The Texas Newborn Bloodspot Saga has Reached a Sad – and Preventable – Conclusion
In late February, the state of Texas incinerated 5.3 million newborn bloodspots.
The background – the Genomics Law Report has had several posts (here and here) about the ongoing situation involving 5.3 million newborn bloodspots in a state biorepository in Texas. Often referred to as “residual” bloodspots, these are the tiny dried bloodspots left over after states conduct mandatory screening for specified diseases. State practices regarding retention of the residual bloodspots vary widely, with some destroying them promptly and others storing them indefinitely. Where post-screening use of the bloodspots occurs, the most common use is for quality assurance and quality control of the screening tests. Some states also permit the release of small sets of bloodspots for research.
Any such research must be done in compliance with the federal Common Rule applicable to clinical research and HIPAA, the federal medical privacy law. To simplify these laws’ complex requirements – what researchers must do depends on whether the samples or information will be made available in an identifiable or de-identified form. If a researcher receives identifiable information, then informed consents, privacy authorizations, and Institutional Review Board (IRB) reviews are mandatory. If the researcher receives only de-identified samples or information, no parental consent or privacy authorizations are required, although some states, including Texas, still insist on IRB review.
In the case of Texas, newborn bloodspots were collected and retained since 2002, building up a repository from 5.3 million children. Between 2002 and 2009, the Department of State Health Service (DSHS) provided 8350 de-identified samples to researchers – 0.16% of the total samples available. DSHS did not obtain parental consent for the distribution of these 8350 samples, as it was not required for de-identified use, although it did conduct an IRB review for each project. The research projects included studying the genetic causes of deafness to investigating inherited immune disorders, as listed on a DSHS web page describing research disclosures and uses. In the very small number of cases where identifiable research was conducted (200 out of 5.3 million), the state obtained prior consent from the parents, as required by research and privacy laws.
As Adam Doerr discussed in a post on February 2, the Texas Civil Rights Project brought a class action against the state in March 2009 on federal constitutional grounds, alleging that the retention and use of the samples without parental knowledge or consent was an illegal search and seizure. The plaintiffs did not allege privacy law violations. Meanwhile, the state legislature passed a bill enacting an opt-out program applicable to babies born after May 2009. After the state failed to win a motion to dismiss, it settled the case with the plaintiffs in December 2009, agreeing, among other things, to destroy all bloodspots collected before the new opt-out law.
Allison Williams Dobson’s post on March 1 updated readers on the ensuing developments. A Texas news site reported that 800 samples had been sent to a federal Armed Forces mitochondrial DNA database used to help categorize the ethnicity of missing persons’ remains. Department emails revealed that the state had considered publicizing its agreement witha state university for the long-term storage of the bloodspots, but chose not to do so out of concerns about public sensitivity. The plaintiffs’ attorney, Jim Harrington, was furious, a key state legislator felt he had been misled by the omission, and sharp criticisms were traded among the attorneys on both sides.
The bottom line – the destruction of the bloodspots proceeded on schedule.
This unfortunate outcome represents an incalculable loss to the research community and, through their work, to the individuals and families who are waiting for breakthrough treatments for diseases. Realizing what a loss this would be if it couldn’t be prevented, an ad hoc coalition came together in January to try to reach a compromise solution and save the bloodspots. Genetic Alliance, a national nonprofit dedicated to advancing health through genetics, for which I serve as Senior Counsel, brought together privacy advocates, University of Texas researchers, prominent Texans, and technology companies that offer online consent management and biospecimen management services, to try to quickly craft a solution whereby the bloodspots could be saved and parents could be offered meaningful consent options. We fashioned a coordinated program involving not only parental consent tools but also public education on the medical advances that could be achieved if parents allowed their children’s blood to be used in research. The coalition was seeking outside philanthropic funding so that the state would bear no additional cost.
Somewhat surprisingly, we quickly succeeded in reaching preliminary agreement with the plaintiff’s attorney, who was amenable to amending the settlement to postpone the destruction of the bloodspots if progress was being made on a parental consent mechanism. Our team also had numerous encouraging conversations with key legislators who hoped for such a compromise. DSHS, however, declined to open the settlement and postpone the destruction, citing their concern that any further disruption might jeopardize the viability of the newborn screening program intended to protect babies’ immediate health. We were, frankly, hopeful that we might be able to persuade DHSH to change its mind.
But then the story about 800 bloodspots being sent to the federal forensics database ran online. Even though those samples were de-identified and sending them was thus permissible under privacy and research laws, the uproar that followed poisoned the atmosphere in Texas. Tempers flared, accusations flew, the blogosphere of people suspicious of government exploded, and in the words of state Senator Duell, “if there was any way the bloodspots were going to be saved, the whole thing fell apart at that point.”
What can we learn from this highly unfortunate outcome? Among the lessons is that when angry and anxious parents confront state health departments who are trying to run public health programs, we should not be surprised that the long-term interests of research and scientific advances are ignored altogether. Neither parents who would have wanted their children’s bloodspots to be saved and used in research, nor countless parents who are eagerly waiting for the discovery of tests and treatments for their children’s conditions, had any voice whatsoever in the litigation or the public policy decision-making. Likewise, researchers who could have defended the tremendous medical benefits expected from their research played no part. Decisions were made under pressure and stress that simply did not reflect a broad spectrum of society’s interests. In addition, this sad case reveals that the status quo of widespread public ignorance about newborn screening and residual bloodspot uses has a high potential for erupting into acrimony and ill-advised decisions. Ignoring parents’ desires for more knowledge and decision-making will continue to put these bloodspot biorepositories – a national treasure trove for research advances – at peril. Surely, we can do better than this.