Opening Remarks, DES Research Update 1999: Current Knowledge, Future Directions

II. Opening Remarks

Welcome and Introduction
Presentation: The Honorable Louise M. Slaughter (D-NY)

Welcome and Introduction

Wanda K. Jones, Dr.P.H., Deputy Assistant Secretary for Women's Health, U.S. Public Health Service's Office on Women's Health (US PHS OWH), opened the 1999 Workshop by welcoming all in attendance. Dr. Jones spoke on behalf of Vivian Pinn, M.D., Director, NIH Office of Research on Women's Health (ORWH), who was not able to attend the workshop. As Dr. Jones noted, the purpose of the current meeting was to follow-up on the 1992 DES Workshop. During the current 1 and 1/2 day meeting, attendees and presenters were to look back at where researchers and advocates were in 1992, review the status of current research efforts in several topical areas, and identify gaps in DES-related research and education/outreach that still exist. The workshop would include four topic-driven breakout sessions, each co-chaired by a researcher and an advocate, to allow for open discussion in those four areas and the development of recommendations for future DES research efforts. The planning and organization of the 1999 Workshop represented the joint efforts of representatives of DES advocacy groups in equal partnerships with researchers and clinicians from the National Cancer Institute (NCI); the National Institute of Environmental Health Sciences (NIEHS); NIH ORWH; US PHS OWH; and the National Center for Environmental Health, Centers for Disease Control and Prevention (CDC). Dr. Jones noted the enthusiastic support for this workshop from the NCI Director, Dr. Richard Klausner.

In continuing her introduction, Dr. Jones stated that the effects of exposure to DES- whether directly to the mother, to her children, or perhaps even to her grandchildren-are of concern to the American public, physicians, and the U.S. Congress. Although DES is no longer used, concerns about the long-term effects of DES exposure persist. Current active research areas include basic mechanistic laboratory research on the effects of DES and other endocrine-disrupting chemicals; clinical and epidemiologic studies assessing the long-term exposure effects and the extent of risk imposed on those exposed to DES; and education and information dissemination efforts focused on the public as well as on educators and health professionals within the health care delivery system. The Women's Health Research and Prevention Amendments of 1998 contained, in the FY99 Senate Appropriations Report for NCI, strong Congressional support for educating the public and health professionals about the impact of exposure to DES. The appropriations language requested that NCI contract with CDC to undertake educational efforts targeting consumers and health professionals on a national basis.

Following that brief background, Dr. Jones welcomed Congresswoman Louise Slaughter (D-NY), a seventh-term member of the House of Representatives. Congresswoman Slaughter is a bacteriologist with a masters degree in public health. She also has had a long-standing interest in all aspects of women's health, and particularly on the impact of DES, during her tenure in Congress. For example, she was responsible for passage of legislation that established the first federal funding and first federal research and education programs on DES. Emblematic of Congresswoman Slaughter's interest in and commitment to research on DES was her participation in the 1992 DES Workshop. Her return to open the current meeting is further demonstration of her ongoing support of DES research and education.

Presentation: The Honorable Louise M. Slaughter (D-NY)

Congresswoman Slaughter began her address by expressing her appreciation at being invited to open the 1999 DES Workshop, whose focus is on current and future research activities related to DES. She recognized that holding this second, international meeting represented a personal and professional aspiration that became a reality only after years of dedicated effort by DES mothers, daughters, and sons, and concerned scientists who would be advocates for DES research. She noted that despite many challenges, DES advocates and scientists pulled together to demonstrate the importance of continued DES research and education.

Congresswoman Slaughter recalled that, in November 1971, the FDA released a bulletin titled "Diethylstil-bestrol Contraindicated in Pregnancy." This modest, two-page notice contradicted decades of physician practice in prescribing DES to pregnant women.⁶ First used in the United States between 1938 and 1945, doctors had prescribed DES to women to prevent miscarriage, and both the doctors and their patients believed they were supplying the best possible health care. The 1971 FDA bulletin referenced the landmark study by Dr. Arthur Herbst documenting a rare vaginal cancer among young women exposed to DES in utero.^{5 (b)} This research, and the subsequent Herbst registry, gave researchers and the public the first definitive links between DES and reproductive tract disorders in DES-exposed children.

Congresswoman Slaughter first became involved in DES issues more than a decade ago, when, while she was serving on the New York State Assembly, she became aware of DES-related liability issues through a group of DES mothers and daughters. She learned that New York State's statute of limitations was preventing many DES mothers and daughters from suing the manufacturers of DES for illnesses and damage the women had suffered, despite the fact that DES-related cancers often take many years to develop and appear. This information led Congresswoman Slaughter to write New York's Toxic Torts Reform Law to ensure that DES was explicitly included among the agents covered under that law. That legislation, enacted in 1986, provided some financial relief to the women of New York who had been affected by the drug.

A few years later, after becoming a member of the U.S. House of Representatives, Congresswoman Slaughter was visited again by DES mothers and children, who expressed concerns that more research on DES was needed, that funding for DES research was insufficient, and that an education program for DES must be established. Already familiar with DES and related issues, Congresswoman Slaughter volunteered to champion DES research and education in Congress. Senator Tom Harkin (D-IA) proved to be a strong and committed ally in the Senate and has worked alongside Congresswoman Slaughter for years to promote DES research and education. With the DES community they drafted the DES Education and Research Amendments of 1992. This bill established the first federal DES program in statute, meaning that the NIH was directed, by law, to continue research on DES. This statute was a significant step in ensuring that DES research would be funded consistently and at an adequate level. The bill also allowed for the establishment of DES education pilot projects to determine how to locate DES-exposed mothers, daughters, and sons and to inform them of their special health needs and risks.

The legislation was signed into law by President George Bush on October 13, 1992. In Congressional terms, Congresswoman Slaughter explained, this legislation had been passed very quickly, after being introduced in January of the same year. Assisting in keeping the bill moving forward was Congressman Henry Waxman (D-CA), who chaired the House Subcommit-tee on Health and helped smooth the way for the bill's passage in the then-Democratic Congress, placing this noncontroversial bill on a fast track. Seventy-one bipartisan sponsors lent their support for the bill in the House, 15 in the Senate.

Five years later, the 1992 bill, which took effect in 1993 and was a 5-year authorization, was up for renewal. Congresswoman Slaughter pulled together the original team that included Senator Harkin and the DES community to draft a new bill-the DES Education and Research Amendments of 1997. The new bill reauthorized DES research and gave DHHS the authority to expand DES education projects nationwide, using the knowledge gained through the pilot projects. Congresswoman Slaughter introduced the new bill in July 1997 with the hope that, as a noncontroversial bill, it would again enjoy bipartisan support and a speedy passage through Congress as had the 1992 bill. The new bill was supported by 60 co-sponsors in the House and seven in the Senate. Supporters of the proposed legislation did face some partisan debate regarding the 1997 reauthorization. An opportunity to move the bill through Congress arrived, however, via a package of women's health bills proposed by the Senate GOP leadership. The Senate added the DES Reauthorization bill to the package and passed the legislation on October 12, 1998, the same day it was introduced on the floor of the Senate. The House of Representatives passed the same bill on October 13, with only one dissenting vote. President Clinton signed the package, including the DES Reauthorization bill, into law on October 31.

In looking to the future, Congresswoman Slaughter noted, researchers and advocates should continue their efforts to keep members of Congress abreast of the most current DES research findings and needs. An important step in that process-the passage of the 1997 legislation-will facilitate those efforts and provide the tools necessary to deliver the DES message across the nation.

Congresswoman Slaughter continued by recognizing that those in attendance have already devoted significant amounts of time, energy, and effort to this cause. For that, she said, she and millions of others extend their sincerest thanks and gratitude. Continued mutual support will be key to conveying the DES message to as large an audience as possible, especially to those who have been exposed and who are at risk. Fundamental to this effort will be the successful implementation of the DES Reauthorization bill and the National DES Education Program through DHHS, CDC, and NIH.

Among the positives to come from the DES legacy, Congresswoman Slaughter noted, are the scientific insights gained into the way in which synthetic hormones such as DES act in the human body. DES research is thus crucial not only for those women exposed to the drug, and their children and grandchildren, but also for all who will benefit from the knowledge scientists will gain about estrogens, environmental health, and the way in which genes interact with our environment. Researchers should continue their search for the answers to the many questions about DES that still remain. For example, as DES mothers and daughters enter menopause, should they take estrogen? The search for the genetic changes induced by DES continues. When these changes are identified, they will provide researchers with invaluable tools in determining who was exposed to DES and their risk of various health consequences from that exposure. Recent indications that a third generation-DES granddaughters and grandsons-may be at risk leaves this chapter open for further investigation. Researchers and advocates must move quickly to assess the reality and extent of the proposed risk and what can be done to mitigate its effects. With so many outstanding questions, the importance of and need for ongoing DES research and education is clear.

Congresswoman Slaughter closed her talk by recognizing the efforts and persistence of the larger DES community and by expressing her interest in continuing her work with that community to educate Congress about the ongoing need for DES research and education.