For about a day, Brewer’s son could not recall his name.
Sean recovered fully from this serious episode of hypoglycemia, but many families are not so lucky.
“People are hurting themselves and killing themselves all the time with insulin,” Brewer says. “The data says one out of every 20 people with this disease might actually die with hypoglycemia.”
That’s where a small cellphone-sized device like Medtronic’s Veo would help, Brewer said. The JDRF organization has been pushing hard to get the FDA to allow these devices to enter the U.S. market without a lot of additional testing. The group, along with other diabetes advocates, have been ramping up the pressure.
In October, the American Diabetes Association, the American Association of Diabetes Educators, the Endocrine Society and the American Association of Clinical Endocrinologists sent a letter to FDA Commissioner Margaret Hamburg urging the agency not to repeat the low glucose suspend decision.
In early November, they sent a petition to the FDA with 100,000 signatures from lawmakers and diabetes experts. They followed up with ads in the New York Times and the Washington Post featuring a young girl named Piper who, like other type 1 diabetics, is at risk of dying from hypoglycemia.
The ad said the new artificial pancreas guidelines are the FDA’s chance to show the world the United States “is leading in medical innovation, not standing in the way.”
SLOWING DOWN RESEARCH
It’s not just the JDRF that is complaining.
A survey of 150 firms from the National Venture Capital Association, released in October, shows that venture capitalists have been cutting back on their investments in medical-device companies, blaming regulatory hurdles at the FDA.
Investment in medical devices last year fell to $2.38 billion from $2.62 billion in 2009 and $3.52 billion in 2008, according to the survey.
While U.S. researchers have been allowed to test artificial pancreas systems in carefully supervised hospital studies, they need to be tested outside of the clinic in real-world settings to see how well they work. That has forced many to seek research partners abroad.
“We have needed to collaborate offshore and continue to do so just because it was taking us so long to get these regulatory approvals,” said Dr. Howard Zisser of the Sansum Diabetes Research Institute in Santa Barbara.
Zisser and Frank Doyle, a chemical engineer at University of California Santa Barbara, have developed the “brain” portion of an artificial pancreas system — a software program that uses blood sugar readings sent wirelessly from a continuous glucose monitor and tells the pump how much insulin to give.
So far, the software from this team can work with pumps from Insulet Corp and Animas, a unit of Johnson Johnson. And it works with sensors from Abbott Laboratories, Dexcom Inc and Roche Holding. That allows components from different device makers to become part of one artificial pancreas system, a new approach for medical technology.
In October, Zisser, Doyle and other members of an international consortium won a $4.5 million National Institutes of Health grant to test the technology in challenging settings. The group has run two pilot studies in Italy and in France.
In these trials, study volunteers placed the control of their disease in the hands of the device while they dined in a restaurant and slept overnight in a hotel. Research teams huddled in nearby rooms wirelessly monitoring their progress.
Zisser says it will be challenging for the FDA to feel confident with these kinds of trials. But there has been progress. The agency last month gave the green light for Medtronic to begin an in-home clinical trial of a low glucose suspend system in the United States.
Dr. Francine Kaufman, former president of the American Diabetes Association and chief medical officer for Medtronic’s diabetes business, says the company worked hard with the FDA to reach agreement on the trial design.
It will not be easy. The company must find a group of diabetics who are especially prone to hypoglycemia and they will try to show that the device is not only safe, but that it reduces such episodes.
“We’ve agreed to do it. We’ll start that trial and get our way down the path,” Kaufman said.
The potential stumbling blocks go beyond the design of clinical trials. Researchers and medical device executives say they still have plenty of work to do to make sure they have a system that functions properly.
While the technology has come a long way from the refrigerator-sized machines developed in the 1970s for hospital use, many of the systems are still using laptops to run the software program instead of more portable devices.
Medtronic Chief Executive Omar Ishrak said the company is committed to developing the technology, but there are many technical and clinical hurdles yet to cross. He says it will take a decade or so before a system is ready.
“It’s early enough for me to not even think about products,” Ishrak said. “We can do demonstrations and we’ve done clinical studies here and there, but we don’t have a product.”
Boston University’s Ed Damiano is part of a team developing an artificial pancreas system that uses both insulin and glucagon, a hormone released by the pancreas to raise blood sugar levels when they drop too low. He says blaming the FDA will not help scientists work out the kinks in the devices.
Damiano, like Brewer and Zimliki, has a personal stake in getting an artificial pancreas approved.
His son David, now in middle school, developed type 1 diabetes when he was 11 months old. Since he was a baby, Damiano has crept into his son’s room several times a night to check on David’s blood sugar.
David’s blood sugar levels have been in the normal range for most of his life. Damiano wants him to have a system that helps ensure his good health when David goes off to college.
“We’ve got seven years,” Damiano said. “It’s important.” (Additional reporting by Janet Roberts in New York and Debra Sherman in Chicago; Editing by Michele Gershberg and Tim Dobbyn)
Copyright 2011 Thomson Reuters. Click for restrictions.
Article source: http://www.msnbc.msn.com/id/40139075