Wrong Way in the War on Cancer

By Merrill Goozner, Gooznews. Posted May 25, 2009.

“Typically it now takes two or three years and a big investment” to get new information from clinical trials about a particular cancer treatment, says Lynn Etheredge, director of the Rapid Learning Project at George Washington University and an advocate for database-derived retrospective research.[6] “In contrast, if the data is in the database, you can answer that question in a few hours, or maybe even a few minutes . . . This could be like hooking up the steam engine to the spinning jenny.”

The National Cancer Institute recently took a major step in building an information superhighway to serve a cancer learning network. The ambitious goal behind CaBIG, the Cancer Biomedical Infomatics Grid, is nothing less than turning the billions the nation spends each year on cancer care into that “learning system.” The agency has already linked the 60 NCI-funded cancer research centers and a network of community cancer centers where 85 percent of patients receive care.

The big problem now is figuring out how to convince the nation’s oncologists to drive on that highway. Kaiser Permanente, whose 14,000 salaried physicians in nine states and the District of Columbia include about 200 oncologists, is already there, since its medical records are already fully computerized. Kaiser oncologists do not enroll their patients in clinical trials, which would require informed consent and institutional review board review. But each oncologist in the Kaiser system follows a pre-specified protocol for each cancer. They are allowed to deviate from that path if and when the cancer progresses and in ways tailored to the individual’s needs.

Each of those new regimens follow a pre-specified path, too. “The goal is not to restrict physicians from personalizing therapy; it’s to create a framework so it can be tracked back to see if it made sense to use that variation,” explains Paul Wallace, medical director for health and productivity management at Kaiser Permanente.

UnitedHealthcare, which has about 20,000 patients on cancer therapy at any point in time, recently set up a demonstration project made up of six panels of 10-to-25 oncologists. Each group will use pre-specified protocols for their patients. The goal over the next few years is to generate data that will reveal which approach worked best for which patients.

Recruiting physicians in its provider networks wasn’t difficult. “I had more volunteers than I had space,” says Lee Newcomer, senior vice president for oncology at UnitedHealthcare. “Lots of doctors want this kind of approach so they’ll learn something.”

But beyond these pioneering efforts, it is going to take a lot of convincing to get large numbers of oncologists to begin entering their patients’ data into CaBIG. Cancer doctors, like physicians generally, have been taught that prospective clinical trials are the gold standard of medical research, and can’t be replaced by a retrospective analysis of outcomes.

That’s where Medicare comes in. The Center for Medicare and Medicaid Services, which pays for the lion’s share of cancer care, could create new financial incentives to get physicians involved—by underwriting their transition to electronic health records and by beefing up reimbursement for data collection. There have some tentative steps in that direction through the coverage with evidence development process, instituted by former CMS chief Mark McClellan, now at the Brookings Institution. In a few cases, CMS paid for experimental therapies or imaging tests as long as physicians gathered data on outcomes so it could be determined later if those treatments truly deserved permanent coverage.

“Medicare has to play the leading role,” argues Etheredge. “Previous efforts to evaluate therapies came out of the regulatory framework. What we’re talking about is learning as much as possible as quickly as possible about new technologies after they’ve been introduced.”

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Merrill Goozner spent more than 25 years in the news business as a foreign correspondent, economics writer and investigative reporter for the Chicago Tribune and other publications. He is the author of The $800 Million Pill: The Truth Behind the Cost of New Drugs and blogs at Gooznews.com.

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