Investigators have been unable to gather much information about the recent U.S. anthrax incidents, FBI officials told Congress yesterday. Meanwhile, anthrax’s reach extended to Siberia, with spores discovered in a U.S. consulate in Russia, according to reports.
The FBI was “pressing hard” to answer many questions relating to the anthrax incidents, including how many people have access to anthrax strains, said James Caruso, deputy assistant director of the FBI’s counterterrorism division. “The research capabilities of thousands of researchers is something that we’re still trying to run down,” Caruso said.
Caruso’s testimony surprised the senators at the hearing, according to the New York Times. “The bottom line is this: As of now, you don’t know where the anthrax came from and you have not been able to identify all the people who may have access to it. Is that correct?” Senator John Edwards (D-N.C.) asked. Caruso said, “That’s correct.”
“I’m very surprised by how little people know,” said Senator Diane Feinstein (D-Calif.), who has sponsored legislation to improve laboratory security. Feinstein said the gaps in the U.S. government system to track laboratories that work with deadly pathogens are “just a symbol of a kind of laissez-faire system that is very detrimental to the security of the American people.” One reason that officials do not know how many laboratories handle pathogens is that not all of them are required to register with the government (see GSN, Oct. 31), according to FBI officials. “There is no doubt we can make some improvements in the law,” Senator John Kyl (R-Ariz.).
Under federal law, anthrax is classified as a “select agent” and is regulated by the U.S. Centers for Disease Control and Prevention, according to the Times. Laboratories that ship select agents must register with the CDC when doing so. Investigators were examining those shipping records for clues, said Justice Department official Jim Reynolds. “I don’t want to leave the impression that we have no idea where anthrax is,” Reynolds said.
There are loopholes in the law, said American Society for Microbiology President-elect Ronald Atlas. If a laboratory acquired anthrax before 1997, it could continue to possess the microbe without notifying the government, as long as it did not ship the anthrax, he said. Atlas said a plan to remove the grandfather clause “makes sense.”
Too much regulation, however, would prevent researchers from studying deadly pathogens, according to Atlas. “We can’t cripple the biomedical community,” Atlas said. “You can impose all the biosafety rules you want and the bioterrorists aren’t going to necessarily follow them” (Stolberg/Johnston, New York Times, Nov. 7).
Anthrax in Siberia
The U.S. Consulate in Yekaterinburg, Russia today confirmed the presence of anthrax spores. The State Center for Medical-Epidemiological Control in Yekaterinburg found spores inside one of six unclassified diplomatic mailbags received from Washington, the consulate said in a statement. The source of the anthrax was unknown.
Since it took a second test to detect the anthrax spores, the amount in the bag is likely to be negligible, consulate officials said. Officials did not know what to do with the potentially tainted mail inside the bag, said a health official. “By Russian rules, it should be destroyed,” said Igor Romanenko, deputy head of the regional health service. “On the other hand, it is American property.”
Yekaterinburg was the scene of an anthrax release in 1979, when it was known as Sverdlovsk. About 100 people died after an accident at a secret germ warfare plant there (Reuters/South China Morning Post, Nov. 7).
Putin Says Russian Pathogens Are Secure
It is impossible for terrorists to steal or buy supplies of anthrax or smallpox from Russia, Russian President Vladimir Putin said Monday. “Those materials have been guarded, we guarded in the Soviet Union and Russia, very securely,” Putin said. “So I exclude that possibility. I believe this is true of anthrax and smallpox” (Barry Schweid, Associated Press/Washington Post, Nov. 7).
Some Tests Turn Out to be Negative
New anthrax tests conducted on U.S. Food and Drug Administration mailrooms (see GSN, Nov. 2), a Health and Human Services Department office (see GSN, Oct. 30) and the clothing of Kathy Nguyen, who died last week from anthrax (see GSN, Oct. 31), have all come back negative, officials said Monday. Preliminary tests had been positive. “Everything is negative,” said FDA spokesman Lawrence Bachorik.
Initial tests, which can be done in a matter of hours, are not precise, said CDC lead investigator Bradley Perkins. To confirm whether a site is contaminated, investigators must conduct tests that take 24 to 48 hours (see GSN, Nov. 7), because they involve growing cultures of bacteria found in samples. The results of the faster, earlier tests are often reported prematurely and that can lead to some people being placed on antibiotics unnecessarily, according to some experts.
The CDC is “trying to find the right balance point,” Perkins said, and added that most findings of anthrax spores in buildings pose little risk to workers (Garrett/Povich, Newsday, Nov. 6).
All recent tests for anthrax at the Pentagon Concourse post office are negative, Defense Department officials said yesterday. Trace amounts of anthrax had been found earlier in two mailboxes at the post office. There was no evidence of contamination and no evidence that the anthrax had spread to the customer service area or any other area of the post office, said Pentagon spokesman Dick McGraw. “Every swab returned negative results,” McGraw said (Jim Garamone, American Forces Press Service, Nov. 6).
Senate Clean-Up Plan Dropped
A plan to clean the anthrax-contaminated Hart Senate Office Building with chlorine dioxide gas (see GSN, Nov. 6) has been abandoned, Senate Majority Leader Tom Daschle (D-S.D.) said yesterday. “There are too many dangers inherent with using gas throughout the entire complex,” Daschle said. A new plan will pump gas into Daschle’s office and Senator Russell Feingold’s (D-Wis.) office, as well as the heating and air conditioning system, while other areas where anthrax spores were found will be treated with disinfectant foam, according to Daschle. He added that he hoped the process would be finished by Thanksgiving week (David Rosenbaum, New York Times, Nov. 6).
Hamas Writer Praises Anthrax
Atallah Abu al-Subh, a Hamas writer, published an article titled “To Anthrax” that encouraged terrorists to continue to use anthrax to create horror in the United States, according to the Jerusalem Post.
“If I may give you a word of advice, enter the air … the water faucets from which they drink, and the pens with which they draft their traps and conspiracies against the wretched peoples,” he wrote (Al-Risala, Middle East Media Research Institute translation/Jerusalem Post, Nov. 7).
Buying enough smallpox vaccine doses for the U.S. population will cost more than the previously requested amount of $509 million (see GSN, Nov. 6), U.S. Health and Human Services Secretary Tommy Thompson said yesterday, and added that the cost could be four times that amount, about the equivalent of the department’s entire $1.9 billion bioterrorism budget (Ceci Connolly, Washington Post, Nov. 7).
The prices drug companies have proposed in negotiations have exceeded the $1.70 per dose the government estimated earlier, Thompson said.
The government might award a contract to a potential vaccine manufacturer by the end of this week, Thompson said. Ten companies originally applied to produce the smallpox vaccine (see GSN, Oct. 25), and HHS is considering three finalists. Last week, GlaxoSmithKline, Merck & Co., American Home Products Corp. and a collaboration including Baxter Healthcare Corp. and Acambis remained in the running. Thompson would not say which company had dropped out of the negotiations.
The United States already has a contract with Acambis to produce 54 million smallpox vaccine doses by next year (see GSN, Oct. 18).
A U.S. federal commission last week recommended the U.S. government create its own facility to produce anti-bioterrorism vaccines, saying, “The private sector is unlikely to be the answer to some of the more difficult vaccine issues” (Charles Ornstein, Los Angeles Times, Nov. 7).
Diluting the Current Vaccine Stockpile
Meanwhile, researchers are beginning a 2 1/2 month study to test the efficacy of diluted smallpox vaccines to learn if the current U.S. stockpile of 15.4 million doses could be stretched to inoculate many more people. Researchers at four institutions will test diluting the vaccine by one-fifth and one-tenth of the original concentration.
In a pilot study last year on 20 people, researchers discovered that vaccines diluted by one-tenth had a significant number of positive results, but doses diluted 100 times offered little protection against infection.
If the experiment works, the diluted vaccine could be ready by the end of this year, said Anthony Fauci, head of the National Institute of Allergy and Infectious Disease, which is funding the research, adding, “It’s a very quick way to markedly expand the amount of vaccine that we already have, which on face value in the undiluted form would not be a lot. It’s prudent to be prepared.”
Diluting the U.S. stockpile would be only a temporary measure to provide a response to a potential smallpox terrorist attack until millions more doses could be produced, experts said. “This is a stopgap measure to make more doses available until that new vaccine is developed,” said Sharon Frey, lead researcher on the smallpox study at St. Louis University.
Anything to increase the number of doses is an improvement, said Neal Halsey of Johns Hopkins University, adding, “I am sure there is nowhere near enough smallpox vaccine to provide it to everyone in the country and even those who would be exposed in a large incident” (TB & Outbreaks Week, Nov. 6).
Canadian Response
Health Canada is considering following a U.S. decision last week to vaccinate some medical personnel who would investigate suspicious smallpox cases, Paul Gully, director general for Health Canada’s Center for Infectious Disease Prevention and Control, said Monday (Ian MacLeod, Ottawa Citizen, Nov. 6).
Researchers at the Mayo Clinic, based in Rochester, Minnesota, said yesterday they had developed a new test that dramatically reduces the time needed to detect anthrax. It can identify the presence of anthrax in about 35 minutes instead of in days, according to the clinic. The test could be available in some regions as soon as Nov. 9.
“The first thing people want to know in a case of suspected exposure is whether the agent was anthrax,” said Mayo Clinic microbiologist Franklin Cockerill, who led the development team. “Until now, local labs have been able to quickly determine the presence of a bacterium, but they can’t tell whether it was anthrax or not. The current process to identify the presence of anthrax may take several days. The events of the last several weeks require as rapid a response as possible” (Mayo Clinic release, Nov. 5).
Mayo Clinic researchers developed diagnostic biochemicals that could be used to identify signature patterns in anthrax DNA, but they needed a large quantity of DNA material on which to run the test. They turned to Switzerland-based Roche Diagnostics, which makes an instrument called LightCycler. The instrument can take a small sample of DNA and replicate many copies using a common laboratory technique known as polymerase chain reaction, or PCR. The LightCycler simultaneously probes for signature anthrax patterns while it replicates the DNA (Mayo Clinic release, May 20).
Roche is working to expedite regulatory approval from the U.S. Food and Drug Administration. Once the test receives FDA approval, which is expected later this year, it will cost about $50 to $60, said Juergen Flach, vice president for Roche Molecular Biochemicals (Knight-Ridder/Baltimore Sun, Nov. 6).
Indian Scientists Develop Safer Anthrax Vaccine
Biochemists in India have developed a new anthrax vaccine that could be available in six to nine moths, the Indian government said on Monday. The new vaccine, which researchers have worked on for more than six years, has already been tested on mice and guinea pigs and would be tested on humans in the next six months under a fast-track plan used in emergencies, scientists said.
The new vaccine “is much easier to produce and the cost of production would be very low,” said Murli Manohar Joshi, India’s science and technology minister. “Vaccines are available even now but they have strong side effects, they need boosters and are expensive, but the recombinant process through which Indian scientists have now developed a vaccine avoids toxic effects.”
To make the new vaccine, biochemists at Jawaharlal Nehru University and the Center for Biochemical Technology extracted a small amount of a protective biochemical called an antigen from E. coli bacteria. Previous versions of the vaccine have used potentially harmful B. anthracis, the bacteria that cause anthrax. After extracting the antigen the biochemists produced five grams—a relatively large amount—by cloning it in the laboratory. “One gram of the protective antigen can make millions of shots of the vaccine,” Joshi said (Y.P. Rajesh, News24.com, Nov. 6).
U.S. Vaccine Supply
The United States is seeking to obtain British- or Russian-made anthrax vaccine, Health and Human Services Secretary Tommy Thompson said Friday. Manufacturers, however, have not done tests to determine whether such vaccines are as safe as those made in the United States, he said, adding, “That’s one of the problems.”
Foreign manufacturers have been urged to present safety data on their vaccines to the FDA as soon as possible, said Scott Lillibridge, a bioterrorism adviser to Thompson. “Arrangements have been made for several people to provide such information, and that’s in progress,” Lillibridge said.
The British vaccine has some side effects, while the Russian vaccine is made with live anthrax bacteria and has been found by the U.S. government to be unsafe for humans, scientists have said (Reuters/Environmental News Network, Nov. 5).
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