[Pflienews] PharmFacts E-News Update: Stem Cell transplants from patient's own cells yields diabetes breakthrough; more....

Tue Apr 14 15:35:32 MDT 2009

*PharmFacts E-News Update -- 14 Apr 2009 AD

*Media Advisory: To contact Richard K. Burt, M.D., call Marla Paul at 
312-503-8928 or email marla-paul at northwestern.edu 
<mailto:marla-paul at northwestern.edu>.
All done without killing innocent, involuntary embryo donors...
*Stem Cell Transplantation Helps Patients With Type 1 Diabetes Achieve 
Long-Term Insulin Independence, Improves Beta-Cell Function *

WASHINGTON, D.C. -- The majority of patients with type 1 diabetes who 
underwent a certain type of stem cell transplantation became insulin 
free, several for more than three years, with good glycemic control, and 
also increased C-peptide levels, an indirect measure of beta-cell 
function, according to a study in the April 15 issue of /JAMA/, a theme 
issue on diabetes.

Richard K. Burt, M.D., of the Northwestern University Feinberg School of 
Medicine, Chicago, presented the findings of the study at a /JAMA/ media 
briefing at the National Press Club in Washington, D.C.

Clinical evidence indicates that there is an inverse association between 
beta-cell (a type of cell in the pancreas that secretes insulin) 
preservation and function and chronic complications of type 1 diabetes 
mellitus (DM), and the higher the C-peptide levels (a byproduct of 
insulin production, made up of amino acids), the lower the incidence of 
some types of complications of type 1 DM. A previous study found that 
autologous nonmyeloablative hematopoietic stem cell transplantation 
(HSCT) in 15 patients with newly diagnosed type 1 DM resulted in the 
majority of patients becoming insulin free during the follow-up, which 
averaged about 19 months. "However, it was suggested that subsequent 
insulin independence was a prolonged honeymoon period due to dietary and 
exercise changes associated with close posttransplant medical 
observation," the authors write, and it was not known if this change was 
because of an improvement in beta-cell preservation.

HSCT, which uses a patient's own blood stem cells, involves the removal 
and treatment of the stem cells, and their return to the patient by 
intravenous injection.

Dr. Burt and colleagues conducted a study to determine if posttransplant 
insulin independence was due to improved beta-cell function by 
monitoring the C-peptide levels of 23 patients who underwent stem cell 
transplantation. The patients, with type 1 DM, were ages 13-31 years.

Of the 23 patients, 20 experienced time free from insulin (12 
continuously and 8 transiently). Patients remained continuously insulin 
free for an average time of 31 months (range, 14-52 months). One patient 
had more than 4 years with no exogenous (produced outside the body) 
insulin use, 4 patients for at least 3 years, 3 patients for at least 2 
years, and 4 patients for at least 1 year. Eight patients relapsed and 
resumed insulin use at low doses. The majority of patients achieved good 
glycemic control.

In the continuously insulin-free group, average area under the curve 
(AUC; a type of measurement) of C-peptide levels before transplantation 
(225.0 ng/mL per 2 hours) showed a significant increase at 24 months 
after transplantation (785.4 ng/mL per 2 hours) and at 36 months after 
transplantation (728.1 ng/mL per 2 hours). In the transient 
insulin--independent group, average AUC of C-peptide levels also 
increased from 148.9 ng/mL per 2 hours pretransplantation to 546.8 ng/mL 
per 2 hours at 36 months, which was sustained at 48 months. In this 
group, 2 patients regained insulin independence after treatment with the 
antihyperglycemic drug sitagliptin, which was associated with an 
increase in C-peptide levels.

Two patients developed pneumonia in the hospital, 3 patients developed 
late endocrine dysfunction, and 9 patients developed oligospermia (sperm 
deficiency). There were no deaths.

"In conclusion, autologous nonmyeloablative HSCT was able to induce 
prolonged and significant increases of C-peptide levels associated with 
absence of or reduction of daily insulin doses in a small group of 
patients with type 1 DM," the researchers write. "At the present time, 
autologous nonmyeloablative HSCT remains the only treatment capable of 
reversing type 1 DM in humans. Randomized controlled trials and further 
biological studies are necessary to confirm the role of this treatment 
in changing the natural history of type 1 DM."

(/JAMA/. 2009;301[15]:1573-1579. Available pre-embargo to the media at 
www.jamamedia.org)

------------------------------------------------------------------------
*
Told ya so Dept: Oral contraceptives might raise lupus risk, study says 
<http://r.smartbrief.com/resp/pqjIolmtfihdliCibTgdCicNDKZE?format=standard>
*Canadian researchers found in an eight-year study that 
second-generation birth control pills made women 1.5 to 2.5 times more 
prone to the autoimmune disease lupus. They also learned that the risk 
of lupus was significantly lower in patients taking newer oral 
contraceptives with less estrogen. HealthDay News 
<http://r.smartbrief.com/resp/pqjIolmtfihdliCibTgdCicNDKZE?format=standard> 
(4/9)

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*http://www.lifeissues.net/writers/irv/irv_139conscienceclause.html*

Dianne N. Irving, M.A., Ph.D.

copyright April 6, 2009

*Testimony to DHHS Re Rescinding Provider Conscience Clause*

*To:*  The Department of Health and Human Services

            (also posted online at www.Regulations.gov; comment ID 80945f22)

*From:*  Dianne N. Irving, M.A., Ph.D., scientist and medical ethicist

            5108 Randall Lane, Bethesda, MD 20816, 301-229-4176

*Date:*  April 6, 2009

*Re:*  *The Existing Provider Conscience Clause (document 0991-AB49)*

Pharmacists, hospitals, doctors and nurses should definitely not have to 
do abortions against their conscience.  To force them by law or 
regulation to do so would force them to kill innocent living human 
beings.  Such a law or regulation would be /de facto/ a grossly unjust 
law that should not be tolerated by any civilized society.

Those who would force others to kill innocent human beings at the 
request of others often attempt to appeal to false scientific claims, 
e.g., the product of fertilization is simply a blob, a bunch of cells, 
or a piece of the mother's tissues, a potential or possible human being, 
a "pre-embryo", etc.  However, such claims are absurd, have no basis in 
scientific fact and surely no viable or just law should be based upon 
them.  It has been known for well over 125 years (with the voluminous 
work of Wilhelm His/ /(/Anatomie menschlicher Embryonen/, 1880-1885) 
that a new, living, individual, genetically unique human being (a 
single-cell human organism) is formed at the beginning of the process of 
fertilization.  This and similar famous research was used as the basis 
of the secular /Carnegie Stages of Early Human _Embryonic_ Development/, 
instituted in 1942, and documented and updated since then by the 
international nomenclature committee on human embryology, i.e., the 
/Nomina Embryologica/ which was part of the larger /Nomina Anatomica/ 
(now called the /Terminologia Embryologica/ and /Terminologia 
Anatomica/).  The /Carnegie Stages of Early Human Embryonic Development/ 
cover the new developing human being through the first 8 weeks of life, 
comprising 23 Stages, and are accessible online at:  
http://nmhm.washingtondc.museum/collections/hdac/Select_Stage_and_Lab_Manual.htm 
at the National Museum of Health and Medicine.  Quoting directly from 
the /Carnegie Stages/: ...continues at the link... 
<http://www.lifeissues.net/writers/irv/irv_139conscienceclause.html>

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