Working Toward FDA Approval for LDN— Jan, 2012

By May 8, 2017LDN info

An excerpt from www.lowdosenaltrexone.org :

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!