Unfortunate events have catalysed the development of medicines regulation more than the evolution of a knowledge base. In 1937 the death of over 100 people in the United States by using a Sulfanilamide elixir is one such event.
Summary:
In the 1930s, Sulfanilamide, a drug used to treat streptococcal infections, had been shown to have dramatic curative effects used as a tablet and powder form. As a result there was a demand for the drug in a liquid form.
In 1937, S.E. Massengil Company created a liquid preparation after experiments showed that sulfanilamide would dissolve in diethylene glycol. The company control lab tested the mixture for flavour, appearance, and fragrance and found it satisfactory, and the product was marketed as “Elixir of Sulfanilamide”. Therefore, the elixir was manufactured in large quantity and distributed across the country.
Within one month, a number of deaths related to the sulphanilamide elixir were reported to the American Medical Association (AMA). The AMA tested the compound and found the excipient, diethylene glycol, as the toxic ingredient.
FDA was notified and they then set out to retrieve the entire drug from across the country. However, by that time 353 patients had received the “Elixir” during a 4-week period resulting in more than 100 deaths (including children), about a 30% fatality rate.
It was found that Diethylene Glycol, a chemical used as antifreeze, is a deadly poison.
GCP Principles violated:
Although there were no GCP guidelines or federal regulations demanding safety testing for drugs in 1937, the sulfanilamide elixir case violated a number of GCP principles.
• The first GCP principle requires ethical conduct of a clinical trial, which have their origin in the Declaration of ...
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Drug Regulation: History, Present and Future 77

Dr. John Abramson’s book Overdosed America debunks the myths about the excellence of American medicine. Abramson backs up this claim by closely examining research about medicine, closely examining the unpublished details submitted by drug manufacturers to the FDA, and discovering that the unpublished data does not coincide with the claims made about the safety and effectiveness of commonly used medicines. Abramsons purpose is to point out the flaws of the pharmaceutical industry in order to warn the readers about the credibility of the drugs they are buying. Given the critical yet technical language of the book, Abramson is writing to an audience that may include academic physicians as well as those who want to learn about the corruption of the pharmaceutical industry.
The drug manufacturing industry is concerned with the development, production and marketing of drugs which are to be used as medication. This is one of the oldest industries in the world. The first drug stores date back to the middle Ages. Some of today’s pharmaceutical companies have been founded in the beginning of the previous century. Important discoveries have been made in the early 20th century such as insulin and penicillin who became mass produced. More drugs were developed during the 1950s-1960s such as contraceptives and heart drugs. During that time numerous organizations and declarations were established in order to regulate the industry. Until the 1970s the drug manufacturing industry remained relatively small, and then it began expanding quickly. With the development of technologies and the internet research, manufacturing, marketing and sales of drugs became a lot easier.
“Dr. Janet Woodcock, director of the F.D.A. 's Center for Drug Evaluation and Research said people are being harmed and some of the harm is preventable ' ' (Le Fanu, 2014). With millions of drugs on the market, and with multiple drugs just for one ailment, it wouldn’t take much to cause a wrong combination that could cause injury or death. Hospitals across the U.S. reported in 2011 adverse reactions from prescription drugs caused 2.2 million injuries and 106,000 deaths that two-thirds could have been prevented with proper monitoring of prescription drugs. (Bremner,
that law was called the Pure Food and Drug Act. By the 1930s, muckrakers, consumer protection groups, and regulators through the government began fighting for stronger reinforcement from the government by publicizing a list of products that were breaking the 1906 law, including radioactive drinks, mascara which caused blindness, and fake cures for diabetes and tuberculosis. “The proposed law was not able to get through the Congress of the United States for five years, but was rapidly made into law after the outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug made with a toxic, unknown
This is a very important aspect of additives in general as before its use the public should have the right to know its effects on society. So the question remains, what are the effects of sodium stearoyl lactylate on the human body? While there are few current published research on the effects of sodium stearoyl lactylate on the human body, experiments have been done in the past on rats. A study made by the World Health Organization in 1969 showed that when 20 male rats were given 5% sodium stearoyl lactylate for 28 days with 20 control on stock diet, their liver weights were slightly higher. (“Toxicological evaluation of some food colours, emulsifiers, stabilizers, anticaking agents and certain other substances") They also tested the effects of sodium stearoyl lactylate on a dog. They started out by feeding the dog SSL for one month at a level of 7.5%, then for two weeks at 12.5%, and finally for a month at 15%. (“Toxicological evaluation of some food colours, emulsifiers, stabilizers, anticaking agents and certain other substances"). When the study was completed, the results showed no changes in blood and organ weights, and the microscopic appearance of the dog's tissues remained the same. (“Toxicological evaluation of some food colours, emulsifiers, stabilizers, anticaking agents and certain other substances") This shows that the sodium stearoyl lactylate had no effect on the dog but a slight effect on rats; faintly increasing their liver weight. The reason this information can be used in order to determine whether or not it is safe for humans is because rats have a similar body structure as humans ("Why Do Scientists Prefer to Experiment on Mice and Rats? FAQ"). This study alone shows that while SSL shows no sign of damaging the body, it can somewhat increase our liver weight, which is a factor that has to be looked into. In all, according to the short term study,
...ot the drug was solely responsible for the deaths, since they died from various causes, such as pulmonary embolism or cardiac infarction.
* There are close to 2 million cases each year of drug complications that result in 180,000 deaths or life-threatening illnesses in the eldery (Langreth, 2004).
Pharmacy is a booming field when it comes to medicine, but it certainly has controversial issues such as compounding drugs. While the practice of making drugs customized to a patient seems ethical, there are problems that come along with it. Drug compounding was the norm in the past, but over time consumers began to see issues with it. Drug compounding still occurs to this day because some patients do need medicine specifically tailored to their needs. Compounding has also been the focus of recent disasters, some of which occurred less than two years ago. Whatever side one may take on this issue, it is clear that compounding medicine will be a polarizing issue for years to come.
Steinbock, Bonnie, Alex J. London, and John D. Arras. "The Principles Approach." Ethical Issues in Modern Medicine. Contemporary Readings in Bioethics. 8th ed. New York: McGraw-Hill, 2013. 36-37. Print.
David was going through a very hard transition in his life from the elementary levels of school to high school. Along the way, he started hanging out with the wrong crowd and doing all sorts of drugs like smoking marijuana and drinking alcohol. In his senior year he realized he wanted to do something different with his life and he joined the boxing team and quit drugs, but one Saturday night that all ended. David was offered a patch that was supposed to make him feel an extremely good feeling. He didn't know what was in the patch, but it contained Fentanyl; a special pain reliever for cancer patients. His friend told him to cut open the patch and ingest what was inside. The next morning, David never woke up. Eight weeks later, his mother found out that it was Fentanyl that killed her son (Fox News). "In 2004, there were 15 million Americans ages 12 and up that took Prescription Drugs and used them non-medically "(Prescription Drugs: Their use and Abuse). All around the country more people are being introduced to prescription drugs and addiction rates increase every year. “In 2013 21.5% of high school seniors admitted to taking prescription drugs for a non-medical reason", in 2012 that number was at 21.2% (National Institute on Drug Abuse). That number slowly increases every single year. This problem is really turning into a pandemic in modern society, therefore it is necessary to examine the causes of prescription drug abuse and implement the solutions such as providing more education and regulating the distribution of prescription drugs.
Ethics refers to the values and customs of a community at a particular point in time. At present, the term ethics is guided by the moral principles that guide our everyday actions. These moral principles guide the researcher into deciding what is ‘right’ or ‘wrong’. The foundation of medical ethics is governed by two philosophical frameworks that are deontology, and utilitarianism. However ultimately the ethics committees need to balance the risks, and benefits for the participants and the community associated with the particular research proposal. This balance is quite important as the well being of participants is at risk.7
Researchers at the Massachusetts Institute of Technology (MIT) observed 80 people who suffered brain seizures after eating or drinking products with aspartame. The Community Nutrition Institute declared: "These 80 cases which fit the FDA definition of imminent risk to public health, which requires the FDA to immediately withdraw the product from the market."
...s are dangerous and toxic. Despite the precaution taken in supplementing these chemicals into water, there still exists the probability that these hazardous chemicals will be reproduced by reactions with bodily fluids in areas where they may cause harm to the individual. The production of these chemicals is outlined in the previous section on Chemistry.
Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987; 317(3): 141-145
Hippocrates' authority lasted throughout the Middle Ages and reminded alchemists and medical experimenters of the potential of inorganic drugs. In fact, a distant descendant of Hippocrates' prescriptions was the use of antimony salts in elixirs (alcoholic solutions) advocated by Basilius Valentius in the middle of the 15th century and by the medical alchemist Phillippus Aureolus Paracelsus (born Theophrastus Bombast von Hohenheim, in Switzerland, 1493-1541).