You are here
Research Briefs February 2018
Trying to Keep Pace With 3D Technology
Three-dimensional printing has revolutionized the drug and device market. The Food and Drug Administration (FDA) has reviewed more than 100 devices currently on the market that were manufactured on 3D printers, including implants“designed to fit like a missing puzzle piece into a patient’s skull for facial reconstruction,” says FDA Commissioner Scott Gottlieb, MD. The FDA has also approved the first drug produced on a 3D printer, with a more porous matrix than the drug made in the conventional way that allows it to dissolve more rapidly. But the technology has been advancing so fast that it has threatened to outpace safeguards.
The FDA is preparing for a wave of new technologies, Dr. Gottlieb says, such as 3D-printed skin cells for burn victims, and is working to provide a regulatory pathway that helps keep those advances safe and effective. So the FDA has issued new guidance for manufacturers on technical aspects of 3D printing. Dr. Gottlieb calls it “leapfrog” guidance because it helps bridge current policy with future innovation. And, as more hospitals and academic centers use 3D printers for innovations in clinical studies, the FDA is also establishing a regulatory framework for applying existing laws to nontraditional manufacturers.
Source: FDA, December 2017
Closer to a Vaccine for the Zika Virus?
A series of National Institutes of Health (NIH) clinical trials are bringing Zika virus vaccines closer to the real world.
According to preliminary findings from three phase 1 clinical trials, an investigational Zika purified inactivated virus vaccine was well tolerated and induced an immune response. Scientists from Walter Reed Army Institute of Research are developing the vaccine. Of 67 adult participants, 55 received the vaccine and 12 the placebo in two intramuscular injections four weeks apart. Researchers detected antibodies in more than 90% of those who received the vaccine four weeks after the last dose.
In phase 2 trials, two versions of an experimental gene-based Zika vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases, were both found to be safe and to induce an immune response. The candidate with the most promise moved into an international phase 2/2b safety and efficacy trial, which began in 2017 and will last for two years.
Source: NIH, December 2017
Flu-Related Deaths Higher Than Estimated
The Centers for Disease Control and Prevention (CDC) and global partners have revised—upward—estimates on how many people worldwide die from seasonal flu-related respiratory illnesses each year. The new numbers are between 291,000 and 646,000, up from earlier estimates of 250,000 to 500,000.
Researchers calculated flu-related deaths (excluding pandemics) for 33 countries that had records for at least four years between 1999 and 2015; they used data from 14 other countries to validate the estimates. The highest flu-related death rates were seen in the poorest regions and among older adults. People 75 years of age and older and people in sub-Saharan Africa had the highest rates. Eastern Mediterranean and Southeast Asian countries had slightly lower but still high rates. Few developing countries have the capabilities to run vaccine programs.
The new estimates are limited to flu-associated respiratory deaths and may underestimate the true impact of seasonal flu. The infection can create or exacerbate other health factors, such as cardiovascular disease or related complications, which are then listed as the cause of death.
Source: CDC, December 2017
Are You Sitting Down for This?
Not all sedentary behavior is equal, say researchers from Universidad Autónoma de Madrid, who evaluated the sedentary habits of 5,459 women and 4,740 men.
Research suggests watching television and other “passive” sedentary behaviors (SBs), such as listening or talking while sitting, could be more harmful than “mentally active” SBs, such as computer use and reading. In this study, “passive” SBs were associated with less recreational activity and higher body weight. Time at the computer and reading were linked to more recreational physical activity but less light-intensity activity at home.
The researchers say older age, lower education, unhealthy lifestyle (smoking, poor diet, less physical activity, greater body mass index) and chronic morbidity, such as diabetes or osteomuscular disease, were linked to more TV time. Longer time at the computer or in commuting was linked to younger age, male gender, higher education, and a sedentary job.
Watching TV was the predominant SB (45% of total sitting time), followed by sitting at the computer (23%), reading (15%), and commuting (12%). Participants spent a mean of 1.96 hours a day watching TV versus less than an hour for the other behaviors.
Source: PLoS One, December 2017
FDA Pledges Faster Updates on Antibiotics
The Food and Drug Administration (FDA) is launching a website to speed critical updates about antibiotics and anti-fungals to health care professionals and help them make more-informed prescribing decisions. The site will provide “direct and timely access” to information about when bacterial or fungal infections are likely to respond to a specific drug.
FDA Commissioner Scott Gottlieb, MD, said that under the old approach, updating each drug’s individual labeling took too long. Only after the revised drug labeling was approved could a drug or device manufacturer update testing criteria and labeling for the latest antimicrobial susceptiblity test results. Each drug and device label had to be updated whenever criteria changed. The new tool will let the FDA simultaneously update for multiple drugs that have the same active ingredient.
Source: FDA, December 2017