Frances Oldham Kelsey: The last American hero

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Photo above: 1962: FDA pharmacologist Frances Oldham Kelsey receives the President’s Award for
Distinguished Federal Civilian Service from President John F. Kennedy for blocking thalidomide in the U.S. (Wikipedia)

America’s greatest living heroine has just celebrated her 100th birthday — and not a single outlet on our benighted, self-regarding, ignorant, Kardashian-crazed media has noticed.

No one, it seems, remembers Frances Oldham Kelsey. Yet this soft-spoken, impeccably mannered Canadian lady and longtime resident of Maryland is one of America’s greatest heroes. She single-handedly prevented a national catastrophe that could have caused 20 times the death toll of al-Qaeda’s attacks on 9/11.

If you are between the ages of 53 and 55, or if you have parents or grandparents of that age, this gentle, careful meticulous scientist is the reason you are alive today. She is the reason you or your parents or grandparents were not born hideously deformed.

You are here because Frances O. Kelsey single-handedly kept the drug thalidomideaway from America’s pregnant mothers.

One of the greatest avoidable pharmaceutical disasters of modern times occurred in the late 1950s and early 1960s when at least 10,000 children in 46 countries (the figure may have been as high as 20,000) were born with appalling birth defects after their mothers had taken the new sedative and tranquilizer drug thalidomide which was also marketed as an antiemetic cure for morning sickness in pregnant women. Countless more expectant mothers suffered miscarriages. The figure certainly ran into the multiple thousands. The full toll was never established.

The defects were appalling and they were as horrifying as many of the mutations caused by radiation from nuclear tests around the world. Babies were born without limbs and with other bizarre distortions of brain and body: Around half of them died within several months. All of the survivors required extensive specialized care for the rest of their short, terrible and agonizing lives. In Britain, by 2010, only 466 of them were still alive.

The CIBA pharmaceutical company developed Thalidomide in 1954 and introduced into general sale by the Gruenenthal Company in West Germany on Oct. 1, 1957. It was introduced on the British commercial market in 1958 and was subsequently marketed under at least 37 different names around the world.

Thalidomide was widely used especially in Britain and West Germany, as well as in other Western European nations and families in those countries were hit disproportionately by the tragedy. To add to the suffering, the giant Distillers Corporation used all its hundreds of millions of dollars of resources to try and out wait the suffering families in an effort to avoid paying them appropriate damages to help them care for the surviving children.

Had thalidomide been marketed in the United States, the consequences would have been infinitely worse. America at that time had almost three times the population of either Britain or West Germany. Its market for medications was far larger. The tradition of buying over-the-counter medications or getting prescriptions from doctors to combat morning sickness and other symptoms during pregnancy was far more widespread and new medicines were marketed far more aggressively than in Europe, especially on television. The number of monstrously-deformed babies that would have been born had thalidomide been approved for sale in the U.S. could have been five or six times the toll in Europe.

However, the United States, the home of free enterprise, which historically has usually had far less government health inspections and regulations than most European nations, was spared all of this suffering, even though the U.S. Food and Drug Administration (FDA) was woefully undermanned at the time.

In an era of dramatic economic and scientific progress when new medications were coming out for the US domestic market on an unprecedented scale, the FDA had only seven full-time researchers and four young part-time assistants for them to work through the massive backlog of drugs awaiting certification.

Kelsey already was  an expert on teratogens, which may cause deformities in babies. So she was assigned to review the application by the Richardson Merrill company for the commercial sale of thalidomide using the trade name Kevadon. It had already been approved in Canada and over 20 European and African countries.

However, Kelsey was cautious, methodical and skeptical. An English study linking thalidomide to side effects on the nervous system bothered her. She insisted that the drug be carefully tested before she would approve it for public use.She got no thanks for her caution. She was subjected to intense personal criticism and pressure to approve the drug. But she would not be rushed. Then, suddenly thousands of babies were born across Europe with horrific deformities of every kind. The cause was traced to their mothers taking thalidomide during their pregnancies. The drug could cross the placental barrier.

Overnight, Kelsey went from being slandered and ridiculed as a power-hungry, bumbling government bureaucrat to hero. Eminent journalist Morton Mintz writing in The Washington Post correctly concluded that she had “prevented … the birth of hundreds or indeed thousands of armless and legless children” across America. Within a few months, a Democrat-controlled Congress imposed much stricter standards on the testing and distribution of new drugs.

Kelsey was unusual in being a hero who actually received her richly deserved recognition in good time. She didn’t have to wait for decades or only be vindicated posthumously. President John F. Kennedy awarded her the President’s Award for Distinguished Civilian Service in 1962 and other honors followed, including the FDA honored her with the first Kelsey award in 2010. The award is given annually to an FDA staff member, and came 50 years after Kelsey reviewed the thalidomide application from the William S. Merrell Company of Cincinnati.

But then Kelsey was forgotten. She became a non-person in the American media and popular memory. In the Republican-conservative era, there was a loud, continuous rhetoric for decades ridiculing the need for sustained government regulation to ensure a safe and healthy society. And Kelsey’s achievement in saving thousands of babies from early deaths or lives of monstrous suffering was dropped down an Orwellian Kelsey never became a folk-hero for the environmentalist movement the way Rachel Carson did for her book Silent Spring. She never wrote a tear-jerking, romanticized potboiler with exaggerated claims the way Carson did. She was just a careful and rigorous scientist.

So far no Hollywood alumni, not even Alec Baldwin, George Clooney or Jodie Foster, has shown any interest in dramatizing Kelsey’s story as a movie or HBO mini-series.

Shamefully, no American president for nearly half a century after John Kennedy recognized Kelsey’s heroic work. She received honorable recognition from private associations but she was never awarded the Congressional Medal of Freedom. That went to such moral giants as Donald Rumsfeld, Tony Blair, Lucille Ball, hydrogen bomb creator Edward Teller and Rachel Carson, even though Carson’s crusade against the pesticide DDT arguably led to the avoidable deaths of millions of African children from mosquito-borne malaria.

Being forgotten does not seem to have bothered Kelsey. She was happily married and raised two daughters. She continued to serve with distinction at the FDA for another 45 years, retiring only in 2005 at the age of 90. In 2010, the agency named its Dr. Frances O. Kelsey Drug Safety Excellence Award in her honor.

In an age of triviality, real heroes are hard to find: Frances Kelsey’s life and achievements fit that criterion. But it is still shameful, pathetic, contemptible that Tony Blair, Donald Rumsfeld and Edward Teller received the Presidential Medal of Freedom and she didn’t: That is a condemnation on the ignorance, incompetence and accelerating infantile condition of our “great” American society.

A society that cannot remember and cherish its true heroes is condemned. it not only deserves to die. It’s death will be inevitable — and contemptible.

Martin Sieff

Martin Sieff is a former senior foreign correspondent for The Washington Times and former Managing Editor, International Affairs for United Press International. Mr. Sieff is the author of “That Should Still Be Us: How Thomas Friedman’s Flat World Myths Are Keeping Us Flat on Our Backs” (Wiley 2012) and “The Politically Incorrect Guide to the Middle East” (Regnery, 2008). He has received three Pulitzer Prize nominations for international reporting.