Cancer Trials Collide With Bush Budget Cuts, Curbing Researc

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By Michelle Fay Cortez and Angela Zimm

March 19 (Bloomberg) -- President George W. Bush lauded the role of medical research as he announced a breakthrough in January: U.S. cancer deaths fell in 2004 for the second straight year, the first back-to-back decline on record.

Three weeks later, Bush asked Congress to trim $11 million from the National Cancer Institute budget, on top of $32 million in cuts over the previous two years.

After growing 80 percent from 1998 to 2003, the NCI budget is in decline, and trials on cancer drugs and therapies conducted by hospital networks are feeling the pinch. Officials at NCI, which funds half of all patient trials in the U.S., have told the networks they should trim operations, in some cases by 10 percent, say specialists who run the tests.

``There is no question that the impact of flat and declining budgets will be real and can be measured in terms of human life,'' says Allen Lichter, chief executive officer of the American Society of Clinical Oncology, a physician group. ``Some trials will not start. Existing trials will take longer to complete. These are devastating effects.''

Bush said in his budget message to Congress that the cuts he's proposed for NCI and some other agencies are part of a plan to balance the federal budget within five years from a current deficit of $244 billion.

The president's proposal would earmark $4.78 billion for the cancer institute in the 2008 fiscal year. The $11 million trim represents a decline of less than 1 percent. Michael Miller, an NCI spokesman, confirmed that the hospital networks, called cooperatives, are being asked to plan for percentage reductions that exceed the overall budget cut.

`10 Percent Cuts'

``We suggested they plan for up to 10 percent cuts,'' Miller says, adding that the agency didn't specify that trials themselves had to be reduced.

The cancer institute will use a portion of its budget to help fund a ``roadmap'' to chart the direction for U.S. medical research in the 21st century, Miller says.

The latest cuts may be overturned by Congress, which is holding hearings today on ``how flat funding of biomedical research threatens scientific and medical progress,'' according to a statement last week by the Senate Appropriations Committee. The accumulated reductions since 2005 already are having an impact, researchers say.

``Research progress will definitely slow down,'' says Richard Schilsky, a University of Chicago cancer specialist who runs one of the 10 cooperatives that conduct some of the NCI- funded cancer trials. Grants can also go to individual hospitals or university medical schools.

Melanoma Trials

Cooperatives receive about $150 million a year to test treatments on more than 30,000 patients. This year, NCI officials told the networks they must reduce the number of patients in trials by 10 percent because of budget shortfalls, Schilsky and others say.

In January, the NCI told doctors at Massachusetts General Hospital Cancer Center in Boston that all NCI-sponsored trials in melanoma, a serious form of skin cancer, were canceled, says Bruce Chabner, the center's clinical director.

NCI officials told one of the 10 cooperatives, the Southwest Oncology Group, to cut its $16 million budget by 20 percent, says Larry Baker, an oncologist at the University of Michigan in Ann Arbor and the group's chairman.

That request put ``an enormous strain on which studies we do and which we don't do,'' he says.

Studies that have already been dropped or delayed as a result of NCI directives to cut costs include early research on AstraZeneca Plc's experimental Recentin for advanced colon cancer, GlaxoSmithKline Plc's lung cancer medicine pazopanib and Genentech Inc.'s Rituxan for leukemia, the groups say.

Genentech Role

Rituxan is already approved for non-Hodgkin's lymphoma and rheumatoid arthritis and is being studied for multiple sclerosis and other autoimmune diseases. While it isn't approved for the blood cancer called chronic lymphocytic leukemia, many doctors already use it for that disease, leaving little incentive for companies to step in to finance trials on their own.

``The cooperative groups play an important role,'' says Ed Lang, a spokesman for Genentech. ``The decrease in the funding for clinical research is a concern.''

Genentech, based in South San Francisco, California, is among the drugmakers and patient advocacy groups that share the cost of some trials. The company and the cooperative are working together on half the 47 large patient studies being conducted on the cancer drug Avastin to expand its use.

Cancer trials range in size from just a few people to thousands and can take a few weeks to years. In most cases, drugs or treatment regimens are tested first on patients whose terminal disease has failed to respond to other treatments. Findings that show a drug extends life by as little as weeks can lead to further research or approval by U.S. regulators.

Rare Malignancies Affected

Most at risk from the budget cuts is testing on rare malignancies, such as brain cancer and the tumors known as sarcomas that grow in the body's connective tissue, says Chicago's Schilsky, who is also president-elect of the American Society for Clinical Oncology. These studies are the most vulnerable because they are the hardest to do and benefit the fewest patients, he says.

Eliminating trials may also mean losing young university researchers to other pursuits, says Deborah Banker, vice president for research communications for the White Plains, New York-based Leukemia & Lymphoma Society.

``We're not only losing research momentum, we may be seeing a real gap in the future, a gap in the intelligence and passion shown by those entering the field,'' Banker says.

Sean Kevelighan, spokesman for the White House's Office of Management and Budget, says the current cuts need to be viewed in the context of past increases.

`Research Will Get Done'

Since 2001, ``the president has worked to increase the annual federal cancer research and prevention budget by approximately 26 percent,'' he said in an e-mail. White House spokesman Tony Fratto said: ``We still think that the most promising research will get done.''

Wendy Selig, vice president of legislative affairs at the American Cancer Society, says more experimental medicines have emerged because scientists have made strides over the past 15 years in understanding the genetic mutations that can lead to malignant cells. Yet only about 10 percent to 12 percent of proposed trials can expect to get U.S. funding, she says.

``We have more opportunities, we have more understanding,'' says the Southwest Oncology Group's Baker. `It just isn't the time to step backward.''

Alec Vachon, president of Washington-based Hamilton PPB, a consulting firm that tracks health-care legislation, says Congress may end up increasing the NCI budget.

``It has a critical mass, because of the large number of people who are affected by cancer,'' he says.

To contact the reporters on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net ; Angela Zimm in Boston azimm@bloomberg.net .

Last Updated: March 19, 2007 00:26 EDT

[RandyW]

Pretty much says it all right there!! Thanks Rich had not seen this yet. Thank heavens for private donations when and where we can get them.