Senator Urges Review Of Dietary Guidance Panel Over Weight Loss Drugs
Citing conflicts of interest, Sen. Chuck Grassley, a Republican, is calling on the HHS and Department of Agriculture to examine vetting of a Dietary Guidelines Advisory Committee, with a focus on one member over weight loss drug company links. Also in the news: gene therapies, ALS drugs, more.
Stat:
Senator Calls For Probe Of Panel Overseeing Dietary Guidelines
A U.S. lawmaker wants the federal government to probe potential conflicts of interest held by members of a panel created to set dietary guidelines after learning one panelist was a paid consultant to a drug company that sells weight loss treatments. (Silverman, 3/20)
In updates from the FDA —
Stat:
Top FDA Official Backs Accelerated Approval For Gene Therapies
A top Food and Drug Administration official said Monday that the agency needs to start using accelerated approval, a much-debated path commonly used for advancing cancer drugs, to advance gene therapies for rare disease. (Mast, 3/20)
CNBC:
FDA Staff Says Biogen's ALS Drug May Have A 'Clinical Benefit' On A Rare Form Of The Disease
U.S. Food and Drug Administration staff on Monday said Biogen’s investigational ALS drug may have a “clinical benefit” on a rare and aggressive form of the disease, despite failing a broader late-stage clinical trial last year. (Constantino, 3/20)
Reuters:
FDA Staff Says Safety Issues With Biogen's ALS Drug To Not Prevent Approval
The U.S. health regulator's staff said on Monday safety issues with Biogen Inc's drug to treat an ultra-rare form of amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig's disease, should not prevent its accelerated approval. (Satija, 3/20)
In other pharmaceutical news —
Stat:
Karuna Therapy Reduced Psychosis Reported By Patients In Key Trial
Karuna Therapeutics said Monday that its treatment for schizophrenia reduced psychosis reported by patients — achieving the main goal of a large clinical trial and supporting similarly positive results from previously conducted studies. (Feuerstein, 3/20)
The Baltimore Sun:
Johns Hopkins Study Highlights Promise Of IV Mistletoe Extract For Cancer Therapy
Ivelisse Page already had 15 inches of her colon and 28 lymph nodes removed to treat her colon cancer, but in the winter of 2008 she received more devastating news. The cancer had spread to her liver. Page’s doctor, Dr. Luis Diaz – an oncologist at the Memorial Sloan Kettering Cancer Center in New York and professor at the Johns Hopkins University School of Medicine — gave her an 8% chance of living for more than two years. Since chemotherapy and radiation wouldn’t increase her chances of survival, Page decided not to undergo either of the intensive treatments. Instead, she and her husband considered another treatment suggested by an integrative practitioner at Baltimore’s Ruscombe Mansion Community Health Center: mistletoe therapy. (Roberts, 3/21)
CIDRAP:
Study: Sharing Of Multidrug-Resistant Bacteria Between People, Pets Rare
A study to be presented at next month's European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) suggests the sharing of multidrug-resistant organisms (MDROs) between pets and their owners can occur but is rare. In a case-control study conducted at Charite University Hospital Berlin in Germany, researchers collected and analyzed nasal and rectal swabs from 2,891 hospital patients, including 1,184 patients with previous MDRO colonization and 1,707 newly admitted control patients. (Dall, 3/20)