Letter

Alteplase for stroke

BMJ 2002; 324 doi: 10.1136/bmj.324.7353.1581 (Published 29 June 2002)
Cite this as: BMJ 2002;324:1581

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Uncertainty remains about efficacy

  1. Howard Mann (howardm@xmission.com), program associate
  1. Division of Medical Ethics, University of Utah School of Medicine, Salt Lake City, UT 84132, USA
  2. Division of Emergency Medicine, Harvard Medical School, Cambridge, MA 02115, USA
  3. Division of Emergency Medicine, Southwestern Medical Center, University of Texas, Dallas, TX 75390, USA
  4. Charity Hospital, Louisiana State University School of Medicine, New Orleans, LA 70112, USA
  5. Tampa General Hospital, University of South Florida, Tampa, FL 33606, USA
  6. John C Lincoln Hospital, Arizona School of Health Sciences, Phoenix, AZ 85020, USA
  7. Cardiology Section, University of Chicago, Chicago, USA
  8. Ohio Valley Medical Center, Wheeling, WV 26002, USA
  9. University of California at Los Angeles School of Medicine, Los Angeles, CA 90077, USA
  10. Oak Ridge Journalism, Ellenville, NY 12428, USA
  11. UCLA Stroke Center, Department of Neurology, and Department of Emergency Medicine, University of California, Los Angeles, USA

    EDITOR—The article by Lenzer and the associated commentary by Saver et al raise many serious issues, among which is the residual state of uncertainty concerning the efficacy of alteplase (tPA) in acute ischaemic stroke.1 Confronted by opposing interpretations of the aggregate data published to date and the now known baseline imbalance in the severity of stroke in the National Institute of Neurological Diseases and Stroke (NINDS) trial, doctors are presented with a conundrum: what action do the data support?

    The reported unwillingness of the investigators and sponsor of the National Institute of Neurological Diseases and Stroke trial to provide data for additional analysis is disturbing. Emanuel et al have described seven requirements for the ethical conduct of clinical research, among which is social and scientific value.2 Social value presupposes the public dissemination of research results. I have formulated a standard for the scientific and ethical review of trials that elaborates on this requirement.3

    Implicit in this requirement is the necessity for the public dissemination of the complete dataset acquired during a clinical trial. This allows interested investigators to apply recognised analytic techniques in an attempt to resolve (or diminish) residual uncertainty concerning the clinical implications of the trial's results. This ethical requirement has not yet been met for the National Institute of Neurological Diseases and Stroke trial.

    Footnotes

    • Competing interests None declared.

    References

    1. 1.↵
      1. Lenzer L
      . Alteplase for stroke: money and optimistic claims buttress the “brain attack” campaign [commentaries by C Warlow; JL Saver, CS Kidwell, S Starkman]. BMJ 2002; 324: 723–729. (23 March.)
      OpenUrlFREE Full Text
    2. 2.↵
      1. Emanuel E,
      2. Wendler D,
      3. Grady C
      . What makes clinical research ethical? JAMA 2000; 283: 2701–2711.
      OpenUrlFREE Full Text
    3. 3.↵
      1. ASSERT
      . A standard for the scientific and ethical review of trials. www.assert-statement.org/publication.html#resultsdissem

    Patients and doctors are being misled by promotional pressures

    1. James Li (jamesli@harvard.edu), assistant professor of medicine,
    2. Larry A Nathanson, instructor of medicine,
    3. Trevor J Mills, assistant professor,
    4. Karin E Netland, clinical faculty, emergency medicine,
    5. Richard Paula, clinical faculty, emergency medicine,
    6. Douglas Ragland, clinical faculty, emergency medicine
    1. Division of Medical Ethics, University of Utah School of Medicine, Salt Lake City, UT 84132, USA
    2. Division of Emergency Medicine, Harvard Medical School, Cambridge, MA 02115, USA
    3. Division of Emergency Medicine, Southwestern Medical Center, University of Texas, Dallas, TX 75390, USA
    4. Charity Hospital, Louisiana State University School of Medicine, New Orleans, LA 70112, USA
    5. Tampa General Hospital, University of South Florida, Tampa, FL 33606, USA
    6. John C Lincoln Hospital, Arizona School of Health Sciences, Phoenix, AZ 85020, USA
    7. Cardiology Section, University of Chicago, Chicago, USA
    8. Ohio Valley Medical Center, Wheeling, WV 26002, USA
    9. University of California at Los Angeles School of Medicine, Los Angeles, CA 90077, USA
    10. Oak Ridge Journalism, Ellenville, NY 12428, USA
    11. UCLA Stroke Center, Department of Neurology, and Department of Emergency Medicine, University of California, Los Angeles, USA

      EDITOR—Alteplase (tPA) is not proved for the treatment of stroke, and payment from the drug's manufacturers to research doctors degrades the premise of unbiased skill.

      In their commentary Saver et al disclose ties to 81 for profit companies linked to treatments for stroke.1 Sponsorship of this magnitude does not “channel the self interest of profit making companies to improving stroke care”: it purchases spokesmen for manufacturers seeking to add credibility to their wares. Although sponsored …

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