At the end of the 1950s, an alarming number of babies were born with malformed limbs and organs.
Initially, nuclear weapons tests were thought to be the cause of the birth defects then it was found that it was thalidomide, which was prescribed during pregnancy. So in 1961, thalidomide’s Germany-based manufacturer Grünenthal withdrew the drug from the market.
The Thalidomide Scandal, which is probably Germany's biggest drug scandal, affected people around the world.
Regulating the drug
In 2007, decades after thalidomide had been withdrawn from the German market, the EU approved its use for treating multiple myeloma – a form of bone marrow cancer.
The US, which had demonstrated the effectiveness of thalidomide earlier, approved its use in the 1990s under certain conditions. The drug was never approved as a sedative in the US, so it caused fewer problems there
The situation in Latin America could not be more different from the US. Thalidomide has been used nearly continuously since the drug was launched in the 50s. It has been mostly used to treat leprosy, which is still prevalent in poor countries.
In Brazil, a number of children were born with defects in the mid-1960s. And close to 1,000 people have been born with the Thalidomide syndrome since then.
Warning label not understood
Several illiterate people misunderstood the warning symbol of a crossed-out pregnant woman, says Claudia Marques Maximino, President of the Brazilian Association of Thalidomide Syndrome Victims (ABPST).
"They thought it was an abortion drug," she notes.
The tragedy of this fatal mistake, says the physician Lavínia Schüler-Faccina, "is that women taking the drug during the early stages of pregnancy are doing so at the only time a threat exists to the fetus."
A single 50-milligram pill contains enough active ingredients to cause serious birth defects.
Schüler-Faccina coordinates the information service "Safe Pregnancy" For the Brazilian government. And she researches thalidomide and its effects on embryos at the University of Porto Alegre. Her work includes documenting the birth of children with malformations and to distinguish these from similar looking gene defects.
"We want to understand exactly how the substance affects the unborn child in order to develop even better precautionary measures," she says.
She hopes that a safer drug can be developed.
The benefits of Thalidomide
In addition to treating leprosy, thalidomide is a good drug for treating the symptoms of chronic diseases like AIDS and spinal cord cancer, Schüler-Faccini says.
And unlike other sedatives, it is only toxic in extremely large amounts
"With the proper doses, thalidomide has almost no side effects, but the one effect, which has a direct impact on a developing baby is so serious that administration of the drug must be strictly controlled," she notes
Maximino, who was one of Brazil’s first thalidomide victims, agrees.
She knows that the drug is the only possibility to relieve symptoms for many chronically ill people.
"In developed countries, there are other medications, especially for AIDS patients," she says.
"But these are too costly in Brazil and other poorer countries. And leprosy occurs especially poverty prevails," she adds.
Strict regulations key
That is why Maximino has been advocating for stricter regulations for years – including the education of patients on the dangers of thalidomide, no administration of the drug to women of childbearing age, a register for physicians who prescribe the drug and patients who receive it, and criminal charges anyone who misuses the drug.
"Unfortunately, we have to expect that compensation payments tempt some people to intentionally harm their children," she says.
Last year, Brazilian lawmakers met the Maximino’s demands.
Maximino and the Association of Thalidomide Syndrome Victims played a major role in ensuring that tougher legislation was passed," Schüler-Faccini says.
"But the risk is still high – about four million tablets are administered annually," she adds.
So Maximino continues to wrangle with authorities.
"Actually, the rules need to be tailored to the very different realities in Brazil," she says.
In 2010, one child was born with the thalidomide syndrome in Brazil but India, with a population six times larger, has not recorded a case in years.
"The best thing would be to administer the drug in hospitals as they do there," Maximino says.