Articles related to BUSINESS & POLICY

Mikkael A. Sekeres, MD, currently Chief of the Division of Hematology at the Sylvester Comprehensive Cancer Center at the University of Miami, worked on the decision to remove Avastin’s indication for the treatment of HER2-negative metastatic breast cancer in 2008. As a result of the hearing, Dr. Sekeres poses the following question in his most recent book, Drugs and the FDA: Safety, Efficacy, and the Public’s Trust: “Had the FDA made a mistake in initially approving the drug?” Dr. Sekeres discussed with OBR the rise of accelerated approvals, progression-free survival as an endpoint, and the consequences of the Avastin hearing.

The new guidelines have drawn criticism and many or most hospitals are sticking to state guidelines, which generally mandate masking. Megan Ranney, MD, MPH, of Brown University tweeted that CDC’s logic “escapes me,” as it pertains to society’s “most health-vulnerable” people in a setting with a higher-than-average risk of COVID positivity.

In a study of parenteral cancer drug pricing at 61 NCI-designated cancer centers, median price markups on 25 commonly used drugs ranged from approximately 120% to 630% over acquisition cost. The paper’s authors recommend public policy prohibiting excessive markup on parenteral chemotherapies as a means to reduce unnecessary financial burden on patients.

A strongly worded opinion piece in The British Medical Journal argues that evidence-based medicine has been corrupted. Specifically, the editorial piece argues that the pharmaceutical industry’s responsibility to its shareholders means that priority must be given to their hierarchical power structures, product loyalty, and public relations propaganda over scientific integrity.

The American Academy of Sleep Medicine (AASM) is taking issue with the US Senate’s recently passed legislation that will make daylight saving time (DST) permanent starting in 2023. AASM cautions that this permanent change would lead to health risks that include adverse cardiovascular events, mood disorders, and motor vehicle crashes. The group advocates for establishing permanent standard time instead.

Admit or treat them on an outpatient basis? Too often it is the health plan that makes the decision, leaving the medical team and patient to bear the burden.