Covance Makes iPledge Changes
Covance, the company that developed and manages the iPLEDGE risk management program for the acne drug isotretinoin, has formally incorporated changes to the program that were finalized by the Food and Drug Administration in early October. The most important change was an elimination of the 23-day lockout period for women of childbearing potential. At that time, the FDA also said the program would now start the 7-day window for the initial prescription for women of childbearing potential from the date of pregnancy testing, instead of the date of the office visit. For more information on all of the changes, visit
Melanoma Grant Worth $1.8 Million
Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, has been chosen to be the lead institution for a $1.8 million collaborative melanoma research project funded by a grant from the W.M. Keck Foundation. Also participating are the California Institute for Technology, Childrens Hospital Los Angeles, and the University of Southern California. Researchers will work together to develop a technology that uses blood stem cells to derive T lymphocytes that will be genetically engineered to turn into killer T cells and home in on the melanoma antigen called MART-1. This would be a big advance because only a very small number of melanoma patients' T cells recognize MART-1. Positron emission tomography will be used to evaluate the cells' attack rate and success, according to a statement from the Jonsson Center. Human trials are expected to start early this year.
FDA Can't Fulfill Mission
Three members of the Food and Drug Administration's Science Board issued a damning report on the state of the agency, saying that "the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities." The authors wrote that the FDA has become weak and unable to fulfill its mission because of the increasing number of demands and an inability to respond because of a lack of resources. "FDA's inability to keep up with scientific advances means that American lives are at risk," wrote the panelists, adding that the agency can't fulfill its mission "without substantial and sustained additional appropriations." The report was written by Gail Cassell, Ph.D., vice president of scientific affairs at Eli Lilly & Co.; Dr. Allen D. Roses, the Jefferson Pilot Corp. Professor of Neurobiology and Genetics at Duke University; and Dr. Barbara J. McNeil, head of the health care policy department at Harvard Medical School. Members of the Coalition for a Stronger FDA and the FDA Alliance urged Congress to heed the report's warnings. "FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources," said coalition member Don Kennedy, Ph.D., a former FDA commissioner and editor in chief of the journal Science, in a statement.
Access Reduced by Cost
Forty million Americans can't get access to needed health care, and 20% said the main reason was because they could not afford the services, according to a report issued in December by the Centers for Disease Control and Prevention. Health, United States, 2007, is a compilation of pertinent data gathered by the CDC's National Center for Health Statistics. According to the report, in 2005, 1 in 10 people between the ages of 18 and 64 years reported that they had not been able to get prescription drugs in the past year because of the cost. Another 10% said they had delayed necessary medical care because of cost issues. The report also found that 30% of 18- to 24-year-olds were uninsured, and another 30% of that age group did not have a usual source of medical care. Ten percent of 45- to 64-year-olds did not have a usual source of care. The report highlighted some other age-specific data as well. For instance, about 70% of men and more than 80% of women over age 75 either had hypertension or were taking antihypertensives in 2001-2004, compared with about 35% of adults aged 45-54. And about 20% of 16- to 17-year-olds, and more than 40% of 18- to 25-year-olds reported binge alcohol use in 2005; 20% of the latter age group reported illicit drug use in the previous month.
Improvement Through Transparency
Transparency of quality and price information is important or very important for improving the U.S. health care system, according to 77% of 241 health care opinion leaders surveyed in October 2007 by Harris Interactive on behalf of the Commonwealth Fund and Modern Healthcare. Stimulating improvement in provider performance was rated an important or very important goal of transparency by 84% of respondents; 76% also cited encouraging payers to reward quality, and 66% thought helping patients make informed choices was an important or very important goal. More than half (56%) thought that a new public-private national entity should be responsible for setting the standards for measurement and reporting, with 75% saying the costs of such measurement and reporting should be shared by providers, insurers, and the government. Most (88%) felt that adoption of health information technology was an important or very important component of any system of transparency. The online poll surveyed peer-identified leaders and experts in academia, research, health care delivery, business, insurance, government, and labor and advocacy groups.