Tysabri and PML: Call and complain to Biogen.

 
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ewizabeth



Joined: 29 May 2006
Posts: 549
Location: Near Chicago

PostPosted: Mon Oct 26, 2009 8:21 am    Post subject: Tysabri and PML: Call and complain to Biogen. Reply with quote

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. 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.
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Ewizabeth
DX 01/28/03 RRMS
Formerly Avonex, Rebif & Copaxone
Tysabri 06/07 through 09/09
On Copaxone again since 12/09 and hoping for oral meds to come out!
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agate
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Joined: 17 May 2006
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Location: Oregon

PostPosted: Mon Oct 26, 2009 1:59 pm    Post subject: Reply with quote

If you think that a call from someone not taking Tysabri would help, I will be glad to make a call.

I have a feeling that Biogen's position is that since the risk is so low--still only 1 in 1,000 according to everything I've read--posting data on PML cases would just alarm people needlessly.

I agree that everyone should know anyway. This is a new drug and presumably people with MS who are on it will be on it for the rest of their lives.

Any new drug has risks. Everyone with MS who might some day have Tysabri as an option--and that is everyone with MS--ought to know about the PML cases.
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ewizabeth



Joined: 29 May 2006
Posts: 549
Location: Near Chicago

PostPosted: Mon Oct 26, 2009 3:42 pm    Post subject: Reply with quote

Hi Agate,

The PML cases have jumped from about 13 to 23 in a week or so and there's no information saying which group they belong to. If these are European cases, I'd like to know that (I'm guessing that they are).

If the patients are mostly over 45, I'd like to know that, or if they all had more than 30 infusions. The basic information should be available to those patients paying the money and taking the infusions.

I posted it here and the other forums that I know about. I just want to make sure the patients, both current and possibly future patients, know about all the risks.

There might be more than that in Europe (who knows?)

I think it should be reported and listed on the Tysabri website as they did before they changed their policy.
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Ewizabeth
DX 01/28/03 RRMS
Formerly Avonex, Rebif & Copaxone
Tysabri 06/07 through 09/09
On Copaxone again since 12/09 and hoping for oral meds to come out!
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agate
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Location: Oregon

PostPosted: Mon Oct 26, 2009 7:26 pm    Post subject: Reply with quote

Just idle speculation here, but do you recall the dozen or so PML cases that were rumored to have been reported on the "adverse event" reporting system--the one where anybody can report an adverse event?

Is it possible that the experts finally finished sifting through those reported adverse events and found that 10 of them were legitimate cases of Tysabri-related PML?

It just seems odd that 10 new cases would pop up in the last month or so. The rate at which they've been occurring hasn't been like that at all in the past.
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ewizabeth



Joined: 29 May 2006
Posts: 549
Location: Near Chicago

PostPosted: Mon Oct 26, 2009 7:37 pm    Post subject: Reply with quote

I don't know, but I'm not happy with them at the moment. If they don't start providing information again, I'll have no problem with stopping the Tysabri, for either a break or indefinitely.
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Ewizabeth
DX 01/28/03 RRMS
Formerly Avonex, Rebif & Copaxone
Tysabri 06/07 through 09/09
On Copaxone again since 12/09 and hoping for oral meds to come out!
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agate
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PostPosted: Mon Oct 26, 2009 11:04 pm    Post subject: Reply with quote

It looks as if people with MS represent far too tempting a market for pharmaceutical companies.

After all, here we are, sitting around hoping desperately for a cure or a remedy--and many of us are or were pretty young when we were diagnosed. That means a long, long time for many people with MS to be sitting around hoping for a cure--the rest of our lives.

What a marketing opportunity! All of those people who are apt to live on for many decades--just put us on some medicine we have to take for all those decades.

Maybe Tysabri is a drug that will work wonders for people. I hope so. But I think some skepticism is in order when so much is at stake for drug companies.
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ewizabeth



Joined: 29 May 2006
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Location: Near Chicago

PostPosted: Tue Oct 27, 2009 7:22 am    Post subject: Reply with quote

I think it's a very good medicine as long as I have the information on the side effects so I can make an informed decision about the risk vs. benefits.

If it starts to affect the profit margins, they'll provide the data. I think they're doing a balancing act, trying to keep the investors and the patients happy at the same time. If I can help to tip the scale in the patients' favor by putting pressure on them, I'll be satisfied. They better provide the data or else I'll be a thorn in their marketing efforts.

When I call or email them I'm very polite but direct. I also let them know that I'm urging everybody I know to do the same thing because of the seriousness of the situation.
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Ewizabeth
DX 01/28/03 RRMS
Formerly Avonex, Rebif & Copaxone
Tysabri 06/07 through 09/09
On Copaxone again since 12/09 and hoping for oral meds to come out!
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ewizabeth



Joined: 29 May 2006
Posts: 549
Location: Near Chicago

PostPosted: Tue Oct 27, 2009 8:47 am    Post subject: Reply with quote

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.
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Ewizabeth
DX 01/28/03 RRMS
Formerly Avonex, Rebif & Copaxone
Tysabri 06/07 through 09/09
On Copaxone again since 12/09 and hoping for oral meds to come out!
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ewizabeth



Joined: 29 May 2006
Posts: 549
Location: Near Chicago

PostPosted: Tue Oct 27, 2009 3:12 pm    Post subject: Reply with quote

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.
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Ewizabeth
DX 01/28/03 RRMS
Formerly Avonex, Rebif & Copaxone
Tysabri 06/07 through 09/09
On Copaxone again since 12/09 and hoping for oral meds to come out!
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agate
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PostPosted: Tue Oct 27, 2009 6:31 pm    Post subject: Reply with quote

A good letter, I think! I hope you get some results. I'll be adding my voice tomorrow, I hope.

I don't suppose Biogen Idec's people have any explanation for why the number of cases suddenly vaulted from 13 to 23?
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ewizabeth



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Location: Near Chicago

PostPosted: Tue Oct 27, 2009 8:01 pm    Post subject: Reply with quote

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. I didn't make that clear before.

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 the time of 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. Maybe in six months a better alternative will be available.

I feel somewhat better on Tysabri in some ways, but I have worse fatigue. I have no qualms whatsoever in taking a break, or stopping Tysabri.
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Ewizabeth
DX 01/28/03 RRMS
Formerly Avonex, Rebif & Copaxone
Tysabri 06/07 through 09/09
On Copaxone again since 12/09 and hoping for oral meds to come out!
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Matt



Joined: 21 May 2006
Posts: 961

PostPosted: Fri Jan 01, 2010 5:57 pm    Post subject: Reply with quote

I agree with your position 100%. I would want all of the information they could possibly give me if I were taking that drug. I hasn`t been my favorite drug company for quite some time, but they are in a awkward position.

Good for you for sticking up for yourself.
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ewizabeth



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Location: Near Chicago

PostPosted: Fri Jan 01, 2010 6:53 pm    Post subject: Reply with quote

Thanks Matt,

By the way, it's good to see you. I hope things are going ok with you?

I started taking Copaxone again a few weeks ago and so far it's going ok.

Happy New Year!
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Ewizabeth
DX 01/28/03 RRMS
Formerly Avonex, Rebif & Copaxone
Tysabri 06/07 through 09/09
On Copaxone again since 12/09 and hoping for oral meds to come out!
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Matt



Joined: 21 May 2006
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PostPosted: Sat Jan 02, 2010 9:28 am    Post subject: Reply with quote

Thags are going grat for me. Thank you for asking.
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agate
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PostPosted: Sun Jan 10, 2010 6:22 pm    Post subject: Biogen to reinstate monthly reporting of PML cases Reply with quote

This is from the Irish Examiner, January 8, 2010:

Quote:

Biogen to reinstate monthly PML updates

By Geoff Percival

BIOGEN IDEC – the Boston-based pharmaceutical firm which co-owns the Tysabri multiple sclerosis drug with Athlone-based Elan – is set to re-instate monthly updates of outbreaks of PML, the rare brain disease which is a potential side effect of using Tysabri, after announcing four further cases of the condition.



The four new instances of PML were developed by Tysabri users in the US during November and bring the total number of outbreaks amongst users of the treatment to 28. Biogen recently ceased updating on new PML cases on its website, but is likely to release data for December before the end of this month.

The risk of contracting PML led to Tysabri being re-labelled after it was initially pulled from the market in 2005 for a year, following the first outbreaks of the disease amongst users. Since then four Tysabri users who have contracted PML have died as a result.

While Elan didn’t comment, yesterday, a spokesperson for Biogen said that a small number of cases of PML do not make any serious impact on the risk rate linked with Tysabri usage. The stated risk rate is one PML case per every 1,000 Tysabri users.

Although Elan’s share price fell by 7c in early trading, yesterday, it closed the day up by more than 3% – or 16c – at €5.20. Indeed, analyst reaction to the latest Tysabri news was broadly upbeat.



This story appeared in the printed version of the Irish Examiner Friday, January 08, 2010







The article can be seen here.
Wiz, you and others helped to make this happen!
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ewizabeth



Joined: 29 May 2006
Posts: 549
Location: Near Chicago

PostPosted: Sun Jan 10, 2010 8:04 pm    Post subject: Reply with quote

Well it's about time! Those patients still taking Tysabri deserve to have updates! Thanks for the update Agate! cheers
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Ewizabeth
DX 01/28/03 RRMS
Formerly Avonex, Rebif & Copaxone
Tysabri 06/07 through 09/09
On Copaxone again since 12/09 and hoping for oral meds to come out!
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Matt



Joined: 21 May 2006
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PostPosted: Mon Jan 11, 2010 8:45 am    Post subject: Reply with quote

Great going!
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agate
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Joined: 17 May 2006
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Location: Oregon

PostPosted: Mon Jan 11, 2010 9:03 am    Post subject: Reply with quote

This is so gratifying. It's not that I'm so grateful to Biogen Idec now. But I'd like to think that maybe, just maybe, consumers were able to bring enough pressure to bear on them that they finally had to do the right thing.
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