NPR, October 6, 2014. The Masima device company created a Patient Safety Movement Foundation but didn’t investigate reports that its devices harmed patients. “When a company refuses to respond in any way to the FDA other than to say that the FDA is wrong on every issue, that’s not very credible,” Zuckerman said. “Especially when users made complaints that the company’s product put patients at risk,” she said.
Read More »News That Quotes Us & Our Work
We are often quoted in major newspapers and magazines, and on well-respected TV shows, radio programs, and websites where we share our opinion on issues that matter to you and your health. Stay up to date on health news and our take on it by reading the articles in this section.
Not Enough Safety Testing On Medical Implant Devices, Studies Claim
CBS News, September 30, 2014. Every day, people receive medical implants — artificial valves, hip replacements, surgical mesh and the like — that may not have been rigorously tested before or after their approval by the U.S. Food and Drug Administration, two new studies contend.
Read More »Medical Devices Lack Safety Evidence, Study Finds
The Wall Street Journal, September 29, 2014. The majority of moderate to high-risk medical devices approved by the U.S. Food and Drug Administration lack publicly available scientific evidence to verify their safety and effectiveness despite requirements in the law, according to a study released Monday.
Read More »FDA is Chastised Over its ‘Action Plan’ to Diversify Clinical Trial Participation
The Wall Street Journal, August 28, 2014: NCHR explains to WSJ that the FDA Diversity Action Plans lacks incentives for companies to study their medical products in a diverse group of patients, including sex, age, and race/ethnicity. The FDA urges diversity but approves drugs and implants that have only been evaluated on mostly white patients under 65.
Read More »Surgery Studies Rarely Use Females
The Scientist, August 28, 2014: The Scientist article on lack of women in clinical trials quotes NCHR telling MedPage Today that FDA must increase incentives for companies to include more women, older patients, and people of color in clinical trials. The FDA urges diversity but approves drugs and implants that have not been evaluated on all the types of patients who will want to use the product.
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