Old 05-21-2008, 04:30 AM Offline   #1 (permalink)



 
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Default Newborn Blood-Storage Law Stirs Fears of DNA Warehouse

An obscure bill that sailed through Congress and was signed into law last month is stoking fears of a nationwide DNA warehouse potentially open to abuse by law enforcement agencies or health insurance companies.
But proponents say the law is a much-needed rationalization of the way the government stores and tests blood from newborns.
The Newborn Screening Saves Lives Act of 2007 (S.1858/H.R. 3825), signed into law on April 24, will provide guidelines to all states on how -- and for how long -- they should store blood. At present, all states store blood from all newborns, and some, like California, store it indefinitely. Critics fear that the samples, which contain recoverable DNA, might in the future be used to identify the subject or their medical profile.
"What we are doing is taking an individual genetic code and saying it's the government's," said Twila Brase, of the Minnesota activist group Citizens' Council on Health Care. "And once we do that, it's available for whatever a legislature wants to do in 20 years. The fact of the matter is that we don't know what they could or would do."
States have been storing blood samples from newborns since blood screening for genetic defects and diseases began in the 1960s. The samples can help detect and treat a wide range of diseases, but in the age of the genome, the issue of storing samples has taken on unprecedented importance. Blood samples contain DNA that can be unambiguously linked to individuals, which may in the future present tempting data to governments, businesses and health providers.
Currently, each state has its own policy about storing newborn blood samples. California has screened and stored more than 12 million newborn babies' blood spots since 1980, while Texas disposes of them within months.
Brase's group wants to see all so-called biobanks destroyed.
"You're building an entire DNA warehouse for the public without the public's consent," Brase said. "Who will own the DNA of the citizens and what is that going to mean? And what we're doing is pushing an entire genetic research program on the population without the consent of the population."
Proponents, however, say the scientific and medical value of the blood samples far outweigh the privacy risks of storing biological material from every newborn.
"They are extremely valuable when they are anonymized for research when looking at new technologies," said Edward Howell, chairman of the committee referred to in the bill, the Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children to the Health Resources and Services Administration. "Those conspiracy theories are very popular on the blogs, but the states have been very careful in dealing with [blood spots]."
Howell says law enforcement agencies have asked states for blood samples and been turned down.
"The bottom line is that many states have kept these for a very long time and I am unaware of anything that has been done with them that would concern even a very conservative person," Howell said.
Edward McCabe, co-director of the UCLA Center for Society and Genetics and co-author of DNA: Promise and Peril, agreed that so far, states have been trustworthy guardians of their biobanks.
McCabe said that even in the case of the identification of a missing child, California's health regulators still turned down a law enforcement request to use a blood spot.
He applauded that decision and others like it that establish a clear policy for dealing with the samples and limiting their use.
"We actually think there ought to be a firewall between forensic and medical uses," McCabe said.
And he argued that -- from a health care perspective -- the samples are extremely and uniquely useful.
"It's one of the most unbiased cross sections of the newborn population of a state," McCabe said.
Donna Levin, who as general counsel for the Massachusetts Department of Public Health works in the trenches with the issue, said she believed her state's policy had the right ethical safeguards in place.
"Parents are told prior to screening that the residual specimen is kept for at least 10 years," she wrote in an e-mail.
She also noted that all research conducted on residual specimens has to be approved by an Institutional Review Board, which set ethical guidelines for human experiments. The state also requires that research on identified specimens only be conducted with the informed consent of the subject of the specimen, or a parent/guardian.
Those are the types of checks-and-balances that the newly empowered committee could take up during their next meeting this September, when they will begin drafting the state guidelines.
One thing is for sure: As scientists and law enforcement officials continue to learn more about how to use the DNA in each of our cells, the way biological samples are handled by the government seems certain to receive more scrutiny.
"The whole confidentiality issue is certainly a huge issue in the age of genomics," McCabe said.

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