Tysabri info

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

Re: Suspicion on Biogen combo test

Postby HarryZ » Tue Mar 22, 2005 8:59 am

Better,

My guess that Biogen ran the combo trial for marketing purposes only wasn't all that bad a guess!! Of course they deny this but understanding Biogen's mode of operation isn't that difficult. As many people have stated, it's all about the $$$$$ and this time in has cost them dearly! And it is has placed an undeserved burdon on thousands of MS patients for an unknown period of time.

Harry
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Tysabri update

Postby better2gether » Wed Mar 23, 2005 2:41 am

Tysabri update

Biogen Idec, Inc. 14 Cambridge Center, Cambridge, MA 02142 Elan Pharmaceuticals, 7475 Lusk Blvd, San Diego, CA 92121

Dear Healthcare Professional,

As part of our ongoing efforts to further understand the findings related to the cases of progressive multifocal leukoencephalopathy (PML) in the TYSABRI® (natalizumab) clinical trials we convened a panel of scientific experts on March 4th, 2005. The panel reviewed the two cases of confirmed PML, as well as the biology of the JC virus, the etiological agent of PML.

Criteria for the diagnosis of PML were discussed. The panel’s consensus was that CSF analysis for JC virus was the most sensitive and specific test to confirm the diagnosis of PML in patients with clinical and MRI findings suggestive of PML. The panel also noted that restoration of the normal immune state might contribute towards clinical stabilization and survival.

During the panel meeting, participants discussed Biogen Idec’s reviews of safety databases completed to date, which revealed no previously reported cases of PML in multiple sclerosis patients treated with interferon beta monotherapy. According to information on FDA’s website, FDA has analyzed data in its post-marketing database and not found any cases of PML reported in patients receiving a beta- interferon.

It remains unclear why PML developed in the two patients treated with combination therapy of TYSABRI and AVONEX® (Interferon beta-1a).
We are extensively evaluating TYSABRI-treated patients in clinical trials. Because we believe in the promising therapeutic benefit of TYSABRI, we are working to complete these evaluations expeditiously. In addition, we remain in close contact with the FDA and other Regulatory Authorities, as well as the advisory and safety monitoring committees for the TYSABRI trials.

Thank you for your patience and continued support over the past few weeks. We will continue to inform you of important new developments or changes.
In the meantime, please contact Medical Information
at 1-888-489-7227 with any questions.

Sincerely,

Whaijen Soo, MD PhD
Lars Ekman, MD, PhD
Senior Vice President Executive Vice President and President
Medical Research Global Research and Development
Biogen Idec Elan Pharmaceuticals

http://www.tysabri.com/
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Re: Tysabri update

Postby HarryZ » Wed Mar 23, 2005 6:45 am

Better,

Thanks for that Tysabri update.

I'm wondering if the unknown nature so far of why those two patients ended up with PML could delay Tysabri's return even longer. I would think that the FDA and the docs who eventually may prescribe Tysabri again would want some definitive answers before they decide use the drug.

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Postby amelia » Wed Mar 23, 2005 9:21 am

Total Agreement Harry! What I don't understand as anything else BUT a marketing plot, most doctors push feverishly to put new patients on Avonex. But yet Copaxon has the same results, is not damaging to the liver, and a person doesn't have to take numerous amounts of other drugs just to tolerate the Avonex. Now we have one woman in our group that doesn't have severe side effects. 2 advil before the shot and she is good to go. But even she is put out of commission for about 12-24 hours. I am not pushing Copaxon, not a company spokesman or anything. So why would a DR push you to take Avonex over everything else, except a hard marketing gimic? Why not Rebif, or Betaseron?
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Copaxone ain't that much fun either

Postby flora68 » Wed Mar 23, 2005 9:26 pm

amelia wrote:Total Agreement Harry! What I don't understand as anything else BUT a marketing plot, most doctors push feverishly to put new patients on Avonex. But yet Copaxon has the same results, is not damaging to the liver, and a person doesn't have to take numerous amounts of other drugs just to tolerate the Avonex. Now we have one woman in our group that doesn't have severe side effects. 2 advil before the shot and she is good to go. But even she is put out of commission for about 12-24 hours. I am not pushing Copaxon, not a company spokesman or anything. So why would a DR push you to take Avonex over everything else, except a hard marketing gimic? Why not Rebif, or Betaseron?


I'm not Harry, but I think I can partially answer your question.

First of all, all of the CRABs are heavily marketed, not just Avonex. Plus, I think we may find less of a push toward Avonex with the recent news about severe liver failure being a possible result of taking it. Although it's hard to say.

But the major reason is that, in the USA at least, Avonex is covered by more insurance plans than Copaxone or Rebif as a first line treatment, largely because it costs less and has been around longer. It's sort of a tradition, and you know how long it takes to break traditions :roll:

(Personally, I look back on my time with Avonex as my MS "hazing", yet another stubborn tradition that's hard to break away from. )

Another, lesser factor in choosing a treatment plan is that every physician has some patients who are intractably needle-phoebic, and most doctors (other than allergists) can also safely assume that the majority of their patients are both unaccustomed to and literally uncomfortable with frequent injections. So naturally it's further assumed that patients may be more compliant, less traumatized, and at the very least, less inconvenienced by a treatment plan involving fewer injections.

Now, please don't assume that I'm endorsing Avonex, or any of the CRABs for that matter; my own experience with Avonex was very nearly fatal, and I wish I'd never allowed myself to be talked into trying it.

There's one other reason why some docs had been backing off Copaxone; it's a daily injection of something generally very irritating to the tissues. About 20% of Copaxone patients have to discontinue it because of local damage such as severe fatty necrosis and chronic tenderness or pain at old injection sites. (As a matter of fact, that's why I had to d/c it, and after more than a year off of Copaxone, I still have countless sore dents and lumps, and can't lay on my left side because that whole thigh is too sore.)

And because of the increase in significant permanent tissue damage among some Copaxone patients, there have been some successful lawsuits. And you know how litigation can influence treatment recommendations!

Oh yeah, the nastiest Copaxone reaction, although much less common, is the immediate post-injection reaction, which can involve sudden chest pain, flushing, shortness of breath, constriction of the throat, palpitations, and anxiety. It isn't that much fun either 8O , and as far as I know, can't be prevented or treated.
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Piper Jaffray survey

Postby better2gether » Thu Mar 24, 2005 7:15 am

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Piper Jaffray survey

Piper Jaffray recently surveyed 134 neurologists (32% have Rx'ed Tysabri) and found a surprising number of physicians who would still Rx Tysabri even in light of the 2 cases of PML.

Results:

1) 94% of all physicians still believe that Tysabri could be a valuable therapy to certain MS patients as monotherapy.

2) If no additional cases of PML are diagnosed, the majority of physicians (66%) would use Tysabri in patients who have failed therapy....

The survey not only gives the firm more hope that Tysabri will ultimately return to market, but it also suggests that the drug will actually have some uptake, should it return.

Elan could be prepared to meet with the FDA by early July. Piper strongly suspects there will be an FDA panel meeting before formal decisions are made, which could take place in the fall timeframe. Then there is a possibility the drug returns to market in 2006.
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Re: Piper Jaffray survey

Postby HarryZ » Thu Mar 24, 2005 8:30 am

Better,

The results of this survey are not surprising. The amount of marketing and sales info that Tysabri was given by Biogen IDEC was huge. In view of the very limited effect that the CRABs have along with their side effects, Tysabri would be considered a breath of fresh air. But you can bet that Biogen will make totally sure that the PML issue is resolved beforehand. The last thing that they would need after all of this is a lawsuit by someone who became ill.

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Postby amelia » Thu Mar 24, 2005 9:07 am

My husband wants to take tysabri. Of course, I would like to see the PML issues are resolved. Out of all the patients that have taken it, have there been any more cases or suspect cases? Anyone heard anything else on the PML?
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Postby HarryZ » Thu Mar 24, 2005 10:23 am

Amelia,

The two people who ended up with PML were on Tysabri with Avonex for more than two years. I would imagine that the vast majority of other Phase III trial patients, either on the combo or monotherapy, were on the drug for two years or less. They have to determine just why the two PML patients became ill and if being on the Tysabri more than two years had anything to do with it. You just can't start patients on the therapy again, waiting to see what may or may not happen, especially after one of the trial patients died!

That's why it may not be the quick fix that some people are hoping for.

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Postby amelia » Thu Mar 24, 2005 10:55 am

Oh yeah, I understand. I would not wish anything bad on anyone. But there are those that are losing ground fast, my husband is one of them. We don't have years and years to wait on stuff. Right now he walks on a cane, barely, is legally blind in L eye and totally blind in R eye. He hasn't had many of the brain type attacks, hearing, swallowing, speech, etc. But has has lower brain issues with balance. I guess it is just frustrating to see some one you love slowly "die", in a sense. One attack could make him bed ridden, easily. And I know there are those out there that already are. I looked at old pics the other night and came across some of Gary before MS started taking its toll. I am not an emotional person, usually. But I just stepped back and had a sinking feeling realizing how bad he really is. I'm sure you can relate to some of that.
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Postby HarryZ » Thu Mar 24, 2005 11:51 am

Amelia,

I understand the frustration that you and your husband are experiencing. I wish that there was something that I could say to reduce that feeling but I know, from experience that there isn't.

There are other considerations. Have you considered using LDN? Yes, there aren't any clinical trials using LDN with MS but there is one heck of a lot of anecdotal information out there from the thousands of patients that are on this very inexpensive, no side-effect drug.

My wife, who has SPMS, has been on Prokarin for 5 years and this drug has relieved and reduced a number of her once very nasty MS symptoms.

Take care.

Harry
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Postby amelia » Thu Mar 24, 2005 2:52 pm

Gary is on Copaxon only. He's got a really good DR. We were going to ask about the LDN. Was going to swap Copaxon for Tysabri. He is only on Medicare and dumb me has my own art business. The biz helps pay some drug cost and food, not much more. Medicare uses my GROSS income for the $600 a year prescription. We don't qualify. Anyway, we have read some on the LDN forum. YOu think it is worth trying? It is hard to describe, but right before he has an attack, something in that area of his body gets remarkably better within about a 24 hour period. then the bottom falls out. He is total blind in R eye, no light no nothing. He started seeing some blurred shapes in it one day and some considerable light. The next day he had an "eye" attack in the left eye. Went blind for about 3 days. Some came back some didn't. We feel if he could get something to "control" the MS a little better, he might gain a few of his symptoms. But just a thought. I'm going to check out the LDN forum more closely.
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Postby HarryZ » Thu Mar 24, 2005 6:56 pm

Amelia,

In my opinion, LDN is certainly worth a try. It won't hurt Gary and the cost to do so is so inexpensive.

That situation that you are describing about Gary experiencing something very good in an area of his body and then an immediate bottoming out....I've seen that a bit in Marg over the years. Very strange to try and understand.

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MS patients angry over loss of drug

Postby better2gether » Fri Mar 25, 2005 7:17 am

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Fri, Mar. 25, 2005

MS patients angry over loss of drug

BY FRED TASKER

Knight Ridder Newspapers


MIAMI - (KRT) - After five tough years fighting multiple sclerosis with current drugs, Carmen Chediak had just received her first infusion of a new one, Tysabri.

She hoped it would give her more relief with fewer side effects. But in late February, Tysabri was pulled from the market. One person in a 500-patient clinical trial of Tysabri, taken in combination with another drug, had died of a rare disease called PML, which attacks brain cells. Another had contracted the usually fatal disease.

Chediak was angry the drug was pulled.
"It's an overreaction. I know they have to be cautious, but I wish they would hurry up and get it right."
She's far from alone. Tysabri was seen as a significant breakthrough for MS treatment; trials had found it nearly twice as effective in preventing relapses after two years of treatment compared with the current drugs called interferons, doctors said.

Because of that, patients and doctors are clamoring for it to be back on the market soon. "It's perfectly ludicrous," said Dr. William Sheremata, director of the MS Center at the University of Miami Miller School of Medicine, of the drug's removal. "But with product liability attorneys hiding behind every bush, there's no alternative to pulling it."

MS affects 400,000 people in the United States, primarily women between ages 20 and 40. It causes loss of muscle and bladder control, blurred vision, speech and hearing problems and fatigue. Symptoms come and go; relapses sometimes worsen, in dire cases causing death.
"For many years we have used other, more dangerous treatments for MS," said Dr. Jeffrey Horstmyer, director of the MS Center at Mercy Hospital in Miami. "Even if Tysabri has the rare side effect of PML, it's still likely safer than a lot of other things being used to treat it."

Still, Tysabri's problems are significant. The Food and Drug Administration approved Tysabri last November, before the end of its two-year clinical trial, because its benefits seemed so apparent. And 5,000 new patients nationwide were taking Tysabri.
But then a patient who had been taking Tysabri for 37 months in one of the trials died of the brain infection PML, or progressive multifocal leukoencephalopathy. Another, who had been on Tysabri for 28 months, came down with PML. Both patients had been taking Tysabri in combination with Avonex, an interferon made by Biogen Idec.

In multiple sclerosis, the body's immune system attacks the myelin, or insulation, around nerve cells in many parts of the body. When the insulation is damaged, it interferes with the brain's ability to send messages along the nerves.
Interferons, the standard treatment for MS since the 1990s, seek to inhibit the replication of the viruses that attack the myelin sheath. Tysabri was different, developed to prevent the immune system cells from passing from the bloodstream into the brain, where they could attack the myelin sheath.

PML is caused by activation of the JC virus, which exists in latent form in 80 percent of even healthy adults. When it is activated, it attacks the myelin sheath around the nerve cells, making it similar to multiple sclerosis_only more dangerous, often leading to death.
Despite the PML problems, doctors say they support Tysabri.
"Tysabri creates a 66 percent decrease in relapses after two years, compared with about 30 percent for the other drugs on the market," says Sheremata, who took part in early clinical trials of Tysabri.

"Of the 15 patients I gave it to, a significant portion showed an improvement that was unexpected," Horstmyer added. "With Tysabri, after one or two doses patients were saying their bladder function was better, their fatigue was better, their balance improved. One woman who couldn't get up for the past year said she now could stand at her kitchen sink."
Despite the concern over PML, Tysabri's makers, Elan Pharmaceuticals and Biogen didn't pull the plug on the drug altogether. Three weeks ago they announced a "voluntary suspension of marketing" and a "pause in clinical tests."

The FDA concurred. The two drug companies, with help from outside experts, will continue to study patients who took Tysabri in the clinical trials and in the general population. The FDA is doing its own study. Neither will say when a conclusion might be reached.
Nicholas LaRocca, director of policy research with the National Multiple Sclerosis Society, said Tysabri's problems were so unexpected, he was not surprised the drug was suspended.

"We need to know what happened and why," he said. But he added: "Within months they should know enough to gauge the risks and benefits of bringing it back."
One possibility would be to bring it back with a strong label warning limiting its use to the most severe cases, La Rocca said.
"I expect it back on the market in a matter of months unless they find more problems," said Sheremata.

And in a conference call with drug officials, analysts, doctors, Tysabri users and the media, G. Kelly Martin, president of Elan, said that if no further cases of PML are found, he hopes Tysabri sales can resume by fall.
Biogen officials declined to comment on Tysabri's return.
Doctors stress they're not minimizing the dangers of PML.
The two Miami doctors point out that the two patients who contracted PML received both Tysabri and Avonex, an interferon also made by Biogen. And FDA statements say none of the 2,500 patients treated with Tysabri alone in another clinical trial got PML. Avonex, on the market since 1996, also never has been associated with the condition when used alone, and has not been pulled from the market.

"There was no case in which Tysabri alone was associated with PML," Sheremata said.
Paul Lammers, chief medical officer for the North American division of Switzerland's drug giant Serono International, a maker of MS drugs, speculated the combined use of Tysabri and Avonex, both of which affect the body's immune system, might have been too much. For now, Tysabri is in limbo.

"Where we stand today is where we stood before Tysabri," said Horstmyer. "We had three different interferons, plus Copaxone, plus chemotherapy."
The interferons_Avonex, by Biogen; Betaseron, by Schering; and Rebif, by Serono; all brought to the market in the 1990s, have provided significant relief, cutting the number of painful relapses in patients, slowing their progression to disability, the MS doctors say.

Still, interferons have side effects, doctors say. Common ones include flu-like symptoms; rarer ones include liver or thyroid damage, depression, suicide, miscarriages.
"The most serious side effects are fairly rare," said Horstmyer. "The more common happen more at first treatment; eventually, patients become more tolerant."

"With interferons I had horrible side effects," Chediak said. "I had to have my liver checked every couple of months. I got depressed. I had mood changes. Interferons make you feel bad. Copaxone makes you feel bad, but not as much."
Copaxone, by Teva Pharmaceuticals of Israel, is not an interferon, but a combination of amino acids that create proteins that decoy the body's immune system away from attacking the myelin sheath.

Still, Tysabri patients say they won't be satisfied until that drug is back.
"There's a young guy in my MS support group who's taking chemo, and he can barely talk," she says. "He's waiting to go on Tysabri. He says, `Carmen, this is my last hope.' "The clock is ticking," she says.


2005, The Miami Herald.


http://www.fortwayne.com/mld/newssentin ... 228547.htm
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Re: MS patients angry over loss of drug

Postby HarryZ » Fri Mar 25, 2005 7:46 am

Better,


"For many years we have used other, more dangerous treatments for MS," said Dr. Jeffrey Horstmyer, director of the MS Center at Mercy Hospital in Miami. "Even if Tysabri has the rare side effect of PML, it's still likely safer than a lot of other things being used to treat it."

Now I find that statement very interesting. For a number of years now, MS docs often told their patients they should go on one of the interferons or Copaxone immediately upon diagnosis. With the arrival of Tysabri, these other drugs are now "more dangerous"!! Although many patients have suffered from some nasty side effects of the CRABs, I can't recall that they had been referred to as "dangerous" by these same docs. Hmmm!

Despite the PML problems, doctors say they support Tysabri.
"Tysabri creates a 66 percent decrease in relapses after two years, compared with about 30 percent for the other drugs on the market," says Sheremata, who took part in early clinical trials of Tysabri.

Despite the CRAB drug makers making claims in the past couple of years that their medications were giving a far higher efficacy than 30%, we now seem to see that the docs who want Tysabri brought back quickly, are stating that indeed the CRABs were giving no better than a 30% benefit! It's no wonder that MS patients continue to be confused by widely differing comments from the MS medical community.

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