A deadly drug, a strong woman

The manufacturer of thalidomide – the anti-morning sickness pill blamed for causing birth defects in thousands of babies – has issued its first ever apology, 50 years after the drug was pulled off the market.

The drug led to birth defects in Europe, Australia, Canada and Japan, but was never approved for use in pregnant women in the U.S.

The reason it was never approved in the U.S., was one courageous woman named Frances Kelsey – who also happens to be an SMS Alumna.

Kelsey attended SMS in the 20's, obtained a degree from McGill University, was offered a fellowship at the University of Chicago (by mistake – they assumed from her name that she was a man) and, in her first month working for the U.S. Food and Drug Administration, she turned down the pharmaceutical company that had purchased North American rights for thalidomide. She was not convinced the drug was safe, and stood her ground for two years before the world realized Kelsey’s instincts were right.

Below is an excerpt from a story published in the Times Colonist which describes Kelsey’s incredible role in saving hundreds of American children:
 

Times Colonist
Published: Sunday, September 26, 2010

…In 1957, German manufacturers developed a new drug called Contergan. It was a tranquilizer and painkiller and also prescribed to thousands of pregnant women to treat morning sickness.

But Contergan, or thalidomide as it is known in North America, causes birth defects. It can be taken by non-pregnant women without risk and is still prescribed for the treatment of cancer.

And even for expectant mothers, there is only a two-week danger period. Before and after that window, thalidomide is no threat.

But fetal limbs develop between the 35th and 49th day of pregnancy. If thalidomide is used during that time, it can wreak havoc.

The progression of impacts makes grim reading: Between the 35th and 37th day, absence of ears and deafness; between the 39th and 41st, absence of arms; during the 43rd and 44th days, hands misshapen as flippers.

Almost 40 per cent of the victims died before their first birthday.

Researchers didn't know that drugs could cross the placental barrier between mother and fetus. As a result, thalidomide was licensed in Britain, Europe and Canada before meaningful research was conducted.

But in the U.S., a young medical officer named Frances Kelsey was assigned the thalidomide file.

Frances Oldham (her maiden name) was born and raised in Cobble Hill. She attended St. Margaret's School in Victoria in the 1920s, then studied science at McGill University in Montreal. She was offered a fellowship at the University of Chicago (by mistake – they assumed from the name on her application that she was a man) and married there.

In 1960, Kelsey was hired by the U.S. Food and Drug Administration. The Richardson-Merrell pharmaceutical company had just purchased North American rights for thalidomide and wanted permission to market the drug immediately.

The application landed on her desk. After studying the impact of drugs on pregnant rabbits, Kelsey became convinced that fetuses are not immune. She also knew that thalidomide might cause tingling in the extremities, a sign of possible nerve damage.

Although it was only her first month on the job, she turned Richardson-Merrell down.

Huge pressure was brought to bear. For two years, the company hammered away and demanded a licence. But Kelsey continually asked questions and refused to cave in.

And by doing so, she saved hundreds of American children from deformity.

In the spring of 1962, the dreadful truth came out. Kelsey had been right.

Between 10,000 and 20,000 children were affected around the world. By a sad irony, some were Canadian. Thalidomide was licensed in this country and more than 100 children suffered birth defects.

Frances Kelsey was a public health official who insisted that evidence, rather than pressure, should guide her decisions. Aged 96, Kelsey lives today in Maryland.

Her efforts 50 years ago should remind us today of the need for caution in assessing medical treatments – and that one determined, ethical person can make a huge difference.

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