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Researchers Suggest That Oxidative Stress Is Strongly Evident In The In-Utero Environment Of The Fetus With Down Syndrome
A paper published in the Proceedings of the National Academy of Sciences by Tufts Medical Center and Tufts University researchers reports that amniotic fluid surrounding Down syndrome fetuses shows oxidative stress, a condition that could harm fetal cells and play a role in affected individuals. The results demonstrate secondary adverse consequences of Down syndrome and suggest potential prenatal therapies.

New York Becomes First State To Allow Payment For Donating Eggs For Stem Cell Research
New York"s Empire State Stem Cell Board earlier this month decided to allow embryonic stem cell researchers who receive state funding to compensate women for donating their eggs for use in research, making New York the first state to enact such a policy, the Washington Post reports (Stein, Washington Post, 6/26). According to the New York Times, the New York state Legislature in 2007 allotted $600 million for an 11-year stem cell research plan (Nelson, New York Times, 6/26). Under the board"s decisions, researchers receiving the state funding may pay women up to $10,000 to compensate them for the time, discomfort and expenses associated with egg donation. David Hohn, vice chair of the board"s two committees that endorsed the decision, said that the board "could not distinguish ethically between the payment for in vitro fertilization, which is very well precedented, and the compensation for donation for research." The board said researchers should follow the same guidelines as infertility clinics that receive donated eggs for infertile couples. Under those guidelines, payments exceeding $5,000 must be justified, and those exceeding $10,000 are considered excessive (Washington Post, 6/26). Robert Klitzman, director of the master"s degree program in bioethics at Columbia University and a member of the stem cell board"s ethics committee, said the payments will be carefully evaluated by an institutional review board (New York Times, 6/26).The Post reports that the decision goes against policies in other states that offer funding for embryonic stem cell research, as well as against current guidelines from scientific organizations like the National Academy of Sciences (Washington Post, 6/26). NAS guidelines, for example, prohibit paying women for eggs used in stem cell research. Similarly, the internal guidelines for New York-based groups like Rockefeller University, Cornell University and the Sloan-Kettering Institute prohibit financial compensation for donated eggs. However, researchers say that efforts to recruit unpaid donors have been unsuccessful and that the board"s decision will give New York an advantage in stem cell research (New York Times, 6/26). The decision was welcomed by scientists and other proponents of stem cell research, who said it will allow them to further research in areas like therapeutic cloning. The process, also known as somatic cell nuclear transfer, involves replacing the genetic material in a human egg with genes from the nucleus of a patient"s cell. The egg is then developed into an early embryo, which, in theory, could be used to produce stem cells that the patient"s immune system would not reject. Although the procedure has been unsuccessful so far, researchers say the board"s decision will help attract more donors, which will allow for more experiments. Egg donation involves weeks of hormone injections to stimulate the ovaries and a painful egg extraction procedure, which carries rare but serious risks. Other attempts at soliciting women to donate eggs for stem cell research have been unsuccessful, according to the Post.Some critics of the board"s decision said that paying women for eggs could lead to exploitation, especially for low-income women. Thomas Berg -- a Roman Catholic priest who is director of the Westchester Institute for Ethics and the Human Person and a member of the Empire State Stem Cell Board"s ethics committee -- said that in the current economic recession, paying a woman $10,000 to participate in a research project is an "undue inducement." He added that he thinks it "manipulates women" and "creates a trafficking in human body parts." Other opponents of the decision questioned if compensating women who donate eggs for research is indeed equivalent to the process for infertility treatments. Jonathan Moreno, a professor of bioethics at the University of Pennsylvania, said that donors recognize that egg donation for infertility treatments is a "very concrete good for society" but that "you can"t be sure any biological material you collect for research wi
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Sexual Health

Vimpat(R) (lacosamide) C-V, A New Antiepileptic Drug (AED), To Be Available In U.S. Pharmacies

Vimpat(R) (lacosamide) C-V, a new antiepileptic drug (AED), will be available in U.S. pharmacies by the first week of June 2009. Vimpat was approved by the U.S. FDA in the fall of 2008 for the use as an add-on therapy for the treatment of partial-onset seizures in people 17 years and older with epilepsy. Vimpat approval is based on safety and efficacy data from three pivotal trials with approximately 1,300 patients. In the studies, many patients taking Vimpat had their seizures reduced by half or more and experienced reductions in median seizure frequency at rates that were significantly greater than those in the placebo group. Across the pivotal trials, 2.7% of the patients taking 200 mg/day and 3.3% of patients taking 400 mg/day of Vimpat were seizure free throughout the 12-week maintenance phase, vs. 0.9% of placebo patients. Vimpat demonstrated efficacy and safety when combined with a broad range of existing AEDs. Vimpat is available in 50, 100, 150, and 200 mg strengths, and as an IV infusion. Formulations can be used interchangeably at equivalent dosing. Vimpat should be taken twice daily; the daily dose should not exceed 400 mg. In clinical trials, treatment-related adverse events were mostly characterized as "mild" or "moderate" in severity and included dizziness, headache, diplopia, and nausea. Epilepsy is a chronic neurological disorder affecting approximately three million people in the U.S. -- Epilepsy can affect anyone at any time; it is a common neurological condition that can be life long -- Less than half (47%) will attain seizure control with the first AED -- More than 30% will continue to experience seizures despite trying two or more AEDs -- 200,000 new cases are diagnosed each year, a number that is expected to grow at a faster rate as the population ages Important safety information about Vimpat in the U.S. Vimpat tablets are indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy who are 17 years and older. Vimpat injection is indicated as short-term replacement when oral administration is not feasible in these patients. Patients should be advised that Vimpat may cause dizziness, ataxia, and syncope. Caution is advised for patients with known cardiac conduction problems, who are taking drugs known to induce PR interval prolongation, or with severe cardiac disease. In patients with seizure disorders, Vimpat should be gradually withdrawn to minimize the potential of increased seizure frequency. Multiorgan hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, treatment with Vimpat should be discontinued. AEDs increase the risk of suicidal behavior and ideation. Patients taking Vimpat should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. The most common adverse reactions occurring in greater than or equal to 10 percent of Vimpat-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia. Vimpat(R) is a registered trademark under license from Harris FRC Corporation. About UCB UCB, Brussels, Belgium is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing more than 10,000 people in over 40 countries, UCB achieved revenue of 3.6 billion Euro in 2008. UCB is listed on Euronext Brussels (symbol: UCB). Forward looking statement This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees. UCB


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