=======================Electronic Edition========================
RACHEL’S HAZARDOUS WASTE NEWS #322
—January 27, 1993—
News and resources for environmental justice.
——
Environmental Research Foundation
P.O. Box 5036, Annapolis, MD 21403
Fax (410) 263-8944; Internet: erf@igc.apc.org
==========
The Back issues and Index
are available
here.
The official RACHEL archive is here.
It’s updated constantly.
To subscribe, send E-mail to rachel-
weekly-
request@world.std.com
with the single word SUBSCRIBE in the message. It’s free.
===Previous Issue==========================================Next Issue===
NEW PESPECTIVES ON TOXICS–PART 1:
AMERICA LEARNS ABOUT TERATOGENS
In 1954, enterprising German chemists created a new drug, which
they named thalidomide.[1] It seemed to be an ideal sleeping pill
and tranquilizer, and after three years of animal tests
thalidomide was judged so safe that it was approved for
over-the-counter (non-prescription) sale throughout Germany. By
1960, thalidomide was Germany’s most popular sleeping pill and
tranquilizer. It was a huge financial success, marketed under 50
different trade names in 24 countries.
In 1960 the Merrell pharmaceutical company of Cincinnati applied
to the U.S. Food and Drug Administration (FDA) for permission to
market thalidomide in the U.S. The application was assigned to
FDA staff member Frances O. Kelsey who had 60 days to consider
the application.
To the Merrell Company’s distress, Dr. Kelsey asked for more
data; she was concerned that thalidomide acted differently in
animals than it did in humans (it wasn’t a sedative in animals).
The Merrell Company sent officials to Washington to complain that
Dr. Kelsey was holding up progress, but FDA officials held firm.
During this time a single report appeared in a British medical
journal, indicating that some long-time users of thalidomide had
developed nerve damage in their hands and feet. The Merrell
company proposed to put a warning label on the package, but Dr.
Kelsey replied that Merrell would need to conduct studies to show
that thalidomide could be safely taken by pregnant women without
harming the fetus. Merrell officials were appalled that this
“stubborn bureaucrat” could derail their plans for marketing a
sure-fire best-seller. However Dr. Kelsey held firm, and so did
her supervisors at FDA.
Long before Merrell could complete its tests, news filtered
across the Atlantic from Germany of an outbreak of phocomelia
(literally “seal limbs”)–a terrible deformity in which babies
are born with tiny flipper-like stumps instead of arms and hands.
In November, 1961, Dr. Widuking Lenz in Germany and Dr. W. G.
McBride in Australia, almost simultaneously, observed that the
mothers of several babies with phocomelia had one thing in
common–they had taken thalidomide in the first 20 to 40 days of
pregnancy.
In September, 1962, the extent of the disaster in West Germany
was officially confirmed. Since 1957, when the pill was first
approved for over-the-counter sales, thalidomide has caused
10,000 cases of birth malformations in West Germany. Nearly a
thousand other cases were reported in England. So far as we know,
no one has ever tallied the damage in the 22 other countries
where thalidomide was sold–in western Europe and Japan, and
throughout South America.
Interestingly enough, the thalidomide story was told in several
places–in SCIENCE magazine (5/25/62), and in the NEW YORK TIMES
(4/12/62)–back on page 37–but it drew no real attention until
Morton Mintz of the WASHINGTON POST told the story on page 1
(7/15/62) about Dr. Kelsey, who had single-handedly held firm
against great pressure and abuse, thus averting an American
thalidomide tragedy. (Seventeen American babies were born with
phocomelia because, as was allowed at the time, Merrell gave
free samples to physicians as soon as the company applied to FDA
for permission to sell the drug.) The heroism of Dr. Kelsey
caught the public imagination, and then the thalidomide story
spread rapidly. President Kennedy eventually awarded Dr. Kelsey
a medal for Distinguished Civilian Service.
Congress responded to thalidomide by passing the Kefauver-Harris
drug law, which the President signed in October, 1962. This law,
for the first time, gave FDA the power to require specific
procedures for testing new drugs for safety and effectiveness.
But a much broader change began to occur as a result of the
thalidomide disaster. Up until this time, some Americans had been
concerned about cancer from chemicals, but thalidomide brought
home the dangers of teratogens and mutagens. Teratogens cause
birth defects and mutagens cause inheritable genetic changes.
As a result, Americans in general became a little less eager to
try the latest drug for every new ailment. And they gained new
respect for the great damage a small amount of a chemical might
do.
The next developments in our consciousness of chemicals occurred
in the workplace. Workers have always been the people exposed
first to new chemicals, and exposed most heavily. Up until 1970,
when Congress passed the Occupational Safety and Health Act,
workers were not protected in any systematic way from chemicals.
There were no federal standards for exposure and no legal
protections except a patchwork quilt of conflicting state
statutes. Naturally, management had some appreciation of acute
toxic effects from chemicals (sick workers can’t be productive,
and they might sue), but the only long-term consequence that
anyone talked about was cancer. Although the systematic medical
literature on occupational health reaches back to the year 1700,
concern about teratogens and mutagens is almost brand new. Even
as recently as 1969, the “standard” work on occupational safety
and health, Donald Hunter’s DISEASES OF OCCUPATIONS, in its
fourth edition contained no references to either teratogens or
mutagens.
However, the thalidomide disaster prompted a great deal of
research on reproductive health and chemicals, and by the
mid-1970s articles began to appear in the medical literature
linking chemical exposures of both men and women to miscarriages,
infertility, and other reproductive disorders.[2]
However, as knowledge of teratogens and mutagens developed,
measures to protect workers took a peculiar turn.
Although the early studies clearly showed that chemical exposures
of both women AND MEN could damage offspring, corporate
management tended to ignore the evidence about male exposures and
developed policies aimed only at “protection” of women.
The issue came to the forefront in the late 1970s when it became
widely publicized that the American Cyanamid Company had
established a policy barring all fertile women from numerous
high-paying jobs at its Willow Island, West Virginia, plant,
claiming the prohibition was necessary to avoid the possibility
of birth defects in the offspring of exposed workers. The
American Cyanamid case was particularly troublesome because five
women workers at the plant “voluntarily” underwent surgical
sterilization so they could keep their jobs.[3] Despite the ugly
cast of these measures to “protect” women, such policies spread
rapidly throughout American industry. Rather than clean up the
workplace, management found it expedient to exclude female
workers on the specious grounds that their reproductive systems
were sensitive to chemicals, whereas men’s were not. (As a
sidelight, it is interesting to recall that the “right to know”
movement has its origins in this same period; rather than clean
up work places, authorities began to agree to allow workers to
learn the names and some of the characteristics of the chemicals
they were being exposed to.)
Throughout the 1980s, the “protection” issue continued to fester.
For many women, it was a simple matter of rights; they did not
want to be told they had to choose between having a child and
having a job. Federal courts decided half a dozen cases involving
“fetal protection” policies (cases involving Olin Corp., General
Motors, B.F. Goodrich, and several hospitals). In no instance was
a company’s discriminatory policy struck down. The best-known
case was that of Johnson Controls, the nation’s largest
manufacturer of automotive batteries. A coalition of labor and
women’s rights activists challenged Johnson’s policy of excluding
women from jobs involving exposure to lead. (To keep her job on
the production line at any Johnson Controls’ battery factory, a
woman had to offer medical proof that she was sterile.)
In October, 1989, a panel of judges on the federal Court of
Appeals for the 7th Circuit in Chicago ruled that Johnson had the
right to exclude fertile women from jobs involving exposure to
lead, even women who said they had no intention of getting
pregnant. One judge on the 7th Circuit bench, who dissented in
the Johnson Controls case, estimated that 15 to 20 million women
would be excluded from high-paying jobs by the majority’s
decision.[4]
However, a broad coalition of labor and women’s rights
organizations pursued the case into the U.S. Supreme Court and on
March 20, 1991, the court ruled unanimously that employers had no
right (under the Civil Rights Act of 1964) to discriminate
against women even to “protect” them or their fetuses.[5]
With that argument settled, scientists and medical researchers
have begun to recognize, and to confirm, what the older
literature had showed 20 years ago.[6] They are finding that
toxic chemicals can cause men to father defective children. Yes,
toxic sperm, a subject we will examine next week.
–Peter Montague, Ph.D.
===============
[1] Edward W. Lawless, TECHNOLOGY AND SOCIAL SHOCK (New
Brunswick, N.J.: Rutgers University Press, 1977), pgs.
140-[147.]147.
Descriptor terms: birth defects; reproductive hazards;
thalidomide; merrell; fda; germany; england; cancer; carcinogens;
teratogens; mutagens; occupational safety and health; workers;
health; exposure; hazardous materials; miscarriages; infertility;
american cyanamid; fetal protection policies; johnson controls;