What is the Army Doing with your Baby’s Blood?

Like many, I used to love watching The X-Files. The appeal of the show was not just the intricacy of the plot, which had seemingly endless layers of conspiracy, but was also because of the clever way in which factual information was interleaved with fiction, almost making me “want to believe.” One of the most memorable scenes occurs in the show’s third season in an episode titled “Paper Clip,” an obvious reference to the post- World War II “Operation Paper Clip” program by the Office of Strategic Services to sanitize the histories of Nazi scientists so that they could obtain security clearances in the United States. Mulder and Scully find themselves in an abandoned mine in West Virginia. The cavern is filled with filing cabinets, housing “lots and lots of files,” as Scully so artfully described it. Inside the cabinets are smallpox vaccination records and tissue samples collected as part of the Smallpox Eradication Program, creating a comprehensive genetic database for every man, woman, and child born since the 1950’s.

It was creepy. And it made me think about the scar I have on my left shoulder from my own smallpox vaccination.

It is hard not to be reminded of that X-Files episode when reading the complaint in the case of Jeffrey Higgins v. Texas Department of State Health Services. Filed at the end of 2010, the case relates not to smallpox vaccination but to newborn blood screening. In an effort to aid parents in the identification of genetic disease of their newborn child, every state in the United States operates a newborn screening program, and many other countries have similar programs. Such programs began in the late 1960’s and have been expanded over the decades so that virtually all of the 4,000,000 infants born in the United States each year have their heel pricked to collect a few drops of blood around the second or third day of life. Exceptions are rare.

The screening is valuable and provides parents with important medical information that may allow infants born with genetic conditions to have those conditions addressed right from the beginning of their lives. But it is not much of a stretch to understand why medical researchers might have a broader interest in the collection of these samples. Rather than being concerned with a single infant’s condition, the availability of a comprehensive database of newborn blood samples would allow a wide variety of studies to be conducted, looking at patterns of disease that could have profound implications for addressing public-health objectives.

Indeed, in a report published this week in the journal Pediatrics, a copy of which can be found here (subscription required), the authors note the increasing research interest in newborn blood samples. A contract awarded by the National Institutes of Health in 2009 was specifically to develop a “repository of dried bloodspots that is either virtual or physical and comprised of those stored by state newborn screening programs and other resources.” There are certainly positive objectives that could only be reached with access to such blood databases. But the problem is that, in the same way that I found Mulder and Scully’s discovery creepy, many people are uncomfortable having their children’s blood stored in a government database.

This discomfort is justified. There are currently few laws that limit the type of research that may be conducted and most states have no requirement to notify parents that the blood samples may be retained and used for other purposes than the screening of their newborn children. It’s probably fair to say that most never even considered what happened to the blood after collection.

The Higgins case has its origins in an earlier case filed in 2009 when five families sued the Texas Department of State Health Services for the unauthorized storage and use of newborn blood spots. A settlement was negotiated in which Texas agreed to destroy some 5,000,000 newborn blood samples that had been collected and retained since 2002. The Texas legislature also acted — not to limit retention of samples but to provide express government authorization for future samples to be retained. Higgins was filed when it was later revealed that about 8800 samples had been turned over to an Armed Forces laboratory as part of an effort to build a national mitochondrial DNA registry. The stated purpose of the database is forensic, namely to provide a tool by which missing persons may be identified and to aid in the resolution of other difficult cases.

The complaint in Higgins, a copy of which can be found here, alleges that Texas has acted deceptively: “Defendants have knowingly, deceptively, routinely, unlawfully and without the knowledge or consent of the infants’ parents, sold, traded, bartered, and distributed blood samples … to private research companies, government agencies, and other third parties.” A report published by The Texas Tribune that can be found here seems to confirm that records now released by the state “show an effort to limit the public’s knowledge of aspects of the newborn blood program, and to manage the debate around it.” The Tribune skeptically describes “oversights” in response to its requests for information, a pattern of suppressing disclosure about activities related to the blood program, and efforts to “plant” information with sympathetic lawmakers.

I have no doubt that blood databases such as are envisaged have the potential for enormous public good by allowing researchers access to a body of information that is nowhere else available. But the privacy concerns are obvious. Of course people weigh these countervailing issues differently, but the only way to settle the tension between them is by discussing them openly and candidly. One benefit of cases like the one in Texas (and a similar one that failed in Minnesota in 2009) is that public visibility over blood programs is increasing so that that discussion can take place.

About Patrick Boucher

The author, Patrick M. Boucher, is a patent attorney living near Denver, Colorado and working at Marsh Fischmann & Breyfogle. He holds a Ph.D. in physics as well as a J.D. He is an active member of the American Physical Society, and is admitted to practice law in the states of Colorado and New York, as well as to practice before the U.S. Patent and Trademark Office. He is also a member of the Authors Guild and of the Colorado Authors League.