[Congressional Record Volume 143, Number 32 (Thursday, March 13, 1997)]
[Senate]
[Pages S2225-S2230]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
MAMMOGRAMS
Mr. SPECTER. Mr. President, the final subject I wish to address
briefly involves the problem of mammograms for women age 40 to 49.
Mr. President, this subject came into sharp focus when a National
Institutes of Health panel on January 23 issued a report that
mammograms were not warranted for women in the 40 to 49 category. That
was immediately met with very widespread criticism, including criticism
from Dr. Richard Klausner, the Director of the National Cancer
Institute, who said that he was shocked by that conclusion. As the
facts later developed, a press release was inadvertently disclosed.
Some of the members of the panel had held that mammograms were not
warranted. But, as I understand it, that had not been thoroughly
analyzed and agreed upon by the panel. But once this press release came
out they stood by the release. And there has been enormous confusion in
America on this issue of women 40 to 49.
The subcommittee, which I chair and which has jurisdiction over the
Department of Health and Human Services, had a hearing on February 5 at
which Dr. Klausner restated his shock about the matter. He thought that
the advantages of mammograms for women 40 to 49 had not been
appropriately emphasized, and the disadvantages had been emphasized too
heavily. He also said that he was going to await a meeting of the
National Cancer Institute later in February--on February 24 and 25. It
was my understanding that the matter would be resolved at that time.
But, in fact, it was not.
When the Secretary of Health and Human Services testified before our
subcommittee on March 4 she said that there would be a 2-month delay,
which I said in those hearings was unacceptable. I have since pressed
Dr. Klausner as to why there would be such a delay.
I wrote to him on March 5, 1997. I ask unanimous consent that the
text of that letter be printed in the Record following my statement.
The PRESIDING OFFICER. Without objection, it is so ordered.
(See exhibit 1.)
Mr. SPECTER. Mr. President, when I was dissatisfied with his
response, I wrote to Dr. Harold Varmus, Director of the National
Institutes of Health, the overall supervisor, on March 6, 1997 asking
that there be some acceleration of this determination because no
further tests were necessary but only a judgment was needed. What I
found was that the matter was being referred to a 7-person subcommittee
which was going to deliberate on the issue and then take it up by an
18-person full committee.
I ask unanimous consent that my letter to Dr. Varmus and a subsequent
letter to Dr. Klausner be included in the Record following my
statement.
The PRESIDING OFFICER. Without objection, it is so ordered.
(See exhibit 2.)
Mr. SPECTER. I am concerned that the delays in mammograms could
constitute a health hazard for women 40 to 49. And, beyond that, that
there is much confusion in America on that subject. The upshot of it
has been that there now appears that the subcommittee will render its
report to the full committee on this Friday, and there will be a final
report rendered next Tuesday which will eliminate the need for
accelerated hearings in our subcommittee to try to come to a conclusion
on this important matter.
I emphasize that I appreciate the need for an independent medical
judgment on this important subject.
It seems to me that where all the tests have been performed and it is
a matter of issuing guidelines, coming to closure and judgment on this
should not require such a lengthy period of time. I believe that there
is not a sufficient sense of urgency generally, and in Government
specifically, as this issue has been addressed. My views are expressed
more fully in these letters, and I shall not take a greater period of
time to elaborate upon them here.
In coming to my own judgment that mammograms are warranted for women
40 to 49, the subcommittee held hearings in Pittsburgh, in Hershey, and
in Philadelphia, where we heard from a long array of witnesses. A
report has
[[Page S2226]]
been prepared by my able staff member, Betty Lou Taylor, and also by
Craig Higgins. I ask unanimous consent that this statement be printed
in the Record following my oral statement. It sets forth the findings
of prominent doctors in Pennsylvania and quite a number of women in the
40-to-49 category who give firsthand testimony about the importance of
mammograms for them and the importance of mammograms generally for
women in the 40-to-49 category.
The PRESIDING OFFICER. Without objection, it is so ordered.
(See exhibit 3.)
Mr. SPECTER. It is my hope, Mr. President, that we will have a
definitive statement, as I say, next Tuesday. We need the definitive
statement so that we come to closure on the issue, and then it is a
matter for scientists acting on their independent judgment. It is my
hope and expectation that the abundance of scientific tests which are
already available will show that mammograms are important for women 40
to 49.
When I talk about medical tests, I speak from some personal
experience, having had an MRI which disclosed a very serious problem.
On these medical examinations, the earlier the better, so I hope we
move ahead as promptly as we can.
I thank the Chair and yield the floor.
Exhibit 1
U.S. Senate,
Committee on Appropriations,
Washington, DC, March 5, 1997.
Richard D. Klausner, M.D.,
Director, National Cancer Institute, Bethesda, MD.
Dear Doctor Klausner: I was very distressed to hear
Secretary Shalala's testimony yesterday that there will be
another two-month delay on having the National Cancer
Institute reach a conclusion on whether mammograms are
warranted for women aged 40 to 49.
As disclosed in our previous hearing, the NIH consensus
development conference panel press statement of January 23,
1997, was probably inadvertently released. That resulted in a
lot of anxiety for women in the 40 to 49 age category and
beyond. When you testified before the Subcommittee on
February 5, 1997, the expectation was that the matter would
be resolved by further NCI proceedings on February 25, 1997.
Now we hear that there will not be a definitive statement
until early May.
During the intervening 60 days, thousands of women in the
40 to 49 age category might be screened which could result in
the saving of many lives.
I would appreciate your immediate response as to why the
National Cancer Institute cannot make a prompt decision, or
in the alternative, give our Subcommittee an earlier date.
Sincerely,
Arlen Specter.
____
Exhibit 2
U.S. Senate,
Committee on Appropriations,
Washington, DC, March 6, 1997.
Dr. Harold Varmus,
Director, National Institutes of Health, Bethesda, MD.
Dear Doctor Varmus: With this letter, I am sending you a
copy of a letter I sent to Dr. Klausner yesterday.
Earlier today Dr. Klausner and I had a conversation which I
considered totally unsatisfactory. Dr. Klausner had set a
time limit of 60 days for the subcommittee to report back to
him; and when I said I thought that was unreasonably long, he
said they would do it as soon as possible. When I asked him
how long that would be, he said he didn't know and referred
me to Dr. Barbara Rimer.
When my Chief of Staff, Craig Snyder, called Dr. Rimer, she
advised that 60 days was the outside period with the hope
that her subcommittee could act more promptly. Dr. Rimer then
outlined a procedure where she had drafted a proposed
statement for her subcommittee of 7 members which was
circulated today with the response time a week from today.
After that, Dr. Rimer expected to have a conference call
among 18 members of the full committee to resolve the issue
with the hope that all of that could be concluded within 10
days.
In my opinion, this is an extraordinarily unwieldy
procedure and judgments could really be made at the National
Cancer Institute since no additional research is necessary.
If the procedure outlined by Dr. Rimer is followed, I urge
you to escalate the pace by having the comments of the 7
subcommittee members returnable next Monday with the
conference call of the full 18 members of the National Cancer
Advisory Board to be completed promptly thereafter so that
the final comments can be completed by the end of next week.
Again, in my opinion, the Department of Health and Human
Services, NIH and NCI do not have an appropriate sense of
urgency on this matter. I do not have to tell you how many
lives could be saved with prompt screening of women 40 to 49
without the kind of delay occasioned since the first release
of January 23.
I would appreciate your immediate response on this matter.
Sincerely,
Arlen Specter.
____
U.S. Senate,
Committee on Appropriations,
Washington, DC, March 11, 1997.
Richard D. Klausner, M.D.,
Director, National Cancer Institute, Bethesda, MD.
Dear Doctor Klausner: I had asked my staff yesterday to set
the hearing for the National Institutes of Health including
the National Cancer Institute for March 18 because of my
concern about the prospective 60-day delay on the issue of
mammograms for women 40 to 49.
When I heard you were going to be out of the country from
March 14 to March 21, I sought to schedule the hearing for
this week, on March 13, because the Senate will be out of
session from March 24 through April 6 and I did not want to
wait so long on this mammogram issue.
I have since been advised that the NIH subcommittee will
circulate its decision to the full committee this Friday and
the full NIH committee will act on March 18. While I really
believe there has been too much delay up to now on the
resolution of this issue, at this point I suppose that's
about as expeditious a decision as can be made.
As I think you understand, my point all along has been that
the matter ought to be resolved one way or another. I
appreciate and understand the importance of independent
medical judgment but the time delays for the NIH subcommittee
and full committee frankly puzzle me. When you had expressed
your own ``shock'' on the NIH panel finding back on January
23, and the bulk of the evidence supports mammograms for
women 40 to 49, I had thought the matter to be pretty much
resolved since there were no further tests to be conducted
but only a judgment to be made. It was my thinking that 60
more days from the testimony of Secretary Shalala on March 4
was unacceptable.
In any event we will await the final guidelines on March 18
and we will defer the NIH/NCI hearing until April at which
time we will take up the procedures which you have employed
on the issue as well as the other substantive matters
affecting the National Institutes of Health including the
National Cancer Institute.
Sincerely,
Arlen Specter.
Exhibit 3
Mr. President, in recent weeks, I have been holding
hearings here in Washington and around my home state of
Pennsylvania on the recommendation made on January 23, 1997
by the NIH Consensus Development Conference Concerning Breast
Cancer Screening for Women Between the Ages of 40 and 49. The
panel concluded, ``that the available data did not warrant a
single recommendation for mammography for all women in their
forties.'' Instead, the panel reiterated the 1993
recommendations of the NCI that each women between the ages
of 40 and 49 should decide for herself whether to undergo
mammography.
On January 23, 1997 after the press release was issued by
the Consensus Panel, Dr. Richard Klausner stated that his own
reading of the studies and information presented to the
conference, in contrast to past years, was that we now have
available more convincing evidence. The evidence is primarily
from Swedish population screening studies that there is a
statistically significant benefit in terms of reduced death
from breast cancer for women who begin screening in their
forties. Women in that age group who decide to begin
screening should be aware of the increased evidence of
benefit and of any potential risk. A women's decision to be
screened or not screened should be made on the basis of
knowledge.
Breast cancer is the second leading cause of cancer death
in American women and according to the American Cancer
Society, nearly 44,000 women will die from the disease this
year, and 10,000 of these women will be in their forties,
making breast cancer the number one cause of death in this
age group. It seems to me that those numbers alone should
signal an alarm that women in this age bracket are at great
risk. And while mammography is not perfect, it is the best
tool currently available.
FEBRUARY 5, 1997, WASHINGTON, DC
On February 5, 1997, at a hearing here in Washington, I
discussed this issue with a panel of distinguished
scientists, including Dr. Richard Klausner, the Director of
the National Cancer Institute, Dr. Susan J. Blumenthal,
Deputy Assistant Secretary for Women's Health, Dr. David
Hoel, a Member of the NIH Consensus Development Conference,
Dr. Marilyn Leitch, Associate Professor of Surgery at the
University of Texas Southwestern Medical School in Dallas,
Texas, and Dr. Barbara Monsees, Associate Professor of
Radiology and Chief of the Breast Imaging Section of the
Mallinckrodt Institute of Radiology, Washington School of
Medicine in St. Louis, Missouri.
Dr. Klausner expressed concern that the balance and tone of
the Panel's draft report overly minimized the benefits and
overly emphasized the risks for women in their 40s. Dr.
Klausner also stated the National Cancer Advisory Board would
discuss the screening issue at their next meeting. That
meeting took place on February 25, and resulted in the
formation of a special subcommittee to
[[Page S2227]]
develop clear recommendations to the NCI on screening
mammography. Dr. Klausner told the subcommittee that the
Board intends to complete the process in two months.
Dr. Blumenthal discussed the Department's efforts to
improve breast cancer detection and diagnosis to ensure that
today's mammography techniques are of the highest quality.
She also stated that breast cancer is perhaps the most
dreaded and feared disease in women and that it has become an
epidemic in our country: the number of women affected by this
disease has increased from 1 in 20 over a time in the 1950s
to 1 in 8 today.
Dr. Blumenthal spoke of the new frontiers in breast imaging
such as ultrasound, digital mammography, breast MRI and
Positron Emission Tomography as ways to improve early breast
cancer detection. She also described the ``Missiles to
Mammograms'' initiative to adapt advanced defense, space, and
intelligence imaging technologies from the DOD, CIA and NASA,
to more accurately detect breast cancer.
Next, the Subcommittee heard testimony from David G. Hoel,
Ph.D., who is Professor and Chairman of the Department of
Biometry and Epidemiology at the Medical University of South
Carolina. Dr. Hoel, who is a member of the NIH Consensus
Panel briefly outlined the process by which the Panel
reviewed available research on the subject and derived its
conclusions. Dr. Hoel also detailed the specific questions
the panel was charged with answering and further noted that
the Panel was restricted to providing answers to specific
questions. The Panel is currently involved in completing its
work and stated that the Panel's final conclusions would
accurately represent the consensus view of its members.
We then heard from a panel of expert witnesses representing
the American Cancer Society, the Breast Cancer Foundation,
and the National Breast Cancer Coalition.
Speaking on behalf of the American Cancer Society was
Marilyn Leitch, M.D., who is Associate Professor of Surgery
at the University of Texas Southwestern Medical School at
Dallas. She reaffirmed the American Cancer Society's position
that the conclusions reached by the Consensus Panel are at
variance with the data presented by both European and U.S.
scientists, and therefore did not offer women and their
physicians the best guidance possible. She noted that the
National Cancer Institute and eleven other organizations in
1989 concluded that women in their forties should have
regular mammograms. That position was reaffirmed in 1992
after a subsequent review of the scientific evidence.
In 1993, however, NCI withdrew its recommendation on the
grounds that randomized clinical trials had not shown a
statistically significant reduction in mortality among women
under age 50. Since that time, however, two Swedish studies
and a statistical compilation of eight clinical studies have
been released showing solid epidemiological and clinical
evidence that routine screening is effective in reducing
breast cancer mortality. The Swedish studies showed
statistically significant reductions in mortality of 36
percent and 44 percent, respectively, for groups invited to
be screened.
Dr. Leitch conveyed the American Cancer Society's
disappointment that the Consensus Panel placed undue emphasis
on two issues: the risk of radiation-induced cancer and the
issue of false positives and false negatives. She noted that
the Society currently recommend that women in their forties
be screened every one to two years. Later this month, the
Society will convene its own expert panel, however, to
determine if, based on new evidence, the mortality benefit
might be even greater if women are screened annually.
The Subcommittee then heard from Ms. Susan Braun and Ms.
Diane Rowden, both representing the Susan G. Komen Breast
Cancer Foundation, a nonprofit organization that supports
research on breast cancer.
Ms. Braun noted that when breast cancer is found in its
earliest stages, the likelihood of 5-year survival is over 95
percent, but when found after it has metastasized, that
survival rate drops precipitously--to 20 percent. Clearly,
early detection is a key to longevity. And while she points
out that mammography is far from a perfect tool, it has
proven to save lives. Ms. Braum contends that the benefits of
early screening outweigh the risks, and that is why the Komen
Foundation guidelines recommend screening every one to two
years, beginning at age 40. Ms. Rowden reaffirmed that
position. She cited data estimating that in 1996, women in
their forties would account for 18.1 percent of newly
diagnosed invasive breast cancers, compared with 16.8 percent
for women in their fifties.
We next heard from Frances M. Visco, Esquire, the first
President of the National Breast Cancer Coalition and a
member of its Board of Directors. Ms. Visco told the
Subcommittee that her breast cancer was diagnosed through a
mammogram when she was 39 years old. She stated that we
cannot act as though the issue whether to recommend screening
for women age 40 to 49 is the most important question
surrounding breast cancer and that our outrage should be
saved for the fact that we do not know how to prevent the
disease, how to cure it, how to detect it at an early stage,
or what to do for a women once we do find it.
Ms. Visco went on to ask what is the goal? A simple message
that is less confusing? She stated that in this situation,
the simple message is wrong. She further stated that we want
mammography to work for all women. It does not. We want to
reduce breast cancer to a sound byte. It cannot be. We should
be devoting our resources to designing mechanisms to get the
message out to women; to get them to understand the risks,
the benefits, the pros, the cons, so they can make their own
decision.
Ms. Visco also told the Subcommittee in her view $590
million should be devoted at the NIH to research on breast
cancer and $150 should be spent for research purposes at the
Department of Defense.
Ms. Visco concluded that women cannot continue to be given
false hope. If women in their 40s are told to get a mammogram
every year, we are saying ignorance is bliss. What we need to
tell them is that there are pros and cons, there are risks
and benefits. That is the information they need to get. Then
let them decide the course of their own care.
Our last witness was Barbara Monsees, M.D., who is Chief of
the Breast Imaging Section at Mallinckrodt Institute of
Radiology at the Washington University School of Medicine in
St. Louis. She shared her unique perspectives as both a
medical professional and as a woman who survived early breast
cancer detected by a mammogram.
Dr. Monsees confirmed the fact that there appears to be
clear scientific evidence that early screening can
substantially reduce the death rate from breast cancer. She,
too, cited the findings from five major population-based
screening programs in Sweden. Two of the trials showed
mortality reductions of 44 percent and 35 percent,
respectively, while an overview study of all five indicated a
23 percent mortality reduction.
Unfortunately, according to Dr. Monsees, the NIH Consensus
Panel chose to ignore this most recent data, resulting in
``an unbalanced presentation of the facts . . .'' Dr. Monsees
raised some provocative questions, such as ``Could this issue
have taxed the NIH consensus development model beyond its
intended purpose?'' And ``Were the panelists given adequate
time, information and instruction regarding the rules of
evidence in order to formulate their report?'' In conclusion,
she voiced hope that the National Cancer Advisory Board will
re-examine all the evidence in an unbiased fashion, and
conclude that screening women in their forties does save
lives.
FEBRUARY 20, 1997, PHILADELPHIA, PENNSYLVANIA
On February 20th, 1997, I reconvened the Subcommittee for
our hearing in Philadelphia.
I opened the hearing with a report on a promising
opportunity I learned of last year, whereby certain defense
imaging technology may prove useful in more accurately
detecting breast cancer in its early stages. I saw to it that
this project received the necessary funding, and I look
forward to seeing the results.
Once again, we heard from a very distinguished group of
witnesses, led off by Dina F. Caroline, M.D., Chief of the
Division of Gastrointestinal Radiology and Mammography at
Temple University Hospital.
Dr. Caroline began by tracing the history of mammographic
screening for women in their forties, beginning in 1977, when
the National Cancer Institute and the American College of
Surgeons recommended it for women with first degree relatives
with breast cancer. Where the controversy came to a head was
in 1993, when NCI reversed its stance, stating that experts
do not agree on the value of routine screening for women in
their forties.
In subsequent testimony, Dr. Caroline noted the concerns of
the NIH Consensus Panel with respect to false positive
results. But as she points out, until technology improves, we
must expect false positive readings simply because the whole
purpose of screening is not to miss any opportunity to
identify breast cancer. False negatives are also a problem.
But with new techniques in development, hopefully these will
begin to diminish in number.
In conclusion, Dr. Caroline finds the available data
sufficient enough to advocate screening for women in their
forties.
Our next witness was Stephen Feig, M.D., Director of Breast
Imaging and Professor of Radiology at Jefferson Medical
College. Like other witnesses, Dr. Feig cited the latest
clinical studies which found that current mammographic
techniques should be able to reduce breast cancer deaths by
at least 40 percent. He went on to point out that 20 percent
of all breast cancer deaths and 33 percent of all years of
life expectancy lost to breast cancer are due to cancer found
in women in their forties. Not to advise screening in this
age group, he contends, is unconscionable.
The Subcommittee then heard from Daniel C. Sullivan, M.D.,
the Chief of Breast Imaging at the Hospital of the University
of Pennsylvania, and a member of the NIH Consensus Panel. Dr.
Sullivan was careful to point out that the Panel's statement
that has raised so much controversy is only a draft version.
More importantly perhaps, Dr. Sullivan advocates annual
mammography for women in their forties and emphasized his
hope that the Panel's final statement will reflect that
position. He went on to underscore the need for more
research, as well as improved access to mammography through
more consistent insurance coverage.
Bonita Falkner, M.D., a Professor of Medicine and
Pediatrics at the MCP Hahnemann School of Medicine at the
Allegheny University of the Health Sciences and Acting
Director of the Institute for Women's Health
[[Page S2228]]
noted in her testimony that the controversy over the
scientific merit of mammography in younger women should not
confuse the facts for women 50 and above. She also stated
that all women in their 40s should have access to a
physicians counseling on mammography, and she found it
particularly troubling that the Panel's failure to endorse
screening has the potential to lead to a failure on the part
of insurers to pay for the procedure. Dr. Falkner stated with
the increased mortality rate among minority and disadvantaged
women, particular efforts must be made to provide access to
physician counseling and breast screening for these women at
all ages.
The Committee then heard from Robert C. Young, M.D. Dr.
Young is the President of the Fox Chase Cancer Center and in
his testimony, Dr. Young maintains that for women under age
40, without other risk factors, the risk of breast cancer is
quite low and there is no convincing argument for mammography
screening at all. Where the gray zone occurs, he notes, is in
women between the ages of 40 and 50, where there is generally
a lower incidence of breast cancer, difficulty in detecting
the disease, and differences in the biology of the tumors
themselves. Because of these complications, small or short-
term studies fail to yield clear results. In order to arrive
at more definitive results, larger, long-term trials are
required. And as he points out, trials such as those done in
Sweden have shown small but definite improvement in survival
rates.
Moreover, Dr. Young made an important point in his
testimony: That guidelines are just that--guidelines. And in
the case of mammography screening for women in their forties,
even though the benefit may be small, the risk is minuscule.
He contends that ultimately the solutions will be found
through research that addresses the more fundamental
questions and leads to new ways to prevent or eliminate this
horrible disease.
The next witness to appear before the Subcommittee was Ms.
Barbara De Luca, the Executive Director of the Linda Creed
Breast Cancer Foundation. Ms. De Luca highlighted the
Consensus Panel's conclusion that there is no clear
indication that yearly mammograms for women in their forties
save lives. She contends that the Panel's conclusion was
based on economic reasons, that mammograms cost money. She
went on to report on a small sampling of her Foundation's
members. The women she surveyed were diagnosed with breast
cancer in their forties. While mammograms had failed to
discover their cancer, each of those surveyed felt strongly
that women in their forties, nevertheless, should be
encouraged to undergo screening every year.
Ms. De Luca reported that a mammogram done seven years ago
had failed to identify her breast cancer, but that since that
time new modes of detection have been developed, including
the MRI and digital mammography. She recommended that tools
like MRI should be made more accessible and less expensive.
She urged more research be directed to finding a blood
test or other methods to turn off cancer cells and arrest
the disease. This, coupled with early detection, can mean
finding an effective cure for breast cancer.
Ms. Lu Ann Cahn, a reporter for WCAU-TV testified that her
experience was similar to Ms. De Luca, in that her mammogram
failed to detect the cancer. And also like Ms. De Luca, she
was appalled by the Consensus Panel's failure to recommend
annual mammograms for women in their forties. She noted that
this year 6,000 women in their forties will die of breast
cancer, while the NIH is relaying a confused message that
many women will take to mean they need not worry.
In a very compelling fashion, Ms. Cahn concludes that the
recommendation of the consensus panel has given every woman
who wants to avoid mammograms an excuse to do so.
The Subcommittee once again heard from Ms. Frances M.
Visco, Esq., the President of the National Breast Cancer
Coalition and a breast cancer survivor. Ms. Visco spoke out
in support of the consensus panel's findings. But more
importantly she urged that we devote our resources to
empowering women to understand the available information and
discuss it with their physician. She issued a call to arms of
sorts, urging us to focus more of our resources and energy on
convincing more women in their fifties to be screened and to
support a greater investment in research to find a cure,
effective treatment, and more accurate ways to detect breast
cancer. And she called for a greater commitment to
guaranteeing access to quality health care for all women and
their families.
Ms. Visco once again told the Committee, as she did in
Washington, DC on February 5, 1997, that the National Breast
Cancer Coalition is recommending $590 million in research
dollars at the NIH and $150 million for the Department of
Defense Breast Cancer Research Program. Ms. Visco stated that
these figures were based on the percentage of proposals that
are scientifically valid, but are not funded because of the
lack of resources.
We then heard from Barbara Mallory, M.S.N., R.N., who
represented the Nurses of Pennsylvania, an advocacy group for
nurses and patients. Her contention is that every health
professional she knows suspects that far too much
consideration was given to the financial rather than the
human costs associated with mammograms.
Her organization has been very active in this field,
drafting legislation ending so-called drive-through
mastectomies. In her position as a nurse she has encountered
many women, some as young as 33, who have had breast cancer
diagnosed as a result of self-examinations and mammograms.
Ms. Mallory went on to cite statistics about Ductal
Carcinoma In Situ (DCIS), where, since the mid-1980s, there
has been a 200 percent increase in the number of lesions
detected by mammography. About one-half of these lesions have
been found in women under age 50. Up to 25 percent will lead
to invasive cancers. While mammography techniques need to be
improved, she argues that ambiguous messages and too much
attention to the financial bottom-line do a great disservice
to the women of this Country.
Our last witness for the day was Lawrence Robinson, M.D.,
M.P.H., the Deputy Commissioner of the Philadelphia
Department of Public Health.
Dr. Robinson told of his strong support for mammography
screening for women between the ages of 40-49 and stressed
this particularly for African American and Hispanic women.
Dr. Robinson reported on a study done at a health event
sponsored by the Philadelphia Health Department, the
Pennsylvania National Guard and the Fox Chase Cancer Center
where a mobile mammography unit performed 43 mammograms. Many
of the women screened were under 50. The screening found 6
abnormal readings or 15% of those screened. This result
points out the need to do screening particularly in
underserved areas.
FEBRUARY 24, 1997, PITTSBURGH, PENNSYLVANIA
The third in a series of special hearings was convened on
February 24th in Pittsburgh. I opened the hearing by telling
the witnesses that the more I hear about this subject, the
stronger I feel that the National Cancer Institute should
take whatever steps are necessary to resolve this issue in
favor of recommending regular mammograms for women in their
forties.
At this hearing, we heard from two panels of distinguished
witnesses, led off by Thomas S. Chang, M.D., who is Assistant
Professor of Radiology at the University of Pittsburgh School
of Medicine and staff radiologist at Magee-Women's Hospital.
Dr. Chang specializes in women's imaging, with a
significant portion of his practice devoted to breast
imaging. As an expert in this field, he reported being
disappointed by the Consensus Panel's inconclusiveness on
this issue, noting that the Panel did nothing to clear the
confusion that now exists. While the panel may have concluded
that insurers should pay for mammograms for women who want
one, he is concerned that companies will interpret the
Panel's overall conclusions as not requiring them to
reimburse the cost of this procedure. In short, many women--
especially those who are economically disadvantaged--will
have their minds made up for them as a result of financial
constraints.
Dr. Chang went on to report that breast cancer is far more
common in women in their forties than some have implied. In
1996, in fact, there were more breast cancers diagnosed in
women in their forties (33,400) than women in their
fifties (30,900).
Dr. Chang is convinced that mammography saves lives and is
a medically effective screening test for women in their
forties. He advises his patients to have regular mammograms
once a year, and encouraged the NIH to make the same
recommendation.
Dr. Howard A. Zaren, Director of the Mercy Breast Center
for the Pittsburgh Mercy Health Systems told the Subcommittee
that in 1997, 11,000 new cases and 2,700 deaths from breast
cancer will occur in Pennsylvania. These figures place
Pennsylvania within the top five states for highest incidence
and mortality from breast cancer. He further stated that
almost 20 percent of all breast cancer deaths, and 34 percent
of all years of life expectancy lost, result from cancers
that are found among women younger than the age of 50 years.
Dr. Zaren also stated that epidemiologic studies show a
shift towards diagnosing breast cancer at earlier stages in
women 40-49, and this is regarded as indirect evidence of a
possible benefit from screening these women. He also cited
the statistics of Dr. Stephen A. Feig, from Thomas Jefferson
University, who had testified before the Subcommittee in
Pittsburgh, that a mortality reduction of up to 35 percent
can be expected if annual screening mammograms are performed
in the 40-49 age group with current mammographic techniques
and two-views per breast.
Our next witness was Dr. Victor G. Vogel, Professor of
Medicine and Epidemiology and Director of the Comprehensive
Breast Cancer Program at the University of Pittsburgh Cancer
Institute and Magee-Women's Hospital. Dr. Vogel told the
committee that mammographic screening holds the promise of
early detection of breast cancer in a curable stage. He also
commented on the eight randomized studies on which the
consensus panel based their recommendation. He stated that
the studies show unequivocally that for women ages 50 to 59
years, mammography reduced the chance of dying from breast
cancer by approximately 30 percent. However, only one study
was designed specifically to investigate screening in women
40 to 49 and that study was seriously flawed. However, meta-
analysis from screening studies demonstrates a 24% reduction
in breast cancer mortality attributed to screening when women
in their 40s are compared with women of the same age who are
not screened.
[[Page S2229]]
Dr. Vogel also cited some very interesting statistics
stating that in Pennsylvania there are nearly 1 million women
between the ages of 40 and 49, and nearly 2,000 will be
diagnosed with breast cancer this year. Tragically, as many
as 1,000 of these women may die. In his opinion, that number
could be reduced by approximately 250 deaths if women between
the ages of 40 and 49 were screened annually with
mammography.
Our next witnesses was D. Lawrence Wickerham, M.D.
Associate Chairman and Director of Operations for the
National Surgical Adjuvant Breast and Bowel Project. Dr.
Wickerham stated that his greatest concern is that the
consensus statement not be used by insurance carriers as a
reason to deny coverage for mammograms. He further stated
that he did not disagree with the consensus statement which
directs women to decide for themselves whether to undergo
mammography. He felt that in order to make an informed
choice, women and their health care providers need to have
the best possible educational materials to aid them in these
decisions. He felt that there is likely to be a sliding scale
of benefit for women in their 40's and that potential
benefits can be assessed by a woman in consultation with her
health care provider and based on her individual
circumstances.
Diane F. Clayton testified she is a breast cancer survivor
mainly due to early detection. The ductile carcinoma in-situ
was found during a routine mammogram--she was 46 years old.
Ms. Clayton questions the NIH consensus panel's motives.
Was it money driving their direction? Was it ignorance? Was
it politics? Who could be against preserving extending the
lives of mom, sis, Aunt Mary and grandma? Her hope was the
recommendation was an honest effort that just went bad. She
felt that if it was a mistake then we should admit it and go
forward by doing the right thing; advice and counsel women in
their forties to have routine mammograms.
The Subcommittee then heard from Ms. Judy Pottgen, a 47
year old woman who was diagnosed with breast cancer when she
was 43. Ms. Pottgen found her breast cancer by self breast
exam. She is passionate about educating women about self
breast exam. She described a program called ``check it out'',
a Pittsburgh program sponsored by the American Cancer
Society, Hadassah, and the Allegheny County Board of Health.
The program teaches junior and senior high school girls the
proper way to do self breast exam.
Ms. Pottgen summed up her testimony by telling the
Subcommittee that preventive medicine is a lot cheaper than
therapeutic medicine and that a mammogram is a lot cheaper
than major surgery followed by radiation and chemotherapy.
She cited the NIH recommendation, many years ago, that yearly
Pap smears were unnecessary and wondered how many women
missed the opportunity to have their cervical cancer
diagnosed at an early stage. She wondered if it would be the
same with mammograms, and questioned how many women will lose
their breasts or be disfigured or die from this dreaded
disease before NIH realizes the tremendous diagnostic benefit
of mammograms.
The next witness was Ms. Yvonne D. Durham, an African
American breast cancer survivor who found her cancer through
self breast exam. She was 46 years old. She stated that she
was deeply troubled by the Consensus Panel's decision not to
recommend regular mammogram screening for women beginning at
age 40 and told the Subcommittee that the recommendation
sends a confusing message to the public.
Ms. Durham cited statistics based on data from 1987, that
African American women, age 35-44, had a breast cancer
mortality rate 2 times that of white women at the same age.
Yet African Americans, as well as Hispanic Americans, have
some of the lowest mammogram screening rates in the United
States.
Ms. Durham concluded her testimony by stating that the
benefit of mammography far outweighs any risks associated
with this screening test. She also urged continued support
for research efforts that may offer a clearer understanding
of how breast cancer disease affects minority populations.
The last witness of the day was Ms. Laurie S. Moser, the
Executive Director of the Pittsburgh Susan G. Komen Breast
Cancer Foundation Race for the Cure. Ms. Moser was diagnosed
with ductal carcinoma in-situ in 1987 at the age of 40.
She stated that the Komen Foundation strongly disagrees
with the latest decision from the NIH Consensus Development
Conference on Breast Cancer Screening for Women Ages 40-49.
She also told the Subcommittee that an estimated 16.5 percent
of new breast cancer cases were women in their 40s. The
position of the Foundation is that the Panel's position
overstated potential risks and understated the benefits of
mammography. The fact is that many consumers look to the
opinion of a body of experts to interpret data and provide
recommendations which they can weigh as they make decisions.
The current Panel statement does nothing more than confuse
the public about an extremely important issue.
Ms. Moser stated that when the Race for the Cure began in
Pittsburgh in 1993, a woman died every 11 minutes from breast
cancer. Today, a woman dies every 12 minutes. Over 2,000
additional lives are saved each year with early detection.
The goal should be to add a minute each year in the hope that
more and more women will survive breast cancer.
Ms. Moser concluded that she hoped Dr. Klausner and his
colleagues at the cancer institute take a closer look at the
conference recommendation and see to it that women are given
the highest degree of encouragement to get screening earlier,
rather than later.
MARCH 3, 1997, HERSHEY, PENNSYLVANIA
On March 3, I convened a hearing at the Hershey Medical
Center.
The Subcommittee's first panel consisted of a distinguished
group of physicians from the local medical centers. Our first
witness was James F. Evans, M.D., Director, of Surgical
Oncology and Assistant director of General Surgery from the
Geisinger Clinic.
Dr. Evans, expressing his personal opinions, stated that he
had studied the clinical trial data and if he were to write
his own consensus statement, it would say that the available
data specifically does not warrant a single guideline
recommendation for women between the ages of 40 and 70 years,
namely annual screening. However, guidelines are not
recommendations for individual women. He further stated that
we would all like to have enough data to make specific
recommendations for each individual based on personal
profiles and highly specific reliable research data. But that
data does not exist. The best data we have comes from trials
and that data supports a guideline recommendation for annual
screening beginning at age 40. Clinicians and women
themselves should then use additional but less reliable data
that we have to make decisions for individuals.
Our next panelist was Mary Simmonds, M.D., Chief of the
Division of Medical Oncology for Pinnacle Health Systems in
Harrisburg. Dr. Simmonds stated that she supported the
American Cancer Society recommendations that women in their
40s should undergo screening mammography every one to two
years.
Dr. Simmonds also shared with the Committee a copy of
Recommendations for a Statewide Plan for the Early Detection
of Breast Cancer formulated as a result of deliberations of a
Pennsylvania Breast Cancer Awareness Consensus Conference.
The recommendations from this conference were that (1)
mammography saves lives; (2) women should have a mammogram
even if you don't have any symptoms; (3) women should ask
their doctor for information about mammography and for access
to mammography (4) follow the American Cancer Society
guidelines for the frequency of mammography and physical
examination of the breast as well as the performance of
breast self examination.
Testifying on behalf of the Hershey Medical Center was
David M. Van Hook M.D., and Assistant Professor of Radiology
and Chief of Mammography at the medical center. Dr. Van Hook
told the Subcommittee that although an analysis of the
combined data from the seven population-based randomized-
controlled trials, which included over 170,000 women in their
40s, demonstrated a statistically significant benefit in
reducing mortality from breast cancer, and data from several
other studies also support a benefit to women 40-49. But, the
problem seems to be that thus far there has been no single
randomized-controlled trial which has showed statistically-
significant proof of benefit from mammography screening for
women ages 40-49. Dr. Van Hook further stated that much more
is at stake here than just dollars spent to save lives and
that the decisions regarding health care intervention which
affects our society should perhaps, involve not only science,
but should also take into account the willingness of those
most affected by those decisions. To accept some degree of
uncertainly, especially when there is controversy or less
than scientific proof of benefit. Dr. Van Hook concluded by
saying that the beneficiaries of breast cancer screening,
those who stand to gain or lose the most from it, our
mothers, wives, and daughters are willing to do just that.
The Committee then turned to Lois A. Anderson, Co-
Facilitator and Founder of A surviving Breast Cancer Support
group and Co-Captain of York County Pennsylvania Breast
Cancer Coalition. Ms. Anderson expressed her outrage by the
NIH Consensus Conference's decision on mammography screening
for women 40 to 49.
Ms. Anderson described her own experience with breast
cancer. She was diagnosed when she was 40 years old. Her
mammogram failed to detect the disease and after some
suspicious bruising, Ms. Anderson found a lump while doing a
self breast exam. A mastectomy was performed one month later
and 5 of 11 lymph nodes were found to be cancerous. These
findings made her a stage III breast cancer patient with less
than a 40 percent chance of surviving 5 years.
Ms. Anderson said that the incidence of breast cancer in
younger women is increasing and the NIHs decision to NOT
recommend mammograms for women below 50 years of age will
certainly cause an increase in the death rate from breast
cancer.
Ms. Anderson presented the Subcommittee with letters from
over 226 women under the age of 50 who have been diagnosed
with Brest cancer through the use of a mammogram.
Ms. Anderson told the Committee that while breast cancer is
not perfect, it is the best tool we have for detecting breast
cancer early and that deadly confusion over screening
mammography will result from the NIH's decision if these
guidelines are not changed.
Next the Subcommittee heard from Ms. Lorene Knight, a
volunteer with the American Cancer Society and a member of
the
[[Page S2230]]
Pennsylvania Breast Cancer Coalition. Ms. Knight is a 54 year
old African American women, and a 7-year breast cancer
survivor. Ms. Knight told the Subcommittee that her first
mammogram was performed at the age of 36 because of the
presence of fibrocystic tissue and a family history of breast
cancer. Her sister lost her life to the disease at the age of
43 and her mother is a 5 year breast cancer survivor.
Ms. Knight stated that she was most disturbed by the
findings of the NIH Consensus Development Conference
statement and felt that their statement would lure entirely
too many women of all races, and in their 40s, into a false
sense of security about the odds that breast cancer will not
likely happen to them during this decade of their lives.
Citing recent statistics from 4 hospitals in Lancaster
County, Ms. Knight stated that one hospital, during the 95-96
fiscal year, 105 women underwent breast cancer surgery and
nearly 36% of them were under the age of 50. At a second
hospital, 21 women underwent breast cancer surgery and 8 of
the 21 women were under the age of 50. She also told the
Subcommittee that as a volunteer with the American Cancer
Society's Reach to Recovery program, she has yet to visit one
recovering breast cancer patient that is African American.
She believes that this is because not enough African American
women are having early detection procedures. The breast
cancer mortality rate for African American women increased by
2.6% at a time when the mortality rate in white women
declined by 5.5%.
Ms. Knight concluded that every women, of every race, in
every community should have access to mammography at age 40
if that is what she determines to be necessary for her,
dictated by family history, her physician and her personal
health factors.
Our last witness of the day was Representative Katie True,
who represents the 37th legislative district in Pennsylvania.
Ms. True told the Subcommittee that one of the weapons that
she has chosen to fight breast cancer is House Bill 134. This
bill which has already passed the House, would provide for a
state income tax checkoff for breast cancer research. The
donation is deducted from the tax refund and does not
constitute a change against the income tax revenue's to the
State.
Representative True also stated that the second weapon used
to battle breast cancer is education. She stated that self
breast exams combined with mammograms can save many lives.
Women still hesitate to look after themselves first, usually
putting others needs before their own.
Representative True concluded that the recommendation of
the NIH Consensus Development Conference on Breast Cancer
Screening is irresponsible, and she questioned the motives
behind such a recommendation--plain and simple--their message
is wrong and deadly.
MARCH 4, 1997--WASHINGTON, DC
On March 4, 1997, Secretary of Health and Human Services
Donna Shalala appeared before the Subcommittee on Labor,
Health and Human Services and Education to discuss the fiscal
year 1998 budget.
At that hearing, I took the opportunity to discuss the NIH
Consensus Development Conference recommendations with the
Secretary and asked her to take immediate steps towards
encouraging women ages 40-49 to undergo mammogram screening.
I told the Secretary that the panel finding that mammograms
were not warranted for women in the age bracket 40 to 49 has
caused quite a stir. And that my own view is that the
evidence is substantial, if not overwhelming, that mammograms
are very helpful for women of this age group, they do save
lives, and that there ought to be a prompt conclusion by HHS
to that effect. When there is a public determination that
mammograms are not warranted for women 40-49, many women are
reading that to mean that a mammogram is not necessary. I
also told the Secretary that I felt that there is not a
sufficient sense of urgency in the approach that the
Department is taking with regard to this issue in allowing
another 60 days to pass before a final judgment is made on
this issue. I further stated that when it's a matter of
dollars and cents, and there is no clear scientific evidence
to the contrary, I think the word ought to come from the
Secretary of Health and Human Services that, notwithstanding
the cost, we're going to make sure that mammograms are made
available to women ages 40-49.
Mr. ROTH addressed the Chair.
The PRESIDING OFFICER. The Senator from Delaware is recognized.
Mr. ROTH. Mr. President, I thank my distinguished friend, Senator
Domenici, for allowing me to go next. I will limit my remarks to 5
minutes.
(The remarks of Mr. Roth pertaining to the introduction of S. 436 are
located in today's Record under ``Statements on Introduced Bills and
Joint Resolutions.'')
The PRESIDING OFFICER. The Senator from New Mexico is recognized.
Mr. DOMENICI. I thank the Chair.
I was pleased to accommodate the distinguished chairman of the
Finance Committee.
(The remarks of Mr. Domenici pertaining to the introduction of S. 437
are located in today's Record under ``Statements on Introduced Bills
and Joint Resolutions.'')
The PRESIDING OFFICER. The Senator from New Jersey.
Mr. LAUTENBERG. Madam President, I ask unanimous consent I be yielded
10 minutes from the time that is allocated to the Democratic side here,
under the auspices of Senator Bingaman.
The PRESIDING OFFICER. Without objection, it is so ordered.
____________________