HER2 Support Group Forums - Bush Budget Cuts cause some cancer clinical trials to be cut

from the Wall St. Journal:

Funding Fears to Halt
Some Cancer Trials
By AMY DOCKSER MARCUS
February 7, 2007
The 10 federally funded cancer cooperative groups, which enroll nearly half of the patients in the nation who are participating in cancer trials, have begun to shut down trials and stop studying certain cancers amid funding concerns.

Robert L. Comis, president and chairman of the Coalition of Cancer Cooperative Groups, a nonprofit group comprising cancer centers, hospitals and patient- advocacy groups that work to increase participation in clinical trials, said 3,000 patient spots in clinical trials will be eliminated in 2007 at centers around the U.S. Although the decrease will affect all cancers, among the hardest-hit will be rarer cancers such as sarcoma, rare childhood tumors and head-and-neck cancers, Dr. Comis said; some of the cooperative groups are totally eliminating trials in those diseases.

The National Cancer Institute, which provides funding for the cancer cooperatives, had asked the groups to come up with cuts because federal funding for the agency has been flat, and inflation is eating into its spending power. All agencies under the Department of Health and Human Services have been operating under a "continuing resolution," which extended the fiscal 2006 budget levels until Feb. 15, when Congress must either pass the fiscal 2007 budget or extend the resolution. Both the '06 and proposed '07 budgets maintained essentially flat funding levels for the NCI, which is part of the National Institutes of Health.

President Bush's proposed fiscal '08 budget includes an increase of 0.8% for the NIH overall, but a decline of 0.2%, or $9 million, in the NCI's budget, to $4.78 billion. So NCI officials are anticipating further financial constraints.

Many groups are facing hard choices as a result of budget woes. The cuts at the cancer cooperative groups come at a time when, for the second year in a row, the number of people dying from cancer declined. The development of so-called targeted therapies that attack cancer cells but don't damage normal cells has increasingly led to cancer being considered a chronic condition rather than a death sentence. Many of the trials that led to the approval of those drugs by the Food and Drug Administration were sponsored by cancer centers participating in the various cooperative groups.

The Southwest Oncology Group recently said it was shutting down its sarcoma and head-and-neck cancer trials and no longer will run trials in those diseases. The Eastern Cooperative Oncology Group will be closing its brain cancer and sarcoma trials. Many of the groups also will stop acquiring new tissue samples for their ovarian, endometrial and lung-cancer tissue banks. The tissue is used by researchers to search for new drug targets, among other things.

Dr. Comis said the cooperative groups are postponing by one to two quarters all Phase II clinical trials. This will delay the chance of getting a new drug approved or getting existing ones approved for additional types of cancer. "The cooperative groups are really the engine for establishing new standards of cancer care for the public," Dr. Comis said.

James Doroshow, director of the division of cancer treatment and diagnosis at NCI, said the agency had asked the cooperative groups to "make contingency plans for the worst-case scenario" and that the cuts are the result of the continuing effort to streamline operations. He said the institute is studying ways to ensure that promising studies can go forward even when the patient population is small. "We won't close down our interest in rare diseases," he said.

Deborah Banker, vice president for research communications at the Leukemia & Lymphoma Society, said the organization is studying ways it can support cooperative-group trials, including the possibility of raising private funding.

Write to Amy Dockser Marcus at amy.marcus@wsj.com