Study Sets Off Debate Over Mammograms' Value
By: Gina Kolata
New York Times, December 9, 2001
A new study in a British medical journal has stirred
a passionate debate among doctors in Europe and the United States by
asserting that mammograms do not prevent women from dying of breast cancer
or help them avoid mastectomies.
The question is dividing experts and women's health
advocates, many of whom acknowledge that they do not know what to think
about the new report. For more than two decades, annual mammograms have
been part of life for millions of women, with the American Cancer Society
and the National Cancer Institute urging women to have them.
Experts are still digesting the new findings, which
appeared in the Oct. 20 issue of the journal The Lancet, and few if any
authorities in the United States are suggesting that women abandon routine
mammography on the basis of this study.
Women have long been urged to have the test every
year starting at age 50 or sooner, and promised that early detection will
reduce their chances of dying from breast cancer by about 30 percent. And
detecting cancer early, they were told, would allow women to avoid
extensive surgery and harsh treatments that might be needed to control a
larger tumor found later.
But the new analysis, of seven large studies of
mammography conducted over the past few decades, says those promises are
an illusion. It calls into question the assumption that early
identification of breast tumors, before they can be felt in an external
examination, improves the chances of a cure.
Those studies that found benefits from mammography
were flawed, say the investigators, Dr. Peter Gotzsche, director of the
Nordic Cochrane Center in Copenhagen, and Ole Olsen, the deputy director.
Recent studies, more rigorously designed and conducted, found no such
effects, they assert.
For example, they criticize a New York study from
more than a quarter of a century ago finding that women who never had a
mammogram died of breast cancer at a rate 30 percent higher than those who
had the test. (Of the 30,565 who were never screened, 196 died over an 18-
year period; of the 30,131 who had the test, 153 died.)
Dr. Gotzsche and Mr. Olsen say this study, and four
others, do not meet agreed-upon standards for well-conducted and reliable
research. They question whether the subjects who had mammograms might have
been substantially healthier than those who did not, and whether deaths
among women who had mammograms might be less likely to be ascribed to
breast cancer than deaths among women who did not have them.
"The quality of the trials was very surprising
because it is pretty low," Dr. Gotzsche said in a telephone
interview. "Even if they are judged by yesterday's standards, the
quality is low. In some cases, we know why that happened — these trials
were conducted by people who were unfamiliar with clinical trial
methodology. They were run by enthusiastic clinicians."
The researchers cite with greater approval a more
recent study in Malmo, Sweden, that compared 21,088 women who had
mammograms to 21,195 who served as controls. After nearly nine years, 63
women in the mammogram group had died of breast cancer, compared with 66
in the control group — an insignificant difference. The other study the
researchers approved of, done in Canada, involved 44,925 women who had
mammograms and 44,910 who did not. There were 120 deaths from breast
cancer in the screened group and 111 among the women who served as
controls.
Nor did mammography lead to fewer mastectomies, the
investigators say. In the Malmo study, for example, 424 women in the
mammography group and just 339 in the control group had mastectomies. One
reason may be that doctors aggressively treated some tiny tumors found in
mammograms — tumors that might never have developed into cancer or might
never have been noticed in a woman's lifetime.
So far, just one country, Switzerland, has taken
action as a result of the study, deciding not to offer a national
mammography screening program. Dr. Gianfranco Domenighetti of the Swiss
Network for Health Technology Assessment said the decision was heavily
influenced by the Danish research.
But Switzerland did not have a national program; it
was thinking of starting one. It is a different matter in a country like
the United States, which has a longstanding policy of urging women to have
mammograms. Once a program has been highly promoted and advanced as a way
to save lives, said Dr. Barnett Kramer, the associate director for disease
prevention at the National Institutes of Health, it can be difficult to
suggest that guidelines be revised.
Nevertheless, some American experts, including
researchers at the National Institutes of Health, say that the analysis
deserves consideration, and that women should at least be aware of the
debate.
But others, like experts at the American Cancer
Society, say the study is unconvincing. And some advocacy groups say they
are agonizing over how to advise women. They say some of their members,
whose cancers were found by mammography, will always be convinced that the
screening test saved their lives.
The debate has nothing to do with the effectiveness
of breast cancer treatment. There is agreement that treatment, with
surgery, hormones and chemotherapy, saves lives. Instead, the question —
which has come up before with screening tests for other kinds of cancer
— is whether earlier treatment is better.
At its heart, the analysis challenges the assumption
that the period when a tumor can be seen on a mammogram but not felt in a
breast examination is a critical period in which cure is possible. If that
assumption is wrong — if cancers can be just as treatable, or just as
deadly, whether they are found early or late — then mammography would
offer no benefits.
A similar problem recently emerged with breast
self-examination, another method of early detection that had been highly
promoted. When studies in China and Russia indicated that it did not
prevent breast cancer deaths, the cancer institute quietly dropped its
emphasis on the method, saying in a database primarily for doctors that
there was insufficient evidence of its value.
The institute will ask a panel of independent experts
that advises it on that same database to look at the new mammography
study, said Dr. Peter Greenwald, the institute's director for cancer
prevention.
Dr. Greenwald added that there might be a simple
explanation for the discrepancy among the studies analyzed by the
researchers in Copenhagen. Newer treatments are saving women's lives, he
said. That may mean that a woman's prognosis is nearly the same whether
tumors are found early, with mammography, or later, when they can be felt.
If this is the case, earlier mammography studies, conducted when
treatments were less effective, would have found that screening prevents
breast cancer deaths; more recent studies might not have found this
effect.
But the most important question, Dr. Gotzsche said,
is not whether women are saved from dying of breast cancer; it is whether
mammograms prolong their lives. It is possible, he said, that a mammogram
might find a cancer early, leading to treatment that might prevent a
breast cancer death. But theoretically, the treatment might be so harsh
that it precipitates another illness, so that the woman lives no longer,
although her death is not attributed to breast cancer.
No one study was large enough to answer that
question, so the investigators combined study data. They concluded that
the overall death rate did not budge when women had mammograms compared
with when they did not.
Dr. Greenwald said that while he had not formed an
opinion about the validity of the analysis, he considered the study
"important." But other experts, like Dr. David Freedman, a
statistician at the University of California at Berkeley, dismiss it as
deeply flawed. Dr. Freedman said some of the studies Dr. Gotzsche and Mr.
Olsen cite as weak were actually the strongest, and vice versa. He called
Dr. Gotzsche "incredibly alert to all difficulties in work he doesn't
like" but added, "In papers he does like, he swallows
anything."
Dr. Freedman said it would be ridiculous to demand
evidence that mammography lowers the overall death rate. The reason, he
said, is that breast cancer accounts for only 1 to 3 percent of deaths
among women, making it impossible to see such an effect even if lives are
saved.
"Mammography is not like aspirin and
headache," he said. "The evidence is complicated. But the advice
I would give someone is to get screened."
Dr. Robert A. Smith, the director of the division of
cancer screening at the American Cancer Society, defended the studies
criticized by the investigators in Denmark. "The trials have been
gone over with a very, very critical eye by a lot of people," he
said. "Although people differ in terms of which ones they prefer,
most people would never have dismissed five out of seven as unworthy of
consideration."
Dr. Smith said the cancer society would examine the
new report as part of a previously scheduled review of publications on
mammography. But, he said, "I do not see anything in the Olsen and
Gotzsche analysis that would lead the review committee to question the
evidence and wisdom of routine screening mammography for women 40 and
older."
Dr. Stephen A. Feig, a radiologist who directs breast
imaging at Mount Sinai School of Medicine in New York, said,
"Screening has weathered controversies before and it will continue to
do so."
Health insurance companies usually pay for
mammograms. Joseph Luchok, a spokesman for the Health Insurance
Association of America said, "If a procedure is covered it would stay
covered until the medical community came to the opinion that it is not a
useful procedure."
But some doctors who want to advise their patients
confess that they are whipsawed by the dueling experts. "The debate
has become so sophisticated from a methodology viewpoint that as a doctor
my head is spinning," said Dr. Barron H. Lerner, an internist and
historian at Columbia University's College of Physicians and Surgeons. Dr.
Lerner wrote "Breast Cancer Wars" (Oxford University Press,
2001).
"You read the article in The Lancet and you nod
your head yes. Then you read the studies by people on the other side and
you nod your head yes," Dr. Lerner said. "We're witnessing this
fight between the pro- and anti-mammography forces and they're both
arguing that `my data is better and we're right and they're wrong.' "
What should be done, Dr. Lerner said, is
"sitting back and trying to analyze how we as patients, as doctors,
as a society, should deal with these conflicting data."
That is an issue that is plaguing some advocacy
groups.
The report "is really causing a huge amount of
concern among activists," said Cindy Pearson, the executive director
of the National Women's Health Network. She said her group no longer
advocates self- examination. Now, she said, if mammograms are not useful,
"you're just left out there with nothing."
Fran Visco, president of the National Breast Cancer
Coalition, said she welcomed the mammography dispute. "We know that
mammography screening has serious limitations, yet it has been sold as the
be-all and end-all for breast cancer," Ms. Visco said. "When
someone says, `We have to question that assumption,' we're thrilled. We've
been questioning it from the beginning."
"I'm not ready to tell women over 50 not to get
screened," Ms. Visco said. "But what we are telling women is
that we don't have a good screening test to detect breast cancer early and
we're not sure what to do when we find it early." It is time, she
said, to focus on these issues rather than assume that mammograms are the
answer.
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