U.S. Response I:  Bioterrorism Cramps Other Federal Research

Nonterrorism research funded by the National Institutes of Health will fall next year — only the second time since 1989 — as U.S. President George W. Bush steps up funding for bioterrorism vaccines, the Washington Post reported yesterday (see GSN, Jan. 30).

“It will be shocking,” said Donald Poppke, NIH’s acting associate director for budget.  “The response will be fairly negative,” he predicted.

For the last five years the NIH has enjoyed annual growth in federal funding of 14 to 15 percent (see GSN, Feb. 4, 2002).  However, in fiscal 2004 it is expecting only a 2 percent increase to $27.9 billion, according to officials.

Meanwhile, the still unfinished 2003 budget will fall about $1 billion short of a 1998 goal of doubling the NIH budget over the subsequent five years, according to the Post.  The typical 4 percent “cost-of-doing-research” annual increase for ongoing grants — which officials said usually grows faster than inflation — will fall to 1 percent.

“Two or three years of 2 or 3 percent increases, and you’ve pretty much lost what you’ve gained,” said Dave Moore, associate vice president at the Association of American Medical Colleges.  “And you’ve certainly lost the morale of investigators who can’t help but be demoralized by trying to compete for funding under those circumstances,” he said.

Both the five-year doubling of the NIH budget and the higher annual increases enjoyed popular support in Congress, the Post reported.

Senators Arlen Specter (R.Pa.) and Tom Harkin (D-Iowa) have proposed a resolution to triple the NIH budget, from its 1998 level, by 2008 (Rick Weiss, Washington Post, Feb. 2).

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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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Anthrax:  FBI Ends Maryland Forest Search in Anthrax Investigation

The FBI Friday wrapped up a second search of a section of forest near Frederick, Md., related to the bureau’s investigation into the autumn 2001 anthrax attacks, the Associated Press said Saturday (see GSN, Jan. 28).

Investigators left the area Wednesday night after scuba divers used video equipment to search three ponds in the area, near the former home of Steven Hatfill.

The anthrax letter attacks left five dead and infected 13 others.

Hatfill, a former U.S. Army biologist, has been the public focus of the FBI’s investigation, said bureau spokeswoman Debra Weierman.  She refused to comment on what, if anything, investigators found during the search (Associated Press/Yahoo.com, Jan. 31).

For further information, see:

CDC Frequently Asked Questions About Anthrax

FBI Amerithrax Investigation

Journal of the American Medical Association Background on Anthrax

GSN Anthrax Attack Chronology (Dec. 12, 2001)

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United States I:  Bush Proposes “Bioshield”

U.S. President George W. Bush called on Congress last night to support a $6 billion “Bioshield” (see GSN, Jan. 22).

“I ask you tonight to add to our future security with a major research and production effort to guard our people against bioterrorism, called Project Bioshield,” Bush said during his State of the Union address.

Project Bioshield would develop new vaccines for diseases such as anthrax, boutlinum toxin, Ebola, the plague and  other diseases that could be used as biological weapons.

 “We must assume that our enemies would use these diseases as weapons, and we must act before the dangers are upon us,” Bush said (White House release, Jan. 28).

For further information, see:

CDC Frequently Asked Questions About Anthrax

Journal of the American Medical Association Background on Anthrax

Journal of the American Medical Association Background on Botulinum Toxin

CDC Basic Information About Botulism

CDC Ebola Fact Sheet

Journal of the American Medical Association Background on Plague

CDC Basic Information

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U.S. Response II:  Universities Prepare to Tighten Labortory Security

Researchers at U.S. universities are implementing more rigorous security measures as a result of last year’s anthrax attacks and mounting concern over biological weapons, the Chronicle of Higher Education reported this month (see GSN, Dec. 12, 2002).

As of Feb. 7, new regulations will require more than 800 U.S. laboratories, including 285 university-owned facilities, to increase security and regulate access to dangerous pathogens, according to the Chronicle.

The new regulations stem from the Public Health Security and Bioterrorism Preparedness and Response Act, which became law in June 2002, the Chronicle  said (see GSN, June 12, 2002).

Laboratories must provide federal officials with details on their inventories of deadly toxins and pathogens, but facilities have some flexibility in implementing physical security changes, said Stephen Ostroff, deputy director of the Centers for Disease Control and Prevention’s National Center for Infectious Diseases.

“Every facility is different,” Ostroff said.  “Every facility may devise different solutions, meeting their security needs, which may work very well in their facility but may not at the facility five miles down the road,” he said.

The University of Medicine and Dentistry of New Jersey, for example, designed a three-level approach to safeguard its stockpiles of anthrax and pneumonic plague, the Chronicle reported. 

The first level of security is the outer laboratory, to which 100 people have access.  To enter, they must swipe identification cards and enter personal identification numbers (PINs), all while being observed by security cameras.

To enter an inner laboratory, where 20 employees have access, they must again use their cards and codes.

The final area is restricted to just four people who must enter in pairs, each person entering another PIN code; this laboratory is where the university keeps its biological stocks.  Finally, the select agents are stored in containers protected by combinations and key locks (Anne Marie Borrego, Chronicle of Higher Education, Jan. 31).

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Anthrax:  U.S. Army Biologists Criticize New Research Restrictions

U.S. Army biological researchers have come under new security restrictions following the FBI’s anthrax investigation, WorldNetDaily reported today.

“We were told that to even be in a room with the select agents we will have to have a special key and Top Secret clearance,” said a biologist at the Army’s Dugway Proving Ground in Utah, a top Pentagon biological weapons research center.

Army biologists are now required to undergo background checks and obtain security clearances before they can work with dangerous pathogens, according to WorldNetDaily.  Security clearances were not required previously.

One biologist told the Web daily that the new restrictions were a “knee-jerk” reaction to the FBI’s profiling of suspects in its anthrax investigation.  The bureau has publicly focused its investigation into the autumn 2001 attacks on former Army biologist Steven Hatfill (see GSN, Jan. 28).

The FBI also recently administered polygraph tests to several scientists working at Dugway, where FBI engineers have been working to identify the source of the mailed anthrax that killed five people.  “They were asked questions about the letters,” the biologist said (Paul Sperry, WorldNetDaily, Jan. 29).

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U.S. Response III:  Gas Masks Stocked at U.S. Capitol for Bush Speech

U.S. security officials had 800 gas masks ready at the U.S. Capitol yesterday during President George W. Bush’s State of the Union address, Agence France-Press reported (see GSN, Jan. 28).

The masks were stacked in corridors around the building before Bush’s speech, according to a U.S. House of Representatives press gallery official.

The security measure was accompanied by extensive road closings and a heavy multi-agency law enforcement presence (Agence France-Presse, Jan. 29).

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Anthrax:  Divers Search Pond in Maryland Forest

Divers yesterday searched a pond in a section of forest near Frederick, Md., as part of the FBI’s investigation into the autumn 2001 anthrax attacks, according to the Washington Post (see GSN, Jan. 27).

The pond is located near the former home of Steven Hatfill, a former U.S. Army biologist, who has been the public focus of the FBI’s investigation. The second sweep of the region in three months was “just a continuation of our investigation on the anthrax case,” bureau spokeswoman Debra Weierman said (Washington Post, Jan. 28).

The area, which contains eight ponds, is located about two miles south of another group of ponds the FBI searched last month, according to the Associated Press.

Area resident Gregory Maddox said FBI officials told him that area roadblocks would be up for about a week. 

“I kind of support what they’re doing,” Maddox said.  “I believe whatever it is they’re doing benefits the entire United States, therefore, I don’t ask them a lot of dumb questions,” he added (David Dishneau, Associated Press/Edmonton Sun, Jan. 28).

For further information, see:

CDC Frequently Asked Questions About Anthrax

FBI Amerithrax Investigation

Journal of the American Medical Association Background on Anthrax

GSN Anthrax Attack Chronology (Dec. 12, 2001)

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International Response:  Bioterrorism Defenses Must Improve, U.S. Official Says

World health systems are unprepared to deal with an inevitable biological terrorist attack, U.S. Health and Human Services Secretary Tommy Thompson said yesterday (see GSN, Jan. 22).

“There is going to be an attack.  Whether it is in Western Europe, the U.S., Africa, Asia or wherever, you have got to anticipate that there is going to be a bioterrorism attack and the only way to defend yourself is by getting prepared,” Thompson said in Davos, Switzerland, site of the World Economic Forum.

In recent years other countries have made great progress preparing for biological terrorism attacks, but they still have much to do, Thompson said in a Financial Times interview (Brian Groom, Financial Times, Jan. 27).

“All I’m suggesting,” he told the Washington Post, “is they should be more vigilant and devote more resources to prepare for a biological attack.”  Thompson said that recent chemical terrorism-related arrests in Europe make the problem all the more clear.

The United States has made the most progress in addressing this issue, he added.

“Everybody would have to admit we’re further along than any of the other countries,” he said.  A greater allocation of resources has given the United States a head start in this area, he added.

“Ours is a model.  I’m not saying ours is the best,” Thompson said.  “As a world community we should get better prepared,” he added (Robert McCartney, Washington Post, Jan. 26).

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U.S. Response:  Washington to Build Eight-City Disease Surveillance Network

The Bush administration plans to develop a national disease surveillance system, starting in eight major cities, to track suspicious outbreaks that could be the work of bioterrorists, the New York Times reported today (see GSN, Dec. 18, 2002).

The U.S. Centers for Disease Control and Prevention is expected to lead the surveillance system effort.  “Our goal is to have a model that any city could pick up and apply,” a senior Bush administration official said.

The system will help detect disease outbreaks by tracking data such as doctors’ reports, emergency room visits and pharmaceutical sales, according to the Times.  Such information will help public heath officials and doctors treat a small-scale outbreak sooner and prevent it from growing into an epidemic, officials and experts said.

“We think this will be important,” said Alan Zelicoff, a physician at Sandia National Laboratories, who helped develop the widely used Rapid Syndrome Validation Project.  “We need to get disease reporting from the 19th to the 21st century,” he added.

While officials would not say which U.S. cities have been selected for the system, Washington is expected to be one of the eight, according to experts.  U.S. President George W. Bush is expected to refer to new U.S. biological terrorism defenses in his State of the Union address tomorrow night, a senior official said.

The plan has raised some privacy concerns, especially because of the U.S. Defense Department’s role in developing disease surveillance systems and because John Poindexter, who leads the Pentagon’s Total Information Awareness computer surveillance system effort, heads the Pentagon agency that finances some disease surveillance research, according to the Times. 

Supporters of the planned system, however, have said it would raise few privacy issues because the gathered data will have patients’ names and personal information removed.  Instead, patients will be tracked by their symptoms and other factors, such as age, sex and postal ZIP code, they said.

The new system will directly deal with privacy concerns, Bush administration officials said.  “We have to satisfy the legal constraints, and also people’s concerns,” a senior official said (Broad/Miller, New York Times, Jan. 27).

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Anthrax:  FBI Resumes Maryland Forest Search

The FBI began a second round of searches near Frederick, Md., Friday related to the autumn 2001 anthrax attacks which killed five people, according to the Baltimore Sun (see GSN, Dec. 19, 2002).

“The FBI is conducting forensic searches on public land located within the City of Frederick, Maryland.  These searches are related to the FBI’s investigation of the origin of the anthrax-laced letters mailed in September and October 2001,” according to an FBI statement.

The new search of a remote section of woods is connected with former U.S. Army biologist Steven Hatfill, who has been “a person of interest” in the bureau’s investigation, a law enforcement source said (see GSN, Jan. 10; Scott Shane, Baltimore Sun, Jan. 25).  Hatfill worked at the army’s nearby Fort Detrick biological defense laboratory from 1997 to 1999.

An initial search of the area last month yielded some materials that were being tested for connections to the anthrax attacks, law enforcement officials said (Allen Lengel, Washington Post, Jan. 25).

Hatfill’s spokesman, Patrick Clawson, criticized the FBI’s intense focus on Hatfill.

“(The) bottom line is, it’s unfortunate the grown-ups aren’t in charge at the FBI. Because they would realize ... Steven Hatfill had nothing to do with the anthrax attacks, period,” Clawson said.  “Somebody needs to seriously ask (Attorney General) John Ashcroft and (FBI Director) Bob Mueller ... why this is continuing when Steve Hatfill has cooperated 100 percent with the FBI from day one.  The surveillance of him continues 24/7” (Lengel, Washington Post).

Frederick Police Chief Kim Dine said the new search focused on a more remote section of woods.  The FBI has imposed flight restrictions over the area to prevent the media from obtaining aerial photographs, officials said (Shane, Baltimore Sun).

For further information, see:

CDC Frequently Asked Questions About Anthrax

FBI Amerithrax Investigation

Journal of the American Medical Association Background on Anthrax

GSN Anthrax Attack Chronology (Dec. 12, 2001)

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Smallpox:  Immunization Plan Sees Slow Beginning

U.S. President George W. Bush’s national civilian smallpox immunization plan began Friday with the inoculation of four Connecticut doctors, a much smaller number than state health officials had expected, the Washington Post reported (see GSN, Jan. 23).

Connecticut officials had been ready to vaccinate 20 volunteers but participants stayed away because of concerns about the vaccine’s side effects and the potential lack of compensation for those sickened by the shots, the Post reported.

“There’s not been a case of smallpox; we’re not yet at war with Iraq.  People’s concerns are reasonable,” said Michael Grey, coordinator of the team that is being initially vaccinated.  “We’re ready to adjust to that,” he said (Ferdinand/Connolly, Washington Post, Jan. 25).

Despite early opposition from health care worker organizations, Connecticut announced suddenly that vaccinations would take place Jan. 24, according to Jean Morningstar, president of University Health Professionals, which represents 1,800 medical personnel at the University of Connecticut’s Health Center.

State officials “rushed through this program before our questions were answered,” she said (Donald McNeil, New York Times, Jan. 25).

Other states also expect their turnout to be lower when vaccinations begin.  Alabama at first planned to immunize 12,000 volunteers in the first phase of the program, according to the Post.

“It’s going to be much lower,” said Donald Williamson, a state health official.  “I wouldn’t be surprised to see it in the 2,000 to 5,000 range,” he added.

Concerns persisted nationwide about the smallpox immunization program and its potential side effects.

“We have a bigger threat with drug-resistant tuberculosis today than we do from smallpox,” said Kay McVay, president of the 50,000-member California Nurses Association.  “I’m wondering if this is not a little play to create some hysteria about the prospects of this horrendous disease and war,” she added.

Wary hospital workers and officials also cited concerns about compensation, the Post reported.

“I have an obligation to take care of my employees, and I have a problem possibly injuring a person who would not be compensated and whose family wouldn’t be compensated,” said Elizabeth MacNeill, chief medical officer of Pima County in Arizona.  “Even though the risk is very small, it’s unconscionable to take that risk with our valuable employees,” she added.

As of Saturday, the U.S. Centers for Disease Control and Prevention had shipped more than 29,000 smallpox vaccine doses to seven states and Los Angeles for civilian use.

Los Angeles County received 9,200 doses, more than any state, according to the Post.  The CDC sent 6,400 doses to Connecticut (Ferdinand/Connolly, Washington Post).

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