Frankie: The Woman Who Saved Millions from Thalidomide

The Woman Who Saved Millions from Thalidomide

James Essinger, Sandra Koutzenko

• Publisher: The History Press
• Year: 2019
• Print ISBN:
  9780750991919
• eBook ISBN:
  9780750991926
• Topic: History
• Subtopic: 20th Century History
• Index: History

Thalidomide: patented in Germany as a non-toxic cure-all for sleeplessness and morning sickness. A wonder drug with no side effects. We know differently now. Today, thalidomide is a byword for tragedy and drug reform – a sign of what happens when things aren't done 'the right way'. But when it was released in the 1950s, it was the best thing since penicillin – something that doctors were encouraged to prescribe to all of their patients. Nobody could anticipate what it actually did: induce sleeping, prevent morning sickness, and drastically harm unborn children. But, whilst thalidomide rampaged and ravaged throughout most of the West, it never reached the United States. It landed on the desk of Dr Frances Kelsey, and there it stayed as she battled bureaucracy, patriarchy, and the Establishment in an effort to prove that it was dangerous. Frankie is her story.

1

AGNES DONNELLON’S NEW BABY

________________________

A photograph on the Facebook wall of Kevin Donnellon, who was born on Tuesday, 28 November 1961, at Walton Hospital near Liverpool in north-west England, shows him taking his daughter Daisy for a walk. These days Kevin prefers to be called Kev. A handsome fellow with stubble and an impressive wide-brimmed black top hat, he looks jaunty and happy in the photo. Daisy, who was five years old when the photo was taken, has just been eating candy and is wiping her mouth with the back of her hand. In many ways, they are like any other father and daughter going for a walk on a sunny spring afternoon.

Except that Kev can’t walk and never has been able to. In the photograph, Kev proceeds down the road in his powered wheelchair, and Daisy stands on the wheelchair behind him, hitching a ride.

Today, Kev is a cheerful, witty, ebullient fellow with a loving and devoted able-bodied wife, Angela, who gave birth to the Donnellons’ second child, Ollie, in August 2016.

Kev can’t walk because, when he was born – in addition to the fact that he was deaf in his right ear – the long bones in his arms and legs hadn’t developed. This was due to his mother, Agnes, having taken, over several days, five tablets of a medicine branded Distaval, which was really a drug called thalidomide. Agnes started taking it soon after she knew she was expecting a baby, because she was suffering from morning sickness.

Kev’s condition is known in the medical profession as ‘phocomelia’. It derives from the Ancient Greek words phoke (‘seal’) and melos (‘limb’), and so in effect describes children born with this condition as ‘seal-limbed’. This cold medical designation is not, of course, much help to the people who live their lives suffering from this problem.

Normally, phocomelia occurs in about one in every two million births. Most doctors never see a single case in their entire careers. But in the late 1950s and early 1960s, thalidomide led to a horrible epidemic of phocomelia in every country where the drug was sold, until the reason for the epidemic finally dawned on doctors and pharmacologists around the world.

One reason why it took so long to determine that thalidomide was the cause of these appalling deformities was that the drug was branded under so many aliases: Distaval in the UK and Contergan in West Germany, to name only two. In the United States, the intention was to use the brand name Kevadon: it was a bizarre coincidence that the US brand name contained the first name and the first three letters of the surname of a man who was to become one of the highest-profile casualties of thalidomide in the UK.

Kev Donnellon is two feet six inches tall. On his right shoulder he has a hand consisting of three fingers. Attached to them is a tiny useless digit he cannot move. On his left shoulder he has a hand consisting of just two fingers. Attached to the bottom of his trunk are no legs at all. Instead, two perfectly formed feet, each with one big toe and four small ones, grow directly out of his trunk. When Kev was born, his feet were bent upwards, with the heels resting on the floor when he was sitting upright. Kev has become adept at using his feet. He can pick things up with his right foot and even draw with it.

Agnes Donnellon takes up the story. She related it to the makers of a World in Action British television documentary about Kev first broadcast in 1971. Several successive episodes were made about Kev as he grew up.

On camera, in that first episode, Agnes explained what had happened late in the evening of Tuesday, 28 November 1961, a few hours after her son was born at Walton Hospital:

A sister came round to the ward at about eleven o’clock in the evening. I thought it was very odd when she came over to my bed and she asked me, did I smoke? I thought it was very strange for her to ask me that at that hour of the night. I said yes I did, and she gave me a cigarette, which I practically choked on, and then she said ‘How do you feel?’ … I said, ‘Oh, fine, I think.’ Then she said, ‘I’m terribly sorry, but I have to tell you that you have a little boy, he has a lovely face … ‘ – which he had – ‘but he’s got very tiny arms and legs.’

Of course I looked at her. I thought she meant they were perfect arms and legs, but that maybe he was a midget. I said, ‘Oh.’ I didn’t really know what else to say … I couldn’t really imagine he was like he was. It’s just that she said small arms and legs and then she gave me a sleeping tablet, and that was it … When I woke up the next morning, I thought I had dreamed all this, and I couldn’t imagine what she meant.

Anyway, the doctors came the next day to tell me exactly what was the matter with him, which was he had no arms or legs, but two fingers on the left shoulder and three little fingers on his right shoulder, with two little feet attached to his bottom. They asked me would I like to see him, but I didn’t feel I was fit enough then anyway, and I don’t think I really wanted to see him at the time.

Agnes Donnellon continues:

Of course I used to ask about [how] the baby was, and they used to say he was doing fine, but they didn’t really hold much hope of him living anyway, because they thought he would have about three months to live at the most. So just before I was due to come out of hospital – it was nearly Christmas – they asked me if I would like to see him, so I thought I would anyway. So I went down in a wheelchair to have a look at him … They just took the bedclothes back, and then of course I realized, you know, what I had imagined, but he was worse than what I had imagined. It was a terrible shock, of course. I came out of there and collapsed.

A nurse came over to me and said, ‘I wouldn’t take him home because you couldn’t possibly look after him. I would advise you to leave him here and just go home to your family.’ Well, after she said that, with me having four children, my mother instinct sort of came up … I didn’t think she had any right to tell me what to do with my child, so I got in a temper. ‘No,’ I said, ‘I’ll take him home. I want to take him home even if he’s only going to have three months to live because, after all, he’s my son.’

I had four other children, so why should he be treated any differently? So we brought him home.

The story of thalidomide changed forever how the world saw medicine. The story is also a painful example of corporate greed at its worst. When the truth about what thalidomide could do to the unborn baby broke, the name of the drug became a word that terrified pregnant women outside the United States, many of whom – sometimes, tragically, with justification – feared that they had taken thalidomide in the early stages of their pregnancy to counteract morning sickness.

In the countries where the drug was allowed to be marketed, the disaster was compounded by the drug corporations’ subsequent haughty indifference to compensating the legion of thalidomide-disabled children. Eventually, compensation was finally paid in some countries, although grudgingly, and in several other countries it wasn’t paid at all. The drug companies who had sold thalidomide often claimed that what happened was an accident for which they were not responsible, which was a preposterous argument.

In Britain, for example, only a national campaign by The Sunday Times in the 1960s, initiated by the editor Harold ‘Harry’ Evans (now Sir Harry) followed by a nationwide customer boycott of the Distillers Company’s products, forced the corporation to pay compensation to Distaval’s victims. In several countries affected by thalidomide there has never been a payout for thalidomide victims at all. In Spain compensation was not awarded until 2013, following a ruling against the German manufacturers.

Other brand names used around the world for thalidomide – which was so potent a teratogenic agent (that is, interfere with the development of the embryo and cause malformation) in humans that it could cause embryonic deformities even if a pregnant mother took only one tablet – included the almost deliberately sinister CC47, and also Actimid, Asmadion, Calmorex, Corona-Robetin, Gastrinide, ImiD 3, Imidene, Profarmil, Quetimid, Quietoplex, Sedimide, Sediserpil, Sedoval K-17, Theophyl-Choline, Ulcerfen, Valip, Softenon, Thalomid, Immunoprin, Talidex, Talizer and Neurosedyn.

According to Dr John Swann of the FDA, there were eighty-nine different brand names for thalidomide worldwide. The drug had far more aliases than any double agent, yet behind its sinister mask, the active ingredient was always the same. When the real side effects of the drug gradually started to become clear, considerable delay in identifying the culprit was caused by the fact that thalidomide had been sold under so many different pseudonyms around the world.

Globally, in the late 1950s and early 1960s, about 100,000 unborn babies – the actual number will never be known for certain – were affected by thalidomide. About half of these died in the womb or a few days after being born. Worldwide, about 50,000 children were born with defects attributable to thalidomide. We estimate that if the drug had been approved by Frankie for distribution, at least another 100,000 thalidomide-affected children would have been born in the United States, and that half as many again would have died.

The devastating effect on these children’s families can be imagined only too easily. In many respects, Agnes Donnellon’s response was comparatively mild. Many parents abandoned their thalidomide-affected babies completely, left them in institutions, and made only occasional visits – or worse, never tried to see them again. Another factor which made this even more difficult for the families was that thalidomide babies were born for up to five years before the cause was known for certain. Parents had no idea whatsoever what had gone wrong.

Mothers and fathers – mothers especially – blamed themselves for what had happened. Once the cause was known, parents felt even guiltier than they already did about what had happened to their child. Many families split up as a result of the stress, misery and guilt, and there were suicides among fathers as well as mothers. All were traumatized for years; many never recovered.

Despite Frankie’s intervention, it is not the case that there were no victims of thalidomide at all in the United States. There were a total of seventeen victims, not due in any way to Frankie being less than diligent in her work but to the fact that, in the early 1960s, bizarrely enough, pharmaceutical companies were allowed to distribute untested drugs to doctors so that the doctors could try them out.

Each one of those seventeen cases of thalidomide in the United States was a disaster, just as every other case was anywhere in the world. Yet, without Dr Kelsey, the thalidomide tragedy in the United States would have been exponentially greater than what it was.

There is no safe way of testing a drug to see if it damages the unborn child. It’s not as if there is some spectrum of chemical formulae within which a drug is likely to cause teratogenic effects. Even now, the mechanisms which lead some drugs to cause damage to unborn children aren’t fully understood. But the natural processes that must occur in order for a fertilized egg to divide sufficient times and develop so that, nine months later, it becomes a fully developed baby are of such complexity that they defy human imagination. It’s not surprising that many artificial compounds – as well as some natural ones – can negatively interfere with the process. Today the concern for possible damage to an unborn child is, quite reasonably, so great that during pregnancy mothers are advised to avoid any medicine at all except what is absolutely essential, and the only medicines that can be safely given during pregnancy are those which anecdotally have shown themselves to be safe.

This approach to medicine and pregnant women is a relatively recent development in the medical industry. In the past, which tragically includes the early 1960s, there was less concern for the effect which artificial substances might have on the unborn child.

This was partly because the idea that drugs could cross the placental barrier – the barrier through which substances, such as nutrients and oxygen, are transferred between the mother and the unborn child – was a relatively new idea, even though it has been known since the nineteenth century that an alcoholic woman could give birth to a malformed child.

The situation wasn’t helped by the way women were seen in the 1950s, 1960s, and even well into the 1970s. It was a widespread notion, at the time, that women were inferior to men. Men liked to think that they knew better in all matters, and that women should listen to them and be guided by them. This extended to topics pertaining to women’s health.

Sadly, even today, this notion hasn’t entirely disappeared. Recent research shows that, in hospitals, women’s physical pain is taken much less seriously than men’s (particularly when male doctors are involved). As a result, severe chronic conditions are significantly more often misdiagnosed in women: their symptoms, no matter how serious, tend to be dismissed as ‘emotional symptoms’.

It may seem a far-fetched hypothesis that the way women were seen at the time would have had an impact on how the thalidomide disaster unfolded, but it isn’t. If you look, for example, at television advertisements from the 1960s – and from the 1970s, and even later – for washing machines, the scientific-looking man, often wearing the white coat of the scientist, is contrasted with housewives portrayed as, at best, ignorant of the best laundry detergent to use and, at worst, just ignorant period. These ludicrous ads were strangely popular with women as well as men.

We even find evidence of this attitude in the most unexpected places, such as the otherwise excellent movie The Sound of Music released in 1965. A movie that has become iconic, it is about the effects on a repressed Austrian family of a life-loving and rather erratic governess, Maria, famously played by Julie Andrews. The first part of the movie, up to the point where Maria gets married, shows with great emotional conviction and many wonderful songs, how Maria changes the lives of the children and their father, Baron von Trapp. Maria’s infectious enthusiasm for life, for music, and for communicating her wonder to the children fills the screen and our hearts.

What is curious about the second part of the film is that, while it remains dramatic, Maria as a character is treated very differently. After she falls in love and then marries the baron, when they return from their month-long honeymoon, Maria is a completely different person. She is quieter, more thoughtful, less impulsive, less imaginative, and less romantic.

There is a clear implication – although probably not intended consciously by the screenwriter and filmmakers – that Maria has been ‘tamed’ by being married and sexually possessed by the baron. Again, this is a s...

Table of contents

• Cover
• Title
• Copyright
• Contents
• Authors’ Note
• Foreword by Sir Harold Evans
• Prologue
• 1 Agnes Donnellon’s New Baby
• 2 The Doctor’s Letter
• 3 Medical Miracles
• 4 The Birth of Thalidomide
• 5 The Advent of Frances Oldham
• 6 Heading toward a Vocation
• 7 Tragedy and Focus
• 8 Marriage and Motherhood
• 9 A New Recruit at the Food and Drug Administration
• 10 The Thalidomide New Drug Application
• 11 The Battle Rages
• 12 Aftermath
• 13 The World Starts to Recognize a Heroine
• 14 The Canadian Experience of Thalidomide
• 15 Fresh Honors
• 16 Last Days
• Epilogue
• Appendix 1 ‘Safety of Drugs during Pregnancy’ by Frances O. Kelsey, PhD, MD
• Appendix 2 Dr Frances Oldham Kelsey’s Curriculum Vitae
• Appendix 3 Publications by Dr Frances Oldham Kelsey
• Appendix 4 Two Letters to Physicians from the Wm. S. Merrell Company
• Acknowledgements