Health Benefits from #Probiotics-Definitely Does The Body Good

I use probiotics, I have to in order to keep my gut balanced.  My Integrated Medicine doctor started me on a probiotic that has done wonders for me.  I attribute a lot of my intestinal healing from taking this combination of Bifidobacterium manufactured by Metagenics.  I recently foound out that the company discontinued this product.  I bought almost all the bottles that my doctor had available, but i'm not sure what I'm going to do when I finish them all.  I'm not having any luck finding anything similar made by other companies and other users of this particular probiotic don't do well either without this combo of Bifidobacterium.   

Probiotics' Benefits May Be More Than a Gut Feeling - WSJ.com

Probiotics, believed to help with digestion, are increasingly being studied to treat wide-ranging conditions, from colic to cholesterol and the common cold.

One of the fastest-growing dietary supplements, probiotics are now prominent on drug and big-box store shelves. They are live microorganisms—or "good" bacteria—that when consumed in capsules or yogurt are said to confer a health benefit. So far, however, there is little scientific proof of their effectiveness—many studies of probiotics have involved less-than-rigorous research standards.

As further data become available, some researchers believe probiotics may evolve into prescription drugs, as doctors focus on specific bacteria strains to target patients' particular conditions. At the moment, however, many experts say probiotics are misunderstood.

"Consumers have shown to be willing to spend the money, just in case [probiotics] work," says Michael Fischbach, an assistant professor of bioengineering and therapeutic sciences at the University of California, San Francisco. "What we all have to be careful about is to not view them as a panacea and to make sure that we don't raise our expectations too high."

U.S. sales of probiotic supplements totaled nearly $770 million last year, up some 22% from the previous year, according to Euromonitor International, a market research firm.

The strongest clinical studies have suggested some probiotics may be beneficial for certain gastrointestinal problems, allergies and vaginal infections. Many doctors recommend probiotics when patients are taking antibiotics. Probiotics are widely considered safe except for people with an impaired immune system, though experts recommend talking to a doctor first.

For other ailments, hundreds of probiotic studies are currently under way, experts say. In a report last month in the British Journal of Nutrition, researchers at the University of Medicine and Dentistry of New Jersey-School of Health Related Professions said a combination of two probiotics may reduce the symptoms and recovery time for the common cold. Other studies have shown similar results, especially with children.

Researchers this month presented evidence at a meeting of the American Heart Association showing that two daily doses of a probiotic lowered bad cholesterol by nearly 12% and reduced total and saturated cholesterol esters which contribute to the hardening of arteries. The study was funded by Micropharma Ltd., a Canadian probiotic research and production company.

Some studies have federal backing. UCSF is exploring possible effects of probiotics on infants and early markers of asthma, as well as on colic. Harvard Medical School researchers are studying what good bacteria might do for the immune system to see if the response to flu vaccine in elderly people can be improved.

The body contains trillions of bacteria, both good and bad. Most live in the gut but they also colonize other areas. Good bacteria help digest food, produce vitamins and protect from infections, among other things.

The Flora Inside

Probiotics are 'good' bacteria believed to confer health benefits.

• Products ranging from yogurt to household cleaners contain probiotics.
• Sales of probiotic supplements totaled $770 million last year, up 22% from 2010.
• For supplements, experts suggest sticking to well-known brands like Culturelle, VSL#3, Align and Florastor.
• Different probiotic strains can affect the body differently. Strains should be listed on a product label.
• Probiotics are largely unregulated but they can't make claims to cure or prevent a disease.

The community of bacteria, the body's intestinal flora, begins at birth, says Esi Lamousé-Smith, an instructor in medicine at Boston Children's Hospital and Harvard Medical School. By age 3 these bacteria, sometimes referred to as our gut or intestinal microbiome, are more or less set, she says. Each person's microbiome is distinct and doesn't change significantly with age unless a person becomes ill, takes an antibiotic or makes major changes in diet.

A probiotic, which adds good bacteria only for the time it is being taken, seems to influence other bacteria already present. For example, it might stimulate other bacteria to turn on or off certain genes. These genes, in turn, might be involved in various functions, such as immune regulation or nutrient metabolism.

"I am wholeheartedly a believer" in probiotics, says Maureen Fitzgerald, a Germantown, Wis., resident who blogs about parenting issues.

As a former teacher, Ms. Fitzgerald was exposed to many germs and says she was looking for something to "beef up" her immune system. Once she started regularly taking probiotics she says she wasn't "getting as many of the colds and the bugs that are around." About five years ago, Ms. Fitzgerald's then 3-year-old son began taking a children's probiotic that cleared up digestion problems he was having. After that, Ms. Fitzgerald says she was hooked on the supplements. She raved about probiotics on her blog and has since received free samples, which she reviews.

There are many different strains of probiotics and each may affect the body differently. The dosage—or number of colony-forming units—in a probiotic is also important. Lactobacilli and bifidobacteria are the two most widely studied types of probiotics. Lactobacillus rhamnosus, widely known as LGG, may treat viral and antibiotic-induced diarrhea, and certain allergies, like childhood eczema. A strain ofLactobacillus reuteri has been shown to help with colic. Bifidobacterium animalis, found in some brands of yogurt, is said to improve digestion.

Experts say taking a probiotic supplement with many bacterial strains isn't necessarily better. The key is ensuring each strain in a product is active and has been clinically proven to work at a certain dosage, they say. Tests done by ConsumerLab.com have shown that the number of living organisms in probiotics doesn't always reflect the label. Of 12 products tested this year, two delivered fewer organisms than listed.

Probiotics aren't required to obtain Food and Drug Administration approval before being marketed. "Right now they're considered a food product or dietary supplement, not a drug," says Gerard Mullin, an associate professor at Johns Hopkins University School of Medicine and author of "The Inside Tract."

There aren't any FDA approved health claims for probiotics, says Diane Hoffmann, a law professor at the University of Maryland Carey School of Law, who oversaw a study on the federal regulation of probiotics. But companies can make broader statements, called "structure function" claims. It is the difference between saying a product reduces the risk of heart disease versus supports a healthy heart. Because the difference isn't discernible to many consumers, there is little incentive in the industry to pursue costlier and more resource-intensive health claims.

"Consumers just need to know that claims are not necessarily preapproved and they may not be well substantiated," says Ms. Hoffmann.

In the short term, experts recommend sticking with the strains of probiotics that have a lot of science behind them, like Lactobacillus GG, and brands that have proven to be safe and truthful in labeling.

Dr. Mullin, of Johns Hopkins, says the future may lie in concocting specific probiotics for people based upon their individual needs and microbiomes.

Probiotics' Benefits May Be More Than a Gut Feeling - WSJ.com:

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Medicinal Marijuana- Studies Show It Helps Crohn's Disease & Ulcerative Colitis (#IBD) - Pass the Pot Please!

I would certainly try this.  Pass the dutch NY!

Article Highlights

• "....cannabidiol (a non-psychoactive and healthful ingredient in marijuana), “is a very promising compound” because it does not have any psychotropic effects, and that it is a “potential candidate for the development of a new class of anti-IBD drugs.”

• "...people who had had IBD for a long time responded favorably to marijuana, experiencing an increase in appetite, weight gain, better social functioning, improved ability to work, and an improvement in depression and pain after three months of treatment..."

By Deborah Mitchell on December 26, 2012 - 5:33am

Marijuana Helps Crohn's Disease, Ulcerative Colitis

Crohn’s disease and ulcerative colitis, the two main types of inflammatory bowel disease (IBD), are a challenge to treat. Among the potential treatment options is marijuana, and several recent studies indicate that this unconventional option offers some significant benefits.

How we treat inflammatory bowel disease

The current treatment options for the more than 1.5 million Americans and millions more who suffer with inflammatory bowel disease include dietary measures (e.g., olive oil extract, vitamin D, probiotics) and a variety of drugs. These treatments attempt to alleviate the diarrhea, rectal bleeding, fever, weight loss and abdominal pain and cramps associated with the disease.

The more common treatments for IBD include anti-inflammatory drugs, such as sulfasalazine, corticosteroids (which have significant side effects and are only suitable for short-term use), mesalamine (e.g., Apriso, Dipentum, Lialda), immune system suppressors (e.g., azathioprine, cyclosporine, infliximab, adalimumab, certolizumab, methotrexate), which can have significant side effects, and antibiotics, which are of questionable benefit. Beyond these drugs are others that can address specific symptoms such as diarrhea, constipation, or pain, or address nutritional deficiencies (e.g., iron, calcium, vitamin B12). Surgery is a last resort.

Inflammatory bowel disease can be life-threatening and thus deserves focused attention. Ulcerative colitis typically affects only the large intestine (colon) and rectum and usually develops gradually over time. Crohn’s disease can occur anywhere along the intestinal tract and can infiltrate the tissues.

Studies of marijuana and IBD
A review of investigations into the use of cannabis for inflammatory bowel disease reveals that its use “in the clinical therapy has been strongly limited by their psychotropic effects.” The authors of this recent Italian study, however, point out that cannabidiol (a non-psychoactive and healthful ingredient in marijuana), “is a very promising compound” because it does not have any psychotropic effects, and that it is a “potential candidate for the development of a new class of anti-IBD drugs.”

A 2012 study published in Digestion noted that people who had had IBD for a long time responded favorably to marijuana, experiencing an increase in appetite, weight gain, better social functioning, improved ability to work, and an improvement in depression and pain after three months of treatment with inhaled cannabis. Earlier studies have also indicated positive effects.

For example, an Israeli study was the first to show that use of marijuana in people with Crohn’s disease could provide a positive result. Twenty-one of the 30 patients in the study experienced significantly improvement after using marijuana, and the need for drugs was significantly reduced as well.

In yet another study, Canadian researchers evaluated 100 people with ulcerative colitis and 191 with Crohn’s disease and their use of marijuana. The investigators found a significant level of marijuana use among people with ulcerative colitis and Crohn’s disease (about 50% in each group). People who had a history of surgery for IBD were more likely to use marijuana (60%) than were those who had not undergone surgery (32%).

The bottom line appears to be that use of marijuana among people who have inflammatory bowel disease may be beneficial. If you have ulcerative colitis or Crohn’s disease, you should ask your healthcare provider or another healthcare professional about the possibility of using marijuana for symptom relief.

SOURCES:
Esposito G et al. Cannabidiol in inflammatory bowel disease: a brief overview. Phytotherapy Research 2012 July; doi:10.1002/ptr.4781
Lahat A et al. Impact of cannabis treatment on the quality of life, weight and clinical disease activity in inflammatory bowel disease patients: a pilot prospective study. Digestion 2012; 85(1): 1-8
Lal S et al. Cannabis use amongst patients with inflammatory bowel disease. European Journal of Gastroenterology and Hepatology 2011 Oct; 23(10): 891-96
Naftali T et al. Treatment of Crohn’s disease with cannabis: an observational study. Israel Medical Association Journal 2011 Aug; 1(8): 455-58

Marijuana Helps Crohn's Disease, Ulcerative Colitis:

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#UC/Ulcerative Colitis Drug Market (Pharms Producing-TNF alpha inhib, CAM inhibitors)-Expected 2 Dbl Over Next Decade - $3.7B

lol I think i'm going to buy stock in Simponi... why the heck not.
There's almost no risk in this area of the market because it's going to make money.  No question about it.  They market the shit like it's going to be gone tomorrow.  Pharmaceutical companies makes $, but the TNF-alpha inhibitor pharms that produce this kind of drug BANK so much money. It's almost in conceivable.

Why not reap the benefits of this shit??  It's almost stupid not to.   That's my view when I see the stats & dollar amount.  The sales amounts have always just increased.

Keep kickem back!  Please do.  It's so obvious and makes sense that they are. It gives me a much better understanding when i'm sitting in the exam room with my doctor and processing everything he is saying to me.... & why.
__________________________________________________________________________________________

The Ulcerative Colitis Drug Market Will Double Over the Next Decade, Increasing to $3.7 Billion in 2021

Primary Factors that Will Drive Market Growth are the Uptake of Humira, Simponi, Vedolizumab and Tofacitinib, According to Findings from ArticlDecision Resources

December 19, 2012-Burlington, Mass. –Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the ulcerative colitis drug market will double over the next decade, increasing to $3.7 billion in 2021 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. The uptake of two premium-priced tumor necrosis factor-alpha (TNF-alpha) inhibitors—Abbott/Eisai’s Humira and Janssen/Merck/Mitsubishi Tanabe’s Simponi—and two novel therapies, Takeda’s cell adhesion molecule (CAM) inhibitor vedolizumab and Pfizer’s oral Janus-activated kinase inhibitor tofacitinib, will primarily drive growth during this period, as will the expanding number of diagnosed prevalent cases of ulcerative colitis.

The upcoming Pharmacor advisory service entitled Ulcerative Colitis, which will be published soon, forecasts that increased physician acceptance of TNF-alpha inhibitors for the treatment of moderate to severe disease and patient preference for convenient subcutaneous administration will fuel the uptake of newer TNF-alpha inhibitors Humira and Simponi through the 2021 study period. Simponi, owing to its perceived greater efficacy than that of Humira in separate Phase III trials and favorable gastroenterologist opinion, will challenge intravenous infliximab’s (Janssen/Merck/Mitsubishi Tanabe’s Remicade) standing as the most frequently prescribed agent in the TNF-alpha inhibitor class. However, Remicade will remain the patient-share leader among the TNF-alpha inhibitors, maintaining a relatively constant patient share across the G7 countries, based on its well-established efficacy. Sales of Simponi are expected to overtake Remicade’s sales in 2017 based largely on the former’s premium price and assumed high dosing in ulcerative colitis, driving the market’s growth as the new sales leader.

The launches of two promising premium-priced novel agents, vedolizumab and tofacitinib, in 2014 and starting in 2016 respectively, will contribute to increasing sales over the ten-year forecast period, gaining most initial use in the TNF-refractory population.

“These agents will likely extend the treatment algorithm by offering, for the first time, additional lines of therapy for patients with inadequate response to the TNF-alpha inhibitors,” said Decision Resources Analyst Kathrina Quinn, Ph.D. “Although the TNF-refractory market is relatively limited in size, the high unmet need for treatments that cater to this population and potentially delay or prevent colectomy will drive major-market sales of approximately $740 million in 2021, constituting about 20 percent total market share.”

Towards the end of the forecast period, Decision Resources anticipates that vedolizumab and tofacitinib will begin to overtake adalimumab’s use as gastroenterologists move to another drug class after trying up to two TNF-alpha inhibitors. Even though vedolizumab is expected to launch first, tofacitinib’s uptake will likely overtake that of vedolizumab’s based on the strengths of its oral delivery and postmarketing safety data for other immune indications.

About Decision Resources

Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources Group company.

About Decision Resources Group

Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group atwww.DecisionResourcesGroup.com.

###

All company, brand or product names contained in this document may be trademarks or registered trademarks of their respective holders.

For more information, contact:

Christopher Comfort
Decision Resources Group
781-993-2597
ccomfort@dresources.com

Ulcerative Colitis Drug Market Will Double Over the Next Decade - Decision Resources:

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#Colectomy - No Improvement Before & After #Surgery for Ulcerative Colitis (#UC) Patients

How discouraging!! I thought surgery is supposed to cure UC?? IDK... It's a pretty large study and these numbers just straight up SUCK!

ARTICLE HIGHLIGHTS

• when followed over the long term, 12.4% of colectomy patients were fully work disabled 3 years after surgery, compared with 5.9% 3 years before. This compares with a rate of 7.2% in the general population.
• In total, 33% of UC patients had a registered sick leave episode or claimed disability pension during 2005 compared with 22% in the general population during 2005.
• Absence rates for colectomized UC patients were even higher, with 43% of these patients having at least one sick leave episode during 2005.

Colectomy fails to ease ulcerative colitis sick leave burden

By Kirsty Oswald, medwireNews Reporter

Patients with ulcerative colitis (UC) take more time off work than the general population, even after undergoing colectomy, shows a large Swedish study.
Furthermore, in study patients who underwent colectomy, postoperative work loss did not return to pre-surgery rates.
The study, published in Gastroenterology, included 19,714 patients with UC during 2005, 16% of whom were colectomized. Patients who underwent colectomy between 1998 and 2002 were followed up for work loss for at least 3 years before and after surgery.
In total, 33% of UC patients had a registered sick leave episode or claimed disability pension during 2005 compared with 22% in the general population during 2005. There was also a significant association between the presence of UC and the number of work days lost, with adjusted analyses showing that UC patients lost 20 more days of work than the general population during the year.
Absence rates for colectomized UC patients were even higher, with 43% of these patients having at least one sick leave episode during 2005.
And, in patients who were followed up before and after colectomy, the mean annual work days lost increased from 58 in the year prior to colectomy to 112 the year after. Furthermore, when followed over the long term, 12.4% of colectomy patients were fully work disabled 3 years after surgery, compared with 5.9% 3 years before. This compares with a rate of 7.2% in the general population.
However, the authors highlight that more than 50% of patients did not experience any work loss in the 3 years before or after colectomy.
They say that their findings are unsurprising given the relapsing nature of the disease and the potential need for hospitalization and surgery.
"For many UC patients, keeping a job may depend on close access to a toilet, and patients with stomas or pouches might face additional practical obstacles," explain Martin Neovius (Karolinska Institute, Stockholm, Sweden) and colleagues.
"Furthermore, major surgery such as colectomy may have social as well as psychological consequences, both of which may increase work loss."

Licensed from medwireNews with permission from Springer Healthcare Ltd. ©Springer Healthcare Ltd. All rights reserved. Neither of these parties endorse or recommend any commercial products, services, or equipment.

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Study on Monkeys w/ - Probiotic Worm Treatment ~ Sounds Good!

Another study, very small study, testing parasite worm (Helminth) eggs that shows that the treatment is effective with improving the gut bacteria balance in monkeys. Awesome.   I have been reading more and more about this treatment.  I may actually inquire about this the next time i see my GI doctor.

ARTICLE HIGHLIGHTS

•  In animal models of autoimmunity these worms have suppressed inflammation, and clinical trials indicate that helminth therapy can be beneficial in inflammatory bowel diseases.

Probiotic Worm treatment may improve symptoms of colitis by restoring gut bacteria to healthy state 

November 15, 2012 in Diseases, Conditions, Syndromes 

A new study on monkeys with chronic diarrhea that were treated by microscopic parasite worm (helminth) eggs has provided insights on how this form of therapy may heal the intestine. This condition in monkeys is similar to the inflammatory bowel diseases that affects up to 1.4 million Americans.  

The study, published today in the Open-Access journal PLOS Pathogens, shows that helminths can restore the balance of gut bacterial communities to the monkeys with chronic diarrhea. Inflammatory bowel diseases are driven by a misdirected immune response against gut bacteria (the microbiome) and are often associated with alterations in gut bacterial communities (known as dysbiosis). 

"The idea for treating colitis with worms is not new, but how this therapy might work remains unclear," says the study's senior corresponding author, P'ng Loke, PhD, assistant professor of microbiology at NYU Langone Medical Center. "Our findings suggest that exposure to helminths may improve symptoms by restoring the balance to the microbial communities that are attached to the intestinal wall." 

Because inflammatory bowel diseases are more common in countries with developed economies and is rare in developing countries, researchers have hypothesized that endemic helminth infections in developing countries may offer protection against this disease. In animal models of autoimmunity these worms have suppressed inflammation, and clinical trials indicate that helminth therapy can be beneficial in inflammatory bowel diseases. 

Juvenile monkeys kept in captivity often spontaneously develop chronic diarrhea that is difficult to treat by veterinarians. Dr. Loke and his colleagues treated 5 monkeys with chronic diarrhea with microscopic helminth eggs and collected tissue samples before and after treatment. 

Tissues samples taken before treatment from sick monkeys had many more attached bacteria than healthy monkeys and the types of attached bacteria were completely altered (dysbiosis). This attachment of altered bacteria was associated with a very strong inflammatory response. After treatment, the types of bacteria attached to tissue samples were much more similar to healthy monkeys, and 4 out of 5 monkeys had less diarrhea and started to gain weight. 

Dr. Loke and colleagues are now embarking on a new clinical trial designed to study how pig helminth eggs (TSO) may relieve symptoms of ulcerative colitis (UC) and have started enrolling patients at NYU Langone Medical Center. TSO is being used because it can be produced under pathogen free conditions certified by the FDA for clinical trials and cannot be transmitted from person to person.      

Journal reference: PLoS Pathogens 

THE LINK ---> Probiotic worm treatment may improve symptoms of colitis by restoring gut bacteria to healthy state:

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Low Dose Naltrexone AKA- LDN FACTS -How it works, diseases it helps, pharmacy info, more

These selected paragraphs represent about 10% of the LDN Website http://www.lowdosenaltrexone.org  1/2004 Low Dose Naltrexone FDA-approved naltrexone, in a low dose, can boost the immune system - helping those with HIV/AIDS, cancer, and autoimmune diseases.    What is low-dose naltrexone and why is it important? Low-dose naltrexone holds great promise for the millions of people worldwide facing a possible death sentence from virtually incurable cancers and other diseases. In the developing world, LDN could provide the first low-cost, easy to administer, and side-effect-free therapy for HIV/AIDS. Naltrexone itself was approved by the FDA in 1984 in a 50mg dose for the purpose of helping heroin or opium addicts, by blocking the effect of such drugs. By blocking opioid receptors, naltrexone also blocks the reception of the opioid hormones that our brain and adrenal glands produce: beta-endorphin and metenkephalin. Many body tissues have receptors for these endorphins and enkephalins, including virtually every cell of the body's immune system. In 1985, Bernard Bihari, MD, a physician with a clinical practice in New York City, discovered the effects of a much smaller dose of naltrexone (approximately 3mg once a day) on the body's immune system. He found that this low dose, taken at bedtime, was able to enhance a patient's response to infection by HIV, the virus that causes AIDS. [Note: Subsequently, the optimal adult dosage of LDN has been found to be 4.5mg.] In the mid-1990’s, Dr. Bihari found that patients in his practice with cancer (such as lymphoma or pancreatic cancer) could benefit, in some cases dramatically, from LDN. In addition, people who had autoimmune disease (such as lupus) often showed prompt control of disease activity while taking LDN. How does LDN work? LDN boosts the immune system, activating the body’s own natural defenses. The brief blockade of opioid receptors between 2 a.m. and 4 a.m. that is caused by taking LDN at bedtime each night is believed to produce a prolonged up-regulation of vital elements of the immune system by causing an increase in endorphin and enkephalin production. Normal volunteers who have taken LDN in this fashion have been found to have much higher levels of beta-endorphins circulating in their blood in the following days. Animal research by I. Zagon, Ph.D., and his colleagues has shown a marked increase in metenkephalin levels as well. [Note: Additional information for Dr. Zagon can be found at the end of this page.] Bihari says that his patients with HIV/AIDS who regularly took LDN before the availability of HAART were generally spared any deterioration of their important helper T cells (CD4+). In human cancer, research by Zagon over many years has demonstrated inhibition of a number of different human tumors in laboratory studies by using endorphins and low dose naltrexone. It is suggested that the increased endorphin and enkephalin levels, induced by LDN, work directly on the tumors' opioid receptors - and, perhaps, induce cancer cell death (apoptosis). In addition, it is believed that they act to increase natural killer cells and other healthy immune defenses against cancer. In general, in people with diseases that are partially or largely triggered by a deficiency of endorphins (including cancer and autoimmune diseases), or are accelerated by a deficiency of endorphins (such as HIV/AIDS), restoration of the body's normal production of endorphins is the major therapeutic action of LDN. What diseases has it been useful for and how effective is it? Bernard Bihari, MD has described beneficial effects of LDN on a variety of diseases: Cancers:Breast Cancer, Carcinoid, Colon & Rectal Cancer, Glioblastoma, Liver Cancer, Lung Cancer (Non-Small Cell),  Lymphocytic Leukemia,  Lymphoma (Hodgkin's and Non-Hodgkin's), Malignant Melanoma,   Multiple Myeloma, Neuroblastoma, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer (untreated), Renal Cell Carcinoma, Throat Cancer and Uterine Cancer. Other Diseases: ALS (Lou Gehrig's Disease), Alzheimer's Disease, Behcet's Disease, Celiac Disease, Chronic Fatigue Syndrome, Crohn's Disease, Emphysema (COPD), Fibromyalgia, HIV/AIDS, Irritable Bowel Syndrome, Multiple Sclerosis (MS), Parkinson's Disease, Pemphigoid, Psoriasis, Rheumatoid Arthritis, Sarcoidosis, Systemic Lupus (SLE), Ulcerative Colitis and Wegener's Granulomatosis. LDN has demonstrated efficacy in hundreds of cases. Cancer. As of mid-2003, Dr. Bihari reports having treated some 300 patients with cancer that had failed to respond to standard treatments. Of that group, some 60%, after four to six months treatment with LDN, began to demonstrate a halt in cancer growth and, of those, half have shown objective signs of tumor shrinkage. Autoimmune disease. Within the group of patients who presented with an autoimmune disease (see above list), none have failed to respond to LDN; all have experienced a halt in progression of their illness. In many patients there was a marked remission in signs and symptoms of the disease. The greatest number of patients within the autoimmune group are people with multiple sclerosis, of whom there are now over 140 in Dr. Bihari's practice. None of these patients has ever experienced a fresh attack of MS while they maintained their regular LDN nightly therapy. HIV/AIDS. As of September 2003, Dr. Bihari has been treating 350 AIDS patients using LDN in conjunction with accepted AIDS therapies. Over the past 7 years over 85% of these patients showed no detectable levels of the HIV virus - a much higher success rate than most current AIDS treatments, and with no significant side effects. It is also worth noting that many HIV/AIDS patients under Dr. Bihari's care have been living symptom-free for years taking only LDN with no other medications. How is it possible that one medication can impact such a wide range of disorders? The disorders listed above all share a particular feature: in all of them, the immune system plays a central role - and low blood levels of endorphins are generally present, playing a role in the disease-associated immune deficiencies. Research by others - on neuropeptide receptors expressed by various human tumors - has found opioid receptors in many types of cancer: Brain tumors (both astrocytoma and glioblastoma) Breast cancer Endometrial cancer Head and neck squamous cell carcinoma Myeloid leukemia Lung cancer (both small cell and non-small cell) Neuroblastoma and others... These findings suggest the possibility for a beneficial LDN effect in a wide variety of common cancers. LDN can be prescribed by your doctor, and prepared by your local pharmacy. Naltrexone is a prescription drug, so your physician would have to give you a prescription after deciding that LDN appears appropriate for you. Naltrexone in the large 50mg size, originally manufactured by DuPont under the brand name ReVia, is now sold by Mallinckrodt as Depade and by Barr Laboratories under the generic name naltrexone. LDN is now being made available by hundreds of local pharmacies, as well as by some mail-order pharmacies, around the US. Some pharmacists have been grinding up the 50mg tablets of naltrexone to prepare the 4.5mg capsules of LDN; others use naltrexone, purchased as a powder, from a primary manufacturer. One of the first pharmacies to do so was Irmat Pharmacy in Manhattan. Their recent price for a one-month's supply of 4.5mg LDN (30 capsules) was $38. Irmat will ship it anywhere, in the US or to other countries, and will accept prescriptions from any licensed physician. Pharmacies that are good sources of LDN: Irmat Pharmacy, New York, NY (212) 685-0500; Village Apothecary, New York, NY (212) 807-7566; The Compounder Pharmacy, Aurora, IL (800) 679-4667; The Medicine Shoppe, Canandaigua, NY (800) 396-9970; The Prescription Center, La Crosse, WI (800) 203-9066; Skip's Pharmacy, Boca Raton, FL (800) 553-7429 and Smith's Pharmacy, Toronto, Canada (800) 361-6624 IMPORTANT: Make sure to fill your Rx at a compounding pharmacy that has a reputation for consistent reliability in the quality of the LDN it delivers. The FDA has found a significant error rate in compounded prescriptions produced at randomly selected pharmacies. Dr. Bihari has reported seeing adverse effects from this problem. Please see our report, Reliability Problem With Compounding Pharmacies . Please see the above list of recommended pharmacies for some suggested sources. What dosage and frequency should my physician prescribe? The usual adult dosage is 4.5mg taken once daily at night. Because of the rhythms of the body's production of master hormones, LDN is best taken between 9pm and 3am. Most patients take it at bedtime. Rarely, the naltrexone may need to be purchased as a solution - in distilled water - with 1mg per ml dispensed with a 5ml medicine dropper. If LDN is used in a liquid form, it is important to keep it refrigerated. The therapeutic dosage range for LDN is from 1.75mg to 4.5mg every night. Dosages below this range are likely to have no effect at all, and dosages above this range are likely to block endorphins for too long a period of time and interfere with its effectiveness. IMPORTANT: Make sure to specify that you do NOT want LDN in a slow-release form (see above) Are there any side effects or cautionary warnings? Side effects: LDN has virtually no side effects. Occasionally, during the first week's use of LDN, patients may complain of some difficulty sleeping. This rarely persists after the first week. Should it do so, dosage can be reduced from 4.5mg to 3mg nightly. Cautionary warnings: Because LDN blocks opioid receptors throughout the body for three or four hours, people using medicine that is an opioid agonist, i.e. narcotic medication - such as Ultram, morphine, Percocet, Duragesic patch or codeine-containing medication - should not take LDN until such medicine is completely out of one's system. In addition, LDN should probably not be taken during pregnancy. Full-dose naltrexone (50mg) carries a cautionary warning against its use in those with liver disease. This warning was placed because of adverse liver effects that were found in experiments involving 300mg daily. The 50mg dose does not apparently produce impairment of liver function nor, of course, do the much smaller 3mg and 4.5mg doses. When will the low-dose use of naltrexone become FDA approved? Although naltrexone itself is an FDA-approved drug, LDN still awaits clinical trials. The FDA approved naltrexone at the 50mg dosage in 1984. LDN (in the 3mg or 4.5mg dosage) has not yet been submitted for approval because the prospective clinical trials that are required for FDA approval need to be funded at the cost of many millions of dollars. All physicians understand that appropriate off-label use of an already FDA-approved medication such as naltrexone is perfectly ethical and legal. Because naltrexone itself has already passed animal toxicity studies, one could expect that once testing is able to begin, LDN could complete its clinical trials in humans and receive FDA approval for one or more uses within two to four years. What You Can Do Talk to your doctor. If you are suffering from HIV/AIDS, cancer, or an autoimmune disease, LDN could help. In AIDS and cancer therapy, LDN is often used in conjunction with other medications. Cancer. Anyone with cancer or a pre-cancerous condition should consider LDN. Many use LDN as a preventive treatment. Post-treatment, others have been using LDN to prevent a recurrence of their cancer. LDN has been shown in many cases to work with virtually incurable cancers such as neuroblastoma, multiple myeloma, and pancreatic cancer. HIV/AIDS. As an AIDS drug, LDN leads to far fewer side effects than the standard “AIDS cocktail”. When used in conjunction with HAART therapies, LDN can boost T-cell populations, prevent disfiguring lipodystrophy, and lower rates of treatment failure. Do not be afraid to approach your doctors - physicians today are increasingly open to learning about new therapies in development. Tell your doctors about this website, or print out and hand them the information, and let them weigh the evidence. Tell others. If someone you know has HIV/AIDS, cancer, or an autoimmune disease, LDN could save them from a great deal of suffering. If they use e-mail, send them the address of this website (www.lowdosenaltrexone.org). Or, print out the site and mail them the information. Help spread the word to the media, the medical community, and to developing countries. Low-dose naltrexone has the potential to reduce the terrible human loss now taking place throughout the globe. It is a drug that could prevent millions of children from becoming AIDS orphans. It is a drug that could be a powerful ally in the war against cancer. If you or someone you know has connections in the media, the medical community, or to those in developing countries involved in AIDS policy or treatment, please let them know about LDN. About This Website This is a not-for-profit website. This website is sponsored by Advocates For Therapeutic Immunology. The purpose of this website is to provide information to patients and physicians about important therapeutic breakthroughs in advanced medical immunology. The authors of this site do not profit from the sale of low-dose naltrexone or from website traffic, and are in no way associated with any pharmaceutical manufacturer or pharmacy. Consult your doctor. This website is not intended as a substitute for professional medical help or advice. A physician should always be consulted for any medical condition. Curriculum Vitae BERNARD BIHARI, M.D. 29 West 15th Street New York, N.Y. 10011 (212) 929-4196 EDUCATION B.A. - Cornell University, Ithaca, N.Y. 1949-1953 M.D. - Harvard Medical School, Boston, Mass. 1953-1957 TRAINING 1962-1965 Resident, Department of Psychiatry, Columbia Presbyterian Medical Center, N.Y.S. Psychiatric Institute 1960-1962 Research Associate in Neurophysiology, Section on Physiology, Laboratory of Clinical Science, N.I.M.H., Bethesda, Maryland 1959-1960 Resident, Department of Neurology, Massachusetts General Hospital, Boston, Mass. 1958-1959 Resident, Department of Medicine, Beth Israel Hospital, Boston, Mass. 1957-1958 Intern, Department of Medicine, Beth Israel Hospital, Boston, Mass. CERTIFICATION Board Certified, American Board of Psychiatry and Neurology. April 14, 1970 New York State Medical License 088158 FACULTY APPOINTMENTS 2002-Present Attending Physician, Beth Israel Medical Center, New York, NY 1981-Present Clinical Associate Professor, SUNY / Health Science Center at Brooklyn 1968-1980 Assistant Professor, Department of Psychiatry, Mount Sinai School of Medicine 1959-1960 Instructor in Neurology, Harvard Medical School EXPERIENCE 1991-Present Medical Director, Foundation for Integrative Research, Inc., New York, NY 1989-1991 Executive Director/Medical Director, Community Research Institute, New York, NY 1981-1989 Director, Division of Alcoholism and Drug Dependence, SUNY/Health Science Center at Brooklyn 1978-1980 Deputy Commissioner, Program Development and Evaluation (Deputy for Public Health Programs), NYC Department of Health 1977-1978 Commissioner, New York City Addiction Services Agency, and Deputy Commissioner for Addictions, NYC Department of Health 1974-1977 Assistant Commissioner for Addictions, NYC Department of Health 1972-1974 Chief, Alcoholism Treatment Program, Department of Psychiatry, Morris J. Bernstein Institute of Beth Israel Medical Center, New York 1971-1972 Chief, Drug Addiction Service, Department of Psychiatry, Morris J. Bernstein Institute of Beth Israel Medical Center, New York Here are random paragraphs taken from other pages of the www.lowdosenaltrexone.org Website: ALS. In the spring of 2002, several people with amyotrophic lateral sclerosis, after reading the material about multiple sclerosis on this website, asked their neurologists to prescribe LDN for their ALS. Two patients with advanced disease showed significant improvement in their forced vital capacity. One had a 25% improvement within two months of beginning LDN and another an 11% improvement A third patient who also has advanced ALS and an impaired FVC has had significant subjective improvement in his ability to breathe and a reduction in his resting pulse from 96 to the low 80's. Given the absence of other effective treatments, the use of LDN appears to have begun spreading through the ALS community, at least to those who are in touch with the Internet. Alzheimer's Disease. Dr. Bihari reports that he currently has three patients who have Alzheimer's disease. Since starting LDN, none of them has shown further progression, which is usually inexorable in this disorder. The initial such patient came to him four years ago to seek treatment for prevention of recurrence of colon cancer. The second patient saw Bihari some two-and-one-half years ago for treatment of non-Hodgkin's lymphoma, and the third began LDN two years ago for an autoimmune problem. Before their first visits, each of the three had been diagnosed with moderately severe Alzheimer's disease by a neurologist. Crohn's Disease. Dr. Bihari is now following eight patients with Crohn's Disease on LDN. In all eight cases, within 14-21 days the signs and symptoms of disease activity stopped. All eight have remained stable since anywhere from 2 months to 36 months. Esophageal Cancer. Reverend X is a patient at John’s Hopkins Hospital where he received most of his medical care. He first developed problems with digestion and some pain in the mid-chest area with swallowing in April 2002. An upper GI exam in May 2002 showed narrowing and irregularity of the lower esophagus. In June 2002, a C-T scan of the chest, abdomen and pelvis showed a 2cm thickening of the lower esophagus extending into the upper stomach. Also seen were five enlarged nodes in the chest and five in the abdomen. Rev X refused chemotherapy and began low dose naltrexone in August 2002. In the following months his difficulty in swallowing has significantly decreased and his weight has stabilized. He notes an improved sense of well being. He has had no therapy but low dose naltrexone. Fibromyalgia. Dr. Bihari reports that he has treated 24 people with fibromyalgia, 22 of whom responded dramatically to low dose naltrexone treatment (4.5mg nightly). Within a few days those 22 patients experienced a decrease of some 80% to 95% in their muscle pains. This improvement has been sustained with continuing use of the LDN. The two exceptions were notable in that they had both been on narcotic pain medications for years prior to weaning off of the narcotics in order to switch to LDN treatment. Their responses were only fair at best. HIV/AIDS. In early May, Dr. Bihari began treating a woman who not only had diabetes, which required a moderately high dosage of insulin (90 units daily), but who also was suffering from lipodystrophy as a complication of her AIDS therapy. At that time, Bihari noted that he expected the LDN would combat her lipodystrophy (which includes insulin resistance) and therefore would probably decrease her insulin needs. Three weeks later, he saw her again for the first time since LDN had been started. Her insulin requirements had dropped from 90 units/day to 20 units/day during those three weeks, and her "buffalo hump" (a swelling at the upper back/lower neck area characteristic of lipodystrophy) had regressed by two-thirds. Her swollen abdomen had begun to recede, enabling her, she said, to cross her legs "for the first time in a year". Lung Cancer. C., a 61 year old woman, previously a heavy smoker, was found to have a lesion in the right upper lobe of the lung in 1999 and a supraclavicular node in April 2001. Biopsy showed that the node was metastatic from the lung tumor. In August 2001 an MRI of the chest showed supraclavicular clusters of nodes and stellate-shaped lesions in the apex of the right upper lobe. She then started taking low dose naltrexone. She began getting quarterly C-T scans of the chest, which showed no change over the following 12 months. The C-T scan interval was changed to every 6 months. Her most recent C-T scan in the spring of 2003 continues to show no change from the August 2001 films. Malignant Melanoma. Dr.Bihari relates the case of a patient who lives in Australia. This man had biopsy-proven malignant melanoma diagnosed three-years ago in a 5mm-deep lesion that was removed from the skin over his left shoulder blade. One year later he developed large masses in his left armpit. These were surgically removed and proved a recurrence. He refused to accept any recommended chemotherapy and contacted Bihari in January of 2000, at which time he began LDN 3mg nightly. He called this month to say he continues to feel fine and he remains in complete remission. Multiple Sclerosis From the GoodShape website: I believe the most important Treatment that currently exists for Multiple Sclerosis is: LDN - Low Dose Naltrexone. My wife started LDN almost four years ago and has never had another exacerbation or further progression of her MS. Directly or indirectly I have helped hundreds of people start using LDN and 99 out of 100 people have had the same miraculous results. In 10 years I have never heard of any good results received from the use of FDA-approved MS drugs, so please do yourself a favor and start taking LDN - Low Dose Naltrexone. Parkinson's Disease. As reported earlier on this page (in May 2003 and twice in 2002), Dr. Bihari has been treating patients with PD. Parkinson's Disease is generally characterized by an inexorably progressive course. Bihari now reports that there are seven patients with the disease in his practice, all of whom have shown no progression since beginning LDN. Indeed, two of them have shown clear evidence of improvement in signs and symptoms. Pulmonary Emphysema. Dr. Bihari reports that he now has four patients in whom the inexorable downward course of pulmonary emphysema/chronic obstructive pulmonary disease (COPD) has been arrested through the use of LDN treatment. The central problem in the usual progression of COPD is almost always repeated respiratory infections. Of Bihari's patients, whose average length of LDN use has been two-and-one-half years, three have been entirely free of respiratory infections and the fourth, who is HIV positive, has had far fewer such events. As a result, their clinical conditions during this time have remained essentially stable. This highlights the potency of LDN in being able to act as a primary preventive therapy against respiratory infections in general. Many people who use LDN for a variety of reasons note a sharp decrease in their usual experience of common colds, generalized viral infections, or sinusitis. Rheumatoid Arthritis. Ten patients with this disease have been treated with LDN in recent years. In all ten patients, the joint pain and swelling cleared, in some, leaving residual joint distortion. Two of the patients stopped LDN for several weeks because of travel. Both had an immediate exacerbation. One patient who was responding well on LDN had a mild exacerbation during a period of severe marital stress. These pages include only 10% of all the information available at the LDN Website. For the complete report of this Miraculous Treatment visit:  http://www.lowdosenaltrexone.org

Link -  LDNHighlights:

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TNI BioTech, Inc. Signs Exclusive Distributor Agreement for Federal Republic of Nigeria to Treat Fatal Diseases w/ Affordable Drug - LDN

FINALLY!!!!  ANOTHER one... Oh man ...I can't take it! Another Happy articles !!!.  Thank you God!  lol

This drug, LDN, will work wonders for the diseases killing the population of Nigeria.  It's been years and years of waiting on a drug that wouldn't work well, but be within a decent price range.  Finally these people will get the help they need that will hopefully extend their lives and improve the quality of them as well.  

ARTICLE HIGHLIGHTS

• According to Frank Aribeana, the managing member of G-Ex Technologies/St Maris Pharma, "We are delighted to enter into this agreement as we believe the introduction of IRT-103 LDN and IRT-104 LDN cream in this market will allow us to provide much needed treatment at an affordable price to the citizens of the Federal Republic of Nigeria."     E P I C   N E W S
• TNI BioTech, Inc., is a biotech company combating fatal diseases through the activation and mobilization of 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, infections such as HIV/AIDS, chronic inflammatory diseases, and autoimmune diseases.
• most advanced clinical programs involve immunotherapy that works by isolating a patient's lymphocytes and then incubating them together with Methionine Enkephalin (MENK) in an enriching external incubation system. After incubation the patient's lymphocytes are re-infused back into the patient where they combat and destroy tumor cells.
  
  Read more here: http://www.sacbee.com/2012/11/15/4988198/tni-biotech-inc-signs-exclusive.html#storylink=cpy
  
  Read more here: http://www.sacbee.com/2012/11/15/4988198/tni-biotech-inc-signs-exclusive.html#storylink=cpy

TNI BioTech, Inc. Signs Exclusive Distributor Agreement for Federal Republic of Nigeria with G-Ex Technologies/St. Maris Pharma & GB Pharma Holdings LLC

By TNI BioTech, Inc.

Published: Thursday, Nov. 15, 2012 - 6:31 am

NEW YORK, Nov. 15, 2012 -- /PRNewswire/ -- TNI BioTech, Inc. (Pinksheets: TNIB) announced today the signing of an exclusive distributor agreement with G-Ex Technologies/St. Maris Pharma & GB Pharma Holdings LLC for the Federal Republic of Nigeria.  Under the terms of the agreement, G-Ex Technologies/St. Maris Pharma & GB Pharma Holdings LLC will have exclusive marketing and distribution rights to IRT-103 LDN and IRT-104 LDN cream in Nigeria. TNIB will be responsible for the manufacture and supply of IRT-103 LDN and IRT-104 LDN cream. The therapies, developed as a treatment for cancer, HIV/AIDS and other autoimmune diseases, will be manufactured in TNI BioTech, Inc.'s facility in Managua, Nicaragua under the supervision and quality control of Dr. Henry "Skip" Lenz.  G-Ex Technologies/St. Maris Pharma, as part of the agreement, will provide TNIB with a revolving letter of credit for the minimum purchase of 750,000 doses monthly of IRT-103 LDN or IRT-104 LDN cream beginning March 1, 2013 priced at $1.00 dollar per dose. 

The agreements calls for G-Ex Technologies/St. Maris Pharma & GB Pharma Holdings LLC to purchase a minimum of 15,000,000 doses monthly within 24 months to maintain their exclusive agreement. Once G-Ex Technologies/St. Maris Pharma & GB Pharma Holdings LLC reach sales of 1,000,000 million doses per day TNIB has agreed to joint venture a factory in the Federal Republic of Nigeria to meet local demands.

Noreen Griffin, CEO of TNI BioTech, Inc. said "this contract shows TNI BioTech's commitment to generate revenue during our first year of operations."

According to Frank Aribeana, the managing member of G-Ex Technologies/St Maris Pharma, "We are delighted to enter into this agreement as we believe the introduction of IRT-103 LDN and IRT-104 LDN cream in this market will allow us to provide much needed treatment at an affordable price to the citizens of the Federal Republic of Nigeria."

About G-Ex Technologies/St. Maris Pharma G.Ex Technologies/St. Maris Pharma is a consortium of management consultant, general pharmaceutical, clinical pharmacy and marketing executives, each with over twenty-five years of industry experience and well versed in the changing dynamics of the prescription and OTC drug international marketplace. Actively supported by medical practice professionals in business and academia who have been involved in the management of related drug therapies for many years, the consortium is poised to champion the successful introduction of IRT-103 LDN and IRT-104 LDN in the territory.  

About TNI BioTech, Inc. TNI BioTech, Inc., is a biotech company combating fatal diseases through the activation and mobilization of 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, infections such as HIV/AIDS, chronic inflammatory diseases, and autoimmune diseases.

Our proprietary technology, therapies and patents, will be used to treat a wide range of cancers. Our most advanced clinical programs involve immunotherapy that works by isolating a patient's lymphocytes and then incubating them together with Methionine Enkephalin (MENK) in an enriching external incubation system. After incubation the patient's lymphocytes are re-infused back into the patient where they combat and destroy tumor cells.

Even though Management considers any condition that results in altered-immune response a target for investigation, the Company will most likely pursue additional investigations for MENK as a valuable candidate in the treatment of the following:

• Autoimmune states such as rheumatoid arthritis and multiple sclerosis;
• As an adjunct to antibiotics in the treatment of infectious diseases;
• In cancer patients undergoing chemotherapy, radiation treatments or surgery;
• Patients with AIDS, in combination with retroviral drug therapy; and
• In wound healing or herpes viral infections.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS: This press release includes various "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which represent the Company's expectations or beliefs concerning future events. Statements containing expressions such as "believes," "anticipates," "intends," or "expects," used in the Company's press releases and in Disclosure Statements and Reports filed with the Over The Counter Markets through the OTC Disclosure and News Service are intended to identify forward-looking statements. All forward-looking statements involve risks and uncertainties. Although the Company believes its expectations are based upon reasonable assumptions within the bounds of its knowledge of its business and operations, there can be no assurances that actual results will not differ materially from expected results. The Company cautions that these and similar statements included in this report are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date thereof. The Company undertakes no obligation to publicly release any revisions to such forward-looking statements to reflect events or circumstances after the date hereof. Contact: Global Investment Media

Phone:  310-353-6277

SOURCE TNI BioTech, Inc.

Read more here: http://www.sacbee.com/2012/11/15/4988198/tni-biotech-inc-signs-exclusive.html#storylink=cpy

TNI BioTech, Inc. Signs Exclusive Distributor Agreement for Federal Republic of Nigeria with G-Ex Technologies/St. Maris Pharma & GB Pharma Holdings LLC - PR Newswire - The Sacramento Bee:

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Drs Doing Poor Job of Warning IBD Patients About Risks of Immunosuppressant Meds & Impt. Screening Tests Prior To Starting Treatment

Take an immunosuppressant drug?  Read this.  Good info to know and keep in mind if you are on certain meds or considering taking them. 
I know that for the short period of time that I was on Remicade, my GI doc never stressed the importance of screening for hepatitis, TB.. not even a simple PPD skin test.  Actually none of what was discussed in this article was taken into consideration.  

ARTICLE HIGHLIGHTS

• Despite evidence to support the importance of vaccinations and prevention of infections in patients with IBD, especially in immunocompromised patients, physicians have done a poor job in this area,” said Miguel Regueiro, MD
•  In one analysis, they set out to determine whether male patients with IBD beginning immunosuppressive treatment received the same information as their female counterparts regarding the potential effect of medications on fertility. Female IBD patients routinely are counseled that some medications may affect conception, pregnancy and teratogenicity.
• ....the need for physicians to do a better job screening IBD patients for opportunistic infections, vaccinating patients against preventable illnesses and counseling male patients on fertility.”
• The gravity of latent TB emerging with anti-TNF treatment also needs to be taken more seriously
• patients taking adalimumab were significantly less likely to be screened for hepatitis infection than those taking infliximab, Dr. Borum said.

link-->  Gastroenterology & Endoscopy News - Physicians Doing ‘Poor Job’ of Warning Patients With IBD About Risks of Medications, Studies Suggest:

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Physicians Doing ‘Poor Job’ of Warning Patients With IBD About Risks of Medications, Studies Suggest

by David Wild

Many gastroenterologists are failing to warn patients with inflammatory bowel disease (IBD) of the possible risks associated with live vaccinations and the effects of IBD medications on male fertility. Clinicians also are not consistently screening patients with IBD for hepatitis, tuberculosis (TB) and other opportunistic infections.
“Despite evidence to support the importance of vaccinations and prevention of infections in patients with IBD, especially in immunocompromised patients, physicians have done a poor job in this area,” said Miguel Regueiro, MD, professor in the Division of Gastroenterology, Hepatology and Nutrition and co-director of the Inflammatory Bowel Disease Center at The University of Pittsburgh’s Department of Medicine. “In the era of outcomes and reimbursement measured by quality indices rather than quantity metrics, preventative strategies for IBD patients are of paramount importance,” said Dr. Regueiro, who was not involved in the research.
Medication-Related Fertility Issues
Marie Borum, MD, EdD, MPH, professor of medicine and director of the Division of Gastroenterology and Liver Diseases at George Washington University in Washington, D.C., and colleagues conducted a series of medical record analyses, examining the rates of compliance with various IBD-related clinical guidelines. They presented their results at last year’s Crohn’s & Colitis Foundation of America’s Advances in Inflammatory Bowel Diseases meeting. In one analysis, they set out to determine whether male patients with IBD beginning immunosuppressive treatment received the same information as their female counterparts regarding the potential effect of medications on fertility. Female IBD patients routinely are counseled that some medications may affect conception, pregnancy and teratogenicity. Although sulfasalazine, methotrexate, thiopurines and anti-tumor necrosis factor (TNF) drugs all have known or suspected effects on male fertility, Dr. Borum’s team believed this group of patients may not be fully informed of these effects prior to initiating treatment.
To document their suspicions, the investigators analyzed medical records from 63 male patients with ulcerative colitis and 76 male patients with Crohn’s disease treated at their institution between June 2010 and June 2011. Eight patients had received sulfasalazine, three were treated with methotrexate, 36 were administered a thiopurine and 33 had been treated with an anti-TNF agent, all for at least one year.
The findings confirmed the researchers’ concerns, showing only one patient receiving sulfasalazine and one patient treated with a thiopurine had a documented discussion with their gastroenterologists about drug-related fertility issues. There were no documented discussions on the topic among those receiving methotrexate or anti-TNF agents.
Dr. Borum said that although some of these discussions may have taken place, they were not documented and the findings, “strongly suggest a need for improved counseling with male patients.”
“Although there is limited and potentially conflicting data available regarding medication impact on spermatogenesis and pregnancy outcome, it is important that available information be provided to all patients,” Dr. Borum said.
Risks Associated With Live Vaccines
In a separate analysis, Dr. Borum’s team found many patients with IBD are not made aware of the risks associated with receiving live vaccines during immunosuppressant treatment.
“Commonly administered live vaccines are given during childhood and often prior to IBD onset, but live vaccines, such as annual influenza and yellow fever for international travel, can be administered in adults,” Dr. Borum noted. “These vaccinations are essential in IBD patients, a group at high-risk of infections, but should be administered in their inactivated form.”
Dr. Borum and her team analyzed medical records from 141 IBD patients receiving immunosuppressant drugs and found no documented discussions with patients advising them to avoid live vaccinations. Furthermore, only 15% of these immunosuppressed patients received inactivated influenza vaccinations, as per published guidelines, and most were vaccinated only “on occasion,” rather than annually (Moscandrew M et al. Inflamm Bowel Dis 2009;15:1399-1409).
“Appropriate vaccination is necessary to reduce the incidence of preventable disease and reduce mortality in the IBD population,” Dr. Borum emphasized. “However, it is imperative that patients receiving immunosuppressants be specifically counseled against receiving live vaccinations because these may be administered by a non-gastroenterology specialist who may not be aware of the risks.”
Risks for Opportunistic Infections
The gravity of latent TB emerging with anti-TNF treatment also needs to be taken more seriously, Dr. Borum’s findings suggested. Of 44 patients treated with an anti-TNF agent between June 2010 and June 2011, only 66% had undergone appropriate TB screening, including the TB skin test (also known as PPD testing) with subsequent chest x-rays and QuantiFeron Gold testing if PPD tests proved positive.
“Although this study is limited by its small sample size, retrospective design and potential undocumented tuberculosis screening, the findings suggest the need for increased awareness among physicians to universally screen for tuberculosis in all IBD patients prior to and during anti-TNF treatment,” Dr. Borum said.
In the same cohort of 44 patients, only 60% and 57% were screened for hepatitis B and C infection, respectively, prior to initiating immunosuppressive treatment, despite recommendations that all patients should be screened for chronic hepatitis prior to immunosuppression. Many infected patients may be asymptomatic, and immunosuppression increases the risk for viral replication and disease progression (Moscandrew M et al. Inflamm Bowel Dis 2009;15:1399-1409).
Although there were no differences in the frequency of screening by age, gender or IBD disease type, patients taking adalimumab were significantly less likely to be screened for hepatitis infection than those taking infliximab, Dr. Borum said.
Dr. Regueiro noted that although the studies were retrospective, small and had a number of methodologic flaws, “they all demonstrated the need for physicians to do a better job screening IBD patients for opportunistic infections, vaccinating patients against preventable illnesses and counseling male patients on fertility.”