Direct-To-Consumer Ads Are Misleading: Concise Statements of Effectiveness Should Be Required

The issue of required disclaimers in direct-to-consumer (DTC) advertising of pharmaceuticals boiled to the surface in May 2019, when the Centers for Medicare and Medicaid Services (CMS) published a final rule requiring the disclosure of a drug’s price in DTC ads. The idea is not a new one––the American Medical Association (AMA) adopted a resolution recommending just such a required disclosure in June 2017. For a number of reasons, even if the proposal is implemented it may not have much effect. Consumers may see price as an indicator of effectiveness, just as a high-priced car is expected to be superior to a lower-priced car, and insurance coverage may reduce patients’ concerns about a high-price for a drug. The significance of drug prices to consumers is further complicated both by the “market-distorting effects of third-party payors” and the requirement for consultation with and prescription by a licensed physician whose decisions may also be impacted by third-party payors, but is not necessarily affected by the list prices of drugs. However, the thesis of this article is not that disclosing prices in DTC ads is a bad idea, but that providing consumers with information about how effective advertised drugs are likely to be for them would provide information that patients need regardless of their insurance or financial status. Additionally, it would likely have a greater impact on the pharmaceutical marketplace. If the problem with DTC ads, as the AMA stated in its proposal to require price disclosures, is that “patients pressure physicians to prescribe certain medications that cost more than lower-cost alternatives and are not necessarily as efficacious,” then requiring DTC ads to provide consumers with clear information about the effectiveness of the advertised drug would be an even more powerful solution. There is a growing awareness of the need to require disclosures of expected effectiveness in pharmaceutical DTC marketing. Currently, consumers are told about the general condition for which a drug is used: e.g. “Drug X is approved for the treatment of major depressive disorder,” or “Drug X has been proven effective for the treatment of depression”; but rarely are consumers given information about the average benefit achieved in clinical trials or in post-market studies. This is a particular problem in DTC advertising for prescription pharmaceuticals. An article, in The New York Times by Elizabeth Rosen, highlighted the problem of DTC ads that are likely to mislead consumers about a drug’s effectiveness and provided this example: “Another ad promoted Jublia, a new topical drug for toenail fungus that costs thousands of dollars for a full course of treatment. Complete cure rates in studies—under 20 percent after 48 weeks of use—aren’t mentioned in the ads.” While the problem is becoming well known, as the New York Times article illustrates, the FDA regulation of pharmaceutical marketing is significantly constrained by the First Amendment’s protection of commercial speech, which would almost certainly make a ban on DTC pharmaceutical ads unconstitutional. This article provides an approach to FDA regulation of DTC ads that would address the problem within the limits of the First Amendment’s protection for commercial speech and provide patients with the information they need most to sort through the glossy promotional advertisements created by pharmaceutical companies and their ad agencies

Drug Prices, Dying Patients, and the Pharmaceutical Marketplace: A New Conditional Approval Pathway for Critical Unmet Medical Needs

Prescription drugs have been a major topic in the news for much of the past year. There are two issues which appear often: first, the very high prices of new drugs, particularly the specialty drugs developed for serious diseases; and second, the time required for FDA approval in relation to the perceived need for earlier access to new therapies for critically ill patients. Much less in the news, but lurking behind both issues, is the need for better information for physicians and patients to use in making decisions about prescribing and taking drugs, and for insurance companies and the government to use to structure their pharmaceutical benefits plans. This Article proposes an approach to accelerated access and drug prices that would generate this much needed information for doctors, patients, the government, and private insurers. The new form of conditional approval proposed here would be similar to the parallel track program developed by the FDA in the 1990s, during the HIV crisis. I argue that, like parallel track, the FDA could implement the conditional approval proposed here under its existing authority, that this approach would allow critically ill patients wide access to desperately needed drugs, and would also control prices for drugs that have not demonstrated clinical benefit until sufficient information is available about their real safety and efficacy

A Rawlsian Approach to Solving the Problem of Genetic Discrimination in Toxic Workplaces

The Human Genome Project (HGP) may well be the beginning of a technological leap that rivals the advent of the Industrial Age.2 The principal goal of the project is to map and fully sequence3 the twenty- four chromosomes that contain the complete genetic contents of a normal human cell. The human genome consists of twenty-two pairs of chromosomes plus the X and Y chromosomes that determine gender.4 As would be expected for such a technologically adventurous undertaking, the HGP has been accompanied by a substantial outpouring of concern about the ethical, legal, and social issues that will arise from this vast new knowledge and anticipated power. These concerns were of such a magnitude that the federal agencies funding the HGP set aside up to five percent of their total budgets to fund projects that would examine the “[e]thical, [l]egal and [s]ocial [i]mplications” of the HGP.5 The ethical, legal, and social problems that surround the potential ramifications of the HGP can be divided into two basic groups: knowledge and power. By this bifurcation I mean that many of the problems involve issues that are raised by the simple availability of a great deal of new knowledge about the genotype6 of people, regardless of whether or not that information is accompanied by any significant new power to affect the possible outcomes of particular genotypes. Other problems, however, would emerge from the availability of any significant new power to alter genotypes or the outcome of particular genotypes. To further illustrate this dichotomy, let us consider the possibility of new genetic information concerning an individual’s probable increased risk of dying of some very deadly form of cancer, such as neuroblastoma glioma. There are ethical, legal, and social problems concerning the use of such knowledge. These problems arise regardless of whether or not there is anything more that a high-risk individual can do beyond current measures, such as monitoring, surgery, and chemotherapy, which are currently largely ineffective to reduce the risk significantly. However, if gene therapy for the particular high risk of neuroblastoma genotype becomes possible, then different issues concerning access and use of that power arise. In both the informational and power categories even more difficult problems arise concerning other possible genotypic information beyond disease susceptibility, such as genotypic information about factors related to intelligence or skills, such as mathematical or musical ability.

Crisis and Cultural Evolution: Steering the Next Normal from Self-Interest to Concern and Fairness

This essay examines the current time of crisis and offers a vision of the way in which our society and our law can evolve in response. Crises of this scale are evolution-forcing events and I argue that the current moment can move us towards a fundamentally different vision of law and justice. It is the first essay or article to show that the autonomous pursuit of self-interest was a common assumption or value in the major intellectual forces of the twentieth century: classical free market economics, behavioral economics, and sociobiology, as well as in the competing visions of a just society of John Rawls and Robert Nozick. After introducing the alternative normative frameworks of caring developed by Carol Gilligan and of concern developed by Leslie Bender, I show how the common law of torts and contracts embraced self-interest as a value and then how tort and contract law could embrace the values of concern and fairness. I conclude that the danger of a culture that values the autonomous pursuit of self-interest above all else has been exposed by our current crisis and that an evolution towards a cultural regard for concern and fairness is a must

Preliminary test estimation for the second order autoregression / 1992:107

Includes bibliographical references (p.17)

Civilian casualties and public support for military action: Experimental evidence

In contrast to the expansive literature on military casualties and support for war, we know very little about public reactions to foreign civilian casualties. This article, based on representative sample surveys in the US and Britain, reports four survey experiments weaving information about civilian casualties into vignettes about Western military action. These produce consistent evidence of civilian casualty aversion: where death tolls were higher, support for force was invariably and significantly lower. Casualty effects were moderate in size but robust across our two cases and across different scenarios. They were also strikingly resistant to moderation by other factors manipulated in the experiments, such as the framing of casualties or their religious affiliation. The importance of numbers over even strongly humanizing frames points towards a utilitarian rather than a social-psychological model of casualty aversion. Either way, civilian casualties deserve a more prominent place in the literature on public support for war

Global transpiration data from sap flow measurements: the SAPFLUXNET database

Plant transpiration links physiological responses of vegetation to water supply and demand with hydrological, energy, and carbon budgets at the land–atmosphere interface. However, despite being the main land evaporative flux at the global scale, transpiration and its response to environmental drivers are currently not well constrained by observations. Here we introduce the first global compilation of whole-plant transpiration data from sap flow measurements (SAPFLUXNET, https://sapfluxnet.creaf.cat/, last access: 8 June 2021). We harmonized and quality-controlled individual datasets supplied by contributors worldwide in a semi-automatic data workflow implemented in the R programming language. Datasets include sub-daily time series of sap flow and hydrometeorological drivers for one or more growing seasons, as well as metadata on the stand characteristics, plant attributes, and technical details of the measurements. SAPFLUXNET contains 202 globally distributed datasets with sap flow time series for 2714 plants, mostly trees, of 174 species. SAPFLUXNET has a broad bioclimatic coverage, with woodland/shrubland and temperate forest biomes especially well represented (80 % of the datasets). The measurements cover a wide variety of stand structural characteristics and plant sizes. The datasets encompass the period between 1995 and 2018, with 50 % of the datasets being at least 3 years long. Accompanying radiation and vapour pressure deficit data are available for most of the datasets, while on-site soil water content is available for 56 % of the datasets. Many datasets contain data for species that make up 90 % or more of the total stand basal area, allowing the estimation of stand transpiration in diverse ecological settings. SAPFLUXNET adds to existing plant trait datasets, ecosystem flux networks, and remote sensing products to help increase our understanding of plant water use, plant responses to drought, and ecohydrological processes. SAPFLUXNET version 0.1.5 is freely available from the Zenodo repository (https://doi.org/10.5281/zenodo.3971689; Poyatos et al., 2020a). The “sapfluxnetr” R package – designed to access, visualize, and process SAPFLUXNET data – is available from CRAN

Global transpiration data from sap flow measurements: the SAPFLUXNET database

Plant transpiration links physiological responses of vegetation to water supply and demand with hydrological, energy, and carbon budgets at the land?atmosphere interface. However, despite being the main land evaporative flux at the global scale, transpiration and its response to environmental drivers are currently not well constrained by observations. Here we introduce the first global compilation of whole-plant transpiration data from sap flow measurements (SAPFLUXNET, https://sapfluxnet.creaf.cat/, last access: 8 June 2021). We harmonized and quality-controlled individual datasets supplied by contributors worldwide in a semi-automatic data workflow implemented in the R programming language. Datasets include sub-daily time series of sap flow and hydrometeorological drivers for one or more growing seasons, as well as metadata on the stand characteristics, plant attributes, and technical details of the measurements. SAPFLUXNET contains 202 globally distributed datasets with sap flow time series for 2714 plants, mostly trees, of 174 species. SAPFLUXNET has a broad bioclimatic coverage, with woodland/shrubland and temperate forest biomes especially well represented (80 % of the datasets). The measurements cover a wide variety of stand structural characteristics and plant sizes. The datasets encompass the period between 1995 and 2018, with 50 % of the datasets being at least 3 years long. Accompanying radiation and vapour pressure deficit data are available for most of the datasets,while on-site soil water content is available for 56 % of the datasets. Many datasets contain data for species that make up 90 % or more of the total stand basal area, allowing the estimation of stand transpiration in diverse ecological settings. SAPFLUXNET adds to existing plant trait datasets, ecosystem flux networks, and remote sensing products to help increase our understanding of plant water use, plant responses to drought, and ecohydrological processes.Fil: Poyatos, Rafael. Universitat Autònoma de Barcelona; EspañaFil: Granda, Víctor. Universitat Autònoma de Barcelona; EspañaFil: Flo, Víctor. Universitat Autònoma de Barcelona; EspañaFil: Adams, Mark A.. Swinburne University of Technology; Australia. University of Sydney; AustraliaFil: Adorján, Balázs. University of Debrecen; HungríaFil: Aguadé, David. Universitat Autònoma de Barcelona; EspañaFil: Aidar, Marcos P. M.. Institute of Botany; BrasilFil: Allen, Scott. University of Nevada; Estados UnidosFil: Alvarado Barrientos, M. Susana. Instituto de Ecología A.C.; MéxicoFil: Anderson Teixeira, Kristina J.. Smithsonian Tropical Research Institute; PanamáFil: Aparecido, Luiza Maria. Arizona State University; Estados Unidos. Texas A&M University; Estados UnidosFil: Arain, M. Altaf. McMaster University; CanadáFil: Aranda, Ismael. National Institute for Agricultural and Food Research and Technology; EspañaFil: Asbjornsen, Heidi. University of New Hampshire; Estados UnidosFil: Robert Baxter. Durham University; Reino UnidoFil: Beamesderfer, Eric. McMaster University; Canadá. Northern Arizona University; Estados UnidosFil: Carter Berry, Z.. Chapman University; Estados UnidosFil: Berveiller, Daniel. Université Paris Saclay; Francia. Centre National de la Recherche Scientifique; FranciaFil: Blakely, Bethany. University of Illinois at Urbana-Champaign; Estados UnidosFil: Boggs, Johnny. United States Forest Service; Estados UnidosFil: Gil Bohrer. Ohio State University; Estados UnidosFil: Bolstad, Paul V.. University of Minnesota; Estados UnidosFil: Bonal, Damien. Université de Lorraine; FranciaFil: Bracho, Rosvel. University of Florida; Estados UnidosFil: Brito, Patricia. Universidad de La Laguna; EspañaFil: Brodeur, Jason. McMaster University; CanadáFil: Casanoves, Fernando. Centro Agronómico Tropical de Investigación y Enseñanza; Costa RicaFil: Chave, Jérôme. Université Paul Sabatier; FranciaFil: Chen, Hui. Xiamen University; ChinaFil: Peri, Pablo Luis. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro de Investigaciones y Transferencia de Santa Cruz. Universidad Tecnológica Nacional. Facultad Regional Santa Cruz. Centro de Investigaciones y Transferencia de Santa Cruz. Universidad Nacional de la Patagonia Austral. Centro de Investigaciones y Transferencia de Santa Cruz; Argentin