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History
It is wrong to neglect the fact that many different organizations around the whole world want to earn easy money. People want to perform their work and get benefits in a short period of time. In such a country as the United States, much attention is paid to control such situations. However, there are cases when it is not expected from a company to break the law or the norms when it is involved in such fields as medicine, healthcare, and pharmacology. Employees have to comprehend that millions of lives may depend on the quality of the work they perform. It is impossible and unethical to steal or cheat on peoples lives just to earn some money. Still, the outbreak of meningitis in 2012 proves that, unfortunately, there are companies that can take such dangerous steps.
The activities of the New England Compounding Center (NECC) led to the outbreak of 753 cases of meningitis with 64 of them being fatal. People from more than 20 states underwent significant threats because of fungal meningitis.1The case ended with a serious trial of the owner and the main pharmacist of the company, Barry J. Cadden, and the up-to-life in a prison sentence. The investigation of a chronicle of the events that led to such an outcome should help to clarify the main reasons and comprehend the peculiarities of the case to avoid similar situations in the future.
September 18, 2012 The Tennessee Department of Health received the report where a 56-year-old patient with no evident risk factors was diagnosed with meningitis.2The only precedent that could be was his 46-day-earlier address to the center with lower back pain and the received epidural glucocorticoid injection.
September 25, 2012 seven more patients with meningitis from the same ambulatory surgical center were reported after the same type of injection. The investigation by the Centers for Disease Control and Prevention (CDC) showed that all vials of methylprednisolone acetate that were used for injections came from the same compounding pharmacy, the NECC. The company was informed about the investigation.
September 27, 2012 a North Caroline patient was diagnosed with subacute meningitis after the same injection.2In several days, all patients, who could have a connection with similar injections, were informed.
October 4, 2012 the microscopic evaluation of all NECC vials with methylprednisolone acetate occurred.
October 18, 2012 the representatives of the CDC and the FDA proved the presence of Exserohilum rostratum, the fungi Rhodotorula laryngitis, Rhizopus stolonifer, Cladosporium cladosporioides, and other types of fungi in all vials. 3
October 19, 2012 all state health departments admitted that they contacted all patients at risk of having meningitis because of the injections.
July 1, 2013 749 cases of meningitis with different complications, including the deaths of 8% of the patients in 20 states were reported.
As soon as the fault of the company was proved, Barry J. Cadden was accused of numerous deaths. The trial related to the outbreak of meningitis took place at the federal level. 4Cadden, as well as his wife, who performed the functions of another pharmacist, took responsibility for the deaths of people from different states.
Commentary and Creativity
In fact, the development of the events could be predicted and understood. The cases of meningitis are not frequent. Each time they occur, much attention is paid to clarify the reasons and identify the actual source of infection. The chronicles of the events in 2012 show that meningitis was not expected. It came from the company no one could even believe. However, at the same time, it is necessary to admit that some representatives of the surgical center where the first case of meningitis was observed in 2012 confessed that they decided to cooperate with the NECC because of low prices on the products and the possibility to buy everything in a short period.
In the field of pharmacy, the conditions under which the NECC employees worked were appropriate. During the trial, Giamei was the first person to testify in a trial4. He underlined that he could hardly believe that the company could be responsible for so many deaths because each product was properly tested. The compounding center followed all federal guidelines.
From pharmacy education, all pharmacists of the company were properly trained and tested before being employed. At the same time, the same witness, Giamei, discussed the peculiar feature of the organization and said that he had never seen the pharmacy laboratory but had to focus on promotions and sales. As well as Giamei, many other workers did not see the problem until the outbreak of 2012. Such a statement seems to be strange and unbelievable indeed.
Pharmacology and microbiology are the fields where numerous tests and analyses should occur regularly. It is not enough to train people or make all employees follow the norms. It is also necessary to take responsibility for each decision and think about the professional improvements but not about financial benefits.
Such organizations as the FDA and the CDC took all necessary steps and precautionary methods to protect people and underline the importance of public health. It is hard for people to deal with such health challenges alone. Therefore, the representatives of the FDA and the CDC demonstrated how it was necessary to organize the case, find the solution, and meet peoples needs.
Future
Many people want to know if it is possible to prevent such cases of meningitis or similar public health problems in the future. The answer is certainly yes. Still, people have to be ready to work hard and take responsibility. In its turn, the government has already demonstrated the intention to improve the situation and develop the regulations under which compounding pharmacies should work. President Obama signed the law within the frames of which it was possible to increase federal oversight and control medical and microbiological organizations1.
There are also many other steps that not only the government, but ordinary people should take. First of all, people should stop thinking that good medicine and pharmacology can be cheap. If there is one or several companies offer cheap production without any reasons in comparison to millions of other organizations with the already established prices, some threats can occur. Todays greed and the intention to save as much money as possible make many people take reckless steps and forget about such factors as safety, quality, and trust. Many companies are ready to provide their customers with guarantees. When something goes wrong, financial compensation turns out to be the best solution. Human life should be priceless. People may save on food, clothes, entertainment, and even education. However, when health is under consideration, no discussions should occur.
The outbreak of meningitis in 2012 occurred due to the mistakes made by the representatives of the compounding pharmacy. People were accused and sentenced. Still, 64 deaths occurred. It is high time for people to start thinking about the outcomes of their pettiness in such fields as pharmacology and medicine.
References
Enwemeka, Zeninjor. 7 things to know about the trial over deadly meningitis outbreak. Wbur News. 2017. Web.
Smith, RM, Schaefer, MK, Kainer, MA, et al. Fungal infections associated with contaminated methylprednisolone injections. N Engl J Med. 2013; 369(17): 1598-1609. Web.
Sulaiman, IM, Jacobs, E, Simpson, S, Kerdahi, K. Genetic characterization of fungi isolated from the environmental swabs collected from a compounding center known to cause multistate meningitis outbreak in United States using ITS sequencing. Pathogens. 2014; 3(3): 732-742. Web.
Valencia, MJ. NECC salesman testifies on fatal meningitis outbreak. The Boston Globe. 2017. Web.
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