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.

A Comparative Analysis of Pyotr Ilich Tchaikovsky’s First and Sixth Symphonies

Pyotr Ilich Tchaikovsky was a great composer of the Romantic Era, and is admired as much—if not more—today as he was during his lifetime. Despite his successes, Tchaikovsky is seen as rather inept in adhering to symphonic forms. This paper contrasts the first and last symphonies that Tchaikovsky wrote, and compares the First Symphony’s adherence to symphonic forms and the Sixth Symphony’s weaker adherence to symphonic form. While both symphonies are well written, the Sixth Symphony is a much more emotional, dramatic, and skillfully crafted work. This is in part due to Tchaikovsky no longer feeling that he needed to follow classical conventions to the letter, and giving himself more freedom to write in ways that suited his compositional tendencies

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

Contribution of Lianas to Plant Area Index and Canopy Structure in A Panamanian Forest

Lianas are an important component of tropical forests, where they reduce tree growth, fecundity, and survival. Competition for light from lianas may be intense; however, the amount of light that lianas intercept is poorly understood. We used a large-scale liana-removal experiment to quantify light interception by lianas in a Panamanian secondary forest. We measured the change in plant area index (PAI) and forest structure before and after cutting lianas (for 4 yr) in eight 80 m × 80 m plots and eight control plots (16 plots total). We used ground-based LiDAR to measure the 3-dimensional canopy structure before cutting lianas, and then annually for 2 yr afterwards. Six weeks after cutting lianas, mean plot PAI was 20% higher in control vs. liana removal plots. One yr after cutting lianas, mean plot PAI was ~17% higher in control plots. The differences between treatments diminished significantly 2 yr after liana cutting and, after 4 yr, trees had fully compensated for liana removal. Ground-based LiDAR revealed that lianas attenuated light in the upper- and middle-forest canopy layers, and not only in the upper canopy as was previously suspected. Thus, lianas compete with trees by intercepting light in the upper- and mid-canopy of this forest

An International Service Learning Guide for Occupational Therapy Students and Clinicians

We ourselves feel that what we are doing is just a drop in the ocean. But the ocean would be less because of that missing drop -Mother Teresa Increased diversity within the U.S. demands the education of occupational therapy clinicians who can deliver culturally responsive care. The number of immigrants to the U.S. is at an all-time high and the African-American and Hispanic populations are expected to double by mid-century (U.S. Census Bureau, 2008). Occupational therapy students and entry-level clinicians have identified the need for more information, resources, and experience with people from different cultures (Murden et aI., 2008). Service learning and cultural immersion were identified as educational methods that may facilitate the development of cultural competence and lead to culturally sensitive care (Bonder, Martin & Miracle, 2002a; Iwama, 2009; O\u27Grady, 2000; Price et aI., 2005). This scholarly project culminated in a guide, which is intended to provide occupational therapy students and clinicians with the framework necessary to develop and complete an international service learning experience for the promotion of cultural competence. Guided by the Canadian Model of Occupational Performance and Engagement (CMOP-E), the model of service learning, and adult learning theory, this guide addresses the emotional, intellectual, financial, physical, and social elements of service learning to achieve both learner and client goals. The guide is intended for use in planning an international service learning project in a developing country, but may be adapted for use in local or regional areas of the U.S

The negative influences of the new brazilian forest code on the conservation of riparian forests

More than one million hectares of riparian forests were degraded or altered in Mato Grosso State (Brazil) up to 2009. The aim of the research is to set a comparative scenario to show differences in the quantification of environmental liabilities in riparian forest areas resulting from the change in native vegetation protection rules due to the transition between Laws 4771/65 and 12651/2012. Data collection took place in a marginal stretch of Vermelho River in Rondonópolis County, Mato Grosso State. The following data set was taken into consideration: aerial images derived from unmanned aerial vehicle, Rapid Eye satellite images and orbital images hosted at Google Earth. The spatial resolution of those images was compared. The aerial photos composed a mosaic that was photo-interpreted to generate land use and occupation classes. The riparian forest areas of a rural property were used as parameter, and their environmental situation was compared in 05 meter and 100 meter strips. Thus, by taking into consideration the current rules, 23,501 m2 of area ceased to be an environmental liability within the riparian forest and became a consolidated rural area. According to the previous Forest Code, in a different scenario, that is, in a set of rural properties, the public authority would receive USD 68,600.00 in fines. The new Brazilian Forestry Code of 2012, which replaces the previous one made in 1965, exempts those responsible for rural property from regenerating previously deforested native vegetation — an obligation established by older Forest Code. We have shown that the new Forest Code has diminished the legal responsibility of the rural owners in relation to the maintenance of forest fragments in their properties