May 13

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News Stories on Human ResearchProtection and
Commentary by Vera Hassner Sharav

May 13, 2002

Experimentationon Newborns: Is it Ethical?


The Wall Street Journal reported: "Oneoutrage now before a court has stunned even bioethicists who thought they’d seenit all. In 1985, University of Wisconsin (UW) researchers launched a study tolearn whether early diagnosis and treatment of cystic fibrosis helpsnewborns."

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

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


By Sharon Begley

Research Involving Tests on Newborns Highlights Need forStricter Ethics

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

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

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

Thanks to a blood test developed in the 1970s, doctorscould identify newborns at risk for CF. For their study, then, the researchersbegan screening every newborn in Wisconsin. They randomly assigned eachCF-positive baby to one of two groups: a treatment group whose parents were toldtheir baby tested positive and who received dietary intervention, and a controlgroup 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 theparents, the scientists reasoned, the parents might have demanded treatment fortheir kid. No more control group.

From the start, red flags bloomed like poppies. NIH askedDr. 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’ta lawsuit possible?" Dr. Fost, who also chaired the UW panel that OK’d thestudy, wrote in a 1985 letter to the CF Foundation that "it would beethically impermissible to conduct the project at all if the benefits … ofearly treatment were established."

In 1989, Drs. Fost and Farrell acknowledged the ethicalproblems of "withholding of diagnostic information." Theirjustification? Early treatment was of unknown value. And besides, were it notfor the study, no parent would know if their newborn had CF anyway.

That rationale doesn’t sit well with the bioethicists Iasked. "It would have been possible to do the research and still inform theparents," says Thomas Murray, president of the Hastings Center, a bioethicsthink tank in New York. Even if some parents opted for therapy for theirasymptomatic child, he says, "It would not have been as statisticallyclean, but in human experiments the interests of the subjects are supposed tooutweigh those of the scientists."

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

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

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

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

Send comments to sciencejournal@wsj.com1.

Updated May 3, 2002
Copyright 2002 Dow Jones & Company, Inc. All Rights Reserved

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