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Huntsman Cancer Institute Announces Major New Training Initiative For Cancer Research
The National Cancer Institute (NCI) has licensed the University of Utah"s Huntsman Cancer Institute (HCI) and Department of Biomedical Informatics as a cancer Biomedical Informatics Grid (caBIG®) Support Service Provider in the category of Training Materials and Services. The distinction is the first to be awarded to an academic medical institution.
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President Obama To Visit Ghana Friday
IRIN reports that Ghanaians "are mixing high hopes with caution" in anticipation of President Obama"s arrival in the country Friday - "his first visit to sub-Saharan Africa." Obama is expected to "make a major policy statement," according to IRIN. The article looks back at some of the commitments that former Presidents Bush and Clinton previously made to Africa (7/8).
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New York Times Examines Changes In Surrogacy Process In Recent Years
The medical, legal and interpersonal processes involved with a surrogate birth have changed significantly since the controversial "Baby M" case two decades ago, the New York Times reports. In the case, the surrogate was the infant"s biological mother and unsuccessfully sought custody of the child after birth. The Times reports that the legal proceedings in the case helped reinforce the validity of surrogacy contracts, which are now standard practice.Most couples today use a gestational surrogate -- meaning that they have no genetic link to the woman carrying the fetus -- and some choose to maintain friendships with the surrogate after birth. According to the Times, people might choose gestational surrogacy if the woman lacks a uterus, has a malformed uterus, must take medication incompatible with pregnancy, or has had repeated miscarriages or failures at in vitro pregnancies. Male couples or single men might also use this option.Legal protections have strengthened since the Baby M case, although surrogacy remains illegal in some states. State laws also vary in the steps required to ensure that the parents" names, rather than the surrogate"s, are on the child"s birth certificate.Despite an increase in popularity, surrogacy remains "fraught with controversy" over criticisms that compensation to surrogates amounts to "baby selling" and exploitation of low-income women, according to the Times. However, surrogacy advocates say that most women who choose to become surrogates have altruistic motives. Surrogates typically receive between $15,000 and $20,000 as compensation for carrying the pregnancy and undergoing hormonal preparations. The Times reports that reputable agencies and lawyers who specialize in surrogacy help guard against exploitation and spurious motives for seeking a surrogate pregnancy. Prospective surrogates and parents typically undergo psychological screening and legal guidance, and most lawyers require that surrogates meet certain age and health criteria (Brody, New York Times, 7/21).
Mental Health

AMCP Endorses Bipartisan Follow-On Biologics Legislation

The Academy of Managed Care Pharmacy (AMCP) has endorsed bipartisan legislation that would create a regulatory pathway for the approval of follow-on biologics and allow competition on brand-name biologics after five years of marketing exclusivity instead of the pharmaceutical industry"s preferred 14-year window. AMCP strongly supports H.R. 1427 and S. 729, the "Promoting Innovation and Access to Live-Savings Medicine Act of 2009," the Academy said in a June 22 letter to Rep. Henry Waxman (D-Calif.), Chairman of the House Energy and Commerce Committee, and Sen. Charles Schumer (D-N.Y.). Waxman and Schumer are lead sponsors of the respective bills. Biologics are drugs made from living cells rather than chemical compounds. Brand-name biologics hold a virtual monopoly on the market because the U.S. Food and Drug Administration (FDA) currently lacks a regulatory pathway to approve less costly versions. "Safe alternatives to some biologics have existed for more than 20 years," Judith Cahill, executive director of AMCP, said in the letter. "In anticipation of the expiration of patents for older biologic products and the new biologic products that are expected to come to market, and in recognition of the fact that these products are often prohibitively expensive, it is imperative that Congress address this issue," she added. According to the legislation, a five-year window of marketing exclusivity would not begin at the time of the bill"s enactment, but rather from the time when the brand-name drug was first approved. In the case of some biologics that have been on the market for 20 years with no competition, drug manufacturers would be able to seek approval for their follow-on versions "right away," according to a release posted on Schumer"s website. AMCP notes that the field of biotechnology holds great promise for the development of new therapies to prevent, treat or cure disease. At the same time, biologics are consuming an ever larger percentage of overall spending on prescription drugs, often putting them out of reach of patients, the Academy adds. AMCP supports an expedited review process by the FDA, but one that recognizes there are potentially significant differences between a follow-on biologic product and a generic chemical drug. "With respect to the issue of interchangeability, AMCP believes that any determination of interchangeability by the FDA should be available to, but not binding on, managed care organizations and pharmacy and therapeutic committees in their assessment as to the use of follow-on biologic products in the development of their formularies," the Academy said. AMCP believes the federal government should provide incentives to encourage innovator companies to pursue the development of safe and effective biologics while encouraging competition to ensure a robust marketplace. "The approach taken in your legislation appears to be consistent in meeting these objectives," Cahill told the lawmakers in the letter. Academy of Managed Care Pharmacy


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