Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: WEDNESDAY, April 17, 1991                   TAG: 9104170049
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A5   EDITION: BEDFORD/FRANKLIN 
SOURCE: Newsday
DATELINE:                                 LENGTH: Medium

QUESTIONED IUD-DANGER STUDY DEFENDED

According to a lengthy article published in the current Journal of Clinical Epidemiology, Dr. Richard Kronmal and two colleagues found the handling of patients and data in the 1981 Women's Health Study "showed an almost complete disregard for epidemiological principles in its design, conduct, analysis and interpretation of the results."

Kronmal was a consultant to a Richmond, Va., IUD maker, the A.H. Robins Co., a decade ago.

Authors of the original study disagreed strongly with the new conclusions. Dr. Ronald T. Burkman, now at Henry Ford Hospital in Detroit, found the re-analysis "replete with factual error, misrepresentation and overstatement." He said his team was aware of the concerns raised in the new analysis, but said there was no violation of research standards.

Current IUDs are considered safe, but in 1981, researchers found the Dalkon Shield, an IUD, was associated with pelvic inflammatory disease. The Dalkon Shield was pulled from the market in 1974, and the Robins company went bankrupt. About 100,000 claims are being made on a $2.5 billion fund set up to compensate women who might have been injured.

An obstetrician-gynecologist at the Oregon Health Sciences Center, Dr. Leon Speroff, said the new analysis of the 1981 study now makes no medical difference.

"This article deals with the past. It's well recognized today that with the IUDs we have, and with the insertion methods we use, any risk of pelvic infection is due to the insertion itself.

"If we screen the patients for infections that are already present, and if we use an aseptic technique, the risk of pelvic inflammatory disease is essentially zero," he said.