close the Nassau County Budget deficit. The Nassau County Medical Center will administer BCG Vaccinations to all interested persons over the age of 15 and sell BCG to same. Even Republicans and Democrats know that a childhood vaccine used all over the world works like magic or simply as Dr. Denise L Faustman knows it to work.
PLoS One. 2012;7(8):e41756. doi: 10.1371/journal.pone.0041756. Epub 2012 Aug 8.
Proof-of-concept, randomized, controlled clinical trial of Bacillus-Calmette-Guerin for treatment of long-term type 1 diabetes.
Faustman DL, Wang L, Okubo Y, Burger D, Ban L, Man G, Zheng H, Schoenfeld D, Pompei R, Avruch J, Nathan DM.
Source
The Immunobiology Laboratory, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, United States of America. faustman@helix.mgh.harvard.eduAbstract
BACKGROUND:
No targeted immunotherapies reverse type 1 diabetes in humans. However, in a rodent model of type 1 diabetes, Bacillus Calmette-Guerin (BCG) reverses disease by restoring insulin secretion. Specifically, it stimulates innate immunity by inducing the host to produce tumor necrosis factor (TNF), which, in turn, kills disease-causing autoimmune cells and restores pancreatic beta-cell function through regeneration.METHODOLOGY/PRINCIPAL FINDINGS:
Translating these findings to humans, we administered BCG, a generic vaccine, in a proof-of-principle, double-blind, placebo-controlled trial of adults with long-term type 1 diabetes (mean: 15.3 years) at one clinical center in North America. Six subjects were randomly assigned to BCG or placebo and compared to self, healthy paired controls (n = 6) or reference subjects with (n = 57) or without (n = 16) type 1 diabetes, depending upon the outcome measure. We monitored weekly blood samples for 20 weeks for insulin-autoreactive T cells, regulatory T cells (Tregs), glutamic acid decarboxylase (GAD) and other autoantibodies, and C-peptide, a marker of insulin secretion. BCG-treated patients and one placebo-treated patient who, after enrollment, unexpectedly developed acute Epstein-Barr virus infection, a known TNF inducer, exclusively showed increases in dead insulin-autoreactive T cells and induction of Tregs. C-peptide levels (pmol/L) significantly rose transiently in two BCG-treated subjects (means: 3.49 pmol/L [95% CI 2.95-3.8], 2.57 [95% CI 1.65-3.49]) and the EBV-infected subject (3.16 [95% CI 2.54-3.69]) vs.1.65 [95% CI 1.55-3.2] in reference diabetic subjects. BCG-treated subjects each had more than 50% of their C-peptide values above the 95(th) percentile of the reference subjects. The EBV-infected subject had 18% of C-peptide values above this level.CONCLUSIONS/SIGNIFICANCE:
We conclude that BCG treatment or EBV infection transiently modified the autoimmunity that underlies type 1 diabetes by stimulating the host innate immune response. This suggests that BCG or other stimulators of host innate immunity may have value in the treatment of long-term diabetes.TRIAL REGISTRATION:
ClinicalTrials.gov NCT00607230.Justice Department Appeals Plan B Age-Limit Ruling
more in Politics & Policy
»
Associated Press
The Justice Department is appealing a judge's decision lifting all age limits on the Plan B morning-after birth-control pill and a cheaper generic.The federal government says the judge who issued the ruling had exceeded his authority and that his decision should be suspended while the appeal is under way.
U.S. District Judge Edward Korman of New York had given the Food and Drug Administration until Monday to lift all age limits on Plan B and cheaper generic. The judge mandated that emergency contraception be sold just like aspirin.
On Tuesday, the FDA said anyone 15 or older could begin buying one brand, Plan B One-Step, without a prescription—two years younger than the current age limit of 17.
Justice Department Appeals Plan B Age-Limit Ruling
more in Politics & Policy
»
Associated Press
The Justice Department is appealing a judge's decision lifting all age limits on the Plan B morning-after birth-control pill and a cheaper generic.The federal government says the judge who issued the ruling had exceeded his authority and that his decision should be suspended while the appeal is under way.
U.S. District Judge Edward Korman of New York had given the Food and Drug Administration until Monday to lift all age limits on Plan B and cheaper generic. The judge mandated that emergency contraception be sold just like aspirin.
On Tuesday, the FDA said anyone 15 or older could begin buying one brand, Plan B One-Step, without a prescription—two years younger than the current age limit of 17.
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