Independent Advisory Board Research Articles

Ximena Aguilera—guiding pandemic preparedness in Chile

Thanks to her early aptitude at reading, Ximena Aguilera skipped a year of primary school and started medical school at the University of Chile (Santiago, Chile), aged just 16 years. It was clear her talents lay in science and she decided on medicine (even though she was also a top 100 m sprinter in her youth). Today, she is Director of the Center of Epidemiology and Public Health Policies, and full professor at the Faculty of Medicine Clínica Alemana Universidad del Desarrollo in Chile, and President of the Independent Advisory Board for the COVID-19 response, which has been working with the Chilean Ministry of Health since the beginning of the pandemic.

Trouble in NY: Opioid settlement money in danger of being co‐opted

The New York legislature took steps to make sure that the opioid settlement money did not suffer the same fate as the Master Settlement Agreement between the tobacco industry and the states, in which the money which was supposed to go to treatment for tobacco‐related diseases went instead into the states' general treasuries. The legislature guaranteed that an independent advisory board would make recommendations on how the opioid settlement money would be spent. But the first batch of that money, $208 million, appears to be disappearing into a state‐run secret system in which the advisory board is being shafted.

NY opioid settlement money in danger of being co‐opted by the state

Advocates across the country have been eagerly awaiting proceeds from lawsuits against the opioid pharmaceutical industry. The New York State legislature passed a bill designed to make sure that the opioid settlement money did not suffer the same fate as the Master Settlement Agreement between the tobacco industry and states' attorneys general in the late ‘90s in which the money that was supposed to go to treatment for tobacco‐related diseases went instead into the state coffers (see Opioid settlement money for treatment? It's up to the states, ADAW Sept. 13, 2021; https://onlinelibrary.wiley.com/doi/10.1002/adaw.33186?af=R). The legislature guaranteed that an independent advisory board would make recommendations on how the opioid settlement money would be spent (see New York law paves way for distributing opioid settlement funds to treatment, ADAW July 11, 2021; https://onlinelibrary.wiley.com/doi/10.1002/adaw.33127). But the first batch of that money, $208 million, has apparently been disappearing into a state‐run secret system in which the advisory board is being shafted. The money is shepherded by the Office of Addiction Services and Supports (OASAS).

7.D. Workshop: Optimal development and interactions between cancer policy tools at the EU and national level

Abstract Cancer planning is a public health activity that has taken an important place in the health policy arena over the past 35 years. Cancer plans, programmes and strategies were mostly presenting with the challenges of inadequate comprehensiveness, uncertainties on implementation, insufficient resources and missing evaluation. EU launched its Europe Against Cancer Programme in 1985 and it was running successfully until 2003, falling short of the date of the biggest enlargement of the EU. The revival of the EU activities followed with Slovenia's Presidency to the Council of the EU bringing cancer back to the top of the agenda. This resulted in triggering several activities that strongly involved Member States (MSs): Establishment of the European Partnership for Action Against Cancer. EC call on the MSs to develop their national cancer control programmes (NCCPs) by 2013. Launch of several joint actions (JAs) - EPAAC, CanCon, JARC, iPAAC, policy projects to support the development of cancer policy both in MSs as well as in the EU Launch of the European Reference Networks (ERNs) All of these activities raised the expectations that the EU should take a more important role in steering activities in cancer control across the entire Union. Adoption of the Europe's Beating Cancer Plan (EBCP) marks a special moment in EU activities in cancer policy. It is the first time there is a comprehensive agenda on cancer, which includes both the classical preventative activities as well as cancer care and the challenges related to survivorship. The workshop is intended to present the main flagships in the EBCP, how they are to be implemented at the EU level and at the level of the MSs. Special reflection will be given to the role of research in cancer at all aspects of the disease. As research and innovation are an important component of the EBCP, the Mission on Cancer by DG RTD is prepared in close alignment and with the Mission Board acting as an independent advisory board to the EBCP, proposing a set of research and other policy actions and assist in its implementation. During the workshop, an assessment will be presented on how the recommendations of the work of the Mission on Cancer are incorporated into the EBCP. Finally, there will be a moderated discussion with the panellists and the audience on: what will be the challenges of developing national cancer policy priorities in response to the flagships of the EBCP, how these actions are going to be reflected in NCCPs, how can cancer policy development become a model for other NCDs. Participants are expected to gain more insight into the key policy priorities and public health actions related to the EBCP, how they are going to be supported by the MSs and what should be jointly undertaken to tackle the challenges related to the full implementation of EBCP across the EU. Key messages Cancer policy needs to be developed at the EU and country levels in a coordinative process. Comprehensiveness is necessary in addressing all public health challenges of the 21st century.

Double blind randomized controlled trial of deep brain stimulation for obsessive-compulsive disorder: Clinical trial design

Obsessive-compulsive disorder (OCD), a leading cause of disability, affects ~1–2% of the population, and can be distressing and disabling. About 1/3 of individuals demonstrate poor responsiveness to conventional treatments. A small proportion of these individuals may be deep brain stimulation (DBS) candidates. Candidacy is assessed through a multidisciplinary process including assessment of illness severity, chronicity, and functional impact. Optimization failure, despite multiple treatments, is critical during screening. Few patients nationwide are eligible for OCD DBS and thus a multi-center approach was necessary to obtain adequate sample size. The study was conducted over a six-year period and was a NIH-funded, eight-center sham-controlled trial of DBS targeting the ventral capsule/ventral striatum (VC/VS) region. There were 269 individuals who initially contacted the sites, in order to achieve 27 participants enrolled. Study enrollment required extensive review for eligibility, which was overseen by an independent advisory board. Disabling OCD had to be persistent for ≥5 years despite exhaustive medication and behavioral treatment. The final cohort was derived from a detailed consent process that included consent monitoring. Mean illness duration was 27.2 years. OCD symptom subtypes and psychiatric comorbidities varied, but all had severe disability with impaired quality of life and functioning. Participants were randomized to receive sham or active DBS for three months. Following this period, all participants received active DBS. Treatment assignment was masked to participants and raters and assessments were blinded. The final sample was consistent in demographic characteristics and clinical features when compared to other contemporary published prospective studies of OCD DBS. We report the clinical trial design, methods, and general demographics of this OCD DBS sample.

Conflict of Interest Mitigation Procedures May Have Little Influence on the Perceived Procedural Fairness of Risk-Related Research.

Two between-subject experiments explored perceived conflict of interest (COI)-operationalized as perceived procedural unfairness-in a hypothetical public-private research partnership to study the health risks of trans fats. Perceived fairness was measured as subjects' perceptions that health researchers would be willing to listen to a range of voices and minimize bias (i.e., COI) in the context of a research project. Experiment 1 (n = 1,263) randomly assigned research subjects to a partnership that included (1) a combination of an industry partner, a university partner, and a nongovernmental organization (NGO) partner; and (2) one of three processes aimed at mitigating the potential for COI to harm the quality of the research. The procedures included an arm's-length process meant to keep the university-based research team from being influenced by the other partners, an independent advisory board to oversee the project, and a commitment to making all data and analyses openly available. The results suggest that having an industry partner has substantial negative effects on perceived fairness and that the benefit of employing a single COI-mitigation process may be relatively small. Experiment 2 (n = 1,076) assessed a partnership of (1) a university and either an NGO or industry partner and (b) zero, one, two, or three of the three COI-mitigation procedures. Results suggest there is little value in combining COI-mitigation procedures. The study has implications for those who aim to foster confidence in scientific findings for which the underlying research may benefit from industry funding.

Ethical challenges in designing and conducting medicine quality surveys

ObjectivesIn this paper we discuss the main ethical challenges related to the conduct of medicine quality surveys and make suggestions on how to address them.MethodMost evidence‐based information regarding medicine quality derives from surveys. However, existing research ethical guidelines do not provide specific guidance for medicine quality surveys. Hence, those conducting surveys are often left wondering how to judge what counts as best practice. A list of the main ethical challenges in the design and conduct of surveys is presented.Results and conclusionsIt is vital that the design and conduct of medicine quality surveys uphold moral and ethical obligations and analyse the ethical implications and consequences of such work. These aspects include the impact on the local availability of and access to medicines; the confidentiality and privacy of the surveyors and the surveyed; questions as to whether outlet staff personnel should be told they are part of a survey; the need of ethical and regulatory approvals; and how the findings should be disseminated. Medicine quality surveys should ideally be conducted in partnership with the relevant national Medicine Regulatory Authorities. An international, but contextually sensitive, model of good ethical practice for such surveys is needed.

Strategic investments in non-communicable diseases (NCD) research in Africa: the GSK Africa NCD Open Lab.

In March 2014, GSK announced a number of new strategic investments in Africa. One of these included investment of up to 25 million Pounds Sterling (£25 million) to create the world’s first R&D Open Lab to increase understanding of non-communicable diseases (NCDs) in Africa. The vision is to create a new global R&D effort with GSK working in partnership with major funders, academic centres and governments to share expertise and resources to conduct high-quality research. The Africa NCD Open Lab will see GSK scientists collaborate with scientific research centres across Africa. An independent advisory board of leading scientists and clinicians will provide input to develop the strategy and selection of NCD research projects within a dynamic and networked open-innovation environment. It is hoped that these research projects will inform prevention and treatment strategies in the future and will enable researchers across academia and industry to discover and develop new medicines to address the specific needs of African patients.

Creating lasting and fulfilling careers for Indigenous Australians

Recruiting Indigenous Australians is part of the oil and gas industry’s social responsibility. Indigenous recruits need to be ensured that they have lasting and fulfilling careers. In Transfield Services’ experience, retention is often the greatest challenge and significant time and resources is spent to identify strategies to help Indigenous employees progress their careers positively. The first and, arguably, the most important element is to engage early with Indigenous communities to identify key local Indigenous stakeholders and establish strong and trusting relationships. This provides a contextual platform and understanding that guides not only the recruitment process and role fit, but also the support required for individuals through their employment. Indigenous employees then are assigned a mentor to assist in developing their occupational skills. Mentors can be volunteers from across the company but they must work closely with Indigenous development managers to ensure full cultural awareness. Cultural awareness training should also be carried out extensively across an organisation and be backed up by day-to-day application of human resource polices that accommodate cultural elements specific to Indigenous Australians. Critically, organisations must also hold themselves accountable. Publicly available Reconciliation Action Plans (RAPs) must set transparent targets for recruitment and retention, and progress must be continually monitored by informed and independent advisory boards. In 2007, Transfield Services launched its first Indigenous participation strategy. It then became the first service provider to implement a RAP in 2009. Since then, it has launched an updated RAP, which earlier this year was endorsed by Reconciliation Australia—one of only a handful in the country to have this accreditation.

Writing publications for advisory boards

Medical communication publications are designed to raise awareness of medicines, cosmetics, and technology. These publications ensure that doctors are informed about the role of new and existing medicines and the literature concerning appropriate prescription for specific patient groups. With the increasing choice of medicines available today, practical guidelines and recommendations are increasingly needed to help practicing clinicians to choose the most appropriate product for their patients. Advisory boards, consisting of clinicians, with a solid experience in a specific therapeutic domain, are well placed to provide this advice. The pharmaceutical industry often supports independent advisory boards to consider current issues in patient care and communicate their opinions on how to best deal with these problems. Medical writers are well placed to be involved in advisory board management. They ensure the quality of this type of communication as they have a solid understanding of science and the ethics, standards, and regulations required for medical publications.

704P - Final Safety Analysis of Erlotinib Plus Gemcitabine in a Post-Marketing Surveillance Study (Polaris) of >800 Japanese Pancreatic Cancer Patients

ABSTRACT Aim: Erlotinib is approved in Japan for the treatment of unresectable pancreatic cancer (PC) in combination with gemcitabine (GE). This surveillance study investigated the safety and efficacy of GE in Japanese patients (pts), focusing on the incidence of interstitial lung disease (ILD), an adverse drug reaction (ADR) of particular concern in these pts. Methods: All pts receiving GE for treatment of PC in Japan between Jul 2011 and Aug 2012 were enrolled; pts with current/former ILD were excluded. Observation period: 28 wks. ADRs: adverse events where GE could not be ruled out as the cause. All ILD-like events were assessed by an independent ILD review committee (IRC). ILD: all ILD-like events excluding those deemed non-ILD by the IRC. Risk factors for ILD occurrence were analysed by multivariate Cox regression analysis. Both PFS and OS were assessed by the investigator. Results: A total of 848 pts had case report forms by the data cut-off of Dec 2013 (safety data were available for 843 pts). Baseline characteristics included: male 58.1%; median age 65 yrs; any smoking history 44.1%; lung metastases 14.0%; ECOG PS 0 69.2%; prior treatment lines 0/1/2/ ≥ 3: 80.5%/11.3%/5.1%/3.1%. ADRs were reported in 83.5% of pts; the most common were skin disorders (69.9%), including rash (63.6%), and diarrhoea (17.6%). Most ADRs were grade ≤2. ILD events were confirmed by IRC in 52 pts (6.2%), of whom 2 pts had grade 5 ILD (0.2%). This is in contrast to the higher ILD mortality rate (1.5%) previously seen in NSCLC pts. The multivariate analysis identified age ≥75 yrs and existence of any lung disease as a potential risk factor for whether pts developed ILD. Median PFS was 104 days (95% CI 92–112) and accumulated OS rate at 8, 16 and 28 wks was 95.3%, 85.0% and 68.2%, respectively. Conclusions: The safety profile from this large surveillance study was similar to previous clinical studies of GE in PC. These final data from this study in Japanese PC pts provide further information, especially on risk factors for ILD occurrence, which will be reported in more detail. Improved awareness of these risk factors will help clinicians guide GE treatment in these pts. Note: Authors Furuse, Gemma, Hatori, Okusaka attended an Independent Advisory Board for Erlotinib. Disclosure: J. Furuse: I have served on an independent erlotinib advisory board for Chugai Pharmaceutical Co., Ltd.; A. Gemma: I have served on an independent erlotinib advisory board for Chugai Pharmaceutical Co., Ltd.; T. Hatori: I have served on an advisory board for Chugai Pharmaceutical Co., Ltd.; T. Okusaka: I have served on an advisory board for Chugai Pharmaceutical Co., Ltd.; A. Seki: I am an employee of Chugai Pharmaceutical Co., Ltd. and have some stock ownership at Kissei Pharmaceutical Co., Ltd.

The Dynamics of Closely Held Family Business, Its Transition Planning and Management

Families are about caring and is about money, combining these two is Family Business. The outcome can be both best and worst. The best may combine values, ethics, dedication and discrete potential of each family member. The worst is when hostile family members have to work together, where self-interest is first. The case becomes challenging when the transfers from generation to generation for example Aditya Birla, Walmart, Samsung, Reliance, Tata, JP, Muruguppa, GVK, GMR group, etc.The owner plays the major role in a closely held family business. Owners may be one or more members of the family itself. Major decisions are under taken by the owner, keeping in mind the emotions within the family. The linkage between the family and has a mutual influence on the firm’s working and on its objectives and interest of the family.Transition management is a “once in a life time” strategic decision, very critical by nature. Thus, sustainability of the family solely depends on successful transition planning and management. It focuses on both procedural and psychological considerations that have to be kept in mind. It is the most crucial and dominant area in family business, the decision made at this stage always have an ever lasting impact on the future of the business, employees, customers and most importantly the founder and their family. On transition, a person with business acumen should be considered and not emotions in business. Transition planning should start at family level. If the core is strong then subsequent trans-generational decisions shall be successful. Unfavourable transition planning is the reason why most of the family declines in the second generation. The invisible challenge is to pass on the baton of family to trans generations, hereby termed transition planning and management.The research is based literature review, existing information on family businesses, besides analysis of few published cases on family in Indian context that reflect how unstructured transition planning became the cause of its failure at inability and the same time how structured transition planning and management transformed the organisational on its sustainability and growth.Purpose: The purpose of the paper is to relay a better understanding on Transition planning and management within a closely held family and how it is critically associated towards the organisation’s sustainability. Theoretical frameworkFamily is a governed and/or managed with the intention to shape and pursue the vision of the held by the dominant coalition controlled by members of the same family or a small number of families in a manner that is potentially sustainable across generations of the family or families (Chua, Chrisman & Sharma, 1999). Rosenblatt, et al (1985, pp.4) define a family as any in which majority ownership or control lies within a single family and in which two or more family members are or at some time were directly involved in the business. The family is the oldest form of multi-party enterprise. In fact the world’s oldest continuously operated family business, Japanese temple-builder Kongo Gumi, began in 578 (Hutcheson, 2002, pp.119). There are 3 overlapping systems in a family business: the family, the and the ownership / governance systems (Federer, 2012). To lead a family successfully, it mandates managing the different systems of the family and business. Balancing the family interests and the interests is of paramount importance. Thus transition planning and management is must.Astrachan (1988) advocates formalizing job descriptions, writing out family protocol manuals, appointing an independent non-executive to the board and/or setting up an independent advisory board so that actions and ideas could be judged objectively by people outside the family.The patriarch must devise systems that clearly define transition planning and management if the organisation must provide sustainable solution for its existence and growth.Results and conclusions: Some Family businesses are not so successful as compared to their peer group. Effective transition planning and management is the clear outcome of this imbroglio, which is explored and discussed in this research paper.Implications for ‘Resilience the New Research Frontier’ Transition planning and management is a critical issue rather say a vector defining the sustainability within closely held family businesses. There has to be a resilience integrated within the operational framework of the organisation that will supplement its growth.

S.P.33 Australasian neuromuscular disease registry

Abstract Disease registries provide opportunity for clinical trials and improved service provision. The most effective registries are those designed in partnerships to operate within a harmonised global network. The Australasian Neuromuscular Disease Registry (ANMDR) has been created in collaboration with Treat–NMD, WA Health, the Centre of Comparative Genomics and clinical and patient stakeholder groups. The purpose of ANMDR is to serve the needs of the neuromuscular disease community by (1) improving health service planning and (2) identifying patients for follow-up, on the basis of their demographic, clinical or genetic profile, who may benefit from access to emerging diagnostic tools or therapeutics. ANMDR houses specific disease registries including muscular dystrophy, myotonic dystrophy, spinal muscular atrophy, with capacity to house registries for other specific diseases in the future, such as fascioscapular humeral dystrophy and congenital muscular dystrophy. The registry collects clinical data in a secure manner that allows interoperability with other registries. Upon approval by an independent Advisory Board, the registry sends anonymised data to those registries and appropriate researchers. ANMDR is internet based and provides for the ability to control and restrict access to the information (as determined by the Registry Curator), and to interpret data outputs.The registry enables participation in integrated and unified approaches for research in service provision and planning, information sharing, best practices, biobanking, harmonised data collection, analyses and reporting, and creating more robust ethical and legal frameworks. The ANMDR is one element of a larger plan to offer local opportunities to access globally consolidated shared resources, infrastructure and policy. Policy and planning to contextualise needs and identify opportunities of the ANMDR requires both local and international input.

Genetic risk estimation in the Coriell Personalized Medicine Collaborative

PurposeRecent genome wide-association studies have identified hundreds of single nucleotide polymorphisms associated with common complex diseases. With the momentum of these discoveries comes a need to communicate this information to individuals. MethodsThe Coriell Personalized Medicine Collaborative is an observational research study designed to evaluate the utility of personalized genomic information in health care. Participants provide saliva samples for genotyping and complete extensive on-line medical history, family history, and lifestyle questionnaires. Only results for diseases deemed potentially actionable by an independent advisory board are reported. ResultsWe present our methodology for developing personalized reports containing risks for both genetic and nongenetic factors. Risk estimates are given as relative risk, derived or reported from representative peer-reviewed publications. Estimates of disease prevalence are also provided. Presenting risk as relative risk allows for consistent reporting across multiple diseases and across genetic and nongenetic factors. Using this approach eliminates the need for assumptions regarding population lifetime risk estimates. Publications used for risk reporting are selected based on the strength of the design and study quality. ConclusionCoriell Personalized Medicine Collaborative risk reports demonstrate an approach to communicating risk of complex disease via the web that encompasses risks due to genetic variants along with risks caused by family history and lifestyle factors. Genet Med 2011:13(2):131–139.

New Health Care Law Brings Changes

New Health Care Law Brings Changes

In the NEWS A QUICK ROUNDUP OF NEWS AND INFORMATION FROM OUR COMMUNITY

In the NEWS A QUICK ROUNDUP OF NEWS AND INFORMATION FROM OUR COMMUNITY

Nitronaproxen

Nitronaproxen [AZD 3582, HCT 3012, naproxen nitroxybutylester, NO-naproxen] is a naproxen derivative with similar anti-inflammatory activity to the parent compound, but with less gastrointestinal toxicity. It is the first of a new class of analgesic and anti-inflammatory drugs known as cyclo-oxygenase-inhibiting nitric oxide donators (CINODs), which are under development by NicOx. The better gastrointestinal tolerability of nitronaproxen appears to be due to its release of nitric oxide (NO) and the consequent maintenance of tissue perfusion and integrity. Nitronaproxen is in phase III clinical development for the treatment of osteoarthritis and is available for licensing. AstraZeneca had been a worldwide licensee for nitronaproxen and other CINODs. However, the results of phase II clinical trials of nitronaproxen did not fulfill AstraZeneca's strategic commercial criteria for further investment and NicOx reacquired rights following AstraZeneca's decision to discontinue its involvement in 2003. NicOx was surprised by AstraZeneca's decision, and remained fully convinced of the potential of nitronaproxen. NicOx is seeking new partners for development of compounds of the CINOD class. Nitronaproxen is in a phase III clinical trial for the treatment of osteoarthritis (OA) of the knee. The 13-week trial completed enrolment of 820 patients from 120 clinical sites in the US in May 2006. The study is designed to confirm that nitronaproxen is superior to placebo and is as effective as naproxen in relieving signs and symptoms of OA. The study will also seek to show that nitronaproxen has no adverse effect on blood pressure. An additional trial has begun that is employing ambulatory blood pressure monitoring to provide a description of the blood pressure effect of nitronaproxen over a 24-hour period in hypertensive subjects. This US trial will enrol approximately 120 volunteers with stable essential hypertension. The volunteers will not have osteoarthritis but will be between the ages of 50 and 75 years (representative of the osteoarthritis population). Results from both trials are expected in the fourth quarter of 2006. The phase II clinical programme for nitronaproxen, which included 2709 patients in five separate clinical studies, showed that the drug is a potent, safe anti-inflammatory agent, with potential for improved cardiovascular safety over NSAIDs and COX-2 selective NSAIDs. An independent advisory board recommended further development of nitronaproxen in the treatment of osteoarthritis in 2004 based on an evaluation of the full results of the phase II clinical programme.A clinical study had begun in September 2004 at the University of Pennsylvania in patients with mild essential hypertension, in which the effects of nitronaproxen and rofecoxib on arterial blood pressure would be compared. However, rofecoxib was withdrawn worldwide on 1 October 2004. It is unclear if the trial was completed. The STAR Multinational Study Group has conducted a phase II gastrointestinal safety and efficacy study of nitronaproxen versus naproxen in 970 patients with osteoarthritis at 80 sites in the following countries: Argentina, Brazil, Hungary, Mexico, Norway, Poland, South Africa and the UK. The study was completed in November 2002. AstraZeneca conducted a randomised, phase II trial evaluating the efficacy and safety of nitronaproxen among 672 subjects with symptomatic knee osteoarthritis. Results have been presented. Certain phase II trial data from 2003 had been somewhat disappointing. However, an underpowered trial and failures and deficiencies in a trial meant that it was not possible to draw conclusions from this data.

Casino Gambling in Switzerland -The Legal Situation, Politics and Prospects for Prevention and Harm Reduction

In April 2000, a new law came into effect in Switzerland that permits casino gambling with unlimited stakes for the first time since 1921. Casinos can now be run only with a concession granted by a newly established federal agency. In addition to economic and administrative information, each casino applying for a concession has to submit a fully developed "social concept" that includes detailed prevention measures for dealing with people with gambling problems, staff training and evaluation research, which an independent advisory board will control. In the fall of 2001, the first casino concessions will be granted based on the quality of each applicant's overall proposal. The new legislation is creating a unique situation in Switzerland. To reduce the potential harm for gamblers that is associated with new forms of gambling, the legislation should be standardized and continuously optimized. These new measures require evaluation and government control.

Radioactive waste: finding a safe place : Civ Engng, N Y V61, N4, April 1991, P48–51

The Nuclear Waste Policy Act of 1981 and its amendments mandate that the U.S. Department of Energy find a repository for the nation's high-level radioactive wastes, characterize that site and begin disposing of this waste at the repository by 2010. The law requires that the wastes be stable for 10,000 yrs. at the site chosen. The search for that site has narrowed to Yucca Mountain in Nevada. There are a host of obstacles: one is the refusal of the State of Nevada to grant the Department of Energy the necessary grants to begin drilling to investigate the site. There are also legal, political and procedural objections to the procedure as set forth in the law. The technical objections to the site should be settled during the 10 year $3 billion characterization process, once it can begin. Several independent advisory boards are now studying potential problems, particularly the coupling of hydrogeological, tectonic and thermal effects within the volcanic tuff site. The not in my backyard syndrome is a powerful deterrent to finding a site anywhere in the U.S. Currently, the wastes are mounting at the nation's utilities, a situation unacceptable to the utility industry. Others agree that utility managers are not appropriate guardians of this waste. Deep subseabed ocean disposal is generally considered to be technically feasible, but politically unacceptable.