- Email: [email protected]
Contemporary issues in women's health
International Journal of Gynecology and Obstetrics (2004) 87, 111--113
www.elsevier.com/locate/ijgo
CONTEMPORARY ISSUES IN WOMEN’S HEALTH S. Arulkumarana, T.R.B. Johnsonb a
Head of the Department of Obstetrics and Gynaecology, St. George’s Hospital Medical School, Cranmer Terrace, London SW17 0RE, UK b Bates Professor of Diseases Women and Children, Chair, Department of Obstetrics and Gynecology, University of Michigan, L4000 Women’s Hospital, 1500 E. Medical Center Drive, Box 0276, Ann Arbor, Michigan, 48109 USA
The editors of Contemporary Issues in Women’s Health solicit reporters and correspondents from throughout the world to make contributions to this section. Please feel free to email or otherwise contact Professor Timothy Johnson at trbj@umich. edu or Prof. S. Arulkumaran at s.arulkumaran@ sghms.ac.uk if you have reports or stories that you would like to have included. We would be happy to attribute the items to those reporters and correspondents who give permission in their transmittal. Otherwise, we will share those reports that we think are of the greatest interest to our readership without attribution.
Emergency Contraception in the United States In May 2004, the Food and Drug Administration of the United States ruled that emergency contraception would not be available over the counter. In December 2003, two FDA expert panels overwhelmingly recommended approval of the drug by a 23 to
E-mail addresses: [email protected] (S. Arulkumaran), [email protected] (T.R.B. Johnson).
doi:10.1016/j.ijgo.2004.08.001
4 vote after reviewing more than 15,000 pages of data for over 40 studies in support of the over the counter (OTC) application. The FDA typically follows the recommendations of the government scientific committees, and the experts in this case made it clear that use of emergency contraception does not increase promiscuity or unprotected sex among teenaged women. In an unusual decision written by Dr. Steven Galson, Acting Director of FDA’s Center for Drug Evaluation and Research, and not supported by other members of the FDA staff, a decision was deferred pending further information about the safety of emergency contraception in girls under the age of 16 or on the possibility raised by the manufacturer in their proposal that the drug be used over the counter for girls over the age of 16 and that there be an age limit to those who could get it without speaking to a pharmacist or without a prescription. Since there is no precedent for this type of age cutoff with over the counter drugs, the feasibility and potential risk to the patient could not be assessed. This decision was broadly criticized calling it bmorally repugnantQ by the President of the American College of Obstetricians and Gynecologists. It is suspected that the decision was politically motivated based on a small but vocal group who
112 were opposed to the drug and who represented what is thought to be President Bush’s key base in the upcoming elections. The company will have six months with which to respond to the Food and Drug Administration from the time that the letter of nonapproval was submitted and this six months will come right after the November elections. At that time, the political implications of this FDA decision will be minimal and it is likely that the EC will become available over the counter in the United States. Once again, women’s health, women’s lives, and women’s reproductive choices are dictated by political considerations.
References [1] Dickerson VM. Statement of the American College of Obstetricians and Gynecologists on the failure of the FDA to approve OTC Status for Plan B. ACOG News Release, May 7, 2004. [2] Steinbrook R. Waiting for Plan B--the FDA and nonprescription use of emergency contraception. N Engl J Med 2004;350:2327--9. [3] h t t p : / / w w w. f d a . g o v / c d e r / d r u g / i n f o p a g e / p l a n B / default.htm.
WHO Reproductive Health Library Number 7, 2004 The WHO Reproductive Health Library Number 7, 2004 issue features 88 Cochrane reviews providing information on beneficial and harmful forms of care, expert commentaries from a resource-poor perspective, implementation aids proposing tools to facilitate the implementation of effective, beneficial practices. New resources have been included including video on caesarean section technique and an introductory training course on bMaking evidence-based decisions in reproductive healthQ. This is targeted at health care professionals and assists them in understanding research evidence, making decisions about best practice, and establishing implementation procedures to assure the change. RHL is now available on the Internet. Both RHL CD ROM and the Internet access are feely available in middle- and low-income countries. Those wishing to subscribe to the Internet version should contact: The WHO Reproductive Health Library, UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research,
S. Arulkumaran, T.R.B. Johnson World Health Organization, CH-1211 Geneva 27, Switzerland, or e-mail: [email protected].
Teaching Safe Sex in Schools Results of the RIPPLE study of peer-led sex education were published in The Lancet July 24, 2004. In this study, 29 schools were randomized to either peer-led sex education or teach-led sex education. Peer educators aged 16--17 delivered three sessions to 13- to 14-year-old students. The positive findings of this study were that fewer 16year-old girls in the peer group had started to become sexually active compared to girls in the control group and that boys and girls preferred peer-group education. Overall, though, peer-led sex education was not as effective as had been hoped and the conclusion was that broader strategies were needed to improve young people’s sexual health. In a Commentary, R. Short noted that this study was a response to the 1999 UK Parliament report on teenage pregnancy which led Prime Minister Tony Blair to comment that bBritain has the worst record of teenage pregnancies in Europe.Q The authors point to an important study from the opposite side of the globe that we should all be aware of as further peer-based intervention are planned. Gao and his Chinese colleagues have apparently tackled peer-group sex education for young people with considerable success (Gao Y, Lu ZZ, Shi R, Sun XY, Cai Y. AIDS and sex education for young people in China. Reprod Fertil Devel 2001;13:729--37). It is critically important that these types of difficult to mount randomized clinical studies be encouraged and that we develop a research agenda for education about sexuality, reproduction and contraception that can better help us deal with this critically important problem. It would seem that shared international experiences may help in developing strategies and, hopefully, despite cultural and local differences, many lessons can be learned from the experience and research of others. Gynecologists need to look to our rapidly growing world wide teen population as an important target of our efforts to improve the health and status of women.
Reference [1] Preparing for adulthood: Adolescent sexual and reproductive health. Progress in Reproductive Health Research 2003;64:1.
Contemporary Issues in Women’s Health
A Leap Toward Cloning With each advance in human stem cell research comes renewed optimism for the success of therapeutic cloning—using stem cells derived from a patient’s own DNA to replace cells damaged by Parkinson’s or diabetes, for example, while avoiding immune rejection. In a breakthrough report published online in Science Express on 12 February 2004, Hwang et al. (http://www.sciencemag.org/cgi/ content/abstract/1094515) reported the successful production of an embryonic stem cell (ESC) line from cloned human embryos—a major achievement toward the realization of therapeutic cloning to treat human disease. The team created the cell line by inserting the nucleus of a human cumulus cell (cells that surround developing eggs in the ovary) into a human egg from which the nucleus had been removed. The egg was then stimulated to divide and allowed to develop for a week to the blastocyst stage, when the embryo forms a hollow ball of cells. The cells the team extracted from this early embryo had many of the characteristics of
113 ESCs, including the ability to divide indefinitely— and, when injected into mice, the cells differentiated into several cell types including bone, muscle, and immature brain cells. The researchers used a gentler procedure to extract the egg nucleus than in previous failed attempts to clone human and monkey embryos. Perhaps more important to their success, however, was the large number of donated eggs they had to work with (242), which gave the team multiple chances to tweak and optimize its protocol. As discussed in an accompanying news story by G. Vogel http:// www.sciencemag.org/cgi/content/short/303/ 5660/937, the achievement has already reignited debate over human cloning and the regulation of stem cell research.
Reference [1] Science Roundup. American Association for the Advancement of Science, February 27, 2004.
www.elsevier.com/locate/ijgo
CONTEMPORARY ISSUES IN WOMEN’S HEALTH S. Arulkumarana, T.R.B. Johnsonb a
Head of the Department of Obstetrics and Gynaecology, St. George’s Hospital Medical School, Cranmer Terrace, London SW17 0RE, UK b Bates Professor of Diseases Women and Children, Chair, Department of Obstetrics and Gynecology, University of Michigan, L4000 Women’s Hospital, 1500 E. Medical Center Drive, Box 0276, Ann Arbor, Michigan, 48109 USA
The editors of Contemporary Issues in Women’s Health solicit reporters and correspondents from throughout the world to make contributions to this section. Please feel free to email or otherwise contact Professor Timothy Johnson at trbj@umich. edu or Prof. S. Arulkumaran at s.arulkumaran@ sghms.ac.uk if you have reports or stories that you would like to have included. We would be happy to attribute the items to those reporters and correspondents who give permission in their transmittal. Otherwise, we will share those reports that we think are of the greatest interest to our readership without attribution.
Emergency Contraception in the United States In May 2004, the Food and Drug Administration of the United States ruled that emergency contraception would not be available over the counter. In December 2003, two FDA expert panels overwhelmingly recommended approval of the drug by a 23 to
E-mail addresses: [email protected] (S. Arulkumaran), [email protected] (T.R.B. Johnson).
doi:10.1016/j.ijgo.2004.08.001
4 vote after reviewing more than 15,000 pages of data for over 40 studies in support of the over the counter (OTC) application. The FDA typically follows the recommendations of the government scientific committees, and the experts in this case made it clear that use of emergency contraception does not increase promiscuity or unprotected sex among teenaged women. In an unusual decision written by Dr. Steven Galson, Acting Director of FDA’s Center for Drug Evaluation and Research, and not supported by other members of the FDA staff, a decision was deferred pending further information about the safety of emergency contraception in girls under the age of 16 or on the possibility raised by the manufacturer in their proposal that the drug be used over the counter for girls over the age of 16 and that there be an age limit to those who could get it without speaking to a pharmacist or without a prescription. Since there is no precedent for this type of age cutoff with over the counter drugs, the feasibility and potential risk to the patient could not be assessed. This decision was broadly criticized calling it bmorally repugnantQ by the President of the American College of Obstetricians and Gynecologists. It is suspected that the decision was politically motivated based on a small but vocal group who
112 were opposed to the drug and who represented what is thought to be President Bush’s key base in the upcoming elections. The company will have six months with which to respond to the Food and Drug Administration from the time that the letter of nonapproval was submitted and this six months will come right after the November elections. At that time, the political implications of this FDA decision will be minimal and it is likely that the EC will become available over the counter in the United States. Once again, women’s health, women’s lives, and women’s reproductive choices are dictated by political considerations.
References [1] Dickerson VM. Statement of the American College of Obstetricians and Gynecologists on the failure of the FDA to approve OTC Status for Plan B. ACOG News Release, May 7, 2004. [2] Steinbrook R. Waiting for Plan B--the FDA and nonprescription use of emergency contraception. N Engl J Med 2004;350:2327--9. [3] h t t p : / / w w w. f d a . g o v / c d e r / d r u g / i n f o p a g e / p l a n B / default.htm.
WHO Reproductive Health Library Number 7, 2004 The WHO Reproductive Health Library Number 7, 2004 issue features 88 Cochrane reviews providing information on beneficial and harmful forms of care, expert commentaries from a resource-poor perspective, implementation aids proposing tools to facilitate the implementation of effective, beneficial practices. New resources have been included including video on caesarean section technique and an introductory training course on bMaking evidence-based decisions in reproductive healthQ. This is targeted at health care professionals and assists them in understanding research evidence, making decisions about best practice, and establishing implementation procedures to assure the change. RHL is now available on the Internet. Both RHL CD ROM and the Internet access are feely available in middle- and low-income countries. Those wishing to subscribe to the Internet version should contact: The WHO Reproductive Health Library, UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research,
S. Arulkumaran, T.R.B. Johnson World Health Organization, CH-1211 Geneva 27, Switzerland, or e-mail: [email protected].
Teaching Safe Sex in Schools Results of the RIPPLE study of peer-led sex education were published in The Lancet July 24, 2004. In this study, 29 schools were randomized to either peer-led sex education or teach-led sex education. Peer educators aged 16--17 delivered three sessions to 13- to 14-year-old students. The positive findings of this study were that fewer 16year-old girls in the peer group had started to become sexually active compared to girls in the control group and that boys and girls preferred peer-group education. Overall, though, peer-led sex education was not as effective as had been hoped and the conclusion was that broader strategies were needed to improve young people’s sexual health. In a Commentary, R. Short noted that this study was a response to the 1999 UK Parliament report on teenage pregnancy which led Prime Minister Tony Blair to comment that bBritain has the worst record of teenage pregnancies in Europe.Q The authors point to an important study from the opposite side of the globe that we should all be aware of as further peer-based intervention are planned. Gao and his Chinese colleagues have apparently tackled peer-group sex education for young people with considerable success (Gao Y, Lu ZZ, Shi R, Sun XY, Cai Y. AIDS and sex education for young people in China. Reprod Fertil Devel 2001;13:729--37). It is critically important that these types of difficult to mount randomized clinical studies be encouraged and that we develop a research agenda for education about sexuality, reproduction and contraception that can better help us deal with this critically important problem. It would seem that shared international experiences may help in developing strategies and, hopefully, despite cultural and local differences, many lessons can be learned from the experience and research of others. Gynecologists need to look to our rapidly growing world wide teen population as an important target of our efforts to improve the health and status of women.
Reference [1] Preparing for adulthood: Adolescent sexual and reproductive health. Progress in Reproductive Health Research 2003;64:1.
Contemporary Issues in Women’s Health
A Leap Toward Cloning With each advance in human stem cell research comes renewed optimism for the success of therapeutic cloning—using stem cells derived from a patient’s own DNA to replace cells damaged by Parkinson’s or diabetes, for example, while avoiding immune rejection. In a breakthrough report published online in Science Express on 12 February 2004, Hwang et al. (http://www.sciencemag.org/cgi/ content/abstract/1094515) reported the successful production of an embryonic stem cell (ESC) line from cloned human embryos—a major achievement toward the realization of therapeutic cloning to treat human disease. The team created the cell line by inserting the nucleus of a human cumulus cell (cells that surround developing eggs in the ovary) into a human egg from which the nucleus had been removed. The egg was then stimulated to divide and allowed to develop for a week to the blastocyst stage, when the embryo forms a hollow ball of cells. The cells the team extracted from this early embryo had many of the characteristics of
113 ESCs, including the ability to divide indefinitely— and, when injected into mice, the cells differentiated into several cell types including bone, muscle, and immature brain cells. The researchers used a gentler procedure to extract the egg nucleus than in previous failed attempts to clone human and monkey embryos. Perhaps more important to their success, however, was the large number of donated eggs they had to work with (242), which gave the team multiple chances to tweak and optimize its protocol. As discussed in an accompanying news story by G. Vogel http:// www.sciencemag.org/cgi/content/short/303/ 5660/937, the achievement has already reignited debate over human cloning and the regulation of stem cell research.
Reference [1] Science Roundup. American Association for the Advancement of Science, February 27, 2004.