Experimentation on Newborns: Is it Ethical?

News Stories on Human Research Protection and
Commentary by Vera Hassner Sharav

May 13, 2002

FYI

The Wall Street Journal reported: "One outrage now before a court has stunned even bioethicists who thought they’d seen it all. In 1985, University of Wisconsin (UW) researchers launched a study to learn whether early diagnosis and treatment of cystic fibrosis helps newborns."

Since the 1970s, a test could identify newborns at risk for cystic fibrosis (CF). UW researchers conducted an experiment randomly assigning babies tested CF-positive to one of two groups: one group received dietary intervention, another group that did not. The WSJ reports that the parents of the CF positive babies who did not receive treatment "weren’t informed of the screening result. If they had told the parents, the scientists reasoned, the parents might have demanded treatment for their kid."

The experiment clearly violates ethical research standards including the obligation to protect the best interest of the individual babies, and the parents’ right to informed consent. Those who defend the experiment demonstrate that they have learned nothing from Tuskegee, nothing from the Willowbrook hepatitis experiments, nothing from the Kennedy Krieger Institute lead poison experiments. The case is before a Court of Appeals.

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http://online.wsj.com/article/0,,SB1020359856219603560.djm,00.html
THE WALL STREET JOURNAL May 3, 2002

SCIENCE JOURNAL 
By Sharon Begley

Research Involving Tests on Newborns Highlights Need for Stricter Ethics

It hasn’t been a good time for scientists who experiment on people — or the people they experiment on.

Last summer a 24-year-old died from medication she inhaled in a study at Johns Hopkins University; the federal government briefly suspended many of the school’s human experiments and demanded reforms in how it protects volunteers. In 1999, an 18-year-old died during a gene-therapy trial at the University of Pennsylvania. The government is considering permanently barring the lead researcher, Dr. James Wilson, from human research (Last month, Dr. Wilson announced that he will resign as director of Penn’s gene institute). Also in 1999, the feds shut down human studies at Duke University for six weeks. Every year the National Institutes of Health identifies dozens of violations in human experiments.

One outrage now before a court has stunned even bioethicists who thought they’d seen it all. In 1985, University of Wisconsin researchers launched a study to learn whether early diagnosis and treatment of cystic fibrosis helps newborns. An inherited disease, CF’s defining symptom is the production of thick mucus that hurts respiration and digestion. Half of CF cases are diagnosed by six months of age, 90% by age four. An idea occurred to UW pediatricians Philip Farrell and Norman Fost: Would diet supplements stave off the malnutrition that CF often brings?

Thanks to a blood test developed in the 1970s, doctors could identify newborns at risk for CF. For their study, then, the researchers began screening every newborn in Wisconsin. They randomly assigned each CF-positive baby to one of two groups: a treatment group whose parents were told their baby tested positive and who received dietary intervention, and a control group who received no such help and — here’s where things get ethically dicey — whose parents weren’t informed of the screening result. If they had told the parents, the scientists reasoned, the parents might have demanded treatment for their kid. No more control group.

From the start, red flags bloomed like poppies. NIH asked Dr. Farrell in 1985, "Will you state specifically that the results of half [the babies] will not be known by the parents until the child is four? … Isn’t a lawsuit possible?" Dr. Fost, who also chaired the UW panel that OK’d the study, wrote in a 1985 letter to the CF Foundation that "it would be ethically impermissible to conduct the project at all if the benefits … of early treatment were established."

In 1989, Drs. Fost and Farrell acknowledged the ethical problems of "withholding of diagnostic information." Their justification? Early treatment was of unknown value. And besides, were it not for the study, no parent would know if their newborn had CF anyway.

That rationale doesn’t sit well with the bioethicists I asked. "It would have been possible to do the research and still inform the parents," says Thomas Murray, president of the Hastings Center, a bioethics think tank in New York. Even if some parents opted for therapy for their asymptomatic child, he says, "It would not have been as statistically clean, but in human experiments the interests of the subjects are supposed to outweigh those of the scientists."

Cut to 1991. In a paper in the American Journal of Clinical Nutrition, Dr. Farrell concluded that "normal growth and … nutritional status can be achieved" in most CF babies if they’re treated early. Six years into the study, then, he knew kids receiving early treatment did better than those untreated. Yet newborns testing positive for CF were still being randomly assigned to the don’t-treat, don’t-tell group. Even when Wisconsin started requiring CF screening for all newborns in 1994, parents from the study weren’t called.

That became acutely relevant for at least one pair of parents. Linda and Charles Ande had a daughter, born in July 1993. The UW study identified her as at risk for CF but, consistent with the study protocol, no one told the Andes. Their pediatrician diagnosed CF in 1995. By then, the Andes had conceived another baby. He, too, was born with CF, in 1996. Had they known their little girl had the disease, say the Andes, they wouldn’t have had another child. They sued the researchers in Circuit Court in Dane County, Wis.

Last year, the circuit court dismissed the Andes’ wrongful birth claim. As government employees, ruled the court, the doctors enjoy "qualified immunity" from prosecution. Dr. Farrell is now dean of the UW medical school. Dr. Fost, too, remains at the university. Neither would talk to me, but a UW statement calls the study "important" and "ethically appropriate."

The case is now before a state appeals court. It makes you wonder if researchers learned anything from the federally funded Tuskegee Study. From 1932 to 1972, black men were denied treatment for syphilis and not told they had the disease – all in the name of science.

Send comments to sciencejournal@wsj.com1.

Updated May 3, 2002
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