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PubMed2001

The TestSmart-HPV Program--development of an integrated approach for testing high production volume chemicals.

The TestSmart program was developed in response to the High Production Volume Chemical Challenge, a voluntary initiative under which chemical producers provide basic toxicity data on chemicals produced in greater than one million pounds annually. Specifically, under the Challenge, chemical producers will generate data as needed to complete the Screening Information Data Set (SIDS), as defined by the Organization for Economic Cooperation and Development (OECD). The TestSmart program is a collaborative effort of the Johns Hopkins Center for Alternatives to Animal Testing, the Environmental Defense Fund, Carnegie-Mellon University, and the University of Pittsburgh. The goal of the TestSmart program is to provide a humane and efficient approach to collecting SIDS data. The program has two objectives, one immediate and the other more long term. The immediate objective has been to make recommendations to reduce the number of animals used in collecting SIDS data under the Challenge. This was accomplished, through a group process, by examining the current status of alternative methods for SIDS endpoints and by providing an assessment of the "state of readiness" of current and potential future alternatives. The long-term objective is to provide a model for other programs to follow the TestSmart concept of a more efficient and humane approach to obtain toxicological data of interest to regulators and the public.

Animal Testing Alternatives↗
PubMed2004

Billions for biodefense: federal agency biodefense funding, FY2001-FY2005.

Over the past several years, the United States government has spent substantial resources on preparing the nation against a bioterrorist attack. This article analyzes the civilian biodefense funding by the federal government from fiscal years 2001 through 2005, specifically analyzing the budgets and allocations for biodefense at the Department of Health and Human Services, the Department of Homeland Security, the Department of Defense, the Department of Agriculture, the Environmental Protection Agency, the National Science Foundation, and the Department of State. In total, approximately $14.5 billion has been funded for civilian biodefense through FY2004, with an additional $7.6 billion in the President's budget request for FY2005.

Bioterrorism↗
PubMed1997

Overview of DOD activities in ecological risk assessment.

Under the Comprehensive Environmental Response, Compensation and Liability Act, Congress has mandated that all designated hazardous waste sites will be remediated to protect human health and the environment. This law is the driving force behind the Department of Defense (DOD) ecological risk assessment (ERA) program. Ecological risk assessments are currently underway at many DOD sites with budgets ranging from five thousand to ten million dollars. However, with the advent of downsizing government and shrinking funds, efforts are being made within DOD to better refine these assessments. Two DOD work groups function to develop guidance for and assist project managers with the ERA process. These groups are the Army Biological Technical Assistance Group chaired by the Army Environmental Center and the Tri-Service Ecological Risk Assessment Work Group (ERWG) chartered by the Tri-Service Environmental Support Centers Coordinating Committee. Membership in the Tri-Service ERWG includes all facets of DOD. In the research arena, the Fate & Effects Research and Development Program is one of four primary thrust areas under the Army's Environmental Quality Technology Program "Clean Up" pillar. This program is currently being executed by three laboratories, the Waterways Experiment Station, Vicksburg, MS, the Army Center for Health Promotion and Preventive Medicine, Aberdeen Proving Ground, MD, and the Army Center for Environmental Health Research (Provisional), Ft. Detrick, MD. The goal of this program is to provide tools to improve environmental risk assessments, both human and ecological. The research is geared toward addressing user requirements and is defined by the Fate and Effects Research Program.

Ecology↗
PubMed1998

Clair Patterson and Robert Kehoe's paradigm of "show me the data" on environmental lead poisoning.

In 1925, Robert A. Kehoe enunciated a paradigm predicated upon categorical distinction between expectations and conjecture ("show me the data" mentality) from hard scientific facts on exposure outcomes. It led to a precedent-setting system of voluntary self-regulation by lead industry as a model for environmental control and implicitly signaled the level of industrial responsibility for lead pollution. It combined a cascading uncertainty rule (there is always uncertainty to be found in a world of imperfect information) with a highly skewed cost-benefit concept (immediate benefits of tetraethyl lead additives must be weighed against possible future health hazards). Many studies were funded by the lead industry to develop a theoretical framework for the paradigm which served as a strong defensive strategy against lead critics. It resulted in an unfettered growth in automotive lead pollution to over 270,000 tons per year in the United States and 350,000 tons per year worldwide during the early 1970s. Clair Patterson is credited with being the first person to mount an effective challenge against the Kehoe paradigm, and with his success came an upsurge of activity and attention to the risks of environmental lead pollution on public health.

Chemical Industry↗
PubMed2006

Manufactured uncertainty: protecting public health in the age of contested science and product defense.

The strategy of "manufacturing uncertainty" has been used with great success by polluters and manufacturers of dangerous products to oppose public health and environmental regulation. This strategy entails questioning the validity of scientific evidence on which the regulation is based. While this approach is most identified with the tobacco industry, it has been used by producers of asbestos, benzene, beryllium, chromium, diesel exhaust, lead, plastics, and other hazardous products to avoid environmental and occupational health regulation. It is also central to the debate on global warming. The approach is now so common that it is unusual for the science not to be challenged by an industry facing regulation. Manufacturing uncertainty has become a business in itself; numerous technical consulting firms provide a service often called "product defense" or "litigation support." As these names imply, the usual objective of these activities is not to generate knowledge to protect public health but to protect a corporation whose products are alleged to have toxic properties. Evidence in the scientific literature of the funding effect--the close correlation between the results of a study desired by a study's funder and the reported results of that study--suggests that the financial interest of a study's sponsors should be taken into account when considering the study's findings. Similarly, the interpretation of data by scientists with financial conflicts should be seen in this light. Manufacturing uncertainty is antithetical to the public health principle that decisions be made using the best evidence currently available.

Environmental Pollutants↗
PubMed1997

Developments in the application of impact assessment methodologies for pollution prevention.

Pollution prevention requires the assessment of various multimedia environmental impacts to ensure that the alternative selected most closely represents the environmental goals and priorities of the facility. While some facility's environmental policies are easy to assess (e.g., reduce TRI emissions), others require a more sophisticated assessment methodology (e.g., select the most environmentally-friendly manufacturing process). Chemical environmental impact assessment for pollution prevention can be very effective, but can only provide a scientifically defensible decision point if the methodologies, analytical tools, and data quality are consistent with the environmental goals and priorities expressed. In many assessments completed in the past, the assessment methodologies have been overly simplistic when compared to the environmental goals projected. More sophisticated chemical impact assessment methodologies have not been used in the past for a variety of reasons, including: poor study design, poor data quality, inadequate funding, inadequate computer systems and databases, and practitioner's lack of understanding. This paper will describe a broad range of assessment methodologies, the steps involved in various evaluations, various resources available to conduct pollution prevention impact assessments, and on-going methodology development.

Ecology↗
PubMed2006

Chemical plants remain vulnerable to terrorists: a call to action.

U.S. chemical plants currently have potentially catastrophic vulnerabilities as terrorist targets. The possible consequences of these vulnerabilities echo from the tragedies of the Bhopal incident in 1984 to the terrorist attacks on 11 September 2001 and, most recently, Hurricanes Katrina and Rita. Findings from a 2004 nationwide participatory research study of 125 local union leaders at sites with very large volumes of highly hazardous chemicals suggest that voluntary efforts to achieve chemical plant security are not succeeding. Study respondents reported that companies had only infrequently taken actions that are most effective in preventing or in preparing to respond to a terrorist threat. In addition, companies reportedly often failed to involve key stakeholders, including workers, local unions, and the surrounding communities, in these efforts. The environmental health community thus has an opportunity to play a key role in advocating for and supporting improvements in prevention of and preparation for terrorist attacks. Policy-level recommendations to redress chemical site vulnerabilities and the related ongoing threats to the nation's security are as follows: a) specify detailed requirements for chemical site assessment and security ; b) mandate audit inspections supported by significant penalties for cases of noncompliance ; c) require progress toward achieving inherently safer processes, including the minimizing of storage of highly hazardous chemicals ; d) examine and require additional effective actions in prevention, emergency preparedness, and response and remediation ; e) mandate and fund the upgrading of emergency communication systems ; and f) involve workers and community members in plan creation and equip and prepare them to prevent and respond effectively to an incident.

Animals↗
PubMed2005

Billions for biodefense: federal agency biodefense budgeting, FY2005-FY2006.

Since 2001, the United States government has spent substantial resources on preparing the nation against a bioterrorist attack. An earlier article analyzed the civilian biodefense funding by the federal government from fiscal years 2001 through 2005. This article updates those figures with budgeted amounts for fiscal year 2006, specifically analyzing the budgets and allocations for biodefense at the Department of Health and Human Services, the Department of Homeland Security, the Department of Agriculture, the Environmental Protection Agency, the National Science Foundation, and the Department of State.

Bioterrorism↗
PubMedDate not supplied

Educational and training systems in Sweden for prehospital response to acts of terrorism.

Sweden has a long tradition in planning for disaster situations in which the National Board of Health and Welfare has a key responsibilty within the health sector. One important part of this disaster preparedness is education and training. Since 11 September 2001, much focus has been placed on the acts of terrorism with special reference to the effects of the use of chemical, biological, or nuclear/radiological (CBNR) agents. In the health sector, the preparedness for such situations is much the same as for other castastrophic events. The National Board of Health and Welfare of Sweden is a national authority under the government, and one of its responsibilities is planning and the provision of supplies for health and medical services, environmental health, and social services in case of war or crises. "Joint Central Disaster Committees" in each County Council/Region in the country are responsible for overseeing major incident planning for their respective counties/regions. The "Disaster Committee" is responsible for ensuring that: (1) plans are established and revised; (2) all personnel involved in planning receive adequate information and training; (3) equipment and supplies are available; and (4) maintenance arrangements are in place. Sweden adopts a "Total Defense" strategy, which means that it places a high value in preparing for peacetime and wartime major incidents. The Swedish Emergency Management Agency coordinates the civilian Total Defense strategy, and provides funding to the relevant responsible authority to this end. The National Board of Health and Welfare takes responsibility in this process. In this area, the main activities of the National Board of Health and Welfare are: (1) the establishment of national guidelines and supervision of standards in emergency and disaster medicine, social welfare, public health, and prevention of infectious diseases; (2) the introduction of new principles, standards, and equipment; (3) the conducting education and training programmes; and (4) the provision of financial support. The budget for National Board of Health and Welfare in this area is approximately 160 million SEK (US dollar 18 million). The National Board of Health and Welfare also provides funding to the County Councils/Regions for the training of healthcare professionals in disaster medicine and crises management by arranging (and financing) courses primarily for teachers and by providing financial support to the County Councils/Regions for providing their own educational and training programmes. The National Board of Health and Welfare provides funding of approximately 20 million SEK (US dollar 2.4 million) to the County Councils/Regions for this training of healthcare professionals in disaster medicine and crises.

Delivery of Health Care↗
PubMed2005

E3LSI research: an essential element of biodefense.

The threat of bioterrorism has prompted the U.S. to undertake a vast biodefense initiative, including funding biodefense-related scientific research at unprecedented levels. Unfortunately, the many ethical, economic, environmental, legal, and social implications (E(3)LSI) of biodefense research and activities are not yet receiving the attention they warrant. Previously, in laudable demonstrations of foresight and responsibility, the federal government has funded research into the E(3)LSI of other recent scientific endeavors--namely, the Human Genome Project and the nanotechnology research program--through directed appropriations from their respective research budgets. This article advocates and proposes a model for a portion of biodefense funding to be similarly set aside for an E(3)LSI research program to complement biodefense research, to ensure that bioterror preparedness does not give rise to harmful or otherwise undesirable unintended consequences.

Bioterrorism↗
PubMed2006

Selected science: an industry campaign to undermine an OSHA hexavalent chromium standard.

While exposure to hexavalent chromium (Cr(VI)) has been associated with increased lung cancer risk for more than 50 years, the chemical is not currently regulated by the U.S. Occupational Safety and Health Administration (OSHA) on the basis of its carcinogenicity. The agency was petitioned in 1993 and sued in 1997 and 2002 to lower the workplace Cr(VI) exposure limit, resulting in a court order to issue a final standard by February 2006. Faced with the threat of stronger regulation, the chromium industry initiated an effort to challenge the scientific evidence supporting a more protective standard. This effort included the use of "product defense" consultants to conduct post hoc analyses of a publicly-funded study to challenge results viewed unfavorably by the industry. The industry also commissioned a study of the mortality experience of workers at four low-exposure chromium plants, but did not make the results available to OSHA in a timely manner, despite multiple agency requests for precisely these sorts of data. The commissioned study found a statistically significant elevation in lung cancer risk among Cr(VI)-exposed workers at levels far below the current standard. This finding changed when the multi-plant cohort was divided into two statistically underpowered components and then published separately. The findings of the first paper published have been used by the chromium industry to attempt to slow OSHA's standard setting process. The second paper was withheld from OSHA until it was accepted for publication in a scientific journal, after the rulemaking record had closed. Studies funded by private sponsors that seek to influence public regulatory proceedings should be subject to the same access and reporting provisions as those applied to publicly funded science. Parties in regulatory proceedings should be required to disclose whether the studies were performed by researchers who had the right to present their findings without the sponsor's consent or influence, and to certify that all relevant data have been submitted to the public record, whether published or not.

Carcinogens, Environmental↗
PubMed2002

The World Health Organization and the Pharmaceutical Industry. Common areas of interest and differing views.

No article published in the scientific press in the last 10 years reviews the various areas of interest common to the World Health Organization (WHO) and the pharmaceutical industry. Despite a vast amount of information in the public domain, the policies expound the views only of the bodies they represent rather than comparing differing views. An understanding of the factors which affect the interaction between these organisations as well as the organisational structures and the actual areas of intersecting interest, may help to find ways for the industry to assist the WHO in its endeavours in developing countries. Modern drug development is performed initially in and for western society, leaving the areas of infectious or tropical diseases with relatively less industry investment than cancer and cardiovascular disorders. Aspects of the development of an ethical drug, regardless of its therapeutic class (selection of drug name, intellectual property rights, drug safety, marketing and pricing, quality assurance and counterfeiting, generic use, emerging drug donations) are influenced to varying degrees by the triad of money, politics and medical need and the perspectives (each defensible) placed thereon by the WHO and industry. Instead of simply defending their positions combining the best of these strategies to optimise drug development for the needs of developing countries appears logical. Similarly, via its philanthropic initiatives, industry will have donated over $US1 billion in drug and research aid in the period 1995 to 2005. These charitable projects should yield useful information for planning and organising future aid efforts. Global warming, only recently given serious governmental consideration, is an area not yet addressed in drug development policy although along with geographical effects, it is likely to have an impact on the epidemiology of diseases e.g. malaria returning to the Mediterranean, worldwide. With changing disease patterns (and particularly if the western world is affected directly), a shift in emphasis on future medical needs and drug development can be anticipated. Furthermore, given the increased modern interest in herbal medicines and the fact that poorer countries rely heavily on traditional medicines, archiving of botanicals under threat would preserve plants for future medicinal testing or use. Coupled with the environmental and poverty issues that the WHO already attempts to address in developing countries, it is timely for both bodies to work towards certain agreed mutual aims. To work effectively, it is realistic that both bodies must benefit and also make concessions in this interactive process.

Developing Countries↗
PubMed2001

[The precautionary principle: advantages and risks].

The extension of the precautionary principle to the field of healthcare is the social response to two demands of the population: improved health safety and the inclusion of an informed public in the decision-making process. The necessary balance between cost (treatment-induced risk) and benefit (therapeutic effect) underlies all healthcare decisions. An underestimation or an overestimation of cost, i.e. risk, is equally harmful in public healthcare. A vaccination should be prescribed when its beneficial effect outweighs its inevitable risk. Mandatory vaccination, such as in the case of the Hepatitis B virus, is a health policy requiring some courage because those who benefit will never be aware of its positive effect while those who are victims of the risk could resort to litigation. Defense against such accusations requires an accurate assessment of risk and benefit, which underlines the importance of expertise. Even within the framework of the precautionary principle, it is impossible to act without knowledge, or at least a plausible estimation, of expected effects. Recent affairs (blood contamination, transmissible spongiform encephalitis by growth hormone, and new variant of Creutzfeldt-Jacob disease) illustrate that in such cases the precautionary principle would have had limited impact and it is only when enough knowledge was available that effective action could be taken. Likewise, in current debates concerning the possible risks of electromagnetic fields, cellular phones and radon, research efforts must be given priority. The general public understands intuitively the concept of cost and benefit. For example, the possible health risks of oral contraceptives and hormone replacement therapy were not ignored, but the public has judged that their advantages justify the risk. Estimating risk and benefit and finding a balance between risk and preventive measures could help avoid the main drawbacks of the precautionary principle, i.e. inaction and refusal of innovation, highly restrictive administrative procedures, and a waste of funds on the search for the utopian goal of zero risk. Other drawbacks are more insidious. The precautionary principle could contribute to a general feeling of anxiety and unease in the population. It could be used by campaigns to manipulate public opinion in favor of a particular commercial interest or ideology. Furthermore, practitioners and public policy makers could be led to make choices not dictated by a search for the optimal solution but rather a solution that would protect them from future accusations (the so-called umbrella phenomenon). On the international level, the precautionary principle must not be used to mask protectionism. Nevertheless, a clear advantage of the precautionary principle is that it requires decision-makers to explain the rationale behind their decisions, to quantify the risks, and to provide objective information. However, the physician must not be tempted to make patients sign documents certifying that they have been given all relevant information on his or her diagnosis and treatment. This example underlines the role of legal texts and jurisprudence in the application of the precautionary principle. Finally, the precautionary principle implies new obligations for the State. In the field of health and healthcare, the State must undertake actions based on fully open and undisguised decision-making and provide complete information to the public. A pplication of the precautionary principle requires much discernment because the final outcome can be beneficial or harmful, depending on the way it is implemented. The precautionary principle, and its applications, must be precise and detailed within a well-defined framework.

Adult↗