David Nipple was less than two miles from home, and his beloved cats, when he died.

It was around 8:30 p.m. on May 4, 2014, and Nipple was  riding his motorcycle eastbound on a Tennessee highway. He checked his rearview mirror, and saw the red glow of his backlight on the blacktop. Then he was blinded by two headlights directly in front of him.

Nipple quickly calculated the height of the vehicle heading toward him--a Chevy Tahoe--and realized he'd either land "in the grill, underneath it or in the windshield." He swerved, but the SUV struck him and sent Nipple flying 30 feet.

He can only recall fragments from the time he spent beside the highway waiting to be airlifted to a hospital. His right hand resting near the knee of his left leg, where four inches of bone protruded from the skin. Seeing several inches of bone sticking out of his left arm, while the night hid the blood pouring from his wounds. Telling the people around him he was worried about his cats--no one had a key to his place, so who would feed them? And the relief at realizing his helmet was still locked on his head as the thunk of incoming helicopter's blades chopped louder and louder. Somewhere in all this, Nipple's heart stopped, hospital staff told him later, but someone was able to revive him. 

When he finally came to in the hospital, Nipple's left leg had been amputated above the knee. While he recuperated, though, the pain was unbearable. He suffered from phantom limb syndrome, the excruciating sensation that an amputated extremity is still attached. 

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"When the phantom pain kicks in, it's like reliving the accident," says Nipple, who's now 62. "The top of the leg is being ripped off to the side and the leg is being twisted."

But Nipple wanted to avoid opioids. He'd seen several friends get hooked and didn't want that to happen to him. Luckily, he found a different solution. Specifically, a pillbox-size device created by the startup SPR Therapeutics, which treats pain by sending low-voltage electrical pulses to a patient's nerves.

SPR is among a clutch of startups explicitly taking aim at the opioid epidemic. Such startups, unfortunately, have a lot of opportunity. Opioid and heroin-related deaths have skyrocketed in the past decade, thanks to the overprescription of legal painkillers like Oxycontin and an influx of heroin, which many who are dependent on opioids turn to after exhausting sources for prescription pills. Nearly 35,600 Americans died of overdoses from such drugs in 2015, according to the most recent data available from Centers for Disease Control and Prevention--up from 12,937 in 2005. 

To understand the work these new companies are doing, it's worth hearing from people like Nipple--who today is back to riding motorcycles, and whose Facebook nickname "Alien Leg" pokes fun at his prosthesis--and a person Inc. will refer to as Will (who requested anonymity), who is a patient of Groups, which provides affordable treatment to people who are addicted to opioids,

"Sometimes I just sat there and cried," says Nipple, describing his agony while abstaining from substances he feared getting hooked on--opioids, marijuana, and the non-narcotic nerve pain medication Gabapentin. "I've got friends that take Gabapentin and they say its not addictive," he says. "But when you start popping it like candy, that's addiction." 

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Nipple learned about SPR while browsing a Facebook page for amputees around a year after his accident. Nipple qualified for SPR's pain study and was outfitted with the company's SPRINT Peripheral Nerve Stimulation System--a small device that physicians attach nonsurgically to a patient's skin, near the afflicted area. A thread-like wire connected to the device is placed under the skin, close to the nerve that's registering pain, to administer electrical pulses. Nipple wore the device for the recommended 60 days--and says he's only felt phantom limb pain twice in the two years since the device was removed. 

This is typical of SPRINT users, says Maria R. Bennett, the founder of SPR Therapeutics. "We see a sustained or carryover effect," she says. "Our device delivers significant relief of pain not only during those 60 days but after the device has been removed." 

Bennett launched the Cleveland-based SPR in 2010 and received clearance last year from the FDA to market the SPRINT system for chronic and acute pain. The company also received nearly $9 million in two contracts from the U.S. Department of Defense to develop SPRINT and specifically target amputees who, like Nipple, suffer from chronic pain caused by nerve damage. Bennett says traditional implantable neurostimulation devices--which provide electrical impulses to treat pain--can cost around $30,000, but SPR's therapy costs more than 80 percent less. 

The long-term goal for SPR is becoming a non-opioid pain treatment for more general use. For example, SPRINT could be used on a patient who's received a knee replacement, a procedure known for its long and painful recovery process. The majority of people who get this operation are prescribed opioids, says Bennett, but SPRINT "could relieve their pain and avoid them ever even taking the opioid or filling that prescription"--the route by which countless Americans became dependent on opioids.

SPRINT would've been helpful for Will, who was prescribed opioids after an Army training injury in 2005. Back then, Will, who's now 33, was carrying a 200-pound rucksack during a drill when he stepped in a pothole and tore his ACL. After finishing his prescription bottle of opioids, Will began using heroin. He saw a doctor to treat his addiction, but after back surgery, he was again prescribed opioids. When that prescription ran out, Will says, he went on a six-month bender.  

Then he heard about Groups, a startup that brings treatment to communities plagued by the opioid crisis. Specifically, Groups targets areas with fewer than 10,000 residents and little access to recovery programs. For $65 a week, patients receive a prescription to Suboxone, a medication that treats opioid addiction, and entry to weekly group therapy sessions. In such settings, they are welcomed into a community of people who are fighting a similar battle. Groups' clients provide the basics of emotional and logistical support to other members, like a social life and transportation, says the startup's co-founder Dr. Jeff De Flavio. 

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"Being in recovery can be really lonely, and being with other people who can really understand you and actually engage in change with you is really important," says De Flavio, who started the company in 2014 with co-founders Silas Howland and Joy Sun. "Rather than meeting alone with a doctor, and having a more shame-based experience." 

Will was initially kicked out of Groups because he kept using opioids--he was spending roughly $1,000 a week on heroin and pills--and failed a urine test. But then he went back to Groups and begged for a second chance. It's been about two and half years since he was readmitted and Will reports he's currently clean. He's also working toward a degree in behavioral science so he can become an addiction counselor himself. 

"You have to really want to try, and you have to be able to get whatever luggage is on your back off," Will says. Once you do, he says, "there's nothing better than that free feeling." But, he adds, "you can't do it in an hour a week," and mentions how Groups encouraged him to participate in additional forms of counseling. 

Groups opened its first clinic in New Hampshire in March of 2014 and has expanded to locations in California, Indiana, Maine, and Ohio. De Flavio got the idea for Groups as a medical student in New Hampshire, at Dartmouth, and saw how opioids were plaguing that community. He worked with a professor who specialized in addiction treatment to open the first clinic in nearby Claremont, a 30 mile drive from his campus. "We tried to focus on a different part of the problem, which is the people who are left out of the traditional treatment options," De Flavio says. "Because they are living in the wrong place, or because they don't have insurance or have Medicaid"--patients with Medicaid can end up waiting a long time for treatment, he points out. And, often, there's little treatment available in rural areas for behavioral or mental health issues. Groups avoids that problem by giving anyone, regardless of their health insurance plan, a place for treatment at a relatively affordable cost.  

"We have better treatment for opioid addiction than any other kind of substance abuse," De Flavio says. "So it's particularly tragic to me that people don't have access to it. That's what got me into this." 

While the country may not be blanketed with Groups facilities just yet, some Medicaid spending on treating opioid dependency has increased in recent years under the Affordable Care Act, according to the public policy think tank Urban Institute. Medicaid spending on addiction treatment drugs buprenorphine and naltrexone, along with naloxone (which reverses opioid overdoses), has increased from around $400 million in 2011 to about $950 million in 2016.

However, that trend line would likely be reversed if President Donald Trump and Congressional Republicans make good on promises to repeal or dismantle the ACA. The most recent attempt to do so--the Senate's Cassidy-Graham bill--would have reduced the amount of federal money designated for Medicaid and private insurance subsidies by $215 billion between 2020, when the plan would start, and 2026, according to The Washington Post

The latest effort was abandoned in late September, but Republicans in the House of Representatives are studying a proposal from Trump to use the new tax plan, released on November 2, to repeal a major part of the ACA. Trump wants to include language in the tax bill that would eliminate the ACA's individual mandate, a change that would leave 15 million Americans without health insurance, according to The Washington Post.

Given that, it's worth keeping in mind what Will's treatment, thanks to Groups, has meant to him. When asked where he'd be without Groups, Will, a husband and father who now can take his family on vacations, and who's just three classes shy of becoming an addiction counselor, has a succinct answer. 

"I'd be dead."

Nov 9, 2017