Federally Funded Trials Praised—and Underfunded

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Clifford A. Hudis, MD, FACP

Richard L. Schilsky, MD, FASCO

Alan P. Venook, MD

The question that we are now facing is who is going to plan, launch, and complete these kinds of trials in the future. This answer, honestly, remains to be seen.

—Clifford A. Hudis, MD, FACP

All four studies presented at the 2014 ASCO Annual Meeting Plenary Session were at least partially funded by federal dollars, bringing long overdue attention to the value of federally supported cancer research. Perhaps because of this high visibility, ASCO leaders took to the soapbox to sound the alarm about the decline in such funding.

“Critically important, clinically relevant research” is being jeopardized because of a lack of federal funding to the NCI, ASCO Immediate Past President Clifford A. Hudis, MD, FACP, said at a press briefing.

“While our country has had a long-standing commitment to funding cancer research, this commitment appears to be diminishing,” said Dr. Hudis, Professor of Medicine at Weill Cornell Medical College and Chief of the Breast Cancer Medicine Service at Memorial Sloan Kettering Cancer Center, New York.

“In this, our 50th year of continued progress against cancer, it is pretty clear that the national clinical trial system that Americans and others around the world have come to depend on to advance clinical research is changing,” he observed.

Dr. Hudis had the numbers to back this up: for ASCO 2014, the number of submitted abstracts that received federal funding dropped from 575 in 2008 to only 169 for this year’s meeting. He called this “a real—and we think disturbing—bit of evidence about the impact of the reduction in this federal support.”

Funding Inadequate for Progress

Richard L. Schilsky, MD, FASCO, Chief Medical Officer of ASCO, had other concerning figures. When adjusted for inflation and the effects of sequestration, the National Institutes of Health (NIH) budget is actually lower today than it was in 2003. As a result, the NIH funded 2,110 fewer grants in 2013 than a decade ago.

“Who knows which of these might have led to the next breakthrough in cancer prevention or treatment?” Dr. Schilsky asked. The impressive progress against cancer is in jeopardy of being stalled, just when the opportunities and also the needs are greatest, he added.

The National Cancer Institute (NCI) plans to reduce trial enrollment over the next 2 to 3 years to 12,000 adult patients per year (approximately 50% of previous highs), he indicated, the result being the lowest participation in clinical trials in a decade. Fewer definitive phase III randomized trials are also being initiated.

Currently, NIH funding stands at $29.9 billion, while the NCI appropriation is $4.92 billion—increases of just 3.5% and 3.0%, respectively, over last year’s postsequestration funding.

“This level of funding is simply inadequate to accelerate progress against cancer in the years ahead,” Dr. Schilsky emphasized.

ASCO and many other advocates for biomedical research are urging Congress to halt the NIH spending decline by budgeting at least $32 billion for the next fiscal year. However, advocates are concerned because neither the House nor the Senate appropriations committees have passed a bill to fund NIH for the fiscal year that begins October 1, potentially setting up a repeat of the gridlock that has plagued the funding process for several years.

Trials of Less Interest
to Industry

The four studies in the Plenary Session “are further testimony to the strides we are making to improve cancer care, and the results answer critical questions that people with cancer and their doctors face every single day,” Dr. Hudis said. “All four studies received funding from the National Institutes of Health. This is a critically important point that may not be fully appreciated by everybody out there in broader ­society.”

The fact that these studies were made possible through federal dollars does not suggest that the outlook on funding is improving. They were all begun years ago, at a time when the U.S. government was better able to support these kinds of studies.

Publicly funded trials are important because they typically address areas of research that may be of less interest to the pharmaceutical industry than to physicians and their patients: cancer screening and prevention, quality of life and symptom control, comparative effectiveness of similar agents, new indications for older generic drugs, and combined modalities of treatment.

“These are often studies that industry is less interested in performing,” Dr. Hudis noted.

Less Biased Approach

Publicly funded trials are also important because they contribute to a position of neutrality, noted Alan P. ­Venook, MD, who presented the CALGB/SWOG 80405 study. Dr. Venook is the Madden Family Distinguished Professor in Medical Oncology and Translational Research at the University of California, San Francisco.

CALGB/SWOG 80405, designed in 2004, was a herculean effort. It was designed to compare the relative efficacy and toxicity of bevacizumab (Avastin) and cetuximab (Erbitux), which had been recently approved for advanced colorectal cancer.

The results of the trial were highly anticipated, since the previous FIRE-3 trial, reported at the 2013 ASCO Annual Meeting, found that cetuximab improved overall survival but not progression-free survival—a result that puzzled many experts. In contrast, CALGB/SWOG 80405 found no survival differences between the arms, with an “unprecedented” median overall survival of 29 months in each arm.

“These patients are doing a little better, and I believe this represents a less biased approach. This is what cooperative groups do: treat patients in studies for which companies are not paying the bill,” Dr. Venook commented.

Dr. Hudis also lauded the study for this reason, and added, “The question that we are now facing is who is going to plan, launch, and complete these kinds of trials in the future. This answer, honestly, remains to be seen.” ■

Disclosure: Dr. Hudis reported no potential conflicts of interest. Dr. Venook reported research support from Genentech/Roche, BMS, and Lilly.