Ed Wolfgang: Final Project

[Comment for Ed: You talk about the benefits of off-label use of hormonal contraceptives, but are there any problematic social consequences of this practice? For instance, are users who are prescribed the Pill for off-label reasons given the same education about contraception, sexually transmitted infections, and pregnancy? Is there any gap to the quality and level of information that users might receive? I also wonder how organizations such as Planned Parenthood have responded to this practice. -Allison]

The Birth Control Pill “Off Label”

The added benefits of hormonal contraceptive development leading to “off label” use has greatly advanced in the past 10-15 years. Today, off label uses of the hormonal contraception (the birth control pill) has the potential to influences almost all American women. American society expects the most advanced and effective diagnosis and therapies for disease. The issues of health care have always been in the forefront of politics, in the past as well as today.

In the past to address health care concerns, Congress passed the Food and Drug Administration Modernization Act (FDAMA) of 1997 Sec. 115 Clinical Investigations. (b) Women and Minorities. — Section 505(b)(1) 21 U.S.C. 355(b)(1) by adding: “The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials. This led to gender based differences on both efficacy and safety of drug products and helped spur a movement of women’s health care. Since 1991 almost 75% of research and development of disease medications that afflict women are being investigated. Prior to this Act FDA’s guidance recommended not including women in clinical trials.

As a result of FDAMA 1997, industry in collaboration with the National Institute of Health and the Food and Drug Administration began conducting gender based clinical trials and publishing these clinical drug findings in peer journals. Health care providers read these peer review journals and responded by prescribing these hormonal contraceptive developments “off label” to their patients. According to the Package Insert, Ortho Tri-Cyclen® Lo-Tablets are licensed for prevention of pregnancy in “women who elect to use oral contraception as a method of contraception” and not for any other health care benefits. Other than some current licensed birth control pills being licensed and prescribed for acne, birth control pills are prescribed “off label” for other health benefits. For example, reduction in menstrual blood loss, anemia, relief of dysmenorrhea, prevention of ovarian and endometrial malignancies, certain types of cancers and prevention of osteopenia to name a few. As a result of Congress, industry and the medical community many women today use the pill for means other than pregnancy prevention. Premenopausal women who are prescribed birth control for bone loss or endometrial and ovarian cancer protection are more likely to be supportive of their daughter’s use of the birth control pill for dysmenorrhea or other benefits other than preventing conception.

The social effects of the “off label” use of the birth control pill are that more and more women across all age groups might be willing to take the birth control pill for other means other than preventing conception. This could lead to additional health benefits for women, effects on the economy, i.e., health care costs, less absenteeism from work etc. Because one of the functions of the birth control pill is to prevent conception, cultural beliefs of many religious beliefs are going to remain opposed to the birth control pill regardless of its health benefits. However, as the American society becomes more and more aware of the additional scientific benefits of hormonal contraceptives, the gap between those against the use of birth control and those for it might be narrowed.

References will be captured in Final Report


Reference List: Birth Control Pill

Many years have passed from early discussions concerning human sterility to the development of the birth control pill. In the early 1900s public discussions were held to discuss concerns about the American economy and overpopulation concerns. It was not until 20 to 30 years later that science advanced to develop an efficacious and safe method to prevent fertility. Many obstacles along the way had to be overcome. These included, laws restricting both birth control research, limitations being placed on health care providers to not discuss birth control methods with patients, religious beliefs, gender and culture issues. My research will focus on the scientific development of the birth control pill in the early to mid 1900s. My plan is to limit my focus on the scientific aspects of birth control development and touch on STS issues (Government roles, ethics, forms of knowledge, etc) as science and the development of the birth control pill.

Research Obstacles
Research obstacles I am having are narrowing my research topic, ensuring my project is an original research issue in STS and collecting additional research sources such as scientific research papers. I hope to read the articles I have collected and narrow my STS topic issue. However, any helpful feedback would be appreciated.

Annotated Bibliography (not final)

Primary Sources

1) Comstock Act Chap CCLVIIL (1873)
- intended to place restrictions on birth control

2) Dickinson, R. Secretary, Committee on Maternal Health, Control of Conception, Present and Future. Delivered February 15, 1929, in the Friday Afternoon lecture series of the New York Academy of Medicine
-Discusses the medical communities responsibility concerning birth control

3) Eisenstadt v Baird, 405 US 438 (1972)
- state laws which made contraceptives unavailable to unmarried women overturned

4) Fourth Session: Recent Developments in Methods of Controlling Conception by Frank W. Notestein, Chairman, The 1950 Meeting of the Population Association Population Index, vol 16, No 3 (Jul., 1950), pp 193-199
-Discussion of recent research advances toward Conception Control.

5) Griswold v Connecticut, 381 US 479 (1965)
- state laws which made contraceptives unavailable to married women overturned

6) Pincus G. (1966) Control of conception by hormonal steroids. Science. Jul 29;153(735):493-500.
-Discusses the use of progestin and estrogen preparations as oral contraceptives and the benefits to prevent pregnancy and improvements in menstrual function.

7) Pincus G, Garcia C, Paniagua M, & Shepard J. (1962) Ethynodiol diacetate as a
new, highly potent oral inhibitor of ovulation. Science. Oct 19;138:439-40.
-Publication which discusses diacetate, a potent progestin and oral inhibitor of ovulation in the rabbit which gives evidence of possessing antiovulatory activity when it is administered orally to women. When combined with an estrogen it provides adequate control of menstrual cycle and contraceptive effectiveness.

8) Pincus, G., Chang, M., Hafez, E &. Zarrow, A., (1956) Effects of Certain 19-Non Steroids on Reproductive Processes in Animals Author(s): Merrill Source: Science, New Series, Vol. 124, No. 3227 (Nov. 2, 1956), pp. 890-891
-Discusses the influences of steroids on the reproductive process in animals and benefits for women

Secondary Sources
1) Applezweig, N. (1973). "Response to contraception. The development of systemic chemical contraceptives." Major Probl Obstet Gynecol 5: 17-37
2) Blom, E. (2000). "Pioneers in animal reproduction - VI. M.C. Chang (1908-1991)." Hist Med Vet 25(1-3): 1-4
3) Bouvier, L. F. (1973). "Changes in the use of oral contraceptives by Rhode Island women between 1967 and 1970." Soc Biol 20(1): 51-63
4) Connell, E. B. (1999). "Contraception in the prepill era." Contraception 59(1 Suppl): 7S-10S
5) Diczfalusy, E. (1979). "Gregory Pincus and steroidal contraception: a new departure in the history of mankind." J Steroid Biochem 11(1A): 3-11
6) Diczfalusy, E. (1982). "Gregory Pincus and steroidal contraception revisited." Acta Obstet Gynecol Scand Suppl 105: 7-15
7) Glasie, A. (2002). "Contraception—past and future." Nat Cell Biol 4 Suppl: s3-6
8) Goldzieher, J. W. (1991). "Thirty years of hormonal contraception: an historical perspective." Int J Fertil 36 Suppl 3: 10-5
9) Goldzieher, J. W. and H. W. Rudel (1974). "How the oral contraceptives came to be developed." JAMA 230(3): 421-5
10) Linn, E. S. (2005). "Hormonal contraceptive methodology: an historical review." Int J Fertil Womens Med 50(2): 88-96
11) MacCornack, F. A., J. K. Nathan, et al. (1977). "Oral contraceptive use. Epidemiology." N Y State J Med 77(2): 200-2
12) Marks, L. (1999). ""Not just a statistic": the history of USA and UK policy over thrombotic disease and the oral contraceptive pill, 1960s-1970s." Social Science & Medicine 49(9): 1139-1155
13) Marks, L. (2001). "'Andromeda freed from her chains': attitudes towards women and the oral contraceptive pill, 1950-1970." Cli Med 61: 217-44
14) Mirkes, R. (2002). "The oral contraceptive pill and the principle of double effect." Ethics Med 18(2): 11-22
15) Mishell, D. R., Jr. (1992). "Oral contraception: past, present, and future perspectives." Int J Fertil 37 Suppl 1: 7-18
16) Murphy, F. X. (1981). "Catholic perspectives on populations issues II." Popul Bull 35(6): 1-44
17) Orchard, W. H. (1969). "Psychiatric aspects of oral contraceptives." Med J Aust 1(17): 872-6
18) Paterson, R. (2001). "Prescribing the pill: obligations to health professionals." N Z Med J 114(1130): 188 Pincus G. (1967) The action of hormonal steroids on the hypothalamo-pituitary-ovarian axis. Arch.Anat.Microsc.Morphol.Exp. 1967;56(3):475-85.
19) Pincus G. (1966). "Leading men of science" Triangle 7(5): 194-5
20) Pincus G. (1966) Steroid labile reproductive processes in mammals.
21) Pincus, G. and M. C. Chang (1978). "Classic Pages in Obstetrics and Gynecology. The effects of progesterone and related compounds on ovulation and early development in the rabbit: Gregory Pincus and Min Chuch Chang. In: Acta physiologica Latinoamericana, vol. 3, pp. 177-83, 1953." Am J Obstet Gynecol 132(2): 215-6
22) Poettgen, H. (1968). "Psychological and theological problems of oral contraception." Arch Ostet Ginecol 73(4): 415-20
23) Potts, M. (2003). "Two pills, two paths: a tale of gender bias." Endeavour 27(3): 127-30
24) Rock J (1965) Let’s be honest about the pill. JAMA. May 3;192:401-2.
25) Rock J. (1965) Science and Charity to the Rescue of Humanity Pac.Med.Surg. Feb;73:25-7.
26) Ryder, N. B. and C. F. Westoff (1966). "Use of oral contraception in the United States, 1965. In only 5 years oral contraception has become a major means of regulating fertility." Science 153(741): 1199-205
27) Sanger M. (1931) Should Legal Barriers Against Birth Control be Removed?
Congressional Digest 1931 Apr;10(4):104-8.
28) Shampo, M. A. and R. A. Kyle (2004). "John Rock: pioneer in the development of oral contraceptives." Mayo Clin Proc 79(7): 844
29) Theriault, E. L. (1966). "A priest looks at 'the pill'." N S Med Bull 45(4): 93-6
30) Westoff, C. F. (1975). "The yield of the imperfect: the 1970 National Fertility Study." Demography 12(4): 573-80
31) Westoff, C. F. and L. Bumpass (1973). "The revolution in birth control practices of U.S. Roman Catholics." Science 179(68): 41-4
32) Westoff, C. F. and N. B. Ryder (1968). "Experience with oral contraception in the United States, 1960-1965." Clin Obstet Gynecol 11(3): 734-52
33) Ziporyn, T. (1985). "John Rock, developer of contraceptive pill, dies." JAMA 253(1): 18

Online Videos

"Timeline: The Pill,"
- PBS did a documentary on the birth control pill and provides a timeline on their website.

Margaret Sanger, interview with Mike Wallace, http://www.hrc.utexas.edu/multimedia/video/2008/wallace/sanger_margaret_t.html
- An interview with Margaret Sanger about why she became an advocate for birth control.

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