Google: LDN !

How could it be that a drug that relieves cancer, AIDS, MS, and immune system
disorders for less than a dollar a day remains unknown 20 years after its discovery?

My name is Joseph Wouk.  I’m the son of novelist Herman Wouk.

My background:

BA Columbia College 1975

JD Columbia Law School 1979

Israeli Navy 1981-1983 (Fought in the first Lebanon war on a Dabur warship)

Film, TV & Stage producer 1984-1994. (Exec. Producer, Robert Altman’s The Caine Mutiny Courtmartial 1988)

Returned to Israel Navy for first Gulf War, Jan-Feb 1991

Book published on Gulf War experience: Ground Zero: From Hollywood to the Holy land 1992

(http://www.amazon.ca/Ground-Zero-Hollywood-Holy-Land/dp/1561711675)

Worked for the (ADD: Ross) Perot campaign as west coast Jewish Community coordinator 1992.

(Came up with the title, United We Stand, which was adopted as the 3^rd party’s name)

My connection to this story:

I have been suffering from progressive relapsing multiple sclerosis for at least the last 7 years.  There is no FDA approved treatment for progressive MS. I took copaxone for two months for the relapsing part of my disease, but the side effects were so awful that I had to stop. My condition had become so extreme that in desperation I was getting ready to go to Peru to try a shamanic cure.

About a week before I was going to go, all my symptoms disappeared.  The only drug I had been taking for 3 months prior was Low Dose Naltrexone, known as LDN.  I knew nothing about the drug but had asked for it because my neurologist who specializes in multiple sclerosis, Dr. Douglas Goodin at UCSF had been personally involved in a patient funded study of it there.

I had actually gone to see Dr. Goodin to ask him to prescribe me a very risky drug, Tysabri. You might have read about this drug, because it has been shown to sometimes cause a deadly brain disease as a side effect. For that reason, it had been taken off the market awhile back, and then put back on the market, but with a black box warning. As I said, I was desperate.

But, when I went to see Dr. Goodin, kind of as an afterthought, I asked about the LDN study.  He said that though he had expected nothing, there were some positive results from the 8 week study. He gave me a prescription for that as well.  Because of the nonchalant way in which he treated the issue, I just took the LDN hoping that maybe it would help prevent relapses.  I didn’t bother to research the drug, and frankly, I didn’t expect much.

The bureaucracy took 2 months before they were ready to give me the Tysabri.  My personal physician recommended I wait till getting back from Peru before beginning the Tysabri in order to avoid potential conflicts with the ayahuasca.  But miraculously and unexpectedly, a week before I was supposed to leave, all my symptoms disappeared.

I was in complete shock. This wasn’t even possible, and yet it had happened to me.

I had already started writing a book entitled, PLACEBO – A Rationalist Seeks a Miracle Cure about my planned Peruvian adventure.  The book is now completely different.  It is called:

Google: LDN !

How an Overlooked Drug Relieves Cancer, AIDS,
MS, and Immune System Disorders for a Dollar a Day

Please check out my book so far at: http://sclerotics.wordpress.com/

Today, about the only way to find out about LDN is to Google the word itself; hence the title of my book. This simple fact means that millions of patients who could benefit from it remain ignorant of it.

The extent of the unnecessary suffering and deaths caused by this is truly mind boggling. I became aware of this when I finally Googled LDN myself. The information is there, just not accessible to anyone who doesn’t know the acronym “LDN”.

I still find it difficult to believe. It’s simply too big and too outrageous to accept easily.

I keep thinking that, if I had known about LDN, one of my best friends might not have died. She had multiple myeloma. I researched the disease online endlessly and never came across anything about LDN.

Yet, patients with multiple myeloma had been saved with LDN for 10 years before she died.

It is my firm belief that the central reason this drug remains essentially unknown more than 20 years after its beneficial effects for the immune system were discovered is that it has been out of patent.

Nobody will pay the millions to do the sort of double blind tests the FDA requires for approval.

Furthermore, there is reason to believe that the pharmaceutical industry may be actively trying to prevent the knowledge from spreading.  For good reason.  Tysabri costs $3,000 a month and must be taken for the remainder of the MS sufferer’s life.  Copaxone and the interferon treatments (CRABS) cost about $1,500 a month, also for the rest of your life?

LDN costs $10 a month.

When you combine this fact with the horrible side effects from all the CRABS treatments and even deaths associated with Tysabri, (Google news: Tysabri) and compare them to the almost complete lack of side effects from LDN, it is easy to understand the pharmaceutical companies’ fears.

There are literally billions of dollars at stake here.

Please Google LDN yourselves. This drug can help anybody with immune system related diseases.  I’m sure there will be more than one family at CBS that will need this information the way I did.

60 Minutes is the program to break this story.

I am putting together this proposal for 60 minutes to investigate why this drug remains essentially unknown to the public more than 20 years after its benefits to immune system related disorders was discovered.

I have come up with a number of possible explanations:

1. Drug is out of patent. No financial incentive to anyone to invest the millions of dollars required to conduct double blind studies to get FDA approval.

2. Drug companies are actively dissuading people from taking the drug seriously.  Many of the larger support boards are infiltrated by members who demonize anyone who mentions success with LDN. I experienced this first hand when I reported on one patient support forum I belonged to that all my symptoms had disappeared from LDN. Afterwards I received a number of emails from other patients who had either experienced it themselves or saw it done to others on their forums. It is possible that these people are affiliated with drug companies and the marketing companies affiliated with those drug companies.

3. Search engines turn up nothing on LDN when a disease itself is searched.  This despite approximately 50,000 sites mentioning the treatment online.  I’m not sure why this happens, but I suspect that there is manipulation behind the scenes.  There is a whole science behind “search engine optimization” (SEO) that is available to those with the cash to utilize it. (This is actually an interesting story in its own right.)

4. Doctors either don’t know about LDN or are reluctant to prescribe an “off label” use of a drug that is routinely characterized as “experimental” and whose success stories are labeled as “anecdotal”.  Anecdotal actually only means that the FDA required tests have not been run, but it is a “loaded” word that gives one the impression that it is an “old wives’ tale” or a flaky new age non-treatment.  Also, the theory behind how it works sounds almost homeopathic, something MDs are just not used to.

5. People who actually do get some information are scared off by the fact that it seems to be effective on almost EVERY major disease.  This gives it an unrealistic aura and lends it to being characterized as a phony “snake oil” cure-all.  When I began researching, it had that effect on me.

“NO drug can do all this!”

But apparently it helps so many major diseases because it does not directly address any of the diseases themselves but instead helps restore the immune system.  The body then fixes itself as it ordinarily would.

Each one of the topics listed above would qualify as a good segment on 60 Minutes. The resources CBS could bring to bear on these issues could uncover much more than I have been able to. Given the amount of money involved, it is hard to believe that there is not a lot more than happenstance involved in the drug’s remaining unknown to the public.

All of the FDA-approved medications for multiple sclerosis are dangerous, ineffective and expensive. Copaxone, Betaseron, Rebif, Novantrone, Avonex and Tysabri all have ghastly side effects and extremely low patient satisfaction.

From available evidence, LDN appears to be helpful in approximately 80% of the patients who try it. This is almost twice the percentage of satisfaction with the treatments listed above. For instance, hundreds of patients evaluated LDN extremely favorably on AOL-founder Steve Case’s Revolution Health website. See http://www.revolutionhealth.com/drugs-treatments/rating/naltrexone

Although I have a personal stake in getting this life saving information out to my fellow sufferers, I also believe that the story, if taken on by 60 minutes, is Pulitzer Prize material.

It isn’t only the personal suffering and financial ruin that this story could help prevent; it is also the savings to our society which is currently spending billions of unnecessary dollars on dangerous and ineffective treatments.

The word about LDN is slowly beginning to get out. Eventually it will become unstoppable. Although I do not yet have a publishing contract for my book, I am confident it will come out this winter. .

There is another book entitled “The Promise of Naltrexone” coming out in September, which is targeted to the medical profession.

In October, The Fourth Annual Low Dose Naltrexone (LDN) Conference will be held. It is reasonable to hope that it will help spread the word as well.

While no network news stories have yet been done on the story, a number of local network affiliates have done stories which can be seen on youtube.com. Also quite a few radio interviews have aired.

The following is from Dr. David Gluck who runs the main LDN information website, www.lowdosenaltrexone.org:

As a Board-certified specialist in both Internal Medicine and in Preventive Medicine, the continuing availability of newly effective medical therapies – treatments to help deal with the problems of devastating disorders such as cancers, HIV, or autoimmune diseases – is a critical issue, not only for those patients who are immediately effected but also for their families and for society in general.

Recent years have demonstrated that the methods we had taken for granted, the unswerving commitment of the pharmaceutical companies to develop more effective treatments, is no longer the case.

Within the past month, I contacted the Medical Director of a pharmaceutical company that had recently had an article about its own new drug use published within the New England Journal of Medicine. I told him of the continued excellent results with an unusual medication that he had been first told about in the 1980’s. Recently, because of contributions by individuals, this off-label medication had been able to accomplish a small but positive study at Penn State in 2007 on Crohn’s disease, and in 2008 two new important studies will be published, one from Milan, Italy and one from the University of California in San Francisco, both on its usefulness in treating multiple sclerosis.

The drug, low dose naltrexone [LDN], is available as an off-label prescription. It is generally taken orally as a 4.5mg capsule once a night at bedtime. Naltrexone itself at 50mg was FDA approved in the early 1980’s as a treatment for heroin abuse. It is off patent and is a generic medication. The Medical Director told me that he has no problem with the question of efficacy of LDN, he knows it works quite well, his problem lay in convincing his Board that they should lay out 10 or 20 million dollars for a clinical trial for FDA approval and thus risk that the company makes no profits from that cost because anyone can obtain the original drug as a liquid and be able to have the small dose that way.

Therefore, under our present system, millions of people who would have benefited from this inexpensive medication, which has absolutely no toxicity and virtually no side effects, will never discover this brilliant medication, which acts by strengthening one’s immune system.

LDN thus far has demonstrated its ability to halt the further progression of any autoimmune disease (such as rheumatoid arthritis,  Crohn’s disease,  systemic lupus erythematosus, multiple sclerosis, etc.), and often has considerably useful effects on any cancer or HIV infection.

In addition, many people with Parkinson’s disease and motor neuron diseases (including ALS) have reported improvements or a halt in progression through taking LDN, and a specialist in Neurology has discovered that some 75% of families whose children with autism use it are reporting impressive changes in the child’s willingness to play with others.

There is no question in terms of LDN’s efficacy. Unquestionably positive reports, both small studies and scientific trials, are continuing to find their way into esteemed peer-reviewed medical journals – and that information joins with over 20 years of strongly supportive anecdotal reports. See “Clinical & Animal Trials of LDN” at www.ldninfo.org.

From the first, FDA approval of LDN’s special uses has been blocked, perhaps unintentionally, by the existing system which sets up the large well-financed pharmaceutical firms as the virtual “gatekeepers”.

Given that the existing system is based on the legal approval of each newly proposed drug by the FDA, and that the FDA requires clinical trials’ results of great cost, it is only the funding pharmaceutical companies’ determination of the potential profitability of any individual candidate drug, no matter its potential therapeutic usefulness, which decides whether a new medication will or will not have an opportunity to reach the public marketplace and thus contribute to the public health.

Thus, the stated health-related mission of a pharmaceutical company is generally not at all compatible with that of its necessary primary motivation, which is to gain earnings and profits.

This leads to an erosion of medical advances, paradoxically in an era of severely mounting medical costs, in that an off-patent generic drug with a newly found usefulness, which could significantly heal the sick and/or prevent further illness, even while substantially reducing health care costs, is for all intents and purposes, made unavailable by our system to the public because of its low profit potential.

(Note: I’ve attached the official information regarding a study being conducted by Hadassah Medical School regarding the use of LDN to help autistic children.)

The 60 Minutes Segment

If 60 minutes decides to do this story, they will naturally have their own way of constructing the segment. Below I have laid out the way I would do the story for you to do with as you please.

Title:

1. Google LDN!

2. LDN – Penicillin for the Immune System?

Introduction:
My story or any of the others helped by LDN. See the 150 page volume attached:
Health Case Studies of Low Dose Naltrexone (LDN) in the treatment of a range of diseases

History:
Naltrexone developed in the 60’s and pushed by the Nixon administration as a way to help heroin addicts.

Naltrexone is a drug called an opiate antagonist. Used to treat opiate drug addiction, it blocks the response to opiate drugs, such as heroin or morphine. Doses for this are 50-150mg. The idea of using LDN for MS was devised by Dr. Bernard Bihari, a practicing neuro-physician in New York, USA. Low-dose Naltrexone (LDN) has been in use in the United States in the treatment of MS since 1985.

Interview with Bernard Bihari M.D. (See attached Curriculum Vitae )

Interview with David Gluck M.D. (Leading expert on LDN therapy)

Problems Presented:

1. FDA approval requirements prevent any drug that is out of patent from getting approved.

· “Orphan Drug” law not applicable because drug helps more than the maximum number of patients required by the legislation.

· The amount of money required to do the testing required for FDA approval makes it impossible for the investor to get a return unless the drug is under patent.

2. Pharmaceutical companies are actively discouraging and preventing information about LDN from reaching the patients.

· Use of phony “patients” in online forums to attack and discredit people who mention the treatment as an alternative to the CRABs and Tysabri. I have received similar reports from forums for other diseases that LDN helps.

· Possible manipulation of search engine results through the use of SEO (Search Engine Optimization) techniques. (I have no proof of this, only suspicions given the amount of money involved and the tactics mentioned above.)

3. Doctors are ill informed and are hesitant to prescribe off-label drugs.

· Doctors do not refer to the smaller academic studies which are the only ones possible without a huge investment. The UCSF study was patient funded and was conducted with a small budget of $25,000. See http://www.ldners.org/.

· Treatments like LDN are for the most part unknown by most of the medical establishment. Reliance on the FDA’s testing, flawed though it is, is their only way of feeling safe from potential malpractice suits.

· Off label prescriptions of FDA approved drugs are legal in most states, yet doctors are hesitant to give them. I’m not sure where the insurance companies stand on this issue, though mine, Blue Cross, is paying for my prescription.

Possible Solutions:

1.
Legislation extending the scope of the “Orphan Drug” law to include those drugs out of patent for which new uses are discovered. This would reduce the requirements for approval and allow for government funding.

Per David Gluck:

2. An Institute of Medicine [IOM] shall be empowered to become the health “czar”, overseeing certain major decisions concerning all new medical treatments and devices. It may overrule the FDA when it deems necessary. The new IOM will be sufficiently funded and staffed to be able to arrange support for any and all necessary clinical trials it deems of value, and it shall choose those appropriate centers of excellence at which such studies shall be performed.

(See attached: The US System to Develop Important Health Treatments at Low Cost is Being Hoodwinked

3. Legislation to allow a substance to be “re-patented” when a new use is discovered for it. Clearly, this would have to be limited to those substances which still required a prescription.

The advantage of this approach would be to bring the significant resources of the pharmaceutical industry to bear on new uses of old drugs as well as new drugs. It is also likely that the industry would actually support such a move rather than fight it, making its passage much more likely.

Summary:

This story represents a chance for 60 Minutes to directly contribute to the health and welfare of literally millions of people around the world. Even if no government action ever resulted, the widespread dissemination of information about LDN would make it much more difficult for the pharmaceutical companies to continue to prevent widespread acceptance of this inexpensive and effective treatment.

The number of people’s lives that would be saved and the amount of suffering that could be prevented is so large that it is impossible for me to think of any precedent in broadcasting history.

The savings to the US economy are hard to estimate, but there is little doubt it would run into billions of dollars per year.

The only way of changing the current flawed system of getting FDA approval for drugs is through extreme pressure on the legislative branch. This segment would likely galvanize the support necessary for this to happen.

These are the reasons why I said in the opening paragraphs that I felt it was Pulitzer Prize material, if handled properly. This is why I decided to submit this proposal exclusively to 60 Minutes. Your show has the best record of doing what is right for the country, even when it may be unpopular among the powers that be.

]]> http://sclerotics.wordpress.com/2009/01/25/my-submission-to-60-minutes-to-do-a-story-on-ldn/feed/ 1 josephwouk http://sclerotics.wordpress.com/2008/08/09/wsj-brain-infections-return-for-multiple-sclerosis-drug-tysabri/ http://sclerotics.wordpress.com/2008/08/09/wsj-brain-infections-return-for-multiple-sclerosis-drug-tysabri/#comments Sat, 09 Aug 2008 18:20:16 +0000 josephwouk http://sclerotics.wordpress.com/?p=294 ]]> http://blogs.wsj.com/health/2008/08/01/brain-infections-return-for-multiple-sclerosis-drug-tysabri/

Brain Infections Return for Multiple Sclerosis Drug Tysabri

Comments

Comment by Anna – August 6, 2008 at 9:37 pm

Kristie, Tennessee
Hi All
I am on LDN for 3 months now and feel WONDERFUL!!! My neuro studied all I gave her on Ldn for 4 months before she started it on me. I was in a study for antibodies for Rebif and tested very high so I was taking shots for years that wasn’t working at all…I took copaxone first,then rebif.the betaseron and solumedrol every 2 months and still had exasberations every few months. I have over 50 lesions in my brain & spine and am walking.climbing,watching grandchildren again and working outside in extreme heat now with no problems..
my neuro has started another patient ( a nurse on ldn ) I saw her the other day at doc’s office and she too is great. she comes far away to see my neuro and works herself at a doc’s office. That doctor is so impressed he started a patient with pancreatic cancer on ldn…Her blood levels have dropped significantly…Hope she stays that way..
just had to let all know how ell LDN is doing for me

http://www.ldnresearchtrust.org/forums/index.php?showtopic=975

From:

http://www.revolutionhealth.com/forums/brain-nerves/multiple-sclerosis/1249

Responses 1-33 of 33 Average Rating9.2

pageNum = 1;
totalAnswers = 33;

I have been on Low Dose Naltrexone 3mg 1 x day for more than 2 years now.  I have not noticed anything other than my mood was a bit less depressed when I first began taking Low Dose Naltrexone.  I have not had an MS attack during that time.  It is hard to say whether that is from the Naltrexone or the Rebif or the weekly 50,000mg vitiman C IV.  Who knows what has been the reason, maybe just the luck of the draw.

I also have been thinking about talking to the Doc who prescribes Naltrexone to change the dose to 4mg.

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Posted 08:32PM (EST) on 2006-12-29 by JaminJim

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I’ve been on 4.5mg of LDN for almost 5 years. No MS attacks but there may be some slight progression. I feel this is the best thing going for those with MS, personally. I’ts not easy to convince neuros to try something that is not mainstream but hey, this is our life and we all have the right to it so don’t take no for an answer. Join the group at yahoogroups to connect with thousands that are taking it. Good luck to all that come here to read and hope for answers.

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Posted 11:34AM (EST) on 2007-01-05 by JoyceF

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I just posted my story on LDN for MS at this site, and the news that patients have banded together to fund the 1st human trial of LDN for MS at Univ. CA. see www.LDNers.org

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Posted 02:29PM (EST) on 2007-01-15 by SammyJo

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I started on 3 mg of LDN in May ’06. My flexibility seemed to improve immediately and I began sleeping through the night ( didn’t have to get up 3 times to go to the bathroom!). We were in France in July during the hottest week on record and usually that kind of heat would be a huge problem for me, but I actually kept up with my husband as we walked through all the hill towns in 100 degree heat. That was amazing to me!

I upped my dosage to 4.5 in October and didn’t seem to be doing nearly as well. My left leg started dragging again and I stopped sleeping well.

I’ve dropped back down to 3.0 but it’s only been 2 weeks so I haven’t noticed too much improvement yet. I’m definitely going to stick with it – the first 3 months were fantastic and I’m hoping to get back to that stage if I persevere. I have read that it can take 6 to 9 months to really make a difference.

I was on Rebif for 4 years prior to the LDN and that was a very expensive joke. When I started it, I was classed as very mild relapsing-remitting and my neuro at the time told me Rebif would dramatically slow progression. Well, now I’m Secondary Progressive and my new neuro said that Rebif  has no effect whatsoever after 2 years! So why was I on it for 4? Could it be because it costs $2000.00 a month?

LDN is cheap and effective unlike Rebif, so give it a try. It has no side effects  whatsoever so what have you got to lose? I would also like to recommend a book called “Up The Creek With A Paddle” about LDN. It had a lot of helpful information.

Good luck, everyone

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Posted 06:24PM (EST) on 2007-01-17 by scrifton

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I was diagnosed in May of 2004 but all symptoms were very mild so I opted to just wait and see instead of the taking the typical ABCRT drugs. When my feet began to tingle 18 months later I knew for sure that I had MS and since I did a lot of research in those 18 months I decided that LDN offers the most hope. I have been on 4.5 mg for over a year and all symptoms that were just mild to start out with are now gone completely. No more tingling feet, no more weak legs, no more cold hands but lot’s more energy. I think that taking LDN, especially so early in my progression, was the best decision of my life. I get it from Skip’s Pharmacy in Florida and anyone considering LDN  should call him up and talk to him. It is an amazing drug with no long term side effects and it has so much to offer, not only for MS.

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Posted 08:20PM (EST) on 2007-01-18 by Gabi

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I’ve been taking LDN for about 4 years.  I feel that it has me at about 75% of my former self.  I still cannot run and I still fall over particularly in the summer at Cedar Point (which I go to with my daughter a couple of times a year).  All in all I feel it is a wonderful drug.  pjmax023@yahoo.com

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Posted 09:09AM (EST) on 2007-01-21 by pjmax023

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I’ve been taking LDN for 4 years.  I feel it has brought me back to 75% of my former self.  I still cannot run and also fall over periodically particularly at Cedar Point (which I go to a couple of times each summer with my daughter).  I am taking 4.5mg.

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Posted 09:13AM (EST) on 2007-01-21 by pjmax023

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My husband started symptoms for MS in Sept. of 2004, right after a very stressful month in his life. His symptoms came on very quickly and strongly.  He was greatly fatigued, depressed, he had bladder frequency, he could not use the cordless screw driver and he could not shoot baskets.  For 2.5 months he would go to work and come home right after lunch.  The Nero wanted to put him on one of the crab medications, but we found LDN and decided to try that first.  The first day after taking LDN, he went to work and stayed the whole day, his fatigue was gone.  Within a week his bladder frequency was gone.  Within the next few months he was back to 2 sports a day.  It has been over 2.5 years now and he is still doing great.  His MRI’s show no new progression.  In fact the one lesion he has no longer enhances.  He gets his LDN from Irmats in New York.  The chat site on Yahoo for LDN has grown from just over 200 people to over 2000 people in the past 2.5 years.  People all over the world have been finding out about LDN.  It is only about $15-30 per month and there are only minor side effects that typically go away within the first month.  It is non-toxic.  The longest that someone has been taking it for MS has been 17 years and she is still doing great.  This is the way to go for MS’rs.  If I had MS, Parkinson’s, Fibro or any other auto-immune disorder this is the way I would go, without a question.  It is good to have my husband healthy and happy.

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Posted 02:58AM (EDT) on 2007-05-04 by Aletha Updated 03:02AM (EDT) on 2007-05-04 (view previous version)

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Thanks everyone!  It would be terrific if you have a few minutes to do a rating of your LDN experience. This is a more permanent way to document the experiences. Here is the page where you can rate LDN for Relapsing-remitting MS.

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Posted 02:08PM (EDT) on 2007-05-04 by earthling

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Apparently UC San Francisco is running a clinical trial on LDN for RRMS (its the third item on the page).

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Posted 01:13AM (EDT) on 2007-05-15 by earthling

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2 years on 4.5 mg / night LDN has resulted in halting of disease progression and an infusion of hope coupled with a bright expectation for a long and healthy life. Copaxone on the other hand had provided only pain, depression, site reactions and increased brain damage. LDN should be a first recommendation.

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Posted 08:48AM (EDT) on 2007-06-07 by NathanKennard

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Suddenly, in mid-September 2006 I lost my ability to walk.  I was 39 years old and I considered myself in good shape — my weight was under control, I was walking 3 or more miles every day, I was probably in the best shape of my life!  But over the course of a week my legs stopped functioning.  Doctors were baffled by me and after spending 4 days in the hospital, they still did not understand why I couldn’t walk.  I spent the next 5 weeks using a walker and being told that my symptoms would go away on their own.  I was told repeatedly that I did not have MS.  On the recommendation of a friend who has MS, I began 3 mg of LDN in late October 2006.  Within three days my symptoms had reversed themselves and I was walking again — without a walker, without a cane — it was nothing short of an amazing miracle and a gift from God!

I was on 3 mg of LDN until February 2007 then switched to 4.5 mg.  I continue to do well!  I still have symptoms (twitching in my arms and legs, occasional muscle spasms, aching and pain, shaky legs, fatigue, etc.).  However, the main difference now is that my legs are under control again.  As I’ve repeatedly explained to my doctors, I still feel everything going on in my legs the main difference now is that my brain controls my legs again and they can function and walk again.  I’m even back to walking for exercise purposes.  I can’t do everything that I did before (I really need to pace myself) but I’ve been walking about 2 miles a day 3 to 4 times a week.  Pretty good for someone who used to walk with a walker, huh?  One of the best things is that my husband and kids now have their wife and mother back.  To God be the glory — He has been very good to me!

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Posted 10:04AM (EDT) on 2007-06-07 by momofsix Updated 10:33AM (EDT) on 2007-06-07 (view previous version)

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I have been on LDN 4.5 mg / night since June, 2005.Prior to that, 1 year on Copaxone. Whereas on C I had new lesions and the old ones enlarged, on LDN, all lesion activity in my brain became inactive. Most importantly, the downside of Copaxone was reversed. On LDN, depression went away, MS symptoms went away, I have had no exacerbations, I have tons of energy, and my outlook on life is filled with hope and a bright expectation of a long, healthy and productive life.

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Posted 10:34AM (EDT) on 2007-06-07 by NathanKennard

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My husband is 51 years old and just found out he has MS. He will be taking Copaxone once a day is this a good medicine. Can someone tell my about it please
Thanks

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Posted 07:40PM (EDT) on 2007-08-07 by beaniedee4 Updated 07:40PM (EDT) on 2007-08-07 (view previous version)

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Hi beaniedee – yes, Copaxone is one of the primary medications used to treat RRMS (along with Avonex, Rebif, Betaseron and now Tysabri).  Here is where you can read up on the user ratings of Copaxone for RRMS.

Interestingly, LDN is said to be compatible with Copaxone, but not wth the interferon meds (and I don’t know about Tysabri).  Does anyone else wish to say anything about using LDN with one of the other meds?

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Posted 08:48PM (EDT) on 2007-08-07 by earthling

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I was diagnosed almost 5 months ago.  I was on Avonex but my liver enzymes went up. I am still in the process of getting them back down – it has been 4 weeks today since my last Avonex injection.  I know my Dr. will want to put me on something else, but I am scared and am unfamiliar with LDN.  What is it? Do ya’ll recommend Copaxone, Rebif, Betaseron? This is confusing.

To top it off my precious 15 year probably has Chrohns disease. We will know after the colonoscopy this week – help.

gagirl

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Posted 01:39PM (EDT) on 2007-08-15 by gagirl7

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Hi gagirl – here’s a summary of Low dose Naltrexone (LDN) which hopefully is helpful. User experiences are typically very positive, but everyone is waiting for clinical studies to be conducted.

Oh – be sure to ask your doctor about the newly reapproved option for RRMS – Tysabri (Natalizumab). It involves a once a month infusion – a lot more user friendly than the weekly shots.

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Posted 02:00PM (EDT) on 2007-08-15 by earthling

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Thanks – are the Drs. certain about the effectivemess of Tysabri? I wonder if I cannot tolerate Avonex would I tolerate that or LDN?

Has anyone had particular luck with diet, probiotics, etc? My chiro and various things I have read make me a believer that the digestive tract is a huge part to this disease and other auto-immune…

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Posted 03:30PM (EDT) on 2007-08-15 by gagirl7

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Hi – however promising LDN sound from patient reports, it has to be considered as an experimental treatment for MS at present. The same would have to be said for diet, probiotics – especially if taken instead of treatments which have been proven to slow the progression of MS.

According to our neurologist expert Olajide Williams MD, the evidence for Tysabri seems to be even better than for Avonex, Copaxone, Rebif and Betaseron. “Natalizumab was recently approved through a registration program after a roller-coaster arrival onto the MS scene. It is given as an intravenous infusion every month and was shown to reduce relapses and slow disease progression in individuals with RRMS. Comparative clinical and MRI efficacies of all DMDs versus their placebo arms suggest that Natalizumab is the most superior of the bunch, although the occurrence of a deadly disease associated with its use called Progressive Multi-focal Leukoencephalopathy (PML) has tempered the initial buzz surrounding this drug.”

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Posted 06:44PM (EDT) on 2007-08-15 by earthling

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I am 50 year old female diagnosed in 2003 with MS. I was on Rebif for from 12-2003 untill 8-2006. The side affects were so painful. There were days I could hardly walk from the pain in my legs, my whole body as far as that goes. My liver functions shot way and I did not feel good most of the time. My Neuro switched me to Copaxone. It seemed to do ok for the first year and then the same kind of side effects started a few months ago. I’m not familiar with Naltrexone,but plan on doing some research on it. I have gone off all medications for now.Any feedback on Naturapathic medicine. Would be very interested in hearing some opinions. I’m glad I stumbled on to this site!

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Posted 09:53PM (EDT) on 2007-09-09 by speedy57

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Hi Speedy57 – you might want to check out the Best Bet / Peleolithinc diet (click on the name to read some user ratings).

Low dose Naltrexone is not a naturopathic treatment, but very few people report any side effects at all and the anecdotal stories are quite positive.

That said, the only treatments which have yet to be clinically proven to slow the progress of RRMS are the 3 interferons, Copaxone and now Tysabri. Have you talked with your doctor about Tysabri? It’s only a 1 x month infusion – which would theoretically make it much more user-friendly than the others.

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Posted 12:04AM (EDT) on 2007-09-10 by earthling Updated 12:04AM (EDT) on 2007-09-10 (view previous version)

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My mother-in-law was recently hospitalized.  The doctors have not idea what could be wrong.  Her symptoms are as follows;  Saturday while driveing her foot went numb, so she used the cruise control.  Sunday while sitting in her chair doing a crossword puzzle, her right hand started to shake.  At noon all of the sudden her right arm and leg start to go spastic, just all over the place.  It was wearing her out to the point she was swetting.  She is 81 yrs old and has had multiple back problems.  No other real health issues.  The doctors first thought it could be MS, then they put her on meds for seizures, then the think it could be a atypical stroke.  The only thing that gives her any relief is valium.  Can you help us figure out what we should do next, or where we should look for help?  Please contact me at lestimbland@yahoo.com if you have any answers.

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Posted 02:57PM (EDT) on 2007-09-11 by lesllit

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2 days ago I was still on Betaseron for my MS, flu-like symptoms constantly and the tired feeling that went with it. I started LDN 2 nights ago, quit the injections and prayed. Today I feel stronger, my flu symptoms are almost gone, though I expect it to take a while to get all the remnants of the Betaseron to get out of my system. I slept through the night without having to go the bathroom, and only have slight tingling in my fingertips.

I waited too long to start treating this, so I cannot walk without the aid of a cane or walker. I truly wish I had known of LDN earlier. The Betaseron did not help, I got worse after starting  it, and of course, my Neurologist claims to have never heard of LDN. Fortunately, my GP was open minded and readily acceepted my plea for the LDN.

I realise I have only just started this treatment, but will try to update this regularly so people can know how it goes from day 1.

My best to all LDN users.

Carye

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Posted 02:01PM (EDT) on 2007-09-28 by okae

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My wife has changed over to LDN about 6 months ago and is doing great on it. She was doing rebif injections 3 times a week and stopped them. We went to Africa and she trooped through most of our safaris with little weariness. Her spirits are up and her sleeping habits are better. I feel that it is something to check into.

Chins Up, Ray

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Posted 08:13PM (EST) on 2007-12-04 by traveltoo

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I am a female 31 yrs old. I was dxed with MS in Feb 2002. I didnt take any of the ABC drugs. I went from Dec.2001 to March 2004 with no attacks. During my attack I started LDN I dont remember the dose strength. I gradually increased the strength to 4.5 over a period of a month.

I fully recovered from the two attacks I had. My most recent MRI showed no new lessions and the old ones were shrinking. I would definetly tell anyone to try LDN, it is worth a try!!

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Posted 03:44PM (EST) on 2008-01-01 by child of God

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can anyone help me???  i have chronic pain from my spine.  i have been taking 80mg of oxycotin per day plus 60mg of fast acting roxycotin a day.  6 weeks ago my new neurologist/pain dr. put me on a very low dose of naltrexone 1/10th of one mg.  after 3 weeks i started having a severe reaction.  whenever i take oxycotin i get shingle type nerve pain all over, sick to my stomach, agitated, and general malaise.  the dr. told me to stop the naltrexone which i did.  however it has been over 3 weeks since i stopped and the naltrexone is still affecting me greatly whenever i take oxy.  i am only able to take a very small dose of the fast acting roxycotin everyday.  if i take any more even close to what i need the side effects from the naltrexone are unbearable.  my pain has increased greatly.  the dr. simply says “we are in unchartered waters”.  will this ever stop.  do not know where to turn.  please help anyway you can.  thank you.  nevetland@sbcglobal.net

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Posted 05:10PM (EST) on 2008-01-22 by nevetland

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can anyone help me????  i have serious chronic pain from my spine.  i normally take 2 40mg of oxycotin and 30mg of fast acting roxycotin every day.   my new neurologist/pain dr. put me on 1/10 of 1 mg of naltrexone.  after 3 weeks i started having a severe reaction every time i took oxycotin.  i get nerve shingle type pains, sick to my stomach, agitated, and general malaise.  the dr. told me to stop taking the naltrexone which i did over 3 weeks ago but the symptoms persist every time i take oxycotin.  i can only take a very little oxy because the side effects from the naltrexone are so bad.  so my normal pain is much worse on top of the naltrexone reaction.  it just won’t stop affecting me.  my dr. says i am in unchartered waters and she does not know what to do.  can anyone offer me any advice or insight.  i need help bad.  thanks  nevetland@sbcglobal.net

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Posted 05:18PM (EST) on 2008-01-22 by nevetland

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Hi – it seems strange that such a small, small dose of naltrexone could have this effect weeks later. According to Wikipedia, the half-life of Naltexone is only about 4 hours. Have you  tried other narcotic pain meds and had the same reaction, or is it only the Oxycontin?

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Posted 05:38PM (EST) on 2008-01-22 by earthling

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me being a patient of MS for the last 7 years after taking steriods. My Doc took me on Copaxone its good drug but very slow and could not take control of the coming relapse I had after giving birth to a normal baby. So after an year of struggling was taken on to Cymotherapy 10 days ACTH and cyclo for 10 days side by side with in 2004. after it was taken off the market TYSABRI I got pregnant with anohter baby. After I delivered the baby was put back on TYSABRI. As it s availabity is very limited in the world only in USA and Europe. took me to a another relapse in 2007.  now again jsut got the therapy of Cyclo for 10 days side by the side ACTH than continue iwth Cyclo every month foe 6 months.  now am in a very stable condition.nothing needed. So i prefer somethng to stablize my MS ot the symptoms. So please if any one of the pateints tried TYSABRi do revert.

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Posted 01:41PM (EDT) on 2008-04-11 by HiQ

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FDA-approved for the treatment of alcohol and opiate abuse, Naltrexone has recently
shown great promise in the treatment of other medical conditions.

The Beginnings

Naltrexone was originally synthesized in 1963 and patented in 1967 as “Endo 1639A”
(US patent no. 3332950) by Endo Laboratories, a small pharmaceutical company in
Long Island, NY, a company with extensive experience in narcotics.

In 1969, DuPont purchased Endo Labs.  DuPont had been struggling to develop its
drug business since the late 1950s, and the acquisition of Endo provided DuPont with
valuable expertise in drug manufacturing and marketing.

In the purchase, DuPont acquired the rights to several successful Endo drugs,
including: Coumadin (warfarin), an anticoagulant; Percodan, a prescription narcotic;
and Naloxone, a drug used for narcotic overdose.

Naltrexone, still in its early development phase, came to DuPont as part of the overall
purchase of Endo.

At the time it seemed unlikely that DuPont would develop naltrexone, because at the
time, naltrexone seemed to have relatively low market potential, and its patent would
probably expire before the completion of any clinical trials.

The Federal Government Steps In

In June 1971, President Nixon created the Special Action Office for Drug Abuse
Prevention (SAODAP).  The first director of SAODAP, Dr. Jerome Taffe, was
determined to improve access to drug abuse treatment by shifting services from
prisons and hospitals to community-based services.  “I regarded the development of
naltrexone as one of my high priorities,” said Dr. Taffe.

SAODAP recognized that the development of naltrexone was of no burning interest to
the private pharmaceutical industry, and that governmental funding would be necessary
to bring it to market.

In March 1972, Congress passed the Drug Abuse Office and Treatment Act, calling for
development of “long-lasting, non-addictive, blocking and antagonist drugs or other
pharmacological substances for the treatment of heroin addiction.”  This Act provided
substantial financial support for research.

By mid-1974, as SAODAP began to phase out of existence, the narcotic antagonist
development project fell to the newly formed National Institute on Drug Abuse (NIDA).
That same year, NIDA approached DuPont with the idea of developing naltrexone as a
drug addiction therapy, and asked for DuPont’s assistance in facilitating naltrexone’s
transit through the FDA approval process.   DuPont agreed to assist NIDA with the
development of naltrexone.  In return, NIDA agreed to pay for the bulk of clinical
development costs.

When asked later, DuPont representatives said that the primary reason for helping the
government was Dupont’s “public spirit”, and that naltrexone would probably not have
been developed without the government’s clinical and financial support.

The clinical trials for naltrexone as a treatment for heroin addiction began in 1973
(Schecter 1974, O’Brien 1978).

Difficulties in Clinical Trials

Early trials of naltrexone in rats, rabbits, dogs and monkeys had determined that the
drug was nontoxic at therapeutic levels, with very few side effects.  The subsequent
human trials confirmed that the drug was safe for humans, but the efficacy trials ran
into some unexpected problems.

Dr. Arnold Schecter, who conducted many of the early studies, reported that many
opiate-addicted patients feared a new drug, lacked a desire to become drug free, were
unwilling to possibly receive a placebo, and disliked the rigid protocols associated with
the clinical trials (Schecter 1980).

Patients had to remain opiate-free for a minimum of 5 to 10 days prior to treatment
because naltrexone causes severe withdrawal symptoms in patients with opioids in their
system (Schecter 1974).  Many addicts were unable to comply, due to the
physiological effects of withdrawal.

Taking naltrexone does not provide any drug reinforcement (“high”), and produces no
negative consequences (withdrawal) when discontinued.  Unlike methadone, which
helps suppress cravings, naltrexone has no effect until the addict attempts to use
heroin.  Some patients feared naltrexone would make them more vulnerable to these
cravings, and felt that methadone was more effective in controlling them.

Because of these recruiting difficulties, researchers made no effort to screen out
patients who might be difficult to manage in clinical trials — e.g., patients who were
poorly compliant — and this may have compromised the results of the trials (Schecter
1980).

Since naltrexone is non-addictive and lacks the reinforcing effect of methadone, it
requires more extensive psychosocial support services than methadone.
Support services are expensive.  Schecter estimated that total clinical treatment with
naltrexone was almost twice as expensive as methadone  – not because of the
medication itself, but because of the more intensive support services.

Early trial results showed that, compared with the methadone patients, the patients who
were attracted to naltrexone therapy were relatively “more motivated and emotionally
stable.”  Other studies showed that although naltrexone was an effective opiate block,
clinical success (a reduction in heroin use), was limited to fully compliant patients.
As a result of these findings, the product labeling for naltrexone reads, “[Naltrexone]…
does not reinforce medication compliance and is expected to have a therapeutic effect
only when given under external conditions that support continued use of the
medication”.

The final results of the clinical trials showed that naltrexone was modestly successful
in the reduction of heroin use.

In 1984, the FDA approved naltrexone in a 50mg dose as a treatment for heroin
addiction.  Dupont brand-named the drug Trexan.

The same year, DuPont’s naltrexone patent expired.

On March 11, 1985, the FDA designated naltrexone as an orphan drug,** which
provided seven additional years of market exclusivity for naltrexone for DuPont.

Marketing Strategy for Trexan

The DuPont sales force had trouble explaining the mechanism of naltrexone and its
benefits to a lay audience. The consumer marketplace had many misunderstandings and
negative perceptions about naltrexone.  One former member of the DuPont sales force
said these misunderstandings were a great barrier to the use of Trexan.

DuPont also had an extremely difficult time trying to convince methadone clinic
personnel to use Trexan.  Most facilities could not afford to implement naltrexone
therapy due to the combined price of the drug, the drug treatment program, and the
additional time and staff necessary for psychosocial counseling.

Methadone clinics were also reluctant to refer patients for Trexan because of their need
to keep their own censuses high enough to receive funding (Schecter 1980).

Pro-methadone treatment providers argued that because methadone was dependence-
producing, it was easier to maintain a patient on methadone, and thus more likely that
treatment would be successful.

As a result of these problems, Trexan failed to penetrate the highly regulated federal
treatment market for opioid addiction.

By 1995, Trexan sales were approximately $5-8 million annually, which represented
approximately 15-25,000 patients per year, or less than 5% of the estimated number of
heroin addicts (Scrip 1993).

Naltexone as a Treatment for Alcoholism

Dr. Joseph Volpicelli first recognized naltrexone’s potential to treat alcoholism while
experimenting with rats as a graduate student in University of Pennsylvania.   In 1981,
he began to publish his findings.

In 1985, Volpicelli and Dr. Charles O’Brien, a professor at Penn and chief of psychiatry
at Philadelphia’s Veterans Administration Center, began a naltrexone study using
volunteers at the Veterans Administration Hospital.

“We did it without any outside funding,” says O’Brien. “We got it started against pretty
great odds.” According to O’Brien, the researchers had difficulty recruiting subjects
because the idea of treating alcoholism with medication was not commonly accepted in
the 1980’s.

They tracked 70 men for 12 weeks in an outpatient detox program. Half received
naltrexone, half a placebo.  While 54% of the volunteers who received a placebo
reverted to drinking, only 23% of those who took naltrexone experienced a relapse.

In 1991, researchers at Yale University School of Medicine tested the effects of
naltrexone in conjunction with psychological therapy in 104 alcohol-dependent men and
women.  Patients who took naltrexone were nearly twice as successful in their clinical
outcomes as those who took a placebo.

After the Penn and Yale studies were published in the Archives of General Psychiatry in
November 1992, DuPont showed interest in marketing naltrexone specifically as an
alcoholism treatment.

Governmental funding for the development of naltrexone as a therapy for alcoholism
was provided by the National Institute on Alcohol Abuse and Alcoholism.
The FDA modified existing regulatory requirements to encourage DuPont to develop
naltrexone as an alcoholism therapy.   They offered DuPont three additional years of
post-approval market exclusivity for naltrexone as an alcohol therapy.

Marketing exclusivity allows a pharmaceutical company to sell its drug for a certain
length of time free of competition from generic versions of the drug. This type of
marketing exclusivity is often granted to encourage pharmaceutical companies to
develop a use for a drug whose patent has expired or to encourage a company to
develop an already approved drug for a new use. With market exclusivity, the expected
returns are higher, thus improving the profitability of the drug.

The FDA also linked phase IV clinical trial requirements to annual sales.  No phase IV
trials would be required if naltrexone as an alcoholism therapy did not meet certain
sales thresholds.  If the drug did well in the alcohol-abuse market, DuPont would have
to conduct phase IV trials based on the level of sales.

By allowing for flexible phase IV studies, the federal government lowered post-
marketing costs, improved profitability projections, and made investment in naltrexone
as an alcoholism therapy more attractive to DuPont.

Clinical Trials

Clinical trials for naltrexone as an alcoholism therapy encountered familiar problems –
difficulties with patient recruitment and compliance, high cost of clinical support
services, and low funding of treatment centers.

Because researchers had difficulty recruiting patients, they accepted all patients who
agreed to participate, and didn’t reject any unsuitable patients. This may have negatively
affected the results of the clinical trials by including a high proportion of high-risk
patients, who may have been motivated more by payment for participating in the trial
than a desire for treatment, which led to poorer compliance and higher drop-out rates
(Schecter 1980).

The study found that naltrexone as an alcoholism therapy did not perform significantly
better than a placebo unless it was administered as part of a comprehensive,
multidisciplinary treatment program (O’Malley 1995).

Although the government funded and supported the clinical trials, the funding fell short
of the amount necessary to provide the necessary intensive psychosocial support.
As a result, the labeling for ReVia (the brand-name eventually chosen by DuPont)
includes the following stipulation, “ReVia should be considered as only one of many
factors determining the success of treatment of alcoholism.”  Understandably, this
labeling had a profoundly negative effect on marketing strategy and sales.

In 1995, the FDA approved naltrexone in a 50mg dose as a treatment for alcohol
abuse.

The FDA surprised the researchers by authorizing naltrexone’s use in alcoholism
treatment in just six months. According to Volpicelli, the FDA was “pretty confident”
that the drug was safe: It had been researched for 20 years and was on the market for
10 as a treatment for heroin addiction.

At this point, Dupont changed the brand name from Trexan to ReVia (pronounced
“REV-ya”..

Marketing Strategy for ReVia

Because the alcohol treatment system is less regulated than the heroin treatment
system, DuPont had more flexibility in marketing ReVia directly to clinics and treatment
providers.  Despite ReVia’s clinical effectiveness and less restrictive distribution
channels, however, DuPont’s sales force encountered marketing problems.

Like Trexan, ReVia is most successful in highly motivated patients who have a strong
psychosocial support and access to counseling services.

DuPont was not successful in selling ReVia, except in comprehensive alcohol treatment
programs such as VA hospitals and “white collar” treatment centers.  These patients
tended to be more highly motivated and have a stronger support network.  ReVia
became the treatment of choice for more upscale patients, such as physicians, nurses,
pharmacists and attorneys (O’Brien).

Another roadblock to naltrexone’s wider acceptance was insurance regulations.
“Insurance companies often don’t allow naltrexone to be prescribed by a primary care
physician,” said Tania Graves, spokeswoman for the Arizona Medical Association.
“Their point of view is that drug or addiction problems should be sent to a specialist.”

Some insurance companies do not accept naltrexone at all.  For example, a chain of
California treatment centers using naltrexone as the primary treatment had to suspend
operations after only six months, citing managed care companies’ unwillingness to
cover the treatment (Behavioral Health Treatment 1996).

Some physicians were reluctant to prescribe naltrexone due to the “black box” warning
of liver toxicity in the package insert. The warning was included based on liver enzyme
elevations reported with the100-300mg/day dose (the recommended dose is 50mg) that
was given during a study of naltrexone treatment for obesity. A review of literature and
adverse effect reports from Dupont demonstrates that a 50 mg/day dose poses no risk
for liver damage, but the warning remains (Galloway).

From the American Council on Alcoholism website, 2005:

Many physicians and non-physicians in treatment programs are unaware of the usefulness of
naltrexone or how to use it. In other areas of medicine, it is highly probable that the
development of such an efficacious medication would prompt physicians to use it readily. The
biggest obstacle to using naltrexone for the treatment of alcoholism is the ‘pharmacophobia’ of
many alcoholism-treatment professionals. This near-hysterical resistance to medication for
treating alcoholism (or other substance-abuse disorders) has deep and tangled roots. Many
recovering professionals learned in their recoveries that MDs and their prescription pads were
evil purveyors of pharmacological lies and temptations. This attitude is often accompanied by
a deeply rooted and strongly held belief that recovery has only one successful formula (usually
the 12-step program) and that any modification to that approach is unethical. Scientific
evidence is irrelevant to these individuals. They believe they have the ‘truth’ about recovery
and don’t want to be bothered with other points of view.  [http://www.aca-usa.org/pharm2.
htm]

Poor Sales

DuPont never expected either Trexan or ReVia to become major revenue generators,
but sales fell far short of even DuPont’s modest expectations.  In 1994, just prior to the
launch of ReVia, Trexan sales were approximately $5-8 million annually, which
represented approximately 15-25,000 patients per year, or less than 5% of the
estimated number of heroin addicts in the US (Scrip 1993).

When ReVia was launched in January 1995, DuPont expected US sales of ReVia to rise
to $15-25 million annually.  As of October 1996, however, ReVia had not even reached
the FDA’s threshold of the 200,000 prescriptions required to trigger phase IV clinical
trials (Pink Sheet 1996).

In 1997, ReVia’s market exclusivity agreement lapsed.  Other companies were now
free to manufacture and market generic naltrexone.   In May 1998, the first generic
version of ReVia was produced by Barr Laboratories in Pomona NY.   At this time,
ReVia had annual sales of approximately $20 million.

In 2001, Bristol Myers Squibb acquired DuPont Pharmaceuticals.   In April 2002,
Bristol Myers Squibb sold the ReVia brand-name rights in the U.S. and Canada to Barr
Laboratories.

As of February 2005, Barr manufactures ReVia in 50mg pills in the U.S and Canada.
Bristol Myers Squibb continues to market ReVia in countries outside of the U.S. and
Canada.

Other versions of naltrexone are currently manufactured in the U.S. by Eon Labs
and Amide Pharmaceutical; Mallinckrodt Pharmaceuticals manufactures 50mg and
100mg naltrexone pills in the U.S. under the trade name Depade.

Other 50mg versions of naltrexone are named Nalorex (manufactured by Bristol-Myers
Squibb in the UK); Nodict (manufactured by Sun Pharma in India); Naltima
(manufactured by INTAS in India), Narpan (by Duopharma in Malaysia), Antaxone (by
Pharmazam in Spain), Celupan (by Lacer in Spain), Narcoral (by Siton in Italy),
Nemexin (Bristol Myers Squibb in Germany), as well as  Revez, Naltrexona, and
Naltrexonum.

The Future of Naltrexone

Researchers continue to explore the potential of naltrexone as a drug and alcohol
therapy.   Attempts to address compliance issues have resulted in the introduction of a
ReVia implant (2003).  In addition, Alkermes, Inc. recently developed Vivitrex, a
naltrexone injection which lasts a month.  (Phase III clinical studies are set to begin in
2005.)

Over the years, researchers have tested naltrexone for a wide variety of medical
conditions, including obesity, schizophrenia, and chronic obstructive pulmonary
disease.  In March 2005, Yale researchers began investigating the use of the naltrexone
to help men and women quit smoking without gaining weight.

The FDA has awarded orphan drug** status to naltrexone to treat symptoms of
childhood autism.  Another orphan grant has been issued to naltrexone as a therapy for
self-injurious behaviors.  (Naltrexone therapy for self-injurious behavior is already used
extensively in veterinary medicine.)

In addition, researchers have used derivatives of naltrexone to treat other conditions.
For example, the FDA granted orphan drug status to methyl-naltrexone as a drug that
blocks the side effects of morphine without interfering with pain relief in cancer
treatment. (Oncology 1996)

Low Dose Naltrexone

Naltrexone in substantially lower doses (Low Dose Naltrexone) is showing great
promise as a treatment for multiple sclerosis, Crohn’s disease, AIDS, rheumatoid
arthritis, celiac disease, CFIDS, lupus, and certain forms of cancer.

Unfortunately, obtaining FDA approval for LDN will not be a straightforward process.
Since naltrexone is now a generic drug, no pharmaceutical company currently holds
exclusive manufacturing rights.  No company is eager to fund an expensive clinical trial
for a drug that will make them so little profit.

However, even without governmental approval or corporate support, LDN is gaining
significant grass-roots attention among patients and doctors.   The exchange of
research information over the internet has greatly accelerated the recognition of the off-
label use of LDN.

In the past, the federal government and the pharmaceutical corporations cooperated to
create an environment where naltrexone was tested, approved and made available to
patients who needed it.  Perhaps someday soon they will find a way to do the same for
Low Dose Naltrexone .

Last edited 9/16/05
Copyright 2005 by Gazorpa.com

===========================================================

*Note on brand names and companies:  Naltrexone as used for drug addiction was
originally brand-named Trexan.  When it was approved for treatment of alcohol
dependence, the name was changed to ReVia.  In 1991, DuPont and Merck & Co.
formed a partnership known as DuPont Merck, which owned the rights to Trexan and
ReVia. DuPont Merck marketed ReVia under the name DuPont Pharma.  In 2001,
Bristol Myers Squibb acquired the rights to ReVia when it acquired DuPont
Pharmaceuticals.  In 2002, BMS sold the ReVia rights in the US and Canada to Barr
Laboratories.    Bristol Myers Squibb continues to market ReVia in countries other than
the US and Canada.

** Orphan drug status is granted by the FDA to qualifying products intended for the
diagnosis, prevention and treatment of rare diseases, or conditions where no current
therapy exists, and which affect fewer than 200,000 patients in the US.

Companies developing products that fit this profile may receive help through the
Orphan Drug Program in facilitating the development of the product, may be able to
gain marketing approval for the product with a smaller amount of data than would
usually be required, and may be entitled to seven years of marketing exclusivity upon
final FDA marketing approval.   Companies may also be eligible to recoup some of the
costs of drug development.

To learn more about the orphan drug  program, visit the Office of Orphan Products
Development at http://www.fda.gov/orphan/.

A major part of the research used to write this article comes from a 2004 case study
on developing and marketing medications for drug abuse and addiction published by the
US Department of Health and Human Services:  http://aspe.hhs.
gov/health/reports/cocaine/4cases.htm

From:     http://www.gazorpa.com/History.html

(A great LDN site)

“Global Medicine Review”

Dr. Kokayi: …the story about Low Dose Naltrexone is really fascinating.  How did you
get the idea?

Dr. Bihari:  Well, we were treating heroin addicts, and in 1984 a new drug for the
treatment of addiction came out.  It was called Naltrexone, and it was designed to
block the heroin “high”and it was a flop.  I used it for a lot of patients, as did most
addiction doctors across the country.  At 50 milligrams a day, it made people feel
terrible.  Not that it blocked the heroin so much as it blocked their own endorphins,
which is a source of our sense of well-being, so that people couldn’t sleep.

Dr. Kokayi:  Your own opium, basically.

Dr. Bihari:   Right.  Your own equivalent.  That’s what heroin is.  And I knew from
work that had been done by the National Institute on Drug Abuse in developing the
drug that it had the ability to trigger the body into making more endorphins, but at the
high 50 milligram dosage, the dose was too high.  It blocks those endorphins.

About six months later our addicts began dying in large numbers of AIDS.   I ran HIV
tests on about a hundred addicts, and fifty percent were already HIV positive.  This
was in 1985; currently it’s eighty eighty-five percent around the country.  And we
began looking for some way to approach this new disease, with a view to the idea that
this disease was likely to turn into a worldwide epidemic.

Dr. Kokayi:  That was about the time where people were just being blasted with AZT
with horrific results.

Dr. Bihari:   Right.  There was nothing else available.  When I discovered that people
with HIV had less than twenty percent of the normal levels of endorphins, that meant
that the virus not only kills the immune system cells, it also weakens the whole
immune system, so that it’s not as able to fight the virus.

We began looking for ways to use this drug to raise endorphins without blocking
them.  We hired a laboratory scientist to measure endorphin levels.  We’d measure in
the afternoon, then we’d give the first dose at bedtime that night.  Then we’d measure
again at the same time the next day; then again at one week, and again at one month.

We found that doses in the range of 1.75 to 4.5 milligrams (which is just a fraction of
the recommended dosage to addicts) would trigger or jumpstart endorphin production
during the night.

Except with exercise, endorphins are made only between two and four in the
morning.  The brain sends a message out to the adrenal and pituitary glands and tells
them to make endorphins.  Giving a dose three, four, five hours before that, at
bedtime, is enough to make that message from the brain much stronger.

Dr. Kokayi:  Were you able to document that the levels of endorphins were then
actually raised?

Dr. Bihari:   The level of endorphins went up by two hundred to three hundred
percent.  We then started a little foundation and did a placebo-controlled trial in which
half the patients got the drug and half got sugar pills.  A year later when we broke the
code, we discovered that people with HIV who took the drug had only an eight percent
death rate in the year, while people who were on the placebo had a thirty-three percent
death rate.  And of course they had many more infections and their immune system
declined.  That was a startling discovery.

Dr. Kokayi:  Now let me jump ahead, because I’m always curious about why this
therapy hasn’t gotten the kind of publicity specifically for this disease.

Dr. Bihari:   Well, at that time there was very little treatment.  AZT came out about ’
87, and as you mentioned, it was not only a flop but made some people sicker.  At the
time we did the study, there was nothing available.

So I met with doctors in New York and in San Francisco (where the largest number
of HIV doctors were at that time) and described this drug and how it worked, and
about forty to fifty doctors on the east and west coast began using it.  Unfortunately,
they measured effectiveness by whether or not the numbers of the immune system
cells that are crucial in AIDS — the CD4 cells — were rising.  On this drug, CD4 cells
don’t rise in people with AIDS.   As I knew from the study, and have known since,
they simply stop dropping.  That means you can freeze the disease wherever it is.  And
if somebody is only mildly immune-suppressed, they stay that way.

Dr. Kokayi:  That’s so important…

Dr. Bihari:  It stops progression.  It stops the count from growing.  I have patients
going back as much as seventeen years who haven’t lost an immune system cell in that
time. They’re very healthy.

Dr. Kokayi:  Wow, that needs to be on the evening news.

Dr. Bihari:   The trouble was, we wrote a paper, but couldn’t get it published.  Nobody
understood the concept.

Dr. Kokayi:   You’re using the dose homeopathically.  You’re using it not for the effect
that the medicine has on the person, but for the body’s reaction to the medicine.

Dr. Bihari:  It strengthens the body’s own defenses.   Rather than directly attacking,
the way antibiotics attack bacteria, or the way chemotherapy tries to attack cancer
cells, or the way anti-viral drugs attack viruses, the purpose of this is to take a weak
defense (which people with AIDS or cancer have), and strengthen it so that the body
can fight the disease more effectively.

Dr. Kokayi:   I’ve often made the point that therapies like acupuncture, therapies that
are foreign to the cultural mindset of doctors and the American public, these therapies
can be effective,  but they won’t be included or in mainstream medicine because the
concept is so foreign.

Dr. Bihari:   It’s a different model of understanding the body — how it works and how
disease works.  I think eventually there will be changes in the paradigm of the way we
think about diseases, and it’s going to be a struggle.   But I think oncologists in
particular are getting more and more frustrated with the failure of chemotherapy.

Dr. Kokayi:  Well, about time.

Dr. Bihari:   The people I talk to at the National Cancer Institute, and the Food and
Drug Administration, are very negative.   All they get from drug companies are
proposals to test new, more toxic chemotherapies, and they’re really looking very hard
for non-toxic ways of modifying the behavior of the cancer cells so that they stop the
cancer from growing.

Dr. Kokayi:   Over the years have you had to modify what you were actually doing
with Naltrexone?  Or is the initial model impetus pretty much on point?

Dr. Bihari:  The initial model was pretty much on point.  A small dose at bedtime
increases endorphin production during the night.  In somebody who has a disease
which is related to low endorphins, the endorphins go back up to normal by the next
day.

… [station break] ….

Dr. Kokayi:  … can you tell us about some of the work with Naltrexone and cancer?

Dr. Bihari:    During that year, when we were doing our first AIDS trial, an old friend
of mine called.   Five years earlier, she’d had Non-Hodgkin’s Lymphoma.  It had
initially responded to chemotherapy, but it had grown back after her husband died.
Her oncologist refused to treat her, saying it would be resistant to chemo the second
time.

She knew what I’d been doing, and she called me and said, “Bernie, do you think your
AIDS drug would help my cancer?”

So I dug around and I found a large body of literature showing that when you give
endorphins, metenkephalins, beta endorphins and even low dose Naltrexone to mice
that had human cancer transplanted, that there is about an 80 percent recovery rate.  I
gave her the drug in the same dose we were using in the AIDS trial.  She had large
masses in her groin, her neck, her chest, and her abdomen, and they all slowly shrank
and disappeared over a (inaudible) period.   (Inaudible) taking the drug every night.

Dr. Kokayi:    Wow!  You know, even if that’s just an anecdote….

Dr. Bihari:   Yes.

Dr. Kokay:   I mean, everyone who has that disease deserves a chance to see if they’re
going to be an anecdote as well.

Dr. Bihari:    It was actually her idea.  She stayed on the drug, and died about eight
years later, in her late seventies, of her third heart attack, which was unrelated.

Then I was in Paris the following summer, presenting a paper at an AIDS conference,
and I met a woman who had a cancer called malignant melanoma.  It starts in the skin,
and in her case it had spread to the brain.  She had four large brain tumors.  The
oncologist told her family that she had perhaps three months to live.  When I got back
to New York, I shipped her the drug from a pharmacy that was making it for our
study.  She started on it, and her neurological symptoms from the tumors in her brain
slowly disappeared.  Seven or eight months later she went back to the oncologist, had
a cat scan of the brain done, and the tumors were gone.

Dr. Kokayi:   Fantastic.

Dr. Bihari:    That was eighteen years ago, and she stayed on it.

Dr. Kokayi:    This is such a non-toxic, simple [inaudible].

Dr. Bihari:    There are absolutely no side effects.  I continued doing a lot of the AIDS
work, but the last four or five years I’ve gotten much more interested in other uses.
We stumbled on the fact, also by chance, that the drug works very well for almost all,
if not all, of the autoimmune diseases like multiple sclerosis, rheumatoid arthritis,
lupus, sarcoidosis, and –

Dr. Kokayi:   When you say “it works”, what actually happens?  What’s been your
experience?

Dr. Bihari:    Well, what happens is that the disease activity stops, as long as people
stay on it.   If they have damage to the brain and spinal cord with multiple sclerosis,
that doesn’t disappear, because that’s due to scarring, but they stop getting new
attacks.

I’ve had people on Low Dose Naltrexone for years.  The longest is a friend of my
daughter, who’s been on it for eighteen years and has not had an attack as long as she
stayed on it.

Dr. Kokayi:    So it’s almost as if it’s up-regulating the endorphin production but
somehow the endorphins actually block or inhibit the effect of the antibodies from
attacking the tissue.

Dr. Bihari:    Not directly.  It’s more that the autoimmune diseases are beginning to
look more and more like they’re diseases of endorphin deficiency.  [Inaudible] models
of all the diseases I mention that can be bred in mice, the endorphin levels are always
fifteen to twenty percent of normal compared with normal mice.

[Female Voice]  How can you naturally increase endorphin levels?

Dr. Bihari:    There’s only three or four ways that I know.  First, Naltrexone increases
them substantially, two to three hundred percent in people with low levels.  Second,
aerobic exercise increases them, but not as much.  If you do an hour of exercise four
or five times a week it will last three, four hours, and that’s one of the reasons that
exercise helps prevent cancer.  A third way, oddly, is acupuncture.  Acupuncture,
especially when used in treating addicts, increases endorphin levels in the blood and the
spinal fluid.  And chocolate increases it.

Dr. Kokayi:    [Inaudible] will be glad to hear that.

Female Voice:  [inaudible]  It actually works out, because you’re going to eat your
chocolate and then run to the gym.

Dr. Bihari:    Chocolate has a substance in it called Phenylalanine, which slows
endorphins from being broken down in the body.

Dr. Kokayi:    And that’s basically an amino acid that we find….

Dr. Bihari:  Yes, that’s the food that has it in the largest amount.   And only people with
a rare disease called [inaudible] can’t eat chocolate.

Dr. Kokayi:   So some people will run to the health food store and get Phenylalanine.

Dr. Bihari:     Well, Phenylalanine is helpful if you’re raising your endorphins by other
means.  Then it keeps them from decaying.  They last much longer. But the crucial
thing still seems to me to be the Naltrexone.  Over the last five or six years, I’ve
treated about 420 patients who have various kinds of cancer with low dose
Naltrexone.   Occasionally, for people who come to me with very advanced cancer, I
add intravenous metenkephalin, which is an endorphin…  intravenously, three times a
week.  It improved immune function substantially, and had no side effects, but that’s
generally not needed.

Among the people I’ve treated with Naltrexone for various kinds of cancer, on the
average the cancer stops growing in about two-thirds.  For half of that group, it
eventually — after six, seven, eight months — goes on to slowly shrink and disappear.

Dr. Kokayi:   And that’s about forty percent.

Dr. Bihari:   Higher.

Dr. Kokayi:   Well, it’s about forty percent of the total number.

Dr. Bihari:    Sixty-five percent actually benefit and don’t go on to
develop [inaudible]. Thirty percent go into remission.

Dr. Kokayi:   That’s phenomenal.  I don’t think there’s any chemo or radiating
oncologist with numbers like that.

Dr. Bihari:   There’s no downside.  One of the reasons that the war on cancer failed is
that the oncologists doing the research failed to take into account that chemotherapy
really wipes out the immune system, which the body needs to fight cancer cells.  So
they are giving drugs that kill cancer cells, but at the same time weakening the body’s
defense against cancer.  Naltrexone strengthens the body’s defense, and the increased
endorphins kill cancer cells directly.  Also, the immune system when it’s strengthened
kills cancer cells through its natural killer cells.

Dr. Kokayi:    What you’re saying is, that a boost in endorphin levels also activates
other components of the immune system.

Dr. Bihari:    The endorphins are the hormones centrally involved in regulating the
immune system.  About 95% of the regulation or orchestration comes from
endorphins.  People with cancer — especially adults – have very low natural killer
cells.  They have a weakened immune system.  I’ve discovered, after seeing such a
large number of people, that the vast majority of them have experienced major life
stresses lasting weeks, months to years – anywhere from two to six years before they
get the cancer.

Dr. Kokayi:    That was one of my other questions.  What really can keep those
endorphin levels down in the body?

Dr. Bihari:    If a child gets sick — children are supposed to outlive us — so if a child
gets sick and dies, or if you have a very bad marital break-up, or if you discover a
business partner is embezzling money and it takes a couple of years to straighten
out…  If you wake up every morning under stress — really serious stress, not
everyday stress — really serious stress, this can lower your endorphin production, and
it never returns to normal.  So the person then walks around with low endorphins.
The body makes cancer cells all the time, but usually the immune system kills them as
they are forming.  But if your endorphin levels are low, then your immune system is
weak, the cancers grow and you become much more vulnerable.   The same thing
with exposure to really toxic substances.

Dr. Kokayi:    Right.  I’m wondering, I’m sure the listening audience would like to get
an idea.  If you could just run down a list of some of the cancers that you have
successfully treated, types of cancers that have seemed to respond where the opiate
levels play a prominent role.

Dr. Bihari:    Well, first one of the things we discovered was that almost all cancers
have a lot of receptors for endorphins on the cell surface, and that seems to be
necessary for it to work.  Some of the cancers that respond most dramatically are
Multiple Myeloma, Lymphoma, Hodgkin’s disease, breast cancer, all the cancers of the
gastrointestinal tract, like pancreatic cancer, non small-cell cancer of the lung, the kind
associated with smoking.   I’ve got several patients with tumors that have stopped
growing; they have no symptoms, and then after a year, year and a half, in about half
of that group, the tumors start shrinking and disappear.

Dr. Kokayi:   This is lung cancer?

Dr. Bihari:   These are lung cancers due to smoking.

Dr. Kokayi:    Because there’s really –

Dr. Bihari:  Very common.

Dr. Kokayi:    It’s very common, but therapeutic effectiveness –

Dr. Bihari:    There’s nothing –

Dr. Kokayi:    There’s nothing, right –

Dr. Bihari:   My own attitude about chemotherapy in patients I see with cancer, is if
they have one of those rare cancers that’s very sensitive to chemotherapy, like cancer
of the testicle, I encourage them to do that, to take it, and take Naltrexone afterwards
to prevent recurrence.   These drugs are licensed to treat cancer.  Naltrexone is not yet
licensed to treat cancer, although it’s a licensed  drug.  It’s been on the market for
nineteen years.  It’s use in these low doses is called an “off-label” use.   Any doctor
can prescribe it.  And growing numbers of oncologists and neurologists in  the country
are prescribing it.

Dr. Kokayi:    I think it would be interesting you know just to talk a little bit about the
process … a lot of physicians don’t really know about it and it’s not talked about. This
is a big deal.

Dr. Bihari:    Well, I think it could turn out to be a big deal when it’s picked up, if it’s
picked up.  We set up a web site,  www.ldninfo.org, which brings up about thirty
pages of written material describing all the diseases, and how they respond, and how
many cases we have of them.  There’s some small trials going on, there’s two trials in
people with Crohn’s Disease, which is an autoimmune disease of the small intestine,
one in Jerusalem, and one in New York.   There’s a trial in Israel for multiple
sclerosis.  The national cancer institute has copies of twenty charts of my patients
who have agreed to share their charts.  These are people who have done well on
Naltrexone when nothing else could explain how well they’ve done.  They intend to
present them to a committee for recommendations as to whether to invest and test it in
the network of cancer research.

Dr. Kokayi:    You know, when I think about Africa and AIDS, this is exactly the kind
of medicine there needs to be there….

Dr. Bihari:   This is perfect.  In fact, we’ve been working with the largest
pharmaceutical company in the developing world called (inaudible) in India to get a trial
going, probably in Africa, in the Republic of South Africa, in which half the HIV
patients get the drug, half get a placebo, and they should be able to show in about nine
months, using two to three hundred patients, that this drug stops progression.

Once it does, it will be manufacturable at less than ten dollars per year per person.
That’s been the big problem — the anti-HIV drugs are so expensive.  The average
income in Africa is about eighty dollars per year.

Dr. Kokayi:    I can only imagine just the financial stress that you’ve had to go through
just to keep this whole project alive.  It’s one thing to prescribe things as an individual
doctor, but to get recognition within the scientific community is a bit difficult.

Dr. Bihari:   It really bothers me when doctors say, “Oh, I can’t prescribe that,
because he hasn’t done a placebo-controlled trial.”  That’s a full-time job, for two,
three years involving eight or nine centers around the country.  I’m working with a
number of diseases in my office, and a lot of money goes out paying for the website,
for patents to cover low dose naltexone, and (inaudible) things like that.  It’s very
veryexpensive.  But I can’t stop doing it.  My wife and I would love to do some
traveling — I think we’ve earned it — but I really can’t stop until the drug is out there.
It’s as much of a burden as it does a pleasure.

Dr. Kokayi:    I really hope that at least your sharing with our listening audience today
helps to make people more aware.  People should be clamoring for it.  We’re running
out of time, but I wanted to go back to the treatment of autoimmune diseases.   I
always pictured them as the body is attacking its own tissues.  I pictured these
antibodies actually honing in there.  But you’re saying that, in large measure it’s an
actual endorphin deficiency.

Dr. Bihari:    It’s an endorphin deficiency which weakens the immune system, so that
certain cells in the body forget to distinguish between the body tissues and bacteria or
viruses, so when these cells are activated by an infection they attack the bacteria and
they attack you.  Restoring the immune function to normal stops that.  So far, the drug
works dramatically in all the diseases that are labeled autoimmune diseases.

Dr. Kokayi:   And you’ve treated lupus with this.

Dr. Bihari:   I’ve treated — I have two dozen cases of lupus.  I have about the same
number of people with rheumatoid arthritis.  I have about twenty people with Crohn’s
Disease.  A number of rheumatologists who specialize in these diseases in New York
are now beginning to use it, because we have cases in common, and they see.

Dr. Kokayi:    Right

Dr. Bihari:   Because they’re using cancer drugs

Female Voice:  Dr. Bihari, is this being used with children with ADD?

Dr. Bihari:    I doubt that it would work, knowing the nature of ADD.  I doubt that it
would work.  It doesn’t do everything for everybody.  I don’t think it would.

Dr. Kokayi:  Again, going back to the idea of giving a medicine that at a
higher dose  actually blocks the chemical system, but a lower dose actually augments
it.

Dr. Bihari:    And enhances the body’s defenses — that’s essential.

Dr. Koyayi:   This idea gives the pharmaceutical industry something to do, rather than
giving people high doses of medication.

Dr. Bihari:    It certainly would.  It will take this drug to be licensed, picked up by a
pharmaceutical company and tested, licensed, and once it’s widely used, then this
approach to medicine — every medical researcher will start thinking about it.  It’s an
entirely different approach to the body and illness.

Dr. Kokayi:    What is the next step? Is there anything that the listening audience can
do that might be helpful for to make this more — not even make it more available,
because it’s just a prescription any doctor can write.  I guess it’s the information –

Dr. Bihari:    The information, getting it from the website, getting doctors to prescribe
it.  I’m always happy to take calls from doctors and spend as much time as I need,
because the more doctors prescribe it, the more widely used it will be.  Currently, as
far as we can calculate it, over eighty thousand people in the U.S. and western Europe
are on the drug, and the numbers are increasing rapidly.

From: http://www.gazorpa.com/interview.html

28. How did this happen?

The first serendipitous event that led to my discovery that LDN could “cure” Progressive Relapsing Multiple sclerosis stands out from the rest. This was about a month after my watch was “on too tight.”

I was sitting out on the rattan swing outside my office. It was my favorite place to listen to lecture series on my Ipod. Where we live, Bonny Doon outside of Santa Cruz, is a mountainous area covered with Redwood trees.

I would stretch out for hours at a time, the swing barely moving. While listening, I got to soak in maybe 200 varieties of lush plants that cover every available centimeter of ground. I was right next to our sloping driveway and my favorite thing was to chuck my still smoldering cigarette butts onto it without having to bother to stub them out first.

I guess it was my way of feeling “wicked” at the time, which shows you just how thin my life had become at that point. Naturally, I would sweep them all up later, but it gave me a real sense of freedom to be able to flick my buts away without a care.

The cordless phone next to me in the swing rang. I fumbled to pause the Ipod and answered.

I couldn’t believe the sound that came out. “Joe?”

I instantly recognized the voice, “Oh my god, Dianne?”

Diane Fenner had been my girlfriend who I had gone out with for about four years in college and law school. We had almost, but not quite, gotten married. I had not heard her voice in over 20 years, but there are some sounds one never forgets.

“It’s been… How long, more than 20 years for sure? Why are you calling me now?”

“I don’t know… I just felt like it.”

She wanted to catch up on what had happened in my life. I took a deep breath.

“I’m sorry Diane, I’ve had the luckiest life one could ask for; it’s just that I’ve recently been diagnosed with Relapsing Remitting MS.”

I went on to explain that it wasn’t the MS that was worrying me at the moment but the operation I had scheduled in 10 days to replace part of my neck with a titanium frame and some dead guy’s bone material.

Because my afflicted left arm has no reflexes rather than the hyper reflexes associated with MS, my neurologist believed it was being caused by the spinal compression that showed up in the MRI, rather than the MS which had shown up as lesions on both my brain and spinal cord.

“I don’t do well in operations, Diane. The last one I had almost killed me.”

I was referring to the abdominal surgery I had had in Los Angeles to sever “adhesions” left from an unnecessary appendectomy I had had at Hadassah hospital in Jerusalem at the age of 17.

My problems with the medical profession go way back…

She sounded a bit crestfallen by the news. I tried to cheer her up by describing all the wonderful things about my life in Bonny Doon. How incredibly peaceful it was… How we didn’t even have a key to lock the house… How my kids didn’t even know what danger was… etc.

“I don’t get it. But what have you been doing?” She wanted to know.

The truth of the matter was that I hadn’t really done anything in the 7 years since 9/11 when I got hit with the depression. The depression had been augmented by a long bout with panic attacks that had rendered me effectively useless.

At the time, after I figured out what was happening to me, I had assumed it was just a reaction to the natural fear prompted by the attacks. I had left Israel 5 years earlier to get as far away from Islamic insanity as I could. The anthrax business had hit me the hardest.

There I was, in the safest, most remote place imaginable and I was scared to death to get my mail out of the mail box. I used surgical gloves handling it and would stand by the outside garbage to slice out only the necessary interiors of the mail I knew I needed. The junk mail and the envelopes went straight into the can.

After months of this, and months of talk-talk therapy, my therapist gave up and told me to go to an MD to get chemical aid. I was given Prozac and Xanax and managed to finally get the symptoms down to a tolerable level. But a deeper damage had remained.

Since that time, I was unable to function properly. I spent all my time studying philosophy and science. My wife was making us money on the internet. I was content to retreat to my world of abstract thinking and avoid anything real. The first half of this book demonstrates precisely the kind of things I absorbed myself in.

I had become your classic luftmenchin, (Yiddish – lit. “flying man”).

Diane couldn’t make any sense out of what I told her. She remembered me most as epitomizing the Billy Joel song “Angry Young Man”. For good reason. Chairman of SDS at Columbia College. Joining the Israeli Navy after finishing Columbia Law School. The list goes on and on.

Diane knew me as an idealistic man of action. The bemused, gentle scholar she was speaking to now just didn’t fit. I defended myself. I thought I had grown past that stage in my life. Age and wisdom had taught me the essential pointlessness of my old patterns and I was much happier this way, I explained.

She didn’t buy it, but all of a sudden she grew quiet.

“Wait a minute… I don’t BELIEVE this!” She almost shouted.

“What are you talking about?”

“I just remembered…” Her voice grew serious and hurried. “The very first case I won after finishing law school concerned a woman who had your exact same diagnoses.”

Diane had been studying for her PHD in psychology when we had broken up. She had gotten the degree, but after a short time working in the field had decided that it was a dead end. She then went to law school, got her JD and had since become a very successful lawyer who specialized in lawsuits against drug companies.

The case she was remembering concerned a woman who had been diagnosed with the identical spinal condition that my MRI showed. It had some 14 syllable, unpronounceable name which she pronounced with ease. It had resulted in the exact same “dead arm” symptom that I was suffering from.

The woman was told she needed the same operation that I was scheduled for, (another unpronounceable string of syllables). After the operation, they realized that in fact she had MS. The stress to her body from the operation caused her to have a major relapse. She had walked into the hospital, and had come out in a wheelchair.

“Joe, they didn’t even go to deposition. They just caved and paid. It was that open and shut.”

Not that different from my case, I thought, though I had already been diagnosed as having both conditions. But this news reminded me of a great truth that in my fear and suffering I had forgotten…

Doctors are HUMAN. They make MISTAKES. What if they were wrong and my dead arm was being caused not by the spinal compression but by the MS? I could end up like that first client. Or maybe worse…?

“Damn…. I better think about this.” I had been looking for an excuse to avoid the operation, and this was my chance. “Maybe I should see an MS specialist. I’ll try and find the number one authority on the west coast. If he tells me my condition can’t be caused by MS, I’ll go ahead with the operation.”

Diane was enthusiastic about this idea. So was I. The operation loomed over me as a possible death sentence. This gave me hope for a commutation.

So I followed up on this conversation that fell on me out of the blue after more than 20 years. I began researching to find this mythical “number one specialist” on the west coast. It didn’t take me that long to find him.

Here’s the listing for him at UCSF:

Douglas Goodin, M.D.
Medical director, Multiple Sclerosis Center

Dr. Douglas Goodin, director of the Multiple Sclerosis Center at UCSF Medical Center, is a neurologist and an internationally renowned expert in the treatment and research of multiple sclerosis.. He earned a bachelor of sciences degree in genetics and biochemistry at the University of Washington in Seattle; a master of sciences degree in molecular biology at Purdue University in Indiana; and a medical degree from the University of California, Irvine. He completed a residency in neurology at UCSF where he joined the medical center staff in 1982. In addition to multiple sclerosis, Goodin’s research interests include various forms of dementia. Goodin also is a professor of neurology at UCSF.

I noticed in a little side box a mention that a “patient funded study” had been done on the effects of LDN on multiple sclerosis. In the box, it said that the study had been completed, but it had no mention of the results. I made a mental note of it to ask Goodin what the results had been, and thought no more about it.

When I got in to see Goodin, a few days before the scheduled operation, I asked him, “If you tell me my dead arm couldn’t be caused by the MS I’ll have the operation.”

“I can’t tell you that,” he replied, “In fact I think it is being caused by the MS?”

“What about it having no reflexes instead of hyper reflexes?”

He answered that though hyper reflexes are usually the case, MS can sometimes cause no reflexes as well.

Utterly relieved, I canceled the operation. I also noted to myself what makes an expert. Experts know all the exceptions to the rule as well as the rule.

I forgot to ask about the LDN box on the website as it was decided that I should begin on the copaxone.

In April, a little more than two months later, I began to panic after the major cognitive problems began to emerge. I also decided I had to give up the copaxone because of the horrible reactions I was having at every injection site.

I went back to Dr. Goodin and asked him to prescribe me the Tysabri. He agreed to do so. I then remembered and asked him about the patient funded LDN study that had been done at UCSF which I had read about online. He told me that he hadn’t expected any results, but that the study had shown some after 8 weeks.

He agreed I might as well try that too. When I asked him about possible conflicts taking it together with the Tysabri he kind of laughed and said the dose was so small there was nothing to worry about.

The almost “afterthought” way in which he treated the LDN made me think that there was nothing much to expect from it. I’d take it because there was nothing to lose, even though there wasn’t much to expect, either.

A month later, the cognitive problems continued to worsen. I began to do research on line in earnest. The kinds of problems I was having should not be caused by the small number of lesions that had shown up on my MRI.

I came across three abstracts that described the characteristics of people with the rare form of MS, progressive relapsing. These included being male, being older, and having “spinal atrophy”. Most MS patients are female and are diagnosed before turning 40.

I didn’t know what “spinal atrophy meant, but when I returned to UCSF to present them with this possible diagnoses I found out it was just a fancy word for the spinal compression that had almost gotten me another unnecessary operation.

After the usual resistance to listening to anything a patient might contribute to his own diagnoses, the doctor there sadly agreed that PRMS was probably the best diagnoses. Unfortunately, since there was nothing that could be done for the progressive part of the MS, it was decided I should go ahead with the Tysabri to at least try to prevent relapses.

It was now June, and I was going to be off to Peru in another month. I finally get word that UCSF was ready to give me the Tysabri. I met with Grace, my GP, together with Bob and we decided it would be best to delay the Tysabri treatment until my return.

The concern was that no shaman could possibly know about the Tysabri and whether there might be conflicts with the ayahuasca.

Soon after that, Bob dumped me for having begun smoking again. I was forced to choose what I wanted to do and I chose the Buddhist dana paramita rather than the shaman approach. I would volunteer full time for Barack Obama.

When Obama failed to lead on the FISA issue, and instead caved in to the Republican talking points, I felt as if the rug had been pulled out from under my feet. I had already made contacts within the campaign and was preparing to spend my time up until the election convincing Jews in Florida to vote for Obama rather than McCain.

I talked it over with my son Barak. He said that though he felt Obama had made a serious mistake, there was still every reason to work for him. “Abba, this election is probably the most important election…” He paused and thought for a while before finishing, “Maybe ever.”

I knew he was right. The US was going into a major nose dive because of the catastrophic policies of the Bush administration. We were headed for some unavoidable very bad times no matter what. The only question was whether it could be turned around before it would destroy the foundation of the world as we knew it. Maybe Obama could do that much.

My problem was that I knew I simply couldn’t get up in front of an audience and urge them to vote for a candidate for which I felt no enthusiasm.

A few days later all my symptoms disappeared.

So here’s what’s needed to have happened for me to have found out what I found out about LDN.

1. Diane needed to call after 20 years to stop the operation.

2. UCSF needed to have done the LDN study for me to have heard of it.

3. Goodin needed to be flip about LDN or I might have researched it and had high hopes. That could have raised the issue of the placebo effect in my cure.

4. I needed to have had horrible cognitive problems to figure out I had PRMS.

5. UCSF had to have bureaucratic problems to allow for the Tysabri delay.

6. I needed to be planning to do the ayahuasca, or I would have begun the Tysabri.

7. Bob had to blow me off for smoking.

8. I needed an Obama-like focus to decide to try dana paramita rather than the ayahuasca.

9. The symptoms had to disappear when they did or I would have credited the Tysabri rather than the LDN.

On July 16, I realized that the greatest chance at dana paramita has just been handed to me on a silver platter.

On my blog I receive the following comment:

Dear Joe,

As editor/owner of http://www.ldninfo.org I was delighted to see your fervent message. Someone who has not only experienced LDN but also is a gifted writer is a real find! We’re counting on you to tell the world.

As a retired internist, my personal hope is that once we can point to a few convincing medical journal articles (at least two more are due this year), we should be able to jump all over the health-related committees of Congress to force them to modify the current damaging system of approvals run by Big Pharma and take advantage of LDN’s enormous possibilities for the public’s health.

Regards,

David Gluck, MD

Unbelievable… The “miracle cure” that I was going to try to find in Peru was available at the corner drug store for about a dollar a day.

It is a cliché and a truism, I know. But I have just experienced the fact that the greatest “miracles” of life often manifest as mundane routine.

It feels as though because I was searching for something to do for the world as a way to find my cure, my cure was handed to me as a way to help the world.

I’ll never stop being a rationalist, but there are some weird things that happen in life that we can’t or maybe shouldn’t ignore. I feel like I owe.

This book is no longer a journal of a desperate man. It has become a call to arms to spread the word of how LDN can help not only MS sufferers like me, but also all people suffering from any immune system disorder.

That’s an awful lot of people. I hope I’m up to the task. It’s so big, with such enormous consequences that it makes me wonder again about my sanity. Grandiose ideas rarely lead to anything other than disappointment.

My first attempts to get the word out on my MS support forums have met with mixed success. The pharmaceutical companies have clearly loaded the forums with reps to push their expensive and ineffective treatments. I have been repeatedly and viciously attacked for trying to get the info out.

Not all the responses have been like that, for sure, but enough have been that way to make me understand that it is not going to be easy for me to spread this truth that was dropped on me from I know not where.

There are literally billions of dollars at stake here that are not going to be surrendered without a fight.

But at least I’m not alone. There’s at least one other book scheduled to come out called The Promise of Naltrexone by Elaine Moore in September 2008.

I intend to try to get this book out for Christmas. With two books being promoted and the new studies getting published, it’s at least possible Dr. Gluck’s plan to pressure congress will come to something.

I haven’t been involved in a “fight” for a long, long time. The last big one was volunteering to return to Israel from LA to fight with my old Navy unit in the first Gulf War.

This time it will be somewhat different. I will try to use what I have learned during my illness to help me make the “fight” not a fight at all.

During the times to come I will try to use as my guide Lao Tzu’s Tao Te Ching.:

The sage does not distinguish between himself and the world;
The needs of other people are as his own.

He is good to those who are good;
He is also good to those who are not good,
Thereby he is good.
He trusts those who are trustworthy;
He also trusts those who are not trustworthy,
Thereby he is trustworthy.

The sage lives in harmony with the world,
And his mind is the world’s mind.
So he nurtures the worlds of others
As a mother does her children.