Kevin Pauza MD ’86 is on the short list to be nominated for the Nobel Prize in Medicine. It’s because he has something wanted, or needed, by millions of people with severe spine pain. It’s a natural biologic healing agent poised to change the way people with spine pain are treated worldwide.
Pauza’s invention will allow millions of people, previously relegated to undergoing complicated spine surgery, to be treated nonsurgically. Instead, Pauza’s patented “squirt gun” infuses the healing agent directly into the spine. Injected into damaged discs, the treatment seals disc cracks, reduces inflammation and regrows new tissue, curing degenerative disc disease and providing new hope for painlessness.
Relatively affordable and successful, the disc sealant has made Pauza phenomenally popular, even before its introduction. His services are so in demand that the hospital he confounded, Texas Spine and Joint Hospital, in Tyler, Texas, leads the world in the number of spinal procedures performed. Pauza himself receives more than 5,000 referrals daily, all from patients who want to avoid spinal fusion, a surgery both expensive and invasive.
“Pain is an incredible motivator; the relief of pain is an even more incredible motivator,” says Pauza from Beverly Hills, Calif., where he was making house calls to royal dignitaries and other VIP patients. Royals are on his patient list, along with professional athletes and diplomats from all corners of the globe. They all know the advantages of getting permanent relief without surgery.
“It’s the same for princes and queens, farmers and the homeless,” says Pauza. “Everyone wants more control over their bodies and their lives. Everyone wants to be pain free.”
Pauza says his interest in medicine probably took hold during his teenage years on his family’s farm, near Hershey, Pa. It was there that he learned the loss of independence that comes with major injuries. He was cycling one day with his brother, when a truck struck his sibling, catapulting him 50 yards into the family orchard. Suffering a broken skull, pelvis and spine, his brother’s long recovery convinced Pauza to become a spine specialist, dedicated to preventing paralysis, an often permanent condition that he says cuts him to the core.
Pauza majored in biology and psychology at Lehigh, two disciplines essential when dealing with the physical and mental wounds of chronic spinal pain. He decided to specialize in the spine, largely because spine injuries ruin lives and consume more health care dollars than any other disease. Pauza wanted to make dramatic changes in a field where he could have a positive impact on the most lives.
His choice was right. More than 1.2 million Americans have spinal surgery annually, more surgeries than those for heart disease or cancer. Nearly 300,000 have spinal fusions, a procedure Pauza finds often ineffective, inappropriate and cruel. Stabilizing vertebrae with screws or rods dramatically limits the spine’s natural flexibility, which can damage adjacent areas and trigger other traumas, he says.
“Fusion, or the metal artificial disc, may be the worst treatment imaginable. To be frank, one of the reasons fusions are so popular is that they’re so profitable for physicians and hospitals, many of whom don’t know any other procedures to offer. So physicians in the know call fusions ‘the annuity plan’ for spine surgeons because, almost without exception, their patients will be back for more treatments. Unless they’re 90 years old, and they die first.”
His quest for a healthier solution began soon after the 2006 opening of his hospital. He discovered that the solution lies in a natural resource-the key proteins of blood plasma. Fibrinogen and thrombin combine to form fibrin, which helps heal cuts. Fibrin sealants are commonly used in surgery because they’re less aggressive than sutures and control bleeding better. Pauza significantly modified the natural sealant, using it to instigate regrowth of young, healthy disc. The FDA said that it’s the first time someone developed a way to make old tissue young.
Pauza sketched his plan for a spinal sealant on a napkin while drinking cocktails with a friend, an intellectual-property expert who became a fellow patent holder. Around midnight, he left the restaurant and returned to his hospital to start working on his compound. Three days later, he concocted a fibrin treatment. Within weeks, he tested the treatment on his first patient.
More than five years later, well over 1,000 people have been treated privately with Pauza’s sealant. A remarkable 86 percent have reported decreased pain, increased function and improved mental health. Patients often return to driving, can walk again and sleep without pain for the first time.
Pauza is the lead investigator for the FDA study evaluating his Biostat Biologx Fibrin Sealant, now in its third phase of clinical trials. He predicts FDA approval by 2015 and widespread availability by 2017.
Not stopping there, Pauza is also studying the success of putting biologic into degenerative joints to regrow them. Imagine the benefits of regrowing cartilage in a hip instead of replacing the hip, he says.
Relatively low cost is another attraction. The fibrin treatment is about $100,000 less than a typical physician’s fee for a spinal fusion. Pauza will save the United States billions of dollars annually. That money can be used to find cures for cancer and other diseases, says Pauza.
“We all want to lower the cost of health care with good outcomes,” says Pauza. “It’s exciting to think we can take a huge chunk of the expenses out of the puzzle completely and free up a big amount of money for more important matters.”
The spinal sealant has political purposes, too. Pauza has treated football players, race car drivers and other professional athletes who need to avoid the sort of surgery that could terminate team contracts and endorsement deals. World leaders have chosen the non-surgical procedure to bypass long recoveries, a potentially dangerous sign of weakness to foreign and civil enemies alike.
Pauza’s relationship with foreign leaders started three years ago with an advance call from an official at the U.S. Department of State. Initially, he worked with Saudi education ministers to develop new medical technologies, programs and schools, part of a campaign to give the Middle Eastern nation a vital industry other than petroleum. Today, thanks to word-of-mouth advertising, he doubles as the resident spine specialist for Saudi royals, a pied piper on call, in more than a half dozen countries.
“When people hear I’m in their country, they come from other countries in the region to see me,” says Pauza. “They ask me: ‘Oh, can you see one more person?’ What can I say but ‘Sure’? They keep arriving uninvited, so sometimes ‘one more’ becomes 12 at a time. It’s like a spider web that keeps growing.” While abroad, his personal assistant tries to plan his days, so he gets at least three hours of sleep. Otherwise, the calls wouldn’t stop.
Fibrin sealant is the spine of Pauza’s empire. He is also a major investor in the artificial spinal disc. He directs a foundation that gives a $250,000 award to pioneers in nonsurgical spine treatments, and his fellowship program trains students around the world.
Pauza lives the creed he adopted as a medical resident: “The reward for hard work is always more hard work.” On a normal day, he sees 30 patients in the operating room at his hospital, consults with clients around the globe and shares conference calls concerning tests of the fibrin sealant and the artificial disc. Every week, his office receives more than 250,000 emails. His voice mail is routinely full, as is his assistant’s.
Pauza works seven days a week, often on four hours of sleep, sometimes on none. He does so easily, even cheerfully, driven by a Hemi-powered Hippocratic oath to heal without harming.
“I’m a little bit of a maverick, a cowboy pushing the envelope,” says Pauza. “I feel that if I didn’t push it, nobody else would. I don’t want money. I don’t want fancy cars. What I want is to make a real difference in society. I want people to say after I’m gone: ‘Wow, imagine growing new tissue in the spine for the first time-imagine that was done by a guy from Lehigh.'”