News Analysis: Interviews, Op-eds, & Editorials
Antibiotics: When Science and Wishful Thinking Collide
Health Affairs blog. January 25, 2013. Antibiotic resistance is a major concern confronting our health care system, and there is tremendous pressure on the Food and Drug Administration (FDA) to “do something” about it. Unfortunately, the FDA is responding by approving drugs that are likely to do more harm than good. Read More
Metal Hip Implants Face Tighter Controls
Wall Street Journal. January 18, 2013. Diana Zuckerman, president of the National Research Center for Women & Families, said: “There are so many shortcuts at the FDA device center that they often take a shortcut and approve a product with minimal safety testing.” Read More
Interview with Dr. Diana Zuckerman on the Dangers of Anti-psychotic Drug Overuse in Nursing Homes
Healthcare Policy Podcast, December 21, 2012. During this 30 minute interview, Dr. Zuckerman discusses the long-standing and widespread overuse or misuse of anti-psychotics in medicating nursing home residents. Read More
Notre Dame Football Players Rape Cover-up – What’s in the News and What Isn’t
Fem2.0 January 9, 2013. The media has extensively covered the college championship football game between Notre Dame and Alabama, but few Americans aware of Notre Dame’s cover-up of rapes by Notre Dame football players. Monday’s football game is an opportunity to acknowledge that raping women is a terrible crime that needs to be taken seriously by the police, the public, and the media. Read More
No Need for Skin Preps to Be Sterile, FDA Told
December 13, 2012. MedPage Today. Requiring that antiseptic skin preparation products be sterile — a standard not currently mandated by the FDA — is unnecessary and wouldn’t produce a dramatic drop in infections, manufacturers, clinicians, and policy analysts told the FDA Wednesday. “We need to have better communication that a product is not sterile,” Dr. Jennifer Yttri said, adding that could come from product labeling. Read More
J&J Bedaquline and the Evolving Role for Accelerated Approval: Confirming Safety, Not Efficacy?
December 4, 2012. FDA Beat. Discussions during an advisory committee review Janssen’s TB drug bedaquiline showed some interesting thinking around accelerated approval and how much uncertainty can be acceptable—especially when it comes to safety. Yttri warned called “approval of drugs based on the promise of benefit” a “dangerous practice.” Read More
Death by Medicine
November 2012. NRC President Dr. Diana Zuckerman calls for closing loopholes in FDA rules in this guest post on the Huffington Post. Read More
Allergan drops bid for FDA approval to promote Lap-Band for teens
October 3, 2012. LA Times. The maker of the Lap-Band weight-loss device, Allergan Inc., has dropped its controversial bid for federal approval to market the product for overweight teens. Doctors already can perform Lap-Band surgery on minors with parental consent. The FDA approval would have allowed Allergan to market Lap-Band specifically for younger people. Read More
F.D.A. Bans BPA From Baby Bottles and Sippy Cups
July 17, 2012. The New York Times. The FDA bans bisphenol A in baby bottles and children’s drinking cups. Read More
U.S. Plans IDs to Track Medical Device Safety
The Food and Drug Administration proposed a new rule that would require each medical device to have a unique code that could improve tracking and catch safety problems earlier. Read More