“Big Brother” and the Growing Controversy Surrounding Newborn Blood Spots
By Linda Turner, Paralegal Intern, Office of the Staff Judge Advocate, U.S. Army Medical Command, Fort Sam Houston, Texas
In the novel, Nineteen Eighty-Four, George Orwell created a world in which Big Brother, Newspeak, and telescreens were used to control the masses and strip ordinary citizens of their privacy and civil liberties. In 1949, that was science fiction, and most people probably thought such a world was outside the realm of possibility. It is now 2010. Welcome to the future. Instead of telescreens on the corner, we have traffic cameras at every major intersection, and most people are not even aware of just how much the line separating science fiction and reality has blurred. Things that were once almost unimaginable are now changing our world and, in some cases, causing unease.
One such case where government encroachment into civil liberties is currently being debated concerns newborn blood spot (NBS) samples. Hospitals have been pricking newborns’ heels and collecting blood samples to test for genetic, metabolic, and developmental disorders since the 1960’s. All states require screening tests, and with good reason. If not caught early, many of the disorders can lead to brain damage, mental retardation, and even death. Consequently, few parents dispute the need for the tests themselves—or give a second thought to the fate of their newborn’s blood samples after they take their baby home.
For years, NBS samples were only kept for a limited time before they were disposed of. Then technology and science exploded in the1990’s, and everything changed. Scientists realized that the NBS samples contained a wealth of genetic information on just about every baby born in the United States. States began storing the NBS samples for research and, in some cases, even sent samples to biobanks. In 2003 and 2007, the US military received 800 NBS samples from the Texas Department of State Health Services in order to “help develop a mitochondrial DNA database for use by law enforcement.” In Michigan, millions of NBS samples in a state warehouse were used to create a “neonatal biobank” in Detroit in the hopes of making the city a center for biomedical research. The Minnesota Department of Health (MDH) also collected newborn blood samples and kept them indefinitely, sharing them not only with hospitals, but private research institutions --all without parental consent.
There is no question genetic databases are a valuable resource. They can be used not only medical research, but also for identifying missing children, and proving guilt or innocence in criminal cases, among other things. Just the words “genetic testing” set off alarm bells, however, especially when a child’s blood is tested in virtual secrecy. Parents worry about privacy and how a child’s genetic information may be used in the future. Could blood that was taken from a baby the day after birth be self-incriminating later in life? Or prohibit the child from certain jobs or health and life insurance because of something in his or her genetic makeup?
The answer is yes. The Equal Employment Opportunity Commission (EEOC) has already received its first complaint. MXenergy, a natural gas and electric supplier in Connecticut, allegedly fired Pamela Fink, the company’s public relations director, when it was discovered through genetic testing that she was a carrier of a mutation in the BRCA2 gene and thus, had a predisposition to breast cancer. If the complaint is not resolved by the EEOC, the Genetic Information Nondiscrimination Act of 2008 (GINA) gives Fink the right to file suit in federal court against her former employer for genetic discrimination. GINA protects Americans against discrimination based on their genetic information when it comes to health insurance and employment.
GINA, however, does not resolve the question of who actually owns the NBS samples, and the law on this issue remains unclear. The Newborn Screening Saves Lives Act of 2007, which allows population research surveillance and epidemiology; research partnerships with the government, academic and private institutions; and provides for the standardization, unification, and nationalization of data collected from state screening programs, seems to give the federal government ownership. The Federal Policy for the Protection of Human Subjects, otherwise referred to as the Common Rule, also regulates federally-funded research for seventeen government agencies. These regulations require, among other things, that researchers must have informed consent before the research is conducted and offers protection to children who are research subjects.
Many states, however, believe the NBS samples belong to them because the initial screening tests are mandated by law. States also regulate research, and in some instances, have extended the Common Rule to include not only government-funded research, but also private, commercially-funded research as well. In Addition, the Supreme Court of California ruled in Moore v. University of California Board of Regents et al. that individuals do not own excised cells. Conversely, four states disagree with that ruling and have passed laws making genetic information the private property of the individual.
Many parents agree, insisting that their child’s DNA is protected by privacy laws and the Common Rule. Because state law gives each state the right to collect NBS samples for screening, parental permission is not needed. Parents argue, however, that newborn screening laws allow use of the samples only for the initial screening. Consequently, a child’s NBS sample cannot be used for any further genetic research without parental permission.
Considering the ambiguity in the law, it is not surprising that in March 2009, separate lawsuits were filed in Minnesota and Texas, challenging each state’s use of NBS samples for unauthorized purposes. In Bearder v. Minnesota, parents claimed that by collecting, indefinitely storing, and sharing NBS samples with private research institutions and hospitals, the Minnesota Department of Health (MDH) violated the Minnesota Genetic Privacy Act (GPA), which prohibits “collection, storage, use, and dissemination of genetic information” without “written informed consent.” MDH, however, argued that an exemption clause specifically related to newborn blood screening allowed the state to “retain, use, or share genetic information for research.” The court agreed that the GPA did not apply to MDH’s collection, storage and use of the NBS samples and dismissed the plaintiff’s complaint.
The outcome of Beleno v. Tex. Dept of State Health Servs., however, was quite different. In Beleno, the plaintiffs alleged that the Texas Department of State Health Services’ (TDSHS) indefinite storage and use of their children’s NBS samples without consent constituted unlawful search and seizure and violated privacy rights protected by the Fourth and Fourteenth Amendments and state law. The parents requested the destruction of all NBS samples stored without consent, as well as disclosure of how the samples had been used and what financial transactions were made concerning their use. When the court denied the defendants’ Motions to Dismiss, TDSHS reached a settlement agreement with the concerned parents. As a part of the settlement, TDSHS agreed to destroy 4.5 million samples collected between 2002 and May 27, 2009, and post on its website all research projects, as well as all categories of quality assurance and quality control uses projects, for which it had provided NBS samples.
As a result of coverage of these cases in the press, more parents are expressing concern and demanding changes in how their children’s NBS samples are used and stored. In August, 2009, the Health and Human Services’ Advisory Committee on Heritable Disorders in Newborns and Children recommended that states give parents the right to either consent or opt out of programs that use NBS samples for research. Both the Minnesota and Texas legislatures have passed legislation regarding opting-out of the tests. In Minnesota, parents who agree to newborn blood screening can have their child’s test results and all blood samples destroyed within twenty-four months of testing. Texas has a similar policy. With a written statement, parents cannot only limit the use of their child’s genetic material to newborn screening tests, they can also prohibit the department or laboratory from retaining any of that genetic material. Once the parents make the request in writing, the department or laboratory has 60 days to destroy the genetic material.
Different states and jurisdictions, however, are still sharply divided not only on how NBS samples can be stored and used, but also on the definition of what constitutes “genetic information.” Oklahoma Senate Bill 1250, which was signed into law on May 10, 2010, prohibits laboratories, medical facilities, hospitals, and birthing places from “the unauthorized storage, transferring, use, or databasing of DNA from any newborn child without express parental consent;” then includes not only NBS samples, but also umbilical cord blood that contains DNA, and other biological samples in the definition of “DNA from any newborn child.” This is in direct contrast to the ruling of the Minnesota Court of Appeals in August, 2010, which determined that NBS samples do not fall under the heading of “genetic information” in spite of the fact that they contain not only DNA, but genetic information.
While the controversy connected to the unauthorized use of NBS samples for genetic research has remained, for the most part, under the national radar screen, the issue is not limited to the United States. In May, 2010, the British Columbia Civil Liberties Association (BCCLA) raised objections to the potential use of 800,000 NBS samples for research without parental consent, and expressed concern regarding B.C. Legislative Assembly 2010, Bill 11, which has been described as “a grab bag of miscellaneous legislative provisions … that give[s] the Minister of Health power to collect, gather, use and share personal information without any notice to or consent from affected individuals.” The BCCLA is pushing the government to detract the bill and destroy the records, but for now, all parents can do is send in a form requesting the return of their children’s records. A similar situation occurred in Dublin in December, 2009, when the Sunday Times exposed what was effectively “a secret national DNA database” of 1,548,300 NBS samples that Children’s University Hospital had been collecting without parental consent since 1984. The Data Protection Commissioner is investigating the hospital’s violation of data protection laws and working with the Health Service Executive and the Department of Health to force the destruction of the records.
Furthermore, the fact that a country does not mandate newborn blood screening does not mean that the policy is without controversy. In New Zealand, where newborn screening is not required by law, neither is consent. Consequently, samples can be taken and stored without the parents’ knowledge. Such a case occurred in 1999, when a father convinced the high court to release his deceased child’s DNA to test for paternity. Surprised by the sample’s existence, the mother argued that allowing the NBS samples to be tested was unlawful, but the New Zealand High Court ruled otherwise.
Civil liberty advocacy groups around the world are concerned, and there is no question that the issue of who controls the use of NBS samples must be resolved. With genetic research, the cure for some of the world’s most debilitating diseases and genetic disorders could be discovered in our lifetime. Some already have. Thanks to the authorized use of leftover NBS samples in research at the University of California, a newborn screening test has been developed for SCID (also known as bubble-boy disease). And public health studies with NBS samples have been particular successful. NBS samples and the DNA extracted from them have been used to identify PCB hazards for children born near Love Canal in New York, exposure to such harmful drugs and infectious organisms as cocaine, hepatitis B, and E. coli, and new candidate biomarkers for autism. Scientists are also researching the environmental toxins that can harm a fetus’ developing heart and genes that trigger childhood cancers.
NBS samples offer not only a ready supply of blood samples for research, but a never-ending one, thanks to state-mandated newborn screening tests. In order for NBS samples to be used to their full potential, however, the states must find a way to balance ethics with science and, at the same time, protect the rights and privacy of the youngest members of our society.
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