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The Developing Nations Project

Updated: Nov 3, 2011


Recent Developments

> Bamako University Hospital, Mali, Western Africa — HIV Studies

October 2011: Studies Published

Two separate studies demonstrating successful LDN use in HIV/AIDS have been published in the October issue of the peer reviewed Journal of AIDS and HIV Research. This was made possible with the financial support and guidance of neurologist Dr. Jaquelyn McCandless and her colleague husband, Jack Zimmerman, the support of Hussein Alfa Nafo, and with the work of the local research team led by Dr. Abdel Kader Traore and other health officials at the University Hospital in Bamako, Mali in Africa.(See Clinical Trials for LDN / Recently Published.)

[Editor’s Note: These long awaited scientific studies on Low Dose Naltrexone for HIV+ individuals not only have helped bring the late Dr. Bihari’s dream of a Developing Nations Project much closer to realization but also have clearly demonstrated LDN’s unique ability to strengthen the immune system. If responsible health care authorities around the globe pay proper attention to these findings, it is still possible to prevent the further deterioration of tens of millions of people who are presently HIV+.]



September 2009: A Personal Plea from the Editors of ldninfo.org

We recently heard very moving and exciting news from Jaquelyn McCandless about the progress of the trial of LDN for HIV/AIDS which she and her husband Jack Zimmerman are helping to conduct in Mali.

Early word is that the group taking HAART plus LDN is doing extraordinarily well. It's evident that the trial will tell us a great deal about the effects of taking LDN for HIV in Africa and in other developing areas around the world.

The trial has been very difficult to run, given the poverty and unpredictable conditions in Mali, the challenge of finding trial participants who fit within the appropriate CD4 range, the need to pay all the local physicians and staff on the project, etc.

Jaquelyn and Jack have personally put in more than half of the $350,000 needed to fund the trial — this comes directly out of their own retirement savings. In addition, about $40,000 more is needed to finish the trial. Jaquelyn reports that they are finding it difficult to raise more funds.

We strongly feel that it is time for all of us to show our support for this trial, which may be pivotal in helping to demonstrate the efficacy of LDN to the world medical community. Beyond the issue of HIV/AIDS, upon completion this will be the largest human trial to date of LDN for any disease.

We also owe it to Jaquelyn and Jack to help support them in this time of need, to give them a boost at a moment when things look especially difficult — with 9 months left to go in the study to complete all the testing.

We are reaching out to you — LDN advocates worldwide — to join us in supporting the Mali trial.

If roughly one-third of us were to give $20, the resulting donation to Jaquelyn and Jack's fiscal sponsor, The Ojai Foundation, would be more than enough to provide the remaining funding for the trial. Since some of us can send more and all of us want to see this study completed, the goal seems realizable!

Please write a generous check now and mail it today. Together we can help complete this trial and give Jaquelyn and Jack the support they need to see it through to completion and publication — benefitting all of us, and potentially the millions of those suffering from HIV/AIDS throughout the world.

Make your check out to: The Ojai Foundation, Africa Project
(Please give whatever you can afford — many of us can give $50 or even $100.)

And mail to:

The Ojai Foundation, Africa Project
Post Office Box 999
Ojai, California 93024

We are writing our own checks and mailing them now — please join us.

Thank you for kindness!

With gratitude,

David Gluck, MD
Joel Gluck, MEd, RDT
www.lowdosenaltrexone.org

p.s. — You can also give at Ojai Foundation’s Africa Fund donations web page.

September 2007: First Scientific LDN-HIV/AIDS Trial Approved by IRB in Mali.

Jaquelyn McCandless, MD and her husband Jack Zimmerman, PhD, have announced that the Institutional Review Board in Bamako, the capital of Mali, has approved the plans for the long awaited clinical trial of LDN in HIV-infected citizens of Mali.

The study, which should last for some 9 months, involves 3 study groups: LDN treatment only; LDN plus antiretroviral drugs; and only antiretroviral drugs. The volunteer subjects must be18 years of age or older and must have reduced CD4 counts in the 275 to 475 cells range at the outset. Laboratory studies will be rechecked at 12-week intervals.

The research team is led by Dr Abdel Kader Traore and other health officials at the University Hospital in Bamako. Irmat Pharmacy of Manhattan has volunteered to supply all of the needed LDN and matching placebo capsules at no cost. In addition, the plans include careful attention to counseling aimed at improving preventive health practices for women and children. [Editor’s Note: Many thanks to Mr. Seyni Nafo of Mali who has tirelessly worked to facilitate all efforts to implement this groundbreaking study.]

Dr. McCandless is actively seeking philanthropic donations (e-mail her here).

April, 2007: Funding Guaranteed for Trial.

Jaquelyn McCandless, MD and her husband Jack Zimmerman, PhD, announced last month that they have committed their own funds to reach the goal of $250,000 needed to fund the LDN-HIV trial in Mali, the first study of its kind. The couple reports: "It is clear to us that the project is definitely going to happen and so we are willing to personally guarantee the funding. Hopefully, there will be many others who share our vision and will join with us but, no matter, we can support it alone if need be." They hope to begin training all involved personnel shortly.

For further information about the trial and how you can help, see McCandless and Zimmerman's March 2007 letter.

The following is a February 2, 2007 letter from the Director of National Center for Disease Control, Mali, confirming support for the trial by the government of Mali:

Letter from Director of National Center for Disease Control, Mali

December, 2006: Trial Planned for Mali.

Jaquelyn McCandless, M.D., the neurologist who is the U.S. Medical Consultant/Coordinator for the Mali LDN HIV+ Study, visited Mali in December 2006 and met with the clinical study team at Bamako University Hospital as well as the head of the Malian Ethics Committee.

The planned Mali study will involve three groups of 50 volunteers each, all of whom are HIV positive and each of whom has a CD4 cell count in the range of 275 to 475. One group will receive LDN only, one will be treated with LDN and antiretroviral drugs, and the third group will receive ARV’s only. The length of the planned study is 48 weeks. The hope is to implement it when funding is completed.

Excerpts from Dr. McCandless's December 2006 report from Mali:

We have been working with the health team at Bamako University Hospital to set up the LDN HIV+AIDS study to ascertain if LDN can prevent progression of HIV+ to full blown AIDS.

The Applied Molecular Biology Laboratory research facility here for virology, parasitology, and bacteriology is very impressive. The lab director, Dr. Ousmane Koita, is a PharmD, PhD graduate in clinical pharamacology from Tulane University, and just returned from a conference there on AIDS. Most of the brand new state of the art equipment is from NIH and Tulane University. Two graduate students are writing their theses on the studies going on here, and there are 5 physician consultants for our project, plus a PhD virologist, an MD, MPH Epidemiologist who is head of AIDS epidemiology in Mali, an MS biostatistician, and several clinicians.

We also spent several hours with the head of the Malian Ethics Committee who was satisfied that our program does not violate any human rights and that everyone will be well-informed as to what the study entails — there will be no placebos in this study.

Everyone we have met so far is very friendly, helpful, and highly interested in the success of this program.

In Brief

Millions are dying of HIV/AIDS in developing nations throughout the world. These countries do not have the resources to pay for and properly administer antiretroviral therapy for all of the infected. Low-dose naltrexone (LDN) could significantly slow this terrible pandemic.

> Why LDN?

Dr. Bernard Bihari has shown that people infected with HIV, whose immune system has not deteriorated to below 300 CD4+ cells, can be successfully treated and stabilized on a long-term basis with LDN alone. Until economic development allows access to a full range of the more costly therapies, LDN at present holds important advantages over antiretroviral (HAART) therapy for developing nations:

  • LDN is inexpensive.  If manufactured in a developing country, it is estimated that LDN could be produced for far less than the least costs projected for antiretroviral therapies, i.e., no more than ten dollars (US) per patient per year.
  • LDN is simple to take — one capsule a day at bedtime. This is in contrast to the multiple dosages of antiretroviral therapies that must be timed appropriately, some taken on an empty stomach and some with food.
  • LDN has no side effects.  Also, drug resistance does not develop with LDN.
  • LDN is an immune system booster.  By strengthening the immune system, LDN should prove helpful to those HIV/AIDS patients who are also combating TB or other chronic infections, which are so prevalent in developing nations.

For these reasons, LDN could well be the ideal near-term solution for the millions of people worldwide who are carrying HIV.

> Goals of the Project

  • A clinical trial.  First, to conduct a full-scale, double-blind, placebo-controlled prospective study of LDN as a treatment for HIV/AIDS in a developing country.
  • To benefit all.  Then, with the successful outcome of the clinical trial, to fulfill these three key objectives:

    1. In the developing country which hosted the trial, to license a capable entity—with no licensing fee—to manufacture LDN, with the stipulation that LDN be sold at close to cost for the benefit of that nation's citizens.
    2. To help ensure the general availability of LDN throughout the developing world, particularly in those nations unable to afford HIV/AIDS treatment for their people.
    3. To gain scientific recognition of the efficacy of LDN for the treatment of HIV/AIDS in all countries.

What Patients Say

LDN Conference Presentation (2006). William Way spoke on the LDN Advocates Panel at the April 2006 LDN Conference on the NIH campus in Bethesda, Maryland. He described having first tested positive for HIV 16 years ago—since that time he has used nothing stronger than nightly LDN to treat the HIV infection. During these many years he reports that his CD4 cell count has, for the most part, remained in a favorable zone, and he has been symptom free. In contrast to virtually any other person who has carried an HIV infection for many years, Mr. Way has never had to use antiretroviral drugs, thus avoiding the attendant expense, annoying schedules, and risk of side-effects. Mr. Way's entire talk can be viewed here.

Recent reports (2005).  Detailed reports from an HIV-infected patient, who has been taking only LDN for his disease for the past 12 months, present strong evidence for the efficacy of LDN in treating HIV. His comments are reprinted in the HIV/AIDS subsection of the linked page "What Others Are Saying About LDN" (his are the three messages dated 2005). We hope that all the developing nations that are struggling to treat their HIV-infected citizens will take note.

Phone survey (2001).  In November 2001, seven of Dr. Bihari's HIV-positive patients who take LDN without antiretrovirals were interviewed by telephone. Here are some of their responses to the following question:

What would you wish to say to international decision-makers and health ministers of developing countries who are deciding whether to host clinical trials of LDN for the treatment of HIV/AIDS?

"LDN is certainly not detrimental—it can only be helpful. It's cost-effective compared to antivirals, and doesn't have the toxic side-effects of antivirals."
"LDN could be very effective for a lot of people. My viral load has stayed undetectable. My T-cells have ranged from 800 to 500…my viral counts never faltered. The naltrexone kind of protects me now."
"I hope that they do [a clinical trial] so that they can gain information and so that the information can be shared throughout the world."
"My experience with the medication has been just wonderful. At least they should try to use it and see if it works for people in the same situation I'm in. I'd encourage them to just try... if you don't try you never know. Be confident to use LDN."
"Go for it. I would definitely say LDN is worth investigating and does have benefits. This drug can extend life and health without running up the national debt further. It definitely should be considered a viable option in treatment. It does have effects on the immune system. I recommend it due to my experience and the state of my health after 13 years. Because it is so inexpensive, you're not involving millions of dollars."
"I've had [HIV] for 13 years and if LDN is what's keeping my numbers up it's a success. Nothing else has changed in my life… and I work 60 hours per week."
"LDN is a safe drug. I feel it's been beneficial to me, and would help a lot of other people. There's been no bad reactions at all. Whereas I had bad experiences with other drugs, this one I haven't."

What You Can Do

Support the Mali Trial.  Contact The Ojai Foundation Africa Project to lend your financial and volunteer support.

Contact Us.  If you know a decision maker in a developing nation (e.g., in government or public health), in an international health organization (e.g., the WHO, UNAIDS, etc.), or in an organization that could potentially provide funding for this project (e.g., the World Bank), we would be happy to follow up with them. Click here for contact information.

Tell Others.  You can adapt the sample letter below to let others know about this important project. Spreading the word increases our chances of success.




Sample Letter


Dear ______:

Given the dire situation of the growing population of HIV-infected people throughout the world, this is to call your attention to a potential treatment that holds enormous promise, and to request your help.

The generic prescription drug naltrexone, an FDA-approved opioid antagonist, has been marketed for years in the US and elsewhere for the treatment of opiate and alcohol addiction. Now it has demonstrated unparalleled success, when used in a very low dose, in strengthening the immune system in hundreds of documented cases of patients with HIV/AIDS.

Bernard Bihari, MD, of New York City, an alumnus of Harvard Medical School and a past Deputy Commissioner of Health for the City of New York, discovered the effect of low-dose naltrexone (LDN) through a placebo-controlled study performed in 1986. Dr. Bihari employed just a 4.5mg dose of naltrexone (less than one-tenth the standard dosage of 50mg). This is taken by mouth in a single capsule each night at bedtime. One such dose of LDN raises the level of endorphins for an entire day, which, in turn, boosts the action of the body's immune system. LDN has no side effects and is very inexpensive.

Dr. Bihari followed some twenty patients with HIV who over many years refused antiviral drugs, but continued to remain healthy on LDN alone. He found that LDN, taken by itself, prevents or reverses deterioration of the immune system in any HIV-positive patient who starts treatment with a CD4+ (T-cell) level of 300 or higher.

Of interest, in 155 patients with AIDS treated for the past 4 years by using LDN in addition to antiretroviral therapy, Bihari found that over 90% continue to show no detectable level of virus. This is a substantially higher success rate than for any reported AIDS treatment group. In addition, these patients did not developed the side effects (e.g., lipodystrophy) which occur without LDN use.

LDN represents a heretofore absent and long-sought therapy, an immune system booster, which is capable of halting the progression of HIV infection into full-blown AIDS.

With local manufacture, LDN's cost should be no more than ten dollars (US) per patient per year—far less than the least costs projected for antiretroviral therapies. Importantly, LDN has the simplicity of being taken just once a day at bedtime, as compared to the complexity of the combination antiviral regimens, and is free of side effects. This, in turn, markedly eases the burden of treatment-related public health education and medical supervision.

The implications are clear for those millions in the developing world who are already HIV positive, and who have little possibility of affording antiretroviral medication. Full-scale scientific clinical trials of LDN are urgently needed.

To fulfill the promise of LDN as a new, affordable treatment for HIV/AIDS, Dr. Bihari initiated a "Developing Nations Project". The first goal of the project is to interest a developing country in conducting a full-scale, double-blind, placebo-controlled prospective study of LDN as a treatment for HIV/AIDS. Then, with the successful outcome of the clinical trial, the project will work to achieve these further objectives:
  1. In the developing country which hosted the trial, to license a capable entity—with no licensing fee—to manufacture LDN, with the stipulation that LDN be sold at close to cost for the benefit of that nation's citizens.
  2. To help ensure the general availability of LDN throughout the developing world, particularly in those nations unable to afford HIV/AIDS treatment for their people.
  3. To gain scientific recognition of the efficacy of LDN for the treatment of HIV/AIDS in all countries.
We are certain you agree that the urgency behind this matter is great: thousands die each day in the developing world of HIV/AIDS. LDN is a drug that could prevent millions of people from sharing the same fate.

Any help that you can provide in this effort would be greatly appreciated. The Developing Nations Project team are seeking high-level governmental contact with developing nations interested in hosting a clinical trial of LDN. In addition, the project is searching for sources of funding, as many of the nations involved cannot afford to run clinical trials without third-party support.

For more information about the Developing Nations Project, please visit the LDN web site: http://www.ldninfo.org.

Thank you for your generosity of time and attention. May we, together, help save the lives of those who are suffering.

Sincerely yours,