Legislatures Race to Define Rights and Obligations Relating to Genetic Information: Avoiding Another Bearder

California is the latest state to take steps toward defining permissible uses and restrictions relating to obtaining, retaining, and sharing individuals’ genetic information.  Senator Alex Padilla recently introduced Senate Bill 1267, the Genetic Information Privacy Act, designed to protect individuals against surreptitious testing of their genetic material without consent.  SB 1267 is a comprehensive piece of legislation which would require a specific authorization to obtain, analyze, or disclose genetic information unless otherwise exempted or allowed by law (exemptions include activities such as newborn screening, duties of the medical examiner, using some types of data for research, and law enforcement uses).  The legislation also contains a civil penalty structure for violations and provides a private right of action for aggrieved individuals who suffer economic, bodily, or emotional harm proximately caused by such violations. 

California’s legislation classifies genetic information within a privacy framework and seeks to increase individual control by requiring the individual to understand the purposes of how the information will be used and stored, as well as which entities have access to the information.  Other states such as Alabama, Massachusetts, South Dakota, and Vermont have introduced similar legislation that govern the collection, retention, and sharing of DNA, genetic information, and or genetic test results.  These states differ in their comprehensiveness and scope- from South Dakota’s paragraph long House Bill 1260 to Alabama’s extensive eleven page House 78.

Unlike California, these states seek to classify DNA, genetic information, and or genetic test results within a property law framework rather than under the umbrella of privacy, which carries distinct legal requirements for transfer, use, and retention.   As legislatures race to define individual rights within existing  legal concepts, they should be well aware of property law’s limitations at upholding individual autonomy while appropriately and efficiently defining permissible research uses depending on how the legislature crafts the language of the statute. 

As we witnessed in the progression of the Bearder v. Minnesota litigation (related to collecting, retaining, and disseminating newborn blood spots) even if a law is seemingly clear, individuals, clinicians, and investigators still may face confusion over relevant terminology and obligations relating to the meaning of key terms and the scope of consent exemptions.  (Blogs and article on that topic here.) Specifically, will these statutes govern the collection, use, and dissemination of genetic information after the analysis of a genetic test using a blood sample or will the language broadly address collecting blood samples, DNA, and genetic test information?  Public health officials, investigators, and individuals have vehemently disagreed over the meaning and scope of these terms and when consent is required.  Individuals have claimed immense injury to privacy and dignity when public health officials and investigators collect, retain, and disseminate their blood samples without consent, while public health officials and investigators decried setbacks to research efforts after they were legally ordered to destroy their improperly obtained blood samples. 

Last November, the Minnesota Supreme Court clarified its state Genetic Privacy Act, holding that an individual’s blood sample contains biological information and biological information falls within the definition of genetic information.   That is, any statutory references to genetic information also applies to blood samples.  It appears that the majority adopted the Plaintiffs' argument  that a blood sample contains DNA and the structure of DNA is genetic information, which means statutory requirements governing the collection, use, storage, and dissemination of genetic information necessarily include blood samples.   

Although this seminal holding is jurisdictionally limited, defining the meaning and scope of biological specimen, blood sample, DNA, and genetic information requires painstaking semantic precision.  Furthermore, the concurrence/dissent in Bearder demonstrates even keen legal minds apply varying logic to interpret terminology and arrive at starkly divergent conclusions.  Defining these terms becomes even more pressing should this or similar state legislation pass because it carries the compliance incentive of a penalty structure for violation.  Legislators should take note of litigation in this area and aim to meticulously and unambiguously define relevant terminology so individuals, public health officials, and investigators can understand their interrelated rights, obligations, and statutory exemptions.  

--Katherine Drabiak-Syed

Oklahoma Legislature Requires Express Consent to Retain Newborn Blood Spots

During the past several months, states continue splitting on the issue of how to approach their state health department’s retention and research use of newborn blood spots (NBS).

On September 13, The Edmond Sun ran an article on Oklahoma’s enrolled Senate Bill 1250, a new law that prevents the state health department from storing and using NBS. The text of the law reads:

“A laboratory, medical facility, hospital, or birthing place is prohibited from the unathorized storage, transferring, use, or databasing of DNA from any newborn child without express parental consent.

It being immediately necessary for the preservation of the public peace, health and safety, an emergency is hereby declared to exist…”

Sen. Nichols explained he sponsored the bill as a deliberate pre-emptive measure in response to ethical and privacy concerns related to unauthorized “databasing” and use of NBS in other states. According to Sharon Vaz, the Oklahoma State Department of Health genetics coordinator, Oklahoma only retains the samples for 42 days and does not have plans for long term NBS retention or to use the NBS for research purposes.

Oklahoma’s law demonstrates that different jurisdictions are arriving at starkly divergent interpretations of seemingly simple definitions such as what is or is not encompassed in the meaning of DNA. SB 1250 refers to storing or using DNA, and Sen. Nichols unequivocally explains that he intends this to encompass the retention of NBS- a blood sample. This interpretation is significant because it means the law will use the term DNA to include biological materials from which DNA can be derived.

Unlike Sen. Nichols’ inclusive approach, in late August the Court of Appeals in Minnesota affirmed that NBS do not fall within the definition of “genetic information.” We previously wrote on the Bearder case here. Minnesota has determined that biological samples (such as NBS) that contain DNA and genetic information are not genetic information.

This distinction of separating the source of raw materials (the blood) used for research from the substance of the raw materials (the DNA) is also playing out in the stem cell legal battles- although here, the debate centers around using embryos to create embryonic stem cells v. research using embryonic stem cells. In both arenas, interpreting uncertainty or disagreement of how to apply a law to favor rsearch connects to the decision to splice parts of the process to circumvent barriers to using raw materials.

SB 1250 attempts to rectify several terms that have been disputed when determining the rules for retaining and using biological materials from newborns. Although Sen. Nichols references the law with regard to NBS, the language broadly refers to “DNA from any newborn child,” which would include NBS as well as other biological samples such as umbilical cord blood that contains DNA. This would mean that if an Oklahoma hospital or a partnering research entity wanted to retain and use other biological samples containing DNA from the newborn, the hospital would need to seek parental consent. Furthermore, this law clarifies that the hospital and state health department are not exempt from compliance with the law under a research exception.

Interestingly, the text refers to the law as necessary to preserve the “public peace, health and safety” in Oklahoma. The law is set to be codified in the Oklahoma statute in the same location as crimes consisting of public disturbances, safety hazards, and physical violations against one’s person- examples of tangible harm to indivduals and society at large. This classification itself nods a recognition to the Beleno case in Texas, where plaintiffs’ emphatically argued unauthorized retention of NBS constituted a serious privacy violation and an unlawful seizure of one’s deeply private medical and genetic information.

Whether other state legislatures and health departments agree with Oklahoma’s requirement for express parental consent or the current state of “emergency,” this law reminds us that each jurisdiction should adopt a prospective law or departmental policy to address these questions in a deliberate manner.

--Katherine Drabiak-Syed

California Department of Public Health Orders Changes to Berkeley's Genetic Test Program

Last week Berkeley altered its Bring Your Genes to Cal Program to stop the genetic test results from being disseminated back to participating students in response to an order from the California Department of Public Health (CDPH). Berkeley will still hold discussions and lectures based on the aggregate information as previously planned. [See our posting on the Bring Your Genes to Cal Program here.]

On August 11, Berkeley and CDPH met to discuss the program’s compliance with the California Business and Professions Code which requires that a physician order clinical laboratory tests. In a statement to CDPH, Berkeley asserted its program should fall under an exemption for labs performing tests as research where the results are not reported to patients as part of a medical or health assessment. Berkeley maintained that these statutory requirements were not applicable to its program because Bring Your Genes to Cal constituted an “educational experiment,” students are not “patients,” and the three specific gene variants tested are not disease related.


Despite these claims, the program would have returned genetic test results back to each student, which should be defined as part of a health assessment because the program directed students to use these results to inform their dietary and nutritional choices as well as make personal health decisions. According to Dean Schissel’s message to students in the informed consent video, these genetic test results would then allow them to take measures to improve their health such as eating more or less of a particular food, or avoiding alcohol if their test results showed an ethanol “allergy.” Schlissel’s assertion stretched the meaning of California’s exemption in denying that this “experiment” constitutes clinical laboratory tests or that this information is medically significant. Arguments over statuory construction closely parallel the current federal regulatory loopholes relating to DTC genetic tests.

As genomeweb observed, the semantic debate between Berkeley and CDPH is strikingly similar to the volleys between CDPH and DTC genetic test companies that occurred back in 2008. In June of 2008, CDPH had responded to consumer complaints and sent out thirteen cease and desist letters to DTC genetic testing companies, asserting that their policies did not comply with licensure requirements set forth in California law. Two of the targeted companies, 23andMe and Navigenics, asserted they offer an “informational service” providing personal genetic information and not “medical testing services,” so they did not need to obtain a license. CDPH agreed and granted licenses to Navigenics and 23andMe in August 2008.

Now, with Congress and the FDA scrutinizing the federal regulatory requirements, CDPH seems to be responding to the current political shift of opinion and the uncertainties related to providing genetic test results without a physician intermediary and oversight of the test's accuracy and validity. Or perhaps CDPH agreed with concerns in the defeated California Assembly Bill 70. This bill would have urged state schools within the California State University and University of California system from requesting students’ DNA for the purpose of genetic testing.

Defeated AB 70 also raised specific privacy concerns stemming from a university collecting students’ DNA samples for genetic testing and retaining students’ coded genetic information. Although Berkeley's program will incinerate students’ DNA samples following testing, it plans to keep students’ genetic information for further study. Data attack in GWAS studies exemplifies the principle that our understanding of data security relating to genetic information is uncertain, and we have continually underestimated the potential for security breaches. Dean Schlissel’s unwavering promises of absolute privacy seems naively optimistic given what we know in this area.

It seems this “teaching study” has given Berkeley and its freshmen more than they could have anticipated. In addition to the campus lectures about genetics and personalized medicine, students have already learned the ethical and legal complexities associated with emerging technology- the varied parties who have a say, the definition debates, and the unpredictability of the resolution.

--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

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

New German Law on Genetic Testing: More Than Just a German GINA

EuroGentest has recently posted an unofficial English translation of the recently passed and soon to be enacted German legislation, the Human genetic examination act (Genetic diaganosis act - GenDG) [PDF - 162 KB]. The new law addresses genetic examinations (including consent, duty to inform, counselling, and disclosure), genetic testing and insurance contracts, workplace issues (including discrimination), and criminal penalties (prison time, in some circumstances, and fines of up to EURO 300,000).

Hat tip: CanGeneTest e-Newsletter, August 3, 2009.

- J.O.

The Best Predictive Health Ethics Blogs - June 2008

California and Direct-to-Consumer Genetic Testing:

California's decision to send cease-and-desist letters to thirteen direct-to-consumer genetic testing companies (including 23andME, deCODEme, Knome, and Navigenics) ignited a blogging wild-fire of mostly outraged responses. Some of the more widely read expressions of protest were blogged at Wired Science and include Thomas Goetz's much-echoed Attention, California Health Dept.: My DNA Is My Data (17 June 2008). For an alternative reaction see Steve Murphy's posts on the topic at Gene Sherpa, which include: Do you hear that sound Mr Anderson? (15 June 2008), A$$ Kicking (17 June 2008), and R'Uh-R'Oh Shaggy!!! (17 June 2008). Although many of the replies to Murphy's posts offer only more expressions of outrage, Daniel MacArthur at Genetic Future engages Murphy in a thoughtful exchange beginning with California cracks down on genetic testing companies (15 June 2008) and Cat-fight over California (18 June 2008). Finally, for a good overview of the news and blogging on the subject, see Blaine Bettinger's recent post The Genetic Mess in California - A Round-Up, and My Thoughts (30 June 2008) at The Genetic Genealogist.

Employee Wellness

Matt Mealiffe of DNA and You writes in response to the news that Japan will require companies and local governments to "measure the waistlines of Japanese people between the ages of 40 and 74 as part of their annual checkups" with the standard of "33.5 inches for men and 35.4 inches for women" (see Norimitsu Onishi, Japan, Seeking Trim Waists, Measures Millions. The New York Times. 13 June 2008). In Mealiffe's assessment (14 June 2008), mandatory waistline measurement is "bold social policy" which may be, however, genetic discrimination.

In an unrelated post on a similar topic, Jane Sarasohn-Kahn of Health Populi reports employee attitudes regarding the privacy risks of employers' wellness programs. Writing in Is worker wellness a privacy issue? (5 June 2008), Sarasohn-Kahn summarizes the findings of a recent report: "Employees are concerned that this information could be used to reduce benefits or for even more egregious purposes". An overview of the findings, "Health and Wellness: the shift from managing illness to promoting health" is available from the Center for Studying Health System Change [PDF].

Law & Policy

Andrew W. Torrance of BioLaw: Law and the Life Sciences reflects on the sometimes presumed amoral status of patent law in U.S. – a status that is not presumed in Europe. In Patently Immoral Genes (2 June 2008), Torrance shares the recent, related work of the European Society of Human Genetics ("ESHG") which "has issued recommendations that would severely limit patents on genes in the European Patent Office (EPO) and member states of the EPC." According to Torrance, "the ESHG recommends that the EPO establish an 'ethics committee' to police the patentability of controversial technological innovations". He believes that this news may be of interest to policy makers in the States, including: California Democrat, Xavier Becerra, a sponsor of the "Genomic Research and Accessibility Act" (H.R.-977 – Thomas | GovTrack.us).

Nick Agar writes at What Sorts of People on a report by The Bioethics Council of New Zealand on the completion of its program Who gets born? Pre-birth testing. The report responds to the New Zealand government's decision to fund pre-implantation genetic diagnosis for couples with a high risk of conceiving a child with a genetic disorder. In NZ bioethics council (27 June 2008), Agar notes that "the emphasis is very much on facilitating parental choice, with health professionals given the role of supplying parents with the information they need to make choices consistent with their values". He observes that the Council made a deliberate effort to solicit participation from a wide range of "interested parties", but cautions that there may be "a bit of fallacy of bureaucratic representativeness here – if a committee’s composition approximately matches the representation of various communities in the general population then its pronouncements must be representative of the viewpoints of those different communities".

Personalized Medicine

Reflecting, in part, on the prevalence of "Personalize Medicine" in the recent 2008 BIO Convention, Jennifer Miller at Bioethics International defines the topic and introduces some of the ethical and legal issues. She identifies six ethical issues in Personalized medicine: an introduction, its promises and the ethics (26 June 2008):

(1) just access to, allocation and application of the new technologies, (2) privacy concerns, (3) respecting parties’ autonomy, (4) obtaining quality informed consents, (5) intellectual property rights, particularly in connection with bio-banking, (6) overall resource allocation and prioritization questions ….

Reviews

Bonnie Green, writing for BioethicsBytes (17 June 2008), reviews "An Adventure into Ourselves", the third episode of a four-part television series entitled DNA: The Human Race (Channel 4, 2003). [BioethicsBytes hosts and reviews resources for ethics education. The project aims "to assist in the teaching of bioethics, with particular emphasis on multimedia materials (film, TV, streamed media) as case studies".] Green's thorough review of "An Adventure into Ourselves" marks interesting quotations and highlights the social and political context of the Human Genome Project (HGP). She observes that the series and the episode form "an excellent basis for teaching both the science and bioethics of the HGP and large scale sociotechnical projects". The post also includes YouTube footage from related programming about the X-Prize.

Writing for Gene Expression, "Herrick" reviews Heredity and Hope: The Case for Genetic Screening, by Ruth Schwartz Cowan (Harvard University Press: 2008. 270 pp. $27.95, £18.95). This blogger points to three aspects of Cowan's book on genetic screening. In Heredity and Hope by Ruth Schwartz Cowan (11 June 2008), "Herrick" observes that Cowan distinguishes contemporary genetic medicine from mid-20th century eugenics by 1) showing that "genetic screening is a bottom-up social phenomenon, not a top-down mandate", 2) highlighting the "pro-natalist" aspects of contemporary genetic screening, and 3) sharing happy-ending stories about the proper use of this technology. In conclusion, "Herrick" observes:

Functionally, Cowan does the same thing for genetic screening that The New Republic did for tough-on-crime policies in the 80's and 90's: Cowan does some liberal hand-wringing while telling the reader that no, you're not becoming a Brownshirt if you agree to an amnio.

The BiDiL Debate: Can "race" serve as a proxy for groups with shared "genetic" characteristics?

Following the debate surrounding the FDA's 2005 approval of BiDiL – a drug to be marketed to treat African-Americans at risk for heart failure – David e. Winickoff and Osagie K. Obasogie propose regulatory policy for future race-specific drug development. Writing in a letter published in Trends in Pharmacological Sciences [Race-specific drugs: regulatory trends and public policy. 2008 Jun;29(6):277-9. Epub 2008 Apr 29 | PMID: 18453000 - CiteULike (excerpt)], the authors argue: "race-specific indications should be rejected unless clinical trials can demonstrate convincingly that the drugs are both better than existing treatments for a specific group and no better than existing treatments for non-specified groups". They conclude that these enhanced regulations might help to reduce health disparities while protecting groups from market exploitation: "Race can be used as a proxy for the group most likely to benefit from a drug as long as the effect is not to deny others valid treatments". In other words, "Pharmaceutical science and biomedicine most certainly should not be colorblind. But they also must not be 'color-struck'".

Unlike one's genetic information, racial identity is a social-construct – so, using race as a proxy for individuals with common genetic characteristics is a messy and controversial process. In this case, would it make sense at all to say: genome-specific "indications should be rejected unless clinical trials can demonstrate convincingly that the drugs are both better than existing treatments for a specific group and no better than existing treatments for non-specified groups"?

Would such a standard be useful or does it merely re-state the obvious? – J.O.

GINA, The Good News: Engaging the Public

This is the third post in a series of posts in which I share what I see as the ups and downs of the Genetic Information Nondiscrimination Act of 2008 (GINA or H.R. 493). In this post I address a potential positive:

A little discussed portion of GINA may be cause for celebration. Title II, Section 208, Subsection (b) of GINA calls for the establishment of the Genetic Nondiscrimination Study Commission after GINA has been enacted for six years. The purpose of the Commission is to evaluate the status of genetic science, genetic discrimination, public perception, and other factors, and to make recommendations to Congress regarding possible future legislation. Here, it would seem as though Congress has exercised a reasonable amount of foresight. Scientific knowledge is expanding at an amazing rate; faster than society and its laws can react, resulting in public fear and apprehension. Public fears are important and they must be listened to; public fears shouldn't always determine legislative action, but they cannot be brushed aside or ignored. In this case, Congress seemed to understand this dichotomy. They did the research. They listened to experts, and they acted. – Sam Beasley

The Best Predictive Health Ethics Blogs - May 2008

It was a busy month for predictive health news: the president signed GINA, Francis Collins announced his eminent retirement, bloggers reported from important conferences at Case Western and Cold Spring Harbor, and Google announced the debut of Google Health. These events, and others, are reflected in this month's edition of the best blogs on the ethical issues of predictive health.

Are you diseased? Pre-diseased? Potentially diseased? Greg Dahlmann, blog.bioethics.net. 6 May 2008.
In this insightful post, Dahlmann examines how predictive health is changing our concept of disease. When, exactly, does increased risk = illness? Dahlmann writes:

So we're moving from the concept of disease as a state of impaired function to it representing particular sets of probabilities. In the past you were sick when you had a heart attack. Today, you're sick -- or pre-sick, perhaps -- when you have high cholesterol. What about when it's possible to identify constellations of genes that significantly increase your chances of having high cholesterol, or a heart attack. Would that be considered a disease?

Also see Dahlmann's follow up post on "previvors": Blood Matters. Greg Dahlmann, blog.bioethics.net. 11 May 2008.

NHGRI Director Francis Collins to Step Down on August 1. Hsien-Hsien Lei, Eye on DNA. 28 May 2008.
Lei shares the news the Francis Collins will retire from his post this summer and that Alan E. Guttmacher will become acting director. Lei also some thoughts on Collins' book The Language of God.

In All Fairness. Fred Trotter, Fred Trotter: My life and thoughts, often about FOSS in medicine. 23 May 2008.
Following the news coverage on the release of Google Health, Fred Trotter weighs in on the privacy questions. Trotter argues that Google is not a health care provider and is, therefore, not covered by HIPAA. He writes:

Both Google Health and HealthVault are designed to make the process of dissemination of your health information to people you want them to be disseminated to easier. Are they doing that in a secure, privacy respecting way? Excellent question; fodder for further posts. Should they be covered by the same laws that cover your healthcare providers? No.

Workman's Compensation, Stereotypes and GATTACA. Steve Murphy, Gene Sherpas: Personalized Medicine and You. 10 May 2008.
Murphy addresses a few of the potential social consequences of predictive medicine, by examining the following scenario:

Young person goes to 23andME/Navigenics/ETC (They just may add this immediately)....gets predictive testing indicating that he is at a 300 fold increased risk of herniating a disc in his back. Avoids manual labor (plays video games all day) never herniates the disc. Did we do society a service?

23andMe, deCODEme and Navigenics at Cold Spring Harbor. Daniel MacArthur, Genetic Future. 9 May 2008.
MacArthur reports, first hand, from the "Biology of Genomes" meeting at Cold Spring Harbor. In addition to the big players in the consumer genomics movement, the speakers at the event included some ethics and policy experts, like Kathy Hudson from Johns Hopkins. Hudson, MacArthur notes, "responded to the problem of patients being given data of very limited predictive value with a very sensible solution: 'In the absence of demonstrable harm, the default should be to provide the information.'"

Genetic testing ethics - consent forms becoming incomprehensible. Elaine Warburton, Genetics and Health. 7 May 2008.
Warburton covers the Translating ELSI, Ethical Legal Social Implications of Human Genetics Research conference at Case Western University in Cleveland. In this entry she reports on Laura Beskow's comments regarding informed consent and the attitudes and concerns of research participants. Also see Warburton's related coverage of pediatric research ethics discussions at the conference in her post: Genetic Ethics - testing and storing our kids’ DNA. Genetics and Health. 7 May 2008.

The FDA ditches the Declaration of Helsinki. Stuart Rennie, Global Bioethics Blog. 6 May 2008.
Stuart Rennie of Global Bioethics Blog examines the implications of the FDA's decision to abandon the Declaration of Helsinki. While Rennie focuses on the potential impact of this decision on US research overseas, and not specifically on predictive health research, this decision may have far reaching consequences on clinical trials of any sort. Rennie concludes with the following verdict: "the decision would seem to encourage pharmaceutical companies to cut ethical corners when working abroad".

GINA Series: Irrational Bureaucratic Risk Abhorrence [Page 1]. Andrew Yates, Think Gene. 24 May 2008.
This is the first post of a (thus far) four part series on GINA. Each post begins with the introduction:

Recently, President Bush signed GINA, the Genetic Information Nondiscrimination Act, into law. GINA makes it illegal for employers or health insurers to discriminate based on genetics. Virtually the entire genetics community has lauds this legislation, yet few have written why it's wrong that employers and services review objective facts to make decisions. … “It’s not fair…” but why?

The Puzzling Consensus in Favor of the Genetic Information Nondiscrimination Act. Eric Posner, The University of Chicago Law School Faculty Blog. 6 May 2008.
In what may be the most influential post covered in this edition of the best predictive health ethics blogs, Chicago Law professor Eric Posner examines the GINA and asks some compelling questions:

Should the insurance company be permitted to offer the cheap insurance policy only to people who obtain a doctor's certification that a genetic test shows that they belong to the low-risk group? If you think that insurers should be able to discriminate on the basis of visible markers and on the basis of simple doctors' tests for the presence of dangerous diseases, then you should think they should be able to discriminate on the basis of genetic tests. There is no morally relevant distinction between looking at a person's blood for the evidence of infection and looking at his DNA for evidence of susceptibility to a disease. ... The only explanation for the enthusiasm for GINA is that there is an inchoate feeling among people that there is something wrong with the way the insurance market operates.

Medical Genetics Is Not Eugenics. Gabriella Coleman ("biella"), What Sorts of People. 16 May 2008.
Coleman responds to Ruth Cowan’s article in The Chronicle of Higher Education, “Medical Genetics Is Not Eugenics”. Although Cowan sees little value in thinking about the similarities of modern medical genetics and the mid-century eugenics movement, Coleman cautions:

Even if, as [Cowan] rightly states that genetic testing is oriented primarily toward easing human suffering, genetic testing is still entangled with fraught ethical questions about what types of life we value, what is acceptable human life, and what is not—the very sorts of questions central to eugenics.

GINA, The Bad News: Adverse Selection

This is the second post in a series of posts in which I share what I see as the ups and downs of the Genetic Information Nondiscrimination Act of 2008 (GINA or H.R. 493).

Although the legislation will hopefully do much to encourage research and protect predictive health patients, GINA is not all roses. The legislation has numerous critics who have good reasons to be critical. For starters, it sets the stage for adverse selection to occur in the health insurance industry.

Adverse selection happens when an information gap emerges between the beneficiary and the insurer; if the beneficiary knows much more than the insurer, then the insurer is unable to accurately assess the beneficiary’s risk. This information imbalance results in more claims being made than the insurer reasonably predicted. GINA facilitates this phenomenon by allowing beneficiaries access to genetic information, but denying it to insurers. If, for example, a beneficiary finds out from a genetic test that he has a significantly increased risk of developing prostate cancer, he would use that information in deciding whether or not to purchase insurance, but the insurer would be unaware of that increased risk in deciding in which group the individual should be placed, what rate he should be charged, etc.

This is potentially a big problem in the insurance industry, because insurers need to be able to accurately determine risk in order to prevent claims exceeding predicted levels. In the long run, inaccurate risk predictions in the industry will result in rate hikes, and rate hikes will drive healthier participants out of groups. In a the worst case scenario, this could start a downward spiral in the direction of group or insurer insolvency. - Sam Beasley

The Good News: GINA; The Bad News ... ?

A few weeks ago, congress passed the Genetic Information Nondiscrimination Act of 2008 (GINA), a much anticipated piece of legislation, nearly thirteen years in the making. Since the first version of the bill prohibiting genetic discrimination was introduced in Congress in 1995, the legislation has received significant bipartisan support and support from both the Clinton and Bush White Houses. Until recently, however, even in the face of all of that support, just a few members of Congress were able to block the legislation's progress. An agreement has finally been reached, and GINA is now the law of the land; it was signed by President Bush on Wednesday, May 21st.

Regular readers of PredictER Blog know that we have been following GINA; now that it has been signed, it's time to kick the tires and to see what we've got. This is the first of a series of posts in which I share what I see as the ups and downs of this legislation. I'll alternate between the good news and the bad news and conclude with an overall "thumbs up" or "thumbs down". For this post, some good news:

GINA really is a big deal, in the legislative sense. It provides (at least in theory) significant protection from discrimination based upon genetic information in the employment and health insurance contexts. Studies by the NIH and other institutions have revealed that the vast majority of the American public is afraid of being discriminated against in these arenas and believes that it would be wrong for employers and insurers to do so. Furthermore, additional studies have revealed that a significant number of people who would be likely to benefit medically from genetic tests choose to forgo them for fear that they will lose their job, or health care coverage depending upon the results. Along the same lines, many people are choosing not to participate in important research that requires subjects to undergo genetic testing out of fear of discrimination. Clearly, then, GINA should help to allay public apprehensions and to encourage both the pace of research and the practice of personalized medicine.

But … stay tuned for the "bad news". – Sam Beasley

Best Predictive Health Ethics Blogs - March, 2008

See February and January 2008 for prior reviews of the best predictive health ethics blogs. I have limited this month's installment to the ten posts. If, after reading these, you believe I've omitted a good post, please let me know. This month's blogs (listed chronologically) include some familiar names and a couple of new ones, including: Adventures in Ethics and Science, Synthesis, and Genetics & Health.

CF "success" story. Steve Murphy, Gene Sherpas. 1 March 2008.
Steve Murphy of Gene Sherpas seldom shies away from an ethical issue. Thus, when the NEJM reported the good news that "The number of infants born with cystic fibrosis in Massachusetts decreased by 50% from one four-year period to the next" (MedPage Today, 28 February 2008). Murphy acknowledged the upside, "children born with CF in the future may actually have less significant disease and may need to have less aggressive or less early interventions". He reminds us, however, that some doctors and patients now face heavy decisions:

The number of infants born with cystic fibrosis in Massachusetts decreased by 50% from one four-year period to the next according to this letter in the NEJM. They attribute this to the Newborn screening available in Massachusetts since 1999. … But here's what they don't say.....Preconception screening for this disease is important, but a highly personal choice. ... despite what the ACMG and ACOG say. There are some children who are doing just fine with CF. As for adults with CF like the 74 year old patient who I diagnosed a few years ago, I am certain they would not want to have never been born.

Should Researchers Share Data? Janet D. Stemwedel, Adventures in Ethics and Science. 3 March 2008.
Janet Stemwedel of Adventures in Ethics and Science comments on the widely discussed Andrew Vickers essay in The New York Times – "Cancer Data? Sorry, Can’t Have It" (22 January 2008). Stemwedel does an excellent job of highlighting the importance of data sharing for the success of translational research. She also acknowledges the research subject's contribution to this research and the exposure to risk that they have assumed. Stemwedel writes:

[R]isk is supposed to be offset by the benefits of the knowledge gained from the research. If that data sits unanalyzed, the benefits of the research are decreased and the risks undertaken by the human subjects are harder to justify. Moreover, to the extent that sitting on data instead of sharing it requires other researchers to go out and get more data of their own, this means that more human subjects are exposed to risk than might be necessary to answer the scientific questions posed in the research.

How Private is Private? Is Google a covered entity? Cheryl Lew, Women's Bioethics Blog. 4 March 2008.
After observing that HIPAA was not written with Google's emerging patient managed, personal health records in mind, Cheryl Lew of Women's Bioethics Blog wonders if additional government protections might be required. Lew writes:

[W]ill Google patients be subject to advertising spam or other intrusive advertisement adduced from their prescription lists? What guarantees that the “client” (read patient lists) won’t be sold to Pharma companies as yet another means of developing data bases about physician prescribing patterns? Who is going to regulate these issues? Google is a great search engine—I use it all the time! But I’m not sure I want to use it to manage my healthcare information.

Genomes of the Rich and Famous. Jesse Reynolds, Biopolitical Times. 5 March 2008.
Reacting, in part, to "Gene Map Becomes a Luxury Item" (Amy Harmon, The New York Times. 4 March 2008), Reynolds was the only blogger that I know about that picked up on the irony in drive towards celebrity genomics. Reynolds observes:

The prospect of biotechnology companies capitalizing on genetic information in order to develop profitable products without properly compensating the studied populations brings to mind biocolonialism, in which politically and economically vulnerable indigenous groups are exploited. But a growing convergence of genomics and information technology may lead, ironically, to the genetic "exploitation" of society's most elite.

The moral manipulation of Gattaca. Daniel MacArthur, Genetic Future. 6 March 2008.
Daniel MacArthur of Genetic Future is becoming a regular here in the "best ethics blogs" series. This month MacArthur introduces (with help from Black Belt Bayesian) us to an essay on one of the favorite films for bioethics classrooms—Gattaca:

A man is given strong medical evidence that he will die from a heart attack if exposed to the exertions of space travel, thus risking how own life and the lives of his crewmates. Ignoring this evidence, he fakes his way into astronaut training - and inexplicably, we cheer him on. How did the makers of Gattaca steer us towards this bizarre response?

The full essay, by Neven Sesardic and forthcoming in The Routledge Companion to Philosophy and Cinema, 2008, is available online: Gattaca (PDF – 209 KB).

Genetic testing - ‘recreational genomics’ or the future of diagnostics? Elaine Warburton, Genetics & Health. 18 March 2008.
Reacting to editorials in The New England Journal of Medicine and The British Medical Journal, Elaine Warburton of Genetics & Health acknowledges the limitations of the current methodologies, but notes that "introducing innovative genetic testing technology has to start somewhere". Warburton observes that 23andMe and other genomics companies are taking "huge financial and clinical risk[s] in bringing these tests to market". Warburton sees the uncertainty involved as merely a part of the ongoing cycle of research and development:

The tests are in their infancy and each of these companies are transparent in advising their customers of this fact. That said, massive scientific research continues to take place to build on the knowledge base of these tests, so that they may be refined. This process will never end.

Also see Warburton's related post: Ethical guidelines for whole genome studies. 26 March 2008.

The G.I.N.A. could be a bad thing for healthcare. William Gunn, Synthesis. 20 March 2008.
William Gunn of Synthesis was one of the few, perhaps the only, blogger brave enough to buck the current dogma on value of GINA. After reading Marcelino Fuentes's letter in Nature, "How genetic censorship would harm everyone" (PMID:18354455), Gunn agrees, but notes that: "This is all jumping the gun a little" (I hope that's not a pun) "because actual rock-solid, high-confidence correlations between a genetic feature and a disease are still rather rare, but one thing’s for sure: The better you see what’s ahead, the better you can plan for it (whether a insurance company or an individual), and having a good plan leads to better outcomes for everyone". Gunn, however, does not have a problem with acknowledging the potential inequities: "Everyone’s worried about enabling social injustice, but it can’t really be said that our current insurance system in which many are so under-served is really all that great to begin with, so let that temper your thoughts, as well".

So, what do you think? Are Fuentes and Gunn right?

Your personal health: Crowdsourcing healthcare - Pitfalls and possibilities. Deepak Singh, bbgm. 25 March 2008.
Although Deepak Singh writes more often about technology, his comments on the progress of personalized medicine and the feasibility of predictive health are usually thought provoking. In this post Deepak reacts to the many consumer privacy concerns and asserts a firm position on data ownership:

Whether it be personal genetics, or social health, our efforts must focus on consumer education, consumer privacy and perhaps most of all data ownership. Who owns the data? That is the most important question. As has been said before in these parts, we essentially need some sort of license for personal health information that establishes ownership with the person whom the data belongs to, i.e. you or I and who has access and under what circumstances. That’s where education comes in. We need access to a lot of patient information and genetic profiles for personalized medicine to be successful.

Well said, Deepak, but do you also think that patient control and "ownership" of data will improve the pace medical research?

Bringing the genome home ... but why? Sue Trinidad, Women's Bioethics Blog. March 26, 2008,
Sue Trinidad, also a regular here in the "best ethics" series, reflects on the need for oversight in the future of genetic and personalized medicine. Trinidad responds to "Genetic Testing Gets Personal" (Rick Weiss, The Washington Post. 25 March 2008.), which profiles the consumer genetics movement and the companies, like 23andMe and Knome, that are fueling it. Trinidad cautions:

Here's a fact about all these businesses: not a one of them is subject to FDA oversight. So all these claims about health benefits, etc., resulting from their services can be completely false (or at least, not based on evidence), and nothing can be done about it. If you read even a *tiny* bit of the scientific literature on genetics and "personalized medicine," you will be struck by how few experts make such claims, at least for the near term … In the meantime, though, consumers should be protected from grossly overstated or unproven claims. Whether that falls to FDA or to someone else (though the Consumer Protection Agency probably has enough work to do at the moment -- lead paint in toys, anyone?), it seems to me the Feds ought to step up on this one.

Will information on risk genes actually change behaviour? Doug MacArthur, Genetic Future. 31 March 2008.
In this second post form Genetic Future in this edition of the "best predictive health blogs", MacArthur reflects on a recent news article in Science (PMID:18369117). The article and MacArthur are among the few that have bothered to acknowledge what may be the true downfall of predictive, personalized medicine—the patient. To some extent everyone (with or without genetic information) knows and ignores health risks. MacArthur acknowledges this and observes:

[I]f it turns out that genetic information doesn't reduce risk behaviour in the real world, then the impact on public health of the hundreds of millions of dollars spent on complex disease genetics may actually be very small. I'm hopeful that this won't be the case - but it would be nice to have some actual evidence one way or the other....

- J.O.

Texas: Your Boss, Your Medical Records and the Information Economy

According to the CDC's Public Health Law News (19 March 2008) and the Houston Chronicle, Texas is now the first state in the nation to require (as of Jan. 1, 2008) that insurance providers hand over employees' health records to their employers. Currently, employees have no way of knowing of (or resisting) their bosses' efforts to acquire their medical records.

This new Texas law, HB 2015 [PDF], passed the legislature despite the opposition of the insurance industry. Thus, at least this time, the insurance industry was arguing in favor of protecting patient privacy rights. As L. M. Sixel writes in the Houston Chronicle: "Medical privacy has been protected for years by the most unlikely guardians: insurance companies." But, before we imagine the insurance industry as a giant defending the front lines in the battle to secure the privacy of medical records, we should think about what was really at stake in this legislative tussle: information in the information economy.

Employers argued that they needed access to their employees' medical records to better assess and more wisely purchase health plans for their workforce. Insurers, on the other hand, would want to restrict access to information they already possess; information, which allows them (and not their customers) to make better bets on their investments. Of course, many worry that employers will misuse medical information about their employees, but I doubt that the insurance industry cares much about discriminatory employment practices. Would, for example, the insurer suffer if employees with increased health risks were some how trimmed from an employer's payroll?

Readers of this blog will want to know what this means for the exchange of genetic and other predictive medical information between insurers and employers. According to the Houston Chronicle, there's nothing to fear in Texas, because "employers still cannot obtain health information protected by other state or federal laws, such as HIV status, genetic test results or mental illness". I'm not a legal scholar, so this was news to me. Do we already have federal protections against the discriminatory use of genetic information in the work place? If so, how will the much discussed GINA add to these protections? - J.O.

GINA and the "Axis of Evil"?

Although the status of S. 358, the Genetic Information Nondiscrimination Act (GINA), has not changed, [Senator Tom Coburn (Rep., Oklahoma) continues to block the bill], its place in legislative limbo still draws the attention of editors and bloggers. Earlier this month Nature reminded readers of the struggle to unblock the bill and provocatively named Coburn a "rogue senator". Coburn's expressed opposition to GINA evolves, but his strongest argument may be that he wants to protect insurers and employers from (as Nature writes) "an avalanche of frivolous litigation". Several states, however, have passed similar legislation and have not encountered the predicted avalanche in the civil courts. Many writers, including the editors of Nature, worry that Coburn's opposition to the bill is slowing the progress of personalized medicine. In response, therefore, the Nature editorial implicitly calls for the genetic research community to lobby on behalf of the bill. The editors note that "scientists should tell" Senate Majority Leader Harry Reid to break Coburn's hold. Reid could bring the bill to a vote by allowing 30 hours of Senate debate on the topic. However, as the Senate has many bills to address, Reid is unlikely to find 30 hours for GINA.

Among other responses, a post in a widely read political blog, Daily Kos, picked up the story and (like many observers in the United States) quickly assumed the worst of the health insurance industry: "actuaries across the coverage denial sector are salivating at the prospect of putting your genetic information to work for their bosses". Is the insurance industry really that pernicious? Yes, they make money by gambling on the health of individuals … and sometimes they refuse to take a bet, but are they (with Coburn) really worthy of Bush's "axis of evil" rhetoric. Although I have to admit that I wouldn't volunteer my genetic information (assuming that I had it) to potential insurance providers, do we really know that insurance companies are eager to access our genetic information? Don't they already have good predictors and other data to use when assessing the odds of gambling on our health? (Smoking comes to mind.) In the immediate future, I wouldn't be surprised if the consumer genomics market will result in an increase in purchases of insurance policy upgrades. Given that the "predictive" value of genomic testing is very far from absolute, isn't it possible that many will overact to their new found "risks" and subsequently go impulse-shopping for more insurance? Perhaps the insurance companies would use genetic information to market more aggressive and supplemental coverage … would this be unjust "discrimination"? - J.O.

Sharing Patient Health Records: Wisconsin Assembly Bill 793

On February 11 legislators in Wisconsin introduced Assembly Bill 793 [PDF – 25.7 KB], which proposes to reduce restrictions on redisclosures of patient health records in particular circumstances to facilitate electronic sharing of information. Wisconsin’s current law (WI ST 51.30) closely follows requirements set forth in HIPAA such as allowing the patient to authorize the disclosure of health records only after the patient is informed of the following: to whom the records will be sent, for what purpose will they be disclosed, and for what length of time the authorization is effective. The current law also requires recording what records are released and to whom they are released, creating a documentation trail.

AB 793 Section 10(b) would modify these restrictions and allow a covered entity to redisclose a patient’s health care record for a purpose for which a release is “otherwise permitted,” such as: if a patient previously has agreed to its release [see Section 9(4)(b)(1)]. Non-covered entities may redisclose [per Section 10(c)] the patient’s record subject to more qualifications, such as redisclosure for a purpose for which the patient health care record was initially received. Read in conjunction with Section 10(c), Section 10(b) would allow a covered entity to redisclose a patient’s health record in more circumstances without that patient’s consent.

As reported by the Wisconsin Technology Network, the Wisconsin Department of Health and Family Services (WDHFS) Secretary, Kevin Hayden, maintains that AB 793 does not apply to disclosures covered under HIPAA. In general, HIPAA requires a patient to consent to the release of protected health information for treatment purposes by the receiving hospital and would extend this release, for example, if the patient is transferred for continuing treatment (45 CFR 164.502). Compiling and transferring patient records for other purposes (such as research or database compilation) not related to the patient’s treatment plan or administrative health care operations generally requires a patient authorization. A valid authorization (45 CFR 164.508) contains, among other elements: to whom the information will be disclosed, the purpose of the disclosure, and the individual’s right to revoke the authorization.

If the purpose of HIPAA is read to limit the release of patient records with exceptions to facilitate present treatment, then in most instances medical records must be explicitly released by the patient for use by other individuals by means of an authorization. If the patient does authorize additional use of his records, HIPAA envisions that the patient can track the release of that record with some accountability. WDHFS seems to modify how they interpret HIPAA’s requirements as AB 793 would eliminate the requirement to obtain consent to disclose the patient’s record as well as eliminating documentation of these disclosures.

It is uncertain how WDHFS and the drafters of AB 793 are interpreting HIPAA coverage, whether their interpretation relies on assuming a patient’s singular consent is sufficient, or they plan to add measures to ensure compliance if the bill is implemented. Do they contemplate “treatment” in terms of all foreseeable future treatment? Is this framework something more state legislatures should adopt to increase the ability to retrieve patient records?

If WDHFS’s further discussion of AB 793 does in fact comply with HIPAA’s requirements, this move toward compiling health records could increase the efficiency of health care for the state’s residents. In order to ensure compliance, WDHFS may need to place additional restrictions to their records system or change the substance of patients’ initial consent. - Katherine Drabiak

A Public Cord Blood Bank in Indiana? Reviewing House Bill 1020

[In this post contributing author Katherine Drabiak shares her assessment of some of the strengths and weaknesses of Indiana House Bill 1020. The legislation was referred the Committee on Public Health on January 14th, 2008. - J.O.]

Drafters of Indiana’s House Bill 1020 proposing to establish a nonprofit operation of umbilical cord blood bank seem to have learned from the ownership battles over donations recently impeding biobank research efforts. Unlike other existing state laws relating to the property rights associated with cord blood donations, HB 1020 explicitly promulgates a waiver of ownership rights. HB 1020 proposes to illuminate the “ownership” transfer (Chapter 1 Section 7) that would ostensibly be drafted into the informed consent form templates. The current draft of HB 1020 and the proposed amendments as of January 18, 2008 unequivocally specify that any property rights related to the cord blood, including intellectual property rights developed, would vest in the Bank.

While this provision on its face provides additional legal certainty, its efficacy assumes several propositions: the informed consent form is legally sufficient and the pregnant patient truly understands the nature of the donation, the Bank’s IRB will ensure precautions to overcome potential conflicts of interest that could undermine the legitimacy of informed consent, and that property waivers will not be found to conflict with federal law.

As HB 1020 is currently drafted, Chapter 1 Section 4 relating to informed consent broadly tasks the Bank with drafting and providing informed consent forms without specific directives. Prior to donating and signing such a waiver, the pregnant patient must be adequately informed of the options to either donate the umbilical cord blood to the Bank or the possibility of using a private banking facility. Yet currently proposed amendments to HB 1020, if passed, would change the amount of information provided and only inform the pregnant patient of the value of donating to the Bank, eliminating the requirement to discuss the possibility of private banking options. This marks a significant departure from other state law practices, which typically present the pregnant patient with the options of public banking, private banking, or forgoing any donation. This departure could potentially undermine consent by insufficiently informing the pregnant patients. Efforts to promote a public bank may topple, if supported by a weakened informed consent process. Is the fact that few pregnant patients would choose (or be able to afford) a private banking facility a legitimate and prudent reason to eliminate this option in the informed consent process?

The legislation also assumes the sufficiency of potentially blanket consent (Chapter 2 Section 2) and the Bank’s adherence of allocating donations to “ethical” research protocols. The amendments to the legislation propose that the Board of Directors for the Bank would form an independent Institutional Review Board to establish and oversee the informed consent process and privacy protections which would occur separately from the allocation decisions. Per Chapter 1 Section 3, an advisory board comprised of at least 51% research scientists would be tasked with reviewing applications of parties interested in receiving nontransplantable donations. The Board and the IRB are guided by the proposition that research use of the donations shall be used “to promote medical advances, life sciences research, or biotechnology research.” (Chapter 1 Section 5) Logistically, the IRB’s representations of potential research uses of the donations to the pregnant patients should align with the allocation criteria used by the research scientists. If for some reason the majority of the Board decides (assuming research scientists would urge maximum distribution to cutting edge research) to allocate donations to a technologically forward yet ethically questionable project, this may not conform to the IRB’s representations to the pregnant patients during the donation process. The question arises whether the Bank will develop an internal mechanism to ensure the function of the IRB is preserved throughout the allocation process.

Even if the informed consent procedure and forms are found to be sufficient, the property waiver itself could be interpreted as potentially conflicting with federal law. The FDA has objected to the terms donation and abandonment of property rights, asserting that 21 CFR 50.20 prohibits requiring subjects to waive or appear to waive any rights as a condition for participation. Yet recent case law suggests that the drafters of HB 1020 may be on to the recent legal trend that disfavors the FDA’s interpretation and instead posits that the pregnant patient is not actually waiving any legal right by signing the "waiver" because she has no legal right to direct the use of the donation after signing the informed consent form, nor is she entitled to any potential intellectual property rights should they arise. Rather, the property waiver serves as a legal clarification to pre-empt potential disputes from spinning into costly or lengthy judicial interference.

If we assume these potential conflicts relating to the informed consent process and allocation procedure are resolved in an ethical manner, the drafters of the Bill may be initiating a trend to adopt property waivers for all banked donations. If this property waiver is adopted, it would most certainly eliminate many of the potential conflicts previously associated with donating banked specimens and, therefore, would allow the Bank to concentrate fully on maximizing its research efforts. – Katherine Drabiak

Cord Blood Biobanking: Indiana Legislative News

Last week at the Second Regular Session of the 115th Indiana General Assembly, Representatives Peggy Welch (District 60), Eric Koch (District 65), Kreg Battles (District 64), and P. Eric Turner (District 32) introduced House Bill 1020. The proposed legislation will establish a nonprofit corporation to operate an umbilical cord blood bank. As written the legislation also "[r]equires physicians and participating hospitals to inform pregnant patients of the option to donate umbilical cord blood". Although the primary purpose of the bank is to provide medical benefits for Indiana's citizens, it may (depending on the progress of the legislation) provide cord blood for future research studies. The bill was referred the the Committee on Public Health on January 14th, 2008.

PredictER Blog will follow this legislation and will post a more thorough commentary on the ethical, legal and social issues of this proposed biobank in the near future.

GINA: Behind-the-Scenes Veto Threat

What kept the "Genetic Information Nondiscrimination Act" out of the omnibus? Apparently "Dr. No" (Sen. Coburn, the GINA's persistent foe) wasn't alone in his opposition to the legistlation. "Capitol Hill Watch" by Kaisernetwork.org relays this bit of back-room negotiating from CQ Today (14 January 2008):

A "behind-the-scenes veto threat from the White House apparently kept a popular genetics anti-discrimination measure" (HR 493) from being attached to the FY 2008 omnibus spending bill (PL 110-161), CQ Today reports. Regan Lachapelle, a spokesperson for Senate Majority Leader Harry Reid (D-Nev.), said senior administration negotiators told Senate Democrats that Bush would veto the package if the genetics measure was included. The legislation would bar employers and insurers from using information from genetic testing to determine how much a person's insurance premiums should be or other business decisions, including hiring. According to CQ Today, "Congress will work to clear the bill early this session".

Congress will work to clear ... that's a rather vague forecast. - J.O.

GINA? Not in the omnibus.

In a recent email to the Genetic Alliance listserv, Sharon F. Terry (President and CEO, Genetic Alliance) announced that the Genetic Information Nondiscrimination Act (S.358) "is not included in the omnibus bill that will come out of the rules committee tonight [Dec. 16] in the House". Terry adds that the House "is worried about a veto from the President, and wants the omnibus to be as noncontroversial as possible".

Two versions of the omnibus, H.R. 2764: Department of State, Foreign Operations, and Related Programs Appropriations Act, 2008, have now passed in both the House and the Senate. Before sending the bill to the President, a conference committee of senators and representatives will work to justify differences in the versions. - J.O.