National Center for Health Research
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Founded | 1999 |
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Founder | Diana Zuckerman |
Type | Think tank |
Focus | Conducts and scrutinizes research to improve the health and safety of adults and children. |
Location | |
Product | Health and medical information and assistance |
Key people | Diana Zuckerman, President |
Website | www |
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 April 2011, NCHR President Diana Zuckerman testified before the U.S. Senate Special Committee on Aging about the study's findings at a hearing on medical devices. [11][12]
In 2014, the organization published a study in the
In 2017, the NCHR staff published a paper in
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]
Publications
- Fox-Rawlings, Stephanie R.; Gottschalk, Laura B.; Doamekpor, Laurén A.; Zuckerman, Diana M. (September 2018). "Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?". The Milbank Quarterly. 96 (3): 499–529. PMID 30203600.
- Ronquillo, Jay G.; Zuckerman, Diana M. (September 2017). "Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health". The Milbank Quarterly. 95 (3): 535–553. PMID 28895231.
- Zuckerman, Diana; Doamekpor, Laurén Abla (June 2015). "More data are needed for Essure hysteroscopic sterilization device". Contraception. 91 (6): 520. PMID 25779602.
- Gonsalves, G.; Zuckerman, D. (25 March 2015). "Commentary: Will 20th century patient safeguards be reversed in the 21st century?". BMJ. 350 (mar25 7): h1500. S2CID 19510018.
- 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. PMID 25265047.
- 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. PMID 21321283.
References
- ^ "Home Page". National Center for Health Research. Retrieved 2022-09-08.
- ^ "The National Center for Health Research - National Center for Health Research". 2018-05-07. Retrieved 2025-03-10.
- ^ "S.Hrg. 112-92 — A DELICATE BALANCE: FDA AND THE REFORM OF THE MEDICAL DEVICE APPROVAL PROCESS". www.congress.gov. Retrieved 2025-03-10.
- ^ "STIFLING INNOVATION: EXAMINING THE IMPACTS OF REGULATORY BURDENS ON SMALL BUSINESSES IN HEALTHCARE". www.congress.gov. Retrieved 2025-03-10.
- ^ "POLITICO Pro: Pfizer hires FDA drug regulator Cavazzoni, sparking revolving door debate". subscriber.politicopro.com. Retrieved 2025-03-10.
- ISSN 0362-4331. Retrieved 2025-03-10.
- ^ Gilbert, Daniel (March 16, 2024). "Failure of ALS drug puts a spotlight on controversial FDA approvals". The Washington Post. Retrieved 2025-03-10.
- PMID 21321283.
- ^ "IMPACT OF MEDICAL DEVICE REGULATION ON JOBS AND PATIENTS". www.congress.gov. Retrieved 2025-03-10.
- ^ Miller, Reed (February 18, 2011). "Debate on 510(k)s and Recalls Reaches Capitol Hill". Medscape. Retrieved 2025-03-09.
{{cite web}}
: CS1 maint: url-status (link) - ^ "S.Hrg. 112-92 — A DELICATE BALANCE: FDA AND THE REFORM OF THE MEDICAL DEVICE APPROVAL PROCESS". www.congress.gov. Retrieved 2025-03-10.
- ^ National Center for Health Research, NCHR (2011-04-13). "Testimony of Dr. Diana Zuckerman at Senate Special Committee on Aging Hearing on Medical Devices - National Center for Health Research". Retrieved 2025-03-09.
- PMID 24449330.
- PMID 28895231.
- ^ PMID 30203600.
- PMC 8101583. Archived from the originalon 2025-02-11.
- ^ a b "Foremother and Health Policy Hero Awards Luncheon". National Center for Health Research. 7 May 2018. Retrieved 17 September 2019.