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  1. Article: COVID-19 pediatric vaccine authorization, FDA authority, and individual misperception of risk.

    Sax, Joanna K / Doran, Neal

    Journal of law and the biosciences

    2024  Volume 11, Issue 1, Page(s) lsae006

    Abstract: Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent ... ...

    Abstract Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to recommend Emergency Use Authorization ('EUA') of the COVID-19 vaccine for children ages 5-11. The results of the study demonstrate that most comments opposed EUA and these comments were associated with statements that indicated misperceptions of risk. Findings provide interesting insights regarding the role of public comments generally but also suggest that the public participation process in notice and comment can be modified to serve as an intervention to align individual perceptions of risk more closely with evidence-based assessment of risk. In addition, the findings provide opportunities to consider strategies for public health messaging.
    Language English
    Publishing date 2024-04-19
    Publishing country England
    Document type Journal Article
    ZDB-ID 2756090-9
    ISSN 2053-9711
    ISSN 2053-9711
    DOI 10.1093/jlb/lsae006
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: COVID-19 Vaccine Hesitancy and (Mis)perception of Risk.

    Sax, Joanna K

    American journal of law & medicine

    2022  Volume 48, Issue 1, Page(s) 54–90

    Abstract: This Article tackles the critical problem of COVID-19 vaccine hesitancy and provides a normative framework for legal policies to address such hesitancy in the ongoing pandemic. The foundation of this Article rests in decision-making theories that allow ... ...

    Abstract This Article tackles the critical problem of COVID-19 vaccine hesitancy and provides a normative framework for legal policies to address such hesitancy in the ongoing pandemic. The foundation of this Article rests in decision-making theories that allow policymakers to understand individual misperception of risk as compared to evidence-based assessment of risk. Vaccine-hesitant individuals assign a high risk to the COVID-19 vaccine and a low risk to the disease-a perception that is disconnected from the science. The backbone of this Article is the timeline of the COVID-19 pandemic and the underlying science of the disease and vaccines. The timeline provides a factual background to demonstrate how vaccine hesitancy to the COVID-19 vaccine emerged. The instant pandemic also demonstrates changes in how individuals see themselves in society, receive information, and are persuaded by economic forces. This Article combines the individual's decision-making process with modern day variables to suggest interventions that can undo anti-vaccine damage. While the novelty of the normative framework provided herein is instructive for current COVID-19 vaccine hesitancy issues, this framework can be applied to other areas in which individual's perceptions of risk are disconnected from evidence-based assessment of risk.
    MeSH term(s) COVID-19/prevention & control ; COVID-19 Vaccines ; Health Knowledge, Attitudes, Practice ; Humans ; Pandemics ; Patient Acceptance of Health Care ; Perception ; Vaccination ; Vaccination Hesitancy ; Vaccines
    Chemical Substances COVID-19 Vaccines ; Vaccines
    Language English
    Publishing date 2022-07-13
    Publishing country England
    Document type Journal Article
    ZDB-ID 753043-2
    ISSN 0098-8588
    ISSN 0098-8588
    DOI 10.1017/amj.2022.13
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Evaluation of Risk Perception of Smoking after the Implementation of California's Tobacco 21 Law.

    Sax, Joanna K / Doran, Neal

    International journal of environmental research and public health

    2022  Volume 19, Issue 24

    Abstract: Decreasing smoking initiation remains a public health priority. In 2016, California, in the United States, enacted the Tobacco 21 law, which raised the minimum age for the purchase of tobacco products from age 18 to age 21. This paper evaluates whether ... ...

    Abstract Decreasing smoking initiation remains a public health priority. In 2016, California, in the United States, enacted the Tobacco 21 law, which raised the minimum age for the purchase of tobacco products from age 18 to age 21. This paper evaluates whether the enactment and implementation of the Tobacco 21 law changed how young adults perceive the risk(s) of smoking. Data were drawn from a cohort of emerging adults (
    MeSH term(s) Young Adult ; Humans ; United States ; Adolescent ; Nicotiana ; Smoking/epidemiology ; Tobacco Products ; Perception ; California/epidemiology ; Smoking Prevention
    Language English
    Publishing date 2022-12-17
    Publishing country Switzerland
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2175195-X
    ISSN 1660-4601 ; 1661-7827
    ISSN (online) 1660-4601
    ISSN 1661-7827
    DOI 10.3390/ijerph192416971
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Biotechnology and Consumer Decision-Making.

    Sax, Joanna K

    Seton Hall law review

    2017  Volume 47, Issue 2, Page(s) 433–486

    MeSH term(s) Affect ; Animals ; Biotechnology ; Cattle ; Consumer Behavior ; Decision Making ; Diffusion of Innovation ; Embryonic Stem Cells/transplantation ; Fluoridation/utilization ; Food Safety ; Food, Genetically Modified/utilization ; Growth Hormone ; Health Knowledge, Attitudes, Practice ; Humans ; Stem Cell Transplantation/utilization ; Vaccination/utilization ; Vaccines/therapeutic use
    Chemical Substances Vaccines ; Growth Hormone (9002-72-6)
    Language English
    Publishing date 2017
    Publishing country United States
    Document type Journal Article
    ISSN 0586-5964
    ISSN 0586-5964
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: Dietary Supplements are Not all Safe and Not all Food: How the Low Cost of Dietary Supplements Preys on the Consumer.

    Sax, Joanna K

    American journal of law & medicine

    2015  Volume 41, Issue 2-3, Page(s) 374–394

    Abstract: Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as 'natural.' This leads many consumers to fail to question the supplements' safety, and some consumers even ...

    Abstract Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as 'natural.' This leads many consumers to fail to question the supplements' safety, and some consumers even equate 'natural' with safe. But, 'natural' does not mean safe. For example, many wild berries and mushrooms are dangerous although they are natural. Another example is tobacco--a key ingredient in cigarettes: it is natural, but overwhelming studies have established the harm of cigarette smoke. The Food and Drug Administration (FDA) requires safety and efficacy testing prior to market entry for drugs. In contrast, the FDA only has limited ability to regulate the entry of new dietary supplements into the marketplace because supplements are treated as food. Two main arguments support the current regulatory structure of dietary supplements: (1) cost and (2) access. But lower cost and increased access to dietary supplements do not necessary have any relationship to safety and efficacy. Manufacturers' marketing techniques tout the health benefits of their supplements. Meanwhile, consumers are ingesting supplements without scientific studies indicating whether or not they are harmful. The FDA Food Safety and Modernization Act, signed into law on January 4, 2011, did not address the safety concerns regarding dietary supplements. This article discusses the regulatory deficiencies concerning dietary supplements and proposes novel solutions to address this specific sector of the food supply. This article advocates for the use of scientific data to support a multi-tiered classification system to ensure that dietary supplements on the market are safe.
    MeSH term(s) Dietary Supplements ; Food Safety ; Government Regulation ; Humans ; Legislation, Food ; United States ; United States Food and Drug Administration
    Language English
    Publishing date 2015-11-16
    Publishing country United States
    Document type Journal Article
    ZDB-ID 753043-2
    ISSN 0098-8588
    ISSN 0098-8588
    DOI 10.1177/0098858815591523
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    Zs.A 1334: Show issues Location:
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  6. Article ; Online: Ending event-based regulation of GMO crops.

    Strauss, Steven H / Sax, Joanna K

    Nature biotechnology

    2016  Volume 34, Issue 5, Page(s) 474–477

    Language English
    Publishing date 2016-05-06
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1311932-1
    ISSN 1546-1696 ; 1087-0156
    ISSN (online) 1546-1696
    ISSN 1087-0156
    DOI 10.1038/nbt.3541
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  7. Article: Protecting scientific integrity: the commercial speech doctrine applied to industry publications.

    Sax, Joanna K

    American journal of law & medicine

    2011  Volume 37, Issue 2-3, Page(s) 203–224

    MeSH term(s) Advertising as Topic/legislation & jurisprudence ; Conflict of Interest/legislation & jurisprudence ; Drug Industry/legislation & jurisprudence ; Government Regulation ; Humans ; Publishing/legislation & jurisprudence ; United States
    Language English
    Publishing date 2011-06-29
    Publishing country United States
    Document type Journal Article ; Legal Case
    ZDB-ID 753043-2
    ISSN 0098-8588
    ISSN 0098-8588
    DOI 10.1177/009885881103700201
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  8. Article: Financial conflicts of interest in science.

    Sax, Joanna K

    Annals of health law

    2012  Volume 21, Issue 2, Page(s) 291–327, 6 p preceding i

    Abstract: This Article proposes a new direction for addressing financial conflicts of interest, which plague biomedical research and threaten scientific integrity. This Article descriptively states the controversy surrounding financial conflicts of interest by ... ...

    Abstract This Article proposes a new direction for addressing financial conflicts of interest, which plague biomedical research and threaten scientific integrity. This Article descriptively states the controversy surrounding financial conflicts of interest by explaining how these conflicts arise and the damage that can be created as a result. By describing the scientific process, the Article explains that changes to the academic environment may allow the public-private interaction to proceed, without creating the problems associated with financial conflicts of interest. Financial conflicts of interest are created when the profit-seeking motive of a private funding source unduly influences an academic scientist's primary responsibilities. The problem with financial conflicts of interest has grown since the passage of the Bayh-Dole Act in 1980. The cornerstone of current policies to address financial conflicts of interest is disclosure, which is inadequate and unsatisfying. The analysis herein changes the trajectory of current approaches in this area by proposing that an analysis of the underlying environment and behavior leading to conflicts of interest must be considered. This Article proposes the use of behavioral economics to craft a policy that effectively addresses conflicts of interest. To this end, this Article applies research from the field of psychology to understand both the environment of academic scientists as well as to begin to understand how academic scientists make decisions. Drawing on psychology literature, this article proposes that academic scientists may experience cognitive dissonance when faced with a situation in which a conflict of interest may arise. This helps to understand why an academic scientist may make a decision that creates a conflict of interest. In addition, this Article utilizes the results of an empirical study conducted by myself and a colleague. In this study, we asked faculty at five medical schools to respond to an anonymous survey containing hypothetical situations in which a conflict may arise. The combination of the psychology literature and our empirical study can provide support to the creation of new policies. Policy proposals include implementation of default rules, education, and changes to academic requirements. Furthermore, this Article considers ways to incentivize medical centers to implement effective policies as well as changes to intellectual property law.
    MeSH term(s) Biomedical Research/economics ; Conflict of Interest ; Disclosure ; Humans ; Intellectual Property ; Publishing ; Research Support as Topic
    Language English
    Publishing date 2012
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1169895-0
    ISSN 1075-2994
    ISSN 1075-2994
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Food Labeling and Consumer Associations with Health, Safety, and Environment.

    Sax, Joanna K / Doran, Neal

    The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics

    2016  Volume 44, Issue 4, Page(s) 630–638

    Abstract: The food supply is complicated and consumers are increasingly calling for labeling on food to be more informative. In particular, consumers are asking for the labeling of food derived from genetically modified organisms (GMO) based on health, safety, and ...

    Abstract The food supply is complicated and consumers are increasingly calling for labeling on food to be more informative. In particular, consumers are asking for the labeling of food derived from genetically modified organisms (GMO) based on health, safety, and environmental concerns. At issue is whether the labels that are sought would accurately provide the information desired. The present study examined consumer (n = 181) perceptions of health, safety and the environment for foods labeled organic, natural, fat free or low fat, GMO, or non-GMO. Findings indicated that respondents consistently believed that foods labeled GMO are less healthy, safe and environmentally-friendly compared to all other labels (ps < .05). These results suggest that labels mean something to consumers, but that a disconnect may exist between the meaning associated with the label and the scientific consensus for GMO food. These findings may provide insight for the development of labels that provide information that consumers seek.
    Language English
    Publishing date 2016-12
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1168812-9
    ISSN 1748-720X ; 1073-1105 ; 0277-8459
    ISSN (online) 1748-720X
    ISSN 1073-1105 ; 0277-8459
    DOI 10.1177/1073110516684805
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  10. Article: The states "race" with the federal government for stem cell research.

    Sax, Joanna K

    Annals of health law

    2006  Volume 15, Issue 1, Page(s) 1–36, table of contents

    Abstract: This article presents an innovative study of the effect of individual states and private institutes in pushing forward stem cell research despite a federal ban on creating new stem cell lines. The author analyzes the impact of state legislation, ... ...

    Abstract This article presents an innovative study of the effect of individual states and private institutes in pushing forward stem cell research despite a federal ban on creating new stem cell lines. The author analyzes the impact of state legislation, proposing that states are reacting to federal policy by serving as laboratories for what is traditionally federally funded biomedical research.
    MeSH term(s) Embryo Research/legislation & jurisprudence ; Embryonic Stem Cells ; Government Regulation ; Humans ; Policy Making ; State Government ; United States
    Language English
    Publishing date 2006
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1169895-0
    ISSN 1075-2994
    ISSN 1075-2994
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