Marcia Angell. 1997. Science on Trial: The clash of
medical evidence and the law in the breast implant case. W.W. Norton. 0-393-31672-6
Chapter 3. David Kessler's
justification of the 1992 FDA Ban and Angell's criticism of it. See pages
62-62.
David Kessler. 1992. The Basis of the FDA's decision on
Breast Implants. N Engl J Med 326(25):1713-1715
Marcia Angell. 1992. Breast Implants- Protection or
Paternalism? N Engl J Med 326(25):1695-1696
Chapter 5. Scientific Evidence.
Marcia Angell. 1990. The Interpretation of Epidemiologic
Studies. N Engl J Med 323(12):823-825
Ralph Keeney. 1994. Decisions about Life-Threatening
Risks. N Engl J Med 331(3):193-196.
Page 101. "the Mayo Clinic Study" -
Sherine E, Gabriel, W. Michael O'fallon, Leonard T. Kurland, C. Mary Beard, John E. Woods,
And L. Joseph Melton, 1994. Risk Of Connective-Tissue Diseases And Other Disorders After
Breast Implantation. N Engl J Med 330:1697-1702 (abstract on
line at PBS site)
Page 101. "the Women's Health Cohort Study"
- Charles H, Hennekens, , DRPH; I-Min Lee, , Nancy R. Cook,; Patricia R. Hebert,Elizabeth
W. Karlson,; Fran LaMotte; JoAnn E. Manson, Julie E. Buring, 1996. Self-reported Breast
Implants and Connective Tissue Diseases in Female Health Professionals. A Retrospective
Cohort Study. JAMA 275(8):616-621. (abstract on
line at PBS site)
Page 102. "the Nurses' Health Study" -
J. Sanchez-Geurrero, G. Colditz, E. Karlson, D. Hunter, F. Speizer, and M. Laing. 1995.
Silicone breast implants and the risk of connective tissue diseases and symptoms. New
England Journal of Medicine 332:1666-1670.(abstract on
line at PBS site)
Page 104. The results of injecting silicone
directly into the breast - Yasuo Kumagai, Yuichi Shiokawa. Thomas A. Medsger. Jr.. And
Gerald P. Rodnan. 1984. Clinical Spectrum Of Connective Tissue Disease After Cosmetic
Surgery. Observations on Eighteen Patients and a Review of the Japanese Literature.
Arthritis and Rheumatism, Vol. 27, No. I pp 1-12.
Page 104, the first report of CTD connected to
implants - Sheryl A. Van Nunen, Paul A. Gatenby, And Antony Basten. 1982.
Post-Mammoplasty Connective Tissue Disease. Arthritis and Rheumatism, Vol. 25, No. 6
pp694-697
Chapter 6. Science in the Courtroom
The Daubert v Merrell Dow case
examines the evidentiary issues in detail. Parts of this case can be used to
supplement Angell's chapters.
Frye v United States - 1923
US Supreme Court Decision was the basis of the Frye rule, which was made
obsolete by the Daubert decision. The Frye rule is a convenient starting point for
issues of social interaction and peer critique. By this rule expert testimony is
admissible if it is "generally accepted" in the appropriate scientific
community.
The were over 20 'friends of the court' briefs
(an extraordinarily high number) filed before the court. The six on the Daubert case reference list make contradictory persuasive
arguments about the need for peer review and general acceptance as measures of reliability
in scientific evidence. They are greatly edited for brevity and clarity.
Gary Taubes. 1995. Epidemiology Faces its Limits.
Science 269:164-169.
The AMA statement on breast implants
and a critical response by David Kessler.
Council on Scientific Affairs, American Medical
Association. 1993. Silicone Gel Breast Implants. JAMA 270:2602-2606
D. Kessler. R. Merkatz, and R. Schapiro. 1993. A call
for higher standards for breast implants. JAMA 270:2607-2608
The Journal of Clinical Epidemiology
published a special section of breast implant articles in 1995 (vol 48 number 4, starting
page number given below), which contained the following articles:
W.O. Spitzer. Editor's note: a special section of breast
implants and the health of women. 503
R.D. Mann. Guest editorial: Breast implants: the tyranny
of the anecdote. p 504
Steven Lamm. Silicone breast implants and long-term
health effects: when are data adequate? p 507
R. LeVier, M. Harrison, R. Cook & T. Lane. What is
silicone? p 513
Ralph R. Cook, Robert.R.Delongchamp, MaryAnn Woodbury,
Laura Perkins. and Myron C. Harrison The prevalence of women with breast implants in the
United States-1989.p 519
Sherine E. Gabriel, W, Michael O'Fallon, C. Mary Beard,
Leonard T. Kurland, John E. Woods and L. Joseph Melton, III Trends in the utilization of
silicone breast implants, 1964-1991, and methodology for a population-based study of
outcomes. p 527
Arnold Engel, Steven H. Lamm and Shenghan H. Lai. Human
breast sarcoma and human breast implantation: a time trend analysis based on SEER data
(1973-1990) p 539
Robert W. Morgan and Maryellen Elcock. Artificial
implants and soft tissue sarcomas p 545
Dennis M. Deapen and Carry S. Brody Augmentation
mammaplasty and breast cancer: a five year update of the Los Angeles study p 551
Louise A. Brinton, Paolo Toniolo and Bernard S.
Pasternack Epidemiologic follow-up studies of breast augmentation patients p 557
Marc C. Hochberg, Robyn Miller and Fredrick M. Wigley
Frequency of augmentation mammoplasty in patients with systemic sclerosis Maryland
Scleroderma Center: data from the Johns Hopkins-University of Maryland Scleroderma Center
p 565
John A. Goldman, Jesse Greenblatt, -Ron Joines, Leslie
White, Bruce Aylward and Steven H. Lamm Breast implants, rheumatoid arthritis, and
connective tissue diseases in a clinical practice p 571
David Schottenfeld, Carol J. Burns, Brenda W. Gillespie,
Timothy J. Laing, Maureen D. Nlayes, Steven G. Heerings and Kirsten H. Alcser The design
of a population-based case-control study of systemic sclerosis (scleroderma): commentary
on the University of Michigan studv p 583
Videotapes (FRONTLINE program, "Breast Implants on
Trial" is available in the Mercer Media Center
and 26-page verbatim Transcript
of the show is on line.
Epidemiology
article "(A good backgrounder on theories of causation, relative risk,
statistical significance and, on what epidemiology can and can't tell you.)"
Defense
Journal "(This describes the Federal Rules of Evidence 702 and 703 pertaining to
specialized knowledge of a witness. No less influential in this area are the Supreme Court
precedents described in Frye vs. U.S. (1923) and Daubert vs. Merrill Dow (1993) which
shaped rules on admitting scientific evidence. These cases created heated debate about
judges' role as 'gatekeepers.')"
Mass Tort
article "Courts know how to treat individual cases. What's new is the explosion
in mass-tort litigation and growing concern about the courts' ability to cope."
Cardozo Law
Review "Taking Daubert's "Focus" Seriously: The Methodology/Conclusion
Distinction"