Thursday, April 28, 2011

FDA finds more blood cancer with TNF blocker drugs *Reuters Article*

FDA finds more blood cancer with TNF blocker drugs

WASHINGTON | Thu Apr 14, 2011 4:15pm EDT

(Reuters) - U.S. health regulators have received more reports of rare blood cancer in young patients taking a class of anti-inflammatory drugs used to treat digestive disorders.

The drugs, called tumor necrosis factor (TNF) blockers, are used to treat Crohn's disease and ulcerative colitis that cause inflammation of the digestive system.

They include such widely used products as Merck & Co Inc's and Johnson & Johnson's Remicade and Simponi, Amgen Inc's Enbrel, Abbott Laboratories Inc's Humira and UCB SA's Cimzia.

The Food and Drug Administration has previously warned of an increased risk of lymphomas and other cancers associated with the use of TNF blockers in children and adolescents.

In its communication on Thursday, the FDA said the blood cancer, known as Hepatosplenic T-Cell Lymphoma or HSTCL, was reported primarily in adolescents and young adults who were taking TNF blockers, as well as other drugs such as azathioprine that also suppress the immune system and mercaptopurine, a leukemia drug.

The product labels for Remicade and Humira have been updated and the product labels for azathioprine and mercaptopurine were being updated to include warnings about HSTCL, the FDA said on its website.

The majority of the cases reported were in patients being treated for Crohn's disease or ulcerative colitis, the FDA said, but the reports also included a patient being treated for psoriasis and two patients being treated for rheumatoid arthritis.

TNF blockers suppress the immune system by blocking the activity of TNF (tumor necrosis factor), a substance in the body that can cause inflammation and lead to immune-system diseases.

Wednesday, April 27, 2011

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 ParkIllinois.
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; Margaret Cronin Fisk in Southfield, Michigan,
To contact the editor responsible for this story: Michael Hytha at

Saturday, April 23, 2011

Bogus baker gets prison term - Crime/Safety -

S**t like this royally pisses me off..... but it doesn't surprise me t all.

That's why I TRUST NO ONE. I always have a reason to continue to have this mindset. sad sad

Bogus baker gets prison term - Crime/Safety -

Tags: crime and safety | Durham County | Wake County | fraud conviction | gluten-free bread | Paul Seelig

RALEIGH -- When Paul Seelig, the Durham "baker" who sold bogus gluten-free bread that sickened dozens of people, was sentenced to up to 11 years in prison in Wake Superior Court on Tuesday, a digital cheer erupted from the nation's celiac community.

It wasn't just that a man whose case was followed on dozens of celiac- and gluten-related blogs and message boards was going to prison. It was also that state agriculture investigators and prosecutors were willing to tackle the case in the first place.

"Good deal," wrote a poster from Owatonna, Minn., who goes by the name Celiabetic on the forum. "Nice to know someone has our back on top of the precedent it sets

An estimated one in 133 Americans has celiac disease. Sufferers can become ill with a host of symptoms after consuming gluten, a protein in grains such as wheat and barley.

Gluten-free products sell at premium prices, but there is no federal standard for them and labeling is voluntary. So Seelig's conviction was an unusual courtroom victory for celiac sufferers, who have to rely on the honesty of food companies and restaurants that claim to produce products without gluten.

The dozens of blogs and message boards devoted to celiac disease often have an underdog, we've-got-to-help-ourselves-because-no-one-else-will tone, along with the tips and information such as what restaurants and shops offer gluten-free foods.

Seelig's case was a popular topic in that world for more than a year. Bloggers on sites such as Gluten Freedom Atlanta, Gluten-Free Faces or The Savvy Celiac opined on the case themselves or linked to mainstream media coverage.

Zach Becker, who writes the GlutenFree Raleigh blog, said he follows more than 100 blogs that deal with gluten issues and corresponds with gluten-free activists and advocacy groups.

There are so many blogs, Becker said, because often those suffering from the disease get little more from their doctors than a diagnosis and instructions to avoid gluten, but little about how to do that.

"They can't tell you much about how, so there's no traditional means to learn it, and so you have to learn from blogs and message boards and Twitter," he said.

Avoiding gluten isn't as simple as not eating wheat bread. The protein can appear in other foods or even products such as shampoo. Restaurants that try to cook without gluten can easily cross-contaminate by doing things such as using the same surfaces to prepare foods with gluten and those without.

A victim speaks

All of the most popular blogs followed Seelig's case, he said.

Becker was one of Seelig's customers who got sick, and he publicized the case heavily on his blog, testified during the trial and, just before Seelig was sentenced, read a statement to the court that included this:

"This case needs to stand as a deterrent to others who might follow in Paul Seelig's footsteps and defraud and poison Gluten Free consumers. Companies need to know that this type of behavior will not be tolerated."

Customers testified during the trial that Seelig's products triggered symptoms that included rashes, nausea and diarrhea. One woman said that she had delivered her baby prematurely, something that can be triggered in celiac patients by exposure to gluten.

Seelig, 48, was sentenced to at least nine years in prison and could serve as many as 11 years. He was found guilty Monday of 23 counts of obtaining property by false pretense after a trial in which he was painted as a prolific liar.

Not baked - repackaged

Among other things, he advertised his baked goods as homemade. Instead, witnesses including a former employee, testified that he bought bread from a commercial bakery in New Jersey and bagels from retailers such as Costco. He then repackaged them in his home kitchen and sold them at the State Fair, at street fairs and by home delivery.

He sold some of those products as gluten-free, though they weren't. Customers and investigators tested the products and found high levels of gluten. Seelig claimed that he tested his bread for gluten weekly, though he couldn't produce test records for the trial. He also maintained that he got his gluten-free products from an Amish baker in Ohio, who had no phone, no street or email address, and said that he paid in cash, so there were no payment records.

Several of Seelig's former customers had attended the trial as spectators or witnesses and returned Tuesday to hear Judge Carl Fox sentence Seelig. They were joined by officials from the state agriculture department and some members of the jury, who had been dismissed after finding Seelig guilty Monday.

Read more:

Friday, April 22, 2011

Voices of Crohn's Disease Patients

This is good!  I found this on and it's men and women talking about their life living with Crohn's Disease.  Stuff like this, helps me to not feel so alone and misunderstood.  I need to read (listen or watch) what other people with this disease are feeling and going through; it helps me.   The fact that other people do struggle with similar issues with Crohn's, helps me to feel validated and not like such an outcast.

Thursday, April 21, 2011

How to Compound Low Dose Naltrexone - Article from E-how

Many people, including myself, have been unsuccessful with getting prescribed LDN from their regular physicians or specialists.  This is mostly due to the lack of knowledge that doctors have about this drug. I send my current doctor that I'm working with for my GI issues, information about the drug so he can learn about LDN.
 I would much prefer to get a "regular" script and fill it the normal way any other drug would get filled.  My options for treatment are limited and i've tried many medications for my Crohn's Disease.  I have done my research on LDN, read reports from the patients who take LDN and I feel confident about the drug and have high hopes that it will work for me.
Anyway, if you have ordered naltrexone independently, and have concerns and questions about compounding/reducing your 50mg tablet, so you are able to take the appropriate dose (between 1mg - 4.5mg), here are the easy instructions.  Very simple to do.

Interesting article - IBD patients and the dangers of C diff

I thought this article was worth reading.  This info was found by London researchers.   

Bug linked to bowel disease deaths
A common hospital bug increases the risk of death for patients with inflammatory bowel disease (IBD) six-fold, research has shown.
Scientists called for all IBD patients to be screened on admission to hospital to protect them against Clostridium difficile (C diff).
IBD, which includes Crohn's disease and ulcerative colitis, affects about 240,000 people in the UK.
The autoimmune conditions cause symptoms of abdominal pain and diarrhoea, which can be severe enough to warrant admission to hospital.
Researchers in London looked at NHS admission records from 2002 to 2008 and found a strong link between IBD, C diff, and death in hospital.
IBD patients infected with C diff were six times more likely to die than those who escaped the bug. After 30 days, their mortality rate was as high as 25%.
The findings, reported in the journal Alimentary Pharmacology and Therapeutics, also showed that IBD patients with C diff had longer stays in hospital and were almost twice as likely to need gastrointestinal surgery.
Typically, they remained in hospital for 26 days, compared with five days for patients without C diff.
Dr Sonia Saxena, one of the researchers from the School of Public Health at Imperial College London, said: "Hospitals must do everything they can to control infections such as C difficile. We are asking for these high-risk patients to be screened for C difficile proactively on admission to hospital so that if they are exposed, they can be diagnosed and treated more quickly."
Co-author Dr Richard Pollok, from St George's Healthcare NHS Trust, said: "At St George's Hospital, we have seen a 70% reduction in hospital-acquired infections after implementing a range of control measures, such as careful handwashing and reduced use of broad spectrum antibiotics. But we need to do more to protect vulnerable patients such as those with IBD."

Sunday, April 10, 2011

BOSWLLIA Herb Reduces Inflammation - Helps Crohn's,arthritis, colitis, more....

Here's the Article....Boswellia Reduces Inflammation
The ancient herb boswellia (Boswellia serrata) has been used for thousands of years to treat conditions that, in recent years, have been found to be caused by inflammation. Originating in Africa, China, and the Middle East, boswellia herbal extract is derived from the sappy resin of the boswellia tree. In the 1970s, German scientists discovered that boswellia produces therapeutic effects similar to those of the non-steroidal anti-inflammatory (NSAID) compounds ibuprofen and aspirin. Unlike boswellia, however, NSAIDs work by inhibiting the cyclooxygenase-2 (COX-2) enzymes. Unfortunately, medications that inhibit COX-2 often inhibit COX-1, which is needed to maintain a healthy stomach lining and common side effects include gastrointestinal bleeding.
Boswellia differs from the NSAIDs in its mode of action. Boswellia has been shown to reduce inflammation in both osteoarthritis and rheumatoid arthritis, inflammatory bowel disease, and other autoimmune conditions by blocking the lethal pro-inflammatory enzyme 5-lipoxygenase (5-LOX). A number of immune system chemicals released during the inflammatory response contribute to the chronic inflammation seen in atherosclerosis, osteoarthritis and certain autoimmune diseases. Blocking these pro-inflammatory chemicals reduces symptoms of inflammation and helps taper the autoimmune mechanism.

The Actions of Boswellia
Although the benefits of boswellia are similar to those of the non-steroidal anti-inflammatory drugs, boswellia works by blocking 5-LOX, which is the first enzyme released in the metabolic pathway leading to the synthesis of the immune system cytokines known as leukotrienes. Leukotrienes are harmful inflammatory substances thought to directly influence the disease process in a number of different disorders, including rheumatoid arthritis, cancer, and asthma.
The active ingredients of boswellia, the boswellic acids, decrease the activity of another pro-inflammatory enzyme known as human leukocyte elastase (HLE). HLE and leukotriene levels are increased in many inflammatory diseases and allergic reactions. To date, boswellia is the only substance known to reduce levels of both HLE and leukotrienes. In 2005, researchers found that boswellia works in part by altering the expression of the cytokine tumor necrosis factor alpha (TNF-α), another integral component in inflammation. An excess of TNF-α promotes chronic inflammation. Applying boswellia to cells has been shown to decrease the TNF-α-induced expression of cell adhesion and matrix metalloproteinase proteins, which are biochemicals related to endothelial dysfunction, cancer metastasis (spreading), arthritis, and other disease processes.

Benefits in Arthritis and Crohn's Disease
Researchers have found that boswellia helps prevent the deterioration of cartilage and joint tissue. This suggests that boswellia may relieve symptoms in arthritis by inhibiting the breakdown of connective tissues that is caused by tumor necrosis factor-alpha-induced expression of matrix metalloproteinase enzymes. Studies in both humans and dogs show after as little as two weeks of boswellia therapy include reduced pain, stiffness, and lameness.
In patients with rheumatoid arthritis and Crohn's disease, boswellia can help reduce the immune cells that promote inflammation while increasing the number of immune cells that inhibit inflammation (anti-inflammatory cells). In studies of patients with inflammatory bowel disease, ulcerative colitis and Crohn's disease boswellia reduced gastrointestinal inflammation and tissue damage. 

LDN Study/Trial for Active Crohn's - *link*

Low Dose Naltrexone study results - show that LDN did help Crohn's Disease sufferers. 

I'm searching to find out why this drug that is said to help people with autoimmune diseases - Crohn's being just one of the diseases, is not approved by the FDA yet for the treatment of autoimmune diseases.

There are so many positives for prescribing this drug vs all the biologics that come with the risk of some very dangerous side effects. Not to mention, naltrexone is super reasonable in price, few side-effects and is effective!

I just wanted to share my findings when searching on the FDA site for clinical trials. Let me know if you find this encouraging or helpful to you.

Thursday, April 07, 2011

Shut up, you're giving me a stomach ache!!

Are You a Gut Responder? Yes, that's me.  Hints on Coping with an Irritable Bowel

The gut and the brain develop from the same part of the human embryo. So it is not surprising that the intestinal tract has such a rich nerve supply that it is sometimes referred to as “the little brain.” The gut shares many of the same kinds of nerve endings and chemical transmitters as the brain to which it remains linked through a large nucleus (the locus ceruleus). This collection of nerve cells is partly responsible for controlling anxiety and fear, which explains why these emotions can sometimes be associated with bowel function.   Read more.......