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Evidence Challenges Effectiveness Of Embryo Screening For Older Women
There is growing evidence that a procedure for identifying chromosomal abnormalities in embryos prior to in vitro fertilization is ineffective at helping older women become pregnant, the Wall Street Journal reports. The procedure -- known as pre-implantation genetic screening, or PGS -- is performed in dozen of U.S. fertility clinics and sometimes marketed to older women as a way to increase the odds of a healthy live birth. PGS involves extracting a single cell from a six-cell embryo and inspecting it for chromosomal abnormalities known as aneuploidies; unaffected embryos can then be implanted through IVF. Women older than age 35 have a higher risk of aneuploidies, in which embryos have fewer or more than the usual number of 23 pairs of chromosomes. Aneuploidies can trigger early miscarriage or certain genetics conditions, such as Down syndrome. Most medical experts agree that embryo screening is capable of significantly reducing the risk of Down syndrome and other serious chromosome-related illnesses. However, evidence from several studies increasingly suggests that the procedure does not increase older women"s chances of healthy live births. The American Society for Reproductive Medicine released an initial opinion about PGS in 2007, saying that available evidence does not support the use of embryo screening to increase live birth rates in older women. Andrew La Barbera, scientific director of the society, said, "Since that time, there have been several more trials that have reached the same conclusion." Another shortcoming is that most clinics can only test for fewer than half of the 23 chromosomes, meaning that many defects can go undetected. However, medical experts say that the use of PGS has increased in the two years since ASRM issued its recommendations. According to the Journal, PGS can add more than $2,000 to the roughly $10,000 cost of one IVF cycle. Very few health insurers cover PGS, though some pay for IVF. Some experts contend that studies showing a lack of clinical benefit from PGS do not use more efficient biopsy techniques that can prevent damage to the embryo. Santiago Munne, scientific director for Reprogenetics, said that the treatment is "effective." In a 2007 study, Munne and colleagues used PGS to reduce the rate at which patients miscarried. However, the chances of a woman getting pregnant largely were unchanged, which the authors said could be attributed to the small number of study participants (Naik, Wall Street Journal, 6/1).
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Merck Seeks European License For Cladribine for relapsing remitting MS
Merck Serono announced that it is seeking a European license for cladribine, its oral therapy that is in late-stage clinical trials for relapsing remitting MS.
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U.S. Moves Forward With Preparations For H1N1 Vaccination Campaign
The Obama administration on Thursday said a nationwide vaccination program could begin as early as mid-October to protect Americans from the H1N1 (swine flu) virus and pledged $350 million to help prepare communities across the country for this effort, the Washington Times reports (Ward, 7/9).
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Wistar Wins Patent For 'Universal' Flu Vaccine Tech, Seeks Development Partner

Philadelphia"s Wistar Institute has been issued U.S. patent No. 7,527,798 for a synthetic vaccine technology with the potential to be developed into a universal flu vaccine that could eliminate annual flu shots and protect against pandemics. Wistar is seeking a corporate partner to license and develop the vaccine, which has been tested in animals and currently is in prototype form. The patent pertains to technology developed by Walter Gerhard, professor emeritus and former professor of immunology at Wistar, and Laszlo Otvos, formerly an associate professor of immunology at Wistar. The vaccine prototype contains an engineered peptide that mimics a viral coat protein called M2 that remains largely constant from year to year. In contrast, current flu vaccines trigger an immune response to a pair of viral-coat proteins known as hemagglutinin and neuraminidase, which mutate constantly and are the reason the flu vaccine must be changed every year to target the appropriate subtypes. Wistar believes that a vaccine targeting M2 has the potential to protect against all strains of the influenza A virus, including the H1N1 swine flu subtype. Other academic laboratories and companies have been developing vaccines that target the M2 protein. But development of a universal vaccine has been slow because humans do not mount a strong immune response against M2. "What we"ve done is taken the M2 and stimulated the body to make something like M2, and linked it to some peptide that will then take this molecule and present it to the right immune cells for a good stimulus," explains Meryl Melnikoff, director of business development for Wistar. "The unique thing is we"ve modified the antigen in such a way to create a good immune response in mice." In preclinical studies Gerhard and Otvos administered the experimental vaccine intranasally to mice. After vaccination, the scientists noted a steep rise in M2-specific antibodies in blood samples, and the mice exhibited protection against influenza virus infection of the respiratory tract. The findings were published in 2003 in Vaccine, and the patent is based on the research behind that paper. Wistar is now seeking a partner to license the vaccine technology "or do some collaborative research with us," Melnikoff says, because as a basic research institute, Wistar is ill-equipped to conduct human testing. Genomeweb


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