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Spring 2005

Reproductive Health and the FDA: Buffeted by Political Battles

DifferenTakes Series
30 ~ Spring 2005
[PDF Version]
By Amy Allina

Since its inception, the Food and Drug Administration (FDA), the U.S. government’s main watchdog agency over the pharmaceutical industry, has been subject to political pressures that undermine its mission to ensure drug safety and protect consumer health. In the last several years, these pressures have intensified as the FDA is buffeted by the Bush administration’s right-wing agenda and an ever more powerful pharmaceutical industry. More often than not, women’s reproductive health and safety are caught in the crossfire of these political and economic agendas.

Amy Allina is Program Director of the National Women’s Health Network, a national organization that is committed to ensuring that women have self-determination in all aspects of their reproductive and sexual health. Prior to joining the NWHN in 1999, she worked on women's health policy issues at the consulting firm of Bass and Howes and as the Political Organizer for the Maryland affiliate of NARAL. She serves on the board of directors of the Reproductive Health Technologies Project and the Alan Guttmacher Institute.

References

  1. “Christian Medical Association Petitions FDA to Shelve RU-486,” http://www.cmdahome.org/index.cgi?cat=100041&art=1893&BISKIT=246794947&CONTEXT=art, last visited October 12, 2004.
  2. “Roundtable on Abstinence,” http://www.family.org/physmag/issues/a0023927.cfm, last visited October 12, 2004.
  3. Stress and the Woman’s Body, by David W. Hager and Linda Carruth. Revell, 1998.
  4. “Sex, Naturally,” First Things: the Journal of Religion, Culture and Public Life, 97 (November 1999): 28-33. http://www.firstthings.com/ftissues/ft9911/articles/stanford.html, last visited October 12, 2004.
  5. “The FDA, Politics, and Plan B,” N Engl J Med 350;15: 1561-1562.
  6. Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation, by Philip J. Hilts. Alfred A. Knopf, 2003.
  7. Food and Drug Administration Modernization Act of 1997, Public Law 105-115, 105th Congress.
  8. Scholes D, LaCroix AZ, Ichikawa LE, et al. “Injectable hormone contraception and bone density: results from a prospective study,” Epidemiology. 2002 Sep;13(5):581-7.
  9. “Depo Provera and Bone Mineral Density,” http://www.nwhn.org/publications/fact_details.php?fid=21, last visited April 19, 2005. Littlecrow-Russell, Sarah. “Time to Take a Critical Look at Depo-Provara,” DifferenTakes, Population and Development Program at Hampshire College, No. 5, Summer 2000.
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Ten Years After Cairo: The Resurgence of Coercive Population Control in India

DifferenTakes Series
31 ~ Spring 2005
[PDF Version]
By Rajani Bhatia

In 1994 at the U.N. International Conference on Population and Development (ICPD) in Cairo, world leaders reached a new consensus on population. Although the ICPD Program of Action (POA) legitimizes demographic goals set by national governments, it recommends policy approaches based on the promotion of reproductive health, informed free choice, and gender equity. The document specifically rejects the use of coercion in family planning programs and discourages the use of social and economic incentives and disincentives to reduce fertility.

Rajani Bhatia is a member of the Committee on Women, Population and the Environment (CWPE). She is an activist and writer in the international movement for women's health, reproductive rights and justice. She is a contributing author in Jael Silliman and Anannya Bhattacharjee, eds., Policing the National Body: Race, Gender and Criminalization, Boston: South End Press, 2002, and Abby L. Ferber, ed., Home-Grown Hate: Gender and White Supremacy, Routledge,2004.

References

  1. For an excellent history of population control policies in India and their present incarnation, see Mohan Rao, From Population Control to Reproductive Health (New Delhi and London: SAGE, 2004).
  2. HealthWatch, “State Population Policies,” Seminar, 511, March 2002.
  3. Mallik, Rupsa and Jodi Jacobson, “The Far Right, Reproductive Rights, and U.S. International Assistance,” Center for Health and Gender Equity, August 8, 2002.
  4. Sharma, Kalpana, “Forget Targets, Remember People,” The Hindu, February 27, 2000.
  5. Mallik, Rupsa, “The Two-Child Norm and Incentives and Disincentives in Population Policies in India,” unpublished, May 12, 2002.
  6. Lakshmi, Rama, “A Choice Between Politics, Progeny in India,” The Washington Post, October 31, 2004.
  7. Ibid.
  8. Ibid.
  9. Farah, Francois, “The two-child norm is a loaded dice,” The Times of India, August 2, 2003.
  10. Quoted in Venkatesan, J. “ SC upholds two-child norm,” The Hindu, July 31, 2003.
  11. Quoted in Rajalakshmi, T.K., “Population Policy: Children as disqualification,” Frontline, Volume 20, Issue 17, August 16-29, 2003.
  12. Hariharan, Githa, “A New Emergency,” The Telegraph, August 2, 2003.
  13. Mukul, Akshaya, “Two child norm cripples women,” The Times of India, March 7, 2003; Special Corresondent, “Two child norm brings little relief for women,” The Hindu, July 2, 2003.
  14. Sharma, Kalpana, “Forget Targets, Remember People,” The Hindu, February 27, 2000.
  15. HealthWatch, “State Population Policies,” Seminar, 511, March 2002.
  16. Ramesh, Randeep, “Outrage at Guns for Sterilisation Policy,” The Guardian, November 1, 2004.
  17. Hariharan, Githa, “A New Emergency,” The Telegraph, August 2, 2003.
  18. HealthWatch, “State Population Policies,” Seminar, 511, March 2002.
  19. Tripathi, Purnima S., “New U.P. Population Policy targets minorities,” The Asian Age, Vol.3, No.5, March 6, 2000, p.1.
  20. Mukul, Akshaya, “Two child norm cripples women,” The Times of India, March 7, 2003
  21. Staff Correspondent, “SC ruling on two-child norm criticized,” The Hindu, August 2, 2003.
  22. Lakshmi, Rama, “A Choice Between Politics, Progeny in India,” The Washington Post, October 31, 2004; Mukul, Akshaya, “Two child norm cripples women,” The Times of India, March 7, 2003.
  23. Mallik, Rupsa, “A Less Valued Life: Population Policy and Sex Selection in India,” Center for Health and Gender Equity, October 2002.
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Depo-Provera: Old Concerns, New Risks

DifferenTakes Series
32 ~ Spring 2005
[PDF Version]
By Amy Oliver and Diana Dukhanova

The Summer 2000 issue of DifferenTakes provided an introductory glance at the injectable contraceptive Depo-Provera (or DMPA), and why many women's health advocates are concerned with its use and misuse around the world. 1 Approved for use in the U.S.

Amy Oliver is the Program Coordinator for the Population and Development Program at Hampshire College, an organization dedicated to promoting reproductive rights, economic justice, and social equality for women. Diana Dukhanova is a fourth-year student at Hampshire College concentrating in Russian literature. She has been working for the Civil Liberties and Public Policy Program and Population and Development Program since her first year and her primary activist interests lie in reproductive rights.

References

  1. Littlecrow-Russell, Sarah. "Time to Take a Critical Look at Depo-Provara," DifferenTakes , Population and Development Program at Hampshire College, No. 5, Summer 2000.
  2. Unveiled Realities: A study on women's experiences with Depo-Provera, and injectable contraceptive , Sama - Resource Group for Women and Health, New Delhi, India, 2003.
  3. Ibid.
  4. "Different Needs at Different Times," Pharmacia Corporation, 2001.
  5. "Black Box Warning Added Concerning Long-Term Use of Depo-Provera Contraceptive Injection," http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01325.html , Last visited February 17, 2005.
  6. "Depo-Provera Appears to Increase Risk for Chlamydial and Gonococcal Infections," http://www.nichd.nih.gov/new/releases/depo-provera-risk.cfm , Last visited February 22, 2005.
  7. "Depo study - USAID Guidance," FHI News email: news@fhi.org , August 31, 2004.
  8. Ibid.
  9. "Depo-Provera Appears to Increase Risk for Chlamydial and Gonococcal Infections," http://www.nichd.nih.gov/new/releases/depo-provera-risk.cfm , Last visited February 22, 2005.
  10. "Hormonal Contraception and HIV: an Update by Dr. Charles Morrison and Kim Best," August, 2004. http://www.fhi.org/NR/Shared/enFHI/PrinterFriendly.asp , Last visited February 16, 2005.
  11. Ibid.
  12. Ibid.
  13. Ibid.
  14. http://www.depoprovera.com/vc-prospect-user.asp , Last visited March 7, 2005.
  15. Rubin, Rita. "Contraceptive is Linked to High STD Risk," USA Today , Gannett Company, Inc., August 23, 2004.
  16. "Different Needs at Different Times," Pharmacia Corporation, 2001.
  17. Ibid.
  18. http://www.plannedparenthood.org/pp2/portal/files/portal/medicalinfo/birthcontrol/pub-contraception-choices-5.xml , Last visited February 23, 2005.
  19. "Adolescents and HIV/AIDS," http://www.advocatesforyouth.org/publications/factsheet/fshivaid.htm , Last visited March 2, 2005.
  20. "Beyond Pro-Choice Versus Pro-Life: Women of Color and Reproductive Justice," Smith, Andrea. NWSA Journal, Vol. 17 No.1 Spring 2005.
  21. Littlecrow-Russell, Sarah. "Time to Take a Critical Look at Depo-Provara," DifferenTakes , Population and Development Program at Hampshire College, No. 5, Summer 2000.
  22. Unveiled Realities: A study on women's experiences with Depo-Provera, and injectable contraceptive , Sama - Resource Group for Women and Health, New Delhi, India, 2003.
  23. "Depo-Provera - Deadly Attempt At Population Control," Reproductive Rights Newsletter , Reproductive Rights National Network, Summer 1981.
  24. Hartmann, Betsy. Reproductive Rights and Wrongs, Hartmann, Betsy. South End Press, Boston, MA, 1995.
  25. "Hormonal Contraceptives Increase HIV Risk; Vitamin A Levels Unrelated to Viral Load," http://www.thebody.com/confs/retro2003/wilkin2.html , Last visited February 9, 2005.
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Egg Donation for IVF and Stem Cell Research: Time to Weigh the Risks to Women’s Health

DifferenTakes Series
33 ~ Spring 2005
[PDF Version]
By Judy Norsigian

Last year, Barbara Seaman’s article, “Is This Any Way to Have a Baby?” in O (Oprah) Magazine (February 2004) caused quite a stir among infertility experts as well as women dealing with infertility. It explored women’s experiences with fertility drugs and underscored the paucity of long term safety data as well as the serious, occasionally irreversible problems experienced by some women using these drugs.

Judy Norsigian is a co-author of Our Bodies, Ourselves and co-founder of the Boston Women’s Health Book Collective, now called Our Bodies Ourselves. She serves as the organization’s Executive Director and is involved with numerous women’s health initiatives nationally and internationally.

References

  1. For example, the treatment of endometriosis and fibroid-associated anemia.
  2. Delvigne, Annick and Rozenberg, Serge. “Epidemiology and prevention of ovarian hyperstimulation syndrome (OHSS): a review” Human Reproduction Update, vol. 8, no. 6, 2002, pp 559-577.
  3. From Dr. Parisian’s February 2005 memo now posted at http://ourbodiesourselves.org
  4. Other language from this document, titled “Consent to Participate in a Study Involving Egg Donation for Stem Cell Research”:

    Complications associated with being an egg donor include unpredictable response to the hormones provided to you, surgical complications during the egg collection, and unknown long-term side effects from the hormones. If any of these complications arise the reproductive biologists involved in this research may choose, at their discretion, to terminate your continued participation in this research.

    Risks and side effects associated with hormones (gonadotropins, hCG and GnRH agonists). The gonadotropins will be used in order to stimulate your ovaries. Adverse reactions reported in women treated with gonadotropins include ovarian hyperstimulation. This is a condition in which the ovaries continue to enlarge even after the eggs have been collected. In addition to enlarged ovaries, fluid begins to be retained in the abdomen and becomes very difficult to control, resulting in fluid imbalance. Rare, but serious, consequences of this imbalance include lung and circulation problems such as collapse of a lung, acute respiratory distress syndrome, blood clot which may lead to inflammation of the veins, obstruction of blood vessels in the lungs, damage to the lung tissues, stroke, obstruction of an artery resulting in the loss of limb(s); blood in the abdominal cavity; kidney damage; large ovaries; increased heart rate; shortness of breath; rapid breathing; flu-like symptoms of fever, chills, musculoskeletal aches, joint pain, nausea, headache and tiredness; breast tenderness; and skin reactions such as dry skin, blood rash, hair loss and hives. Severe lung and blood clot events have resulted in death.

    The following adverse reactions have been reported in patients receiving human chorionic gonadotropin therapy: headache, irritability, restlessness, depression, fatigue, edema, and pain at the injection site.

    Adverse reactions regarding GnRH agonists include anemia; changes in various heart problems; high blood pressure; fluid accumulation in the limbs; formation of blood clots which potentially could be dislodged from the involved vein or artery causing damage to vital organs such as lungs, heart or brain; intestinal problems such as decreased appetite, constipation; nausea and vomiting, diarrhea, difficulty in swallowing; intestinal bleeding, intestinal ulcers and polyps; thyroid enlargement; breast tenderness; hot flashes; bone, muscle and joint pain; anxiety; depression; blurred vision; mood swings; nervousness; numbness; taste changes; memory problems; lightheadedness; blackouts; and headaches.

  5. See “Risks to women in embryo cloning,” op ed by Judy Norsigian, February 25, 2005, Boston Globe.

  6. Lazar, Kay “Wonder drug for men alleged to cause harm in women,” Boston Herald, August 22, 23, 24, 1999.

  7. Ibid.

  8. Duenwald, Mary “After 25 Years, New Ideas in the Prenatal Test Tube,” New York Times, July 15, 2003.

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Quinacrine Sterilization in India: Women’s Health and Medical Ethics Still at Risk

DifferenTakes Series
34 ~ Spring 2005
[PDF Version]
By Rajashri Dasgupta

Women’s groups in India are only too aware that the “real battles” are fought outside the court room. In 1998, when the Supreme Court of India banned quinacrine sterilization (QS) because its long-term effects on women are unknown and are potentially harmful, activists knew they had to continue the struggle outside the courts. Their fears proved true when a group of medical practitioners violated the ban on the use of the drug for female sterilization.

Rajashri Dasgupta is a journalist with a special interest in issues relating to gender, health, development and politics. She is active in the women’s and peace movements.

References

  1. Mulay, Shree; Singh, Navsharan; Dasgupta, Rajashri (2003) “Quinacrine Non-Surgical Sterilisation In West Bengal: What We Have Learned From The Women On The Ground,” A report presented in a workshop to discuss the research findings, Kolkata, India, November 28.
  2. The interviews quoted in the text were conducted by the author either on phone or through email. Interview with Elton Kessel was conducted personally in November 1998 when he was in Kolkata to attend a medical conference. In March 2005 Dr Mumford replied to the set of questions I sent to April Mayberry referred to by Dr. A. Sarin. He said she was out of the office traveling.
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