(Freyhofer 104)
Globalizing clinical research has reportedly proven to be one solution for America's pharmaceutical paradox. Doctors prescribe more than 10 prescriptions for the average American each year. Only one person in 350, however, will submit themselves to be a participant in experimental drug testing. On the other side of the globe, however a profusion of under-treated, poor, physician-trusting patients who live in Latin America, Eastern Europe, and Southeast Asia provide the rapid, positive results needed for new drugs to receive quick approval. One review noted that 99% of controlled trials published in China netted positive results upon the drug/treatment being investigated. (Shah 23) In Nigeria during 2002, thirty Nigerian families filed a class-action suit against Pfizer, who allegedly violated the Nuremberg Code in 1996 as they presided over an experiment on Nigerian children suffering with meningitis. Researchers reportedly forced a risky, unapproved, experiment on unsuspecting subjects who, as a result, consequently suffered hearing loses, paralysis, brain damage, and, for some, death. One recent report by the Health and Human Services (HHS) raised questions regarding ethics in overseas experimentation. Between 1990 and 1999, the number of foreign investigators seeking FDA approvals increased sixteen fold. As companies do not report projects to the FDA prior to conducting research overseas, actual numbers are likely higher. In addition, after approving new drugs, the FDA does not track research by location. (Ibid.) During late March 1996, Pfizer obtained permission from the Nigerian government, who silenced local physicians' criticism regarding the testing of experimental medicine. Pfizer argues a Nigerian hospital ethics committee sanctioned its study design, however, two Nigerian doctors contend, "There was no ethical committee at the time of the trial, none met, and no approval was properly given for the trial." After the experiment concluded, the "approval" document was created and backdated.
Dr. Juan Walterspiel, one of Pfizer's scientists, who prior to and after the study, warned management this study's methods were "improper and unsafe" was dismissed.
Pfizer planned to "give 100 deathly ill Nigerian children experimental Trovan either orally or by injection, and compare their outcomes to 100 others given shots of competitor Roche's FDA-approved Rocephin." The oral form of Trovan, however, was considered too risky to test on the critically ill, mostly malnourished children.
Pfizer, nevertheless, according to Nigerian families forced the sick children to participate in the study, neglecting to inform of the drugs' experimental nature or the availability of WHO-approved meningitis treatment, available at Doctors Without Borders team, located near the experimentation site.
No Helsinki-required informed-consent form was signed, Pfizer admits, neither did any witnesses sign statements, confirming "verbal consent. Elaine Kusel, an attorney who represented Nigerian families suing Pfizer, states: "These people had no idea they were part of any clinical trial." (Ibid.)
In another analysis of a Third World trial, results determined 90% of South African patients participating in a study of HIV transmission felt they were forced to participate in this trial. "Informed consent is a joke," one clinical investigator, working in developing countries, states.
Public Citizen's Health Research Group loudly criticize unethical study designs, yet are not able to appropriately police study conduct, which the FDA and drug industry perceive to be confidential, "proprietary" information. Ethics documents by international the World Medical Association, the WHO/UNESCO's Council for International Organizations of Medical Sciences and other organizations are reportedly alarmingly powerless to insure experimentations are ethically conducted.
Although Pharma companies have ttempted to voluntarily harmonize clinical research standards abroad to comply with FDA standards, efforts remain dreadfully nascent innumerous developing countries. Basically, Shah (23) contends, although voluntary endeavors by Pharma companies to conduct ethical experimentations are necessary, they do not adequately protect those individuals, whose well-being is sacrificed for profits.
Another questionable research practice which involves deliberate human exposure to pesticide chemicals appears to compromise the "do no harm" principle. All pesticide research, by definition, is designed to determine NOELs carries risk of unknown consequence. Some low-level health effects, potential risks, may not present themselves in onset of experimentation and manifest after the testing period's conclusion. In the past, such negative effects have been noted after participants' were exposed to some pesticides considered "safe." (Oleskey et al.) During the past decade, pesticide manufacturers have increasingly tested pesticides in human volunteers, with the obvious goal to establish threshold levels for symptoms, "termed 'n observed effect levels.' Data from these studies have been submitted to the U.S. Environmental Protection Agency (EPA) for consideration in standard setting." (Ibid.)
The Dearth of Ethical Guidelines
Currently, no required ethical study guidelines for pesticides toxicity conducted in humans exists, nor is any governmental...
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Cloning is among the feats in science that many of us, as part of our childish character, ideas, and imaginations, have only visualized before. We used to say in our mind, "what would happen if we create someone who is an exact duplicate of ourselves?" Again we say, "how convenient it would be to have that someone do the things we don't want to do." Or, "have that someone face the
COVID-19 VACCINE HESITATION IN THE BLACK COMMUNITY 14COVID-19 Vaccine Hesitation in the Black CommunityErica A. WoodsDepartment of English, Community College of PhiladelphiaEnglish 102-016Dr. Mary GriffinApril 5, 2021COVID-19 Vaccine Hesitation in the African American CommunityThere is no doubt whatsoever the COVID-19 has wreaked havoc around the globe. With over 3 million people dead across the world, with the US having registered more than half a million deaths, this is a pandemic
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