Viewpoints: Changes Needed In Nursing; Congress Must Strengthen FDA’s Accelerated Approval Program
Editorial writers tackle these public health topics.
The New York Times:
Yes, Nurses Are Heroes. Let’s Treat Them Like It
The Covid-19 pandemic exposed strengths in the nation’s health care system — one of the greatest being our awesome nurses. But it also exposed many weaknesses, foremost among them being chronic nurse understaffing in hospitals, nursing homes and schools. (Linda H. Aiken, 8/12)
Stat:
Congress: Fix Accelerated Approval For The Next 30 Years
The Food and Drug Administration’s approval of the Alzheimer’s drug Aduhelm has sparked a broader debate on the merits and limitations of the FDA’s accelerated approval program. This debate — and its timing — are important. The FDA issued its accelerated approval regulation nearly 30 years ago, and has since applied this approach for more than 200 new drug indications. This program allows for faster approval of drugs for severe conditions based on markers predicting clinical benefit, on the rationale that patients with no alternatives need options sooner, not later. (Keith Flanagan, 8/12)
San Diego Union-Tribune:
Why Are Overdoses Up? Many Factors Work Against Recovery And There Are No Sure-Fire Solutions
Last year, Father Joe’s Villages’ security officers saved the lives of 42 individuals who were experiencing an overdose by administering naloxone, a medicine that reverses an opioid overdose. According to the National Institute on Drug Abuse, naloxone can quickly restore normal breathing and save the life of a person who is overdosing on opioids. While I’m deeply proud of my team for saving the lives of people in need, it’s disheartening to see their heroic actions needed so frequently. (Jim Vargas, 8/11)
Stat:
Clinical Research Must Reflect The Diversity Of Patients
In the journey from lab to label for a new and promising treatment, clinical research conducted under controlled, laboratory conditions must transition to a tangible medicine that exists within the complex and unpredictable conditions of real life. For scientists and innovators, the challenge is to ensure they’ve done their best to model that complexity in the clinical setting and thoroughly test treatments to not only understand if they work but how they work for the broad spectrum of people who may one day need them. (Clare Grace, 8/12)