Off-label drug promotion and the ephemeral line between marketing and education

Fueled by massive settlements and concerns about pharmaceutical company influence over medical practice, the fight over off-label promotion has become a rancorous one with little middle ground. For some, off-label restrictions are both bad law and bad medicine, violating the First Amendment while denying physicians access to crucial information. For others, the battle pits the very soul of the FDA against the excesses of a profit-driven marketplace. Far from ameliorating concerns over manufacturer influence, the New Model proposed by Bennett et al. would exacerbate them. The Model would limit FDA authority to core communications proposing immediate commercial transactions, giving manufacturers unfettered discretion over scientific exchanges and nearly free rein over truthful quasi-commercial communications. Most problematically, the New Model relies on the longstanding assumption that truly educational and scientific activities can be distinguished from simple product promotion – a dichotomy that exists not only in federal law and professional association codes, but also underlies the jurisdiction of the federal agencies overseeing the pharmaceutical sector. Experience invites skepticism that these activities can be cleanly separated, suggesting that the New Model may simply perpetuate abusive behaviors without offering concomitant benefits to physicians or patients.     

A hypothetical neurological association between dehumanization and human rights abuses

Dehumanization is anecdotally and historically associated with reduced empathy for the pain of dehumanized individuals and groups and with psychological and legal denial of their human rights and extreme violence against them. We hypothesize that ‘empathy’ for the pain and suffering of dehumanized social groups is automatically reduced because, as the research we review suggests, an individual''s neural mechanisms of pain empathy best respond to (or produce empathy for) the pain of people whom the individual automatically or implicitly associates with her or his own species. This theory has implications for the philosophical conception of ‘human’ and of ‘legal personhood’ in human rights jurisprudence. It further has implications for First Amendment free speech jurisprudence, including the doctrine of ‘corporate personhood’ and consideration of the potential harm caused by dehumanizing hate speech. We suggest that the new, social neuroscience of empathy provides evidence that both the vagaries of the legal definition or legal fiction of ‘personhood’ and hate speech that explicitly and implicitly dehumanizes may (in their respective capacities to artificially humanize or dehumanize) manipulate the neural mechanisms of pain empathy in ways that could pose more of a true threat to human rights and rights-based democracy than previously appreciated.     

Egg freezing,stratified reproduction and the logic of not

This commentary examines social and political implications of social egg freezing in a market that is stratified, globalized, and part of a larger bioeconomy. John Robertson''s article and public discourse prompted by Facebook and Apple''s ‘corporate egg freezing’ benefits provide touchstones for interrogating social and industry practices that embrace making reproductive capacity marketable. Supply of the cells and bodies necessary for assisted reproductive technology use depends on market thinking and structural inequality. What the industry produces are carefully calibrated social-political distances between participants in egg freezing and banking, as well as ‘third party reproduction.’     

New science,old convictions ? Texas Senate Bill 344: identifying further necessary reform in forensic science

In June 2013, Texas Senate Bill 344 (SB 344) was signed into law after strong Innocence Project support. SB 344 has since transformed the Texan judicial landscape. Known as the ‘Junk Science Writ’, SB 344 enables the court to grant habeas corpus relief based on scientific evidence that ‘(1) was not available to be offered by a convicted person at the convicted person''s trial; or (2) contradicts scientific evidence relied on by the state at trial’. Inmates, such as the ‘San Antonio Four’, whose convictions were based upon what is now considered ‘faulty’ medical and forensic testimony, have been released under SB 344. Yet, science, as a field dependent on innovation, is inherently prone to debunking the scientific and forensic methods the law has relied upon to convict individuals. This commentary identifies policy behind SB 344, how SB 344 may influence the perception of science in the courtroom, and how ‘junk science’ is defined and/or limited. Furthermore, this commentary concludes that to achieve justice in the legal system through habeas relief based on ‘junk science’, it is necessary to revitalize and standardize forensic science.     

The first amendment at the crossroads: Free expression and new media technology

A century and a half after it became part of the Constitution, the First Amendment finally began to fulfill its promise of protecting freedom of speech and press. Only in recent decades have courts extended that protection to a broad range of expressive activity. In an era of emerging media technology, courts will be called on to establish new constitutional principles to deal with the changing communications landscape. Once unleashed, the “new”; First Amendment standards will be available to change the legacy of landmark cases that some consider to be overly‐solicitous of freedom of speech and press. Protecting the First Amendment in the cyberspace era is best accomplished not by creating new standards, but by applying and thus preserving established First Amendment principles.     

The most plausible pro-coercion view: requiring informed agreement while penalizing non-participation in research

In ‘(Why) should we require consent to research?’ Alan Wertheimer probes whether it is legitimate for the government to ‘coerce’ people into participating in biomedical research, including interventional biomedical research. In debating the rules that ought to govern participation in interventional biomedical research, we should distinguish two separate moral claims. First, interventional research should proceed only when the subject has given her informed agreement. Second, it is legitimate for the state to set a requirement that people participate in interventional biomedical research, and to penalize or punish those who refuse to participate. The most plausible ‘pro-coercion’ view accepts both of these claims. Though I stop short of endorsing this view, it captures important ‘pro-coercion’ and ‘anti-coercion’ intuitions.     

From Sullivan to Nike: Will the Noble Purpose of the Landmark Free Speech Case Be Subverted to Immunize False Advertising?

In deciding not to rule in Nike, Inc. v. Kasky, the Supreme Court of the United States passed up an ideal opportunity to answer an urgent question that derives from two legacies of New York Times v. Sullivan: When speech implicates both the commercial speech doctrine and the political speech doctrine, how should that speech be assessed in terms of First Amendment protection? This analysis focuses upon the essential principles emphasized in Sullivan's landmark assessment of the societal value in protecting some false speech in the discussion of public issues. Concerns over the Nike case's implications for corporate expression must be weighed against the societal interest in preventing false commercial speech from being immunized by attaching it to a public issue.     

INCORPORATION OF UNCITRAL MODEL LAW ON INTERNATIONAL

Globalization has enabled China to rationalize and institutionalize its economic and political system. China has been quite successful in accommodating globalization in its legal reform. As China becomes one of the important trade players in the international market, the commercial disputes between Chinese companies and foreign trade-partners to be resolved through the arbitration are arising substantially. To an extent, China’s accession to the World Trade Organization (WTO) has sped up its legal reform in the past decades. However, there are some deficiencies with respect to the mechanism and legislation of China’s arbitration law that arguably is not responsive to the norms of the United Nations Commission on International Trade (UNCITRAL) Model Law (1985) and its Amendment (2006). This paper provides an overview of arbitration in China from the legislative and practical perspectives, covering the arbitration’s evolution history and problems before and after 1994. The paper focuses on some important issues in China’s Arbitration Law (“CAL”), evaluating its legislative defects which are inconsistent with the Model Law and its Amendment, clarifying how the Model Law was incorporated into China’s CAL. Some legislative amendments are recommended for CAL’s modernization and its practices, to align it with international arbitration norms in the future.     

A Doctrine at Risk: Content Neutrality in a Post-Reed Landscape

Although the Supreme Court of the United States has deployed the content-neutrality doctrine at least twenty-three times in the last decade, two recent cases — McCullen v. Coakley and Reed v. Town of Gilbert — demonstrate that disagreement among the justices over the meaning of the doctrine is endangering its utility for First Amendment jurisprudence. This article describes the manifestations of this disagreement and suggests that without further clarification about the doctrine's nature, purpose and application, the venerable First Amendment canon may soon either lose practical tenability or disintegrate into constitutional oblivion. Such an outcome, the article suggests, is both ill advised and avoidable. By taking several practical steps, the Supreme Court can go a long way toward preserving the doctrine's usefulness for upholding legitimate government interests and protecting the freedom of expression.     

The FCC's Broadcast News Distortion Rules: Regulation by Drooping Eyelid

In an era of sweeping deregulation of broadcast content, the Federal Communications Commission has retained its rules against licensees' deliberately distorting news. This article reviews the origins and codification of the distortion policy and presents the first quantitative analysis of the FCC's decisions in this area. The results indicate that the distortion policy is a largely symbolic regulation. The Commission's evidentiary requirements, burden of proof, changing definition of news and sometimes arbitrary reasoning erect formidable barriers to complainants. The study concludes with recommendations for rethinking the distortion rules in light of their First Amendment implications and the dramatic changes in broadcast news since the FCC set its distortion policy over 30 years ago.     

The development of technical and spectrum requirements for meeting federal, state and local public safety agency communication requirements through the year 2010, establishment of rules and requirements for priority access service--FCC. Final rule

The Federal Communications Commission (Commission) adopted a First Report and Order ("First Report") contemporaneously with a Third Notice of Proposed Rulemaking that is summarized elsewhere in this edition of the Federal Register. In the First Report, the Commission amends its rules relating to public safety communications in the 764-806 MHz band ("700 MHz band") that the Commission previously reallocated for public safety services and in general. This action commences the process of assigning licenses for frequencies in the 700 MHz band and addresses an urgent need for additional public safety radio spectrum and the need for nationwide interoperability among local, state, and federal entities. By this action, the Commission also takes additional steps toward achieving its goals of developing a flexible regulatory framework to meet vital current and future public safety communications needs and ensuring that sufficient spectrum to accommodate efficient, effective telecommunications facilities and services will be available to satisfy public safety communications needs into the 21st century.     

Are ethics promulgations self-defeating?

Alan Wertheimer argues that promulgating some ethical standards of international clinical research may be self-defeating: the intended purpose of these standards is to promote the interests of subjects and communities in LMICs, while the outcome of promulgation could be to undermine these very same interests. If enforced, such standards would increase the costs of performing beneficial research in LMICs, potentially diverting opportunities to participate in this research away from those who have no other access to the care participation allows. I argue that these standards are really intended as deontological constraints protecting subjects from being exploited by research sponsors. First, I show that Wertheimer begs the question against this deontological interpretation of ethics promulgations, rejecting it on non-deontological grounds. I go on to show that non-exploitation is an important goal on its own, sometimes independent from—and sometimes even outweighing—the goal of promoting the interests of subjects and communities in LMICs. I conclude by suggesting that those who criticize the promulgation of non-exploitation on the grounds that exploitative practices help those badly off might do best to reconsider the background assumption that sponsors in wealthier countries have no pre-existing obligation to promote the interests of the world''s poor.     

Government‐operated public broadcast stations and candidates' access to political debates

Under the Communications Act's equal opportunity requirement and FCC interpretations of that provision, licensees can choose which political candidates to include in a broadcast debate. However, a 1994 decision by a federal appellate court has clouded the ability of public broadcast stations licensed to government entities to exclude particular candidates. According to the court, such stations, as a form of state action, generate a limited First Amendment right on the part of candidates to demand inclusion in a broadcast debate. This article examines the unique constitutional questions raised by the court's decision. An assessment of the competing rights and interests of candidates, stations licensed to government entities and the public indicates that such stations should provide access to political debates.     

Prosecuting the press: First amendment balancing and state statutes that punish publication of information of crimes and official misconduct

The press has been sued and prosecuted under state criminal statutes prohibiting the truthful publication of information. These cases have involved the truthful publication of information of sexual assault victims, juvenile offenders and public officials under confidential investigation, as well as grand jury information. The Supreme Court generally has provided relief to the press, but has eschewed finding specific statutes facially unconstitutional. Instead, the Court has used an ad hoc balancing approach and rendered fact‐specific holdings. The article concludes that categorical First Amendment protection for truthful information of alleged crimes and acts of official misconduct is an appropriate goal.     

The Right and the Duty: Jefferson,Sedition and the Birth of the First Amendment's Central Meaning

When the right and duty to criticize government and its officials is under attack in the United States, the democracy is threatened. The idea of holding those in power accountable, and its origin, assume particular importance. While this “central meaning” of the First Amendment culminated with Justice William Brennan's New York Times Co. v. Sullivan opinion in 1964, the process of discovering that meaning actually began more than a century and a half before. Near the end of the eighteenth century, a political battle ensued over the meaning of the First Amendment. The Alien and Sedition Acts of 1798 were signed into law by a chief executive who sought to control political criticism of him and the government over which he presided. This article focuses on the role of Thomas Jefferson in the resistance to these laws. This battle, according to Justice Brennan, “[F]irst crystalized a national awareness of the central meaning of the First Amendment.” This article posits that this conflict resulted in birth of the modern First Amendment – the discovery of its central meaning – and is premised on the notion that revisiting the events described herein is especially relevant within a period in which officials in high office threaten speech and press rights.     

Medical regulation of cognitive enhancement devices: some concerns

The authors present a cogent and detailed case for altering the Medical Devices Directive to allow regulation of cognitive enhancement devices (CEDs). Protection against significant risk of harm, especially for the vulnerable, and promotion of benefit through informed use of CEDs are all good features of the proposal. However, the pre-market approval process has limitations, which we explore. We raise the possibility of ‘risk compensation’ in response to the introduction of safety measures, which could alter its effectiveness. The proposal alludes to use of ‘formally trained practitioners,’ which provide a further tier of regulation for CEDs within the proposal. We consider some positive and negative implications of this aspect of the proposal that might warrant further consideration.