Highlights in Gynecology

David Scott Cole, MD

Disclosures

June 22, 2005

Editorial Collaboration

Medscape &

Introduction

The 53rd Annual Clinical Meeting of the American College of Obstetricians and Gynecologists was held May 7-11, 2005 at the Moscone Center in San Francisco, California. This report will detail the highlights in the Gynecology portion of the program. The following topics will be covered: (1) the ACOG President's Program, (2) women and cardiovascular disease, and (3) updates in the treatment of sexually transmitted diseases (STDs).

The President's Program: Sex, Power, and Politics

Vivian M. Dickerson, MD, 2004-2005 ACOG President, moderated the President's Program. Dr. Dickerson has made the centerpiece of her presidency the equal socioeconomic, political, and reproductive rights of women in the United States. Last year she introduced her 10-point "Women's Bill of Rights." Many of these points were discussed during by the speakers during this program.

  • Accessible, affordable, and safe forms of contraception, including postcoital contraceptives

  • Freedom of reproductive choice

  • Freedom from domestic and socio-political violence in the United States and throughout the world

  • Equity in gender-specific research

  • Socioeconomic and political equality

  • Safety and accountability in healthcare

  • Appropriate and effective health insurance coverage

  • Freedom from discrimination based on gender, age, race, or ethnicity

  • Culturally sensitive education and information

  • Access to healing environments and integrative approaches to health and healthcare[1]

Malcolm Potts, MB, PhD, Bixby Professor at the School of Public Health, University of California, Berkeley, presented the Samuel A. Cosgrove Memorial Lecture entitled "Why Can't a Man Be More Like a Woman?" during the ACOG President's Program - the 1st Scientific Program.

Dr. Potts traced the roots of male control over female reproduction, which developed over the course of 2 billion years of Darwinian evolution. For most of human history, the male drive to control female reproduction has overridden the female drive for autonomy and family planning. Unfortunately, this control over female autonomy still exists in the 21st century. Dr. Potts believes that certain behaviors helped our ancestors' genes survive over the generations as they evolved into a hunter-gatherer society. These behaviors, however, are not beneficial in modern society.

Dr. Potts then discussed "the tale of 2 pills." The issue of the birth control pill vs sildenafil (Viagra) demonstrates a modern example of reproductive dominance of men over women. The contrasts between the introduction of oral contraceptives vs Viagra are not accidental but are rooted deeply in human evolution. The concept of the birth control pill was in 1921, but it took the efforts of Margaret Sanger in the 1950s to push for a research lab to develop the Pill in the 1960s. Whereas the Pill was developed in an academic laboratory, Viagra was developed by a large drug company. It was then made into a blockbuster pill very quickly. Senator Robert Dole was seen all over the media marketing Viagra. On the other hand, Dr. Potts argues that the Pill does not have a prominent female spokesperson marketing the Pill. In the 1970s, the media was quick to report any possible deaths from oral contraceptives. Since its introduction in 1998, over 500 deaths have been attributed worldwide to Viagra, but the media does not discuss this. When Viagra was introduced into Japan, it was approved in 6 months. The Pill, however, took much longer to be approved. In fact, the Pill was only approved on Viagra's coattails -- 35 years after first seeking approval.[2]

If it took 35 years for Japanese women to obtain access to the Pill, then women in the third world will have an even more difficult time. There is 1 maternal death every minute in the world -- 99% in the third world. Dr. Potts pointed out that annual maternal mortality rates are 2 to 3 times higher than the number of men, women, and children who died in the December 26, 2004 tsunami. The number 1 cause of maternal mortality in the world is postpartum hemorrhage. Approximately 125,000 deaths annually worldwide result from primary postpartum hemorrhage.[3] An inexpensive medication that could help fix this problem is misoprostol, which, in its generic formulation, costs $1 to $2 per patient. However, the same medication can also be used for abortion, so many third-world countries oppose its use. Abortion is also a big issue in the first world, as we know only too well. First-trimester surgical abortion is the first surgical procedure in the United States about which you can say that the operator is more likely to be killed than the patient.

American women now have access to education, but they don't have access to the reproductive rights that they should. The new Iraqi constitution says that 25% of the candidates for the new Iraqi Assembly must be women. If we applied the same standards to our own US Senate, then we would need 11 more female Senators tomorrow. It is therefore no surprise that the Japanese Ministry of Health, which approved Viagra in only 6 months and delayed the Pill for 35 years, has 196 men to 6 women.

One recent country to give women reproductive control, surprisingly, is Iran. All Iranian couples must go to family planning classes. Furthermore, there are now more Iranian women in universities than men. In the past 10 years, Iran's birth rate, maternal mortality and infant mortality rates have all fallen. Iran can become a model for the rest of the Middle East. Giving women reproductive freedom can lead to a genesis of other freedoms.

Although women have made great reproductive strides in the United States leading to great economic strides, these reproductive freedoms are under attack. Ideology is trumping science in the United States. The biggest problem in the United States is not between Democrats and Republicans but between science and anti-science. Dr. Potts closed by saying that giving women control over their fertility has made the world a better place. Finally, he said that the United States must restore its role in international family planning.

Women's Reproductive Rights at Risk in the United States

David A. Grimes, MD, Vice President of Biomedical Affairs, Family Health International, Research Triangle Park, North Carolina, then followed with an exciting talk entitled "Politics, Power, and Procreation" (see footnote). According to Dr. Grimes, no federal government during our lifetimes has shown so much disdain for science or public health as the current one. Ideology is followed instead of science, and revelation is followed instead of research. This has especially been the case with women's reproductive rights. In effect, Dr. Grimes argues that the far right has hijacked the US government. He then gave multiple examples of how federal policies have hurt women in the United States as well as worldwide. The 4 most compelling examples will be reviewed here.

  • Global Gag Rule. The "Global Gag Rule" denies foreign organizations receiving US family planning assistance the right to use their own non-US funds to provide legal abortion, counsel, or to refer for abortion in their country. This includes countries in which abortion is legal. The rule began in 1984 during the Reagan administration related to the 1984 United Nations International Conference on Population in Mexico City, Mexico. President Clinton rescinded the Global Gag Rule in 1993. President Bush then reinstated this rule in 2001 during his first day in office. Ironically, this censorship is only used overseas, as it is unconstitutional on the US mainland. Basically, it denies funds to women seeking abortions, leading to tragic results including more unintended pregnancies, more unsafe abortions, and more maternal deaths.[4] In effect, our Administration does not just control US physicians, but physicians worldwide!

  • Federal censorship at the National Cancer Institute (NCI) and Centers for Disease Control and Prevention (CDC). By 2002, most major medical organizations agreed that there was no increase in breast cancer from induced abortion. The NCI then changed its Web site in 2002 to say that there was an increased risk of breast cancer in women who had undergone induced abortions. A blue ribbon commission then met and found no link between breast cancer and induced abortion, and the NCI Web site was corrected. Basically, within a 5-month period, the NCI Web site said there was no association, then they said there was an association, and again, they said there was no association between breast cancer risk and abortion -- when no new scientific information had been released in that time period. Furthermore, the CDC then changed its Web site on condom information and emphasized that condoms do not prevent the spread of STDs. In short, our Administration has put ideology over science.

  • The Food and Drug Administration (FDA) Advisory Committee and Plan B. On December 16, 2003, the FDA Scientific Advisory Committee voted 23-4 in favor of switching Plan B (levonorgestrel) from Barr Laboratories from a prescription medication to an unrestricted over-the-counter medication.[5] Both Dr. Grimes and Dr. Dickerson testified in front of the committee in favor of Plan B, and ACOG endorsed the change to over-the-counter status. The advisory committee reviewed 15,000 pages of clinical data from about 40 studies. Usually, the FDA follows the advice of its advisory committees. Unfortunately, on May 6, 2004, the FDA decided not to approve Plan B as an over-the-counter medication. The FDA felt that there was a lack of demonstration that women younger than 16 years of age could safely take the medication as prescribed.[6] In effect, the current administration feels that abstinence-only programs are the best choice for teenagers, who should "just say no!" This could lead to more unintended pregnancies, especially adolescent pregnancies and, ironically, more abortions!

  • Intact dilatation and extraction (D & X). Politicians have termed this "partial birth abortion" -- a term that does not appear in any medical textbooks -- and have tried to paint the procedure as unsafe. D & X entails obstetric procedures that have been in medical textbooks for generations -- cephalocentesis, internal podalic version, and total breech extraction. In fact, a recent study demonstrated that D & X is just as safe as dilatation and evacuation.[7] Although Congress and the President tried to outlaw D & X, 3 Federal courts found that "new and improved" partial birth abortion ban to be unconstitutional.

Women and Heart Disease: Gender Does Matter!

Another major theme of ACOG's 53rd Clinical Meeting was heart disease among women. The Donald F. Richardson Memorial Symposium on Women and Cardiovascular Disease was presented in conjunction with the American Heart Association. The American Heart Association has launched a Go Red for Women campaign to alert women that cardiovascular disease (CVD) is their greatest health risk. Vivian M. Dickerson, MD, ACOG President, has made fighting heart disease in women a major priority and reminded the audience that heart disease is the number 1 killer of women in the United States, claiming about 500,000 American women's lives every year. American women do not realize that they are at risk and believe that issues such as breast cancer are more deadly. Dr. Dickerson pointed out that in many cases, an ob/gyn is the only physician that many women visit. Therefore, ob/gyns need to be especially vigilant about the risk factors for CVD. The following key points about cardiovascular disease and women should be noted:

  • Data from the American Heart Association demonstrate that CVD kills more women every year than the next 6 causes (including cancer) combined![8]

  • Since 1984, the number of CVD deaths for females has exceeded those for males.

  • Women younger than 65 years who suffer a myocardial infarction (MI) are twice as likely as men to die.

  • Among survivors, 25% of men vs 38% of women will die within 1 year of acute MI.

  • Women admitted to the hospital with acute MI get less aggressive treatment than males: women with MIs are less likely to receive aspirin than males with 24 hours of presentation (82.6% vs 87.1%).[9]

Alice K. Jacobs, President of the American Heart Association and Director of the Cardiac Catheterization Lab and Interventional Cardiology at the Boston University School of Medicine, Boston, Massachusetts, directed the symposium with Dr. Dickerson. She gave the first lecture, entitled "Are There Gender Disparities in Diagnosis, Treatment, and Outcomes?" The answer is clearly, Yes, there are gender disparities in diagnosis and treatment of CVD in women. Women have increased risk factors such as diabetes, hypertension, congestive heart failure and high cholesterol, but get treatment later in the disease cycle. Part of this failure of CVD in women is that women do not always present with the classic symptoms of angina -- chest pressure and pain in the arm, neck, or jaw. Instead, many women complain of fatigue. Because women are diagnosed later in the course of their MI, they do not always get the early benefit of cardiac revascularization that men receive. Women tend to have more microvascular disease and less multivessel disease than men, so their MIs are probably different.

Could a decrease in calcium in bones have any relationship to an increase in calcium in blood vessels? J. Jeffrey Carr, MD, Associate Professor, Division of Radiologic Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, followed with an exciting talk entitled "Is There a Relationship Between Osteoporosis and Atherosclerosis, and How Important Is It?" Osteoporosis and atherosclerosis were once thought to be unrelated diseases except for the fact that they both occur in postmenopausal women. However, recent studies have shown that there is a relationship between osteoporosis and atherosclerosis, and aortic plaque is a strong predictor of osteoporosis and fractures.[10] Osteoporosis and calcified plaques are related by several pathways. In a recent study in the Journal of Clinical Endocrinology and Metabolism, researchers found a strong association between the progression of vascular calcification and bone loss. They concluded that aortic calcifications are a strong predictor for low bone density and fragility fractures.[11] Could there be a genetic relationship between osteoporosis and atherosclerosis? Matrix proteins have already been shown to be involved in the pathogenesis of atherosclerosis. However, a recent study, of which Dr. Carr was a part, did not demonstrate an association involving matrix proteins in both osteoporosis and atherosclerosis.[12] Further research is needed with this interesting concept.

JoAnn E. Manson, MD, Professor of Medicine, Harvard Medical School, Boston, Massachusetts, then presented "Have We Heard the Last on Hormone Replacement Therapy? What's Next...?" Dr. Manson asked how clinicians could be so wrong regarding menopausal hormone therapy (HT). She reminded the audience that observational studies such as the Nurses' Health Study showed a protective benefit of HT while the Women's Health Initiative (WHI), a randomized, controlled trial, shattered that belief.[13] Data from the Nurses' Health Study, a prospective, observational cohort study, showed a decrease in major coronary events in women without heart disease who took HT.[14] On the other hand, the Heart and Estrogen Replacement Study (HERS) was a blinded, randomized controlled trial, which found that HT did not reduce the overall rate of coronary heart disease in postmenopausal women with established coronary disease. In fact, there was even an increase reported in CHD events during the first year after randomization![15] The Women's Health Initiative (WHI) was actually 2 studies. The first portion, the combined study, used the same regimen of estrogen plus progestin as in HERS, but evaluated predominately healthy women.[16] The second portion of WHI used only estrogen in postmenopausal women with hysterectomy.[17] The WHI combined study was discontinued after a mean of 5.2 years of follow up because the test statistic for invasive breast cancer exceeded the stopping boundary, and the global index statistic supported risks exceeding benefits. In the WHI combined trial, there was also an increase in CHD, stroke, and pulmonary embolism. There was a decreased risk of colon cancer and hip fracture. For the WHI estrogen-alone study, there was an increased risk of stroke, but a decreased risk of hip fracture. Actually, the results from the WHI combined trial and HERS trial are very similar to observational studies except for the issue of CHD.

So, why were clinicians so wrong regarding the outcomes of hormone replacement on CHD? Perhaps there was bias in the observational studies. For instance, the person who reported the cause of death in the Nurses' Study could have been biased not to select CHD as the cause of death. Perhaps it is because the Nurses' study did not try to detect silent MI, whereas the WHI did. Or perhaps the Nurses' Study patients were just a healthier population than the patients in WHI and HERS. In fact, some subgroups of patients might benefit from HT. However, we should not be surprised that there was an increase in MI or pulmonary embolus. According to Dr. Manson, estrogen is a double-edged sword. While estrogen does many good things, it is also thrombotic and increases clotting factors such as Factor V11 prothrombin fragments 1 and 2, decreases anti-thrombin III, and increases triglycerides. At this point, HT should not be given for cardiac protection.

Update for STDs: New CDC Guidelines for 2006 Coming Soon

Gail Bolan, MD, Chief STD Control Branch, CA Department of Health Services, spoke at the Late Breaking News session with a talk entitled "New Directions in STD Treatment: An Insider's Perspective into National Guideline Changes for 2006." In 2006, the CDC plans to update its guidelines for STDs. Until that time, the 2002 Sexually Transmitted Diseases Treatment Guidelines are still in place.[18]

With regard to Chlamydia trachomatis, the main treatment changes in 2006 will be those relating to pregnancy.

Proposed 2006 Chlamydia treatment in pregnancy:

  • Azithromycin 1 gram PO once daily for 1 day or

  • Amoxicillin 500 mg PO 3 times daily for 7 days.

(Erythromycin 500 mg PO 4 times daily for 7 days will move to the alternative regimens group.)

Furthermore, with regard to Chlamydia, the CDC is developing guidelines for patient delivered partner therapy (PDPT), which is a hot topic. The rationale is that an untreated male partner can reinfect the female partner. Concern with PDPT includes the legal issue of treating a patient who was not examined (ie, the male partner).[19]

With regard to gonorrhea, there is an increase in resistance to fluoroquinolones – quinolone-resistant Neisseria gonorrhea (QRNG). This has mainly been seen in homosexual men and in cases in California and Hawaii. Therefore, according to the CDC, flouroquinolones are not recommended for MSM (men having sex with men), any foreign acquisition, or acquisition in California or Hawaii.[20]

Proposed gonorrhea treatment regimens for 2006:

  • Cefixime 400 mg PO x 1

  • Ceftriaxone 125 mg IM x 1

  • Ciprofloxacin 500 mg PO x 1 (unless in California or Hawaii)

  • Ofloxacin 400 mg PO x 1 (unless in California or Hawaii)

  • Levofloxacin 250 mg PO x 1 (unless in California or Hawaii)

*Co-treatment for Chlamydia is recommended.

Proposed PID oral treatment regimens for 2006:

  • Ofloxacin 400 mg PO twice daily for 14 days Levofloxacin 500 mg PO once daily for 14 days Ceftriaxone 250 mg IM (or other parenteral third-generation cephalosporin x 1)

Plus Doxycycline 100 mg PO twice daily for 14 days Or

  • Cefoxitin 2 g IM and probenecid 1 g PO x 1

Plus doxycycline 100 mg PO twice daily for 14 days

Proposed bacterial vaginosis regimen for 2006:

  • Metronidazole 500 mg PO twice daily for 7 days

  • Metronidazole get 0.75% 5 g per vagina once daily for 5 days

  • Clindamycin cream 2% 5 g per vagina once a day at bed time for 7 days

*For bacterial vaginosis, the main change will be to delete metronidazole 2 g PO x 1.

The proposed regimen in pregnancy: (1) metronidazole 500 mg PO twice daily for 7 days, or (2) clindamycin 300 mg PO twice daily for 7 days.

For trichomoniasis, the new treatment option is tinidazole, a second generation 5-nitroimidazole. It is especially effective for metronidazole-resistant trichomoniasis, with 22/24 cases being cured in the largest report.

Summary
  • The male drive to control female reproduction still exists in modern society.

  • The contrast between the way society handled the introductions of oral contraceptives vs Viagra is not accidental but rather was dictated by agendas rooted in human evolution.

  • Many federal policies actually hurt the reproductive rights of American women, even if their intentions are good.

  • Heart disease is the number 1 killer of women in the United States; most women do not appreciate their own risk.

  • Women with MI may present with different symptoms and get less aggressive treatments than male patients.

  • There is a relationship between atherosclerosis and osteoporosis.

  • Randomized studies of HT did not duplicate the results of observational studies in terms of protection from CVD.

  • New guidelines for the treatment of STDs will be released by the CDC in 2006.

  • The incidence of quinolone-resistant Neisseria gonorrhea is increasing in California and Hawaii.

  • Tinidazole is a new treatment for trichomoniasis.

Footnote: Please see the commentary "Politics, Power, and Procreation" by Dr. Grimes in MedGenMed Ob/Gyn & Women's Health, http://www.medscape.com/viewarticle/505887.

References
  1. American College of Obstetricians and Gynecologists. ACOG News Release: Vivian M. Dickerson, MD Becomes President of The American College of Obstetricians and Gynecologist. Available at http://acog.com. Accessed June 5, 2005.

  2. Potts M. Two pills, two paths: a tale of gender bias. Endeavour. 2003;27:127-130.

  3. Miller S, Lester F, Hensleigh P. Prevention and treatment of postpartum hemorrhage: new advances for low-resource settings. J Midwifery Womens Health. 2004;49:283-292.

  4. Population Action International. How the global gag rule undermines U.S. foreign policy and harms women's health. Available at http://www.populationaction.org. Accessed June 5, 2005.

  5. Grimes DA. Emergency contraception: Politics trumps science at the US Food and Drug Administration. Obstet Gynecol. 2004;104:220-221.

  6. US Food and Drug Administration. FDA Decision Regarding Plan B: Questions and Answers. Available at http://www.fda.gov/cder/drug/infopage/planB/planBQandA.htm. Accessed June 5, 2005.

  7. Chasen ST, Kalish RB, Gupta M, et al. Dilation and evacuation at ≥ 20 weeks: Comparison of operative techniques. Am J Obstet Gynecol. 2004;190:1180-1183.

  8. American Heart Association. Heart Disease and Stroke Statistics-2005 Update. Available at http://www.Americanheart.org. Accessed June 5, 2005.

  9. Wenger NK. You've come a long way baby: cardiovascular health and disease in women: Problems and prospects. Circulation. 2004;109:558-560.

  10. Uyama O, Yoshimoto Y, Yamamoto Y, et al. Bone changes and carotid atherosclerosis in postmenopausal Women. Stroke. 1997;28:1730-1732.

  11. Schulz E, Arfai K, Liu X, et al. Aortic calcifications and the risk of osteoporosis fractures. J Clin Endocrinol Metab. 2004;89:4246-4253.

  12. Taylor BC, Schreiner PJ, Doherty TM, et al. Matrix Gla protein and osteopontin genetic associations with coronary artery calcification and bone density: the CARDIA study. Hum Genet. 2005;116: 525-528.

  13. Col NF, Pauker SG. The discrepancy between observational studies and randomized trials of menopausal hormone therapy: Did expectations shape experience? Ann Intern Med. 2003;139:923-929.

  14. Grodstein F, Manson JE, Colditz GA, et al. A prospective, observational study of postmenopausal hormone therapy and primary prevention of cardiovascular disease. Ann Intern Med. 2000;133:933-941.

  15. Hulley S, Grady D, Bush T, et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. JAMA. 1998;280:605-613.

  16. Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288:321-333.

  17. Anderson GL, Limacher M, Assaf AR, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: The Women's Health Initiative randomized controlled trial. JAMA. 2004;291:1701-1712.

  18. Centers for Disease Control and Prevention. 2002 Sexually Transmitted Diseases Treatment Guidelines. Available at http://www.cdc.gov/std/treament. Accessed June 5, 2005.

  19. Golden MR, Whittington ML, Handsfield HH, et al. Effects of expedited treatment of sex partners on recurrent or persistent gonorrhea or chlamydial infection. N Engl J Med. 2005;352:676-685.

  20. Increases in Fluoroquinolone-Resistant Neisseria gonorrhoeae Among Men Who Have Sex with Men-United States, 2003 and Revised Recommendations for Gonorrhea Treatment, 2004. MMWR Morb Mortal Wkly Rep. 2004;53:335-338. Available at http://www.cdc.gov. Accessed June 5, 2005.

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