faustmanlab.org and pubmed.org faustman dl and pubmed.org ristori + BCG
Bostonians should consider the work of Dr. Denise L Faustman et al before and/or in addition to what the WSJ reports below.
I will let anyone shoot me with BCG anytime, anywhere and observe the results and publish same on You Tube et al. Preliminary indications show activity to mitigate plaque psoriasis.
The US and people such as those mentioned below do little or nothing to mitigate the destruction caused by autoimmune diseases. There own children may suffer as a result of the inability of their parents to distinguish gadgets and gizmos from art and science.
The only gizmo that has stood the test of time and human nature is Hiram Maxim's automatic weapon, the machine gun.
Citizen Hackers Tinker With Medical Devices
Diabetes Patients, Family Members Try to Make Glucose Monitors More Useful
Updated Sept. 26, 2014 6:25 p.m. ET
A group of tech-savvy parents have built NightScout, a
remote-monitoring system that gives young diabetics and their families
more flexibility in managing the disease.
Jason Adams,
a business-development executive by day and a molecular biologist
by training, had never considered himself a hacker. That changed when
he discovered an off-label way to monitor his 8-year-old daughter's
blood-sugar levels from afar.
His daughter Ella has Type 1 diabetes and wears a glucose monitor made by
Dexcom Inc.
DXCM +0.95%
The device measures her blood sugar every five minutes and
displays it on a nearby receiver the size of a pager, a huge advantage
in helping monitor her blood sugar for spikes and potentially fatal
drops. But it can't transmit the data to the Internet, which meant Mr.
Adams never sent Ella to sleepovers for fear she could slip into a coma
during the night.
Then Mr. Adams found
NightScout, a system cobbled together by a constellation of software
engineers, many with diabetic children, who were frustrated by the
limitations of current technology. The open-source system they developed
essentially hacks the Dexcom device and uploads its data to the
Internet, which lets Mr. Adams see Ella's blood-sugar levels on his
Pebble smartwatch wherever she is. It isn't perfect. It drains cellphone
batteries, can cut out at times and hasn't been approved by the Food
and Drug Administration. But for many, it has filled a gap.
Ella Adams, 8, who has Type 1 diabetes, with her father,
Jason, who can monitor her blood-sugar levels throughout the day via a
display on his watch.
Sam Hodgson for The Wall Street Journal
The home-built setup is part of a
shift in the way Americans relate to the medical industry and their own
health care. Technologically savvy patients are starting to tinker under
the hoods of medical contraptions, seeking more influence over devices
like blood-sugar monitors, insulin pumps and defibrillators that record
and control bodily functions. Their goal is greater access to data and
faster invention than is possible under the formal regulatory process.
Patients
have been tweaking hearing aids so they play music, using 3-D printers
to make their own prosthetics and fiddling with a device used to measure
acidity levels in the esophagus. The Massachusetts Institute of
Technologyhas been hosting "hackathons"
where engineers and students try to improve medical products and work
out new solutions to common diseases. The latest one, held last weekend,
was aimed at improving breast pumps.
"I
have a huge bet on there being many other diseases that can be helped
by these new forces in medicine," said
Joyce Lee,
a diabetes specialist and associate professor of pediatrics at
the University of Michigan who researches design as it relates to health
care. "It is not the new blockbuster drug. It's not the newest
FDA-approved device. But it's the free hack that the patient came up
with."
The tinkering is raising concern
at the FDA, medical-device companies and among some academics and
clinicians that modifications are being used before they are fully
tested and safe for a broad audience. Continuous glucose monitors such
as the one Ella Adams uses are Class III medical devices, meaning they
get the highest level of regulatory scrutiny, and even new support
software must clear a battery of approvals.
The
rigorous approval process is there for a reason. A diabetes patient can
come to rely on an alarm that prompts him or her to address dangerously
high or low blood sugar, so devices need to work predictably and be
comprehensible to patients who aren't schooled in technology.
Dexcom,
the maker of the glucose monitor, is aware of NightScout, as is the
FDA, and neither is taking issue with it for now. While not completely
comfortable with the software, the FDA takes a risk-based approach to
enforcement and is concerned about its distribution and how it affects
patient safety.
After Evan Costik, 6, was diagnosed with Type 1 diabetes,
his father, a software engineer, began working on a system to monitor
his son's blood-sugar levels from afar.
Mike Bradley for The Wall Street Journal
"These parents are clearly crying out for ways to access their children's devices in a way that isn't available," said
Courtney Lias,
an official from the agency's Center for Devices and Radiological Health.
Representatives
of the FDA have encouraged NightScout's backers to consult formally
with the agency. The NightScout team said it filed an application in August, and a formal meeting has been scheduled for next month.
Benjamin West,
a choral singer and software engineer with Type 1 who uses a
Dexcom device and is leading the meeting with the FDA, said the agency
has expressed concerns about how users can get support if they run into
problems, how software updates are distributed and whether there is any
consideration of steps to prevent unauthorized access to the data.
Other
do-it-yourself developments in diabetes control—in particular efforts
to come up with software to govern dosages of insulin, where errors
could be fatal—have prompted more serious concerns.
Such
efforts are spreading anyway. At a recent diabetes conference, Mr. West
was showing how he had devised a way to control his
Medtronic Inc.
MDT -1.26%
insulin pump with his laptop. A nonprofit group started by a former
Amazon.com Inc.
AMZN -0.43%
engineer, called Tidepool, is teaming up with makers of diabetes
devices to create better data displays for patients and their doctors.
The
homegrown efforts are springing up, in part, because approvals through
formal channels can take a long time. A new Medtronic pump that
communicates with a glucose monitor and suspends insulin delivery when
blood sugars are low wasn't approved in the U.S. until 2013, after being
used in Europe since 2009.
Johnson & Johnson
JNJ -0.52%
submitted a new version of its Animas insulin pump that uses the
Dexcom monitor in April 2013 and is still waiting for approval. The
device was approved in Europe in 2011.
The
FDA acknowledges the frustration and doesn't want to be seen as
standing in the way of innovation, the FDA's Ms. Lias said. The FDA
notes there are different requirements in Europe for device approvals
and that approvals depend on when manufacturers submit their
applications to U.S. regulators.
Dexcom
plans to seek FDA approval for a software system similar to NightScout
by early next year with hopes of getting it on the market by year-end.
"We
are working proactively with the FDA to bring similar features and
functionality to market," said Steve Pacelli, Dexcom's executive vice
president for strategy.
Chronic diseases
such as diabetes, asthma and heart conditions—where cross referencing
data can help improve health—have been an early focus of hacking.
Between 1.5 million and three million Americans have Type 1 diabetes,
an autoimmune condition that destroys insulin-producing cells in the
pancreas. Managing it requires carefully matching injections of insulin
to the consumption of carbohydrates, while taking into account factors
like exercise and illness. The better the match, the lower the risk of
complications. Blood sugar that gets too high can cause severe
dehydration and other life-threatening conditions. Too low, and a person
could have seizures or slip into a coma.
NightScout got its start in the
Livonia, N.Y., home of
John Costik,
a software engineer at the Wegmans supermarket chain. In 2012,
his son Evan was diagnosed with Type 1 diabetes at the age of four. The
father of two bought a Dexcom continuous glucose monitoring system,
which uses a hair's width sensor under the skin to measure blood-sugar
levels. He was frustrated that he couldn't see Evan's numbers when he
was at work. So he started fiddling around.
On
May 14 last year, he tweeted a picture of his solution: a way to upload
the Dexcom receiver's data to the Internet using his software, a $4
cable and an Android phone.
That tweet caught the eye of other engineers across the country.
One
was
Lane Desborough,
an engineer with a background in control systems for oil
refineries and chemical plants whose son, 15, has diabetes. Mr.
Desborough had designed a home-display system for glucose-monitor data
and called it NightScout. But his system couldn't connect to the
Internet, so it was merged with Mr. Costik's software to create the
system used today.
Mr. Adams also saw
the tweet. After the code became public, the San Diego father of three
stayed up until three in the morning trying to make it work before
giving up and hiring a freelance computer-science student in India, who
solved his problem in 20 minutes. Two weeks later, Ella had her first
sleepover.
The experience hasn't been
seamless. The Android phone Mr. Adams uses to upload Dexcom data to the
Internet has inexplicably frozen twice. His daughter was fine both
times, but the outages were a warning that the system isn't fail-safe.
Mr. Adams and his wife still get up twice a night—at midnight and 3
a.m.—to check Ella's blood sugar with a finger prick.
NightScout
relies on outside sites to receive the data and display glucose levels.
On a recent night, two of the online hosting sites had an outage that
shut down NightScout for about three hours for some users.
The code also tends to drain the batteries of phones used to upload the data. As yet, there are no security settings.
The
system does, however, give users a monitoring option that hadn't
existed.
Kristin Andrews Derichsweiler,
a California nurse and single mother of four, got the Dexcom
glucose monitor to help her 15-year-old son manage his diabetes.
Two
weeks after setting it up, she says she noticed her son's blood-sugar
levels were dropping while he was alone at home. When he didn't answer
the phone, she rushed back from work and found him unresponsive in bed.
His blood sugar level was dangerously low—28 milligrams per deciliter,
well below a normal level of 80. She got him to drink two boxes of juice
and he recovered.
Users stay in touch
with each other and the developers via a Facebook group set up by Mr.
Adams. It now has more than 6,800 members. The developers are making
fixes as bugs arise and adding functions such as text-message alarms and
access controls via updates.
The
release-and-repair approach is typical of Silicon Valley, where speed is
at a premium, but alien to the medical business, where liability and
regulators are major concerns. Some experts welcome the speed and
inventiveness, but worry the ad hoc developers could fail to build in
the necessary safeguards such as alerts for when the system goes down.
"This
grass-roots initiative and drive is very important in accelerating the
development of these technologies," said
Howard Wolpert,
who runs a technology institute at the Harvard-affiliated Joslin
Diabetes Center. "It is also important that the processes for approval
can be accelerated so that this can be done in a way that there is an
element of regulatory oversight." The institute has received funding
from Dexcom.
John Costik with son Evan and wife Laura at their home in
Livonia, N.Y. His remote-monitoring system uses software he wrote, along
with a $4 cable and an Android phone.
Mike Bradley for The Wall Street Journal
Medical do-it-yourselfers—including
some of the people behind NightScout—are now pushing to develop systems
that combine the blood-sugar data from glucose monitors with insulin
dosing to even out spikes and troughs in blood sugar.
Twitter
engineer
Scott Leibrand
and his fiancée,
Dana Lewis,
who has Type 1 diabetes, have come up with a software program
they call the "do-it-yourself pancreas." It calculates insulin doses
with data from the Dexcom monitor, details of Ms. Lewis's meals and
estimates of the length of time insulin remains active in body. The
system then sends notifications to her phone and Pebble watch with
suggested insulin doses to level out her blood sugar.
In
June, after watching Ms. Lewis's average blood-glucose levels improve,
the couple set up a table at a diabetes meeting to talk about their
findings.
Stayce Beck,
an FDA staff member in the diabetes-device branch, asked Ms.
Lewis for a demonstration.
After asking
some questions, Ms. Beck cautioned that because the system generates
insulin recommendations based on the Dexcom monitor, which isn't
authorized for that use, it looked to her that the FDA would consider
the system a Class III medical device.
"They
really recommended that we wouldn't distribute the thing as is," said
Mr. Leibrand, who said that isn't their intention. He also recognizes
that if his model were able to control insulin delivery, "it would be a
lot more dangerous."
A number of
researchers at medical-device makers are working on similar systems that
would actually inject insulin. The automated devices have shown promise
in clinical trials, but none have been submitted for approval, a
process that could take years.
Some
do-it-yourselfers are taking steps to commercialize their inventions.
Former Wall Street trader
Bryan Mazlish
has launched a startup—Smartloop LLC—that has filed patents on
computer-assisted technology to help manage blood-sugar levels. Mr.
Mazlish, whose son and wife have Type 1 diabetes, has built a smartphone
app that runs an algorithm to optimize blood-glucose levels by advising
on insulin dosing using data from glucose monitors.
 |
Joyce Lee, M.D., M.P.H.
Associate Professor, Department of Pediatrics and Communicable Diseases
300 NIB, Room 6E18 Associate Professor, Environmental Health Sciences 
Campus Box 5456 Ann Arbor, Michigan 48109 Tel: 734-936-9360; Fax: 734-764-2599 E-mail: joyclee@umich.edu Website(s): University of Michigan Health System Profile; http://joycelee.me/; Joyce Lee on LinkedIn; Joyce Lee on Twitter |
Professional SummaryJoyce Lee is a pediatrician, diabetes specialist, and clinical and health services researcher. She is very interested in the notion that human centered design and design thinking combined with emerging technologies such as mobile technology, data visualization, and social media can transform the research enterprise and the delivery of clinical care.She attended Brown University for her undergraduate education, the University of Pennsylvania for her medical degree, where she was elected to the Alpha Omega Alpha Honors Society, and she completed her internship and residency in General Pediatrics at the Boston Combined Residency Program (Children's Hospital, Boston, and Boston Medical Center). She is one of few individuals across the country who has completed dual training in Pediatric Endocrinology and Pediatric Health Services Research. In addition, she received her Master in Public Health degree from the Department of Health Management and Policy at the University of Michigan. Lee is the principal investigator on several NIH-funded studies focusing on childhood obesity, and on type 2 diabetes risk. To study obesity and diabetes, she incorporates a variety of methodologies, including cross-sectional and longitudinal epidemiologic analyses, transition state modeling techniques, agent based modeling techniques, applied clinical research, and cost-effectiveness analysis. She co-directs the Program in Mobile Technology for Enhancing Child Health, which has the goal of creating mobile technology systems that can enhance chronic disease adherence in children, with a specific focus on adolescents with type 1 diabetes. In addition, in June 2013, she was appointed as the first Social Media Editor for JAMA Pediatrics. EducationM.P.H., University of Michigan, 2006M.D., University of Pennsylvania, 2000 Research Interests & ProjectsDr. Lee's research focuses on the epidemiology of diabetes (type 1 and type 2) and obesity in children, health outcomes and quality of life for children with diabetes, and the link between childhood obesity and its long-term endocrine consequences, including pubertal maturation and development of diabetes over the life | |
Mr.
Mazlish said he thinks the current system for developing new medical
devices could be improved upon, but figures he can have the most impact
going the commercial route.
"I've decided to play within the current system," he said.
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