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.

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.