By Norm Singleton on December 18, 2014 in National Blog
Newborn
screening for medical disorders is becoming an increasingly common
practice. This seems like a good thing; however, along with the
potential benefits of screening, there are concerns that some states are
not obtaining parental consent before doing the screening. There are
also legitimate concerns that state governments will store the child’s
DNA in a database.
No one should be surprised to learn that
there is a federal program funding newborn screening, and readers of
this blog should not be surprised to learn that legislation extending
this program was rammed into law in the lame duck session of Congress.
However,
Senator Rand Paul was successful in getting a victory for parents’
rights by attaching an amendment to the bill forbidding the use of a
newborn’s blood spots in federally funded medical research without
parental consent.
http://www.worldmag.com/2014/12/expanded_newborn_screening_raises_privacy_concerns
Expanded newborn screening raises privacy concerns
By Daniel James DevinePosted Dec. 16, 2014, 08:30 a.m.
President Barack Obama is expected this week to sign into law a $100 million bill
renewing federal funding for newborn screening. Involving a pinprick to
a baby’s heel and a few drops of blood, newborn screening is intended
to identify serious disorders within a few days of birth. But privacy
advocates worry about the government collection and long-term storage of
newborn DNA.
The federal law, first authorized in 2008, now
includes for the first time an amendment acknowledging privacy concerns
over dried blood spots stored on cards
and kept on file by state governments: For blood spots used in
federally funded research, scientists must obtain a consent form signed
by the parents. (The consent requirement will remain in place for up to
two years, until the Department of Health and Human Services updates
rules governing research on human subjects.)
Citizens’ Council
for Health Freedom, a patient privacy group in St. Paul, Minn., helped
craft the language of the amendment, which was introduced by Sen. Rand
Paul, R-Ky. “Most parents don’t know newborn screening happens,” said
Twila Brase, president of the organization. “Some states have been
keeping the blood, the DNA of the child, indefinitely.” Brase is happy
the amendment was included in the bill but still has concerns about the
screenings’ potential implications for genetic privacy.
The
Newborn Screening Saves Lives Reauthorization Act, which unanimously
passed the U.S. House on Wednesday, provides funding to support newborn
screening programs already required by law in every state.
Newborn screening
has existed for more than 50 years but has grown more comprehensive in
the past decade. Around 2003, most states only tested for six treatable
disorders. Today, most states require testing for at least 29 disorders,
such as sickle cell anemia, cystic fibrosis, or various vitamin or
protein disorders. Parents may refuse the tests on religious grounds,
but 98 percent of U.S. newborns ultimately are screened.
According to the March of Dimes, 1 in 300 infants has a disorder that
can be identified by screening. It’s important for doctors to find the
disorders within a few days of a child’s birth, since early treatment
may prevent serious harm.
A news investigation last year by the Milwaukee Journal Sentinel found widespread delays
in lab testing of newborn blood samples, sometimes because hospitals
were trying to save on postage costs. The delays resulted in children
going untreated for serious genetic diseases within the first days after
birth, sometimes resulting in disability or death. Following the
investigation, dozens of states made changes to their screening programs
to minimize delays.
The new federal law requires the U.S.
Government Accountability Office to report within two years on the
timeliness of newborn blood testing across the United States.
Brase acknowledged screening is beneficial in allowing early treatment
of certain disorders, but she wants parents to be adequately informed
and to understand how their state handles the blood samples. Some states
retain the samples for just three months, others for 25 years or
longer. Citizens’ Council for Health Freedom keeps a list of state retention policies.
The group is concerned about federal and state involvement in the
screening programs: “The best way that this should be run is that the
hospitals should do it, like every other test that they do on the mother
and child,” Brase said. “The state should be completely out of it.”
