Vedolizumab, A New Treatment for Ulcerative Colitis & Crohn's Disease Looks Promising - Info & Clinical Trial Included

Vedolizumab, a potentially new treatment for UC and Crohn's disease is being fast tracked for review by the FDA.  The BLA (biologics license application) will give priority review to the ulcerative colitis application and standard review to the Crohn's disease application.
The part of the clinical trial that is most important to me is the said adverse effects that were found in the patients who participated in the study.  Based on the concluding trial results, the adverse effects of the drug is said to be the same as the placebo.  That's great news.  I'm going to continue to watch this drug for new updates and news pertaining to safety. So far, this new treatment by Takeda Pharmaceuticals looks promising.
I have also included the clinical trial abstract below.  

Gastroenterology & Endoscopy News - New IBD Drug, Vedolizumab, Receives Priority Review Status for Ulcerative Colitis: 

On Sept. 4, Takeda Pharmaceutical Company Ltd., announced that it received priority review status from the FDA for its drug vedolizumab, an investigational antibody for the treatment of adults with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC). Takeda submitted a biologics license application (BLA) to the FDA in June for the treatment of CD and UC; the UC application will receive priority review, and the application for CD will be reviewed under the standard timeline.

The FDA grants priority review status for drugs that are designed to treat a serious condition, and that if approved, would provide a significant improvement in safety or effectiveness. Priority review designation allows for an eight-month review period compared with the standard 12-month review.

“The need to seek new treatment options is well recognized,” said William J. Sandborn, MD, chief, Division of Gastroenterology, and professor of medicine, University of California, San Diego School of Medicine, in a press statement. “Vedolizumab has demonstrated the potential to be another possible treatment option for people with moderately to severely active CD and UC.”

Vedolizumab is a humanized monoclonal antibody that specifically antagonizes α4β7 integrin and inhibits it from binding to its target receptor, mucosal addressin cell adhesion molecule-1 (MAdCAM-1). MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract. It interacts with α4β7 integrin, which is expressed on a subset of circulating white blood cells, to mediate the inflammatory process in patients with CD and UC.

Takeda’s BLA submission is supported by four Phase III clinical studies—GEMINI I, II and III, and GEMINI LTS (Long-Term Safety)—which comprise the GEMINI Studies^TM, a clinical program designed to investigate the efficacy and safety of vedolizumab in clinical response and remission in patients with moderate to severe CD and UC. Patients enrolled in the studies failed at least one conventional therapy for inflammatory bowel disease, including corticosteroids, immunomodulators and/or a tumor necrosis factor–alpha antagonist. The results of the Phase III studies of vedolizumab in patients with CD and UC were published recently in the New England Journal of Medicine (Sandborn WJ et al. N Engl J Med2013;369:711-721 and Feagan BG et al. N Engl J Med 2013;369:699-710, respectively).

According to Takeda, vedolizumab has been studied in 2,700 patients in nearly 40 countries, making it the largest Phase III clinical trial program to date to simultaneously evaluate CD and UC. GEMINI LTS is an ongoing, open-label, long-term safety study of vedolizumab and is designed to collect data on the occurrence of important clinical safety events resulting from the administration of vedolizumab.

—Based on a press release from Takeda Pharmaceutical Company Ltd.

Clinical Trial - PUBMED.gov

 N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734.

Vedolizumab as induction and maintenance therapy for ulcerative colitis.

Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group.

Collaborators (225)

Source

Robarts Clinical Trials, Robarts Research Institute, and Department of Medicine, University of Western Ontario, London, Canada. bfeagan@robarts.ca

Abstract

BACKGROUND:

Gut-selective blockade of lymphocyte trafficking by vedolizumab may constitute effective treatment for ulcerative colitis.

METHODS:

We conducted two integrated randomized, double-blind, placebo-controlled trials of vedolizumab in patients with active disease. In the trial of induction therapy, 374 patients (cohort 1) received vedolizumab (at a dose of 300 mg) or placebo intravenously at weeks 0 and 2, and 521 patients (cohort 2) received open-label vedolizumab at weeks 0 and 2, with disease evaluation at week 6. In the trial of maintenance therapy, patients in either cohort who had a response to vedolizumab at week 6 were randomly assigned to continue receiving vedolizumab every 8 or 4 weeks or to switch to placebo for up to 52 weeks. A response was defined as a reduction in the Mayo Clinic score (range, 0 to 12, with higher scores indicating more active disease) of at least 3 points and a decrease of at least 30% from baseline, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1.

RESULTS:

Response rates at week 6 were 47.1% and 25.5% among patients in the vedolizumab group and placebo group, respectively (difference with adjustment for stratification factors, 21.7 percentage points; 95% confidence interval [CI], 11.6 to 31.7; P<0 .001="" 41.8="" 44.8="" 4="" 52="" 8="" and="" at="" ayo="" clinic="" clinical="" continued="" every="" in="" no="" of="" patients="" receive="" remission="" score="" subscore="" to="" vedolizumab="" week="" weeks="" were="" who="">1), as compared with 15.9% of patients who switched to placebo (adjusted difference, 26.1 percentage points for vedolizumab every 8 weeks vs. placebo [95% CI, 14.9 to 37.2; P<0 .001="" 17.9="" 29.1="" 40.4="" 4="" adverse="" and="" ci="" events="" every="" for="" frequency="" groups.="" in="" of="" p="" percentage="" placebo="" points="" similar="" the="" to="" vedolizumab="" vs.="" was="" weeks="">

CONCLUSIONS:

Vedolizumab was more effective than placebo as induction and maintenance therapy for ulcerative colitis. (Funded by Millennium Pharmaceuticals; GEMINI 1 ClinicalTrials.gov number, NCT00783718.).

Comment in

• Inhibition of leukocyte trafficking in inflammatory bowel disease. [N Engl J Med. 2013]

PMID:

 

23964932

 

[PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/?term=23964932

Another Study Reveals Benefits of Medicinal Marijuana -Crohn's Remission

I have read dozens of articles, studies, reports, etc. that read similar to this article!  How many more studies are necessary for people to realize pot is not harmful and isn't going to kill anyone? It's actually almost funny that this herb is still looked at as a dangerous drug.  It's a plant... and it's shown to provide more benefits than harm.   The research always results in a significant benefit when studies are conducted.  I don't ever remember reading anything negative about marijuana, or it causing serious problems for the people that smoke it.  We would definitely know by now if weed were harmful.  Even if there were terrible outcomes from smoking pot, we do not hear these reports because of all the legality issues surrounding the word "marijuana".  It's ridiculous that the plant is still illegal and considered harmful here in the US!  Wake Up America!

Eventually, pot will be legal in all US states, but it's going to take a long time for all of them to adopt legislation (NY will probably be one of the last states to legalize it).  Turtle pace.... because that's how the US of A rolls.  Nice and s loooooooooooowwww. 

Medical Marijuana Causes 'Complete Remission' In Crohn's Disease Patients Without Side Effects, Study Finds : Latin Times:

Crohn's Disease has long been a fickle illness that requires meticulous attention to treat and live with. Researchers at the Department of Gastroenterology and Hepatology, Meir Medical Center in Israel, however, may have found relief for patients of the disease in medical marijuana. The study split 21 patients who received a high Crohn's disease activity index and were not responding to other treatments into two groups. One group was given a joint to smoke twice a day while the other group were given placebos lacking cannabinoids for the duration of eight weeks.

The study found complete remission for 45 percent of the group that smoked cannabis, or 5 out of 11 patients, as compared to the control group, which only experienced a 1 in 10 remission rate, the Huffington Post reported. It is speculated that cannabinoids with their anti-inflammatory properties are likely the cause of relief for the disease, which causes inflamation of the bowels. This inflammation can lead to extreme discomfort, diarhrea that may contain blood, weight loss, vomiting, rashes, inflammation of other parts of the body and tiredness among other symptoms, SF Gate reported. Others in the cannabis group reported lessened strength in their usual symptoms without the side effects caused by steroids often used to treat the illness.

"THC-rich cannabis produced significant clinical, steroid-free benefits to 11 patients with active Crohn's disease, compared with placebo, without side effects," the researchers wrote in the study. "Subjects receiving cannabis reported improved appetite and sleep, with no significant side effects."

The study, the authors conceded, was not a complete success as it was hypothesized that induced remission would occur for all or most of the patients. Still, researchers say that the relative success of this study is worth noting. The results have indeed produced a need for further investigation, the study says.

RELATED: Marijuana Diabetes: Pot Smokers Have Lower Diabetes Risk; Are Pot Smokers Skinnier? 

Crohn's disease is highly prevalent for whites, with 43.6 percent of every 100,000 being affected by the disease, one study by the Department of Family Medicine in San Bernardino, Calif. found. Latinos, by contrast, have the lowest rate of the disease with only 4.1 percent in every group of 100,000 being affected. Latinos, especially immigrants to the U.S., however, have notably higher rates of ulcerative colitis than most whites, VOXXI reported. A study in the American Journal of Gastroenterology, the urgency of treatment also contrasted non-Hispanics. Whites needed surgery at a much higher rate than Hispanics. Access to care may influence how often the disease is actually diagnosed, but researchers said that it does not explain the difference between U.S.-born and foreign-born Hispanics in terms of the prevalence of the disease.

"It is unclear what is responsible for this observation, but possibilities include changes in the environment with migration, diet and other factors related to acculturation," Daniel Sussman, assistant professor of clinical medicine in the Division of Gastroenterology, Jackson Memorial Hospital and University of Miami, said. "Our research did not measure the incidence or prevalence of IBD in Hispanics. Available population-based studies show that the incidence of IBD in some Latin American countries is higher than anticipated; this may be a result of the "westernization" of many Latin-American countries. As the Hispanic population continues to grow in the U.S., we expect that the number of Hispanic patients with IBD will also rise."

Researchers Report - 200 Genes Have a Connection to Crohn's Disease

Wish there was more to be said about these 200 genes they found that point to Crohn's.  Nice to know.  

Crohn's Disease, from what I read on a regular basis, is one of the most complex diseases to understand.  Scientists seem to always discover a relationship with "A" ("A" could be any of the following, I'm only listing a few:  impaired  immune response, an increased level of a serine protease, an antigen/toxin, introduced into the body,  a pathogen {a bacteria(especially MAP), virus, fungus} are associated with Crohn's, genetic factors... 200 of them apparently, drugs ( Accutane is the one I hear about the most), environmental factors such as hormonal therapy, ex. birth control.  Not enough exposure to parasites, microorganisms and infectious agents in early childhood- See: Hygiene Hypothesis.     OK that's enough.    You get the point.  

Crohn's can be associated with so many factors, but the progression to determine more components about that factor "A", may lead to other discoveries that bring understanding about how "A" and "B", but not enough to progress with more research studies. 

Then ... That's it!  Scientists reach dead ends. It seems as if the findings discovered do not provide enough concrete information to bring more understanding about the disease which halts additional  research You never hear  much more about the relationship between A & B again. This happens so much with so many of the studies that seek to understand the disease and they all seem to reach a dead end at some point during the research.  There's  a few factors that have a pretty good progression that continue to lead to more connections; & its MAP.  It is the only information that I have read  and continue to read that discover  new findings and links to Crohn's.  Scientists are able to get somewhere with their findings that allow them to be able to do more studies and they gain more  understanding about the disease. 

The other factor that stands out is the Hygiene Hypothesis.  Read about it, it makes sense. 

Of all the conditions we would have to have is one as complicated as the Crohn.    I associate the Crohn's with a nightmare person that is sorta like a stalker/rude/unpredictable/enjoys messing up my day(s) and overstays their welcome ... but they were never welocome to begin with ... The nightmare just comes right in and makes itself at home.   

Anyway... enough of my babble.  Feel free to comment on your thoughts on what research seems to stand and  make progress toward an effective treatment and maybe even a cure.  I'd love to hear what you've found .

Scientists Now See 200 Genes Linked to Crohn's Disease: MedlinePlus:

WEDNESDAY, Dec. 19 (HealthDay News) -- Using a new technique, researchers have pinpointed a large number of additional genes associated with Crohn's disease, bringing the total to 200.

The scientists at University College London, in England, created a new method to identify and map the locations of genes associated with complex inherited diseases such as Crohn's.

Crohn's disease, a type of inflammatory bowel disease, affects about 100 to 150 people out of every 100,000. Understanding more about the genes associated with the disease may lead to improved treatments, the researchers said.

The 200 genes so far linked to Crohn's are more than have been found for any other disease, according to the researchers. For example, just 66 gene regions are known for type 2 diabetes.

"The discovery of so many gene locations for Crohn's disease is an important step forward in understanding the disease, which has a very complicated genetic basis," study senior author Dr. Nikolas Maniatis said in a university news release. "We hope that the method we have used here can be used to identify the genes involved in other diseases which are similarly complex -- for example different cancers and diabetes."

The new research was published Dec. 13 in the American Journal of Human Genetics.

SOURCE: University College London, news release, Dec. 13, 2012

HealthDay

Copyright (c) 2012 HealthDay. All rights reserved.

Nutrition & Crohn's Disease: Vitamins & Supplement Information From WebMD

Vitamins for Crohn's Disease: Supplement Information From WebMD:

Vitamins for Crohn's Disease

If you have Crohn's disease, good nutrition is crucial so you can stay as healthy as possible. Unfortunately, the disease -- as well as treatments for it -- can make it much harder to get enough of the vitamins and minerals you need.

Doctors often recommend vitamins for Crohn's disease to work around this problem. Whether you need Crohn's disease vitamins -- and which ones -- depends on your case and the your medical treatments.  

Here's a rundown of the minerals and vitamins for Crohn's disease that your body might not be getting -- and advice on how to get more of them.

Crohn's Disease Nutrition

Poor nutrition has real risks if you have Crohn's disease. You may feel run-down and sick. Medications may not work as well. In children and teens, poor nutrition related to Crohn's disease can stunt growth.

Why does Crohn's disease affect nutrition? There are several reasons.

• Inflammation and damage to the small intestine fromCrohn's diseasecan make it hard for the body to absorb substances from food, such as carbs, fats, water, and many vitamins and minerals. Surgery for Crohn’s may also make it more difficult to absorb nutrients.
• Reduced appetite -- from pain, diarrhea, anxiety, and changes in taste -- makes it hard to eat enough.  
• Some medications for Crohn's disease make it harder to absorb nutrients.
• Internal bleeding in the digestive tract can lead to anemia, which can cause low levels of iron.

Crohn's Disease Nutrition: What's Missing?

What vitamins and minerals are missing in your diet? People with Crohn's disease are likely to have lower levels of:

• Vitamin B12. After surgery in the ileum -- the lower section of the small intestine -- it may not be possible to absorb enough vitamin B12. Dietary changes and oral vitamins can help. Some people with Crohn's disease need injections of vitamin B12 or a B12 nasal spray.
• Folic acid. Some drugs for Crohn's disease, such as sulfasalazine or methotrexate, can lower levels of folic acid. A daily 1 mg dose of a folate supplement could help. 
• Vitamin D. Studies have shown the people with Crohn's disease often have low levels of vitamin D, which helps your body absorb calcium for strong bones.  Many people with Crohn's disease take an 800 IU supplement of vitamin D daily.
• Vitamin A, vitamin E, and vitamin K can be low in people who have trouble absorbing fats because of surgery for Crohn's disease.
• Calcium. Steroids for Crohn's disease can weaken bones and affect your body’s ability to absorb calcium. On top of that, some people with Crohn's disease avoid milk because they're also lactose intolerant, further reducing calcium. Up to 50% of people with Crohn's have osteopenia, or thinning of the bones. Taking additional supplements -- often 1,500 mg of calcium a day -- can help keep bones strong and prevent other problems.
• Iron. People with active Crohn's disease may develop anemia from blood loss in the intestines. The best treatment for anemia is with iron. Most people take iron tablets or liquid, but some get infusions instead.
• Potassium, magnesium, and zinc may be lower in people with Crohn's disease. Taking a daily supplement can help.

• Vitamins for Crohn's Disease: Diet vs. Supplements

  In general, any dietitian or nutritionist would tell you it's better to get your nutrition from whole foods instead of supplements.
  For some people with Crohn's disease, that's just not possible. Because of absorption problems, pain, and nausea, it may be hard to eat enough of the healthy foods that would give you the nutrition you need.
  What's more, Crohn's disease -- especially when it's active -- can make your body work harder. You may need more calories and nutrients than normal -- precisely at the time when it's hard to eat. Some healthy foods, such as high-fiber nuts and seeds, can also trigger flares in some people with Crohn's disease.
  In these cases, vitamin supplements for Crohn's disease can help fill any gaps in your nutrition. 

  Crohn's Disease Nutrition: Working With Your Doctor

  While supplements can be a good idea for some people with Crohn's disease, don't start treating yourself with handfuls of vitamins every day. That's risky.
  Talk to your doctor first. Some supplements could interact with your medication or make your Crohn's symptoms worse.
  Before suggesting supplements, your doctor may want to check you for nutritional deficiencies. The doctor may test your levels of iron, vitamin D, vitamin B12, and other vitamins and minerals. The vitamins you need may also depend on where the damage is in your small intestine.
  Schedule an appointment with a doctor. Getting good nutrition -- whether it's through dietary changes or supplements -- is essential to protect your health and help you feel better with Crohn's disease.
  
  
  WebMD Medical Reference
  View Article Source
  Reviewed by Louise Chang, MD on April 02, 2012
  © 2012 WebMD, LLC. All rights reserved.

Crohns & Colitis Movie Trailer

The Body-rejects medicine, non-tolerant of food, flares sporadically=MY BODY

FRAGILE, BREAKABLE,VULNERABLE, EASILY DISTURBED.     CALL IT WHAT YOU WILL.  
FYI - I PREFER AMY.  TRUST ME, I DON'T LIKE IT EITHER

I'm sick of searching and searching, always looking for something.  This is my cycle living with the Crohn with a mind of it's own!  It's a stubborn disease and is very hard to determine what actually brought on pain, increase in symptoms or even a flare.  It's all about trial and error.
I must say, you'll experience a lot more errors and it can change it's mind at any time (always have to keep that in mind)
Today, I'm sorry I'm negative and bitchin.   I should be starting the day with a  better attitude,and I will after I'm done ranting.
My hope was crushed again! I think I had a negative reaction to the LDN I started taking a little over a month ago.  My fragile body was accepting the ldn and it was helping me!!  I haven't taken the ldn in over a week because I don't want to be alone when I take it , just in case... ya never know. I also dont want to take another trip to the ER again, Oh.... & I'd like a doctor to oversee & prescribe LDN  for me.  Not  have all these clueless doctors.  I'm just frustrated w/ searching, finding, flopping, repeat  GRRRRRR.

I'm still hopeful and have faith that things will turn out positive, eventually.  Till then, I just need to shut the F up and get reading.      I think i'll get on that :)

Mycobacterium avium subspecies paratuberculosis (MAP) "suspected as a causative agent in Crohn's disease"

Hmmmmm... interesting.  My friend happened to stumble upon this on Wikipedia when she was reading about milk pasteurization (totally unrelated to Crohn's).  I thought that milk is supposed to do our body good.. Well, that's what they used to say.  And if this is a possible cause of Crohn's disease (because remember no one knows the cause of Crohn's), why are they not doing more research to find out for sure.  

Maybe this explains why children as young as 3 or 4 years old get Crohn's Disease.  The whole time they are sippin on their yummy warm milk in their bottle or sippy cup, they're possibly swallowing some MAP, which is a stubborn, resistant bastard.    That could explain where Crohn's gets it's stubbornness from.  

Just  thought this was something to think about. Feel free to leave opinions  :)

MAP causes Johne's disease in cattle and other ruminants, and it has long been suspected as a causative agent in Crohn's disease in humans;^[3] this connection is controversial.^[4]

Recent studies have shown that MAP present in milk can survive pasteurization, which has raised human health concerns due to the widespread nature of MAP in modern dairy herds. MAP survival during pasteurization is dependent on the D_72C-value of the strains present and their concentration in milk. It is heat resistant and is capable of sequestering itself inside white blood cells, which may contribute to its persistence in milk. It has also been reported to survive chlorination in municipal water supplies.

Even though MAP is hardy, it is slow growing and fastidious, which means it is difficult to culture. Many negative studies for MAP presence in living tissue, food, and water have used culture methods to determine whether the bacteria are present. Due to recent advances in our knowledge of the bacterium, some or all of these studies may need to be re-evaluated on the basis of culture methodology.

MAP infections, like with most mycobacteria, are difficult to treat. It is not susceptible to antituberculosis drugs (which can generally kill Mycobacterium tuberculosis), but can only be treated with a combination of antibioticssuch as rifabutin and a macrolide such as clarithromycin. Treatment regimens can last years.^[5][6]

[edit]Crohn's disease

MAP is recognized as a multi-host mycobacterial pathogen with a proven specific ability to initiate and maintain systemic infection and chronic inflammation of the intestine of a range of histopathological types in many animal species, including primates.^[7]

On the assumption that MAP is a causative agent in Crohn's disease, the Australian biotechnology company Giaconda is seeking to commercialize a combination of rifabutin, clarithromycin, and clofazimine as a potential drug therapy, called Myoconda, for Crohn's. As of April 2007, Giaconda received United States FDA IND approval for a new Phase 2/3 trial.^[8]

MAP has been found in larger numbers within the intestines of Crohn's disease patients^[9] than those with ulcerative colitis and healthy controls.

http://en.wikipedia.org/wiki/Mycobacterium_avium_subspecies_paratuberculosis

A Short Article That Says A Lot About LDN

I like this short article because it covers the history of the drug LDN, how it started to get used for autoimmune diseases and why the FDA hasn't approved it for conditions other than drug addiction.  This article is from 2007 however, it's now 2011 and people still haven't heard about low dose naltrexone as an alternative treatment for many diseases.  I began doing research for SAFE and effective treatment for Crohn's Disease because I was on Remicade.  In my opinion, Remicade and other biologic drugs that weaken the immune system are not SAFE options.  Read the side-effect and safety indications for any of the biologics that are being used for many inflammatory diseases.  After reading this for yourself, you will understand why I consider this an unsafe treatment. Next, look up the side-effect and safety warnings for LDN/naltrexone.  

Now which one would you choose ?   

LDN - An Emerging Treatment - Article By Carl Frankel, Care2 Green Living contribution writer

If you’re one of the millions of people with auto-immune disease, there may be help for you. It’s a drug with a mouthful of a name—Low-Dosage Naltrexone, or LDN for short.

LDN is best known for its effect on multiple sclerosis. Thousands of people with MS are persuaded that it has halted the disease’s downward progression, and even reversed their symptoms. People with lupus, fibromyalgia, chronic fatigue syndrome, Crohn’s disease, and psoriasis also report benefits.

The good news doesn’t stop here. LDN is affordable—a bit over a dollar a day. Side effects——and many people don’t have them—are mild and short-term. It’s even FDA-approved, sort of. (It has “off-label” approval, meaning the FDA okayed it for a different purpose.)

The story of LDN is an intriguing saga of one man’s pioneering work, followed by a grass-roots, Internet-driven movement.

Naltrexone, without the “low-dosage” part, was developed by Dupont to treat drug addition, and approved in 1984 by the FDA for that purpose. The standard dosage was 50 milligrams, and it didn’t pan out as a treatment. Naltrexone blocks the opiate receptors in the brain. It works, in other words, by taking the fun out of taking opiates. The problem is, it takes the fun out of just about everything else, too. The result: People wouldn’t stay with the program.

Bernard Bihari, a Harvard-trained neurologist, began researching naltrexone and discovered something remarkable. When people took the drug in very low doses (3.0—4.5 milligrams instead of the standard 50 mg. dosage), it appeared to have a dramatic effect on auto-immune diseases. Bihari hypothesized that this essentially homeopathic dosage caused the body to manufacture more endorphins, which are centrally involved in supporting and regulating the immune system. He also came to believe it helped fight cancer and HIV.

Over the past 15 years or so, many thousands of people have taken LDN, to positive effect. The “anecdotal” evidence, so-called because it’s derived from stories, not studies, is overwhelmingly positive. It is also hugely persuasive, if you’re not the sort of person (your typical doctor, for instance) who requires clinical trials to be persuaded.

Where has the medical establishment been during this explosion of grassroots interest? Until recently, unmotivated and indifferent. Because the patent has expired and the drug is so inexpensive, there’s little money to be made from LDN, and therefore little reason to conduct clinical trials.

This can make it difficult to get a prescription for LDN. Because it hasn’t been clinically proven to be an effective auto-immune disease treatment, many doctors won’t prescribe it.

Recently, the medical establishment has started turning its attention to LDN, for a very simple reason: The anecdotal evidence is that overwhelming. Three national conferences on LDN have been held, and clinical trials have been launched in the United States and elsewhere. The first study to report results came out of Penn State University: “LDN therapy appears effective and safe in subjects with active Crohn’s disease.”

If you’re interested in learning more about LDN, a wealth of information is available at
www.ldninfo.org.

As for whether or not to try LDN, at the end of the day, there’s only one person who knows what’s right for you. And that’s you.

Carl Frankel is a journalist and author who has been writing about green business, green products, and integral living for the past 20 years.

More on Alternative Therapies (184 articles available)
More from Carl Frankel (12 articles available)

Read more: http://www.care2.com/greenliving/ldn-an-emerging-treatment.html#ixzz1LfORWCGV

Naltrexone - general info & other conditions it could possibly treat

So many people are clueless about this treatment... Thank you FDA, we love you too.
*Naltrexone is only FDA approved for the treatment of opiate/alcohol addiction in the US*  

Low doses of naltrexone can treat Crohn's, Colitis, MS, Cancer, AIDS & an array of other autoimmune diseases (this we know because the clinical trials say so & from personal experience ....  I'm feeling better and I've only been on it for 6 days!!!! YAYYYY)

This is just basic information about naltrexone.   Click on **Other Uses** and see the list of other conditions that Naltrexone can possibly treat.. I can't believe the list.  Autism to sexual dysfunction  Whaaaaaat?

http://en.wikipedia.org/wiki/Naltrexone
http://en.wikipedia.org/wiki/Naltrexone#Other_uses

 

Yuck = Biologic Drugs-Article states Humira causes permanent nerve damage

Abbott Labs Sued on Claim Humira Caused Lasting Nerve Damage

Abbott Laboratories (ABT) was sued on claims that its top-selling drug Humira caused permanent nerve damage in the feet of a Montana woman who took it for Crohn’s disease.

Two doctors who treated Kara Mae Pletan at the Mayo Clinic in 2008 said the nerve damage in her feet “was most likely due to Humira,” according to the lawsuit, which was filed today in state court in Chicago, near the company’s headquarters in Abbott Park, Illinois.

The complaint also alleges Abbott knew that Humira, which had 2010 worldwide sales of $6.5 billion, could cause peripheral neuropathy before it began marketing the drug to Crohn’s patients in 2007. Earlier this year, Abbott was sued by two arthritis sufferers in Texas andMassachusetts who claim Humira gave them cancer.

“Abbott has downplayed the risk of side effects, including the very real risk of permanent neuropathy,” Andy Vickery, Pletan’s lawyer, said in an e-mail.

Abbott initially sold Humira in 2003 as a treatment for rheumatoid arthritis. The U.S. Food and Drug Administration now approves Humira for the treatment of five additional autoimmune diseases, including Crohn’s.

Humira is expected to outsell Roche Holding AG (ROG)’s Avastin cancer medicine by 2016 to become the world’s most lucrative drug, according to a May 2010 forecast by research company EvaluatePharma.

Safety Data

“Humira has more than 12 years of clinical and safety data and best-in-class efficacy,” Adelle Infante, an Abbott spokeswoman, said in January, after the filing of the first lawsuit claiming Humira caused a Texas woman’s cancer. “The therapeutic risks associated with Humira are well known and documented in the prescribing label.”

Infante today declined to comment on the nerve-damage suit because Abbott hasn’t read the complaint.

Humira’s full package insert as of July 2004 warned that patients in clinical trials of similar types of drugs had developed more cancers than patients receiving other rheumatoid arthritis treatments. The class of drugs, known as tumor necrosis factor-blockers, prevent the body’s cancer-killing cells from working.

“The FDA has yet to focus in on the risk of neuropathy and other forms of neurological side effects, and Abbott has chosen to provide little if any information about these risks to either physicians or patients,” Pletan said in the complaint.

Issued Report

Doctors at Angers University in France issued a report in April 2006 suggesting that Humira could cause peripheral neuropathy, Pletan said in court papers.

“Abbott was actually aware of this article prior to the 2007 launch for Crohn’s,” she said.

In January, Gayathri Murthy, a Houston hospital worker, sued Abbott claiming she developed lymphoma while taking Humira for arthritis in 2005 and 2006. Earlier this month, a Massachusetts arthritis patient, Maureen Calisi, sued the company for allegedly causing her lymphoma after she took Humira from 2003 until 2008. Both cases are pending.

Both Murthy and Calisi are represented by Vickery, of Vickery, Waldner & Mallia LLP in Houston, who said he has “more than a dozen clients with legitimate legal claims involving Humira.”

Months of Injections

Pletan, 32, claims she developed small fiber peripheral neuropathy after receiving three months of Humira injections in 2008. The resulting “stabbing pains and hypersensitivity” in her feet forced her to give up outdoor activities and sell her family’s retail furniture store in Bozeman,Montana, when she could no longer work on her feet, she said in her complaint.

“The progression of the nerve damage seems to have stopped” after ceasing Humira injections, Pletan said in the filing. The nerve damage “appears to be permanent,” she said. Pletan is seeking both economic and punitive damages.

The case is Pletan v. Abbott Laboratories, 2011L004270, Circuit Court of Cook County, Illinois (Chicago).

To contact the reporters on this story: Laurel Brubaker Calkins in Houston atlaurel@calkins.us.com; Margaret Cronin Fisk in Southfield, Michigan, atmcfisk@bloomberg.net.

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net