Pharmaceutical Clinical Trials Gone Wrong

Life-saving drugs such as penicillin and insulin have fundamentally changed the course of human history by enabling health care professionals to control – and in some cases eradicate – many of the illnesses that have plagued civilizations for centuries.

To meet the demand for new weapons in the war against disease, pharmaceutical companies spend millions of dollars developing and testing new drugs through clinical trials. Although many trial volunteers and patients benefit as a result, these advancements in medicine come at a terrible price when clinical trials go wrong.

Fatality during drug trials

One particularly horrifying case occurred in 2006, when six test subjects were hospitalized in London after taking an experimental immune stimulant designed to treat leukemia and rheumatoid arthritis. The subjects, who were all healthy young men, suffered from severe breathing problems, chills and nausea soon after taking the drug, and one man experienced multiple organ failure that nearly led to his death. Even though the drug had been approved for testing on humans, the subjects may not have received enough information about its potential side effects before agreeing to volunteer for the trial.

Unrecognized Errors

While the tragedy in London represents the most frightening kind of clinical trial failure, others come from errors in scientific studies that can go unnoticed for years. One of these studies, for instance, advocated a combination of two drugs to treat high blood pressure. Because the study was published in The Lancet, a highly influential medical journal, many doctors prescribed these drugs to patients without knowing that the treatment provided little added benefit and could possibly lead to severe kidney damage.

Eventually, the study was retracted by the Lancet after citing “serious concerns” about the findings, but the pressure for researchers to publish too soon remains high as the drug market becomes more competitive.

The FDA’s Reaction

Cases such as these have prompted the Food and Drug Administration to establish new regulations to help clinical trial sponsors and their staffs to identify potentially fatal reactions. In the past, investigators were only required to report threatening side effects related to the drug, but as of March 28, 2011, they must report all adverse reactions that could lead to death or hospitalization.

New FDA Regulations

The new regulation also requires more thorough surveillance to catch data entry errors. Some hospitals, such as The Clinical Center at the National Institutes of Health (NIH) in Bethseda, Maryland, are already using methods to reduce these errors. Because all of their patients are clinical trial subjects, they have designed a robust data collection system that alerts nurses, pharmacy technicians and their supervisors to discrepancies in patient records. The system analyzes information as it is recorded, as opposed to a “double entry” system typically used in medical transcription and other kinds of sensitive data entry such as accounting. Not only does this reduce costs, but it also allows clinicians to detect errors more quickly.

Although these new rules will help prevent further clinical trial disasters, the first line of defense remains with the trial staff, as they are the ones who administer drugs to the test subjects. Proper nursing and pharmacy technician training will enable them to identify adverse side effects to the drug, provide the correct dosage, and report their findings to the supervising doctors and pharmacists. Lastly, staff members represent the human “face” of the clinical trial world, offering the information and support that test subjects need to feel safe enough to complete the trial.

Brandi Tolleson has a master’s degree in journalism, and writes on various topics, including health, education and history.

Contributing Author

This post was written by contributing author at Hive Health Media. If you would like to write for us about health, fitness, or blogging topics, click here.

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