FDA Rejects Merck Cholesterol Drug
An experimental cholesterol drug developed by Merck & Co. has been rejected by the U.S. Food and Drug Administration.
In issuing the "not approvable" letter, the agency said Monday that it needed more information about Cordaptive, also known as MK-0524A. The FDA also rejected Cordaptive as a brand name for the drug, the Associated Press reported.
The drug lowers bad (LDL) cholesterol and raises good (HDL) cholesterol, according to Merck officials, who said they'll make another application for FDA approval of the drug, but under the brand name Tredaptive.
"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate" the drug, Peter S. Kim, president of Merck Research Laboratories, said in a prepared statement, the AP reported. "We firmly believe that MK-0524A provides physicians with an important option to manage their patients' cholesterol."
Last week, an advisory committee recommended that European countries approve the drug, Merck noted.
White House Hinders EPA Action on Toxic Chemicals: Report
The U.S. Environmental Protection Agency's capacity to determine the health threat posed by toxic chemicals is being compromised by the Bush administration, which allows nonscientists to have a larger -- often secret -- role in the process, according to a Government Accountability Office (GAO) report.
The GAO said allowing the Defense Department, the Energy Department, NASA and other agencies to be involved in the early stages of the process adds years of delay to the EPA's ability to take action on dangerous chemicals and threatens the program's credibility, the Associated Press reported.
In many cases, discussions involving outside agencies "occur in what amounts to a black box" of secrecy because the Bush administration claims they're private executive branch meetings, said the GAO, which noted this kind of secrecy "reduces the credibility of the ... assessments and hinders the EPA's ability to manage them."
The GAO report will be the subject of a Senate Environment Committee hearing Tuesday.
"The (EPA) scientists feel as if they have lost complete control of the process, that it's been taken over by the White House and that they're calling the shots," said an EPA scientist who spoke on condition of anonymity, the AP reported.
Daycare May Reduce Children's Leukemia Risk
Children who attend daycare or playgroups are about 30 percent less likely to develop the most common type of childhood leukemia, according to University of California, Berkeley researchers who reviewed 14 studies involving nearly 20,000 children, including 6,000 who developed acute lymphoblastic leukemia (ALL).
It's believed that early infections that prime the immune system may help fight off ALL, which accounts for more than 80 percent of leukemia cases among children, and most often occurs between ages 2 to 5, BBC News reported.