When a California company asked Texas for blood samples from newborns in 2008, the state charged $1,600 for 400 blood spots. A North Carolina company swapped 16 HIV testing kits for 5,400 blood spots from the Department of State Health Services in 2006 and 2007. And another company has a five-year contract to get 3,800 blood spots a month in exchange for $456,000 worth of lab supplies.
Blood taken from Texas newborns in a state-mandated program to screen for defects and potentially deadly disorders has proved to be a valuable commodity — not just for researchers who might discover causes and treatments for diseases, but for companies developing, manufacturing and selling lab tests around the world. The blood samples — which were stored indefinitely starting in July 2002 without parents’ knowledge until recently — help companies evaluate and bring disease screening tests to market. In exchange, the health department gets needed supplies to conduct lab tests on newborns and other patients…
…In March 2009, the Texas Civil Rights Project sued the state over the storage program, claiming the state was violating constitutional protections against unlawful searches and seizures as well as state privacy laws. It wanted the state to stop storing blood without parental consent — state law doesn’t require consent — and asked that samples be destroyed unless consent was obtained.
The issue struck a chord nationally as parents learned other states had similar programs and feared the potential for misusing private genetic information.
“Newborn screening programs are under attack nationally, and they hope this will just go away, but it won’t,” said Dr. Deborah Peel, founder and chairwoman of Patient Privacy Rights, a national organization that advocates for patient privacy. “The public is terrified of the state owning their DNA.”
The Texas suit was settled in December when the state agreed to destroy 5.3 million blood spots stored since 2002, despite last-minute efforts led by Peel and others to try to save the spots by creating an informed consent process. New state laws passed last year put controls on the samples, and now the department must inform parents of possible uses and allow them to opt out of having their baby’s blood stored for up to 25 years.