Newsletter #62–Nov./Dec. 2000
Digital Imaging: A Marketing Triumph
by Lauren John
When it comes to marketing its mammography machines, General Electric Medical Systems is rich and well connected. The $7 billion medical information and technology corporation boasts partnerships with the Department of Defense Breast Cancer Research Program and Massachusetts General Hospital, which are helping GE develop and test equipment for technology known as digital mammography.
GE is also good at making friends in Washington. Last April, Jeffrey R. Immelt, the company’s president, bestowed its honorific “Partners in Vision” award upon U.S. Secretary of Health and Human Services Donna Shalala and a team of U.S. Army and Navy medical researchers. At the same time, Immelt took the opportunity to offer lawmakers a product demonstration of its digital mammography system: the Senographe 2000D, which had just been approved by the U.S. government’s Food and Drug Administration.
Manipulating Images
Several manufacturers have developed digital X-ray machines for different types of examinations, but GE Medical’s Senographe 2000D was the first digital mammography machine to receive FDA approval. Simply speaking, digital mammography is a new method of X-ray photography that replaces the traditional X-ray film and cassette with a computer and electronic scanner. The digital machines change the way X-ray images are viewed, not the way they are administered.
Unlike traditional mammograms, digital mammography pictures can be manipulated for easier viewing. X-ray film is usually viewed against a fluorescent light box on the wall, but digital images produced by the Senographe 2000D can be displayed on a computer screen with images stored in bits and bytes. This enables radiologists to zoom in on certain parts of the mammogram, enlarge an image of a suspicious mass, and darken the photograph for greater contrast.
In many cases, a technician will be able to take fewer pictures. And the system could potentially make mammograms more accurate for women with dense breast tissue, since it could, for example, darken some of the tissue and make a lump more evident.
If a woman wants or needs a second opinion, her digital mammogram can be transmitted via the Internet—a feature that could be particularly helpful to women in remote areas without access to specialists.
Manipulating the Public?
Given GE’s wealth and political savvy, it should come as no surprise that in the past few months there has been some highly public enthusiasm for the Senographe 2000D.
“This new technology represents the biggest breakthrough in mammography in more than 20 years,” says Senator Connie Mack, a Florida Republican, adding that “these new life-saving systems are a powerful tool for helping doctors better detect and diagnose breast cancer.”1
Considering that a tumor can grow in a woman’s breast for up to eight years before it shows up on a traditional mammogram, it’s clear that the technology should be improved. And the testimony above would suggest that the Senographe 2000D can find signs of cancer a whole lot earlier than the mammograms we have been using all these years.
But for now, it just ain’t happening. “The evidence so far does not show that the digital images are more helpful in finding cancer than the analog/film images,” the FDA stated in a press release after approving the system.
So why did the agency approve it in the first place?
“The Senographe 2000D was approved on the basis of clinical data showing its safety and effectiveness,” the release continued. “The study compared digital mammography films with analog mammography films of 625 women, 44 of whom had breast cancer. The digital and film/screen images were analyzed and evaluated by five qualified radiologists specializing in mammography and found to have comparable clinical performance in screening and diagnosis of breast cancer.”
Still confused about why the FDA approved a system that isn’t any better than traditional mammography? Edward A. Sickles, a radiology professor and section chief of Breast Imaging at the University of California at San Francisco, offers this clarification. “The FDA’s role was to approve the Senographe 2000D based on safety and effectiveness rather than on how good the technology could get,” he says. “In order to get FDA approval, the research and development efforts were aimed at showing that digital mammography is equivalent to, rather than better than, traditional mammography.”
What this means is that five to ten years from now, as R&D efforts shift, digital mammography could greatly surpass the systems we have in place today, Sickles says. “Right here, right now, most women won’t see immediate benefits. [But] there’s a lot of promise that hasn’t been tapped yet.”
Noted breast surgeon Susan Love, however, is less optimistic. “I think that we’ve gotten as far as we can with mammography,” she writes in the second edition of Dr. Susan Love’s Breast Book, pointing out that the technology is limited by the breast tissue. “No matter how great the technique becomes, the body it’s photographing is the same.”
BCA has argued to the FDA that new devices and treatments should only be approved if they improve outcomes, lower cost, or improve quality of life for patients. Meanwhile, scientists are working on a wide range of early detection methods that do not involve X-rays at all, including ultrasound and blood and nipple-fluid tests. Not all of them, however, are as well funded or as well connected as GE.
“Doctors around the world have concluded that new digital X-ray capabilities open new opportunities for better patient care,” GE Medical Systems boasts in its marketing material. The company also claims that the Senographe 2000D’s accuracy and speed reduces patient call-backs, bringing “peace of mind to the busy woman.”
One would think that with all the money that GE has spent developing and promoting this very expensive machine—a single Senographe 2000D right now costs about half a million dollars—the company could come up with a more creative and less condescending way to sell women on the product.
Of course, what would really produce peace of mind would be earlier detection of breast cancer—something that mammography, digital or otherwise, is thus far unable to do.
1 “New Breakthrough: Digital Mammography Imaging Technology Previewed on Capitol Hill,” press release issued by GE Medical Systems, 4/4/00. Senator Mack is a member of the Senate Cancer Coalition.