Direct-to-Consumer Fetal Sex Prediction Tests: the US is Not Immune to Sex Selection

In January, Dutch researchers published a study relating to a new method for screening maternal blood to determine fetal sex as early as seven weeks after conception. Although this test reports 100% accuracy, other direct-to-consumer (DTC) fetal sex prediction tests that advertise online offer similar tests with unregulated accuracy.


Recently, these tests have come under increased scrutiny based on the possibility that consumers both in the US and abroad may purchase the tests as a means obtaining information about fetal sex as the first step in seeking a sex selection abortion. Unlike an ultrasound (performed at 18-20 weeks in the second trimester), these DTC tests advertise the ability to predict fetal sex between 5-10 weeks in the first trimester. This offers parents an opportunity to determine fetal sex and make corresponding planning decisions to produce a child of a specific sex that may have been previously unaffordable (through means such as preimplantation genetic diagnosis or sperm selection) or inaccessible (second trimester sex selection abortions).


Three main countries- China, India, and Korea- are often used as examples of countries with socio-cultural environments that contribute to male child bias in attitude and action. Literature contains extensive discussion on how and why socio-cultural attitudes have traditionally, and still to a large extent, continue to favor male children and perpetuate extensive gender discrimination within the respective countries. The magnitude of bias is reflected in the skewed population ratios such as the 50 million “missing” females that should otherwise exist in the Chinese population. These deeply entrenched reasons for male bias and the pervasiveness of these attitudes means that even despite legal steps to explicitly limit or prohibit sex selection abortions, for decades both parents and practitioners have ignored laws designed to prevent this practice in each respective country.


In recognition of this issue, some DTC fetal sex prediction companies specify that they do not sell the product to consumers in China and or India. However, some companies have not issued such restrictions, and consumers in India or China can locate these products by a simple internet search. In India, scholar and activist Dr. Sabu George filed a lawsuit against Google and Yahoo seeking to enforce an Indian law against advertising products that reveal fetal sex. While the search engines have pulled some advertisements, internet searches still provide links to the DTC fetal sex prediction company websites.


The potential of using fetal sex prediction tests as a means of sex selection is not only a problematic issue limited to other countries. Both attitudinal research and recent litigation suggests that some parents in the US may use these tests for sex selection purposes.


Despite a notion that the general US population does not possess a preference for a child of a specific sex, statistics suggest this assumption may not be correct. Numerous studies demonstrate that members of the US population do possess attitudinal bias favoring male children, either as only children or first born. Some parents not only hold this male child bias, but are also willing to translate these attitudes into practice to achieve the desired outcome.


Another lawsuit against the Baby Gender Mentor product, Duffy et al. v. Acu-Gen Biolabs et al., also confirms these attitudes exist within the US population. Plaintiffs allege the tests were inaccurate and falsely predicted their baby’s sex, which caused them emotional distress and had a “devastating effect.” One plaintiff asserts that the incorrect test results contributed to the demise of her marriage because her husband wanted a boy, while another plaintiff upon learning the results “struggled, needlessly, with whether to keep [the pregnancy.]”


Granted, vast socio-cultural differences exist between counties such as India, China, and the US that could lead to less devastating population wide outcomes. However, does this mean we should be less concerned that only a small percentage of the population may use these tests for sex selection purposes? What can we learn from these countries when formulating our policy relating to how these tests can or cannot be used?

--Katherine Drabiak-Syed

In the Literature: Altruism, the Self and Genetic Research

Ethicists and medical researchers often think about the barriers to participation in research. People want to know exactly what keeps potential participants away from a valuable research project? Likewise, many want to know what could be done to (safely and fairly) lower the barriers to participation in research. The opposite question, however, is equally interesting: Why do people do it? What motivates patients and others to consent to medical research?

Nina Hallowell, et al. examine these questions in the context of cancer research and biobanks in their recent paper “An investigation of patients’ motivations for their participation in genetics-related research” (J Med Ethics. 2010 Jan;36(1):37-45). The authors conducted interviews with 59 patients formerly enrolled in research studies at a regional genetics service (Wessex Clinical Genetics Service, Southampton, UK). After pouring through what must have been a large stack of transcripts, the authors identified three frequently expressed motivations: 1) “Selfish” – subjects expected to benefit from the research by receiving better care or other rewards; 2) Familial altruism – subjects wanted to contribute to efforts that might help future cancer patients (including grandchildren) in their families; and 3) Social altruism – subjects expressed a desire to do something that would benefit society and improve the health of all. After using these categories to evaluate the motivational statements, the authors declined to assert that any single type was a sufficient description of why patients consent to genetic research studies. They write: "these framings were frequently juxtaposed within the interviews, so that, in practice, it was difficult to characterise interviewees’ accounts as either self- or other-oriented". And again: "drawing upon any one motive to account for one’s behaviour in this context is not sufficient, for each motive would appear to impact upon, alter and modify others in a recursive or dynamic fashion".

They also provide a graphic to help us visualize the inter-related motivators in the genetic research participation engine:


My thoughts:

While I do not doubt that motivations are multi-layered and that a single individual may be motivated simultaneously by personal need and social altruism, I think the authors decided to down play the importance of the "personal framing" (or “selfish reasons”) in subjects’ decisions to consent to genetic research. In fact, the paper reports: "The majority of interviewees, like P124, offered personally motivated reasons for their research participation at some point in their interview". The importance of self-centered motivations is also clear in the graphic above. In other words, while it may be difficult to untangle these motivations, the gears might stop turning altogether if one were to remove "personal framing". I do not think the authors would disagree with me (and if they read this post, they are more than welcome to comment); perhaps the authors do not want to lose the point that altruism cannot be a stand-alone motivator. In fact, the discussion ends with a compelling statement:

Such observations suggest that we may need to rethink the concept of altruism … the “moral character of research participation”. Also, as we noted earlier, we need to recognise that when it comes to accounting for research participation we can no longer regard altruism and selfishness as incompatible or oppositional concepts. Indeed, it would appear that research participation is experienced as a more ethically contentious activity than has heretofore been assumed.

Reference:

Hallowell N, Cooke S, Crawford G, Lucassen A, Parker M, Snowdon C. An investigation of patients' motivations for their participation in genetics-related research. J Med Ethics. 2010 Jan;36(1):37-45. PubMed PMID: 20026692.

Related:

Dixon-Woods M, Tarrant C. Why do people cooperate with medical research? Findings from three studies. Soc Sci Med. 2009 Jun;68(12):2215-22. Epub 2009 Apr 24. PubMed PMID: 19394741.

Geller G, Doksum T, Bernhardt BA, Metz SA. Participation in breast cancer susceptibility testing protocols: influence of recruitment source, altruism, and family involvement on women's decisions. Cancer Epidemiol Biomarkers Prev. 1999 Apr;8(4 Pt 2):377-83. PubMed PMID: 10207643.

Treloar SA, Morley KI, Taylor SD, Hall WD. Why do they do it? A pilot study towards understanding participant motivation and experience in a large genetic epidemiological study of endometriosis. Community Genet. 2007;10(2):61-71. PubMed PMID: 17380055.

Other Recent Predictive Health Ethics Articles – PubMed, Nov 2009 -Jan 2010

-- J.O.

Minnesota Judge’s Dismissal of Newborn Blood Spot Case Misses the Mark

On November 24, 2009, Judge Marilyn Rosenbaum signed an order dismissing plaintiffs’ complaint with prejudice in the Bearder et al. v. Minnesota et al. (MDH) lawsuit. This dismissal quickly disposed of plaintiffs’ claims that MDH’s practices of retention and research use of newborn blood spots (NBS) conflicted with specific protections outlined in the Minnesota Genetic Privacy Act (GPA) and constituted violations of their childrens’ property and privacy interests.

Judge Rosenbaum responded to plaintiffs’ claim that MDH failed to comply with the GPA by ruling that the GPA does not even apply to MDH’s actions because:

• NBS samples do not constitute genetic information; and
• The statute contains reference that it will not apply if an express provision in the law exists.

The GPA clearly defines genetic information as:

• “Information about an identifiable individual derived from the presence, absence, alternation, or mutation of a gene… which has been obtained from an analysis of the individual’s biological information or specimen” and
• “Medical and biological information about a particular genetic condition that is or might be used to provide medical care to that individual.”

Judge Rosenbaum’s finding that NBS are not classified as genetic information ignores the plain language of the statute. NBS are collected to analyze the presence, absence, or mutation of a disease during the newborn screening process and used to obtain medical and biological information about a particular genetic condition so parents of newborns can make medical decisions accordingly. Thus, logic compels classifying NBS as genetic information.

Defendants argued that the newborn screening statute which states that the NBS and results of the screening tests “may be retained by the [MDH]” amounts to an express provision authorizing exemption from the GPA. Judge Rosenbaum’s agreement disregards the meaning of “express provision” and the substantive fact that the collection and temporary retention for screening purposes is distinct from the collection, retention, and use for additional research reasons. Accounting for this important division, the statute would have explicitly and distinctly contained a section authorizing additional retention and research use beyond the collection and retention for detection, treatment, and follow up of heritable and congenital disorders if the legislature intended.

Additionally, this interpretation ignores the purpose of the GPA as a means to limit collection of genetic information by a government entity.

The finding that this section of the newborn screening statute (“may be retained by the [MDH]”) constitutes an express provision allowing retention and research beyond the initial screening poses two additional dilemmas. First, it problematically ratifies blurring screening with additional retention and research. Second, Judge Rosenbaum’s finding ignores that the retention and research is not limited to the MDH but extends to its research partners such as the University of Minnesota, the Mayo Clinic, and the CDC.

Randall Knutson, attorney for the plaintiffs, responded:

“It is our hope to bring some legal guidance and common sense to DNA issues, including the storage and dissemination of genetic information by our government agencies. As it now stands, the State of Minnesota appears free to use and sell our genetic information, without us having any say in the matter. That is simply unacceptable, and we intend to continue to fight on to change this situation.”

Knutson plans to appeal Judge Rosenbaum’s decision.

--Katherine Drabiak-Syed

Lawsuit Challenging Myriad’s BRCA1 and BRCA2 Patents Will Go Forward: Judge Rejects Defendants’ Attempts to Preclude Plaintiffs’ Day in Court

Association for Molecular Pathology v. United States Patent and Trademark Office, Civil Action No. 09-4515 RWS ((S.D.N.Y. 2009) known as the lawsuit against Myriad Genetics challenging its gene patents related to BRCA1 and BRCA2 will go forward.

On November 1, 2009 Judge Robert Sweet handed down an order denying the defendants’ motion to dismiss. In the 85 page order, Judge Sweet accepted many of plaintiffs’ arguments set forth in the complaint and accompanying affidavits, finding that the court may properly hear the case and plaintiffs may properly sue each defendant.

The court flatly rejected defendants’ assertion that plaintiffs could not use the court as an arena to challenge questions of patentability.

Judge Sweet declined to adopt defendants’ arguments that the existence of the Patent Act as a comprehensive statutory scheme demonstrates Congressional intent to provide an internal remedy and preclude judicial challenges of the nature in this suit. The court noted that despite the USPTO’s statutory scheme to address patent questions, it does not provide a comparable statutory framework to raise Constitutional concerns and provide remedy accordingly; thus, plaintiffs may still bring an action to enforce the asserted Constitutional rights.

The court’s arrival at this reasoning is closely connected to Judge Sweet’s lengthy description of why the plaintiffs’ allegations of Constitutional violations are adequate and why the Court will not grant defendants’ motions to dismiss. The order described plaintiffs’ assertions that Myriad’s patents in question grant Myriad ownership rights over products of nature, laws of nature, natural phenomena, abstract ideas, basic human knowledge, and thought, which would violate the First Amendment. Additionally, plaintiffs pled that Myriad’s ownership of the patents in question inhibited further research, which would violate of Article I, section 8, clause 8 of the Constitution that directs Congress (and by delegation, the USPTO) to promote the progress of science.

The court also rejected Myriad’s arguments that plaintiffs could not show Myriad acted affirmatively to enforce the patents or that plaintiffs undertook meaningful preparation to potentially infringe the patents.

Judge Sweet adopted facts set forth in plaintiffs’ complaint and affidavits describing how Myriad sent out cease and desist letters to researcher plaintiffs and initiated two actions against infringers, demonstrating Myriad’s affirmative actions and willingness to enforce the patents. Importantly, the court further noted that given the widespread knowledge of the breadth of Myriad’s claims and its willingness to enforce its patents, a court would likely find that infringement of the patents would be considered willful and result in treble damages- meaning a scientist attempting BRCA research could be subject to extraordinary damages above merely compensating Myriad for any monetary losses.

Additionally, Judge Sweet accepted the researcher plaintiffs’ assertions that they are ready, willing, and able to infringe the patent because they are prepared to advance BRCA research, and or offer testing, and could do so within a matter of weeks. The court also noted that the plaintiff women affected by breast or ovarian cancer could take advantage of testing alternatives to find another test covered by their insurance or obtain a second opinion (options currently denied to them because of Myriad’s patents) that would potentially classify them as contributory infringers, meaning they could also properly sue the defendants.

The case moves forward and the court will hear parties’ oral arguments on motions for summary judgment on January 21, 2010. At this hearing, the court will decide whether there are genuine issues of material fact in dispute that would preclude the court from ruling as a matter of law for one party. If Judge Sweet’s order is any indication, a multitude of problems exist that are ripe for a hearing, and in the near future this court could squarely address these contentious issues arising from gene sequence patents. Perhaps finally the judicial system could address both the USPTO's and Congress' failure to re-examine patentability standards for gene sequences and decide whether issuing gene patents run contrary to Constitutional and statutory requirements.

-Katherine Drabiak-Syed

Newborn Blood Spot Litigation Continues in Minnesota and Texas

The litigation occurring in Minnesota and Texas regarding the unauthorized retention and research use of newborn blood spots (NBS) continues, and has developed into respective battles seeking judicial recognition for a property and privacy interest in one’s genetic material from which governmental entities such as state health departments are not exempt.

In September 2009, the Minnesota district court heard the defendants’ motion to dismiss and motion for summary judgment in Bearder et al. v. Minnesota et al. (MDH). MDH argued that there are no genuine issues of material fact so the court could simply rule as a matter of law in its favor to exempt the application of the Minnesota Genetic Privacy statute to the state health department's activities as well as preclude any of the plaintiffs’ privacy claims. Following this interpretation, two active bills in the Minnesota House (HF 1341) and Senate (SF 1478) seek to alter Minnesota state law by creating a compliance exemption for the state health department.

According to Bearder et al.'s attorney Randall Knutson, the parties are waiting for the court’s ruling, which is scheduled for return before December 18, 2009. Plaintiffs contend that NBS are genetic information, individuals have a property and privacy interest in their DNA, both tort and Constitutional law protect these interests, and they seek to compel MDH’s compliance with the Minnesota Genetic Privacy Act.

Bearder et al.’s memorandum of law submitted to the court prior to the hearing developed concerns related to MDH’s continued noncompliance with the Minnesota Genetic Privacy Act. Mark McCann, Manager of Public Health Laboratory in the Newborn Screening Program testified before the Minnesota Senate that “the number of parents who have given consent to store…the residual dried blood spots with the Minnesota Department of Health is zero” and despite the Minnesota Genetic Privacy Law requiring that the MDH obtain parental consent for retention and research use, according to McCann, actually obtaining consent is not a current practice.

The memorandum also describes the intersection of problematic shortcomings related to parental requests for destruction, “de-identification,” and research sharing with outside entities such as MDH’s $6 million contract with the Mayo Clinic. According to plaintiffs’ affidavits, some parents were not even told that the specimens would be retained and used for genetic research purposes (undermining the ability to request their destruction) or their requests for destruction were not honored. MDH refers to its system of storing and sharing the NBS as “de-identified” but it provides linked and coded NBS to the Mayo Clinic, retains the key to re-link the specimens (meaning they are not in fact “de-identified,”) and admits there is no standardized procedure for this process.

In Texas, the companion case Beleno et al. v. Texas Department of State Health Services et al. (TDSHS) asserts that individuals have a fundamental privacy interest in their DNA, which exists even absent any statutory provision specifically recognizing genetic privacy. On September 22, 2009, the Texas district court judge denied TDSHS’s motion to dismiss, meaning the court would schedule a hearing for the merits of the case unless the parties arrived at an alternate settlement. The Texas Civil Rights Project which represents plaintiffs indicated that the parties are in settlement negotiations, but as of November 20, 2009, parties have yet to sign an agreement.

Even if parties reach a settlement, Beleno et al.’s arguments used in this case merit pause and further examination. In plaintiffs’ response to defendants’ motion to dismiss, Beleno et al. argue that the defendants committed unlawful and unreasonable seizure, because although parents may have consented to providing the NBS for screening tests, they did not consent to the retention and research use of NBS. Even if the NBS were de-identified, plaintiffs argue that TDSHS unlawfully seized the specimens if they did not obtain actual parental consent, highlighting that issues of consent and privacy are both distinct yet inextricably linked both in practice and legal analysis. Importantly, Beleno et al. also argue that passive storage even absent any additional research or sharing of NBS constitutes a per se violation of Constitutional and tort privacy principles given the fact that they contain deeply private medical and genetic information.

Independent of how these courts proceed, these two cases continue to ask:

• Do, or should, we have a property or privacy interest arising from tort or Constitutional principles in our genetic material (here, in the form of NBS) that requires consent to transfer this interest?
• Can we minimize the potential for future litigation simply by obtaining parental consent for retention and research use?
• Would creating codified exemptions for state health departments deter or encourage privacy advocates from litigation?
  

-Katherine Drabiak-Syed

Data Sharing and Privacy: In the News

Roughly one year after the NIH and The Wellcome Trust restricted access to genome-wide association studies [see: Modifications to Genome-Wide Association Studies (GWAS) Data Access (NIH, August 28, 2008 - PDF)], data sharing is back in the news. In August, researchers in Tel Aviv and Berkeley announced a new method of protecting the privacy of individuals in genetic research studies. In the press release, one of the authors, Eran Halperin, alludes to the PLoS Genetics paper that led to the NIH's data access modifications (Homer N, et al.). As Halperin sees it, the "knee-jerk response stymied potential breakthrough genetic research." Perhaps he hopes that the new privacy approach will re-open the doors of safe data sharing. Halperin's method (published in Nature Genetics) uses a likelihood ratio (LR) test to measure the risk of exposing a single individual within a data set. Ultimately, the LR test limits the number of SNPs shared and thereby decreases the chances of privacy losses. If you would like to give this method a try, the software is available online (with registration) at SECUREGENOME.

In related news, The Toronto International Data Release Workshop (Genome Canada, May 2009) recently recommended the "rapid release of prepublication data" to speed the pace of scientific discover. The recommendation was published in a special, data sharing edition of Nature. The Workshop cites the Human Genome Project as an example of how sharing data leads to public benefits: "This experience ultimately demonstrated that the broad and early availability of sequence data greatly benefited life sciences research by leading to many new insights and discoveries, including new information on 30 disease genes published prior to the draft sequence." In a note addressing the human subjects concerns, the Workshop acknowledges the privacy risks: "Data about human subjects participating in genetic and epidemiological research require particularly careful consideration owing to privacy-protection issues and the potential harms that could arise from misuse. ... [F]or clinical and genomic data that are associated with a unique, but not directly identifiable individual, access may be restricted."

Will these developments (a proposed technical solution to the privacy barrier and a reaffirmation of the social benefits of data sharing) encourage the NIH and The Wellcome Trust to reduce some of the restrictions on data sharing? (I’d say: not yet.) While the safety of data sharing may be increased with technical solutions, it seems unlikely that all privacy risks will be eliminated. After all, if I share something "private" with you (or with anyone else), it's not so "private" any more. At the same time, if data access is restricted (for example, by using smaller, "safer" data sets), the public benefit of sharing resources declines. Clearly, we are looking for a way to eat our cake and have it too; protecting the individual's privacy while sharing for common benefits. Perhaps we should ask ourselves, what are the risks that we are willing to impose on individuals for the benefit of the common good? As an individual, exactly how private is your privacy? And at what cost?

References:

Homer N, et al. Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays. PLoS Genet. 2008 Aug 29;4(8):e1000167. PMID: 18769715

Sankararaman S, Obozinski G, Jordan MI, Halperin E. Genomic privacy and limits of individual detection in a pool. Nat Genet. 2009 Sep;41(9):965-7. Epub 2009 Aug 23. PMID: 19701190.

Toronto International Data Release Workshop Authors, et al. Prepublication data sharing. Nature. 2009 Sep 10;461(7261):168-70. PMID: 19741685.

Other Predictive Health Ethics News

Nikki Tait. Pan-European biobanking moves closer. Financial Times. September 16, 2009.

Michael Rugnetta and Whitney Kramer. Paving the Way for Personalized Medicine. Science Progress. September 14, 2009.

Daniel Vorhaus and Lawrence Moore. What happens when a personal genomics company goes bankrupt? Genetic Future. September 14, 2009.

Caroline Wright. HGC public consultation on DTC genetic testing services. PHG Foundation News. September 8, 2009.

Over Ninety Per Cent Of Pathologists Find Research Rules Too Complex. Medical News Today, September 8, 2009.

Jane E. Brody. Buyer beware of home DNA tests. The New York Times. August 31, 2009.

Brad Therrell, Harry Hannon, Don Bailey, et al. Considerations and Recommendations for a National Policy Regarding the Retention and Use of Dried Blood Spot Specimens after Newborn Screening. Genetic Alliance. August 21, 2009.

Turner Ray. Lack of Physician Education, Genetic Counseling Could Ruin Value Proposition of PGx Testing, Insurer Says. Genomeweb: Pharmacogenomics Reporter. August 12, 2009.

The Genetics and Public Policy Center. Center publishes new survey of state false advertising laws. dnapolicy.org, August 11, 2009.

• Related: State Laws Could Cover DTC Gene Testing. GenomeWeb Daily News, August 13, 2009.

- J.O.

Critiquing HHS's Summary Recommendations on Newborn Blood Spots: Opt-Out is Not Optimal

On August 21, 2009 the Department of Health and Human Services (HHS) issued “Considerations and Recommendations for a National Policy Regarding the Retention and Use of Dried Blood Spot Specimens after Newborn Screening” relating to storage and use of newborn blood spots (NBS). The agency recommendations discussed assurances of privacy and confidentiality for storage and advised that each state should disseminate policies that promote public trust, emphasize transparency, and encourage informed public participation. It promulgated seven recommendations, including: all states should have a policy in place to address NBS retention, use, and research access; states should provide educational materials to the public and expecting mothers on use and potential future uses; and states should adopt an opt-in or opt-out model if NBS are available for any process outside the screening process or internal screening test development.

However, parental attitudes and pending litigation in this area suggests that the agency’s goals to promote public trust and encourage public participation may not be achieved with these guidelines.

Tarini, et al.’s survey in Public Health Genomics examined parental willingness to permit NBS storage and research. If permission is obtained, 76.2% of parents were very or somewhat willing to permit use of NBS for research, but if permission was not obtained, only 28.2% of parents would be very or somewhat willing to permit use of NBS for research. These results show most parents will permit retention and use as long as they are asked, reiterating the importance of respecting a person’s autonomy and dignity to permit or refuse participation.

Two pending cases in Minnesota and Texas confirm the results of Tarini et al.’s study and demonstrate that collection, retention, and research use of NBS and associated PHI even if conducted or facilitated by the state department of health is biobanking research. Accordingly, it should be governed under the Common Rule and Privacy Rule, meaning actual consent is not only optimal but perhaps required.

In June 2009, Minnesota parents (Bearder, et al.) filed a civil complaint against the state of Minnesota and the Minnesota Department of Health (MDH, et al.) for failing to comply with the Minnesota Genetic Privacy Act and continuing to store and use NBS without consent. The complaint contains a litany of claims, including violation of the Minnesota Genetic Privacy Act, eight tort claims, fundamental right claims, and government taking. Plaintiffs’ claims for intrusion into seclusion, fraud and misrepresentation, and government taking summarize the essence of the alleged injury:

• A person has a privacy interest in his or her own blood (acting as guardian for the newborns’ blood) and the medical information that may be obtained from it;
• The MDH intentionally omitted that the NBS was not taken solely for screening but would be retained and used, knew that parents would provide them NBS for the purpose of screening, and parents relied on these representations but would not have consented to providing MDH the NBS had they known; and
• Blood and genetic information constitute a “valuable national resource” and a represent a “gold mine” for the state and affiliated researchers that the government cannot automatically appropriate even in the name of public health research.

In a prayer for relief, plaintiffs request damages as statutorily indicated, request an injunction, and a cease and desist order against MDH. Minnesota’s history confirms that NBS collection, retention, and research falls within its Genetic Privacy Act, meaning a separate consent is required for each activity; and importantly, that the research conducted or approved by the Minnesota Department of Health is not exempt from these requirements.

In Texas, parents (Beleno, et al.) filed a civil complaint in March 2009 against the Texas Department of State Health Services (TDSHS, et al.) claiming TDSHS has no legal authority to retain and use NBS without consent. Beleno et al. assert this practice violates the privacy principles as well as violates the prohibition against seizure. Plaintiffs request that the court order the destruction of all NBS stored without consent (around 4.2 million samples) since it began the practice in 2002 or obtain retroactive parental consent. Additionally, plaintiffs seek an order to compel TDSHS to disclose for what purposes the NBS have been used and financial transactions involving the NBS.

New legislation TX HB 1672 that implements a compromise by using an opt-out system was signed into law and will take effect September 2009. It remains to be seen whether all Texas parents will agree with this solution and how the court will address the issue of what to do with the 4.2 million NBS that were stored without consent.

If NBS constitute such a valuable resource, then it is incumbent on us to encourage transparency of state health departments’ intentions by educating parents on the importance of using NBS for research purposes, how the state plans to use them, and respect parents enough not to circumvent the law’s intent but actually obtain their consent. If not, parents could turn to the judicial system and potentially prevail, creating a costly and lengthy legal battle for the state health department as well as jeopardizing the current collection of NBS.

-Katherine Drabiak-Syed