By Alan Prendergast
By Michael Roberts
By Michael Roberts
By Amber Taufen
By Patricia Calhoun
By William Breathes
By Michael Roberts
By Melanie Asmar
After nearly two dozen surgeries in twenty years, Nyla Bailey thought she knew what doctors could do about her excruciating pain, which wasn't much.
They could make her feel worse, certainly. They could anger and humiliate her, labeling her a hysterical female -- or, as one skeptical internist put it, "a drug-seeking psychotic woman." But no one, it seemed, could take away the pain.
The agony was so severe, so relentless, like a rat gnawing at her insides, that she drove herself to exhaustion simply to get a couple hours of sleep. Work took her mind off the pain, so she held up to three jobs at a time while raising two children. She cleaned house in the middle of the night, keeping the place as spotless as an army barracks. She subsisted largely on cigarettes and Diet Coke. Even her most idle moments were filled with frenzied activity. She watched TV and knitted and read books all at the same time, trying to ignore the beast inside.
Then she was introduced to Dr. Richard Schmidt and his magic box. The result, she says, was "five days of absolute wonder," followed by five years of a mostly pain-free existence that she thought she'd never have.
Bailey, now 44, has suffered from chronic pelvic pain since she was a teenager. She's undergone a hysterectomy, had her bowels rebuilt, endured more exploratory surgeries than she cares to remember. She's had surgeries to try to remove the scar tissue built up from previous surgeries. In 1995, after years of shuttling between gynecologists and neurologists in Laramie, Wyoming, she sought help at the University of Colorado's Health Sciences Center, the premier medical research and treatment center in the Rocky Mountain region.
Tests indicated that Bailey's pain was related to a urological condition, one of a wide range of bladder and bowel problems grouped in the medical literature under the ungainly term "voiding dysfunction." She was referred to urologist Richard Schmidt, a member of the UCHSC faculty who specialized in the treatment of incontinence and pelvic pain. He told her that "the fourth sacral nerve center in my spine did not function properly, and the urinary system was in constant spasm," Bailey recalls.
Schmidt proposed that she join a research program involving a kind of pelvic pacemaker -- a device he'd invented that sent electrical impulses through wires placed under the skin to nerve centers at the base of the spine. The device was still awaiting FDA approval, Schmidt explained, but in clinical trials it was providing a significant degree of pain reduction and increased bladder control in three or four out of every ten patients.
Bailey filled out the necessary consent forms. The effect, in her case, was immediate and dramatic. Hours after Schmidt inserted some "test" wires into her back and connected them to an external, pager-sized generator, the pain was gone. After several days of relief, she was reluctant to have the wires removed.
Under the strict protocols of the FDA study, Bailey was randomly assigned to a "delay" group that had to wait six months for further treatment. She was hospitalized frequently during that time; her pain had returned with a vengeance after the test wires were gone. By the end of six months, she was taking 180 milligrams of morphine a day.
In January 1996 she underwent surgery to have a new generator, with a battery that could last up to eight years, implanted in her abdomen. Three days later she was off morphine for good.
Eighteen months after the surgery, Bailey testified before the FDA, urging the agency to approve the device for more widespread use. "What is my life like now? I walk. I laugh. I relax," she said. "I know now how other people experience life."
The FDA has since decided that Schmidt's device, the Medtronic InterStim System for Urinary Control, is a safe and effective treatment for various forms of pelvic pain and voiding dysfunction. From 1993 through 1999, more than 170 patients, mostly women, enrolled in Schmidt's study at the Health Sciences Center. Although not every candidate fared as well as Bailey, dozens saw marked improvement in their condition, paving the way for commercial marketing of a product that could better the lives of thousands of people. It's estimated that up to 40 percent of the American population over the age of 65 experience some form of voiding dysfunction, and Medtronic, the Minnesota-based manufacturer of the device, now reports a hundred new implants a month.
But none of those implants are being done at the Health Sciences Center. Richard Schmidt doesn't work there anymore, and the program he started no longer exists. Bedeviled by litigation, his career in ruins and his reputation under attack, the urologist has been locked in a battle with CU to clear his name since his firing two years ago. He is also haunted by what could have been, by the groundbreaking work that ended abruptly with his dismissal.
"They said I was the worst guy on earth," Schmidt says. "That I was incompetent surgically. That I was teaching experimental programs. In just six years, I had FDA approval of a new device. I'd obtained a patent for botox [botulism toxin, used in nerve-blocking treatments] that has the potential to bring the university millions of dollars in royalties after clinical trials. I was bringing in national media.