EDMOND — Most states do not inform parents of the retention and research use of newborn blood spot samples, according to the Indiana Center for Bioethics.

However, a new Oklahoma law, Senate Bill 1250, authored by state Sen. Jonathan Nichols, R-Norman, prohibits any medical facility from storing or using infant DNA for research without parental consent.

The bill took effect immediately after Gov. Brad Henry signed it into law on May 10.

Nichols said serious privacy and ethics issues have arisen around the country with unauthorized databasing of infant DNA. In some states samples have been used for unauthorized purposes, he said.

“We don’t want that to happen in Oklahoma,” Nichols said.



OKLAHOMA POLICY, PRACTICE

Every baby born in Oklahoma is required to be screened for hearing loss and disorders such as Phenylketonuria (PKU), cystic fibrosis, congenital hypothyroidism and sickle cell disease.

Babies born with these “hidden” disorders often appear healthy at birth, making diagnosis difficult without a blood test, health officials say. Failure to treat an infant with one of these disorders within the first month of life can lead to mental retardation, severe illness or death.

State genetics coordinator Sharon Vaz said Oklahoma hospitals are responsible for informing parents about newborn screening before blood samples are collected. The state makes a newborn screening brochure available to each birthing facility for free and provides education to hospital staff on the diseases that are screened and follow-up, Vaz said.

“Hospitals are supposed to provide this brochure to each parent before specimens are collected,” Vaz said. “It would be ideal for (obstetricians) to discuss the testing during the pregnancy so parents have even more time to process information and ask questions.”

Newborn screening requires that a small amount of blood be collected from a baby’s heel. To collect the sample, medical personnel place a few drops of blood on a card, which is kept for varying lengths of time, depending on the state.

Samples are to be collected by the hospital as early as possible after 24 hours of age; the same applies to infants not born in hospitals, according to state newborn screening rules and regulations.



INFANTS and DNA DATABANKING

Some states keep samples indefinitely, according to Citizens’ Council on Health Care 2009 data. Oklahoma keeps samples for 42 days, after which they are destroyed; currently the state has no plans for changing the length of time specimens are kept, Vaz said.

Long-term storage of specimens is a very expensive proposition because the blood spots have to be stored in a very controlled temperature with backup, very precise cataloging and other measures, Vaz said. All this requires space, equipment and personnel, which is costly, she said.

The testing is biochemical testing, which essentially means that enzymes and analytes are screened, and if elevated they may call for a positive newborn screen, Vaz said. Only one test — cystic fibrosis — has a second-tier test that is DNA-based, she said. This is only tested if the analyte or enzyme for cystic fibrosis is positive.

“So, essentially, newborn screening is not DNA-based, but biochemically based,” Vaz said.



NEWBORN SCREENING LAWSUITS

Nichols points out that the unauthorized collection of DNA samples sparked lawsuits in other states, including Texas, where five parents claimed the Texas Department of State Health Services and Texas A&M unlawfully and deceptively collected blood samples from their children at the time of birth and stored those samples indefinitely for undisclosed research purposes without their knowledge or consent.

The settlement required the destruction of 4.5 million samples stored without the parents’ knowledge or consent.

In Minnesota, nine parents sued the State Department of Health, challenging the collection, retention, use and dissemination of newborn DNA as unconstitutional and in violation of state law.

Twila Brase, president of the Citizens’ Council on Health Care, said the judges dismissed parental consent rights existing under state law and found retention and use law in the newborn screening law where none existed.

“As was underscored by the recent Texas court’s decision, the Minnesota Department of Health’s taking, retention and use of newborn citizen DNA without informed written parental consent is an unprecedented and unconstitutional seizure of the individual’s secret self,” Brase said.

The case is being appealed to the Minnesota Supreme Court, Brase said.

Vaz said Oklahoma does not send any DNA-related information to any agency public or private.

“No personal information about the baby is ever registered anywhere,” she said.

For more information on newborn screening in Oklahoma visit nsp.health.ok.gov. For more information on genetic research, visit genome.gov, site of the National Human Genome Research Institute.



marks@edmondsun.com | 341-2121, ext. 108