Clinical Research Past and Present

Clinical Research Past and Present

Tina Ross-Cruz

Abstract

Research disasters have been noted for years. In the early years, the reasons for these disasters was that there were no regulations governing the protection of human beings; and there were no guidelines for safety and efficacy of a new medication or treatment prior to the use in humans. Now regulations and guidelines are in effect for the protection of human subjects. These guidelines and regulations also protect the researchers. These regulations have enabled the researchers to further scientific knowledge of diseases and the etiology, along with the bioavailability, toxicology, and pharmacology of the new medication or treatment. Even with all of these regulations and guidelines, still researchers perform unethical research on human subjects. This could be attributed to several factors: One is the financial gain; second, is the need to be the best; and third, the professional and academic pressure put on the researchers. Although there are these pressures, the research subject should still be aware of the research at hand and the qualifications of the researchers.

Clinical Research Past and Present

Imagine living in the early twentieth century and suffering from chronic headaches. A physician suggests trying something different, a medication not approved by the Food and Drug Administration (FDA) for chronic headaches. The medication is taken at the physician's request and the result is death. This kind of pre-clinical research actually did happen and still does today. There are regulations today that govern clinical research in humans because of this type of disregard for human life. These regulations enable healthcare providers to enhance scientific development and to minimize risks involved with participation in a clinical research trial.

The need for current and accurate information concerning the proper conduct of clinical research has never been greater than it is today. Researchers are aware of the vulnerability of the data supporting research trials today; this is why properly conducted randomized clinical trials have profound effects on the advancement of medicine. Research involving human patients can be performed in unethical manners. More importantly, if it is not conducted under stringent standards there is a potential for criminal deviations. That is why there is a need for the potential research subject to select ethical sites to ensure their regard for safety and moral conduct.

History of Clinical Research

In the year 1780, Benjamin Franklin said, (Shryock-1947)

"The rapid true science now makes occasion, my regretting sometimes that I was born so soon. It is impossible to imagine the height to which maybe carried, in a thousand years, the power of man over matter all diseases maybe prevented or cured, not even expecting even that of old age, and our lives lengthened at pleasure beyond the

anti-diluvium standard."

The history of medical science in the United States falls into four epochs; the first era began early in the 18th century and ended approximately in 1820. The second era falls in the year 1820 and ended around 1860; the third era started in 1860 and ended around 1895. Finally, the last era began in 1895 and has proceeded to the present era. During this time, American medicine surpassed a long persisting colonial status and emerged on a level of cultural independence.

Physicians have for years attempted to understand diseases, to use the knowledge to cure and relieve suffering in the ill. There is a sense of the term "experimentation" in which it would be true to say that physicians have been experimenting on their patients since a time beyond memory, record or knowledge. From earliest times when a patient presented with unusual symptoms or a condition that failed to response to usual treatment, doctors have experimented with new therapies. "This approach to medical knowledge, trying out new treatments and procedures and then carefully observing the results, was the dominant method in Western medical science until well into the present century" (Schafer, Vol. 307, P 719-724). Therapies were not based on observational studies but on the authority of tradition. For instance, take the great cough medicine; people were sold the recipe of whiskey, honey, and lemon to quiet the cough. Recipes similar to these were sold to the public without any evidence of safety and efficacy. The products that were non-effective; most of them were 99% water. In the words of Oliver Wendell Holmes, M.D., "If all of these patent medications were thrown into the ocean it would be good for the population, but bad for the fish in the ocean" (Parasandola, 1999).

"The history of medicine is abundantly endowed with therapies that were widely used and then were shown ineffective or deadly" (Passamani, 1991). For instance, radiation therapy was used on patients between 1940 and 1968 for the treatment of acne. The radiation treatment was found later to lead to a high incidence of thyroid cancer in the treated patients.

The thalidomide disaster was another treatment found to be toxic. Thalidomide was used in pregnant women for morning sickness in the early 1950's. This led to birth defects in hundreds of babies. Because of the birth defects in infants, the drug was banned from use in the United States. In 1906 a law was passed to set standards for drug purity and quality through the United States Pharmacopoeia and the National Formulary; however, there still was not a law regulating the safety profile of drugs at this time.

Disasters of Clinical Research

"Research was not as it is today" (Code of Federal Regulations, 1999). For instance, a study that was performed in 1937 involved the death of 107 Americans, most of whom were children. The deaths occurred after taking Elixir Sulfanilamide, a medicine used to treat bacterial infections. The drug Sulfanilamide itself was safe, but the solvent dethylene glycol added made the elixir deadly. The incident received major media coverage, which led to the 1938 Food, Drug and Cosmetic Act. "The most important outcome of the disaster was that new drugs had to be tested and proven safe before marketing" (Parascandola, 1999).

Another disaster of medical research occurred during World War II. The public views doctors as some of the most respected and intelligent individuals in our society. So how can doctors be transformed from healers