Hazardous Chemical Paper
Introduction:
In 1957, one of the worst chemical drugs was put on the market to result in a major tragedy in the Chemical field. This drug was Thalidomide. Thalidomide is a mutagen, studied in toxicology, in which it causes damage to the chemical material within an embryo when in development. This drug was created in West Germany by a pharmaceutical company, Chemie Grünenthal (Recognition of Thalidomide Defects, n.d.). During this time when Thalidomide was introduced to the market, it was classified as safe to use. This drug was originally prescribed to pregnant women to prevent morning sickness, insomnia, anxiety and upset stomachs (Breaking News., n.d.). However, it was later determined that this drug caused
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10,000-12,000 people have been affected by this drug worldwide. This number shows how many people got affected by this poisonous drug from the years 1957 to 1962, with only about 40% of those people surviving (Knutel, n.d.). Even a single dose of this drug could result in a terrible defect in the offspring, which is why companies should take Thalidomide off the market completely. As well with this great tragedy, the company Chemie Grünenthal didn’t even have Thalidomide pass regulations with full evaluation. According to NewsMedical.net, “Thalidomide was the first example of a drug that passed legal specifications and regulations without full evaluation of its safety for use in pregnant and breastfeeding mothers.” This quote shows that Chemie Grünenthal didn’t have the drug tested 100% safe, before they put it onto the market to sell. Taking drugs from a company that doesn’t test their items fully, doesn’t seem too reliable. This is a perfectly good reason not to trust this company and buy their products. The threshold of how much Thalidomide to take could be off, their research could be off, any other drug that this company sells could also be very risky, due to this huge fault in one of their main products. In the end, the Precautionary principle was used to take this item off the market for the safety of …show more content…
Thalidomide has been shown to help stop the growing process of cancer, and other skin conditions. One example of this was in 1964, a professor named Jacob Sheskin from Hadassah University Hospital had a patient with leprosy. This professor then used thalidomide to help treat it, and the results were successful (Robertson, Jan 11, 2015.). By looking at the image on the right, it can be seen that Thalidomide does bind to the protein CRBN, as recently stated up above. When a carcinogen begins to cause a cancer, thalidomide actually stops the process of the cancer from growing. Similarly, when a baby is growing, thalidomide stops the advancements in the body, creating a negative outcome. But when thalidomide is taken when negative advancements are already occurring like cancer, it is helpful to stop them. This is a great example to show that Thalidomide should remain on the market to help people with certain conditions. However, there should be rules set into place. For example, if a person doesn’t want to have any more kids, then they should be able to take thalidomide as they won’t be affected. Thalidomide only affects the baby when it is developing, so it should be perfectly fine for the mother to take it if she is done having kids. (Strong, Jan. 11,
As Rosemarie Garland Thomson states, "Disability performance art is a genre of self-representation, a form of autobiography, that merges the visual with the narrative." (Thomson 1). Duffy, an Irishwoman, is armless and has a delicate hand attached directly to one shoulder. She is a survivor of the effects of the Thalidomide drug. This drug was introduced in West Germany in 1956. The Thalidomide drug was used to treat nausea and vomiting associated with pregnancy, in addition to its uses as a sedative and hypnotic. It was not until 1961 that the drug was taken off the market, being identified as a human teratogen. More than 10,000 infants worldwide were born with malformations attributed to this drug, specifically malformations in the upper extremities.
Often, these side effects are more dangerous than the condition being treated. Yet, this medication are appovered by the FDA. And, this medications are used to treat many Americans without knowing if they are safe for use or not.
In the late 1950s, the Thalidomide drug was used in Europe to treat morning sickness in pregnant women among other things. This study involved manufacturing company providing samples of this drug to physicians and compensating them to study the benefits and results of this drug. Although allegedly this drug did not cause any harm to the mother the fetus suffered severe damage as a result. There were thousands of children born with
“The clinical trials looked at by the European Medicines Agency (EMA) reported on a single dose per menstrual cycle in a limited group of women. In the real world, it will be used more frequently and by all types of females”(wright).this is a real issue,thousands of women are taking these abortion pills thinking they are safe but instead affecting their wellbeing.there should be more research done on this type of abortion medication because deaths and health issues have already occurred. there should be better labeling on this product to prevent future health issues or even death, this problem happens everyday when women from other parts of the world don't understand what the label is saying.this product should be removed from the market immediately until the problem is fixed. it has been proven that this pill is 10 times worse than abortion through surgery “it has caused the deaths of at least eight women (that are known); and it is at least ten times deadlier than its surgical alternative”(michelle).i think this pill should be banned,it has already caused serious
The same drug that caused thousands of birth defects is now being utilised as a way to help mouth sores in AIDs patients as well as a medicine to help with pancreatic cancer and other diseases (Feller, 2016). In the 1950’s and 60’s thalidomide was a drug used as a sedative that quickly became primarily for pregnant women with bad morning sickness. However, there were soon many birth defects that came from the mothers who were using thalidomide while pregnant (Winerip, 2013). Instead of giving birth to healthy babies, children were being born without ears or with flippers replacing their arms. The connection between thalidomide and the birth defects were not made right away causing the problem to be widespread. Thalidomide was and still is
When taken in the first trimester thalidomide prevented the proper growth of the fetus, and resulting in a birth defect in thousands of children around the world. When taken in first world countries between day 20 to 36 of fertilization. The child or children would be born with limb and other birth defects. During the 1950s and 1960s the children were known as Thalidomide babies. The damage or the drug, which manifested itself in the form of absence or severe deformation of the extremities ( arms, legs, hands and feet) and sometimes damage to the eyes, ears and internal organs. One pill during the first three to four months is enough to cause these birth defects.
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, a dangerous and extremely harmful teratogen, is one that has harmed children all over the world. Despite the fact that the US banned the chemical before it could be too widely distributed, it still affected thousands of families here that continue to live with the consequences today. Although Thalidomide is still used to successfully treat a variety of diseases and disorders, its history of unethical use resulting in the harm of thousands of fetuses should not be forgotten.
However, when the drug was released, it caused horrible birth defects to numerous babies, mainly in Continental Europe and affected many families.
In 1952, a drug named K17 was being developed in post-war Switzerland by drug company Ciba. Although intended for animals, it showed no effects on animals. This drug would be later developed by Chemie Grunenthal and be marketed as thalidomide, a mild sedative (alpha-phthalimido-glutarimide). Thalidomide would later go on to be primarily responsible for the deformity (Phocomelia) of tens of thousands of children across the world. The aim of this study is to highlight the medical disaster associated with thalidomide administration to pregnant women, the steps taken to mitigate them and the lessons learnt from the problems.
Thalidomide or ‘Wonder Drug” was introduced in Australia in 1956. It was considered, in all areas to be safe, even an overdose from this drug didn’t result in death, just an extra-long sleep. It was so named “Wonder Drug” because it was said to help with headaches, insomnia, coughing and it was an effective pain killer, it was also supposed to help pregnant women with morning sickness. Everyone started buying and using this drug and it wasn’t until years later that scientists connected a rise in babies with severe abnormalities with the use of Thalidomide.
Scientists use animals as an initial experiment to study the toxicity of new medicine. After collecting data throughout the laboratory result, scientists can make decisions on dosages of medicine which is safe for humans' usage. In 1937, a pharmaceutical company distributed Sulfanilamide which contained Diethylene Glycol(DEG). Before distributing the product to market, this company also added raspberry flavoring to the sulfa drug, which had dissolved in DEG. This preparation led a mass killing death of hundred people.Importantly, it was reported that there was no animal testing had done on this product before publicly distributed to consumers(Hajar 1). Another tragic evidence of not using animal testing that killed people is a usage of thalidomide. Hajar stated that “It was found to act as an effective tranquilizer and painkiller and was proclaimed a ‘wonder drug’ for insomnia, coughs, colds, and headaches”. It was found to have an inhibitory effect on morning sickness, and hence, thousands of pregnant women took the drug to relieve their symptoms. Consequently, more than 10,000 children in 46 countries were born with malformations or missing limbs(Hajar
Why it is important in our society to know what teratogen is, and some ways to prevent this birth defect in our society. Teratogen is a agent that disturbs the development of an embryo. Well, what exactly causes these disturbances in the embryo? By taking medicine during pregnancy, medicine prescribe to new mothers can cause abnormality in pregnancy. Although many women take medications during pregnancy, the medicine prescribe can be harmful. A example may be a woman during pregnancy comes across morning sickness; therefore, she may ask her doctor to prescribe medicine to treat her morning sickness. A common medicine to take during the 60's was thalidomide. However, over the years researchers found that thalidomide caused partial absence
The incident resulted in the FDA revising manufacturing and Quality Control standards, which would later become the GMPs. In the 1960s, Thalidomide was widely distributed throughout Europe, and was used as a sleeping pill, a treatment for Morning Sickness, and other health issues. However, the drug also had Teratogenic effects and resulted in severe, sometimes fatal, deformities (Immel). Thousands of victims were children. However, the drug never made it onto markets in the US, because it was blocked by Dr. Frances Kelsey, who was the FDA’s drug reviewer for Thalidomide at the time. This helped avert a major health crisis in the US, and Dr. Kelsey was awarded the President’s Distinguished Federal Civilian Service Award, for her vigilance (Immel). The horrifying side effects of Thalidomide galvanized the public into action. Congressmen Kefauver and Harris were able to pass more stringent regulations in Congress, which required all companies to properly test their products, and prove that they are safe and effective for their intended purposes, before being sold on the market. The FDA was given the power to regulate advertising for prescription drugs, and in 1963, the first GMPs were finalized (Immel). In the 1970s, the Good Manufacturing Practices (GMPs) were greatly expanded, through Federal 21 CRF Parts 210 and 211 (Immel). In 1979, the Good Laboratory Practices (GLPs)
There were two important developments in the 1970s which further shaped the industry in the form that we see today. Firstly, the Thalidomide tragedy (where an antiemetic given for morning sickness caused birth defects) led to much tighter regulatory controls on clinical trials, greatly increasing development costs. Secondly, enactment of legislation to set a fixed period on patent protection (typically 20 years from initial filing as a research discovery) led to the appearance of “generic” medicines. Generics medicines are those that have exactly the same active ingredients as the original brand, and compete on price.