Denise L Faustman see faustmanlab.org and pubmed.org faustman dl is not god but she is better than any of the crap reported in the New York Times.
Shoot BCG and if you like it you will have plenty of cash left over to do with as you please.
The New York Times and Catherine Hayley are invited to same my blood and observe any changes as BCG is shot again and again
read this Catherine Hayley
Front Immunol. 2013 Dec 23;4:478. eCollection 2013.
TNF Receptor 2 and Disease: Autoimmunity and Regenerative Medicine.
Faustman DL1, Davis M2.
Abstract
THE
REGULATORY CYTOKINE TUMOR NECROSIS FACTOR (TNF) EXERTS ITS EFFECTS
THROUGH TWO RECEPTORS: TNFR1 and TNFR2. Defects in TNFR2 signaling are
evident in a variety of autoimmune diseases. One new treatment strategy
for autoimmune disease is selective destruction of autoreactive T cells
by administration of TNF, TNF inducers, or TNFR2 agonism. A related
strategy is to rely on TNFR2 agonism to induce T-regulatory cells (Tregs)
that suppress cytotoxic T cells. Targeting TNFR2 as a treatment
strategy is likely superior to TNFR1 because of its more limited
cellular distribution on T cells, subsets of neurons, and a few other
cell types, whereas TNFR1 is expressed throughout the body. This review
focuses on TNFR2 expression, structure, and signaling; TNFR2 signaling
in autoimmune disease; treatment strategies targeting TNFR2 in
autoimmunity; and the potential for TNFR2 to facilitate end organ
regeneration.
KEYWORDS:
TNF, TNF receptor 2, autoimmune disease, regeneration, type 1 diabetesHow many relatives of Catherine Hayley have autoimmune diseases and what diseases are they?
I would like to compare my answers with hers?
Result Filters
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 DL1, Wang L, Okubo Y, Burger D, Ban L, Man G, Zheng H, Schoenfeld D, Pompei R, Avruch J, Nathan DM.
Abstract
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]
MEMPHIS
— Catherine Hayley is saving up for an important purchase: an updated
version of the tiny digital pump at her waist that delivers lifesaving
insulin under her skin.
Such
devices, which tailor insulin dosing more precisely to the body’s
needs, have transformed the lives of people with Type 1 diabetes like
Ms. Hayley. But as diabetics live longer, healthier lives and worries
fade about dreaded complications like heart attacks, kidney failure,
amputations and blindness, they have been replaced by another
preoccupation: soaring treatment costs.
“It
looks like a beeper,” said Ms. Hayley, a 36-year-old manager here for
an environmental services company, referring to the vintage 2007 pump on
the waistband of her jeans. “It’s made of plastic and runs on triple-A
batteries, but it’s the most expensive thing I own, aside from my
house.”
A
new model, along with related treatment supplies, prices out at tens of
thousands of dollars for this year and will cost her about $5,000, even
with top-notch insurance. “It’s great,” Ms. Hayley said, “but it all
adds up.”
Continue reading the main story
As you read this article, please share your experiences by responding to the questions that will appear. Your responses will inspire future articles in this series.
Readers’ Perspectives
As you read this article, please share your experiences by responding to the questions that will appear. Your responses will inspire future articles in this series.
Traditionally,
insurers lost money by covering people with chronic illnesses, because
they often ended up hospitalized with myriad complications as their
diseases progressed. Today, the routine care costs of many chronic
illnesses eclipse that of acute care because new treatments that keep
patients well have become a multibillion-dollar business opportunity for
device and drug makers and medical providers.
The
high price of new treatments for diabetes, rheumatoid arthritis,
colitis and other chronic diseases contribute mightily to the United
States’ $2.7 trillion annual health care bill.
More
than 1.5 million Americans have Type 1 diabetes and cannot survive
without frequent insulin doses, so they are utterly dependent on a small
number of producers of supplies and drugs, which have great leeway to
set prices. (Patients with the far more common Type 2 diabetes — linked
to obesity — still produce insulin and can improve with lifestyle
changes and weight loss, or on oral medicines.)
That
captive audience of Type 1 diabetics has spawned lines of high-priced
gadgets and disposable accouterments, borrowing business models from
technology companies like Apple: Each pump and monitor requires the
separate purchase of an array of items that are often brand and model
specific.
A
steady stream of new models and updates often offer dubious
improvement: colored pumps; talking, bilingual meters; sensors reporting
minute-by-minute sugar readouts. Ms. Hayley’s new pump will cost $7,350
(she will pay $2,500 under the terms of her insurance). But she will
also need to pay her part for supplies, including $100 monitor probes
that must be replaced every week, disposable tubing that she must change
every three days and 10 or so test strips every day.
That
does not even include insulin, which has been produced with genetic
engineering and protected by patents, so that a medicine that cost a few
dollars when Ms. Hayley was a child now often sells for more than $200 a
vial, meaning some patients must pay more than $4,000 a year. Other
refinements have benefited a minority of patients but raised prices for
all. There are no generics in the United States.
The Cost to Treat One Woman’s Diabetes in 2014
Delivering Insulin
Catherine Hayley’s cost
$4,224
Insulin
Insulin pump
reservoir
Cost with no insurance
AAA
battery
$26,470
Insulin pump
infusion set
Testing Blood Sugar
Lancets
Insulin pump
Costs Ms. Hayley $2,500. Her insurance
allows her to upgrade every four years.
In Case of
Emergency
Emergency
glucagon kit
Test strips
Because she has not yet made some of the
2014 purchases, the old version of the pump is shown here and the total
cost does not include an additional transmitter and disposable sensors.
Companies
that produce the treatments say the higher costs reflect medical
advances and the need to recoup money spent on research. But David
Kliff, a financial analyst who is editor of Diabetic Investor, an independent newsletter on the industry, points out: “Diabetes is not just a disease state; it’s a huge business, too.”
Those
companies spend millions of dollars recruiting patients at health
fairs, through physicians’ offices and with aggressive advertising —
often urging them to get devices and treatments that are not necessary,
doctors say. “They may be better in some abstract sense, but the
clinical relevance is minor,” said Dr. Joel Zonszein, director of the
Clinical Diabetes Center at Montefiore Medical Center.
“People don’t need a meter that talks to them,” he added. “There’s an incredible waste of money.”
Even
patients with insurance often feel squeezed by large out-of-pocket
costs, and many describe holding old pumps together with duct tape,
rationing their test strips and skimping on insulin. Dr. Jeoffry B.
Gordon, a family practitioner in San Diego, said he had patients with
failing kidneys and others who had ended up in emergency rooms because
they could not afford their maintenance care.
“From
a guy on the front lines, the improvements have been miraculous,” he
said. “But the acquisition cost is very high, and the pricing dictates
what treatment you get.”
Complication rates from diabetes in the United States are generally higher
than in other developed countries. That is true even though the United
States spends more per patient and per capita treating diabetes than
elsewhere, said Ping Zhang, an economist at the Centers for Disease
Control and Prevention.
The
high costs are taking their toll on public coffers, since 62 percent of
that treatment money comes from government insurers. The cumulative
outlays for treating Type 1 and Type 2 diabetes reached nearly $200 billion in 2012, or about 7 percent of America’s health care bill.
Expenditures could well double by 2030,
according to estimates by the C.D.C., in large part because the number
of Americans found to have diabetes has been increasing more than 50
percent every 10 years. Most of the increase is attributable to Type 2
diabetes patients, whom manufacturers are encouraging to try insulin
treatment and glucose monitoring, even though that is rarely medically
required. Also, the Affordable Care Act requires health insurers to
cover people with chronic disease, meaning they will have better access
to treatments.
“This
is not just a health care crisis,” said Mr. Kliff, the newsletter
editor, who has Type 1 diabetes. “It’s an economic crisis as well.”
Maintaining Control
Catherine
Hayley was born in 1977, the year before the first synthetic human
insulin was made using new gene-splicing technology. Her diabetes was
diagnosed when she was 9, about the time this new generation of
genetically engineered insulin was brought to market. One of her
earliest memories is practicing insulin injections on an orange.
The
development of insulin therapy in the 1920s was one of the great
medical triumphs of the 20th century, on a par with the discovery of
antibiotics. Before then, Type 1 diabetics often died within a year and
were on such restrictive diets that they sometimes succumbed to
starvation.
Diabetes
is an autoimmune disease in which the pancreas stops producing the
hormone insulin. Without it, sugars build up in the blood, producing
symptoms like blurry vision, exhaustion and frequent urination and
leading to a severe accumulation of acids that can be rapidly fatal.
Even when treated with insulin shots, moderately high sugar levels over
the long term can damage the eyes, heart, kidneys and nerves. But if too
much insulin is given, blood sugar can plummet, leading to
unconsciousness and seizures. Because digestive enzymes degrade insulin,
it cannot be swallowed, and must be injected.
When
Ms. Hayley’s diabetes was diagnosed, maintaining that balance involved
testing a drop of blood on a paper strip that would change color to
indicate — within a wide range — the patient’s glucose level. Patients
would typically give themselves a shot of insulin morning and night in
response to the results.
“What
I ate was all very regimented, and it had to be at the same time each
day,” she recalled. At school every day at 10 a.m., she pulled out a
snack of a precisely weighed chunk of cheese and rice cakes.
The
treatment tools were initially cheap: simple syringes and pig insulin,
which is almost identical to that made by the human body. But that all
changed after a landmark study in 1992 showed that patients did better
if they maintained very tight control — keeping their blood sugar within
a nearly normal range by checking it frequently and taking multiple
insulin shots a day. Around the same time the business of American
medicine was changing, too, with direct-to-consumer advertising,
proprietary treatments and designer insulin in development.
When
Ms. Hayley left Memphis for Colorado College in 1996, she was using a
tiny meter through which she could get more precise measures of her
blood sugar level, a penlike injector containing insulin with an
adjustable dose, and human insulin made with gene-splicing technology.
All were covered by patents.
She
did not switch to a pump until 2006 when, after years of waiting tables
and studying in graduate school, she got her first job with insurance
benefits. “It controls my blood sugar better,” she said, on her way to a
dinner that included sharing a once-forbidden fruit cobbler. “I’m
really able to live how I want. However, the price has increased
dramatically.”
The
tiny squirts from her pump are delivered more precisely by patented
systems with microchip sensors and Bluetooth capability, with technical
support by company representatives in endocrinologists’ offices. When
Ms. Hayley pricks her finger, it is with a customized lancet to go with a
customized test strip that fits into a customized meter, which
transmits the result wirelessly to her compatible insulin pump, which
delivers the appropriate insulin dose. (There is not yet a
one-device-does-all that automatically performs the pricking, measuring
and dosing.)
While
some components, like the meters, are low cost or even free for
patients, their supplies are costly. Dr. Spencer Owades, a dentist in
suburban Denver with Type 1 diabetes, said he was shocked to discover
that his test strips — which cost just pennies to make — were priced at
$1.50 apiece when he ran out and had to buy them at a pharmacy. He
usually received them in the mail through his insurer and uses five to
10 a day.
“It’s
a printer model,” he said, “where the printer is cheap, but they get
you on the cartridges.” He added: “But if you have diabetes, they have
you over a barrel.”
