[Congressional Record Volume 143, Number 76 (Thursday, June 5, 1997)]
[Senate]
[Pages S5345-S5346]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. HARKIN (for himself and Mr. Reed):
  S. 834. A bill to amend the Public Health Service Act to ensure 
adequate research and education regarding the drug DES; to the 
Committee on Labor and Human Resources.


           the DES Research and Education Amendments of 1997

  Mr. HARKIN. Mr. President, today I am pleased to be joined by my 
distinguished colleague from Rhode Island, Senator Reed, in introducing 
an important women's health initiative. The DES Research and Education 
Amendments of 1997 would extend and expand our effort to assist the 
over 5 million Americans who have been exposed to

[[Page S5346]]

the drug, DES. Representative Louise Slaughter, a long-time leader on 
this issue, is introducing companion legislation today in the other 
body.
  Between 1938 and 1971, some 5 million American women were given the 
synthetic drug, diethylstilbestrol, commonly known as DES. Women were 
given the drug during pregnancy in the mistaken belief it would help 
prevent miscarriage. The drug was pulled from the market based on 
studies that found that it was ineffective and might result in damage 
to children born to the women who had been given it.
  Since the 1970's, studies have shown that DES does damage the 
reproductive systems of those exposed in utero and increases these 
individuals' risk for cancer, infertility, and a wide range of other 
serious reproductive tract disorders. The women exposed in utero to DES 
are five times more likely to have an ectopic pregnancy and three times 
more likely to miscarry when they in turn try to have children. Studies 
also show that one of every thousand women exposed to DES in utero will 
develop clear cell cancer. Women who took DES have also been found to 
face a higher risk for breast cancer.
  In 1992, while there had been a number of research studies on DES 
exposure and its effects, much more research was necessary. That year, 
President Bush signed legislation introduced by myself and 
Representative Slaughter, that mandated a significant increase in DES 
research supported by the National Institutes of Health [NIH]. Our 
legislation also required NIH to support long-term studies of Americans 
impacted by this drug. Those studies are now underway and must be 
continued. The legislation we are introducing today will ensure that 
this critical medical research continues. In addition, there is now 
preliminary evidence that the grandkids of women who took DES may also 
be at higher risk for certain health problems, and this legislation 
would help ensure that further research into this is supported.
  Another major problem in this area is that millions of Americans 
don't know the risks they face because of their exposure to DES. Many 
health professionals who see these people also lack sufficient 
information about DES exposure and the appropriate steps that should be 
taken to identify and assist their patients. As a result, many people 
do not seek or get the appropriate preventive care or take appropriate 
preventive measures to reduce their risks of adverse affects. For 
example, women exposed to DES in utero and therefore at higher risk of 
miscarriage may be able to reduce their risks with appropriate 
precautionary steps.
  In an initial attempt to address this need for better information, 
our 1992 legislation required NIH to test ways to educate the public 
and health professionals about how to deal with DES exposure. The 
legislation we are introducing today would give people across the 
Nation access to the information developed through these pilot programs 
by requiring a national consumer and health professional education 
effort.
  Mr. President, we took a very important step in 1992 to begin to 
address the significant problem presented by DES exposure. And we did 
it with strong bipartisan cooperation between a Democratic Congress and 
a Republican President. That legislation expires this year. We need to 
make sure that the progress we've made is continued. The 5 million 
Americans whose health is at risk are depending on us to work together 
to make sure that happens. I urge my colleagues to join me in support 
of that effort. I ask unanimous consent that a copy of the legislation 
be included in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 834

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``DES Research and Education 
     Amendments of 1997''.

     SEC. 2. FINDINGS.

       With respect to diethylstilbestrol (a drug commonly known 
     as DES), the Congress finds as follows:
       (1) DES was widely prescribed to American women from 1938 
     to 1971 in the mistaken belief it would prevent miscarriage. 
     Approximately 5,000,000 pregnant women took the drug, 
     resulting in DES exposure for approximately 5,000,000 
     daughters and sons.
       (2) Studies conducted since the 1970s have shown that DES 
     damages the reproductive systems of those exposed in utero 
     and increases the risk for cancer, infertility, and a wide 
     range of other serious reproductive tract disorders. These 
     disorders include a five-fold increased risk for ectopic 
     pregnancy for DES daughters and a three-fold increase in risk 
     for miscarriage and preterm labor. Studies have indicated 
     that exposure to DES may increase the risk for autoimmune 
     disorders and diseases.
       (3) An estimated 1 in 1,000 women exposed to DES in utero 
     will develop clear cell cancer of the vagina or cervix. While 
     survival rates for clear cell cancer are over 80 percent when 
     it is detected early, there is still no effective treatment 
     for recurrences of this cancer.
       (4) Studies also indicate a higher incidence of breast 
     cancer among mothers who took DES during pregnancy.
       (5) While research on DES and its effects has produced 
     important advances to date, much more remains to be learned.
       (6) Preliminary research results indicate that DES exposure 
     may have a genetic impact on the third generation--the 
     children of parents exposed to DES in utero--and that 
     estrogen replacement therapy may not be advisable for DES-
     exposed women.
       (7) All DES-exposed individuals have special screening and 
     health care needs, especially during gynecological exams and 
     pregnancy for DES daughters, who should receive high risk 
     care.
       (8) Many Americans remain unaware of their DES exposure or 
     ignorant about proper health care and screening. There 
     remains a great need for a national education effort to 
     inform both the public and health care providers about the 
     health effects and proper health care practices for DES-
     exposed individuals.

     SEC. 3. REVISION AND EXTENSION OF PROGRAM FOR RESEARCH AND 
                   AUTHORIZATION OF NEW NATIONAL PROGRAM OF 
                   EDUCATION REGARDING DRUG DES.

       (a) Permanent Extension of General Program.--Section 
     403A(e) of the Public Health Service Act (42 U.S.C. 283a(e)) 
     is amended by striking ``for each of the fiscal years 1993 
     through 1996'' and inserting ``for fiscal year 1997 and each 
     subsequent fiscal year''.
       (b) National Program for Education of Health Professionals 
     and Public.--From amounts appropriated for carrying out 
     section 403A of the Public Health Service Act (42 U.S.C. 
     283a), the Secretary of Health and Human Services, acting 
     through the heads of the appropriate agencies of the Public 
     Health Service, shall carry out a national program for the 
     education of health professionals and the public with respect 
     to the drug diethylstilbestrol (commonly known as DES). To 
     the extent appropriate, such national program shall use 
     methodologies developed through the education demonstration 
     program carried out under such section 403A. In developing 
     and carrying out the national program, the Secretary shall 
     consult closely with representatives of nonprofit private 
     entities that represent individuals who have been exposed to 
     DES and that have expertise in community-based information 
     campaigns for the public and for health care providers. The 
     implementation of the national program shall begin during 
     fiscal year 1998.
                                 ______