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In 1960, in her first month at the US Food and Drug Administration, Frances Oldham Kelsey was asked to approve the sedative thalidomide. She found the safety data thin and held out for more than a year despite company pressure. The drug, soon linked to severe birth defects, was never sold in the US as a sedative.

Frances Oldham Kelsey

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The story behind the card

Kelsey was a Canadian-born pharmacologist and doctor; in 1938 she earned the University of Chicago's first PhD in pharmacology. At the FDA she was one of only seven full-time physicians reviewing new drugs. The maker, Richardson-Merrell, pressed her repeatedly, but she kept asking for more evidence. By late 1961 doctors in Germany and Australia had linked thalidomide to severe birth defects, and in March 1962 the company withdrew its application. Even so, experimental tablets had already been given to thousands of American patients. In August 1962 President Kennedy gave Kelsey the President's Award for Distinguished Federal Civilian Service, only the second woman to receive it, and that October Congress passed the Kefauver-Harris Amendment, tightening US drug law. Decades later, in 1998, the FDA approved thalidomide under strict controls to treat a painful complication of leprosy.

Türkçe oku
Frances Oldham Kelsey'den, ABD Gıda ve İlaç Dairesi'ndeki (FDA) ilk ayında, 1960'ta, talidomid adlı sakinleştiriciyi onaylaması istendi. Güvenlik verilerini yetersiz buldu ve şirket baskısına rağmen bir yılı aşkın süre direndi. Kısa süre sonra ağır doğum kusurlarına yol açtığı anlaşılan ilaç, ABD'de sakinleştirici olarak hiç satılmadı.

Kanada doğumlu Kelsey hem farmakolog hem hekimdi; 1938'de Chicago Üniversitesi'nin farmakoloji alanında verdiği ilk doktora unvanını almıştı. FDA'da yeni ilaç başvurularını inceleyen yalnızca yedi tam zamanlı hekimden biriydi. Üretici firma Richardson-Merrell onu defalarca sıkıştırdı, ama Kelsey her seferinde yeni kanıt istedi. 1961'in sonunda Almanya ve Avustralya'daki hekimler talidomidi ağır doğum kusurlarıyla ilişkilendirdi; firma da Mart 1962'de başvurusunu geri çekti. Buna rağmen deneme amaçlı tabletler binlerce Amerikalı hastaya çoktan verilmişti. Başkan Kennedy Ağustos 1962'de Kelsey'ye Seçkin Federal Sivil Hizmet Başkanlık Ödülü'nü verdi; bu ödülü alan ikinci kadındı. Aynı yılın ekim ayında Kongre, ilaç denetimini sıkılaştıran Kefauver-Harris Yasası'nı kabul etti. FDA talidomidi ancak onlarca yıl sonra, 1998'de, cüzzamın ağrılı bir komplikasyonunu tedavi etmek için sıkı denetim şartıyla onayladı.

Sources and further reading

Background reading: Frances Oldham Kelsey
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