When a baby is born in the United States, a few drops of blood are taken from their heel to test for many conditions that could affect the child’s long-term health or survival. This test is part of newborn screening (which also includes hearing and heart screening) and it has changed and saved the lives of thousands of babies and families since its development in the 1960s.
One of the first and greatest newborn screening success stories revolves around a condition called phenylketonuria (PKU). Babies with PKU cannot process phenylalanine, which is found in all protein foods. Healthy babies who have PKU and eat protein may develop permanent brain damage. Before the introduction of newborn screening, families learned that their child had PKU only after developing permanent brain damage. At that time, the family often had other children with PKU who met the same fate. Then newborn screening for PKU was developed in the 1960s. Since that time, families learn that their child has PKU as a newborn, as this condition is included in all newborn screening programs. If the family learns that their child has PKU, that child is given a special formula and diet that helps them avoid developing brain damage. Avoiding this path is nothing short of miraculous.
Many other conditions have since been added to newborn screening, and the list varies by state. But the overall goal of this laudable program is to find treatable conditions early in newborns and prevent or treat those conditions early, in hopes of reducing their severity.
Newborn screening is hailed as one of the most important achievements of pediatric medicine over the past century. Babies born in the United States are required by law to undergo newborn screening within the first few days after birth. Parents can refuse testing if it conflicts with their religious beliefs or practices.
Parents who know that newborn screening exists believe that the blood sample is used to screen their child for disease. Maybe some parents know that some programs use these blood samples for research. Few people know that states can keep these blood samples for years after they are taken – in some states for up to 23 years – and use them for purposes that the parents, and certainly the child, would probably not have. consented. A lawsuit in New Jersey focuses solely on this issue.
According to court case filed by the New Jersey Office of the Public Defender, on New Jersey State Police successfully subpoenaed a testing laboratory for a newborn screening sample that had been taken from a child 9 years ago. The child’s newborn screening sample was used to link the child’s father to a crime committed more than 25 years ago.
Unfortunately, this is not the first time that a newborn screening sample has been used for purposes other than those for which it was intended. An article written in 2011 details the presence and absence of state laws regarding the retention and use of newborn screening specimens. In 4 states, residual blood samples become state property. In several instances, states have used residual blood samples for purposes other than newborn screening. One of the most egregious examples occurred in Texas, where the Newborn Screening Program donated 800 dried blood samples to the US Armed Forces pathology lab for use in a forensic database. . The department has been accused of taking samples and selling, bartering and distributing them without parental permission for undisclosed purposes unrelated to the purpose for which the blood was taken.
Currently, there are no federal laws on the limits of newborn screening specimens, their retention, or the scope of discovery for them. State laws are a hodgepodge of different standards. In Connecticut, for example, the state requires the collection of newborn screening samples but does not clearly state how long the sample will be retained. The law provides for a religious exemption from the test. Worryingly, parents of newborns, worried about the use and abuse of police retrieval of residual samples, might find a way to opt out of screening. And this exclusion will put innocent newborn babies at risk.
These concerns were raised over a decade ago. The current New Jersey case proves that there are still major flaws in the way newborn screening samples are used and potentially abused. Uniform state or federal law governing how long residual specimens may be retained and, more importantly, used, and by whom, must be enacted to protect newborn screening programs, as well as children and participating families. Without such protections, there is a risk that families will withdraw from newborn screening, which would be a devastating setback for newborns and their families, our health care system and pediatric medicine.