2 Social value presupposes the public dissemination of research results. However, tPA also prevents an approximately equal number of patients from experiencing symptomatic worsening from stroke extension, cerebral herniation, and other complications of large infarcts. The typical opinion page dichotomy of one pro opinion and one con opinion that the BMJarranged provides an entirely misleading view of the state of informed opinion.

Journal List > BMJ > v.324(7353); Jun 29, 2002

Copyright &x000a9; 2002, BMJ Alteplase for stroke Uncertainty remains about efficacy Division of Medical Ethics, University of Utah School of Medicine, Salt Lake City, UT 84132, USA ; Email: howardm/at/xmission.com

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. 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.

Copyright &x000a9; 2002, BMJ Patients and doctors are being misled by promotional pressures James Li, assistant professor of medicine Larry A Nathanson, instructor of medicine

centres where thrombolytic therapy can be expertly administered.&x0201d; Physicians should master the key elements of care that are of proved benefit.

Lenzer is not a scientist, so it was appropriate that she merely referenced concerns of critics without trying to argue their points in detail. Would the BMJ have solicited two contrary commentaries had her article praised the use of alteplase' (The BMJ could hardly have predicted Warlow's cautionary stance, since he is an investigator in the third international stroke trial (IST-3), &x0201c;designed to generate the data needed to persuade everyone involved in stroke medicine .

that rt-PA &x0005b;recombinant tPA&x0005d; thrombolysis should be more widely available.&x0201d;)..

Copyright &x000a9; 2002, BMJ

Experts without competing interests may be hard (though not impossible) to find, but it begs the question: what is to be done'

Copyright &x000a9; 2002, BMJ Authors of commentary reply . Jeffrey L Saver, associate professor, neurology .. . Chelsea S Kidwell, assistant professor, neurology .. Sidney Starkman, professor, emergency medicine and neurology UCLA Stroke Center, Department of Neurology, and Department of Emergency Medicine, University of California, Los Angeles, USA However, tPA also prevents an approximately equal number of patients from experiencing symptomatic worsening from stroke extension, cerebral herniation, and other complications of large infarcts.

Baldly stated, if you receive tPA the risk is increased that you may bleed and die. If you don't receive tPA the risk is increased that you may herniate and die. The salient number needed to harm is the net sum of these two factors, and across all under three hour trials there is no net harm.

So do we. It is important, however, to realise what such balanced commentaries would look like. The typical opinion page dichotomy of one pro opinion and one con opinion that the BMJarranged provides an entirely misleading view of the state of informed opinion. Among American experts on stroke there is overwhelming consensus that tPA is efficacious.

In this regard, it is noteworthy that in his letter Hoffman has declared his own financial competing interest with regard to the use of tPA in stroke. This myth was long ago demonstrated to be false 6-1 but persists among tPA contrarians as an article of faith impervious to actual evidence. However devoutly the tPA contrarians wish they only had a single NINDS-tPA trial with which to contend, the fact is there were two trials, as the Food and Drug Administration recognised when ascertaining that the evidence for the benefit of tPA in acute stroke was quite adequate to approve the indication.

We will close by again seeking common ground. We concur, as before, with calls to bar experts with major financial competing interests from service on guideline committees and to require experts with minor financial competing interests to disclose them publicly.

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