[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.

                          ____________________