PML 3 more cases

10yearsandstillkicken · Fri Oct 23, 2009 11:59 am

Wonderful. I think the next few months will be telling. If there are exponential increases in pml cases like this month, houston, we have a bigger problem than we thought we did...

Loobie · Post by **Loobie** » Fri Oct 23, 2009 3:32 pm

SO GLAD I quit that shit.

dreddk · Post by **dreddk** » Fri Oct 23, 2009 5:42 pm

Clearly the JC Virus test is the only realistic hope for this drug long-term. Surely Elan are putting a substantial effort into this...

"In a presentation to analysts this week, Elan president Carlos Paya said the development of “a simple and reliable test” that can accurately detect the presence of JC Virus (without which PML cannot develop) in patients before and during Tysabri therapy is the first step and of paramount urgency. It could “allow for rapid identification of those patients that should have almost no risk of PML. Current data suggest that 30-50 per cent of patients are JCV negative, depending on the test used,” Dr Paya said."

HarryZ · Post by **HarryZ** » Sat Oct 24, 2009 6:25 am

"In a presentation to analysts this week, Elan president Carlos Paya said the development of “a simple and reliable test” that can accurately detect the presence of JC Virus (without which PML cannot develop) in patients before and during Tysabri therapy is the first step and of paramount urgency. It could “allow for rapid identification of those patients that should have almost no risk of PML. Current data suggest that 30-50 per cent of patients are JCV negative, depending on the test used,” Dr Paya said."

This is a fairly substantial gap in determining whether a MS patient is JCV negative and saying that current data "suggests" those numbers can't be much of a comfort to the potential user.

You are certainly correct in pointing out that a reliable and easy JCV test is needed. Using a 40% JCV negative result would mean that about 60% of potential Tysabri users would have a much higher PML risk. This would really cut into Biogen/Elan's Tysabri sales and that would be devastating to an already compromised sales revenue situation. It will be interesting to see how Biogen/Elan will handle this business problem.

Harry

10yearsandstillkicken · Sat Oct 24, 2009 8:20 am

If the numbers of PML cases do grow exponentially, do you think that it will stay on the market?

dino84 · Post by **dino84** » Sat Oct 24, 2009 9:51 am

10yearsandstillkicken wrote:If the numbers of PML cases do grow exponentially, do you think that it will stay on the market?

i think that it will be taken off.
but how many pml cases there has to be for them taking this drug away...who knows?

RuSmolikova · Post by **RuSmolikova** » Sat Oct 24, 2009 1:40 pm

<shortened url>
A European panel has started a review of the controversial Multiple Sclerosis drug Tysabri, sold by Biogen Idec Inc. (BIIB) and Elan Corp. PLC The European panel said its review will discuss "any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment."
Christopher Raymond, an analyst with Robert Baird, said European regulators are unlikely to remove it from the market, but they may recommend that long-term patients take a break from using the drug to help balance risk. Duration of use is seen as raising the risk factor for PML.
Earlier this week, Biogen acknowledged that it is talks with the U.S. Food and Drug Administration to amend Tysabri's label to reflect increased PML risk with longer-term usage. Changing the label marks a shift for Biogen, which has long maintained there was no clear connection to duration and increased risk of PML, but mounting evidence has made that link clear.
(ELN), citing a much higher number of rare brain infections than previously disclosed.

http://www.xe.com/news/2009-10-23%2013: ... htm?c=1&t=
The European Medicines Agency, Europe's top pharmaceuticals watchdog, said on its website it has initiated a review to discuss any additional measures necessary to ensure the safe use of Tysabri.
'At worst, we anticipate (the agency) may recommend a drug holiday after an extended period on therapy,' said Christopher Raymond, an analyst at Robert W. Baird. 'But it is unlikely to suspend Tysabri's marketing authorization.'

http://www.bloomberg.com/apps/news?pid= ... GNNokyNLcw
European regulators will review “any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment,” the European Medicines Agency said today in a statement on its Web site disclosing the new brain infections.
“These new cases are likely to alarm physicians whose comfort with the product had been increasing in recent months, and should catalyze academic and regulatory discussions about more active risk mitigation strategies,” said Geoff Porges, a New York analyst with Sanford C. Bernstein & Co., in a note to clients today.

<shortened url>
Biogen finance chief Paul Clancy told Dow Jones earlier this week that the company will discuss how to communicate the link between long-term use of the drug and increasing incidence of the dangerous side effect.
Regulators might choose to recommend that patients who take the drug for long periods of time take breaks, or “drug holidays,” said analyst Christopher Raymond of Robert W. Baird & Co., in a note to clients this morning. Since so many patients depend on the product to control their symptoms, it’s unlikely that regulators would force it off the market, he said.
“We deem it highly unlikely that either FDA or EMEA would pull Tysabri from the market,” Raymond said. “With PML risk well known, we think the most likely scenario would be additional labeling restrictions suggesting perhaps a drug holiday after an extended treatment period.”

prof8 · Post by **prof8** » Sat Oct 24, 2009 8:52 pm

If Elan is searching for a PML virus test it would have to be both very specific and sensitive. I'm not sure how close they are to this but perhaps they have a serious incentive now. My neuro has my blood tested every 3 months for the PML virus but that is not as accurate as the spinal tap. And having a spinal tap done every 3 months is totally out of the question! And whatever blood test they use hasn't always registered positive in the beginning stages of PML.
I don't know how well the drug holiday will go over. My neuro believes that taking a break from Tysabri and going back increases your chance of developing antibodies which makes the drug useless. I believe it takes many many months for your immune system to go back to normal based on what I've read. If you started up again after a holiday how quickly would your immune system suppress again?
I doubt they will take the drug off the market but can they tell neuros only to use the drug if patients have aggressive MS and have truly failed all other drugs? I went on Tysabri not because I had bad MS or failed the CRABs but simply because I couldn't tolerate feeling sick on them. Perhaps someone like me might not be permitted to start the drug in the future?? I started before there were any PML cases post clinical trials. Now we apparently have 23!!

RuSmolikova · Post by **RuSmolikova** » Sat Oct 24, 2009 9:28 pm

prof8 wrote:I don't know how well the drug holiday will go over.

They discuss 2 or 3 months. To turn the body to the beginning level of therapy is out of question.

prof8 wrote:...but can they tell neuros only to use the drug if patients have aggressive MS and have truly failed all other drugs?

Yes, they can. That is what they do in Europe. It is a rule accepted by EMEA. Treatment is restricted to patients:
a) who have failed to respond to a full and adequate course of beta-interferon. Patients should have had at least 1 relapse in the previous year while on therapy and have at least 9 T2-hyperintense lesions in cranial MRI or at least 1 gadoliniun-enhancing lesion on brain MRI
or
b) rapidly envolving severe RR-MS defined by 2 or more desabling relapses in 1 year, and with 1 or more gadolinium-enhancing lesions or significant increase in T2 lesion load as compared to a previous MRI.

Nevertheess the most of the PML cases is in Europe...

screamner · Post by **screamner** » Sat Oct 24, 2009 10:24 pm

Yes, we have this rule but a lot of docs didn't follow. We have no infusion centers, every neuro with a littel training from biogen can give it.

There are no questions before infusion and every neuro has his own procedure. Also we have an university MS center who called Tysabri sugared water and give it to young people, which are new diagnosed.

Maybe because of our insurance we have a lot of patients who received Novantron bevore Tysabri.

RuSmolikova · Post by **RuSmolikova** » Sun Oct 25, 2009 2:46 am

screamner wrote:Yes, we have this rule but a lot of docs didn't follow. We have no infusion centers, every neuro with a littel training from biogen can give it. There are no questions before infusion and every neuro has his own procedure.

Wow! Is it the reason why there is so many cases of PML in Germany???

screamner · Post by **screamner** » Sun Oct 25, 2009 2:50 am

No I don't think, could be a part of a lot of reasons.

prof8 · Post by **prof8** » Sun Oct 25, 2009 1:01 pm

I have decided that I have completely lost all faith in Biogen. Of course profits always drive the pharmaceutical companies and I weighed that in my decision to take Tysabri. But now it is clear to me that Biogen has NO interest in the health of its patients--jumping from 13 to 23 cases of PML in one month is unacceptable. It makes me very angry. Not sure how much longer I will stay on this drug.

10yearsandstillkicken · Sun Oct 25, 2009 7:19 pm

Harry beats the Biogen drum and he is right on. I, like you, am becoming very apprehensive about my monthy vistit for infusion. Biogen has one thing in mind, profits. I expect they know damn well what this stuff will do and figure they will profit even if they end up in court...

screamner · Post by **screamner** » Sun Oct 25, 2009 10:23 pm

The wife from the fourth case (germany, male, 57) told in a german blog, that her husband died last week. It occurred after 10 months, obviously was it impossible to stop the virus.