“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 …show more content…
France Kelsey reviewed the application for the FDA and blocked its sale in the United States until the cases of birth defects were linked to the drug; her stand protected countless unborn children and drastically changed the FDA’s procedures when approving drugs. Dr. Kelsey’s stand against Grunenthal and thalidomide revolutionized how medicine is accepted today. She was one of the few people who could see the truth behind all of the false data and gushing testimonials. Hence sparing unborn infants from being disfigured with horrifying disabilities. Dr. Kelsey’s does not seem like much, but by delaying the application she gave other doctors enough time to connect the dots between the maimed children and
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.
It was mainly used to treat the common symptoms associated with pregnancy. It was also used for epilepsy, however, there was a lack of empirical evidence supporting its use as an appropriate measure for epilepsy. The drug received an abundance of praise for its ability to relieve nausea and when 1957 hit, it was branded as a suitable treatment for morning sickness. On the surface, it did well for the mother but indirect affects on the baby in the mother’s womb were occurring. It wasn’t until hundreds of cases of malformations in children came about, that we realized it was correlated with mothers who had taken thalidomide during their pregnancy. In all, 8,000-12,000 babies were affected and only about 5,000 surviving after childhood. Some might assume that the dated year of this case is the reason why it might’ve happened and that science wouldn’t let this happen in the 20th century. The case of Vioxx, which was launched in 1999, proves that safety is not
The Food, Drug, and Cosmetic Act of 1938: Sulfonamide tested for flavor and fragrance but not safety, children died and 350 more were poisoned. This act made it so the sale of unsafe drugs could be stopped, that toxic drugs could be seized, and the burden of proof was given to the manufactures to show data of safety experiments.
Nowadays, the drug is only used for advanced cancers and severe complications of leprosy. Also, due to the German measles (Rubella) epidemic in the United States in 1962, thousands of children were born with birth defects. Sometimes, the pregnant women were also affected by these high risk pregnancies. However, these women could not seek abortions due to the strict bans. (Supreme Court Drama, wikipedia.org, time.com)
A terrible incident happened in Tennessee in 1937 when a drug called Elixir Sulfanilamide was mislabeled and contained toxic quantities of antifreeze that killed over 100 people (FDA's Origin & Functions - FDA History). Before this event, Congress debated substituting the 1906 Act and this instance in Tennessee drove Congress to approve the Food, Drug and Cosmetic Act of 1938 that provided an updated set of standards. Unlike before when the government had to disprove a drug was effective, the new act stated that drugs had to be proven effective before being sold. It not only replaced the Pure Food and Durg Act, but the Sherley Amendment as well (Centennial Edition of FDA Consumer).
In general, with every pregnancy there is a 3-5% chance of having a baby with a birth defect. If a woman takes Thalidomide during her first trimester of pregnancy, the chance of her giving birth to a child with a birth defect increased to a 20%+ chance and the fetal and infant death rate is estimated to be 40% or more due to severe birth defects. (Thalidomide Side Effects on Babies). A portion of the children who suffer from birth defects caused by Thalidomide also suffer from developmental disabilities such as autism. Thalidomide victim survivors still suffer from these symptoms today. How does Thalidomide create all of these issues? The answer is science. The placenta is a very important organ that develops in the womb during pregnancy. The placenta nourishes the baby through through the umbilical cord and gets rid of all waste. The placenta is the first line of defense for the baby. It is a barrier that many harmful substances do not have the ability to cross. Before a pharmaceutical is offered to
Methaqualone, is also referred to as Disco Biscuits, Down And Dirties, Jekyll-and-Hyde, Joe Fridays, Lemmon 714, Lemons, Lennon's, Lovers, Ludes, Mandies, Mandrake, Q, Qua, Quack, Quad, Quaaludes, Soaper, Supper, Vitamin Q, The Love Drug, Wallbangers, Whore Pills, and Sopor. This list of street names for the drug goes on and on.
Attached to your discharge papers you will find a list of the medications that the doctor wants you to take at home. The prescriptions have already been sent to your pharmacy and the pharmacy will deliver them all to your home this afternoon after 4:00 PM. I will go over each of your medications with you.
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
Located in the magazine named Woman’s World was the article “God’s love and medicine” which is about a Newborn baby named Levi who was diagnosed with a severe condition called “The boy in the bubble” disease. This extremely rare condition occurs when a deficiency of the immune system’s two major weapons-Anti-bodies and T cells-are missing or disabled. The average person contains 2,000 T cells while baby Levi only had 10 to begin with. The author of the article named Kristin Higson- Hughes focused this piece to not only be about little Levi and the precautions he had to take throughout the beginning stages of his life but also how doctors are trying to cure children like Levi of SCID without resorting to chemotherapy as an option.
The Food and Drug Administration is a regulation agency within the Department of Health and Human Services. It’s role in our nation is to be responsible for “protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation” ("What We Do."). One of the most important responsibilities and the topic I will be discussing throughout this paper is drug regulation. The Food and Drug Administration approves drugs that are intended for use in diagnosis, cure, relief, treatment, or prevention of disease, and is intended to affect the function of the body. In order to do so, The Food and Drug Administration reviews drug manufacturer’s via application to put drugs on the market; therefore, a drug may not be sold or marketed unless it has and remains approved by the FDA. Even though a drug has been approved does not mean it will remain on the market, drugs have the likelihood to be recalled. For example, when you see those late night personal injury lawyer commercials saying, “If you have been prescribed and taken said drug, and experienced any of these side effects such as blood clots, seizures, etc., you may be entitled to compensation.” those drugs have usually been recalled due to adverse effects
Unfortunately, profit comes over health for the major pharmaceutical companies. This is because, in a capitalist society, death and suffering is of no consequence to those who are making a gain off of it. The executives who are benefiting from the profits, do not care about the family that no longer has a daughter because of their medication. Capitalism makes things that are supposed to be about saving lives extremely corruptible and profit-centric. Previously, new medications were researched by those who had no affiliations with any drug companies.
In the medical journal Animal Testing and Medicine, the article outlined an incident in 1937, in which a pharmaceutical company released a drug containing a harmful chemical compound known as “diethylene glycol,” which was marketed to the public (Hajar). The scientist had failed to acknowledge the potential of poisoning by the compound to the public, and upon its release there was mass poisoning. This frivolity of the scientists led to massive public outcry, and in turn lead for the movement of the passing of the “1938 Federal Food, Drug, and Cosmetic Act requiring the safety testing of drugs on animals before they could be marketed”(Hajar). More incidents following these lead scientists into the belief that animal testing was necessary as a safety net to prevent such tragedies from occurring again in the
Thalidomide is a medicine that is used for nausea. Many women who used it did not know that they were pregnant. Once they gave birth, they realized their child was severely deformed and ask how that could be? Scientists gave Thalidomide to pregnant rabbits and also gave birth
Valproate, a commonly worldwide drug treatment used since 1967 (in France,) to prevent a series of epilepsy or bipolar disorder symptoms during a women’s pregnancy or a woman was likely able to reproduce at age of her mid-thirties and mid-forties. French studies shown Valproate is “four times likelier” to cause disfiguration during the development of the babies. About 2,150 to 4,100 children were affected by the “link ‘of’ the drug” causing severe defects including malformations and autism. Many families spoke out about the crisis. APESAC, a French umbrella organization, (a large association of institutions, which coordinates the activities of its member organizations and works to protect their shared interests) sued Sanofi, the drug’s manufacturer