Jonathan Sackner Bernstein

Jonathan Sackner Bernstein

Sackner Bernstein in 2016.
Born (1961-01-27)January 27, 1961
Philadelphia, PA
Nationality American
Alma mater University of Pennsylvania
Moore School of Electrical Engineering
Jefferson Medical College
Occupation Cardiologist
Organization Mt. Sinai Hospital
Columbia University
Food and Drug Administration
SRD Med
Known for Medical Product Regulation, Clinical Research
Spouse(s) Audrey Sackner Bernstein

Jonathan Sackner Bernstein (born 27 January 1961) is an American physician, researcher, and administrator. He has published more than 80 scientific articles, which have been cited more than 4,000 times...[1] His research has ranged from cardiac care to the efficacy of drugs. His research led to increased scrutiny of Nesiritide, a widely marketed drug, which led to its decline in the marketplace.[2]

Education

Sackner Bernstein graduated from the University of Pennsylvania's Moore School of Electrical Engineering in 1983 (BSEE), where he was president of Eta Kappa Nu, the electrical engineering honor society. He completed his MD from Jefferson Medical College, during which he moonlit writing code.[3] He completed a residency in internal medicine and subsequently cardiology at Mount Sinai Hospital in New York. In addition, Sackner Bernstein completed a research fellowship in heart failure under Milton Packer, MD at Mount Sinai.[4]

Academic, clinical and research experience

Bernstein joined the Columbia University faculty in 1993 in the Division of Circulatory Physiology, where he established its clinical research program. As a clinical investigator, he accumulated a large experience with the beta-blocker carvedilol prior to the application by its developer (GlaxoSmithKline) to the US Food and Drug Administration (FDA).[5]

Bernstein's most cited research focused on whether the newly marketed heart failure drug nesiritide (hr-BNP, Natrecor) was safe and effective, with a call for large-scale clinical trials prior to widespread use.[6][7][8] While nesiritide was projected to generate $1 billion in sales in 2006,[9] these studies triggered controversy[10] that eventually led to markedly lower use by physicians.[11]

Other frequently cited articles include work on Carvedilol [12] and cardiac hypertrophy [13]

He is also the author of a book on heart disease, Before It Happens To You[14]

US government projects

Bernstein joined the FDA in 2008 as Associate Center Director, leading Post Market Operations as well as Technology and Innovation programs.[15]

He also helped establish a formal relationship between FDA and DARPA (Defense Advanced Research Projects Agency),[16] then serving as architect for the initial White House Office of Science and Technology Policy (OSTP) sponsored Entrepreneurs-in-Residence Program.[17]

Commercial projects

Sackner Bernstein launched SRD Med, LLC in 2015.

References

  1. "jonathan sackner bernstein - Google Scholar".
  2. http://www.nytimes.com/2005/05/17/business/the-marketing-and-success-of-natrecor.html?_r=0
  3. "Creative Computing Magazine (December 1983) Volume 09 Number 12".
  4. "Medscape: Medscape Access".
  5. European Heart Journal (abstract P1651): http://eurheartj.oxfordjournals.org/content/ehj/21/Abstract_Supplement/1.full.pdf
  6. Sackner Bernstein, JD; Skopicki, HA; Aaronson, KD (Mar 2005). "Risk of worsening renal function with nesiritide in patients with acutely decompensated heart failure". Circulation. 111 (12): 1487–91. doi:10.1161/01.CIR.0000159340.93220.E4. PMID 15781736.
  7. Sackner-Bernstein, JD; Kowalski, M; Fox, M; Aaronson, K (2005). "Short-term risk of death after treatment with nesiritide for decompensated heart failure: a pooled analysis of randomized controlled trials". JAMA. 293: 1900–5. doi:10.1001/jama.293.15.1900. PMID 15840865.
  8. Aaronson, KD; Sackner-Bernstein, J (2006). "Risk of death associated with nesiritide in patients with acutely decompensated heart failure". JAMA. 296: 1465–6. doi:10.1001/jama.296.12.1465. PMID 17003394.
  9. "Heart drug's usage causes concern among some doctors".
  10. NY Times May 4, 2005: http://www.nytimes.com/2005/05/04/health/heart-clinic-may-end-or-curtail-use-of-a-drug.html?_r=0 and 17, 2005: http://www.nytimes.com/2005/05/17/business/the-marketing-and-success-of-natrecor.html?_r=0
  11. Hauptman, PJ; Schnitzler, MA; Swindle, J; Burroughs, TE (Oct 2006). "Use of nesiritide before and after publications suggesting drug-related risks in patients with acute decompensated heart failure". JAMA. 296 (15): 1877–84. doi:10.1001/jama.296.15.1877.
  12. Wilson S. Colucci. "Carvedilol Inhibits Clinical Progression in Patients With Mild Symptoms of Heart Failure".
  13. Thomas M. Behr. "Hypertensive End-Organ Damage and Premature Mortality Are p38 Mitogen-Activated Protein Kinase–Dependent in a Rat Model of Cardiac Hypertrophy and Dysfunction".
  14. "Nonfiction Book Review: Before It Happens to You: A Breakthrough Program for Reversing or Preventing Heart Disease by Jonathan Sackner Bernstein, Author, Kate Kelly, With Da Capo Press $26 (249p) ISBN 978-0-7382-0918-0". PublishersWeekly.com.
  15. http://www.medscape.com/viewarticle/790276, October 16, 2008
  16. Dec 2010: https://www.gpo.gov/fdsys/pkg/FR-2010-12-20/html/2010-31811.htm
  17. https://www.signup4.net/Upload/BOOZ12A/CTSA37E/File%208_Speaker%20Biographies.pdf
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