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  • November 15, 2016 9:57 AM | Deleted user

    On September 30, 2016, this report was posted online as an MMWR Early Release.

    Emily E. Petersen, MD1; Dana Meaney-Delman, MD1; Robyn Neblett-Fanfair, MD1; Fiona Havers, MD1; Titilope Oduyebo, MD1; Susan L. Hills, MBBS1; Ingrid B. Rabe, MBChB1; Amy Lambert, PhD1; Julia Abercrombie, MPH1; Stacey W. Martin, MSc1; Carolyn V. Gould, MD1; Nadia Oussayef, JD1; Kara N.D. Polen, MPH1; Matthew J. Kuehnert, MD1; Satish K. Pillai, MD1; Lyle R. Petersen, MD1; Margaret A. Honein, PhD1; Denise J. Jamieson, MD1; John T. Brooks, MD1 (View author affiliations)

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    CDC has updated its interim guidance for persons with possible Zika virus exposure who are planning to conceive (1) and interim guidance to prevent transmission of Zika virus through sexual contact (2), now combined into a single document. Guidance for care for pregnant women with possible Zika virus exposure was previously published (3). Possible Zika virus exposure is defined as travel to or residence in an area of active Zika virus transmission (http://www.cdc.gov/zika/geo/index.html), or sex* without a condom† with a partner who traveled to or lived in an area of active transmission. Based on new though limited data, CDC now recommends that all men with possible Zika virus exposure who are considering attempting conception with their partner, regardless of symptom status,§ wait to conceive until at least 6 months after symptom onset (if symptomatic) or last possible Zika virus exposure (if asymptomatic). Recommendations for women planning to conceive remain unchanged: women with possible Zika virus exposure are recommended to wait to conceive until at least 8 weeks after symptom onset (if symptomatic) or last possible Zika virus exposure (if asymptomatic). Couples with possible Zika virus exposure, who are not pregnant and do not plan to become pregnant, who want to minimize their risk for sexual transmission of Zika virus should use a condom or abstain from sex for the same periods for men and women described above. Women of reproductive age who have had or anticipate future Zika virus exposure who do not want to become pregnant should use the most effective contraceptive method that can be used correctly and consistently. These recommendations will be further updated when additional data become available.

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    Review of Evidence

    Zika virus infection during pregnancy is a cause of congenital microcephaly and serious brain abnormalities (4). The risk for adverse pregnancy outcomes associated with maternal Zika virus infection around the time of conception is unknown. To date, there have been no published reports of adverse pregnancy outcomes after periconceptional Zika virus infection. Infections with other viruses (e.g., cytomegalovirus, rubella, parvovirus) around the time of conception have been associated with congenital infection and adverse pregnancy outcomes, although the exact timing of infection relative to conception was sometimes uncertain (59).

    Zika virus is transmitted primarily through the bite of Aedes aegypti mosquitoes. Zika virus can also be transmitted through sex without a condom. The risk for sexual transmission of Zika virus from a person infected with Zika virus remains unknown. Most reported sexual transmissions have been from persons with symptomatic Zika virus infections, including from men to female sex partners (1012), from a man to his male sex partner (13), and from a woman to her male sex partner (14). Two new reports describe one presumed and one more definitive case of sexual transmission from men with asymptomatic Zika virus infection to female sex partners (15,16). Sexual transmission of Zika virus has been associated with condomless anal sex and vaginal sex and possibly also with fellatio (17). Among reported cases of sexually transmitted Zika virus infection, the longest reported period between sexual contact that might have transmitted Zika virus and symptom onset was 32–41 days (based on an incubation period of 3–12 days) (18).

    Data on the detection of Zika virus RNA in semen can inform estimates of the periods during which sexual transmission might occur. However, detection of Zika virus RNA in semen might not indicate the presence of infectious virus and thus the potential for sexual transmission. Reports indicate that concentrations of detectable Zika virus RNA in semen decrease after infection (17,1928). Zika virus RNA was detected in semen of five men more than 90 days after symptom onset, with the longest period of reported detection 188 days after symptom onset (20,26,29,30). Culture is considered the gold standard for demonstrating the presence of replicative and thus infectious virus, and among four published reports of Zika virus cultured from semen, virus was reported in semen up to 69 days after symptom onset (17,19,21,31). Culture methods varied in these studies and additional studies are needed to confirm the presence of infectious virus in semen.

    New data on the persistence of Zika virus RNA in serum and whole blood might have implications, both for sexual transmission of Zika virus and for fetal exposure to Zika virus. Zika virus RNA has been detected in the serum of nonpregnant persons up to 11–13 days after symptom onset (32); in the serum of pregnant women, Zika virus RNA has been detected up to 10 weeks after symptom onset (33,34). Zika virus RNA was detected in whole blood of a nonpregnant person up to 58 days after symptom onset followed by a negative result at 79 days; however, Zika virus could not be cultured at 58 days (35). Experience with other flaviviruses suggests that if a person’s immune system has activated an antibody response, viral transmission (i.e., through blood transfusion) is unlikely (36). Detection of Zika virus RNA in blood might not indicate the presence of infectious virus, and thus the potential risk for maternal-fetal Zika virus transmission periconceptionally is unknown.

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    Guidance for Preconception Counseling and Prevention of Sexual Transmission

    CDC is updating its guidance on timing of conception after possible Zika virus exposure and prevention of sexual transmission of Zika virus. CDC continues to evaluate all available evidence and update recommendations as new data become available. Most of the recommendations for preconception counseling and prevention of sexual transmission are dependent on whether persons live in or travel to areas of active Zika virus transmission.¶ As of September 26, 2016, 59 countries and U.S. territories reported active Zika virus transmission. The Florida Department of Health identified two areas of Miami-Dade County with active local mosquito-borne Zika virus transmission; as of September 20, 2016, only one remains an area of active transmission (37). Updates on areas with active Zika virus transmission are available online at http://www.cdc.gov/zika/geo/index.html.

    For Couples Planning to Conceive Who Do Not Live in Areas with Active Zika Virus Transmission. Health care providers should discuss couples’ travel plans in preconception counseling. Women and men who are planning to conceive in the near future should consider avoiding nonessential travel to areas with active Zika virus transmission.

    Women who have had possible Zika virus exposure through travel or sexual contact and do not have ongoing risks for exposure should wait at least 8 weeks from symptom onset (if symptomatic) or last possible exposure (if asymptomatic) to attempt conception. Women who wait at least 8 weeks to conceive might have an increased likelihood that Zika virus no longer presents a risk for maternal-fetal transmission.

    CDC now recommends that men with possible Zika virus exposure, regardless of symptom status, wait at least 6 months from symptom onset (if symptomatic) or last possible exposure (if asymptomatic) before attempting conception with their partner. CDC previously recommended that men with possible Zika virus exposure who were asymptomatic wait at least 8 weeks from last possible exposure. The updated recommendation minimizes the likelihood that periconceptional sexual transmission will result in fetal exposure to Zika virus. The recommendation to wait at least 6 months for asymptomatic men is based on the range of time after symptom onset that Zika virus RNA has been detected in semen of symptomatic men and the absence of definitive data that the risk for sexual transmission differs between symptomatic and asymptomatic men. Zika virus has not been definitively cultured from semen more than 3 months after symptom onset. It is unknown whether detection of Zika virus RNA in semen indicates presence of infectious virus and the potential for transmission. Current recommendations provide couples planning to conceive with periods that, based on existing data, are expected to minimize risk for Zika virus transmission to an uninfected partner. Studies are underway to better understand the persistence of infectious Zika virus in semen and the associated risk for sexual transmission of the virus. Given that limited data are available, some couples in whom a partner had possible Zika virus exposure might choose to wait longer or shorter than the recommended period to conceive, depending on individual circumstances (e.g., age, fertility, details of possible exposure) and risk tolerance. For example, after consultation with their health care provider, symptomatic persons with negative test results who received testing in the appropriate time window and in accordance with the testing algorithm (38) might choose not to wait to conceive.

    For Couples Who Want to Conceive, in Which One or Both Partners Live in Areas with Active Zika Virus Transmission. Women and men who reside in areas with active Zika virus transmission and who experience symptoms of Zika virus disease should be tested for Zika virus infection (38). Men with results that indicate recent Zika virus or unspecified flavivirus infection should wait at least 6 months from symptom onset to attempt conception with their partner; women with results that indicate recent Zika virus or unspecified flavivirus infection should wait at least 8 weeks from symptom onset to attempt conception. Persons who have had symptoms of Zika virus disease with negative Zika virus test results should talk with their health care provider about timing of conception in the setting of ongoing risk for possible exposure.

    Persons living in an area with active Zika virus transmission should be counseled on the possible risk for Zika virus infection during the periconception period. CDC has developed tools to assist health care providers with preconception counseling (39). Health care providers should provide counseling about the potential consequences to the fetus associated with Zika virus infection during pregnancy, such as microcephaly and other serious brain abnormalities. Women and men should discuss their reproductive life plans** with their health care provider, in the context of potential and ongoing Zika virus exposure. Health care providers should review factors that might influence pregnancy timing (e.g., unknown duration of Zika virus outbreak, fertility, age, reproductive history, medical history, personal values and preferences). For couples who choose to conceive, health care providers should stress use of mosquito bite prevention strategies†† while attempting pregnancy and during pregnancy. Health care providers should counsel couples who decide to wait to attempt conception about strategies to prevent unintended pregnancy, including the most effective contraceptive methods (i.e., long-acting reversible contraception) and provide contraception or referral to appropriate providers for contraception care (40).

    Special Considerations for Women Undergoing Fertility Treatment. Zika virus transmission through assisted reproductive technology has not been reported. However, transmission through gametes or embryos is theoretically possible. Recommendations for sexually intimate couples with Zika virus infection or possible Zika virus exposure undergoing fertility treatment with their own gametes and embryos should follow the testing and timing recommendations as described above; recommendations might need to be adjusted depending on individual circumstances. The Food and Drug Administration has issued guidance to reduce the risk for Zika virus transmission by donated human cells, tissues, and cellular and tissue-based products, including reproductive tissues (41).

    For Couples Who Are Not Pregnant and Are Not Planning to Become Pregnant in the Near Future. Couples in whom the man or woman has had possible Zika virus exposure who want to maximally reduce their risk for sexually transmitting Zika virus to the uninfected partner should use condoms consistently and correctly or abstain from sex for at least 6 months for men or 8 weeks for women after symptom onset (if symptomatic) or last possible Zika virus exposure (if asymptomatic). Some couples might choose to use condoms or abstain from sex for a shorter or longer period than recommended depending on individual circumstances and risk tolerance. Couples should be advised that correct and consistent use of condoms reduces the risk for other sexually transmitted infections.

    Health care providers should discuss strategies to prevent unintended pregnancy with couples who do not want to become pregnant. Safety, effectiveness, availability, and acceptability should be considered when choosing a contraceptive method (42). Patients should be counseled to use the most effective contraceptive method that can be used correctly and consistently. Long-acting reversible contraception, including contraceptive implants and intrauterine devices, provide highly effective reversible options.

    For Pregnant Women and Their Partners. Pregnant women living in areas without active Zika virus transmission should be advised to avoid nonessential travel to areas with active transmission. Persons who have traveled to or live in an area with active Zika virus transmission and whose partner is pregnant should be advised to consistently and correctly use condoms during sex or abstain from sex for the duration of the pregnancy. These actions reduce the risk for sexual transmission of Zika virus during pregnancy. Health care providers should ask pregnant women about their own and their sex partner’s history of travel to areas with active Zika virus transmission. Pregnant women with possible Zika virus exposure, either through sex or through traveling to or living in an area with active Zika virus transmission, should be tested for Zika virus infection in accordance with CDC’s “Updated Interim Pregnancy Guidance: Testing and Interpretation Recommendations for a Pregnant Women with Possible Exposure to Zika Virus” (http://www.cdc.gov/zika/pdfs/testing_algorithm.pdf ), including pregnant women with possible sexual exposure whose sex partner has had no symptoms of Zika virus disease. Further guidance for care of pregnant women with possible Zika virus exposure has been published (3).

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    Zika Virus Testing

    Persons with possible Zika virus exposure who have symptoms of Zika virus disease should receive testing in accordance with CDC interim guidance: “Algorithm for U.S. Testing of Symptomatic Individuals” (38). CDC does not recommend Zika virus testing of nonpregnant persons with possible Zika virus exposure who do not have symptoms of Zika virus disease, including persons who are planning to attempt conception, or to assess the risk for sexual transmission of Zika virus. Zika virus testing for this purpose remains of uncertain value, because current understanding of the duration and pattern of shedding of Zika virus in reproductive tissues is limited. Information on the performance of serologic Zika virus testing remains limited, with falsely positive tests resulting in avoidable stress and expense and falsely negative tests providing false reassurance and possibly leading to inadvertent fetal exposure to Zika virus.

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    Corresponding author: Emily E. Petersen; zikamch@cdc.gov; 770-488-7100.

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    1Zika Response, CDC.

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    References

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    15. Fréour T, Mirallié S, Hubert B, et al. Sexual transmission of Zika virus in an entirely asymptomatic couple returning from a Zika epidemic area, France, April 2016. Euro Surveill 2016;21:30254.CrossRef  PubMed
    16. Brooks RB, Carlos MP, Myers RA, et al. Likely sexual transmission of Zika virus from a man with no symptoms of infection—Maryland, 2016. MMWR Morb Mortal Wkly Rep 2016;65:915–6.CrossRef  PubMed
    17. D’Ortenzio E, Matheron S, Yazdanpanah Y, et al. Evidence of sexual transmission of Zika virus. N Engl J Med 2016;374:2195–8. CrossRef  PubMed
    18. Turmel JM, Abgueguen P, Hubert B, et al. Late sexual transmission of Zika virus related to persistence in the semen. Lancet 2016;387:2501. CrossRef  PubMed
    19. Musso D, Roche C, Robin E, Nhan T, Teissier A, Cao-Lormeau VM. Potential sexual transmission of Zika virus. Emerg Infect Dis 2015;21:359–61. CrossRef  PubMed
    20. Mansuy JM, Suberbielle E, Chapuy-Regaud S, et al. Zika virus in semen and spermatozoa. Lancet Infect Dis 2016;16:1106–7. CrossRef  PubMed
    21. Mansuy JM, Dutertre M, Mengelle C, et al. Zika virus: high infectious viral load in semen, a new sexually transmitted pathogen? Lancet Infect Dis 2016;16:405. CrossRef  PubMed
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    35. Lustig Y, Mendelson E, Paran N, Melamed S, Schwartz E. Detection of Zika virus RNA in whole blood of imported Zika virus disease cases up to 2 months after symptom onset, Israel, December 2015 to April 2016. Euro Surveill 2016;21:30269. CrossRef  PubMed
    36. Busch MP, Kleinman SH, Tobler LH, et al. Virus and antibody dynamics in acute west nile virus infection. J Infect Dis 2008;198:984–93. CrossRef  PubMed
    37. CDC. CDC updates guidance for travel and testing of pregnant women and women of reproductive age for Zika virus infection related to the ongoing investigation of local mosquito-borne Zika virus transmission in Miami-Dade County, Florida. Atlanta, GA: US Department of Health and Human Services, CDC; 2016. https://emergency.cdc.gov/han/han00396.asp
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    39. CDC. Preconception counseling for women and men living in areas with ongoing spread of Zika virus who are interested in conceiving. Atlanta, GA: US Department of Health and Human Services, CDC; 2016. https://www.cdc.gov/zika/pdfs/preconception-counseling.pdf
    40. CDC. Effectiveness of family planning methods. Atlanta, GA: US Department of Health and Human Services, CDC; 2016. https://www.cdc.gov/reproductivehealth/unintendedpregnancy/pdf/contraceptive_methods_508.pdf
    41. Food and Drug Administration. Donor screening recommendations to reduce the risk of transmission of Zika virus by human cells, tissues, and cellular and tissue-based products. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2016. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM488582.pdf
    42. Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. selected practice recommendations for contraceptive use, 2016. MMWR Recomm Rep 2016;65(No. RR-4). CrossRef  PubMed

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    * For the purpose of this guidance, sex is specifically defined as vaginal sex (penis-to-vagina sex), anal sex (penis-to-anus sex), oral sex (mouth-to-penis sex or mouth-to-vagina sex), and the sharing of sex toys.

    † Condoms include the use of male or female condoms for vaginal or anal sex, male condoms for oral sex (mouth-to-penis), and male condoms cut to create a flat barrier or dental dams for oral sex (mouth-to-vagina).

    § A person is considered symptomatic if one or more signs or symptoms (acute onset of fever, rash, arthralgia, or conjunctivitis) consistent with Zika virus disease is reported. A person is considered asymptomatic if these symptoms are not reported.

    ¶ http://www.cdc.gov/zika/geo/index.html.

    ** http://www.cdc.gov/preconception/reproductiveplan.html.

    †† https://www.cdc.gov/zika/prevention/prevent-mosquito-bites.html.

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    Petersen EE, Meaney-Delman D, Neblett-Fanfair R, et al. Update: Interim Guidance for Preconception Counseling and Prevention of Sexual Transmission of Zika Virus for Persons with Possible Zika Virus Exposure — United States, September 2016. MMWR Morb Mortal Wkly Rep 2016;65:1077-1081. DOI: http://dx.doi.org/10.15585/mmwr.mm6539e1 .


  • November 14, 2016 8:36 AM | Deleted user

    More than one-third of U.S. adults are obese, which puts them at higher risk for conditions including heart disease, stroke, and type 2 diabetes, according to the Centers for Disease Control and Prevention. But, gaining some extra pounds could come with even more serious health risks: A new study from the University of Manchester and The Health eResearch Centre has found that significant adult weight gain can increase cancer risk by up to 50 percent.

    weight gainJust how unhealthy is it to gain weight? Photo courtesy of Pixabay

    To reach these findings, researchers examined the body mass index (BMI) of 300,000 men and women from the US. The team looked at changes in BMI between the ages of 18 and 65 and then followed up for an average of 15 years to see who went on to develop obesity-related cancers.

    By the age of 65, 9,400 women and 5,500 men participating in the study were diagnosed with an obesity-related cancer.

    “This research shows how important it is to look at weight gain over a person’s lifetime — to give a clearer picture of cancer risk through life compared to assessing someone’s BMI at a single point,” lead author Dr Hannah Lennon said in a press release.

    “This study could also be really useful in public health. It could help identify people who would benefit the most from taking action to control their weight before any health problems arise — including a cancer diagnosis.”

    Source: Lennon H, Sperrin M, Renehan A. Lifetime BMI trajectory classes and obesity-related cancer risk in a US retrospective cohort study. NCRI Cancer Conference abstracts. 2016.


  • November 14, 2016 8:32 AM | Deleted user

    By Julie Steenhuysen | CHICAGO

    Adult women in Puerto Rico were significantly more likely to develop Zika than men, researchers said on Thursday, raising new questions about the potential role of sexual transmission of the virus from males to females.

    The study, published in the U.S. Centers for Disease Control and Prevention's weekly report on death and disease, evaluated more than 29,000 laboratory-confirmed cases of Zika since the outbreak began in Puerto Rico in November 2015.

    The data show that of all Zika cases with laboratory evidence of infection, 62 percent were female. The results pattern similar observations from Brazil and El Salvador, the authors said.

    One obvious explanation might be that pregnant women are more likely than men to seek treatment for Zika because of the potential risk of birth defects.

    To account for that, the researchers excluded all pregnant women who tested positive for the virus. Of the remaining 28,219 non-pregnant women and men testing positive for Zika, 61 percent of these cases occurred in women over the age of 20.

    The Zika findings differ from prior outbreaks in Puerto Rico of arboviruses transmitted by the same mosquitoes as Zika. For example, in the 2010 dengue outbreak and the 2014 chikungunya outbreak, infections were equally distributed among men and women.

    "It is possible that male-to-female sexual transmission is a contributing factor to this skewing of the burden of disease toward women," the CDC said in a statement summarizing the findings.

    However, the contribution of sexual transmission to overall Zika rates is just beginning to be explored, the CDC said. It could be that women are more likely than men to seek care if they are sick, or that women are more likely to develop Zika symptoms if they become infected.

    The CDC is conducting blood tests of individuals living near people with confirmed Zika to try to answer some of these questions.

    Zika infections in pregnant women have been shown to cause microcephaly - a severe birth defect in which the head and brain are undersized - as well as other brain abnormalities. The connection between Zika and microcephaly first came to light last year in Brazil, which has since confirmed more than 2,000 cases of microcephaly.

    (Reporting by Julie Steenhuysen; Editing by Andrew Hay)


  • November 14, 2016 8:07 AM | Deleted user

    Dear ARHP Members, Friends, and Colleagues,

    We are delighted to share new changes at ARHP that reflect over a year of thoughtful and hard work on behalf of our board members, staff, and advisors.

    With an historic election just days away, now is a critical and urgent time for sexual and reproductive health (SRH) professionals and advocates to share, communicate, and collaborate.

    Since the passage of the Patient Care and Affordable Care Act in 2010, there has been a shift in health care to emphasize primary care services and patient clinical homes. Yet despite a greater number of insured people and expanded coverage for preventive health services, millions still do not receive comprehensive sexual and reproductive health care. We strongly believe that health care is a social justice issue and should be accessible to everyone, everywhere.

    In response, ARHP is launching a new long-term strategy to improve access to high quality, science-driven sexual and reproductive health (SRH) care for all people regardless of age, ethnicity, gender identity and expression, ability, race, sexual orientation, religion, national origin, socioeconomic status, HIV status, and immigration status.

    Our approach is based on a strong commitment to support team-based care so all members can contribute to their fullest potential, including but not limited to: clinicians, researchers, educators, counselors, clinical staff, and advocates.

    We proudly share with you our new mission statement and new organizational values that were informed by emerging issues in our field and will provide a roadmap for our future work. As part of our commitment to members, we have created a new membership structure that will save you money without compromising the quality of our resources. Finally, we will give you a glimpse of plans to improve our communications and outreach to our members and the public at large.

    1. A New Mission Statement

    ARHP transforms and improves sexual and reproductive health care through professional training and advocacy

    2. New Organizational Values

    We are inherently: Driven by science
    Person-centered

    We believe: Health care is a right
    Diversity and inclusion strengthens

    We are committed to:
    Disseminating evidence-based, open-access information
    Inspiring, connecting, and collaborating
    Promoting team-based health care
    Applying imagination and innovation to our work

    3. A new membership model with a flat structure and lower fees

    You spoke and we listened. Based on your feedback, we are launching a new and equitable membership platform that respects the contributions of all SRH professionals. Fees have been reduced to a reasonable $95 per year for everyone – regardless of professional background or discipline. Students and retirees professionals will pay even less.

    4. An unfaltering commitment to open-access resources and improved delivery of these resources

    We believe the best health care happens when trusted information is freely available, easy to access, and evidence-based. We recognize the importance of leveraging technology to make sure our resources are available to as many people as possible, regardless of where they work or live. To do so, we plan to update and seamlessly integrate all our communication systems, including our website and social media platforms. This work will be challenging, but is necessary to promote far-reaching and meaningful knowledge and skills-transfer and dissemination.

    As your professional home, ARHP serves as a nexus for you to access continuing education, stay abreast of relevant legislation and policy, and network with others who share your commitment and passion to improving sexual and reproductive health.

    This just the start—there is so much more work to be done and challenges ahead for us and for everyone in the field of sexual and reproductive health. Thank you for being part of a vital and evolving movement to ensure that every individual receives the best possible sexual and reproductive health care.

    Please give us your impressions of ARHP’s new mission, values, and focus. And if you’re not already involved, please let us know how you could help. Contact arhp@arhp.org, or call 202-466-3825 any time with your comments, suggestions, and follow-up information about volunteering for ARHP.

    Warmly,


    Justine Wu
    ARHP Board Chair


    Wayne C. Shields
    ARHP President and CEO

    P.S., Click here for a visual of our new mission and values.


  • November 11, 2016 8:39 AM | Deleted user

    On November 10, 2016, APAOG hosted a webinar with Dr. Neil Silverman who gave an update on the Zika Virus situation that is facing many of our states and country.

    A recording of the webinar is available on the webinar library page and handouts are available for download as well.

    APAOG is currently looking into 2017 Webinar topics, please consider submitting an idea to our office today!


  • November 10, 2016 9:17 AM | Deleted user

    Timothy Jost - Health Affairs Blog

    On November 8, 2016, in a stunning upset, Donald Trump was elected president of the United States. The Republican Party, under whose banner he ran, retained control over both the House and Senate. President Trump will be able to appoint at least one Supreme Court justice almost immediately and possibly more during his term in office. He will also appoint dozens of district and appellate court judges. Finally, he will presumably replace the cabinet secretaries and most of the political appointees in the Departments of Health and Human Services, Labor, and Treasury — that administer the Affordable Care Act. The Republicans own the national government, and many state governments.

    So what does his victory mean for the Affordable Care Act? This post is a tentative first pass at this question. More will follow. It only addresses the coverage expansion of the ACA and does not discuss Medicare or prescription drugs, two other areas likely deeply affected by a Trump presidency.

    Donald Trump states at his website, “On day one of the Trump Administration, we will ask Congress to immediately deliver a full repeal of Obamacare.” If by Obamacare Trump means the Affordable Care Act in its entirety, this will not happen. First, any repeal proposal would be subject to a filibuster in the Senate and the Democrats retain more than enough votes to stop a repeal bill. Second, the Affordable Care Act contains hundreds of provisions affecting Medicare, program integrity, the health care workforce, biosimilars, prevention, and other issues unrelated to what most Americans think of as “Obamacare.” Immediate repeal of the ACA and presumably restoring the law that preceded it would likely bring the Medicare program, for example, to a halt until new rules could be written. The ACA is inextricably interwoven into our health care system and is not going away immediately.

    The Uses And Limits Of The Budget Reconciliation Process

    Congress and the President, can, however, repeal many of the provisions that are identified by the public as “Obamacare” using the budget reconciliation process. A budget reconciliation bill can be passed by a simple majority and cannot be stopped by a filibuster. The final ACA in 2010 contained provisions passed through the budget reconciliation process after the Democrats lost their filibuster-proof majority.

    Budget reconciliation legislation is subject to strict procedural and substantive limits. Reconciliation in the Senate can only contain provisions that affect the revenues and outlays of the United States and cannot contain “extraneous provisions” that only incidentally affect revenue and expenditures. Budget reconciliation is a two-step process—first Congress adopts a budget resolution with instructions to committees to meet reconciliation targets and then it adopts the reconciliation itself. This cannot happen on “day one.”

    Congress took a dry run at repeal budget reconciliation legislation in 2015. Both houses of Congress passed reconciliation legislation that would have repealed the premium tax credits; the small business tax credit; the individual mandate, the employer mandate; the expansion of Medicaid coverage for adults up to 138 percent of the federal poverty level, presumptive eligibility, maintenance of effort, and benchmark plans for Medicaid; and the ACA’s taxes—the medical device tax, insurer fee, “Cadillac” high cost plan tax, and tax increases imposed on the wealthy—most of the provisions that the public identifies as “Obamacare.” The legislation was vetoed by President Obama. The legislation would also have defunded Planned Parenthood. Presumably this legislation, already vetted for compliance with reconciliation requirements, could serve as a model for ACA repeal.

    Importantly, reconciliation legislation could probably not change the insurance reform provisions of the ACA—the ban on preexisting condition exclusions and health status underwriting, caps on annual and lifetime dollar limits, actuarial value requirements, age underwriting restrictions, as they do not affect revenues and outlays. The continued imposition of these requirements without the financing provided by the ACA could cause serious distortions and damage in insurance markets. It is possible that changes to other sections of the ACA could be made part of other “must pass” legislation, although it is hard to see what that might be.

    The ‘Replace’ Part Of Repeal And Replace

    Repeal would, moreover, raise the question of what would replace the ACA. The Congressional Budget Office estimated that enacting the 2015 reconciliation legislation would increase the number of uninsured Americans by 22 million. The legislation would have delayed the end of the premium tax credits until 2018 to allow time for replacement legislation, which was not part of the bill.

    Donald Trump has advocated tax deductions and tax subsidies for health savings accounts (HSAs) to make health insurance more affordable for those who lack it. These provisions may help some wealthier individuals, but would do little or nothing for the millions of people now receiving tax credits for coverage through the ACA, who often pay little in taxes and receive little benefit from deductions and have little to save in HSAs. Other Republican plans offer fixed dollar tax credits to purchase insurance, which would be of more value to low-income Americans, but would likely fall far short of the cost of coverage now covered by the ACA.

    A Republican replacement plan could not be implemented overnight, however. Regulations would have to be written and published for comment and mechanisms set up to handle the deductions or credits, particularly if they were provided in advance, as they would have to be. Even a two year delay might not be enough to get a program in place, much less to educate the public as to how it operated.

    What President Trump Could Do On His Own To Undermine The ACA

    Although Donald Trump cannot unilaterally repeal and replace the ACA, he can do a great deal to interfere with its implementation. As has been exhaustively chronicled on this blog, the ACA has been implemented by hundreds of pages of regulations and thousands of pages of guidance. Regulations cannot legally be changed without an opportunity for notice and comment and some explanation as to why a change is necessary. Guidance is easier to change.

    Indeed, a Trump administration could do a great deal of damage to the ACA without even changing regulations or guidance. If a Trump administration simply stopped implementing or enforcing certain regulatory requirements, there might be little that could be done about it. Just a change in leadership in the agencies implementing the ACA will cause months of disruption, and appointment of leadership committed to destroying rather than implementing the ACA will likely cause a mass exodus of lower level employees, causing an implementation vacuum.

    The Obama administration is currently engaged in an aggressive campaign to enroll individuals for the 2017 open enrollment period. A Trump administration could abandon this effort, as well as efforts to work with insurers to ensure continued ACA participation or with consumers to resolve enrollment issues. The 2015 reconciliation legislation would have required marketplace enrollees who underestimated their income to pay back all excess tax credits, regardless of the financial hardship this would cause. This might create a significant deterrence to enrollment. The repeal of the individual mandate would also discourage participation.

    A number of insurers have lost money in the marketplaces. Some have withdrawn and others have stuck with the program in hopes it would turn around. Without an administration committed to the program, more will almost certainly withdraw, potentially leaving parts of the country where no marketplace plans are available. Others might raise their rates in the face of the uncertainty caused by the transition, making coverage even less affordable to individuals without premium tax credits.

    A Trump administration is likely to work with conservative states to loosen remaining ACA requirements. Under section 1332 states can be granted “innovation” waivers from many ACA requirements if they can provide similar coverage under their own proposals. The Obama administration has interpreted the requirements of this provision quite conservatively, but Trump could give out the waivers much more loosely to allow states to opt out of the ACA. Trump has also proposed block-granting Medicaid, a proposal that would shift much of the burden of Medicaid financing to the states. Republicans believe that the flexibility afforded by block grants could allow states to innovate and run Medicaid more cost-effectively, but millions of Americans could lose Medicaid coverage if the block grants do not keep pace with costs.

    The CHIP program also comes up for reauthorization in 2017, and Trump opposition could end CHIP as well, potentially leaving millions of children without coverage.

    The Obama administration is currently involved in a number of lawsuits involving the ACA. A Trump administration might simply cease defending these lawsuits, effectively allowing the plaintiffs to triumph. If the government withdrew its appeal in House v. Burwell, for example, reimbursement to insurers for cost-sharing reduction payments could cease. Indeed, the administration could simply stop paying cost-sharing reduction payments, although this would probably take a rule change. Ending cost-sharing reduction payments would dramatically increase the cost of marketplace participation by insurers and likely lead to many insurers exiting the program. It is possible that beneficiaries or insurers could sue to reinstate the payments, but that would take time, and would likely not happen quickly enough to save the program.

    The administration will also likely cease defending the contraceptive cases, indeed may likely revoke the contraceptive coverage requirement. And it will likely take a more aggressive position opposing the insurer risk corridor cases in the court of claims.

    It is possible that consumer and insurer groups will file lawsuits against the administration seeking to force implementation of provisions of the ACA that remain in place. This litigation could take the place of the anti-ACA litigation the administration has fought for years. Litigants may follow the path of ACA opponents and find sympathetic district court judges in isolated districts in liberal circuits looking for easy victories. A Trump appointed Supreme Court will make progressive litigation victories harder to stick.

    Now It’s The GOP’s Turn

    The Democrats controlled the presidency and both houses of Congress in 2010. They adopted legislation that they hoped would dramatically increase access to health care for lower-income Americans. In many respects they succeeded, covering 20 million Americans and reducing the uninsured rate to the lowest levels in history. But many Americans believe, rightly or wrongly, that they have been disadvantaged by the ACA, and dissatisfaction with it has remained high, particularly as premiums increased and insurer participation decreased in the marketplaces this year.

    It is now the Republicans’ turn.  They will have to decide what they want to do with our health care system and figure out how to do it.  They now own the problems of health care, and they will be judged in future elections for how they address them.


  • November 10, 2016 9:15 AM | Deleted user
    NOVEMBER 9, 2016

    BY INES MARTINS, PHD IN NEWS.

    Researchers are working to develop a new breast-friendly, radiation-free method that may replace the unpleasant mammogram currently used to detect breast cancer.

    The new method, described in the study “Towards Dynamic Contrast Specific Ultrasound Tomography,” and published in Scientific Reports, uses ultrasounds to provide 3-D images of the breast, and is meant to reduce not only a woman’s discomfort during the procedure, but also the number of false-positive results seen frequently with current mammogram methods.

    Currently, women are screened for breast cancer through a mammogram, where the breast is squeezed tight between two plates to generate 2D X-ray images. The method is not only physically unpleasant and one of the reasons women choose to skip screening, it also comes with the risk that the radiation used in the mammograms can contribute to the development of cancer.

    In addition, mammograms generate large numbers of false-positive results. In more than two-thirds of cases where doctors find an abnormal tissue that is recommended for biopsy, it turns out that the abnormal regions are not cancer. In the meantime, women are subjected to high levels of unnecessary worrisome stress.

    Researchers have been trying to develop alternatives to this method that provide more accurate results and that reduce women’s discomfort. Recently, a team at Eindhoven University of Technology has been working on a possible alternative for mammograms.

    According to a press release, the new technology requires patients to lie on a table with their breast hanging freely in a bowl. Using ultrasounds, a 3-D image of the breast is generated and scanned for tumors. The researchers believe this method will generate far fewer false negative results.

    The technology builds up on a patient-friendly prostate cancer detection method also developed at the Eindhoven University of Technology. The approach takes advantage of the distinct vessel architecture found in tumors and healthy tissues. Tiny micro-bubbles that can be precisely monitored with an echoscanner are injected in the prostate blood vessels, allowing doctors to precisely identify the presence and location of the tumor.

    Although this method is now being tested for prostate cancer in hospitals worldwide, breast motion and size have largely limited its application in breast cancer screening.

    But researchers may have developed a new variant of the echography method that is suitable to be used in breast cancer. Libertario Demi, Ruud van Sloun and Massimo Mischi developed the Dynamic Contrast Specific Ultrasound Tomography, which uses the same micro-bubbles, but under a different principle. They use the fact that bubbles vibrate in the blood at the same frequency as the sound produced by the echoscanner, and at twice that frequency — the second harmonic.

    When the scanner captures that vibration, it knows where the bubbles are located. Similar to the micro-bubbles, the body tissue also generated harmonics, which limited the researchers’ observations. But the researchers found that, contrary to the body tissues, the gas bubbles delayed the second harmonic. And the more bubbles the sound-waves encountered, the bigger the delay.

    This, however, can be detected only if the sound is captured on the other side, which makes the technology ideal for the breast tissue.

    The researchers are now starting a collaborative effort to conduct preclinical studies with the new tool, and hope it will be included in clinical practice within 10 years, possibly in combination with other methods that will generate high-quality images that allow for highly accurate diagnoses.


  • November 08, 2016 11:00 AM | Deleted user

    Global Health

    By DONALD G. McNEIL Jr. 
    NOV. 7, 2016

    Women should see a doctor, nurse or trained midwife at least eight times during each pregnancy, with five of those visits in the last trimester, the World Health Organization said Monday as it issued 49 recommendations to prevent deaths in childbirth.

    Previously, the agency had advised women to visit clinics four times per pregnancy. It also acknowledges the important role of local midwives in poor countries where mothers must travel long distances to see doctors or nurses.

    But each visit should be with someone with at least two years’ medical training, “not a traditional birth attendant or a community health worker trained for a few weeks,” said Dr. Metin Gülmezoglu, W.H.O’s coordinator of maternal and perinatal health.

    About 300,000 women die in pregnancy or childbirth each year, the agency said, and more than six million babies die in the womb, during birth or within their first month. Many of those deaths can by prevented through simple interventions.

    Another recommendation is that every pregnant woman have one ultrasound scan before the 24-week mark to detect fetal defects and twin or triplet pregnancies and determine accurate gestational ages. Many clinics lack ultrasound machines and even electricity, Dr. Gülmezoglu said.

    The agency also recommended that all women get:

    ■ Daily iron and folic acid pills to prevent anemiasepsis and premature birth.

    ■ A tetanus shot to prevent neonatal tetanus.

    ■ Blood-sugar testing to detect diabetes.

    ■ Antibiotics when bacteria are detected in the urine.

    ■ Counseling about what affordable local foods contain vitamins and minerals, about the dangers of alcohol and tobacco, and about the need for exercise.

    Other recommendations directed to women at higher risk for problems included calcium to prevent pre-eclampsia; vitamin A to prevent night blindness; deworming drugs; and prophylactic doses of drugs to prevent malaria or H.I.V.

    The W.H.O. also recommended a spate of home remedies, like bran for constipation, compression stockings for leg swelling, antacids for heartburn and exercise or acupuncture for back pain.



  • November 08, 2016 10:56 AM | Deleted user

    by MAGGIE FOX

    Researchers reported two steps toward fighting the Zika virus Monday — one from a team that has found a potential way to protect unborn babies from the virus, and a second from a team that announced the start of human trials of a new vaccine.

    Neither offers immediate relief against the epidemic of Zika that has swept across the Americas and the Caribbean and parts of Asia, but they both provide hope of eventually being able to protect pregnant women and their babies from the infection.

    A researcher holds a tray of Zika virus growing in cells at Washington University School of Medicine in St. Louis. No treatments exist to block Zika virus in a pregnant woman from infecting her fetus and potentially causing severe birth defects. But now, researchers report that they have identified a human antibody that prevents -- in pregnant mice -- the fetus from becoming infected and damage to the placenta. The antibody also protects adult mice from Zika disease. 

    The treatment is based on the body's own defenses — an immune system particle called a monoclonal antibody that homes in specifically on the virus. In mice, it helped decrease the damage that the virus causes to developing fetuses and it also helped protect adult mice against infection in the first place.

    "This is the first antiviral that has been shown to work in pregnancy to protect developing fetuses from Zika virus," said Dr. Michael Diamond at Washington University School of Medicine in St. Louis, who helped lead the research.

    "This is proof of principle that Zika virus during pregnancy is treatable, and we already have a human antibody that treats it, at least in mice," Diamond added.

    Zika virus doesn't cause serious disease in most people, but it causes profound birth defects in babies infected in the womb. The virus, transmitted by mosquitoes and through sex, can also cause rare neurological syndromes in a few adults.

    "THIS IS PROOF OF PRINCIPLE THAT ZIKA VIRUS DURING PREGNANCY IS TREATABLE, AND WE ALREADY HAVE A HUMAN ANTIBODY THAT TREATS IT, AT LEAST IN MICE."

    Mice don't naturally catch Zika, so the study is not completely able to predict what would happen in people. But lab mice bred to be susceptible to Zika show some of the same effects that humans do, with the virus going into the brains of developing fetuses and causing extensive damage.

    The team scanned blood samples from people who had been infected with Zika, looking for antibodies that appeared especially effective against Zika. They found one that looked especially effective and named it ZIKV-117.

    "Even a single ZIKV-117 dose given five days after infection protected mice against lethal infection," they wrote in a report published in the journal Nature.

    When they gave the antibody to pregnant female mice either just before or just after infection, it reduced how quickly the virus invaded tissue.

    "These naturally occurring antibodies isolated from humans represent the first medical intervention that prevents Zika infection and damage to fetuses," said Dr. James Crowe of Vanderbilt University School of Medicine in Tennessee, who also worked on the study.

    The antibodies did not appear to be dangerous to the developing mouse pups, said Indira Mysorekar at Washington University. "The anti-Zika antibodies are able to keep the fetus safe from harm by blocking the virus from crossing the placenta."

    It's still a long way from testing in people. Pregnant women would be the No. 1 target for any Zika therapy, and doctors will need to be very sure that a treatment is both safe and effective before trying it in pregnant women.

    But the researchers say their findings also increase hope that a vaccine might be effective.

    A second team started human trials of a Zika vaccine Monday. It's an unusual trial — they will first vaccinate two-thirds of the volunteers against other, related viruses to see if that makes a difference.

    That's because Zika belongs to an unusual family of viruses that includes dengue virus and the yellow fever virus. Doctors have long known that dengue virus has unusual effects on the human immune system.

    People who are infected with dengue once don't usually get very sick. But if they get infected with a second strain of dengue, their risk of dangerous dengue hemorrhagic fever goes up.

    There are some indications that Zika may be affected by previous dengue infections.

    So Dr. Kayvon Modjarrad, who helps lead the Zika program at the Walter Reed Army Institute of Research, says volunteers will have to be free of any previous infection with or vaccination against yellow fever, dengue or Japanese encephalitis.

    Those getting Zika vaccines will be divided into three groups. One will just get a Zika vaccine.

    "One of the groups is going to be given the Japanese encephalitis virus first and then wait a period of time and then get the Zika vaccine," Modjarrad said. "Another group will get a yellow fever vaccine, wait a few months and then get a Zika vaccine."

    Military personnel often get yellow fever and Japanese encephalitis vaccines, so the researchers want to make sure a previous vaccination doesn't interfere with the new Zika vaccine.

    Later, teams will test people who've had natural dengue, yellow fever or other viral infections to see if their immune response to those infections affects how the Zika vaccine works.

    The vaccine has shown good effects in monkeys. It's made using Zika viruses inactivated by chemicals, and is based on an existing vaccine that protects against Japanese encephalitis.

    The volunteers will be tested to see if their bodies produce a healthy response that would be expected to protect them against infection.

    Florida reports more than 200 home-grown cases of Zika, caused by locally-infected mosquitoes.

    Overall, more than 1,000 cases of Zika have been reported in the state, most in people who traveled from other Zika-affected regions. The state says 133 cases involve pregnant women.

    The U.S. Centers for Disease Control and Prevention reports more than 30,000 cases in U.S. territories such as Puerto Rico, and more than 4,000 in the U.S., but says there are almost certainly many times more cases that have not been reported.

    "We urgently need a safe and effective vaccine to protect people from Zika virus infection as the virus continues to spread and cause serious public health consequences, particularly for pregnant women and their babies," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said. 

    Original article: http://www.nbcnews.com/storyline/zika-virus-outbreak/antibody-might-protect-fetus-zika-study-finds-n679161


  • November 04, 2016 8:21 AM | Deleted user

    (HealthDay)—Three injections of a therapeutic vaccine may control genital herpes as effectively as daily pills for at least a year, a new study suggests.

    Researchers tested the experimental vaccine in 310 people with herpes from 17 centers around the United States. The three shots, administered three weeks apart, appeared to reduce patients' genital lesions and the process of "viral shedding" in which they can spread the disease through sexual contact.

    Infectious disease experts hailed the vaccine as a promising development in the treatment of genital herpes. The incurable disease affects about one in every six people ages 14 to 49 in the United States, according to the U.S. Centers for Disease Control and Prevention.

    "In general terms, people receiving [the vaccine] have greater than 50 percent fewer days in which virus is present in their genital tracts, which in theory may reduce transmission," said study author Jessica Baker Flechtner. She's chief scientific officer at Genocea Biosciences, the Cambridge, Mass., manufacturer of the vaccine.

    "However, this would need to be proven in a well-powered clinical trial," she added. "Our trials have included both men and women, and to date, we have not seen a difference in the vaccine impact between genders."

    Currently named GEN-003, the vaccine is believed to work by prompting a type of white blood cell known as a T-cell to recognize and kill cells in which the virus lives, Flechtner explained.

    Patients were randomly split into seven dosing groups, including a placebo group.

    Testing was repeated periodically for 12 months after dosing and included analyzing genital swab samples for the presence of the herpes virus. The days when genital lesions were present were also recorded.

    Current herpes treatment involves taking antiviral pills that can control the length and severity of symptoms and reduce patients' outbreaks. But many patients struggle with taking their treatments regularly, infectious disease experts said.

    "The antiviral drugs available for use orally are pretty good and very safe, but they don't work on everybody, and some find it very hard to take on a daily basis," said Dr. Lawrence Stanberry. He is chair of pediatrics at Columbia University Medical Center/New York-Presbyterian Morgan Stanley Children's Hospital in New York City.

    "Some patients aren't very good about taking medication every day, and some don't like to for herpes because they say it's intrusive and reminds them they have genital herpes," added Stanberry, who was involved in herpes research for many years. "Regrettably, there's still a stigma... but some say a vaccine wouldn't remind them on a constant basis about their illness."

    Stanberry agreed with Dr. Matthew Hoffman, of Christiana Care Health System in Wilmington, Del., that it would take at least several years until the experimental vaccine might become widely available. The U.S. Food and Drug Administration has yet to approve the vaccine, a process that requires additional successful clinical trials.

    The most common side effects patients experienced after vaccination included muscle aches, fatigue and pain or tenderness at the injection site. No patients experienced life-threatening reactions, Flechtner said.

    Hoffman called the vaccine "an exciting, novel approach" to genital herpes treatment, noting that it enables patients' own immune systems to "come to the rescue and create chronic suppression."

    It could also positively influence patients' intimate relationships, he said, which can be dramatically affected by herpes flare-ups.

    "Herpes is an uncomfortable, embarrassing disease," Hoffman said. "This [vaccine] offers the opportunity to protect people going into new relationships.

    "As you can imagine, if one partner has six to 10 episodes of herpes per year and the other partner is unaffected, it can really change the nature of the relationship," he added. "But if that number goes down to one to two episodes per year based on immunization, it can help protect the other partner."

    Stanberry predicted that future research would look at combining the vaccine with antiviral pills to gauge the impact on reducing sexual transmission. On its own, the vaccine "is likely to reduce the risk, but the likelihood of eliminating the risk is exceedingly small," he said.

    The study was presented at the Infectious Disease Society of America's annual meeting in New Orleans that ended Oct. 30. Research presented at conferences typically hasn't been peer-reviewed or published, and results are considered preliminary.

     Copyright © 2016 HealthDay. All rights reserved. 


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