Letter writing Campaign to ALSA- join us!

[Sequoia]

We want to start a campaign of letter writing to every ALS Association state by state. We have a draft letter to send you which you can personalize with your story. We will be sending them all at once, with also the signatures of the 3800 petitioners.

Our purpose is to get the ALSA national to get on board with compassionate early access to new drug treatments that have proven safe and effective. So far ALSA have been politely ignoring us, so that is why a letter writing campaign all at once from every state may prove more effective.

Please let me know if you are interested.
sharon/sequoia

 

[AKjo]

Hi Sharon, I would be happy to send a letter to ALSA. Evergreen chapter in WA also covers Alaska, so it would be sent there. Gary and I attended a "Practical Solutions Workshop" there last weekend. It was a really informative gathering, and we were lucky that it coincided with Gary's NP001 dosing schedule. Have you met Mary Rebar? She is very pleasant and so helpful. Also, it sounds like they have a great loan closet.

Please give me your draft letter, and we will make some additions before mailing. Thanks for all your work.

 

[Sequoia]

Thanks Jo! I am also in the Evergreen ALSA....too bad I didnt go to that event, I could have met you! Let me know next you come our way to an event.

 

[beckysuenc]

I too would be happy to send a letter to ALSA? Please send the draft letter.
Bekysuenc

 

[ltbeauti]

I will write for VA. Send me a draft
Lisa

 

[andy leopold]

Hi. My wife and I obviously want to send the e mail..send me the info..Thanks, Andy

 

[Susan10]

I'll send for Oklahoma!

 

[Sequoia]

Thank you all for writing these letters! Perhaps if enough of us did this, like the Komen foundations reversal, perhaps the ALSA would rally around us in our endeavors to get early access. Please encourage others to do this letter campaign.

BIG ((HUGS)) TO ALL OF YOU

 

[DeansWife]

We're in Alabama, send letter please.

 

[tmasters]

Maybe they are listening...

This was posted on ALSA's national site on February 8:
http://www.alsa.org/news/archive/compassionate-use.html

In our quest to create a world without ALS, The ALS Association believes that people with ALS should have access to effective treatments as quickly as possible. Our primary core value is that people with ALS and their families come first in everything we do. When it comes to advancing therapies for ALS, we work with all stakeholders in an effort to find the best path forward.

We realize that time is the most precious commodity for people living with ALS. For this reason, we are working closely with academic institutions and pharmaceutical companies developing potential treatments for ALS. Our goal is to facilitate clinical trials and accelerate the availability of treatments, including access to compassionate use programs in our discussions with these organizations.

The ALS Association is committed to helping make promising treatments available as quickly as possible. We will continue to communicate with academic institutions and pharmaceutical companies about the needs and concerns of people with ALS and their families. In the meantime, it is absolutely critical that people with ALS continue to participate in clinical trials. Ultimately, patient enrollment and participation in clinical trials is the only way to determine the effectiveness of treatments for this devastating disease.

I'm not sure how to read this. They seem to be saying "yes" to compassionate use, but at the same time they are downplaying it. What do you think? Is this just lip service?

-Tom

 

[trfogey]

I'm not sure how to read this. They seem to be saying "yes" to compassionate use, but at the same time they are downplaying it. What do you think? Is this just lip service?

tmasters,

One probable reason that ALSA isn't full-bore behind "compassionate use" is that not all pharma companies have or are willing to invest the resources required to support "extended access/compassionate use" programs for their investigational drugs.

An extended access program can be likened to a new clinical trial phase. Conditions for participation, both for patients and for providers, have to be determined. Treatment parameters have to be specified. Reporting standards and methods have to be specified. And the FDA has to approve all of these things before the extended access program can be offered, so all the evidence from prior trial phases has to be sorted and sifted and organized for presentation to the FDA.

Some companies may not have the financial capital available to support something like this. It's optional, so why do it if they don't have to?

Other companies may be working with a manufacturing company on a license basis, and may not have the ability to bring manufacturing assets online to support such an effort.

Finally, the ALS market is so small that there may never be a case in which the "goodwill" extended to the ALS community through an early access program for the drug is ever recouped through sales back into that community. The cost of that program might be too large a gift for the management and stockholders to be comfortable giving, and justifiably so.

ALSA is caught in the middle. If they push compassionate use/extended access, they need to be able to put capital support behind their requests. There simply isn't an ALSA-controlled or -influenced market large enough to compel companies to play ball the ALSA way.

We know ALSA doesn't have that kind of free capital lying around. So, they have to find some kind of happy medium -- encourage without obligating, so to speak. And that's what we see in that statement .

 

[Sequoia]

From ALSA:
"In our quest to create a world without ALS, The ALS Association believes that people with ALS should have access to effective treatments as quickly as possible. Our first core value is that people with ALS and their families come first in everything we do. When it comes to advancing therapies for ALS, we work with all stakeholders in an effort to find the best path forward.

We realize that time is the most precious commodity for people living with ALS. For this reason, we are working closely with Biogen Idec and other companies developing potential treatments for ALS. Our goal is to facilitate clinical trials and accelerate the availability of treatments, including access to compassionate use programs. As a result of the effort, we are pleased to report that Biogen has indicated that they will provide compassionate use access to dexpramipexole as soon as data becomes available showing that the compound is effective and safe in the larger Phase III study.

The ALS Association is committed to helping make promising treatments available as quickly as possible. We will continue to communicate with Biogen and other organizations about the needs and concerns of people with ALS and their families. In the meantime, it is absolutely critical that people with ALS continue to participate in clinical trials. Ultimately, patient enrollment and participation in clinical trials is the only way to determine the effectiveness of treatments for this devastating disease."

 

[st123]

If you're still looking, please send me a draft - thanks!

 

[Sequoia]

I sure will st123!

 

[rictak in IA]

I'll take one to send for Iowa. Thanks
Gary