Article: Four deaths linked to MS drug Tysabri, say authorities

The_Conductor

http://www.independent.ie/business/world/four-deaths-linked-to-ms-drug-tysabri-say-authorities-1929156.html

Elan and Biogen Idec's multiple sclerosis drug Tysabri has been linked to four deaths by the European Medicines Agency.

The European drug regulators confirmed the four deaths, tied to a deadly brain infection progressive multifocal leukoencephalopathy or PML, in a statement yesterday.

Shares in the two firms fell on the news yesterday. Elan hit a new year low before finishing flat at €3.44 yesterday.

The news comes just a week after the agency said it would be reviewing Tysabri, citing 23 cases of PML.

That number is far higher than the previously known figure of 13 cases. Elan shares fell nearly 20pc as a result of the news last Friday. Biogen dropped over 7pc.

A spokeswoman for the US Food and Drug Administration also said there have been 24 confirmed cases since 2006 but said the agency was "still receiving and reviewing follow-up information information on cases of PML".

Tysabri was removed from the market for 18 months, beginning in 2005, because of the link to PML.

The drug was allowed back on the market after patients and physicians pushed for its return. It is a key revenue driver for both firms and produces nearly $1bn in annual sales.

European regulators also reported another case of potentially deadly brain infection in patients on Tysabri since Friday, taking the worldwide total since 2006 to 24.

Of those, 16 cases have occurred in Europe, compared to eight in the US.

Confused

The imbalance of PML cases in Europe has confused analysts and, despite its investigations, Biogen has been unable to explain the difference.

Some Wall Street analysts have questioned whether some US cases have slipped through the cracks, but Biogen has vehemently denied this, saying the risk-management programme for Tysabri in America is rigorous.

The number of PML cases among Tysabri users is closely watched, as its label suggests an infection risk to one in every 1,000 patients.

Despite the PML risk, Tysabri is still seen as one of the most effective MS treatments on the market. Leerink Swann analyst Joshua Schimmer said in a note:

"For a disease which previously had an extremely high mortality rate, an 83pc rate of survival is outstanding."

byhookorbycrook

great, down to 1 in a thousand :eek:

FluffyCat

This has been in the news for ages now. I think there are other factors that have to be considered.
Im not on this med but it has done well for others

EL_Loco

despite the fatalities most users were distraught when it got pulled a few years back due to 2 deaths at the time.

FluffyCat

Well its inmportant to remember that with every drug you take you run the risk of death. Its just a shame MS drugs are not on the market long enough to get a full user profile

mickman

medication interacts differently with everyone. i mean someone can get a seizure and even die from a neurofen or an aspirin for gods sake. the same way that a person can die from drinking and a person can be killed crossing the road

life is a risk and i most certainly would take my chances with a drug that has benefits for any disease i was suffering from. life is all about quality and not quantity people.

shazba

hi just to let ye know i would not be without tysabri the best decision i ever made was to get it, it has turned my life around. I have had 15 infusions and gone from an exhausted reck to almost my old self . Thank god for Tysabri:)

nesf

It really is a simple cost/benefit analysis. MS is horrible for sufferers and for many a small risk of death due to a brain infection is worth having some semblance of a normal life back. I know if I was in the situation I'd find it hard to say no to the drug.

mickman

indeed. the chances of getting in are something like 1 in 1000. you have 1 in 70 chance of being killed in a car crash

Old'n'Cranky

I'm currently being reviewed as my meds don't seem to be helping, I have had long discussions with my partner about moving to Tysabri, it's not an easy decision. A 1 in 70 chance of dying in a car crash is good odds considering the amount of cars on the road, A 1 in 1000 chance of PML is not so good, considering the amount of people with MS (approx. 7000 in Ireland)

mickman

dont get you?

the odds of being killed in a car crash are 1 in 70 due to the large volume of cars on the road, thats what brings the odds down!!

7 people from 7000 MS suffers could get PML, thats 1 in 1000

if a million irish people had MS and took tysabri the ammount of people expected to get pml would be 1000. the odds would still be 1 in 1000

odds dont change due to the ammount of sufferrs etc.

if you take tysabri your chance of geting pml is 0.1%

byhookorbycrook

old N' Cranky (love the name),I had two relapses last year, close together, so I moved to Tysabri, as those two relapses did a good bit of damage. I'd say go for it!Pm me if you want.

Old'n'Cranky

byhookorbycrook wrote: »

old N' Cranky (love the name),I had two relapses last year, close together, so I moved to Tysabri, as those two relapses did a good bit of damage. I'd say go for it!Pm me if you want.

Thanks, maybe when the time is closer I send you a pm

Old'n'Cranky

mickman wrote: »

dont get you?

the odds of being killed in a car crash are 1 in 70 due to the large volume of cars on the road, thats what brings the odds down!!

7 people from 7000 MS suffers could get PML, thats 1 in 1000

if a million irish people had MS and took tysabri the ammount of people expected to get pml would be 1000. the odds would still be 1 in 1000

odds dont change due to the ammount of sufferrs etc.

if you take tysabri your chance of geting pml is 0.1%

hat's abit like the "its safer to fly than drive because there'as less plane crashes" arguement if the amount of people with ms was the same as the amount of people driving what would the odds be then?