#AANAM — ALS Therapy Radicava Limits Functional Decline, Study Says

[Dagmar]

Unfortunately, this retrospective look at 3 studies on Radicava is a rehash of earlier reports and findings.

The real title should be: “ALS Therapy Radicava Limits Functional Decline by 30% Only in Patients within 1-2 Years of ALS.” Note: all studies were done on patients of first 2 years of ALS; results are only “predicted” for those further along in the disease.

This meta-analysis could only find 3 studies on the drug – – a total of 368 patients, half of them were on placebo. So, the drug was approved by the FDA based on: 184 patients in their first 2 years of ALS experiencing a slowing of progression. No data was shared as to how long the patients had symptoms before being diagnosed, their ALSFRS-R score at diagnosis or, if they were a fast- or slow-progressor.

The cost of Radicava and its delivery requirements are hefty compared to predicted outcome.

You can guess that I am not a fan of Radicava (brought to market too soon, high costs, intense delivery) and from what I’ve read of patient comments, many stop taking it due to not seeing expected results.

Is there anyone in our forum who is on it and seeing results? I’d be interested to read our other member’s thoughts about this drug?

[Glen North]

I was on Radicava (edaravone) for 5 months, I know my body extremely well and I’m certain it did absolutely nothing for me.  I stopped taking it even though it was supplied free of charge.

I din’t think Radicava should have been permitted to be marketed as an ALS treatment due to the sketchy trial, but this will continue to take place as long as we try to rush treatments for ALS to market.  Until robust biomarkers can be established there is no real way to determine if such products work to marginally slow progression.

With ALS presenting itself so differently in individuals, I believe that in a case such as Radicava, the trial results should have been duplicated 3 consecutive times in order to attain market authorization.  MT Pharma didn’t do that because they didn’t have to and perhaps worried on what the outcome would be.

To the people that say they notice a difference, I say terrific, but the placebo effect cannot be understated, and it indeed may help, although a placebo doesn’t cost an exorbitant amount.

[Dagmar]

I’m in total agreement Glen. And thank you for sharing your own experiences with Radicava.

It’s always funny when researchers discount placebo – – as the “Placebo Effect” has been proven to be 10 – 90% effective! Here is an interesting explanation of placebo: More Than Just a Sugar Pill

I do take Riluzole (50mg 2x/day) and have been for the past 9 years. Other than that, I’m sticking with what is working for me: daily gentle exercise, good nutrition, positive mindset, practice mindfulness & keep stress low, sleep well and…stay engaged in life.

This forum is an excellent resource for how others are living good lives while living with ALS.

[Diana Belland]

Glen and Dagmar,

None of the three neurologists I saw during the course of my diagnosis were advocates of Radicava, but I have still continued to worry from time to time if I am missing out on a therapy that could help me.  Your discussion helps to lay those worries to rest.   I’m glad to know, Dagmar, that you do take Riluzole—I’m on the same dosage but sometimes wonder whether or not it will make a difference.  But I am trying to keep up with your wonderful recipe for living well with ALS.

Thanks!

[Dagmar]

Riluzole and Radicava have different mechanisms in the body.

Riluzole helps eliminate glutamate (metabolic waste) from the brain. Build-up of glutamate has been linked with ALS and loss of motor neurons. Riluzole is said to “stop working” when it can’t keep up with the amount of glutamate produced by the brain – – that is usually about the time the patient needs a tracheotomy in order to continue breathing. Riluzole is then no longer recommended.

Radicava helps eliminate free radical toxins due to oxidative stress. It could be called an antioxidant. Other forms of antioxidants are being examined for possible use for ALS – – turmeric (curcurmin) in the form of Theracurmin (by Integrative Technologies) is of recent interest by Dr. Bedlack, of Duke University.

I recommend taking the time to watch this very informative webinar from ALS TDI that gives a great explanation of ALS, drug mechanisms and future goals. https://youtu.be/UHnhiPQNmKg

 

[Jean-Pierre Le Rouzic]

The case for “ALS reversals” made in 2015 by dr Bedlack and his team and specially about Curcumin is a bit strange.

In this recent article:

* They report that there were nine cases who regained normal strength. One pALS without an ALSFRS-R score came off a ventilator after 17 years of dependency and another began walking after a year of quadriplegia! They are the only scientists to claim that one can heal from ALS.

* They mixed confirmed ALS cases with non confirmed case as well with patients with PMA, why?

* They are supposed to have found ALS reversal in literature then confirmed “reversals” by EMG. How can they confirm anything if there was no EMG done in non confirmed cases?

* They include one case who, at nadir, was unable to stand and after her improvement was able to walk several miles but did not have a formally documented strength exam. So why including it in the study?

* They wrote (and it is their main point) that odds of taking curcumin, luteolin, cannabidiol, azathioprine, copper, glutathione, vitamin D, and fish oil were higher for their cases than for controls. As the control is the PRO-ACT database, and there are NO MENTION OF ANY OF THOSE PRODUCTS IN THE PRO-ACT database, they could not reach any conclusion.

No one has shown a true case of ALS reversal up to now (May 2019). You can see here that, as of today 4 years later after the first article about “ALS reversals”, that dr Bedlack does not claim that Curcumin “cure” ALS.

[Dagmar]

Jean-Pierre, You are correct that Dr. Bedlack and his team at Duke University is looking into the phenomena of als-reversals. His ALS Untangled website tracks the various treatments they have researched and scrutinized.

Curcumin does not “cure” ALS – – but according to Dr. Bedlack it is worth looking into for its actions: antioxidant, anti-inflammatory and balancing gut geome. These actions at least address a few ALS symptoms.

I found his recent webinar on the topic helpful to my understanding of the issues involved. He is planning to organize a trial to study of curcumin (Theracurmin) using ALS patients.

Webinar: https://vimeo.com/284788558