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Clinical Drug Testing: Is Drug Research Safe, Effective and Unbiased
Drug Discoveries: Is Research Safe, Effective and Unbiased
Jaytonia Wilson (60003372)
Santa Fe College
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Clinical Drug Testing: Is Drug Research Safe, Effective and Unbiased
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Overview
An important duty of conducting research and testing of new medications is to ensure that
they are safe and effective. This is extremely important considering the catastrophic outcomes of
experiments on humans in the past. Before clinical testing was regulated by the Food and Drug
Administration (FDA), unethical experiments were conducted in which healthy people fell ill,
patients’ conditions worsened or participants died. This provokes the questions of whether the
government is not protecting the vulnerable populations; are people putting themselves at risk by
becoming desperate guinea pigs, or is the research necessary to enable the discovery of life
saving drugs. The purpose of the Food and Drug Administration is to make sure food, drugs and
cosmetics are not only safe and effective, but adhere to labeling standards. Medication in
particular, must go through a rigorous process by meeting guidelines, and conducting clinical
testing before they are deemed as unfavorable or favorable for marketing.
Food and Drug Administration (FDA) Guidelines
The FDA’s rigorous process and guidelines for approval of drugs institute’s strict
regulations and aims to protect the potential liability for negative participant outcomes The
FDA’s oversight of clinical trials imposes the principles of Good Clinical Practices (GMP).
GMP secures the procedures of the trial and the policies will protect the safety of the patient. It
is their commitment that routine investigations are conducted of clinical research centers that
observe the quality of the study and document their research plan. Research plans generally
indicate the types of study, and plan of action for any expected risk, and side effects on humans
and animals. Researchers must also obtain informed consent from patients who choose to
participate in the study.
Stages and Phases of Clinical Trials
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Research to establish a drug’s safety and efficacy proceeds through the following
investigative, preclinical, and clinical stages (Shah, 2006).
Stage 1. Investigative (basic research)
Stage 2. Preclinical research using animals and human tissues
Stage 3. Clinical trials using human subjects
Phase I. Safe dosage levels (establish safety)
Phase II. Safety and effectiveness (establish efficacy)
Phase III. Large group studies (confirm efficacy)
Phase IV. Post marketing studies
In the investigative stage, researchers formulate hypotheses and carry out basic research
without animal or human testing. The preclinical stage conducts experimentation on human
tissue and on animals, by increasing and evaluating the dosage of the medication, related to the
equivalence of consumption and the body mass of human subjects. The toxicity levels determine
if it is then safe to begin human experimentation on a small group of participants. The FDA will
allow clinical trials to commence only if the investigational new drug (IND), shows that human
subjects will be protected and that scientific evaluation is rigorous enough to allow the drug’s
effectiveness and safety to be evaluated (CISCRP, 2010). Procedures are then enacted to ensure
the study will follow ethical and moral principles and there is a potential for the study to enable a
decision about marketing the drug.
Phase I investigates the safety of the minimum and maximum dosages on a small
population of test subjects. In this phase, therapeutic, and adverse effects are documented in an
effort to identify if the drug action is beneficial to the condition being treated. Approximately
seventy percent of drugs fail in the Phase I stage. In Phase II, several hundred participants are
Clinical Drug Testing: Is Drug Research Safe, Effective and Unbiased
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evaluated by being placed in a “double-blind” study, in which half of the participants receive the
actual drug and the other half receive a placebo. A placebo is an inactive drug used to test the
psychological perception that the patient is receiving the actual drug. Phase III involves a larger
group of participants and allows the manufacturer to evaluate the benefits, risks, and compare it
to the commonly used treatments for the condition, if any. Although many participants may be
jeopardizing their health and possibly their lives, the offer of cash incentives, and therapeutic
treatment, is no reservation to participate in the clinical trials.
Unfavorable Studies
One of the most blatant and disturbing clinical trials sponsored by the U.S. government
was the Tuskegee Study of Untreated Syphilis in the Negro Male (Shah, 2006). The study began
in 1932, where approximately 500 African-American males, mostly poor, illiterate,
sharecroppers and farmhands were recruited. The subjects of the clinical research were never
informed of their ultimate contraction of the illness or the purpose of the study, which was not to
cure, but detect if syphilis affected black people and white people differently. Doctors proposed
that by volunteering for the study, they would receive overall medical care, transportation to and
from the clinic, a meal upon examination and the earning of fifty-dollars for burial expenses.
The study was proposed to only last 6 months, but unfortunately concluded some forty years
later in 1972.
Over the forty years, 399 African-American males who were unknowingly infected with
syphilis, according to the figures, were tracked by the clinical study. If left untreated, syphilis in
its final, or tertiary stage, can cause blindness, problems with the nervous and cardiovascular
system, mental disorders and death. The researchers allowed the participants to die, collecting
data through autopsy, to investigate how the disease spreads and eventually torments the body.
Clinical Drug Testing: Is Drug Research Safe, Effective and Unbiased
The most astounding and flagrant injustices to these test subjects, was that penicillin became
available thirteen years into the study, and became the ultimate cure. Consequently, many men
had infected their families, their children and eventually died from complications related to the
disease. Years later, President Bill Clinton made a formal apology on behalf of the U.S.
government for the lives lost to the unethical study.
“Tuskegee fits almost all the negative characteristics of a clinical trial you can identify.
No consent. There was deception and needless harm. There wasn’t even a clear scientific
justification for the study to begin with” (Shah, 2006). Consequently, due to the openly racist
nature of the Tuskegee experiment that involved the U.S. government, many black Americans
believe it was part of a plot to annihilate their race and that the effort continues today. A poll
showed that nearly half of blacks asked thought AIDS was produced in a lab by the U.S.
government, and 43 percent said that the government was not revealing all there was to know
about the disease (Carroll, 2009). Although clinical trials often have stipulations to be of a
certain race to study the effects of an experimental drug, currently there continues to be a high
level of distrust in the African-American community in participating in clinical studies.
Despite suspicion of clinical trials targeting minority populations, testing drugs on
humans is the only way to discover if the treatment will work on people, but it involves great
risk. For example, the drug Thalidomide was introduced in Europe in 1957 as a sedative to
induce sleep. The nature of the drug caused severe birth defects in women who were pregnant,
and affected 10,000-20,000 worldwide with teratology of limbs. Thalidomide was never
approved for use in the United States at the request of its manufacturer Richardson-Merrell,
however, it prompted stricter guidelines on clinical testing of drugs and the passing of the
Kefauver-Harris Amendment of 1962. It states that a drug must be proven safe and effective
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before marketing. Yet to prove safety and effectiveness, product testing on human subjects is
necessary.
Drug Discoveries
Despite the history and the risk associated with clinical trials, there have been many medical
breakthroughs in the advancement of healthcare due to the clinical trial process. Polio was one of
the most dreaded childhood diseases of the 20th Century in the United States. There were usually
about 13,000 to 20,000 cases of paralytic polio reported each year in the US before the
introduction of Salk inactivated polio vaccine (IPV) in 1955 (CDC.com). Currently, polio is
considered an eradicated disease mercifully on the part of many participants in its clinical trial
stage.
The Gardasil vaccination is a medical breakthrough in the prevention of certain strains of the
human papilloma virus (HPV). There are over 30 strains of HPV that are sexually transmitted,
and 15 that could lead to a 70%-90% probability of producing cervical, penile, anal, and vaginal
cancers (CDC, 2007). Although Gardasil only protects against HPV strains 6, 11, 16 and 18, the
vaccination has vastly decreased the infection of HPV and cancer in many men and women,
especially sexual adolescent teens. As of 2008, Gardasil has been approved for use in 41 states
and 120 countries.
Conclusion
Participants are no longer being misled by clinicians, being withheld treatment or exposing them
to a drug that has not been clinically tested and approved for marketing. But subjects still have
to sign a disclaimer understanding the consequences of guinea pig participation. Americans
today are more in charge of their healthcare than ever before and have access to resources to
understand and appreciate the reality before they sign. Despite, the FDA’s regulations, no
Clinical Drug Testing: Is Drug Research Safe, Effective and Unbiased
government can control every aspect of an enterprise as risky as clinical trials. It always has
been and always will be a gamble.
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Clinical Drug Testing: Is Drug Research Safe, Effective and Unbiased
References
Carroll, J. (2009). The pharmaceutical industry: Opposing viewpoints. Michigan:
Greenhaven Press.
Centers for Disease Control and Prevention (2007, April 6). Vaccines and preventable diseases.
Retrieved March 1, 2014, from http://www.cdc.gov
Center for Information & Study on Clinical Research Participation. (2010). About clinical
research participation. Retrieved March 1, 2014, from http://www.ciscrp.org
Clinical Trials (2007, September 20). Understanding clinical trials. Retrieved March 1,
2014, from http://clinicaltrials.gov
Shah, S. (2006). The body hunters: Testing new drugs on the world’s poorest populations.
New York: New Press.
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