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Daily Women's Health Policy Report
Public Health & Education
Roche's Organ-Rejection Drug CellCept Increases Risk of Birth Defects, Miscarriage, FDA Says
Pope Benedict Says Pharmacists Have Right To Conscientiously Object To Fill Emergency Contraception
Federal Judge Retracts Previous Ruling in Favor of AT&T Employee Who Sued Company for Contraceptive Coverage
Coalition's Guidelines on Fish Consumption for Pregnant Women 'Misleading,' Opinion Piece Says
More Comprehensive Sex Education Programs Needed, Opinion Piece Says
Guttmacher Institute, Kaiser Family Foundation Release Report on Medicaid Coverage for Family Planning Services
Special Notice
Change in Kaiser Coverage of Women's Health Policy News
[Oct 31, 2007]
The Kaiser Family Foundation is pleased to announce that on Nov. 5, 2007, the National Partnership for Women & Families will become the new publisher of the Daily Women's Health Policy Report. To receive their free, daily report on women's reproductive health policy, please sign up at NationalPartnership.org/dailyreport.
The National Partnership, established in 1971, is a Washington, D.C.-based nonprofit, nonpartisan organization. Through its work on access to quality and affordable health care and on reproductive health and rights, the National Partnership promotes public policies and business practices that expand opportunities for women and strengthen families.
Also beginning Nov. 5, 2007, the Kaiser Daily Health Policy Report -- a news summary service also operated by the Kaiser Family Foundation -- will be expanded to include a new "Women's Health Policy" section covering issues related to health care coverage and access for women. Archives of the Kaiser Daily Women's Health Policy Report will continue to be accessible through the kaisernetwork.org search. In addition, other Kaiser Family Foundation Web sites will continue to provide resources and information on women's health policy issues - kff.org, kaiserEDU.org, and statehealthfacts.org.
Thank you for your readership of the Kaiser Daily Reports and your interest in the work of the Kaiser Family Foundation.
Public Health & Education
Roche's Organ-Rejection Drug CellCept Increases Risk of Birth Defects, Miscarriage, FDA Says
[Oct 31, 2007]
FDA on Monday said Roche's organ-rejection drug CellCept increases the risk of birth defects and miscarriage during the first trimester of pregnancy, Reuters reports. CellCept prevents organ rejection among kidney, liver and heart transplant recipients.
FDA issued a new black box warning to the drug's label about the increased risk of ear and facial deformities -- as well as problems in limbs, the heart and other organs -- among fetuses and infants exposed to the drug (Reuters, 10/29). FDA cited National Transplantation Pregnancy Registry data published in December 2006 of 24 women who were exposed to CellCept. The women had a total of 33 pregnancies, of which 15 resulted in a miscarriage and 18 in a live birth. Among the 18 live births, four infants had birth defects, according to Dow Jones. According to postmarketing data, which were collected by Roche and involved 77 women who took CellCept, there were 25 miscarriages and 14 defects among fetuses and infants. Six of the defects were ear abnormalities (Corbett Dooren, Dow Jones, 10/29).
In addition, FDA said the drug, which is known generically as mycophenolate mofetil, might lower blood levels of the hormones in oral contraceptives, making the pills less effective at preventing pregnancy. FDA said women of childbearing age should have a negative pregnancy test within one week before beginning treatment with CellCept, receive birth control counseling and use effective contraception (AP/Google.com, 10/29).
Roche sent a letter to physicians explaining the new warnings (Dow Jones, 10/29). According to FDA, prehuman trials of the drug found some signs of fetal defects (Reuters, 10/29).
International News
Pope Benedict Says Pharmacists Have Right To Conscientiously Object To Fill Emergency Contraception
[Oct 31, 2007]
Pope Benedict XVI on Monday at the 25th International Congress of Catholic Pharmacists in Rome told attendees that they have a right to conscientiously object to dispensing drugs such as emergency contraception, which can prevent pregnancy if take up to 72 hours after sexual intercourse, the AP/Google.com reports (Winfield, AP/Google.com, 10/29). Conscientious objection is a "right that must be recognized for your profession so you can avoid collaborating, directly or indirectly, in the supply of products which clearly have immoral aims" -- such as abortion and euthanasia -- Benedict said (Reuters, 10/29).
He also encouraged pharmacists to inform patients on the ethical implications of taking such medications. "Pharmacists must seek to raise people's awareness so that all human beings are protected from conception to natural death and so that medicines truly play a therapeutic role," he said (AP/Google.com, 10/29). He added, "It is not possible to anesthetize the conscience, for example, when it comes to molecules whose aim is to stop an embryo implanting or to cut short a person's life" (Reuters, 10/29).
Benedict's remarks "resonated strongly" among Italian pharmacists, who are required to fill prescriptions regardless of their moral or ethical beliefs, according to Federfarma, the national federation that represents 15,500 private pharmacists, the AP/Google.com reports. The federation in a statement said that the country's law would need to be amended to allow for conscientious objection but noted that such a change would be hard to apply because pharmacists could object to dispensing basic contraception or other hormonal medications. The International Pharmaceutical Federation, which represents pharmaceutical associations worldwide, has a code calling for the continuity of service "in the event of conflict with personal moral beliefs." However, Henri Manasse -- Federfarma's professional secretary -- said the group is updating its standards because new medications constantly introduce new moral issues (AP/Google.com, 10/29).
In The Courts
Federal Judge Retracts Previous Ruling in Favor of AT&T Employee Who Sued Company for Contraceptive Coverage
[Oct 31, 2007]
U.S. District Judge Howard Sachs recently retracted his previous ruling regarding a case in which two AT&T employees sued the company for failing to cover prescription contraceptives under the company's health insurance plan, the Kansas City Star reports. Sachs originally ruled in favor of one plaintiff and certified the case as class action. However, Sachs last week rescinded his ruling, saying he is bound by a precedent established by the 8th Circuit Court of Appeals in St. Louis that found Union Pacific Railroad's policy of not covering contraceptives does not discriminate against women (Margolies, Kansas City Star, 10/29).
The two AT&T employees in January 2003 filed a class-action lawsuit on behalf of the company's female employees alleging that the failure of its health insurance plan to cover prescription contraceptives violated Title VII of the Civil Rights Act of 1964, as well as the Pregnancy Discrimination Act of 1978. Title VII prohibits discrimination on the basis of sex, while the Pregnancy Discrimination Act prohibits discrimination on the basis of pregnancy, childbirth or related medical conditions. Although the company's health insurance plan began covering oral contraceptives ordered by mail, the lawsuit contests the plan's failure to provide other forms of birth control -- including Pfizer's injection contraceptive Depo-Provera, intrauterine devices and diaphragms -- because it covers other sex-related prescription drugs for men, such as Viagra (Kaiser Daily Women's Health Policy Report, 1/22/03).
Sachs in his previous ruling -- which limited one of the plaintiff's damages to $1 daily for 300 days -- found that the Pregnancy Discrimination Act required employers to cover contraceptives, although he "expressed some reservation on the matter," according to the Star. Sachs' certification of the case as class action could have had large-scale implications for the company because of its large number of female employees, the Star reports (Kansas City Star, 10/29).
Opinion
Coalition's Guidelines on Fish Consumption for Pregnant Women 'Misleading,' Opinion Piece Says
[Oct 31, 2007]
The National Healthy Mothers, Healthy Babies Coalition's recent recommendations for fish and seafood consumption for pregnant and breast-feeding women are "misleading" and a "classic example of industry-driven marketing under the cloak of scientific research," Andrea Kavanagh, director of the National Environmental Trust's Pure Salmon Campaign, writes in a Los Angeles Times opinion piece (Kavanagh, Los Angeles Times, 10/31).
The coalition is a not-for-profit group with nearly 150 members, including the American Academy of Pediatrics, March of Dimes, CDC and the National Institute of Child Health and Human Development. The guidelines, released earlier this month, recommended that pregnant and breast-feeding women should consume at least 12 ounces of fish and seafood weekly for optimal brain development of fetuses, infants and young children. The group recommended eating ocean fish, such as salmon, tuna and sardines, which are highest in omega-3s. The guidelines also recommended higher fish and seafood consumption to protect women's health.
The coalition's guidelines conflict with current FDA and Environmental Protection Agency guidelines. FDA and EPA in 2005 issued separate warnings that advise young children, pregnant women, nursing women and women of childbearing age to avoid consuming swordfish, king mackerel, shark and tilefish because of high mercury levels. The warnings also recommended that those groups consume no more than 12 ounces of fish weekly and eat no more than six ounces of canned albacore tuna weekly (Kaiser Daily Women's Health Policy Report, 10/11). Some members of the coalition declined to endorse the guidelines, and some members criticized the coalition for accepting a $60,000 grant from the National Fisheries Institute, a fishing industry trade association, to help fund the research (Kaiser Daily Women's Health Policy Report, 10/18).
Kavanagh writes that it is "disturbing" that the coalition would "encourag[e] pregnant women to increase their consumption of fish despite the well-known risk of mercury and other contaminants commonly found in certain seafoods." In addition, the "researchers who developed the report ... didn't bother to vet its decidedly contentious findings and advice with the coalition's wider membership before public release," Kavanagh writes.
The "selective repackaging of science, combined with slick marketing to sell more fish to pregnant women and women of childbearing age, show the height of corporate irresponsibility," Kavanagh writes, concluding that the report is "one fishy marketing scheme that consumers should throw back" (Los Angeles Times, 10/31).
More Comprehensive Sex Education Programs Needed, Opinion Piece Says
[Oct 31, 2007]
Although abstinence messages are effective for some teenagers "who embrace [their] religious roots or who choose to abstain for other reasons," they should not be the "centerpiece for any state's sexual education policy" because such messages "wor[k] only for some" teens, Abigail Jones and Marissa Miley, co-authors of Restless Virgins: Love, Sex, and Survival at a New England Prep School, write in a USA Today opinion piece.
According to Jones and Miley, a study published earlier this year in Public Health Reports found that three-fourths of U.S. teenagers have premarital sex by age 20 and that 58% have it before age 18. CDC found that in 2005, 50% of teenagers had sex during their high school years and that about 14% reported having sex with four or more partners, the authors write. In addition, a report released in April found that abstinence-only sex education programs are not effective in preventing or delaying teenagers from having sexual intercourse, according to the authors.
More national and local comprehensive sex education programs that include teaching students about contraception, sexually transmitted infections and safe sex are needed, Jones and Miley write, adding, "Sexual health is not just physical but emotional," and students "need to learn how to develop healthy sexual relationships, whether or not they are forever" (Jones/Miley, USA Today, 10/31).
Recent Releases
Guttmacher Institute, Kaiser Family Foundation Release Report on Medicaid Coverage for Family Planning Services
[Oct 31, 2007]
"Medicaid's Role in Family Planning," Guttmacher Institute, Kaiser Family Foundation: The issue brief examines coverage provided by Medicaid for women of reproductive age at the national and state levels; the range of services covered as part of family planning; state-initiated family planning expansions and their impact in reducing abortions, and unintended pregnancies and births; and recent changes in Medicaid policy, including the federal Deficit Reduction Act of 2005. According to the brief, Medicaid is the largest source of public funding for family planning services in the U.S., providing coverage of contraceptive services for millions of low-income women (Kaiser Family Foundation release, 10/30).
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