Introduction:
In 1957 a German pharmaceutical company, Chemie Grunenthal produced the drug Thalidomide, that would impact the life of more than 10,000 babies worldwide. Originally this drug was produced and marketed as a sedative that was thought to be nearly impossible to over dose on. It was a cheap over the counter drug that was marketed to pregnant women because of its effectiveness of combating morning sickness. Over time this drug became very common throughout Europe, Oceanic Regions, and even Africa. However, this drug had little testing behind it resulting in huge implications. Originally, this drug was tested on lab rats for its sedative purposes, but it was never tested on pregnant rats. Subsequently, many children were born with
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This is because in developing countries, there are less laws and regulations about drugs like Thalidomide and other power teratogens. Additionally, there are less health consultations in these areas to help inform people of the deadly effects of Thalidomide. These developing countries experience large scale health effects of Thalidomide because of other diseases in the country. For example, Brazil has more than 35,000 cases of leprosy diagnosed each year (Battling Leprosy in Brazil, 2016). So, Thalidomide has become a very popular drug there because of its ability to inhibit ENL. Now, Brazil is also the country that is distributing the most Thalidomide in the world. Between 2005-2010 Brazil distributed 5.8 million Thalidomide pills throughout the country (Brazils New Generation, 2013). Because of ill-informed people, mass amounts of people with leprosy, and nearly limitless supplies of Thalidomide a new generation of Thalidomide babies has been born again. The children are born with deformed appendages and in some cases serious nerve and organ damage. These birth defects effect the way these children are going to live the rest of their lives. They may not be able to carry out simple tasks because of how Thalidomide effected their bodies. Thus, they will have to rely on other people to help them throughout the rest of their lives, which may be dramatically shorten due to Thalidomide …show more content…
Thalidomide can cause huge amounts of damage to embryos while they are developing. Moreover, Thalidomide can also be used to lessen the effects of leprosy and help in cancers. Although, Thalidomide can be an effective treatment for these diseases, we cannot turn a blind eye to the fact that a major disaster occurred because of the use of Thalidomide. Additionally, we can use this past disaster to shape the way we test drugs today. This drug was a great example of a product that had little testing and huge consequences. Now we know how important testing is for every product, no matter how harmless it may
The author emphasizes in biological difference between human beings and animals meaning drugs safe for animals might not be safe for humans. It argues that the FDA should not mandate animal testing and should look to the alternative methods for evidence that supports drug approval. Author suggests many alternative methods other then animal testing that can make drugs more efficient and safe for human use, consequently saving animals from experimental cruelty which provides excellent quotations for the research paper.
There are many reasons that certain drugs damage to an embryo very early in pregnancy even before the mother realizes she is pregnant. Firstly, some of the mother already exposed to certain drugs before she get pregnant such as tobacco and alcohol. For example, the women who take cigarettes everyday in their daily life will continue to smoke before they realize it. Due to this, the babies of mother who smoke tend to grow more slowly in the womb and are likely to be born prematurely and small (Habek et al., 2002). Apart from that, some of the women did not go to consult doctor when they were sick, and just simply take any medicine they have in the house. Especially antibiotics, analgesics, and asthma medications, these kinds of medicines
A little white pill, sold as an over-the-counter drug, lined the shelves of pharmacies across the globe. Originating from the German drug company, Chemie Grütinethal, this pill was advertised to a highly receptive international market and was a success in 1959. Several years later, physicians began to form a link between phocomelia, a birth deformity, and pregnant woman who ingested the German-created drug. That little white pill is known as Thalidomide. Staying in the market for almost six years, Thalidomide changed the lives of mothers and their newborns for the worse making it one of the largest pharmaceutical failures in the course of mankind. Although the horrific effects of distributing Thalidomide in the late 1950s is historically
Pregnancy is a very difficult time in a women’s life, everything that is digested, breathed, and felt affects the fetus. Teratogens are factors that cause developmental problems of an embryo. These factors include stress; toxin such as drug and cigarette use, the health and even the age of the mother can have an impact on the development of the fetus. Teratogen can cause birth defect that may lead to life long consequences to the child. I am very passionate about this topic due to the alarming increase of birth defects and abnormalities that have been occurring during my generation. In America one in every thirty-three babies are born with a defect
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
They are dangers to human health. To being with, an expected mother who takes these drugs in early stage of pregnancy usually have spontaneous abortions. Moreover, it causes deformity to new born babies such as septal heart effect in which a baby born with hole in the tissue that separates
From 1958 through 1961 a mild barbiturate wreaked havoc for expectant mothers and their fetuses. The drug was originally marketed in Europe, by a pharmaceutical company named Grunenthal. The, unknown at the time teratogen or placenta passing, drug is called Thalidomide. Its popularity grew quickly because it is nonlethal, even in overdose, and a deadly quantity has yet to be found. Thalidomide is still used today, despite the extraordinary suffering, it has caused. Alas, Thalidomide was prescribed to pregnant women to help them through pregnancy symptoms, caused thousands of infants to be born with terrible deformities and deficient in countless areas, and has made a life of struggles for the children of Thalidomide.
“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
Some of the most tragic incidents noted in 1930 involved untested products, masses of women were blinded due to Lash Lure, a mascara containing a chemical which can burn the skin. One women had significantly severe burns which have caused infections that lead to her death. In addition, Elixir Sulfanilamide, a new medication for cough has caused the death of more than 100 people in 1937. (4) The two tragic incidents have caused the necessity for animal testing and accordingly, in 1938, the ‘U.S law has required animal safety testing of drugs and cosmetics’ (4) due to the consequences of untested products which have resulted in numerous, catastrophic
At the time, It was well known that substances could infiltrate the womb especially during the early phases of pregnancy, this however was not part of the tests conducted by drug company Chemie Grunenthal. According to Lenz (1988) Chemie Grunenthal claimed to have conducted tested on three women and none were pregnant. In addition, Greek (2011) highlights that no testing on pregnant animals were conducted. The evidence suggests that the effects of thalidomide on pregnant women were not considered before being released for sale. The second ethical issue to contribute to the disaster, was the withholding of vital test information from drug regulatory bodies. According to Daemmrich (2004) reports existed of possible side effects attributed to thalidomide, however drug distributor in the United States William Merrell failed to disclose this information to the FDA. This shows that despite the possibility of harm drug marketers still sought profit over safety. They were however, not fully to blame as Kessel (2013) point out, in Germany where Thalidomide was produced, pharmaceutical companies need just show process of manufacture and sale, before being permitted to market their drugs.
Thalidomide was a drug made to treat many different health problems and is now known as one of the worst teratogens in history. Thalidomide is most well-known to help with morning sickness in pregnant women, but that’s not what its original purpose was. The original purpose of thalidomide was to use for respiratory problems. Another use of thalidomide that was practiced was to “provide a safe sound sleep” (Thalidomide Victims Association of Canada, n.d.). Overall thalidomide was used as a sedative and was a wonder drug, because it helped many problems. The problems that thalidomide caused were on a global scale. Thalidomide was an over- the- counter drug for multiple countries across the world. In most countries thalidomide was prescribed by a doctor in a certain dose. Some countries that used Thalidomide include Canada, Germany, UK, and Brazil. Including these, Thalidomide was used in about 30 other countries, and effected them on different scales. The problems that thalidomide was originally intended to fix, could have been fixed many other, safer ways. For morning sickness, there are hundreds of safe home remedies, instead of taking Thalidomide. For respiratory problems, you can take an inhaler, or have an oxygen mask. Also, for sleeping problems, there are multiple home remedies. You can take melatonin, which relaxes you, and can naturally be found in the body. A German pharmaceutical company, Grunenthal, was the first to start
Neurologist, Aysha Akhtar, stated that in an experiment with a drug named TGN 1412, the results from the mice, rabbits, and monkeys that it was used on was that the drug was non-toxic. The monkeys in the test were even given “500x” more the dosage amount of humans and when human volunteers in clinical trials were given the drug they almost instantly felt “ill” results. During the year 2003, Pharmaceuticals were told to stop trials of an Alzheimer’s vaccine that had been curing the disease in mice but turned out to cause brain inflammation in humans (Akhtar, Aysha). These kinds of results often get looked over because people think that animals, for the most part, have the same anatomy as humans. Even when results in animal testing do point out flaws of the drugs, we can’t fully rely on the results because they may not be harmful in humans. For example, a drug used to treat leukemia, Gleevec, was almost thrown away because it was found to cause “liver toxicity” in dogs but not humans. This was also true with the drug Cyclosporine, which is used to treat autoimmune disorders and given to patients who have organ donations to prevent rejections (Akhtar,
THALOMID(thalidomide) is “an immunomodulatory agent”[1]. Thalidomide was first put into marker in 1957, which trade-name is Contergan under a German drug company-Chemie Grünenthal. The aim of this drug is used as a sedative or hypnotic, Chemie Grünenthal also claimed that this drug cured "anxiety, insomnia, gastritis, and tension"[2]. Meanwhile, this drug was found efficiently on contraception. People in that time believed THALOMID as a drug without risks, however, after few years, about 10,000 cases on worldwide "were reported of infants with phocomelia due to thalidomide; only 50% of the 10,000 survived"[2]. "Those subjected to thalidomide while in the womb experienced limb deficiencies in a way that the long limbs either were not developed or presented themselves as stumps. Other effects included deformed eyes and hearts, deformed alimentary and urinary tracts, blindness and
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
in three patients. Overall, 5 (25 %) PR, 3 (15 %) SD and 12 (60 %) PD was noted. Although there were some responses observed, the authors suggested that despite some responses observed with this therapy, rosiglitazone did not result in clinically significant response [36]. In another study including more patients, increases in radioiodine uptake after[6 weeks of pretreatment with up to 8 mg of rosiglitazone were observed in 26 % of the patients. However, post-therapy decreases in TG levels were only noted in 17 % of cases [37].