How one scientist averted a national health crisis Andrea Tone
In the fall of 1960,
Frances Oldham Kelsey
was one of the Food
and Drug Administration’s newest recruits.
Before the year was out,
she would begin a fight that would
save thousands of lives,
though no one knew it at the time.
Although she was new to the FDA,
Kelsey was no novice as a scientist.
After graduating
from high school at age 15,
she enrolled
at McGill University in Montreal
and earned both undergraduate
and master’s degrees in pharmacology.
From there, she applied
for a research post
at the University of Chicago’s
pharmacology department.
Her acceptance letter was addressed
to Mr. Oldham.
Kelsey later joked that had her name
been Elizabeth or Mary Jane,
her career might have ended there.
Fortunately, it didn’t.
She earned her doctorate
in pharmacology
and accepted Chicago’s invitation
to stay as faculty,
where she undertook pioneering
research on drugs and fetal safety.
In 1950, she earned an MD,
her fourth and final degree.
By the time she joined the FDA,
Frances Kelsey was one of the most
educated, experienced scientists around.
Yet, as the newest member
of the team,
Kelsey was assigned what everyone
thought would be an easy review:
an application from the
US drug company Merrell
to sell a drug called thalidomide.
Thalidomide was a sedative
developed in Germany
that was already being widely used
in dozens of countries
to treat insomnia and workplace stress.
Thalidomide’s anti-nausea properties
also made it a popular remedy for pregnant
women with morning sickness.
Reviewing Merrell’s application,
Kelsey found its data on thalidomide’s
absorption and toxicity inadequate.
Today, the FDA classifies drugs based
on their safety for a fetus.
But in 1960, many experts believed
that the placental barrier
shielded a fetus from harm.
Kelsey’s earlier animal-based research
demonstrated the opposite:
drugs could pass from mother
to fetus through the placenta.
Like other drug companies at this time,
Merrell had not tested its drug
on pregnant animals.
Kelsey later said Merrell’s evidence
for thalidomide’s safety seemed
“more like testimonials than
the results of well-designed studies.”
Kelsey rejected Merrell’s application
and asked them to submit a second
backed by better evidence.
Her FDA colleagues
supported this decision.
Merrell had expected a quick,
affirmative reply
so it could launch thalidomide
for the holiday season,
when sedative sales soar.
Instead of supplying Kelsey
with the data she requested
they first tried to convince her
to approve the drug
over a series of calls and visits.
When these failed to sway her,
Merrell executives complained
that stubborn and nit-picking
Kelsey was the problem,
not thalidomide.
The FDA backed Kelsey,
forcing Merrell to file
another application,
and another,
and another.
As Kelsey reviewed
and rejected each new application,
news of thalidomide’s adverse
side effects began to surface.
Doctors reported cases of nerve damage
in early 1961,
and by fall,
they’d unmasked a more horrible truth.
Thalidomide, widely used by pregnant
women, caused severe birth defects.
Thousands of babies died in utero,
and tens of thousands more
were born with extra appendages,
shorter limbs,
or no limbs at all.
In November 1961, thalidomide
was pulled from the German market.
Nonetheless, Merrell continued trying
to get it approved in the US
for several months before withdrawing
their sixth and final application.
While Kelsey wasn’t the only scientist
to identify the risks of thalidomide,
she sounded the alarm
that kept it off the multi-billion-dollar
American drug market.
As public awareness
of the thalidomide tragedy grew,
the quiet scientist
became a media sensation.
Headlines in newspapers
and magazines heralded her heroism
while a smiling President John F. Kennedy
presented her an award
on the White House lawn.
After the thalidomide scare,
Congress passed laws that expanded
the FDA’s authority
and toughened requirements
for new drug applications.
Kelsey was tapped to head
the agency’s drug investigation branch.
Working at the FDA in
different capacities into her 90s,
Kelsey was able to witness the changes
her actions helped inspire.
Her visibility may have dimmed since,
but her legacy endures.
Privileging facts over opinions,
and patience over shortcuts,
she made evidence-based medicine
the foundation of reforms
that continue to protect people today.