Unethical Experimentation Issues and Concerns Term Paper

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(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.

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' 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 oversight implemented. No measures are in place to protect human participants; however, adverse health effects are noted to include cancer, acute and persistent nervous system injury, reproductive organ injury, lung damage, dysfunction of the immune and endocrine system, and birth defects.

Ethical and policy concerns include the dearth of mandatory ethical guidelines for research pesticide that manufacturers conduct and submit to the U.S. EPA. During research, procedures for minimizing harm to study participants and subjecting them to no unreasonable risk are non-existent. Approaches to obtain subjects' informed consent may also be less stringent than those specified by the Common Rule (Office of Science and Technology Policy 1991). Others, nevertheless, have argued testing pesticides in humans is valuable; as humans serve as the best predictor of human toxicity. (Ibid.)

The following list summarizes required elements of informed consent stipulated by the Common Rule:

statement that the study involves research, an explanation of the research, and a description of the procedures to be followed;

description of any reasonably foreseeable risks or discomforts to the subject;

description of any benefits to the subjects or to others that might reasonably be expected;

disclosure of alternative procedures or courses of treatment;

statement describing the extent to which confidentiality of records identifying the subject will be maintained;

For research involving more than minimal risk, an explanation of the availability and nature of any compensation or medical treatment if injury occurs;

Identification of whom to contact for further information about the research and about subjects' rights, and whom to contact in the event of a research-related injury; and statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time. ("Chapter 14:...")

III. International Positions

As Openly As Possible

During February 1995, the United States Department of Energy's (DOE) Office of Human Radiation Experiments published Human Radiation Experiments: The Department of Energy Roadmap to the Story and the Records ("The DOE Roadmap"). "The Roadmap summarized work undertaken at the direction of Secretary of Energy Hazel R. O'Leary to find, declassify, and make publicly available DOE records related to human experimentation." Secretary O'Leary's larger openness initiative also committed the Department to conduct business as openly as possible, while providing information needed to assess this agency's past activities. (Human Radiation Experiments...) The Roadmap includes approximately 150 human radiation experiments summaries, as well as, summaries of more than 275 additional studies which are identified; documented; confirmed. Methodological and historical descriptions, topical discussions, and records series descriptions describe a variety of activities from the early 1940s through the early 1970s. The posited intent for this project is to inclusively identify human radiation research projects and help insure the continuation of the Secretary's openness initiative. (Ibid.) The following lists International Laws regarding the ethical issue of stem cell research for experimentation:

1.Great Britain - Great Britain's law, the to allow limited human cloning for the purpose of cloning stem cells from human embryos (amending the Human Fertilization and Embryology Act of 1990, passed in January 2001, amidst strong, vocal opposition from religious leaders. Following seven hours of Parliamentary debate in Parliament, proponents of prevailed by a vote of 212 to 92. (Stevens) Great Britain's law:

Guarantees that a committee of experts would closely examine ethical and scientific aspects of the issue won over opponents and allowed the victory. It should be noted that human cloning in Great Britain remains illegal. Furthermore, regulations mandate that any embryo involved in stem cell research cannot be used after fourteen days. (Ibid.)

2. Australia - In 2003, Australia had not yet passed federal legislation regulating stem cell research. In some part of Australia, stem cell research is legal; however, legislation differs throughout Australia's six states and two territories.

For example, Tasmania, Victoria, Western Australia and South Australia have laws regulating cloning and stem cell research. The Federal Cabinet, faced with a proposal to ban the use of embryo cells, decided the ban would not.....

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