Healthy Volunteers?

In an article published in the January 7, 2008 issue of The New Yorker, columnist Carl Elliott sheds light on the ethics of clinical trials http://www.newyorker.com/reporting/2008/01/07/080107fa_fact_elliott


After new drugs have been tested in animals for safety and tolerability, initial clinical trials in humans are conducted. These Phase 1 trials assess the pharmacokinetic and pharmacodynamic characteristics of the study drug as well as assess its safety and tolerability in humans. Most often, Phase 1 trials are conducted using "healthy volunteers" with no concomitant diseases who are not taking any other medications. The reason for this approach is to avoid confounding; making it easier to determine possible side effects associated with the study drug.


Phase 1 trials may often involve frequent blood draws to determine the plasma concentration of the drug in the bloodstream, collection of urine and feces to determine the metabolism and excretion of the drug, and administration of the drug after fasting or a high-fat meal to assess whether food affects absorption of the drug. For some studies, procedures such as biopsies, endoscopies, or echocardiograms are performed. Therefore, the people who volunteer to participate in these studies are often confined to a hospital ward or inpatient facility for several days or up to several weeks. These participants receive monetary remuneration from the pharmaceutical company that sponsors the trial.

Because of the nature of these clinical trials, the pool of potential participants includes those who have the time and need the money. This means that the healthy volunteers in many phase 1 trials are made up of the unemployed, college students, contract workers, ex-cons, and young adults living on the margins.

Under these circumstances, many ethical dilemmas may arise:

• Are people volunteering to participate in clinical trials for altruistic reasons or are they only doing it for the money?
• Should volunteers in clinical trials be paid by the pharmaceutical companies? If so, how much?
• If the sites conducting the clinical trials are being paid by the pharmaceutical companies, can they be objective when determining who is eligible to enroll in a trial?
• Are "healthy volunteers" truly representative of the target population or even the general population?
• If individuals are participating in multiple trials, are the results from subsequent trials affected by study drugs taken in previous trials?
• Is it ethical to use people in clinical trials to study a drug that those same people will never be able to afford to take, if the need arises, because they cannot afford or are not eligible for health insurance?
• Are investigators so focused on the fees that they receive from the sponsor for enrolling more subjects that they forget the Hippocratic Oath? First, do no harm.