Wiz,

The question here isn't whether we offer drugs like Tysabri to the public but making sure this same public is given all the information required BEFORE making their decision.

If you can recall PRIOR to Tysabri becoming approved on the first go around....Biogen posted their marketing plan on the internet describing how it would be the first choice of treatment and within a year, have a huge share of the MS medication world. All their development costs would be recovered within 18 months!

It's this very approach that I am concerned about....promoting the heck out of a drug and then discovering all the problems afterwards. Let's get the revenue flowing and then worry about the fall-out later. Is this fair to the MS patient and/or doc who is trying to determine if the patient should use this drug?

I am glad to hear that Tysabri appears to have given you some quality of life back but wouldn't it have been better to know about these problems before you started on the drug? Again, my concern is that Biogen was aware of these potential problems but chose not to disclose them fully.

I'm not suggesting that we take Tysabri away but perhaps the FDA should be demanding more information from companies like Biogen. We know very well why Biogen strongly minimizes the potential problems of this kind of drug...it's very bad for potential sales.

At first we were told that the PML problem was due to combining immunosuppressive drugs. Then it was because the patient had taken this kind of drug in the past.....monotherapy was perfectly safe. And now we see monotherapy patients getting PML and subjected to other immune system problems. What else don't we know about Tysabri?

I also realize that you aren't baiting me in your questions. From reading your several posts I know that you simply aren't the kind of person who would do that and I respect your opinion.

Take care.

Harry

Harry,

My neuro would agree with you. I spoke to him today and he's generally not that fond of many of the pharma companies. Thanks for your concern. Hopefully it won't get much worse with the PML and other side effects. I just wish they'd come out with a pill that has low side effects really soon.

Seems Patient #3 with PML (in the US) has died :

UPDATE:Patient On Biogen, Elan MS Drug Dies Of Brain Disease

DOW JONES NEWSWIRES

By Thomas Gryta
Of DOW JONES NEWSWIRES

NEW YORK (Dow Jones)--A multiple sclerosis patient being treated with Tysabri, from Biogen Idec Inc. (BIIB) and Elan Plc (ELN), has died of a previously disclosed occurrence of a rare brain infection.

Biogen originally reported the confirmed case of progressive multifocal leukoencephalopathy, or PML, in late October. Tysabri, key to the future growth of both companies, is very effective in fighting MS, but a suspected link to PML led to its withdrawal from the market for 18 months beginning in 2005.

Patients on the drug are now closely monitored and four cases of the often fatal infection have occurred since its July 2006 relaunch, but the death may quell hope that PML could be a treatable side effect of the drug.

Shares of Biogen were recently down $1.15, or 2.4%, to $46.86, while Elan dropped 32 cents, or 5%, to $5.96.
The patient who died was the third case and the only one in the U.S. The other three are in Europe and remain alive.

A Biogen spokeswoman said that the company was informed earlier this week of the death and wouldn't disclose more information out of respect for the patient and her family.

The patient received 14 monthly infusions of Tysabri as a monotherapy and was previously treated with Teva Pharmaceuticals Industries Inc.'s (TEVA) Copaxone, Bayer AG's (BAY.XE) Betaseron and Biogen's Avonex. She also took methotrexate for a rheumatolgical condition.

All of the patients that developed PML were given plasmapharesis, a process that removes large molecules from the blood, speeding up Tysabri's removal and allowing the immune system to fight the PML infection.

When the drug is removed from the system, patients often experience an inflammatory response as the immune system reconstitutes itself, which can lead to their condition getting worse before any improvement is seen.

The death of the patient may temper arguments that the intricate distribution and monitoring program used for Tysabri, and use of plasmapharesis may ease the risk of PML for patients. Biogen has hoped that PML could eventually could be a "survivable adverse event."
But given the severity of PML, some believe that the death of a patient shouldn't be a surprise.

"We think the odds of surviving PML are still better than initially thought," said analyst Geoffrey Meacham of JPMorgan.

Tysabri's label implies that one in every 1,000 patients could get PML, but the actual number remain well below that ratio. As of Sept. 30, more than 35,500 patients use Tysabri, with 9,500 patients on it for at least 18 months and 3,700 for more than two years.

Steven Harr, an analyst with Morgan Stanley, writes that the recent death may demonstrate that Tysabri's risk is consistent with the label, to the disappointment of some investors and physicians that thought it might actually be lower.

-By Thomas Gryta, Dow Jones Newswires; 201-938-2053; thomas.gryta@dowjones.com

http://www.djnewsplus.com/article/DN...Brain+Disease+

All sources of information, even the co-founder of Tysabri, need to be questioned. I'm not saying that Biogen played fair (I don't know the details) but Lawrence Steinman runs his own pharmaceutical company, Bayhill Therapeutics, that is working on its own MS drug to be taken once a month. I believe Phase IIb trials are starting now. Competition? You betcha. It's a multi-billion dollar market out there and it seems that money will always drive the process to initiate new MS drugs. That's how the pharmaceutical industry works. And unfortunately, one of the by products of the free market is the unwanted or unexpected effects on the patients who take these drugs. The same thing goes on in the pharmaceutical market for anti-depressants.

By the way, just look at what Steinman's company says on its website regarding its drug, BHT-3009.

"BHT-3009 is an antigen-specific plasmid encoding myelin basic protein (MBP) that has the potential to gain a significant share of the multi-billion dollar MS market as an effective treatment with limited side effects and a superior administration profile."

http://www.bayhilltherapeutics.com/BHT-3009.html

$$$$$ play a role in everything. And what might Steinman's company not be telling us during their process to gain a share of the market? I'm not a diehard pro-Tysabri advocate or defender necessarily. Just playing devil's advocate.

Steinman could have hung in and cashed in on the Tysabri glory . . . but walked away when he realized the danger, WAY back when. He has been researching and testing other methods ever since . . . and why wouldn't he? He believed Tysabri was a time-bomb long before most others would suggest that.

Cherie

We don't know what Stenman's company will or won't tell us...that remains to be seen. But we do, however, know how Biogen handled the introduction of Tysabri, don't we? Combined it with Avonex before the drug was even approved by the FDA....outlined their market plan in detail on the net before the drug was approved.....conducted "staged" netcasts creating a "this is the MS drug of the century".....delayed telling the public about PML for a few weeks so their execs could cash in on $$$ millions in stock sales...

I could go on and on and yes, I fully realize that big pharma is driven by the almighty dollar and not by the health benefits to patients. I just find it disgusting that a company like Biogen has again placed MS patients in a precarious position in how they handle Tysabri....something that MS patients really don't need on top of fighting this lousy disease.

Harry

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