Updated: Nov 5, 2022
A Potential Tipping Point for LDN — November 2022
Long COVID may be LDN’s “killer app”
It has been said, “build a better mousetrap, and the world will beat a path to your door.”
Bernie Bihari discovered that better mousetrap—the human uses of low dose naltrexone—in 1985.
Since then, I and others have spent many thousands of days in often fruitless attempts to persuade the US government, hospitals, and physicians that LDN is a medication of enormous importance.
Sadly, once FDA-approved-naltrexone at 50mg daily became a generic drug and, thus, inexpensive, no large pharmaceutical company would bring any of LDN’s special uses to the FDA for testing and approval—because at an average cost from start to finish of $2.5B (that’s billions of dollars) for clinical trials, the company would never be able to defray its costs.
Consequently, LDN was never able to have a large Phase 3 trial and thus was never able to appear in a major U.S. medical journal. It follows that LDN has been largely unknown to the general public and to physicians everywhere.
Beginning in 2020, this was all the more upsetting with the knowledge of how helpful LDN could be in facing down the COVID-19 pandemic. Yes, one might become infected, but if LDN were being used, no major COVID symptoms were likely to follow.
But now, two years later, seemingly quite suddenly, LDN is emerging as an ideal treatment for post-COVID conditions (PCC), also known as long COVID.
LDN appears to address many—perhaps most—of the major symptoms of long COVID, including chronic fatigue, cognitive deficits (“brain fog”), and persistent pain.
According to the news service Reuters, in an article dated October 18, interest in researching LDN for long COVID is spreading rapidly, not only to research centers but also to the NIH:
Drawing on its use in ME/CFS and a handful of long COVID pilot studies, there are now at least four clinical trials planned to test naltrexone in hundreds of patients with long COVID, according to a Reuters review of Clinicaltrials.gov and interviews with 12 ME/CFS and long COVID researchers.
It is also on the short list of treatments to be tested in the U.S. National Institutes of Health's $1 billion RECOVER Initiative, which aims to uncover underlying causes and find treatments for long COVID, advisers to the trial told Reuters.
We were also heartened to learn of a new study out of Dublin, Ireland, originally published in the journal Brain, Behavior, & Immunity — Health in July. Out of a group of 52 patients, 38 began a course of LDN after contracting COVID and experiencing persistent symptoms beyond three months. Of the patients taking LDN, significant improvement was seen in 6 out of 7 parameters measured, including recovery from COVID-19, limitation in activities of daily living, energy levels, pain levels, levels of concentration, and sleep disturbance.
We look forward to seeing rapid progress in researching LDN for long COVID, and urge the NIH to make LDN a top recommendation for clinical trial funding.
The Immune System, Darwin, and DNA — Updated July 29, 2022
It is likely that the complete function of the immune system has never been fully explored
Let’s consider the question of low dose naltrexone (LDN) in regard to the immune system.
The central role of LDN appears to be a strengthening, or normalization, of one’s immune system at any age. In the absence of LDN, the immune system will typically deteriorate progressively throughout one’s lifetime. We can see Darwin’s theory of evolution at work here: “Variation, inheritance, selection and time”. These are the four major keys to natural selection.
Most people will function normally up to age 25 or so; but after ages 30 or 40 the immune system may begin to show some signs of becoming impaired; and, certainly, when one is over 70 years of age, one’s immune system is likely to have become moderately dysfunctional. The results, in Covid-19 hospitalizations, are clear to see.
Charles Darwin might have observed that as youth draws to a close and middle age approaches, reproduction will generally have been accomplished. So, there is no need for Nature to expend further energy to maintain a completely normal immune system into middle age and beyond, because the next generation has likely been acquired by then.
Interestingly, a deterioration in a human’s appearance over the decades seems to parallel the decline we’ve noted for the untreated immune system. Obviously, the visible outward form of elderly people is far different than that of people in middle age; they in turn have a physique very different from women and men in their 20s or 30s. Might there be some unappreciated link between the waning of one’s looks and the declining of one’s immune system? And, could the effects of low dose naltrexone possibly play a protective role?
My brilliant childhood friend, the late Dr. Bernard Bihari, was the discoverer of the human uses of LDN, and its ability to normalize one’s immune system at advanced ages. My wife and I have been taking LDN preventively each night for some 20 years now, and we have hardly ever had a common cold during that time. It may be just my imagination, or a simple coincidence, but we, who are now in our 80s, appear to look and act somewhat younger than others in the general population who have reached that age.
Could it be that the immune system, strengthened by LDN, in addition to shielding one from foreign invaders such as bacteria and viruses, is helping almost all of one’s tissues and organs avoid a gradual withering?
Of course, such thoughts are quite speculative. Unfortunately, other than for a Phase II study of LDN for Crohn’s Disease at Penn State, no large clinical trials of LDN (not to mention LDN’s effects on the immune system) have been published.
That is due to the generic status of the original drug, naltrexone. Large pharmaceutical companies act as the gatekeepers in deciding what drugs are brought to the FDA for testing. Because generic LDN can be purchased at a compounding pharmacy for less than one dollar, and since the average cost of developing a new drug, from start to finish, is 2.6 billion dollars, no drug company would be able to recoup the costs of clinical trials of LDN—and therefore, no Phase III study on LDN has ever been performed.
Without a large clinical trial, information about LDN has never been published in any major medical journal or in any major media. Therefore, LDN is generally unknown to physicians, researchers and the general public.
Since there are already many thousands of people taking LDN daily, it may turn out that we “LDNers” have been running our own virtual Phase III trial—we’ve just been unaware of doing so. And, as the years go by, we’ll be experiencing the results of decades of LDN use. Perhaps we’ll live to see LDN Google Groups composed of only people that have already celebrated their 110th birthday!
LDN's Potential Use Against COVID-19 — Updated July 29, 2020
An inexpensive, readily available immune booster
A vaccine for the novel coronavirus may yet be a year away; and it is likely to take a year, as well, before any new COVID-19 anti-viral medication may become ready for use.
People with a weak or dysfunctional immune system (e.g., the elderly, those with diabetes, obesity, heart or lung disease, etc.), who become infected by the coronavirus, are at very high risk and often require hospitalization. Sadly, perhaps one-third of that group will suffer severely even after the virus is gone, as their immune system continues its violent attack, often causing death.
However, because LDN acts to normalize one's immune system, daily users of LDN avoid the high-risk category.
And LDN is available now. We know that the NIAID has received detailed information about LDN and about its enormous potential as therapy against the coronavirus. We need to make as many people as possible aware of what an important protection against COVID-19 LDN can be.
LDN has the potential to save countless lives in the U.S. and around the world. Please help spread the word.
Excellent Book on LDN Published — December 2018
Julia Schopick writes detailed compendium about LDN
“The Power of Honest Medicine: LDN, an Inexpensive Alternative to the Costly, Toxic Medications Doctors Prescribe for Autoimmune and Other Diseases” by Julia Schopick (with Don Schwartz) is available both in print and as an ebook.
This extraordinary book is highly recommended. And it is out just in time for holiday presents.
Schopick to Publish Superb Book — June 2018
Best-selling Honest Medicine author focuses on LDN and autoimmune diseases
“The Power of Honest Medicine: LDN, the Life-Changing Treatment for Autoimmune Diseases” by Julia Schopick (with Don Schwartz) is the must-read book for lay people regarding the effects of low dose naltrexone on autoimmune diseases. Publication is due in a few months.
The book is filled with individual stories, presented in vivid detail, by people who went through heartbreaking difficulties for far too many years before they finally became aware of LDN and thus were often able “to get [their] life back”.
In addition, Schopick goes on to add a cornucopia of guidance, including advice on how to approach a physician when seeking a prescription for LDN, and links to a host of online information: LDN websites in the USA and globally, disease-specific LDN groups, related forums, all past conferences, audios, videos, documentaries and books about LDN, the best known studies and clinical trials of LDN, sources for finding LDN-prescribing doctors, and lists of recommended LDN-compounding pharmacies.
I can’t recommend this compelling and valuable book highly enough.
Light at the End of the Tunnel — March 2018
Immune Therapeutics to run phase 3 trial of LDN under aegis of FDA
A meeting held in January 2018, between Immune Therapeutics, Inc. and the US Food and Drug Administration (FDA) discussed future measures in the development of LDN (Brand name: Lodonal) as an oral once-a-day supplementary treatment to the standard of care for moderate to severe Crohn’s disease in adults and for mild to severe Crohn’s in pediatric patients.
The company announced that it will “immediately move forward” with its IND 067442 (Investigational New Drug) proposal for Phase 3 clinical research in patients age 12 and older who have moderate to severe Crohn’s disease. The company has agreed to conduct a 52-week study (including measuring endpoints at week 12) and to use the Crohn's Disease Activity Index as the trial’s primary endpoint.
Over 5 years ago, I had written the following in my Blog of October 2012. We have waited a very long time for this moment, but the hopes expressed remain as true:
(For further details about the trial, read the online article here.)
Major International Progress — Oct 2016
Immune Therapeutics, Inc. has vigorous plans for its Lodonal brand of LDN
At its recent stockholders meeting, the company announced its intention to seek approval of Lodonal by the United Nations, the President’s Emergency Plan for AIDS Relief, and UNAIDS. In addition, it is awaiting a meeting with the FDA to discuss plans for a trial of Lodonal for Crohn’s Disease.
Not only has it gained approval from NAFDAC, Nigeria’s FDA (see The Latest News of May 2016), but it also received approval from the Pharmacy, Medicines and Poison Board in Malawi in conjunction with a planned clinical trial there for prevention of deaths from cervical cancer. This will involve a single cryosurgery intervention and starting on an LDN regimen.
And that’s not all. The company hopes to begin other trials in Kenya and in Ghana within the next six months, which will use Lodonal as an adjunct to chemotherapy. It has further plans for Malawi, where it intends to use Lodonal in a trial for those with HIV/AIDS. Last, but not least, Immune Therapeutics has, over several years, completed many of the steps required to run a clinical trial in China utilizing Lodonal in the treatment of hepatic cancer. So, there is much happening and much more to look forward to!
Scandinavia Impresses Again — Sep 2015
Important health research points to LDN use
Here is the citation for a very significant research study which was published just last month in one of the top US medical journals: Stable Peptide of the Endogenous Opioid Enkephalin Precursor and Breast Cancer Risk. By Olle Melander, MD, et al. Journal of Clinical Oncology; 2015 Aug 20;33(24):2632-8.
Olle Melander, MD, and colleagues, from Lund University in Malmo, Sweden, sought an answer to the question of whether enkephalins (opioids made in the body) had any protective effect on the development of breast cancer. In two large studies, enkephalins were measured in fasting plasma samples in thousands of women. The convincing answer was a resounding “YES!”. The lower one’s enkephalins, the higher one’s risk of developing breast cancer! The results were published recently in the oncologists' “bible”, the Journal of Clinical Oncology.
From our viewpoint, to say more enkephalin (or endorphins) is also to say “read here: LDN!” And that is because those who take LDN are surely doubling or tripling their levels of those opioids. So, this wonderful Swedish study reassures us: regular use of LDN has now been shown to be a reliable preventive against cancer—and there is no reason to think this applies solely to breast cancer. We can only continue to hope that clinical trials utilizing LDN for the prevention of cancers of any sort will eventually see the light of day.
An Eloquent Video, A Must See — April 2015
Norwegian, with English subtitles
At long last, a most professional, most persuasive video concerning LDN!
It was made in Norway in 2013, with English subtitles. Far from a sales pitch, it tries to tell an evenhanded story. Its sole omission, which one often finds in Europe, is the total disregard for the role of the late Bernard Bihari, M.D., who discovered the human uses of LDN in 1985. Other than that, it is nearly perfect and a joy to watch. It has led to an avalanche of LDN sales in that country (from a mere 300 users beforehand, it is now used by some 15,000 patients in Norway).
Please do not miss watching: http://www.tv2.no/a/5316228
A Modest Proposal — January 2014
Not new, but worth repeating
There is no longer any serious question remaining about the efficacy and safety of LDN. Unquestionably positive reports, both small studies and scientific trials, have found their way into esteemed peer-reviewed medical journals – and that information joins with over 25 years of many thousands of strongly supportive anecdotal reports. (See Research Trials of LDN at www.ldninfo.org.)
From the first, FDA approval of LDN’s special uses has been blocked, perhaps unintentionally, by the current system, which depends on the large well-financed pharmaceutical firms acting as virtual “gatekeepers”. Given that the existing procedure is based on the legal approval of each newly proposed drug by the FDA, and that the FDA requires results of clinical trials which are very costly, progress is essentially left to the determination of the funding pharmaceutical companies. Big Pharma clearly uses the potential profitability of any individual candidate drug, no matter its potential for general therapeutic usefulness, to decide whether a new medication will or will not be tested and thus have any opportunity to reach the public marketplace and thereby contribute to the public health.
Thus, the stated health-related mission of any large pharmaceutical company is generally not at all compatible with its obvious primary motivation, which is to expand earnings and profits. This has led to an erosion of medical advances, paradoxically in an era of mounting medical costs, in that any off-patent generic drug with a newly discovered 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 for Big Pharma.
In order to remedy this system of non-performance, and to permit governmental agencies to truly serve the health of the citizenry, systematic change is called for. Some key elements of suggested change:
- A newly fashioned Institute of Medicine [IOM] should 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 should it need to arrange support for any necessary clinical trials it deems of value, and it shall choose those appropriate centers of excellence at which such studies shall be performed. The IOM shall freely seek out potential treatments which encompass the human organism.
- The professional directors of the IOM shall be retained and remunerated in a fashion parallel to that of the U.S. Supreme Court, and members shall hold their assignments (unless duly impeached) until a preset age (? age 75) or until prior resignation. No member shall be permitted to join with or consult for any pharmaceutical company in any capacity at any time during, or at any time after, his or her IOM tenure.
- Members shall be nominated by the President of the United States, and each must be duly confirmed by the Senate, as entirely disinterested medical academics and/or research experts of unimpeachable reputations. Highest qualifications must be sought in all cases, and a member’s total commitment to the most significant goals for the public’s improved health at the most reasonable expense shall be mandatory.
- A mandated function of the IOM must include the continual detailed screening of all submitted ideas for improved treatments from medical practitioners and from the general public as well as from career researchers. Summary reports and comments shall be distributed to both the President and appropriate members of the cabinet, and published in print and online at least quarterly throughout the calendar year. Significant penalties for staff performance inadequacy in this area will be mandatory. An exclusive attention to only those ideas generated by known medical research centers and/or by Big Pharma must be rigorously avoided.
- It is expected that, other than as above provided, current functions of the NIH, CDC, Attorney General, FDA, and our Patent system should be generally unimpaired by this new system, with which they will cooperate, and which will be devoted to serving the development of new, useful, and cost-saving medication and medical devices for the public health in a truly disinterested manner.
Let us hope that there are enough representatives in government who will see the importance of the United States having other than its current medical free market system, which has been badly handicapped by the pharmaceutical industry’s need for profits, and instead allow leadership by committed, disinterested medical professionals in order to encourage the discovery of new useful treatments at the lowest prices.
Further Good News from TNI Biotech — June 2013
In addition to patents and licenses, TNI BioTech has obtained the rights to the clinical data and the transfer of the Investigational New Drug (IND) and orphan drug designations from the U.S. Food & Drug Administration for pancreatic cancer and Crohn's disease.
TNI Biotech believes the orphan drug designations will allow the company to fast track the development of clinical trials for both of these indications in the United States and internationally [utilizing either Met-enkephalin (“MENK”) and/or low dose naltrexone (“LDN”)].
The Form 10 document, financial statements, auditor's footnotes, and opinion letter can be found on the company's website.
Good News from TNI BioTech — October 2012
When our Latest News for October went online, it understandably led to a number of vocal concerns about the possibility that, following any successful Phase III trial and subsequent FDA approval, the price for LDN would skyrocket.
Since then, we were delighted to receive a statement from the CEO of TNI BioTech, Noreen Griffin, that her company is committed to charging no more than $1.00 a day for LDN, because it does not want to undermine LDN’s use as an affordable treatment. Kudos to TNIB!
Fears of a potential increase in LDN’s price are unwarranted. The FDA and any pharmaceutical company making an application for new drug approval are quite limited under the law. A clinical trial, by its very nature, can focus on only one disease. Such trials are very expensive—often at the level of tens of millions of dollars. Therefore, in the event that TNIB does receive FDA approval and patent rights for LDN treatment of Disease XYZ with a brand-named product, the pharmaceutical company is strictly limited to advertising and marketing that new brand as only for patients with Disease XYZ. Doubtless, there will be many people with XYZ who, with good reason, will insist on purchasing that new brand-name drug for their personal care.
However, totally unaffected will be the right of every physician to continue prescribing appropriate off-label uses of the FDA-approved generic medication naltrexone (in the form of LDN) for all of its many medical uses (other than Disease XYZ). Also unaffected will be the right of compounding pharmacies to fill such prescriptions requesting LDN and to do so at the accustomed price.
Most importantly, should the research efforts of TNI BioTech prove successful, FDA-approval of any one of LDN’s special uses could open up a whole world of recognition for LDN and, for the first time, considerable understanding and acceptance by both the media and the medical community. With that, the ability for anyone to receive an Rx of LDN (either as the brand or as a compounded off-label generic) for any of the great numbers of medical problems for which it is beneficial should then become a matter of course.
As a result, I dream of a subsequent decline, in the US alone, in both the annual rates of general morbidity/mortality and of health care costs of a whopping 15% to 20%. And beyond that, perhaps we will eventually live to see LDN sold over-the-counter at pharmacies around the world.
Please Join In — March 2012
Since January 31, 2012, the revolutionary attempt on the part of Transparency Life Sciences to launch a wide-open clinical study of low dose naltrexone on the Internet has been under way. LDN is one of just three medications on its first list.
The approach is unprecedented, in that it asks all of the participants for their guidance in crafting the elements of the study. This design phase is scheduled to be completed in only a very few months, so it is imperative for everyone who is at all interested to PLEASE GET INVOLVED NOW!
Please carefully check out www.transparencyls.com, if you haven’t already done so. Although this initial study of LDN is aimed at those who have Crohn’s disease, there are also surveys for people who have multiple sclerosis, which should help in planning further studies. In addition, there is a considerable need for researchers and physicians to have their say as well.
The TLS goal of “get more effective drugs to market faster, and at a lower end cost, to patients who need them” could well benefit many, many millions of people around the world. Please do your part, and suggest to others that they get involved as well. This is a rare opportunity for all of us.
Working Toward FDA Approval for LDN— Jan, 2012
The many years of waiting have finally come to an end. Since 1986, when Dr. Bernard Bihari first demonstrated that less than a tenth part of the FDA-approved drug naltrexone could help protect people who had HIV, we have been trying, with only modest success, to persuade the world of science and medicine that LDN is the long-sought "panacea" that can enhance and normalize a dysfunctional immune system. Many of those who have an autoimmune disease, or cancer, or HIV/AIDS, numberless patients over these years, have sought in vain for a physician willing to give them a prescription for this effective yet harmless drug.
What was always lacking was a large clinical trial, which could convince the FDA of LDN's safety and efficacy. Certainly no pharmaceutical company would dare upset its shareholders by wasting even a dime on a medication like this — the original large dosage naltrexone was long off of patent, naltrexone is a common generic drug made by several companies, and LDN is just a small inexpensive off-label use of naltrexone, with no hope of profitability.
But now comes Transparency Life Sciences (TLS), which on January 31, 2012 initiated its online crowdsourcing program, which is initially aimed at LDN and two other neglected medications. TLS is asking all of us who might fit into one of the possible participatory groups to please become involved in this new, cutting-edge approach to openly designing and running a clinical trial on the Internet. The goal is to demonstrate to FDA's satisfaction the efficacy and safety of the trial medicines. The mission aims at attaining general medical acceptance through FDA approval, to be followed by the lowest feasible cost in manufacture and sale of the newly marketable medications.
After a quarter century of awaiting opportunities to authenticate this remarkable medication, crowdsourcing by TLS, under the aegis of Dr. Tomasz Sablinski and his colleagues, intends to finally open the door for low dose naltrexone.
The editors of www.ldninfo.org implore all of you who have become aware of LDN's unique usefulness and who have grieved for the millions of suffering people who still are refused access to it by their physicians and/or their insurance carriers: this is your moment!
Please go to the TLS website—and suggest to others that they go as well—to join us, at long last, in righting this wrong!
Time For A Change — December 2011
With only a few weeks remaining in 2011, it’s the right time to look back at some recent LDN accomplishments and to consider even brighter possibilities for the year ahead.
This year brought two outstanding published research reports:
In the spring, Jill P. Smith, M.D., Professor of Gastroenterology at Pennsylvania State University, published her Phase II study on adults with Crohn's disease, “Therapy With the Opioid Antagonist Naltrexone Promotes Mucosal Healing in Active Crohn's Disease: a Randomized Placebo-Controlled Trial”.
And this fall saw the publication of the long awaited results from the Mali studies on LDN in HIV/AIDS. Made possible by the extraordinary support of neurologist Dr. Jacqueline McCandless and her husband, Jack Zimmerman, PhD, the resulting data unquestionably demonstrate the power of LDN to maintain the strength of one's immune system even against the withering attack of the HIV virus.
Because considerable past research by others had taught us that every autoimmune disease depends on the presence of a weak, dysfunctional immune system, it was always clear to us that LDN’s mechanism must involve a strengthening/normalization of the immune system. Finally, because of this elegant study from Mali, we are able to unassailably prove the point.
More importantly, the study should bring hope to the tens of millions of people in developing countries who are HIV infected and who, up till now, could look forward only to a short future life with AIDS, along with the unlikely odds of ever receiving needed therapy. Let us hope that health authorities around the globe will pay attention to LDN’s enormous potential here.
Our central goal for LDN always has been for its general endorsement by the field of Medicine. It became clear over time that such recognition could only happen through FDA approval of at least one of LDN’s many capabilities. Which brings me to our hope for 2012.
Many of you may recall our regular announcements about a start-up drug development company, Transparency Life Sciences, which is interested in performing community driven clinical trials (that will include LDN) through the Internet by so-called crowdsourcing. Its preliminary work has now been accomplished and we can expect to experience its launch in the near future. Most exciting is this groundbreaking method’s openness and efficiency – it should have the capability of finally bringing LDN to regulatory approval, and then to patients, without the usual price increases standardly associated with new medications.
It’s now been a quarter-century since my late friend Bernard Bihari, MD, discovered the human uses of LDN treatment. Rather than the world beating a path to his door, this safe and effective medication has been resisted by physicians at every turn, even as LDN has improved the lives of many tens of thousands of people over the years. May 2012 be the year in which low dose naltrexone receives the official recognition it so richly deserves.
Here’s wishing you all a Happy, Healthy and Peaceful New Year.