Yet both agree that but for the COX-2 calamity there would have been no withdrawal and it's wrong for Vioxx's tentacles to be reaching out and grabbing other drugs.

"The Biogen and Elan people were trying to demonstrate the highest level of scrutiny" in pulling Tysabri until all patients could be evaluated," says Horstmyer. But, "All the MS drugs have serious side effects," he adds. Moreover, patients with MS "are among the most well-informed," he says, and best able to balance the risks of their disease vs. the rewards and risks of various drugs.

Says Horstmyer, "I really hope they can bring Tysabri back."



http://www.theunionleader.com/articles_ ... icle=54121
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Re: Drug withdrawal a travesty for multiple sclerosis suffer

Postby HarryZ » Mon May 02, 2005 5:56 am

Better,

It all boils down to the fact that if Biogen/Elan had done things properly in the first place, they likely wouldn't have been in the Tysabri mess they are in today. Of course other drugs to treat MS can be deadly but the fact is the docs know this in advance and aren't "blind sided" like they were with the PML cases. Nobody knows if Tysabri alone is the culprit behind PML or if it had nothing to do with it at all. If Biogen had stuck to their original plan of testing time guidelines, the recall would not have been required. Now it's going to take months and months to investigate this properly.

And now there is rumor of additional melanoma cases among the Tysabri users. Like I said, a mess that was avoidable with proper testing. And, as usual, the MS patient is asked to sit by and wait and wait and wait!!!

Harry
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Postby better2gether » Tue May 03, 2005 5:03 am

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Harry,

This is the third time that you mention this melanoma cases.
So I assume you have a VERY RELIABLE source for this information.
The only place I read about this rumor is on the CafePharma website
by an ANONYMOUS person.

Better
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Postby amelia » Tue May 03, 2005 7:05 am

Has anyone listened to the assortment of drug advertisements on TV lately? I have and have heard the phrase "may cause fatal ..." more times than you can imagine. And this is on MANY drugs out there. As far as melanoma, isn't this on the increase anyway? With ALL people. Kind of like many cancers. They can say that something may INCREASE your risk for something, but they can't say, definitely, that you got this cancer because you did "this". You are going to be hard pressed to prove something comes from Tysabri alone unless a very large percentage of the people who took it, develope the ailment.
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Postby bromley » Tue May 03, 2005 9:16 am

Amelia,

I agree with you.

MS in many ways is a slow death anyway - watching yourself or your loved one deteriorate physically and mentally. I saw a posting on another site where the contributor said that he would gladly take a risk that Tysabri might cause death as his life was already hell with ms. This treatment gave people some hope and for many who received it appeared to have some real benefits. Let the sufferer decide about risks. I recall a case last year where a brother had assisted his sister to die (she had suffered from ms for 14 years and couldn't take it any more) - in many cases this is the reality of this disease. If the authorities are happy for people to purchase cigarettes, which in many cases can lead to death, they should allow those suffering from a grim disease to decide whether to take a risk with an MS treatment.

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