Stimulation programs for pediatric drug research – do children really benefit?

Most drugs that are currently prescribed in pediatrics have not been tested in children. Pediatric drug studies are stimulated in the USA by the pediatric exclusivity provision under the Food and Drug Administration Modernization Act (FDAMA) that grants patent extensions when pediatric labeling is provided. We investigated the effectiveness of these programs in stimulating drug research in children, thereby increasing the evidence for safe and effective drug use in the pediatric population. All drugs granted pediatric exclusivity under the FDAMA were analyzed by studying the relevant summaries of medical and clinical pharmacology reviews of the pediatric studies or, if these were unavailable, the labeling information as provided by the manufacturer. A systematic search of the literature was performed to identify drug utilization patterns in children. From July 1998 to August 2006, 135 drug entities were granted pediatric exclusivity. Most frequent drug groups were anti-depressants and mood stabilizers, ACE inhibitors, lipid-lowering preparations, HIV antivirals, and non-steroidal anti-inflammatory and anti-rheumatic drugs. The distribution of the different drugs closely matched the distribution of these drugs over the adult market, and not the drug utilization by children

Trends of cervical cancer in Greenland: A 60-year overview

<p><b><i>Background.</i></b> Due to its extraordinarily fast economic and social transition, virtually closed borders before 1940 and, moreover, that 85% of the population has the distinctive genetics of the Inuit, Greenland is a very interesting country to study cervical cancer from a historical perspective. Nevertheless, little has been reported about long-term cancer trends in Greenland. Our aim was to describe and interpret the incidence of cervical cancer from 1950 to 2009.</p> <p><b><i>Material and methods.</i></b> We systematically searched PubMed for articles reporting the incidence of cervical cancer in Greenland. We supplemented this with data for 1980–2009 obtained from the Chief Medical Officer of Greenland.</p> <p><b><i>Results.</i></b> Incidence of cervical cancer was around 10 per 100 000 women (age-standardised, world population, ASW) in the 1950s, 30 per 100 000 in the 1960s, and in the 1980s around 60 per 100 000. From 1985 onwards, the incidence of cervical cancer started decreasing to the current level of 25 per 100 000.</p> <p><b><i>Conclusion.</i></b> The steep increase in the incidence of cervical cancer from the 1950s onwards is unlikely to be explained by increasing completeness of data. In parallel with the economic development, however, out-of-wedlock births (proxy for sexual behaviour) increased dramatically from 1935 onwards while tobacco use increased from the 1950s onwards. From the late 1960s to around 1990, data suggested rather stable but high levels of sexual habits. The decrease in the incidence of cervical cancer since 1985 is consistent with the introduction of screening. The data strongly suggested that the increased burden of cervical cancer in Greenlandic women was real and followed earlier changes in sexual behaviour; these changes were likely a consequence of the tremendous societal changes.</p