FDA announces more state support for FSMA produce safety rule
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, yesterday announced the second year of funding to states—totaling $30.9 million—to support the implementation of the Food Safety Modernization Act (FSMA).
In a press release, he said the funding will ensure that 43 states have the resources they need to formulate a multiyear plan to implement a food safety system and to develop education, outreach, and technical assistance. The programs prioritize farming operations that fall under the produce safety rule.
The availability of funding was first announced in May 2016, and the bids were open to all states and territories. The first round of funding totaling $21.8 million was announced in September 2016 and involved 42 states.
In the press release, Gottlieb said, "We look forward to continuing our work with states and all those who grow fruits and vegetables covered by the rule to improve produce safety, consistent with the mandate Congress gave the FDA under the new law. Working with the states, the FDA will also continue its vigorous outreach."
Jul 19 FDA press release
Age, viral load may predict mortality in Ebola patients
Being under the age of 5 years, over 45, and having high viral counts are all associated with an increased risk of death from Ebola, according to a study yesterday in PLoS Neglected Tropical Diseases.
The study used data collected from five Ebola Treatment Units in Liberia and Sierra Leone from September of 2014 to September of 2015. The prevalence of clinical symptoms in the 470 patients was matched with demographics and outcomes to gain a better understanding of the natural progression of Ebola virus disease.
Patients between the ages of 15 and 24 years were most likely to survive infections, while those under 5 and those over 45 were more likely to die from the disease. There was no statistical significance for survival based on sex.
In addition, higher viral loads in the blood at presentation to the clinic and over the course of the illness were both associated with higher mortality rates. Viral loads typical peaked after 3 to 5 days of illness.
Among patients who died, over half experienced weakness on each day of illness, and diarrhea increased over the duration of illness. While survivors and non-survivors experienced similar symptoms, dyspnea and tachycardia were associated with increased mortality if present during the first week of illness.
“Our study demonstrates that nearly all signs/symptoms increase to their own peak in the first week of illness, followed by a slow decline thereafter in survivors and remaining relatively steady until death in non-survivors,” the authors concluded.
Jul 19 PLoS Negl Trop Dis study
Study shows link between GBS, recent Zika infection
A prospective study published today in Clinical Infectious Diseases involving Guillain-Barre syndrome (GBS) and Zika on Martinique in 2016 found that, out of 34 suspected GBS cases, 23 patients had recent Zika virus infections.
Thirty of the 34 cases had confirmed GBS, and the incidence rate ratio of GBS in 2016 was 4.52 times greater than in the previous decade. Thus, the authors concluded that testing for arboviruses such as Zika should be a standard part of GBS intake and treatment.
In other Zika news, a team at the University of California-Riverside was awarded a $14.9 million grant from the Defense Advanced Research Projects Agency (DARPA) to study genetic techniques that could control mosquito populations. Gene drive, which uses CRISPR gene editing techniques, could suppress disease-carrying mosquitoes in the wild.
The researchers will initially focus on the Aedes aegypti mosquito, which transmits Zika, yellow fever, and dengue, according to a UC-Riverside news release.
Jul 20 Clin Infect Dis study
Jul 19 UC-Riverside press release
