Bioethics: Enduring pain to aid others

Their daughter, Brianna, was still in kindergarten when Jim and Valerie Oas, of Poulsbo, Kitsap County, enrolled her in a research study.

Brianna was to be stuck with a needle and made to exhale with excruciating force, making her ribs hurt, her mother recalled. And she was too young to understand, much less consent to the ordeal.

But Brianna had cystic fibrosis (CF), a genetic defect that causes the body to produce abnormally thick mucous. Twelve years ago, it was so deadly she wasn't expected to live beyond her mid-teens.

Now Brianna is 17, active, with a full schedule of work and friends. One of the drugs she helped test now helps keep her lungs healthy, and CF patients routinely live into their 30s.

"If people don't do testing, how are we going to find drugs for these diseases?" Brianna said this week.

Such decisions to conduct research on children are often much more complicated and controversial.

Should parents be able to submit healthy children to painful or dangerous treatment? Should a child be able to say no? What about the risks of not doing research on children?

Today, leading experts in the field of pediatric bioethics will gather in Seattle for a first-of-its-kind summit on such debates: The "Current Controversies in Pediatric Research Ethics" conference at the Center for Pediatric Bioethics at Children's Hospital & Regional Medical Center.

The bioethics center, which opened late last year, is the first in the country devoted to exploring the growing number of controversies in research and health care involving children.

At the conference, a key debate will focus on federal standards for research on children.

One speaker, Dr. Norman Fost, will argue that it's unethical not to do research on children, and that current regulations are too strict. "The main problem is there's not enough research," says Fost, director of the bioethics program at the University of Wisconsin.

About 80 percent of the drugs now used for children haven't been formally tested on them, Fost says.

"Not surprisingly, we find that large numbers of children have died because of use of drugs that were perfectly safe in adults, but dangerous in children," he says. Lack of research often leaves pediatricians "just walking in the dark and whistling Dixie."

Fost points to the use of oxygen for premature infants. After 70 years, researchers studied oxygen use on preemies and found that concentrations that were safe for adults could cause blindness in preemies. That's just one example that leads Fost to conclude that "it's much more risky to be a patient than to be a research subject."

Researchers have to prove expertise, have their work reviewed, monitor for adverse effects and seek patient consent, for example, Fost argues.

But "a doctor in an office doesn't have to know anything about anything, doesn't have to prove anything to anyone — just show a medical degree from 20 or 30 years ago. Maybe they haven't read an article since," Fost argues. They don't monitor patients, rarely seek consent, and have no system to reveal whether "patients are dying in Cincinnati and Omaha and Newark from this drug."

Dr. Jerome Kassirer, author of "On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health," said he will warn about financial incentives he believes permeate medicine, including research.

"We have to be very concerned about research being done on patients by people with a vested financial interest," says Kassirer, a former editor of the New England Journal of Medicine

Fost doesn't argue.

"The whole system is really corrupted," from research design to financial inducement of doctors, Fost agrees.

"That said, I still think you're safer in a research study than you are in a (doctor's) office."

Other issues include consent in research, said Dr. Douglas Diekema, interim director of the bioethics center.

"The understanding parents have of what they've been asked to do is pretty poor," Diekema said. "We need to fix the informed consent process so it actually informs parents."

And what about the children themselves? Should they be able to say no?

Diekema said most people agree that a 14-year old should be able to refuse to participate. But what about 10, or 5? Is a small parental bribe OK?

When Brianna Oas was younger, her mother said she was bribed into research at least once. But as she got older, she came to understand the need for research.

"One of the biggest reasons I do it is for other CF'ers who aren't doing as well as I am," Brianna now says. "I want to help them get better."

Carol M. Ostrom: 206-464-2249 or costrom@seattletimes.com