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Laboratory to Pharmacy
A physician has just diagnosed the pain in your joints
as arthritis or the cause of your headaches or dizziness as high blood
pressure. He gives you a prescription for a drug he believes to be safe and
effective for the treatment of your condition. This drug may have been
approved by the Food and Drug Administration as a result of research studies
done locally by a group that offers contract clinical research services to
the pharmaceutical industry.
Drug
Research and Analysis Corporation (DRAC) in Montgomery, Alabama performs
such a service and is one link in the chain of extensive testing required by
the Food and Drug Administration (FDA) before a drug may be placed on the
market. Dr. Henry A. Frazer, president of DRAC, says his company performs a
vital part of the research on many drugs that eventually will be dispensed from
your pharmacy.
Most of the
drugs DRAC researches are new drugs not yet approved by the FDA. New drugs are
those that have been studied extensively in animals and found to be safe for
human trials. Only after animal studies
show a drug to be safe and effective is a research program begun with both
healthy people and patients with a particular illness. Some people have
suggested that humans are used as ''guinea pigs'' for research studies, but
that is not so. In the laboratory guinea pigs and other animals are used to
study the effects of a drug about which very little is known. Before human
studies are begun, the main action of a particular drug is already known
from previous animal studies. If these previous studies had shown that there
was a good chance that a serious side effect would occur after taking a
particular drug, the FDA would not allow that drug to be studied in humans.
The procedures followed by DRAC are the same as those used to study all new
drugs before they are declared safe and effective by the FDA.
The pharmaceutical company contracting DRAC'S services supplies a
protocol which must be observed. This protocol, submitted to the FDA before
any testing begins, dictates the conditions under which the study is to be
conducted. DRAC also has an Institutional Review board composed of
practicing physicians, nurses, scientists and other professionals including
lawyers and ministers which approves each study before it begins.
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