Category Archives: disability

20 things to know regarding Pharmaceutical vs. Nutraceutical protocols for ALS!

Radicava® vs Deanna Protocol®

To understand what the differences between Pharmaceutical and Nutraceutical are, we should begin with their definitions:

phar·ma·ceu·ti·cal

Adjective

  1. Relating to medicinal drugs, or their preparation, use, or sale.

Noun

  1. a compound manufactured for use as a medicinal drug.

nu·tra·ceu·ti·cal

Noun

Plural noun: nutraceuticals 

a food containing health-giving additives and having medicinal benefit.

Now, let’s compare the new drug approved by the FDA Radicava® vs The Natural alternative for a better quality of life, the Deanna Protocol®.

  • 10 Things to Know About the New ALS Drug Radicava®
  1. It is a Pharmaceutical drug.
  2. The drug underwent a phase 3 clinical trial in Japan and South Korea where 137 ALS patients were given either Radicava® or a placebo. The group given Radicava® experienced a 33 percent reduction in the decline of their physical abilities compared to the placebo group.
  3. Radicava® works by reducing the oxidative stress in the body. People with ALS have high levels of oxidative stress.
  4. Radicava® is administered via intravenous infusions. Initially, patients have a daily infusion for two weeks and then have two weeks’ rest. After that, they need to have 10 consecutive daily infusions followed by two weeks of rest.
  5. Each infusion takes around an hour to complete.
  6. The dosage of each infusion is 60 mg.
  7. The cost of each Radicava® infusion is about $1,000 and it’s reported that the treatment costs about $146,000 annually.
  8. Radicava® should be available to ALS patients in the U.S. by August.
  9. The most common side effects associated with the drug are headaches, bruising and gait problems.
  10. Radicava® infusion contains sodium bisulfite which is known to cause both mild and severe allergic reactions in some people (particularly those with asthma).
  • 10 Things to Know About the Deanna Protocol®
  1. It is a naturally derived Nutraceutical program.
  2. Developed by Doctor Vincent Tedone, a retired physician (Orthopedic Surgeon), for his daughter Deanna who was diagnosed with ALS at the age of 30 in 2007.
  3. The Deanna Protocol® has undergone double blind clinical trials at the University of South Florida in mice models. The Deanna Protocol® has over 1,500 anecdotal case studies from patients with ALS.
  4. The Deanna Protocol® is a blend of nutritional powders and liquids that contain powerful antioxidants and amino acids essential to assist your body in its natural efforts to fight neurodegenerative damage. People suffering from other neurodegenerative diseases, such as Parkinson’s and Alzheimer’s, have also reported improvements.
  5. It is taken in the morning, in the afternoon and at night as part of your regular, at home, breakfast, lunch and dinner routine. No need to go to the clinic.
  6. The Protocol is the same for everyone but the dosages might vary, depending on the person and what their specific needs are. The most common side effect is an upset stomach usually reported during the initial days as the body adjusts to the protocol.
  7. The cost of the Deanna Protocol® starts at $219.99 for the Core Bundle #1. The next most inclusive package is the Plus Bundle #1 at $249.99. And our most inclusive bundle is the Comprehensive Bundle #1 at $349.99. Above prices are for a 1 month supply and include easy-to-follow, step-by-step instructions and an actual human to answer your questions and provide you with the support you need.
  8. Not sure? At Simplesa’s website there’re 330+ reviews with 4.5 stars from verified and satisfied buyers at simplesanutrition.com or call 1-888-578-5528.
  9. Deanna Protocol® has been in the market for almost 4 years. The popularity of the protocol and the positive reports from the clients, speak for themselves.
  10. The freshness of the products used in the Deanna Protocol is guaranteed, these products are naturally derived and are manufactured in a facility that follows strict Current Good Manufacturing Practice (cGMP) (Enforced by the FDA) and is UL (Underwriters Laboratories) certified.

 This Blog is for educational purposes. We hope that the above information helps you make the right decisions to address your neuro-degenerative concerns. And as always consult your physician.

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These statements have not been evaluated by the FDA. These products are not intended to diagnose, treat, cure or prevent any diseases.

Sources:
alsnewstoday.com
winningthefight.org
simplesanutrition.com/deanna-protocol/

 

Simplesa® is now offering the Deanna Protocol® and Lunasin to ALS Patients

Simplesa, a nutrition company established in 2013 after the amyotrophic lateral sclerosis (ALS) community showed its support for a metabolic supplement treatment called the Deanna Protocol (DP), has expanded its products for the Deanna Protocol with the addition of LunaCell™ for consumers.

Patients with ALS (PALS) have been following the Deanna Protocol (DP) since it was first released in 2011. The Deanna Protocol is an all-natural metabolic program developed by Dr. Vincent Tedone, a retired physician whose daughter, Deanna, was diagnosed with ALS. The Deanna Protocol works to support mitochondria dysfunction with energy production and the counteracting oxidative stress. The Deanna Protocol (DP) helps improve the quality of life for people with ALS. Patients who consistently follow the plan have reported an improvement in energy production, reduction in muscle twitching and cramping, and improved coordination, balance, and limberness.

lunacellLunasin first caught the attention of physicians and the ALS community when Mike McDuff, who was diagnosed with ALS, took the nutrient in 2012 and had a remarkable recovery. Therefore, Lunasin, a soy peptide that may alter histone acetylation, has been associated with ALS reversal.[1] Lunasin was the first dietary compound with an identified epigenetic mechanism of action.  PALS often have elevated levels of free radicals. Lunasin is significant to the ALS population as multiple studies show Lunasin helps reduce free radical production while also scavenging free radicals.    Since that time, Lunasin has caught the attention of many trying to cure and/or treat ALS.  Among those interested in Lunasin and ALS is Dr. Richard Bedlack, Director of the ALS Clinic at Duke University. He started the first of its kind study on Lunasin with reporting conducted through a patient network and real-time research platform called Patients Like Me.

As with the Deanna Protocol, Simplesa saw the potential to help PALS with Lunasin.  Simplesa® recently released its Lunasin product, LunaCell™, which consists of a superior bioavailable form of Lunasin and is priced relatively lower than other Lunasin products. This formulation allows patients to take less capsules and quickly absorb more Lunasin into their system.

Feedback from verified consumers of the products has been very positive:

It seems impossible but after two days my dad muscle movement on leg that is useless for more than a year. – Andrej

 

I only take half of the capsules and it costs half as much as other Lunasin I took. Thank you. – Pedro O.

Simplesa® has always been committed to meeting the unmet needs of its consumers, and they quickly saw the benefit to PALS to provide more options with the Deanna Protocol® products and LunaCell™. This new program is opening doors for additional choices for PALS to try both complimentary regimes and improve their quality of life.

Sources:

  1. Oxidative Stress and Radivcava: 

https://alsnewstoday.com/2017/08/03/nine-things-to-know-about-the-new-als-drug-radicava/

  1. Oxidative Stress and Lunasin:

https://core.ac.uk/download/pdf/3616328.pdf

  1. Oxidative Stress and Deanna protocol: 

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0103526

https://www.researchgate.net/publication/272828777_ALS_Untangled_No_20_the_Deanna_protocol

[1]www.mndassociation.org%2Fwp-content%2Fuploads%2FFINAL-WIP-booklet-Dublin-081116.docx&usg=AOvVaw0QgHpgvjCAB2Dae8-77Ins

Getting PALS the Help They Need FASTER!

ALS is an incurable disease at this time. When a patient and family is dealing with ALS, the last thing they should have to do is wait for financial and medical assistance. Currently, Social Security Disability Insurance (SSDI) has a typical 5-month waiting period for patients with ALS (PALS).

On Thursday, Feb. 16, Congressmen Seth Moulton (D-MA) and Peter King (R-NY) re-introduced The ALS Disability Insurance Access Act, bipartisan legislation they spearheaded to ensure that amyotrophic lateral sclerosis (ALS) patients are provided vital support and benefits in a timelier manner. The legislation would waive the Social Security Disability Insurance (SSDI) five-month waiting period for people living with ALS, commonly referred to as Lou Gehrig’s Disease.[1]

Many PALS are often diagnosed after they experience significant health deterioration and symptoms.  After dealing with the shock of this devastating diagnosis, PALS have to then apply for SSDI, which can be a lengthy and timely process. The ALS Association reports that fifty percent of all PALS succumb to their illness within 16 months of diagnosis.  The waiver of this 5-month waiting period to get sorely needed resources in an expedient and timely manner is critical.  “This legislation is especially important for people with ALS, for whom five months can mean the difference between life and death,” said Barbara Newhouse, President and CEO of The ALS Association.

The waiver implications go beyond just financial support. Medicare coverage is tied to the onset of the approval and start of SSDI.  The waiting period not only stalls much needed financial assistance to PALS and their families but also medical coverage for very costly care and potential medications.

We need your help to get this very important legislation quickly passed. You can send an e-mail to your members of Congress and personalize it with your story. Please urge your members of Congress to co-sponsor H.R. 1171/S. 379!  You can click here to send your support via the ALS Association website.

To track and monitor the status of this very important legislation you can visit the bill status on this website:   https://www.congress.gov/bill/115th-congress/house-bill/1171

Please see an excerpt of the bill here:

Bill History in the Congressional Record

Page numbers for legislative actions on this bill link to the Congressional Record. Learn more about the History of Bills and Resolutions.

From the Congressional Record, Volume 163 (2017)

——————————————————H.R. 1171–A bill to amend title II of the Social Security Act to     eliminate the five month waiting period for disability insurance     benefits for individuals with amyotrophic lateral sclerosis (ALS);     to the Committee on Ways and Means.  By Mr. MOULTON (for himself, Mr. King of New York, Mr. Bilirakis, Mr. Blumenauer, Mr. Cicilline, Ms. Clark of Massachusetts, Mr. Cohen, Mr. Conyers, Mr. DeFazio, Ms. DelBene, Mr. Engel, Mr. Garamendi, Mr. Heck, Mr. Jones, Mr. Keating, Mr. Kilmer, Ms. Michelle Lujan Grisham of New Mexico, Mr. MacArthur, Mr. McGovern, Mr. Peters, Ms. Pingree, Mr. Pocan, Miss Rice of New York, Mr. Richmond, Mr. Ruppersberger, Mr. Ryan of Ohio, Mr. Schiff, Mr. Sessions, Mr. Tonko, Mr. Walz, and Mr. Swalwell of California), H1300 [16FE]

If you need additional information on the bill or getting help read the original article form the ALS Association here:  http://www.alsa.org/news/media/press-releases/als-disability-insurance-access-act-021617.html

Please get involved today to CURE ALS and help PALS and their families improve their quality of lives.

[1] http://beverly.wickedlocal.com/news/20170220/moulton-king-continue-fight-for-als-patients