Clinic, courtroom or (specialist) committee: in the best interests of the critically Ill child?

Law's processes are likely always to be needed when particularly intractable conflicts arise in relation to the care of a critically ill child like Charlie Gard. Recourse to law has its merits, but it also imposes costs, and the courts' decisions about the best interests of such children appear to suffer from uncertainty, unpredictability and insufficiency. The insufficiency arises from the courts' apparent reluctance to enter into the ethical dimensions of such cases. Presuming that such reflection is warranted, this article explores alternatives to the courts, and in particular the merits of specialist ethics support services, which appear to be on the rise in the UK. Such specialist services show promise, as they are less formal and adversarial than the courts and they appear capable of offering expert ethical advice. However, further research is needed into such services - and into generalist ethics support services - in order to gauge whether this is indeed a promising development.

United States Food and Drug Administration Advisory Committee outcomes and agency approval analysis from 2010 to 2015.

OBJECTIVES: This analysis sought to quantify voting behavior and other characteristics of advisory committee (AC) meetings and compare that with the U.S. Food and Drug Administration's (FDA) approval decisions from 2010 to 2015. METHODS: The analysis of the Center for Drug Evaluation and Research AC meetings was conducted using publicly available information from the FDA website and the sponsors' websites. RESULTS: There were 163 voting sessions, 207 votes, and 229 meetings. Voting questions assessed approval (63%), acceptable risk-benefit profile (19%), efficacy (8%), safety and efficacy (7%), and safety (3%). The AC voted in favor of approval 67% of the time and against approval 33% of the time, although it heavily favored one outcome when voting favorably or unfavorably. The FDA approval decision supported the committee's decision in 90% of cases. When such agreement did not occur, it was due to differences in clinical opinion (43%), manufacturing deficiencies (14%), lack of manufacturing data (14%), and a post-AC event (5%). There was insufficient information to determine why there was a differing opinion in 24% of cases. When FDA had a differing opinion, the agency typically did not approve a substance in which the committee recommended approval (81%). CONCLUSION: The results support past research examining the topic from 2001 to 2010. Voting patterns were relatively constant, and they generally heavily favored one outcome. The FDA's ultimate approval decision was in line with the AC vote the vast majority of cases. Any disagreement was usually due to FDA having a differing opinion regarding clinical importance, furthering the notion that AC insight is heavily considered but not the final determinant in agency action. This topic has importance in understanding pharmaceutical approval in the United States, and this has clinical practice implications.

Patient Engagement Advisory Committee. Final rule.

The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to add the Patient Engagement Advisory Committee.

State Health Insurance Assistance Program (SHIP). Interim final rule.

This rule implements a provision enacted by the Consolidated Appropriations Act of 2014 and reflects the transfer of the State Health Insurance Assistance Program (SHIP) from the Centers for Medicare & Medicaid Services (CMS), in the Department of Health and Human Services (HHS) to the Administration for Community Living (ACL) in HHS. The previous regulations were issued by CMS under the authority granted by the Omnibus Budget Reconciliation Act of 1990 (OBRA `90), Section 4360.

[Control of the legal practice of euthanasia in Belgium]. / Le contrôle de la pratique légale de I'euthanasie en Belgique.

The Belgian law legalizing euthanasia under strict conditions came into effect September 22, 2002. Any physician performing euthanasia has to complete a registration document and to send it within four days to a federal commission whose mission is to verify that the legal conditions were fulfilled. From September 22, 2002 to December 31, 2013, 8.767 documents have been registered and analyzed by this commission. They are described in six reports referred to Parliament. The present paper analyzes the work of this commission and answers the criticisms concerning its quality and its efficiency. The allegations that clandestine euthanasia's escaping any control are performed are also discussed. In conclusion, it appears that the legal obligations concerning the practice of euthanasia in Belgium are fully effective.

State Dental Boards and Public Protection: Fulfilling the Contract.

Dental boards are agents of the state, sworn to protect the public. They combine the skills of professional training with responsibility to ensure that patients receive safe and effective care. They can play a vital role in ensuring that the profession does not invite more regulation by working to maintain the public's trust. Two cases are presented illustrating that one's perspective can cloud the sense of what is right and that it is wrong to pass ethical responsibilities on to others.

Who are the PDCO?

In January 2007, the Paediatric Regulation entered into force and established the Paediatric Committee (PDCO) within the European Medicines Agency. The goal of the PDCO is to improve the health of the children of Europe by increasing high-quality research for medicinal products and promoting the development and authorization of such medicines at the EU level. A major function of the PDCO is to formulate and authorize Paediatric Investigation Plans and Paediatric Use Marketing Authorisations. The EU's Seventh Framework Programme for Research has facilitated the establishment of consortia whose ultimate goal is to answer important clinical questions involving medicines commonly used "off-label", in children. The benefits of these consortia include enhanced collaboration amongst paediatricians, scientists and small to medium enterprises whose ultimate goal is to obtain an authorization for a new indication or formulation for use in the paediatric population. It will be interesting in a number of years time to measure the success of this very important European initiative.

Irreconcilable conflict: the tobacco industry and the public health challenge of tobacco use.

Thomas Novotny reflects on new research by Stanton Glantz and colleagues and the implications of their findings for engaging the tobacco industry on tobacco product regulation.

Tobacco company efforts to influence the Food and Drug Administration-commissioned Institute of Medicine report clearing the smoke: an analysis of documents released through litigation.

BACKGROUND: Spurred by the creation of potential modified risk tobacco products, the US Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to assess the science base for tobacco "harm reduction," leading to the 2001 IOM report Clearing the Smoke. The objective of this study was to determine how the tobacco industry organized to try to influence the IOM committee that prepared the report. METHODS AND FINDINGS: We analyzed previously secret tobacco industry documents in the University of California, San Francisco Legacy Tobacco Documents Library, and IOM public access files. (A limitation of this method includes the fact that the tobacco companies have withheld some possibly relevant documents.) Tobacco companies considered the IOM report to have high-stakes regulatory implications. They developed and implemented strategies with consulting and legal firms to access the IOM proceedings. When the IOM study staff invited the companies to provide information on exposure and disease markers, clinical trial design for safety and efficacy, and implications for initiation and cessation, tobacco company lawyers, consultants, and in-house regulatory staff shaped presentations from company scientists. Although the available evidence does not permit drawing cause-and-effect conclusions, and the IOM may have come to the same conclusions without the influence of the tobacco industry, the companies were pleased with the final report, particularly the recommendations for a tiered claims system (with separate tiers for exposure and risk, which they believed would ease the process of qualifying for a claim) and license to sell products comparable to existing conventional cigarettes ("substantial equivalence") without prior regulatory approval. Some principles from the IOM report, including elements of the substantial equivalence recommendation, appear in the 2009 Family Smoking Prevention and Tobacco Control Act. CONCLUSIONS: Tobacco companies strategically interacted with the IOM to win several favored scientific and regulatory recommendations.

Childhood obesity task forces established by state legislatures, 2001-2010.

INTRODUCTION: States and communities are considering policy and environmental strategies, including enacting legislation, to reduce and prevent childhood obesity. One legislative approach has been to create task forces to understand key issues and develop a course of action. The goal of this study was to describe state-level, childhood obesity task forces in the United States created by legislation from 2001 through 2010. METHODS: We used the Center for Disease Control and Prevention's Division of Nutrition, Physical Activity, and Obesity database to identify state-level childhood obesity task forces created through legislation from 2001 through 2010. RESULTS: We identified 21 states that had enacted legislation creating childhood obesity task forces of which 6 had created more than one task force. Most task forces were charged with both gathering and reviewing information and making recommendations for obesity-prevention actions in the state. Most legislation required that task forces include representation from the state legislature, state agencies, community organizations, and community members. CONCLUSION: Evaluation of the effectiveness of obesity-prevention task forces and the primary components that contribute to their success may help to determine the advantages of the use of such strategies in obesity prevention.

Supporting recovery by improving patient engagement in a forensic mental health hospital: results from a demonstration project.

BACKGROUND: Mental health services are shifting toward approaches that promote patients' choices and acknowledge the value of their lived experiences. OBJECTIVE: To support patients' recovery and improve their experiences of care in a Canadian forensic mental health hospital, an intervention was launched to increase patient engagement by establishing a peer support program, strengthening a patient advisory committee, and creating a patient-led research team. DESIGN: The effect of the intervention on patient- and system-level outcomes was studied using a naturalistic, prospective, longitudinal approach. Quantitative and qualitative data were gathered from inpatients and service providers twice during the 19-month intervention. RESULTS: Despite succeeding in supporting patients' participation, the intervention had minimal impacts on internalized stigma, personal recovery, personal empowerment, service engagement, therapeutic milieu, and the recovery orientation of services. Peer support demonstrated positive effects on internalized stigma and personal recovery. CONCLUSIONS: Strengthening patient engagement contributes toward improving experiences of care in a forensic hospital, but it may have limited effects on outcomes.