From far left: Joan Nidiffer, the six year old killed by the medicine; a bottle of elixir sulfanilamide; Frances Kelsey, seen here in the 1930s helping Dr EMK Geiling; President Roosevelt


and aſter some political horse-trading it was passed and Roosevelt signed it into law in 1938, eight months aſter the first ‘elixir’ deaths. Te resulting Food Drug and Cosmetics


Act of 1938 has been described as “one of the most important regulatory statutes in American and perhaps global history.” It created a new legal category: the ‘new drug’ and authorised the FDA to serve as gatekeepers for such compounds entering the market place. Tus, the FDA acquired greater status and considerably sharper teeth, with pharmaceutical companies now compelled to work in a new landscape of greater scrutiny and transparency. Kelsey’s involvement in the 1938


“It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind…”


sulfanilamide or the solvent. Geiling later published these findings showing conclusively that the solvent was the culprit, confirming a number of previous papers. Tus the literature, even in 1937, could have been used to highlight the toxicity of diethylene glycol, but Massengill denied any responsibility. Te company owner, said: “My chemists


and I deeply regret the fatal results, but there was no error in the manufacture of the product. We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part.” While this may have been true from a


strictly legal perspective, perhaps not all of Massengill’s staff agreed with this abrogation of any moral responsibility. Indeed, the 108th death as a result of the tragedy was the company pharmacist, Harold Watkins, who had first proposed the use of diethylene glycol. He committed suicide in January 1939.


New regulation Medicines at the beginning of the 20th century were almost completely unregulated. Te 1906 US Pure Food and Drugs Act had established penalties for


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adulteration and misbranding, but by the 1920s this legislation was increasingly thought unfit for purpose. In the 1930s new legislation had been proposed to strengthen pharmaceutical regulation, but by 1937 this had failed to make it through Congress. Te only legal charge that could be


brought against Massengill at the time was one of misbranding. Tey had labelled their product an ‘elixir’, but it contained no alcohol. For this they were fined a total of $26,100. If they had called their product a ‘preparation’ or a ‘solution’ they would have committed no crime at all, despite the death toll. Te powerlessness of the Federal Government to act, other than on the basis of such a trivial matter, was used in the argument to force through tougher legislation to control the future manufacture and sales of drugs. Te US Secretary of Agriculture


produced a report on the tragedy. His report included the Nidiffer letter and photo and set out principles that now form the basis of modern pharmaceutical regulation. Te report very much framed the sulfanilamide affair as an avoidable tragedy, and one that needed a change in the law to prevent its recurrence. Based on this report, the stalled bill was redraſted,


legislative reform was obviously peripheral, but she was at the centre of the laboratory work that confirmed the toxicity of the ‘elixir’. Twenty-five years later Kelsey recalled: “Te urgency of the situation, the intensive round-the-clock toxicologic studies and the subsequent changes in the law relative to the control of drugs could not, and did not, fail to make a deep impression on a graduate student such as myself ”. Te legislative journey that began in the US in 1938 would not end there. Troughout the 20th and into the 21st centuries this law which strives to create an environment that puts patient and public safety at the forefront would be amended many times. One of the most important legislative


changes still to come would be in 1962 in the marketing of a new drug to treat nausea in pregnant women – and this time Frances Kelsey would play the starring role.*


 Dr Allan Gaw is a clinical researcher and writer in Glasgow


* Go to Publications at mddus.com to read more about Frances Kelsey and the thalidomide scandal in the Summons Winter 2014 issue


SOURCES • Carpenter D. Reputation and power. Princeton University Press 2010


• FDA Consumer Magazine June 1981 & March-April 2001


• USDA, Report of the Secretary of Agriculture on Deaths Due to Elixir Sulfanilamide-Massengill, 1937


• Journal of Law, Medicine, and Ethics, 16: 3-4 (Winter 1988)


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