Thalidomide Was First Introduced By German Pharmaceutical

The fight to keep thalidomide off the U.S market is over, thousands had been spared the horrible consequences of this horrific drug. This event would have passed quietly if not for an article on Dr. Frances Kelsey in the Washington Post. The article drew attention of thousands of Americans and letter began to come in thanking Dr.Kelsey for her work. Along with this gratefulness also awareness. The awareness that the FDA did not have as much power as it needed, awareness that the correct laws were not in place to protect the people like they should be. This event would not be watered down and soon the government had to act. The proposed legislation became number one priority and the new law became known as the Kefauver-Harris Amendments (Washington

The United states has taken consistent efforts to control the distribution and manufacture of medications and other drugs, with many efforts regulate possession importation and sales of various types of drugs. While there are several historic pieces of legislation that deal with the regulation and control of various substances, there is no other single piece of legislation that is an important and impactful to health care as the Controlled Substances Act of 1970. This essay will explore the history of this legislation, its purpose and passage from proposal to law. Some may argue American this is true for American society as a whole, because of the implementation of this law and the addition of the Drug enforcement Agency as the agency that

The final move was the 1962 Kefuaver- Harris Amendment, which tightened safety requirements and also recquired the manufacturers to provide FDA with evidence that the drug was both safe and effective for its intended clinical purpose. People of the drug industry were outraged because this would delay, often by many years, the time and cost of which a company could market a new product and begin to recoup its investment.2

The use of Thalidomide by pregnant women caused their babies to develop severe abnormalities. These babies were born with characteristic limb defects and 40% of them died within a year of

However, when the drug was released, it caused horrible birth defects to numerous babies, mainly in Continental Europe and affected many families.

“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, 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.

Kefauver Harris Amendement or "Drug Efficacy Amendment" is a 1962 amendment according to this drug cannot be brought into united states without proving its efficacy and safety. This act says that manufacturers need to prove the effectiveness of drug products before they go on the market, and report any serious side effects to us (FDA). It also requires that evidence of effectiveness of the unapproved drug be based on adequate and well-controlled clinical studies conducted by qualified experts and all this information to be documented in the appropriate form according to ICH guidelines and submitted for approval. The drug is allowed for marketing after the FDA approves the NDA when all the information is reviewed and is considered safe and appropriate.

Would you take a drug that would relieve you of pregnancy sickness, even if it meant your baby would have birth defects? I definitely would not! This happened when mothers took Thalidomide. Thalidomide is a drug that, in the 1950’s, was known as a sedative to morning sickness during your pregnancy. They didn’t know at the time but it was causing birth defects to their children, which got the name phocomelia. Here are a few topics that will be covered in the following essay: The adverse effects of Thalidomide, The history about it, and How did it affect the society and culture.

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

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.

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

Phase III is the first large-scale trial of human testing. This phase can only begin if the new drug shows to be effective in the phase II. Phase III seeks to further determine the effectiveness of the drug. This is done by testing the drug on different populations, meaning that testing will be done on more people, testing will be done on different drug doses, and the drug will be tested on patients who are also taking other drugs. If Phases I through III show the investigational new drug to be safe and effective, then the pharmaceutical company will file a New Drug Application (NDA). The NDA includes both the results of the first three trial phases and data on how the drug is manufactured (Frank & Hargreaves, 2003; Lipsky & Sharp, 2001;

In the late 1950’s and early 1960’s, a pharmaceutical drug hit the market that caused a global uproar. Thalidomide, an over-the-counter sedative and anti-nausea drug caused dramatic birth defects called phocomelia, in newborns. Because one of thalidomide’s purposes was as an anti-nausea drug, a large section of its buyers were pregnant women. Birth defects included being born without arms or legs, blind and deaf, heart defects or intestinal abnormalities. Some of the babies were only a trunk with an eyeless, earless head, some were mentally retarded. Around 10,000 babies were born with these symptoms all around the world. (N. Schlager, 2008)

After all research has been conducted including the testing of all animal and human studies associated, the New Drug application is completed by the drug developer. The results provided are used by the FDA to determine whether the drug is approved or the recommendation of further testing. Finally phase four is based on the monitoring of the drug’s risks and benefits monitored by various sponsors hired by the FDA.