Thalidomide tragedy: Lesson learned in the past

Abstract

Thalidomide disaster was one of the biggest disasters in pharmaceutical industry. Since mid fifties of the twentieth century, more than 10.000 children have been born with stunted arms and legs, and damaged internal organs. Today, many questions sill stand: Was the tragedy preventable? What were the main reasons for borning more than 4.000 thalidomide children in West Germany, and 17 in United States? We tried to answer these questions, by comparing thalidomide stories in West Germany and United States. In West Germany, law regulations were very flexible. Federal Health Office registered new drugs, but had no authority to withdraw a drug that was approved dangerous on the market. Analyzing the stories he heard from his patients and colleagues, pediatrician dr. Widunkind Lenz realized that Contergan® (brand name for thalidomide) was responsible for birth defects. Pharmaceutical company, Chemie Grünenthal developed thalidomide, but re- fused to withdraw drug from the market. It took years, until the trial started. Dr. Lenz was dismissed from trial, as biased. As a result of two years long trial, company and federal government established the fund for children injured by Contergan®. In United States, pharmacologist dr. Frances Kelsey had been employed in Food and Drug Administration (FDA). She was the one who received a new drug application for thalidomide. Realized that application was in- complete, she refused to approve application. Unlike dr. Lenz, law regulations and FDA stood behind her. Thalidomide has never been approved in United States, and Dr. Kelsey was promotioned. She was also awarded for preventing thalidomide to reach the market. By comparing these stories, we realize how are important ethics and regulations in approving new drugs and their withdrawing.

Talidomidska tragedija, sa preko 10 000 novorođenčadi sa oštećenim ekstremitetima širom sveta, predstavlja jednu od najvećih katastrofa u istoriji industrije lekova. Iako je od početaka ove priče prošlo gotovo pola veka i dalje stoji pitanje da li je i kako, bilo moguće sprečiti katastrofu? Uporednom analizom okolnosti pod kojima se tragedija dešavala u Sjedinjenim Američkim Državama (SAD) i Zapadnoj Nemačkoj u ovom radu je pokušano da se utvrdi da li su poštovani etički principi tokom uvođenja ovog leka u terapiju i koliko su zakonski propisi u oblasti registracije lekova doprineli da se u SAD rodi 17 dece sa anomalijama, naspram 4.000 dece u Zapadnoj Nemačkoj. Prema zakonu o lekovima u Zapadnoj Nemačkoj, procesi licenciranja, registracije i pojavljivanja leka na tržištu, bili su u nadležnosti Državnog zdravstvenog zavoda. Ipak, eventualno povlačenje leka sa tržišta niko nije mogao narediti. Pedijatar dr. Widukind Lenz je prvi ukazao na povezanost upotrebe talidomida kod trudnica i pojave malformacije na fetusima. Zbog manjkavosti u zakonskoj ragulativi, Contergan® (talidomid) je tek posle dugo vremena povučen iz terapije, a dr. Lenz je degradiran i kao stručnjak i kao čovek. Ishod sudskog procesa protiv farmaceutske kompanije bio je osnivanje fondacije za decu oštećenu talidomidom. U SAD-u su i zakon i Agencija za hranu i lekove (FDA) stajali uz dr. Frances Kelsey, koja je sprečila registraciju talidomida bez izvršenih kliničkih ispitivanja. Uporednom analizom talidomidskih priča u ove dve zemlje može se zaključiti da su pri uvođenju novog leka u terapiju, pored poštovanja strogih zakonskih propisa, neophodni savest i odgovornost pojedinaca u institucijama koje u tom procesu učestvuju ali i samih farmaceutskih kompanija koje lekove registruju.