ALS Advocacy

ALS Advocacy
Lou Gehrig's Disease - Motor Neuron Disease - Amyotrophic Lateral Sclerosis
Thought it had been cured by now? Still no known cause. Still no cure. Still quickly fatal. Still outrageous.

Sunday, April 5, 2015

We're Ticked

The ALS ticking clock goes tickticktickticktick.  And then they're gone.


The clocks of those who are to deliver on behalf of those with ALS often go tick........tick................tick................................tick...............................................................tick.                                                          

The difference is palpable.

On February 25, 2013 (that's over two years or a quarter million ALS funerals ago), there was an FDA hearing on ALS.  The big ALS organizations were in the front row with bells on.  They had a lot to say.

ALSA Item

MDA Press Blurb

Joint ALSA MDA Statement

When you look at the joint ALSA MDA statement, an FDA guidance document for ALS is mentioned repeatedly.  Back at the time of the hearing, the first such document had just been issued for Alzheimer's Disease and it was felt to be a huge step forward in helping researchers design trials that would hit the marks that the FDA needs to do its job.  Having a similar document for ALS seemed to be a no-brainer for a disease needing faster trials and approvals.  The big ALS organizations talked of driving that effort.

Where is our document? It was not on the list of guidance documents that the FDA is scheduled to release anytime in 2015.  Tick.

DMD advocates submitted their draft last year.
DMD Draft FDA Guidance Document

Is it true that wagons are just starting to be circled for ALS organizational stakeholders to begin to talk about an ALS document?   Over two years later?  Tick.

At least the DMD folks blazed a nice trail to follow.

Need anyone wonder why people with ALS and caregivers are rallying in Washington again on May 11 to demand faster FDA paths to approval for possible ALS therapies?  They're ticked, and they live at a far different pace than bureaucracies.  I encourage you to stop by the rally and listen.  They are thoughtful and bright people, and, yes, they're ticked.  All of the talk of over two years ago has delivered nothing. And it seems like organizations are now convening to talk so they can talk about talking at ALS Advocacy Day in May.  We should all be alarmed.




1 comment:

  1. Alarmed? No armed! I was there two years ago, while people were pleading with the FDA for changes on policies regarding drug testing, trials and a list of other things. It was pathetic. People crying their hearts out to the panel playing on their cell phones and doodling. This was my first introduction to the system. Nothing has changed, except lives lost, and younger people being diagnosed. Armed to the teeth..with data, with hope, with courage, and with a voice.. May 11... Armed with solutions, with politics, armed to play it out. The Game is On. #nospeechbutavoice #thegameison

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