Smallpox:  Public Comment Period Begins for Children’s Smallpox Tests

The U.S. Food and Drug Administration yesterday began a month-long public comment period on pediatric tests of smallpox vaccine (see GSN, Sept. 25).

Health officials have proposed tests in which researchers would inoculate 40 children between the ages of 2 and 5 — the first children immunized for smallpox since the 1970s.

Officials presented the opportunity for the public to voice its views after research oversight boards expressed mixed reactions to the tests.  Any tests that pose risk to a child and fail to provide benefits require special government oversight.

“It is a very challenging issue because there is no smallpox circulating right now,” said Karen Midthun, FDA’s head of vaccine research.  “There is great concern that there be a lot of safeguards for studies being conducted in children.”

One concern is that children might tear the bandage off the inoculation site and spread the live vaccine virus — vaccinia — to family members who are not immunized, but researchers believe they might have solved this problem.  The bandage used for children is extremely adhesive, “very, very hard to get off,” Midthun said (Associated Press/Baltimore Sun, Nov. 1).

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Anthrax:  Thousands Abandoned Treatment Prematurely

More than half of the government, media and postal workers who received antibiotics during last year’s anthrax attacks failed to finish taking the full course of the drugs, the Atlanta Journal-Constitution reported today (see GSN, Oct. 3).

Of the 10,000 people who received the medicine, 44 percent took the complete 60-day prescription, according to a study by the Centers for Disease Control and Prevention (see GSN, Oct. 26, 2001).

The CDC plans to examine how it can better explain the risks of not completing the prescription if another emergency arises.  Anthrax spores can remain dormant for an indefinite amount of time, potentially affecting people more than a month after infection.  Many patients who stopped taking antibiotics thought they were safe, but they put themselves in danger, health officials said.

“We would probably make greater efforts to stay in contact with them, to determine if they were having difficulties and to make sure we could answer their questions,” said Stephen Ostroff, deputy director of the CDC’s National Center for Infectious Diseases.

Another reason that many people abandoned their prescriptions was that side effects were much more prevalent than expected, the study says.  Of those who took the antibiotics, 57 percent suffered from headache, dizziness, diarrhea or nausea, 14 percent said their side effects were severe and 26 percent missed at least one day of work.  Four of those taking the medicine were hospitalized.  One manufacturer had said that 16.5 percent of people would experience side effects (M.A.J. McKenna, Atlanta Journal-Constitution, Oct. 30).

Some officials took the CDC statistics as good news.

“Adverse events were commonly reported, but serious adverse events were rare,” CDC official Colin Shepard said.

“I’m gratified by how effective the [treatment] seemed to be,” Ostroff said.  “No one put on it developed anthrax” (Daniel Yee, Associated Press/Boston Globe, Oct. 30).

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United States:  Research Efforts Could Undermine Treaties, Scientists Say

U.S. efforts to develop nonlethal weapons and biological agents, ostensibly for defensive purposes, might undermine biological and chemical nonproliferation agreements, the South African Mail and Guardian reported yesterday (see GSN, Aug. 5).

In a paper to be published in the Bulletin of the Atomic Scientists, Malcolm Dando, an international security professor at the University of Bradford in the United Kingdom, and Mark Wheelis, a microbiology professor at the University of California, named several U.S. research programs that appear to violate the Biological Weapons Convention.  The projects include:

*         the copying of a Soviet cluster bomb designed to disperse biological agents;

*         a U.S. Defense Department effort to build a biological weapons plant from commercially available materials to demonstrate that terrorists could do the same;

*         research into genetically engineered antibiotic-resistant anthrax and

*         a program to produce weaponized anthrax to test biological weapons defenses (see GSN, May 20).

The United States rejected a treaty enforcement protocol, which had high levels of international support, to keep U.S. research programs secret, according to Dando (see GSN, Oct. 1).

Additionally, the United States is investigating several nonlethal weapons similar to the gas used by Russian troops to end the takeover of a Moscow theater by Chechen militants, Dando said (see related GSN story, today).  Such weapons include “calmative” agents meant to incapacitate rather than kill a person.

“What happened in Moscow is a harbinger of what is to come,” Dando said.  “There is a revolution in life sciences which could be applied in a major way to warfare.  It’s an early example of the mess we may be creating” (Mail and Guardian, Oct. 29).

The Pentagon has denied conducting research on calmative agents, according to BBC News.

“There are no projects or research into calmatives,” a Pentagon spokesman said.

The United States is also not conducting any biological research that would require BWC oversight, said a spokesman for the Pentagon’s Joint Nonlethal Weapons Directorate.

“We have lawyers who are experts ... and they tell us right away if something is a technology they should or should not be looking at,” the spokesman said.  “We don’t have to go to a higher entity — they keep us honest” (BBC News, Oct. 29).

For further information, see:

BWC Text and Associated Documents (U.S. Defense Department)

BWC States Parties (U.S. State Department)

U.N. Background on BWC

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Smallpox:  Swine Flu Immunization Plan Has Lessons For Smallpox

The United States should look to the swine flu vaccinations of the 1970s for help in the current debate over smallpox vaccinations, according to a recent New York Times commentary (see GSN, Oct. 24).

U.S. President George W. Bush is right to show caution in the immunization process, according to Philip Boffey, deputy editorial page editor for the Times.

The plan to immunize the entire country against swine flu in 1976 was “a fiasco, a debacle, a ghastly mistake, a medical Vietnam,” Boffey wrote.

Guillain-Barre syndrome, an unanticipated paralyzing side effect of the swine flu vaccine, began to appear after the immunization program began.  The nation was outraged and the national campaign was called off after 45 million people had been inoculated.

“Pretty much everything that could go wrong did go wrong,” Boffey wrote.  “Manufacturing the vaccine took far longer than expected.  The vaccine didn’t work well in children.  Bitter arguments over who should accept liability for side effects almost derailed the effort until the government assumed responsibility.  And the states differed greatly in their enthusiasm and competence” (see GSN, Oct. 24).

Boffey faulted government officials and the Centers for Disease Control and Prevention for rushing into a national swine flu immunization in 1976 with unnecessary haste.  U.S. officials now, however, should not avoid the smallpox vaccination but merely deal with it cautiously, Boffey wrote.

“That experience … does not mean that health officials should shrink from offering smallpox vaccinations today.  But it does suggest there are lessons to be learned on how best to do it,” Boffey wrote.

Boffey lauded the Bush administration for producing and stockpiling the vaccine without making a pre-emptive decision to administer it.  He also praised the phased approach — inoculating health care workers before the general public (see GSN, Oct. 17).

When swine flu failed to appear, the immunization effort looked foolish, according to Boffey.  He wrote, however, that if smallpox does not appear it may well be because the United States is prepared to deal with such an attack — a smallpox immunization plan can contain or even deter an attack and stockpiles provide much-needed security.  Immunizations, however, must not be rushed without information of an imminent smallpox attack, Boffey wrote.

“Most of the mistakes in the swine flu campaign were driven by the perceived urgency of acting quickly,” Boffey wrote.  In the case of smallpox, however, “there is plenty of time for President Bush to get it right” (Philip Boffey, New York Times, Oct. 27).

For further information, see:

CDC Smallpox Information

Journal of the American Medical Association Background on Smallpox

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Anthrax:  Experts Dog Bloodhound Usage in “Amerithrax” Investigation

Sources close to the FBI’s investigation into last year’s anthrax attacks have said evidence gathered by bloodhounds is a major factor in the bureau’s interest in former U.S. Army biologist Steven Hatfill, but the techniques and equipment used by the bloodhounds’ handlers has come under criticism, the Baltimore Sun reported today (see GSN, Oct. 28).

In August, Newsweek reported that the FBI presented bloodhounds with scent packs taken from the decontaminated anthrax letters sent to Senate Majority Leader Tom Daschle (D-S.D.) and Senator Patrick Leahy (D-Vt.).  The dogs reacted only when taken to Hatfill’s apartment, Newsweek reported (see GSN, Aug. 5).

The methods used by the bloodhounds’ handlers — Bill Kift, a Long Beach, Calif., police officer, Dennis Slavin, an urban planner and reserve officer with the Pasadena, Calif., Police Department and Ted Hamm, a civilian who runs his own bloodhound business and is used by the Los Angeles County Sheriff’s Department — have been criticized by others in the field, said FBI Agent Rex Stockham, who selected the handlers.

“The guys in Southern California are social outcasts in the bloodhound handling community,” said Stockham, a forensic examiner in the explosives unit at the FBI Laboratory in Washington.

Typically, a bloodhound handler uses a “scent article,” such as a piece of clothing, to start a dog looking for a trail, according to the Sun.  The Southern California handlers, however, use a “scent pad” — a piece of gauze placed on the article to absorb the scent — that is preserved in a plastic bag, instead of the actual article.  The handlers also often use a machine called the Scent Transfer Unit to take the scent off the article and place it onto the pad.

Truc Do, a Los Angeles County deputy district attorney who has had successes in prosecuting cases with evidence gathered by Hamm and Slavin, defended the handlers’ methods.

“They’ve been working at the forefront of this kind of evidence,” Do said.  “You really have to see it to believe it.”

Criticism

The two major bloodhound handlers associations, the Law Enforcement Bloodhound Association and the National Police Bloodhound Association, however, have criticized the Southern California handlers and their methods, the Sun reported (see GSN, Aug. 8).

“These are people we have credibility problems with,” said Jerry Nichols, president of the Law Enforcement Bloodhound Association.  “I’m extremely skeptical.  I don’t believe these dogs really do what they claim to do.”

Neither of the two associations has endorsed the use of the Scent Transfer Unit.  Officials from the two groups have said the machine offers little advantage over the use of a gauze pad alone and might confuse the dogs with older smells lingering in the machine. 

The Southern California handlers have also often used the dogs to identify a potential suspect in a case, such as Hatfill, in addition to tracking down missing persons, bloodhound experts said.  That, however, raises the possibility of a false positive, since there is always a possibility that an eager-to-please dog will falsely identify someone, some bloodhound handlers said.

Lehr Brisbin, a biologist at the University of Georgia, has conducted experiments where a bloodhound tried to identify who among a half dozen people wore a baseball cap given to the dog.  No bloodhound was able to successfully identify the person consistently, Brisbin said.

“As a scientist, what they’re supposed to have done (in the anthrax case) sounds like a miracle,” said Brisbin, a bloodhound handler himself.  “Every time I ask a dog to identify a suspect under controlled conditions, the dog can’t do it” (Scott Shane, Baltimore Sun, Oct. 29).

For further information, see:

CDC Frequently Asked Questions About Anthrax

GSN Anthrax Attack Chronology (Dec. 12, 2001)

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Anthrax:  Scientists Criticize FBI’s Theory on Lone Culprit in Attacks

Some experts have said the spores used in last fall’s anthrax attacks required technical knowledge and production capabilities beyond that of a lone individual, contrary to the FBI’s views, the Washington Post reported today (see GSN, Oct. 23).

Instead of pursuing a “lone individual” theory, investigators might want to examine if state-sponsored terrorism played some role in the attacks, or if the person responsible obtained the spores from a foreign biological defense program, experts said. 

“In my opinion, there are maybe four or five people in the whole country who might be able to make this stuff, and I’m one of them,” said Richard Spertzel, chief biological inspector for the U.N. Special Commission from 1994 to 1998.  “And even with a good lab and staff to help run it, it might take me a year to come up with a product as good.”

An FBI profile released last November described the person believed to be responsible as a “lone individual” with “some” scientific knowledge who could have made the spores in a primitive laboratory for as little as $2,500 (see GSN, Aug. 15).  The FBI also said there appeared to be no “direct or clear link” between the attacks and foreign terrorism. 

That profile, however, clashed with what was known about the complexity of the spores used in the attacks, according to experts.  The profile was issued three weeks after U.S. Army scientists examined spores taken from a tainted letter sent to U.S. Senate Majority Leader Tom Daschle (D-S.D.).  The scientists found that the spores were processed to a size of 1 trillion per gram — 50 times finer than the spores made through the now-closed U.S. biological weapons program and 10 times finer than known Soviet-made anthrax, the Post reported (see GSN, June 13).

“Just collecting this stuff is a trick,” said Steven Lancos, executive vice president of Niro Inc., a leading manufacturer of spray dryers, viewed by several sources as the likeliest tool needed to weaponize anthrax.  “Even on a small scale, you still need containment.  If you’re going to do it right, it could cost millions of dollars.”

Silica

The FBI had initially ruled out the possibility that Iraq might have been behind the anthrax attacks because the spores used were coated in silica to aid in their dispersion, rather than mineral bentonite, believed to have been used in Iraq’s anthrax weaponization program.  That belief, however, appears to be based on a single sample taken by U.N. authorities in the mid-1990s, according to the Post.  As early as 1989, the U.S. Defense Intelligence Agency reported that Iraq was acquiring silica to use in chemical weapons and in 1998, Iraq informed the United Nations that it had conducted an artillery test of a live biological agent that used silica as a dispersant, the Post reported (see GSN, April 24).

“Iraq almost certainly had their anthrax spores in a powdered form,” Spertzel said.  “They had used silica gel to aid in dispersibility of (wheat) smut spores, and also indicated they were looking at it as a carrier for aflatoxin,” a carcinogen, he said.

The silica-coated spores used in the attacks were probably produced through mixing fine glass particles, known as “fumed silica,” with the spores in a spray dryer.  “I know of no other technique that might give you that finished product,” Spertzel said.

Fumed silica particles are tiny and will stick to larger particles, such as an anthrax spore.  Fumed silica particles also absorb moisture and can acquire an electric charge, both of which keep the particles from clumping together and aid in their dispersion, according to the Post.

“This concept of using something that would serve as a dessicant and a carrier at the same time is new,” said Harvard University chemical engineer David Edwards.  “It’s a diabolically brilliant idea.”

While some fumed silicas are difficult to produce, two brands — Aerosil and Cab-O-Sil — are internationally available for purchase in bulk, according to the Post.  The Soviet Union used Aerosil in producing biological agents, said Ken Alibek, former deputy director of the Soviet biological weapons program.  A 1991 Pentagon memo said Iraq had “imported approximately 100 MT (metric tons) of Aerosil during the last 8-9 years.”  The United Nations also reported in the 1990s that Iraq possessed about 10 metric tons of Cab-O-Sil, Spertzel said.

Equipment

The anthrax production would also require expensive and specialized equipment — several hundred thousand dollars worth, according to experts.  Niro’s least expensive spray dryer costs about $50,000.  An electron microscope, needed to examine the results of the production process, also costs hundreds of thousands of dollars, the Post reported.

The United Nations discovered three Niro spray dryers in Iraq during inspections conducted in the 1990s, according to the Post.  Two of the spray dryers were destroyed and the third was sterilized before it could be inspected, Spertzel said.

Whoever produced the anthrax spores used in the attack would “need some experience” with aerosols and “would have to have a lot of anthrax, so you could practice,” Edwards said.  “You’d have to do a lot of trial and error to get the particles you wanted.”

All together, “you would need (a) chemist who is familiar with colloidal [fumed] silica, and a material science person to put it all together, and then some mechanical engineers to make this work . . . probably some containment people, if you don't want to kill anybody,” Lancos said.  “You need half a dozen, I think, really smart people”(Gugliotta/Matsumoto, Washington Post, Oct. 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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