The Dirty Business of Sowing Mammography Doubt

The University of North Carolina just announced that it received a $26 million grant from the National Cancer Institute "to save women’s lives."

Beyond the rhetoric, though, the grant to compare new and conventional mammogram technology likely will be a waste of taxpayer money. What taxpayers may be unwittingly underwriting instead is an effort by a Johnny-come-lately manufacturer of the new technology to thwart the head-starts of others.

Mammograms are X-ray images used to help detect abnormalities that may indicate the early stages of breast cancer. In conventional mammography, the image is printed on film. The new digital technology creates an image in a matter of seconds on a computer screen.

Digital mammography has clear advantages over conventional film mammography, including speed and the ability to correct immediately images that are under- or over-exposed.

Digital images may be stored on disk as references for future mammograms and may be easily e-mailed to get a second opinion or if a patient changes doctors. Women in rural areas without access to qualified radiologists can e-mail images for evaluation.

Other potential benefits of the new technology include improved contrast resolution that may help reveal cancers in women with dense breast tissue and a reduction in the number of women called back for further diagnostic procedures.

Of every 1,000 women who receive mammograms, approximately 100 will be called back for additional exams. The data collected so far indicate that digital mammography may reduce the number of callbacks by 20 percent to 30 percent.

The Food and Drug Administration approved for use the first digital mammography technology in February 2000. The FDA’s Chief of Radiologic Devices Dan Schultz noted at the time, "Just about everything we do is digital, and it’s about time mammography was also."

Case closed. Digital mammography is the future of mammography. Conventional film technology will go the way of vinyl records and analog cell phones. Though digital technology is now much more expensive, like everything digital, costs doubtlessly will decrease over time.

But the $26 million project isn’t a waste of money to everyone. For one company, it may be money in the bank.

Fischer Imaging is a relative newcomer to the field of digital mammography and, compared with other manufacturers, is well behind on the technology and FDA approval curves. Fischer’s digital mammography system wasn’t submitted to the FDA until March 2001, more than a year after the approval of the first digital mammography technology.

Fischer may be late, but it’s not unlucky. A co-leader of the University of North Carolina study is Dr. Etta Pisano, professor of radiology at the UNC School of Medicine.

When the study was announced this week, Pisano said, "Before it is widely used, we want to make sure that digital mammography is at least as good as standard mammography at finding early breast cancers."

This seemingly innocuous quote may not be so benign.

Digital mammography was already deemed at least as good as film mammography when the FDA approved the new technology in February 2000. Pisano readily acknowledged this in November 1998, telling the Chicago Tribune that "To get FDA approval, digital mammography need only establishment itself as good as film."

The pre-grant Pisano used to be openly enthusiastic about digital mammography, noting in 1998 that radiologists often preferred digital images, and predicting it would "ultimately replace film screen mammography." She told the Chicago Tribune, "We expect that [digital mammography] will actually prove superior to film." Expanding on her views to USA Today in December 1999, Pisano said, "When you take a photo wrong the first time, you can’t do anything with it. With digital, you can play around with it."

So why is Pisano now seemingly sowing doubt about digital mammography? The answer may lie in Pisano’s connection to the regulatory approval-impaired Fischer.

Pisano was the principal investigator for Fischer’s study of its own digital mammography system – that is, the study that was submitted as part of Fischer’s application for FDA approval.

By luck or otherwise, the Fischer-funded scientist is now head of the government-funded study that will compare existing digital mammography products to Fisher’s. No conflict of interest there.

The market for digital mammography machines is competitive and other manufacturers have had quite a head start on Fischer. This doesn’t bode well for Fischer’s investment in digital mammography technology unless sales of its competitors’ products can be significantly slowed.

If doubt is sown about the advantages of digital mammography, budget-strapped medical centers may be reluctant to spend $300,000 to $500,000 for new digital systems when they could simply keep existing film systems or buy new ones for $100,000.

With the doubt-spreading Pisano running the massive and visible federal study, it seems Fischer may have a good shot at slowing its competitors’ sales for the foreseeable future. We should look on the bright side, though. At least someone will benefit from the $26 million of taxpayer largesse.

Steven Milloy is the publisher of JunkScience.com, an adjunct scholar at the Cato Institute and the author of the upcoming book Junk Science Judo: Self-defense Against Health Scares and Scams (Cato Institute, 2001). Mr. Milloy may be reached at milloy@cais.com.