Biogen-Idec reported yesterday that the US patient who was reported to have PML on Oct. 29, 2008 has died.

The death was likely as a result of IRIS from PLEX and treatment for PML. This is the patient who was 49 yrs old, female, previously treated with Copaxone,Beta-interferons and methotrexate for RA. She had received 14 infusions of Tysabri.

Her last methotrexate treatment was 4 months before starting Tysabri. It is unknown when she was last treated with interferons and Copaxone.

More information as and if it becomes available. Since this patient lives in the USA, there may be no further information available due to the HIPAA laws.

As an update to this post:

I can find NO 8k from Biogen on this patient.

I cannot find any mention of this announcement on Biogen's site, where any announcement from Biogen to the public is always posted as it is announced.

There is no cause of death listed in any of the news reports about this announcement.

The death was reported to Biogen, according to news reports, but no further details are available in any news reports I have read.

In my previous post, I speculated on the likely cause of death and posted "The death was likely as a result of IRIS from PLEX and treatment for PML"
That is my opinion and not fact, since no cause of death has been published.

Thanks and carry on...

Biogen has admitted that she had PML, by way of a 8-K form already:

http://www.sec.gov/Archives/edgar/da...2762bie8vk.htm

Even if it is ultimately IRIS that killed her, that doesn't make things any prettier. PML, IRIS . . . they are BOTH wicked "side-effects", and that would just mean that Tysabri caused a double-whammy for her.

Biogen's spokespeople have also announced her death in many articles:

http://www.newstin.co.uk/tag/uk/94432260

http://www.google.com/search?sourcei...L+patient+dies

Form 8-K "is the current report companies must file with the SEC to announce major events that shareholders should know about." Shareholders already know this lady had PML, so there may be no further obligation to file with the Securities and Exchange Commission (SEC) when a person dies from a previously reported medically induced disease.

Cherie

I understand that many many articles written by financial reporters and news reporters can be found by googling them, Cherie. I am not stupid.

What I do NOT find is the original announcement by Biogen, nor do I find an 8k, which the SEC requires when ANY material event that may affect the share price of a listed company's stock happens. This includes patients previously reported as having contracted a disease that may or may not be from the use of that company's product dying as a consequence of taking that drug.

I find a lot of speculative articles about the event, along with speculations about what caused the death.

While there is a very good chance that this patient died from IRIS, I refuse to speculate further as to how she died until more information becomes available, but thanks for your input.

IRIS with PML is often referred to as PML-IRIS because, as I understand, the use of plasmapheresis (to treat the PML) may cause the IRIS. Either way, IF she ultimately died from the previously announced case of PML, or from IRIS due to the treatment used to slow the devastation of PML . . . the chain reaction would clearly start with the use of Tysabri.

http://investorvillage.com/mbthread....wall=1#6097376

They will likely want to wait on autopsy results BEFORE they might intend to officially “announce” the cause of death and/or file an 8-K form (if that even occurs). In the meantime you are as entitled to “predict” her death might not be related to the PML, as I am to “speculate” that it was.

"Biogen says Tysabri PML patient dies in U.S.

Fri Dec 19, 2008 9:52pm GMT
By Toni Clarke

BOSTON (Reuters) - Biogen Idec Inc said on Friday that a multiple sclerosis patient who had been diagnosed with a rare brain infection while taking its drug Tysabri has died, sending the company's shares down nearly 3 percent.

Biogen and its partner Elan Corp Plc disclosed the case in October. Naomi Aoki, a spokeswoman for Biogen, said the company learned of the patient's death earlier this week.

Tysabri is seen as crucial to the growth of both companies. The drug was temporarily withdrawn from the market in 2005 after it was linked with a rare brain infection known as progressive multifocal leukoencephalopathy, or PML.

The drug was reintroduced in July 2006 with stricter safety warnings.
So far, there have been four new cases of PML, an infection rate that is still less than the one in 1,000 warned of in the drug's label. Nearly 18,000 patients have received at least a year of Tysabri. But investors are watching to see if the rate increases, and they are also looking at how successfully patients can recover.

"While we continue to believe the benefit/risk profile of Tysabri as favorable, we believe this death could lead the FDA and physicians to alter how future PML cases are managed," said Christopher James, an analyst at Rodman & Renshaw.

The patient who died was a United States patient who had received 14 monthly infusions of Tysabri as a stand-alone treatment. Previously she had received other therapies.

After developing the brain infection, the patient was treated with a procedure known as plasmapheresis, in which blood is removed, cleared of the drug, and replaced.

While the U.S. patient died, two patients who developed PML in Europe, and whose cases were announced in July, appear to be recovering following treatment, even though one had not been expected to survive. Earlier this month, Biogen announced that a fourth patient had developed PML. This patient, in Europe, is still alive.

The European patient that had not been expected to survive had developed a condition known as immune reconstitution inflammatory syndrome, or IRIS. This occurs when the immune system, in eliminating an infection, produces an excessive inflammatory response that can worsen symptoms.
The patient was treated with corticosteroids.

Geoff Meacham, an analyst at J.P. Morgan, said it seems likely the U.S. patient, having gone through plasmapheresis, died of IRIS, and that since the European patient recovered, it might be possible to manage IRIS using steroids and close monitoring. Biogen declined to confirm this theory, citing patient privacy.

"In our view, the rate of PML is now critical to assessing the launch trajectory, and the regulatory outlook, should it stay in the 1/1000 range," Meacham said in a research note."

http://uk.reuters.com/article/health...BrandChannel=0

Cherie

TMI, Redundant, TMI!!! Sheesh!!

June of 2007, I was asked to participate on an FDA panel as an MS Patient Advocate to evaluate the RiskMAP for the TOUCH protocol for Tysabri. Some of you may remember the extensive questionnaire (anonymous) I sent out for your to fill out.

I was the first speaker of the first day of the 2-day conference. I had 15 minutes to present this information. I spent almost 2 weeks putting it all together in a power point presentation.

Biogen was the first speaker on the 2nd day of the Conference. It was obvious to all that their presentation was redone as their speaker did not match their slide presentation and my name was mentioned more than once.

My point being that the FDA is monitoring Biogen and Tysabri. After that conference and since then, the labeling and monitoring process has changed. Biogen had hoped to have the black box warning label removed. It will never happen. Biogen and the FDA are well aware of the risks involved with Tysabri. No drug is 100% safe, I don't care who you are or what the drug companies say...there is no such thing as a 100% safe medication. Period.

As to the publication or notification to the patients of the risks involved of Tysabri -- It's called informed consent. I am not saying that Biogen is doing everything they are supposed to be doing, but there are MANDATORY, not ADVISORY, requirements that must take place before the patients have their first infusion of Tysabri.

Please take a look at the track record of other drugs on the market. Sometimes adverse events/side effects aren't known until the drug has been on the market for well over 10 years, sometimes longer. This drug has only been on the market since 2004.

It was the first new drug on the market to treat MS in almost a decade. It was clearly stated at the first hearing in 2005 that there WOULD BE, not MAY BE, PML cases reported. I was there, I heard it. The FDA heard it...any one who listened to the transcripts of the hearing heard it. None of us are stupid, as RW stated.

PML is going to happen. It was predicted by Biogen. It was predicted by the FDA panel when they approved the drug to be returned back on the market. That was the reason for the TOUCH protocol. That was the reason for the PML Tracking system. That was the reason for the evaluation of the TOUCH protocol every year.

Now, let's look on the positive side. How many people has this drug helped to have a better quality of life? How many people have other drugs helped have a better quality of life that have a much higher death rate? Aspirin is always a good example, tylenol is another one. Do they pull those OTC drugs from the market, no. They don't even lower the stock market price of the makers of these drugs...not even a blip on the radar. Does it make the headlines...NO WAY.

I am not trying to lessen the degree of this lady's death in any way shape or form. It's sad. Very sad. But this one ups man's ship stuff has got to stop. The reporters are the ones who are letting this get out of hand - again - and some of you are taking the bait. Let's let the experts, like say her doctor, report what her REAL cause of death was, before jumping to conclusions and picking fights.

There are a lot of people on this forum (and others) who are benefitting from the drug and don't need all this negativism right now. Reporting facts is one thing, but continuing to belittle one's opinion who is actually taking the drug is unbecoming and serves no purpose.

Let's stick to the facts and stop speculating.