Baruch A. Brody, Ethical Issues in Drug Testing, Approval, and Pricing (Oxford University Press 1995). Conclusions, index, introduction, preface. LC 94-4479; ISBN 0-19-508831-X. [268 pp. Cloth $35.00. 200 Madison Avenue, New York NY 10016.]
Dr. Brody presents an encyclopedic chronology of the clinical trial sequence which led to the approval of thrombolytic agents that dissolve clots in coronary arteries. A member of an Institutional Review Board (IRB) that dealt with streptokinase and tPA thrombolitic agents, he uses this experience to shed light on ethical issues involved in drug development. Readers gain an understanding of how the interdigitating roles of the Food and Drug Administration (FDA), National Institutes of Health, Health Care Finance Administration, pharmaceutical industry, hospitals, physicians, investors and journalists play out against the background of science, the economy, medical ethics and patent law.
Ethical issues regarding streptokinase and tPA are magnified and methodically analyzed. Brody weighs the scientific merit of placebo controlled studies against risks and benefits of the drugs to individual patients. He demonstrates that the risk-benefit ratio continually alters as further information about the drugs' safety and efficacy becomes available and is factored into the equation.
A section on informed consent includes thoughtful discussion of the Nuremberg Code and Declaration of Helsinki. These provide a philosophical basis to remind us of the necessity for a responsible and informed consent. A history of informed consent, its current relevancy and circumstances when it is not needed are included.
Brody's conflict of interest section is refreshing. It acknowledges that double-masked studies using objective criteria, when well controlled and properly executed, dramatically limit the potential for biased results. However, the author does not acknowledge the role of the IRB and the FDA in reviewing study design and execution as further protection of integrity. He feels that stock ownership and consulting agreements by investigators, while creating the perception of conflicts, are unlikely to lead to biased results. Brody finds investigator grants or per capita reimbursement, the usual means by which investigators are remunerated, as having more potential for fostering conflicts of interest but proposes no satisfactory alternative.
Readers are also encouraged to think about the justice of health resource allocation, and a two tiered system is suggested: One with reasonable basic benefits, the other for those who choose to use their wealth to obtain more expensive, only marginally more efficient, drugs. Brody challenges readers to put a price on life to evaluate whether we should be using very expensive drugs that enhance survival by a small percentage. He relates this to using tPA over streptokinase where tPA is ten times the price.
In this regard it would have been good to have seen some mention of the new field of pharmacoeconomics which attempts to place an objective value on an agent according to benefits derived from its use. Also, while Brody shows that pricing in other countries is directly related to the number of new drugs developed, he advances socializing the pharmaceutical industry without apparent recognition that a free market economy is most likely propulsion behind drug development.
Ethical Issues deals thoughtfully with critical ethical issues in drug development. It is well organized, readable and informative. While there will always be excitement surrounding the prospects of new agents, investigators can never forget that they are dealing with the unknown consequences of new chemicals. Patients have rights; anyone involved in drug development must consider those rights and will find this book a scholarly approach to the subject.
Amer El-Ahraf & William V. Willis, Management of Animal Waste -- Environmental Health Problems and Technological Solutions (Praeger Publishers 1996). About the authors, bibliography, index, introduction, tables. LC 95-654; ISBN 0-275-93529-9 [185 pp.Cloth $65.00. 88 Post Road West, Westport CT 06881.]
This book is designed to help make informed policy decisions about the ever-increasing problem of animal waste disposal. It also offers advice in the selection (based on an individual's needs and type of waste involved) of practical methods for getting rid of animal wastes. Its intended audience is said to include [at xiv]:
students, faculty, and researchers in the schools of agriculture, engineering, veterinary medicine, and public health; environmental control and public health agencies, agricultural inspectors; planners and legislative staff... farmers, entrepreneurs, Farm Bureau advisors, environ-mental and consumer groups, and legislators....Unfortunately, many members of this broad audience will have difficulty comprehending much of the book or making decisions based upon its content. As a person who grew up on a farm raising beef cattle and hogs, whose family is still involved in crop farming, I found the chemical reactions and technical references daunting.
Also, if one has difficulty with acronyms, this book will pose a challenge. From the start, once terms were used, many were thereafter referred to by acronym -- for example CZARA (Coastal Zone Act Reauthorization Amendment); BMP (Best Management Practices), BOD (Biological Oxygen Demand); TS, VS and VSS (total, volatile and volatile suspended solids); COD (chemical oxygen demand); TKN (total Kjeldhal nitrogen) and NPDES (National Pollution Discharge Emission Standards). A glossary would have been helpful.
Another problem is that the authors list measured levels of chemicals in relation to water quality but do not interpret them. I could not find "acceptable" levels for listed chemicals; hence raw numbers had little meaning. Although the authors state that certain measured levels are unacceptable per named standards, the reader is not told how far out of line various levels are. The book could have been improved by selective inclusion of such information.
Notwithstanding these shortcomings, Management of Animal Waste provides a comprehensive view of choices available to confront problems that show no sign of diminishing. Its bibliography is broad and includes sources that pointedly disagree with the authors. Overall, the book provides a useful comparative overview of available choices for addressing animal waste disposal.
However, in approaching this work, the authors should have considerably reduced the scope of its intended audience or given more effort to meeting needs of those without technical educations and extensive regulatory experience.
Families, Physicians, and Children with Special Health Needs (Rosalyn Benjamin Darling & Margo I. Peter, eds., Auburn House 1994) About the authors and contributors, foreword, index, preface, resource list. ISBN 0-86569-226-2. [206 pp. Cloth $49.95. 88 Post Road West, Westport CT 06881.]
True to its title, this book concerns the relationship between physicians and families having children with special needs. It is a collection of essays by participants in a national conference held in May 1992. Views represented include those of physicians, early intervention professionals, professionals with backgrounds in education, psychology and sociology, and parents. Each chapter stresses the need for greater parent-professional partnerships through greater interaction. All essays find greater communication between parents and professionals to be necessary but strongly state that more is required. It is said that, as experts concerning their children, parents of special needs children should actively participate in a truly collaborative way with professionals.
Most centrally, however, all contributors emphasize that families with special needs children have special needs themselves. Such families experience greater frustration and expend greater energy on what are routine for other families and need greater understanding because of these added burdens. A unifying theme is that the traditional approach of clinical medicine, focusing primarily on the patient's presenting problem, is inappropriate because family needs go beyond the child's problem. Medical professionals must learn to use an approach that takes into account total family needs.
It is suggested that medical students, pediatric residents and currently practicing physicians each receive specific training to facilitate being more sensitive to the total needs of these families. Several education models are presented. Chapter 5, A First-year Medical Student Curriculum about Family Views of Chronic and Disabling Conditions, suggests including a clinical course for first year medical students. Chapter 7, Graduate Medical Education in Pediatrics: Preparing Reliable Allies for Parents of Children with Special Health Care Needs, would have residents provide respite care for a family who has a child with a disability or chronic illness during pediatric rotations. Chapter 9, Overcoming Obstacles to Early Intervention Referral: The Development of a Video-based Training Model for Community Physicians, deals with training already practicing physicians through video.
While these families' need for special care and consideration may seem obvious, often the obvious needs to be stated to gain the attention that it deserves. However, acknowledging the needs of these families could have been more appropriately accomplished in another venue. The book was repetitive; this reviewer found it difficult to maintain interest after reading similar material several times. A journal article could have more succinctly presented this material and, at the same time, allowed the authors' calls for greater sensitivity to be heard by many more.
Michael D. Green, Bendectin and Birth Defects: The Challenges of Mass Toxic Substances Litigation (University of Pennsylvania Press 1996). Acknowledgements, index, preface, selected bibliography. LC 95-42306; ISBN 0-8122-3257-7 [368 pp. $29.95 Cloth. 1300 Blockley Hall, 418 Service Drive, Philadelphia PA 19104-6097.]
The drug industry is one of the most heavily regulated in the U.S. In determining whether to approve a particular drug, the Food and Drug Administration (FDA) must consider two factors. First, it must consider the safety of its citizens. It must next consider the public benefit which would be associated with the use of the drug in question. Professor Green's account of litigation over birth defects linked to a drug approved by the FDA captures readers' attention from the onset. Throughout, Green draws on our emotions as many are particularly sympathetic to injured children. While maintaining the reader's attention because of the subject matter, Green does not compromise the integrity of his description of the legal process in doing so.
After making us aware of the problem of birth defects, which Green links to the use of Bendectin by pregnant women, he gives a thoughtful account of the ensuing legal process, as well as an adequate scientific background for those who need it. Although parts of the book are more suitable for some than others, overall, readers need neither a legal nor scientific background to follow the process. Throughout the book, Green references legal terms, then follows with a short explanation. This enables non-lawyers to understand terms without boring those familiar with the law. There are, however, a few exceptions. While chapters 2, Locating Benedectin Within the Mass Toxic Landscape, and 4, The Food and Drug Administration, are designed for those who are not at all familiar with tort law, chapter 15, Aggressive Procedure in Mass Toxic Substances Litigation, may be hard to follow for one without a legal background. Green is sensitive to this, and but for these exceptions, the book should be accessible to all.
Safety is a priority, but readers begin to understand that some FDA oversights may be inevitable. To make what appears to be a safe and useful drug available as soon as possible, the FDA may err on the side of utility.
Of particular interest to me was Green's account of the litigation of the birth defects. It was the proverbial David and Goliath story. There were internal conflicts among the plaintiff's lawyers and their legal team was understaffed. The defendant was represented by a prestigious New York law firm with a plethora of resources. Furthermore, as this was the seminal Bendectin case, there were plenty of opportunities for mistakes.
In general, many participating lawyers were looking almost solely for a big payday. By and large, their conduct certainly raises ethical issues. Although it is not a matter of professional pride, the public definitely enjoys hearing about such conduct.
Overall, Green gives a thorough account of the vicissitudes of litigation. He neither bores lawyers nor alienates those unfamiliar with legal process. Bendectin and Birth Defects is an interesting read for those who enjoy reading a legal account with a scientific overlay.
Kenneth F. McCallion, Shoreham and the Rise and Fall of the Nuclear Power Industry (Praeger 1995). About the author, acknowledgements, foreword by Irving Like, index, preface, prologue, selected bibliography. LC 94-32930; ISBN 0-275-94299-6 [221 pp. Cloth $55.00. 88 Post Road West, Westport CT 06881.]
McCallion's Prologue starts the reading off with the taste of a legal thriller that includes organized crime, fraud and deceit. Yet, the book is not simply light entertainment.
It begins with a look at what McCallion calls the "Nuclear Club". The club was to become a living embodiment of the peacetime promises for nuclear power by everyone from the government to Oppenheimer, that it would produce inexpensive, pollution-free electricity and free us from the instabilities of the Middle East. This part of the first chapter is one of the few areas in the book where the author deals with the nuclear power industry as a whole.
Thus, the book is more aptly a chronicle of the rise and fall of the Shoreham nuclear power facility on Long Island. including the residents' fight for justice from electricity rate hikes and their fear for safety than a history of the industry itself. The author, Kenneth F. McCallion, presents the events first hand. In his role as Suffolk County's lead trial counsel in the County's case against the Long Island Lighting Company over the Shoreham project, he carried the responsibility of ascertaining the facts and prosecuting the case [at xvii]:
8:30 A.M., October 3, 1988, New York, New York -- within the next few hours, I would stand before a jury in a federal courtroom in Brooklyn and deliver an opening statement In a lawsuit that had been three years in the making, a case that would break new legal ground and could result in a damage award measuring in the billions of dollars... there was no denying that this was far and away the biggest case of my career.Long Island Lighting Company's decision to make Shoreham a "go" is the true beginning for the bulk of the book. McCallion gives a detailed history of building the facility, its financing, safety studies and cover-ups. He proceeds to recount details of a Suffolk County investigation of the Shoreham project, the trial and the appeal. The book is written with an overtone of negativity towards the nuclear power industry as a whole. The thrust of the case was on the economic recovery for citizens of Suffolk County but, in addition to recovery, it also raised serious questions and concerns encompassing the safety of nuclear power facilities as well. This tone is set early [at xiii] when McCallion makes the statement that "nuclear power plants in this country have become `unsafe at any price'." At the end, the book spends but one more chapter on the nuclear power industry as a whole, in both the U.S. and abroad. The final chapter quickly reviews existing nuclear facilities in the U.S., their costs, efficiency and shut down histories and schedules. McCallion also looks briefly at the undeniable success of the French nuclear power industry and the efforts of U.S. industry to move towards a standardized reactor and facility design.
Shoreham and the Rise and Fall of the Nuclear Power Industry is quite readable with specific, point illustrating stories, along the way. Yet, it mostly concerns the Shoreham facility on Long Island. Those interested in the nuclear industry as a whole will have to look eslewhere.
Bruce M. Owen, David A. Argue, Harold W. Furchtgott-Roth, Gloria J. Hurdle & Gale Mosteller, The Economics of a Disaster -- The Exxon Valdez Oil Spill (Quorum Books 1995). Acknowledgments, appendices, author index, figures, selected bibliography, subject index, tables. LC 95-3782; ISBN 0-89930-987-9. [200 pp. Cloth $55.00. 88 Post Road West, Westport CT 06881.]
On March 24, 1989, the Exxon Valdez ran aground off the southern coast of Alaska -- spilling in excess of eleven millions gallons of oil into Prince William Sound. Besides its obvious environmental impact, the spill caused clear economic harm to commercial fish and seafood harvesting.
This marine tragedy has prompted many to examine U.S. laws to determine how such disastrous accidents might be prevented in the future. This is such a study, both insightful and detailed.
Here, a team of economists addresses the costs of accidents and legal loss-prevention mechanisms, by applying well-regarded economic theory to the specifics of one of the worst oil spills ever. From the outset, the authors articulate their data and economic and liability theory in such a way that their arguments can be understood by readers other than economists and legal scholars [at 1]:
Any liability system that seeks to optimize the trade-off between the costs of accidents and the costs of preventing them must take into account, among other things, all the costs associated with the accidents. If some important category of costs is ignored by the system, individuals will tend to take too little precautionary action. By the same token, if the system exaggerates the costs, there will be a tendency to take too much precaution.The Economics of a Disaster is not light reading, but it presents abstract concepts clearly and in an interesting context. The combination provides a compelling education in law and economics.
Large-scale, fault-born disasters are an ever-present danger. Their impact may increase as our control of technology strengthens. Prevention clearly warrants the kind of close examination these authors have undertaken.
The Economics of a Disaster, however, doesn't attempt to answer all questions. It points out weaknesses in our existing system and discusses problems alternatve systems may succumb to. It is recommended as a valuable case study for those who do or aspire to shape the law.
Clovis E. Semmes, Racism, Health, and Post-Industrialism: A Theory of African-American Health (Praeger Publishers 1996). About the author, acknowledgements, index, introduction, selected bibliography. LC-95-34440; ISBN 0-275-95428-5 [178 pp. Cloth $59.95, paper $18.95. 88 Post Road West, Westport CT 06881.]
Not until well into in his book does Clovis Semmes provide statistics that justify close attention by a wide audience. Throughout Chapter 8, for example, he recites higher proportional incidence of heart disease, stroke, cancer, diabetes, obesity, infant mortality, alcohol consumption, cigarette smoking and AIDS in African Americans. While, as late as 1960, 78% of all African American families with children were headed by married couples, by 1990, that had declined to 39% [at 60]. Such matters have much to do with health as Semmes broadly defines it and may contribute to increased use of illegal drugs, spread of AIDS, continuing nutritional deficiencies and increasing violence. Homicide is the third leading cause of death for African-American males, six times greater than for white males [at 134]. Although such problems exist throughout American society, Semmes claims that they are exacerbated by structured inequality toward African Americans.
Semmes shows how the combination of industrialization and racism have negatively affected African-American health over a long period of time. In doing so, he refers to his own publications and to noted African-American historians such as E. Franklin Frazier, John Hope Franklin, Molefi Kete Asante, St. Clair Drake and W.E.B. DuBois. Moreover, throughout his book, he furthers his own theory regarding cultural hegemony [a systematic negation of one culture by another], a problem challenging the development of African-Americans earlier set forth in Cultural Hegemony and African American Development (1992)
Semmes begins by contrasting the philosophies of Booker T. Washington and W.E.B. DuBois, both renown at the turn of the 20th century. He distinguishes approaches these two men took toward improvement in African-Americans' lifestyles at the birth of the industrial revolution and uses the comparison to begin a discussion of the political and social climate at that time. Then he explains his views of the social basis of health, pointing out five matters that relate to it: psychosocial factors, environmental toxicity, lifestyle, family and religion. He explains each and relates it to his holistic view, citing evidence that others recognize the psychosocial dimensions of health.
Semmes relates current African-American health problems to conditions during the African slave trade. Even though both slaves and whites suffered from a low standard of health and health care during this period, slaves had additional burdens imposed by their enslavement and evolving White supremacy. Dehumanizing conditions seriously affected both their physical and psychological health. Diseases and work-related injuries, commonly untreated or prevented, provided the most threatening attacks.
Poor diet also played a big role. Meals basically consisted of fatty pork and corn meal. Slaves never consumed fresh meat, milk, eggs, or fruit and rarely any vegetables. Their diet lacked nutritional balance, quality food and generally sufficient quantity. The combination of poor nutrition, and physical, emotional, psychological and environmental stress affects the body, depletes it of vital vitamins, and basically over loads the body's adaptive resources. This made slaves more susceptible to antebellum epidemics such as cholera, yellow fever, smallpox, influenza, pneumonia and malaria. Diet also affected their ability to resist infectious diseases, recover from injuries and to survive the physical and psychological stresses of slavery itself.
Having set this foundation, Semmes describes the state of African-American health from post slavery times to present, pointing out how racism had a negative effect throughout the course of American development. He also notes that some adaptive responses which were circumstantial became dysfunctional cultural habits. The Reconstruction era was especially a time where African Americans still predominately lived in the rural South and were dependant upon an agriculturally-based economy. Many diets continued to be high in fat and low in vitamin content with few fresh garden foods.
As African-Americans migrated to Northern urban centers at the turn of the century, and more after World War I, racism confined most to low paying, unskilled jobs, sub-standard health care and poor housing. These conditions caused high mortality rates and a greater susceptibility to infectious diseases -- notwithstanding a slight influx of African-American doctors and dentists and efforts of those who opened free clinics and began to educate newly urbanized citizens on proper health care.
After reciting circumstances as they have evolved to now, Semmes sums up, stating [at 145] that the structured inequality and other post-industrial stresses have disproportionately affected African-American health, "Inequality tends to produce disproportionate institutional destabilization, cultural maladaptation and consumer manipulation."
Although his book contains a wealth of fact, Semmes does not stop with a mere catalog of African American health problems and a description of how racism has exacerbated them. He proposes a health infrastructure comprising a strengthening of families; developing a community based health ethic; reducing and managing stress; promoting better nutritional habits; increasing in health education; emphasizing self help; and increasing accessibility to quality health care.
Semmes concludes by discussing models that could be combined in developing a health infrastructure. He proposes a revival of the National Negro Health Movement, originally initiated by Booker T. Washington in 1915 and integration of the alternative health approaches associated with Black Consciousness Movement in the 1960's and 70's.
Racism, Health, and Post-Industrialism is useful for anyone interested in African American health. Those interested in African-American history will also find its thorough bibliography especially valuable. To the extent that the book suggests that African-Americans are a monolithic group, that is the only basis for criticism.
Alla Yaroshinskaya, Chernobyl: The Forbidden Truth (Michéle Kahn & Julia Sallabank, trans. University of Nebraska Press 1995). Introduction, foreword, list of illustrations, photographs. ISBN 0-8032-4912-8. [136 pp. Cloth $25.00; Paper $10.00. 312 N. 14th Street, Lincoln NE 68588-0484.]
From the Introduction and Foreword through eleven brief chapters, Chernobyl: The Forbidden Truth, is an in-depth look at one of the biggest tragedies of the 20th Century. Written by an Ukranian journalist who later was a member of the commission created by the Supreme Soviet to investigate this tragedy, her book examines failure of Soviet and post-Soviet governments to protect the health of citizens in radiation-contaminated regions -- and worse.
In the Introduction,David R. Marples notes that evidence of a massive "cover-up" meant that the affected population, remaining ignorant for three years, tilled irradiated soil and ate contaminated food. He condemns "failure to publicize the fact that more than 10,000 people were hospitalized less than two weeks after the explosion... or that some 1,500 were diagnosed as having radiation sickness." [At xiii.] Marples also notes that the government reports that 8,000 cleanup workers have died, many workers who returned home are not included in follow-up monitoring, and that the death toll continues to climb among the three million citizens living in affected areas.
In the Foreword, John Gofman, a scientist studying the Chernobyl aftermath, discusses "biomedical unknowledge" -- findings that are the opposite of truth regarding health and disease -- and notes that financially and politically powerful interests are eager for unknowledge. They have a radiation research wish list that includes these propositions: (1) a little radiation improves human health, (2) there is a radiation threshold below which no bad health effects occur, and (3) slow delivery of radiation (from accidents such as Chernobyl) is less harmful than what would occur in war. Gofman discusses nine Rules of Research alleged to have been violated in nearly all epidemiological studies of radiation health effects. To ensure that Chernobyl studies do not further contribute to biomedical unknowledge, Gofman cautions that the public must avoid compromising control over input, processing, and analysis of data by having an independent team of scientists monitor any studies.
In Chapter 10, Yaroshinskaya lists 40, mind-numbing, secret protocols of the Politburo's group that dealt with Chernobyl. He classifies their protocols as lies, e.g., that "clean" products can grow on radioactive land. Yaroshinskaya also presents a long list of callous human behavior. Here are some examples. First, senior civil servants rushed their children to airports to remove them from danger, but only days after the April 26 accident, affected populations were permitted to engage in May Day activities. Second, when finally moved, some evacuees were relocated to quickly-built housing, much constructed on radioactive land, without stoves or ovens. Third, lacking funds to renovate a decrepit hospital at Obikhodi, a new building for the village Soviet could nevertheless be built across the street. Last, to achieve "equalization of internal levels of radioactivity," contaminated food was shipped to other parts of the Soviet Union to avoid destroying it -- on the apparent premise that, if highly contaminated products are spread around, no one would be too badly affected
This book can be read in a few hours; I recommend it to anyone interested in issues such those it addresses. However, the book is not well produced. For example, indented paragraphs are mixed with ones that are not, and typesizes change for a line or two within paragraphs. One expects better quality from a university press.
Jeffrey W. Vincoli, Risk Management for Hazardous Chemicals (2 vols. CRC Lewis Publishers 1996). Acknowledgments, author, Chemical Abstracts Number index, chemical name index, introduction, preface, references, structure diagrams, tables. LC 96-35282, ISBN 1-56670-200-3 [3040+ pp. Cloth $297.00, $9.95 shipping. 2000 Corporate Blvd., N.W. Boca Raton, FL 33431.]
André R. Cooper, Sr., Cooper's Toxic Exposures Desk Reference (CRC Lewis Publishers 1997). Chemical Abstracts Number index, chemical name index, introduction, synonyms and trade name index, tables. LC 96-35221, ISBN 1-56670-220-8 [2006+ pp. Cloth $199.00, $9.95 shipping.]
These well-produced reference works are essentially encyclopedias for those who handle or manage the handling of chemicals.[1]1 Substances are addressed seriatim in alphabetical order, and each work contains information about risks and ways to avoid them. It is interesting to compare these works from the same publisher.
Besides being similar in content and purpose, both are accompanied by CD-ROMs with Adobe Acrobat (.pdf) files. A Windows version of Acrobat Reader is included, but those who use other computers or operating systems can also use these disks by acquiring the (free) software from, e.g., Adobe's website.
The files are constructed so that one may go from contents pages to files for particular substances by clicking on their names. This is very helpful, but, at least with Macintosh software, one cannot easily return; it is necessary to use the file menu. Given the number of files on each disk, this is a nuisance that could have been readily avoided -- by having at least one hot link to contents or indices within each file. Also, while one can do simple string searches within given files, it was not apparent that users can search the entire disk as with other other works on CD.
With regard to the content of these works, it would have been helpful if each contained a scope note. Neither states how substances were chosen. Cooper deals with fewer substances, in fewer overall pages, at lower cost -- and devotes more pages to each.[2] Yet, arguably expanded coverage is not compelling if one is looking for an omitted substance. For example, Cooper omits formaldehyde,[3] but Vincoli lists it as a confirmed animal and suspected human carcinogen. Cooper's rationale for this omission is not transparent.
Both works provide summary tables. Vincoli's two-page Material Safety Data Sheets begin with "Hazard Warning Information" coded under health, fire, reactive and other. The remainder is in eight sections titled: "General Information," "Hazardous Ingredients and Identity Information," "Physical and Chemical Characteristics," "Fire and Explosion Hazard Data," "Reactivity Data," "Health Hazard Data,"[4] "Precautions for Safe Handling and Use" and "Control Measures and Personal Protective Equipment." Still, as he points out in his preface[5] and introduction, LD50 and LC50, for example, are omitted as of little use in "the real world of risk management."[6] Cooper's single-page tables list only physical properties, warning properties, permissible exposure limits and hazard information and appear to be less useful.
Cooper's well-written discussions of chemicals begin with simple formulas, followed by a brief catalog of ID numbers, toxic designation, synonyms, identifying properties and labeling requirements. After a short overview of uses and characteristics, each substance is addressed under the main headings: "Health Hazard Information," "Exposure Routes and Health Effects," "Chemical Protective Clothing and Equipment," "Emergency Response," "First Aid Procedures," "Sanitation," "Medical Management" and "Workplace Monitoring and Measurement Procedures." As does Vincoli, Cooper makes helpful use of icons such as the skull and crossbones.
For example, Cooper's overview of benzene[7] reads in part:[8]
Benzene is used mainly as raw material for synthesizing chemicals such as styrene.... It is obtained from crude petroleum. It is also used in some industrial solvents and as a constituent of motor fuels, and unleaded gasoline in particular. At room temperature, benzene is a clear, colorless-to-light-yellow liquid.Vincoli 's narratives are also well-written and begin with helpful diagrams of products' chemical structures where appropriate, their Chemical Abstracts Numbers and a grid showing health, fire, reactive and other hazard severity codes.[9] After briefly treating identifying characteristics and typical uses, he discusses three kinds of "risk assessment" under the headings health, environment and business. He concludes with about 30 references to a variety of private and government publications concerning e ach substance.Benzene is a highly volatile, flammable liquid. Because it is volatile, it can spread to a source of ignition and flash back. Its vapor is heavier than air and may accumulate in low-lying areas. ....
Benzene is absorbed rapidly after inhalation and ingestion. It is absorbed slowly through the skin; however....
The National Institute for Occupational Safety and Health... recommends that benzene be controlled and handled as a potential human carcinogen... and that exposure be reduced to the lowest feasible limit. The American Conference of Governmental Industrial Hygienists... has designated benzene as an A2 substance (suspected human carcinogen) having an assigned threshold limit value... of 10 ppm... as a TWA for a normal 8-hour workday and a 40-hour workweek.
Addressing the health risk of benzene, Vincoli begins:[10]
Benzene is an acute as well as chronic toxicant. It is a confirmed human carcinogen producing myeloid leukemia, Hodgkin's disease, and lymphomas by inhalation. It is also believed to be a human poison by skin contact. It is moderately toxic by ingestion. Benzene can severely irritate the eyes.... Chronic effects are much more severe than its acute toxicity.Addressing the business risk of benzene, he advises:[11]
Accidents or mishaps involving benzene can present a serious threat to business operations. ....Although a minor criticism, surely Vincoli could have treated the latter topic generically -- in considerably more detail -- one time, in one place.Company attorneys, safety and health professionals, and environmental specialists should be involved in the development of any procedures for responding to chemical incidents. .... Corporate plans and policies should be developed, approved, and implemented long before any need for such arises.
Should potential users of such references buy one, both or neither of these works? The last option is beyond the scope of this review, but both seem potentially quite useful for not only their intended audience but others as well. Between the two, however, I find Risk Management for Hazardous Chemicals more compelling notwithstanding the higher price. By themselves, Cooper's total omission of formaldehyde and his characterization of benzene as merely a suspected human carcinogen seem inappropriate enough to make one have general doubts. Moreover, while Cooper's discussions are generally longer than Vincoli's, his tables are not nearly as helpful -- and the lack of bibliographic content is conspicuous.
[2] Eleven vs. six pages.
[3] See, e.g., Gulf South Insulation v. U.S. C.P.S.C., 701 F.2d 1137 (5thCir. 1983).
[4] Subheadings include inhalation, absorption and ingestion -- as well as separate treatment of carcinogenicity and emergency and first-aid procedures.
[6] At ii.
[6] At 5.
[7] See, e.g., Industrial Union Dept., AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607 (1980).
[8] At 243 (emphasis added).
[9] As elaborated at the top of preceding data sheet.
[10] At 255 (emphasis added).
[11] At 258.
Bonnie Cashin Farmer, A Nursing Home and its Organizational Climate: An Ethnography (Auburn House 1996). About the author, acknowledgments, appendix, bibliography, index. ISBN 0-86569-262-9 [176 pp. $49.95 Cloth. 88 Post Road West, Westport CT 06881.]
Ms. Farmer is a former nurse and an Assistant Professor of Nursing. Her goal is to develop an understanding of the values that underlie a "nice place" [The quotation marks are hers.] for possible replication by nursing homes attempting to improve their institutional climate.
She identifies three core values that make up a nice nursing home: appearance, service and residents' rights. [ At 45.] While she did not explain how she identified these values, she notes that the central values are "enduring over time, situations, and organizational members." [ At 46.] Yet, she acknowledges that other institutions may have different value systems.
Farmer's ethnographic research is based on the assumption that nursing homes are, as a rule, stigmatized as places of doom and death. She seeks to identify ways that one, Meadows of Madison, overcomes the stereotype through an integrated value system that permeates all aspects of the institution and includes residents, guests, employees, management and the surrounding community.
However through focusing on a single institution, her study suffers from specificity and may have marginal general usefulness. Still, Farmer's observations may be helpful for those making policy at other nursing homes who seek to better understand the general relationship between institutional values and a home's reputation, both internally and externally.
Farmer attempts to overcome the stigmatizing stereotypes of nursing homes, essentially, by replacing the nursing home paradigm with that of a hotel. [At 106.] Farmer points out, however, that "[t]he weakness of the hotel model for long-term care is underscored by [a lack of focus on the primary function of] nursing." [Id.]
According to Farmer, the hotel model can be reinforced with a set of well-established rules for residents and employees to promote her institutional objectives of pleasant appearances, courteous service and residents' rights. "[P]articularly for the residents, rules guide behavior but d[o] not necessarily dictate behavior, thereby making Meadows a nice place." [At 40.]
Hence, A Nursing Home and its Organizational Climate attempts to show how one institution, by understanding and applying key values throughout, was able to overcome general and well-established negative perceptions of nursing homes.
Global AIDS Policy (Douglas A. Feldman, ed.; Bergin & Garvey 1994). About the editor and contributors, index, introduction, preface, references. LC 94-2850; ISBN 0-89789-412-X. [250 pp. $18.95 paper; $65.00 cloth. 88 Post Road West, Wesport CT 06881.]
Global AIDS Policy is a collection of essays by epidemiologists, anthropologists, sociologists, political scientists, ethnographers and others involved in AIDS research. In sum, they detail the worldwide failure of governments and organizations to identify and implement competent strategies for dealing with the AIDS pandemic. Incomplete and socially biased epidemiology, difficulties in implementing strategies that challenge traditional moralities, as well as policies based on thinly-veiled political agendas have all harmed efforts to deal successfully with AIDS. Geographical areas highlighted are China, Brazil, Latin America, Uganda, Ghana, South Africa and the U.S.
Contributors provide a great deal of well-supported criticism of trends in AIDS policy from the perspective of their respective disciplines. They attack decisions said to be doomed to failure because scientific and practical constraints are overlooked. While their data and conclusions isolate sources of failure in many decisions, some appear idealistic in their synopsis of potential solutions.
Essays vary greatly in style, approach and breadth. Many contain detailed summaries of information gathering methodologies and considerable statistical analysis of AIDS infection and transmission, and surveys of cultural attitudes towards sex and matters such as condom and intravenous drug use. Data-rich essays do not typically make interesting reading, but such presentations are critical to supporting the credibility of observations and conclusions.
Several essays examine the impact of political agendas on education and resource allocation in China, South Africa and the U.S. These highlight the danger of allowing biases within political institutions to determine responses to health-related issues. Others discuss the effects of cultural biases towards homosexuals, intravenous drug users, the sexually promiscuous and the economically less fortunate, as well as toward racial minorities. Such biases are said to place blame and divert attention from the most practical, efficient remedies; they are also said to present challenges in overcoming misinformation and traditional social behaviors. Still other essays point out, e.g., the consequences of non-governmental organizations' failures to cooperate.
The objective of Global AIDS Policy is to awaken individuals and policy makers to several past mistakes in combating the AIDS crisis and to suggest approaches to research, funding and education that should guide future AIDS-related decisions.
No book of this size can furnish a complete analysis of world AIDS policy. Yet, its critiques and case studies isolate specific problems in a range of diverse nations and provide some basis for general insights. For example, Feldman urges that [At 239.]:
If you want to learn what is wrong with a given society, look at how it handles the question of AIDS. Nations under the sway of fundamentalism, fascism, or totalitarianism are quick to employ the emergence of HIV as a mechanism to further political repression. Legislation, enforcement, and changing attitudes are needed to protect the human rights of persons living with HIV. There is no acceptable rationale for discriminating against a person based on his or her HIV serostatus.
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Joshua M. Epstein & Robert Axtell, Growing Artificial Societies: Social Science from the Bottom Up (MIT Press 1996). Acknowledgements, appendices, index, introduction references. LC 96-25332; ISBN 0-262-05053-6. [208 pp. Cloth $39.95. 55 Hayward St., Cambridge MA 02142.]
Growing Artificial Societies presents a method for overcoming basic problems experienced by sociologists in systematically studying highly heterogeneous populations. Computer modeling is used to study various aspects of human social phenomena, including trade, migration, group formation, combat, environmental interaction, transmission of culture, propagation of disease and population dynamics. These various social phenomena combine to form artificial societies[ At 4.]:
In this approach fundamental social structures and group behaviors emerge from the interaction of individuals operating in artificial environments under rules that place only bounded demands on each agent's information and computational capacity. We view artificial societies as laboratories, where we attempt to `grow' certain social structures in the computer -- or in silico -- the aim being to discover fundamental local or micro mechanisms that are sufficient to generate the macroscopic social structures and collective behaviors of interest.The book begins with an initial population of "agents" scattered throughout the environment. It progresses as additional elements are added to an increasingly complex scenario. Chapter II, Life and Death on the Sugarscape, introduces a sugarscape in which agents are programmed to gravitate towards and consume "sugar". They die if and when they use it all up.
In Chapter III, Sex, Culture, and Conflict: The Emergence of History, mating occurs. Social networks develop, and cultures with identifiable characteristics form. Occasionally, agents from one culture penetrate another; conflicts may arise as "tribes" battle for control of sugar sources. Populations can flourish or disintegrate.
In Chapter IV, Sugar and Spice: Trade Comes to the Sugarscape, agents are presented with the commodity "spice." Agents have varying metabolisms and individual preferences for spice over sugar. Thus, trading evolves, and agents can operate on credit. Various equilibriums may occur as individuals operate to benefit themselves rather than their society. Finally, in Chapter V, Disease Processes, each agent receives its own immune system to battle diseases that are introduced and can cross societal boundaries.
Unlike the methodology of other studies, that used here is dynamic. The authors focus on altering individual behavior and examining each alteration's social effect. The methodology also refrains from separating people from their environment, instead: "The agent society and its spatial environment are coupled." [At 19.] Further, "interagent dynamics affect the environmental dynamics, which feed back into the agent dynamics, and so on." [Id.] Also, the authors attempt to erase artificial boundaries found in the study of social science by combining economics, demography, cultural anthropology, politics and epidemiology.
The societies are modeled with mathematical formulas and representations. However, one does not need to be an expert in mathematics to read the book -- understandable graphs, charts and tables illustrate the results of scenarios as presented.
Growing Artificial Societies -- Social Science from the Bottom Up combines classic heterogeneous population studies with modern computer modeling in an interesting way. One must remain cautious and not assume that quantitative methodology yields objective results. Still, a step in the direction of a future branch of sociology is demonstrated -- one in which millions of variables and iterations combine to generate results that might be more applicable to real life.
David Lester, Making Sense of Suicide: An In-depth Look at Why People Kill Themselves (The Charles Press 1997). Preface, bibliographical references, index. ISBN 0-914783-82-3. [208 pp. Paper $22.95. P.O. Box 15715, Philadelphia, PA 19103.]
Suicide is the third leading cause of death for 15-24 year-old U.S. citizens. It is the eighth foremost cause of death for all ages, ending the lives of 30,000 people in this country each year. In the past fifteen years, the suicide rate increased an alarming 358% for young African American males. Both appalled and fascinated by the topic that permeates our society, people seek information: Why do people kill themselves? Who is most at risk? What are the warning signs?
Making Sense of Suicide promises a thorough overview of all aspects of all kinds of suicidal behavior and examines a wide range of topics, e.g., the definition of suicide, difficulties in research, possible causes, risk categories, signs of persons in jeopardy and possible interventions. Dr. Lester's book also separates myths from facts and discusses many popular beliefs [ At 2.]:
...suicide is often described with statements such as "suicide strikes 30,000 people in the course of a year," or "suicide is the third most common killer of young people." The implications of these descriptions are misleading. Suicide does not "strike" in the sense that measles and tuberculosis strike. Suicide is the result of a gradual process that unfolds within an individual; it is not the work of a mysterious external agency. The Suicide "strikes" idea relieves people of the idea that others can sometimes be responsible for a person's suicide. It implies that suicide cannot be predicted and prevented, that people who commit suicide are incomprehensibly struck with the need or desire to kill themselves. We know that this is not true....Lester, a Professor of psychology who has devoted a considerable part of his career to the study of suicide and homicide, examines various suicide-associated factors such as drugs, alcohol, mental illness and depression. He also presents other possibly associated factors such as heredity, environment, gender, weather, personality, childhood experiences, social factors and time of the year.
On the possibility of physique as a cause, Lester writes [ At 31-32.]:
Some studies have examined the possible relationship between a person's weight and suicide. In general, it appears that underweight or overweight people are more likely to kill themselves than people of normal weight. ....Making Sense of Suicide is well organized. Easily read in a few hours, its relatively short twenty chapters do not provide the "in-depth" treatment claimed by the subtitle. Rather, it seems more an introduction. Yet, extensive references to prominent authorities, a comprehensive index and generous use of statistics makes it a good starting point for research by, e.g., students in psychology, sociology or any mental health field. Dr. Lester presents the information in a "teaching" style that is easy to read and understand, with short sentences and paragraphs. Examples add to its interest and enhance understanding. It offers an excellent quick reference for health workers, teachers, crisis workers, police officers, prison workers, social workers, parents and other dealing with people possibly at risk.
We must remember, when thinking about physique and suicide, that causality need not work in only one direction. People who become suicidal may have changes in physique due to their mood. They may change their dietary habits and become overweight or underweight because of their obsession with suicide.
I would recommend this book for acqusition by public and college libraries, and for reading by anyone with an interest in the topic.
Deborah G. Mayo, Error and the Growth of Experimental Knowledge (University of Chicago Press 1996). Figures, index, preface, references. ISBN 0-226-51197-9 [493 pp. $74.00 Cloth; $29.95 Paper. 5801 S. Ellis Ave., Chicago, IL 60637.]
At the heart of many risk estimation controversies is the use of subjective probabilities and expert judgments of risk. It is well known that different experts often calculate annual risk probabilities for new technologies or impacts, that vary by as much as six orders of magnitude. The subjectivity in risk estimation and the disagreement among risk assessors would not be so troublesome if they did not have practical consequences in terms of life and death. Overconfidence biases in risk estimates could lead to underregulation and greater threats to life, while underconfidence biases in risk estimates could lead to overregulation and fears of technology that are not warranted.
One reason for the controversy over risk estimates and for the failure to correct subjective risk assessments is that mathematicians themselves are divided on the meaning of probabilities and how to check for probabilistic and statistical error. Presently, statistical practice in science is at odds with the dominant philosophy of experiment. On the one hand, the cornerstone of the current philosophy of experiment is one or another of Bayesian methods. All presuppose that one can use prior probability assignments to hypotheses, generally interpreted as an agent's subjective degrees of belief. For Bayesians, a probability represents the degree of subjective confidence (usually varying with the evidence) in a proposition. On the other hand, statistical practice is based on classical and Neyman-Pearson (NP) statistics (e.g., statistical significance tests, confidence-internal methods) that eschew the use of prior probabilities when these cannot be based on actual frequencies.
Mayo attempts to show that her reinterpretation of NP statistics is a viable alternative to Bayesian approaches. She argues, for example, that defects of one (behavioral) model of NP tests erroneously have been taken as defects in NP methods themselves. When one uses her model of NP tests, as Mayo says Egon Pearson intended, then "accept H" does not mean "take action A rather than B" (as Newman saw it) but rather "infer a specific error is ruled out" by the data. If one accepts Mayo's account of NP methods and interprets Peircean induction as severe testing, then it is possible to reconcile philosophy of experiment with statistical practice in science.
Mayo's approach is premised on what she calls the "error-statistical account," learning piecemeal from mistakes and focusing on a statistical procedure's error probabilities to scrutinize objectively inferences based on test results. By her account, methodological rules for experimental learning are strategies that enable learning from common types of experimental mistakes. The rules systematize the day-to-day learning from mistakes. From the history of mistakes made in reaching a type of inference, one can develop a repertoire of errors and methodological rules (techniques for circumventing and uncovering errors). Some rules refer to before-trial experimental planning, others to after-trial data analysis. Although similar to Karl Popper's approach, Mayo shows that an hypothesis that he would count as "best tested" is not necessarily "well tested" for her.
Apart from its theoretical contributions to new intepretations of Kuhn and Popper, as well as solutions to important problems in philosophy of science (underdetermination, the nature of scientific progress, induction, objectivity and the role of novel evidence), Mayo's book is significantly practical. Researchers in all sciences can profit from her analyses of modelling patterns of irregularities useful for discovering errors. She discusses both philosophy of statistics and statistical meth-odology insightfully, making them accessible to laypeople and thought- provoking for experts -- and a major contribution to science and philosophy and the foundations of risk identification and estimation.
Thanks to penetrating works like this, risk assessors, mathematicians and
scientists may be more likely to learn from mistakes. They also may be less
likely to exhibit the subjective and prejudicial probabilities for which risk
assessment is sometimes infamous.