Archive for November, 2009

 

Is generic Remicade (Humira, etc.) in our future?

November 20th, 2009 by Kevin A. Barnes

As part of $3K in 3 Weeks, here is another in a series of articles on current issues and topics related to Crohn’s disease and ulcerative colitis.

BiologicsDid you know that biologics1 such as Remicade, Humira, and Cimzia – used in the treatment of Crohn’s disease and ulcerative colitis – are governed by different rules and laws than other traditional medications? As a result, there currently are no approved generic biologics in the U.S. So while you might be able to buy a generic version of a brand name pain killer or blood pressure medication, you can’t buy generic Remicade (at least not legally).

Why are generic biologics not available, and is that likely to change?

To answer those questions, we need to start with a quick history lesson: The generic drug industry arose in 1984 when the Hatch-Waxman Act made it much easier (and much less expensive) for qualified companies to produce a molecularly identical version of a drug after its patent had expired. (Prior to Hatch-Waxman, a company wishing to manufacture a generic drug would have had to repeat the full – and costly – clinical studies and the same FDA approval process that the original manufacturer went through.) Read the rest of this entry »

  1. Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combination of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources – human, animal, or microorganism – and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available. — Source: U.S. Food and Drug Administration []
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Research Update: The Human Gut Microbiome Initiative

November 18th, 2009 by Kevin A. Barnes

As part of $3K in 3 Weeks, here is the first in a series of articles on current research initiatives related to Crohn’s disease and ulcerative colitis.

Future IBD ResearcherThe Human Gut Microbiome Initiative, based at the Genome Center of Washington University in St. Louis,1 is the first major investigation into the thousands of species of bacteria that live in the human digestive system.

What’s a microbiome? The “microbiome” is defined as all bacteria in the human body, as well as all the products they make. To put this in perspective, scientists estimate that as much as 90% of the cells in the human body are actually bacteria.2 In the past, since most of the species of bacteria found in the human body could not be cultured (grown outside the body for study), we’ve been essentially clueless about how those bacteria functioned and their potential role in the human body. Read the rest of this entry »

  1. The Human Gut Microbiome Initiative is under the direction of Dr. Jeffrey I. Gordon of Washington University, a gastroenterologist and Director of the Center for Genome Sciences, and Dr. Rob Knight, Assistant Professor of Chemistry and Biochemistry at the University of Colorado, an expert in bioinformatics. []
  2. That’s not a typo! For every traditional human cell in you, there are nine bacteria cells. []
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Announcing $3K in 3 Weeks — Help beat Crohn’s and colitis

November 15th, 2009 by Kevin A. Barnes

$3K in 3 Weeks is a special effort I’ve established to raise both awareness and at least $3,000 to help defeat Crohn’s disease and ulcerative colitis — hence $3K in 3 Weeks.

Future IBD ResearcherThe effort runs from today (Sunday, November 15) through Sunday, December 6 when I will run the 13.1-mile Las Vegas Rock ‘n’ Roll Half Marathon to demonstrate my commitment to defeating Crohn’s and colitis. (What are Crohn’s disease and ulcerative colitis? Read an overview of these diseases and their impact at the end of this article. )

In recent years, we’ve seen dramatic advances in the understanding of these devastating diseases, to the point where our knowledge has already begun to improve the lives of those with Crohn’s and colitis (an estimated 1.4 million people in the U.S. alone). And recently one researcher after another has begun telling us the same thing:

We know what remains to be done — the only thing standing between us and a cure is money.”

That’s right — money has become the critical factor in helping find a cure. Here’s how you can help: Read the rest of this entry »

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Research identifies more IBD genes

November 5th, 2009 by Kevin A. Barnes

A new study published in the New England Journal of Medicine yesterday1 identifies three different genetic mutations that appear to be associated with early-onset inflammatory bowel disease (IBD).

Researchers examined two families which had a total of nine cases of early-onset IBD and identified “three distinct homozygous mutations in genes IL10RA and IL10RB, encoding the IL10R1 and IL10R2 proteins, respectively, which form a heterotetramer to make up the interleukin-10 receptor.” They also tested a small sample of IBD patients from outside those two families to determine if similar genetic mutations could be involved in other cases of IBD. The researchers go on to theorize that in these particular patients a lack of interleukin-10 signaling is “the principal malfunction and is a likely cause of inflammatory bowel disease in patients with IL10R2 deficiency.” Read the rest of this entry »

  1. Inflammatory Bowel Disease and Mutations Affecting the Interleukin-10 Receptor, Erik-Oliver Glocker, M.D., et. al., New England Journal of Medicine, 4 November 2009. []
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Recommitment vs. Being Committed

November 2nd, 2009 by Kevin A. Barnes

It’s going to be an interesting (and busy) November and December.

I recently reviewed a list of all of the non-work projects I currently have underway, with the hope of dropping (or at the very least deferring) some of them. After that exercise, I was still left with an overly ambitious set of goals I hope to accomplish before the end of 2009, all on top of the usual background noise of my day job and my on-again-off-again health.

Late in the officeThe challenge is that there are too many important things that must get done. Things whose time has come. Things that I’m not willing to give up on, and can no longer delay.

Major Project #1: Raise funds to cure Crohn’s disease and ulcerative colitis
October 19 was recommitment for the Las Vegas Half Marathon for Team Challenge. What that means is that I’m now committed to run 13.1 miles on December 6 and raise at least $4,000 to help fund research and other vital programs to beat Crohn’s and colitis. This is my third half marathon for this cause, and although progress is being made by the researchers and medical experts, there still is no cure. So I keep running.1 And despite what my body (and my own Crohn’s disease) tells me, I’ll continue running until we beat this thing. If you’d like to help this effort, please visit my Team Challenge donation page.

Read the rest of this entry »

  1. For the record, in addition to running I am also a donor. During the last twelve months alone, I’ve donated over $3,000 of my own money toward vital Crohn’s and colitis research projects. []
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