Saturday, February 25, 2012

Brentuximab - FDA Approved in August 2011- Current Date - 3 Reported Cases of Serious Brain Infection

Another dangerous drug Biologic Therapy -

Approval of this drug was in August 2011 and at that time of approval, there was 1 reported case of PML (serious brain infection) out of 102 participants.  That's a very small amount of participants and out of the 100 people , 1 person ends up with this rare, but very disabling brain infection.  Maybe the FDA should have looked at the number of participants (it's not freaking 500 people and 1 ended up with this rare infection.. making the chances a lot less and a little more reassuring that the drug is safe).
Well, as of January of this year, there are now 3 cases of PML caused by Brentuximab.  This drug should only be prescribed to the sick patient that has exhausted all other options of treatment and the patient has had no success.  If that' the case and you don't have anything to lose, because treating the disease is now a matter of life or death, yes.  I would use that last possible option because at that point there would be no weighing risks versus benefits.  The posed risk is that if the said medication does not work, the chances of survival is slim.
"Brentuximab was approved by the FDA in August 2011 for the treatment of Hodgkin's lymphoma and systemic anaplastic large cell lymphoma. At the time of approval, 1 case of PML was described in the warnings and precautions section of the label. So there are now 3 cases associated with the drug.""Brentuximab vedotin (INN, codenamed SGN-35 and previously cAC10-vcMMAE) is an antibody-drug conjugate approved to treat anaplastic large cell lymphoma (ALCL) and Hodgkin lymphoma. The U.S. Food and Drug Administration granted the agent an accelerated approval on August 19, 2011 for use against these two diseases.[1] It is marketed as Adcetris.[2
Accelerated approval basically means the study didn't run the full coarse length of time that would have been necessary to determine the drug's safety and effectiveness.

I wanted to see when the study began,  how long it was supposed to run for and the actual amount of time it did run and was completed.  I went to the reputable site to look up this information for it's accuracy.   This was what I found

Study was supposed to be completed in 7 years from the start date.
Study was completed in a little less than 2 years

2 years is just not enough time when you are trying to determine it's safety!!  How can it be determined in 2 years how the drug may effect the body in the long term.  Even 4 years isn't enough time, but it's still more reasonable and will give more reliable results.  I once again, still don't understand how the FDA could say yes to making this treatment available now.    As we know,  Biologic therapies come with a side-effect profile that is extremely long and with some possibility for long term damage.  Some of the risks that come with these drugs are life threatening. From what is seen in the documentation of reported effects from the use of  Biologic therapies  (ones that have been on the drug market for several years now such as, Remicade, Humira) range from long term nerve damage, severe & life threatening infections,  death.  

Enrollment:102 Participated in Study
Study Start Date:February 2009
Estimated Study Completion Date:August 2015
Primary Completion Date:August 2010 (Final data collection date for primary outcome measure)

Rainbow Acres, Raw Milk Farm Prohibited by FDA From Selling Products Outside PA

Raw Milk Farmer Daniel Allgyer Forbidden From Selling His Product Outside Pa.

PHILADELPHIA — A central Pennsylvania farmer has been prohibited from selling to out-of-state customers unpasteurized milk, which the government says can be unsafe.
The U.S. Food and Drug Administration announced Wednesday it obtained a permanent injunction against Daniel Allgyer (AL'-guy-ur) and his Rainbow Acres Farm in Kinzers.
The agency says raw milk can contain harmful bacteria. The milk can be legally sold within Pennsylvania but not elsewhere. A federal judge granted an injunction Feb. 2.
Allgyer argued he was leasing his cows through a private organization to consumers in Washington, D.C. He can still sell raw milk in Pennsylvania. He hasn't returned a message seeking comment.
Another dairy, Family Cow, in Chambersburg, resumed bottling raw milk earlier this month following an 11-day shutdown after dozens of illnesses were reported in four states.  

Friday, February 24, 2012

IBD Cases - Increasing In Developed Countries - & What Countries Do You Think Have The Highest Rate Of IBD Patients??

This is a good write up about the increased # of IBD patients that are being seen around the globe. Researchers have not yet discovered the reason for the growing rates, however they've noticed a trend geographically.
So the answer to the question... : What countries come out on top for having the largest population of diagnosed people with IBD?
"Something needs to be done. I agree with Rosee that we need more research but also we need to start focusing on new areas of treatment. To focus more on getting better information out there to newly diagnosed patients. This isn’t a problem that can be swept under the rug. It has a potential to cripple government health budgets with cases of IBD raising over the developed countries at new staggering rates. With countries like China & India suddenly having a growing rate in new cases, we need to focus on the differences between developed countries & those of their industrialized counter-parts.
There are theories circulating around developed societies becoming more sterile over time causing new children to be born with weakened immune systems. Other theories state that the ‘Western’ diet is at the core of the problem. <--------------- BAM!! In my opinion, this is the main cause. The "Western" diet is junk - processed, hormone boosted, made with artificial dangerous chemicals, pesticide sprayed.... the list goes on. Can someone tell me WTF a Dorito is? Next time your in a close proximity to a bag of dorito's, just for the hell of it, read the ingredients. LOL you won't be adding this to your cart (unless you have a death wish).
Another theory considered by researchers focuses on vitamin D deficiency due to the lack of sun in countries like Canada & Scandinavia. " The reason that I feel that this is not the culprit (It may certainly have some importance) for the cause of IBD, is because if you look at the weather patterns 50 years ago compared to today, there have not been much fluctuation in the amounts of sunlight to have such an impact on a population.
The area that we know for a fact that has changed for the worse and not for the better is DIET. The way our food is made and what it's made out of . The quality of everything we eat today is much worse than it used to be... HELLLLO, Doctor Blind?????????, maybe this is somewhat of the cause for IBD. Our bodies are not designed to process and metabolize chemically engineered crap. When we do, our bodies reject what we have eaten by manifesting symptoms that say "Ouch !!! I can't break that down " or "What the hell is this stuff... YUCK" - What I'm saying, is that you end up ill. Until doctors start to put some concentration on the importance of diet & IBD, we will forever NOT KNOW what the root cause for IBD is.. PERIOD! When a doctor says "Diet has nothing to do with the disease, it could impact symptoms, but it's not the cause", that's bullshit and i've heard that so many times that it's almost retarded to go along with this theory. DIET HAS EVERYTHING TO DO WITH THE MAIN CAUSE FOR IBD!
*Vitamin D deficiency is seen a lot and should be supplemented, especially if you live in an area where sunlight is minimal. If you live in a seasonal state, like NY or in a region that has changing weather patterns, during the times that you rarely are outdoors and during dreary seasons, take vitamin D. The majority of people that are deficient, aren't even aware.

Canada & UK top list of countries for inflammatory bowel disease

Thursday, February 23, 2012

UPDATED: Do Probiotics Play A Role In Maintaining Remission In Ulcerative Colitis Patients?


I'm editing this blog post to just add what probiotics I am currently taking and also ones that have helped in the past.These are the probiotics that I take, excluding Mutaflor due to the availability of the product.

VSL#3 - Prescription probiotic.  You must get an actual prescription fro your doctor to get this.  The packets of powder vs the capsules work better for me. This may be due to easier absorption, the powder mixed with water or juice instantly is dissolved and metabolized.  Very good product.

S.Boulardii - Beneficial for IBD patients(also beneficial to these medical conditions - HIV/AIDS, C. Difficile infection, IBS, Acute diarrhea, Travelers' diarrhea, Anti-biotic diarrhea.

Mutaflor - (sold in Canada.  Have not been able to get this in the US) Efficacy of Mutaflor for a variety of inflammatory bowel diseases has been tested through 80 years of clinical experience. There are numerous double-blind placebo-controlled studies showing the efficacy of Mutaflor in the treatment and prevention of gastrointestinal disorders. These include Ulcerative Colitis, Chronic constipation, Crohn's Disease, IBS, Pouchitis, Antibiotic -associated/ Pseudo-membranous, Prophylaxis against colonization of pathogens and enhanced immunity of newborn infants.

LactoFlamX (Metagenics)relieve intestinal irritation, promote the integrity of the GI intestinal barrier, and support a healthy immune response. 

Metagenics has a large product supply of GI beneficial products to help maintain microbial balance, address GI function and support the immune system:  Here's the link to the GI health products.

I already knew this to be true.  I don't have UC, I have Crohn's and I need to take Probiotics to keep my intestinal flora in balance.  

This last sentence in the article, pretty much sums up the findings of their study.....
"Through meta-analysis, they concluded that probiotics should be considered as an auxiliary medicine in the remission induction stage and maintenance stage of ulcerative colitis."

Which treatment is effective in maintaining remission in ulcerative colitis: Probiotic or placebo?

According to, A Leaky Gut May Be Root Of Some Cancers Forming In The Body - Read on...

This is published online Feb. 21 in PLoS ONE by Thomas Jefferson University, if anyone would like to read where the original source of info came from.

This is one quote in article that says a lot in very few words

"If the intestinal barrier breaks down, it becomes a portal for stuff in the outside world to leak into the inside world. When these worlds collide, it can cause many diseases, like inflammation and cancer." - Waldman.

Stronger intestinal barrier may prevent cancer in the rest of the body, new study suggests

Tuesday, February 21, 2012


I'm making my special chicken soup today. In the past few days, i've had to eliminate a lot of foods from my diet due to symptoms.  The good old Crohnie is visiting again... Of course always unpredictable by dropping by at unexpected times and staying wayyy longer than anticipated.  So annoying!

So yeah, I'm back to square 1 right now with just eating chicken soup (It's the intro diet to GAPS/SCD).  CHICKEN SOUP... Mmmmmmmm yummy.  That's what I say now...After about 7 days of just eating chicken soup, it becomes a lot less yummy.  It does help with balancing the flora and healing the pipes.

This is the 1st time I'm making it myself.  Gotta go stir up the pot now actually. :)

Interesting Article by The Irish Times- People with IBD Suffer Discrimination

People that do not have IBD have no clue what it's like to live with this disease. I was surprised to see an article about this issue. So many people downplay the symptoms of the disease because we "look fine". It's not a disease you can see, making it so difficult for some people to wrap their minds around the severity of Crohn's.

Nice to see people are bringing awareness to this issue.

People with IBD suffer discrimination, says report

Saturday, February 18, 2012

Research Study Children - Ones with IBD & Ones w/out. Read Results.

This is a pretty logical article that discusses Children (between ages of 11 & 17) with some form of IBD and what has been seen as a trend with students that do have IBD and ones that do not.  What was concluded from the studies that are mentioned is pretty much expected.  I did find the fact that most students with IBD tended to "internalize" their feelings.  I can certainly relate to this fact and when I look back  on my last 2 years of highschool (when I was diagnosed with UC) I internalized most of my emotions and feelings.  This alone, not taking the disease into consideration is in my opinion a possible contributing factor that can lead to stomach problems, IBD or IBS.  At around the time of my diagnosis (I was 17)was also when I 1st began taking psychotropic medications and have yet been able to discontinue the use of them.

Kids With Crohn’s Disease, Colitis Often Struggle at School: Study

Last Updated: February 17, 2012.

Frequent absences, depression can affect how well students with bowel disease do academically

Comments: (0)

Frequent absences, depression can affect how well students with bowel disease do academically.

FRIDAY, Feb. 17 (HealthDay News) -- Children with inflammatory bowel disease may have difficulty in school due to frequent absences that are largely the result of mental struggles such as depression rather than the disease itself, a new study finds.
Researchers from Nationwide Children's Hospital in Columbus, Ohio, had students aged 11 to 17 years with and without inflammatory bowel disease -- which generally takes the form of Crohn's disease or ulcerative colitis -- answer questionnaires about their mental health, school functioning and quality of life. Schools provided report cards and school absence information.
Children with the condition missed more days of school than healthy kids, and those who missed lots of school had lower grade point averages, according to the study.
Kids with inflammatory bowel disease were also at risk of "internalizing" problems, such as depression, according to the study. Kids who were struggling more mentally also tended to have more absences.
"Youth with [inflammatory bowel disease] are at increased risk for depression, so the finding that internalizing problems are associated with school absence is a particular concern with important implications," said lead study author Laura Mackner, an investigator in the hospital's Center for Biobehavioral Health, in a hospital news release.
The study recently appeared in the Journal of Developmental & Behavioral Pediatrics.
Symptoms of inflammatory bowel disease include abdominal pain, fatigue and diarrhea. Children may be prescribed corticosteroids, which may affect learning and memory, or have to take intravenous medication requiring hours in an infusion clinic, according to Dr. Wallace Crandall, director of the hospital's Center for Pediatric and Adolescent Inflammatory Bowel Disease.
"Both [inflammatory bowel disease] and its treatment have the potential to disrupt school functioning," Crandall said in the release.
The study authors noted that most of the children studied were in remission or had only a mild form of the disease, so it's unclear if their findings would apply to children with more severe cases.
More information
Nemours has more on inflammatory bowel disease.

SOURCE: Nationwide Children's Hospital, news release, Feb. 14, 2012
Copyright © 2012 HealthDay. All rights reserved.

Tuesday, February 14, 2012

The Epoch Times Highlights 7 Diseases That Will Increase Drug Companies Profits - They Hope & Pray That You Have At Least 1 Of Them.

This article covers several different conditions and health problems from depression, to arthritis that are big money makers for the drug industry.  Conditions that can be easily categorized into a "treatable" (meaning you will be prescribed expensive medication to manage your condition) diagnosis which then allows the $$$ to come pouring in!
I have included some highlights from 1 of 3 and 2 of 3 and include the link below each highlight.  Next week I will post the 3rd and last article.
(This posting is not focused directly on Crohn's Disease and digestive diseases, however the the medications they discuss are used for some patients with Crohns, UC ect.  Also, more times than not, people have a dual diagnosis or more than 2 and are taking medication to treat the condition.  Due to the fact that these articles discuss several conditions and medications, I thought it would be worth posting to educate and expand awareness.
I like to draw attention to articles that touch on the motivations of the big pharmaceutical companies and the FDA.  When it comes to health care in the US, the system is highly flawed.  I've figured that out by reading and researching Crohn's Disease and it has lead me to read some very eye opening articles (yes they are reputable). I'm not frowning upon all drug companies and medications, I just want to inform people to be cautious and not so trusting of our medical system.  Being skeptical is being smart.


"Supply-driven marketing, also known as “have drug, need disease and patients,” not only turns the nation into pill-popping hypochondriacs, it distracts from pharma’s drought of real drugs for real medical problems.
Of course not all diseases are Wall Street pleasers. To be a true blockbuster disease, a condition must meet certain criteria" 

read more............
seven-diseases-big-pharma-hopes-you-get-in-2012 1OF3

"In 2008, the FDA announced that 45 people on Humira, Enbrel, Remicade, and Cimzia died from fungal diseases. The FDA also investigated Humira’s links to lymphoma, leukemia, and melanoma in children.
This year, the FDA warned that the drugs can cause “a rare cancer of white blood cells” in young people, and the Journal of the American Medical Association (JAMA) warned of “potentially fatal Legionella and Listeria infections” from the use of these drugs."

read more............
seven-diseases-big-pharma-hopes-you-get-in-2012 2OF3

Friday, February 10, 2012

Is Your Gut Leaking? Sounds Gross, Yes. But, Can It Happen? Yes

From WEBMD posted this AM
My next blog will have more info about Leaky Gut.  I also would like to post a very indepth, well explained video on Leaky Gut Syndrome.

Come back & read/watch

Leaky Gut Syndrome: What Is It?

What you should know if you think you have leaky gut syndrome.
WebMD Feature
Reviewed by Louise Chang, MD

"Leaky gut syndrome" is said to have symptoms including bloating, gas, cramps, food sensitivities, and aches and pains. But it's something of a medical mystery.
“From an MD’s standpoint, it’s a very gray area,” says gastroenterologist Donald Kirby, MD, director of the Center for Human Nutrition at the Cleveland Clinic. “Physicians don’t know enough about the gut, which is our biggest immune system organ.”

Recommended Related to Digestive Disorders

Online. Founded 1999. Online internet discussion group which serves as a means of support and information for persons with pancreatitis. Website: Verified: 9/28/2010
"Leaky gut syndrome" isn't a diagnosis taught in medical school. Instead, "leaky gut really means you’ve got a diagnosis that still needs to be made,” Kirby says. “You hope that your doctor is a good-enough Sherlock Holmes, but sometimes it is very hard to make a diagnosis.”
“We don’t know a lot but we know that it exists,” says Linda A. Lee, MD, a gastroenterologist and director of the Johns Hopkins Integrative Medicine and Digestive Center. “In the absence of evidence, we don’t know what it means or what therapies can directly address it.”

Intestinal Permeability

A possible cause of leaky gut is increased intestinal permeability or intestinal hyperpermeability.
That could happen when tight junctions in the gut, which control what passes through the lining of the small intestine, don't work properly. That could let substances leak into the bloodstream.
People with celiac disease and Crohn’s disease experience this. “Molecules can get across in some cases, such as Crohn’s, but we don’t know all the causes,” Lee says. Whether hyperpermeability is more of a contributing factor or a consequence is unclear.
But why or how this would happen in someone without those conditions is not clear.
Little is known about other causes of leaky gut that aren't linked to certain types of drugs, radiation therapy, or food allergies.
Leaky gut symptoms aren't unique. They're shared by other problems, too. And tests often fail to uncover a definite cause of the problem. That can leave people without a diagnosis and, therefore, untreated.

Unsolved Mystery

It’s crucial, Kirby says, to find a doctor who will take time with you and take your concerns seriously.
“You may have leaky gut and we may be able to treat what causes it,” Kirby says. “If you have something going on, it is incumbent upon the medical community to listen to you.”
Unfortunately, Lee says, not all doctors make the effort to get at the root of the problem, and that’s what frequently sends patients to alternative practitioners.
“Often, the reason they have resorted to alternative medicine is because of what they have been told and how they have been treated by other practitioners,” Lee says.  “We need to listen.”

Wednesday, February 01, 2012

Could Transparency Life Sciences, LLC Drug Company Actually Be One With Right Intentions? This Makes Me Smile :)

Like Whoa!!! The timing of this article couldn't have come at a better time. I was just thinkig about this exact issue that this company pretty much addresses. Very cool! the fact that funding for trials cost just way too much freaking $$$. TLS drug company will use a different approach in the way they go about gathering potential trial participants, read the article, very different approach. In addition, FINALLY a company that wants to put an end to the stagnant progress with the older drugs that are off patent that no drug companies want to invest their money in for more clinical trials (mainly due to the fact that they will not get much $$ in return with these drugs - one being LDN) Money has always been the main barrier to gaining headway with the FDA for approvAL of certain drugs, especially older effective and safe drugs like LDN. It will be a very happy day when the FDA finally has to approve LDN as a treatment for something else besides addiction. I wonder which 1 out of the hundreds of conditions will be known to improve with the treatment of low dose naltrexone. My guess is.... hmmm.. Multiple Sclerosis or IBD. Hopefully we'll find out soon. Enjoy the article.

—Transformational Approach Aims to Leverage 21st Century Technology and Connectivity to Boost Patient Involvement, Slash Costs and Improve Success Rates in Its Clinical Trials—

—TLS' Crowdsourced Web Platform Allows Patients, Physicians, Researchers and Other Stakeholders to Participate in Clinical Trial Design

Transparency Life Sciences, LLC Launched as World's First Drug Development Company Based on Open Innovation