Doctors Downplaying Drug’s Suicide Risks Attract FDA’s Scrutiny - Bloomberg, September 13, 2016
The U.S. Food and Drug Administration has a message for doctors: The money you’re taking from pharmaceutical companies may be clouding your judgment. NCHR president Dr. Diana Zuckerman points out questions about the accuracy of safety data submitted by Pfizer about Chantix, the smoking cessation drug.
Medical Devices Approved Using Low-Quality Data Affect Medicare Costs - Bloomberg BNA, September 8, 2016
High-risk medical devices are sometimes approved using low-quality clinical data and this increases Medicare costs, a member of a Medicare congressional advisory panel said Sept. 8. The session may portend a deeper examination of the device industry’s practices, which could cause Congress to change payment rates for devices and related services, as the commission’s recommendations are fairly influential. Commissioner Rita Redberg, a cardiologist at the University of California San Francisco Medical Center, called for further MedPAC examination of how to push Medicare to more broadly consider quality over an entire episode of care when deciding whether to cover a device. NCHR’s president Dr. Diana Zuckerman said “I agree completely.”
21st Century Cures Act: Yes or No? No: Act’s promise of quick cures is a brew of ultra-hype mixed with snake oil - Chicago Tribune, By Diana Zuckerman
Imagine that you or someone you love has a potentially fatal disease with no proven treatment, but there is a new experimental treatment available.
Would you rather be given that treatment for free by a top physician who carefully monitors your treatment as part of a clinical trial to study whether it works, or, would you rather pay more than $100,000 a year for the same experimental drug and hope your doctor gives you the right dose?
Faster Drug Approval: Winners and Losers - HealthZette, June 28, 2016. By the time a drug is approved by the Federal Drug Administration, it’s been through extensive human clinical trials. There are so many obstacles to greenlighting any new medication or treatment, in fact, that it seems like it can take forever — with countless lives lost in the meantime.
Women’s Health Bills are now in Committee - Legal Reader, June 28, 2016. Three important pieces of legislation, one introduced last year and two introduced this month, could change the way certain women’s health issues are handled. These women’s health bills are now in Committee.
Why we shouldn’t trade a weakened FDA for more medical research funds - STAT, May 17, 2016. In a quest to bring new medical products to Americans, Congress is considering a grand bargain, but it may benefit pharmaceutical companies more than patients.