Despite suspension, Hopkins researchers continue vital tests

Sun Staff

Children on the cancer ward at Johns Hopkins Hospital got their chemotherapy yesterday. People with diabetes who have implantable insulin pumps got them refilled at the clinic. Many other patients involved in research, though, including people with rare disorders who had planned to fly to Baltimore for studies, were told to stay home.

Across the campus, physicians and nurses were working around the clock, sifting through case files and trying to handle the fallout of Thursday's federal order suspending research involving human subjects at Hopkins.

"It was amazing. It was like, we can't believe this is happening to us," said Tammy Scott, a research nurse who worked with colleagues until midnight Thursday, writing 60 letters to regulators to ask that children with cancer be allowed to continue receiving their therapies.

One of those appeals was for Mason Maddox, a 4-year-old with acute lymphocytic leukemia. He was in the hospital this past week for his final inpatient treatment as part of a clinical trial. His mother, April Maddox, 39, said she was relieved to hear that her son could continue in the study. She felt Mason was getting the best possible care in the trial, and not interrupting it meant he could go home today.

"When we lay him down for bed at night, very often, one of the last questions he asks us is, 'Do I have to sleep in the hospital anymore?'" said the Linthicum mother last night. "I told him tonight was the last night."

By yesterday, hundreds of appeals to continue research trials had been filed, and Hopkins physicians expected thousands would be filed by Monday. Many researchers said their studies are helping people, and they did not want to stop beneficial treatments.

"We are going to treat these children, and we are going to treat these adults if they need treatment today. We're going to do that, even if the approval is not coming," said Dr. John Fetting, clinical director of the oncology center. "We are here for the patients."

Many researchers said they quickly received approvals yesterday from Hopkins' Institutional Review Board to continue studies, and others said they planned to continue providing experimental treatment while their appeals were being reviewed.

Some of the cases included a man with diabetes who needed an implantable insulin pump refilled, and a pregnant woman with a genetic disorder who was on a special diet. Dr. Christopher Saudek, director of the General Clinical Research Center at Hopkins, said the patients would have been harmed if their studies had been stopped.

In pediatrics, doctors worried over a baby with a rare, metabolic disease, for whom the only treatment is an experimental drug.

"There was no doubt in my mind that there would have been significant risk of damage to this child's liver and brain if the experimental therapy was stopped last night," said Dr. George Dover, director of the Hopkins' Children's Center.

Dover walked the halls of the pediatric wards until midnight Thursday, talking to patients, doctors and nurses, trying to assure them that every patient would still get the care they needed.

"What we're being asked to do is pretty close to administratively impossible, but we're going to do it," Dover said. "I don't think the government understood the immediate impact this could have."

Some people couldn't get medicine that doctors believe could help them. A man with HIV who hadn't responded to standard drugs began enrolling in a study that gave him access to new medicine. But now, the patient can't get in the study, said Dr. Joel Gallant, associate director of the Hopkins AIDS service.

Other patients with rare diseases, who had plane tickets and vacation days lined up to arrive at Hopkins next week to be involved in trials, are now staying home, Dover said.

Halting some studies wouldn't cause any problems, researchers noted, because patients hadn't been enrolled. Some were observational studies - tests of normal function or watching how a parent interacts with a baby. Others were surveys - questionnaires about lifestyle or health habits. Still others that were put on hold included research on school-health programs for asthma, a sleep study and an investigational HIV vaccine.

From the middle of the day Thursday, top officials from across the institution started meeting in an ad-hoc command center set up in medical school Dean Edward D. Miller's office suite. E-mails, phone calls, faxes buzzed and rang. Secretaries pulled doctors out of clinic rooms. Department heads called emergency meetings. Investigators scrutinized lists of studies and patients.

Some never slept that night.

"Everyone's just gone from overdrive to super-overdrive. It's sort of like being on-call, when you work 36-hour shifts," said Dr. Bob Arceci, director of pediatric oncology. He met with many patients, hugging the children and their parents. "It's very unnerving, frustrating to go through all of this. It's very tough on patients."

As far as the research, scientists said they couldn't say what impact the suspension might have on studies that had been meticulously planned and in the works for months, sometimes years. But yesterday, some expressed fears that the federal action may erode the trust they have built up with patients over the years.

Several studies were sending out letters to patients, explaining the situation. In some clinics, staffers passed out Q&As. And some researchers, like Dover, walked the halls and reassured patients and staff alike.

"This kind of research is a partnership between doctors and patients and their families," Dover said. "It's only effective with trust."

Still, many researchers reported that patients took the news in stride, especially when told their cases were being appealed and their trials would continue. Some investigators said they didn't even receive that many calls from patients. And those who did call had sympathy for them.

"Many of them kind of understood we were having a hard day," said Gallant, the AIDS researcher. "They almost felt a little apologetic that they were even calling."

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