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Karen Rothenberg’s (Not So) Secret Roles and Contributions at the U.S. National Institutes of Health
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Direct-To-Consumer Ads Are Misleading: Concise Statements of Effectiveness Should Be Required
Get PDFThe 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
Race Decriminalization and Criminal Legal System Reform
Get PDFThere is emerging consensus that various components of the criminal legal system have gone too far in capturing and punishing masses of Black men, women, and children. This evolving recognition has helped propel important and pathbreaking criminal legal reforms in recent years, with significant bipartisan support. These reforms have targeted the criminal legal system itself. They strive to address the pain inflicted by the system. However, by concerning themselves solely with the criminal legal system, these reforms do not confront the reality that Black men, women, and children will continue to be devastatingly overrepresented in each stitch of the system. As a result, these reforms do not reach deeply enough. They do not address or confront the reality that simply being Black has been and will continue to be criminalized.
This Article asserts that measures beyond these reforms—measures that reach the root of racial criminalization—are necessary for true criminal legal system transformation
Advancing Equal Access to Justice by Challenging Gender Bias in the Legal Profession: Part 2
No full textPanel II: When does Incivility, Bullying, Sexual Harassment, or Free Speech Amount to Unprofessional or Sanctionable Attorney Misconduct?
Panelists and moderator: Introductions by Linda H. Lamone, Esq., Chair, Attorney Grievance Commission
Lydia E. Lawless, Esq., Bar Counsel
Thomas E. Lynch III, Esq., Miles & Stockbridge, P.C.
Kathleen Howard Meredith, Esq., Iliff, Meredith, Wildberger & Brennan, P.C
Intersections in International Cultural Heritage Law
No full textThe recent spate of threats to cultural heritage, including in Iraq, Mali, Nepal, Syria, and Yemen, has led to increased focus on the sources of international cultural heritage law. This edited volume shows that international cultural heritage law is not a discrete and contained body of law, but one whose component parts are drawn from diverse fields of public international law. It shows how cultural heritage law has been shaped by its interaction with other areas of international law, and how it has contributed to international law in turn.
In this volume, scholars and practitioners explore some of the primary points of intersection between international cultural heritage law and public international law. Chapters explore instersections with the law of armed conflict, international and transnational criminal law, international human rights, the international movement, regulation, and restitution of cultural artefacts, and the UN system. The result is a cohesive collection that not only explores many facets of the intersections of cultural heritage law and public international law, but also examines how the regimes operate together and how the relationship between them largely facilitates, but also sometimes hinders, the development of international law governing the protection of cultural heritage.https://digitalcommons.law.umaryland.edu/books/1128/thumbnail.jp
