The owner of Gazorpa.com has asked me to take over her information from her website because she is too busy doing other things to keep up with the website so I am adding a page of her stuff to my website.
Autoimmune Diseases and Cancer Treatment with Low Dose Naltrexone
Low-dose Naltrexone (abbreviated LDN) holds great promise for the millions of people worldwide with autoimmune diseases or central nervous system disorders or who face a deadly cancer. It is the first low-cost, easy to administer, and side-effect-free therapy for HIV / AIDS. Naltrexone was approved by the FDA in 1984 in a 50 mg. dose for the purpose of helping heroin and opium addicts. It acts by blocking the by blocking opioid receptors, and thus the effect of such drugs. Naltrexone also blocks the reception of the naturally produced opioids (yes, your body makes opioids!) in the brain and adrenal glands: beta-endorphin and metenkephalin. Many body tissues have receptors for these endorphins and enkephalins, including virtually every cell of the immune system.
In 1985 Bernard Bihari, M.D., a New York City physician, discovered the effects of a much smaller dose of Naltrexone (approximately 3 mg. daily) on the body's immune system. He found that this low dose, taken at bedtime, enhanced a patient's response to infection by HIV. Subsequently, the optimal adult dosage of LDN has been found to be 4.5 mg. In the mid-1990's, Dr. Bihari found that patients with cancer such as lymphoma or pancreatic cancer also benefited from LDN, in some cases dramatically. Also, people with autoimmune diseases (such as lupus) often showed prompt control of disease activity while taking LDN.
Mechanism of Action
LDN boosts the immune system by its action on the naturally produced endorphins (internal opioids). As stated in the
By taking a bedtime dose of LDN the brief blockade of opioid receptors between and produces a prolonged up-regulation of the immune system causing an increase in endorphin and enkephalin production. Study subjects who have taken LDN in this fashion are found to have much higher levels of beta-endorphins circulating in their blood in the following days. Animal research by
Bihari says that his patients with HIV / AIDS who regularly took LDN EVEN before the availability of HAART (Highly Active Antiretroviral Treatment) were generally spared deterioration of their important helper T cells. In human cancer research by Zagon inhibition of a number of different human tumors in laboratory studies by using endorphins and low dose Naltrexone has been demonstrated. It appears increased endorphin and enkephalin levels, induced by LDN, work directly on the tumors' opioid receptors and, perhaps, induce cancer cell death (apoptosis). It is also believed they act to increase natural killer cells and other healthy immune defenses against cancer. In diseases partially or largely triggered by a deficiency of endorphins (including cancer and autoimmune diseases), or are accelerated by a deficiency of endorphins (such as HIV / AIDS), restoration of the body's normal production of endorphins is the major therapeutic action of LDN. By blocking the opioid receptors, there is a rebound overproduction of these endorphins.
Diseases Which Are Treated with LDN
Bernard Bihari, MD, as well as other physicians and researchers, have described beneficial effects of LDN on a variety of diseases, as follows.
Bladder, breast, carcinoid, colon and rectal, glioblastoma, liver, non-small cell lung, chronic lymphocytic leukemia, lymphoma (Hodgkin's and non-Hodgkin's), malignant melanoma, multiple myeloma, neuroblastoma, ovarian, pancreas, prostate, renal cell, throat, uterine
As 2004, Dr. Bihari reported having treated over 300 patients who had a cancer that had failed to respond to standard treatments. Of that group, some 50%, after four to six months treatment with LDN, began to demonstrate a halt in cancer growth and, of those, over one-third have shown objective signs of tumor shrinkage.
Amyotrophic lateral sclerosis (ALS, Lou Gehrig's), Alzheimer's, autism, Behcet's disease, celiac disease, chronic fatigue syndrome, CREST, Crohn's disease, emphysema, COPD, endometriosis, fibromyalgia, pemphigoid, irritable bowel syndrome, multiple sclerosis, psoriasis, rheumatoid arthritis, sarcoidosis, scleroderma, systemic lupus erythematosis, transverse myelitis, ulcerative colitis, Wegener's granulomatosis
Within the group of patients with autoimmune diseases, none have failed to respond to LDN and all have experienced a halt in progression of their illness. In many there is a marked remission in signs and symptoms of the disease. Among some 400 MS patients in Dr. Bihari's practice. Less than 1% of these patients have ever experienced a fresh attack of MS while they maintained their regular LDN nightly therapy.
As of September 2003, Dr. Bihari had treated 350 AIDS patients using LDN in conjunction with accepted AIDS therapies. In the previous seven years over 85% of these patients showed no detectable levels of the HIV virus, a much higher success rate than most current AIDS treatments, and with no significant side effects. Many HIV / AIDS patients have been living symptom-free for years taking only LDN with no other medications.
Central Nervous System Disorders
Anecdotal reports continue to be received concerning beneficial effects of LDN on the course of Parkinsons disease, Alzheimers disease, amyotrophic lateral sclerosis (ALS, Lou Gehrigs disease), and primary lateral sclerosis (PLS). Dr. Jaquelyn McCandless has found a very positive effect of LDN, in appropriately reduced dosage and applied as a transdermal cream, in children with autism.
Some pharmacies have been supplying a slow-release form of Naltrexone. Pharmacies should be instructed NOT to provide LDN in an "SR" or slow-release or timed-release form. Unless the low dose of Naltrexone is in an unaltered form, which permits it to reach a prompt "spike" in the blood stream, its therapeutic effects may be inhibited. The use of calcium carbonate as a filler will interfere with absorption of the LDN capsule. Therefore, it is suggested that calcium carbonate filler not be employed in compounding LDN capsules. Either Avicel, lactose (if lactose intolerance is not a problem), or sucrose fillers as useful fast-release fillers can be used. The usual adult dosage is 4.5 mg. taken once daily at night. Because of the rhythms of the body's production of master hormones, LDN is best taken between and . Most patients take it at bedtime. People who have multiple sclerosis that has led to muscle spasms are advised to use only 3 mg. daily and to maintain that dosage. The therapeutic dosage range for LDN is from 1.75 mg. to 4.5 mg. every night. Dosages below this range are likely to have no effect at all, and dosages above this range are likely to block endorphins for too long a period of time and interfere with its effectiveness.
Occasionally, during the first week's use of LDN, patients may complain of some difficulty sleeping. This rarely persists after the first week. Should it do so, dosage can be reduced from 4.5 mg. to 3 mg. nightly. Otherwise, LDN has virtually no side effects.
Because LDN blocks opioid receptors throughout the body for three or four hours, people using medicine that is an opioid agonist, i.e. narcotic medication such as Ultram (Tramadol), morphine, Percocet, Duragesic patch or codeine-containing medication should not take LDN until such medicine is completely out of one's system. Patients who have become dependant on daily use of narcotic-containing pain medication may require 10 days to 2 weeks of slowly weaning off of such drugs entirely (while first substituting full doses of non-narcotic pain medications) before being able to begin LDN safely. LDN should probably not be taken during pregnancy until research into that question is completed. Full-dose Naltrexone (50 mg.) carries a cautionary warning against its use in those with liver disease. This warning was placed because of adverse liver effects that were found in experiments involving 300 mg. daily. The 50 mg. dose does not apparently produce impairment of liver function nor, of course, do the much smaller 3 mg. and 4.5 mg. doses. People who have received organ transplants and who therefore are taking immuno-suppressive medication on a permanent basis are cautioned against the use of LDN because it may act to counter the effect of those medications.
The job of the FDA is to evaluate the safety of drugs and if found safe to certify them as safe. After that doctors are free to use a certified drug for the approved indication, or for an "off-label use." Physicians understand that appropriate off-label use of an already FDA-approved medication such as Naltrexone is perfectly ethical and legal. Because Naltrexone itself has already passed animal toxicity studies, one could expect that once testing is able to begin, LDN could complete its clinical trials in humans and receive FDA approval for one or more uses within two to four years.
Consult Your Doctor
This website is not intended as a substitute for professional medical help or advice. A physician should always be consulted for any medical condition.
Bernard Bihari, MD, is the discoverer of the major clinical effects of low dose Naltrexone. A private practitioner in
Frequently-Asked Questions about Low Dose Naltrexone (LDN) as a
Therapy for Multiple Sclerosis
What is Low Dose Naltrexone?
Naltrexone is short for Naltrexone Hydrochloride (C20H23NO4-HCl), an opiate antagonist. Naltrexone was approved by the FDA (at a 50mg dosage) in 1984 for opiate addiction, and again in 1995 for alcohol abuse. At a much lower dose (1.75-4.5mg), it has been gaining popularity as a treatment for symptoms of auto-immune disorders such as Multiple Sclerosis. Low Dose Naltrexone is administered orally, usually in capsule form.
What MS symptoms does LDN help?
Primarily neuromuscular spasm, fatigue, and urinary problems, although patients have also reported improvements of other symptoms. In addition, patients who start LDN while in the middle of an acute relapse often show rapid resolution of the attack.
Does LDN halt progression of MS?
Evidence suggests that LDN can significantly reduce the chances of either a relapse or progression for many MS patients.
How does LDN work?
It is believed that LDN briefly obstructs the effects of brain endorphins (the brain's natural painkillers). Sensing an endorphin deficit, the pituitary signals for increased production of endorphins, which re-balances the immune system, thus reducing the activity of the MS. The effect lasts around 18 hours.
But how can this work? Isnt MS is caused by an overactive immune system?
Although there is a long-held theory that MS might be caused by an overactive immune system, this theory has never been proven. Recent clinical studies indicate that this theory might not be true at all. The October 2004 issue of The Archives of Neurology reports a clinical study which found that intravenous immunoglobulin therapy applied after the first signs of MS significantly reduced the probability of developing clinically definite multiple sclerosis. Patients receiving this immune-system boosting therapy also suffered fewer brain lesions. [Intravenous Immunoglobulin Treatment Following the First Demyelinating Event Suggestive of Multiple Sclerosis; a Randomized Double Blind, Placebo-Controlled Trial; Arch. Neurol. Oct. 2004; 61:1515-1520.]
How fast does LDN work?
Although some patients have no symptom changes, around two-thirds of MS patients report some symptom improvement within the first few days. Other patients report improvement over the course of several weeks or even months.
What dosage and frequency are usually prescribed?
The usual adult dosage of LDN for the treatment of MS is 1.5-4.5mg taken orally once daily at bedtime, because of the natural rhythms of the body's hormone production, LDN is best taken between and . It is generally recommended that the patient begin on 3.0mg per day, and adjust the dosage if necessary. Prescribing 1.5mg capsules allows easy adjustment of dosage. (For example, the patient can take either 2 capsules for 3mg, or 3 capsules for a 4.5mg dose.)
How is LDN prepared?
LDN is usually prepared by a compounding pharmacist, who makes capsules by either grinding up 50mg Naltrexone tablets, or using Naltrexone powder purchased from a primary manufacturer. (The most popular Naltrexone tablet is the 50mg "ReVia" Naltrexone tablet, usually prescribed for treatment of drug and alcohol addictions.)
LDN may also be prepared in a solution of distilled water, with 1mg per ml dispensed with a 5ml medicine dropper. If LDN is used in a liquid form, it is recommended that it be refrigerated.
Are there any side effects?
All sources indicate that LDN has virtually no side effects. Some patients report vivid dreams, and occasionally, during the first week of use, patients may complain of difficulty sleeping. (Reports indicate that sleep disturbance is rare, occurring in less than 2% of users.) If this persists after the first week, dosage can be reduced from 4.5mg to 3mg.
Full-dose Naltrexone (50mg 3 x days) carries a cautionary warning for patients with liver disease. (This warning was placed because adverse liver effects were noted in early experiments involving 300mg daily, given for alcohol abuse.) The 50mg dose does not apparently produce impairment of liver function nor, of course, does the much smaller 3mg - 4.5mg dose. LDN is virtually non-toxic, simple to administer, and, compared with other MS drug therapy, very inexpensive usually costs less than $40 per month.
What about cautionary warnings?
Because LDN blocks opioid receptors throughout the body for three or four hours, people using narcotic medication such as Ultram, Morphine, Percocet, Tramadol, Duragesic patch or codeine should not take LDN until such medicine is completely out of the system. Steroids would counteract the effects of LDN, and so should not be combined.
LDN should not be used by people already receiving interferon (Betaseron, Avonex, or Rebif), because LDN stimulates the immune system and interferon suppresses it, the two therapies are incompatible. The combination of these therapies does not cause any adverse reactions, but it is believed that they cancel out each others effectiveness.
What does it feel like to be on LDN?
At both high and low dosages, patients taking Naltrexone usually say they are largely unaware of being on medication. Naltrexone usually has no psychological effects and patients (at both high and low dosages) don't feel either "high" or "down" while they are on Naltrexone. It is not addicting.
Why LDN isnt routinely prescribed for MS?
Many physicians simply have not yet learned about the positive effects of LDN on MS symptoms, because Naltrexone is a generic medication, there are no commercial marketing campaigns to increase awareness of LDN in the medical community. Other doctors may be hesitant to prescribe LDN because it hasnt yet been approved as an MS treatment by the FDA but a prescription can be written Off Label as a lot of Drs do with other medications.
Why hasnt LDN been approved by the FDA for MS?
Naltrexone (in the higher 50mg dosage) was approved by the FDA in 1984 for opiate abuse therapy, and again in 1995 for alcohol addiction. Its safety and efficacy have been proven in clinical trials. In the much lower dosage of 3 or 4.5mg, Naltrexone has not yet been submitted for FDA approval. Federal regulations prevent the FDA from approving LDN as an MS therapy until it undergoes specific clinical trials for MS.
Why hasnt LDN gone through a clinical trial as an MS therapy?
Clinical trials are usually initiated and funded by pharmaceutical companies, and these companies are not interested in promoting or marketing LDN.
Why arent pharmaceutical companies interested in exploring the
possibility of LDN as an MS therapy?
Naltrexone was developed so long ago; it is now a generic drug, manufactured by many different companies. Since no single company owns exclusive manufacturing rights, Naltrexone can be manufactured and sold very inexpensively by any pharmaceutical company.
This means that LDN can't make anyone any money. Pharmaceutical companies are not eager to fund clinical trials for a drug that will make them no profit. Also, if LDN were FDA-approved and became a preferred treatment for MS, the pharmaceutical companies who make the expensive CRAB drugs could lose millions of dollars.
Are there any plans for a clinical trial for LDN as an MS therapy?
In May 2007, the MindBrain Consortium, the Department of Psychiatry of
In March 2007, the
In December 2006, a study of LDN in MS was begun in
In August 2004, the LDN Research Trust (www.ldnresearchtrust.org) was created in
Since LDN has also shown promise as a therapy for other autoimmune disorders, there has research activity in that area. In September 2007, the Institutional Review Board in
Has LDN as an MS therapy been reported in any of the major medical journals?
Most medical journals are not interested in reviewing a drug therapy that has not yet had a clinical trial. However, the peer-reviewed medical journal Medical Hypothesis recently published an article about the LDNs success as an MS therapy.
(For full text, see: ldners.org/Articles/LDN_Medical_Hypotheses.pdf)
Can a doctor legally prescribe LDN?
YES!! While it is illegal for a pharmaceutical company to market or promote a drug for a use other than that approved by the FDA, it is NOT illegal for a physician to prescribe an FDA-approved drug for a non-FDA-approved use. This is called an off-label prescription, and physicians do it all the time. (Neurontin, for example, was approved by the FDA in 1993 for the treatment of epilepsy; yet it is routinely prescribed off-label for the treatment of MS.) All physicians understand that the responsible off-label use of an FDA-approved medication such as Naltrexone is perfectly ethical and legal.
Who first thought of using Low Dose Naltrexone for MS?
Initial research on LDN was conducted by Ian S. Zagon, Ph.D., Professor of Neural and Behavioral Sciences at
Does anyone profit from the promotion and sale of LDN?
NO!! Some people are initially suspicious of LDN, thinking that it might be an internet "snake-oil" scheme, but no one markets or sells LDN for profit. Naltrexone is an inexpensive, generic medication, manufactured by a number of large pharmaceutical corporations. Low-Dose Naltrexone is compounded at individual compounding pharmacies, and is not marketed by anyone.
How many MS patients are taking LDN for Multiple Sclerosis?
No one is sure of the exact number, but it is known that thousands of MS patients worldwide are now using LDN, and the number is increasing. Without the financial support of the pharmaceutical industry, the growing reputation of LDN has been driven solely by positive reports from MS patients.
Are MS patients getting positive results from LDN?
A review of the anecdotal evidence shows that most MS patients taking LDN have experienced considerable improvement, often within days or weeks of beginning the treatment.
The first annual LDN Conference was held on
The Second Annual LDN Conference was held on Friday, April 7, 2006 in the Lister Hill Center Auditorium of the National Library of Medicine (NLM) in Bethesda, Maryland.
The Third Annual LDN Conference was held
For more information about the conference, visit: http://www.lowdosenaltrexone.org/events.htm
Pharmaceutical Information about Low Dose Naltrexone
The protocol is 1.5 to 4.5mg at bedtime. It must NOT be a timed-release preparation and should be given at bedtime. Up until recently, Dr. Bihari had routinely used 3 mg, reducing it down to as low as 1.5 mg in the rare patient who experienced a mild sleep disturbance. (Many patients report improved sleeping.) However, recently, he has noted that some patients who did not respond to 3mg did respond to 4.5mg and has begun to use this dose more frequently. No more than 4.5mg must be used. Occasionally, lower doses are necessary.
The usual, commercial oral preparation of Naltrexone is 50 mg; so, the 1.5 to 4.5 mg dose must be made up by a compounding pharmacy. A months supply should run about $30. Although there are no known significant side effects to the treatment, in about 1 out of 50 patients, the patient will experience a sleep disturbance. In this case, Dr. Bihari recommends that the pharmacy make up a 100-ml. solution containing Naltrexone in distilled water at a concentration of 1 mg/ml. The patient is told to take 1 to 1 ½ ml. at bedtimepossibly working up to 2 ml. or 2 mg.
--- Michael B. Schachter, M.D., CNS, F.A.C.A.
For further information about LDN, visit this site:
Several of these pharmacies do a significant mail-order LDN business. However, most Compounding Pharmacies now have experience with LDN, because LDN is becoming an increasingly effective part of the treatment of AIDS, cancer and various other immune disorders.
LDN Compounding Pharmacies - http://crystalangel6267.webs.com/compoundingpharmacies.htm
Patient Guide: How To Talk to Your Doctor about LDN
Before you visit your doctor
1. Practice saying Low Dose Naltrexone out loud. This might sound silly, but it can be a tongue twister, and you dont want to stumble over your words when you say it to your doctor.
2. Locate a compounding pharmacy. Dont know how to find one? Go to
3. Get a nice new manila folder.
4. Click here for the LDN FAQs -- Frequently-Asked Questions about LDN -- print out this file and put it in the manila folder. This has been assembled many different sources. It is streamlined and factual, without too much medical terminology. (Some doctors dont like patients who use medical jargon.) Claims of LDNs effectiveness
are deliberately cautious and unemotional. Your doctor doesnt want to hear the words miracle drug.
5. Familiarize yourself with everything in the FAQ's. You don't want to be a know-it-all, but you should be ready to answer your doctors questions, or at least know where to find the answers.
Dont include any other material in the Folder. These pages are just enough for a busy doctor to absorb during a short appointment. Most doctors will recoil from a big stack of paper.
During the Visit with Your Doctor...
1. Play it cool. Dont say that you think LDN is a miracle drug. Dont volunteer a lot of information at first. Let your doctor be the smart one. Nod a lot.
2. Without telling lies or hiding symptoms, try to appear as healthy as possible. Don't complain about your symptoms. A doctor is more likely to prescribe an experimental drug if he thinks your health is not in immediate jeopardy.
3. Keep in mind that many doctors are simply unaware of Low Dose Naltrexone. Some doctors might think you are asking for Novantrone, another MS therapy. If your doctor dismisses you outright, make sure he isn't confusing the two.
4. Present the material in the Doctors Folder a little bit at a time. How should you do that? Keep reading
Talking to Your Doctor...
All doctors are different, so I cant guarantee that my approach will work with your doctor, but perhaps my story will help you figure out the best way to approach your doctor.
I created the Doctor's Folder. I included everything I imagined the doctor would want to know.
Your doctor and the internet
How does your doctor feel about patients who do medical research on the internet? Some doctors think its great. Others are infuriated by it. If your doctor disapproves of it, tread very softly. If your doctor says something like All those people are crazies, dont get defensive. Just shrug and say something like, Yeah, thats for sure, there really are some lunatics out there but I did find some interesting stuff, and
I wanted your opinion about it.
Avoid using the word internet. Use the words information and research instead. If your doctor asks you a question you cant answer, just say, I dont know, but I can find out for you.
Addressing your doctors objections ...
If your doctor objects to LDN dont panic. Ask (in a friendly, curious way) what his objections are. Heres what he might say:
Its too experimental. Or, Its not FDA approved.
You can point out that Naltrexone (at the higher 50mg dose) has had FDA approval for a long time, and guide your doctor to the Q&A section that discusses FDA approval.
Youre already on [Avonex, Betaseron, Rebif, or another drug]. LDN might conflict.
Your doctor might be right about this one. Most of the standard MS drugs (with the exception of Copaxone), are immunosuppressant and thus tend to counteract the beneficial effects of LDN. Depending on your general health, if you ask your neurologist to take you off the standard MS drugs to try LDN, you might be facing an uphill battle. Dont give up. It just means that you have more homework to do. Tell
your doctor you will look into it and find out for sure.
I just dont know enough about it.
Some doctors are uncomfortable admitting they dont know something, especially to a patient. This might be a good time to back off, give your doctor the folder, and ask her to look it over at her convenience. Suggest this in a way that indicates that youre not trying to prove your case, you value your doctors opinion, and youre willing to wait.
Naltrexone is a prescription drug, so your physician would have to give you a prescription after deciding that LDN appears appropriate for you.
Naltrexone in the large 50mg size, originally manufactured by DuPont under the brand name ReVia, is now sold by Mallinckrodt as Depade and by Barr Laboratories under the generic name naltrexone.
LDN prescriptions are now being filled by hundreds of local pharmacies, as well as by some mail-order pharmacies, around the
Compounding Pharmacy List - http://crystalangel6267.webs.com/compoundingpharmacies.htm
IMPORTANT: Make sure to specify that you Do NOT want LDN in a Slow-Release Form.
IMPORTANT: Make sure to fill your Rx at a compounding pharmacy that has a reputation for consistent reliability in the quality of the LDN it delivers.
I keep an LDN List of Prescribing LDN Drs in the US and Overseas so if your Dr wont prescribe LDN to you and/or you cant find one in your area that will then email me at [email protected] or [email protected] and let me know where you live and I will email you what I have in your area and if I have none in your area I also keep a list of LDN Prescribing Drs that will do Phone Consults by phone.
Also if your Dr is willing and you get their permission to be added to my Dr List then email me all of their information. (Name, Address, Phone #, Fax #, Email Address and Website if they have one)
Let me know how it goes for you I welcome any advice or suggestions to improve the contents of this site. You can send your comments to
If your Low Dose Naltrexone comes from a compounding pharmacy and arrives as a liquid, then youre getting pure Naltrexone powder dissolved in distilled water. This is probably the purest way to ingest Naltrexone. You dont need to worry about fillers.
BUT -- If you get your LDN in any other form, you're swallowing filler.
A filler is an inert, inactive ingredient that accompanies every
dose of Naltrexone you take.
If you make your own LDN --
If you make LDN by crushing ReVia (pronounced REV-yah) or another commercially manufactured 50mg Naltrexone tablet, you're still ingesting filler, because each tablet is comprised of about 16% Naltrexone and 84% filler.
What kind of filler is in your tablet? This depends on the manufacturer. Here are the main manufacturers:
Barr Labs Barr manufactures naltrexone under the brand name ReVia for the
Prescription Products Guide.]
Mallinckrodt makes a 50mg naltrexone pill called Depade. This tablet contains 50mg naltrexone, plus these inactive ingredients (filler): crospovidone, hydropropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicone dioxide, titanium dioxide, yellow iron oxide, and red iron oxide. [Information from Mallinckrodt website.]
[Historical Note: The original ReVia was made by DuPont. The inactive ingredients were: lactose, microcrystalline cellulose, crospovidone, silicon dioxide, magnesium stearate, and pale yellow Opadry (colouring). In 2001,
If your LDN is made by a compounding pharmacy
Ask your pharmacist how it is made.
1. Some compounders make LDN by crushing commercially manufactured 50mg tablets and putting the powder into capsules, because the amount of powder that goes into each capsule is not enough to fill the capsule, most pharmacies add additional filler. If this is how you get your LDN, you can find out which commercially manufactured tablet is being used and what kind of additional filler is being added.
2. Other compounders dont crush 50mg tablets; instead, they use pure naltrexone powder (purchased in bulk from pharmaceutical companies), which they mix with filler. From these pharmacists, you can learn what kind of filler you are taking.
Here are some of the most common fillers used by compounding pharmacists:
LACTOSE: Lactose is a naturally-occurring simple carbohydrate, or sugar, found only in the milk of mammals. For this reason, it is also commonly referred to as milk sugar.
Lactose has long been used as a soluble filler in the manufacture of orally administered pharmaceuticals. It is safe, stable, inexpensive, and has a fast dissolution rate. Pharmaceutical-grade lactose powder is highly pure, and specifically produced to meet government standards of safety and purity.
Lactose is easily tolerated by most patients. However, if you are lactose-intolerant (that is, if milk products give you nausea, diarrhea, abdominal cramping, bloating, or flatulence), you might want to try another filler.
Note: Dr Bihari asks his patients to use lactose, unless they have an adverse reaction not because he believes lactose is better than other fillers, but because he began his study of LDN with lactose, and he wants his records to be consistent.
ACIDOPHILOUS (pronounced Ah-SID-uh-FILL-us) is lactic bacteria, or one-celled micro-organisms, used by the body to promote immunity and proper nutrition. Sold over the counter as a nutritional supplement and digestive aid, Acidophilus is sometimes used as a treatment for diarrhea and constipation. It is commercially available as powder, tablets, capsules or liquid.
Lactose-intolerant patients sometimes switch to Acidophilus filler in their LDN capsules.
AVICEL a brand name for microcrystalline cellulose. Avicel has been used safely and effectively for 35 years in the food and pharmaceutical industries. Virtually inert, it is not absorbed into the system, and will not interfere or interact with other nutrients, vitamins or minerals. Avicel is made of wood which has been purified and powdered into extremely tiny particles -- between 0.000039 and 0.0001560 of an inch of pure fiber, with the consistency of a very fine face powder.
Avicel is the filler used by Skips Pharmacy in
CALCIUM CARBONATE a mineral that occurs naturally in limestone, marble and coral. Crushed to a fine, flavorless, odorless powder, it is a natural food additive, and the most common ingredient in calcium supplements and antacids.
Calcium is absorbed by the small intestine and is used by the body to build bone tissue. Calcium supplements are generally well tolerated, but in some patients may cause constipation, bloating, gas and flatulence.
People with kidney stones, hypocalcaemia, sarcoidosis, hyperparathyroidism, hypervitaminosis D or cancer should not take calcium carbonate.
People taking calcium supplements are usually advised to take them with food.
There has been some concern among LDN users that calcium carbonate is occasionally packed too tight in the capsule, which can cause a slow-release reaction, rather than the desired fast-release.
Any questions about filler should be referred to your doctor or your pharmacist.
Dr. Kamau B. Kokayi
"Global Medicine Review
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 its 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 its 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. Wed measure in the afternoon, then we'd give the first dose at bedtime that night. Then wed 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 , 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
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 couldnt get it published. Nobody understood the concept.
Dr. Kokayi: Youre using the dose homeopathically. Youre using it not for the effect that the medicine has on the person, but for the bodys reaction to the medicine.
Dr. Bihari: It strengthens the bodys 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 wont 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 theyre 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, shed 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 Id 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. Kokayi: I mean, everyone who has that disease deserves a chance to see if theyre 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
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 thats 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, whos been on it for eighteen years and has not had an attack as long as she stayed on it.
Dr. Kokayi: So its almost as if its 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 theyre 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 youre 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 youre 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, Ive 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 metenkephalins, 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 Ive 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 theres 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 youre 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. Ive 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: Its 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. Its 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 its picked up, if its 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
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
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. Thats a full-time job, for two, three years involving eight or nine centers around the country. Im 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 Naltrexone, and (inaudible) things like that. It's very very expensive 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. Were 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 youre saying that, in large measure its an actual endorphin deficiency.
Dr. Bihari: Its 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
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 bodys 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
Dr. Kokayi: I'd like you to give your website one more time and the number where people can reach you
Well with that, thank you again and I'm sure we will be talking to you again soon.