Life Sciences Commons^™

A Drug's Life: The Untapped Potential Of Secondary Pharmacology Studies In Drug Development, Christina Scott

The University of New Hampshire Law Review

The United States Food and Drug Administration has evolved over the past century to regulate new medicine and protect the public from harmful or ineffective drugs. Drug development and testing science have advanced rapidly alongside the FDA’s increased regulation, enabling pharmaceutical companies to assess a drug's potential adverse reactions by studying its reactivity with various proteins called "off-target receptors." Off-target proteins are often screened and reported in the Investigational New Drug Application as a percentage indicating the drug's binding strength to each protein, which suggests the strength of a particular adverse drug effect. Adverse drug effects often lead to unfavorable …

Exhausted Or Unlicensed: Can Field-Of-Use Restrictions In Biotech License Agreements Still Prevent Off-Label Use Promotion After Quanta Computer?, Kristal M. Wicks

The University of New Hampshire Law Review

[Excerpt] “In the biotechnology (biotech) industry, companies must be increasingly aware of their intellectual property and how their licensing strategies can impact their rights. When licensing patented technology, it is common practice for biotech companies to include restricted field-of-use provisions in their license agreements. Such provisions permit a licensee to only use licensed technology in a defined field and restrict use or development in another field. This licensing strategy plays an important role within the biotech industry because it allows companies to more effectively control their intellectual property and to more efficiently research and develop pharmaceutical products.

A problem that …

Indivisible Injury Negligence And Nuisance Cases –Proving Causation Among Multiple-Source Polluters: A State-By-State Survey Of The Law For New England, And A Proposal For A New Causation Framework, Paul Homer

The University of New Hampshire Law Review

[Excerpt] "The skies, soil, and water of every state are polluted every day. Whether the pollutants enter the atmos phere from coal plants or the water-ways from large farms, materials a bnormal to the “natural” environment are regularly emitted by a variety of sources over wide regions of the nation. To some extent, such emissions are normal and acceptable activities in modern society."

Introduction To Special Issue On Radiation Effects, P. Andrew Karam

The University of New Hampshire Law Review

[Excerpt] "How dangerous is radiation? How much radiation does it take to give us cancer? Are we wasting money on overly restrictive regulations, or are we not being sufficiently protective of our radiation workers and the public? How much clean-up is necessary on our Department of Energy facilities? What about Yucca Mountain and nuclear reactor plants – can they be made safe?

These are only a few of the questions that have been asked, and will continue to be asked, about radiation. Unfortunately, these all come down, in part or in whole, to the question “What is the shape of …

Historical Development Of The Linear Nonthreshold Dose-Response Model As Applied To Radiation, Ronald L. Kathren

The University of New Hampshire Law Review

[Excerpt] "Despite the nearly universal adoption of the linear nonthreshold dose response model (LNT) as the primary basis for radiation protection standards for the past half century, the LNT remains highly controversial and a contentious topic of discussion among health physicists, radiation biologists, and other radiological scientists. Indeed, it has been pointed out that the LNT has assumed the status of a paradigm, synonymous with an ideal, standard, or paragon or perhaps to some, a sacred cow. Reduced to its very basics, the LNT postulates that every increment of ionizing radiation dose, however small, carries with it a commensurate increase …

Effects Of The Shape Of The Radiation Dose-Response Curve On Public Acceptance Of Radiation And Nuclear Energy, Audeen W. Fentiman

The University of New Hampshire Law Review

[Excerpt] “The public generally accepts the premise that exposure to radiation can have an undesirable effect. Furthermore, it believes that as the radiation dose increases, the magnitude of the effect will increase. On the other hand, while the background radiation dose varies from a few hundred millirem/year (a few millisieverts/yr) in some places to a few thousand millirem/yr (tens of millisieverts/yr) in others, researchers have been unable to find a correlation between the level of background radiation and incidence of cancer or other maladies attributable to radiation.

…

Because there is considerable controversy about the relationship between radiation dose and …

The Debate On The Health Effects Attributable To Low Radiation Exposure, Abel J. Gonzalez

The University of New Hampshire Law Review

[Excerpt] "Few scientific issues have aroused passions more than the dispute about the health effects attributable to low levels of exposure to ionizing radiation (or radiation in short) and the currently authoritative dose response hypothesis, termed “linear non-threshold,” or LNT. Finding out whether health effects are induced by low-level radiation exposures, and if so, what they are, has become a kind of contest rather than a serious scientific inquiry. Sometimes it seems that rationality, or a methodical examination of the unknown, has disappeared from this debate. While the confrontation of different hypotheses is typical in academic discussions – at least …

Five-Hundred Life-Saving Interventions And Their Misuse In The Debate Over Regulatory Reform, Lisa Heinzerling

RISK: Health, Safety & Environment (1990-2002)

The author argues that John D. Graham, administrator of the Office of Information and Regulatory Affairs, holds strong anti-environmental biases and has perpetuated and encouraged a misrepresentation of his own research, which has largely influenced health, safety, and environmental regulation.

Redressing The Silent Interim: Precautionary Action & Short Term Tests In Toxicological Risk Assessment, Timothy Riley

RISK: Health, Safety & Environment (1990-2002)

The author recommends that a stronger emphasis be placed on creating and implementing short-term tests that use iterative, conservative-based, tiered procedures in conjunction with a precautionary attitude during the interim phase of toxicological risk assessments.

Workplace Pollution: Nuclear Safety, Ethics, And The Exploitation--Avoidance Argument, Kristin Shrader-Frechette

RISK: Health, Safety & Environment (1990-2002)

The author reviews evidence of poor worker health and safety practices in United States Department of Energy nuclear facilities in contending that less protective standards for workplace hazards constitute an environmental injustice not rectified by a hazard pay premium.

Review Of: Risk In The Modern Age: Social Theory, Science And Environmental Decision Making (Maurie J. Cohen, Ed.), Amy Cutler

RISK: Health, Safety & Environment (1990-2002)

Review of the book: Risk in the Modern Age: Social Theory, Science and Environmental Decision Making (Maurie J. Cohen, ed., St. Martin's Press 2000). List of Figures and Tables, List of Contributors, Preface, Index. ISBN 0-312-22216-5 [264 pp. $65.00. Hardbound, 175 Fifth Avenue, New York, NY 10010].

Looking Back At Fluoridation, Allan Mazur

RISK: Health, Safety & Environment (1990-2002)

The author reviews the 50-year history of the debate over fluoridating drinking water as a public health measure.

Over A Decade Of Comparative Risk Analysis: A Review Of The Human Health Rankings, David M. Konisky

RISK: Health, Safety & Environment (1990-2002)

The author reviews a method for undertaking a cross-project comparison of comparative risk analyses to understand which environmental problem areas have been cited most as often posing the severest risks.

A Case For Caution: An Evaluation Of Calabrese And Baldwin's Studies Of Chemical Hormesis, Kevin C. Elliott

RISK: Health, Safety & Environment (1990-2002)

Suggesting a need for more research, Mr. Elliott argues that it is too soon for risk-assessment policy to account for recent challenges to a toxicological linear dose-response assumption.

Comparing The Epa Indoor Air Quality Personal Computer Model And Field Data, Arash Behravesh, Wilbur A. Spaul

RISK: Health, Safety & Environment (1990-2002)

The authors recommend caution in using an EPA model for reconstructing past exposure events as well as for predicting future exposures.

Frequency Of Use And Perceived Credibility Of Information Sources And Variations By Socioeconomic Factors Among Savannah River Stakeholders, Bryan L. Williams, Alex Vallei, Sylvia Brown, Michael Greenberg

RISK: Health, Safety & Environment (1990-2002)

The authors examine the factors effecting credibility of risk communication in the communities surrounding the Savannah River Nuclear Weapons Site.

Media Coverage Of Epa's Draft Dioxin Reassessment Report, Sharon M. Friedman, Megan A. Fitzpatrick, Brenda P. Egolf

RISK: Health, Safety & Environment (1990-2002)

Using content analysis, the authors examine the utility of news media in democratic decision making.

Review Of: Lewis' Dictionary Of Toxicology (Robert A. Lewis, Ed.; Lewis Publishers 1998), Dana E. Evans

RISK: Health, Safety & Environment (1990-2002)

Review of the book: Lewis' Dictionary of Toxicology (Robert A. Lewis, ed.; Lewis Publishers 1998). About the author, acknowledgments, alphabetical listing of terms defined. ISBN 1-56670-223-2; [1127 pp. $84.95. Hardbound. 2000 Corporate Blvd. N.W., Boca Raton, FL 33431.]

Review Of: Allan Mazur, A Hazardous Inquiry: The Rashomon Effect At Love Canal, Thomas G. Field Jr.

RISK: Health, Safety & Environment (1990-2002)

Review of: Allan Mazur, A Hazardous Inquiry: The Rashomon Effect at Love Canal (Harvard University Press 1998). Abbreviations,, appendices: Chron- ology and The Basics of Toxicology, bibliography, chronology, figures, index, photos, references. LC 97-44639; ISBN 0-674-74833-6 [255+xiv pp. $26.00 Cloth, 79 Garden Street; Cambridge MA 02138.]

Review Of: National Research Council, Issues In Risk Assessment, Diane M. Albert

RISK: Health, Safety & Environment (1990-2002)

Review of: National Research Council, Issues in Risk Assessment (National Academy Press). Appendices, executive summary, figures, preface, references, tables. LC 92-61838; ISBN 0-309-04786-2. [374 pp. Paper $37.50 - S&H, $4 for first and $0.50 for each additional copy. 2101 Constitution Avenue, NW, Washington DC 20418.]

Review Of: M. Stuart Madden, Toxic Torts Deskbook, Laura Marron

RISK: Health, Safety & Environment (1990-2002)

M. Stuart Madden, Toxic Torts Deskbook (Lewis Publishers 1992). Acknowledgements, case index, general index, notes, preface. LC 91-48238; ISBN 0- 87371-508-X. [230 pp. Cloth $69.95 domestic, $84.00 elsewhere. 2000 Corporate Boulevard, NW, Boca Raton FL 33431.]Review of:

Regulate Pollution Or Land Use - Managing Toxic Air Contaminants In Southern California, Marc Dohan

RISK: Health, Safety & Environment (1990-2002)

A California air quality management district recently proposed to limit the location of potential receivers, in contrast with sources, of air toxics. The author argues that, although this particular proposal was later abandoned, it amounted to land use regulation. He also argues that such action usurps local control and is unwarranted.

Daubert's Significance, Thomas G. Field Jr., Colleen M. Keegan

RISK: Health, Safety & Environment (1990-2002)

The authors review and note the limited reach of Daubert v. Merrell Dow Pharmaceuticals. They also address its implications for concerned non-lawyers.

Book Review, Allan M. Soobert

RISK: Health, Safety & Environment (1990-2002)

Review of: VALERIE M. FOGLEMAN, HAZARDOUS WASTE CLEANUP, LIABILITY AND LITIGATION: A COMPREHENSIVE GUIDE TO SUPERFUND LAW. (Quorum Books 1992) [320 pp.] Acronyms, index, preface, selected bibliography. LC 91-47999, ISBN 0-89930-647-0. [$59.95 cloth. 88 Post Road West; Westport CT 06881.)

Toxics Use Reduction: Pro And Con, Francine Laden, George M. Gray

RISK: Health, Safety & Environment (1990-2002)

With the Massachusetts Toxics Use Reduction Act as an example, important issues related to the goals and effectiveness of TUR are examined. The benefits as claimed by proponents are contrasted with shortcomings outlined by opponents in point-counterpoint style. Ultimately, the authors call for more balanced analysis.

Book Review, James R. Baum

RISK: Health, Safety & Environment (1990-2002)

Review of: MANAGEMENT OF HAZARDOUS AGENTS. Vol. 1: INDUSTRIAL AND REGULATORY APPROACHES. Vol. 2: SOCIAL, POLITICAL, AND POLICY ASPECTS. (Duane G. LeVine & Arthur C. Upton eds., Praeger 1992). Each volume contains: bibliography, series foreword, foreword, figures, notes, biographical references, tables, index. Vol. 1: [194 pp.] LC-92-167 ISBN 0-275-94322-4. Vol. 2: [188 pp.] ISBN 0-275-94323-2. [Cloth, each $49.95. 88 Post Road West; Westport CT 06881.]

Regulating Air Toxics In Rhode Island: Policy Vs. Technical Decisions, Julie A. Roque

RISK: Health, Safety & Environment (1990-2002)

Dr. Roqu6 recounts her work as a doctoral candidate at Brown in developing standards for the regulation of airborne carcinogens. Based in part on this experience, she argues that care needs be taken lest those who regulate Risk bury key policy decisions within a mass of often irrelevant technical details.

Pharmaceutical Risk And The Quality Of Life, Beat Hiltbrunner, Andreas Breitsprecher

RISK: Health, Safety & Environment (1990-2002)

Quality-of-life research is briefly described and said to be in its infancy. However, the authors observe that such studies may, e.g., make it possible to better match patients and therapies. They also predict that, as scientific difficulties are overcome, the pharmaceutical industry will become more active in planning, implementing and evaluating such research.

Book Reviews, Risk Editorial Board

RISK: Health, Safety & Environment (1990-2002)

Reviews of the following books prepared by the editors of Risk on the topic of toxic tort litigation and/or public regulation of toxic substances:

Frank B. Cross, Environmentally Induced Cancer and the Law: Risks, Regulation and Victim Compensation, (1989).

Chemical Contamination and Its Victims: Medical Remedies, Legal Redress, and Public Policy (David W. Schnare & Martin T. Katzman, eds., 1989.

The Role of Science in Toxic Tort Litigation: Evaluating Causation and Risk: Drawn from Papers Presented at the TIPS Annual Meeting, August 1988, Toronto, Canada. Chicago, Ill: Tort and Insurance Practice Section, American Bar Association.