A Voucher System To Speed Review Could Promote A New Generation Of Insecticides To Fight Vector-Borne Diseases.

Many in the scientific community are concerned about the potential increase in prevalence of insect-borne diseases such as Chagas disease, Chikungunya, dengue fever, malaria, and Zika in the United States and around the world. Beyond vaccines and drugs to prevent and treat these diseases, a comprehensive approach to fighting these diseases should include control of disease-carrying vectors, such as mosquitoes. Vector-control methods, such as using insecticides to treat bed nets and spray the walls of homes, have prevented millions of deaths from malaria. However, mosquitoes are becoming resistant to insecticides, and no new class of insecticides for vector control has been introduced in decades. We recommend the creation of a new type of incentive for the development and commercialization of safe new insecticides: a Vector Expedited Review Voucher, to be awarded to a sponsor that introduces a novel insecticide for public health use. The voucher could be redeemed to expedite registration of a second, more profitable, product by the US Environmental Protection Agency.

Medication monitoring and drug testing ethics project.

In 2012, Duke University initiated a research project, funded by an unrestricted research grant from Millennium Laboratories, a drug testing company. The project focused on assessing the frequency and nature of questionable, unethical, and illegal business practices in the clinical drug testing industry and assessing the potential for establishing a business code of ethics. Laboratory leaders, clinicians, industry attorneys, ethicists, and consultants participated in the survey, were interviewed, and attended two face-to-face meetings to discuss a way forward. The study demonstrated broad acknowledgment of variations in the legal and regulatory environment, resulting in inconsistent enforcement of industry practices. Study participants expressed agreement that overtly illegal practices sometimes exist, particularly when laboratory representatives and clinicians discuss reimbursement, extent of testing, and potential business incentives with medical practitioners. Most respondents reported directly observing probable violations involving marketing materials, contracts, or, in the case of some individuals, directly soliciting people with offers of clinical supplies and other "freebies." While many study respondents were skeptical that voluntary standards alone would eliminate questionable business practices, most viewed ethics codes and credentialing as an important first step that could potentially mitigate uneven enforcement, while improving quality of care and facilitating preferred payment options for credentialed parties. Many were willing to participate in future discussions and industry-wide initiatives to improve the environment.

Impact of economic, regulatory, and patent policies on innovation in cancer chemoprevention.

Chemoprevention agents are an emerging new scientific area that holds out the promise of delaying or avoiding a number of common cancers. These new agents face significant scientific, regulatory, and economic barriers, however, which have limited investment in their research and development (R&D). These barriers include above-average clinical trial scales, lengthy time frames between discovery and Food and Drug Administration approval, liability risks (because they are given to healthy individuals), and a growing funding gap for early-stage candidates. The longer time frames and risks associated with chemoprevention also cause exclusivity time on core patents to be limited or subject to significant uncertainties. We conclude that chemoprevention uniquely challenges the structure of incentives embodied in the economic, regulatory, and patent policies for the biopharmaceutical industry. Many of these policy issues are illustrated by the recently Food and Drug Administration-approved preventive agents Gardasil and raloxifene. Our recommendations to increase R&D investment in chemoprevention agents include (a) increased data exclusivity times on new biological and chemical drugs to compensate for longer gestation periods and increasing R&D costs; chemoprevention is at the far end of the distribution in this regard; (b) policies such as early-stage research grants and clinical development tax credits targeted specifically to chemoprevention agents (these are policies that have been very successful in increasing R&D investment for orphan drugs); and (c) a no-fault liability insurance program like that currently in place for children's vaccines.

Transformational leadership, transnational culture and political competence in globalizing health care services: a case study of Jordan's King Hussein Cancer Center.

BACKGROUND: Following the demise of Jordan's King Hussein bin Talal to cancer in 1999, the country's Al-Amal Center was transformed from a poorly perceived and ineffectual cancer care institution into a Western-style comprehensive cancer center. Renamed King Hussein Cancer Center (KHCC), it achieved improved levels of quality, expanded cancer care services and achieved Joint Commission International accreditation under new leadership over a three-year period (2002-2005). METHODS: An exploratory case research method was used to explain the rapid change to international standards. Sources including personal interviews, document review and on-site observations were combined to conduct a robust examination of KHCC's rapid changes. RESULTS: The changes which occurred at the KHCC during its formation and leading up to its Joint Commission International (JCI) accreditation can be understood within the conceptual frame of the transformational leadership model. Interviewees and other sources for the case study suggest the use of inspirational motivation, idealized influence, individualized consideration and intellectual stimulation, four factors in the transformational leadership model, had significant impact upon the attitudes and motivation of staff within KHCC. Changes in the institution were achieved through increased motivation and positive attitudes toward the use of JCI continuous improvement processes as well as increased professional training. The case study suggests the role of culture and political sensitivity needs re-definition and expansion within the transformational leadership model to adequately explain leadership in the context of globalizing health care services, specifically when governments are involved in the change initiative. CONCLUSION: The KHCC case underscores the utility of the transformational leadership model in an international health care context. To understand leadership in globalizing health care services, KHCC suggests culture is broader than organizational or societal culture to include an informal global network of medical professionals and Western technologies which facilitate global interaction. Additionally, political competencies among leaders may be particularly relevant in globalizing health care services where the goal is achieving international standards of care. Western communication technologies facilitate cross-border interaction, but social and political capital possessed by the leaders may be necessary for transactions across national borders to occur thus gaining access to specialized information and global thought leaders in a medical sub-specialty such as oncology.

Developing drugs for developing countries.

Infectious and parasitic diseases create enormous health burdens, but because most of the people suffering from these diseases are poor, little is invested in developing treatments. We propose that developers of treatments for neglected diseases receive a "priority review voucher." The voucher could save an average of one year of U.S. Food and Drug Administration (FDA) review and be sold by the developer to the manufacturer of a blockbuster drug. In a well-functioning market, the voucher would speed access to highly valued treatments. Thus, the voucher could benefit consumers in both developing and developed countries at relatively low cost to the taxpayer.