Prozac Politics: How a Drug Helps Us to Understand Transparency in the Health Sector

Abstract

While Prozac initially came to be termed the ‘wonder-drug’ for adults suffering from depression, the trend inevitably spread to the treatment of the pediatric population – that is, to children and adolescents aged 8 to 17 years. In 2003, however, America’s main drug regulator – the Food and Drug Authority (FDA) – was the first to approve Prozac for this age group. But reports of the scientific community followed soon, claiming that patients under the age of 18 should not be given antidepressants. There had been disturbing evidence that Prozac’s risks outweighed its benefits and that it led to severe adverse effects, most notably aggressive and suicidal behavior. Unfortunately, their voice was only partly heard: later that same year, the British Medicine and Healthcare Products Regulatory Agency (MHRA) issued a ban on new-generation antidepressants for the treatment of the pediatric population. But while it excluded Prozac from the ban, the European Medicine Agency (EMA) thought differently: it did not only decide to join the bandwagon of prohibiting the prescription of antidepressants for children two years later, but to extend the ban to Prozac as well. Eventually, the decisions by different European drug regulators – and their clashes with the American FDA – unleashed a heated debate about secretive proceedings in the health sector that affected the industry, its regulators, the scientific community, and the patient population. Only three years later, in 2006, the EMA suddenly approved Prozac for the treatment of children and adolescents under the condition that further clinical research was done – notwithstanding previous skepticism. And the debate continues until today. As such, it illustrates the thin line between economic benefit, consumer protection, and scientific progress, together with its mediating factor: disclosure of information or transparency. Furthermore, the case-study mentioned above serves well to highlight the shallow proceedings in the pharmaceutical industry, which, to date, remain corrupt and secretive.