40-15 Mind the Gap? 1

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Varmus Pledges No Funding Gap for NCORP, Blames Snafu on “Unclear Communication”
By Paul Goldberg

Following an explosion of criticism, NCI said funding for community oncology clinics would not be interrupted.

In “an open letter to the cancer community” April 10, NCI Director Harold Varmus assured researchers that funding for the NCI Community Clinical Oncology Program sites would continue as it morphs into the NCI Community Oncology Research Program.

“While this was always our intention, this has not been clearly communicated,” Varmus wrote.

Official correspondence and interviews indicate that the NCI plan, as originally described, was to force these clinics to find the resources to fill the funding gap between June 1—the day CCOP ends—and sometime in September, when NCORP begins.

Taking an unusual public stance, community clinical researchers said the funding gap, which was announced in correspondence from NCI, would have put patients at risk.

“There are thousands of patients on trials that require close monitoring,” the principal investigators of the CCOPs wrote in a letter to Varmus. “We have a legal, ethical and moral obligation to our patients to provide a safe environment for patients receiving investigational and life-preserving cancer treatments. This obligation will be severely hampered if there is no gap funding.”

A copy of the letter, dated April 4, but sent to the institute sometime this week, was obtained by The Cancer Letter. On April 10, Varmus responded with the open letter that blamed unclear communication for the dispute.

While intentions are difficult to assess independently, documents obtained by The Cancer Letter show that information about the funding gap was, in fact, conveyed in writing by officials of the NCI Office of Grant Management, and that CCOP investigators, as well as the American Society of Clinical Oncology, which took up their cause, made significant efforts to find out whether NCI indeed intended to interrupt funding.

Also, when the controversy first surfaced last week, NCI officials didn’t take the opportunity to state unequivocally that there would be no gap in funding (The Cancer Letter, April 4). An NCI statement issued later that day similarly stopped short of stating that there would be no gap in funding.

If the institute had, in fact, altered its plans, this would demonstrate its vulnerability to public pressure.

For decades, researchers have sought to settle their disputes with NCI behind closed doors. The institute hasn’t seen significant public and congressional scrutiny for more than two decades, and its spending priorities during the subsequent doubling of the NIH budget went essentially unexamined as they shifted wildly from director to director.

In recent weeks, Varmus’s cuts in the clinical research programs seemed to be fraying nerves—and changing the NCI-Knows-Best attitude.

Last week, the chairs of the adult clinical trials groups wrote a letter to Varmus, putting him on notice that his policies, which they say amount to a 40-percent cut in spending on clinical research, have touched off a “crisis” in clinical research.

NCI officials challenged this calculation, but the chairs have not received a formal response.

ASCO supported the letter from the group chairs. On top of that, Clifford Hudis, president of the society, publicly criticized the institute for the CCOP funding gap (The Cancer Letter, April 4). The ASCO statement first brought the gap into public view.

Richard Schilsky, ASCO’s chief medical officer, said the society is “encouraged to receive assurance, as stated in Dr. Varmus’ letter of April 10, that CCOP grantees that receive positive peer review and are funded through NCORP will not experience a gap in funding—as they had previously understood would be the case.”

However, Schilsky said that “further clarification to CCOP PIs about how to access bridge funding will be essential.”

“We understand that NCI has worked hard to preserve a stable level of funding for the NCTN in the face of severe budget constraints,” Schilsky said. “However, we remain concerned that the distribution of funds among the various components of the NCTN will place severe constraints on NCTN operations and limit its ability to activate new studies. ASCO looks forward to working with NCI to address these concerns.”

This controversy is playing out as the institute stands poised to launch a new generation of smart clinical trials—and before full details of its plans for clinical trials network groups and the NCORP program are announced.

Phil Stella, the principal investigator of the Michigan Cancer Research Consortium and one of the authors of the CCOP investigators’ letter to Varmus, said he has no complaints about the staff of the NCI Division of Cancer Prevention or the division’s leadership.

The problem is broader: it’s about research priorities, he said. “How are we as a nation going to prioritize the funds that we have, and what are the priorities of the NCI?” Stella said to The Cancer Letter. “It should be discussed publicly. This is a big issue, that should be brought out into the light.”

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President Joe Biden’s proposed Advanced Research Projects Agency-Health would be a welcome partner to NCI—particularly in conducting large, collaborative clinical investigations, NCI Director Ned Sharpless said.“I think having ARPA-H as part of the NIH is good for the NCI,” Sharpless said April 11 in his remarks at the annual meeting of the American Association for Cancer Research. “How this would fit with the ongoing efforts in cancer at the NCI is still something to work out.”
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