BCG or insulin? You decide.
I thing BCG is safe and useful.
California Court Rules Unlicensed School Staff Can Give Insulin
Decision Has Potential to Serve as a National Precedent
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The ruling, which comes as many other states grapple with the issue amid a reduction in campus nurses, is a setback for the American Nurses Association. The group has waged a six-year legal battle against the California Department of Education over its 2007 legal advisory allowing teachers and other untrained school employees to administer insulin. The nurses claimed only they or other licensed professionals were qualified to do so in the absence of a parent or legal guardian at the school.
The legal advisory was issued in a settlement the state education department entered in response a 2005 federal lawsuit by parents of some diabetic students who alleged their schools failed to administer insulin when nurses weren't available.
Some parents applauded the high court's ruling. With just 2,800 school nurses for six million public-school students in California—including 14,000 with diabetes, according to state estimates cited by the high court—these parents said not allowing someone else to administer insulin imposed hardships.
"As a working parent, I either left my job to help my child or employed a nanny who could provide that service when my child was too young to administer his own doses," said Laura Mecoy, mother of a now-19-year-old diabetic son in Manhattan Beach, Calif.
Officials at the American Nurses Association, a Silver Spring, Md.-based trade group which led a coalition of nursing groups in pursuing the California case, said the court's ruling could encourage other states to follow California's lead in not requiring training to administer the drugs.
"Our biggest concern is this is a slippery slope," said Maureen Cones, an attorney for the nurses' association who argued the case. "We don't want physical therapy given by the gym teacher, for example." Ms. Cones added her group is considering its legal options, including a possible appeal to the U.S. Supreme Court.
Tom Torlakson, state superintendent of public instruction, said in a statement: [T]he fact remains that not every student has access to a school nurse and, for some of them, that has been a very real obstacle to attending school and learning with their peers. I hope this decision removes that obstacle."
Nationwide, 22 states allow unlicensed school personnel to administer insulin, including some—such as Arizona, Georgia, and Missouri—that began permitting it in just the past year, following a decline in campus nurses in recent years, said Alan Yatvin, chairman of the legal advocacy subcommittee for the American Diabetes Association. The group intervened to defend the state in the case.
"There never are going to be enough nurses," Mr. Yatvin said.
Write to Jim Carlton at jim.carlton@wsj.com
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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.Comment in
- Targeting innate immunity to treat long-term type 1 diabetes. [Regen Med. 2012]
- PMID:
- 22905105
- [PubMed - indexed for MEDLINE]
- PMCID:
- PMC3414482
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