Bioethics

Got GMOs?

by Ude Lu, UMN Law Student, MJLST Staff.

Ude-Lue.jpgGMOs, genetically modified organisms, have long been a part of our daily diet. For example, most of the soybeans and corn on the supermarket shelves are GMOs. Currently, the issue of whether these GMOs should be labeled so that customers can make informed purchases is in a heated debate in California. California Proposition 37, which would require labeling of GMOs, will soon be voted in November this year. Proponents from both sides have poured millions of dollars into the campaign.

GMOs are plants that have been genetically engineered to be enhanced with characteristics that do not occur naturally, so that the harvest can be increased and the cost can be lowered. One example of a prominent GMO is soybean. Monsanto–a Missouri based chemical and agriculture company–introduced its genetically modified soybean, Roundup Ready, in 1996. Roundup Ready is infused with genes that resist weed-killers. In 2010, 93% of soybeans planted in the United States were Roundup Ready soybeans.

Although GMOs are one of the most promising solutions to address the sustainability of food supply in view of the growing global population, there are concerns in the public regarding their safety, and confusion as to which federal agency has responsibility for regulating them.

Amanda Welters in her article “Striking a balance: revising USDA regulations to promote competition without stifling innovation” published in the Minnesota Journal of Law, Science, and Technology explains the current regulatory scheme of GMOs. Three primary agencies regulate GMOs: the Food & Drug Administration (FDA), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA). The FDA regulates GMOs in interstate commerce that are intended to be consumed by animals or humans as foods, the EPA monitors how growing of GMOs impacts the environment, and the USDA assesses the safety of growing GMO plants themselves.

Specifically, the Animal and Plant Health Inspection Service (APHIS) in the USDA is responsible for ensuring crops are free of pests and diseases. APHIS is currently in the process of revising its regulations for GMOs in an attempt to improve transparency, eliminate unnecessary regulations and enhance clarity of regulations. Under the proposed regulations there will be three types of permits for GMOs: interstate movement, importation, and environmental release.

Taking the position that GMOs are generally beneficial and unavoidable, Welters suggests that the USDA should frame a regulatory structure similar to the Hatch-Waxman Act and the Biosimilar Act to promote both innovation and competition. Readers interested in the regulatory issues of GMOs and the balance between the interests of patent innovators and generic follow-ons would find Welters’ article informative and insightful.


An Individual Right to Return of Research Results

by Keli Holzapfel, MJLST Student Editor-in-Chief

Keli-Holzapfel-Thumb-White-Back-II.pngGiven the importance of results discovered by biorepositories and their implications for an individual’s health care choices, I believe that the individual has the right to receive his results despite their lack of verification. However, this right to receive results should be premised upon the individual’s explicit consent to receive his results, and upon the understanding that by receiving these results, the burden of their verification shifts from the biorepostory to the individual.

Biorepositories are collections of biospecimens that are tested and analyzed for scientific purposes. The testing performed on these biospecimens has become the basis for development of various molecular tests, which is becoming critical for the shift toward personalized medicine. Therefore, as technology advances, the quality and management of biorepositories is becoming more important. This is especially critical for the return of accurate patient data resulting from biospecimen analysis. However, managing and conducting a biorepository in the way necessary for return of results can be very complex and expensive. There must be many measures in place to prevent mistakes in identification and to ensure the quality of the biospecimen being tested. Currently, there are many existing biorepositories that do not meet the needed Clinical Laboratory Improvement Amendments (CLIA) standards for return of results. For an in-depth discussion of the current state of biorepositiories and issues surrounding return of results, see the article “Perspective on Biorepository Return of Results and Incidental Findings” written by Steve Jewell. For an example on what biorespositories need to do to improve their management and specimen oversight, see the College of American Pathologists, Accrediation Information.

As alluded to above, some of the important questions that arise from the return of results to an individual are inherently linked to the reliability of the result. For example, what should be the necessary standard for a result to be returned to the individual? Is the current threshold for returning results too high? As mentioned, many biorepositories do not meet the necessary guidelines for CLIA certification, which is required for returning of results. This means that potentially critical information is not shared with the individual involved. Is this ethical? Should biorepositories that discover critical information be required to return results to an individual even though the results are not CLIA certified? But if the results are wrong, is the emotional distress that may ensue from the return of results as unethical as withholding the results?

Due to the current state of biorepositories, and the huge implications that return of results may have, I think the best solution is to allow for consent-based return to an individual, with the understanding that any returned result needs to be independently CLIA certified. Therefore, only individuals who consent to receive results would get them, the individuals would receive the results with the understanding they could be incorrect, and then further testing would be done to validate the results to the necessary high standards. For additional in-depth discussion of issues surrounding CLIA and non-CLIA certified return of results, see “Ethical and Practical Guidelines for Reporting Genetic Research Results To Study Participants: Updated Guidelines from an NHLBI Working Group.”

For other insights and recommendations regarding return of research results, see MLST’s Winter 2012 symposium issue, “Debating Return of Incidental Findings and Research Results in Genomic Biobank Research–Law, Ethics, and Oversight


Bioethic Concerns 34 Years After 1st Test Tube Baby

mjlst-logo-button.pngProfessor Susan Wolf, Founding Chair of the Consortium on Law and Values in Health, Environment & the Life Sciences (which oversees and manages MJLST) discusses the latest bioethical concerns related to in vitro fertilization (IVF) on Minnesota Public Radio‘s The Daily Circuit program (click play button below):

In related content, MJLST Issue 10.1 included an article by Debora Spar, author of The Baby Business: How Money, Science and Politics Drive the Commerce of Conception and attorney Anna M. Harrington entitled “Building a Better Baby Business” that offers a road map to ensuring quality and equity in the reproductive technology industry.

For insights into understanding legal responses to technological change, using in vitro fertilization as an example, see Understanding Legal Responses to Technological Change of In Vitro Fertilization, by Lyria Bennett Moses in MJLST Issue 6.2.