Contraception
Volume 73, Issue 5 , Pages 440-442, May 2006

Surrogate markers, emboldened and boxed warnings, and an expanding culture of misinformation:

Evidence-based clinical science should guide FDA decision making about product labeling

  • Lee P. Shulman

      Affiliations

    • Department of Obstetrics and Gynecology, Division of Reproductive Genetics, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA
    • Corresponding Author InformationCorresponding author.
    • ,
  • Louise H. Bateman

      Affiliations

    • Houston, TX, USA
    • ,
  • Mitchell D. Creinin

      Affiliations

    • Department of Obstetrics, Gynecology and Reproductive Science, Magee Women's Hospital, University of Pittsburgh, Pittsburgh, PA 15213, USA
    • ,
  • Vanessa E. Cullins

      Affiliations

    • Planned Parenthood Federation of America, New York, NY 10001, USA
    • ,
  • Lee Lee Doyle

      Affiliations

    • University of Arkansas for Medical Science, Little Rock, AR 72205-7199, USA
    • ,
  • Emily Godfrey

      Affiliations

    • Department of Family Medicine, University of Illinois, Chicago, Chicago, IL 60612, USA
    • ,
  • Patricia Murphy

      Affiliations

    • University of Utah School of Nursing, Salt Lake City, UT 84112, USA
    • ,
  • Pablo Rodriguez

      Affiliations

    • Planned Parenthood of Rhode Island, Warwick, RI 02889, USA
    • ,
  • Scott J. Spear

      Affiliations

    • University Health Services, University of Wisconsin-Madison, Madison, WI 53726, USA
    • ,
  • Felicia H. Stewart

      Affiliations

    • Department of Obstetrics, Gynecology and Reproductive Sciences, Bixby UCSF Center for Reproductive Health Research and Policy, University of California, San Francisco, San Francisco, CA 94143-1744, USA
    • ,
  • Michael A. Thomas

      Affiliations

    • Medical Center for Reproductive Health, University of Cincinnati, Cincinnati, OH 45219, USA
    • ,
  • Carolyn L. Westhoff

      Affiliations

    • Columbia University Medical Center, New York, NY 10032, USA
    • ,
  • Sandra Worthington

      Affiliations

    • Planned Parenthood Federation of America Nurse Practitioner Program, Philadelphia, PA 19102, USA

Received 16 January 2006; received in revised form 17 January 2006; accepted 18 January 2006. published online 13 March 2006.

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PII: S0010-7824(06)00034-5

doi:10.1016/j.contraception.2006.01.007

Contraception
Volume 73, Issue 5 , Pages 440-442, May 2006

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