The Pros And Cons Of Thalidomide

After reviewing the article it is clear that more needs to be done to create transparency in the study of drugs and public awareness. As a doctor in Canada Dr. Navindra has a right to access and study information so he can provide due diligence to his patients. If the study found that this drug was harmful to pregnant mothers,

Along the way, your body becomes dependent on the substance to where they can’t live without constant reprieves. If they had slowly cut down on the technology use, the children wouldn’t have caused such a fuss. Unfortunately, their solution had them tossed from the frying pan and into the

Many Americans continue to believe that if a medication has been approved by the FDA it is safe for us to use, but the facts are many times they are not. You only have to look at all the medications that have been pulled from the market after many people lost their lives or had their health decay from these medications to know that nothing could be further from the truth. It helps to find a physician who will tell you to change your lifestyle rather than prescribe a pill that might have harmful side effects.

chemicals. Many women, who took diethylstilbestrol (DES) to prevent miscarriages, increased the risk for breat cancer in their children.

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.

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.

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

For instance, in the US thalidomide is only used under very strict circumstances and typically in case studies. On the contrary, in Brazil thalidomide is used more frequently because of the disease of leprosy, which can be helped by using thalidomide to slow its growth. Yet there is still some controversy surrounding the use of thalidomide within Brazil. Some say that thalidomide should only be used under strict circumstances because of its outcomes. In the 1950s and the 1960s, 10,000 babies were born with birth defects worldwide because of the overuse of thalidomide (Crawford, 2013). There have already been around 100 babies born in Brazil that have the birth defects caused by thalidomide in this generation (FfDn, N.D.). These birth defects should not be happening because they are so easily preventable. All that is needed is to not have not take the drug while pregnant. Additionally, in Brazil, there is not adequate healthcare for everyone and not all women taking the drug are monitored properly or warned against it by a doctor (Crawford, 2013). There's also the problem that a lot of pregnancies are unknown so mothers don’t stop taking the medicine until one or two months into the pregnancy when there's already damage done to the growing fetus (FfDn, N.D.). For these reasons, thalidomide should not be a widely used drug, especially in countries with inadequate health care and where a new generation of babies is already

When the drug came into question around 1961, it took a long time before Chemie Grünenthal took responsibility for the mass of tragedies. In the beginning of the trials that would expose the untrustworthy nature of Chemie Grünenthal, they denied all allegations of being connected with the thousands of babies born with severe birth defects. They blamed everything from “nuclear fallout to botched home abortions” (Schlager 2008). Settlements were made to assist Thalidomide babies. However, now those affected who are well into their fifties claim that those settlements are no longer enough to cover the costs anymore (Winerip 2013). It took a long and unnecessary battle, but Thalidomide was banned in 1962. Dr. Kelsey, a hero of the time and the one who blocked the licensing of Thalidomide in the United States, then created regulations for the FDA that still control testing today. It called for complete use of ethical practice, the precautionary principle, which assumes that all drugs are dangerous until proven safe to ensure the safety of citizens from unknown dangers. As a result of this dark spot in world history, Congress passed legislation dictating that the testing of drugs on patients without their consent is illegal, and requires thorough and reliable testing before any distribution whatsoever (N.a., 2015). Even though it was acknowledged that Thalidomide was a drug

“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

With the level of technology at where it is today there are many risks involved with many treatments. What the companies tend to do is advertise products and try to make the risks seem small. Every time you watch TV nowadays there is a commercial on there about a treatment that has

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.

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.

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)