James Essinger on How One Woman Prevented a Pharmaceutical Disaster

In the fall of 1960, Richardson-Merrell had ten million thalidomide pills manufactured and ready to release onto the U.S. market.

All its executives had to do was to get pro-forma approval from the Food and Drug Administration (FDA). 

After all, millions of the anti-nausea pills were already being given to pregnant women in Europe and Asia and around the world. Thalidomide was considered safe and very effective in combating morning sickness.  

Merrell submitted its new drug application (NDA) for thalidomide to the FDA in September 1960. 

Merrell was expecting a quick approval and Christmas bonuses for its executives by the end of the year.

And the bosses at the FDA decided that since it was such a routine application that would in all likelihood be approved quickly, they would assign it to a newcomer, a Canadian born doctor, who had just joined the FDA earlier in the year. 

Her name was Frances Kelsey.

Kelsey didn’t like what she saw in the NDA. She delayed the application for more than a year until in late 1961, the world learned that from 1955 to 1961, thalidomide was causing severe birth deformities in babies born to women who took the drug in the first 45 days of pregnancy. 

Thousands of babies were born with no arms and legs.

With Sandra Koutzekno, James Essinger, who lives and works in Coventry in the UK,  has written the first biography of Frances Kelsey. 

It’s called – Frankie: How One Woman Prevented a Pharmaceutical Disaster. 

How did you come to write this book?

“There is a British television series – Call the Midwife,” Essinger told Corporate Crime Reporter in an interview last month. “It’s a high quality television series about the lives of midwives in the 1950s. It’s an historical drama.” 

“I don’t watch much television. But my office is next to the room where my housemate Fran watches television.” 

“She was watching this program back in March 2016. I went into the room to have a cup of tea with her and to sit for a bit. The program had a thalidomide baby storyline.” 

“They could only do thalidomide baby storylines when they had computer graphics. Otherwise, you couldn’t simulate a thalidomide baby. It was a very good episode about a thalidomide baby born in the late 1950s. They had no idea what was causing the severe deformities.”  

“I remembered that thalidomide had never been a scourge in the United States. I remembered that a woman had prevented that from being the case. I did some research about Frances Kelsey. I assumed there must be a book about her, but there wasn’t, so I wrote one.”

“I went to the Library of Congress in late 2017 to research it. And I began researching and writing in August 2017 after on and off researching it for about a year.”

Why did the book get so little notice in the United States when it was published here in 2018?

“Most books get very little notice. It got very little notice in the UK as well. However, there is a very important Hollywood agent interested in the book and it might become a movie, which would change the dynamics.”

“I can’t really answer your question. Frances Kelsey, a heroic woman, was awarded a  President’s Award for Distinguished Federal Civilian Service by President Kennedy. She courageously stood up to drug companies in the United States and around the world and said – I’m not authorizing this drug for the United States market because I don’t trust it, I don’t trust the evidence you’ve got that it’s safe.”

“She didn’t suspect until later in the process that it might cause birth deformities. But she certainly had a very good instinct about it. She was a kind of fairy godmother to women in America.”

“The book pretty much covers her entire life. She had a distinguished medical career before she became involved with thalidomide, which she did in September 1960.”

“She joined the Food and Drug Administration (FDA) on August 1, 1960. The FDA today is a big organization, very well respected, and well resourced. When Frankie joined it, it wasn’t. It was a bit of a hole in the corner organization, poorly resourced.  It was not a high status job.” 

“She had a dingy little office where she worked. It was very much a peripheral American institution. But she was drawn to it because she liked the idea of helping people by making sure drugs were safe.”

“There had been all sorts of horrible scandals of drugs that killed many children. One particularly horrible example mentioned in the book was a drug sulfanilamide in the 1930s.” 

“It was an antibiotic liquid which was mixed with a substance that is now used in antifreeze in cars. It killed many children. There was poor drug regulation in the 1930s and 1940s. There was particularly poor drug regulation for drugs for women.”

She was sitting in her office on the mall in Washington, D.C. when she was assigned this case.

“In early 1960, she was given this new drug application (NDA) for thalidomide. Ironically, she was given it because she was relatively junior at the FDA and they wanted to give her a nice easy project to get her started at the FDA.”

“We must remember that thalidomide was first marketed to treat morning sickness, as it is called today. It was and still is a scourge for many women. Prince William’s wife Kate suffered from morning sickness.” 

“And some women terminate their pregnancies because they can’t deal with morning sickness. Thalidomide was found by accident to be a highly effective treatment for morning sickness. And you can’t overdose on it.” 

“So at one level, it was seen as being a miracle drug. They didn’t know that one of the side effects was to prevent babies in the womb from developing properly.”

It was approved throughout Europe. And one of the big issues in this case was that it wasn’t known as thalidomide. It went under a whole different number of names.”

“The word aliases is probably better. Worldwide it had about 80 aliases. The problem of ascribing these fetal deformities to thalidomide was made very difficult.”

“First of all there wasn’t good information sharing.”’

“Second, nine months would elapse between the time the mother was given the drug and the baby was born. Often mothers didn’t even remember taking the drug.” 

“And thirdly, thalidomide was marketed with all sorts of aliases. In England, it was called Distaval. In America, it was going to be called Kevadon. There were all sorts of names, some more sinister sounding than those.”

You estimate that outside of the United States there were 100,000 thalidomide babies, half of whom died in the womb and half with deformities.

“The deformities varied with almost uncanny precision depending on what stage of the pregnancy the mother took the tablet. And by the way, one tablet was enough. The way the human fetus develops is that it develops certain areas on certain days of the pregnancy.” 

“After about 45 days of pregnancy from conception, the fetus was strong enough not to be affected by thalidomide. In that first month or so, the fetus does not look like a baby. It’s just a clump of cells. But during that period, the doctors realized that when the mother took the drug, there were different deformities. But they were all pretty awful.”

How did it come about that the drug was approved throughout Europe and Asia but not in the United States?

“The United States is in many ways a more self critical society than Britain, France and Japan were at the time. What interests me as a non American about the United States is that for a country that is capitalistic as it is, in all fairness to America, it is also a country that has a well developed socially responsible framework.” 

“I’m not saying it’s perfect but institutions in America tend to be effective. And certain people at institutions have a real sense of vocation that I’m going to not become a millionaire in my job, but I’m going to help other people. And that is what France Kelsey was like.”

“She was a hard working, astute, committed doctor. She was fascinated by medicine. She played a role in identifying insulin and developing effective treatments for diabetes. She was an enthusiastic student, fascinated by her profession.” 

“She applied for a job in Chicago and the man who hired her didn’t seem to realize she was a woman. He wrote to her – Dear Mr. Kelsey. Her name was Frances and Frances with an e is normally a woman’s name and Francis with an I is a man’s name. This guy thought she was a man.” 

“So he wrote – Dear Mr. Kelsey. She accepted the job with a letter signed off as (Miss) Frances Kelsey, thinking she might not get the job. But she got the job.” 

“That was a time when many women didn’t have the chance to develop careers. But she managed to do so.”

Her decision to not approve the NDA for thalidomide probably saved, you estimate, another 100,000 babies. How did you come to that estimate?

“It’s a reasonable estimate. Richardson-Merrell had 10 million Kevadon tablets ready for distribution throughout the United States.” 

“As it was, hundreds of those tablets went to doctors throughout the United States. Believe it or not, at the time, a doctor could be given samples of an untested drug without FDA approval. And there were mercifully only a few thalidomide babies resulting from that.”

“The NDA was given to Frances in September 1960. As Christmas was coming, the Richardson-Merrell executives were looking forward to their Christmas bonuses so that they could buy nice presents for the kids. You can’t blame them. They are only human. They wanted the drug to be approved. And they were annoyed that it didn’t happen.”

“In all fairness to Merrell, they didn’t have the imagination to think what it might do. It had never happened before. It had been known that women who were chronic alcoholics often gave birth to deformed or sickly babies. But the idea that a drug that was apparently an innocent analgesic could have these inconceivably awful effects was totally new to medical history.”

Although many women, including Frances Kelsey, had an instinct that they should not take any drugs while pregnant.

“We have to be careful here. That instinct was not that widespread at the time. Frances herself had said that she wouldn’t take anything like this when she was pregnant herself.” 

“But it was a time when women were seen as being a bit thick. It was a different kind of world where men told women what to do. At one level, it was a battle of the sexes. As far as I’m aware, there wasn’t one female executive at Richardson-Merrell.” 

“They didn’t like that idea that not only was the FDA delaying their application, not only was it a junior official denying their application, but it was a woman official as well.”

You mentioned a Hollywood movie. Where is that?

“All I can say at the moment is that it is with a very prominent well known movie agency in the United States. She is taking it to a number of female writers for the screenplay and female actresses. I have no aspirations to write the screenplay myself.” 

Who would you like to see play Frances Kelsey?

“I would like to see Anne Hathaway play Frances Kelsey. We need an actress who can tether a wide range of ages. But many actresses could do a very good job of playing her.”

[For the complete Interview with James Essinger, see 34 Corporate Crime Reporter 47(11), Monday December 7, 2020, print edition only.]

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