Thalidomide In The 1950's

There are many expecting mothers who suffer from serious mental illnesses like schizophrenia, bipolar disorder, or borderline personality disorder that requires they must take antipsychotic drugs to remain stable. There are different types of antipsychotics like typical and atypical. Typical antipsychotics are classified as the first generation of antipyschotics. The atypical antipsychotics, the second generation, are reported to be safer than the typical antipsychotics because they are the newer form of antipsychotic medication. Even though they are reported to be safer, they still have severe side effects on the individual consuming it, like tardive dyskinesia, which are uncontrollable movements of the mouth (McCauley et al., 2009). Some drugs can affect the fetus by transferring to the blood-brain barrier. The blood-brain barrier is a permeable barrier that allows some chemicals to pass through. It separates the circulating blood from the brain extracellular fluid in the central nervous system. The blood-brain barrier also transports molecules to the brain that are essential to function properly, like glucose and amino acids. Since capillary endothelial cells, which line the whole circulatory system, form the blood-brain barrier the medication could be transported to the fetus. From

According to the Centers for Disease Control and Prevention (CDC), birth defects results in one of every 33 babies. Teratogens account for 4 out of 5% of birth defects when chemical and drugs are in the system. The use of this or even infections can cause abnormal fetal development.

Several medical studies published in recent years have linked Zofran to the increased occurrence of major birth defects:

An example could be, if the mother or father is showing signs of depression, they may neglect to take proper care for the child. Maybe because they are depressed, they may not focus all their time into the child, rather focusing on their depression. A woman who avoids taking antidepressants during her pregnancy to try and ensure her baby is born without defects could still have a child with some sort of birth defect, other things can cause birth defects, such as current or prior drug use illegal or prescribed, or in other cases that child is just genetically predisposed to it. Birth defects can happen due to genes malfunctioning or even when there are problems with a chromosome (Berk, 2018). So, it is impossible to say that a pregnant mother can avoid birth defects by not taking antidepressants. This idea is further reinforced by Jennita Reefhuis in her abstract video when she cautions us that antidepressants are not the only thing that can cause birth defects, other possibilities such as pre-existing conditions in the mother who takes antidepressants or other unknown influences may have a large impact on birth defects as well (Reefhuis,

inability to keep the child to a mother risk of dying in the process of birth. As beautiful as the birth of life seems, it is a dangerous process that could end the carrier’s life. The idea others are getting is that these embryos were created for the purpose of reproduction, not to be test experiments.

According to the author of this article, the syndrome is preventable only if the mother is able to change their behavior. This syndrome is said to cause disabilities in children especially the unborn children. Mothers found abusing drugs during pregnancy might be charged in court for risking the health of the unborn child. However, every person has the right to choose what to eat or drink during his or her pregnancy period but putting the health of the child in danger is out of question. As much as we want to protect these mothers, we also have to bear in mind the idea of making an innocent child suffer simply because you want to enjoy yourself without considering the risks you are exposing the child to. For instance, the syndrome may cause a series of disabilities in children, according to the author of this article states that one out of every woman in the United States of America uses alcohol or other drugs (Heinen,

With an increase in articles discussing external effects that can be avoided to help protect the fetus will help several mothers increase the chance of having a healthier child. Websites such as the CDC in collaboration with other websites can lead to mothers that are properly informed of possible defects that can occur with their child. For a drug to receive pregnancy category research is required. However to find subjects willing to risk their child having a defect to help categories a drug is limited. There are instances where some women may not even be aware that they are pregnant. They may be on an opioid regimen and be total unaware of the damage it could cause their unborn fetus. Once realized by the physician, the mother should be tapered off and place on a pregnancy appropriate therapy of either Methadone or Buprenorphine. There are some mothers that may be addicted to the opioid therapy prior to pregnancy. These mothers require a switch of therapy and behavioral therapy to ensure safety of both the mother and child. Some mothers might be opioid naïve till pregnancy. They may need opioid therapy due them needing surgical procedure (car accident, emergency surgeries), infection, injuries or chronic diseases (such as nephropathy).

Until recently, very little drug testing was done to women in childbearing years (Burchum & Rosenthal, 2016). This is due in part to the drug, thalidomide, women took to prevent early miscarriages. The drug caused 100,000 birth defects worldwide (FDA, 2001). Unfortunately in 1977, the FDA took this concern to the extreme and barred all women of childbearing age from phase 1 and phase 2 trials even if the woman was not pregnant (Burchum & Rosenthal, 2016). Because of the limited testing on women there was no way to know how women would respond to most drugs. There was no way to know if the drugs would have the same benefits or adverse effects as they did in men. We had no idea how the drug would be affected by the menstrual cycle. (Burchum & Rosenthal, 2016).

After the pills got taken off the market, over 10,000 children had already been affected by it. A short time after, it began to get used as a cure for leprosy in the more poor countries In 1964, despite the drug being banned from use, an Israeli physician named Jacob Sheskin gave his patient who was critically ill with leprosy a dose of Thalidomide and after he woke up he was able to get out of bed without any help. Only 50% of the 10,000

Grunenthal began clinical trials to test Thalidomide’s effect as an anticonvulsant, anesthetic and spasmolytic. The test results showed it made the test subjects drowsy. In 1956 it was marketed as Grippex, designed to treat influenza. (Lenz 1988) Thalidomide was also tested on people with anxiety and suffering from stress. Grunenthal then remarketed the drug under the name Contergan in 1957 to reduce stress and as a sedative. (Mandal 2015) Although it was known that compounds could cause teratogen effects, it was not yet a law that all drugs must be tested on pregnant women or animals. Scientist at Grunenthal discovered that Thalidomide had similar chemical structures to popular sedatives Diazepam and Barbital. They performed clinical trials to confirm this. At this time extensive testing was not necessary to be performed on new drugs, “thalidomide had passed safety tests performed on animals. In some tests, dosages of over 600 times the normal human dosage had no effect at all on rodents” (BBC, 2014) these tests lead scientists to believe that Thalidomide was safe to use on humans, pregnant women inclusive, due to having an almost non existent toxicity level and the drug was released with only minor side effect warnings. Physicians across Germany recommended Thalidomide to women to treat morning sickness; this advice was wide spread across western Germany and eventually across the 46 countries that sold

“Thalidomide was introduced by the method of Russian roulette. Practically nothing was known about the drug at the time of its marketing.” A seemingly harmless drug with a dangerous secret, that was overlooked due to the corporate greed of Grünenthal, the company that synthesized thalidomide. A short time after its release, the drug became a sudden hit in countries across the world. It was known as the “wonder drug” due to the fact that scientists could not get a test rat to overdose. The illusion that thalidomide was safe, went to the point that manufacturers were claiming that even pregnant women could take the drug for morning sickness. Alas nearly 12,000 infants would be maimed at birth with a once rare disease known as Phocomelia, meaning “seal limbs”, and only 5,000 would survive past childhood (Brynner and Stephens 9). Richardson-Merrell attempted to submit an application to the FDA to approve the drug Thalidomide; but Dr. Frances Kelsey, the doctor assigned to the application, repeatedly rejected the drug until the birth defects were linked to thalidomide. Consequently saving millions of American babies from suffering horrible birth defects and

Thalidomide is a drug that was invented in Germany in the 1950’s. It was originally intended to treat respiratory infections but during testing, it was noted that the drug worked to relieve morning sickness for pregnant women. This new reason allowed the drug to be prescribed to many new patients all over the world. Eventually Thalidomide was discovered to be causing birth defects in all of the pregnant women that were taking it. It caused the fetus to not develop correctly by causing limbs of the body or ears to develop improperly or not develop at all. It also cause spinal cord and digestive system defects as well as problems to the heart and kidneys. Thalidomide stopped being prescribed but not before many children and families were affected worldwide who had taken the drug. It took a couple of years before other countries caught up to realize that thalidomide was causing the birth defects and removed from being an over the counter drug in many countries. It wasn’t until 1961 that it was completely removed after it was confirmed that it was causing birth defects. More than 10000 babies were born with defects and approximately killed 2000 before birth, but fewer than 100 were born here in the U.S.

Thalidomide started in Germany in 1957 as a calming medicine for pregnant women. As time went on they discovered that the uses for it could also be used to alleviate morning sickness. After this new use was discovered, it became an over the counter drug available to everyone. Shortly after the drug was available to the public five thousand to seven thousand infants had been reported to be born with phocomelia, which is the malformation of limbs. Only about forty percent of these infants survived. Throughout the world over ten thousand cases had been reported and only fifty percent of those cases survived.

In the decade of 1950 there took place the sadly crisis of the thalidomide that was motivated by the prescription of this agent to pregnant women as treatment to relieve the morning vomits. The drug was sold either directly or under license, in over 46 countries. What caused a considerable number of alterations in the extremities of many newborn children. Countless children died at birth or in the womb. In spite of the fact that when the drug was tested on rats, it appeared to have no toxic side effects. In response to this crisis, the United States congress improves the procedures to increase the safety of medicines and in 1962 Senator Estes Kefauver, of Tennessee and the representative Oren Harris, of Arkansas, realized a very important amendment.

The Thalidomide tragedy was distressing to many around the world; this so called pill first