By James Essinger – Most people in the United States today have never heard of the drug thalidomide, but they ought to know the danger they escaped.
In early September 1960, the Cincinnati-based drug company Richardson Merrell launched a New Drug Application at the United States Food and Drug Administration (FDA) to gain approval for a drug called Kevadon.
In the last week of November 1961, Merrell withdrew this application because thalidomide had been banned worldwide. Dr. Frances Kelsey – or ‘Frankie’ as she was known to her colleagues, friends and family – was the heroine of the FDA who prevented Merrell from distributing ten million Kevadon tablets into the bloodstreams of pregnant American women.
Kevadon was the brand name for a drug called thalidomide, which had been developed in the 1950s by a German drug company (with Nazi roots) called Grünenthal. By the time Kelsey found herself – a junior official at the FDA in the autumn of 1960 – considering whether she ought to approve the thalidomide application, the drug had already been extensively distributed in forty different countries.
Grünenthal and its distributors such as Merrell, believed that thalidomide was a “wonder drug” that not only had potent pain-relieving properties but was also impossible to overdose on, not a trivial consideration in the early 1960s, when accidental deaths through barbiturate overdose were relatively common.
Kelsey’s concerns about Kevadon became more pronounced when she looked into the way that Merrell was attempting to get the drug approved. She continually found fault with the clinical evidence that suggested the drug was safe.
Merrell became increasingly infuriated that a junior official at the FDA – and a woman at that; it was a time when women were often seen as secondary to men in every respect – was inhibiting their plans to sell their wonder drug throughout the United States and bring its benefits to millions of suffering women.
A medical executive, Dr. Joseph Murray, who was chosen by Merrell to be their principal contact with the FDA, soon found it impossible to keep his frustration out of letters he sent her. Kelsey was frustrated herself, in a calmer and professional way with Merrell’s unwillingness to comply with the FDA’s New Drug application approval requirements.
Murray used a variety of special pleading techniques including personal representation and, on several occasions, trying to go above Kelsey’s head was an increasing feature of the conflict between Frances and Merrell over Kevadon between September 1960 and November 1961. Merrell evidently regarded Kelsey as being unreasonable in delaying their application.
Kelsey became aware that thalidomide was known to cause the condition called peripheral neuritis – a painful tingling of the extremities of the body – which Merrell and Grünenthal acknowledged were sometimes due to thalidomide but they insisted that once thalidomide was no longer taken the symptoms would disappear, however this was usually not the case. In May 1961 – Kelsey began to wonder what effects Kevadon would have on an unborn child if it caused peripheral neuritis in a mother.
Kelsey’s sudden anxiety that thalidomide might have a disastrous effect on unborn children was a consequence of her extensive medical training. She immediately communicated her anxiety to Murray, who brushed it off as another unreasonable suspicion by this troublesome woman and assured Kelsey that there had never been a case in any of the countries where thalidomide was approved for distribution where a child had been born with any deformity or any other health problems caused by thalidomide.
By May 1960 several thousands of babies had been born in the countries where thalidomide was approved. Altogether, about ten thousand babies were born with thalidomide-associated deformities. Half of these babies were stillborn, some were born with brain damage, blind or deaf but the primary symptom was a condition called phocomelia, where the long bones of either the arms or the legs did not develop properly or at all. Babies were born with very short arms and legs or none at all, their hands and feet attached directly to the body.
For the next six months Merrell continued its war against Kelsey until finally, November 1961, a Doctor William McBride in Australia reached the conclusion that numerous cases of children born deformed in Australia were caused by the mothers having taken thalidomide. This evidence was accepted among the global medical community, and the drug was withdrawn, though not before about ten thousand babies had either died or been born with a wide range of horrific deformities due to the drug.
Kelsey’s story was made known to the world through an article by the science journalist Morton Mintz in the Sunday edition of The Washington Post on July 15, 1962 under the headline ‘Heroine of FDA keeps bad drug off market’.
His article initiated a chain of media recognition that led, on Tuesday, August 7, 1962 to President Kennedy presenting Kelsey with the prestigious President’s Award for Distinguished Federal Civilian Service.
Shortly afterwards, the US Congress unanimously passed into law tougher federal controls regulating the safety of pharmaceutical drugs. Dr. Frances Kelsey spent thirty more years at the FDA improving their processes.
Sir Harry Evans, the famous editor of The Times, wrote to Kelsey for her one-hundredth birthday:
You are only 100 but you saved many, many hundreds of thousands of your fellow human beings from cruel lives and early deaths… your heroism was two-fold: one, in your insistence on the primacy of scientific evidence; two, in your courage in the face of incessant pressure from powerful interests… by your integrity and your courage, you also testified to the endurable virtue of truth.
Ironically, the very word ‘thalidomide’ is much less well-known in the US than in the countries of the world where it was permitted, precisely because Dr. Frances Kelsey was so successful at keeping it out of the US.
About the author: James Essinger and Sandra Koutzenko are the co-authors of Frankie: How One Woman Prevented a Pharmaceutical Disaster published on April 15, 2019 by Wellspring and available as a hardback and an ebook.