Science of Koop Study Challenged
Health Care Without Harm Press Release 15sep99
An international coalition of health professionals, health advocacy groups and environmental organizations released a critique today that challenges the scientific integrity of a recent report on chemicals used in vinyl medical products and toys. The panel responsible for the report under scrutiny was chaired by former Surgeon General C. Everett Koop for the American Council on Science and Health (ACSH).
The analysis released today details factual errors and omissions of data in the Koop/ACSH review of the health effects of chemicals that can leach out of vinyl toys and medical products. At issue is whether these chemicals, called phthalate plasticizers, have the potential to cause harm in people who are exposed. In February, Dr. Koop convened a "blue-ribbon" panel of experts to examine the effects of the plasticizers, di-ethylhexyl-phthalate (DEHP) and di-isononyl-phthalate (DINP). In June, the panel announced it had found no cause for consumer concern.
On behalf of Health Care Without Harm, Ted Schettler, MD, MPH, reviewed the portion of the ACSH report that addressed vinyl medical products. He found that despite assertions by Elizabeth Whelan of ACSH that the task of Dr. Koop's panel was to "thoroughly assess the broad body of scientific evidence that's available," the panel, in fact,
- selectively reported the literature on DEHP toxicity. Their analysis omitted studies from readily available, peer-reviewed literature that describe toxic effects of DEHP at exposure levels relevant to humans;
- claimed that a cited study reports a finding that, in fact, is never addressed or reported in the published manuscript; and
- misrepresented data from peer-reviewed studies.
"I am deeply disappointed that a physician with Dr. Koop’s reputation as 'America's family doctor' has produced a report based on an incomplete, deceptive and misleading analysis of the scientific literature," remarked Schettler, who is the Science Director for the Science and Environmental Health Network and a former member of the Environmental Protection Agency’s Endocrine Disrupter Screening and Testing Advisory Committee.
The Koop findings differed dramatically from those in a recent report commissioned by Health Care Without Harm from the Lowell Center for Sustainable Production at the University of Massachusetts at Lowell. That report cited additional animal studies as well as human data that document health effects of exposure to DEHP, the plasticizer found in vinyl medical products. Other non-vinyl materials that do not contain phthalate plasticizers are potentially safer alternatives to the vinyl currently being used in many products.
"We believe that Dr. Koop and the other ACSH panel members have an ethical obligation to acknowledge and correct the flaws in their report," said Charlotte Brody, RN, national co-coordinator for Health Care Without Harm. "The American public and the regulatory agencies that are currently evaluating the health risks of DEHP have a right to know that the conclusions of this report are not based upon complete and honest analysis of the science."
In June 1999, HCWH petitioned the Food and Drug Administration (FDA) to require labeling of all medical products that contain DEHP and to expedite the development of phthalate-free alternatives. The National Toxicology Program of the National Institute of Environmental Health Sciences is also reviewing the toxicity of the plasticizers. The ACSH report has been submitted to both agencies as justification of the safety of DEHP.
HCWH’s charge of shoddy science comes on the heels of allegations of improperly disclosed financial ties between Dr. Koop and advertisers on his Internet venture, DrKoop.com.
Dr. Schettler’s critique, "Do We Have a Right to Higher Standards? C. Everett Koop, MD and an ACSH Panel Review the Toxicity and Metabolism of DEHP," as well as "The Use of Di-2-EthylHexyl Phthalate in PVC Medical Devices: Exposure, Toxicity, and Alternatives," the report by the Lowell Center for Sustainable Production, are available on the Health Care Without Harm web site, www.noharm.org. Health Care Without Harm is an international coalition of more than 180 organizations dedicated to eliminating environmental pollution from health care. Members include more than 40 hospitals, the American Public Health Association, the American Nurses Association, the General Board of Church and Society of the United Methodist Church, the Ambulatory Pediatric Association, and many others.
Contact:
Charlotte Brody, RN, Health Care Without Harm, 703-237-2249
Ted Schettler, MD, MPH, Science & Environmental Health Network, 617-536-7033
Jackie Hunt Christensen, Health Care Without Harm, 612-870-3424
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