LDN Editor’s Blog
From the Desk of David Gluck, MD
Updated: June 9, 2013
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.