Posted by: Ben Lillie
In her TEDWomen talk, Deborah Rhodes, a physician and researcher at the Mayo Clinic, describes a new technique for screening women for breast tumors, and how innovation can proceed by tailoring the test to individual characteristics — in the case of Rhodes’ MBI, based on the tissue density — and also about the politics that gets in the way of making those innovations.
One of the things that jumped out at the beginning of your talk is when you said, “The breast is the most political organ there is.”
In some ways, being a political organ is a good thing, because it means you have a very strong base of interest, and that can serve a good cause. There is a stronger advocacy group around breast cancer than around any other type of cancer, or in fact any other health issue period. The Susan G. Komen Foundation is a wonderful example of grassroots advocacy becoming extremely powerful in changing the course of breast cancer research, and indeed the lives of women with breast cancer.
So, the advocacy group is powerful, it exerts a lot of political power, but that can also, sometimes, cause a very impassioned topic to be ruled by what people want and hope for, rather than necessarily by the precise science. When the United States Preventative Services task force recommended against mammography in women in their 40s, people were shocked, like “How could this happen? This has never happened before!” Well, in fact, the exact same thing happened in 1997, when the National Cancer Institute convened an independent consensus panel to look at all the mammography data and make recommendations. My medical fellowship director at that time, Leon Gordis, was actually the person appointed to be the chair of this consensus panel. At the end of the analysis the panel announced that the data did not support routine mammography of women in their 40s. He came back and he just looked disheartened, and he said, “It was literally like facing a pack of hungry wolves. ” They were vilified. This panel was vilified. There was a quote in The New York Times that said, this is tantamount to a death sentence for women in their 40s.
The director of the NCI, the very director who had convened the panel in the first place, held a press conference where he said, “It is my hope and expectation that the data will support a routine recommendation for mammography.”
Now that is a shocking statement. Here is a NIH-level scientist — career scientist — saying, “it is my hope and expectation that the data will show X”? The data show what the data show. The data should not be interpreted through the glasses of our hopes and expectations. And yet, this type of thing happens over and over and over again, because nobody wants women to die from breast cancer. But using a test that’s not well suited to discovering breast cancer in young women is not the answer.
What we need to do is find a better test for women with dense breasts. We need to stop debating mammography. Mammography has been debated, debated and debated to the point where the horse is dead. We have spent millions of dollars in this country debating what to do with mammography instead of innovating to find a better test for the women in whom mammography doesn’t work well. There have been six and possibly more meta-analyses of the mammography screening trials that have combined all the data to look for trends in the totality of data that were not evident in the individual studies. What’s fascinating is that each meta-analysis conclusion contradicts the one that came immediately before it in regard to whether we should screen women in their 40s. That’s incredible – analyzing the exact same data and reaching a different conclusion every time. And so what that tells me is that you can re-sift and re-analyze the data a million more times, but the only thing you can say at the end of all this is that the benefit of mammography for women in their 40s is not strong enough. And not just for women in their 40s, but for all women with dense tissue, because that’s what it ultimately boils down to is that mammography can’t reliably find tumors in dense tissue, so if you have dense tissue you need something else.
I hadn’t realized how much money had been spent on debating this. Do you have a theory of why this money hasn’t gone to innovation?
I do. That lies in this conundrum that exists around the mortality issue. When you’re talking about cancer, the only endpoint that matters at the end of the day is, ‘are lives saved?’ or ‘are lives extended?’ To demonstrate that Test A reduces mortality more than Test B requires a tremendously long period of time in the case of breast cancer, because most women don’t die of breast cancer. If you’re looking at a test to evaluate pancreatic cancer, it’s easy, because most people with pancreatic cancer die, and they die quickly. So, it’ll only take you five years to assess whether Test A is better than Test B. It takes twenty, possibly even thirty, years to address that for breast cancer, because most women don’t die, thank God, and some women who do die, die many, many years after their diagnosis. So it takes such a long time to demonstrate a mortality reduction. The shocking thing is that these mammography trials that keep getting debated and debated and debated — most of these trials were started in the 1970s.
So the problem is whenever a new technology comes around, the mammography mafia, as we call them, says, “Your test is no good, because you can’t demonstrate a mortality benefit.” Well, of course we can’t demonstrate a mortality benefit. Mammography’s been around since the 1960s; they’re the only ones who have a prayer of demonstrating a mortality benefit, because it takes that long to demonstrate.
What do you think the solution is?
First, we need to stop debating mammography and put our resources into developing and evaluating alternative screening techniques for women with dense breasts. MBI is certainly a very promising technique, and there are other promising techniques.
Second, we need to accept an endpoint for success that is not strictly mortality-based. Although mortality is the most important outcome, there are intermediate outcomes that can serve as acceptable proxies for mortality. For example, instead of insisting that each technique must demonstrate a reduction in mortality from breast cancer, I believe it is acceptable instead to evaluate whether one technique can find tumors at an earlier stage – in other words, small tumors that have not spread to the lymph nodes.
Third, there should be a collective effort among radiologists, breast cancer advocacy groups, and government health organizations to promote the implementation of the technique that demonstrates the most success in regard to this intermediate outcome. Right now, implementation of new radiologic techniques is very haphazard.
And fourth, we need to choose something that is not only better than mammography in women with dense breasts and as safe as mammography, but also comparable in cost. Medical imaging companies are currently focused on very high-cost imaging techniques, such as MRI, which are these unbelievably complex, enormous, expensive machines; this is not an answer for a screening test. I mean, it’s perfectly good if you have a diagnostic dilemma. where you have a patient and you can’t figure out what’s going on and you can do this beautiful picture of their breast, but it’s not the answer for large-scale screening, for the 40% or higher of women that have dense tissue. It would bankrupt our health-care system. It’s just not a realistic or rational way to apportion our health care dollars. We need to find something that’s as good as MRI, or almost exactly as good, but much less expensive. That’s what I feel that we have developed.
Read the full Q&A on the TED Blog and see the TEDWomen talk.
Post your Comment
Please login or sign up to comment
Comments