Thalidomide Research Paper

Margaux Brewer

Chemistry, p.4

1/12/15

The Thalidomide Tragedy

The continuous introduction of new drugs into the pharmaceutical world proves to have immense benefits to society’s treatment of medical issues, however it has also proved to cause disaster. A seamless example of the often terrible events that occur due to quickly advancing medicine is the disaster caused by the drug Thalidomide in the late 1950’s to the early 1960’s. Thalidomide was taken by thousands of pregnant mothers to battle symptoms of morning sickness. It is estimated that ten to twenty thousand babies were born with serious disabilities and physical defects due to this seemingly harmless drug. As researchers are finding new uses for the drug, controversy has arisen whether

it is ethical to continue using a drug that caused so much damage to our society.
Thalidomide was first created in Switzerland by the company Ciba, but it was never released to the public until 1954 by the company Chemie Grunenthal in West Germany. It first entered pharmacies as an over-the-counter sleep aid. Thalidomide was very popular because during a time of high demand for sleep aids, Thalidomide was the only sedative that was not a neurotoxin and did not have many side effects. The pharmaceutical was marketed as a narcotic, and had the ability to reduce brain activity and induce sleep. FDA approval was not required for the distribution of an over-the-counter drug before the Thalidomide disaster, so nearly 20,000 tablets were distributed to patients in the U.S for a “test” of the drug, however these patients were not well monitored so the effects of the drug were never properly recorded. Shortly after Thalidomide became popular as a sleep aid, obstetrician William McBride found that when he gave the drug to his pregnant patients, it greatly helped reduce the symptoms of morning sickness. When pregnant women took Thalidomide in their first trimester, it helped treat nausea and vomiting that were symptoms of morning sickness. Before it was banned, nearly 1 out of every 7 Americans took Thalidomide regularly.
Thalidomide was advertised to be “completely safe, even during pregnancy”.

It became known as the “wonder drug” that would stop morning sickness without any risk. It was only found to be extremely dangerous in 1961 when McBride began to notice that the severe birth defects that had appeared in the babies of his patients was linked to the taking of Thalidomide. It was then found that Thalidomide is a teratogen, or a factor that causes malformations of an embryo. “Before 1961, there was very little evidence for drug-induced malformations in humans. But in that year, Lenz and McBride independently accumulated evidence that a mild sedative, thalidomide, caused an enormous increase in a previously rare syndrome of congenital anomalies. Nowack documented the period of susceptibility during which thalidomide caused these abnormalities. The drug was found to be teratogenic only during days 34-50 after the last menstruation” (Gilbert, 2013, ch. 21). It was found that Thalidomide could cross the placental wall and into the fetus and cause malformations of the fetus. Although it is still unclear exactly how Thalidomide acts as a mutagen so that the babies are born disabled, and there are new theories being developed to this day of how Thalidomide works exactly to cause these malformations, it is obvious to scientists that it penetrated the placental wall and somehow entered thefetus. Thalidomide produced the most devastating effects when taken in the first trimester of pregnancy. The “Thalidomide babies” that survived were born with severe defects including blindness, deafness, cleft palate, and the most common deformity of a Thalidomide baby, phocomelia, which is malformation of the limbs, so that all four limbs are very short and flipper-like. The number of deformed babies born from mothers who took Thalidomide varies from source to source, however 10-20 thousand would be an accurate number. The Thalidomide disaster was most definitely a global issue because Thalidomide

was available in 46 countries and devastation occurred in all 46 of these countries. “A woman need only have taken one dose to produce children with all four limbs deformed” (Gilbert, 2013, ch.21).
Chemie Grunenthal stopped the manufacture of Thalidomide in 1961. By March of 1962, it was banned in most of the countries where it had been sold. In the United States, FDA inspector Frances Kelsey was praised by President JFK and American press corporations because she had prevented Thalidomide from being approved in the U.S. Kelsey had been suspicious about the lack of research done on the new drug, especially the lack of research on whether or not the drug could cross the placental wall and into a fetus. Frances is now honored as a hero across the globe for her actions to regulate the circulation of pharmaceuticals. The Thalidomide disaster sparked huge changes in the FDA’s safety laws. “By passing the Kefauver-Harris Drug Amendments Act in 1962, legislators tightened restrictions surrounding the surveillance and approval process for drugs to be sold in the U.S., requiring that manufacturers prove they are both safe and effective before they are marketed. Now, drug approval can take between eight and twelve years, involving animal testing and tightly regulated human clinical trials” (Fintel, Samaras, and Carias, 2009). In Germany, a government investigation took place which led to a criminal trial of 9 of the main people of Chemie Grunenthal in 1968. The trial was discontinued without anything established to pay the victims of Thalidomide back. Lawsuits were filed for nearly 50 years, but the victims of Thalidomide were left without any financial aid until finally Ken Youdale of the Australian Thalidomide Trust won a lawsuit in December of 2013. 89 million dollars was given to 100 victims of Thalidomide, but not nearly enough to cover for the 5,000 surviving victims in need of support. “No amount of money of course could ever do justice to the injuries thalidomiders have lived with all their lives” (Gordon Legal, 2013). The head of Grunenthal formally apologized to the victims of Thalidomide, 50 years after the tragedy.
Although it may seem that everyone is against the company Chemie Grunenthal and the use of Thalidomide, scientists are continuing to find more uses for Thalidomide in the medical world, and controversy has arisen for whether or not it is ethical to continue using the drug that caused so much damage to so many people. In 1964, a leprosy patient in Jerusalem was given Thalidomide as a painkiller when no other painkillers would work. Thalidomide worked. Researchers are still finding more uses for the drug that could save the lives of thousands. It has been used so far to also help AIDS-related symptoms and fighting some cancers. Today, the FDA approves Thalidomide for the use of treating Hansen’s disease and as a chemotherapeutic agent for patients with multiple myeloma. The “Thalidomide babies” still alive today are the most active in the issue of bringing Thalidomide back. In an article on the perspective of a person living with disabilities caused by Thalidomide, the author states “On the one hand, she has no desire to deny anyone a drug that might help them. On the other, she doesn’t want to see the birth of another generation of thalidomide impaired people” (Rix, 2007). Organizations of victims of Thalidomide such as the Spanish Association of Thalidomide Victims (AVITE) are cautious in allowing Thalidomide to return to the medical world. They feel that it is unethical to continue the use of the drug that impacted their lives so negatively, however they do support helping other patients. The perspective of medical researchers is that even though Thalidomide caused so much harm in the past, safety regulations have changed, and if it is prescribed extremely cautiously, Thalidomide should be available to patients in need. This is an issue of ethics because despite the implications of furthering medicine and helping save lives of thousands of patients, there are limitations such as the risk of causing another similar disaster due to the lack of proper examination of the drug and the risk of black market trade, and the ethical argument of the emotional hesitation of the survivors to allow Thalidomide to be back into the world surrounding them.
The Thalidomide Tragedy has proved to be a globally horrifying event that sparked change in safety regulations surrounding the distribution of pharmaceuticals. Although Thalidomide is beginning to be used again in the medical field, it becomes a situation of ethics of whether or not the use of the drug should be continued because of the damage it has done to the lives of thousands.