ALEXANDRIA, Ky. -- Jen Stansbury Koenig had just finished wrestling a sock and rain boot onto her right foot when her left leg stopped cooperating.
The tremors can come on suddenly now, and Koenig has to be patient. She took a deep breath, smiled and used both hands to lift her left foot off her lap until the shaking stopped long enough to try again.
It wasn’t long ago that Koenig, 39, could rock climb and camp and hike any trail she wanted, no matter how treacherous. But that was before she was diagnosed with Multiple Sclerosis, before she found out she also has Lyme disease and before three different types of drugs that were supposed to make her better only seemed to make her symptoms worse.
Now she walks unevenly, shakes unexpectedly and falls frequently. She refuses to use a cane.
“I’m stubborn,” she said. “I keep a smile on my face, and I stay positive, and I don’t let it get me down.”
That combination has gotten Koenig where she is today, preparing to undergo an innovative treatment in Chicago that could virtually cure her MS with help from her own stem cells.
The journey has been anything but easy, and it’s far from over. But Koenig said she wants to tell her story now to offer hope to others with MS and shine light on what she views as the needless suffering that too many people with autoimmune diseases endure.
When the medicine makes things worse
Koenig started having random, shocking pains in her back and neck when she was 17. She had MRIs nearly every year and multiple blood tests and screenings to try to figure out the problem. But it wasn’t until she was 32 that a doctor told her she had MS.
Koenig was stunned. She and her husband, Andy, had wanted to start a family, and she couldn’t imagine having a baby as she was trying to figure out what her own future held.
But the day after her diagnosis, Koenig found out she was pregnant.
She refused to start taking medication for her MS because she was worried it might be bad for her baby. She focused on her health, felt good throughout her pregnancy and gave birth to a healthy, 10-pound baby girl. Koenig put off taking medication for her MS until a couple years after little Adelaide was born.
All that time, she had continued hiking, rock-climbing and camping, and she felt pretty good. But just a couple of weeks after starting her first medication for MS, she started feeling worse.
“The worsening of my symptoms started to slowly occur,” she said. “I still had new lesions.”
Koenig switched to another medication that was supposed to keep the MS at bay but kept getting worse. In 2015, doctors figured out that Koenig also had Lyme disease, and a specialist told her that was probably the infection that triggered the MS in the first place. Koenig said the drugs designed to help her MS suppressed her immune system, allowing the Lyme disease to flourish.
She took antibiotics for almost a year to kill the active Lyme disease infection and started to feel better.
After that she started a course of steroids and a milder drug for MS that she had to inject herself with every three days. That medication wasn’t helping either.
Then she read a story in Northern Kentucky University’s student newspaper about a student who had been treated by Dr. Richard Burt at Northwestern University Memorial Hospital. She searched the Internet for information and sent his office her MRI reports in April 2016. Her first visit to his office was in July of that year.
Yes then no
“When I got there, they took one look at me walking and said, ‘You’re absolutely eligible for this -- a good candidate. You’re young. You’re strong. You have a good mindset,’” Koenig said.
Her brain and cervical spine were covered with lesions from the MS, but the disease had not progressed to the point where the treatment wouldn’t help.
Koenig describes the treatment as a bone marrow transplant for people with autoimmune diseases. The technical name for it is a hematopoietic stem cell transplant, or HSCT.
Burt has been performing the procedure for years and estimates he has treated “several hundred” people through the Division of Immunotherapy and Autoimmune Diseases at Northwestern University’s Feinberg School of Medicine.
Burt and his colleagues published results in the Journal of the American Medical Association in 2015 for 151 patients who had undergone the procedure and found that HSCT could be the first MS therapy to reverse the disability.
But the Federal Drug Administration has not approved HSCT as a “standard of care” for MS. And that can be a problem for patients like Koenig -- and the companies that insure them.
Humana insures Koenig through her husband’s employer, Northern Kentucky University.
In a letter dated Dec. 1, 2016, the company approved coverage for her HSCT. But a week later, Koenig received notice of an “adverse benefit determination” dated Dec. 8 that reversed Humana’s previous decision, stating: “We have denied this request after thoroughly reviewing the information.”
The reversal left Koenig confused and frustrated. As she understands it, Humana would have covered her treatment if she had been part of Burt’s clinical trial. But by the time Burt was ready to treat her, he wasn’t accepting patients for the trial any longer.
Burt agreed to treat Koenig on a “compassionate care” basis, using all the same protocols that the trial uses. But because Koenig isn’t part of the clinical trial, she said, Humana considered the treatment experimental.
“Even though the definition of a clinical trial is that it’s experimental,” Koenig said. “It’s circular reasoning.”
‘It’s hard to change minds’
Koenig has a Ph.D. in education, a brother-in-law who is a lawyer and a brother-in-law who is a Kentucky state lawmaker. She appealed the decision every way she knows how but has been denied.
WCPO contacted Humana to ask about the decision and got a statement in writing from a spokeswoman based in Chicago:
“In the case of this particular plan, which is known as a self-funded plan, the employer pays its own medical claims, as well as holds responsibility for determining what is, and is not, covered for its members.”
The statement continued:
“In declining to authorize experimental treatment, the employer’s position is one that is followed by many plan sponsors (employers) and insurers, as well as, for example, the U.S. Department of Health and Human Services’ Centers for Medicare & Medicaid Services.”
That response came as a surprise to Koenig, who said that Humana never referenced NKU as being part of the reason for the denial of her claim in any of the correspondence she received.
An NKU spokeswoman responded to questions about Koenig’s case with a statement that said:
"We contract with Humana as our health insurance plan administrator. In this role, Humana grants or denies claims and handles all appeals in accordance with our health insurance plan. NKU does not review or adjudicate these claims or appeals. Under our health insurance plan, experimental transplant services are excluded."
For his part, Burt said it’s not unusual for his patients to have problems with insurance coverage.
Some plans will only cover patients that are part of a clinical trial, he said, while other plans will only cover patients if they aren’t.
“Medicine is a very conservative field,” he said. “It’s hard to change minds, and there’s a lot of skepticism.”
None of it changes how much money Burt earns, he said.
“I’m at the university. I get a set salary. I don’t have anything to do with the money,” he said. “We’re not doing this for the money. But we’ve got to follow the rules that are out there and the decisions that are made whether it’s public or private insurance.”
Burt said he knows that leaves many patients frustrated. And while some patients might have the time to wait until the FDA approves HSCT as a standard of care for MS, he said, others do not.
‘I don’t have four years’
The treatment isn’t effective after the MS has progressed too much, Burt said. It works best for patients whose disease has progressed but isn’t so far along that it’s “secondary progressive,” he said.
That’s Koenig’s problem.
“I’m worse today than I was a year and a half ago,” she said. “By the time they finish publishing their data and publishing their articles, it won’t happen until 2022. I don’t have four years to wait for the FDA to say this is an approved standard of care.”
So Koenig isn’t waiting. She and her husband, Andy, are leaving for Chicago to start her treatment.
Friends and family members have raised about $15,000 to help pay for the treatment’s $125,000 down payment. Koenig’s parents and in-laws are funding the rest.
The family has a fundraiser planned for Oct. 9 to keep raising money because there will be more bills to pay, too. Koenig estimates the total cost of the treatment at $160,000, which is actually less expensive than the $200,000 per year her MS drugs would cost.
“I’m hoping Jen is around to be able to see her daughter graduate from high school,” said Eileen Stansbury, Koenig’s mother. “I’d sell my soul for her to get better.”
Or at least, she said, not get worse.
That’s all Dustin Fairchild was hoping for when he started his own treatment with Burt.
Fairchild, 39, had been walking with a cane for several years and also had gone through three different MS drugs that were making him feel worse instead of better.
He had an evaluation in Chicago in January and did his pre-testing in February.
Before Burt and his colleagues do the transplant, patients undergo a treatment that helps their bodies make more stem cells that are then harvested for use later. Patients also undergo chemotherapy to kill off their white blood cells and then take steroids to reduce the inflammation in their bodies.
That way, when their bodies begin to produce new immune systems, it happens in a “non-inflammatory environment,” he said, which means those white blood cells no longer attack the brain.
Fairchild said he started to feel better almost right away.
“I noticed some changes before the actual transplant,” he said. “I could think clearer. I saw things clearly, and I saw details.”
The stem cell transplant is the last part of the treatment, and it simply helps speed up the creation of new white blood cells, Burt said.
Nearly five months past his transplant, Fairchild said he feels a big difference.
“I can run now,” he said. “I mean, it’s not pretty. It won’t last for long. But I never thought I was going to run again.”
Koenig wants to run. She wants to hike. She wants to be able to take Adelaide on Girl Scout camp outs and walk around the zoo with her and learn how to ride a bike all over again while her daughter learns to ride without training wheels.
“While she struggles, I want to struggle with her,” she said. “To me, this transplant is the only option to be able to get my life back.”
Adelaide will turn 7 in October, and seven days after that Koenig is scheduled to get the transplant to jumpstart her new immune system.
The thought of two important birthdays so close together makes the two of them smile.
But for now, Koenig must watch from a distance when her daughter and husband race down the steps and tromp through their soggy back yard to the deck in the woods they call “base camp.”
“One step at a time,” she said with a smile, slowly making her way down the steps in her rain boots to see them go.
It’s how Koenig plans to approach just about everything over the next few months: One step at a time.
Koenig's friends and family are holding a fundraiser for her from 5 p.m. to 10 p.m. on Monday Oct. 9 at The Globe in Covington. Tickets are $25 for live music, pizza from Goodfellas and two drink tickets for wine or beer. You can read more about her journey in her online blog or donate online to her Generosity Campaign.
Lucy May writes about the people, places and issues that define our region – to celebrate what makes the Tri-State great and shine a spotlight on issues we need to address. To read more stories by Lucy, go to www.wcpo.com/may. To reach her, email firstname.lastname@example.org. Follow her on Twitter @LucyMayCincy.