Despite political backing, cancer-screening device yielded limited benefits

When politics and medicine mix, the results are not always best for patients. That’s the upshot of an article by UC Davis physician and assistant professor Joshua Fenton, who studied the cost and efficacy of a device meant to scan breast-screening images for possible cancer.

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In an article published Monday in the Archives of Internal Medicine, Fenton connects the dots between politics and breast cancer treatment. “This is a case study that illustrates the potential for politics to trump science when it comes to health policy,” Fenton said in an interview. 

This story starts in 2000. During that year, Los Altos-based R2 Technology, which developed a breast cancer-screening device, spent about $20,000 lobbying government officials, according to the Center for Responsive Politics.

By the year’s end, R2 Teachnology won congressional approval for Medicare to reimburse radiologists $15 for each mammogram scanned using the device. Fenton said the device rapidly scans images, marking those with oddities that radiologists can then examine more closely.

The Washington Post wrote about the R2 Technology approval, and others, in December 2000, in light of a lobbying blitz that brought potential windfalls to medical and pharmaceutical companies:

The success illustrates the difficulty of containing federal health outlays in an era of budget surpluses. Members of Congress find it hard to resist the lobbying pressure of medical groups and the lure of new devices that promise health care advances, at higher cost to Medicare.

In a 2001 Forbes article artfully called “Breast Men,” the magazine further explains how big of a win Medicare approval was for R2:

Medicare reimbursement will help persuade private insurers to cover the fancy mammogram, says Scott Halsted, general partner of Morgan Stanley Dean Witter Venture Partners, an investor in R2. R2 will help hospitals advertise their own high-end mammography equipment. The goal is to create peer pressure in health care. "We refer to this as the viral marketing effect," says Michael Klein, who runs R2.

Capitalism thrived. Computer-aided detection use jumped from about 5 percent in 2001 to about 27 percent in 2003, according to the latest data that Fenton analyzed. The government paid $19.5 million for using the detection device in 2003.

But did patients do as well?

Fenton conducted a study in 2007 of 200,000 women who'd had mammograms that were scanned by the device. He concluded that it produced significant false-positive results, meaning that 19 percent more women were called back to the doctor’s office for a breast cancer biopsy. Despite the increase in tests, cancer detection did not improve significantly, Fenton found. 

“It’s anxiety-provoking for women to be recalled and potentially traumatic; those are the major concerns,” Fenton said.

Overall, the article published Monday says, “Systematic reviews point to persistent uncertainty regarding whether [computer-aided detection] has a clinically important impact on key breast cancer outcomes.”

Fenton said he is currently gathering data on whether computer-aided detection leads to better survival rates. Nonetheless, he said his research points to a need for Congress to get unbiased, evidence-based medical advice when facing technical decisions.

Additionally, he said the Food and Drug Administration may need to take a second look at medical devices after approval to get a clear view of their costs, benefits and measure against similar devices Because, Fenton said, the newest technique is not always the best, and more procedures, tests and screening is not always better.

“This is something we need to grapple with as a society: More is not necessarily better,” Fenton said. “More can be worse. You can harm people by applying new techniques before they are carefully evaluated.”

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