Morning Briefing
Summaries of health policy coverage from major news organizations
'Date Rape' Drug GHB Gets Official Use As Hypersomnia Treatment
The New York Times: F.D.A. Approves GHB, A 'Date Rape' Drug, For Narcolepsy Patients
In the 1960s, the drug was given to women during childbirth to dampen their consciousness. In the 1990s, an illicit version made headlines as a “date rape” drug, linked to dozens of deaths and sexual assaults. And for the last two decades, a pharmaceutical-grade slurry of gamma-hydroxybutyrate, or GHB, has been tightly regulated as a treatment for narcolepsy, a disorder known for its sudden sleep attacks. Now, the Food and Drug Administration has approved the drug for a new use: treating “idiopathic hypersomnia,” a mysterious condition in which people sleep nine or more hours a day, yet never feel rested. (Hughes, 8/12)
In news about the opioid crisis —
Houston Chronicle: DEA Suspends Operations, Seizes Millions Of Pills From Sugar Land Company
The Drug Enforcement Administration on Wednesday shut down operations at a Sugar Land pharmaceutical company and seized millions of controlled pills after the company reportedly violated regulations, the agency said. Investigators with the DEA Houston Division served immediate suspension orders to Woodfield Distribution, LLC, and Woodfield Pharmaceuticals, LLC, for failing to control the diversion of controlled substances and creating "imminent danger to public health and safety," according to authorities. ... The company illegally imported more than 200 million opioid pills and failed to account for more than 5 million pills, the DEA said. (Bauman, 8/12)
AP: Purdue Pharma Director Grilled On Proposed Opioid Settlement
Purdue Pharma’s quest to settle thousands of lawsuits over the toll of OxyContin and its other prescription opioid painkillers entered its final phase Thursday with the grudging support of many of those who have claims against the company. But the lingering opposition from some state attorneys general took center stage in the first day of a confirmation hearing in U.S. Bankruptcy Court about the company’s reorganization plan. (Mulvihill, 8/12)
AP: How COVID Pandemic Changed Methadone Treatment For Addiction
Here’s one more lesson from the COVID-19 pandemic: It appears safe to relax restrictions on methadone, the oldest and most stigmatized treatment drug for opioid addiction. Last spring, with coronavirus shutting down the nation, the government told methadone clinics they could allow stable patients to take their medicine at home unsupervised. Early research shows it didn’t lead to surges of methadone overdoses or illegal sales. And the phone counseling that went along with take-home doses worked better for some people, helping them stay in recovery and get on with their lives. (Johnson, 8/12)
In other pharmaceutical and biotech industry updates —
CIDRAP: Clinical Trial Shows Promise For Monoclonal Antibody Malaria Preventive
For the first time, researchers yesterday reported that a monoclonal antibody can prevent malaria in humans. A team based at the National Institute Allergy and Infectious Diseases (NIAID) Vaccine Research Centers published their phase 1 clinical trial results yesterday in the New England Journal of Medicine. The monoclonal antibody, called CIS43LS, was developed from a neutralizing antibody isolated from the blood of a volunteer who had received an investigational malaria vaccine. Researchers examined whether the monoclonal antibody could safely prompt high-level protection against experimental exposure to infected mosquitoes. (8/12)
The Hill: Senators Want Answers About Amazon's Biometric Data Collection
A bipartisan group of senators sent a letter to Amazon Friday raising questions about its collection of biometric data. The lawmakers are particularly interested in the expansion of the company’s palm print scanners program, Amazon One. The scanners are used at Amazon stores to let customers pay without having to take out cards or cash if they enroll in the program. (Rodrigo, 8/13)
