The Strange Case of Dr. Schmidt
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.
"And the university said, 'This is crap. This is junk. You're a lousy doctor and a lousy professor, and we're going to fire you.' We had an opportunity to completely change the way health care is delivered in the world of the pelvis, and the university squashed the whole program."
The notion that Richard Schmidt was a "lousy" professor is disputed by several of his former colleagues, who cite his surgical skills and extensive track record of research and publication. And many of his patients vigorously deny that he was ever a bad doctor.
"He is one of the most compassionate men I have met," says Darlane Crow, a 38-year-old nurse who'd endured various unsuccessful surgeries and therapies before the Medtronic device drastically reduced her pelvic pain. "I call him my angel in a white lab coat."
"What happened to Rick has nothing to do with patient care," says Nyla Bailey. "It was about politics. I watched his program get dismantled and a lot of good people get chased away, for no good reason at all."
Crow and Bailey are more fortunate than some other members of the FDA study; over the past two years, both women have been able to arrange occasional "appointments" with Schmidt in hospital lobbies or restaurants so that he can make necessary adjustments to the devices implanted inside them. But six former patients are now suing Schmidt -- as well as UCHSC, the university's Board of Regents, and the former heads of both the Division of Urology and the Department of Surgery -- claiming that Schmidt's termination left them with wires and generators stuck in their bodies and no one to care for them.
According to Robert Ozer, the patients' attorney, the implants exacerbated the pain for some of his clients. "In most cases, it actually caused severe additional problems," he says. "Even where there was some relief, the device requires frequent monitoring and adjustment. Here they are with this thing in their body, and then Schmidt got the boot and they were left high and dry."
UCHSC officials have been tight-lipped about Schmidt's departure and the fate of his research program. Medical school dean Richard Krugman, former surgery chair Alden Harken and former urology chief John Whitesel did not respond to requests for comment. "Institutionally, it is our policy not to comment on any matters involving pending litigation," says UCHSC spokeswoman Sarah Ellis.
The "official" version of Schmidt's firing, laid out in court records, states that the university declined to renew his annual contract after two internal review committees deemed his work unsatisfactory. The two evaluations alleged certain "deficiencies" in his research methods, his teaching and his approach to patient care. None of these supposed shortcomings were ever brought to the attention of his patients, Ozer's group has been quick to point out in its lawsuit.
But there are many reasons to doubt the official version of what happened to Richard Schmidt. The physician describes himself as the target of a vendetta, waged against him by Harken and Whitesel with Krugman's blessing. It's a strange story, with disturbing implications that go beyond the concerns of a single personnel dispute. Confidential documents and internal memoranda obtained by Westword indicate that the Schmidt affair is only one strand in a string of ugly power plays and costly purges at the Health Sciences Center over the past decade, a ruthless political contest in which the big losers have been patients and the university's own battered reputation.
At the same time that UCHSC has embarked on an ambitious billion-dollar expansion of its facilities to the Fitzsimons campus, the center has been subject to an embarrassing shutdown by the FDA of hundreds of inadequately monitored clinical trials, as well as a federal investigation of improper Medicaid and Medicare billing. Three years ago, the attempted firing of one of the center's most respected and influential surgeons, a case that has a direct bearing on Schmidt's claims, led to a bruising showdown between UCHSC top brass and powerful state legislators.
Other blunders and missteps -- fractious infighting within the urology division, the departure of talented researchers in protest over "hostile" working conditions, the quiet resignation of one of Schmidt's principal accusers last spring after a bizarre encounter with a Denver police undercover sting -- have received no public mention at all. But the turmoil hasn't gone unnoticed at other top medical centers across the country, where the Health Sciences Center is often regarded as a kind of troubled second cousin.
"The place is infamous for its problems," says one former division head, now retired. "Everywhere you go, people ask what in the world is going on at the University of Colorado."
Schmidt, for one, has no patience with the high-priest atmosphere of the medical center, the genteel cone of silence that surrounds it. There are too many questions, he insists, about academic freedom, attitudes toward pain management, the center's old-boy network, medical mediocrity, and new technology and patient care that no one is addressing.
"The big question is, why isn't this medical center one of the leading places in the country?" he asks. "What's holding it back? I think that egos are running the place rather than people with vision."
Eight years ago, administrators at the Health Sciences Center had an entirely different opinion of Richard Schmidt. They thought so highly of him that they aggressively recruited him, offering him $200,000 a year in salary and bonuses if he would leave his position at the blue-ribbon medical center at the University of California at San Francisco, where he'd been a member of the urology faculty for fifteen years. They also promised that he'd be eligible for a tenured position as soon as one became available -- a promise that was soon broken.
In a 1993 letter to Dean Krugman urging the hiring, surgery chair Alden Harken reported that he felt "extraordinarily lucky to have lured Dr. Schmidt to the University of Colorado...[He] is a superb urologist with excellent teaching skills, in addition to his national and international recognition for his achievements in urodynamics and neurostimulation applications."
Although his initial appointment was only year to year, Schmidt saw the move as an opportunity to expand his research on pelvic pain and voiding dysfunction in a new setting. The field has none of the sexiness quotient or big-bucks potential of cancer research or heart transplants, and many of the patients tend to be "difficult" cases with a dismal record of unsuccessful surgeries and therapies. But Schmidt's pioneering work using electrical stimulation of nerves -- a long-accepted therapy in the treatment of spinal injuries and other conditions -- had already produced an impressive body of publications and research grants.
"As residents in the '70s, we used to see men with impotency, and we'd chuckle and tell them to go see a shrink," Schmidt recalls. "That's the attitude now toward pelvic-pain syndrome. It's a real insidious, disabling condition, and it's not generally understood. We do know that stimulation is like a massage. It has this inherent ability to calm things down. If you apply it to the nerves that go to the bladder and the sphincter muscle, it has a specific effect."
Schmidt can be positively evangelical about the possible benefits of his implants compared to traditional bladder surgeries, and he bristles at the notion that his work is somehow "experimental." "I've been doing these since 1980," he says. "I have maybe 300 to 400 people in California that have these implants."
In California, Schmidt had been the principal developer of a sacral-nerve stimulator; his university subsequently sold the patent to Medtronic. When he came to Colorado, he set about establishing the Health Sciences Center as the lead facility out of sixteen centers around the world engaged in FDA-monitored clinical trials of the device.
Schmidt's hiring was one of several moves designed to make the UCHSC Division of Urology one of the top programs of its kind in the country. The man who recruited Schmidt, prostate specialist David Crawford, was the division's chairman, and Crawford made no secret of his desire to seek departmental status for urology, which would allow its faculty greater independence in the competition for research grants, fellowships and other resources. Yet that quest was soon derailed by a power struggle between Crawford and Harken, the chairman of the department he was trying to escape.
Harken had run the surgery department since the early 1980s -- and, in the process, acquired a sizable reputation as a heavy-handed administrator. His run-ins with division chiefs and others under his authority were legendary. One 1990 letter to Krugman from Robert Rutherford, head of vascular surgery, complained that Harken's treatment had "reached the point of harassment, with the apparent purpose of forcing me to step down or leave." Rutherford deplored Harken's "autocratic style, lack of communication...putting profitability above [academic] productivity...playing favorites to the point of polarizing the surgical faculty, etc." (Now retired, Rutherford did not respond to a request for comment.)
But none of Harken's previous disputes with other faculty could compare to the costly battle that erupted between the surgery chair and Crawford. After Harken learned of Crawford's plan to break away from his department, the two had several memorable confrontations. A tape recording Crawford made of Harken swearing at him, in terms that would make a sailor blush, would later find its way to university officials and legislators; according to Crawford supporters, Harken even hurled a wastebasket at his colleague. (Harken did not respond to interview requests.)
"Crawford told me that Harken came up to him in the hallway and told him he was going to ruin him," Schmidt says. "Harken started on this campaign to purge everyone who was in his gunsights, to tear the division down to nothing and install a bunch of lemmings. He did this with the full cooperation of the hierarchy of the university."
Schmidt acknowledges that he didn't see eye-to-eye with Crawford. In fact, at Harken's request, he agreed to chair a committee that was supposed to look into various allegations of improper conduct by Crawford. It was only after some discussion with colleagues about what was happening, Schmidt says, that he became convinced that Crawford, a leading figure nationally in prostate-cancer research, was being railroaded.
Schmidt refused to be part of it. "We disbanded the committee," he says. "There was no merit to what he was being accused of. It was nothing but a bunch of outrageous lies."
In 1996, Harken removed Crawford as head of urology; the following year, he was "recommended for termination" by UCHSC chancellor Vince Fulginiti. Among the most serious accusations against him was that he had supposedly misappropriated $175,000; an internal audit questioned whether money used to promote prostate-cancer awareness should have gone to another account. But Greg Piche, Crawford's attorney, insists that the charge was baseless and that his client received no personal benefit from the expenditures.
"There's a complex process of reallocating things over there," Piche says. "Anybody who has a grant is in a position at one point or another of being vulnerable."
Crawford, in any case, had recourse beyond the usual appeals process available to tenured professors. His patients included some of the most powerful men in the state. Several rallied to his defense, and the dispute erupted into headlines in 1998 after state representative Tony Grampsas refused to release $15 million in state funds to CU until Crawford's situation was reviewed.
Grampsas credited Crawford for keeping him alive in his battle with kidney cancer. And as chairman of the legislature's Joint Budget Committee, Grampsas was someone the university couldn't afford to ignore. John Buechner, CU's president at the time, soon reinstated Crawford. Vince Fulginiti promptly resigned as chancellor in protest over what he called the legislature's "unwarranted intrusion into academic life."
An ethics investigation of Grampsas, urged by Fulginiti's supporters, went nowhere. Harken's role in the matter received little scrutiny. And no one, with the possible exception of Buechner, seemed to wonder why the university was so determined to rid itself of a top asset over what appeared to be overblown allegations, or what such radical surgery might cost the Health Sciences Center in terms of litigation, morale, prestige and political support.
The details of Crawford's subsequent settlement with CU have never been disclosed, but sources in the legislature say that he received more than $200,000 in compensation and that the university shelled out over $150,000 in legal fees to keep the matter from going to court. Other sources claim that the true cost was much higher, involving allocations of research funds and other resources that didn't appear as cash payments.
Crawford declined to comment for this story, citing the confidential nature of his settlement. But he has prospered at UCHSC since the legislature's intervention. Moved out of Harken's department and into oncology, he now heads the Tony Grampsas Urologic Oncology Program on the Fitzsimons campus. (Grampsas died in 1999, after overseeing the establishment of a state trust fund that will allocate more than $100 million to help pay for the medical center's move to Fitzsimons.) Crawford's work helps attract millions of dollars in support of cancer programs at the university that tried to fire him.
Unlike Crawford, Richard Schmidt didn't have powerful patrons or a high profile in cancer circles. He didn't even have tenure; his contract was still renewed on an annual basis. What he did have, he says, was a powerful enemy in Alden Harken, particularly after he refused to participate in the process of "reviewing" Crawford's performance.
Not long after Crawford's battle with Harken began, Schmidt found that he, too, was under review. But in his case, he says, the outcome was decided even before the review took place.
The turmoil in Schmidt's department didn't end with Crawford's removal as chair. By some accounts, it merely intensified.
In the summer of 1997, nine members of the support staff signed a letter to Chancellor Fulginiti declaring that "the atmosphere in the Division of Urology has become absolutely untenable. People have been threatened, interrogated, laid off, and harassed simply because of their presumed connection to Dr. David Crawford."
That fall, Schmidt himself wrote to President Buechner to complain about the alleged purges. "I have received little or no support for a program that was -- until the past year -- generating good revenues, attracting excellent fellows for research, and putting Colorado urology back 'on the map' nationally and internationally," he wrote. "I would encourage you to start an investigation into the way Dr. Harken runs his department and the subspecialty divisions under his control. As I see it, the manner of governance is arbitrary, inconsiderate, and as ruthless as [that of] a despot in the Middle Ages."
It was an audacious memo, but by that point, Schmidt was already in a perilous position. Three months earlier, he'd received a terse letter from Harken stating that his contract would not be renewed after it expired in June 1998. The termination was based on an unfavorable faculty review of Schmidt, Harken stated, as well as "my own assessment of your performance."
Yet internal documents indicate that Harken had decided to fire Schmidt long before the supposedly impartial evaluation by other faculty members occurred. In a confidential memo from one of Harken's lieutenants to an associate dean, dated April 8, 1997, and copied to Harken, the writer states: "Dr. Harken mentioned yesterday afternoon that a non-renewal letter will be written to Dr. Richard Schmidt prior to June 30, 1997." The review committee was organized six weeks later and presented its findings in written form a day after Harken's termination letter.
Schmidt describes the faculty review process he underwent as a "kangaroo court," staffed by three professors under Harken's authority. Much of its input came from urology faculty members who'd been on the other side of the Crawford debacle or had other reasons for complaining about Schmidt and his "esoteric" research. Accustomed to lively debates over ethics and practice at the University of California, Schmidt had been sharply critical of some of his colleagues at UCHSC -- perhaps too critical for his own good. And his relationship with Crawford's successor as division chief, John Whitesel, whom Schmidt regarded as a Harken ally, quickly devolved into exchanges of testy memos about their respective duties.
"I did complain a lot," Schmidt says. "My fatal mistake was when I turned to Whitesel in a faculty meeting and said, 'It's nice you agreed to serve as interim chair, but what's our plan for a long-term academic chair?' There was no plan."
The scathing report issued by the committee focused at length on Schmidt's "interpersonal conflicts" with colleagues and residents. It questioned his teaching abilities and adherence to accepted scientific methods, flatly declared that patients are "confused by him" -- although there is no indication that any patients were interviewed for the report -- and even went so far as to describe his thought processes as "disorganized, illogical, and without clinical justification."
Schmidt filed a grievance with the university's tenure committee. After months of interviews and investigation, that committee concluded that Schmidt's review was badly flawed and that certain criticisms of his performance -- for example, his refusal to teach surgical procedures that he considered "immoral" because of their miserable success rate -- were wrongheaded: "University faculty are expected to challenge current practices that they feel are wrong without fear of reprisal."
Chancellor Fulginiti had recently resigned over the Crawford flap. His successor, James Shore, concurred with the tenure committee's recommendation that Schmidt be re-appointed for another year and given another, more objective review. Yet the second evaluation, while more thorough and seemingly evenhanded than the first, reached remarkably similar conclusions.
The second report characterized Schmidt as a "good surgical technician" but a somewhat "disorganized" administrator, one who "does not seem to recognize the need to be a team player." As for his teaching, "he reported that he gives no scheduled lectures, that he sees essentially no students, and has no residents assigned to him...The residents apparently choose not to go to his clinics." Research papers reviewed by the committee "were found to be lacking in scientific methodology." The group concluded that Schmidt didn't meet the criteria to be considered for tenure.
In his defense, Schmidt says that he'd been stripped of some of his duties and resources by the ongoing warfare within the urology division; that many of the research papers, co-authored by him and others, that the committee scorned have since been published in respected, peer-reviewed journals; and that he was shunned by some residents because of his philosophical differences with most of his colleagues over what he considered to be unnecessary bladder surgeries.
"Operations for incontinence have only a 30 percent, five-year success rate," he says. "Why are we doing this, when I can do one of these wires and get them better? They viewed that claim skeptically, like I was some kind of wacko quack."
After the evaluation was completed, one of Schmidt's supporters faxed him a memo stating that he'd appeared "burned out" by the stress and hadn't defended himself during the interview process as vigorously as he could have. Yet it's also true that many aspects of the evaluation, such as the appraisal of his research and work habits, are far more subjective than they appear. Certainly, the portrait of him rendered in the report bore little resemblance to the dedicated doctor praised by those who worked closest with him.
"Dr. Schmidt was a straight arrow," says Jean Abel, his clinical nurse at UCHSC for more than three years. "High values, very compassionate. He's one of the hardest-working physicians I've known in 42 years as an RN. He saw more patients than any of the others, and he'd never do anything to jeopardize his patients or the program."
A few UCHSC faculty members did speak to the committee in support of Schmidt, including gynecologist John Slocumb. "He's a brilliant man," says Slocumb, who referred several pelvic-pain patients to Schmidt. "We had a number of patients who improved markedly, and they tended to be patients who didn't have a lot of other resources."
The most telling aspect of the report may be the composition of the group that produced it. The tenure committee had recommended that the second review be conducted by faculty outside the Department of Surgery, to avoid the accusation that it was Harken's handiwork. Chancellor Shore, too, had insisted on an "extramural" evaluation. But all five members of the second review were associated with the Department of Surgery; one had even participated in the first review, which both Shore and the tenure committee felt was biased.
Schmidt concedes that he didn't challenge the committee's makeup. "I had a letter from the chancellor promising me a fair review," he says. "Then he turned it over to the dean, who, I believe, allowed Harken to appoint the committee."
In a letter to Dean Krugman, written shortly after the second evaluation, Harken proposed that Schmidt's remaining salary be paid out of the university's malpractice trust fund, since the only reason Schmidt was being tolerated on the campus for one more year was because of what Harken described as "our litigation avoidance policy."
Ironically, at the same time that the medical center was seeking to purge itself of "disruptive" influences, the center's University Hospital was running newspaper ads touting its doctors who were listed in The Best Doctors in America 1999, an annual survey based on ratings provided by other physicians in the same specialty. David Crawford and Richard Schmidt were among six UCHSC urologists who made the list.
Absent from the documents dealing with Schmidt's termination is any serious discussion of his other achievements: his clinical results in neurostimulation, which Harken had praised years earlier, his work on the botoxin patent, his efforts to bring the annual conference of the International Continence Society -- a global gathering of hundreds of top researchers -- to Colorado. (The meeting was held in Denver in 1999, with Schmidt as general chairman; the Health Sciences Center had no formal involvement, and Schmidt was cautioned against using university time or resources for the event.)
Absent, too, was any discussion of what would happen to Schmidt's patients after he was gone -- men and women with wires and batteries inside of them that required regular monitoring and adjustment.
In the months leading up to Schmidt's departure, dozens of his patients peppered UCHSC officials with anguished letters asking who was going to be responsible for their ongoing care. For the most part, their concerns were dismissed or ignored.
One of the letter-writing campaign organizers was Larry Coffee, a local dentist and executive director of the National Foundation of Dentistry for the Handicapped. Coffee's developmentally disabled sister, Barbara, had been diagnosed with bilateral hydronephrosis, a condition that allows urine to back up from the bladder to the kidneys and can lead to kidney failure. Several local urologists, including a prominent member of the UCHSC urology faculty, had told Coffee that the only thing that could be done for Barbara was for Coffee to catheterize her five times a day.
Then a relative saw an article about Schmidt in the newspaper. Schmidt suggested that Barbara try a new kind of catheter, one developed in Israel, that she could open and close with an electromagnet. Now Barbara's catheter only has to be changed every six months.
"Too many physicians are egomaniacs," Coffee says. "Dr. Schmidt was truly humble, truly concerned about her condition."
So two years ago, Coffee drafted a letter, signed by 52 of Schmidt's patients, urging Chancellor Shore and Dean Krugman to reconsider Schmidt's termination. The vast majority of the petitioners had the Medtronic implants -- people like Nyla Bailey and Darlane Crow, who says she spent "four years living in a recliner" before Schmidt's magic box "brought me back to the person I used to be."
"The university made no arrangements for us to have help," Crow says. "We had no clue where Dr. Schmidt was going. We were just stuck."
Coffee's letter received no response whatsoever. Other inquiries were referred to Medtronic, which was also trying to determine what the university's "transition plan" might be, since no one else on staff had been trained in the use of the company's device.
Crow, a military veteran, refused to hand her own written pleas over to a secretary; she insisted on a meeting with Shore and Krugman. She asked them what she was supposed to do about her implant after Schmidt left.
"I was told, 'We don't have to do anything,'" she recalls. "They told me to shut it off and have it removed."
Perhaps the only Schmidt patient to receive detailed responses from the university was the wife of a wealthy donor. She was not an implant patient, but she'd been under Schmidt's care for six years. Harken assured her that the urology division is "committed to providing the kind of medical expertise that you should expect and certainly deserve." While the "chaos" in the division "has become both a disastrous and an embarrassing situation," he wrote, the program was now able to provide "a level of disciplinary synergy that will exceed what you have had in the past."
The woman wasn't satisfied with Harken's effusive letter. In emotionally charged laments to President Buechner, she pointed out that the physician hired to replace Schmidt was "barely out of his residency" and had little experience in Schmidt's approach to voiding dysfunction. "Fortunately, I am financially able to go elsewhere if CU so drastically fails me," she wrote. "The sad aspect is the number of other patients who do not have this option, especially those with the Medtronic implant. Who at CU is going to be able to maintain them?"
After months of delays, Schmidt's replacement did see a few of the implant patients -- usually for the purpose of having the implants and wires removed. But that physician is no longer at the medical center, and several of the Medtronic patients say they were never able to obtain appointments or even returned phone calls after Schmidt left.
Such claims are at the heart of the lawsuits filed by six former patients against Schmidt, Harken, Whitesel and the university. In court filings, the university's attorneys have argued that no doctor-patient relationship existed between the patients and the Health Sciences Center.
"That may be true," says Robert Ozer, the plaintiffs' attorney. "But just because you don't have a doctor-patient relationship doesn't mean you don't have a responsibility. If you're operating a clinic and you're bringing the doctor in and having this thing put into them, and then you fire the doctor, you can't just dust off your hands and say you have no relationship."
Five of the six patients now suing Schmidt signed Coffee's petition in support of him two years ago. One, who'd been a patient of his since 1986, had once described him as "a brilliant, compassionate man." But the lawsuits claim that Schmidt failed to provide further treatment after his termination, didn't return phone calls and otherwise avoided them -- in other words, that he abandoned them, just as the university did.
Schmidt says he was able to perform minor adjustments in some cases, meeting patients with a computer and other equipment in his briefcase that allowed him to reprogram their generators. But he also warned patients that he wouldn't be able to provide the kind of treatment they received when his research program was intact.
"These are very, very ill people," he says. "I think they're frustrated that they've found a brick wall since I left. The claim isn't malpractice; it's abandonment. But I don't know how you take care of these people in a private practice. You've got to have research protocols, and a lot it doesn't get paid for. A big institution can underwrite the materials. I need the university in order to do it right."
At least one of the plaintiffs was unhappy with her care from the outset, however. The complaint filed by Cindy Breece, a forty-year-old Denver resident, claims she endured numerous painful procedures by Schmidt that provided her no relief and left her with useless wires surgically implanted inside her.
Breece says she was referred to Schmidt after a 1993 hysterectomy left her with chronic pain. Several attempts to insert test wires under her skin failed because the wires wouldn't stay put in her slender frame. "We did this at least eight times," she recalls. "He had me on a lot of drugs, but it still hurt."
In 1996 Schmidt performed surgery to implant the wires. When tests with an external generator failed to reduce Breece's pain, Schmidt declined to implant a generator in her abdomen -- because, she claims, "Medtronic or Medicare wasn't going to pay to have the procedure done." He also refused to remove the wires, Breece says, which resulted in four years of agony.
"After he found out I wasn't going to be a guinea pig, he moved on to patients who had better health insurance than I did," she says. "I pleaded with him to take the wires out of me. They hurt. I couldn't wear a pair of jeans; I had to sit on pillows. This went on for years and years. Sometimes you'd have to wait six or eight hours to see him. Sometimes you wouldn't get to see him. He was avoiding me."
Schmidt denies that he ever avoided Breece or ignored her pleas. He maintains that implanting the wires is an accepted practice if the subcutaneous method fails, and that there was no point in placing a $14,000 generator in Breece's abdomen after the trial period with an external pack produced no helpful results.
And removing the wires? "It was an additional surgery, and she had no insurance," he says. "There was concern about the additional trauma and financial stress that would cause. There was no aggravation of symptoms, no harm to her because we put the electrodes in. If she wanted them out, we would have taken them out, but she never made that demand."
Breece, though, says she couldn't have made her wishes any clearer. "I would love to take a lie detector against this man," she says. "I begged him to take the wires out. I couldn't afford to go anywhere else."
After Schmidt left the medical center, Breece went to see his successor. At first she was put off, told that someone was being "trained" to take over the Medtronic program, but last year she finally had the wires removed. She still suffers from pelvic pain, but her condition is no worse than it was seven years ago.
Coffee and other supporters failed to get Schmidt's job back, but their efforts weren't entirely futile. Taking a page from Crawford's playbook, they went to state lawmakers, including then-state Senate president Ray Powers. Already distressed by the Crawford affair, Powers asked Buechner and Shore to arrange for an outside evaluation of UCHSC's Department of Surgery and its chairman.
"I found out that hospital politics is worse than General Assembly politics," says Powers, whose term ended last year. "I expressed my concern that Harken was running roughshod, that he was the bad apple. They said they would look into it."
Powers has never seen the confidential report that was prepared in response to his request, but he did receive a verbal briefing on it last year: "They told me they felt that 95 percent of the time [Harken] was an excellent administrator, but there was 5 percent of the time that he steamrolled people, and they would have to keep a heavy hammer on him."
Harken resigned as department chair last March. His resignation appears to have been unrelated to the evaluation and his overall performance at the medical center, however. In a letter to colleagues explaining his decision, he acknowledged that he'd been charged with solicitation of prostitution in February after stumbling into a police undercover operation on East Colfax Avenue.
According to Harken, he had just delivered food to a women's shelter off Colfax and was driving away in his Mercedes, dictating a patient referral letter, when he decided to pull over "momentarily" to check an address. A female police officer opened his car door and took him into custody.
"Upon reviewing the evidence, I was offered a diversion -- this means I did not plead guilty," he wrote. "I had hoped to save embarrassment for the School, our Department, and our family. I am devastated that I have disrupted our Department and caused you all concern."
By agreeing to enter a diversion program, Harken did not have to enter a plea, and the charges against him were dismissed. But the police account of what happened that day is somewhat different than Harken's. According to the official complaint, Harken was busted after offering the undercover officer twenty dollars to perform a well-known procedure for pelvic stimulation. The officer's version of the conversation:
Suspect: "I'm in a hurry."
Officer: "Whatcha lookin' for?"
Suspect: "A handjob."
Some observers who considered Harken a bad apple also tend to believe that the working environment at the Health Sciences Center has improved in recent months. "I assume it's much better," says Powers. "I feel relatively satisfied that things are in fairly good shape with Harken demoted."
Richard Schmidt respectfully disagrees. "Life goes on with the same recipe," he says. "You still have the potential for the same rottenness to take place. All these chairs are so protected; there's no one to scrutinize their behavior. The dean doesn't want to get involved in what the chairs do, the chancellor doesn't want to interfere with the dean, and so on. How could Dean Krugman allow this guy Harken to go on for so long despite his track record?"
Perhaps you missed it, but the August 2001 issue of The Journal of Urology reports that sacral-nerve stimulation "has emerged as a reigning new therapy for some of the most daunting neurological conditions." A recent Italian study concludes that using implants such as the Medtronic device, an approach pioneered by Richard Schmidt and two other researchers, "is effective therapy for treating lower urinary tract symptoms resistant to less invasive therapy."
Schmidt hasn't had much time to savor the articles. Having lost two lawsuits against the University of Colorado, he's now in the process of moving his practice to Illinois.
Schmidt sued the university over his termination, but many of his claims were thrown out on procedural grounds. The case was reduced to a contract dispute, and since the tenure promises made to Schmidt hadn't been authorized by the Board of Regents, CU prevailed.
The university also countersued, demanding the money Schmidt had been paid by Medtronics for helping train other physicians in the use of the implants. Schmidt insisted that the payments amounted to honoraria, which a professor can keep, rather than outside contractual income, which must be turned over to the university. But he lost that round, too, and was socked for more than $250,000 in payments, interest and legal fees.
Schmidt says he disclosed his $2,500-a-session Medtronic payments to Krugman two years before he left the university. "I had a conversation with the dean," he says. "He asked me how much I was getting paid, and I told him. I didn't think much about it. What I was doing with Medtronic was no different than what other docs do -- going off to give lectures on behalf of drug companies, participating in workshops.
"The difference was that it became more regular. And, of course, then I filed a lawsuit against the university. The week after I left, I got a letter saying that I was being sued for this honoraria income."
Troubling as the hits to his wallet and reputation might be, Schmidt insists that the "larger issue" in his battles with CU concerns the university's attitude toward new therapies and new, non-surgical approaches to managing pain. If even his work, backed by nearly two decades of basic research, came under attack, what about those engaged in truly experimental therapies?
"You get some guy in there with a wild idea, which just might be a Nobel Prize-winning idea, and all the critics are going to put him down," he says. "But that's not the way a university is supposed to operate."
John Slocumb, the gynecologist who worked with Schmidt on many chronic-pain cases, says UCHSC's environment is improving for those engaged in treating pain without surgery. At the same time, he concedes, "we've had some setbacks, with people leaving -- Dr. Schmidt being one of them. There isn't the income from this that other therapies have, and there isn't the federal funding or private support.
"Patients with chronic pain require chronic therapy, which can be very expensive. Most people just don't want to deal with it. We see patients every day who've been told that it's all in their head."
Brandie Casas knows the feeling. Now thirty, she started suffering from pelvic pain eleven years ago, after the birth of her daughter. Two surgeries on her bladder failed to help. When she complained to the urologist that she was still in pain, he became angry and snapped, "I fixed you, sweetheart. You're okay." He told her she needed to talk to a psychologist.
Casas has had only sporadic relief from her Medtronic implant; her experience falls somewhere between the dramatic relief provided to Nyla Bailey and the aggravation and discomfort endured by Cindy Breece. Still, she says she is grateful to Schmidt for taking her pain seriously, and she is now interviewing other patients for a master's thesis on women and pelvic pain.
"Nobody looks at the body as an integrated unit," Casas says. "I'll bet I've seen forty doctors. I've had nine surgeries. When the doctors get to a point where they don't know what the problem is, then they decide you're crazy or 'drug-seeking.' One of the ladies I interviewed, a doctor asked her why she was spending so much time focusing on that area of her body. I don't think there's a good understanding of pain and how it works."
The first rule of medicine is to do no harm. But Schmidt says the horrendous power struggle that raged through the Health Sciences Center in recent years only increased the pain, for doctors and patients alike.
"The harm is enormous," he says. "You get people of marginal skills in power who direct the philosophy of care. You've got all these guys doing inappropriate surgeries. Women getting hysterectomies who shouldn't be getting them. Men getting prostatectomies who shouldn't be getting them. Nobody sitting back and saying the data isn't right. I never got the sense that the culture here was capable of asking the right questions, to be critical of its own efforts."
Schmidt has taken another ancient maxim to heart: He's leaving the state to heal himself. The pain left behind in Colorado is now someone else's problem.
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