PML cases take alarming jump
 

Per the news item in this link, the number of PML cases has risen dramatically from 13 about a month ago to 23 today. Hmmmm....

Harry

http://www.xconomy.com/boston/2009/1...-drug-holiday/

Wow, a bit scary but the risk hasn't changed....still about 1 in a 1,000.

Still too risky for me.

Are these people dying or are they catching it in time?

Sally,

I'm not a statistician but read that the risk of PML goes up a large degree for people who have had more than 24 infusions...about 1/640. Not sure what these additional cases would do to that number but you know it would increase the potential a lot.

Don't know if these people are dying but did read something a month ago that even if you don't die from PML, the residual effects in most cases leave the patient in poor shape.

And isn't it sad that we always seem to hear this information from the business world and not from medical resources.

Harry

The 23 cases of PML was identified by the EMEA in their monthly meeting minutes. The EMEA is the European equivalent of the FDA.

The financial press is doing MS patients no favours as they tend to sentionalize the news rather than giving it detailed research and balanced reporting.

As far as outcomes from the PML infections, I do believe the outcomes have been better than expected but they still run the gamut from death/severe disability to only minor remnant effects. We haven't seen much info from the more recent April 09 to present cases which may be a better indicator of outcomes (been looking for PML more vigorously).

Chris

Wow that totally kills my thrill of opening the surprise box containing the fleece blanket and tote bag that Biogen Idec sent me with copy number 3 of the drug info.

They must be getting short on money. I got tickets to the opera and a weekend in Vegas with all meals paid. ;) :p :lookaround:

Just kidding Legzz. :D It's still less than 1 in 1000 for risk of PML according to the person I spoke to on Wednesday morning at Biogen.

I told him (George) that I had lots of friends taking Tysabri, and that we had known each other for years, and that I wanted to get an update on the latest info. He put me on hold for several minutes to make sure he gave me the correct info, lol. I told him that I might consider taking a break for 5-6 months if data showed any evidence that it would benefit me. He concurred with my MS neuro that there is no known benefit of doing this.

Anyway, I think you're doing the right thing in trying Tysabri. You're young and the other meds haven't helped much. If T helps, it will be so awesome. :hug:

I hate to say this but the financial press really doesn't give two hoots about the health or well-being of MS patients. Their only reason for reporting this information is about how it will effect Biogen's stock prices and what ramifications that means to the world of business. Detailed research and balanced reporting means nothing to them in this situation.

Harry

Hi Wiz,

Do you really think that anyone from Biogen would admit if the risk of PML would change from 1/1000? With these extra cases showing up in a very short period of time, one would have to think that the risk factor would have to be higher than what it was a month ago. At the same time, tabulating risk factors is quite complex and nobody might actually know what the true numbers are at this time.

Harry

I got a "new patients" kit with a letter saying my MD said he was asking me to consider Tysabri, and they wanted me to know more about it. I got a DVD/VHS tape and a booklet. Loads of smiling shiney faced folks in the brochures talking about how wonderful their life is now. They ID the PML risk as 1 in 1000.

I have been complaining that I want to stop C and my MD told me I could go to A or T and and said I would stick with C a while longer. It seems that T is now recruiting me! :eek:

Suggest all the Tysabri patients contact MS ActiveSource on Monday and state that we will take no more infusions of Tysabri until they provide us more info on PML cases.

MS Active Source in the US is 1-800-456-2255. Let’s hit them with some serious patient driven pressure.

A jump in PML cases is concerning, but also remember that Biogen/Elan are testing various assays to diagnose PML earlier and risk stratify patients. It’s possible that these PML cases were identified (in this large clump) as a result of testing patients (those in Trials most likely) with these assays possibly before clinical symptoms.

Chris

Biogen stopped updating investors on the number of PML cases at the end of July, saying it wanted to focus on the drug's benefits, and would update the medical community at scientific meetings.

Biogen spokeswoman Naomi Aoki declined to comment on whether the figure of 23 cases were consistent with its own records, and she reiterated that the company would not update the public case by case.


*According to Reuters*

They are reviewing the need to declare on their labeling, the increased risk factor .... based on number of infusions, as per on their October, 3rd quarter Conference Call.

"Biogen Idec and our partner Elan currently believe, as the recent FDA update indicated, that the risk of developing PML increases with the number of TYSABRI infusions received. ...."

"We have proposed, and are currently discussing with the regulatory authorities, a potential label change to reflect this increased risk of PML with increased duration of TYSABRI exposure."

From the Q & A:

"QUESTION: May-Kin Ho - Goldman Sachs

Will you have to spell out what the risks are at different time periods?

ANSWER: Al Sandrock, MD

We are still in discussions with the regulators at this point."

"QUESTION: Steven Harr - Morgan Stanley

I wanted to get an understanding, previously you guys have said that you did not believe that TYSABRI PML risk was related to time on the drug and then clearly something changed. You gave us exposure numbers, is there something new on number of PML cases you can offer us, or is there something you can offer us as an explanation as to why you saw more patients exposed to the drug during the quarter than on therapy? It must have been 1,300 patients that dropped off during the course of the quarter.

ANSWER: Bob Hamm

You know we are not giving out actual patient numbers, but I can tell you as time goes on the numbers of patients treated for the longer duration is increased and our 95% competence intervals on the incident rate narrows and as that happens we get more clarity about the risk. That was the reason why we had decided to update the label with this increase in the risk with the length of exposure."

They also brought up the JC testing they are working on:

"Additionally, we continue to allocate significant time and resources to identifying PML risk factors and in developing ways to stratify, mitigate, and manage the risks. We are working on this internally and we are also working to set up a consortium of other interested collaborators. The premise of our work is that PML in TYSABRI treated patients' results from a convergence of factors including the presence of JC virus, immune compromise, viral mutations, duration of treatment, and perhaps other factors such as risk [oleal] MFO.

With respect to the presence of virus recent published data in larger cohorts using more refined serological techniques indicates that seroprevalence is in fact less frequent in the textbook dogma of 80% or 90%. We have analytically validated a serological method with the goal of one day offering a commercially available assay that may inform about the relative risk of developing PML."

http://seekingalpha.com/article/1676...ngs-call-trans...

10 cases in a month is a lot, even if there are 46,000 on the drug right now, and 13-odd thousand who've been on for more than 24 months. If every month 10 people continued to be added to the total, it would not be good!!.
Cherie

Hi Cheri,

Didn't Biogen rush this drug to market saying it was safe?

Didn't they state that PML only happened in MS patients who had taken other immune system altering drugs?

Didn't they state earlier that there wasn't additional risk of PML when using the drug for long periods of time?

Didn't they tell Dr. L. Steinman, the co-inventor of the drug, to keep quiet when he initially told the media that this drug would prove dangerous as time went on?

Like you said, if this increased incidence of PML continues with the numbers that we have seen in the last month, it will be more than "not good" for Biogen. Like one of the business analysts stated, it will be "devastating"!

Take care.

Harry

As I said earlier, maybe the case jump is due to assay testing of patients in the long term monitoring trials

From Forbes article today

http://www.forbes.com/2009/10/27/ms-...rtner=yahootix

"The test Yednock and his colleagues developed found that something like 50% of the patients have JC virus. There are eight cases of patients who developed PML where Elan and Biogen-Idec have blood samples going back long before the infection happened. All of those cases had JC virus antibodies in their bloodstreams a year before they got PML. "That's a pretty good starting point," says Yednock.

Elan has transferred the assay to a commercial laboratory, a step toward making it available to patients. The test, which uses antibodies to detect the presence of JC virus, could be done with just a saliva sample. It has not been evaluated by regulators or the larger scientific community, but the hope is that doctors might be able to use it to pick which patients are the best candidates for Tysabri therapy."

Chris