Bioterror Remedy Program Yielding Few Results: Report
A bioterror drug stockpiling program whose roots stem from the 2001 anthrax-by-mail attacks has produced only a fraction of the anticipated remedies, The New York Times reported Monday.
Project Bioshield, a $5.6 billion effort to gather remedies for a host of possible terror threats, is partly stymied by government agencies that can't seem to decide which treatments they want and in what quantities, the newspaper reported.
Also unable to attract the world's largest drugmakers, the government has enlisted smaller start-up firms with no proven history, the Times said.
The problem is most acute in development of a new anthrax vaccine. The two biotech firms picked for the $900 million effort have hired lobbyists to attack each other's pending products, and the delivery date is far behind schedule, the newspaper said.
Outside observers, including Michael Greenberger, director of the Center for Health and Homeland Security at the University of Maryland, offered grim assessments of Project Bioshield's progress.
"The inept implementation of the program has led the best brains and the best scientists to give up, to look elsewhere or devote their resources to medical initiatives that are not focused on biodefense," he told the Times.
A spokesman for the U.S. Department of Health and Human Services acknowledged problems, but denied the project was floundering. "Medical discovery is an unpredictable process," spokesman Bill Hall told the newspaper. "It is the nature of science."
Novel Drug Approved for Fungal Infections
A new molecular drug designed to prevent fungal infections in post-surgical patients and others with weaker immune systems has been approved by the U.S. Food and Drug Administration.
Schering Corp.'s Noxafil (posaconazole) contains a substance that has never before been approved in the United States, the FDA said in a statement. The drug was approved to prevent infections caused by certain molds and yeast-like fungi called Aspergillus and Candida.
While people with healthy immune systems are normally unaffected by these fungi, they tend to cause invasive infections in people who have had bone-marrow transplants and people with low white blood cell counts, the agency said.
Noxafil's safety and effectiveness were evaluated in clinical trials involving 1,844 people between ages 13 and 82. Common side effects included nausea, vomiting, diarrhea, rash, a drop in blood potassium levels, and in rare cases, problems with heart or liver function.
The drug should be taken with a full meal to allow for adequate absorption into the body, the FDA said.
Preemies Die After Getting Wrong Drug Doses
Two premature infants died after an Indianapolis hospital gave them adult doses of a blood thinner, the Associated Press reported.
Four other infants at Methodist Hospital also got adult doses of Heparin, the wire service said. One may require surgery and the other three were listed in serious condition.
The drug is frequently given to premature infants to prevent blood clots. Experts told the wire service that an overdose could lead to severe internal bleeding.
A hospital spokesman said pre-measured vials containing adult doses of the drug were mistakenly placed in a cabinet drawer that was reserved only for preemies. The packaging for both doses is similar, the AP said.
The hospital said it was investigating the incident and had taken unspecified steps to prevent a recurrence.
DDT Endorsed by World Health Organization to Fight Malaria
DDT, the pesticide long banned in the United States, has received a limited endorsement from an unlikely source -- the World Health Organization (WHO).
In order to combat the growing scourge of malaria, which kills more than 800,000 African children annually, the health expert leading WHO's effort to fight malaria in Africa "unequivocally declared" that DDT should be used in small amounts on the inner walls of people's homes to kill the mosquitoes that carry the disease, according to The New York Times.
WHO's Dr. Arata Kochi was joined at a news conference by Adm. R. Timothy Ziemer, representing the Bush administration's $1.2 billion anti-malaria project. The Times quoted Ziemer as saying that spraying with insecticides was a method "that must be deployed as robustly and strategically as possible."
For almost 45 years, DDT's use as an insecticide has been questioned -- and sometimes banned -- after Rachel Carson's 1962 book "The Silent Spring" documented how massive spraying allowed DDT to enter the food chain and suggested it might be a cause for cancer and genetic damage.
According to the Times, an international nonprofit group, Beyond Pesticides, distributed news releases on Friday opposing WHO's change in direction. Dependence on pesticides like DDT "causes greater long-tem problems than those that are being addressed in the short-term," the group said.
U.K. Scientists Report New Test to Detect TB
A new blood test to detect tuberculosis has been developed by scientists in the United Kingdom. It is hoped that the test will be particularly effective in developing countries where TB still kills millions of people, BBC News reported.
According to the BBC, researchers from George's Hospital and the Medical Research Council National Institute for Medical Research say the serum test is 94 percent accurate. Results of the study were published in the latest issue of The Lancet.
This isn't the first time scientists have tried to come up with an alternative to the standard examination of sputum from the lungs under a microscope. This test requires equipment that may not be available in many parts of the world, and it takes a long time to get results. According to BBC News, the blood test looks for indicators of infection, and these results could outperform alternatives.
The World Health Organization estimates that there were 1.4 million deaths from tuberculosis in 2004, with Southeast Asia and Africa particularly hard hit. In 2003, 14,000 new cases of TB were reported in the United States. The United Kingdom has about 7,000 new cases annually.
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