Tysabri info

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

Harry,

with all due respect the issue here has nothing to do with whether or not you share/do not share the same optimism regarding Tysabri as other PWMS. The point the author makes is that we should have the right to informed consent use.

The FDA (as a result of public demand) expanded it's mission to not only protect the public, but to also "advance the public health by helping to speed innovations", thus the advent of the Accellerated Approval process.

Researchers are still not certain what, if any, the link between PML and Tysabri use is. But if there is a correlation, the incidence of PML is slim in relation to the number of patient months logged of Tysabri use. Without a doubt "slim risk" to me is not the same as "slim risk" to you. That is precisely why the option of informed consent should be available for drugs like Tysabri.

IMO informed consent is the next logical step regarding the FDA's mission of speeding drug innovations to the public.
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Post by HarryZ »

Denver,

I got from reading Lewis Fein's message that he was upset that the FDA was unnecessarily holding up the re-introduction of Tysabri. (he referred to them as imperial whims which I guess isn't the most flattering comment one could use!) He went on further to say that patients such as himself should have the right to make an informed decision on a drug such as Tysabri that according to Lewis, had a history of excellent results in the treatment of Crohn's disease.

I couldn't agree more that a person should have the right to decide for themselves on whether to use a particular medication. But where you and I obviously differ in opinion is whether Biogen has given us the data and information to make this"informed" decision.

We have trial data from Biogen that comes from mild MS patients. It's no secret that Biogen used this data to market Tysabri as "the" MS drug of all time. But PML jumped in a threw their entire plan into chaos. At the moment, nobody really knows the risk of PML in Tysabri patients even though Biogen says it's minimal. I've read comments on the net from researchers that say that 3 cases of PML among the MS and Crohn's patients is very high when you consider the number of patients who actually used the drug in the trials. This comes from experts, not me.

The FDA doesn't know the connection of PML and Tysabri and thus doesn't scientifically know the risk. Until Biogen can provide them a lot more data on this issue they can't tell patients what level of risk is involved. Nobody can do that at the moment and the FDA isn't going to conditionally approve Tysabri until they know the answer.

So while I share Lewis's concern I can't agree with his comment of blaming the FDA for dragging its feet on the issue. That blame should be placed solely on Biogen/Elan because they were the ones who got caught with their pants down.

Whatever the decision, I really do hope that it comes this year because as usual, MS (and Crohn's) patients have to sit back and wait again!

Take care.

Harry
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Post by bromley »

DenverCo,

I fully agree with your position on choice. Let's be honest about this disease - it can be, and very often is, very grim - brain atrophy, double incontinence, dementia, mobility problems etc etc, are phrases used in the scientific articles. It's not just issues about quality of life, but also about the impact upon families, finances etc etc. We face the prospect of this grim future every day. When a treatment comes along that looks like making our lives that tiny bit more bearable, then we should be able to decide whether we want to take the risk. If they work out that 5% of Tysabri users die from using this treatment, then we, the sufferers, should be able to make that choice. It would be interesting to take a poll to see what risks those with this disease might be prepared to take. What if they had a drug which halted progression and allowed repair to take place, but there was a risk that 40% of those taking it would die? We'll all have different views on this, but WE should be allowed to make the decision as to whether we are prepared to take the risk. If only the researchers and drugs companies could come up with effective and safe treatments, then we would not be in this position.


But Harry is right - the risks need to be properly quantified and robust.

Bromley
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TWO-YEAR SENTINEL DATA

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TWO-YEAR SENTINEL DATA EVALUATING TYSABRI® IN ADDITION TO AVONEX® REINFORCE EFFICACY IN MULTIPLE SCLEROSIS

Compared to AVONEX Alone, Data Show 24% Reduction in the Risk of Disability Progression and Sustained 56% Reduction in Relapse Rate

Cambridge, MA and Dublin, Ireland - July 18, 2005 -

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today that SENTINEL, the Phase III TYSABRI® (natalizumab) add-on trial with AVONEX® (Interferon beta-1a), achieved the two-year primary endpoint of slowing the progression of disability in patients with relapsing forms of multiple sclerosis (MS). The addition of TYSABRI to AVONEX resulted in a 24 percent reduction in the risk of disability progression compared to the effect provided by AVONEX alone. Data from SENTINEL also demonstrated that the addition of TYSABRI to AVONEX led to a 56 percent relative reduction in the rate of clinical relapses compared to that provided by AVONEX alone. The reduction in relapse rate was statistically significant and sustained over the entire two-year study period.

Other efficacy data from SENTINEL at two years, including MRI measures and immunogenicity, were similar to previously reported one-year results.

Common adverse events included headache, nasopharyngitis, limb pain, depression, flu-like symptoms, diarrhea, insomnia, sinusitis, influenza, nausea, muscle pain, anxiety and cough. The rate of infection was 1.6 per patient-year in both AVONEX plus TYSABRI-treated patients and AVONEX plus placebo-treated patients. Serious infections occurred in 2.9 percent of AVONEX plus placebo-treated patients and 2.7 percent of AVONEX plus TYSABRI-treated patients. TYSABRI has been associated with hypersensitivity reactions, including serious systemic reactions which occurred at an incidence of less than 1 percent of patients.

On February 28, 2005, Biogen Idec and Elan announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system. The companies have previously reported three confirmed cases of PML, two of which were fatal. Two of the patients with confirmed PML had received AVONEX plus TYSABRI for over two years as part of the SENTINEL trial. Biogen Idec and Elan's comprehensive safety evaluation concerning TYSABRI and any possible link to PML is ongoing. The results of this safety evaluation will be discussed with regulatory agencies to determine the appropriate path forward for TYSABRI.

"These data demonstrate the effect of TYSABRI on disability progression and clinical relapses. We continue to believe in the therapeutic benefit of TYSABRI in MS, a disease with significant unmet medical need," said Burt Adelman, MD, executive vice president, Development, Biogen Idec. "Our extensive safety evaluation, in collaboration with leading experts and regulatory agencies, is on track and we hope to have findings by the end of the summer. As always, our primary commitment is to improving the lives of people with MS."

"TYSABRI continues to show benefit in the treatment of immune-mediated diseases," said Lars Ekman, MD, PhD, executive vice president and president, Research and Development, Elan.

"Patient safety is our top priority. We remain strongly committed to defining TYSABRI's benefit-risk profile and determining the appropriate path forward."

SENTINEL is a two-year, randomized, multi-center, placebo-controlled, double-blind study of 1,171 AVONEX-treated patients in 123 clinical trial sites worldwide. In the trial, AVONEX-treated patients who continued to experience disease activity were randomized to add TYSABRI (n=589) or placebo (n=582) to their standard regimen.

The companies anticipate that two-year data from SENTINEL will be presented at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Thessaloniki, Greece, which begins September 28, 2005.


http://www.biogenidec.com./news/BiogenIDECPR_084.htm
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Should the FDA Always 'Err on the Side of Safety'?

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Should the FDA Always 'Err on the Side of Safety'?

By Henry I. Miller Published 07/20/2005

These are turbulent times for the FDA. The almost daily barrage of negative headlines questioning the safety of marketed drugs is likely depleting regulators' individual stocks of aspirin and antacids. But as they try to soothe their own pain, regulators must not forget their mission -- to ease the plight of patients who need new medicines.

Past criticism of FDA mostly concentrated on what arguably remains the agency's most important shortcoming: the delays and escalating expense of getting drugs through the development pipeline and into the marketplace. Lately, however, events have shifted the focus to issues of safety. First there were claims that the labeling of certain antidepressants failed to warn doctors that the drugs caused some adolescents to commit suicide. Then the agency was blind-sided by contamination that made half the nation's flu vaccine supply unavailable. Finally, there were revelations about previously unknown side effects of several widely prescribed anti-inflammatory analgesic drugs.

Regulators' increasing sensitivity to safety concerns may have become contagious: Drug manufacturers, too, seem to have begun to "err on the side of safety" to a degree that causes safe and effective drugs to be taken off the market voluntarily.

Consider Tysabri, only the sixth medication approved -- and the first in several years -- for the treatment of Multiple Sclerosis (MS), a debilitating autoimmune disease that affects the central nervous system. The stunning results of the drug's testing in clinical trials -- the frequency of clinical relapses was cut by more than half -- induced FDA to grant accelerated approval last fall. MS patients eagerly put their names on waiting lists to get the medicine.

But this ray of hope for MS sufferers was short-lived. By the time that several thousand patients were being treated with Tysabri, three confirmed cases of a rare neurological disorder caused by a virus were reported. (Because the drug suppresses certain aspects of the immune response, regulators, clinicians and the drug's developers had from the beginning been sensitive to the possibility of infections as a side effect.)

Immediately -- some would say prematurely -- the manufacturers of the medicine voluntarily halted production and distribution and withdrew Tysabri from the market. MS victims and many neurologists were bitterly disappointed. Now they can only hope that a comprehensive review that is under way of all the clinical data -- including the results of new diagnostic tests being conducted on Tysabri recipients -- will permit a return of the drug to the market.

The "safety" of a drug is a relative thing. Safety and efficacy, the two criteria required for marketing approval of a drug, are inextricably linked. Regulators' judgments require a global and often difficult calculation of risk and benefit, including consideration of what alternative therapies are available. We would tolerate greater uncertainty and more severe side effects for a potential cure for pancreatic cancer or AIDS, for example, than for treating heartburn. When FDA grants marketing approval, the drug is deemed to be safe and effective for the conditions on the label.

In the current climate of litigiousness and antipathy to big companies, one can understand the haste to withdraw Tysabri voluntarily from the market. What is also understandable (and lamentable) is the chattering classes' hyping of the drug's health concerns and of the stock market impacts of the withdrawal, while ignoring that real people who were able to lead more normal lives with Tysabri are now prevented from obtaining it.

Another casualty of the withdrawal is the ability of patients, after consultation with their health care providers, to make informed decisions about possible treatment options. That fundamental right should not be usurped by risk-averse, publicity-shy bureaucrats, anti-FDA healthcare activists, or members of Congress.

As more breakthrough drugs come before FDA for approval, the agency must curb its paternalistic instincts and find a way to balance more sensibly the assurance of safety with patients' right to assume responsibility for their own medical decisions. This would be a sea change for FDA, which in many areas -- "off-label" prescribing, and dissemination of new information about drug therapy, among others -- has sought repeatedly to limit the discretion of physicians and patients to make treatment decisions.

To this point, FDA has been even-handed in its treatment of Tysabri. The clinical data justified the accelerated approval; the ongoing analysis of safety data is a responsible action; and if the data support it, FDA should work with Tysabri's producers to move rapidly toward reintroduction of the drug. Labeling restrictions, such as a prominent "black box" warning or strict limitations on which patients can receive a drug, are "risk-management" options within FDA's purview. In any case, the agency's actions must be driven by the data.

The notion that FDA should "err on the side of safety" must be qualified for patients with incurable or poorly treatable diseases: For them, there is no safety in the status quo, and we only damage them further with paternalistic public policy that prevents individuals from exercising their own judgment about risks and benefits. If FDA must err, it should be on the side of patients' freedom to choose.

Henry I. Miller, a physician and fellow at the Hoover Institution and Competitive Enterprise Institute, headed the FDA's Office of Biotechnology from 1989-1993. His most recent book," The Frankenfood Myth," was chosen by Barron's as one of the 25 Best Books of 2004.


http://www.techcentralstation.com/072005G.html
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Re: Should the FDA Always 'Err on the Side of Safety'?

Post by DenverCO »

better2gether wrote: Regulators' judgments require a global and often difficult calculation of risk and benefit, including consideration of what alternative therapies are available. We would tolerate greater uncertainty and more severe side effects for a potential cure for pancreatic cancer or AIDS, for example, than for treating heartburn.
The writer hit the nail right on the head.
As more breakthrough drugs come before FDA for approval, the agency must curb its paternalistic instincts and find a way to balance more sensibly the assurance of safety with patients' right to assume responsibility for their own medical decisions. This would be a sea change for FDA, which in many areas -- "off-label" prescribing, and dissemination of new information about drug therapy, among others -- has sought repeatedly to limit the discretion of physicians and patients to make treatment decisions.....

The notion that FDA should "err on the side of safety" must be qualified for patients with incurable or poorly treatable diseases: For them, there is no safety in the status quo, and we only damage them further with paternalistic public policy that prevents individuals from exercising their own judgment about risks and benefits. If FDA must err, it should be on the side of patients' freedom to choose.
Since the writer worked for the FDA for portion of his career, he is in a far more knowlegable position to comment on the FDA's position of always "erring on the side of safety".

However, I am inclined to give the FDA credit for slowly beginning to expand their role. The Accelerated Approval process was definately a move in the right direction. The Tysabri decision is an opportunity for the FDA to take the next step and allow patients the opportunity to assume more ownership of our treatment.

My hope is that the FDA will live up to their newly expanded mission by allowing us to take responsibility for our own individual decisions regarding Tysabri.
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Re: Should the FDA Always 'Err on the Side of Safety'?

Post by HarryZ »

Denver,
However, I am inclined to give the FDA credit for slowly beginning to expand their role. The Accelerated Approval process was definately a move in the right direction. The Tysabri decision is an opportunity for the FDA to take the next step and allow patients the opportunity to assume more ownership of our treatment.

My hope is that the FDA will live up to their newly expanded mission by allowing us to take responsibility for our own individual decisions regarding Tysabri.
I agree with allowing the patient more decision powers in determining what kind of treatment he/she wants but what is "the" important aspect here is the patient having the proper information at his/her disposal.

With Tysabri, this isn't possible yet because of the way that Biogen/Elan introduced the drug. They have had to go back and review all the trial data and provide the FDA with a lot more information about the possibility of PML and other potential problems with this drug. After this has been done and everything properly reviewed, then and only then will the patient have the proper ability to make this decision.

Harry
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DenverCO
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Re: Should the FDA Always 'Err on the Side of Safety'?

Post by DenverCO »

Harry,

I am beginning to get the feeling that you and I do not agree on the past and future of Tysabri!
I agree with allowing the patient more decision powers in determining what kind of treatment he/she wants but what is "the" important aspect here is the patient having the proper information at his/her disposal.

With Tysabri, this isn't possible yet because of the way that Biogen/Elan introduced the drug. They have had to go back and review all the trial data and provide the FDA with a lot more information about the possibility of PML and other potential problems with this drug. After this has been done and everything properly reviewed, then and only then will the patient have the proper ability to make this decision.
Your comments imply that Biogen withheld information about a possible link between Tysabri use and PML. It is my understanding that the PML death that occured during the trial was not at that time identified as being Tysabri related. (Let us not forget, that a correlation has STILL not been proven.) That is far different than brushing the truth under the carpet.

As far as "the way Biogen introduced the drug" I'm not sure I inderstand what you are talking about. Accelerated Approval requires that the drug company continue the Phase III study and report to the FDA. Doctors explain to patients that the drug has not undergone the complete trial process but that it has shown such promising results that it is being introduced before the completion of Phase III.

Some view "fast-tracking" as the manipulation of data in order to rake in profits earlier. Others of us view it as an ethical necessity...when new drugs for deadly or disabling diseases show significantly superior efficacy over currently available threatments, then it is unethical to make patients wait another 2-3 years at which time they will probably be dead or severely disabled.
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Re: Should the FDA Always 'Err on the Side of Safety'?

Post by HarryZ »

Denver,
Your comments imply that Biogen withheld information about a possible link between Tysabri use and PML. It is my understanding that the PML death that occurred during the trial was not at that time identified as being Tysabri related. (Let us not forget, that a correlation has STILL not been proven.) That is far different than brushing the truth under the carpet.
No, that's not what my intention was and I'm sorry if you got that impression. PML blind-sided Biogen/Elan and threw Tysabri's entire marketing plan out the window.

My concern was that Biogen/Elan raced Tysabri through the accelerated approval process even though they were very aware of how potentially dangerous this drug was. They were told on more than one occasion by experts in the field that tampering with T cells entering the brain could leave the patient open to danger.

Although the Phase 1 and II trials showed the drug to be safe, the real test could only happen in the two year Phase III trials where many more patients would be subjected to the drug. Don't forget, the original plan for Tysabri was to complete the Phase III trials by the end of 2004, analyze the data during the first few months of 2005, apply for FDA approval and then hopefully have it available sometime in the fourth quarter of 2005. But Elan got excited when they looked at first year data from a couple of the Phase III trials and stated that this was good enough to try and get early approval of the drug.

And that is what irks me! You have a drug that tampers with the immune system's function within the brain, you know there can be problems and are warned about it. Yet you still go ahead with limited data from two trials and go the fast-track route! We know that Elan was counting big-time on Tysabri to bring them back to a profitable level and you have to wonder if the profit motivation was front and center.

So what happens....two MS trial patients get PML, one dies, one becomes very sick and another Crohn's patient dies. And Tysabri enters into a world of chaos with thousands of MS patients having the carpet pulled from under them. That's all Bigoen/Elan had to do was follow their original plan and the Tysabri problems would have been known before the drug got approved. And we would have seen a very different plan of attack because of it. Nobody will ever convince me that rushing this drug to approval was the right thing to do.

Add to this the stock selling fiasco that took place at Biogen just prior to the drug being pulled and you have a first class mess.

Now MS patients have to wait several months to see if Tysabri ever comes back as the experts try and figure out where PML fits into the puzzle.

Take care.

Harry
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Post by lady_express_44 »

I agree with Harry that we do not have enough information to move forward with bringing Tysabri back on the market.

My biggest pet peeve is that I don't like what happened with execs selling their shares, just prior to releasing the information about the first death due to PML. If it was an innocent coincidence, I feel they should have found a way to restore their integrity. Personally, I haven't heard of any offering to make amends . . .?

I don't like that one person was already buried before they realized they actually died from PML. Does anyone know for a FACT, how many other people were buried before the real cause was determined? I'd definitely want to know that.

I don't appreciate the original propoganda that surfaced, implicating that the PML deaths may have been caused by combining Avonex & Tysabri. Later we find out someone with Crohn's (who had previously been on immunosuppressants) also died during the trials. Now, the drug seems to pose a potential problem if a person had been on either immunosuppressants, &/or combined Tysabri with Avonex. . . . is that all?

There is rumor out there that there may be another 2 people who may have PML as a result of the clinical trials. Yes, it is hear-say at this point, but I have not heard Biogen denying there is a possibility this is true. Their response is that we have to "wait until their investigation is completed". Does anyone know at this point, how many have actually contracted PML?

I am concerned that if it is back on the market prematurely, many unsuspecting patients will be put on this drug, oblivious to the potential risks. Time and time again I've heard that people aren't advised about the risks associated to steroids and CRABs, and many aren't ever tested for rejection, or the liver problems that are associated with taking them.

You are obviously well-informed about the MS drugs, but a great number of MS'ers are not. Many do not have access to a computer, and rely solely on what their Neuro/doctor tells them. My experience is that many doctors/Neuros are not up-to-date on the potential side-effects of many of the drugs either.

So naive & innocent MS'ers are really at the mercy of the the medical community to be knowledgable, informative, and to communicate the risk of using a particular therapy. I think this is a huge risk in itself.

I suspect that vast majority of people would not want to take an "unknown" risk of PML or death, if they knew this was what they were being set up for. Obviously some people are risk takers, or are desperate, and may be willing to take a 2, 5, 10, 25 (???) percent chance that this drug may cause PML, or kill them. I do not think this is a compelling enough reason to release the drug to the masses though.

I have a few questions too . . . regarding this new press release. They are saying that the Tysabri/Avonex group saw 24% improvement in the risk of disability, over what the Avonex (alone) group saw.

As I understand it, in the original Avonex trials, the Placebo group saw a 22% improvement in the risk of disability, and the Avonex group saw a 35% improvement in the risk of disability. The difference between using Avonex and Placebo was 13% then, correct?

Using the old stats as a reference point, if there is a 24% improvement by combining Tysabri/Avonex, over Avonex alone (35%), does this mean that the Tysabri/Avonex group proved to have a 43% (24%*35% = +8%) risk improvement, vs. 22 % on Placebo, and 35% on Avonex?

Does anyone know what the numbers were for "improvement in risk of disability" for Avonex alone, during this new trial? Is it still 35%?

Hmmm . . . and how do they factor in a death (or two or three) into the statistics?

I imagine someone here knows the answers to these questions . . . but if not, I suggest that this just adds more credence to the argument that we DON'T YET have enough information to make an INFORMED decision.

As far as the 56% reduction in the clinical relapse rate, what does this really matter if only 24% saw improvement in risk of disability?

Thanks, in advance, for any responses to my questions/comments. Much appreciated!
<div><span class="postbody">''In the last analysis, we see only what we are ready to see, what we have been taught to see. We eliminate and ignore everything that is not a part of our prejudices.''&nbsp; </span><span cla
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Post by HarryZ »

Cherie,

You bring up some interesting numbers when it comes to the efficacy of Tysabri. They sort of compare to a very analytical writer on the Brain Talk MS forum by the name of Mark. He looked very carefully at the trial data given by Biogen and came up with Tysabri showing a 12% increase in efficacy over the CRAB drugs. I haven't been able to understand why Elan got so excited over the one year data from two trials and decided to fast-track Tysabri....... without waiting for more safety data.

Hopefully the experts will be able to sort this whole PML mess out sooner rather than later.

Harry
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Post by DenverCO »

Cherie,

I agree with you that there are many PWMS who do not follow the drug developments and rely strictly on what their doctors tell them. Even scarier still, there are many neurologists who don't keep up with their reading and continuing ed requirements. There was a post on one of the boards recently from a patient who questioned her neuro about Tysabri's return and she got the distinct impression from his "duh?" response that he hadn't even heard of it.

The point of the Black Box label is to insure that the risks don't get overlooked in the fine print. Even though physicians never lay hands on the actual package that the drug comes in, letters go out from the manufactuer, memos go out within departments, articles are published in industry publications, etc.

A neurologist would have to be living under a rock (a rock on the golf course no doubt!) to not know about the risk, but I guess that's a possibility.
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Post by HarryZ »

You know this had to happen sooner or later with the shark lawyers lurking out there. I really wonder just how much of a case they have against Biogen/Elan when trial participants have to sign a waiver to participate in a drug trial.

Harry

______________________

Parker & Waichman, LLP Files Suit Against Biogen Idec, Inc. and Elan Corp. on Behalf of Family of Tysabri PML Victim
Thursday July 21, 9:43 am ET
Victim Died of Progressive Multifocal Leukoencephalopathy after Receiving 30 Doses of Tysabri in Combination with Avonex while Participating in Clinical Study


NEW YORK, July 21, 2005 (PRIMEZONE) -- Parker & Waichman, LLP (http://www.yourlawyer.com) announces that it has filed a claim on behalf of the family of Mrs. Anita Smith against Biogen Idec, Inc. (NasdaqNM:BIIB - News) and Elan Corp. (NYSE:ELN - News), the manufacturers of Tysabri (Natalizumab). Mrs. Smith died of Progressive Multifocal Leukoencephalopathy, or PML, a fatal disorder of the nervous system that has been linked to monotherapy with Tysabri and Tysabri in conjunction with Avonex (Interferon Beta-1a), another Biogen pharmaceutical. Tysabri, a powerful immunosuppressant, received fast track FDA approval in November 2004 for the treatment of Multiple Sclerosis (MS). Tysabri was voluntarily withdrawn from the market by its manufacturers on February 28, 2005, after two cases of PML were diagnosed. The suit was filed in Massachusetts Middlesex Superior Court on July 20,
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Post by OddDuck »

Hi, Harry.

The lawyers will have a pretty good case. Trust me, those waivers can be torn apart legally (I tore one apart myself - legally speaking). If you look back on some of my prior posts here from "long ago", I had a "discussion" regarding that with someone else here. Trust me, waivers of just about any type can only protect someone so far, and it's not as far as you think. And clinical trial waivers are very poorly constructed.

What is, once again, also funny to me are two things:

1. I notified the NMSS after the Tysabri deaths and explained that very same "known or should have known" doctrine to them as this article refers to regarding Biogen and Tysabri and how that would be very easily used in court to nail Biogen to the wall. How do they explain that someone like "me" could see enough biological evidence that justified strong warnings to MSers and they claim they did not or could not? Excuse me for not believing that one. The "should have known" doctrine is a slam dunk.

2. Besides, Biogen DID know beforehand (enough anyway) to have provided better warnings, and knew enough to have taken better precautions and researched further before testing any combination on humans. Again, look back at my posts. I found physical evidence, and it was PUBLISHED no less, that Biogen ITSELF did research into the infection problem, so that's enough to show in court that they DID know, yet didn't make it clear to people. (Hence the reason for all of MY warnings here in thisisms, a result of which I was attacked viciously for. Gee, was I sort of on the right track after all?)

The discussions on this website alone can/will be extremely useful in court. Not to mention............put me on the stand. A regular everyday person providing warnings to people that Biogen didn't, and who had truthful biological evidence as to why she was doing so? Yeah............explain that one away, Biogen/Elan.

Deb
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Post by HarryZ »

Hi Deb,

Thanks for responding to this message. You have a far greater understanding of the legal system than I'll ever have and made some good and interesting points.

I suspect that if the litigation lawyers didn't think they had a very good chance of winning this case, they wouldn't have filed it. I also figure that they have "dug up" a fair amount of evidence against Biogen/Elan that will come out in court....that is unless Biogen/Elan decide to settle this out of court which is likely.

Harry
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