University Times

Lewis M. Popper, general counsel, responds:

With respect to Dr. Fisher's letter addressing the National Cancer Institute's insistence that it see NSABP articles before publication, I have several comments. Candor requires me to say that Dr. Fisher's account materially misstates what happened.

The University of Pittsburgh was and is committed to the freedom of its faculty to publish what they want. The University accepts the hazard, among others, that faculty, perhaps in good faith, will publish externally-sponsored scientific articles that contain fraudulent data generated elsewhere. In the context of its belief that the administration of NSABP under Dr. Fisher's stewardship had been repeatedly and substantially deficient in that and other respects, NCI demanded assurance, by access to NSABP manuscripts, that what it took to be a pattern in this regard would not persist. The circumstances with NSABP were, to say the least, "unusual or extenuating," to cite the University's 1992 policy statement to which Dr. Fisher refers.

Notwithstanding that trying context and the myriad of other preoccupying issues that were the sequelae of attacks on the administration of NSABP, the University and others worked to persuade NCI to be more sensitive to academic freedom concerns regarding NSABP publications. Dr. Fisher does not note that it was Dr. Herberman, the University's Principal Investigator for the NSABP research after March 29, 1994, who presented the issue to the NSABP Oversight Committee and the NSABP Executive Committee in mid-April. This led to the prompt issuance of the NSABP statement condemning the requirement as an "unacceptable intrusion into the scientific, intellectual and academic freedom of cooperative groups." On April 20, Dr. Herberman submitted to NCI a first draft NSABP Plan for Corrective Actions, as NCI had mandated. The draft recited NSABP's vehement objection to the NCI requirement, and proposed instead that NSABP submit manuscripts only for NCI's "information at the time of submission for publication." NCI rejected this proposal and the debate continued. Dr. Herberman participated in the debate within a high-level NCI advisory board, following which the NCI requirement was substantially narrowed and clarified. On May 24, Dr. Herberman submitted a final NSABP plan, reiterating NSABP's sharp criticism of the NCI prior-approval requirement, but then stipulating the newly-negotiated understanding that the requirement is only intended to apply during the probationary period [then expected to last several months] and only to verify the appropriateness of the patient population included in the report. Our current understanding is that the NCI has no intention to make editorial comments or changes in the text of the manuscripts. Given the more limited scope of review, the anticipation that the probationary period would not last long, and the many other issues under scrutiny by NCI, Congress, the media, and others, the University chose to hold its fire for the moment. That course of action in hindsight appears likely to have averted rigid and irreversible collision.

We proceeded to research the issue thoroughly, determined that NCI's approach raised serious constitutional questions, and communicated our concerns to the NIH legal office, which clearly gave attention to the issue. It may be noted that, as far as I am aware, Dr. Fisher voiced no concern to the University about the NCI mandate until his attorney wrote me a letter on the point, in the midst of a broader lawsuit, in late August.

On Dec. 5, I received a thoughtful letter from an NSABP investigator (not, by the way, Dr. Fisher) who urged the University to take up its "cudgels" on the issue. The University continued to press the matter with NIH. NIH counsel agreed to raise it with NCI again, and there was a back-and-forth through the holidays.

In January 1995, I discussed with NSABP investigators acceptable alternatives, and advocated these in writing to the NCI and NIH counsel. The University attempted, by a several-pronged campaign, to persuade NCI to accept a less restrictive approach.

These efforts bore fruit when it became evident in February that NCI had waived its demand for prior review of one recent NSABP manuscript. We thereupon advised NCI that we took this to mean that NSABP manuscripts need no longer be submitted for prior review and that we would no longer do so.

I should add that Dr. Herberman, the University's PI on the NSABP research, was actively involved in each decision along the way. Dr. Detre and Chancellor O'Connor approved our overall course of action. Each of them consistently urged every reasonable means to resolve the matter in a manner that protected both academic freedom and the University's reputation for responsible stewardship of government research funds.