Biogen, Elan Voluntarily Withdraw MS Drug (Tysabri)

[happynewyear]

From the latest businesss news:
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BOSTON (AP) -- The makers of Tysabri, a new drug used to treat multiple sclerosis, announced Monday they are voluntarily suspending sales of the drug after one patient died and another developed a serious disease of the central nervous system.

Stocks of both Biogen Idec Inc. and Elan Corp. tumbled, while shares of ther makers of rival MS drugs rose.

The biotechnology companies said in a news release that they have suspended supplying and marketing the drug Tysabri and advised doctors to suspend prescribing the medication. The companies also have stopped using the drug in clinical trials.

The companies said the decision to withdraw the drug came after recent reports of two cases of serious effects among patients who used it along with an earlier Biogen Idec MS drug, called Avonex, in clinical trials. In one case, the person died, while in another, the person developed a suspected case of progressive multifocal leukoencephalopathy, a rare and frequently fatal disease of the central nervous system.

Both patients had taken Tysabri for more than two years in combination with Avonex, the companies said.

http://biz.yahoo.com/ap/050228/ms_drug_suspension_25.html

:scared: :scared: :scared:


What next FDA? And, who next?

:dem:

[Liberal Veteran]

1. I don't see the problem here....

The drug was fast-tracked (as drugs for many diseases including HIV are), and when a problem occurred that didn't show up in clinical trials, they voluntarily withdrew the medication from the market until more research can be done to see if the PML was the result of the drug or not.

[happynewyear]

2. well .......

The problem I see with this is that they do not know what MS is still. It is suspected, alleged, thought to be automimmune in orgin but there is no proof of this theory.

It seems about 5,000 people with MS have gotten infusions of Tysabri. I wonder if any of these 5,000 persons might develop the serious disease that apparently kills you?

They fast tracked it alright but then again the other drug they market Avonex is also a Biogen drug that hasn't been faring too well lately.

Now they get this fast tracked and a couple of people die. What's two people dead anyway? Nothing to a big pharmaceutical company like Biogen that experiments on people with MS IMO. And also, isn't it just a "coincidence" that they were using this drug with Avonex, the other one they are pushing that seems to not be selling so well either?

Money talks, bullshit and sick people walk.

:(

[Liberal Veteran]

3. Unfortunately, there is ALWAYS the potential for long term risks...

...that didn't show up in clinical trials.

That's why we have Phase V trials. To track this sort of thing after a drug is released.

In this case, we have no idea if the PML was the result of the drug or not, but they did the responsible thing and pulled it until they could study it further.

I know it's easy to bash pharmaceutical companies, but I think you are jumping the gun on this one.

Hell, I am taking a drug that has been on the market for only 5 years for my HIV. Of course, I'd probably be dead without it, but we may find out that 10 years of daily causes something totally unexpected. We just don't know yet.

New drugs come with these kinds of unforeseen risks. That's a fact of medicine. But the alternative is taking 15 or 20 years to bring a drug to market if you want to be absolutely sure of something.

[happynewyear]

4. there are many other factors

than meet the eye with this drug. Can you say the words "insider trading"? It was, always has been and always will be about money until they can state what the cause of MS is.

In the case of other diseases, it was not until the cause was known before a cure or viable treatment could be found.

Certainly you must understand this process:

cause ---> treatment ----> possible cure or viable treatment that can help.

So far they haven't gotten to step #1 with MS. Very sad fact.

They are experimenting on people and not telling them the truth.

Look up BIIB on the DOW and read the message board too:

http://finance.yahoo.com/q?s=BIIB&d=t

http://finance.yahoo.com/q/mb?s=BIIB

I see at least there are a few that admit what happened and are suggesting a STRONG SELL for this.

I am totally shocked by this as everyone should be. They are betting on human lives knowing the ugly truth!

:argh:

[happynewyear]

5. Biogen execs reaped millions before FDA notified

<< WASHINGTON, Feb 28 (Reuters) - Biogen Idec (BIIB.O: Quote, Profile, Research) insiders reaped millions in cash bonuses and stock sales shortly before the company informed regulators of safety concerns regarding its new blockbuster multiple sclerosis drug, regulatory filings show.

On Feb. 17, the day before Biogen provided the U.S. Food and Drug Administration information on a patient death and another serious injury from its Tysabri drug, the company's board of directors approved $4.6 million in 2004 executive cash bonuses, according to a filing with the U.S. Securities and Exchange Commission.

On Feb. 18, the same day as the company's FDA notification, Biogen General Counsel Thomas Bucknum sold 89,700 shares for a profit of $1.94 million, according to an SEC filing.

On Feb. 15, three days before the company's notification to the FDA, Biogen Executive Chairman William Rastetter sold 120,313 shares for a profit of $7.45 million, in accordance with a previously filed trading plan, SEC filings show. >>

<< SEC filings also show that on Feb. 14, Biogen director Robert Pangia sold 15,570 shares for a $954,844 profit, also in accordance with a previously filed trading plan.

Biogen's spokesman denied that either Rastetter or Pangia had knowledge of Tysabri safety concerns prior to the trades. (ed. well they sure weren't going to ADMIT it! >>

more .....

http://yahoo.reuters.com/financeQuoteCompanyNewsArticle.jhtml?duid=mtfh53001_2005-03-01_01-13-40_n28305650_newsml

Don't tell me its not all about money, please don't tell me this.

How many have and will die? How many?


:grr: :grr: :grr:

[sevendogs]

6. I was scheduled to have my 2nd infusion on Thursday

I have MS. I had an infusion and felt wonderful. I do not and never have taken the drug that the others who got sick also took.

I am devastated by this action and cannot wait to have it back on the market.

This drug was very, very well received by those MS patients who received it. There was symptom relief immediately.

Too bad for us. Well, more waiting for something, I guess. I do NOT blame the drug company nor FDA and I have done my homework about this drug.