Purpose : This randomized cross‐over group pilot trial assessed feasibility of recruiting survivors from a long‐term follow‐up clinic to an exercise group and measured whether outdoor or indoor exercise sessions better supported exercise motivation and behaviors in survivors of cancer. Methods : Sixteen adolescent and young adult survivors of any cancer completed indoor and outdoor exercise sessions in this randomized cross‐over pilot trial. Measures of physical activity, motivation, and fatigue were taken 2 weeks before and 2 weeks after indoor sessions and 2 weeks before and 2 weeks after outdoor sessions. Measures of physical activity and fatigue were also taken during each exercise session. Results : Initial recruiting of 19 participants met recruiting goals. Survivors who attended the most sessions lived an average of 8.7 km closer to the clinic. Objectively measured physical activity intensity was 0.63 metabolic equivalents of a task (METs) per minute greater during outdoor exercise sessions as compared to indoor exercise sessions. There were no meaningful differences in long term, habitual physical activity behavior, motivation, or fatigue in the weeks following the outdoor exercise sessions as compared to the indoor exercise sessions. Conclusions : This study shows the feasibility of recruiting survivors from a long‐term follow‐up clinic to community‐based exercise groups. Although this brief pilot intervention did not show significant effects on habitual physical activity behavior or motivation in adolescent and young adult survivors of cancer, the greater exercise intensity during the outdoor exercise sessions indicate that holding group exercise sessions for survivors outdoors may promote greater intensity during exercise.
IMPORTANCE Some sole-source, off-patent drugs in the United States have undergone substantial price hikes in recent years. Despite increased attention by lawmakers, there are limited data to guide policy. OBJECTIVES To describe key attributes of sole-source, off-patent, off-exclusivity drugs; to characterize the prevalence of price increases; and to identify attributes associated with price increases. DESIGN, SETTING, AND PARTICIPANTS In this cross-sectional study, 300 sole-source, off-patent, off-exclusivity drug products met inclusion criteria and were selected for analysis from January 1, 2008, to December 31, 2018. Attributes were identified from multiple sources, and yearly wholesale acquisition cost prices were determined from First Databank. MAIN OUTCOMES AND MEASURES The association of drug attributes with the following 2 price change thresholds was measured after adjusting for inflation: 25% or more price increase in a calendar year (wholesale acquisition cost) and 50% or more price increase in a calendar year. The rate of annual price increase over time was also measured. RESULTS Of the 300 drug products and 2242 observations analyzed, the overall inflation-adjusted mean increase in drug prices was 8.8% (95% CI, 7.8%-9.8%) per year. Ninety-five drugs (31.7%) increased by 25% or more during any calendar year, and 66 drugs (22.
High prescription drug prices contribute significantly to healthcare spending in the United States and compromise patients' access to quality medical care. A number of factors allow drug manufacturers to set much higher prices in the US than in other comparable high-income nations. Price-control depends primarily on the entry and persistence of generic products following the expiration of the market exclusivity period granted to the manufacturer of the brand name drug. Unfortunately, barriers to generic entry are common, allowing off-patent drugs like albendazole to remain relatively expensive despite having been marketed in the US for decades. By contrast, miltefosine became FDA approved more recently and has maintained a high price tag by way of a novel incentive program-the neglected tropical disease (NTD) priority review voucher (PRV) program. The voucher has a high market value and can be sold or transferred well before the drug for which it was awarded becomes available on the market. While both drugs are used to treat parasitic infections that are uncommon in the US, they differ by market and regulatory conditions-each telling an interesting pricing story.
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