| These selected paragraphs represent about 10% of the LDN Website http://www.lowdosenaltrexone.org 1/2004 Low Dose Naltrexone FDA-approved naltrexone, in a low dose, can boost the immune system - helping those with HIV/AIDS, cancer, and autoimmune diseases. What is low-dose naltrexone and why is it important? Low-dose naltrexone holds great promise for the millions of people worldwide facing a possible death sentence from virtually incurable cancers and other diseases. In the developing world, LDN could provide the first low-cost, easy to administer, and side-effect-free therapy for HIV/AIDS. Naltrexone itself was approved by the FDA in 1984 in a 50mg dose for the purpose of helping heroin or opium addicts, by blocking the effect of such drugs. By blocking opioid receptors, naltrexone also blocks the reception of the opioid hormones that our brain and adrenal glands produce: beta-endorphin and metenkephalin. Many body tissues have receptors for these endorphins and enkephalins, including virtually every cell of the body's immune system. In 1985, Bernard Bihari, MD, a physician with a clinical practice in New York City, discovered the effects of a much smaller dose of naltrexone (approximately 3mg once a day) on the body's immune system. He found that this low dose, taken at bedtime, was able to enhance a patient's response to infection by HIV, the virus that causes AIDS. [Note: Subsequently, the optimal adult dosage of LDN has been found to be 4.5mg.] In the mid-1990’s, Dr. Bihari found that patients in his practice with cancer (such as lymphoma or pancreatic cancer) could benefit, in some cases dramatically, from LDN. In addition, people who had autoimmune disease (such as lupus) often showed prompt control of disease activity while taking LDN. How does LDN work? LDN boosts the immune system, activating the body’s own natural defenses. The brief blockade of opioid receptors between 2 a.m. and 4 a.m. that is caused by taking LDN at bedtime each night is believed to produce a prolonged up-regulation of vital elements of the immune system by causing an increase in endorphin and enkephalin production. Normal volunteers who have taken LDN in this fashion have been found to have much higher levels of beta-endorphins circulating in their blood in the following days. Animal research by I. Zagon, Ph.D., and his colleagues has shown a marked increase in metenkephalin levels as well. [Note: Additional information for Dr. Zagon can be found at the end of this page.] Bihari says that his patients with HIV/AIDS who regularly took LDN before the availability of HAART were generally spared any deterioration of their important helper T cells (CD4+). In human cancer, research by Zagon over many years has demonstrated inhibition of a number of different human tumors in laboratory studies by using endorphins and low dose naltrexone. It is suggested that the increased endorphin and enkephalin levels, induced by LDN, work directly on the tumors' opioid receptors - and, perhaps, induce cancer cell death (apoptosis). In addition, it is believed that they act to increase natural killer cells and other healthy immune defenses against cancer. In general, in people with diseases that are 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. What diseases has it been useful for and how effective is it? Bernard Bihari, MD has described beneficial effects of LDN on a variety of diseases: Cancers:Breast Cancer, Carcinoid, Colon & Rectal Cancer, Glioblastoma, Liver Cancer, Lung Cancer (Non-Small Cell), Lymphocytic Leukemia, Lymphoma (Hodgkin's and Non-Hodgkin's), Malignant Melanoma, Multiple Myeloma, Neuroblastoma, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer (untreated), Renal Cell Carcinoma, Throat Cancer and Uterine Cancer. Other Diseases: ALS (Lou Gehrig's Disease), Alzheimer's Disease, Behcet's Disease, Celiac Disease, Chronic Fatigue Syndrome, Crohn's Disease, Emphysema (COPD), Fibromyalgia, HIV/AIDS, Irritable Bowel Syndrome, Multiple Sclerosis (MS), Parkinson's Disease, Pemphigoid, Psoriasis, Rheumatoid Arthritis, Sarcoidosis, Systemic Lupus (SLE), Ulcerative Colitis and Wegener's Granulomatosis. LDN has demonstrated efficacy in hundreds of cases. Cancer. As of mid-2003, Dr. Bihari reports having treated some 300 patients with cancer that had failed to respond to standard treatments. Of that group, some 60%, after four to six months treatment with LDN, began to demonstrate a halt in cancer growth and, of those, half have shown objective signs of tumor shrinkage. Autoimmune disease. Within the group of patients who presented with an autoimmune disease (see above list), none have failed to respond to LDN; all have experienced a halt in progression of their illness. In many patients there was a marked remission in signs and symptoms of the disease. The greatest number of patients within the autoimmune group are people with multiple sclerosis, of whom there are now over 140 in Dr. Bihari's practice. None of these patients has ever experienced a fresh attack of MS while they maintained their regular LDN nightly therapy. HIV/AIDS. As of September 2003, Dr. Bihari has been treating 350 AIDS patients using LDN in conjunction with accepted AIDS therapies. Over the past 7 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. It is also worth noting that many HIV/AIDS patients under Dr. Bihari's care have been living symptom-free for years taking only LDN with no other medications. How is it possible that one medication can impact such a wide range of disorders? The disorders listed above all share a particular feature: in all of them, the immune system plays a central role - and low blood levels of endorphins are generally present, playing a role in the disease-associated immune deficiencies. Research by others - on neuropeptide receptors expressed by various human tumors - has found opioid receptors in many types of cancer: Brain tumors (both astrocytoma and glioblastoma) Breast cancer Endometrial cancer Head and neck squamous cell carcinoma Myeloid leukemia Lung cancer (both small cell and non-small cell) Neuroblastoma and others... These findings suggest the possibility for a beneficial LDN effect in a wide variety of common cancers. LDN can be prescribed by your doctor, and prepared by your local pharmacy. 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 is now being made available by hundreds of local pharmacies, as well as by some mail-order pharmacies, around the US. Some pharmacists have been grinding up the 50mg tablets of naltrexone to prepare the 4.5mg capsules of LDN; others use naltrexone, purchased as a powder, from a primary manufacturer. One of the first pharmacies to do so was Irmat Pharmacy in Manhattan. Their recent price for a one-month's supply of 4.5mg LDN (30 capsules) was $38. Irmat will ship it anywhere, in the US or to other countries, and will accept prescriptions from any licensed physician. Pharmacies that are good sources of LDN: Irmat Pharmacy, New York, NY (212) 685-0500; Village Apothecary, New York, NY (212) 807-7566; The Compounder Pharmacy, Aurora, IL (800) 679-4667; The Medicine Shoppe, Canandaigua, NY (800) 396-9970; The Prescription Center, La Crosse, WI (800) 203-9066; Skip's Pharmacy, Boca Raton, FL (800) 553-7429 and Smith's Pharmacy, Toronto, Canada (800) 361-6624 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. The FDA has found a significant error rate in compounded prescriptions produced at randomly selected pharmacies. Dr. Bihari has reported seeing adverse effects from this problem. Please see our report, Reliability Problem With Compounding Pharmacies . Please see the above list of recommended pharmacies for some suggested sources. What dosage and frequency should my physician prescribe? The usual adult dosage is 4.5mg taken once daily at night. Because of the rhythms of the body's production of master hormones, LDN is best taken between 9pm and 3am. Most patients take it at bedtime. Rarely, the naltrexone may need to be purchased as a solution - in distilled water - with 1mg per ml dispensed with a 5ml medicine dropper. If LDN is used in a liquid form, it is important to keep it refrigerated. The therapeutic dosage range for LDN is from 1.75mg to 4.5mg 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. IMPORTANT: Make sure to specify that you do NOT want LDN in a slow-release form (see above) Are there any side effects or cautionary warnings? Side effects: LDN has virtually no side effects. 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 4.5mg to 3mg nightly. Cautionary warnings: 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, morphine, Percocet, Duragesic patch or codeine-containing medication - should not take LDN until such medicine is completely out of one's system. In addition, LDN should probably not be taken during pregnancy. Full-dose naltrexone (50mg) 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 300mg daily. The 50mg dose does not apparently produce impairment of liver function nor, of course, do the much smaller 3mg and 4.5mg doses. When will the low-dose use of naltrexone become FDA approved? Although naltrexone itself is an FDA-approved drug, LDN still awaits clinical trials. The FDA approved naltrexone at the 50mg dosage in 1984. LDN (in the 3mg or 4.5mg dosage) has not yet been submitted for approval because the prospective clinical trials that are required for FDA approval need to be funded at the cost of many millions of dollars. All 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. What You Can Do Talk to your doctor. If you are suffering from HIV/AIDS, cancer, or an autoimmune disease, LDN could help. In AIDS and cancer therapy, LDN is often used in conjunction with other medications. Cancer. Anyone with cancer or a pre-cancerous condition should consider LDN. Many use LDN as a preventive treatment. Post-treatment, others have been using LDN to prevent a recurrence of their cancer. LDN has been shown in many cases to work with virtually incurable cancers such as neuroblastoma, multiple myeloma, and pancreatic cancer. HIV/AIDS. As an AIDS drug, LDN leads to far fewer side effects than the standard “AIDS cocktail”. When used in conjunction with HAART therapies, LDN can boost T-cell populations, prevent disfiguring lipodystrophy, and lower rates of treatment failure. Do not be afraid to approach your doctors - physicians today are increasingly open to learning about new therapies in development. Tell your doctors about this website, or print out and hand them the information, and let them weigh the evidence. Tell others. If someone you know has HIV/AIDS, cancer, or an autoimmune disease, LDN could save them from a great deal of suffering. If they use e-mail, send them the address of this website (www.lowdosenaltrexone.org). Or, print out the site and mail them the information. Help spread the word to the media, the medical community, and to developing countries. Low-dose naltrexone has the potential to reduce the terrible human loss now taking place throughout the globe. It is a drug that could prevent millions of children from becoming AIDS orphans. It is a drug that could be a powerful ally in the war against cancer. If you or someone you know has connections in the media, the medical community, or to those in developing countries involved in AIDS policy or treatment, please let them know about LDN. About This Website This is a not-for-profit website. This website is sponsored by Advocates For Therapeutic Immunology. The purpose of this website is to provide information to patients and physicians about important therapeutic breakthroughs in advanced medical immunology. The authors of this site do not profit from the sale of low-dose naltrexone or from website traffic, and are in no way associated with any pharmaceutical manufacturer or pharmacy. 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. Curriculum Vitae BERNARD BIHARI, M.D. 29 West 15th Street New York, N.Y. 10011 (212) 929-4196 EDUCATION B.A. - Cornell University, Ithaca, N.Y. 1949-1953 M.D. - Harvard Medical School, Boston, Mass. 1953-1957 TRAINING 1962-1965 Resident, Department of Psychiatry, Columbia Presbyterian Medical Center, N.Y.S. Psychiatric Institute 1960-1962 Research Associate in Neurophysiology, Section on Physiology, Laboratory of Clinical Science, N.I.M.H., Bethesda, Maryland 1959-1960 Resident, Department of Neurology, Massachusetts General Hospital, Boston, Mass. 1958-1959 Resident, Department of Medicine, Beth Israel Hospital, Boston, Mass. 1957-1958 Intern, Department of Medicine, Beth Israel Hospital, Boston, Mass. CERTIFICATION Board Certified, American Board of Psychiatry and Neurology. April 14, 1970 New York State Medical License 088158 FACULTY APPOINTMENTS 2002-Present Attending Physician, Beth Israel Medical Center, New York, NY 1981-Present Clinical Associate Professor, SUNY / Health Science Center at Brooklyn 1968-1980 Assistant Professor, Department of Psychiatry, Mount Sinai School of Medicine 1959-1960 Instructor in Neurology, Harvard Medical School EXPERIENCE 1991-Present Medical Director, Foundation for Integrative Research, Inc., New York, NY 1989-1991 Executive Director/Medical Director, Community Research Institute, New York, NY 1981-1989 Director, Division of Alcoholism and Drug Dependence, SUNY/Health Science Center at Brooklyn 1978-1980 Deputy Commissioner, Program Development and Evaluation (Deputy for Public Health Programs), NYC Department of Health 1977-1978 Commissioner, New York City Addiction Services Agency, and Deputy Commissioner for Addictions, NYC Department of Health 1974-1977 Assistant Commissioner for Addictions, NYC Department of Health 1972-1974 Chief, Alcoholism Treatment Program, Department of Psychiatry, Morris J. Bernstein Institute of Beth Israel Medical Center, New York 1971-1972 Chief, Drug Addiction Service, Department of Psychiatry, Morris J. Bernstein Institute of Beth Israel Medical Center, New York Here are random paragraphs taken from other pages of the www.lowdosenaltrexone.org Website: ALS. In the spring of 2002, several people with amyotrophic lateral sclerosis, after reading the material about multiple sclerosis on this website, asked their neurologists to prescribe LDN for their ALS. Two patients with advanced disease showed significant improvement in their forced vital capacity. One had a 25% improvement within two months of beginning LDN and another an 11% improvement A third patient who also has advanced ALS and an impaired FVC has had significant subjective improvement in his ability to breathe and a reduction in his resting pulse from 96 to the low 80's. Given the absence of other effective treatments, the use of LDN appears to have begun spreading through the ALS community, at least to those who are in touch with the Internet. Alzheimer's Disease. Dr. Bihari reports that he currently has three patients who have Alzheimer's disease. Since starting LDN, none of them has shown further progression, which is usually inexorable in this disorder. The initial such patient came to him four years ago to seek treatment for prevention of recurrence of colon cancer. The second patient saw Bihari some two-and-one-half years ago for treatment of non-Hodgkin's lymphoma, and the third began LDN two years ago for an autoimmune problem. Before their first visits, each of the three had been diagnosed with moderately severe Alzheimer's disease by a neurologist. Crohn's Disease. Dr. Bihari is now following eight patients with Crohn's Disease on LDN. In all eight cases, within 14-21 days the signs and symptoms of disease activity stopped. All eight have remained stable since anywhere from 2 months to 36 months. Esophageal Cancer. Reverend X is a patient at John’s Hopkins Hospital where he received most of his medical care. He first developed problems with digestion and some pain in the mid-chest area with swallowing in April 2002. An upper GI exam in May 2002 showed narrowing and irregularity of the lower esophagus. In June 2002, a C-T scan of the chest, abdomen and pelvis showed a 2cm thickening of the lower esophagus extending into the upper stomach. Also seen were five enlarged nodes in the chest and five in the abdomen. Rev X refused chemotherapy and began low dose naltrexone in August 2002. In the following months his difficulty in swallowing has significantly decreased and his weight has stabilized. He notes an improved sense of well being. He has had no therapy but low dose naltrexone. Fibromyalgia. Dr. Bihari reports that he has treated 24 people with fibromyalgia, 22 of whom responded dramatically to low dose naltrexone treatment (4.5mg nightly). Within a few days those 22 patients experienced a decrease of some 80% to 95% in their muscle pains. This improvement has been sustained with continuing use of the LDN. The two exceptions were notable in that they had both been on narcotic pain medications for years prior to weaning off of the narcotics in order to switch to LDN treatment. Their responses were only fair at best. HIV/AIDS. In early May, Dr. Bihari began treating a woman who not only had diabetes, which required a moderately high dosage of insulin (90 units daily), but who also was suffering from lipodystrophy as a complication of her AIDS therapy. At that time, Bihari noted that he expected the LDN would combat her lipodystrophy (which includes insulin resistance) and therefore would probably decrease her insulin needs. Three weeks later, he saw her again for the first time since LDN had been started. Her insulin requirements had dropped from 90 units/day to 20 units/day during those three weeks, and her "buffalo hump" (a swelling at the upper back/lower neck area characteristic of lipodystrophy) had regressed by two-thirds. Her swollen abdomen had begun to recede, enabling her, she said, to cross her legs "for the first time in a year". Lung Cancer. C., a 61 year old woman, previously a heavy smoker, was found to have a lesion in the right upper lobe of the lung in 1999 and a supraclavicular node in April 2001. Biopsy showed that the node was metastatic from the lung tumor. In August 2001 an MRI of the chest showed supraclavicular clusters of nodes and stellate-shaped lesions in the apex of the right upper lobe. She then started taking low dose naltrexone. She began getting quarterly C-T scans of the chest, which showed no change over the following 12 months. The C-T scan interval was changed to every 6 months. Her most recent C-T scan in the spring of 2003 continues to show no change from the August 2001 films. Malignant Melanoma. Dr.Bihari relates the case of a patient who lives in Australia. This man had biopsy-proven malignant melanoma diagnosed three-years ago in a 5mm-deep lesion that was removed from the skin over his left shoulder blade. One year later he developed large masses in his left armpit. These were surgically removed and proved a recurrence. He refused to accept any recommended chemotherapy and contacted Bihari in January of 2000, at which time he began LDN 3mg nightly. He called this month to say he continues to feel fine and he remains in complete remission. Multiple Sclerosis From the GoodShape Parkinson's Disease. As reported earlier on this page (in May 2003 and twice in 2002), Dr. Bihari has been treating patients with PD. Parkinson's Disease is generally characterized by an inexorably progressive course. Bihari now reports that there are seven patients with the disease in his practice, all of whom have shown no progression since beginning LDN. Indeed, two of them have shown clear evidence of improvement in signs and symptoms. Pulmonary Emphysema. Dr. Bihari reports that he now has four patients in whom the inexorable downward course of pulmonary emphysema/chronic obstructive pulmonary disease (COPD) has been arrested through the use of LDN treatment. The central problem in the usual progression of COPD is almost always repeated respiratory infections. Of Bihari's patients, whose average length of LDN use has been two-and-one-half years, three have been entirely free of respiratory infections and the fourth, who is HIV positive, has had far fewer such events. As a result, their clinical conditions during this time have remained essentially stable. This highlights the potency of LDN in being able to act as a primary preventive therapy against respiratory infections in general. Many people who use LDN for a variety of reasons note a sharp decrease in their usual experience of common colds, generalized viral infections, or sinusitis. Rheumatoid Arthritis. Ten patients with this disease have been treated with LDN in recent years. In all ten patients, the joint pain and swelling cleared, in some, leaving residual joint distortion. Two of the patients stopped LDN for several weeks because of travel. Both had an immediate exacerbation. One patient who was responding well on LDN had a mild exacerbation during a period of severe marital stress. These pages include only 10% of all the information available at the LDN Website. For the complete report of this Miraculous Treatment visit: http://www.lowdosenaltrexone.org |
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