September 14, 2017. In order to keep our children safe, it is essential to regulate OFRs collectively as a class unless and until there is scientific evidence that one or more particular OFRs is proven to be safe, and then treat that specific OFR differently.
An effective shingles vaccine is important for public health. As patients get older, they are more likely to develop long-term pain, or post-herpetic neuralgia (PHN), as a complication of shingles. This pain can be severe and chronic. There is no cure, and treatments do not reliably relieve pain for all patients. The only way to reduce the risk of developing shingles and PHN is to get vaccinated. We urge this Advisory Committee to recommend that the FDA require critical post-approval long-term studies to further evaluate the efficacy and safety of Shingrix. We also strongly recommend that the company conduct subgroup analyses to ensure that the vaccine is safe and effective for both women and men and also people of color.
STAT News, September 12, 2017. The Food and Drug Administration carefully polices many categories of drugs and devices. But when it comes to software, the agency’s oversight is scanty at best — something that a new study finds is resulting in failure to detect dangerous glitches in software-enabled medical equipment.
The innovation of medical IT has the potential to save lives, but even a small “glitch” can harm patients. Our study found hundreds of recalls of flawed devices that affected millions of patients. Examples include electronic medical records that provide info about the wrong patient and “physician support” devices that miscalculate the dosage of medication. But the FDA is set to deregulate these devices.
September 8, 2017. I am going to Charlottesville on September 13 to honor Dr. Vivian Pinn, our 2013 Foremother Awards honoree, as a major UVA medical school building is named in her honor. Dr. Pinn received her medical degree from the University of Virginia in 1967, where she was the only African-American and only woman in her graduating class.