NCHR says YES to the Medical Device Guardians Act

NCHR supports this bill because there is clear scientific evidence that the vast majority of adverse events from medical products are not reported by physicians, and the percentage may be especially low for devices. “Since most devices are allowed to be without any scientific evidence of safety,” Zuckerman points out, “requiring adverse events to be reported by physicians is especially important.” Continue reading

Congress Shouldn’t Pass The 21st Century Cures Act In A Summer Rush

The full Senate may in the next few days consider companion legislation to the 21st Century Cures Act that passed the House last year. The legislation—currently 19 separate bills—makes substantial changes to the way the Food and Drug Administration (FDA) approves drugs and devices. The legislation, while containing some useful measures, is flawed. Instead of hastily agreeing to it, Congress should postpone consideration until 2017 and attach the best of the 19 bills (see below) to must-pass legislation on FDA funding through industry user fees. Continue reading

What would impact of 21st Century Cures Act be on your healthcare costs and the lives of Alzheimer’s patients?

A controversial proposed new health law would have had a terrible impact on the lives of Alzheimer’s patients and their families, who would have spent billions on medications that don’t work and can cause cancer. Continue reading

Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices

The US Food and Drug Administration (FDA) approves about 400 implanted medical devices each year through an abbreviated process called the 510(k) process, which only rarely requires clinical trials (studies of patients). Continue reading

Notre Dame football players rape cover-up – what’s in the news and what isn’t

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. Continue reading

Report: Medical Devices Lack Evidence of Safety and Effectiveness

July 29, 2011 — The prestigious Institute of Medicine (IOM) released a report on the Food and Drug Administration’s 510(k) medical device clearance process stating the system is “flawed” and should be revised. The report echoes the National Research Center for Women & Families’ concerns about the lack of evidence that these devises actually work and are safe. Continue reading

Study on Medical Device Recalls Released Today

February 14, 2011 — Our new study finds that most medical devices recalled during the last five years for “serious health problems or death” were originally cleared (approved) by the Food and Drug Administration (FDA) using a less stringent process that does not require testing in patients. The study, released on-line on February 14 prior to publication in the Archives of Internal Medicine, was co-authored by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women & Families and Dr. Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic. Continue reading