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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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The U.S. Food and Drug Administration announced that it is conducting a safety review of Xolair (omalizumab), a drug used to treat certain adults and adolescents with moderate-to-severe persistent asthma.
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Could Estrogen Improve Outcomes After Traumatic Brain Injury, Shock?
UT Southwestern Medical Center researchers are conducting two pilot clinical trials to determine whether a single, early dose of estrogen can improve survival and neurological outcomes after severe traumatic brain injury or traumatic hemorrhagic shock.
Diagnostics

Vi Typhoid Vaccine Proves Highly Effective In Young Children

A new study has found that a currently available yet underused vaccine against typhoid fever is highly effective in young children and protects unvaccinated neighbors of vaccinees. The study, conducted by the International Vaccine Institute (IVI) in collaboration with the National Institute of Cholera and Enteric Diseases (NICED) in Kolkata, India, was published in the July 23 issue of the New England Journal of Medicine (NEJM). The IVI, based in Seoul, Korea, is a non-profit international organization devoted exclusively to development and deployment of new vaccines primarily for people in developing countries. Typhoid fever remains an important cause of illness and death in the developing world, killing an estimated 216,000 to 600,000 people annually. Multidrug-resistant Salmonella typhi has spread to many parts of the world, limiting the ability to treat typhoid fever with available antibiotics. Typhoid is both a waterborne and food-borne gastrointestinal infection, with incidence approaching one percent of the population annually in certain endemic areas. Experts say that in the absence of affordable programs to assure safe water and better sanitation, short and medium-term efforts need to be directed towards prevention through vaccines. Safe and effective vaccines against typhoid fever exist, but they are used primarily for affluent travelers to developing countries, rather than for the poor residing in these countries, who account for almost all the global burden of typhoid morbidity and mortality. One of these vaccines, Vi polysaccharide, is ideally suited to use in developing countries because it is cheap (about $.50 per dose) and requires only a single dose. Despite a recommendation by the World Health Organization for use of Vi vaccines in developing countries, its use has been limited, partly because of doubts about Vi"s ability to protect pre-school age children. This age group is at exceptionally high risk in the poorest settings. There are also doubts about Vi"s ability to confer "herd protection," or protection of unvaccinated residents living in highly vaccinated areas. To address these uncertainties, the IVI in collaboration with NICED conducted a phase 4 cluster-randomized effectiveness trial, which randomized 80 geographic clusters of an urban Kolkata slum to either Vi or a control vaccine. Over two years of follow-up, the Vi group was shown to have 61 percent fewer episodes of typhoid than the control group. Protection of vaccinated children under five years of age by Vi was even higher, 80%. Interestingly, unvaccinated neighbors of Vi vaccinated persons had a 44 percent lower risk of typhoid, indicating that Vi vaccine conferred substantial herd protection. The overall level of protection among all residents of the Vi clusters, regardless of whether they were vaccinated was 57 percent. Since the coverage of residents of the Vi clusters was about 60%, this observation indicates that Vi vaccine prevented as many cases of typhoid in the total population as a vaccine that was nearly 100% protective in vaccinated persons. "The protection for children under the age of five years is important because this age group has been shown to be at high risk for typhoid fever in many areas where the disease is endemic," said Dr. John Clemens, Director-General of the IVI and an international expert in vaccine evaluation. In a separate IVI study conducted in five Asian countries and supported by the Bill and Melinda Gates Foundation, children less than five years of age were found to have high rates of typhoid in Kolkata, India, Jakarta, Indonesia and Karachi, Pakistan, confirming that the disease is not limited to school-aged children and adults. The IVI-NICED study, which was supported by the Gates Foundation and the governments of Korea, Sweden, and Kuwait, also revealed that delivering the low-cost Vi typhoid vaccine is logistically and programmatically possible. "The fact that the level of overall protection (57 percent) was similar to the adjusted level of total protection among vaccinees (61 percent), despite vaccine coverage of only about 60 percent of the subjects, underscores the importance of herd protection by the Vi vaccine," said Dr. Clemens, a co-author of the study. "It also suggests the need for consideration of herd protective effects in future deliberations about the use of this vaccine in developing countries." Meanwhile, in a separate vaccine development project, IVI laboratories have more than tripled the manufacturing yield of Vi polysaccharide, which is expected to further reduce the vaccine"s production cost, thus making it more accessible for developing countries. The production technology for the high-yield Vi polysaccharide is being transferred to high-quality producers in developing countries. Tae Kyung Byun International Vaccine Institute


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