WHAT DNA CAN AND CANNOT SAY: PERSPECTIVES OF IMMIGRANT FAMILIES ABOUT THE USE OF GENETIC TESTING IN IMMIGRATION.

Genetic technologies are being implemented in areas that extend beyond the field of medicine to address social and legal problems. An emerging example is the implementation of genetic testing in the family petitioning process in immigration policy. This use of genetic testing offers the potential benefits of reducing immigration fraud and making the process more efficient and accessible for immigrants, especially those without documentation. However, little is known about the positive or negative impacts of such testing on immigrant families and their communities. This study collected empirical data through family interviews to understand the experiences and attitudes of individuals who have taken a DNA test to prove a family relationship for immigration purposes. Based on study results, we present a set of recommendations to improve the processes with which DNA testing is applied to immigration cases. We argue that DNA testing might serve as a useful tool for families who lack documentary evidence of a family relationship. However, testing might also reveal sensitive information, such as misattributed parentage, that can damage relationships and cause serious harm to beneficiaries, especially children. Petitioners should be provided with adequate information to form an understanding of the DNA test and its implementation as well as the positive and negative consequences from using it, in order to carefully assess whether DNA testing will help their case. We recommend that additional protections be put in place to safeguard children from the potential impacts of misattributed parentage or disclosure of hidden social adoptions. This research provides empirical evidence to inform policy related to the use of genetic testing in immigration.

Police officers' and paramedics' experiences with overdose and their knowledge and opinions of Washington State's drug overdose-naloxone-Good Samaritan law.

Opioid overdoses are an important public health concern. Concerns about police involvement at overdose events may decrease calls to 911 for emergency medical care thereby increasing the chances than an overdose becomes fatal. To address this concern, Washington State passed a law that provides immunity from drug possession charges and facilitates the availability of take-home-naloxone (the opioid overdose antidote) to bystanders in 2010. To examine the knowledge and opinions regarding opioid overdoses and this new law, police (n = 251) and paramedics (n = 28) in Seattle, WA were surveyed. The majority of police (64 %) and paramedics (89 %) had been at an opioid overdose in the prior year. Few officers (16 %) or paramedics (7 %) were aware of the new law. While arrests at overdose scenes were rare, drugs or paraphernalia were confiscated at 25 % of the most recent overdoses police responded to. Three quarters of officers felt it was important they were at the scene of an overdose to protect medical personnel, and a minority, 34 %, indicated it was important they were present for the purpose of enforcing laws. Police opinions about the immunity and naloxone provisions of the law were split, and we present a summary of the reasons for their opinions. The results of this survey were utilized in public health efforts by the police department which developed a roll call training video shown to all patrol officers. Knowledge of the law was low, and opinions of it were mixed; however, police were concerned about the issue of opioid overdose and willing to implement agency-wide training.

Managing incidental genomic findings: legal obligations of clinicians.

PURPOSE: Clinical whole-exome and whole-genome sequencing will result in a broad range of incidental findings, but clinicians' obligations to identify and disclose such findings are a matter of debate. We sought legal cases that could offer insights into clinicians' legal liability. METHODS: We searched for cases in which incidental findings were related to the cause of action, using the search engines WestLaw, WestLaw Next, Lexis, and Lexis Advance. RESULTS: We found no case law related to incidental findings from genetic testing but identified eight cases involving incidental findings in medical imaging. These cases suggest that clinicians may face liability for failing to disclose incidental findings that would have offered an opportunity for interventions to improve health outcome, if under the applicable standard of care, they fail to identify or appreciate the significance of the incidental finding or they negligently fail to notify other clinicians and/or the patient of the identified incidental finding. Other cases support liability for failure to refer appropriately to a clinician with greater expertise. CONCLUSIONS: Clinicians may face liability if they fail to disclose incidental information that could inform interventions to improve health outcome; information lacking clinical actionability is likely to have less import.

The impact of patents on the development of genome-based clinical diagnostics: an analysis of case studies.

PURPOSE: Fragmented ownership of diagnostic gene patents has the potential to create an "anticommons" in the area of genomic diagnostics, making it difficult and expensive to assemble the patent rights necessary to develop a panel of genetic tests. The objectives of this study were to identify US patents that protect existing panels of genetic tests, describe how (or if) test providers acquired rights to these patents, and determine if fragmented patent ownership has inhibited the commercialization of these panels. METHODS: As case studies, we selected four clinical applications of genetic testing (cystic fibrosis, maturity-onset diabetes of the young, long QT syndrome, and hereditary breast cancer) that use tests protected by > or =3 US patents. We summarized publically available information on relevant patents, test providers, licenses, and litigation. RESULTS: For each case study, all tests of major genes/mutations were patented, and at least one party held the collective rights to conduct all relevant tests, often as a result of licensing agreements. CONCLUSIONS: We did not find evidence that fragmentation of patent rights has inhibited commercialization of genetic testing services. However, as knowledge of genetic susceptibility increases, it will be important to consider the potential consequences of fragmented ownership of diagnostic gene patents.

A review of public policy issues in promoting the development and commercialization of pharmacogenomic applications: challenges and implications.

This article reviews the regulatory, social, policy, and other issues that will shape the development of pharmacogenomics applications. We identify and analyze 19 key public policy issues, ranging from the economic incentives for linked diagnostic-drug development, to the regulation of tests and drugs, and to privacy and informed consent. Challenging technical, business, and policy-related issues might either hinder progress in the field of pharmacogenomics or potentially accelerate it, depending on how they are addressed and resolved. How well the numerous important stakeholders - both private and public - address these issues will be critical for pharmacogenomics to deliver on its promise.

Biotechnology entrepreneurship and ethics: principles, paradigms, and products.

Biotechnology, whether in the context of new drugs derived from DNA and genetic technology, genetically modified food, or biologics making use of living cells, raises ethical concerns at a variety of different levels. At the research level, there is concern that the very nature of research is being subverted, rather than enhanced, by entrepreneurship. This area of ethical concern has intensified in the United States as a result of the conflicts of interests resulting from the growing alliance between University academia and private industry in the research enterprise. As we travel down the research path into development of a drug or technology, ethical questions arise with respect to protecting human subjects and society from danger and exploitation by researchers. As development gives way to marketing and dissemination of a new product, government regulators are pressed to get drugs and biologics through the regulatory pipeline into the market faster, walking an ethical tightrope between speed and safety. As new biotechnology products enter the market place, doctors and patients traverse yet another tightrope, that between unknown risk and the promise of benefit. And finally, patent protection is increasingly viewed as a unethical culprit in keeping prices high and depriving the global poor from lifesaving drugs and biologics. Bioethics has, to date, been largely a creation of Western research and medicine. As such it is wholly inadequate to respond to the cascade of ethical issues that flow from a vibrant biotechnology industry. And if biotechnology is in its infancy, as most believe, it is crucial that scientists, entrepreneurs and governments engage in dialogue about the ethical and societal questions raised on the road of scientific progress.