Controversies in off-label prescriptions in dermatology: the perspective of the patient, the physician, and the pharmaceutical companies.

The term "off-label drug use" involves the prescription of medications for unapproved indications or in unapproved dosage, dosage form, or route of administration. Off-label medications are common in the management of dermatologic diseases. In the recent years, new indications for botulinum toxin, biologics, spironolactone, topical calcineurin, and topical vitamin D analogues emerged, and these drugs are being used off-label to treat a variety of conditions. The high cost and long time required for the approval discourage pharmaceutical companies from developing studies and pursuing the approval by regulatory agencies. Patients and physicians may have a different perspective regarding the off-label use of medications. The ethical discussion is based on the different opinions concerning the need for informed consent by the patient and how this could be applicable in the clinical practice.

Do Infant Formula Giveaways Undermine or Support Women's Choices?

Eliminating formula giveaways ("banning the bag") has been embraced as a way to reduce the influence of formula marketing in hospitals and to increase breastfeeding rates among new mothers, but the policy raises ethical concerns in the mind of some, notably because it denies a useful benefit to mothers who have trouble affording formula. Hospital policies to promote breastfeeding, including banning the bag, should be sensitive to the economic and other costs associated with breastfeeding and should be consciously designed to make breastfeeding easier and not just to make formula feeding more difficult. We recommend that hospitals evaluate the negative impacts of banning the bag on their patient population in order to ensure that families are not being negatively affected.

IQOS labelling will mislead consumers.

BACKGROUND: Philip Morris International (PMI) continually expands and diversifies their nicotine product portfolio, which includes IQOS, a heated tobacco product. In December 2016, PMI filed a modified risk tobacco product (MRTP) application with the US Food and Drug Administration (FDA), seeking authorisation to market IQOS in USA with three claims of reduced harm: 'switching completely from conventional cigarettes to the IQOS system…' (1) 'can reduce the risks of tobacco-related diseases;' (2) 'significantly reduce[s] your body's exposure to harmful or potentially harmful chemicals;' and (3) 'presents less risk of harm than continuing to smoke cigarettes.' Consumers may misunderstand what is meant by 'switching completely'. METHODS: We critically reviewed study reports submitted to FDA by PMI in support of proposed marketing claims in its MRTP application for IQOS and focused on the statement that switching completely to IQOS reduces risk. RESULTS: We found deficiencies with evidence provided by PMI supporting their assertions that: current smokers will understand what is meant by the phrase 'switching completely'; the proposed claims will not decrease smokers' intentions to quit; and IQOS users will in fact 'switch completely' from smoking cigarettes to using IQOS. The studies and measurement instruments employed by PMI suffer from design flaws and their reporting of associated findings is misleading. CONCLUSION: Consumers will not understand the condition of the claims-that they must quit using cigarettes completely to achieve the inferred health benefits of IQOS. Rather, they are likely to misunderstand the unsupported claims of reduced risks to mean IQOS are harm-free.

Implementation of international code of marketing breast-milk substitutes in China.

BACKGROUND: Breastmilk is the best source of nourishment for infants and young children, and breastfeeding is one of the most effective ways to ensure child health and survival. In May 1981, the World Health Assembly adopted the International Code of Marketing Breast-Milk Substitutes. Since then several subsequent resolutions have been adopted by the World Health Assembly, which both update and clarify the articles within the International Code (herein after the term "Code" refers to both the International Code and all subsequent resolutions). The Code is designed to regulate "inappropriate sales promotion" of breastmilk substitutes and instructs signatory governments to ensure the implementation of its aims through legislation. The Chinese Regulations of the Code were adopted by six government sectors in 1995. However, challenges in promotion, protection, and support of breastfeeding remain. This study aimed to monitor the implementation of the Code in China. SUBJECTS AND METHODS: Six cities were selected with considerable geographic coverage. In each city three hospitals and six stores were surveyed. The International Baby Food Action Network Interview Form was adapted, and direct observations were made. Research assistants administered the questionnaires to a random sample of mothers of infants under 6 months old who were in the outpatient department of the hospitals. In total, 291 mothers of infants, 35 stores, 17 hospitals, and 26 companies were surveyed. RESULTS: From the whole sample of 291 mothers, the proportion who reported exclusively breastfeeding their infant was 30.9%; 69.1% of mothers reported feeding their infant with commercially available formula. Regarding violations of the Code, 40.2% of the mothers reported receiving free formula samples. Of these, 76.1% received the free samples in or near hospitals. Among the stores surveyed, 45.7% were found promoting products in a way that violates the Code. Also, 69.0% of the labeling on the formula products did not comply with the regulations set out in the Code. CONCLUSIONS: As the social and economic developments continue, the interactions of more and more factors curb further success in breastfeeding. Support from all sectors of the society is needed in order to create a social environment to enable the promotion of breastfeeding, in addition to the efforts already made by the healthcare system.

Is consumer response to plain/standardised tobacco packaging consistent with framework convention on tobacco control guidelines? A systematic review of quantitative studies.

BACKGROUND AND OBJECTIVES: Standardised or 'plain' tobacco packaging was introduced in Australia in December 2012 and is currently being considered in other countries. The primary objective of this systematic review was to locate, assess and synthesise published and grey literature relating to the potential impacts of standardised tobacco packaging as proposed by the guidelines for the international Framework Convention on Tobacco Control: reduced appeal, increased salience and effectiveness of health warnings, and more accurate perceptions of product strength and harm. METHODS: Electronic databases were searched and researchers in the field were contacted to identify studies. Eligible studies were published or unpublished primary research of any design, issued since 1980 and concerning tobacco packaging. Twenty-five quantitative studies reported relevant outcomes and met the inclusion criteria. A narrative synthesis was conducted. RESULTS: Studies that explored the impact of package design on appeal consistently found that standardised packaging reduced the appeal of cigarettes and smoking, and was associated with perceived lower quality, poorer taste and less desirable smoker identities. Although findings were mixed, standardised packs tended to increase the salience and effectiveness of health warnings in terms of recall, attention, believability and seriousness, with effects being mediated by the warning size, type and position on pack. Pack colour was found to influence perceptions of product harm and strength, with darker coloured standardised packs generally perceived as containing stronger tasting and more harmful cigarettes than fully branded packs; lighter coloured standardised packs suggested weaker and less harmful cigarettes. Findings were largely consistent, irrespective of location and sample. CONCLUSIONS: The evidence strongly suggests that standardised packaging will reduce the appeal of packaging and of smoking in general; that it will go some way to reduce consumer misperceptions regarding product harm based upon package design; and will help make the legally required on-pack health warnings more salient.

Between reason and coercion: ethically permissible influence in health care and health policy contexts.

In bioethics, the predominant categorization of various types of influence has been a tripartite classification of rational persuasion (meaning influence by reason and argument), coercion (meaning influence by irresistible threats-or on a few accounts, offers), and manipulation (meaning everything in between). The standard ethical analysis in bioethics has been that rational persuasion is always permissible, and coercion is almost always impermissible save a few cases such as imminent threat to self or others. However, many forms of influence fall into the broad middle terrain-and this terrain is in desperate need of conceptual refining and ethical analysis in light of recent interest in using principles from behavioral science to influence health decisions and behaviors. This paper aims to address the neglected space between rational persuasion and coercion in bioethics. First, I argue for conceptual revisions that include removing the "manipulation" label and relabeling this space "nonargumentative influence," with two subtypes: "reason-bypassing" and "reason-countering." Second, I argue that bioethicists have made the mistake of relying heavily on the conceptual categories themselves for normative work and instead should assess the ethical permissibility of a particular instance of influence by asking several key ethical questions, which I elucidate, that relate to (1) the impact of the form of influence on autonomy and (2) the relationship between the influencer and the influenced. Finally, I apply my analysis to two examples of nonargumentative influence in health care and health policy: (1) governmental agencies such as the Food and Drug Administration (FDA) trying to influence the public to be healthier using nonargumentative measures such as vivid images on cigarette packages to make more salient the negative effects of smoking, and (2) a physician framing a surgery in terms of survival rates instead of mortality rates to influence her patient to consent to the surgery.

Productos de higiene infantil: la importancia de un correcto etiquetado / Infant hygiene products: the importance of correct labeling

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The essential element of ethics.

Companies must operate in a cost-effective manner in an increasingly competitive business environment. At the same time, their products must meet patient and user needs, be safe, perform as labelled and meet regulatory requirements. This article discusses three codes of practice developed to assist companies in balancing these sometimes opposing forces.