The integrity of science and the preservation of civilized medicine are being systematically undermined. The New York Times reported that "more than 60 influential scientists, including 20 Nobel laureates, issued a statement asserting that the Bush administration had systematically distorted scientific fact in the service of policy goals on the environment, health, biomedical research and nuclear weaponry at home and abroad." See: NY Times, February 19, 2004, Scientists Say Administration Distorts Facts By JAMES GLANZ
The National Academies' National Research Council held a public briefing today to announce its support for industry's demand permitting the experimental dosing of human beings with toxic substances, including pesticides. Industry has clamored for such tests ever since Congress passed the Food Quality and Protection Act in 1996, which tightened safety standards on pesticides.
To be sure, the Academy's infamous document is couched in carefully nuanced language - "ethically sound" "scientifically valid" "environmental benefits"... etc. The committee's co-chair, James F. Childress, a professor of ethics and medical education, and director, Institute for Practical Ethics, University of Virginia, states: "EPA Should Impose Stringent Scientific and Ethical Standards on Studies That Deliberately Expose People to Toxins, and Evaluate Such Experiments To Ensure That Standards Have Been Met"
Dr. Childress seems to have forgotten that the Nuremberg Code mandates that ALL human research should be held to stringent scientific and ethical standards!
The document demonstrates how adept such advisory panelists are at obfuscating the purpose of a radical public policy shift. While this panel of bioethicists, scientists, government officials, and industry representatives are helping industry to lower environmental protection standards that will affect children's health, they make vague and unenforceable assertions about "a framework": "Our report proposes a framework for EPA's oversight of this research. And the recommended framework should apply to studies that are sponsored by so-called 'third parties' - private companies or other sources outside the agency - as well as by EPA."
In fact, the radical recommendations by this panel will overturn the ethical principles enshrined in The Nuremberg Code, thereby opening the door to uncivilized human experimentation.
It is not a coincidence that Bayer Crop-Life, with its long and unsavory history of unspeakable human experimentation, slave labor, and corrupt corporate practices should be the leading force in this effort to overturn the Nuremberg Code standards. The National Academy of Sciences has sullied its reputation by lending its support to a policy that would suspend universal standards of permissible human research to promote commercial interests.
See our testimony before the NAS panel at: http://www.ahrp.org/testimonypresentations/EPApesticide.php
Support the efforts of the Alliance for Human Research Protection to preserve human rights and dignity in biomedical research-- Support our efforts to halt the erosion of ethical standards.
Contact: Vera Hassner Sharav
Date: Feb. 19, 2004
Contacts: Vanee Vines, Media Relations Officer
Heather McDonald, Media Relations Assistant
Office of News and Public Information
FOR IMMEDIATE RELEASE
EPA Should Impose Stringent Scientific and Ethical Standards on Studies That Deliberately Expose People to Toxins, and Evaluate Such Experiments To Ensure That Standards Have Been Met
WASHINGTON - When regulating chemicals to protect public health, the U.S. Environmental Protection Agency should consider information from studies that involve intentional dosing of humans with toxic chemicals only if such experiments meet the most stringent scientific and ethical standards, ensuring that research participants are protected and that the studies are scientifically necessary and valid, says a new report from the National Academies' National Research Council. At the same time, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studies - both at the beginning and upon completion of the experiments - if they are carried out with the intent of affecting the agency's policy-making. Human testing of chemicals must be approached with the utmost caution and care, warned the committee that wrote the report.
"Human studies involving pesticides, air pollutants, or other toxicants - as opposed to therapeutic agents - are particularly controversial, and because of this, EPA should subject these studies to the highest level of scientific and ethical scrutiny," said committee co-chair James F. Childress, a professor of ethics and medical education, and director, Institute for Practical Ethics, University of Virginia, Charlottesville. "Our report proposes a framework for EPA's oversight of this research. And the recommended framework should apply to studies that are sponsored by so-called 'third parties' - private companies or other sources outside the agency - as well as by EPA."
The issue of whether - and if so, how - EPA should use information from such studies when formulating regulations has long been highly controversial. In 1996 Congress passed the Food Quality and Protection Act, which tightened safety standards on pesticides. Some chemical manufacturers asserted that the new standards and "reference doses" were not based on a solid scientific foundation. In support of this assertion, several companies sponsored or conducted clinical trials to assess human risk from exposure to pesticides and submitted the results to the agency for consideration. Some public health advocates and others, questioning the industry's research findings, urged the agency to reject the results.
In response to the controversy, EPA announced in 1998 that it would not use the studies to inform its policy-making until many ethical and scientific issues had been resolved. Later, a majority of a joint subcommittee of EPA's Science Advisory Board and the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel concluded that human dosing studies could be ethically and scientifically justified under certain circumstances, subject to stringent conditions and oversight. EPA sought a broader scientific review from the National Academies evaluating key issues of third-party human dosing studies of pesticides and of some chemical regulatory programs within the agency. EPA itself has sponsored human dosing studies of air pollutants and other potentially hazardous chemicals when it considered the studies necessary to set health-related regulations. But typically, EPA assesses human risk from exposure to toxic substances by determining the lowest level that is harmful to laboratory animals and then reducing that amount by a series of extrapolating factors.
Setting a High Bar
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The study was sponsored by the U.S. Environmental Protection Agency. The National Research Council is the principal operating agency of the National Academy of Sciences and the National Academy of Engineering. It is a private, nonprofit institution that provides science advice under a congressional charter. A committee roster follows.
Copies of Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).
NATIONAL RESEARCH COUNCIL
Division on Policy and Global Affairs
Science, Technology, and Law Program
Committee on the Use of Third-Party Toxicity Research with Human Research Participants
James F. Childress (co-chair)
John Allen Hollingsworth Professor of Ethics, Professor of Medical Education, and Director Institute for Practical Ethics and Public Life
Department of Religious Studies University of Virginia Charlottesville
Michael R. Taylor (co-chair)
Senior Fellow and Director Risk, Resource, and Environmental Management Division Resources for the Future Washington, D.C.
James V. Bruckner Professor of Pharmacology and Toxicology Department of Pharmaceutical and Biomedical Sciences College of Pharmacy University of Georgia
Alicia L. Carriquiry
Associate Provost, and Professor of Statistics Iowa State University
Ellen Wright Clayton Professor of Pediatrics, Professor of Law, rosalind E. Franklin Professor of Genetics and Health Policy, Director of Genetics and Health Policy Center, and Senior Fellow
Institute for Public Policy Studies Vanderbilt University Nashville, Tenn.
Professor Emeritus Department of Pharmacology, Toxicology, and Therapeutics
University of Kansas Medical Center
Henry T. Greely
C. Wendell and Edith M. Carlsmith Professor of Law, and Co-Director Program in Genomics, Ethics, and Society and Program in Law, Science, and Technology
Stanford University Law School
Siob�n D. Harlow
Associate Professor Department of Epidemiology School of Public Health, and Associate Director International Institute, and Faculty Associate Center for Research, Culture, and Health
University of Michigan Ann Arbor
Lester B. Lave
University Professor, The Harry B. and James H. Higgins Professor of Economics, and Professor of Engineering and Public Policy; Director Green Design Initiative; and Co-Director University Electricity Industry Center Graduate School of Industrial Administration
Carnegie Mellon University Pittsburgh
Professor of Medicine, and Director Program in Medical Ethics
University of California San Francisco
Thomas A. Louis
Professor Department of Biostatistics Bloomberg School of Public Health
Johns Hopkins University Baltimore
Joseph V. Rodricks
Founding Principal ENVIRON International Corp. Arlington, Va.
Christopher H. Schroeder Charles S. Murphy Professor of Law and Public Policy Studies, and Director Program in Public Law
Duke University Law School Durham, N.C.
Director Office of Medical Policy, and Acting Director Center for Drug Evaluation and Research
U.S. Food and Drug Administration
LIAISON FROM SCIENCE, TECHNOLOGY AND LAW PROGRAM
David Korn Senior Vice President Biomedical and Health Sciences Research
Association of American Medical Colleges Washington, D.C.