Re: Utilization of Intravenous Tissue-Type Plasminogen Activator for Ischemic Stroke at Academic Medical Centers
To the Editor:
We write in response to the recent significant article of Johnston et al.1 The authors’ hypothesis is that racism, even on an unconscious level, may contribute to the disparity between administration of tissue plasminogen activator (tPA) to blacks and the administration of tPA to whites for acute ischemic stroke at academic medical centers in the United States.
While we do not dispute their findings, we wish to introduce an additional point that was not considered in their article, and to forward a means to partially remedy the disparity. Their findings were based on a retrospective analysis at 42 academic medical centers in the United States. tPA may have been administered at some of these institutions under the auspices of a phase II or III clinical study. If so, a community consultation should have been performed prior to this emergent research, per FDA and NIH requirements. However, the community consultation requirement has not been appropriately explained by the FDA or the NIH, and researchers may be at a loss as to how to effectively inform the community that experimental treatments are being administered without consent of either the patient-subject or a surrogate.
If physicians knew that an effective community consultation had been performed, one that reached all segments of the community, they would be less likely to unconsciously bias themselves against administering experimental treatment to minority populations. The specter of unethical research may account for some of the unconscious bias against administering experimental therapies to populations that have experienced historical injustices in clinical research. Rather than discriminating on the basis of racism, physician-researchers may be overly cautious in administering experimental therapies. Knowledge that an effective community consultation had taken place may allow physician-researchers to confidently administer experimental, albeit potentially lifesaving, treatments.
Johnson et al may have told us something we already knew: more work needs to be done to determine what counts as an effective community consultation before emergent research, which in turn may be one step toward remedying racial disparities in emergent research subject populations. Researchers must do more to understand both the procedures as well as the value systems that shape effective community consultations.
The authors are currently performing research on effective community consultations prior to emergent research, supported by Summa Health Foundation.
Utilization of intravenous tissue-type plasminogen activator for ischemic stroke at academic medical centers. Stroke. 2001; 32: 1061–1070.
tPA was approved for use in patients with ischemic stroke for 3 years prior to the study period, and the initial study proving its efficacy was not performed in most of the communities studied. Therefore, we cannot comment on the potential effect of community consultation. However, we agree in principal that informing communities about the use of tPA for stroke could reduce underutilization in all ethnic groups.