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U.S. Response II: Regulations Slow Bioterrorism Medicines, Expert Says Required U.S. procedures for testing new drugs are slowing the development of medicines that could potentially be used to counter bioterrorism threats, according to a leading expert (see GSN, Dec. 18, 2002). Ken Alibek, former head of the Soviet Union’s chemical weapons development who is now a U.S. researcher, recently encountered such delays from the U.S. Food and Drug Administration and the National Institutes of Health, he said. Alibek’s team combined a protein with antibiotics and the result proved 100 percent effective against anthrax in animals, he said. “We said to NIH, ‘Here is a product. Do you have any fast, accelerated way of organizing production, testing and so on?’ They said, ‘No, we don’t,’” according to Alibek. He said officials told him that before testing and production, the anthrax treatment must first be presented in a proposal and then pass through several levels of review before they would consider directing additional funding to the effort. “I said I don’t care if I am going to get money. Here is the product — take it. We’ve already gotten our government money to develop this product,” Alibek said. However, Alibek said officials responded, saying the treatment would not be available to the public for another five or six years. The FDA has special programs to accelerate drugs that can save lives, according to Dianne Murphy, director of the FDA’s Office of Pediatric Drug Development and Program Initiatives. It is important, however, to ensure that the drug is safe for human use, she added. “You can’t do studies on a few mice and say it looks good,” according to Murphy. A U.S. biological defense program, supported by Washington, could solve many problems in creating needed vaccines and treatments, Alibek said. “In all senses this would be best — in terms of funding, in terms of quality — this would be preferred,” he said (Divis/Horrock, United Press International, Jan. 31).
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