The ink hadn't dried on the headline of the lead story in the Dec. 29 issue of The New York Times when on Jan. 2 HHS Secretary Alex Azar and newly arrived FDA Commissioner Stephen M. Hahn made the following announcement:
Since March 2018, P.A.I.N. (Prescription Addiction Intervention Now), an organization founded in 2017 by photographer Nan Goldin, has held demonstrations at art museums in New York, Washington, DC, Boston, London and Paris to protest their acceptance of money from the Sackler family, owners of Purdue Pharma, a company that been accused of fomenting the prescription opioid addiction crisis.
One day in 1996, in my role as chief science correspondent for NBC News, I was rummaging through the usual huge (pre-internet) pile of press releases on my desk and zeroed in on one: a phase III trial of a treatment for an aggressive type of breast cancer that was desperate to accrue volunteers.
The initial reports of the near-miraculous benefits of CAR-T in pediatric acute lymphoblastic leukemia generated tremendous excitement—there was a Lazarus-like quality to these stories.
Soon after the Chernobyl accident, while caring for victims at Moscow's Hospital No. 6, I commented: “In a nuclear age, an accident anywhere is an accident everywhere.”
Almost 35 years ago, while the nation suffered in the vicious grip of the HIV epidemic, a young man from South Carolina with AIDS named Boyd Helton found his way to the NIH Clinical Center in Bethesda. While there, he was recruited into a clinical research protocol designed to lower the expression of viral proteins in his blood, and, ideally, to increase the numbers of his circulating CD4+ T-cells.
The pit in my stomach used to come once a year.
Most Americans receive cancer treatment close to home, at community hospitals or in community oncologists' offices. And based on patient satisfaction surveys, most Americans are very happy with the care they receive.
At a recent NIH study section that I chaired, we had many applications that we reviewed as a group before the meeting. At the meeting, we were required to discuss over 50% of the grants.
Creation of Big Data repositories is now emphasized at virtually all research institutions and the NIH, but the number of publications describing patient outcomes from these sources appears modest.1 Why is this so; what factors limit what should be a hugely productive resource, and how can we improve the impact of this use of Big Data? Why does this issue require greater physician engagement and understanding to solve? The integration of clinical, laboratory, and financial data is required to describe disease and treatment outcomes as well as treatment value.
