Books

‘PATIENTS ARE FALLING BETWEEN THE CRACKS’

As the doctor’s fight escalated, relations with colleagues suffered

May 9 2005
Books

‘PATIENTS ARE FALLING BETWEEN THE CRACKS’

As the doctor’s fight escalated, relations with colleagues suffered

May 9 2005

‘PATIENTS ARE FALLING BETWEEN THE CRACKS’

As the doctor’s fight escalated, relations with colleagues suffered

IN THE SPRING OF1998, Dr. Nancy Olivieri learned that the New England Journal of Medicine would, that summer, publish her paper on LÍ, a drug produced by pharmaceutical giant Apotex. Toward the end of May 1998, she told her story at an invitation-only conference on medicine and the media in Chicago that was also attended by journalists from the Wall Street Journal, Nightline and National Public Radio. With the provision that nothing be written until her article appeared, she described her battle with Apotex over her claims that LÍ, intended to help treat patients suffering from the sickle cell disease thalassemia, was not only working inadequately but was also toxic. She was being continually threa tened by Apotex, she said, and being gi ven no support by Toronto ’s Hospital for Sick Children and Toronto General, where she was in charge of the sickle cell programs.

Also present at that conference was Miriam Shuchman, then reporting for CBC Radio. In her new book, The Drug Trial, she relates how Olivieri described herself as a busy clinician, responsible for more than 500 patients at Sick Kids and Toronto General. But as Shuchman writes in this excerpt, the doctor’s fight against Apotex was taking a toll on her time-and on her professional relationships.

The Drug Trial: Nancy Olivieri and the Science Scandal that Rocked The Hospital for Sick Children; Random House Canada; $34.95

MUCH LATER, I learned from her patients and her staff that she was so busy coping with her multiple commitments that her patients saw little of her. Her sickle cell patients mostly saw the new staff doctor she’d hired, a young man named Manuel Carcao. Carcao’s work for Olivieri was part of a job he’d patched together-four clinics per week, including two with sickle cell patients, combined with multiple research projects. He was doing a sort of research fellowship, supporting himself with his clinical earnings. With Olivieri, he was studying patients with Diamond Blackfan anemia and performing a genetic analysis of a family with an unusual hemoglobin disorder. And Carcao had begun a project with another hematologist at the hospital to develop guidelines for the care of hospitalized sickle cell patients. He knew why the guidelines mattered: a sickle cell patient had died at the hospital the year before and some doctors thought the death might have been prevented.

In February, Carcao was assigned to put together the guidelines.

If anyone had asked Manny Carcao what he thought of Nancy Olivieri, he would have said she was brilliant. She always seemed to have an idea of something they could study further.

And she knew everyone. In their clinical meetings, Olivieri generally praised his work and his clinical intuition. Their research collaborations were also going well. He knew she didn’t trust her fellow hematologists at the hospital, but he didn’t know about her conflict with Apotex. He didn’t know her as a fighter with an invisible fence to guard her from those she perceived as her enemies. Then he took a wrong turn and was caught in the crossfire.

It happened in May. Carcao was giving a talk on the guidelines he’d prepared for how to treat the fevers, infections and intensely painful crises that children with sickle cell disease suffer. As head of the sickle cell program and one of Carcao’s supervisors, Nancy Olivieri was scheduled to be there. Carcao had given her drafts of his report as he was writing it, but she’d been too busy to get back to him. She arrived 20 minutes after his presentation. Carcao had already covered most of his material and was at the point of asking for comments and expressing his thanks for the help he’d had from various doctors at the hospital. He noticed that Olivieri seemed angry in some way.

After the comment period ended, she told him to come see her “right away.” A senior hematologist noticed Carcao’s expression. Carcao explained that he was about to receive a talking-to. His senior colleague told him that Olivieri might simply need a cooling-off period and advised him to not go to her office right away. Carcao had no clue what he’d done wrong, and he decided not to go. Carcao next saw Olivieri a week later, at their usual clinic rounds. She sounded cross with him as she questioned him about everything he’d done with the patients, and she was critical of his answers. He tried to explain, but Olivieri didn’t accept his explanations and responded with sarcasm.

[Carcao subsequently tried to arrange meetings with Olivieri, but to no avail. After a month, and increasingly frustrated, he wrote her a letter asking about his future, but received no response. In a few weeks he tried again, and managed to secure a meeting with Olivieri.]

“Would you be willing to take on a clinician role?” she asked when they finally spoke. He told her he liked the patients, but he also liked research. He already had presentations and publications to his credit. He expected to present on their collaborative projects at ASH [the American Society of Hematology], but the abstracts were in limbo because he’d been unable to discuss them with Olivieri and get her to sign off on them. Now they’d met, but she was suggesting he give up doing research and focus solely on the patients. Carcao couldn’t understand it. If she didn’t think he was cut out to do research, why had she encouraged him and praised his work before? It was disheartening and depressing.

Afterwards, Carcao met with his mentor in hematology. His message was simple: “Take me out of the sickle cell clinic or I’ll resign.” People in the division who didn’t know the whole story heard the rumblings. “Whatever happened [to Manuel Carcao] was very, very unpleasant,” said

one of the hospital’s oncologists. Carcao wrote Olivieri that she should find someone to replace him, and he left the program that summer. The sickle cell guidelines were almost ready. He was told that the guidelines were the property of the hemoglobinopathy program-Nancy Olivieri’s program. The guidelines project was left for Olivieri and her staff to finish up; Carcao felt he’d been directed to walk away from it.

In July 1998, a new resident had started working with Nancy Olivieri. Soon the resident approached Carcao about one of his research projects. It seemed as if Olivieri had suggested that Carcao might be willing to provide her with the data he’d gathered. Carcao said no. A few weeks later, he was working on one of the computers that the fellows all shared. A file looked familiar. It was an abstract on the patients at Sick Kids with Diamond Blackfan anemia, similar to the abstract he’d prepared. But Carcao’s name wasn’t on this new version, and neither was the name of the McMaster resident who had worked with him. The only thing the same on the list of authors was Nancy Olivieri; she had been listed as senior author when Carcao had prepared the abstract, and she was still listed as senior author. It was as if he and the McMaster resident had never done the work in the first place.

Carcao didn’t think Olivieri was stealing his work; after all, it was her work too. But she was taking a collaborative project and cutting him out. Carcao’s mentor wrote Olivieri about it and she wrote back with an explanation. “Because Dr. Carcao has chosen not to discuss the analysis of this work with me despite repeated opportunities to do so, because Dr. Carcao’s analysis of the data was preliminary and because of Dr. Carcao’s repeated declarations that he would not continue to work with the program,” her summer student had done “a completely new analysis of these data.”

The division scheduled a meeting to discuss it. Olivieri came carrying a tape recorder and accompanied by Brenda Gallie [head of research for hematology and oncology at Sick Kids], but she didn’t acknowledge doing anything wrong. “F— this,” she said at one point. Gallie attempted to mediate. Other hematologists at Sick Kids thought Gallie probably couldn’t believe that anyone would undercut a junior doctor’s efforts the way Olivieri had, since Gallie would never have done it herself.

IN HER STRUGGLE with Apotex, Olivieri had come to stand for all the medical school teachers who weren’t for sale. She was a living hero winning honours on an almost monthly basis for her courage. She flew from city to city to speak about her experiences. But these efforts came at a very high price. She was losing ground on all of her professional fronts-her science, her

teaching and her clinical work. Friends and colleagues said she’d almost disappeared from the scientific arena. Some of the thalassemia patients continued to complain behind Olivieri’s back that she’d almost disappeared from their clinics as well. One said, “There’s the fear that patients are falling between the cracks because the director’s attention is focused elsewhere. What it comes down to is, the patients aren’t being seen.”

The patients were scared. During 1999 and 2000, three thalassemia patients died, two at home without ever making it to the hospital. Anxiously, patients chatted about it with each other. Some wrote to nurse Bev Tyler to ask what was going on. “Two patients dying in their sleep at home,” one said. “That’s what seems odd. Why at home and not in the ICU? Why didn’t [the doctors] know they were sick?”

In the fall of 2000, while thalassemia patients were worrying about their losses, a 17-year-old girl with sickle cell disease entered the Hospital for Sick Children for an operation on her gall bladder. The surgery wasn’t billed as life-threatening. But while recovering, Sanchia Bulgin bled to death internally. The coroner and the hospital both investigated, and the hospital soon claimed responsibility for the death. An internal report of the hospital’s investigation listed a series of errors that had contributed to Sanchia’s death. Apparently the various doctors involved hadn’t communicated. The sickle cell doctors hadn’t been in close touch with Sanchia’s surgeons. The nurses and doctors hadn’t monitored the patient’s hemoglobin level and blood pressure closely after the operation. And the nurses were underinformed about sickle cell disease.

Hearing about Sanchia’s death, Manuel Carcao felt personally devastated. It wasn’t just that he’d known the young woman from his time on the sickle cell service. It was that he’d spent hundreds of hours on a project aimed at preventing the sorts of errors that had cost Sanchia her life: the guidelines project, with its special section on the best way to care for sickle cell patients undergoing surgery. But the guidelines he worked on in 1998 were never finalized. The coroner grilled the pediatrician from the sickle cell disease clinic about the guidelines, but she was reluctant to say very much. “Why the process took so long is not for me to comment on,” she told the coroner’s jury.

The sickle cell guidelines were finally adopted and distributed at Sick Kids in the late fall of 2000, two months after Sanchia’s

death. The inquest jury completed its deliberations in the late spring of 2001 and issued 31 recommendations. One was that sickle cell patients should be admitted the day before the operation. Another was that doctors should consider preoperative transfusions for such children undergoing surgical procedures. Both recommendations had been contained in the draft guidelines that had gone on the shelf in 1998. The inquest also found that Sick Kids nurses were overworked and there was a serious lack of communication by key physicians and surgeons caring for Sanchia Bulgin. In part, the poor communication between the sickle cell program and other programs in the hospital was one of the costs of the hospital’s battle with Nancy Olivieri. fil

From The Drug Trial by Miriam Shuchman. Copyright 2005 by Miriam Shuchman. Published by Random House Canada. Reproduced by arrangement with the publisher. All rights reserved.