With an estimated 60 percent of American cancer patients now over age 65, and a rapidly graying population, the National Institutes of Health (NIH) has put out calls for research into how to better detect cancer and tailor chemotherapy regimens in this group. But so far, about a year into the effort, few researchers have submitted grant applications: Diane Bronzert, of the National Cancer Institute's (NCI) Division of Cancer Treatment and Diagnosis, has received only two submissions—neither of which has been funded—for a program announced last May seeking better pharmacokinetic and pharmacodynamic information on chemotherapies in the aged.

So why haven't there been more? Bronzert believes research in the area is hindered by multiple factors, including the difficulty of making a hypothesis-driven application with little available historical data, but she admits, "I was disappointed with this response because we pushed [the program] hard at the ASCO clinical meeting last year."

At its 1998 meeting, ASCO (the American Society of Clinical Oncology) highlighted the difficulties of studying cancer therapies in the elderly. Older patients have traditionally been underrepresented in trials—only about 1.5 percent of those over 65 with cancer participate. Seniors are often reluctant, fearing new therapy that might be extremely toxic; or they and their oncologists may hesitate, believing their treatment will not be covered by Medicare or insurance (Nature Med. 4, 992; 1998).

Drug companies have avoided studying their products in the aged, because those patients' co-morbidities and multiple-drug regimens make them poor candidates for getting the best results. "If you want to prove a drug is useful, you choose the healthiest possible individual to give yourself a chance," says Michael O'Connell, a Mayo Clinic oncologist and chair of the NCI-sponsored North Central Treatment Group.

The North Central Group and Mayo Clinic plan to submit a grant application to NIH this fall, seeking some of the several million dollars put aside by the NCI and the National Institute on Aging. Last October, the agencies asked for new treatment strategies for the over-65 age group and North Central hopes to begin studies in early 2000, according to O'Connell. Mayo is also developing its own program in geriatric oncology. "We can see in the future that the majority of patients we're going to be serving are going to be in this elderly population, "says O'Connell.

Meanwhile, some members of Congress are trying to ensure that seniors' clinical trial care costs are covered by Medicare. At an August briefing for Senate and House staff, ASCO president Joseph Bailes revealed that many oncologists have begun simply to submit treatment bills, and are already getting reimbursed by Medicare. Thus, it would not be so costly to formalize the coverage, he claims. In fact, Medicare coverage bills have been introduced in both houses of Congress, and may pass as part of "patients' rights" proposals in October. This is despite the fact that President Clinton asked for a three-year demonstration program in which Medicare would pay for clinical trials in FY99, 00 and 01, which has not been done. The Congressional Budget Office, has estimated that this three-year trial period alone would have added $750 million to the cost of the Medicare program.