Law Commons^™

Financial Conflicts Of Interest In Science, Joanna K. Sax

Joanna K Sax

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. …

Dietary Supplements Are Not All Safe And Not All Food: How The Low Cost Of Dietary Supplements Preys On The Consumer, Joanna K. Sax

Joanna K Sax

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) only has limited ability to regulate the entry of …

The States "Race" With The Federal Government For Stem Cell Research, Joanna K. Sax

Joanna K Sax

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.

Reforming Fda Policy For Pediatric Testing: Challenges And Changes In The Wake Of Studies Using Antidepressant Drugs, Joanna K. Sax

Joanna K Sax

No abstract provided.

The Separation Of Politics And Science, Joanna K. Sax

Joanna K Sax

This article proposes that scientific inquiry regarding questions of fact should have an autonomous zone that is protected from politics. Although many scholars promote the idea that science is politicized, little empirical data exists to support this conclusion. This article contains an empirical study that demonstrates that the public received inaccurate information in the debate over a highly politicized and controversial area of scientific inquiry, embryonic stem cell research. This article utilizes the data from the empirical study and public choice theory to explain that there are process defects; this economic model can help explain, but cannot be used to …

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Joanna K Sax

This Article examines the future role of the FDA in the regulation of the dietary supplement industry. To address the role of the FDA in the twenty-first century with respect to the dietary supplement industry, Part I of this Article begins by describing the dietary supplement industry and the role of the FDA in this industry. In Part II, this Article provides a brief exposé of the tactics used by the tobacco industry to evade regulation. The purpose of Part II is to provide insight into the tobacco industry’s ability to manipulate consumers and discount scientific proof of the harmful …

Evaluation Of Academic Scientists’ Responses To Situations That Pose A Conflict Of Interest, Joanna K. Sax

Joanna K Sax

The industry-academy relationship has many benefits, but it also has potential drawbacks, including potential conflicts of interest (e.g., when the profit motives of a private company unduly influence academic responsibilities). To date, policies intended to regulate or manage financial conflicts of interest appear to be unsatisfying and inadequate. The present study examined predictors of the responses of academic scientists and clinicians to hypothetical situations in which financial and other conflicts of interest may arise. Academic scientists and clinicians at five medical schools completed an anonymous survey that included vignettes that posed a potential conflict of interest. Participants indicated the likelihood …

Financial Conflicts Of Interest In Science, Joanna K. Sax

Joanna K Sax

This article proposes that an analysis of behavior may be utilized to create an effective policy addressing financial conflicts of interest. Importantly, this article focuses on the academics that conduct basic science. An understanding of the background of the public-private interaction is critical to fully appreciate the rise of the financial conflicts of interest in biomedical science. Part II of this Article describes the rise of financial conflicts of interest and the types of harms that can occur in the absence of effective policy to regulate financial conflicts of interest. Part III describes the current system addressing conflicts of interest, …

Access To Prescription Drugs: A Normative Economic Approach To Pharmacist Conscience Clause Legislation, Joanna K. Sax

Joanna K Sax

The goals of this Article are two-fold: (1) to explain that pharmacist conscience clause legislation may be expanded to areas concerning controversial biomedical research; and (2) to demonstrate that welfare economics can be applied to analyze pharmacist conscience clause legislation. Regarding the first goal, the broad language of existing and proposed conscience clause legislation creates an umbrella that allows a pharmacist to escape liability for refusing to fill a prescription for almost any type of medication. With respect to the second goal, this Article applies welfare economics to demonstrate that pharmacist conscience clauses are a part of tort law and …

The States "Race" With The Federal Government For Stem Cell Research, Joanna K. Sax

Joanna K Sax

The goal of this paper is to analyze and explain the impact of state legislation and funding on the future of stem cell research. Without federal law regulating stem cell research, funding by states and private organizations may spur competition to attract and retain leading scientists and industry in individual states. Alternatively, state-funded stem cell research may incite the federal government to react either positively or negatively to pre-empt state and private action. Traditionally, most support for scientific research comes in the form of grants from the National Institutes of Health (NIH). Due to the practical ban on stem cell …

Application Of Default Rules To Address Financial Conflicts Of Interest In Academic Medical Centers, Joanna K. Sax

Joanna K Sax

This Essay proposes that the rules governing financial conflicts of interest for scientists within the National Institutes of Health apply to scientists at Academic Medical Centers because scientists at both places receive federal funding. The rules governing financial conflicts of interest within the National Institutes of Health are stricter than the rules at Academic Medical Centers. The cornerstone of financial conflicts of interest rules at Academic Medical Centers is disclosure, which is inadequate. This Essay builds on previous work calling for significant changes to rules addressing financial conflicts of interest, and it promotes changes by calling for the application of …

Protecting Scientific Integrity: The Commercial Speech Doctrine Applied To Industry Publications, Joanna K. Sax

Joanna K Sax

Pharmaceutical companies face increasing pressure to bring new treatments to market in order to survive. The economic reality of survival and profits may distort a company’s decision-making process regarding full disclosure on a particular new drug. Part II of this article analyzes the publication tactics employed by some members of the pharmaceutical industry (hereinafter “industry”) and explains how some of the publications promote misleading information. Part III proposes policy recommendations to require accurate dissemination of the results of clinical trials in order to protect scientific integrity and the public welfare. Part IV of this article addresses whether industry publications are …