The National Center for Health Research (NCHR) is a nonpartisan think tank based in Washington, D.C., founded by Dr. Diana Zuckerman, its current president. Originally founded on December 21, 1999 under the name National Research Center for Women & Families (changed to the National Center for Health Research in 2014), its mission is to conduct, analyze, and explain health research to the public.[1]
NCHR states that it works with federal and state governments, health professionals, and the public on a wide range of health issues, focusing primarily on research and policies regarding the evidence standards for the safety and effectiveness of medical and consumer products[2], providing testimony at hearing in the U.S Senate[3] and U.S House of Representatives[4] and quoted in national newspapers [5][6][7]. The testimony and quotes in the media often criticize the FDA's standards as not sufficiently scientific, in contrast to the statements of the industry experts who testify at those same hearings and are quoted in the same news stories.
Research
In February 2011, NCHR staff completed a study on the various alternative approval processes for medical devices at the Food and Drug Administration (FDA). Authors associated with the NCHR published a study examining how often the different approval or clearance processes were used for medical devices that were subsequently recalled for life-threatening problems.[8] The study resulted in a hearing by the U.S. House of Representatives that debated the safety of medical devices and the reason for high-risk recalls. The House hearing featured testimony from the NCHR study co-author, Dr. Steven Nissen of the Cleveland Clinic, and cardiologist Dr. Rita Redberg from University of California, San Francisco, who had published an editorial supporting the findings of the NCHR study. [9][10]
In 2014, the organization published a study in the JAMA Internal Medicine journal about the scientific evidence submitted to the FDA to support the marketing of implanted medical devices under the agency’s 510(k) review process. The study concluded that most of the implanted devices were not required to submit data from clinical trials or scientific evidence of safety or effectiveness before they could be sold.[13]
In 2017, the NCHR staff published a paper in Milbank Quarterly criticizing the FDA for its failure to safeguard electronic health records and other device software from hacking and other cybersecurity threats. They stated, "Current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market".[14] They added that legislative changes resulting from the law entitled the 21st Century Cures Act "will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients."
The NCHR published another study in Milbank Quarterly in 2018 called "Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?".[15] The study investigated whether new, high-risk medical devices had been proven safe and effective for women, minorities, or patients over 65 years of age. The paper concluded that most studies did not conduct subgroup analysis on all these major demographic groups, thus providing no information about safety or effectiveness for most patients.[15]
In 2021, NCHR published an article in the American Journal of Public Health entitled, "Emergency Use Authorizations (EUAS) Versus FDA Approval: Implications for COVID-19 and Public Health", explaining how FDA's emergency pathway was used by the agency to rapidly respond to the need for diagnostic tests, treatments, and personal protective equipment during the COVID pandemic, in ways that were sometimes beneficial but also resulted in inaccurate test results and products that were later found to be ineffective.[16]
Awards
Two awards are given by the Center each year:
The Foremother Lifetime Achievement Award "recognizes women who expanded women’s horizons, improved our communities, and made remarkable contributions to our country".[17]
The Health Policy Heroes Award "honors men and women (and sometimes boys and girls) who have changed the public debate and public policies in ways that help to improve the lives of adults and children nationwide".[17]
Zuckerman, Diana; Doamekpor, Laurén Abla (June 2015). "More data are needed for Essure hysteroscopic sterilization device". Contraception. 91 (6): 520. doi:10.1016/j.contraception.2015.02.027. PMID25779602.
Gonsalves, G.; Zuckerman, D. (25 March 2015). "Commentary: Will 20th century patient safeguards be reversed in the 21st century?". BMJ. 350 (mar25 7): h1500. doi:10.1136/bmj.h1500. PMID25814537. S2CID19510018.
Zuckerman, Diana; Brown, Paul; Das, Aditi (1 November 2014). "Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices". JAMA Internal Medicine. 174 (11): 1781–7. doi:10.1001/jamainternmed.2014.4193. PMID25265047.
Zuckerman, Diana M.; Brown, Paul; Nissen, Steven E. (13 June 2011). "Medical Device Recalls and the FDA Approval Process". Archives of Internal Medicine. 171 (11): 1006–11. doi:10.1001/archinternmed.2011.30. PMID21321283.
References
↑ "Home Page". National Center for Health Research. Retrieved 2022-09-08.
↑ Zuckerman, Diana M.; Brown, Paul; Nissen, Steven E. (13 June 2011). "Medical Device Recalls and the FDA Approval Process". Archives of Internal Medicine. 171 (11): 1006–11. doi:10.1001/archinternmed.2011.30. PMID21321283.
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