A more sensitive exam?
Take two pieces of polyurethane, put a lubricating gel between them, seal it all up and what have you got?
Maybe a powerful weapon in the fight against breast cancer. Maybe a gimmick. Maybe a tool for a job that doesn’t need to be done.
The device -- sold in several breast self-exam kits -- is said to reduce friction between skin on the fingers and skin on the breasts, increasing sensitivity and making it possible to detect even very small lumps.
Among the most visible promoters of the device is singer Olivia Newton-John, part owner of Liv International, an Upland-based company that distributes the device in a self-exam kit called Liv Aid.
Newton-John found a malignant lump during a self-exam in 1992 and thinks that may have saved her life.
“I’m 58 and lucky to get there,” she says. “I want other women to have that opportunity.”
But even as promoters of the kits work to make breast self-exams easier and more sensitive -- and more common among women -- many cancer researchers and doctors say there’s no evidence that careful monthly self-exams actually save lives. Further, they say, such exams increase unnecessary testing and biopsies, as well as anxiety.
“For years, people thought they could only be beneficial, at worst not helpful, but at least not harmful,” says Dr. Barnett Kramer, associate director for disease prevention at the National Institutes of Health in Washington, D.C. “But as often happens, intuition served us poorly. If everything in medicine were intuitive, we wouldn’t need science.”
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Languishing device
The polyurethane-and-gel sandwich for use in performing breast self-exams was patented in 1987 as the Touch Enhancing Pad. Often described as “a magnifying glass for your fingers,” the simple product won its deviser, Don Perry of Decatur, Ill., an award from the Intellectual Property Owners Foundation as Outstanding American Inventor of 1989.
But it didn’t win FDA approval for over-the-counter sale until 1997 and has yet to catch on with women, even though it’s been sold under various brands and in various guises -- as a pad, a glove and even a T-shirt.
“We keep running into walls,” says Ulli Haslacher, president of Liv International, noting that the kit can be hard to find in stores, people don’t always know what it is and not everyone can afford it at a cost of about $25.
The company is working to develop corporate partnerships that would make the product less expensive and even free to some.
“Olivia’s not giving up,” Haslacher says. “She’s still trying to figure this out.”
Some research has suggested that the device may be useful in detecting breast lumps. One study, reported at the Midwestern Psychological Assn. meeting in 1987, found that women could detect hard plastic lumps in foam squares 40% of the time when using just their fingers and 70% to 90% of the time when using the device. They detected softer lumps 30% of the time when using just their fingers and 40% to 50% of the time when using the device.
Other unpublished studies have suggested that women trained in using the product could detect malignant lumps as often as trained nurses and that women who used the device were more likely to do self-exams.
But some physicians say the gel device doesn’t do anything that a little soap and water can’t do just as well.
“Just do your exam in the shower, with a little bit of soap on your fingers. That makes it a little more slippery,” says Dr. Mindy Wiser-Estin, a gynecologist in Little Silver, N.J.
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Self-exams in question
But there’s a much larger question about the need for self-exam kits.
When the gel pad was approved by the FDA, few health experts doubted that self-exams helped save lives. So if kits made for easier, more sensitive self-exams, it followed that kits might save more lives.
But many of those experts now question the need for self-exams at all -- largely because of one landmark study published in the Journal of the National Cancer Institute in October 2002.
The study followed about 266,000 women born between 1925 and 1958 and who were current or retired employees of textile factories in Shanghai. From October 1989 to October 1991, the women were randomly assigned to two groups.
In the instruction group, the women were taught the proper way to do a breast self-exam. This initial training was followed up in several ways: by two reinforcement sessions one and three years later; by practice sessions under medical supervision at least every six months for five years; and by regular reminders to give themselves exams every month.
In the control group, women received no information about breast self-exams. Women in both groups were followed through December 2000.
The results did not confirm commonly accepted beliefs. The risk of dying from cancer was virtually identical in both groups.
Breast self-exams did not seem to save lives.
But there was a significant difference between the two groups: Nearly twice as many benign tumors were diagnosed in the instruction group as in the control group.
This implied that breast self-exams could actually cause harm by leading to unnecessary anxiety and possibly unnecessary tests and even biopsies.
Because such results were widely unexpected, a preliminary report published five years into the study was met with some skepticism. But the 10-year report convinced many doubters.
“The Shanghai study is the strongest evidence that’s out there,” says Kramer of the NIH. “Therefore, it’s the best evidence we have to go on in advising women.”
Many experts now recommend that women should simply be aware of, and familiar with, their breasts so they will notice any changes -- and then see a doctor.
Others are not ready to give up on the exam completely. “I do recommend self-exams,” says Wiser-Estin, the New Jersey gynecologist. “For patients under 40, not yet of an age to have mammograms, it’s the only way to pick something up between doctor visits.”
Dr. David Thomas, a professor at the Fred Hutchinson Research Center in Seattle and lead author of the Shanghai study, takes a middle-of-the-road stance on self-exams by drawing a distinction between recommendations to individuals and recommendations to whole populations.
“Suppose a woman comes in with a family history of breast cancer, highly motivated,” he says. “Should she practice breast self-exams? Of course, she should. But that’s very different from a public-health department trying to get all the women in the land to do it.”
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False alarms versus early detection
Which brings us back to self-exam kits.
Even some who favor self-exams in general worry that widespread use of the highly sensitive kits would only compound the problem of false alarms.
But Dr. Ernie Bodai, medical advisor to Liv International and director of breast surgical services at Kaiser Permanente in Sacramento, considers that a minor concern compared with the greater good of possibly finding a malignant tumor while it’s still very small.
“The trade-off of anxiety against early detection is surely in favor of early detection,” he says.
No one knows exactly how sensitive self-exam kits are. No studies comparing the kits to self-exams without kits have ever been done.
If the devices are sensitive enough, though, they could redeem self-exams by turning them into a useful screening tool after all.
“I’d like to see studies to evaluate their efficacy,” Thomas says. One such study could look at the size of lumps found when using kits compared with the size of lumps found when not using them. “Clearly smaller is better. If we had good evidence that the lump size is smaller with kits, who knows? They could turn out to be as good as a mammogram.”
But Thomas does not expect to see such studies done. “A trial like we did is expensive, long-term, difficult,” he says. “It takes millions of dollars over decades.”
