The Food and Drug Administration in the USA is under pressure to speed up drugs that may be helpful in the treatment of COVID-19. Remdesivir, originally approved for Ebola, may be helpful, as may the malaria drugs chloroquine and hydroxychloroquine. However, the safety / efficacy profile of these drugs needs to be clarified before they are used on a large scale to treat a disease for which they have not been studied. At this time, it is instructive to reflect on the situation that has given the FDA the authority to regulate drugs. This takes us back to 1938 and the passing of the Foods and Drugs Act.
In 1937, the little girl’s parents took her to the doctor because she had a sore throat that would simply not go away. Say “Ahhhh”, said the doctor and quickly diagnosed a streptococcus infection. “Do you like raspberry syrup?” he asked? “Sure!” And with that, mother and daughter went to the local druggist to fill the prescription for elixir sulfanilamide.
The doctor did not expect to see this patient again, since sulfanilamide, which had been introduced a few years earlier, had proven its value not only against sore throats, but also against gonorrhea and meningitis. In many cases the doctor had prescribed sulfanilamide in the form of powders and pills with excellent results. But children had never liked to take pills and he was glad that someone had finally come up with a delicious sweet syrup that would make the medicine go down easily. Elixir sulfanilamide did just that. It also killed little Joan.
Death had not come quickly. There were days of vomiting, excruciating stomach pains and cramps. When the suffering finally ended, a distraught mother wrote to President Roosevelt: “Even the memory of my little girl is mixed with grief, because we can see her little body twirling back and forth and hear this little voice screaming in pain. It is my request that you take steps to prevent the sale of such medicines that cost little in the way of life and leave so much suffering and such bleak prospects for the future as I have tonight. “
President Roosevelt heard this plea and took action. Because this was not the first such case to have been brought to his attention. The Food and Drug Administration had informed him that Elixir Sulfanilamide was responsible for over a hundred deaths. A single doctor reported the deaths of six of his patients, including his best friend. In a heartbreaking letter to the FDA, he described his mental and emotional anguish at having innocently prescribed a deadly drug.
How could such a dangerous drug come onto the market? Easy. Incredible as it may seem now, drugs could be marketed without any kind of testing. Of course it was not in the interest of a company to sell harmful substances, but there were no legal safety requirements. This had to change, Roosevelt decreed, and within a year the Food and Drug Law of 1938 became law. Manufacturers would now have to obtain government approval to sell a drug and obtain such approval. They would have to prove that the product was safe. They still did not have to show that the drug was effective! This demand was only made in 1962 after the tragedy of Thalidomide. It is important to learn from the past and ensure that medicines are not put on the market without sufficient testing.