COMMITTEE ON GOVERNMENT OPERATIONS

JOHN CONYERS, JR., Michigan, Chairman

Caplan, Arthur, Ph.D., director, center for biomedical ethics, University

of Minnesota

DeGregorio, Michael W., Phar.D., professor of oncology, University of

Texas Health Science Center, San Antonio, TX

Evans, Nancy, vice president, Breast Cancer Action, San Francisco, CA

Fainberg, Sybil, Chevy Chase, MD

17

39

5

14

Fugh-Berman, Adriane, M.D., medical advisor, National Women's Health

Network

......

Greenwald, Peter, M.D., Director, Division of Cancer Prevention and

Control, National Cancer Institute, accompanied by Leslie Ford, M.D.,

and Susan Nayfield, M.D., Community Oncology and Rehabilitation

Branch

Healy, Bernadine, M.D., Director, National Institutes of Health, accom-

panied by Thomas Puglisi, Ph.D., Office for Protection from Research

Risks

Payne, Hon. Donald M., a Representative in Congress from the State

of New Jersey, and chairman, Human Resources and Intergovern-

mental Relations Subcommittee: Opening statement

Peck, Carl, M.D., Director, Center for Drug Evaluation and Research,

Food and Drug Administration, accompanied by Gregory P. Burke,

M.D., Director, and Robert L. Justice, M.D., medical officer, Division

of Oncology and Pulmonary Drug Products

Piantadosi, Steven, M.D., Ph.D., associate professor of oncology, and di-

rector, biostatistics, oncology center, Johns Hopkins University School

of Medicine

Rodriguez-Trias, Helen, M.D., president-elect, American Public Health

Association

Letters, statements, etc., submitted for the record by:

Caplan, Arthur, Ph.D., director, center for biomedical ethics, University

of Minnesota: Prepared statement

27

.....

41

DeGregorio, Michael W., Phar.D., professor of oncology, University of
Texas Health Science Center, San Antonio, TX: Prepared statement

Evans, Nancy, vice president, Breast Cancer Action, San Francisco, CA:

Prepared statement

Fainberg, Sybil, Chevy Chase, MD: Prepared statement

Fugh-Berman, Adriane, M.D., medical advisor, National Women's Health

Network: Prepared statement

Greenwald, Peter, M.D., Director, Division of Cancer Prevention and

Control, National Cancer Institute:

Chart comparing placebo and tamoxifen in the number of new breast

cancers in 5-year study

Informed consent form from the National Surgical Adjuvant Breast
and Bowel Project

Prepared statement

Healy, Bernadine, M.D., Director, National Institutes of Health: Press

release from the National Coalition for Cancer Research entitled

"NCCR policy statement: The Breast Cancer Prevention Trial"

Payne, Hon. Donald M., a Representative in Congress from the State

of New Jersey, and chairman, Human Resources and Intergovern-

mental Relations Subcommittee:

Concerns expressed by the FDA advisory board members

138

Letters, statements, etc., submitted for the record by-Continued

Payne, Hon. Donald M., a Representative in Congress from the State
of New Jersey, and chairman, Human Resources and Intergovern-
mental Relations Subcommittee-Continued

Letter dated October 15, 1992, from Dr. Lynn Rosenberg, president,
Society for Epidemiological Research, regarding premenopausal

women

Letter from Gregory P. Burke, M.D., Director, Division of Oncology
and Pulmonary Drug Products, Food and Drug Administration,
regarding clinical eye exams

Results of the cancer research campaign adjuvant trial
Summary statement regarding tamoxifen health trial

Peck, Carl, M.D., Director, Center for Drug Evaluation and Research,
Food and Drug Administration: Prepared statement
Piantadosi, Steven, M.D., Ph.D., associate professor of oncology, and di-
rector, biostatistics, oncology center, Johns Hopkins University School
of Medicine: Prepared statement

Rodriguez-Trias, Helen, M.D., president-elect, American Public Health
Association: Prepared statement

Thomas, Hon. Craig, a Representative in Congress from the State of
Wyoming: Prepared statement

Page

133

154

125

117

101

56

47

3

APPENDIXES

Appendix 1.-Letters from patients and the National Network to Prevent
Birth Defects

173

Appendix 2.-Informed consent form: May 1992 version of model form, proposed changes, Lahay Clinic form

185

Appendix 3.-Articles on the risks of tamoxifen

208

Appendix 4.-FDA criticism of informed consent document
Appendix 5.-Staff summary of subcommittee investigation

238

247

Appendix 6.-Letter from FDA in response to Chairman Payne's followup questions

270