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Physician apathy, patient fear slowing cancer discoveries

Todd Zwillich

Reuters Health

Posting Date: May 13, 2004

Last Updated: 2004-05-13 17:21:34 -0400 (Reuters Health)

WASHINGTON (Reuters Health) - Public unease over safety as well as poor financial incentives for doctors are damaging enrollment in clinical trials and slowing the search for new cancer treatments, government officials and researchers told lawmakers Thursday.

Patient enrollment in cancer clinical trials remains abysmally low, despite billions of dollars in spending by the federal government and private industry. Only 3% of adult cancer patients sign up for trials though some 20% typically meet eligibility requirements, according to a 1999 survey conducted by American Society of Clinical Oncology (ASCO).

The number of innovative cancer drugs in development "has decreased significantly," partly as a result of these trends, Dr. Richard Pazdur, director of division of oncology drug products at the Food and Drug Administration, told members of the House Committee on Government Reform.

Most cancer of studies rely on community based physicians to identify and enroll suitable patients. Doctors typically deliver experimental care according to a research protocol and then report results back to study director.

Studies count on this system for up to 80% of their research subjects, though few doctors who treat cancer patients regularly refer patients for trials, said Ellen Stovall, president of the National Coalition for Cancer Survivorship.

"Of primary concern is that so few doctors recommend a clinical trial as a viable treatment option," she said.

Stovall and others blamed poor incentives for physicians' apparent lack of interest in trials. The National Cancer Institute, which funds about 70% of the approximately 1700 ongoing U.S. cancer trials, pays doctors $2,000 per patient to carry out trials, though the actual cost is nearly $4,000, according to ASCO.

The shortfall prevents doctors from buying needed computers and hiring specially trained nurses to help with trials, said Dr. Robert L. Comis, a professor of medicine at Drexel University and president of the Coalition of National Cancer Cooperative Groups.

The problem could get worse in 2005 when Medicare is scheduled to lower overall payments for oncologist services, he warned.

Dr. Michaele Christian, associate director of NCI's division of cancer treatment and diagnosis told lawmakers that inadequate payment "has been a subject of great interest and concern to us."

Committee chairman Rep. Tom Davis (R-Va.) said that Clinton-era Medicare reforms authorizing the program to pay for the care of patients who participate in cancer trials did not go far enough. He urged NCI to do more to address physicians' unwillingness to participate and suggested that professional societies make it part of ongoing medical education. "It really starts and ends with the physician," he said.

Others stressed that physicians' lack of interest is only part of the problem. Many patients, especially minorities, shy away from participating in trials even when they know about them.

For African Americans, the reticence owes largely to the legacy of the Tuskegee experiments, where researchers observed the effects of syphilis in black men rather then treat them. Others are frightened by publicity around patients like Jesse Gelsinger, an 18-year-old who died in 1999 while participating in a gene therapy trial at the University of Pennsylvania.

"They have seen, or heard rumors at least, of African Americans that have been experimented upon. It causes them not to want to be apart of any experiment," said Rep. Elijah Cummings (D-Md).

Dr. Andrew Pecora, director of the Cancer Center at Hackensack University Medical Center in New Jersey, said that many patients -- even those with difficult-to-treat cancers --- remain afraid to participate in trials, while few understand the potential benefits.

"The minute you start talking about clinical trials, alarm bells start to go off," he said. "I don't think at an individual physician level that's going to be reversed very readily."

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