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Diana Zuckerman

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Diana Zuckerman
BornJune 17, 1950
NationalityAmerican
EducationSmith College (B.A)
Ohio State University (Ph.D)

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 specializes in 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]

Early life and education

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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

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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 to work on health policy issues 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 in the U.S. Congress in a House oversight subcommittee chaired by Rep. Ted Weiss, 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)[4] 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 breast implant manufacturers to submit safety studies for the first time in 1991.[5]

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. This resulted in her working in the White House on Gulf War Syndrome issues in 1995 as a senior policy advisor in the Clinton Administration. From 1996, she held health policy positions at several non-profit organizations, and she became the founding president of the National Center for Health Research in 1999 (which changed its name from National Research Center for Women & Families in 2014).[3] The Center includes 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.[6]

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.[7] 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.[8] In April 2011, Zuckerman presented the results of the study at a hearing by the U.S. Senate Special Committee on Aging.[9]

In 2014, Zuckerman and Brown published another study of medical devices entitled "Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices,"[10] in JAMA Internal Medicine, which attracted major media coverage because it criticized the FDA for not following its own regulations requiring that information on safety and effectiveness be made available for all implanted devices.[11][12][13]

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,[14][15][16][17] The Washington Post,[18] The Washington Times, Los Angeles Times,[19] The Boston Globe,[20][21] USA Today, Detroit Free Press, New York Daily News, Newsweek, Time, U.S. News & World Report, Family Circle, The New Yorker, Glamour, Self,[22] as well as many other newspapers, magazines, and radio programs.[23][24][25]

Published articles

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In addition to the studies noted above, Zuckerman frequently writes articles in peer-reviewed medical and public health journals regarding medical drugs and devices, as well as public health policy. For example, in 2021, her article describing the shortcuts that the FDA took during the COVID pandemic, entitled "Emergency Use Authorizations (EUAs) Versus FDA Approval: Implications for COVID-19 and Public Health,"[26] was published in the American Journal of Public Health.

In 2017-2018 she was the author or co-author of several published peer-review research studies and commentaries questioning the safety and effectiveness of pharmaceuticals and medical devices, such as "Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?",[27] which was published in Milbank Quarterly; "Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health" also published in Milbank Quarterly;[28] an editorial entitled "Can the FDA Help Reduce Drug Prices or the Cost of Medical Care?,"[29] published in the American Journal of Public Health; "Electronic Health Records,"[30] published in Annals of Internal Medicine; "Setting the Record Straight on FDA Approvals in Oncology-Reply,"[31] in JAMA Internal Medicine; "Quality of Life, Overall Survival, and Costs of Cancer Drugs Approved Based on Surrogate Endpoints;"[32] also in JAMA Internal Medicine; and a commentary entitled "A Major Shortcoming in the Public Health Legacy of the Obama Administration,"[33]published in American Journal of Public Health.

In 2016, Zuckerman co-authored a book chapter entitled "The Challenges of Informed Consent When Information and Time are Limited" in the book Informed Consent: Procedures, Ethics and Best Practices [34]

In 2014-2015 she published several commentaries about a new law that lowered FDA evidence standards, including "21st Century Cures Act and similar policy efforts: at what cost?,"[35] which was published in BMJ; "Understanding the Controversies Over a Groundbreaking New Health Care Law,"[36] published in Milbank Quarterly; and "Will 20th century patient safeguards be reversed in the 21st century?,"[37] also published in BMJ.

Also in 2014 and 2010-2013, Zuckerman was the author or co-author of several published research studies and commentaries, such as, "Lack of diversity in cancer drug clinical trials may exacerbate racial disparities in mortality rates,"[38] in Cancer Epidemiology; "Comment on "Silicone wristbands as personal passive samplers,"[39] in Environmental Science & Technology; "Regulatory reticence and medical devices,"[40] in Milbank Quarterly; "Addressing the need for new antibacterial,"[41]in The Lancet Infectious Diseases; "Comment on 'Statement on combined hormonal contraceptives containing third- or fourth-generation progestogens or cyproterone acetate, and the associated risk of thromboembolism,"[42] in Journal of Family Planning and Reproductive Health Care; "Hip implant failure for men and women: what and when we need to know Comment on "Sex and Risk of Hip Implant Failure,"[43]. in JAMA Internal Medicine; "Public health implications of differences in U.S. and European Union regulatory policies for breast implants,"[44] in Reproductive Health Matters; "Adolescents, celebrity worship, and cosmetic surgery,"[45] in Journal of Adolescent Health; "and "Reasonably safe? Breast implants and informed consent,"[46] in Reproductive Health Matters.

References

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  1. ^ http://authorities.loc.gov/cgi-bin/Pwebrecon.cgi?AuthRecID=3305166&v1=1&HC=1&SEQ=20071211042258&PID=27945 [full citation needed]
  2. ^ "Stop Cancer Fund - Information you can use. A voice you can trust". stopcancerfund.org. Retrieved April 11, 2017.
  3. ^ a b National Research Center for Women & Families staff listing Retrieved June 14, 2010.
  4. ^ Sciences (US), National Academy of; Research, National Academy of Engineering (US) and Institute of Medicine (US) Panel on Scientific Responsibility and the Conduct of (1993), "Congressional Activities Regarding Misconduct and Integrity in Science", Responsible Science: Ensuring the Integrity of the Research Process: Volume II, National Academies Press (US), retrieved 2025-03-14
  5. ^ Health, Center for Devices and Radiological (2020-09-28). "Saline, Silicone Gel, and Alternative Breast Implants". www.fda.gov. Retrieved 2025-03-12.
  6. ^ Zuckerman, Diana (2002)Hype in health reporting Archived 2006-05-23 at the Wayback Machine. Retrieved August 16, 2006.
  7. ^ 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.
  8. ^ 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.
  9. ^ "A Delicate Balance: FDA and the Reform of the Medical Device Approval Process". 13 April 2011.
  10. ^ Zuckerman, Diana; Brown, Paul; Das, Aditi (2014-11-01). "Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices". JAMA Internal Medicine. 174 (11): 1781–1787. doi:10.1001/jamainternmed.2014.4193. ISSN 2168-6106.
  11. ^ "Studies criticize U.S. medical device approval process". Reuters. September 30, 2014. Retrieved April 11, 2017.
  12. ^ "Not enough safety testing on medical implant devices, studies claim". cbsnews.com. CBS News. September 30, 2014. Retrieved April 11, 2017.
  13. ^ Thomas M. Burton (September 29, 2014). "Medical Devices Lack Safety Evidence, Study Finds". The Wall Street Journal. Retrieved April 11, 2017.
  14. ^ Gardiner Harris (April 8, 2009). "F.D.A. to Check Safety of Old Devices". The New York Times. Retrieved April 11, 2017.
  15. ^ Reed Abelson (October 27, 2009). "Quickly Vetted, Treatment Is Offered to Patients". The New York Times. Retrieved April 11, 2017.
  16. ^ Ronio Caryn Rabin (May 3, 2015). "Long-Term Data on Complications Adds to Criticism of Essure Contraceptive Implant". The New York Times. Retrieved April 11, 2017.
  17. ^ Marshall Allen; Olga Pierce (February 6, 2015). "Knee Replacement Device Unapproved, but Used in Surgery". The New York Times. Retrieved April 11, 2017.
  18. ^ "Implant Maker Fixed Samples Only". The Washington Post. December 4, 2005. Retrieved April 11, 2017.
  19. ^ "Breast implants: FDA stands by silicone implants". Los Angeles Times. June 23, 2011. Retrieved April 11, 2017.
  20. ^ "Hip implants a bit more likely to fail in women". The Boston Globe. Associated Press. February 19, 2013. Retrieved April 11, 2017.
  21. ^ "FDA panel supports firm's breast implant". boston.com. Retrieved April 11, 2017.
  22. ^ SELF Staffers (January 26, 2011). "The True Price of Cheap Cosmetic Surgery". SELF. Retrieved April 11, 2017.
  23. ^ "Key Staff". National Center for Health Research. Retrieved April 11, 2017.
  24. ^ "Are Breast Implants Safe?". Medscape. Retrieved April 11, 2017.
  25. ^ "FDA Reviewing Safety of Essure Birth Control Implant". The New York Times. Archived from the original on 2015-09-25. Retrieved 2017-02-24.
  26. ^ Zuckerman, Diana M. (2021-06-01). "Emergency Use Authorizations (EUAs) Versus FDA Approval: Implications for COVID-19 and Public Health". American Journal of Public Health. 111 (6): 1065–1069 – via AJPH.
  27. ^ FOX‐RAWLINGS, STEPHANIE R.; GOTTSCHALK, LAURA B.; DOAMEKPOR, LAURÉN A.; ZUCKERMAN, DIANA M. (2018). "Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?". The Milbank Quarterly. 96 (3): 499–529. doi:10.1111/1468-0009.12344. ISSN 0887-378X. PMC 6131322.
  28. ^ Ronquillo, Jay G.; Zuckerman, Diana 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. ISSN 1468-0009. PMC 5594275. PMID 28895231 – via PubMed.
  29. ^ Zuckerman, Diana 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. ISSN 0090-0036. PMC 5637698 – via PubMed.
  30. ^ Ronquillo, Jay G.; Zuckerman, Diana M. (2017-04-04). "Electronic Health Records". Annals of Internal Medicine. 166 (7): 536. doi:10.7326/L17-0050. ISSN 0003-4819.
  31. ^ Zuckerman, Diana (2017-08-01). "Setting the Record Straight on FDA Approvals in Oncology—Reply". JAMA Internal Medicine. 177 (8): 1222–1223. doi:10.1001/jamainternmed.2017.2251. ISSN 2168-6106.
  32. ^ Rupp, Tracy; Zuckerman, Diana (2017-02-01). "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. ISSN 2168-6106.
  33. ^ Zuckerman, Diana (2017). "A Major Shortcoming in the Public Health Legacy of the Obama Administration". [American Journal of Public Health]. 107: 29–30 – via PubMed.
  34. ^ "What Is the Difference Between Written and Verbal Informed Consent, and When Can Verbal Informed Consent Be Used?", 100 Questions (and Answers) About Research Ethics, 2455 Teller Road, Thousand Oaks California 91320: SAGE Publications, Inc, pp. 74–75, 2018, retrieved 2025-03-13{{citation}}: CS1 maint: location (link)
  35. ^ Zuckerman, Diana M; Jury, Nicholas J; Silcox, Christina E (2015-11-23). "21st Century Cures Act and similar policy efforts: at what cost?:". BMJ: h6122. doi:10.1136/bmj.h6122. ISSN 1756-1833.
  36. ^ Gostin, Larry (1986). "The Future of Communicable Disease Control: Toward a New Concept in Public Health Law". The Milbank Quarterly. 64: 79. doi:10.2307/3350042. ISSN 0887-378X.
  37. ^ Gonsalves, G.; Zuckerman, D. (2015-03-25). "Commentary: Will 20th century patient safeguards be reversed in the 21st century?". BMJ. 350 (mar25 7): h1500 – h1500. doi:10.1136/bmj.h1500. ISSN 1756-1833.
  38. ^ Zuckerman, Diana; Brown, Paul; Das, Aditi (2014-11-01). "Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices". JAMA Internal Medicine. 174 (11): 1781. doi:10.1001/jamainternmed.2014.4193. ISSN 2168-6106.
  39. ^ Mazzucco, Anna E.; Zuckerman, Diana M. (2014-08-05). "Comment on "Silicone Wristbands as Personal Passive Samplers"". Environmental Science & Technology. 48 (15): 8926–8926. doi:10.1021/es502594c. ISSN 0013-936X.
  40. ^ Fox, Daniel M.; Zuckerman, Diana M. (2014). "Regulatory Reticence and Medical Devices". The Milbank Quarterly (in Enlgish). 92 (1): 151–159. doi:10.1111/1468-0009.12044. ISSN 0887-378X. PMC 3955381 – via PubMed Central.{{cite journal}}: CS1 maint: unrecognized language (link)
  41. ^ Yttri, Jennifer; Zuckerman, Diana (2013). "Addressing the need for new antibacterials". The Lancet Infectious Diseases. 13 (10): 834. doi:10.1016/S1473-3099(13)70240-8 – via The Lancet.
  42. ^ Terplan, Mishka; Zuckerman, Diana (2013). "Comment on 'Statement on combined hormonal contraceptives containing third- or fourth-generation progestogens or cyproterone acetate, and the associated risk of thromboembolism'". Journal of Family Planning and Reproductive Health Care. 39 (4): 304.1–304. doi:10.1136/jfprhc-2013-100693. ISSN 1471-1893 – via Research Gate.
  43. ^ Zuckerman, Diana (2013-03-25). "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): 442–443. doi:10.1001/jamainternmed.2013.19. ISSN 2168-6106.
  44. ^ Zuckerman, Diana; Booker, Nyedra; Nagda, Sonia (2012). "Public health implications of differences in U.S. and European Union regulatory policies for breast implants". Reproductive Health Matters. 20 (40): 102–111. doi:10.1016/S0968-8080(12)40662-0. ISSN 1460-9576. PMID 23245415 – via PubMed.
  45. ^ Abraham, Anisha; Zuckerman, Diana (2011). "Adolescents, celebrity worship, and cosmetic surgery". The Journal of Adolescent Health: Official Publication of the Society for Adolescent Medicine. 49 (5): 453–454. doi:10.1016/j.jadohealth.2011.08.014. ISSN 1879-1972. PMID 22018558 – via PubMed.
  46. ^ Zuckerman, Diana M (2010). "Reasonably safe? Breast implants and informed consent". Reproductive Health Matters. 18 (35): 94–102. ISSN 0968-8080.
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