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Malawian Government Supplies 250,000 HIV-Positive Citizens With Free Antiretrovirals
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European CHMP Adopts Positive Opinion For Aztreonam Lysine
Gilead Sciences, Inc. (Nasdaq:GILD) announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company"s Marketing Authorisation Application for aztreonam lysine 75 mg powder and solvent for nebuliser solution (aztreonam lysine) for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 18 years and older. The opinion is for conditional approval, contingent on the successful completion of an ongoing study.
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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
Diagnostics

Evaluating More Lymph Nodes May Not Improve Identification Of Late-Stage Colorectal Cancer

Surgically removing and evaluating an increasing number of lymph nodes does not appear to identify a greater number of patients with stage III colorectal cancer, according to a report in the July issue of Archives of Surgery, one of the JAMA/Archives journals. Colorectal cancer is the third most common type of cancer and the third leading cause of cancer-related death in the United States, according to background information in the article. More than 80 percent of newly diagnosed colorectal cancer patients will have locoregional disease (limited to a small region) and will be offered surgery that may cure their illness. The status of lymph nodes near the cancer has been recognized as the most powerful prognostic factor for recurrence and survival in these patients. "Accurate lymph node staging also is important for determining prognosis and the need for adjuvant chemotherapy," the authors write. "In addition, lymphadenectomy [lymph node removal] may be therapeutic; several studies have shown a positive association between the number of lymph nodes removed and survival for patients with negative and positive lymph nodes." In 1990, the World Congress of Gastroenterology first proposed a minimum threshold of 12 lymph nodes to be removed during surgery for colorectal cancer. This benchmark has since been adopted as a quality measure for surgical practice by multiple organizations. Sachin S. Kukreja, M.D., and colleagues at Rush North Shore Medical Center (now Skokie Hospital, NorthShore University HealthSystem), Skokie, Ill., and Rush University Medical Center and Rush Medical College, Chicago, in late 2004 began a multidisciplinary institutional initiative to increase the number of lymph nodes removed during colorectal cancer surgery. The effort involved discussing unacceptably low lymph node counts and reviewing the rationale for increased lymph node evaluation at multidisciplinary cancer committee meetings, along with a program of institutional awareness of the issue and a change in pathologists" lymph node assessment technique. The researchers then evaluated 701 consecutive colorectal cancer cases treated with surgery from 1996 through 2007. The initiative appeared successful in increasing the numbers of lymph nodes removed-when patients operated on in January 2005 or after were compared with those who had surgery before the initiative began, both the average number of lymph nodes removed (17.3 vs. 12.8) and the percentage of patients who had at least 12 lymph nodes removed (71.6 percent vs. 53 percent) increased. However, the proportion of patients diagnosed with stage III colorectal cancer did not change, with 204 of 553 (36.9 percent) of the earlier cases and 48 of 148 (32.4 percent) of the late cases having positive lymph nodes. "Overall, our improvement in lymph node yield demonstrates the value and impact of communication through a multidisciplinary initiative engaged in adherence to recommended standards and improving quality of care," the authors conclude. However, "our data suggest that mandatory harvest of a minimum of 12 lymph nodes as a quality indicator or performance measure appears unfounded." Arch Surg. 2009;144[7]:612-617. Archives of Surgery


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