Thursday, February 21, 2013

Just To Know: The Baby & The DNA Testers

In Mankato, Minnesota, Isabel was a month old, her pediatrician told her parents that Isabel carried a gene that put her at risk for cystic fibrosis. Isabel received further testing and she doesn't have the disease; her couple wondered how the doctor knew about Isabel's genes in the first place.

They never agreed to genetic testing.
 Newborn babies in the United States are routinely screened for a panel of genetic diseases. Since the testing is mandated by the government, it's often done without the parents' consent, according to Brad Therrell, director of the National Newborn Screening & Genetics Resource Center.

In many states, like in Florida, where Isabel was born, babies' DNA are stored. Many parents don't realize their baby's DNA is being stored in a government lab, but sometimes they tend to find out. In Texas, and Minnesota; parents have filed lawsuits.
Samples are kept so tests can be repeated, or if DNA is ever needed to help parents identify a missing or passed child, and are also used for medical research, the DNA is also given to outside researchers. Genetic testing for newborns started in the 1960s with testing for diseases and conditions, if undetected, could kill a child or cause severe problems.

Over the years, many other tests were added to the list.

 Now, states mandate that newborns be tested for anywhere, and the DNA samples are stored in state labs from three months and up, depending on the state.

They don't stay in the state labs all the time and are often given to outside researchers, sometimes with the baby's name. More than 20 scientific papers have been published in the United States since 2000 using newborn blood samples.

The researchers do not have to have parental consent to obtain samples as long as the baby's name is not attached. If a researcher wants a sample with a baby's name attached, consent first must be obtained from the parents.
The health insurance that paid for Isabel's genetic screening now has record of her positive test for a cystic fibrosis gene.

  "And let's say in the future they can test for a gene for schizophrenia or manic-depression and your baby tests positive -- that would be on there, too." Mrs. Brown (Isabel's mother).

Along with Minnesota and Texas, the states are required to destroy a baby's DNA sample if a parent asks.
Parents who want their baby's DNA destroyed are to fill a form in Minnesota and in Texas.

It would be a challenge to get the states to destroy your baby's sample.

This project is supported through a cooperative agreement from the Genetic Services Branch of the Maternal Child Health Bureau/HRSA/DHHS.
Genetic Alliance, is in partnership with the University of Maryland School of Medicine and the Genetics and Public Policy Center.
 There have been no published reports on the misuse of residual dried blood spots. Privacy protections and patient confidentiality rules ensures that blood spots cannot be accessed by a third party, insurers and law enforcement. States continue to make guidelines for the persistent and expanded use of residual samples.
Papers & Reports

Bioethicists are now arguing that blood samples  from newborns have information and  should be made available to scientists, and not necessarily with the consent of the child's parents.

"Retention and use, without explicit parental permission, of residual dried blood samples from newborn screening has generated public controversy over concerns about violations of family privacy rights and loss of parental autonomy," 
-Michelle Huckaby Lewis, Michael E. Scheurer, Robert C. Green and Amy L. McGuire, in an op-ed for the journal Science Translational Medicine.

"The public debate about this issue has included little discussion about the destruction of a potentially valuable public resource that can be used for research that may yield improvements in public health," 

 "The research community must advocate for policies and infrastructure that promote retention of residual dried blood samples and their use in biomedical research."