• 2/10/2007
  • Washington, D.C.
  • Aaron Lorenzo
  • BioWorld News (www.bioworld.com)

The National Cancer Institute faces a funding cut in the coming fiscal year, per President Bush’s proposed budget, and oncology drug developers are in for a pinch.

Cancer study cooperative groups, which include researchers, cancer centers and community doctors who evaluate investigational and approved therapies, are expected to pare back their work significantly. The Coalition of Cancer Cooperative Groups, comprised of the 10 U.S. groups whose research is sponsored by the NCI, says up to 95 of their trials may have to be closed or delayed this year. That’s nearly half of the studies they conduct annually, and such cuts would affect up to 3,000 patients. That’s a sizable chunk of the 20,000 enrolled in their trials each year for access to investigational drugs, newer frontline treatment modalities and quality care.

Such reductions, said Richard Schilsky, chairman of a study cooperative called Cancer and Leukemia Group B, “can trickle down” to biotech companies “in a fairly negative way.” Because these groups enroll nearly half the patients in the U.S. who participate in cancer trials, there will be a direct impact on drug development firms. That’s especially true of smaller firms with limited finances that make their investigational products available to the NCI for use in cooperative group testing.

“Oftentimes these are Phase II, but also occasionally even Phase III studies,” he told BioWorld Today, though he noted that Phase II trials are most likely to absorb the cuts. That translates to less opportunity for some companies’ drugs to be studied in the NCI framework, Schilsky continued. He added that this is an especially difficult consequence for those that “may actually rely on that as an important part of their whole drug development strategy.”

There’s no immunity for the overall industry, which benefits from essentially free data from these studies, and even the biggest biotech companies acknowledge the potential pitfalls of the budget cuts.

Noting their role “in answering a lot of the questions patients and doctors have about how to best treat cancer and in making new medicines available,” Ed Lang, the manager of product and patient advocacy communications for Genentech Inc., said any actual decrease in clinical research funding “is of concern to us because we share a common goal” of curing cancer.

One of the top-selling drugs in the South San Francisco company’s portfolio, Avastin (bevacizumab), which last year generated $1.7 billion in revenue, received FDA approval based largely on data from a study conducted by the Eastern Cooperative Oncology Group.

At present, Lang told BioWorld Today, nearly half of Genentech’s 47 ongoing Phase III trials are being conducted through cooperative groups. “And even if our studies are not directly affected by the proposed cuts,” he said, “a decrease in funding from the underlying research and infrastructure could potentially impact the speed at which we open and execute these trials.”

Schilsky, who chairs the research committee for the American Society of Clinical Oncology, also said it’s probable that cooperative groups will phase out entire areas of research, especially in less common tumor types, leaving such patients disproportionately disadvantaged. Schilsky’s group is no longer pursuing melanoma studies, for example. The Southwest Oncology Group is phasing out research into sarcoma and head and neck cancer and the Eastern Cooperative Oncology Group is giving up on brain cancer research.

Community research centers, that typically offer only modest accrual numbers but drain regulatory resources, will also feel the impact. They’re likely to be dropped from cooperative group rosters, further limiting patient access to clinical studies run out of larger cancer centers.

An NCI spokesperson told BioWorld Today that about 85 percent of its funds are already committed to multi-year grants and other ongoing activities conducted at academic medical centers across the U.S., as well as in government labs. Thus, a budget reduction in one year can have a ripple effect in future years. The rest of the NCI’s funding primarily goes to competitively awarded research grants that are just starting or being renewed. When the budget fluctuates, these activities tend to be affected the most.

The president’s fiscal 2008 proposal calls for an NCI budget of $4.782 billion, which is $9 million less than the current funding under the continuing resolution that’s financing most domestic government agencies so far this fiscal year, and $6 million less than the fiscal 2006 budget. The NCI stands to receive $4.793 billion this year under a revised continuing resolution that’s passed a House of Representatives vote and still awaits Senate clearance.

Of note, none of these figures address the estimated 3.8 percent annual inflation rate of biomedical research.

Schilsky said he’s “not too optimistic” about changing the direction of the budget for next year. Congressional staffers weren’t “terribly sympathetic” to the message he and other researchers delivered during a meeting a few months ago, he said. But continuing efforts to raise public awareness about NCI budget cuts are moving forward, he said. He added that he hopes patient advocates make their voice heard, given “that it’s a lot harder” to turn a blind eye to patients than to researchers.

Still, in this current tight fiscal environment for the federal government, Schilsky acknowledged the pushback against continuing to fund the whole National Institutes of Health at the rate that doubled its budget to nearly $29 billion over the last couple of years.

For the coming year, the president requested $28.8 billion for the NIH, which includes more than two dozen entities, and more than $15 billion is tabbed for their myriad research project grants. Aside from the NCI, nearly all the others are slated to receive moderate budget increases next year, between 0.2 percent and 0.4 percent.

It’s worth noting that even with the proposed cuts, the NCI budget remains the highest budgeted research organization within the NIH. But Schilsky pointed out that cooperative group funding went up only about 65 percent during the NIH doubling period.

“It’s true, we did get more money from 1998 to 2002, but from 2003 until now our budgets have been flat or declining,” he said. “And this is at a time when we have more opportunities than we’ve ever had before. There are more interesting drugs and more diseases to study, in a sense, because we’re now studying molecular subtypes of different cancer. So we can’t afford to be complacent.”