Another Drug MS and Other Immune Problems

NATIONAL LDN AWARENESS WEEK

October 19 – 25th, 2009

an old drug, a controversial treatment, successful across a range of diseases, linked by immune system dysfunction BUT YOU won’t hear of it, and YOU won’t be offered it.

On October 19th, patients, physicians and researchers alike will convene at the National Institutes of Health in Bethesda, MD, for the Fifth Annual Conference on Low Dose Naltrexone.       October 19th will also kick off the First International LDN Awareness Week – a concerted push to get the word out through the media, about thousands of patients with autoimmune diseases who are benefitting from the off-label use of one inexpensive generic drug protocol, low dose naltrexone (commonly referred to as LDN).

      It is estimated that thousands of patients worldwide are now enjoying improved health due to LDN. Most learn about it through a combination of word of mouth, success stories, internet research, online forums, and an ever-growing number of doctors who are prescribing it for their patients with autoimmune diseases. The LDN protocol employs approximately 1/10 the dose of naltrexone, a drug that was approved in 1984 by the FDA to treat alcoholism and drug addiction. Today, thanks to the work of patient advocates, dedicated physicians and researchers, thousands of patients are taking LDN to successfully halt the progression of diseases that are compromised by an impaired immune system, such as Multiple Sclerosis, HIV, Rheumatoid Arthritis, Crohn’s Disease, Lupus and Fibromyalgia. 

Low Dose Naltrexone (LDN) is literally changing their lives.

     “Before I started taking LDN in 2003, I was an invalid,” says Linda Elsegood, one of the founders of the LDN Research Trust, a non-profit charity in England, which was formed in 2004 to raise both awareness of and research for LDN. “I had just about every symptom of Multiple Sclerosis that a person could have. I was constantly fatigued, I had numbness over much of my body, a loss of hearing, twitching muscles, vertigo. You name the symptom, and I had it.” Now, thanks to LDN, Linda is almost back to normal, and works tirelessly to raise money and awareness of LDN. “This drug has saved my life,” she says. “Along with hundreds of other people, I am working hard to get the word out about LDN. Many patients who don’t yet know about this drug, desperately need it.” Linda adds that LDN has virtually no side effects – unlike most of the much costlier, highly toxic medications doctors routinely prescribe to treat the disease. 

     Vicki Finlayson, of Auburn, California, tells a story of a life that was filled with 9 years of side-effect-laden medications approved by the FDA for MS. “I was on just about every one of these medications,” she says, “and often, I was on several at one time – along with medications for the pain. Yet, my MS was getting progressively worse, until I was virtually bedridden.” Happily, in 2005, she found LDN, and she hasn’t looked back. “I felt improvement in two days,” she says. She is now back to normal, and all of her symptoms are gone. In fact, in May, 2008, she walked 53 miles to the State Capitol Building in Sacramento to meet with state officials to raise awareness about LDN. She will be back on the Capitol steps this October 21st, as part of the ongoing effort to educate the public, doctors and government officials about the importance of this inexpensive, effective, patient-driven treatment. “LDN gave me my life back. I feel that it’s very important to spread the word about it.” Because low dose naltrexone treatment represents an inexpensive, off-label use for a drug approved long ago by the FDA, pharmaceutical companies — who carry out most of today’s research on medications — aren’t much interested in funding research on LDN. 

      But the incredible thing is that hundreds of patients – and several doctors, too – who have experienced remarkable results in themselves and in their patients, are conducting research and raising money and awareness on their own. In fact, one group of patients in the US raised enough money to help fund a successful trial at the University of California in San Francisco, and there are now trials being conducted in Mali, Africa, as well as in Milan, Italy.

     In addition, Dr. Ian Zagon and his colleagues at Penn State are doing both animal and human trials for several disorders, including multiple sclerosis, Parkinson’s disease and various cancers; and Stanford University is entering into a Phase II trial for fibromyalgia. It is estimated that hundreds of doctors throughout the United States, the UK and Canada, as well as in countries as far-reaching as Italy, Israel, Australia, and even Nigeria, prescribe LDN for their patients.

  LDN’s HISTORY: 

     The low dose naltrexone protocol has a long history of success treating autoimmune diseases. Over 20 years ago, naltrexone was approved by the FDA to treat addiction, at much higher doses. But in 1982 Dr. Ian Zagon and other researchers at Penn State University discovered its ability to normalize a dysfunctional immune system, when used in very low doses. Bernard Bihari, MD, a Harvard trained neurologist in New York City, observed positive clinical results using LDN for HIV, MS and other immune system disorders. His observations led to years of devoted work with patients, treating every kind of immune disease — including HIV/AIDS – with extremely positive results, and virtually no side effects.

     According to Dr. Bihari’s friend and colleague, David Gluck, MD, who also works tirelessly to get the word out about LDN: ““Low Dose Naltrexone may well be the most important therapeutic breakthrough in over fifty years. It provides a safe and inexpensive method of medical treatment by mobilizing the natural defenses of one’s own immune system.”

The aim of International LDN Awareness Week is to bring LDN out of the shadows, so more disease sufferers might benefit.

LDN RESOURCES: WEBSITES, BOOKS  

     There are several key websites devoted to LDN, including Dr. David Gluck’s site, www.lowdosenaltrexone.org; and the websites of patient advocates, Linda Elsegood and Samantha Jo Wilkinson, www.ldnresearchtrust.orgg and www.ldners.org. All three of these websites are dedicated to helping patients and funding research.

In addition, books have been written on the topic of LDN, including;

The Promise of Low Dose Naltrexone, by Elaine Moore and SammyJo Wilkinson

Low Dose Naltrexone Clinical Trials

Medical professionals and patients should rest assured there is now significant research into LDN occurring around the globe.

 A Case of Remission from Crohn’s Disease with LDN.
   Reported by Jeffrey Dach, MD

 Four LDN Studies Presented at the 2008 MS World Congress Meeting 
   9/22/08 Elaine Moore reports on the important MS/LDN studies at Penn State
  and University of California.

 Low Dose Naltrexone: Hope for PPMS 
   9/18/08 Maija Haavisto reports on the Italian human trial 6 month report.
   A pilot trial of low-dose naltrexone in primary progressive multiple sclerosis. 
  First LDN/MS trial data to be published. J. Mult. Scler. Sept 08

   Pilot multi-center study of low dose naltrexone in primary progressive
    multiple sclerosis University of Milan.
   Results presented at the American Academy of Neurology; ECTRIMS.

 A Randomized Placebo-Controlled, Crossover-Design Study of the
    Effects of Low Dose Naltrexone. (for MS) 
   University of California, San Francisco – Completed 2008
  Presented at AAN 2008; MS World Congress 2008. Publication pending.
  See Elaine Moore’s 9/22/08 report.

 Scottish doctor is raising money to fund LDN drug trial for MS
   At the 2008 LDN conference, Dr. Gihooly reported this trial is nearing launch.

 Jan 2008: National MS Society clinical Update on LDN 
   Links to the research mentioned are available above.

 Evers Multiple Sclerosis Clinic
   The first trial of LDN for Multiple Sclerosis. 2004, Germany.  

 Jan 2008: Low Dose Naltrexone for the Treatment of Fibromyalgia   
   Stanford Medical Center. Recruiting patients that live near Bay Area.

 The Mali HIV+ AIDS LDN Initiative – Dr. Jaquelyn McCandless

 Penn State
   Successful Trial of Low Dose Naltrexone for Crohn’s Disease
   2008 Phase II (trial website) and Pediatric Crohn’s (trial website)

 Met-enkephalin therapy for autoimmune diseases: Selective immunomodulation and extention of steroid therapy
   This human study was done in Croatia, 1997, and found positive effects across multiple autoimmune conditions, such as "significant reduction in the number and severity of relapses".  Met-enkephalin is the beta-endorphin released by LDN, which may play a role in returning the immune system to homeostasis.

Articles, Publications related to Low Dose Naltrexone Therapy

 Glutamate Excess in Multiple Sclerosis Variants: Why LDN Offers Benefits       11/3/08 Elaine Moore reports on new research from Mayo Clinic that supports
   Dr. Agrawal’s 2005 LDN/MS hypothesis (see below).

 Low dose naltrexone therapy in multiple sclerosis 
   Medical Hypotheses, 2005;64(4):721-4, Y.P. Agrawal
    Abstract           Full-PDF

 The Use of LDN for MS, Crohn’s, and Other Autoimmune Diseases
   by Elaine Moore, who has published extensively on autoimmunity.

 Possible importance of antibiotics and naltrexone in
    neurodegenerative disease (email for copy of article)
   European Journal of Neurology 2005, 12: 1, Y.P. Agrawal

 Jan 2005: Interview with LDN researcher Dr. Agrawal (PDF)
   Interviewed by Robert Lester, published by the Boston Cure Project

 Dr Zagon at Penn State has a long research history with "opiod growth factor" (invoked via LDN), and human trials for Crohn’s Disease and  Pancreatic Cancer. The National MS Society has funded an animal study to investigate LDN effects on MS (update).

 Beta endorphin concentrations in PBMC of patients with different clinical
    phenotypes of multiple sclerosis.
   Dr Gironi’s research found lowered endorphins in MS patients. LDN raises
    endorphins, our own endogenous opiates, which may have a modulating
    effect on the immune system (see below).

 How LDN helps fight Lyme Ken Singleton, M.D.

 Predictors of Interferon Non-Response
   If you are trying to decide whether to continue Interferons or switch to LDN

Related  Research:

 Imiquimod, An Immune Response Modifier, Is Dependent On
    The OGF-OGFr Signaling Pathway – MedicalNewsToday.com 7/27/08
   Exp Biol Med, Aug 2008 Abstract

 The role of glutamate transporters in neurodegenerative diseases and
    potential opportunities for intervention.
   Neurochem Int. 2007 Apr 19, Sheldon AL, Robinson MB. 

A team including JS Hong at the National Institutes of Health has been researching the neuroprotective effects other compounds similar to Naltrexone:

 Role of Microglia in Inflammation-Mediated Neurodegenerative Diseases: Mechanisms and Strategies for Therapeutic Intervention

 Role of nitric oxide in inflammation-mediated neurodegeneration 

 Inhibition by naloxone stereoisomers of beta-amyloid peptide (1-42)-induced superoxide production in microglia and degeneration of cortical and mesencephalic neurons

 Dextromethorphan Protects Dopaminergic Neurons against Inflammation-Mediated Degeneration through Inhibition of Microglial Activation

Is MS an Autoimmune Disease?
Many of the FDA approved treatments for MS are immune suppressants, aimed at down-regulating what is thought to be an overactive immune system that is attacking the myelin sheath. It is speculated that LDN works by placing the immune system back into normal mode, or homeostasis. While this may be at odds with the autoimmune theory, recent research is calling into question the traditional definition of MS.

 Popular Hypothesis Concerning Emergence Of Multiple Sclerosis Contested ScienceDaily, Dec 2008.
Journal reference: Haak et al. IL-17A and IL-17F do not contribute vitally to autoimmune neuro-inflammation in mice. Journal of Clinical Investigation, 2008 
 

Neuroimmunology References:

 Experimental Evidence for Immunomodulatory Effects of Opioids
   Discussion on the developing science of neuroimmunology.

 More detail on
LDN Clinical Trials at lowdosenaltrexone.org