INTRODUCTION
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.
TECHNICAL PROBLEM
Structurally, Thalidomide exists in an asymmetric chiral configuration when
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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.
PUBLIC PERCEPTION OF THE INDUSTRY (200 WORDS)
In the wake of the thalidomide disaster, the overall perception of the pharmaceutical industry and indeed that of drug regulatory bodies had turned to that
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
This poisonous drug that had the ability to severely damage the anatomical structure of fetuses to the point of death passed unnoticed for several years. The highly concentrated infant mortality toll is a despairing loss of innocent life. Additionally, several hundred more babies from Australia, Great Britain, Japan, and Canada were affected. The international widespread death magnified the tragedy, adding salt to the wound. The immense death toll is considered an international failure because of the shared infant death crisis. Since the distribution of Thalidomide caused thousands of premature infant deaths, it can be classified as historically tragic. In addition to premature deaths, Thalidomide’s consumption in the early 1960s is also tragic in another way.
The FDA behaves in ways that enhance its reputation for protecting consumer safety and public health. As gauged by public opinion polls, the FDA remains one of the most popular agencies in government, regularly securing 70 percent or greater “approval” of its performance among sampled respondents.5 Buttressing this popularity are powerful symbolic lessons of history: The FDA is widely credited with saving thousands of American lives in its response to the sulfanilamide tragedy of 1937 and the thalidomide scandal of 1959–1961.6 Congress dramatically strengthened pharmaceutical regulations after each of these events. Thereby whether or not the agency deserves it, the FDA clearly possesses a reputation for protecting public health and consumer safety.
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
He illustrates all the wrong doings of the pharmaceutical companies from their unethical ‘standard company sales pitch’ to their ‘deadly drug.’ He also shed light on all those who were on the brink of discovery on the drugs deadly secrete. Dr Leslie Florence published a paper linking thalidomide to nerve damage in 1960 followed by an interview some 51 years later. After inserts of evidence in the past tense he refers back to the trial in the present tense continuing the narrative. The structure of his writing follows a narrative rather than a diary or catalogue.
phocomelia, dysmelia, amelia, bone hypoplasticity are some of the aftereffects of the mother's taking the drug. At the time in 1957 people were rushing to buy sleeping pills or other medication to help with any problems they we experiencing, so when Thalidomide came onto the market, they had no idea what they were actually putting into their body. ¨The German makers of the drug advertised the peroduct as completely safe for everyone including mother and child because they couldn't find a dose high enough to kill a rat.¨ says Helix Magazine. 40% of the children died before their first birthday, the ones who survived had to learn to cope.
In “Selling sickness: the pharmaceutical industry and disease mongering”, the authors Moynihan, Heath, and Henry (2002) draw attention to the under-recognized phenomenon of pharmaceutical companies increasing sales on medication by promoting maladies to consumers. The article provides illustrations along with five examples that represent the act of disease mongering that occurs internationally. The authors suggest that the rational approach to this issue is for the public to begin to rely on independent sources of information about health problems instead of articles and ads that misrepresent data in order to maximize profit.
In 1966 at a Denver hospital, a Spanish couple welcomed a new baby to the world. The couple only spoke Spanish, and this caused communication between the couple and the healthcare staff to be impaired. The mother had a history of syphilis, and it was hard for the hospital to receive how the mother had been treated for this disease. After discussion amongst the employees, a decision was made to treat their newborn for congenital syphilis and an order was written for Benzathine penicillin G 150,000U IM. When the pharmacist received the order, she read it incorrectly mistaking the “U” for a zero making the order 1,500,000 units. The nurse expressed concern about injecting a high amount
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.
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
The thalidomide disaster was another treatment found to be toxic. Thalidomide was used in pregnant women for morning sickness in the early 1950 's. This led to birth defects in hundreds of babies. Because of the birth defects in infants, the drug was banned from use in the United States. In 1906 a law was passed to set standards for drug purity and quality through the United States Pharmacopoeia and the National Formulary; however, there still was not a law regulating the safety profile
Teratogenesis is a medical term. It refers to various malformations of embryo & fetus. It entails wide array of deformity in various organs of the body ranging from slightest anomaly to complete absence. Approximately 3% of all babies may born with signifcant cosmetic or functional deformity . In the year 2010, Teratogenesis alone was responsible for 510,000 deaths around the globe . The causes of teratogenesis is also widely varied. Most important reasons are genetic disorders, low nutrients , environmental toxins, vertically transmitted infection and various pregnancy drugs. Thalidomide is an example of drug that if used during pregnancy leads to various congenital malformation in embryo and fetus. Thalidomide was introduced into marketplace
The pharmaceutical industry confronts several dilemmas every year. Most of these dilemmas revolve around money or whether or not to sacrifice now for a bigger payoff in the end concerning money and/or lives. Pharmaceutical companies tend to use shortcuts that create ethical problems. Drug companies have spent millions/billions of dollars in research, and they obviously want to see
The drugs that are used to treat neonates can be used multipurposely and often innovation drives creative uses of drugs to treat uncommon multifactorial complications (Allegaert & van den Anker, 2015). Knowledge of the drugs and their adverse effects is increasingly important when dosing a neonate. Due to their undeveloped body systems, in an event of an undesired reaction or drug error, the neonate would not be able to compensate and recover like the other patient groups may (Skene, Gupta, Flaherty, & Sherwood, 2012). Furthermore, this stresses the importance of being competent in drug calculations and being aware of the effect of medicines on this particularly vulnerable patient group (Stavroudis, Shore, Morlock, Hicks, Bundy, & Miller,
Pharmacovigilance (PV or PhV) , also known as Drug Safety, is defined as the science and activities relating to the detection, collection, assessment, monitoring, understanding and prevention of adverse effects (AEs) or any other drug-related problem. World health organization (WHO) established its programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to ensure the risk-benefit profile of medicines.