January 14th, 2015
Hidden Clinical Trial Data: A Dam About to Burst
Larry Husten, PHD
Two important new developments may mean that many more researchers will soon be able to access and analyze data from many more clinical trials. In recent years, in response to troubling and far-reaching questions about the availability and reliability of clinical trial data, reformers have called for new policies that would require drug companies and other […]
March 11th, 2013
Devices vs. Drugs: A Distinction Without a Difference? Blogging from ACC.13
Sandeep Mangalmurti, MD, JD
How are devices regulated? Due to some quirks, the tail now wags the dog.
July 29th, 2011
Controversial IOM Report Highly Critical of 510(k) Process
Larry Husten, PHD
The Institute of Medicine (IOM) has released a report highly critical of the FDA’s 510(k) medical device clearance process and called on the FDA to develop “a new framework that used both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices.” The […]
June 22nd, 2011
JAMA: Skeptical Perspectives on Consumer Cardiac Tests and Vitamin D
Larry Husten, PHD
Two commentaries published in JAMA offer skeptical perspectives on the roles of direct-to-consumer (DTC) cardiac tests and vitamin D in cardiovascular health. In the first commentary, Kimberly Lovett and Bryan Liang write that DTC screening tests “likely pose more risk than benefit to patients,” and point out that for companies selling these tests there is no requirement […]
NEJM Journal Watch — Recent Cardiology Articles- Persistent Symptoms After Valve Replacement for Severe Aortic Stenosis
- Is Diltiazem Safe in Patients with AF Taking Apixaban or Rivaroxaban?
- Does Lowering High Childhood Lipid Levels Prevent Adverse Cardiovascular Events in Adulthood?
- Self-Expanding Supraannular Valve vs. Balloon-Expandable Valve in TAVR for Small Aortic Annulus
- A New TAVR Prosthesis for Aortic Regurgitation Shows Promise