Skip to comments.Expert: Drug Rules Stymie Biowar Defenses (Ken Alibek)
Posted on 02/01/2003 10:42:14 PM PST by FairOpinion
WASHINGTON -- U.S. procedures for testing drugs are delaying approval of vital treatments for the victims of biological weapons attacks, a top biowar expert told United Press International. Dr. Ken Alibek, chief of a major biological research program at George Mason University in Virginia, told UPI that some existing drugs might be crucial to saving the lives of victims of anthrax and smallpox attacks. But he said that procedures of the National Institutes of Health and the Food and Drug Administration are delaying their use for as many as five or six years.
Alibek has hands-on experience in biological warfare, having helped lead the development of Soviet bioweapons before defecting to the United States.
One example, he said, is a protein that Alibek's team developed to fight the anthrax infection. When combined with antibiotics, experiments showed that the protein, called antibodies, were 100 percent effective against anthrax in laboratory animals.
"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,'" he said.
Alibek was told that, even in the case where he was offering the already developed anthrax antibodies for testing and production, he first needed to develop a proposal, go through two levels and peer review and then --- maybe six months later --- he might get money.
He said he told NIH that his team didn't care about getting the money.
"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." Even so, Alibek said, he was told it might take two or three years for testing and that the antibodies might not be ready for the public for five or six years.
Alibek said that if testing were accelerated, it should require "maybe 12 more months to finalize everything to organize production and get FDA approval." But Alibek said the FDA told him, "We cannot do anything because it is our official procedure. This approach is going to take years and years."
Dr. Dianne Murphy, director of FDA's Office of Pediatric Drug Development and Program Initiatives, said she understood Alibek's frustration, but that without knowing the details of his research, could not comment on them.
But she said the FDA has long had various programs to accelerate approval for drugs for "life-threatening diseases" built into the agency's regulations. She stressed that the important factor is the effect of the drug on humans. "You can't do studies on a few mice and say it looks good."
Human testing is complicated in diseases like smallpox or anthrax because it is unethical for doctors to give human beings those diseases to test treatments or vaccines, she said. After the terrorist attacks on Sept. 11, 2001, the FDA established procedures giving special attention to diseases that could be caused by biological terrorist weapons. In May 2002, the agency adopted what is known informally as the "animal rule," which allows testing of a drug in an animal if the disease affects the animal as it would a human being.
FDA Working to be Proactive
Murphy said ciprofloxacin was used to treat people exposed to anthrax without first testing it on people for that disease. She said the FDA is working to become more proactive, seeking drugs to treat critical diseases and not simply waiting for them to be brought in, and that a special office is working to find drugs to fight diseases like anthrax, plague and smallpox as well as treatments for children.
UPI contacted NIH spokesmen, but no public affairs officer responded to questions despite repeated calls.
The former Soviet scientist, who developed deadly biological weapons early in his career, argued that the United States cannot wait for these long procedures in the bioterrorism era.
"Who is going to be responsible if something happens in an year? We'll still be talking about the necessity to do 'additional review' for this work ... who is going to be responsible for those lives?" he said.
Don McLearn, an FDA official for 17 years who is now with Ruder and Finn, a Washington public affairs firm, said the FDA "cannot tell you how long a testing process would be" without knowing the drug involved. He said some of the figures, like 10 years from conception to the drug counter, include the research time at the pharmaceutical firm.
But McLearn stressed that the safety of people has to be the high priority. He said you cannot use soldiers or the public as "guinea pigs" and that sometimes a drug might not hurt an animal but would hurt a human.
Alibek gave several examples of current drugs that could be used for treating a victim of a biological attack or the adverse effects of a vaccine -- including antibiotics that could be useful against smallpox, a virus.
Antibiotics are not normally thought to be effective against viruses, but years ago when there were still cases of smallpox appearing, doctors discovered that antibiotics helped patients infected with the smallpox virus. Back then it was thought that the antibiotics were just combating secondary infections, Alibek told UPI.
"At that time people did not understand that some antibiotics could have a direct effect on the smallpox virus itself. It's because this virus is a so-called 'DNA containing virus.'" If an antibiotic attacks DNA synthesis, explained Alibek, it means this antibiotic will be effective against the virus.
In the more than 25 years since the last case of smallpox in the United States, "We have developed a huge number of new antibiotics," said Alibek. "Some of these would work ... against the adverse effects of smallpox vaccination."
Some of the drugs are already on the market, he said. "In nine months to 12 months we could have something in the physicians' hands to treat people who are having severe adverse effects (from the smallpox vaccination)," he said.
Need for Testing
Rifampin, which has been used for decades to treat tuberculosis, could be used to treat smallpox complications, he said. The drug is already approved for human use and would only require FDA testing for this particular application. There are other such drugs already on the market with similar promise that just need to be tested, he said.
Alibek said he believes that the whole apparatus for defense against biological weapons in the United States should be revamped to speed defense against terrorist attacks. He said bioweapons defense should be put under one national agency and under rules that would allow an urgent response to the growing danger of biological terrorist attack.
President George W. Bush proposed earlier this week in the State of Union address "Project BioShield," a 10-year, $6 billion program for defense against bioattack. The FDA was ordered to "make new and promising treatments under development available quickly in emergency situations." Murphy said steps were under way to carry out these assignments.
Alibek said that now the research is split among the military at the U.S. Army's Medical Research Institute for Infectious Diseases at Fort Detrick, Md., NIH and private research groups.
Alibek said that private pharmaceutical companies can't find enough profit in producing vaccines and antidotes for biological weapons to make it worthwhile. Alibek suggested the creation of a special biodefense scientific entity funded by tax dollars.
"In all senses this would be best -- in terms of funding, in terms of quality -- this would be preferred," he said.
Copyright 2003 by United Press International.
All rights reserved.
I am all in favor of abolishing it and replacing it with a streamlined advisory agency.
Another gaffe. An antibiotic that attack DNA synthesis. You don't want to give that to a human being. Humans are DNA based. Most antibiotics are targeted a weaknesses in a bacterium that are not shared by the infected host. Penicillin attacks the peptidoglycan mesh that makes up the cell wall of a Gram position bacterium. Chloramphicol and Clindamycin disrupts bacterial ribosomal transcription of mRNA into proteins without disrupting the protein systhesis of the host's cells.
The article is busy baffling the uninformed with technical BS in an attempt to gain credibility. The FDA certainly needs some reform, but the crusaders need to hire some better informed troops to carry their water.
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