Academic journal article The Hastings Center Report

The Quality of Mercy

Academic journal article The Hastings Center Report

The Quality of Mercy

Article excerpt

In October (1992) Sen. Tom Harkin of Iowa, chairman of the subcommittee that overseees the budget for the National Institutes of Health, asked NIH director Bernadine Healy to allow one of Harkin's former constituents who is dying of brain cancer to receive unapproved gene therapy. Healy initially denied the request for compassionate exemption, since there was no provision in NIH guidelines for expedited review of gene transfer protocols. Moreover, the NIH's Recombinant DNA Advisory Committee (RAC) had earlier rejected an essentially identical protocol for lack of data demonstrating its safety and efficacy.

In late December, however, Healy exercised her prerogative as agency director to bypass an advisory committee and approved the treatment, at the same time calling for an emergency meeting of the RAC to develop guidelines for expedited review of genetic therapies. By way of jutifying the decision to allow "compassionate use" of the proposed therapy, NIH deputy director Lance A. Liotta pointed out that the vector which researchers intended to use to transfer the altered genetic material had already been approved, and the the woman's physician, Dr. Ivor Royston of the San Diego Regional Cancer Center, already had the approval of his local institutional review board and biosafety committee (Science, 8 & 22 January 1993).

Responding to Healy's call for guidelines, the RAC drafted a proposal for expedited review of genetic therapies at the emergency meeting in January. Among their recommendations were that review by the advisory committee was to be preferred to internal review by NIH staff. Protocols under internal review should be subject to the same criteria as those employed by the RAC (JAMA, 17 February 1993).

At its most recent meeting in February, the committee recommended amending those guidelines, unanimously approving the following ten principles for expedited review of gene transfer protocols:

* Investigators requesting expedited review must provide detailed information as to the need for expedited review. …

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