In 1957, a drug, produced by the German drug company Grunenthal, was released following the drug safety trials normal for that time. The drug had been tested on rodents and seemed to be safe. It was marketed as a sedative and anti-emetic and, as such, was prescribed to pregnant women in many countries around the world. The drugs name has become well known for the tetragenic syndrome it caused. The world was to become all too aware of Thalidomide.
To many pregnant women suffering through morning sickness the drug Thalidomide seemed a blessing it eased their symptoms and also allowed a good nights sleep. However, the blessing turned into a nightmare as children started being born with severe birth defects.
The most common and obvious was the shorted limbs known as phocomelia, which comes from the Greek and means seal limbed. In this condition, the long bones of legs or arms are shortened or missing. The hands and feet of the affected limbs appear flipper like. Children could be born with any number of their limbs affected by this condition. Other conditions seen were the addition of small vestigial extra limbs and occasional mental disorders.
As the number of children born with these defects increased, Thalidomide was eventually implicated as a possible cause. At this point further animal testing was carried out using primates and rabbits instead of rodents. The young of the new set of animals were born with similar defects as the children. Therefore, the name Thalidomide children was given to the innocent victims of the drug.
An estimated 12,000 children were born with this condition worldwide. Most of those births occurred in Europe and Africa. The drug may have also been responsible for numerous miscarriages as well but this cannot be proven.
The United States was fortunate to have Frances Kelsey reviewing the drug for FDA approval. As the drug was freely available around the world, approval was expected. However, she decided insufficient testing had been carried out and FDA approval for the drug was not granted. As a result, only seventeen Thalidomide babies were born in the States these resulting from drugs imported from other countries outside of government approval.
Once the drug had been shown to be tetragenic the manufactures withdrew it from use and investigations on how it caused damage to the children began. Research found that Thalidomide acts by targeting blood vessels leading to areas that are undergoing growth. If the mother took the drug at the time that a fetal limb was growing, then the blood flow to that limb would be restricted and the limb disfigured.
Closer examination on the chemistry of Thalidomide showed that is existed as two isomers. One was the mirror image of the other. This led to the discovery that the R-isomer was responsible for relieving morning sickness while the S-isomer caused birth defects. Unfortunately, even if the medication were formulated just to contain the R-isomer it would revert to having both present in the body of the patient.
The tragedy has not stopped with the generation of children born in the late ’50s and early ’60s. Children born to Thalidomide affected adults have a five times higher rate of limb deformities than the general population.
Thalidomide is available on prescription for certain life threatening conditions. It is proving an effective treatment for certain cancers. It is also aiding patients suffering from leprosy. Other conditions that have benefited from its use are Chron’s disease and the weight loss associated with AIDS. While wishing such patients to benefit from the drug members of organizations for Thalidomide affected patients wish the drug to remain known as Thalidomide and not given a new trade name.
Since the Thalidomide tragedy drug, testing protocols particularly for drugs for use by pregnant women, have quite rightly, been improved.
The children affected by the drug are adults now, it is a credit to them and to their parents how well many of them have coped with their disability, many reaching the top of professions around the world.
In 2012, Harald F. Stock, PhD the Chief Executive of Grunenthal gave a speech at the Thalidomide-Memorial inauguration in Stolberg/Rhineland. In this speech he expressed the company’s regret for the problems caused by the drug thalidomide.
