Hospitals, Doctors Relying On Rationing Amid Severe Shortage Of Lifesaving Immune Globulin
Manufacturers say the current shortage is among the worst they have experienced since the popular, wide-ranging treatment came to market. In other pharmaceutical news: Sen. Bill Cassidy (R-La.) touts value-based payments for cutting drug costs; a new approach to gene therapy offers tentative hope; a controversy arises over a pre-term birth medication; and more.
The Washington Post:
A Severe Shortage Hits A Drug Used For Cancer, Immune Disorders, Epilepsy, Causing Canceled Treatments And Rationing
A severe shortage of immune globulin — a popular medicine used to treat epilepsy, cancer and immune disorders — is forcing doctors nationwide to cancel patients’ lifesaving infusions, even as hospitals and treatment centers are resorting to rationing and dose-cutting. Immune globulin helps protect patients from infections, and it is used to treat many medical conditions including seizures, leukemia, autoimmune diseases, organ transplants, acute muscle illnesses and nerve disorders. (Rosenkrantz, 11/4)
Stat:
Sen. Cassidy On Trump’s Drug Plan: Price Index Still Preferable To Imports
Sen. Bill Cassidy is the rare Republican who has long been open to drug pricing reforms, espousing the virtues of value-based payment arrangements and his home state’s newfangled “Netflix” model for funding hepatitis treatments. As Cassidy has pushed for reforms, however, the rest of his party’s position on the issue has shifted under his feet, largely thanks to the Trump administration’s unpredictable and aggressive stance on efforts to lower drug costs. President Trump has espoused, for example, a far-reaching proposal to use foreign prices to cap some payments for drugs in the U.S. (Facher, 11/4)
The Wall Street Journal:
A New Approach To Gene Therapy—Now In Dogs, Maybe Later In Humans
A Cavalier King Charles spaniel named Shadow was at the front lines of a new approach to gene therapy. Earlier this month, 7-year-old Shadow was the first dog to be screened at Tufts University for a pilot study attempting to use gene therapy to treat a type of heart disease that often afflicts aging cavaliers. It’s part of a novel approach to gene therapy that has successfully treated age-related ailments in mice. Now it is being studied in dogs, with eventual hopes to test it in humans. (Reddy, 11/4)
NPR:
Can Makena Prevent Premature Birth? FDA Panel Votes No, But Some Doctors Disagree
An independent panel of advisers to the Food and Drug Administration recommended last week that a medication to prevent preterm birth be taken off the market because, the advisers decided, the preponderance of evidence suggests it doesn't work. But some other leading OB-GYNs say they hope the FDA won't take the panel's advice this time. The medication is a synthetic form of the hormone progesterone, brand-named Makena. (Neighmond, 11/4)
Kaiser Health News:
FDA Keeps Brand-Name Drugs On A Fast Path To Market ― Despite Manufacturing Concerns
After unanimously voting to recommend a miraculous hepatitis C drug for approval in 2013, a panel of experts advising the Food and Drug Administration gushed about what they’d accomplished. “I voted ‘yes’ because, quite simply, this is a game changer,” National Institutes of Health hepatologist Dr. Marc Ghany said of Sovaldi, Gilead Science’s new pill designed to cure most cases of hepatitis C within 12 weeks. (Lupkin, 11/5)
