MS Drug Pulled After Patient Died

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http://www.mercola.com/2005/mar/16/ms_drug_death.htm

 

MS Drug Pulled After Patient Died

 

Multiple Sclerosis Drug

 

Multiple Sclerosis (MS) drug Tysabri, which was expected to become the

world's leading treatment for the condition, was pulled from the

market after a patient died from a rare central nervous system infection.

 

The patient died from progressive multifocal leukoencephalopathy

(PML), a rare infection of the brain and spinal cord, and another case

was suspected, prompting the drug's makers, Biogen Idec and Elan

Corp., to stop sales of the drug. They also stopped clinical trials of

Tysabri to treat rheumatoid arthritis and Crohn's disease,

 

PML occurred in patients who had been taking Tysabri in combination

with Avonex, another MS drug made by Biogen Idec, for two years or

more--the condition was not found in patients taking Tysabri alone.

 

The companies plan to re-examine brain scans from patients in former

clinical trials to see if a connection exists between Tysabri and PML.

If no other cases of PML are found, Elan said it hopes that Tysabri

will be back on the market by the third quarter of 2005.

 

The Food and Drug Administration (FDA) approved Tysabri in November

2004 under an accelerated program the FDA reserves for drugs it

believes will have " extraordinary benefits " to patients. It's the

first in a class of MS drugs called selective adhesion molecule, or

SAM, inhibitors, and it works by blocking a molecule known as alpha-4

integrin and preventing inflammatory cells from working into brain tissue.

 

However, at least one expert sounded an alarm to the FDA prior to the

drug's approval. Dr. Lawrence Steinman, a Stanford University

professor and an MS specialist who has developed MS drugs himself,

said he repeatedly warned of the potential for serious immune-system

side effects with Tysabri and drugs like it. The agency's expedited

approval system has been criticized in the past for rushing drugs to

market before they've been thoroughly tested.

 

The FDA said the drug fit the criteria for accelerated approval, and

the decision was based on clinical trials that showed it reduced the

rate of MS attacks by up to 66 percent. Existing therapies reduced the

frequency by 30 percent to 40 percent.

 

The recall has had a major impact on the drug's makers. After Tysabri,

which was expected to generate more than $1 billion in sales, was

withdrawn, Biogen shares went down 43 percent while Elan shares went

down 70 percent. Combined, the two companies lost $16.9 billion in

market value.

 

Further, in the two weeks before the recall, three Biogen executives

sold thousands of company shares for millions of dollars in profits.

Elan execs did not make any sales in the days before the FDA recall

notification.

 

ABC News February 28, 2005

 

Los Angeles Times March 2, 2005

 

USA Today March 1, 2005

 

Dr. Mercola's Comment:

 

When I heard the news that Tysabri--that so-called " wonder drug " for

multiple sclerosis (MS)--had been pulled from the market, I suspected

there was more to the story than was being first reported.

Particularly when a patient dies unexpectedly of a rare disease like

progressive multifocal leukoencephalopathy (PML), a central nervous

system disease usually seen in AIDS patients. (Although it is a tragic

disease, it is my absolutely favorite sounding medical term; I have

frequently used it in the past to kid with patients about a terrible

condition they might have, as virtually no one has ever heard of this

disease.)

 

There were certainly enough warnings about Tysabri, including the ones

from the Stanford University professor and MS expert who had

repeatedly written about the potential for serious side effects

involving the immune system with this type of drug. This expert ought

to know the risks, considering he had spent part of his career

developing MS drugs. And his warnings came long before a cautionary

editorial published in the New England Journal of Medicine (NEJM) two

years ago.

 

It's unknown whether the FDA listened to any of those concerns,

especially when they fast-tracked Tysabri to market under their

accelerated program for " breakthrough medicines. " But that was after a

Phase II trial in which a relatively small number of people taking the

drug were studied for six months. Not too long after that, NEJM

reported, " firm conclusions about safety must await the results of

much larger " studies.

 

Even more telling was the report in USA Today in which three Biogen

executives sold hundreds of thousands of company shares in the two

weeks before Tysabri was withdrawn from the market to the tune of

about $10.5 million.

 

Yet one more case of massive conflict of interest resulting in tragic

patient outcomes. This is particularly in light of the fact that there

are effective inexpensive, natural options that actually work. Let's

learn the lesson, taking a toxic drug that claims to " cure " a

condition can sometimes kill you.

 

If you or anyone you know has MS, please have them avoid interferons,

http://www.mercola.com/2004/jul/14/interferons.htm

as they have many harmful affects on the central nervous system. Have

them consider some of the following much safer alternatives:

 

*

 

It is imperative to have your vitamin D blood levels checked. I

would check the level every month or two until the level was between

45 and 55. Believe me, it is worth the hassle, time and expense to get

this one right as vitamin D clearly is vital in the treatment of MS.

*

 

MS patients must receive adequate amounts of vitamin D, as it

keeps your cell growth and activity in check. Although sunshine is

your best natural source of vitamin D, with winter's cold touch still

being felt, you probably won't get enough of it to make a difference.

That's why I recommend consuming high-quality fish oil or cod liver oil.

*

 

The fish oil and cod liver oil are also loaded with beneficial

omega-3 fats like DHA and EPA. These are also critical in the

treatment of MS. You may not need any supplemental vitamin D in the

form of cod liver oil, but virtually every single MS patient needs a

high-quality fish oil once their vitamin D levels have stabilized with

sun exposure.

*

 

 

On the brighter side, that Tysabri was recalled at all shows a very

important benefit of the recent Vioxx scandal: Pharmaceutical

companies, both big and small, appear to be much more sensitive these

days to anything involving a deadly side effect related to one of

their toxic drugs.

 

Related Articles:

 

How to Improve Multiple Sclerosis

 

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Sun Exposure Decreases Risk of MS

 

Amazing Recovery From Multiple Sclerosis

 

Vitamin D Treats & Prevents MS