Desperate for Dollars: The Fight for Medical Research
Author: Janet Roach
Published: 11:50 AM EST January 18, 2018
Updated: 11:50 AM EST January 18, 2018
HEALTH 6 Articles

Desperate for Dollars: The Fight for Medical Research

Chapter 1

The Fight for Medical Research

Chloe Jarratt is 8-years-old and loves to dance. The Franklin third grader has been battling Type One Diabetes since she was five-years-old. While Chloe practices her dance steps at The Contemporary School of Dance, her mother, Amanda Jarratt recalls the scary moments of a new diagnosis.

"She was in the emergency room in Franklin and CHKD sent an ambulance to Franklin to pick her up. By the time a meter could register her blood sugar, it was 596. So she was in diabetic ketoacidosis."

Chloe joined the 1.25 million Americans with Type 1. It's an auto-immune disease in which a person's pancreas stops producing insulin. Insulin is necessary to regulate blood sugar levels.

"I have to check my blood sugar, give myself insulin, change my sets and my sensors," says Chloe.

As a diabetic, Chloe always has to worry about blood sugar spikes and lows, which can be immediately medically dangerous.

"It puts them at risk of a seizure. It puts them at risk of death, if it's not addressed and that's a constant fear," says Jarratt.

Chapter 2

The Artificial Pancreas

Recently, fear turned to hope when Chloe was selected to participate in a clinical trial at the University of Virginia in Charlottesville to test an artificial pancreas under development.

Inside Fontaine Research Park, UVA's Medical Director for the Center for Diabetes Technology, Dr. Stacy Anderson demonstrates how the artificial pancreas works. It has nothing to do with transplanting a body part. It's about connecting to real advanced technology. First, a continuous glucose monitor is worn under the skin that can constantly detect a person's blood sugar level.

Through Bluetooth, that information is sent to a smartphone app, which then tells an insulin pump how much insulin to dispense. Several factors influence insulin levels, including exercise but primarily the number of carbohydrates ingested during a meal.

"The advantage of the artificial pancreas is two hours after the meal, it's taking an assessment and saying, 'was that enough insulin or should I be giving a little bit of a correction?' So even though the person is kind of going about their own business between breakfast and lunch, the system is thinking for them," says Anderson.

The technology has been decades in the making. Dr. Boris Kovatchev is the mathematical mind behind the algorithms that make the system work. The concept began by first answering some key questions.

“First with quantifying diabetes in general, what are the risks? How do you quantify? Then how does the human metabolic system work in diabetes? What is deficient?” says Kovatchev.

By 2005, Kovatchev and his team were on to something. He and a group of scientists gathered at the National Institutes of Health in Bethesda and decided it was time to figure out if diabetes could be controlled automatically.

“There was this meeting where we were discussing whether it’s even possible to make an artificial pancreas with the means of the day and we decided to give it a try.”

In 2008, after a few years of animal trials, primarily on dogs, Kovatchev created a computer simulator and convinced the FDA to allow it to replace animals in trials.

Chloe was selected to participate in a UVA clinical trial to test an artificial pancreas.

That accelerated the process and human trials began with inpatient trials where everything was closely monitored. By 2011, the team began looking for ways to marry the artificial pancreas technology with a portable device.

“We needed a portable device with significant computing power and the logical host for that kind of device with significant computing power was the smartphone.”

Jarratt says the trial experience for Chloe was incredible and that the device kept her blood sugar levels in the safe target range, under 150 and higher than 80.

Kovatchev doesn’t say when the device could actually hit the market, but predictions are sometime during 2018.

Much of the funding for the artificial pancreas project has come from JDRF (Juvenile Diabetes Research Foundation). JDRF is the leading global organization funding Type 1 Diabetes Research.

It heavily lobbies Congress for federal support, particularly for the Special Diabetes Program (SDP).

The $150 million a year program is set to expire Sept. 30 and JDRF is asking for a three-year renewal. It has been instrumental in funding several research advances including the artificial pancreas and diabetic eye disease.

Chapter 3

Children's Congress

JDRF taps on the experiences of the people who understand Type One Diabetes the most: children with the disease and their parents.

Every two years, about 150 young diabetic kids converge on Capitol Hill for three days during the summer for what’s called Children’s Congress.

Four kids made up the Virginia Delegation. The children were Michael Sevila, 17, Keira Realmuto, 13, Trevor Roach, 11 and Joshua Davis, 8.

In addition to testimony before the Senate Committee on Aging, the young delegates fanned out across the Congressional office buildings and met face-to-face with their representatives.

PHOTOS: The Fight for Medical Research

While meeting with Senator Tim Kaine, the four delegates asked for his support of the Special Diabetes Program. It’s an easy sell, as the democratic lawmaker has already signed a letter of intent to back the program.

For about 30 minutes, they shared a scrapbook with the Senator that creatively depicts what life is like living with Type 1.

“This is all my first year of insulin shots,” says Davis, as he shows the Senator a picture with a huge pile of needles.

“My blood sugar was well over 800 and I stayed at CHKD,“ Roach says as he recalls the day he was diagnosed at the age of 8.

Sevila points out that he and his family, over the years have raised a quarter-of-a-million dollars for JDRF, since he was diagnosed at age 12.

“We've done our part raising money and we would like for the House and Senate to do their part,” says Sevila.

The Senator is impressed.

The delegates think one down, 534 to go.

Chapter 4

The Fight for Cancer Research

At the National Institutes of Health’s Clinical Center in Bethesda, Maryland there are between 1500 to 1600 clinical trials going on at the same time. The center is the largest hospital in the country devoted entirely to clinical research and Chief Executive Officer, Dr. James Gilman says it is known for a number of firsts.

“Since the Clinical Center opened in 1953, there have been lots and lots of those firsts in human trials: first drugs to use in HIV infection and AIDS and first successful use of chemotherapy to treat cancer.”

Cancer research has come a long way and much of it now centers around Immunotherapy, using the body’s immune system to fight cancer cells.

“We take cells that are missing something from a patient and we put that something in or we take cells from another patient that's not missing it and we transplant them to a patient that's missing something,” explains Gilman.

In the laboratory of Transplantation Immunotherapy, researchers are working with immune cells referred to as natural killer cells. They’re turning them into superheroes to fight cancer.

“The immune system can surveil this cancer and when it sees a cell behaving irregularly, that has become cancerous, it can kill it at its early stages,” says Dr. Richard Childs.

So what Childs and his team are trying to figure out is why the natural killer cells lose their destructive ability once the cancer cells grow. “We spent a lot of time to enhance their ability to kill.”

By taking the cells out of the body and genetically manipulating them.

In another lab, down the hall where the main area of interest is the human papilloma virus induced cancers, scientists are growing T-cells in incubators.

“We would do surgery and operate and remove one of the widespread tumors of a patient with cervical cancer and we would grow the T-cells that were attacking the tumor out of the tumor,” says Dr. Christian Hinrichs.

They grow the T-cells in large numbers, making them more destructive and then give them back to the patient. “We have two patients whose tumors went away completely.”

It’s immunotherapy that makes CHKD Pediatric Doctor Eric Lowe excited. He works in the child cancer department where the most common form of cancer is acute lymphoblastic leukemia.

He says using T-cell therapy has been very effective on treating leukemia. “Right now, it’s getting through clinical trials and it’s had amazing results. “

Eventually Lowe, hopes the therapy will come to CHKD, but NIH is funding about 70 clinical trials at the hospital.

Pictured here is Brodie Henderson as he waits for a chemotherapy session at CHKD.

So naturally, there’s worry about the $5.8 billion in proposed cuts to NIH in President Trump’s budget.

“Right now, they aren’t funding some things that they think are worthwhile because they don’t have the funding,” adds Lowe.

Lawmakers on both sides of the aisle have come out against the cuts.

And so have research advocates who hang on to hope that medical advances continue.

Kelly Henderson of Hampton has an 11-year-old boy fight brain cancer right now. Brodie was diagnosed with astrocytoma at six-months-old. It recently returned.

Hoping to get into a clinical trial, Brodie applied for one in Washington D.C., but was denied.

His mom says they’ll keep trying.

“If a trial comes up again and he has the opportunity to join it, we would love to do that.”

Chapter 5

Brain Imaging Study opens doors for Alzheimer’s patients

70-year-old Walter Mooney has Alzheimer's disease. The Virginia Beach man just participated in a study that confirms that. It's called the IDEAS study, which stands for Imaging Dementia—Evidence for Amyloid Scanning.

His doctor, Hamid Okhravi, is the director of the Memory Consultation Clinic in the Glennan Center for Geriatrics and Gerontology at EVMS in Norfolk. Okhravi says the $100 million study is allowing doctors to make a good case for insurance companies to cover the $5,000 to $10,000 cost of amyloid imaging.

"Insurance companies like Medicare, they do not cover the cost," says Okhravi.

But the imaging has a much greater purpose for Mooney. Because it shows the presence of amyloid protein in the brain -- a strong indicator of Alzheimer's -- it's giving dementia specialists the knowledge to determine the most effective treatment plans.

The goal for the first 4,000 patients in this study was to see a 30 percent change in medical or nonmedical management toward the patients. Okhravi says that turned out to be a lot higher at over 65 percent, and an even greater percentage in his practice.

"Probably, I have changed my management towards patients based on the knowledge of this study much more than 65 or 68 percent. I really can't tell you exactly, but I would probably say it's closer to 80 to 85 percent."

And it's boosting morale among dementia specialists.

"It's just another tool that we have available to offer to our patients and to be able to help them more than we did before."

Having an amyloid image makes Mooney more attractive to clinical trials. His wife Marla says they are anxiously awaiting word on one in Richmond that will test a drug called, Aducanumab.

"It's in the third phase now, and it's actually causing Alzheimer's patients to do better on the cognitive tests. So to my knowledge, it's the first there's ever been any reversal. So it's extremely promising, " says Marla.

Chapter 6

Beach woman hopes for better research to treat Lupus

For Carshena Jackson, a peaceful Friday evening at the Lynnhaven Fishing Pier in Virginia Beach is such a contrast to the attack going on inside her body. Jackson has had lupus for more than 20 years, and she's desperate for better treatment.

“They don’t have a specific drug. They just have the cancer drugs or random drugs to treat us right now. We need something,” she says.

Lupus is an autoimmune disease that causes a person’s immune system to attack their organs. There is no cure.

Carshena Jackson at a doctor's appointment for lupus treatment

According to the Lupus Foundation, the disease has a history of disappointing results from clinical drug trials. The foundation has launched a vigorous effort to push for more efficient research. Jackson, who works as a Medicare Team Coordinator for Sentara plans to be part of that effort.

She was in one trial at the Virginia Research Clinic sponsored by drug giant Pfizer to test a drug designed to fight inflammation. Jackson says that trial was suspended, so she’s waiting on word to participate in another one.

“I know that doing this trial, it can just better us. That's how I feel. That's how I look at it. That’s how I feel about it. A lot of people don't want to me to do it.”

Jackson says this past year has been the most difficult one yet trying to manage the disease. The disease can cause a skin rashes on parts of the body that are exposed the most to the sun. Painful and swollen joints, fatigue, headaches are common lupus symptoms.

Jackson has been prescribed at least 14 different drugs.

Chastity Corbett, a lupus survivor and the chair of the “Walk to End Lupus Now” says better research of the disease has to start with raising awareness.

“A lot of people still don’t know what lupus is or how it affects patients and they don’t understand that our bodies are attacking ourselves.”

Finding a Clinical Trial