Tysabri and PML: Call and complain to Biogen.
 

Tysabri and PML: Call and complain to Biogen.

I get my 32nd infusion on Friday. Biogen isn't reporting the details of PML cases anymore. I need to know what the risk is for people my age, with similar health profiles, having similar number of infusions, etc... I don't want the name and addresses of the patients, but I want the general data.

I've spoken to Biogen about this twice in less than a week.

Call them at 1-800-456-2255 for patient support. Tell them you want the information made available about the current number of PML patients. You want to know the country, the age, number of infusions, previous drug therapy, etc...

I told the last person I spoke to that I wanted to make sure the call was being recorded and that she would report my concerns to upper management.

I told her that I belong to a world wide support group and I know a lot of people taking Tysabri and that we're concerned.

I also said that I realize the reporting of PML cases isn't helping the company financially, but that since we are the ones that can be affected by PML, we need to know the information.

I told the person I spoke to that I'd be calling my doctor.

But they don't have the spare time or resources to be giving me Biogen's secret data details. :mad: So that's why I started this thread. I'm not going to make my doctor's office do Biogen's work. We need to make Biogen do their own reporting.

Thanks to RW for getting my dander up, lol. :hissyfit:

Good Job Wiz!!:hug::hug:

If enough of us stand up and take them on, we'll get some answers! Make some noise!:ranting:

I just called to complain and was read a boxed answer over the phone. She said she will take note of my complaint. Not good enough.

I just called too. They feigned cluelessness. See my report on the Tysabri sticky.

Biogen bought out a company that was working on a cure for PML over a year ago. Soon they may be able to fix your PML and pocket those profits too.

It would seem if a large number of patients refused their next infusion that would grab Biogen's attention more than calling their toll free number.

Even calling the infusion center and letting them know that you will not do any more infusions until you are able to obtain some info on PML will get word back to Biogen via the people in charge of the infusions.

gmi

I went to the Biogen Idec website and clicked on management names. Then I found the contact us phone number and called asking for a name from the management list. I chose Susan Alexander (but she's out on vacation) so somebody from legal counsel is going to be calling me back.

Don't let them redirect you to patient support at Tysabri if you call them, get someone from corporate to talk to directly. I also left a voicemail for someone at the FDA to call me back.

Go get em Wizzer!!!:D

Go Wiz!!!! :hissyfit: :You-Rock:

Paul Clancy is the chief financial officer at Biogen Idec. He might be a good one to ask for, and make sure you let him know that you know hundreds, if not thousands of patients that take Tysabri around the world.

The main contact number at Biogen Idec is 617-679-2000, when you call, tell the receptionist you want to talk to one of management.

Part of the company core values are listed as, Quality, Integrity and Honesty. They need to give us the information we need if they want to uphold those values.

You might also ask for Carmen Bozic, MD, vice president and global head of drug safety and risk management. She is really the head of TOUCH and safety.

Hey Wiz, I was thinking about this after answering your other post already ...

We don't know if the 23 (+ perhaps the three from the trials) is an accurate number; it could less, or it could be more. Going with the numbers we have though, I don't know there would be any advantage what-so-ever in them publishing this information.

So long as no one "knows", this might work best for them ... don't you think?

Let's <say> that close to 20 patients of the 13-thousand-odd patients who've used it more than 24 months (or maybe 15 patients out of the 6,000 that have used it for 30+ months) .... NOTE: just making up numbers for demonstration purposes ..... have come down with PML. The risk factor for that number of infusions might be as high as 1:100, 1:300 or 1:500.

My question is what useful purpose would it be for Biogen to release that information? So long as no one knows, it's all just "speculation" ... which might anger some people, but it MAY be better than revealing the truth too.

They want to focus on the positives of this med, as they said in June when they told us they don't intend to share the numbers any more. They also said they had hoped they would have a better idea of the cause of PML (from the use of Tysabri) by the time they stopped telling us the PML patient numbers (although that doesn't seem to have happened yet). They are getting closer to maybe identifying a test that will help with mitigating risk though.

In the meantime, I think it was apparent that they intended to keep the PML cases as low-key as possible, now that they are up there with patient numbers/number of infusions.

Ten in one month is crazy, especially if they are ALL in the "high number of infusions category", no matter how many are on the drug right now. For all we know, it might only be 5 though, in which case most everyone would likely sigh with relief at that news (at least compared to 10).

If it really is 10 in the last month though, I would be suprised if they would change their policy of telling people, as I just don't see how that could work for them to do so.

Has anyone noticed exec's cashing in their shares lately?

Cherie

Here is some interesting information reported in an article online today.

http://english.capital.gr/news.asp?id=840194

Public companies are typically required to disclose any material information to investors through a filing with the Securities and Exchange Commission. Officials from the agency didn't respond to requests for comment. By definition, material information is that which a reasonable investor would find important in deciding on how to invest or vote on shareholder matters, said Charles Elson, director of the Weinberg Center for Corporate Governance at the University of Delaware. While that leaves room for interpretation, Elson noted that stock movement can help determine whether information is material

So this means that Biogen can decide what they think a "reasonable investor" would want to know regarding investing or shareholding when they determine what to report to the SEC? If that is true than there is no way to ever know how many PML cases there are.

While the company contends that the PML-related information doesn't help physicians or patients, Morgan Stanley analyst Steven Harr notes that Biogen's decision to stop reporting cases, just as evidence of accelerating risk was developing, may in fact cause increased concern.

Shocking that Biogen is claiming that PML-related info doesn't help physicians or patients.

In addition, other analysts are challenging Biogen's assertion that the PML rate remains "well within" the risk rate implied by the label. Barclays Capital analyst Jim Birchenough said the new cases could push the rate as high as 1-in-700 patients among those patients on the drug for more than two years. Bernstein's Porges estimates the risk jumps to 1-in-400 patients after three years of use.

That is even scarier information.

I'm still waiting for my neurologist to call me back. Maybe she will know something more but I don't really count on it.

I guess I'll call the neuro tomorrow as well as my senator. I haven't received any calls back yet from those I left messages with today.

I have no problem whatsoever to stop Tysabri and go back to Copaxone and just take it every other day. I did ok on Copaxone. If they're withholding this information, what else are they leaving out? :confused:

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.

It is surprising that a company can legally just quit giving out info about a drug and its side effects. It makes sense that they don't want their investors to freak out, but it may cause a great deal of harm to unsuspecting and uninformed patients.

Good letter to your senators.

gmi

Call the FDA too!
 

Call the FDA as well 1-888-463-6332. I've got a message in.

You know I'd like to add here...and forgive me if you've discussed this but...

Another drug is newly being tagged for causing PML...
it is called Rituxan:

I just saw this yesterday in fact:
http://www.newsinferno.com/archives/13571

I am so proud of all of you being so proactive...I'm not on Ty, but I know that those who decide on that DMD do so with a great deal of forethought.

Just take care of yourselves, and keep on fighting.

I love you guys!!:hug:

Information about the status of the JC Virus Assay - looks close
 

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

Excerpt from Forbes article

“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.”

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.

Here is an article suggesting that the monitoring of Tysabri in Europe (and in particular Germany) is lax and this might be one risk factor for higher numbers of PML. Interesting.....

http://industry.bnet.com/pharma/1000...opean-doctors/

The person I spoke to today said that the risk of PML is more with an increase in infusions, but that even those people fall within the 1:1000. Those patients with less infusions have less risk. Sorry I didn't make that clear.

He also said that they do not recommend taking a break from Tysabri. When I asked him about the comment someone from the help center said to me yesterday, that disease activity seems to resume after about six months from stopping Tysabri, he admitted he didn't know that for sure, but that if somebody told me that from his support center, it's definitely true.

I'll be asking my MS neuro about taking a break when I see him Friday.

Just to clarify:
 

The person I spoke to today said that the risk of PML is more with an increase in infusions, but that even those people fall within the 1:1000. Those patients with less infusions have less risk. Sorry I didn't make that clear.

He also said that they do not recommend taking a break from Tysabri. When I asked him about the comment someone from the help center said to me yesterday, that disease activity seems to resume after about six months from stopping Tysabri, he admitted he didn't know that for sure, but that if somebody told me that from his support center, it's definitely true.

I'll be asking my MS neuro about taking a break when I see him Friday.

Please dont make them stop prescibing Tysabri cause i'm progressing in the worst way past 9 months on Copaxone, Rebif, back to Copaxone, supps ect.
I'm history in 12 months at most if Ty doesn't slow it down.

Nobody wants them to stop precribing Tysabri. We just want to know what the risks are. They were providing the details of the PML cases to the patients but they don't do that anymore. If they're keeping side effects from us, especially deadly side effects, we can't decide if it's safe for us to take it.

Many of us have been on Tysabri for a long time and we need to know the statistics of those who get PML so if we find ourselves in a high risk group, we can either take a break or switch to a different therapy.

I want Tysabri as an option, but they need to be honest with the patients if they want us to relax on this subject. I hope you can take it and get good results. We want it to be safe though, and that includes for you and anyone else about to start taking it. :hug:

Edife,

I absolutely agree with Wiz, we do not want the choice to take Tysabri removed again. we just want the drug company to give us information so we can make informed decisions.

If you start Tysabri today, you will be in a group of 45,000+- patients who are taking Tysabri with a risk of 1:1000 of PML.

Wiz and I and some of the others here belong to a much smaller subset within that 45K number. We are in a group of 7500+- who have been on the drug for more than 30 months within that group of 45K. The longer a person is on Tysabri, the higher they say your risk is now, according to the information being alluded to everywhere except where it should be stated truthfully, immediately and accurately, to the patients who may be affected by the information that leads to understanding that rate of risk

That is what we are fighting for, information, so when you get to where we are right now, you will HAVE the information you need to assess your risk and comfort level and not have to go through what we are going through right now.

I know a few people who were in the original trials and have had 75+ infusions and they are not happy either. Imagine how they feel knowing their subset, which is less than 2500, can't make an informed risk assessment because the drug company won't tell them what they need to know either.

We are not trying to limit choice. We are trying to make sure that we make good choices for ourselves, and we cannot do that without information.

Well said, Wiz and RW.

Honesty from this company, so that people can make fully INFORMED personal desions, is all I've EVER cared about when it comes to this drug.

Cherie

Hi Cherie,

What you and others are saying makes a lot of common sense but common sense and how big pharma operates unfortunately don't match up!

In the pharmaceutical world, most companies are in a very competitive battle to get a share of the revenue dollar. A small shift in market share can translate into millions and millions of dollars of revenue gain or loss. If Biogen continued to post information like they did about PML cases, it would only hurt their revenue generation and Tysabri's rough road for them is anything but what they had hoped would be a blockbuster medication.

I'm guessing that Biogen knew very well that the number of PML cases would start to rise quickly as time went on and that likely had a large influence in their decision to stop posting information on their site. It's all about the money with Biogen and little if anything to do with what is best for MS patients in helping them make an informed decision.

I have followed Biogen's handling of Tysabri from the beginning and this has left a VERY sour taste with me. Their tactics have pretty much been the same from the start....and it has been very little to do with MS patients and all about revenue generation.

Harry

They have to operate like a business Harry, and that includes battling for the revenues. But I agree that they're handing this very poorly. Most of the pharma companies have had questionable practices from time to time it seems. I think this one stands out so much for us because it affects MS patients and it's a deadly side effect. :(

I think this one will reflect in the revenue department if they don't change something so the patients who take the risks and pay the money for Tysabri can get the information they need to make informed decisions.

Ironically, if Biogen keeps withholding information to protect their share of the market and keep the investors happy they could be shooting themselves in the foot. Patients may not have a lot of power but they have some. If patients decide to go off Tysabri or refuse to begin it because of the lack of transparency then it could still wind up hurting Biogen and the investors. I think they made a poor call when it comes to disseminating information--they hoped us "passive" patients would just keep taking the drug if they stayed quiet. I think they also hoped the PML cases wouldn't be high enough to ultimately cause concern. But I think the line has been crossed. Bad policy and planning on their part. (not to mentione ethically questionable)

I think the insurance companies are unhappy with this as well. My insurance company is now dragging their feet about getting me approved for the TY. When i spoke to the neuro's office today they said that all of the insurance co's are being slower to approve TY even for people already on it. She thinks it may be because of Biogens refusal to disclose information to anyone who is not a shareholder in the company.

So again, the withholding of information is coming back to bite them--withhold info and patients start to go off the drug or never start. Withhold info and the insurance companies decide they don't want to pay.

We just got home and I chose not to get my infusion today. The neuro spoke to me for about an hour. I'm going to go back in three months and talk about whether I want to go back on Tysabri, or go on something else. I'll check back in later with more details. I have another appt this afternoon and won't be home until later on.

Ok I agree users should know but please let me get mine 1st? :)
Death is certain for me if I progress at this rate anyway so I'll take the chance.
Good luck getting Ty back if you cause bgen to cease production.
See..you made a choice not to get it. Great. But i'd like the choice to get it.

Edife,

You'll be able to get your Tysabri, don't worry. :hug: :hug:

But if I cause them to cease production, then I'm going to apply for jobs in higher places because I'm seriously underestimating my own power and influence, lol. Maybe I can run for governor of Illinois? :lookaround:

:ROTFLMAO::ROTFLMAO::ROTFLMAO::ROTFLMAO::ROTFLMAO: :ROTFLMAO:

:Noooo: Nah, I guess not.

I would vote for you:)!

my neuro is pushing me to chose T. for years now they asked me to not consider it, and stay on the first line of defense DMDs and blah blah. now, they are doing a hard sell to me! I am getting letters from Biogen and Touch, and I have stated to my MD i DONT want to go on TY right now. He wanted to talk to me about PML and had this whole speach prepared. sounded pretty rehearsed to me, but when he was done (couldnt get a word in edgewise) I said so, PML is 1:1000 ratio? well, in my humble opinion its either 100% or zero, there is NO middle ground. If YOU get it, its 100% and if YOU dont get it, then its Zero! There is no grey area in my own mind about this. I asked why they have stopped public reports about such cases being discovered, and got this whole speach on how fear based media reports are causing unnessecary panic in the general public, who are not educated enough about ALL the facts to understand the "true" implication of what such reports mean...

Even tho I have firmly said NO! it seems as tho they are romancing me.

They know you're a friend of Wiz's and the want you to replace the place in their wallet/heart..:D

Is it possible your neuro gets kickbacks from Biogen? I have never had a neuro or any other physician push me to take a certain med.

Biogen would definitely be playing footsies with you as you are a possible hunk of $$$.

gmi

Yesterday my doctor was telling me how many of the hospitals and clinics doing the infusion are charging thousands of dollars each month (this really bugs him a lot). He said if a clinic charges $10,000 per month per patient and they have 100 patients getting Tysabri, that increases their revenue by $1,000,000 per year. That's an interesting way of looking at it.

He said that when the orals come out, the sham doctors will be easy to identify because those will be the places that are still pushing Tysabri aggressively.