A Conference Hosted by Yale Law School, Yale Medical School, and the Yale School of Public Health
Sponsored by the Information Society Project (ISP), the Yale Global Health Justice Partnership (GHJP), and the Yale Health Law and Policy Society (YHeLPS), with generous support from the Samuel and Liselotte Herman Fund for the Social and Behavioral Sciences at The Yale School of Public Health, and the Oscar M. Reubhausen Fund.
Agenda and Overview
Friday, Oct. 17, 2014
1:00 pm Registration opens (Room 122)
1:30 pm Introduction (Dean Robert Post) Room 127
2:00 pm Panel 1: Food and Drug Regulation (Room 127)
Amy Kapczynski (moderator), Aaron Kesselheim, Chief Judge Alex Kozinski, William Schultz, David Vladeck
The protection and promotion of health requires high quality information about the safety and efficacy of drugs, as well as truthful and non-misleading marketing of foods and supplements. In order to promote rigorous clinical trials of medicines and police product marketing, government frequently restricts certain speech. For example, the FDA’s drug regulatory structure forbids pharmaceutical companies from promoting a drug for any use that has not been approved by the FDA. Recent developments in commercial speech doctrine, however, gravely threaten that regulatory structure. A federal appeals court recently concluded that the government may not prosecute pharmaceutical detailers for off-label marketing, if such prosecution is solely based on their speech. The case, Caronia, pointed out that the government may still prosecute companies for speech that is false or misleading, but this raises difficult questions about how courts determine the truth or sufficiency of scientific information. This same question was raised in the recent POM Wonderful case, where the Federal Trade Commission concluded that the marketers of pomegranate juice were misleading consumers when they suggested that the juice treats diseases, because the juice company lacked two randomized controlled trials supporting that claim. The company had scientific evidence that fell short of that standard, and is challenging the FTC’s decision on First Amendment grounds. In another recent federal court case, a pharmaceutical CEO raised First Amendment challenges to his conviction for fraud. The government has argued that the CEO misrepresented the results of a clinical trial in a press release. The CEO has argued, in response, that his statements were a protected form of First Amendment opinion. This panel will assess the threat that current developments in commercial speech doctrine pose to food and drug regulation, and consider whether existing doctrine is capable of protecting our collective interests in the accuracy and quality of health information in this context.
3:45 pm Panel 2: Health Behaviors: Tobacco, Obesity, and Children (Room 127)
Abbe Gluck (moderator), Kelly Brownell, Christine Jolls, Ted Mermin, Nadia Sawicki
Today, the First Amendment comes into potential conflict with any public health campaign that is designed to highlight particular information or risks to individuals, or to influence an individual’s perception of legal products. Such programs are, however, an increasingly prominent aspect of public health efforts to combat obesity and smoking. For example, prominent campaigns have been launched recently to require the disclosure of nutritional/caloric information at restaurants, to mandate graphic warnings on cigarette cartons, to restrict the marketing of food to children, and to “put cigarettes below the counter” – and all have been subject to First Amendment challenge. Even disclosure of plainly factual information, such as caloric content, is not immune from constitutional challenge (although such challenges have so far not succeeded). More risky are strategies that seek to condense information into simple heuristics, or that deliberately invoke emotion in order to persuade the public. A prominent federal appeals court recently concluded, for example, that the FDA’s proposed graphic warnings on cigarettes were unconstitutional because they strayed from the presentation of factual information to attempts to use emotion to persuade. Similarly, public health scholars have argued that laws that require women to view ultrasound photos in the context of abortion violate the First Amendment because they seek to mobilize emotion in improper ways. Finally, children are the targets of sophisticated food and cigarette marketing, and evidence clearly shows that such marketing has significant effects on their experience and choices. This panel will address conflicts between the First Amendment and campaigns or regulations designed to reduce smoking and the consumption of unhealthy foods. It will address questions such as: How important are information campaigns to reducing the ill-health effects of obesity and smoking? How important is emotion to such campaigns, and should the use of emotion in social marketing raise constitutional concerns? Should courts consider evidence from behavioral psychology when assessing the validity of social marketing campaigns? What leeway does government have to constrain marketing to children in particular, especially given that it may be difficult to regulate marketing to children without also affecting marketing that reaches adults?
Saturday, Oct. 18, 2014
8:00 am Breakfast (Dining Hall)
9:00 am Panel 3: First Amendment and Professional Conduct (Room 127)
John Robertson (moderator), Bill Sage, Jennifer Keighley, Shannon Minter, Dr. Nancy Stanwood
Free and accurate information exchange between doctors and patients is critical to good medical practice. Standards of professional practice and tort law have long regulated speech in this setting in order to protect patients from harm. But legislatures in recent years have also sought, independently of medical licensing boards, to regulate what physicians must or may not say to patients. Recent examples involve legislative efforts to compel physicians to “inform” patients that abortion causes health risks such as breast cancer (though such information is scientifically unfounded), efforts to prohibit doctors from asking patients about guns in the home, and the regulation of the disclosure of incidental findings in genetic or other testing. How the First Amendment should respond to such measures is unsettled, and increasingly the subject of litigation. A recent California law forbidding mental health providers from practicing sexual orientation change therapy to under-18s, for example, was judged in violation of the First Amendment by one federal trial court, and consistent with the First Amendment by another. This panel will address the implications of the First Amendment for the regulation of the speech and workflow of health professionals. Issues for discussion include (1) how First Amendment doctrine should approach government regulation that mandates or forbids certain statements or disclosures to patients; (2) how and whether the First Amendment protects health professionals’ duties of loyalty and advocacy (e.g., contrasting Rust v. Sullivan with Legal Services Corp. v. Velazquez), (3) the implications, for the First Amendment, of the fact that medicine frequently intersects with controversial social issues, and that medical evidence can be misconstrued or inadequate in the face of such social conflict; and (4) the First Amendment implications of moving from a health care system governed by professional self-regulation (e.g., of advertising) and individual care delivery to a system more governed by direct government regulation and corporate care delivery.
10:45 am Panel 4: First Amendment Theory (Room 127)
Jack Balkin (moderator), Jane Bambauer, Robert Post, Frederick Schauer, Eugene Volokh
The expansive quality of recent First Amendment decisions, like Sorrell v. IMS Health Inc., 131 S.Ct. 2653 (2011), and United States v. Alvarez, 132 S.Ct. 2537 (2012), have potentially put First Amendment doctrine on a collision course with the basic regulatory strategies by which the state presently seeks to advance public health and medical practice. Participants in this panel will reflect on the issues of First Amendment doctrine and theory raised by the previous panels. They will in particular explore how the regulation of professional medical practice should be understood within First Amendment doctrine, reflecting on cases about legislative mandates related to professional speech in the context of abortion, guns, and sexual orientation. They will also seek to define the limits that First Amendment rights should place on government efforts to regulate the promotion of drugs (see the Caronia discussion above), and the marketing of food and tobacco. Finally, whether and how the First Amendment regulates data flows has important cross-cutting implications in the health context, which this panel will also address.
12:15 pm Lunch (Dining Hall)
1:00 pm Keynote: Joshua M. Sharfstein, M.D., Secretary of Health & Mental Hygiene for Maryland; Introduction by Professor Abbe Gluck (Dining Hall)
2:15 pm Panel 5: Science and Democracy (Room 127)
Frank Pasquale (moderator), Aziza Ahmed, Dan Kahan, Wendy Wagner, Paul Starr
Public health and medicine rely critically on scientific integrity and expert knowledge. Expert knowledge cannot be directly subject to political control and retain its independent quality. And yet, science clearly is necessarily subject to certain kinds of governmental influence, for example when government makes decisions about funding streams for science, and when agencies make decisions that rely upon scientific expertise. Today, there are repeated calls for more direct political control over the generation of scientific knowledge (for example, when Congress seeks to forbid or discourage research on issues such as gun violence), as well as increasingly acute conflicts over the analysis of science in agencies and courts (for example, in the context of legislation mandating certain disclosures to patients in the abortion context). This panel will consider these emerging conflicts, and address questions such as: How should we understand the relationship and possible tensions between science and democracy? What mechanisms exist to protect scientific integrity in the context of legislatures, agencies, and courts? Does First Amendment law give adequate attention to questions of scientific expertise?
4:00 pm Closing Keynote: Peter Galison, Joseph Pellegrino University Professor and Director, Collection of Historical Scientific Instruments at Harvard University; Introduced by Professor Jack Balkin (Room 127)