Tuesday, September 16, 2008

Diabetics Less Likely to Lose Weight After Gastric Bypass

Title: Diabetics Less Likely to Lose Weight After Gastric Bypass
Category: Health News
Created: 9/16/2008 2:00:00 AM
Last Editorial Review: 9/16/2008

The most specific tests are tests for Celiac disease endomysial antibodies (EMA) and
tissue transglutaminase antibody (tTG) tests. These two tests are IgA based tests and can be negative if you are deficient in the immunoglobin IgA, which occurs in 10-20% of people with Celiac. When either EMA or tTG are positive Celiac disease is very likely and usually the intestine biopsy is positive. Recent studies indicate that the tTG may only be positive in 40% of true Celiacs when mild degrees of intestine damage are present on biopsy. Seronegative Celiac, meaning the blood tests are negative but the biopsy is positive, may occur in up to 20% of Celiacs.

The most distressing problem for people with lesser forms of gluten intolerance who have blood tests and/or biopsies that are normal or borderline yet respond to a gluten free diet is either not being taken seriously or knowing for sure if they are sensitive to gluten. For these individuals stool
antibody testing for antigliadin and tTG have been helpful. Such stool testing has been performed in research labs and published in a few studies but are only recently available through the commercial lab, Enterolab. Founded by a former Baylor research gastroenterologist, Dr Ken Fine, the tests are available to people online without a doctors order but are not generally covered by insurance. Dr. Fine, who patented the test, has yet to publish the results of his findings in a peer reviewed journal so his tests are not widely accepted. However, his unpublished data and the clinical experience of some of us who have used his test have
indicated the tests are very sensitive for signs of gluten sensitivity. He reports that they are 100% sensitive for Celiac disease and highly sensitive
for gluten sensitivity of lesser degrees. In the presence of symptoms, that reverse on a gluten-free diet,
abnormal stool antibody levels can be found in most people before blood tests or biopsies become
abnormal.

Small intestine biopsies during upper gastrointestinal endoscopy
are considered the gold standard for the diagnosis of Celiac disease.
However, recent studies have demonstrated that some people with gluten sensitivity, especially relatives of Celiacs
with little or no symptoms, have changes from gluten injury to the intestine that can not be seen with normal microscope examination. They can only be seen with special stains not routinely done or with a research electron microscope. The special stains are known as immunohistochemistry stains. They stain specialized white
blood cells called lymphocytes in the intestinal lining tips or villi. When these lymphocytes are increased it is known as intraepithelial lymphocytosis or increased IELs and it is the earliest sign
of gluten induced injury or irritation. Electron microscopy also reveals very early ultrastructural changes in some individuals when blood tests and standard biopsy examination are normal. When people who have these changes are
offered the option of a gluten-free diet they usually responded favorably. In contrast, those who continue to eat gluten often later developed classic Celiac disease.

Celiac disease, also known as gluten sensitive enteropathy is very common but frequently missed. It is an autoimmune disease of intestinal damage due to gluten in people who are genetically predisposed. Classic Celiac disease is diagnosed by abnormal blood tests and an abnormal
appearing intestine on biopsy and symptoms that resolve with a gluten free diet.

Enterolab's stool testing for gliadin antibodies and tissue
transglutaminase antibodies, though not widely accepted, have gained favor in the lay
publics opinion as an option for determining sensitivity to gluten either despite negative blood tests and/or biopsies or in place of the more invasive tests. Most doctors still recommend the accepted blood tests and small
bowel biopsy for confirmation of Celiac. Though the reports in the lay community
are overwhelmingly positive they have not been subjected to peer review in
the medical community pending Dr. Fine publishing his data or other researchers reproducing his results.

Several blood tests exist for Celiac disease. They have varying degrees of accuracy. Some are more sensitive, meaning they will be positive in milder forms of the disease but are not specific, meaning a positive test may not indicate Celiac disease. Others are felt to be very specific, meaning that when they are positive, it is almost certain you have the disease.

What these studies suggest is that a normal small intestine biopsy may exclude
Celiac disease as defined by strict criteria but it is not a gold standard for detecting gluten sensitivity. This fact is appreciated by many individuals who have respond to a gluten-free diet they start
based on their symptoms, family history, suggestive blood test or stool antibody
test(s).

Diagnosing Celiac Disease and Gluten Sensitivity

Testing for all the DQ patterns is advocated by Dr. Fine, based on his
experience with stool antibody test results. He reports that other DQ types are
associated with elevated levels of gliadin and tTG in the stool and symptoms that respond to a gluten-free diet.
According to his unpublished data, all the DQ types except DQ4 are associated with
a risk of intolerance to gluten. Therefore, testing for all the DQ types allows a person to
determine if they carry one of the two high risk gene types for Celiac disease or
any of the other "minor DQ" genes Fine has found associated with gluten sensitivity.

However, doctors open to
the broader problem of gluten
sensitivity are reporting these tests helpful in many patients suspected of gluten
intolerance. Especially when someone has symptoms consistent with gluten sensitivity but has negative or inconclusive blood tests and/or biopsies these tests may be very helpful though some are not certain
how to interpret the tests. The national Celiac organizations are uncertain about how to
comment on their application without published research though a recent article
in the British Medical Journal did show stool tests highly specific for Celiac. Dr.
Fine has publicly commented that his unpublished data demonstrates those with
abnormal stool tests indicating gluten sensitivity
overwhelmingly respond favorably to a gluten free diet with improvement of
symptoms and general quality of life.

Antibodies for gliadin (AGA), the toxic fraction of gluten are considered very sensitive but not specific for Celiac disease. Newer assays for AGA antibodies for gluten that has undergone a chemical change
called deamidation appear to be more specific for Celiac disease (Gliadin II,
Inova) than the older gliadin tests. They also may be as or more accurate than EMA and tTG
antibody tests but are not yet widely available.

Another problem is that there are not universally agreed upon definitions for gluten sensitivity or intolerance. This becomes especially difficult for those who do not meet strict criteria for Celiac disease yet may have abnormal tests and/or symptoms that respond to a gluten-free diet. Those individuals become confused when they try to find information but do not have a formal diagnosis of Celiac disease. Consensus in the medical community on definitions and more research in this area is greatly needed.



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Health Highlights: Sept. 14, 2008

Title: Health Highlights: Sept. 14, 2008
Category: Health News
Created: 9/15/2008 2:00:00 AM
Last Editorial Review: 9/15/2008

Separately, it is ironic for Washburn to complain that WARF is asserting its patent rights while, at the same time, CIRM will be seeking to obtain patent rights to enforce against others. Although the patent royalty distribution under Proposition 71 is muddied by federal tax issues associated with the planned use of tax exempt bonds, California voters were told that there would be income from patent royalties.

Obliquely, Washburn suggests that California's CIRM should challenge the validity of WARF's patents: "The Foundation
for Taxpayer and Consumer Rights, based in Santa Monica, has urged California's stem cell agency to challenge the Wisconsin patents."

Washburn wrote: "The foundation's [WARF's] patents are based on the work of James Thompson, a University of Wisconsin professor who was the first scientist to isolate embryonic stem cells, in 1998. But the patents are so broad -- unreasonably broad -- that they cover all human embryonic stem cell lines in the U.S., not just the specific lines developed by Thompson."

The basic WARF patent is US 5,843,780 (issued 1 Dec 1998 to James A. Thomson, based on application 591246 filed 18 Jan 1996; the application was a continuation-in-part of U.S. application Ser. No. 08/376,327 filed Jan. 20, 1995. This invention was made with United States government support awarded by NIH NCRR Grant No. RR00167. Thus, if California's CIRM were to challenge the '780 patent, one would have state taxpayer money of California used to challenge a patent held by a Wisconsin agency (WARF), based on research paid by for by the federal National Institutes of Health (NIH). It is doubtful that state taxpayers in California or in Wisconsin, or federal taxpayers, would find this a useful expenditutre of money.

Los Angeles Times Article Way Off Base on Stem Cell Issues

Lawrence B. Ebert is a registered patent attorney located in central New Jersey. He holds a Ph.D. from Stanford, a J.D. from the University of Chicago, maintains a blog at IPBiz.blogspot.com, and is the author of LESSONS TO BE LEARNED FROM THE HWANG MATTER: ANALYZING INNOVATION THE RIGHT WAY, published in the Journal of the Patent & Trademark Office Society [88 JPTOS 239 (March 2006)]. Ezine draft submitted April 12, 2006.

The previous ezine article stated: An important message to appreciate is that money from state-funding of stem cell research intended to create new horizons in medical treatment may be directed to paying off holders of already-created rights. It may well happen that there are valid patent rights in the stem cell area, and states working in the area must negotiate with the holders of those rights. Separately, the Hatch-Waxman Act created in 35 USC 271(e)(1) a safe harbor for research used to furnish information to federal agencies (such as the FDA). The Supreme Court gave this safe harbor great breadth in the case Merck v. Integra.



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