Diana Zuckerman

Diana M. Zuckerman (born 16 June 1950[1]) is an American health policy analyst who focuses on the implications of policies for public health and patients’ health. She is an expert on national health policy, particularly in women's health and the safety and effectiveness of medical products. She is the President of the National Center for Health Research (formerly National Research Center for Women & Families) and the Cancer Prevention and Treatment Fund.[2]

Dr. Diana Zuckerman

Early life and education

Zuckerman earned her B.A. in psychology from Smith College and then obtained a Ph.D in psychology from The Ohio State University in 1977. At Yale Medical School she was a post-doctoral fellow in epidemiology and public health from 1979 to 1980.

Career

She was on the faculty at Vassar College and Yale University, and directed a longitudinal study of college students as director of the Seven College Study at Harvard University, publishing books and articles on the impact of media on children, the impact of religion on the health of the elderly, and how women's life experiences influence their mental and physical health. She left academia in 1983 when she was selected as a Fellow in the American Association for the Advancement of Science Congressional Science Fellowship program.[3]

From 1985 to 1993 she worked at the U.S. Congress in a House subcommittee where she was responsible for a dozen Congressional oversight investigations on health and social policy, including political manipulation of government grants to prevent child abuse, lack of safeguards for infertility treatments, financial conflicts of interest among National Institutes of Health (NIH) grant recipients, and the lack of safety studies on breast implants. Information from the hearings received widespread public health, government, and media attention, resulting in several policy and regulatory changes, including the U.S. Food and Drug Administration (FDA) requiring implant manufacturers to submit safety studies for the first time.[3]

In 1993, Zuckerman joined the staff of the Senate Veterans Affairs Committee and began an investigation that resulted in the first Congressional hearings focused on the possible causes of Gulf War syndrome. In 1995 she was a senior policy advisor in the Clinton Administration. From 1996, she undertook leading roles in non-profit organizations, including, from 1999, presidency of the National Research Center for Women & Families[3] (renamed the National Center for Health Research in 2014) and The Cancer Prevention and Treatment Fund.

Her work focuses on improving the quality of medical products and healthcare in the United States. She has been highly critical of scientific and medical research paid for by companies, who then use this to promote their products, as well as the lack of media coverage on independently funded research that challenges industry-funded research. She has said:

You've heard of junk science a term coined by corporations to describe research they don’t like but the real danger to public health might be called "checkbook science": research intended not to expand knowledge or to benefit humanity, but instead to sell products.[4]

In February 2011, Zuckerman and colleagues Paul Brown and Dr. Steven Nissen published a study in the peer-reviewed journal Archives of Internal Medicine, which evaluated the FDA's recalls of devices that the agency considered potentially deadly or otherwise very high risk.[5] Based on FDA data, the authors determined that most of the devices that were high-risk recalls had never been studied in clinical trials prior to FDA approval, and that the FDA needed to use more stringent criteria for implanted medical devices and those used to diagnose serious illnesses, and an editorial in the same issue agreed.[6][7][8][9] In April 2011, Zuckerman presented the results of the study at a hearing by the U.S. Senate Special Committee on Aging.[10]

Zuckerman is the author of five books, several book chapters, and dozens of articles in medical and academic journals, and in newspapers across the country. Her policy work has resulted in news coverage on all the major TV networks, including ABC, CBS, NBC, CNN, Fox News, public television, 60 Minutes, 20/20, National Public Radio, and in major U.S. print media such as The New York Times,[11][12][13][14] The Washington Post,[15] The Washington Times, Los Angeles Times,[16] Boston Globe,[17][18] USA Today, Detroit Free Press, New York Daily News, Newsweek, Time, U.S. News and World Report, Family Circle, The New Yorker, Glamour, Self,[19] as well as many other newspapers, magazines, and radio programs.[20][21][22]

Testimonies

Zuckerman has appeared before numerous FDA advisory committees to testify as a medical expert on a variety of drugs and devices.

On December 12, 2013, Zuckerman testified regarding the type-2 diabetes drug dapagliflozin (Farxiga), saying: "My concern about this drug is that there are just too many unanswered questions – and those unanswered questions are frightening ones. That was true when the FDA rejected this application for approval 2 years ago, and it is still true today." She cited studies that highlighted the risks that the drug poses, as well as methodological concerns such as a lack of diversity in clinical trials.[23]

On November 14, 2012, Zuckerman made a statement at a Capitol Hill press conference about the VALID Compounding Act. She stated that loopholes in the FDA law, including compounding pharmacies, have allowed hundreds of people to get sick with meningitis and several to die. The VALID Compounding Act is designed to close the loopholes that are so harmful to patients.[24]

Dr. Zuckerman spoke at the FDA Opioid Policy Steering Committee on January 30, 2018, recommending better data and improved resources for the safe disposal of unused opioid medications.[25] Additionally, she suggested requiring more effective Risk Evaluation and Mitigation Strategy (REMS) training for physicians that prescribe opioids as part of that presentation and as an invited speaker at the National Academies of Sciences, Engineering, and Medicine in 2016.

In 2017 and 2018, she testified about the risks of artificial turf used on playing fields and playgrounds before government hearings of legislative committees of the state of Maryland and District of Columbia, as well as before the federal Consumer Product Safety Commission. Dr. Zuckerman urged that natural grass be used instead of artificial turf and that engineered wood fiber be used instead of artificial rubber playgrounds.[26]

Awards

  • APA Media Award for co-authorship of Big World, Small Screen: The Role of Television in American Society (1992)
  • Listed in Who's Who of American Women (1995-1996)
  • Women in Medicine International Hall of Fame by the American Medical Women's Association (2010)

Published articles

Zuckerman frequently writes articles regarding medical drugs and devices, as well as public health policy. Recent articles published in peer-reviewed journals include:

  • Ronquillo J. G., Zuckerman D. M. (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. doi:10.1111/1468-0009.12278. PMC 5594275. PMID 28895231.
  • Zuckerman D.M. (2017). "Can the FDA Help Reduce Drug Prices or the Cost of Medical Care?". American Journal of Public Health. 107 (11): 1752–1754. doi:10.2105/ajph.2017.304093. PMC 5637698. PMID 29019779.
  • Zuckerman, D., Tomes, M & Murphy, A. (2017) Are Gummy Bear Breast Implants the Safer Implants? In Breast Implants, Rene Simon (ed), Nova Science.
  • Ronquillo J.G., Zuckerman D.M. (2017). "Electronic Health Records". Annals of Internal Medicine. 166 (7): 536–36. doi:10.7326/l17-0050. PMID 28384740.
  • Ronquillo, J.G. & Zuckerman, D. M. (2017) Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health. Milbank Quarterly. 95(3): 535-553.
  • Zuckerman D.M. (2017). "Setting the Record Straight on FDA Approvals in Oncology-Reply". JAMA Internal Medicine. 177 (8): 1222–23. doi:10.1001/jamainternmed.2017.2251. PMID 28783833.
  • Rupp T., Zuckerman D.M. (2017). "Quality of Life, Overall Survival, and Costs of Cancer Drugs Approved Based on Surrogate Endpoints". JAMA Internal Medicine. 177 (2): 276–277. doi:10.1001/jamainternmed.2016.7761. PMID 27898978.
  • Zuckerman D.M. (2017). "A Major Shortcoming in the Public Health Legacy of the Obama Administration". Am J Public Health. 107 (1): 29–30. doi:10.2105/ajph.2016.303559. PMC 5308193. PMID 27925820.
  • Zuckerman, D.M. & Silcox, C.E. (2016) The Challenges of Informed Consent When Information and Time are Limited. In Informed Consent: Procedures, Ethics and Best Practices, Winston Hammond (ed.), Nova Science.
  • Zuckerman D.M., Jury N.J., Silcox C.E. (2015). "21st Century Cures Act and similar policy efforts: at what cost?". BMJ. 351: h6122. doi:10.1136/bmj.h6122. PMID 26597099.CS1 maint: multiple names: authors list (link)
  • Zuckerman, D.M. (2015) Understanding the Controversies Over a Groundbreaking New Health Care Law. http://www.milbank.org/the-milbank-quarterly/the-op-eds/understanding-thecontroversies-over-a-groundbreaking-new-health-care-law
  • Zuckerman D, Doamekpor LA (2015). "More data are needed for Essure hysteroscopic sterilization device". Contraception. 91 (6): 520. doi:10.1016/j.contraception.2015.02.027. PMID 25779602.
  • Gonsalves G, Zuckerman D (2015). "Commentary: Will 20th century patient safeguards be reversed in the 21st century?". BMJ. 350: h1500. doi:10.1136/bmj.h1500. PMID 25814537.
  • Zuckerman D, Brown P, Das A (2014). "Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices". JAMA Intern. Med. 174 (11): 1781–1787. doi:10.1001/jamainternmed.2014.4193. PMID 25265047.
  • Doamekpor, LA; Zuckerman, DM (October 2014). "Lack of diversity in cancer drug clinical trials may exacerbate racial disparities in mortality rates". Cancer Epidemiology. 38 (5): 645–6. doi:10.1016/j.canep.2014.06.007. PMID 25048155.
  • Mazzucco, AE; Zuckerman, DM (August 2014). "Comment on "Silicone wristbands as personal passive samplers"". Environmental Science & Technology. 48 (15): 8926. Bibcode:2014EnST...48.8926M. doi:10.1021/es502594c. PMID 25010518.
  • Fox DM, Zuckerman DM (March 2014). "Regulatory reticence and medical devices". The Milbank Quarterly. 92 (1): 151–9. doi:10.1111/1468-0009.12044. PMC 3955381. PMID 24597559.
  • Yttri, J; Zuckerman, D (October 2013). "Addressing the need for new antibacterials". The Lancet. Infectious Diseases. 13 (10): 834. doi:10.1016/S1473-3099(13)70240-8. PMID 24070559.
  • Terplan, M; Zuckerman, D (October 2013). "Comment on 'Statement on combined hormonal contraceptives containing third- or fourth-generation progestogens or cyproterone acetate, and the associated risk of thromboembolism'". The Journal of Family Planning and Reproductive Health Care. 39 (4): 304. doi:10.1136/jfprhc-2013-100693. PMID 24062505.
  • Zuckerman, D (March 2013). "Hip implant failure for men and women: what and when we need to know. Comment on 'Sex and risk of hip implant failure'". JAMA Internal Medicine. 173 (6): 442–3. doi:10.1001/jamainternmed.2013.19. PMID 23420302.
  • Zuckerman, D; Booker, N; Nagda, S (December 2012). "Public health implications of differences in U.S. and European Union regulatory policies for breast implants". Reproductive Health Matters. 20 (40): 102–11. doi:10.1016/S0968-8080(12)40662-0. PMID 23245415.
  • Abraham, A; Zuckerman, D (November 2011). "Adolescents, celebrity worship, and cosmetic surgery". The Journal of Adolescent Health. 49 (5): 453–4. doi:10.1016/j.jadohealth.2011.08.014. PMID 22018558.
  • Zuckerman DM, Brown P, Nissen SE (June 2011). "Medical device recalls and the FDA approval process". Archives of Internal Medicine. 171 (11): 1006–11. doi:10.1001/archinternmed.2011.30. PMID 21321283.
  • Zuckerman, DM (May 2010). "Reasonably safe? Breast implants and informed consent". Reproductive Health Matters. 18 (35): 94–102. doi:10.1016/S0968-8080(10)35520-0. PMID 20541088.

References

  1. http://authorities.loc.gov/cgi-bin/Pwebrecon.cgi?AuthRecID=3305166&v1=1&HC=1&SEQ=20071211042258&PID=27945
  2. "Stop Cancer Fund - Information you can use. A voice you can trust". stopcancerfund.org. Retrieved April 11, 2017.
  3. National Research Center for Women & Families staff listing Retrieved June 14, 2010.
  4. Zuckerman, Diana (2002)Hype in health reporting Archived 2006-05-23 at the Wayback Machine. Retrieved August 16, 2006.
  5. Zuckerman DM, Brown P, Nissen SE (June 2011). "Medical device recalls and the FDA approval process". Archives of Internal Medicine. 171 (11): 1006–11. doi:10.1001/archinternmed.2011.30. PMID 21321283.
  6. Redberg RF, Dhruva SS (June 2011). "Medical device recalls: get it right the first time: Comment on "Medical device recalls and the FDA approval process"". Archives of Internal Medicine. 171 (11): 1011–2. doi:10.1001/archinternmed.2011.27. PMID 21321286.
  7. "Not enough safety testing on medical implant devices, studies claim". cbsnews.com. CBS News. September 30, 2014. Retrieved April 11, 2017.
  8. Thomas M. Burton (September 29, 2014). "Medical Devices Lack Safety Evidence, Study Finds". Wall Street Journal. Retrieved April 11, 2017.
  9. "Studies criticize U.S. medical device approval process". Reuters. September 30, 2014. Retrieved April 11, 2017.
  10. "A Delicate Balance: FDA and the Reform of the Medical Device Approval Process".
  11. Gardiner Harris (April 8, 2009). "F.D.A. to Check Safety of Old Devices". The New York Times. The New York Times Company. Retrieved April 11, 2017.
  12. Reed Abelson (October 27, 2009). "Quickly Vetted, Treatment Is Offered to Patients". The New York Times. The New York Times Company. Retrieved April 11, 2017.
  13. Ronio Caryn Rabin (May 3, 2015). "Long-Term Data on Complications Adds to Criticism of Essure Contraceptive Implant". The New York Times. The New York Times Company. Retrieved April 11, 2017.
  14. Marshall Allen; Olga Pierce (February 6, 2015). "Knee Replacement Device Unapproved, but Used in Surgery". The New York Times. The New York Times Company. Retrieved April 11, 2017.
  15. "Implant Maker Fixed Samples Only". Washington Post. December 4, 2005. Retrieved April 11, 2017.
  16. "Breast implants: FDA stands by silicone implants". Los Angeles Times. June 23, 2011. Retrieved April 11, 2017.
  17. "Hip implants a bit more likely to fail in women". The Boston Globe. Associated Press. February 19, 2013. Retrieved April 11, 2017.
  18. "FDA panel supports firm's breast implant". boston.com. Retrieved April 11, 2017.
  19. SELF Staffers (January 26, 2011). "The True Price of Cheap Cosmetic Surgery". SELF. Retrieved April 11, 2017.
  20. "Key Staff". National Center for Health Research. Retrieved April 11, 2017.
  21. "Are Breast Implants Safe?". Medscape. Retrieved April 11, 2017.
  22. "FDA Reviewing Safety of Essure Birth Control Implant". Archived from the original on 2015-09-25. Retrieved 2017-02-24.
  23. http://center4research.org/public-policy/testimony-briefings-statements/statementdapagliflozin/%5B%5D
  24. "Statement by Dr. Diana Zuckerman, Capitol Hill Press Conference". The Cancer Prevention and Treatment Fund. November 14, 2012. Retrieved April 11, 2017.
  25. "Microsoft Word - OPSC Part 15 Transcript.doc" (PDF). Retrieved 2019-06-11.
  26. CPTFadmin (8 February 2018). "Testimony of Dr. Diana Zuckerman Before the Maryland House of Delegates Appropriations Committee on the Health Risks of Artificial Turf".
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