I’m done playing nice.
I’m supposed to be dead.
This is an urgent call to action. Keep reading.
I need your help!
With an ALS diagnosis in 2013, I was given 2-5 years. I’m alive but being protected to death by the FDA, and I’m not alone. Every 90 minutes someone is diagnosed with ALS and every 90 minutes someone dies from ALS.
The 2014 Ice Bucket Challenge raised over 100 million dollars for research. Today, promising treatments are sitting in the FDA pipeline. It takes decades and billions of dollars to get an effective treatment approved.
We’ve played nice and we’ve been ignored.
Two years ago, the National ALS Association (ALSA) wrote an FDA Guidance Document that is being lauded as the gold standard of industry guidance. Half of the 14 patients on the guidance committee died waiting for public comments. The FDA just released Its version of ALS Industry Guidance. I, the remaining committee members, and thousands of others will die waiting because the guidance does very little to advance treatments through the lengthy and costly approval process.
The voice, concerns, and suggestions of patients and our allies were largely ignored in the original guidance and our Call to Action was buried in the very last pages of a 139 page document. We had high hopes that the efforts of so many would dramatically impact drug trial design and approval process. Our lives depend on it. Nope. The new and exciting guidance from the FDA Includes: patients with ALS are willing to take greater risks because the condition is terminal. Thank you, Captain Obvious.
I’m waiting to test the California Right to Try law or use the FDA’s Expanded Access Program when a new drug I’ve been following passes Phase 1 safety and tolerability studies. There is no requirement for the company to give me the drug, only a moral imperative. I gladly spent a total of six weeks in the hospital and dozens of appointments in San Francisco. I have great hope that this new molecule will dramatically slow my progression or stop it all together. The trial is still in Phase 1 two years later. Waiting those two years cost me the functional use of my hands and arms, it cost other people their lives.
We are not asking for a safe and effective treatment for erectile dysfunction. We are demanding access to potential life-saving treatments that are stuck in a 15 year, billion dollar approval process. Answering FAQs and minor tweaking don’t come close to the paradigm shift required to save lives today. Stem cell therapies and promising treatments exist but are not accessible.
ACT UP seized the FDA 30 years ago with the same obstacles facing people with HIV/AIDS. It’s time for us to do the same. Most with ALS can’t march or yell because many are paralyzed and can’t speak. But we have assistive technology and 400 pound wheelchairs. Get on board or get out of our way.
Urgent Call to Action
- Immediate access to promising treatments that have passed safety studies.
- No placebos in clinical trials, use historical controls instead.
Stop protecting us to death. The cost of a military parade could provide life saving treatments to every American living with ALS. US veterans like me are twice as likely to have ALS. It’s time for the US Government to cut through the regulatory red tape of the FDA and provide life-saving treatments now.
The patient community has the right and responsibility to get loud and demand our voices be heard. We need 1,000 public comments to get the FDA’s attention. You can help by leaving a public comment of your own. Click here.
Tell your story and demand access to treatments and radical changes in how ALS drug trials are designed now! Status Quo = Death.
It’s easy to comment. Here’s how:
- Click here to go to the public comment website.
- Type your comment. Note: It’s best if you write your own comment, but here are some suggestions on what to include:
1. Your relationship to ALS (patient, loved one, friend, etc)
2. A statement about how this guidance document is unacceptable. For example: The proposed guidance document doesn’t adequately address the urgent needs of patients who have a terminal illness – especially an illness without an effective treatment. It is cruel to withhold access to treatments that have been proven safe and show promise, but are stuck in a 15 year, billion dollar approval process. It is time for the FDA to stop protecting ALS patients to death. ALS patients need immediate access to promising treatments that have passed safety studies. ALS clinical trials should NOT require placebos and use historical controls instead.
- DO NOT put your name and contact information in the comment as it will become part of the public record. There will be a place later in the process to put this information. It is optional and will not become part of the public record.
- Uncheck the checkbox that says: I am submitting on behalf of a third party.
- From the drop-down category menu, choose: Individual Consumer
- Your comments won’t post until they have been reviewed by the FDA, so don’t be surprised if you see zero comments posted.
Make your public comment and share this far and wide. Thank you.
If you’re having trouble submitting a comment on the above link, try
here and click the green button. Note that the 270 comments listed refer to a previous document from 2013.
If our voices are dismissed again, we will show up at their door demand action. Imagine 250 power wheelchairs at the FDA headquarters. Here’s how ACT UP did it 30 years ago.