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 ,Revised 17 January 2006 ,Accepted 18 January 2006.

References 

  1. Grimes DA, Schulz KF. Surrogate end points in clinical research: hazardous to your health. Obstet Gynecol. 2005;105:1114–1118
  2. Kaunitz AM. Depo-Provera's black box: time to reconsider?. Contraception. 2005;72(3):165–167
  3. Preston RA, White WB, Pitt B, Bakris G, Norris PM, Hanes V. Effects of drospirenone/17-beta estradiol on blood pressure and potassium balance in hypertensive postmenopausal women. Am J Hypertens. 2005;18:797–804
  4. Heinemann LA, Dinger J. Safety of a new oral contraceptive containing drospirenone. Drug Saf. 2004;27:1001–1018
  5. van den Heuvel MW, van Bragt AJM, Alnabawy AKM, Kaptein MCJ. Comparison of ethinyl estradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive. Contraception. 2005;72:168–174
  6. Chaker AM. Doctors back off birth-control patch after FDA warning on excessive hormones, some stop prescribing popular method weighing choices. Wall St J. 2005;

PII: S0010-7824(06)00034-5

doi: 10.1016/j.contraception.2006.01.007

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