The LDN 2013 Conference website goes live http://ldn2013.com/
The LDN 2013 AIIC Conference is a charity event organised by the LDN Research Trust, which is being held at Harper College, Palatine Illinois on 5th October 2013.
LDN 2013 AIIC Conference Schedule
Please be aware that this schedule is subject to change. In any event we will update this page accordingly.
08:30 - Registration
09:00 - Linda Elsegood Welcome Address
09:05 - Dr Mark Mandel, Introduction
09:10 - Dr Pradeep Chopra - Pain Specialist
09:40 - Speaker
10:00 - Dr Kent Holtorf - Thyroid Disorders/CFS/ Fibro/Lyme
10:40 - Break
10:45 - Jackie Young-Bihari - LDN Research Trust Patron
10:55 - LDN Expert Panel - Pharmacist Dr Skip Lenz
11:55 - Q&A Panel
12:15 - Lunch
13:15 - Dr Ronald Herberman – Planned LDN Clinical Trials
13:45 - Paul Battle PA-C - Crohn's/MS
14:15 - Dr Burt Berkson - Cancer
14:45 - Dr Deanna Windham – Allergies/Autoimmune diseases in Children/Lupus
15:15 - Break
15:30 - Dr Mark Shukhman - Psychiatrist
16:00 - Dr Mark Mandel and Stephen Dickson – LDN Compounding Pharmacists
16:30 - Q&A Panel
16:50 - Dr Mark Mandel - Summary
The LDN Research Trust would like to thank:
Dr Mark Mandel and Linda Elsegood for all their hard work and dedication in organising the conference and to Lee Reynolds for building the website. They all worked on a volunteer basis.
TNI Biotech,inc for sponsoring and hosting the Networking Party. More:
http://ldn2013.com/
Friday, April 26, 2013
Why 3 mg. Low Dose Naltrexone Might Be Best
Why 3 mg. Low Dose Naltrexone Might Be Best
The above title should probably say 3 mg. being the best dose in those with liver disease, cirrhosis or cancer. More evidence is being produced on why a lower dose of LDN might be best. Jayne Crocker of LDN NOW has been in touch with Dr. Ian Zagon over the years (he discovered LDN and OGF) and she has shared his thoughts on why 3mg LDN is the optimal dosage and not 4.5. Particularly in those who have problems clearing LDN from their systems or liver. Dr. Zagon also said that some may benefit from every other night dosing but at the maximum of 3 mg.
Remember, the discovery of LDN came about through research of an opioid system that has remarkable effects on mood an d *cell proliferation*. I highlight *cell proliferation* as I can’t stress enough the understanding of this. When anyone asks how LDN works, we always seem to tell them ‘it modulates the immune system’, which is correct, but let’s break that down a bit and explain what this actually means for cancer.
Once you are diagnosed with cancer, your body lives with cancer cells. These cells have a tendency to grow. The effect you want from taking LDN is to *regulate* cell proliferation, do what you can to stop the cancer cells from spreading. If taken at a low enough dose, LDN can stop the cancerous cells from proliferating by putting a stop to them spreading. In other words, it works by preventing cells from reproducing.
In order to achieve this effect from taking LDN, you need to allow as much time as possible for that endorphin OGF to do its magic (rebound effect). Endorphins are found in most cells of your body and are an important regulator of cell growth. OGF is the one endorphin that has been found to have an influence on cell growth (meaning it can put the brakes on) – which is a good thing!
Now, the duration of the ‘rebound effect’ which happens once LDN clears your system (hopefully in 4-6 hours) is usually around 20 hours, which is why people then take another dose of LDN. It very much is a supply and demand protocol. Once the rebound effect wears off, you take another dose of LDN and 4-6 hours later you allow the endorphins to to go to work for another 20 hours or so.
If for whatever reason you are not clearing LDN out of your system in 4-6 hours, you are diminishing the amount of time you are giving yourself for OGF to do all the good work (it’s not LDN that’s helping you here, but OGF). LDN is just a decoy! There are numerous people with compromised immune systems who cannot metabolize LDN efficiently at a dose of 4.5mg. It is the experience of Dr Zagon, that no more than 3mg will have this positive effect for everyone and I believe he is very adamant about this, especially those using LDN for cancer.
Dr. Zagon email:
The 4.5 mg story.
In 1983 after we published a series of papers in Science announcing our discovery of LDN/HDN - and opioids as growth factors - I received a telephone call from a Dr. Bihari. He was director of medical affairs at Downstate Medical Center in Brookl yn. He thought what we were doing was fabulous and should be used on patients immediately. He asked me what dosage to use. In our patents that were filed, we estimated 1--10 mg/day of LDN - this was based on human pharmacology work with naltrexone that others had done. I said to take a 50 mg tablet and cut it down to around 5 mg. He called me the next day and to my amazement he told me he took it the night before and awoke feeling terrific (remember, you get an endorphin high because LDN raises the endogenous opioids). Apparently, he then went on prescribing close to this dosage - 4.5 mg - to patients as an off-label drug. And, it was working. Now, in fact 4.5 mg probably is not maximizing the window of effect, and is prolonging the naltrexone in the body longer than it should be. That is why 3 mg is best - keeps to a short window of 4-6 hours for NTX, and then 18-20 for the opioids to react with the receptors.Dr. Zagon
It is my understanding that Dr Smith obtained funding and approval to go ahead with the Crohns trial at a dose of 4.5mg when it was thought that 4.5mg was the best dose to take, but you can see from Dr Zagon’s explanation that in order to get the benefit from the OGF effect, a dose of 3mg is preferable. Dr Smith’s trial also had patients combining LDN with steroids. Now, with all the latest research done and knowledge base we have as of todate, one has to ask if this trial would have produced more favourable results if patients were taking 3mg?
Remember, the minute you take LDN, it is doing everything you do not want it to do (activates cells). In other words as soon as LDN blocks the opioids, it becomes a negative. Increasing the dose means you are increasing the time of the blockade period. You want to control cell activation, not encourage it and this only happens when LDN clears your system and OGF goes to work. The goal from using LDN is to get the maximum effect from the Opioid Growth Factor (OGF), not Naltrexone itself.
Let’s say if you take 3mg you are blocking the opioids for 4 hours, You then have to allow for another 4 hours for OGF to undo all the activity that LD N has done. So 8 hours later you are really benefitting from the OGF for the remainder of the 24 hour cycle. This means 16 hours of great work. Increasing the dose of LDN to 4.5mg means the blockade will last longer, maybe 6 hours. So you then have to allow another 6 hours for OGF to get your body back to what it was prior to taking LDN (12 hours), so you then only have 12 hours of benefitting from taking LDN as opposed to 16 hours with taking a dose of 3mg. And 24 hours later we start again.
And over the last few years it seems that by and far most folks with liver issues and elevated enzymes all do very well with LDN, with great reduction in their lft's. However, in a few folks, usually in those with cirrhosis, they have reported elevations - and I believe that all of them were taking 4.5mg. The couple that did know their ferritin levels also reported high levels (350+).
How do we know if we are clearing the LDN? Good question - but again, another reason that each person needs to find out what dose works best for them - and not think that one must take 3mg or 4.5mg. Experiment with dosage if you can. More later..
Thanks Jayne!
It's Jazz Fest in New Orleans!
Ahh....nothing like Spring in New Orleans! The calm before the white knuckle days of Hurricane season....but now we party - and party right at the 2013 New Orleans Jazz Fest - go to WWOZ radio here and listen to the Fest live - on the greatest radio station in the world!
Monday, March 4, 2013
A New Year
New Year - New Life
Well, months later, I am celebrating a new life - again! After a hellish 2-3 years of poverty and becoming used to a day to day existence, things finally took a financial turn for the better in 2013. Yay - so at the time, I took a pic of the supplements that I had just had shipped in that day - I'd been out of so many supplements for so long - Note - the black cat is Voodoo - a recent addition to the troops - his story is a strange one - lived in City Park for about a year until he finally let me get him into a carrier. He turned out to be a tame cat, already fixed and used to being in a home - unfortunately, he tested positive for the FIV virus (cat aids), so I am holding on to him for now - might even try the LDN on him too. He was rescued a week before the Voodoo Festival last Halloween.
Anyway, also in January, I turned 60! - yay - I made it. It was also a celebration of my 10+ years of being HCV+ through the diagnosis in late 2002. (of course, I've probably been infected since the early 70's)
I also tried a low carb/high fat diet for a time but guess went about it the wrong way - too much too fast. I'd already been gluten free for several years - mostly dairy/soy free too, however, I was finding that small amounts of dairy was not bothering me as much as it had in the past, which I attributed to the LDN. However, I found myself getting those "Laughing Cow" packets and sucking them down. I shunned the gluten free flours and breads that I had been pretty much living on for the last few gf years - I was shocked to learn about all of the carbs involved in most of these foods - hell, sometimes, I was eating 300-350 carbs daily of "Healthy Food". Huh. So anyway, I decided to cut way back on carbs to the tune of 25 or so a day - wrong move - my body rebelled big time - yeast infection, non-stop urination for weeks; getting up 7 times at night to go to the bathroom. I had first thought that it was some sort of ketosis but when I finally ordered the urine test strips, they read normal. Once I ditched the dairy, it went away.
Retrospective update to above
I ran across my old Food Sensitivity Panel done by Alletess Medical Laboratory back in January of 2009 (shortly before Dr. Berkson and LDN). Some of the sensitivities were almond, cashew, peanut, sunflower seed, soybean, lentil, nutmeg, pecan, pumpkin, and quinoa. The highest were of course for gluten, yeast (bakers and brewers), rye, and sky-high for cow's milk, including yogurt. And with the exception of gluten/wheat, with the new diet, I had been eating most of the above. So perhaps that panel is very accurate when it comes to my personal make-up! For the first year or two after I had it done, I pretty much kept away from those foods but over time, I thought that I was a lot less sensitive to small amounts of them. Plus, a few folks over on the big LDN forum insisted that their food allergies disappeared after being on LDN for awhile. At any rate, it makes sense to me as most, if not all of the symptoms I had were do to the foods that I am still sensitive.Personal make up is so important with diet - and with the dosing of LDN - it just depends on how that person metabolizes it. (See next post "Why 3 mg. LDN Might Be Best" {in folks with bum livers} George H had mentioned in the comments that perhaps taking the LDN in split doses might be an option - and at one time, I had looked into it. There are a couple of studies in Europe (and folks on the LDN forum) that are using twice a day dosing - I believe that it is a pain/fibro related study. However, after learning of the info from Dr. Zagon via Jayne Crocker in the next post, I am back to the "less is more" approach.
Also in the mix is being IgA deficient as well as having MTHFR mutations A1298C and C677T, which according to my doc is causing the elevation in MCV and MCH. Am taking lots of methyl-folate along with B-12 sublingually (and B-complex 100).
At any rate, I am working on coming up with my own diet - again - Gluten-Free worked so well for so long that I lost sight of other things that could also benefit along the way. George Henderson's blog "The Hep C High Fat Diet" blog is very interesting - he is saying that by using a strict Paleo type diet, his overall health has improved - what I found interesting was that his typical HCV viral load stuck around 450,000 for years - and his last two test had them at the 45,000-65,000 levels (or close to that) - he is thinking that his diet is the reason - heavy stuff but, as usual with George, backed up by impeccable research. I found "Wheat Belly" by Dr. William Davis very interesting as was "The Paleo Diet; Loren Cordain". I also resubscribed to the Well Being Journal - a great bi-monthly magazine that has lots of great stuff. One included an article, " Carbohydrates, Hormones, and Weight Gain" that spoke a great deal about Gary Taubes research. I ran across his book at Good Will - "Good Calories, Bad Calories", which is excellent.
Also, in the pic above, shows a loaf of Udi's Gluten Free bread - too me, the most delicious GF bread out there - however, it does have 11g of carbs in each slice, so I now limit my portions to 1 slice instead of two - Going back to steaming, cooking lots of veggies, really like Whole Food ground turkey thigh; great for chili, sauces, etc. I have been eating the WF Applegate organic GF/CF nitrate free bacon with an omega egg or two. Now, back to pretty much eating what I was but watching the amount of carbs.
So much stuff - I had my 6 month appointment with my Rheumatolgist over at the LSU spot on St Charles. After having vitals taken (bp: 116/ 54 - or so, can never remember), I was placed in a room with miserable looking young woman with an active 4 year old. We got to talking and she said that she had Lupus and had been in and out of ER's and doctors offices. I asked her if she had ever been tested for Celiac Disease or gluten sensitivity - no, she had never heard of either. But I was very surprised when the rheumatology nurse chimed in that yes, she had heard that celiac was very much related to so many conditions, including Lupus. - The nurse even went so far as to write out some info for the young woman about celiac, and gluten - I was very impressed - you have to remember that it wasn't all that long ago, that no one, including most doctors and medical staff couldn't spell gluten. Later, when I was being checked out, the nurse thanked me for the info on gluten - she was looking into it - so that was way cool.
The visit was ok - a handsome young new doctor (prob 3 or 4th year), I showed him lab results, he asked if I had been treated for HCV, no, I told him brief LDN story, blah, blah, - he asked a couple of general questions and then went to get Dr. E - the top dude who I have seen since @2004 or so. Dr. E swept in, as he does and then asked me how long I'd been on the LDN - which has been almost 4 years exactly (drberkson in 2/09!)
So then Dr. E said that they had heard that LSU was going to start using LDN in the clinic - or "looking into it" - What? I pumped my arms - yay, finally some kind of medical institution finally recognizes that LDN might actually benefit all types of disorders, particularly in those with rheumatic type problems - though LDN seems to help darn near everything.. I told them about Dr. Berkson's presentation at the LDN Conference at the NIH a couple of years ago - one being about treating RA (and other disorders) via LDN and ALA -
RA with Lymphoma from Humira - B Cell Lymphoma - Breast Cancer - Rheumatoid Disorders - Dermatomyositis -
4) http://www.youtube.com/watch?v=RXz3VIuyHHk
RA - SLE (Lupus) -
5) http://www.youtube.com/watch?v=nttilGKpJvU
And all of his videos from that conference are here - (including the HCV, pancreatic cancer, liver cancer, and others, including Q & A sessions:
http://nolahepper.blogspot.com/2009/11/dr-berksons-2009-videos-pancreatic.html
I mentioned again that for me, a gluten-free diet combined with 3 mg. LDN seemed to work the best - the doctor mentioned something about "they told us about that too", which I took to be celiac I will say this - for a rheumy, this guy knows more about HCV than my gastros do. And, he is the only doctor besides my integrative doc, Dr. Rai, who wsa impressed by my labs - the rest just tell me that "I'm lucky".
At any rate, that's what's been going on of late. Hopefully, I will finally update this blog, particularly in the Diet/Supplement and Treating HCV with LDN sections very soon.
I'm still here and back among the living - back to my quest of living to the fullest - back in the light! And back to my quest of clearing this HCV crap - that's what's getting me the most. I am simply thrilled that my viral load has remained basically in the 11,000-35,000 range for 4 years. My question is why it won't go down any lower? Why did it stop at those numbers? - why not 100,000-150,000? Oh well, if all else fails, the non-interferon- non-side-effect- 100% effective antivirals are coming soon - or at least are on the horizon!
Oh, one of the questions that I get the most is this:
If you do ever clear the HCV virus, will you still use LDN?
Yes! And many people who do not have any disorders take it as a preventative. Including Dr. Berkson and other doctors who know about it. For example, in the almost 4 years since I have been on 3 mg. LDN, I have not had any colds, flu, etc. It has enhanced my immune system. On another note, I have not had the flu shot in over 30 years and don't recall having the flu during that time. That's not to say that there have been times when I have felt "something" come on. And that's when I go to Elderberry/Zinc - either the liquid elixer or the lozenges. The ZAND.com Elderberry Zinc Herbalozenge work great! It's also sweetened with brown rice syrup so great for diabetics.Of course, mainstream Docs refuse to understand this - for example, a few years back when I last went through the University Hospital "Medicine" system (and don't get me wrong - that is a great place to go if you don't have any money or insurance for health care!) I told the Dr - either intern or resident - that I did not want the Flu vaccine. He seemed to undersand. However, within 5 minutes, in came the nurse with both the influenza and pneumococcal vaccines. She explained that because I had a "compromised immune system due to having HCV," I needed both. I just started laughing and probably ended up with yet another AMA (against medical advice) on my chart for "refusing treatment."
Tuesday, January 22, 2013
Hello Health New HCV Drugs TV Show Rant
The other night, Ochsner Health System presented a show called "New Treatment Options for Hepatitis C." Dr. Nigel Girgrah (Multi-Organ Transplant Institute) and PA-C Jennifer Barrett spoke about the newer protease inhibitors that have been added to the Interferon/Riba standard treatment as well as the "unique patient centered clinic setting at the Hepatitis C clinic at Ochsner."
I submitted an email that had several questions about these new treatments as well as their opinions on supplements, diet, etc. I spent some time on it and included several links to NIH abstracts as well as an article about the limits on the newer Direct Acting Antivirals. At the end of the presentation, many folks called in and a couple of emails were read. Mine wasn't but it turned out that they had not received it.
At any rate, the show was both sad and comical at times. Most callers knew nothing about HCV and a couple had just learned that they had the virus after donating blood. But most wanted to know what they could do to help out their livers via diet or supplements.
Of course, they were told that there was no known diet that could help them and that milk thistle really didn't do anything. Dr. Girgrah said that there had been some early research done that showed that it helped but overall, nothing could help them except treatment. He also said that there really wasn't a "Hep C diet". I did a lot of screaming at the TV. There is so much info out there that there is no excuse for any medical doctor to not be aware of the importance of diet in any disorder. But this is not uncommon as back when a lot of these docs were in Med School, diet was a non-issue and they were not trained at all when it came to the importance of food. To be fair, New Orleans is probably the worst place on the planet for expousing "healthy food." Going gluten-free is extremely difficult and going low carb at the same time is almost next to impossible, particularly if one goes out to eat in restaurants. Still, when dealing with liver patients, I would hope that over at the unique patient centered clinic, there is at least a nutritionist available for consult - and not just for obese patients.
A worried Mom called in about her 20 something son who had just gotten out of the hospital with complications due to his HCV. He had no insurance. She asked the team what she should do. There was a deer in the headlights moment of absolute silence. I let out a laugh that I fear woke up my neighbor's 2 year old baby. The doctor did rally and mentioned getting into University Hospital"s system which offers care to low or no income people. Then he concluded by telling the woman to get him into "some kind of insurance program". At this point, I could hear the baby crying through my apartment's wall from my shrieking. Oh sure, try getting health insurance with Hep C. I had called Ochsner years ago and was told that they needed a $500.00 deposit just to walk into their clinic - it's probably much more now.
A man called in to report that his viral load had recently skyrocketed. What could he do? Of course, nothing but treatment would bring it down. Yes, treatment or using LDN. Whoever you are, please check out my labs - any of them. From 1,500,000 to it's current 16,500 by using Low Dose Naltrexone or LDN. It might not quite clear the virus but it will knock the crap out of it!
A 77 year old woman with congestive heart failure also called and asked if the new treatments would benefit her. She was told that with her condition, she wouldn't be a candidate but hopefully, in a few years when the interferon free stuff in the pipeline comes out, that would work for her. She'll be in her 80's then. The lady also asked if there was something she could buy at the drug store to help her liver and of course was told no.
I guess that it's been too long since my diagnosis of HCV over ten years ago. I was two months short of my 50th birthday and thought that I was going to die. I forgot that paralyzing fear that I felt until a couple of callers said that they had found out recently that they had the virus but had done nothing about it. They were scared to death and didn't know what to do - that was the heartbreaking part. I found out one day that I had it - spent the night reading about it and was at Charity Hospital clinic the next morning at 6:30 to get in line. But that's me - these poor folks paralyzed with fear. For their part, the Dr. and PA Jennifer Barrett did tell them to go see their doctors for more testing. It's very evident that they both care deeply about their patients and only want the best for them. And what it is best for them is to clear the virus. I am assuming that they are using the Response Guided Therapy to monitor the patients progress.
What has become more evident to me through this show is the desperate need for a Hepatitis C support group in New Orleans. Prior to Katrina, E. Jefferson Hospital offered one but they never started it up again. In New Orleans, musician Timothea Beckerman had established "Siren to Wail" and was very active in securing free HCV testing as well as organizing musical events to raise awareness of HCV. She appeared often on WWL TV. I spoke with her on the phone a few times after I was first diagnosed but never met her. Sadly, she passed away soon after Katrina in 2006. I'll never forget. I was watching the noon news on WWL and Eric Paulsen reported her death. I was shocked and numb.
I have been toying with starting such a group but as you all know, my interest is in alternatives - LDN, supplements and diet. I never wanted to be a cheerleader for those who actualy want to do the current treatment, direct acting antivirals or not. There is a lot of research out there that could help folks get through treatment with more success - lowering one's serum ferritin before treatment and raising both their Vitamin D3 and B12 levels. And I suspect that eliminating gluten would go a long way, particularly as both the Incivek and Ribavirin cause horrible rashes. Vertex just had to put a black box warning on Inivek (telaprevir), due to it killing people due to skin rashes. The FDA has received at least 112 reports of patients developing very serious skin conditions, particularly as a result of using Incivek. There are hundreds of NIH abstracts linking gluten with all skin conditons, as well as most medical conditions out there.
I guess that I don't know what I was expecting from the show, but it turned out to be the same old, same old. Medical staff trumpeting the higher SVR rates with the new drugs - up to 90%! What wasn't mentioned was that in people who had failed treatment before, the percentage was at @ 30-35%. And also the chance of developing a resistance to the drugs and having to stop - which would probably make future treatments with similar non-interferon therapies even more difficult.
Sigh, all of the above was in my email to the show that supposedly never got to them. Maybe it would have turned out differently if it had though I doubt it.
I submitted an email that had several questions about these new treatments as well as their opinions on supplements, diet, etc. I spent some time on it and included several links to NIH abstracts as well as an article about the limits on the newer Direct Acting Antivirals. At the end of the presentation, many folks called in and a couple of emails were read. Mine wasn't but it turned out that they had not received it.
At any rate, the show was both sad and comical at times. Most callers knew nothing about HCV and a couple had just learned that they had the virus after donating blood. But most wanted to know what they could do to help out their livers via diet or supplements.
Of course, they were told that there was no known diet that could help them and that milk thistle really didn't do anything. Dr. Girgrah said that there had been some early research done that showed that it helped but overall, nothing could help them except treatment. He also said that there really wasn't a "Hep C diet". I did a lot of screaming at the TV. There is so much info out there that there is no excuse for any medical doctor to not be aware of the importance of diet in any disorder. But this is not uncommon as back when a lot of these docs were in Med School, diet was a non-issue and they were not trained at all when it came to the importance of food. To be fair, New Orleans is probably the worst place on the planet for expousing "healthy food." Going gluten-free is extremely difficult and going low carb at the same time is almost next to impossible, particularly if one goes out to eat in restaurants. Still, when dealing with liver patients, I would hope that over at the unique patient centered clinic, there is at least a nutritionist available for consult - and not just for obese patients.
A worried Mom called in about her 20 something son who had just gotten out of the hospital with complications due to his HCV. He had no insurance. She asked the team what she should do. There was a deer in the headlights moment of absolute silence. I let out a laugh that I fear woke up my neighbor's 2 year old baby. The doctor did rally and mentioned getting into University Hospital"s system which offers care to low or no income people. Then he concluded by telling the woman to get him into "some kind of insurance program". At this point, I could hear the baby crying through my apartment's wall from my shrieking. Oh sure, try getting health insurance with Hep C. I had called Ochsner years ago and was told that they needed a $500.00 deposit just to walk into their clinic - it's probably much more now.
A man called in to report that his viral load had recently skyrocketed. What could he do? Of course, nothing but treatment would bring it down. Yes, treatment or using LDN. Whoever you are, please check out my labs - any of them. From 1,500,000 to it's current 16,500 by using Low Dose Naltrexone or LDN. It might not quite clear the virus but it will knock the crap out of it!
A 77 year old woman with congestive heart failure also called and asked if the new treatments would benefit her. She was told that with her condition, she wouldn't be a candidate but hopefully, in a few years when the interferon free stuff in the pipeline comes out, that would work for her. She'll be in her 80's then. The lady also asked if there was something she could buy at the drug store to help her liver and of course was told no.
I guess that it's been too long since my diagnosis of HCV over ten years ago. I was two months short of my 50th birthday and thought that I was going to die. I forgot that paralyzing fear that I felt until a couple of callers said that they had found out recently that they had the virus but had done nothing about it. They were scared to death and didn't know what to do - that was the heartbreaking part. I found out one day that I had it - spent the night reading about it and was at Charity Hospital clinic the next morning at 6:30 to get in line. But that's me - these poor folks paralyzed with fear. For their part, the Dr. and PA Jennifer Barrett did tell them to go see their doctors for more testing. It's very evident that they both care deeply about their patients and only want the best for them. And what it is best for them is to clear the virus. I am assuming that they are using the Response Guided Therapy to monitor the patients progress.
What has become more evident to me through this show is the desperate need for a Hepatitis C support group in New Orleans. Prior to Katrina, E. Jefferson Hospital offered one but they never started it up again. In New Orleans, musician Timothea Beckerman had established "Siren to Wail" and was very active in securing free HCV testing as well as organizing musical events to raise awareness of HCV. She appeared often on WWL TV. I spoke with her on the phone a few times after I was first diagnosed but never met her. Sadly, she passed away soon after Katrina in 2006. I'll never forget. I was watching the noon news on WWL and Eric Paulsen reported her death. I was shocked and numb.
I have been toying with starting such a group but as you all know, my interest is in alternatives - LDN, supplements and diet. I never wanted to be a cheerleader for those who actualy want to do the current treatment, direct acting antivirals or not. There is a lot of research out there that could help folks get through treatment with more success - lowering one's serum ferritin before treatment and raising both their Vitamin D3 and B12 levels. And I suspect that eliminating gluten would go a long way, particularly as both the Incivek and Ribavirin cause horrible rashes. Vertex just had to put a black box warning on Inivek (telaprevir), due to it killing people due to skin rashes. The FDA has received at least 112 reports of patients developing very serious skin conditions, particularly as a result of using Incivek. There are hundreds of NIH abstracts linking gluten with all skin conditons, as well as most medical conditions out there.
I guess that I don't know what I was expecting from the show, but it turned out to be the same old, same old. Medical staff trumpeting the higher SVR rates with the new drugs - up to 90%! What wasn't mentioned was that in people who had failed treatment before, the percentage was at @ 30-35%. And also the chance of developing a resistance to the drugs and having to stop - which would probably make future treatments with similar non-interferon therapies even more difficult.
Sigh, all of the above was in my email to the show that supposedly never got to them. Maybe it would have turned out differently if it had though I doubt it.
Monday, January 14, 2013
BioTech Acquires the Exclusive Rights to Low Dose Naltrexone...
TNI BioTech, Inc. Acquires the Exclusive Rights to Low Dose Naltrexone and Other Opioid Antagonists for the Treatment of Inflammatory and Ulcerative Diseases of the Bowel
TNI BioTech, Inc. (PINKSHEETS: TNIB) announced that it has signed an agreement for the acquisition of patent rights and orphan drug designation by the FDA to a novel late-stage drug, trademarked "LDN," for the treatment of Pediatric Crohn's Disease.
TNI BioTech has signed a licensing agreement to acquire the exclusive patent rights for the intellectual property of Dr. Jill Smith and LDN Research LLC, whose members are Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Moshe Rogosnitzky. The patent covers methods and formulations for treatment of the inflammatory and ulcerative diseases of the bowel, using naltrexone in low dose as an opioid antagonist. Endogenous opioids and opioid antagonists have been shown to play a role in stimulating and rebalancing the immune system and the healing and repair of tissues.
As part of the Agreement, TNI BioTech has the right to apply to the Food and Drug Administration (FDA) for the transfer of the orphan drug status, the investigational new drug applications (INDs), and the right to acquire the relevant clinical data set from Dr. Smith. The FDA has designated orphan drug status for the use of low dose naltrexone in the treatment of pediatric patients with Crohn's disease and ulcerative colitis.
The agreement calls for the formation of a Development Committee to monitor the clinical progress of the Licensed Products and will consist of independent scientific and technical leaders who are highly regarded by the scientific community in the Field of Use of each Licensed Product. The development committee will consist of at least one representative from the Licensor Parties and one representative from the Company in addition to outside experts in the field. The inventors input will be highly valued due to their history and expertise with the therapies.
"TNI BioTech is extremely pleased to acquire the exclusive rights to low dose naltrexone and other opioid antagonists for the treatment of inflammatory and ulcerative diseases of the bowel," stated Noreen Griffin, CEO of TNI BioTech. "We believe that low dose naltrexone has the potential to provide significant relief to those who suffer from Crohn's disease or other auto-immune disorders of the bowel." Low dose naltrexone has already been evaluated in two randomized placebo-controlled phase II trials, one for adult patients with Crohn's disease and the other for children with Crohn's disease by Dr. Jill Smith. Naltrexone in low dose has been well tolerated in almost all patients, and it showed significantly greater treatment efficacy than the control group in both trials. TNI BioTech is now planning to meet soon with the FDA to design and implement pivotal phase III trial(s) for treatment for patients with Crohn's disease using naltrexone in low dose. A platform immunomodulatory technology, naltrexone in low dose also is expected to be clinically tested for treatment of other immune-mediated or immune-deficient diseases, for which the company has previously acquired additional patents.
About TNI BioTech, Inc.
TNI BioTech, Inc. is a biotech company working to combat chronic, life-threatening diseases through the activation and modulation the body's immune system using our patented immunotherapy. Our products and immunotherapy technologies are designed to harness the power of the immune system to improve the treatment of cancer, chronic inflammatory diseases and autoimmune diseases, such as HIV/AIDS.
Our proprietary technology, therapies and patents include the treatment of a wide range of cancers. Our most advanced clinical program involves immunotherapy with Methionine Enkephalin (MENK) also termed Opioid Growth Factor (OGF), which has been shown to stimulate the immune system even in patients with advanced cancer. Management considers any condition that results in altered-immune response as a target for investigation, and the Company will most likely pursue additional investigations for low dose naltrexone and/or MENK as valuable candidates in the treatment of the following:
•Autoimmune disorders such as rheumatoid arthritis and multiple sclerosis
•As an adjunct in cancer patients undergoing chemotherapy, radiation treatments or surgery
•As an adjunct to antibiotics in the treatment of a variety of infectious diseases
•Patients with HIV/AIDS, in combination with retroviral drug therapy
Over on the big Low Dose Naltrexone forum, folks voiced concerns about a price increase because of this news. I was wondering about the cost issue too with this TNI Biotec deal. But according to what is on the Low Dose Naltrexone site, Dr. Gluck posted this:
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.
http://www.lowdosenaltrexone.org/editorials.htm
TNI BioTech, Inc. (PINKSHEETS: TNIB) announced that it has signed an agreement for the acquisition of patent rights and orphan drug designation by the FDA to a novel late-stage drug, trademarked "LDN," for the treatment of Pediatric Crohn's Disease.
TNI BioTech has signed a licensing agreement to acquire the exclusive patent rights for the intellectual property of Dr. Jill Smith and LDN Research LLC, whose members are Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Moshe Rogosnitzky. The patent covers methods and formulations for treatment of the inflammatory and ulcerative diseases of the bowel, using naltrexone in low dose as an opioid antagonist. Endogenous opioids and opioid antagonists have been shown to play a role in stimulating and rebalancing the immune system and the healing and repair of tissues.
As part of the Agreement, TNI BioTech has the right to apply to the Food and Drug Administration (FDA) for the transfer of the orphan drug status, the investigational new drug applications (INDs), and the right to acquire the relevant clinical data set from Dr. Smith. The FDA has designated orphan drug status for the use of low dose naltrexone in the treatment of pediatric patients with Crohn's disease and ulcerative colitis.
The agreement calls for the formation of a Development Committee to monitor the clinical progress of the Licensed Products and will consist of independent scientific and technical leaders who are highly regarded by the scientific community in the Field of Use of each Licensed Product. The development committee will consist of at least one representative from the Licensor Parties and one representative from the Company in addition to outside experts in the field. The inventors input will be highly valued due to their history and expertise with the therapies.
"TNI BioTech is extremely pleased to acquire the exclusive rights to low dose naltrexone and other opioid antagonists for the treatment of inflammatory and ulcerative diseases of the bowel," stated Noreen Griffin, CEO of TNI BioTech. "We believe that low dose naltrexone has the potential to provide significant relief to those who suffer from Crohn's disease or other auto-immune disorders of the bowel." Low dose naltrexone has already been evaluated in two randomized placebo-controlled phase II trials, one for adult patients with Crohn's disease and the other for children with Crohn's disease by Dr. Jill Smith. Naltrexone in low dose has been well tolerated in almost all patients, and it showed significantly greater treatment efficacy than the control group in both trials. TNI BioTech is now planning to meet soon with the FDA to design and implement pivotal phase III trial(s) for treatment for patients with Crohn's disease using naltrexone in low dose. A platform immunomodulatory technology, naltrexone in low dose also is expected to be clinically tested for treatment of other immune-mediated or immune-deficient diseases, for which the company has previously acquired additional patents.
About TNI BioTech, Inc.
TNI BioTech, Inc. is a biotech company working to combat chronic, life-threatening diseases through the activation and modulation the body's immune system using our patented immunotherapy. Our products and immunotherapy technologies are designed to harness the power of the immune system to improve the treatment of cancer, chronic inflammatory diseases and autoimmune diseases, such as HIV/AIDS.
Our proprietary technology, therapies and patents include the treatment of a wide range of cancers. Our most advanced clinical program involves immunotherapy with Methionine Enkephalin (MENK) also termed Opioid Growth Factor (OGF), which has been shown to stimulate the immune system even in patients with advanced cancer. Management considers any condition that results in altered-immune response as a target for investigation, and the Company will most likely pursue additional investigations for low dose naltrexone and/or MENK as valuable candidates in the treatment of the following:
•Autoimmune disorders such as rheumatoid arthritis and multiple sclerosis
•As an adjunct in cancer patients undergoing chemotherapy, radiation treatments or surgery
•As an adjunct to antibiotics in the treatment of a variety of infectious diseases
•Patients with HIV/AIDS, in combination with retroviral drug therapy
Over on the big Low Dose Naltrexone forum, folks voiced concerns about a price increase because of this news. I was wondering about the cost issue too with this TNI Biotec deal. But according to what is on the Low Dose Naltrexone site, Dr. Gluck posted this:
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.
http://www.lowdosenaltrexone.org/editorials.htm
Thursday, November 29, 2012
2013 NEW LABS HEP C and LDN
I have to admit that I was sweating these labs since it has been so long since the last ones - and having been out of so many supplements, I was concerned that my lft's would have gone up. Thankfully, they did not.
HCV RNA PCR - (viral load test) - 16,288 from 36,902 (1,400,000 pre-ldn)
ALT 25 was 27 (6-40)
AST 28 was 28 (10-35)
ALK PHOS 65 was 64 (33-130)
ALBUMIN 5.2 was 5.1 (3.6-5.1)
Globulin - 2.7 was 2.7 (2.2-3.9)
Bilirubin Tot. .05 was 0.8 (0.2-1.2)
Protein Tot 7.9 was 7.8 (6.2-8.3)
Alpha Fetoprotein (tumor marker) 5.1 was 5.2
White Blood cell - 4.8 was 4.3 (3.8-10.8)
Red Blood cell - 4.04 was 4.02 (3.80-5.10)
Platelets - 152 was 156 (140-400)
(all others pretty much same)
Glucose 75 was 80 (65-99)
Urea Nitrogen (Bun) 13 was 8 (7-25)
Creatinine 0.83 was 0.75
Sodium 136 was 137
Potassium 4.0 was 4.3 (3.5-5.3)
Chloride 99 was 100 (98-110)
Carbon Dioxide 22 was 21 (21-33)
Calcium 10.3 was 10.3 (8.6-10.4)
Cortisol.A.M. 17.7 was 18.5
Rheumatoid Factor 25 (H) was 21 (H)
Cyclic Citrullinated Peptide <16>
C-Reactive Protein - <0 .10=".10">
DHEA - 60 was 93 (15-170)
Estradiol - 15 was 21
FERRITIN - 89 was 47 (10-232) note - this is the highest this has been in years - HAVE NOT BEEN TAKING IP6!
IgA (Immunoglobulin A) 64 (L) was 61 (L) (81-463) note - am IGA deficient
IgG (Immunoglobulin G) 1327 was 1353 (694-1618)
IgM (Immunoglobulin M) 105 was 101 (48-271)
Insulin - 2 (<17>
Sjogren's antibody 1.4Pos was 1.7 was 2.5 was 3.5 in 2009
T3, FREE 2.6 was 3,1 (2,3-4,2)
T4, FREE 1.0 was 1.1 (0.8-1.8)
TSH, 3RD Generation - 1.85 WAS 2.19 (0.40-4.50)
Testosterone 45 was 17 (2-45) which is not surprising due to the constant stress!
Vitamin D, 25-OH total 53 was 72 (30-100) need more
A lot of other tests weren't run - lymphocytes, various hhv stuff and a few other things. However, absolute Lymphocytes increased 1718 from 1290 (850-3900) so despite everything, my immune system is in pretty good shape.
I am very pleased with these labs under the circumstances :<) But will me most happy to get my viral load level back - hopefully still low!
THE POWER OF LDN!!!!!!!!!!!!
Nola Chris
HCV RNA PCR - (viral load test) - 16,288 from 36,902 (1,400,000 pre-ldn)
ALT 25 was 27 (6-40)
AST 28 was 28 (10-35)
ALK PHOS 65 was 64 (33-130)
ALBUMIN 5.2 was 5.1 (3.6-5.1)
Globulin - 2.7 was 2.7 (2.2-3.9)
Bilirubin Tot. .05 was 0.8 (0.2-1.2)
Protein Tot 7.9 was 7.8 (6.2-8.3)
Alpha Fetoprotein (tumor marker) 5.1 was 5.2
White Blood cell - 4.8 was 4.3 (3.8-10.8)
Red Blood cell - 4.04 was 4.02 (3.80-5.10)
Platelets - 152 was 156 (140-400)
(all others pretty much same)
Glucose 75 was 80 (65-99)
Urea Nitrogen (Bun) 13 was 8 (7-25)
Creatinine 0.83 was 0.75
Sodium 136 was 137
Potassium 4.0 was 4.3 (3.5-5.3)
Chloride 99 was 100 (98-110)
Carbon Dioxide 22 was 21 (21-33)
Calcium 10.3 was 10.3 (8.6-10.4)
Cortisol.A.M. 17.7 was 18.5
Rheumatoid Factor 25 (H) was 21 (H)
Cyclic Citrullinated Peptide <16>
C-Reactive Protein - <0 .10=".10">
DHEA - 60 was 93 (15-170)
Estradiol - 15 was 21
FERRITIN - 89 was 47 (10-232) note - this is the highest this has been in years - HAVE NOT BEEN TAKING IP6!
IgA (Immunoglobulin A) 64 (L) was 61 (L) (81-463) note - am IGA deficient
IgG (Immunoglobulin G) 1327 was 1353 (694-1618)
IgM (Immunoglobulin M) 105 was 101 (48-271)
Insulin - 2 (<17>
Sjogren's antibody 1.4Pos was 1.7 was 2.5 was 3.5 in 2009
T3, FREE 2.6 was 3,1 (2,3-4,2)
T4, FREE 1.0 was 1.1 (0.8-1.8)
TSH, 3RD Generation - 1.85 WAS 2.19 (0.40-4.50)
Testosterone 45 was 17 (2-45) which is not surprising due to the constant stress!
Vitamin D, 25-OH total 53 was 72 (30-100) need more
A lot of other tests weren't run - lymphocytes, various hhv stuff and a few other things. However, absolute Lymphocytes increased 1718 from 1290 (850-3900) so despite everything, my immune system is in pretty good shape.
I am very pleased with these labs under the circumstances :<) But will me most happy to get my viral load level back - hopefully still low!
THE POWER OF LDN!!!!!!!!!!!!
Nola Chris
Subscribe to:
Comments (Atom)