Two-Year “Plus” Plan

We see the current Mali LDN Project as part of the evolution of a new approach to medicine that is gaining favor among many clinicians and researchers, even as mainstream, orthodox medicine clings to its allopathic foundations and tendency to treat symptoms rather than causes of disease. It is becoming clear that we need to pay more direct attention to the human immune system (and the earth’s as well!) as a way to stay healthy in an increasingly toxic world. Explorations of medicines, dietary practices, nutritional supplements and life-style changes that strengthen the immune system will likely become more effective in preventing disease than our past approach of treating each illness that comes along by trying to diminish the negative effects of its symptoms on the human body (and psyche). The use of LDN and similar agents in the treatment of HIV is an excellent case in point and may turn out to be a major part of the New Medicine’s “black bag.”

For this and many other reasons, we see the clinical and social/cultural project that has been ongoing in Mali since the fall of 2007 as the first phase of a long-term, multiphase program that can eventually play an important role in improving the health of perhaps millions of people, particularly in the Developing World. At this point we want to envision the next two-plus years of the LDN and Social Change Project we have undertaken, knowing that the truly long-term implications of what is about to happen in Mali may be beyond our present capability to envision.

Phase I:

  1. Clinical evaluation of LDN relative to the Anti-Retroviral Medications; and
  2. The Exploration of Dialogs among adult men and women concerning changes in social and relational mores.

This is the program currently being enacted and described on the pages of this web site.

Time Frame: September, 2007 – December, 2009

Phase II:

  1. Clinical evaluation of LDN for HIV+ infants and children
  2. Establishing an LDN manufacturing and distribution system in Mali
  3. Expansion of the Council Program to adults not in the present clinical study

Time Frame: March, 2009 – December, 2010

The first task of Phase II is to expand what we have learned in Phase I into the treatment of HIV positive infants and children using LDN in its transdermal cream form. We envision a clinical nine-month to one year pilot program involving HIV positive children from new-born infants to ten years of age that will confirm the safety and efficacy of LDN in maintaining a sufficiently high CD-4+ count to prevent the onset of AIDS symptoms. The safety of transdermal LDN with children has been shown by the many thousands of American children with autism now safely using this medication for immune modulation and cognitive/social enhancement. And once effectiveness against HIV + status is shown for adults in our current study, standard medical practices support that the same will likely hold true in children in appropriately smaller doses. However, though safety is not an issue, specific efficacy and dosage of LDN to help immunity against HIV+ in infants and small children does need to be established in a clinical trial.

The second task of Phase II is to create the capability in Bamako, Mali to manufacture LDN in both its capsule and transdermal cream forms at a level of productivity that would serve the entire Mali HIV positive population—estimated currently to be about 400,000 people. LDN is simple to make in both forms and the technology to do this is readily available and easily transferred to a Mali team made up of pharmacological, manufacturing and entrepreneurial specialists. We are already in the process of exploring patent issues, and have begun contacting funding and technical support in both the Mali Government and private sector for creating this manufacturing capability.

The Government has already established a medical distribution system that reaches many villages, as well as the urban centers of the Country, so it will be sufficient to deliver the medications in bulk to the appropriate government authorities in order to make them available to many who may be served by the use of LDN. Gaining approval for such distribution will be facilitated by the Principal Investigator, Professor Kader Traore, who leads the Mali CNAM, which is the government agency responsible for the distribution of medications.

The third task of Phase II will make use of what we learn from the eight ongoing and completed council groups that were started in the spring of 2008. These have been effective in bringing about changes in the way men and women relate to each other in the Malian Culture—changes that will make it possible for women (and men!) to protect their health and that of their children. We envision a continuation of the men’s, women’s and mixed councils and initiating new councils with adults who are informed of this opportunity through the various AIDS centers in Bamako, including CNAM, CESAC, Point G Hospital and the University of Bamako.

“Plus” – Phase III:

  1. Education About and Expansion of the Distribution of LDN to Other African Countries
  2. Introduction of Council in Selected Mali Schools and Other Organizations

 

Time Frame: July 2010 – ?

We leave a description of this phase of the Project to future envisioning when we have results from the Phase I clinical and gender education studies now ongoing.