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Study To Follow Pregnant Women To Better Understand Causes, Early Signs Of Autism
NIH and the advocacy group Autism Speaks are enrolling 1,200 pregnant women who have other children with autism spectrum disorders to participate in a large study that aims to identify early signs of the condition and its possible causes, the Wall Street Journal reports. Women who participate in the study -- known as the Early Autism Risk Longitudinal Investigation, or EARLI, study -- will be monitored throughout their pregnancies, and their infants will be monitored until age three. The Centers for Disease Control and Prevention estimates that one in 150 children in the U.S. has an autism spectrum disorder, which includes autism, Asperger"s syndrome and pervasive developmental disorders. The study will focus on women who already have one child with an autism spectrum disorder because such women have a higher chance of having another child with the condition. Craig Newschaffer, the study"s lead investigator and a department chair at Philadelphia"s Drexel University School of Public Health, said, "By studying families who are already affected by autism, we feel we have the best chance at learning how genetics and environmental factors could work together to cause autism." Autism usually is characterized by social interaction and communication impairments, as well as unusual interests or behaviors. Although there is no cure for autism, its symptoms can be improved through therapy and medication, the Journal reports.According to Newschaffer, researchers throughout the study will collect blood and urine for DNA analysis. Samples also will be collected from the umbilical cord, placenta and meconium -- the infant"s first stool -- after birth. Infants born during the study will be provided with a series of developmental assessments, and older siblings with autism also could receive assessments to confirm their diagnosis (Corbett Dooren, Wall Street Journal, 6/9).

Washington Times Examines Proposed Teen Pregnancy Prevention Initiative In Obama Budget Plan
The Washington Times recently included a two-part series examining President Obama"s proposed reallocation of abstinence-only sex education funding in his 2010 budget plan. The proposal would redirect funding toward a new Teen Pregnancy Prevention Initiative that uses comprehensive sex education curriculums. Summaries of the series appear below.~ Part 1: Obama"s budget proposal states that funds for the Teen Pregnancy Prevention Initiative should go to programs that are proven to help delay first sex, increase contraceptive use or reduce teen pregnancy, though a few advocates of comprehensive sex education say such goals are laudable but too narrow, the Times reports. William Smith -- vice president for public policy for the Sexuality Information and Education Council of the United States -- and James Wagoner -- president of Advocates for Youth -- wrote in a June 17 blog entry that preventing unintended pregnancy among teens is "incredibly important" but that it is "not the only sexual and reproductive health issue facing our nation"s youth." They continued that it would be more beneficial to "expand the scope" of the initiative so it can serve "all young people in all communities, including lesbian, gay, bisexual, transgender and questioning youth, whose needs fall wholly outside of the narrow teen-pregnancy-prevention framework." According to the Times, Smith said in an interview that money allotted for the initiative would be best used if it went to programs focused on "good outcomes" for youth, "not these disaster-aversion silos that don"t serve us well." Wagoner said that advocates have been "very clear in giving the president credit for shifting tracks here in a big way" by ending funding for abstinence-only sex education. However, he added that it is "our job to press for the right destination" and to see the changes implemented into law (Wetzstein, Washington Times, 6/28).~ Part 2: Some supporters of Obama"s proposal argue that it is "exactly the right idea, at the right time," as the U.S. teen birth rate has increased in the last two years after 14 years of decline, the Times reports. Sarah Brown, CEO of the National Campaign To Prevent Teen and Unplanned Pregnancy, said that Obama"s proposal is the "first really focused expenditure on effective teen pregnancy prevention programs." Brown noted that the U.S. has the highest rates of teen pregnancy and birth in the industrialized world. She said that the best programs will address one or more of the three goals of the initiative -- delaying first sex, increasing contraceptive use or reducing teen pregnancy. Last month, about 175 organizations sent a letter to Obama and members of Congress calling for an expanded initiative that would include subjects such as sexually transmitted infections and abusive relationships. However, Brown said that many teen pregnancy prevention programs include discussion of STIs and other areas, "[s]o we really don"t see much tension here" (Wetzstein, Washington Times, 7/5).
News of the day
Improvements In Sexual And Reproductive Health Of Teens And Young Adults Slowing
After a period of improvement, trends in the sexual and reproductive health of U.S. teens and young adults have flattened, or in some instances may be worsening, according to a new report from the Centers for Disease Control and Prevention.
Sexual Health

Genzyme And Isis Announce That Mipomersen Phase 3 Study In Patients With Homozygous Familial Hypercholesterolemia Met Primary Endpoint

Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) today announced that the phase 3 study of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) met its primary endpoint, with a 25 percent reduction in LDL cholesterol after 26 weeks of treatment, vs. 3 percent for placebo (pAbout Familial Hypercholesterolemia (FH) FH is a genetic disorder in which patients are unable to properly metabolize LDL cholesterol, resulting in elevated LDL-C levels. FH patients experience a markedly increased risk of premature cardiovascular disease (CVD) and CVD-related death. There are two forms of FH: homozygous (hoFH), where the same defective gene is inherited from both parents, or heterozygous (heFH), where the defective gene is inherited from only one parent so that some function is preserved. The homozygous form of FH is a very rare condition estimated to affect approximately one in a million people. HoFH patients can have LDL-C levels greater than 600 mg/dL and are at very high risk for early coronary events and sudden death. Because many patients are resistant to the lipid-lowering effects of currently available therapies, effective treatment of hoFH patients is difficult. HeFH is a more common form of the disorder, with a prevalence of approximately one in 500, and results in untreated LDL cholesterol levels of approximately 300 mg/dL, double those of the general population. About Mipomersen Mipomersen is a first-in-class apo-B synthesis inhibitor currently in late-stage development. It is intended to reduce LDL-C by preventing the formation of atherogenic lipoproteins. Genzyme and Isis are currently conducting several clinical trials of mipomersen, including: - A phase 3 study in patients with heterozygous FH; - A phase 3 study in patients with severe hypercholesterolemia; - A phase 3 study in hypercholesterolemic patients at high risk for coronary heart disease; and - A phase 2 study in high-risk, high-cholesterol patients who are intolerant to statins. Data from these trials are expected to be available at the time of the initial hoFH regulatory filing, and will continue to build the body of clinical evidence around the treatment"s value in managing high-risk, high-cholesterol patients. In 2008, Genzyme and Isis completed a licensing agreement that provides Genzyme with exclusive worldwide rights to mipomersen, which was discovered and initially developed by Isis. Isis Pharmaceuticals Inc.


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