[Congressional Record Volume 143, Number 131 (Friday, September 26, 1997)]
[Senate]
[Page S10062]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. CAMPBELL:
  S. 1229. A bill to provide for the conduct of a clinical trial 
concerning digital mammography; to the Committee on Labor and Human 
Resources.


       THE DIGITAL MAMMOGRAPHY CLINICAL TRIAL CONDUCT ACT OF 1997

  Mr. CAMPBELL. Mr. President, today I am introducing a bill that will 
provide for a much needed clinical trial for the benefit of women's 
health. My bill would provide $20 million to the Nation's Office of 
Women's Health to conduct a large-scale clinical trial of digital 
mammography, involving 50,000 women and 20 sites, which could yield 
hard data in as little as a year regarding the potential of this 
technology.

  Digital mammography is our best bet for bringing the fight against 
breast cancer into the 21st century. This technology could answer the 
question of what age a woman should begin seeking annual mammograms. It 
could prevent unnecessary biopsies, as well as catch the countless 
breast masses undetected by conventional mammography. Dr. Martin Yaffe, 
a senior cancer-imaging researcher from Canada, is quoted in the Wall 
Street Journal of March 20, 1997, as drawing this comparison, ``Using a 
conventional x ray mammography to find a tumor in dense breast tissue 
is like trying to find a cotton ball in a cloud. Digital technology 
allows us to improve the quality of the image and avoid missing the 
cancer.''
  While conventional mammography invokes the usual procedure for x 
rays, which views the film of a breast image on a light box, digital 
mammography takes advantage of an advanced x ray source for digital 
image capture, allowing image enhancement, feature recognition, and the 
ability to adjust the display contrast to highlight shadows and 
otherwise undetected signs of breast cancer. Mammography is the only 
means for detecting breast micro-calcifications, typically the earliest 
indicator of nonpalpable breast cancers.
  Many of my Senate colleagues have taken a personal and avid interest 
in combating breast cancer. With good reason. More than 40,000 women 
will lose their battle with breast cancer this year alone, while 
another 2.6 million will continue to live with the disease. Further, 
the rate of diagnosis has been steadily increasing for the last 50 
years. For women aged 40 to 45, breast cancer is the leading cause of 
death. Given these staggering statistics and the fact that women are 
literally defenseless against this disease, it is imperative that we do 
everything possible to promote early detection and treatment.
  On June 3 of this year, 62 U.S. Senators sent a letter to the 
Appropriations Committee, urging funding for the Department of Defense 
Peer Reviewed Breast Cancer Research Program. This program is world 
renowned and responsible for many of the most important advances in 
breast cancer research. It has even facilitated several small-scale 
trials in digital mammography.
  However, this program has, to date, proven unable to conduct a large-
scale clinical trial of digital mammography. And yet, it is only a 
large-scale trial that can determine definitively the efficacy of this 
technology in saving women's lives. There are two bottom lines here. 
First, the trial would tell women at what age and with what frequency 
they should receive mammograms. Second, the trial would provide the 
Health Care Financing Administration with the data it needs to set a 
reasonable and appropriate cost for a digital mammography. We are all 
familiar with the role HCFA plays in setting not just rates of 
reimbursement but standards for reimbursement of healthcare services; 
the private sector takes its lead from HCFA. Once HCFA acts to make 
digital mammographies available to women, private pay insurers will 
follow suit. Therefore, in the interest of public health, the onus is 
on us to move these trials forward.
  The NIH has an appropriation from the Senate for next year that 
reflects almost a billion dollar boost. Rightly so. But despite that, 
the National Cancer Institute simply does not have the resources to 
fund a clinical trial of this size. Grant dollars are still scarce 
relative to the number of compelling grant applications. The reality 
that NCI is simply unable to dedicate the necessary resources to 
conduct a large-scale trial of digital mammography is unfortunate yet 
understandable. The Senate is aware of this dilemma, and shares the 
frustration of the Nation's breast cancer victims. In explaining its 
fiscal year 1998 allocation for the National Cancer Institute, the 
Appropriations Committee report for Labor, Health and Human Services 
and Education noted that ``the national investment in cancer research 
remains the key to bringing down spiraling heath care costs, as 
treatment, cures, and prevention remain much cheaper than chronic and 
catastrophic diseases, like cancer.''
  As Congress is well aware, the financial cost of breast cancer is 
indeed staggering. We spend over $5 billion annually on healthcare for 
women fighting breast cancer, a figure that is matched in the cost of 
lost productivity to our overall economy. Further, the human cost of 
this disease is felt tenfold by the families and communities whose 
lives it touches.
  I realize this bill breaks with convention, to a certain degree. I am 
not assuming a level of scientific expertise that supplants that of the 
true experts at NIH. I am a firm believer in letting science drive 
where our research dollars are spent. However, I am willing to force 
the issue for the sake of women's health. We have available to us 
cutting edge technology that could yield us a remarkable return in the 
form of women's lives. My bill provides a modest sum to ensure that a 
large-scale clinical trial of digital mammography does not go unfunded 
any longer.
                                 ______