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#322 - New Pespectives On Toxics -- Part 1: America Learns About Teratogens, 26-Jan-1993

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

=====

[1] Edward W. Lawless, TECHNOLOGY AND SOCIAL SHOCK (New Brunswick,
N.J.: Rutgers University Press, 1977), pgs. 140-[147.]147.

[2] For example, I. V. Sanotskii, "Aspects of the Toxicology of
Chloroprene: Immediate and Long-Term Effects," ENVIRONMENTAL HEALTH
PERSPECTIVES Vol. 17 (1976), pgs. 85-93. And: Peter F, Infante and
others, "Genetic Risks of Vinyl Chloride," THE LANCET (April 3, 1976),
pgs. 734-735.

[3] Joan E. Bertin, "People Protection Not 'Fetal Protection,'" NEW
SOLUTIONS (Summer 1991), pgs. 5-9.

[4] William E. Schmidt, "Risk to Fetus Ruled as Barring Women from
Jobs," NEW YORK TIMES October 3, 1989, pg. A16.

[5] Linda Greenhouse, "Court Backs Right of Women to Jobs With Health
Risks," NEW YORK TIMES March 21, 1991, pgs. 1, B12.

[6] Sandra Blakeslee, "Research on Birth Defects Turns to Flaws in
Sperm," NEW YORK TIMES Jan. 1, 1991, pgs. 1, 36.

Descriptor terms: birth defects; reproductive hazards; thalidomide;
merrell pharmaceutical co; fda; germany; great britain; cancer;
carcinogens; teratogens; mutagens; occupational safety and health;
workers; health; exposure; hazardous materials; miscarriages;
infertility; american cyanamid; fetal protection policies; johnson
controls;