PML 3 more cases

Loobie · Post by **Loobie** » Mon Oct 26, 2009 3:44 am

Believe it or not, the thought of continuing to give them my money while they quit reporting deaths that were heavily correlated with Tysabri use was as big of a reason for me to quit than the fear of PML. The amount I was giving them each month made it impossible for me to continue if they were going to just take it and not keep their patients' informed. That to me is shady and Biogen goes on the list of companies whose drugs I personally won't buy unless they go back to full disclosure. It's the only ethical thing to do and if they gave a damn about the actual patients, they would continue to put that out front and center, and talk to how their drug is risky, they know it, but understand that many people are willing to take the risk because of their desperate situation. I don't think that type of behavior would be perceived as negatively as them seeming to want to 'hide' the information.

10yearsandstillkicken · Mon Oct 26, 2009 5:47 am

I can't help but think that their decision to stop the weekly update was because they knew what was coming. Having an easy way to monitor the number of PML cases is apparently bad for business in their opinion. Not sure I agree though. Being up front would keep speculation to a minimum. Or less anyway.

prof8 · Post by **prof8** » Mon Oct 26, 2009 10:22 am

Lew, I agree with you. Hiding this looks worse than being up front and saying hey: here are the risks, this is what the drug can do for you, we know you can make the best call for your own individual situation regarding benefits v. risks, and we will continue to give you the updates so you can reassess as needed. But I'm sure that is not how it works with the financial market. The ironic thing is, if they keep things quiet to prevent the investors from freaking out they are still shooting themselves in the foot because the patients are the ones that buy the crap. If the patients stop taking the drug because of lack of clear truthful information and the numbers begin to decrease than the investors are still screwed.

I just called Biogen to complain about the lack of info. The entry level person who answered the 1-800 number claimed not to know anything about the new cases and just gave me the same old--the risk is 1:1000. Yeah, right.

Anyway, I go for CCSVI in December. I will have to make a decision about staying on Tysabri.

ewizabeth · Post by **ewizabeth** » Mon Oct 26, 2009 8:52 pm

If you go to the Biogen Idec website and click on management, you can get a list of contact names. Then go to the contact us section to get the main number for the US headquarters and call and ask for one of the management team.

I also contacted the FDA, and I'll be calling my senator tomorrow.

I'd have no problem stopping the Tysabri and going back to Copaxone. If they can't be honest with the people who are paying for the medicine and taking all the risk, why would I continue to support their company?

ewizabeth · Post by **ewizabeth** » Tue Oct 27, 2009 7:46 am

My letter to my senators (feel free to copy the text to email your senator at the congress.org website)

Biogen Idec produces a medication called Tysabri for the treatment of multiple sclerosis (MS). Tysabri is very expensive for patients and is administered via infusion. There are currently more than 46,000 MS patients taking Tysabri, myself included.

There's a known side effect called progressive multifocal leukoencephalopathy (PML) - a potentially deadly disease, that's listed on the medication packaging and also gives Tysabri a "Black Box" label category and requires consistent patient monitoring for symptoms of PML.

Biogen Idec was previously providing statistical details of new cases of PML so that patients could decide if the risks were worth the benefits of the drug. They recently discontinued their reporting policy and the statistics of PML are not available to the patients taking the risks and paying for the medication.

Last week an EU news agency reported ten new cases of PML and Biogen Idec has stated they will not provide any details on the age, country of origin or length of time taking Tysabri - all necessary details for existing patients to decide if they will continue with this highly effective but potentially dangerous drug.

I urge you to contact the FDA today and also James C. Mullen, CEO of Biogen Idec to insist the company provide the statistical data publicly so that patients taking the risks and paying for this expensive medication will be able to make an informed decision in managing their general health and disease therapy.

ewizabeth · Post by **ewizabeth** » Tue Oct 27, 2009 2:15 pm

I got a call from the Senior Director of Patient Services of Biogen Idec this afternoon and I have his direct phone number for future reference. He assured me that the risk is still within the 1:1000 even for patients with a greater number of infusions. The current number of confirmed PML cases is 23.

I explained to him why I disagree with the change in their reporting policy and why I don't think it's acceptable for them to put this duty on the backs of the physicians.

I thanked him for calling but until they change this policy or make it easier for patients to get accurate data and reports, I'll keep working for this to change.

HarryZ · Post by **HarryZ** » Tue Oct 27, 2009 4:24 pm

ewizabeth wrote:I got a call from the Senior Director of Patient Services of Biogen Idec this afternoon and I have his direct phone number for future reference. He assured me that the risk is still within the 1:1000 even for patients with a greater number of infusions. The current number of confirmed PML cases is 23.

With his math skills, I'm not too sure I would trust this guy for a second!!!

Harry

prof8 · Post by **prof8** » Tue Oct 27, 2009 4:36 pm

Here is an article that came out today suggesting that monitoring of Tysabri in Europe may be poor--could explain the higher numbers in Europe.

http://industry.bnet.com/pharma/1000501 ... n-doctors/

screamner · Post by **screamner** » Tue Oct 27, 2009 10:46 pm

suggesting that monitoring of Tysabri in Europe may be poor

It is poor! We have no monitoring! We have no infusion center! Every neuro can give it.

RuSmolikova · Post by **RuSmolikova** » Wed Oct 28, 2009 12:20 am

HarryZ wrote:
ewizabeth wrote:I got a call from the Senior Director of Patient Services of Biogen Idec this afternoon. He assured me that the risk is still within the 1:1000. The current number of confirmed PML cases is 23.
With his math skills, I'm not too sure I would trust this guy for a second!!!
Harry

I wouldn´t trust him for a nano-second!
Since Sunday 25-th of October, there is 24 cases of PML at least. And he was talking about 23 on Tuesday 27-th of October...
http://www.mednous.com/news/emea-receiv ... ed-tysabri
Something stinks here!

Post by **euphoniaa** » Wed Oct 28, 2009 5:42 am

RuSmolikova wrote: Since Sunday 25-th of October, there is 24 cases of PML at least. And he was talking about 23 on Tuesday 27-th of October...
http://www.mednous.com/news/emea-receiv ... ed-tysabri
Something stinks here!

Thank you for a link to the confirmation of a 24th case of PML. I've been sharing it around...

Sharon · Post by **Sharon** » Wed Oct 28, 2009 6:24 am

ewizabeth
Just wanted to commend you on your efforts. I normally do not look at this forum (spend my time over on the CCSVI forum) -- came over here the other day looking for some information on Tysarbi in answer to a question about the rebound effect. This new non-data reporting by Biogen is a real concern for those MS'rs who are taking the drug. Keep up the good work -- great letter to the Senator.

Sharon

ewizabeth · Post by **ewizabeth** » Wed Oct 28, 2009 7:24 am

Thanks everybody for the additional info. I have to do some work in the office today but hope to get back to this later this afternoon. I'm writing about this issue all over the net, including major news sites. This has to change. I feel the worst for those patients in other parts of the world who don't have the TOUCH program set up. I hope that will change soon so all patients can be monitored more closely.

turbotaguy · Post by **turbotaguy** » Wed Oct 28, 2009 11:01 am

This whole thing has soured me on Tysabri. I started it almost 2 years ago back when we all thought the original 3 PML cases were from being on Ty and Avonex. The risk profile is now way out of my comfort zone so I'm probably out.

One more comment - is Biogen stupid? When they released details of PML cases they were in control of the information and when it was released. Now that they refuse to provide this info it seems to be a free for all. 23 cases, now 24 cases. This is just the tip of the ice berg, you watch. They were very short sighted in refusing to hold the data. It gives them more power.

Loobie · Post by **Loobie** » Wed Oct 28, 2009 12:50 pm

I think it's going to really rise now that there are so many people who've been on it for over two years. That sounds awful, but the way that guy at Vanderbilt had expressed the odds and how they decrease so drastically after 18 mos. and 2 years and so on really gives me pause because a huge chunk of the tysabri taking population is probably approaching those doses.