Papers by Kayte Spector-Bagdady
The Hastings Center report, 2021
Covid-19 raised many novel ethical issues including regarding the allocation of opportunities to ... more Covid-19 raised many novel ethical issues including regarding the allocation of opportunities to participate in clinical trials during a public health emergency. In this article, we explore how hospitals that have a scarcity of trial opportunities, either overall or in a specific trial, can equitably allocate those opportunities in the context of an urgent medical need with limited therapeutic interventions. We assess the three main approaches to allocating trial opportunities discussed in the literature: patient choice, physician referral, and randomization/lottery. As, we argue, none of the three typical approaches are ethically ideal for allocating trial opportunities in the pandemic context, many hospitals have instead implemented hybrid solutions. We offer practical guidance to support those continuing to face these challenges, and we analyze options for the future.
The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 2013
The STD experiments in Guatemala from 1946-1948 have earned a place of infamy in the history of m... more The STD experiments in Guatemala from 1946-1948 have earned a place of infamy in the history of medical ethics. But if the Guatemala STD experiments were so "ethically impossible," how did the U.S. government approve their funding? Although much of the literature has targeted the failings of Dr. John Cutler, we focus on the institutional context and research ethos that shaped the outcome of the research. After the end of WWII, Dr. Cassius Van Slyke reconstructed the federal research contracts process into a grant program. The inaugural NIH study section recommended approval of the Guatemala STD experiments at its first meeting. The funding and oversight process of the Guatemala research was marked with serious conflicts of interest and a lack of oversight, and it was this structure, as opposed to merely a maleficent individual, that allowed the Guatemala STD experiments to proceed. We conclude that while current research regulations are designed to prevent the abuses perpe...
Public Health Ethics Analysis, 2016
While "public health" has been defi ned as what society does to "assure the conditions for people... more While "public health" has been defi ned as what society does to "assure the conditions for people to be healthy" (Institute of Medicine 2003 , xi), public health ethics is a "systematic process to clarify, prioritize , and justify possible courses of public health action based on ethical principles , values and beliefs of stakeholders , and scientifi c and other information " (Schools of Public Health Application Service 2013). Despite several important characteristics that distinguish public health from clinical medicine, at its start public health ethics borrowed heavily from clinical ethics and research ethics (see Chap. 1). In the 1980s, with the onset of the AIDS epidemic and unprecedented advances in biomedicine, the inability of clinical ethics to accommodate the ethical challenges in public health from existing frameworks led pioneering ethicists to reframe and adapt clinical ethics from an individual and autonomy focused approach to one that better refl ected the tension between individual rights and the health of a group or population (Bayer et al. 1986 ; Beauchamp 1988 ; Kass 2001 ; Childress et al. 2002 ; Upshur 2002). Others called for public health ethics to emphasize relational ethics and political philosophy (Jennings 2007). More recently, some authors have suggested outlining foundational values from which operating principles for public health ethics can be articulated only after careful consideration of the goals and purpose of public health. This approach would require us to establish a clear defi nition of the moral endeavor of public The opinions, fi ndings, and conclusions of the authors do not necessarily refl ect the offi cial position, views, or policies of the editors, the editors' host institutions, or the authors' host institutions.
Respecting Autonomy And Enabling Diversity: The Effect Of Eligibility And Enrollment On Research Data Demographics
Health Affairs
npj Genomic Medicine
Consumer interest in genetic and genomic testing is growing rapidly, with more than 26 million Am... more Consumer interest in genetic and genomic testing is growing rapidly, with more than 26 million Americans having purchased direct-to-consumer genetic testing services. Capitalizing on the increasing comfort of consumers with genetic testing outside the clinical environment, commercial vendors are expanding their customer base by marketing genetic and genomic testing services, including testing for pharmacogenomic and pathogenic variants, to employers for inclusion in workplace wellness programs. We describe the appeal of voluntary workplace genomic testing (wGT) to employers and employees, how the ethical, legal, and social implications literature has approached the issue of genetic testing in the workplace in the past, and outline the relevant legal landscape. Given that we are in the early stages of development of the wGT market, now is the time to identify the critical interests and concerns of employees and employers, so that governance can develop and evolve along with the wGT m...
The Regulation of Prescription Drug and Restricted Medical Device Advertising
LSN: Regulation of Information & Privacy Issues Involving Consumers (Topic), 2010
Th is Article discusses the current legal framework of FDA regulation of labeling and advertising... more Th is Article discusses the current legal framework of FDA regulation of labeling and advertising, how the medium of the Internet confounds the premises upon which current regulations are built, and the steps the FDA currently is taking to understand and regulate prescription drug and restricted medical device advertising on the Internet. Th e Article then proposes possible approaches to regulation that the FDA may consider.
Industry Compensation to Physician Vascular Specialist Authors of Highly-Referenced Aortic Aneurysm Studies
Annals of vascular surgery, 2021
BACKGROUND Industry payments to physicians may influence their attitudes toward medical devices a... more BACKGROUND Industry payments to physicians may influence their attitudes toward medical devices and products. Disclosure of industry compensation by authors of scientific manuscripts usually occurs at the authors' discretion and is seldom audited as part of the peer review process. The purpose of this analysis was to characterize industry compensation among highly cited research articles related to aortic aneurysm. METHODS A Web of Science search for English language articles published from 2013-2017 using the search term "aortic aneurysm" identified publications for this study. The top 99 most-cited publications were abstracted by author. Physician authors with reported industry compensation from 2013-2016 were identified using the ProPublica Dollars for Docs search tool (linked to Centers for Medicare and Medicaid Services Open Payments data), based on provider name, medical specialty, and geographic location. Statistical analysis included descriptive statistics and ...
Nebraska law review, 2014
Since its advent in 2007, direct-to-consumer (DTC) genetic testing has raised increasingly comple... more Since its advent in 2007, direct-to-consumer (DTC) genetic testing has raised increasingly complex regulatory and policy issues for the industry and regulators alike. In November 2013, FDA sent its first DTC genetic testing Warning Letter to 23andMe, one of the few remaining providers of DTC genetic data and interpretation, prompting the company to cease its health-related marketing indefinitely. Even before 23andMe stopped marketing its health-related product however, some DTC companies had begun to bifurcate into entities that offer genetic data — a file of As, Ts Cs, and Gs without any interpretation — and entities that interpret and analyze this genetic data to provide medical information — for example the consumer’s risk of developing breast cancer. This Article analyzes the regulatory disposition of DTC genetic testing and concludes that entities that provide genetic data for research use only likely do not fit within FDA’s definition of a device and will remain unregulated. H...
Governing secondary research use of health data and specimens: the inequitable distribution of regulatory burden between federally funded and industry research
Journal of Law and the Biosciences, 2021
Some of the most promising recent advances in health research offer opportunities to improve diag... more Some of the most promising recent advances in health research offer opportunities to improve diagnosis and therapy for millions of patients. They also require access to massive collections of health data and specimens. This need has generated an aggressive and lucrative push toward amassing troves of human data and biospecimens within academia and private industry. But the differences between the strict regulations that govern federally funded researchers in academic medical centers (AMCs) versus those that apply to the collection of health data and specimens by industry can entrench disparities. This article will discuss the value of secondary research with data and specimens and analyze why AMCs have been put at a disadvantage as compared to industry in amassing the large datasets that enable this work. It will explore the limitations of this current governance structure and propose that, moving forward, AMCs should set their own standards for commercialization of the data and spe...
Head and Neck Cancer Research Ethics : A Primer 1
The rapidly evolving landscape of clinical research in head and neck cancer promises scientific d... more The rapidly evolving landscape of clinical research in head and neck cancer promises scientific discovery that will benefit patients and stand to improve the human condition for years to come. However, it is imperative that the head and neck oncology research community remains cognizant of the ethical conundrums posed by novel clinical investigation and respects and honors the primacy of the patients and participants upon whom such discoveries depend. It is as vital as ever to revisit the ethical debates of the past, the novel issues of the present, and potential ethical concerns of the future, to ensure research subject protection and respect evolves at the same pace as the research enterprise itself. Herein, we review the basic ethical principles required of human subjects research, the regulatory landscape, and selected emerging debates with relevant examples for head and neck providers and researchers.
Present Lessons from Past Infractions
While “public health” has been defined as what society does to “assure the conditions for people ... more While “public health” has been defined as what society does to “assure the conditions for people to be healthy” (Institute of Medicine 2003, xi), public health ethics is a “systematic process to clarify, prioritize , and justify possible courses of public health action based on ethical principles , values and beliefs of stakeholders , and scientific and other information ” (Schools of Public Health Application Service 2013). Despite several important characteristics that distinguish public health from clinical medicine, at its start public health ethics borrowed heavily from clinical ethics and research ethics (see Chap. 1). In the 1980s, with the onset of the AIDS epidemic and unprecedented advances in biomedicine, the inability of clinical ethics to accommodate the ethical challenges in public health from existing frameworks led pioneering ethicists to reframe and adapt clinical ethics from an individual and autonomy focused approach to one that better reflected the tension betwee...
Posthumous Sperm Procurement: The Critical Condition of Autonomous Consent
Even though during Posthumous Sperm Procurement (PSP) the patient has passed away, the decedent s... more Even though during Posthumous Sperm Procurement (PSP) the patient has passed away, the decedent still has an interest in informed consent. With increasing requests for PSP by surviving loved ones, institutions struggle how to honor both the interests of the decedent and requests of the living -- sometimes with inconsistent results. This Article argues that institutions should adopt the policy that informed consent to PSP require that the decedent would have consented to PSP with a particular partner and intended parent specifically, not the vague sentiment that the decedent wanted children in the future. This policy clarifies ethically complex situations such as whether parents of a single male should be allowed to inseminate a surrogate to create a child to raise themselves, whether an unmarried couple should have access to PSP (and the common but flawed assumption that marriage is the same as consent to reproduction), and whether clinicians have the ethical duty to tell the family...
Clinical Trials
Given the dearth of established safe and effective interventions to respond to COVID-19, there is... more Given the dearth of established safe and effective interventions to respond to COVID-19, there is an urgent ethical imperative to conduct meaningful clinical research. The good news is that interventions to be tested are not in short supply. Unfortunately, the human and material resources needed to conduct these trials are finite. It is essential that trials be robust and meet enrollment targets and that lower-quality studies not be permitted to displace higher-quality studies, delaying answers to critical questions. Yet, with few exceptions, existing research review bodies and processes are not designed to ensure these conditions are satisfied. To meet this challenge, we offer guidance for research institutions about how to ethically consolidate and prioritize COVID-19 clinical trials, while recognizing that consolidation and prioritization should also take place upstream (among manufacturers and funders) and at a higher level (e.g. nationally). In our proposed three-stage process,...
COVID-19 Clinical Trial Oversight at a Major Academic Medical Center: Approach of the Michigan Medicine COVID-19 Clinical Trial Committees
Clinical Infectious Diseases
Clinicians – eager to offer the best care in the absence of guiding data – have provided patients... more Clinicians – eager to offer the best care in the absence of guiding data – have provided patients with COVID-19 diverse clinical interventions. This usage has led to perceptions of efficacy of some interventions that, while receiving media coverage, lack robust evidence. Moving forward, randomized controlled clinical trials (RCTs) are necessary to ensure that clinicians can treat patients effectively during this outbreak and the next. To do so, academic medical centers must address two key research issues: (1) how to effectively and efficiently determine which trials have the best chance of benefiting current and future patients, and (2) how to establish a transparent and ethical process for subject recruitment while maintaining research integrity and without overburdening patients or staff. We share here the current methods used by the University of Michigan to address these issues.
AMA Journal of Ethics
Many patients choose to undergo some type of carrier screening when pregnant or planning to becom... more Many patients choose to undergo some type of carrier screening when pregnant or planning to become pregnant. "Expanded" carrier screening products test all patients for the same conditions, regardless of family history, race, or ethnicity. Proponents of expanded screening argue that testing everyone for everything can identify more couples at risk of having an affected fetus. However, most conditions on expanded carrier screening panels do not adhere to criteria recommended by professional organizations and can leave patients with a positive test result but little helpful information about actual clinical risk for their future baby. Confusion persists about whether clinicians should leave carrier screening decisions to patients. Need for More Accurate Carrier Screening Many patients choose to undergo reproductive genetic testing either when they are planning to become pregnant or once they are pregnant. 1,2 One type of reproductive genetic test is carrier screening, used to identify people at risk of having a child with an autosomal recessive or X-linked recessive genetic condition. If both the woman and her male partner are found to be carriers, the child has a 25% chance of being affected by the disease and a 50% chance of being a carrier.
Enabling privacy and progress: Protecting individual participants in big data
Hospital Visitation Policies During the SARS-CoV-2 Pandemic
American Journal of Infection Control
Industry compensation and self-reported financial conflicts of interest among authors of highly cited peripheral artery disease studies
Journal of Vascular Surgery
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Papers by Kayte Spector-Bagdady