US HOUSE OF REPRESENTATIVES
COMMITTEE ON COMMERCE
Room 2125, Rayburn House Office Building
Washington, DC 20515-6115

January 12,1999

Richard Klausner M.D.
Director
National Cancer Institute
31 Center Drive. MSC 2590
Building 31. Room 11A48
Bethesda, Maryland 20892-2590
Dear Dr. Klausner:

I have worked very hard this past year to pass legislation of importance to public health, but especially on areas related to the special health concerns of women, The Committee is concerned about women's health issues, specifically breast and cervical cancer, two lethal diseases that were the subject matter of many Members' questions to witnesses at hearings in the 105th Congress.

As the 106th Congress convenes in order for the Committee to get a more complete understanding of National Cancer Institute work in areas related to breast cancer and cervical cancer I am writing to you for a response from the National Cancer Institute on the matters addressed below. For each numbered question, please restate the question and number your answers accordingly. In order to ensure enough time for a full treatment of the questions posed, I request that your responses arrive at the Committee offices, in hard copy and in electronic form, by the close of business Friday, January 29, 1999.

  1. At the July 20 hearing on "The State of Cancer Research," the National Cancer Institute testimony addressed the importance of epidemiologic research in identifying the factors that increase cancer risk. How much of the NCI budget is allocated to the funding of intramural and extramural epidemiologic studies done for that purpose?

  2. NCI has a long-standing focus on "preventable causes." Are there preventable causes for breast cancer that have been identified by NCI? What preventable causes have been identified for cervical cancer?

  3. The NIH written testimony for the July 20 hearing states that communicating with... individuals at high risk for cancer, the general public, and the health care community is a central component of NCI's mission and mandate." To that end, NCI has identified preventable target exposures of cancer-causing agents as a key element in the prevention of cancer. What work has NCI done to coordinate a Federal response to the prevention of breast and cervical cancer? Specifically, what work has NCI done with the Department Of Health and Human Services ("HHS") Office of Population Affairs and the HHS Health Resources and Services Administration ("HRSA") to alert women to avoidable exposure to carcinogenic Agents? Who are the liaisons within NCI, HRSA, and the Office of Population Affairs? Has NCI coordinated activity with the Title V and Title XX programs within those agencies?

  4. The July 20 NCI written testimony states that NCI is actively pursuing development of a vaccine to prevent cervical cancer... based on the concept that almost all cervical cancers are caused, at least in part, by papilloma virus infections," What is the status of the development of a vaccine for this disease? How long will it be before a vaccine enters clinical trials? Have any private sector entities partnered with NCI in the development of this vaccine?

  5. Earlier this year the New England Journal of Medicine published the results of a study on human papilloma virus ("HPV"). Among sexually active female students at Rutgers University, approximately 60 percent tested positive for HPV at some time during the three-year study period. Given that HPV is an agent of most cervical cancer cases which kill nearly as many women each year as AIDS, what does a 60 percent infection rate suggest to NCI about the long-term consequences of this virus? Does this infection rate suggest that condom usage is less effective at preventing HPV infection than it is in preventing pregnancy? Has NCI sponsored any research as to the effectiveness of condoms to prevent the transmission of HPV?

  6. What is the amount of research dollars expended on HPV as compared to the virus that causes AIDS? What is the ratio between the two research budgets as compared to the number of women who die of the respective viruses?

  7. What action does NCI recommend be undertaken by the Federal government to address the public health threats of HPV?

  8. According to an Associated Press report on a Supreme Court ruling dated January 11, 1999. HHS had a hand in the removal of controversial posters in the Philadelphia public transit authority that linked abortion to breast cancer. According to this report, in "early February [1996], the authority received a copy of a letter a federal health official had sent to the Washington Metropolitan Area Transit Authority, Dr. Philip Lee, assistant secretary of health in the Department of Health and Human Services, called the anti-abortion ad 'unfortunately misleading' and 'unduly alarming' and said it "does not accurately reflect the weight of the scientific literature." Based on Lee's letter, SEPTA [the Southeastern Pennsylvania Transportation Authority] removed the posters on Feb. 16, 1996." Please provide the Committee with a copy of this letter, and copies of all other letters HHS has sent since 1993 raising concerns about ads making cancer claims that may be "unduly alarming." On what scientific basis was the ad found to be "unfortunately misleading," "unduly alarming." and that it "does not accurately reflect the weight of the scientific literature"?

  9. In a line of questioning at the July 20 hearing before the Health and Environment Subcommittee, the NCI witness was asked about a very substantial body of research linking cancer to what is clearly an eminently avoidable exposure which you did not mention in your written testimony. Fully 25 out of 31 epidemiologic studies worldwide and 11 out of 12 studies in the United States (many of which, I am told, were conducted or funded by the NCI) show that women who elect to have even one induced abortion show an elevated risk of subsequent breast cancer. What studies has NCI conducted or funded related to the link between abortion and breast cancer?

  10. Research presented the Committee shows that induced abortion has been linked with increased risk of breast cancer. What has NCI done to alert women that induced abortion has been consistently associated with increased breast cancer risk? How has NCI focused its public information on at-risk populations?

  11. 1 understand that the body of worldwide epidemiological research on the link between abortion and breast cancer reaches back as far as 1957, and the first such study conducted in the United States occurred as early as 1981. Is it not a fact that a majority of these studies show an increased risk (average about 30%) among women who have chosen abortion even just once?

  12. The NCI website on "Abortion and Breast Cancer" states that "although it has been the subject of extensive research, there is no convincing evidence of a direct relationship between breast cancer and either induced or Spontaneous abortion. Available data are inconsistent and inconclusive, with some studies indicating small elevations in risk, and others showing no risk associated with either induced or spontaneous abortions,"

    1. Please identify and provide copies of the "extensive research" to which the website text refers. Was this research peer-reviewed?

    2. The website states that there is no "convincing evidence." What are NCl's criteria for identifying research that would be considered "convincing"? Are there statistical benchmarks that NCI uses to distinguish evidence that is convincing and that which is not? How is this evidence measured that would control for bias among researchers or program evaluators?

    3. Does NCI draw a distinction between "direct relationship" and "indirect relationship'" in determining causality?

    4. NCI states that "available data are inconsistent and inconclusive." Are the data inconsistent, or are the studies inconsistent? What accounts for data that '"are inconsistent and inconclusive"? Has NCI attempted to replicate studies that may have shown a link between breast cancer and induced abortion?

    5. The NCI website states that some studies indicate a "small elevation in risk." What does "small elevation in risk" mean in this context? By saying there is a "small elevation in risk," is NCI placing the risk on a continuum between no risk and high risk? How does the "small elevation in risk" rank on a comparative risk analysis continuum? Based on this continuum, what action has NCI or other Federal agencies taken to warn consumers of cancer risk-factors that are comparable to that of induced abortion? Does "small elevation in risk" mean "acceptable risk"? How does NCI determine that something is an acceptably small risk?

    6. NCI also states that some studies indicate "no risk," What level of "elevation of risk" Is considered to be "no risk" by NCI? How is '"no risk" distinguished from that of "small risk" when proving causality is so difficult?

  1. Is it true that epidemiologic research has found no overall link between spontaneous abortion and breast cancer? Is that not also consistent with the fact that most pregnancies which abort spontaneously are characterized by subnormal estrogen levels, whereas normal pregnancy levels of estrogen are several times higher than non-pregnant levels? Is it also true that some form of overexposure to estrogen which stimulates the growth of both normal and pre-cancerous breast tissue is the mechanism by which most of the known breast cancer risk factors operate?

  2. The NCI website's first paragraph concludes with the sentence: "The scientific rationale for an association between abortion and breast cancer is based an limited experimental data in rats and is not consistent with human data." Is this data to which you refer the Russo and Russo 1980 study? Is it accurate to summarize that this study, where rats were all given a chemical carcinogen, most of those rats which were allowed to bear offspring did not get breast cancer, while most of those which had their pregnancies surgically aborted did get breast cancer?

  3. The NCI website refers to studies finding "small elevations in risk" in the link between abortion and breast cancer. A 1994 Howard University study on African-American women here in the Washington DC area showed a more than three-fold increase in breast cancer risk with induced abortion. That same study showed that the risk was almost five-fold for African-American women over 50 years old. Is it accurate to call that kind of risk elevation "small"?

If you have any questions concerning this letter. please contact Marc Wheat of the Commerce Committee staff at (202) 226-2424.

Sincerely

Tom Bliley
Chairman