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Wednesday, November 29, 2000

Disturbing Discovery

By Colleen Heild and Leslie Linthicum
Journal Staff Writers


Click to enlarge


    Stuart Winter felt a gnawing concern almost from the time he began his new job in the pediatric oncology division at University of New Mexico Hospital.
    After 11 years of medical training, it was great to be a certified specialist setting out to treat kids with cancer.
    But Winter had questions about how children with one particular type of cancer acute lymphoblastic leukemia, or ALL were being treated at UNM.
    The chemotherapy approaches he had learned about in his fellowship training treatments used at many other hospitals were not being used here.
    Winter, the new doctor on the unit, questioned the treatment and did not like the explanations. But, for the most part, he kept his feelings to himself.
    Then one summer day, for reasons Winter still cannot really explain, he decided to do something about his concerns.
    "You know," he told himself that morning, "today I'm going to live my life a little differently."
    It was a Friday in the summer of 1996, and Winter decided he would no longer place the children he was diagnosing with ALL on a treatment regimen with which he did not agree.
    His epiphany that day, and the support of another young doctor who would arrive at the hospital within weeks, eventually would have consequences that would be felt within the medical school and across the state.
    One veteran doctor would give up her license. Two young doctors' professional lives would be upended. The state's major hospital would make a startling admission that children with ALL did not get the recommended treatment.
    And New Mexico children with ALL would begin receiving newer and more aggressive treatments that gave them better odds of survival.
   
Promising start
    The summer of 1995 had been a coming home of sorts for Stuart Winter.
    Although he grew up in Wisconsin and was moving to New Mexico from Duke University in North Carolina, Winter had spent his residency at UNM. During that hands-on training period, he had spent a month working alongside Marilyn Duncan, the hospital's chief pediatric oncologist.
    That month was enough to persuade Winter he wanted to specialize in cancer treatment. And his years in New Mexico had persuaded Winter and his wife to come back.
    A cross-country runner, Winter, then 34, had plans to organize a 5K race to raise money for kids with cancer. And he looked forward to pursuing a research project that might shed light on how leukemia cells sometimes escape the effects of chemotherapy, leading to relapses.
    Nothing in those upbeat first days of his new career at UNM prepared Winter for what would consume his next few years the unraveling of a treatment crisis and the downfall of Duncan, New Mexico's pre-eminent pediatric oncologist.
    Depositions taken during malpractice lawsuits filed over the treatment provided for children at UNM Hospital paint a picture of a clinic awash in turmoil and increasing doubts about Duncan's competence.
    Winter had arrived on the first day of July in 1995 and quickly began to see differences between the way doctors at Duke approached ALL and the way it was being done at UNM.
    One difference was resources.
    The UNM and Duke cancer clinics saw roughly the same number of new patients each year, but Duke had seven doctors while UNM had just two.
    Before Winter arrived, Duncan had been the only full-time oncologist and had been responsible for seeing all patients.
    Duke had a database to track the outcomes of children being treated for ALL. UNM's pediatric oncology division did no formal tracking.
    Duke put children with ALL on nationally used treatments that required three or four drugs during the first weeks of chemotherapy and frequent injections of chemotherapy drugs into the spine.
    At UNM, Winter found that no child with ALL was on a national plan. And high-risk children with the most common form of leukemia typically received only two drugs in the initial weeks of treatment and fewer spinal treatments down the road.
    Chemotherapy recipes, or protocols, are commonly known by a combination of numbers or letters.
    The protocol Duncan was using for kids with the most serious cases of the disease, LSA2-L2, was a treatment from the late 1970s modified to eliminate two of the four drugs administered in the first, monthlong cycle of treatment.
    Soon after he arrived at UNM, Winter asked Duncan why she used that treatment.
    According to Winter's deposition, Duncan told him the modified LSA2-L2 treatment was "amenable" to New Mexico's vast distances and rural nature. He said she told him that using chemotherapy routines that did not make patients so sick allowed them to get treatments from their local doctors and stay closer to home.
    Duncan has since said in statements and in a deposition that her approach to ALL treatment was no mistake. She said she chose the treatments she did because they worked as well as others without having toxic side effects. Duncan declined to be interviewed for this story.
    Winter accepted her rationale at the time. He respected Duncan. After all, she had helped train him, and she had 20 years' experience taking care of children.
    Additionally, she was highly regarded within the Pediatric Oncology Group, a national research organization of which UNM was a member.
    Winter said in his deposition that Duncan told him the modified treatment was achieving the same results as chemotherapy being used at other cancer centers.
    As time went on, though, Winter said, "I became suspicious that that wasn't really the case."
    It did not take Winter long to notice differences in patient outcomes.
    When cancer cells have been largely eliminated, a patient is said to be in remission. When the cancer returns, that is known as a relapse.
    At UNM, Winter testified, it seemed he was seeing more relapses than he had at Duke, and a very specific and serious type of relapse.
    In his four years at Duke, where doctors treated more high-risk ALL patients, Winter had seen only one case of cancer cells multiplying in a testicle. At UNM, he saw four in his first year.
    Once again, Winter approached Duncan with concerns about the treatment. He pressed her to seek approval from a UNM institutional review board of formal, nationally recommended treatment plans and to put children on them.
    But, according to Winter, Duncan said the toxicity on one nationally recommended treatment plan for high-risk patients was unacceptable. He said she told him another plan for intermediate-risk patients might not pass the muster of the committee.
    Hospitals, including UNM, had the option of using those standardized treatments without seeking the institutional review board's approval and enrolling patients in complicated research studies.
    According to Cathy Chavez, a nurse on the children's cancer floor, the division's longtime pharmacologist also approached Duncan to talk about new recipes for ALL treatment, only to be rebuffed.
    According to a deposition by Chavez, pharmacologist Mark Holdsworth said Duncan "just blew me off."
    UNM officials would not allow Holdsworth to be interviewed for this story because of pending litigation.
    Chavez had been having problems of her own with Duncan. She fielded phone calls of complaint from patients' parents who told her Duncan had not returned their pages or had been rude when they called.
    Other members of the pediatric oncology team also said in depositions that Duncan had been tired and detached for some time and was increasingly short-tempered with families.
    Nurse Mary Leasure said Duncan was neglectful of the children she treated and was rude to their parents.
    Yolanda Vinajeras, the division's social worker, had complained as far back as 1993 that Duncan was tired and needed help.
    Parents complained that Duncan was irritated at being called at home, Vinajeras said. When Duncan was asked to talk to a parent who had a question, Vinajeras said Duncan at times would say, "I have better things to do with my time."
    Pediatrics Department chairwoman Shirley Murphy acted on Duncan's "burnout" by asking Duncan to take a sabbatical from June 15 to Oct. 1, 1996.
    Her absence left Winter as the only full-time physician in the division, and he seized the opportunity.
    Winter spurred by his epiphany began to use newer treatment regimens for kids with ALL.
    Then Jami Frost came to town.
   
Confrontation
    Frost, a 33-year-old pediatric oncology fellow, and her husband, an anesthesiologist, were ready to leave Wisconsin and were looking for a city that had job openings in both their specialties.
    It was a long shot, but they lucked out. UNM had an opening in anesthesiology and was looking to add a third doctor to its pediatric oncology team.
    Frost, who through a UNM Hospital attorney declined to be interviewed by the Journal, arrived in August 1996 while Duncan still was on sabbatical and Winter had just begun to take treatment decisions into his own hands.
    Like Winter, Frost also found that ALL patients at the University of New Mexico were being treated differently than she had seen elsewhere, and she was disturbed by what she found.
    "It appeared to me that there were more children relapsing and dying with leukemia here than I had seen during my fellowship," Frost said in a deposition.
    She said she met with Winter and Holdsworth, the pharmacologist, and the three agreed that treatment needed to move in a different direction.
    "I think we all had concern that the treatment they were receiving was not the best that they could get," Frost said.
    Duncan returned from her sabbatical in October 1996 to a very different scene.
    Her long-used treatment regimens had been abandoned for new ALL patients, who were being treated on national treatment plans.
    And during a conference concerning a young patient from Santo Domingo Pueblo, Frost confronted Duncan with her concerns.
    Doctors and nurses were gathered together to discuss the 4-year-old's condition.
    The child had relapsed a second time, and a bone-marrow match could not be found. There was nothing left to do but to tell her parents their only child was going to die.
    The staff knew the family well. Her parents had invited the whole staff to their home for feast day dances and celebrations. And the girl had been a sunny presence in the cancer unit for more than two years.
    Members of the oncology team were in the conference room when Frost confronted Duncan with her concerns about the girl's initial treatment.
    Why had she been given two drugs and not four drugs? Frost asked.
    Nurses Chavez and Leasure recalled in their depositions that Duncan replied that the child's prognosis had been poor to begin with and it would not have made any difference which drugs she received.
    Frost started to cry.
    "But, Marilyn," she said, "they deserve a chance."
    The team, Frost said, had "missed the boat" in the initial treatment of ALL patients.
    "What do you mean we missed the boat?" nurse Chavez asked.
    Frost explained that by not receiving two other drugs during the first critical weeks of treatment, patients' chances of recovery were diminished.
    Chavez, Leasure and Frost all said in depositions that Duncan said nothing in response.
    Based on her concerns, Frost asked UNM's tumor registry board for a list of patients diagnosed with ALL as far back as 1981 and their survival statistics. She also did her own research to find out which patients had died.
    Frost was not certain the numbers were complete, but what they showed upset her: From 1981 through 1995, 46 percent of the patients treated at UNM for acute lymphoblastic leukemia had died.
    Frost had anticipated that the survival rate would have been between 65 percent and 75 percent.
    Winter had additional concerns. Duncan was making decisions regarding the day-to-day care of patients that he considered mistakes.
    Two incidents that occurred after Duncan's return in the fall of 1996 spurred him to lodge formal complaints. Winter felt both times that patient safety was compromised, and he told her so in a letter that February.
    Winter met with John Johnson, who at the time was acting chairman of the hospital's pediatrics department, to spell out his concerns about Duncan's medical decisions and the staff's complaints about her interactions with patients and families.
    Within six days, Duncan was placed on administrative leave. Johnson promised an investigation by different members of the department.
    Meanwhile, even though new ALL patients had been switched to what Winter and Frost considered more effective treatments, the question arose: What about children already being treated under outdated chemotherapy regimens? Should they stay on the old medicine or be switched?
    "I had no idea," Frost said, "what to do about how to make it better."
    Frost telephoned two national experts in childhood leukemia from Wisconsin.
    "What if this was happening?" she asked them. "What would you do?"
    The experts said there was no research to support changing therapy in the middle of a protocol. No one had ever studied that.
    On March 3, 1997, Frost told Johnson in a letter that both experts agreed UNM's older treatment was substandard.
    They advised to switch only those children who had been on the older LSA2-L2 therapy for approximately a year or less to the newer therapy, Frost related.
    And she presented an approach to telling the parents of children who were being switched.
    "We do not intend to imply to any patient's family that their child has been receiving inappropriate treatment," she wrote to Johnson, "but will explain that there is evidence to believe that making this change in treatment may improve the chance of prolonged remission."
    Winter and Frost switched about 10 to 12 children. They did not tell families of the other children still receiving the outdated treatment.
    "At the time we were making these changes, we really had not had any sanctification, if you will, from the university to do this. We just did it," Winter said in a deposition.
    By late March, members of the pediatric oncology division were concerned to see Duncan back in the office.
    The entire team sent a letter to Johnson, this time recommending an external review of Duncan's activities.
    They also presented UNM with a plea: Do not allow Duncan to resume taking care of patients.
    They arranged for a meeting in April to air their complaints to Johnson, a UNM lawyer and a representative from the medical school's office of academic affairs.
    They were told their concerns would be investigated. And they were assured they would not have to work in a professional capacity with Duncan.
    Over the team's objections, Marilyn Duncan retained her title as UNM's principal investigator for the Pediatric Oncology Group. Records show she traveled to seven professional meetings from April to October 1997 at least four of which related to her work with POG.
    Frost continued to make a case that the ALL treatment had been inferior. She wrote several letters to Johnson about the issue over two months.
    "The people I was drafting the letters to were not oncologists, and they had questions," she explained.
    Winter said he was told his conclusions about Duncan might be wrong and that UNM would not act until it had completed its investigation.
    The hospital administration also decided to ask a UNM pathologist to evaluate the survival rates of patients with ALL.
    The atmosphere around the clinic was uneasy while the university investigation process continued.
    One Saturday evening in June, Stuart Winter answered the phone at home. Paul Duncan, Marilyn Duncan's husband, was calling.
    Winter said in his deposition that Paul Duncan, an oncologist, threatened to sue him "because I blew the whistle on his wife."
    According to Winter, Duncan said the allegations against his wife were unfair and that Winter was in a position to stop the university's course of action.
    If Winter refused to help, Paul Duncan said, Winter's tenure track at UNM would be blocked. Winter said he just listened.
    Paul Duncan declined to be interviewed for this story.
    An internal review process of past care was not ordered until chairwoman Murphy returned from sabbatical in mid-1997. By the fall of 1997, Murphy, along with medical school dean Paul Roth, determined that an outside expert needed to look at the situation.
    Roth in an interview said it was not until about the summer of 1997 that the issues surrounding Duncan were more than a clash of personalities, but "something real happening on the patient care."
    He said it was the persistence of Frost and Winter that prompted Murphy to realize that " 'now, wait a second, there seems to be also this concern, this real issue around patient care.' ''
    On Dec. 3 and 4, that outside reviewer came to town to look over patients' records. Susan Shurin, a pediatric oncologist from Cleveland, reported her findings to Roth. UNM has refused to disclose what Shurin found.
    A few days later 10 months after Winter had first raised complaints about Duncan to UNM officials Roth put Duncan on notice that she was suspended from the medical staff and, pending a hearing, would never treat another child at UNM.
    It would take another three months before parents of the children treated for ALL would learn what the pediatric oncology division now knew.
    While newer leukemia treatments with higher survival rates were being used elsewhere, physicians at University of New Mexico Hospital continued to use older treatments.
    It took two junior faculty members to notice the difference and get the treatments changed.