Culture

Loopholes in Right-to-Try Law Still Prevent ALS Patients From Potential Life-Extending Drugs

(Credit: Photo courtesy of Michael Moutsoulas)

It’s been two years since President Trump signed the “Right-to-Try” Drug Bill into law. The legislation gave terminally ill patients access to experimental medical treatments yet to be approved by the Food and Drug Administration (FDA).

Despite the opportunities offered by the new law, some patients are still struggling to get access to experimental drugs that are awaiting approval from the FDA that could improve their conditions.

Mike Moutsoulas, a 43-year-old father of three children between the ages of 4 and 7, was diagnosed with amyotrophic lateral sclerosis (ALS), the neurodegenerative disease commonly known as Lou Gehrig’s disease in November 2019. He and his sister, Stephenie, 44, who was also diagnosed with ALS back in December 2018, have been fighting to make more promising treatments for the disease available to ALS patients like themselves that loopholes in the Right-to-Try Drug Bill prevent them from having access to.

Mike and Stephenie have a form of the disease that is genetic. Their biological mother and her sister both died of ALS. The disease has a 100 percent fatality rate.

There are currently two bills that would open up access to various treatments that could offer hope to the Moutsoulases and other ALS patients: the Promising Pathway Act, and the  Accelerated Access to Critical Therapies (ACT) for ALS Act. While these bills would provide expedited access to new treatments and increase funding for ALS, it could take a year for these bills to go through the legislative process and become law. Moutsoulas and other ALS patients would benefit greatly if existing treatments stuck in clinical trials were accessible to them.

Moutsoulas is a Navy veteran and a longtime active member of his local community. In 2005, he ran and won a four-year term on the School Committee of his hometown, and later served on the city’s Board of Registrars.

In May, Moutsoulas participated in the #ShaveALSChallenge, which, similar to ALS Ice Bucket Challenge, encouraged people to shave their heads to raise awareness about promising ALS treatments stuck in clinical trials:

Today, I participated in the #shaveALSchallenge at the challenge of my sister Alex Brownlee! I was diagnosed with ALS in November 2019. My sister Stephenie Moutsoulas has been battling ALS since 2018. #feffin'strong! 💪💪💪The reasoning for this challenge is to raise awareness on the lack of distribution of a successful treatment called NurOwn.NurOwn is a treatment for ALS patients created by the company Brainstorm that can mitigate, stabilize, and in some case Reverse symptoms of ALS! Unfortunately it is being Delayed in FDA Trials and cannot be accessed by terminal ALS patients that need it today.PLEASE like and share this challenge with your friends and family here on Facebook and Instagram! Heck, participate in the challenge if you would like! Some people have shaved their heads, their beards, or even their legs, ETC… just to help spread the awareness!!Since we participated in the challenge, it’s only right to nominate some people to keep this thing going! The people We nominate must participate in the challenge themselves and nominate more people! I nominate Michael Martins and Chris Nobes! Let's keep it going, Gents!HELP those fighting this disease today by sharing this post and captioning it #shaveALSchallenge! Let the FDA know that you support the distribution of NurOwn treatment to those fighting ALS! #alsawareness #nurown #executiveorder #presidenttrump #fdacommissionerhahn #help

Posted by Michael Moutsoulas on Saturday, May 2, 2020

Moutsoulas and 55 other ALS patients and their families also traveled to Washington, D.C., to demonstrate in front of the White House, calling for greater access to experimental treatments. Moutsoulas also wrote a letter to President Trump (which he provided to PJ Media) noting that during the COVID-19 pandemic the FDA was able fast-track experimental drugs through the approval process, and urged him to sign an executive order that could provide similar hope for people suffering from ALS.

Here is a portion of Moutsoulas’s letter:

Currently, there are no approved treatments or a cure for ALS. There is a safe and promising treatment called NurOwn that has been in clinical trials for a DECADE. It has shown in the clinical trials to have slowed, stopped, and even reversed ALS in some patients. It’s not a cure, but could be a long-term treatment option, much how we treat Diabetes and other chronic illnesses. There has never been anything more promising in the 150 year history of ALS than NurOwn. Sadly, we only have 2 FDA approved drugs for ALS, which are said to extend a patient’s life by a few months if taken early enough.

The recent urgency in which the FDA is pushing experimental Covid-19 drugs through their process, gives ALS patients hope that a similar pathway can be created to allow patients the right to try NurOwn and other promising treatments, such as T-REGS, CuATSM, AMX0035, Prosetin, Mastinib, and others. ALS is 100% fatal. Why can’t the same urgency apply for ALS?

I write to you Mr. President to ask that you please sign an Executive Order to allow an immediate pathway to NurOwn, and other promising ALS treatments. By doing this, you will make a terminal disease in ALS a treatable one. The Moutsoulas Family would be forever grateful. Thank you for your time and consideration.

President Trump would be well within his authority to sign an executive order to expand the availability of these potential long-term treatments for ALS in the spirit of the Right-to-Try law. Waiting for a dysfunctional U.S. Congress to pass legislation isn’t good enough for those afflicted with ALS whose only roadblock to potentially life-extending drugs is government bureaucracy.

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Disclaimer: Mike Moutsoulas is a personal acquaintance of the author of this article.