White Paper

The Environmental Impact of Clinical Trials

For many years it has been almost universally accepted that there are various sources that may impact or cause disease among which biological, social and environmental differences have all been investigated. Many clinical trials have been conducted to assess the impact of the environment on outcomes e.g., the effect of the environment on the outcome of studies assessing the efficacy of drugs for patients with dry-eye syndrome, the impact of diet on obesity and cardiovascular disease, and the impact of the environment on autoimmune diseases have all been studied, as have many other interactions.

A growing vox populi and increasing government legislation have led to pharmaceutical companies being required to document the impact of their drug products on the environment. This has given rise to new terminology such as ecopharmacology and pharmacoenvironmentology. The first study that detected drugs in sewage was reported in 1977 and as recently as September 2011, the FDA published a notification that epinephrine inhalers using chlorofluorocarbons as the propellant will be phased out at the end of this year, thus bringing to a close a process begun in 2008. Because of the ecological impact of these chlorofluorocarbons on the environment, manufacturers of drugs given by aerosols have switched to a more environmentally-friendly propellant called hydroflouroalkane (HFA).