Bureaucracy Be Damned as “World First” Diabetes Treatment Accelerates to Market
Bureaucracy is stubborn… but it can be broken. You have to be well-funded, organized, creative, and focused on a worthy cause (ideally, in service of children).
It’s a medical device with the potential to change the lives of more than 1 million Americans who suffer from Type 1 diabetes (T1D).
It also represents a complicated victory that validates the effectiveness of patient advocacy groups but also suggests they have to be way more aggressive in their approach and less concerned about with whom they rub elbows.
And its approval by the Food and Drug Administration (FDA) is a sign that things may be changing for a part of government bureaucracy where life and death are, literally, everyday matters.
It’s a medical device with the potential to change the lives of more than 1 million Americans who suffer from Type 1 diabetes.
Medtronic PLC’s (MDT) MiniMed 670G hybrid closed loop system monitors glucose and automatically adjusts the delivery of long-acting or basal insulin based on the user’s glucose reading.
In other words, it’s the world’s first artificial pancreas. And last week, the FDA approved it for treatment in people 14 years of age and older with Type 1 diabetes.
The pancreas is a relatively “remote” organ located between the stomach and the spine. It serves two basic functions: to help the digestion of food and to regulate blood sugar levels.
T1D – previously known as “juvenile diabetes” – is an autoimmune disease characterized by the inability of a person’s pancreas to make insulin. Insulin is a hormone that allows people to turn food into energy.
Type 1 diabetes is a chronic condition. It can’t be cured, but it can be treated. It afflicts about 1.25 million people in the United States, including 200,000 kids under 20 years old and more than a million adults, with approximately 40,000 new diagnoses every year.
According to patient advocacy group JDRF, which was founded in 1970 as the Juvenile Diabetes Research Foundation, “Type 1 diabetes strikes both children and adults at any age. It comes on suddenly, causes dependence on injected or pumped insulin for life, and carries the constant threat of devastating complications.”
These complications include kidney failure, blindness, nerve damage, heart attack, stroke, pregnancy complications, and a life span about 13 years shorter than average.
The compact MiniMed 670G system includes a continuous glucose monitor (CGM) that measures the user’s glucose levels for up to seven days, an insulin pump that delivers insulin to the user, and a glucose meter used to calibrate the monitor.
According to The Journal of the American Medical Association, 124 patients using the system suffered no episodes of hypoglycemia or ketoacidosis across 12,389 patient days.
And, as JDRF notes, it also maintained tested patients within “a desired blood sugar range 73.4% of the time, versus 67.8% without the system.”
“At night,” notes the JDRF, “the most dangerous time for blood sugar highs and lows, the difference was even more pronounced, 76.4% in range versus 67.8% without the system.”
124 patients using the system suffered no episodes of hypoglycemia or ketoacidosis across 12,389 patient days.
Still of major concern for patients, as ever, is the question of cost. Medtronic hasn’t set a price yet.
But MiniMed 670G nevertheless represents a significant step for the treatment of Type 1 diabetes, and its approval is a major success for JDRF.
Rebecca Robbins, writing for STAT, frames the problem:
Academics had been trying for years to develop algorithms to power a fully automated system for regulating blood glucose, a task that again and again proved unfeasible. Device makers were squeamish about letting a computer control an insulin delivery system that could kill a patient if it malfunctioned at the wrong time. And even if somebody could build an artificial pancreas, no one knew what kind of tests and data the FDA would require to be convinced that it was safe and effective.
As is often the case, the wheels of progress are greased with money.
In 2004, JDRF accepted a $1 million gift from Jeffrey Brewer, the founder of Citysearch and GoTo.com. Brewer’s child was diagnosed with T1D, and he attached one condition to his donation: Use it to make an artificial pancreas.
JDRF, one of the best-funded charities in the United States, didn’t necessarily need Brewer’s money. But the idea of researching, developing, and bringing to market an integrated continuous glucose monitor and pump was compelling.
JDRF funded academic research, paid for “emotional newspaper ads,” cajoled members of Congress, and leaned on the FDA.
As Robbins of STAT reports, JDRF’s decade-long effort funded the science, raised political awareness, and broke down administrative barriers. By 2012, the path to profits for medical device makers was cleared.
And in 2012, the regulators laid out guidelines for medical device makers based on JDRF’s recommendations.
Having such a road map was enough to encourage medical device companies, including Medtronic, to increase their research and development efforts.
There are broader implications of JDRF’s successful campaign: Bureaucratic inertia can be broken.
You have to be well-funded, organized, creative, and focused on a worthy cause (ideally, in service of children).
But it can be done.
Sometimes, all it takes is a motivated 18-year-old kid whose nonsmoking math teacher developed lung cancer: Google Science Fair Finalist Invents Cheap Lung Cancer Screening Breathalyzer.
According to IEEE Spectrum, Zheng Xin Yong of Malaysia “set out to develop a low-cost, easy-to-use screening test for early-stage lung cancer.”
“He came up with a combination of tetracosane and carbon powder that changes resistance according to alkane levels in air,” explains IEEE Spectrum’s Tekla Perry. “Alkane, sometimes called paraffin, is a naturally occurring product of oxidation and is dramatically higher in the breath of people with lung cancer than those with healthy lungs.”
The sensor costs 15 cents to produce, and the breathalyzer is about $15, all in.
Editorial Director, Wall Street Daily