The Boston Globe
August 14, 2011
By Mary Carmichael
In what doctors hope is a big step forward, new 3-D mammograms promise better detection and fewer false alarms for hundreds of thousands of American women.
Dr. Elizabeth Rafferty is trying not to lapse into rhapsodic cliches. “I don’t want to call it a magic bullet, because that would oversell,” she says. “It’s not a panacea.” Then, five minutes later: “I don’t want to say it’s catching on like wildfire.” After a few minutes more, though, Rafferty can’t help herself. She lets her enthusiasm loose. “People have been waiting for it for a long time,” she says. “It’s a step, but it’s a step by a person who has a stride of 7 feet.” “It” is a 3-D mammography machine, the Selenia Dimensions system, one of which sits in the breast imaging clinic at Massachusetts General Hospital that Rafferty, a radiologist, runs. The machine, which is made by the Bedford company Hologic and developed partly at MGH under Rafferty’s supervision, produces images that are so vivid and clear they seem to speak out loud: “Hey, right here! This is a tumor!” If you look at enough of them, you may become convinced that you don’t need medical training to spot a case of breast cancer or distinguish a false positive on a mammogram from a true one. The distinction seems that clear. “If you can tell the difference as a non-radiologist, imagine how a radiologist feels,” says Rafferty. “The images sort of sell themselves.”
Indeed they do. They’re catching on like – well, it’s not a slow burn. The device earned Food and Drug Administration approval on February 11, and for a short time it was available only at MGH. Now it is available in at least nine states, three of which have multiple sites, and most of the several dozen hospitals around the United States that assisted with clinical trials are planning to buy systems, too. The images aren’t the only selling point. The early data are compelling as well. In studies presented to the FDA, radiologists reported a 7 percent improvement in their ability to distinguish cancerous from noncancerous cases when they used the new system. If that sounds unimpressive, consider that 39 million women are screened each year; any significant reduction in callbacks for additional testing would mean hundreds of thousands of women would be spared painful, and expensive, follow-up.
Of course, Hologic has done some selling of its own. The firm, which markets itself as “The Women’s Health Company,” makes other products, including a 2-D digital mammography machine, a test that assesses risk of preterm labor, gynecological products, including Adiana (a permanent contraception technique), and widely used equipment that measures bone density. But 3-D mammography could become its flagship, because for the moment it owns the entire market – although other companies, including powerhouse GE, are developing their own 3-D machines, Hologic is the only one with FDA approval thus far. Of course, given the sluggish economy and the continuing state of uncertainty around American health care, persuading hospitals to upgrade may be challenging. So perhaps it’s not surprising that the company’s PowerPoint presentation to the FDA included the unsubtle phrase “huge breakthrough,” or that the first American patient to undergo 3-D mammography – Laura Lang, a polished 55-year-old Boston marketing executive and breast cancer survivor – did so in front of a CBS camera crew last February.
But the company, and the rest of us, should be careful not to overhype 3-D mammography. As Rafferty says, it’s not a panacea. The technology does come with costs, financial and medical. A fully equipped 3-D machine runs on average $474,541, not including the annual service fee Hologic charges for maintenance, and even hospitals that already own an upgradeable 2-D system made by Hologic have to pay about $125,000 to get it adapted for 3-D use. There are also costs in the sense of risks: Women who get a combo 2-D and 3-D mammogram, the protocol that confers the most dramatic jump in benefits, are exposed to twice as much X-ray radiation as the norm (albeit still an amount that’s under the FDA’s permitted limit). And no one yet knows if the new technique will actually save lives.
Debates about mammography are often so emotionally charged that this type of nuance goes missing. “I think some of our rhetoric – medicine’s in general, and also that of advocates?– has made people think that every metastatic breast cancer is a failure of the woman to get a mammogram or of a doctor to read a mammogram correctly,” says Otis Brawley, chief medical officer of the American Cancer Society and a professor at Emory University’s School of Medicine in Atlanta. “In reality, yes, mammography does save lives – but it is far from perfect. It’s not as good as many people think it is.” So if the new 3-D mammography isn’t perfect, just how good is it?
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