POLITICS, POWER, AND PROCREATION: HOW FEDERAL POLICIES ARE UNDERMINING WOMEN’S REPRODUCTIVE HEALTH

2. POLITICS, POWER, AND PROCREATION:HOW FEDERAL POLICIES ARE UNDERMINING WOMEN’S REPRODUCTIVE HEALTH David A. Grimes, M.D.

3. OBJECTIVES • Give six examples of damage to women’s health care by politics • Provide the evidence refuting these policies • Explain why these policies are both unscientific and unethical

4. DISCLOSURE OF CONFLICT OF INTEREST • None relevant to this presentation • Testified as an unpaid consultant for Barr Laboratories at FDA hearing, 2003

5. “I hate all bungling as I do sin, but particularly bungling in politics, which leads to the misery and ruin of many thousands and millions of people.” Goethe

6. “a well-established pattern of suppression and distortion of scientific findings by high-ranking …. political appointees across numerous federal agencies… .consequence for human health, public safety, and community well-being.” Union of Concerned Scientists, March 2004

14. “If I’m the President, we’re going to have emergency-room care, we’re going to have gag orders.” Gov. George W. Bush 2000

15. 1. THE GLOBAL GAG RULE • “The Mexico City Policy” first implemented in 1984 • Denies U.S. funds to any foreign nongovernmental organization that uses its own money in relation to abortion • Includes organizations in countries where abortion is legal

17. A DOUBLE STANDARD The gag rule would be unconstitutional in the U.S. • First Amendment infringement • Discriminates between non-governmental organizations and governments Violates clinicians’ ethical obligation to provide informed consent

18. GAG RULE IN ACTION • Denies care to refugees, migrants displaced by war and civil unrest, and victims of rape and sexual violence • Increases unplanned pregnancies • Increases unsafe abortion • Indirectly kills poor women International Women’s Health Coalition www.iwhc.org/resources

20. “What is politics, after all, but the compulsion to preside over property and make other peoples' decisions for them?”

21. 2. A DISAPPEARING WEB SITE……

22. ABORTION AND BREAST CANCER: WORLD CONSENSUS, 2002 • World Health Organization • American College of Obstetricians and Gynecologists • Royal College of Obstetricians and Gynaecologists • National Cancer Institute NO ASSOCIATION

23. National Cancer Institute website November, 2002: “Some studies have reported statistically significant evidence of an increased risk of breast cancer in women who have had abortions, while others have merely suggested an increased risk.”

24. “…an egregious distortion of the scientific evidence.” The New York Times January 6, 2003

25. A PROMPT RESPONSE • February 2003: Three-day meeting to review all the evidence • March 2003: “induced abortion is not associated with an increase in breast cancer risk” • Conclusion rated by the NCI as “well-established.” http://cis.nci.nih.gov/fact/3_75.htm

26. SHIFTING EVIDENCE OR SHIFTING POLITICAL WINDS? • October 2002: No association • November 2002: Increased risk after abortion • March 2003: No association, well-established (All in the absence of any new reports in the literature over the 5 months)

31. 3. EMERGENCY CONTRACEPTION

32. TESTIMONY AT THE FDA • Full-day hearing at the FDA on December 16, 2003 • Formal presentations, comments from audience, discussion by joint committee members • Formal vote in favor of unrestricted over-the-counter access: 23-4

33. “NOT APPROVABLE” Insufficient data provided by an “actual use” study previously approved by the FDA ! (Catch 22?)

34. BARR LABORATORIES REVISES APPLICATION AND RE-APPLIES • Revised New Drug Application, July 2004, requiring prescription for women younger than 16 years (the only objection from the FDA) • After the 180 days allowed for FDA to respond……

35. THE FDA RESPONSE:(verbatim) “ ”

40. SHOCKING NEWS • On September 16, 2004, the FDA approved over-the-counter sales of an automatic external defibrillator • Any 13-year-old can buy a defibrillator to shock her grandmother

41. DEPOSITION OF DR. STEVEN GALSON APRIL 26-27, 2006

42. OTHER DEPOSITIONS • January 15-17, 2004: During a phone conversation, Dr. Janet Woodcock, then-Acting Deputy Commissioner for Operations, divulges to Dr. Florence Houn, Director of the FDA’s Office of Drug Evaluation III, that denying Barr’s application, then granting limited approval is "the only way to go" to "appease the administration's constituents." (Houn deposition) • May 4 or 5, 2004: Galson tells Dr. Susan Wood, Director of the FDA’s Office of Women's Health, that denying Barr's application was necessary in order for him to keep his job. (Wood deposition)

43. REWARD FOR FOLLOWING THE PARTY LINE

45. The first national, comprehensive? guideline (141 pages) September, 2004

46. ??

47. 4. ABSTINENCE The answer!

49. ABSTINENCE-BASED PROGRAMS • The Texas experiment: from 1995-2000, last among all 50 states in pregnancy declines among women aged 15-17 yr. • Nevertheless, $176 million in 2007 federal budget ($1.5 billion cumulative)

50. THE EVIDENCE • Abstinence programs significantly increase the number of pregnancies among partners of young male participants: • Relative risk = 1.54 (95% CI 1.03-2.29) • Such programs have a paradoxical effect DiCenso. BMJ 1998;324:1426