By: Rebecca A. Meseroll, Ph.D.
Climate change and food supply policy
Global food supply imperiled by severe weather
In recent years, droughts and other severe weather conditions have contributed to crop failure and subsequent spikes in the global food price index measured by the Food and Agricultural Organization of the United Nations (FAO). Last week, the Global Food Security (GFS) program, released an in-depth report highlighting the potential risks to the worldwide food supply due to increasing extreme weather events brought on by climate change, as well as potential social, political, and economic consequences of a stressed global food supply. The report lays out a theoretical “plausible” worst-case scenario of a significant global production decrease of four major crops (rice, wheat, corn, and soybeans) simultaneously, based on actual data from years when these crops were affected by drought. Under the conditions of this worst-case scenario model, the GFS program report expects that developing nations would suffer the most, as people in those nations would likely go hungry, while other import-dependent nations could experience social and political upheaval as a result of rapidly increasing food prices. Meanwhile, consumers in richer, industrialized nations would be not be especially affected. The report makes several recommendations to prevent a future food supply catastrophe, including a call for increased research to understand the actual risk of the theoretical scenarios laid out in the report, improving governmental policies to buffer against spikes in the food supply market, and innovating agricultural techniques to improve productivity and production resilience in the face of extreme weather. (Erik Stokstad, ScienceInsider)
Positive results for cardiovascular clinical trials in decline
A study published in PLoS One earlier this month found that there has been a steep decrease in positive results in a subset of clinical trials published since 2000, as compared to those published between 1970 to 2000. Specifically, the study examined the outcomes of all large randomized clinical trials supported by the National Heart, Lung, and Blood Institute (NHLBI) between 1970 and 2012 to evaluate drugs or dietary supplements that aimed to treat or prevent cardiovascular disease. A total of 55 trials met the researchers’ criteria, and were scored for whether they reported a positive, negative, or null result for the main outcome tested. In the trials conducted prior to 2000, 57% reported a positive result, in stark contrast to the mere 8% after 2000. The authors of the study conclude that the difference in outcomes is associated with the inception of preregistration of trials with clinicaltrials.gov, which was created by the Food and Drug Administration Modernization Act of 1997 and requires trials to disclose their study design and expected outcomes before data collection begins. This suggests that an increase in transparency resulted in more stringent science, and also calls into question the results from the pre-2000 trials. Although the authors of this study note that the association of trial registration and the upward trend of null trial outcomes cannot be determined to be causal based on the limited dataset they present, the scientific ideal of impartiality is certainly encouraged by increased transparency and a priori identification of expected outcomes. (Chris Woolston, Nature)
Celebrity drug endorsements
Kardashian drug endorsement prompts FDA admonition
Prompted by an Instagram post in which Kim Kardashian extolled the virtues of the morning sickness drug Diclegis, the drug’s manufacturer, Duchesnay Inc., was issued a warning letter from the FDA’s Office of Prescription Drug Promotion. Although Kardashian publicized her partnership with Duchesnay Inc., included links in her post to Diclegis’ safety information website, and encouraged women considering the drug to talk to their doctor about it, the FDA concluded that complete omission of any drug risk and limitation information was inconsistent with the FDA guidelines for celebrity drug endorsements and testimonials. One major limitation of Diclegis noted by Robert Dean, who penned the FDA’s warning letter, is that it has not been studied in women who suffer from hyperemesis gravidarum, a condition marked by severe and persistent nausea during pregnancy. Kardashian’s post has since been removed, but this episode raises the issue of how celebrity medical endorsements in general should be regulated, especially on social media platforms where advertisements can intermingle with other content more readily than it can in a clearly delineated commercial break on television or radio. (Christine Hauser, The New York Times)
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