June 29, 2004

Proposed U.S. Biological Research Could Challenge Treaty Restrictions, Experts Charge

by David Ruppe
Global Security Newswire

WASHINGTON — Offering a controversial justification, the Bush administration is planning to perform certain biological defense activities that some arms control experts say could violate the Biological Weapons Convention and potentially render its restrictions meaningless.

The proposed work could include developing and testing new and existing biological weapons agents and delivery devices, studying new potential means of delivery, and modeling production processes, according to a government presentation delivered earlier this year. It would be funded through a newly created Homeland Security Department “Biothreat Characterization Center” and would occur primarily at a multiagency biological defense campus at Fort Detrick, Md.

The program’s principal purpose would be to inform U.S. policy-makers about the nature of the most serious and credible biological threats potentially facing the United States in order to guide defensive efforts, Maureen McCarthy, director of research and development at the Department of Homeland Security, said in an interview with Global Security Newswire.

It would comply with the treaty’s restrictions, she said, because the work is intended solely for defense.

“The treaty is intent-based. Our intent and the intent of all the biodefense programs going on in the nation right now is to develop protective measures to protect the American public,” she said.

“We are and will continue to be fully compliant with the BWC,” McCarthy added.
Nongovernmental arms control experts, however, say that elements of the plan would probably violate the 32-year-old treaty’s restriction on developing and producing agent delivery devices.

They say, furthermore, that the planned work as a whole could undermine international confidence in and adherence to the treaty because, although the work would be defensive, it would effectively give the United States a modern offensive biological weapons capability.

“This is absolutely without any question what one would do to develop an offensive biological weapons capability,” said Mark Wheelis, a professor of microbiology at the University of California-Davis.

“We’re going to develop new pathogens for various purposes. We’re going to develop new ways of packaging them, new ways of disseminating them. We’re going to harden them to environmental degradation. We’ll be prepared to go offensive at the drop of a hat if we so desire,” he said.

What the administration is planning “would look like a violation to them if anybody else did it,” said former Ambassador James Leonard, who led U.S. negotiations of the treaty.

No review has yet been done within the administration on whether the proposed programs would comply with the treaty or U.S. law, but specific proposals would be so evaluated, according to McCarthy.

A State Department official said that the department had not done a compliance review and that “relevant interagency consultations are ongoing.”

Justification Previously Used

The program’s work was ordered by President George W. Bush in a classified presidential directive and explained very generally in a White House initiative called “Biodefense for the 21st Century” announced in April (see GSN, April 28).
“The proliferation of biological materials, technologies, and expertise increases the potential for adversaries to design a pathogen to evade our existing medical and nonmedical countermeasures,” says an unclassified version of the directive.

“To address this challenge, we are taking advantage of these same technologies to ensure that we can anticipate and prepare for the emergence of this threat,” it says.
The Biothreat Characterization Center is part of a larger National Biodefense Analysis and Countermeasures Center (NBACC), also headquartered at Fort Detrick. Its plans were first publicly detailed by then-NBACC Deputy Director U.S. Army Lt. Col. George W. Korch Jr., in a February slide presentation.

The BTCC program activities could include genetically engineering new pathogens, improving the environmental stability of agents, exploring novel ways to package and deliver bioweapons agents, and modeling bioweapons production processes, according to Korch’s slides.

The program apparently would be a more coordinated and visible Homeland Security version of classified CIA and DOD efforts initiated during the Clinton administration in the late 1990s and publicly revealed during the Bush administration.

The New York Times on Sept. 4, 2001, reported details of such programs, including a CIA project that built and tested a model of a Soviet-designed bomb and the U.S. Army assembly of a mock germ factory for assessing potential terrorist capability. A Pentagon spokeswoman that same day told reporters that the Army intended to develop a copy of a genetically modified Russian anthrax strain to see whether the U.S. anthrax vaccine could handle it.

“A functional, gradual, incremental equivalent [to the BTCC], eroding the boundary between defensive and offensive research, may already have been in place for a half dozen years,” said Milton Leitenberg, an arms control expert at the University of Maryland.

Military and CIA lawyers reportedly had concluded such work was allowed by the treaty because the intent was defensive, a conclusion some other government officials reportedly disputed.

“The Biological Weapons Convention allows you to do work that is purely defensive in nature,” Pentagon spokeswoman Victoria Clarke said at the Sept. 4, 2001 press briefing.

The administration also that summer said it would oppose a negotiated protocol creating a BWC inspections mechanism, citing in part concerns that inspections might compromise U.S. biological defense secrets.

U.S. Undersecretary of State for Arms Control and International Security John Bolton in a 2002 speech argued that a country’s intent, rather than equipment, should be the used to judge treaty compliance, as offensive equipment also has uses for “the study of defensive measures against a biological attack.”

Intent vs. Letter of the Treaty

Homeland Security’s McCarthy in her interview with GSN asserted that the treaty allows nations to conduct some biological weapons activity if it is intended for defensive purposes.

The treaty is “intent-based,” she said, and “says you can’t do a whole bunch of things unless there’s a justification for prophylactic, or protective, or peaceful purposes,” she said.

Critics say that interpretation is at odds with Article 1 of the treaty. While the article’s first paragraph forbids biological weapons agent development, production, stockpiling or acquisition except for types and in quantities justifiable for “prophylactic, protective or other peaceful purposes,” it makes no such specific exception for delivery devices.

Instead, the article’s second paragraph forbids obtaining or producing “weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict.”

Echoing Clarke in 2001, McCarthy suggested the Article 1 “prophylactic, protective or other peaceful purposes” applies generally to biological defense “work.”
Leonard disputed that interpretation, saying it appeared to extend the exception for agents to delivery systems.

“Paragraph one and paragraph two are written differently and one has to assume that there’s a reason for that difference,” he said.

The obvious reason, he said, is that legitimizing the development and production of delivery devices for defensive purposes would enable countries to develop and build the components for an entire weapon in the name of defense.

It “makes any kind of policing of the treaty, of assuring that it is functioning in a proper way, virtually impossible,” he said.

Mary Elizabeth Hoinkes, a former State Department general counsel, said she was convinced after reviewing the BWC negotiating record that the negotiators’ “fear of breakout” drove the more restrictive language for delivery devices.

“If you had small amounts of agent, the time to go into production and to switch from research to reduction would be a protection. But if the weapon is lying on the shelf, all you would have to do is gear up the production line,” she said.

Anticipated Costs and Benefits

Critics also charge that while particular elements of the threat characterization program would probably conflict with Article I, the program as a whole could undermine the treaty by raising doubts about U.S. compliance.

Treaty parties might “see this as dangerous to their country to have anybody, especially the trend-setter, the leader, the model, the United States, doing something that is so clearly over the edge of what the treaty permits,” Leonard said.
“The costs of creating an ambiguity that bad people predictably would shelter behind … clearly don’t outweigh this alleged advantage of seeing what kind of devices people are going to be interested in developing,” he said.

McCarthy, on the other hand, argued the proposed work is needed to help guide U.S. biological defense plans.

“This country is investing billions of dollars in biodefense right now. … It is the responsibility of the U.S. government to ensure that we are working on the right problems and so the threat characterization program that we’ve developed is really targeted toward filling in those knowledge gaps,” she said.

“Because the last thing in the world we want to do is spend several billion dollars working on yesterday’s problems and find out five years from now we weren’t targeted on working on the right problems,” she said.

Leitenberg said the administration is effectively asserting a “justification of necessity” for the proposed activities, as it did with a 2003 Justice Department memorandum on procedures for handling captives. He called it U.S. “exceptionalism” to treaty compliance, and questioned the judgment that such work is necessary.
“I argue that the whole basic threat assessment has been exaggerated” by the administration, Leitenberg said.

Interagency Discussions Ongoing

McCarthy, a former nuclear weapons and Antiballistic Missile Treaty compliance expert at the Defense Department, said Homeland Security has administration backing for the program.

“We have reviewed our program plans extensively in the interagency, through the interagency groups,” she said.

She said an extensive end-to-end review “was fully coordinated by all the departments in the government, including the State Department, [that mentions a] need to do certain types of research in order to ensure that we understand the threats,” she said.

McCarthy said, though, assessments have not yet been done for treaty compliance, and that the National Biodefense Analysis and Countermeasures Center is just now developing a compliance process with input from the White House and other agencies that would be used to review particular BTCC proposals.

“I can assure you that inside of the administration and certainly inside of the White House they are very engaged with us in the development of the compliance processes that we’re doing,” she said.

While the Biothreat Characterization Center already is running with $20 million in funding, McCarthy said it has not initiated any work that might raise compliance questions.

“The programs we have going on right now I can assure you are compliant and I take personal responsibility for those programs in my office,” she said.

June 28, 2004

Bioterrorism Fight Could Be Creating New Hazards

Global Security Newswire

The push to defend the United States against bioterrorism by licensing more researchers and facilities to conduct related experiments could be creating new hazards, the Baltimore Sun reported yesterday (see GSN, June 25).

Some scientists say the increase in the number of individuals and organizations conducting germ research in the United States — now standing at 11,119 workers in 317 laboratories — heightens the possibility of an accidental or even deliberate release of those pathogens.

The growing effort has achieved some successes, such as developing new ways to detect anthrax, said Martin Hugh-Jones, an anthrax researcher at Louisiana State University. However, “I think we’ve spent an awful lot of money, and I'm not sure we’re much better off,” he added.

The U.S. Bioterrorism Act, passed after the anthrax mail attacks of 2001 killed five people, imposed new regulations on germ research.

American Biological Safety Association President Stefan Wagener said many of the new regulations have been beneficial.

“I would say the impact has been positive,” said Wagener, a microbiologist who oversees the Canada’s highest-security biological defense lab. “But has the law made the United States safer from an insider’s bioterrorist attack? That’s harder to answer,” he added.

Since registration began last year, the Centers for Disease Control and Prevention has inspected and certified 235 facilities nationwide and granted provisional approval to 82 more to work with anthrax and other select agents. The 11,119 researchers have been cleared by the FBI of criminal or terrorist backgrounds.
The number of projects involving anthrax went from 28 in 2000 to 253 last year, while projects mentioning “bioterrorism” and related terms increased from 25 in 2000 to 665 last year, according to the National Institutes of Health.

“The number of institutions working actively with select agents has skyrocketed,” said Edward Hammond, who tracks biodefense research for the Sunshine Project, a Texas-based watchdog group. “In terms of accidental release, I think we’re unquestionably less safe than we were before 2001,” he added (Scott Shane, Baltimore Sun, June 27).

Researchers Seek Volunteers To Test Anthrax Vaccine

BALTIMORE -- The Johns Hopkins Bloomberg School of Public Health is testing a new vaccine that researchers hope will aid in preventing anthrax.

A synthetic protein and aluminum hydroxide comprise the vaccine, developed by VaxGen Inc., that health officials hope will encourage immune response. The formula will be given in different combinations to 480 healthy volunteers.

The vaccine is base on research conducted by the U.S. Army Medical Research Institute of Infectious Diseases. The study is funded by an $80.3 million contract from the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health.

Hopkins is looking for volunteers to take part in the anthrax vaccine trial. Those interested may be able to participate by calling the school, dial: (410) 614-9702.

June 24, 2004

VA alerts doctors to malaria-drug concerns

United Press International

WASHINGTON, June 24 (UPI) -- The Department of Veterans Affairs is warning doctors to watch for long-term mental problems and other health effects from an anti-malaria drug given to soldiers in Afghanistan and Iraq.

The drug is mefloquine, known by the brand name Lariam, which has been given to tens of thousands of soldiers since the war on terrorism began. Some of those soldiers say it has provoked severe mental and physical problems including suicidal and violent behavior, psychosis, convulsions and balance disorders. Last year the Food and Drug Administration began warning that problems might last "long after" someone stops taking it.

The VA warned its own doctors Wednesday that the drug "may rarely be associated with certain long-term chronic health problems that persist for weeks, months, and even years after the drug is stopped," according to a summary of published studies by a VA panel of experts. The summary accompanies an "information letter" from the VA's acting undersecretary for health, Dr. Jonathan B. Perlin, to healthcare professionals who treat veterans.

Veterans' advocates praised the VA but said the Pentagon seems to have lost track of who has taken the drug -- making the size of a potentially serious problem unclear.

While little mefloquine was used in the first Gulf War, advocates said a similar dearth of medical data has thwarted efforts to get to the bottom of Gulf War Syndrome for a decade. Investigators simply did not know what drugs or vaccines -- possible contributors to that syndrome -- were given to solders.

"We are pleased that the VA is taking a proactive approach to this situation," said Steve Smithson, assistant director of the American Legion's National Veterans Affairs and Rehabilitation Commission.

"It is no secret that the military did not do a good job of record keeping in the first Gulf War," said Smithson. "Early reports on Lariam make me concerned that we did not learn the lessons from the first Gulf War in that it is not being documented in health records."

United Press International has reviewed many medical records and has interviewed dozens of soldiers at eight military bases in the United States and Europe who said they took the drug. None of the soldiers who said they took mefloquine had it noted in their medical records.

The VA letter told doctors that a "number of anecdotal and media reports have suggested that mefloquine has caused more serious effects, including violent and suicidal behavior, and symptoms similar to Post-traumatic Stress Disorder." The letter cited reports linking the drug to a wave of domestic murder-suicides at Fort Bragg, N.C., in the summer of 2002. The Army has dismissed Lariam as a factor in those murder-suicides.

UPI has been investigating mefloquine side effects for two years and reported in May 2002 that mounting evidence suggests it has caused such serious mental problems that in a small percentage of cases it has led to suicide.

Most recently, UPI reported that a number of soldiers at Fort Carson, Colo., who returned from Iraq are showing possible signs of mefloquine problems. In one case, a Green Beret tried to kill his wife and then shot himself to death; she blames mefloquine for triggering the behavior. In another, a medic said she hallucinated an attacker and responded by biting and kicking her husband.

The Walter Reed Army Institute of Research developed mefloquine in the 1970s after malaria developed resistance to earlier drugs. The Army then licensed the drug to Swiss pharmaceutical giant Hoffmann-La Roche. Mefloquine is one of several drugs the Army uses to prevent malaria.

Roche has added increasing warnings about Lariam side effects in the years since it was approved for use in the United States in 1989. Last year the FDA ordered that everyone prescribed the drug be given a written warning about rare reports of suicide and the possibility that problems with the drug might last "long after" someone stops using it.

A Roche spokesman has told UPI that there is "no credible scientific evidence" linking the drug with "violent criminal behavior." Aggression is listed under the Adverse Reactions section of the official product label.

In February Dr. William Winkenwerder Jr., the Pentagon's assistant secretary for health affairs, told Congress that the military is launching a study to see whether reports of severe side effects among soldiers are real. Both he and Army Surgeon General James B. Peake have consistently said the drug is safe. Peake said that reports about problems with the drug are coming from "a Web full of people who have mystique about Lariam."

Wednesday's letter to VA medical personnel noted, "Concern that mefloquine might cause violent behavior is not new; a Canadian soldier accused of homicide claimed that taking mefloquine while deployed to Somalia in 1992 had caused his violent behavior." That soldier subsequently tried to hang himself and is brain-damaged. About 25,000 U.S. soldiers took mefloquine during the Somalia operation, and a number have complained of long-term mental and physical problems, including violent and suicidal behavior.

The Army has said it doled out 45,000 mefloquine prescriptions in the year that ended last October.

The three-page VA letter is accompanied by a 19-page summary of scientific studies and case reports compiled by an expert group that included medical, surgical, public-health and pharmacy experts from the department. Some of the titles among the 61 publications cited are: "Paranoid psychosis related to mefloquine antimalarial prophylaxis (prevention)"; "Seizures after antimalarial medication in previously healthy persons"; "Prolonged visual illusions induced by mefloquine (Lariam); a case report."

The letter states that "there are no practical tests for mefloquine, nor are there any specific tests that can be recommended specifically for veterans who took mefloquine on active duty."

However, a doctor at the Defense Department's Spatial Orientation Center in San Diego recently has begun diagnosing a number of service members with permanent brainstem and vestibular -- or balance system -- damage that he believes is due to the drug.

One such diagnosis was given to retired Navy Reserve Cmdr. William Manofsky, who served in the Iraq war and said he experienced seizures, balance problems and mental disorders as a result of taking the drug.

Another soldier who has been diagnosed at the center is Staff Sgt. Georg-Andreas Pogany, a Fort Carson soldier who was attached to a Special Forces unit in Iraq. He suffered a panic attack after seeing a mangled Iraqi corpse, he said, and sought help from his superiors. They sent him back to the United States, where he was charged with cowardice, an offense punishable by death. That charge was later dropped, but his career is in limbo. He is currently at Walter Reed Army Medical Center in Washington undergoing further medical testing and treatment.

Soldiers at Fort Carson say their complaints about problems they believe were caused by the drug are being ignored by their command and by medical officials. Several soldiers at the base have told UPI that they are being pushed out of the military for problems caused by the drug.

In February the Army said it had ruled out mefloquine as a factor in suicides during Operation Iraqi Freedom in 2003, because only four of 23 confirmed suicides had occurred in units where the drug was prescribed, and only one soldier who killed himself tested positive for the drug in his system. In some units, however, soldiers have told UPI they took the drug, while the Pentagon has said they did not.

Early this year, the Pentagon said it would no longer use mefloquine in Iraq, because the risk of malaria is small.

June 23, 2004

NIH Scientists Broke Rules, Panel Says

Deals With Companies Went Unreported, Probe of Potential Conflicts of Interest Finds
By Rick Weiss
Washington Post Staff Writer

Researchers at the National Institutes of Health violated federal rules by engaging in lucrative collaborations with pharmaceutical and biotechnology companies and not reporting those arrangements to ethics officials as required, according to documents released yesterday as part of an escalating congressional investigation into conflicts of interest at the agency.

The House oversight subcommittee had already identified several instances in which scientists engaged in outside activities that posed at least the appearance of a conflict of interest. But in those cases the arrangements had been approved by top legal and ethics officials. Now, NIH officials said, disciplinary actions may be needed.

Testimony yesterday also provided evidence that Lance A. Liotta, a researcher at the National Cancer Institute, continued to receive thousands of dollars in compensation from one such business arrangement through May, despite his testimony under oath last month that he had suspended the collaboration months before.

The subcommittee said Liotta and others used their government computer systems to exchange e-mails relating to their private consultancies, supporting some lawmakers' contention that some government scientists have been illegally using federal resources for personal gain.

It remains to be seen how many of the subcommittee's allegations will stand up to closer scrutiny as bona fide breaches of ethics rules. Many details of the cases were still missing as of yesterday, and key individuals could not be reached to comment after the hard-hitting six-hour hearing came to a close.

But having learned of some of the new findings late last week, NIH Director Elias A. Zerhouni came before the subcommittee yesterday with proposed revisions to NIH ethics rules more severe than those he had recommended a month earlier.

"I have reached the conclusion that drastic changes are needed," he said.

The new allegations emerged as part of the panel's expanding investigation into government employees' consulting deals with private companies. Although House members began by focusing on NIH, where top scientists' spare time is in great demand by drug companies wishing to capitalize on their expertise, they widened their probe last week to include 15 other federal agencies. In letters sent to agency heads, the subcommittee chairman, James C. Greenwood (R-Pa.), and House Energy and Commerce Committee Chairman Joe Barton (R-Tex.) asked that records of all such collaborations be provided to them by July 2.

Yesterday's surprise disclosure that many NIH scientists may be engaging in outside deals without the required agency reviews and approvals grew from inquiries Greenwood made to 20 pharmaceutical companies.

Given the lack of a centralized NIH database of all agency scientists' outside collaborations, Greenwood went directly to the companies, asking them to reveal all the arrangements they had.

Of the 264 arrangements the companies reported, Greenwood said, "about 100" were apparently unknown to NIH officials.

That sampling has Congress wondering, "What else is out there?," said Rep. John D. Dingell (D-Mich.).

In one example detailed by Greenwood, drug giant Pfizer Inc. reported that Trey Sunderland, a researcher at the National Institute of Mental Health, was paid $517,000 in fees, honoraria and expense reimbursements related to consulting arrangements with the company over the past five years. Greenwood said the information was not on Sunderland's financial disclosure reports as required by federal ethics rules.

An NIH official said Sunderland was traveling abroad and could not be contacted.

In another highlighted arrangement, Alan Moshell of the National Institute of Arthritis and Musculoskeletal and Skin Diseases was retained as an expert witness in several private product-liability lawsuits involving the drug Accutane at a rate of $600 per hour -- and did so without required agency permission -- Greenwood said. Those arrangements were described by Health and Human Services general counsel Alex M. Azar II as particularly worrisome as Moshell allegedly testified in those trials to the inadequacy of the government's own warning label on the drug.

Moshell did not respond to calls and an e-mail late yesterday.

The subcommittee also provided new details regarding an alleged conflict of interest outlined in a May hearing, in which cancer researcher Liotta and an FDA scientist became paid consultants for a California biotechnology company that is in competition with a Bethesda company with which the two scientists and the Cancer Institute were already collaborating.

Liotta testified last month that by March of this year he had suspended the California arrangement, pending a fresh ethics review by agency officials who initially approved the deal but later expressed regret at having done so.

Yesterday, Greenwood flashed on a giant screen copies of several canceled checks from the company -- Biospect Inc. of South San Francisco, recently renamed Predicant Biosciences -- made out to Liotta. The latest check, for $3,125, was dated May 1.

Greenwood also showed evidence supplied by the company that it had paid Liotta a total of $70,000, significantly more than the approximately $49,000 that Liotta reported to ethics officials.

A cancer institute spokesman said yesterday that Liotta had an appointment and would not be able to respond to media queries.

Zerhouni has already imposed new tiers of ethics review for all proposed outside consulting arrangements by NIH employees and greater public disclosure of approved arrangements. Yesterday, he proposed additional restrictions, including some that could be accomplished internally and others that may require new legislation.

Among them: a ban on ownership of drug company or biotech stocks by some key employees, and restricted stock ownership for all other employees; no membership on corporate boards; creation of a centralized registry of all outside arrangements and a public list of the awards that employees may receive; and prohibition of all paid consulting or speaking engagements at institutions that receive NIH funding.

June 16, 2004

Congress approves 'Bioshield' legislation

By Joe Fiorill, Global Security Newswire

Congress approved legislation that would guarantee a government market for medical countermeasures against a biological, chemical, radiological or nuclear attack.

The chamber voted 414-2 in favor of a bill to implement Project Bioshield, which President George W. Bush first proposed in January of last year. The Senate passed identical legislation May 19. Bush is expected within a week or two to sign the bill, which is intended primarily to spur production of drugs that manufacturers would otherwise find unprofitable.

Select Committee on Homeland Security Chairman Christopher Cox, R-Calif., called the passage "a watershed in our mission to defend America against bioterrorism, establishing our first line of defense against biological weapons."

"This is the most significant first-responder program in our nation's history. It will ensure that we have treatments immediately on hand to save lives," Cox said.

Besides authorizing the government to spend $5.6 billion over the next decade on countermeasures produced by private drugmakers, the act would speed National Institutes of Health countermeasure research and development, as well as allow the Food and Drug Administration to approve new drugs more quickly during emergencies.

A $700 million contract for a new anthrax vaccine, the first contract under the new law, is likely to be awarded "as soon as next month," said Rep. Jim Turner, D-Texas, the top Democrat on the House committee.

"By bringing researchers, medical experts and the biomedical industry together in new and innovative ways," Bush said in a statement today, "we will not only help protect the homeland but also gain insights into other diseases. This will break new ground in the search for treatments and cures while strengthening our overall biotechnology infrastructure."

Lawmakers Take "First Step," Eye Long Road Ahead

The measure passed with nearly unanimous bipartisan support, but representatives from both parties cautioned that it is only a first step in bolstering the country's biological defenses. Several outside experts and industry representatives agreed.

"From the beginning of this process," Turner said, "I have been concerned that this legislation will not be enough. Project Bioshield is an experiment. We do not know if the incentives in this bill will drive our pharmaceutical industry to develop medicines for biodefense when they can make so much more money on other products."

Seeking to plug another perceived gap in the Bioshield plan, Turner and other Democrats in May introduced a bill seeking to shorten the time needed to produce countermeasures against new agents. The Democrats said at the time that Bioshield would not address the threat of future pathogens that could be engineered to resist existing drugs.

Rep. Christopher Shays, R-Conn., said Wednesday that "implementation of Bioshield must be linked to the threat," with spending guided by a list of high-priority pathogens maintained by the Centers for Disease Control and intelligence agencies.

"The success of Bioshield also depends upon broader biopreparedness priorities," Shays added. "Massive caches of stockpiled vaccines, antibiotics and drugs," he said, "will protect no one if they cannot be administered quickly and safely. Public-health capacity is a critical enabler to Bioshield success."

Executive Director Shelley Hearne of the Trust for America's Health, a nonpartisan advocacy group, expressed similar sentiments today. "While we feel that Bioshield is an important and laudable step toward better preparedness," Hearne said through a spokesman, "we also need a simultaneous upgrade on distribution systems and work-force shortages. We need to shore up the full spectrum of our bioterrorism and public-health capabilities in order to really improve our readiness."

American Public Health Association Executive Director Georges Benjamin said Bioshield "will serve as a good way of funding cutting-edge research in a time of extraordinary need." In an interview Thursday, Benjamin expressed optimism that Bioshield will prove flexible enough to address broad public-health concerns in addition to drug procurement.

"It makes no sense to create a new vaccine and then not figure out how to get people to take it," Benjamin said.

Some drug makers also highlighted the work left to be done after passage of the measure, calling in particular for special legal protections for the government's vendors. Congress is preparing legislation known as "Bioshield 2" that could set limits on the legal liability of drug makers whose government-purchased products are said to cause harm to users.

In an e-mail Thursday, Pharmaceutical Research and Manufacturers of America spokesman Court Rosen called for "meaningful product liability protection for products specifically designed to be used (or used in new ways) to combat bioterrorism threats, as well as procurement provisions that more closely resemble the competitive private market in which the biotechnology and pharmaceutical industries ordinarily operate."

Democrats Slam Previous Bush Biological-Defense Efforts

Rep. John Shadegg, R-Ariz., said Wednesday that although the Bioshield act is not "perfect ... I do not think we will hear anyone take to the floor and say that this is not a bicameral, bipartisan proposal to address a serious threat to this nation."

Democrats nonetheless took the opportunity to blast the Bush administration for what they called the failure of previous efforts to protect the United States against potential WMD attacks.

Turner called on Congress for "vigorous oversight" of Bioshield implementation, criticizing the Bush administration for past "biodefense failures." He cited the administration's civilian smallpox vaccination program, which he said has vaccinated only about 10 percent of its goal of 500,000 health care workers.

"We need to be asking now, before the ink is dry on this [anthrax-vaccine] contract, 'What's the plan? How does this vaccine fit into our biodefenses?'" Turner said.

"Given the failure of the smallpox vaccination program, do we really expect our citizens to be any more receptive to an anthrax vaccine?" he asked.

Shadegg said simply readying countermeasures can serve as a deterrent against an attack.

"If al Qaeda knows that we are unprepared for a chemical, a biological or a radiological attack," he said, "then they are incentivized to make that kind of attack. On the other hand, if they know that we have invested the money and done the research and we have developed countermeasures ... then they are discouraged to even make that kind of attack."

June 14, 2004

Possible California Anthrax Exposure Raises Concerns

Global Security Newswire

The number of facilities performing anthrax research has increased significantly in recent years without corresponding regulation hikes, experts said last week following the possible exposure of seven California researchers to the biological agent (see GSN, June 11).

“This is a cautionary tale,” Jonathan Tucker, a senior researcher at the Monterey Institute of International Studies and an expert in biological weapons, told the San Mateo County Times. “You have a lot of inexperienced researchers working at facilities around the country on these projects,” he added.

Up until about five years ago, only about 10 to 15 researchers in the United States were studying anthrax, according to the Times. Interest and government funding for such work have increased since then, according to Martin Hugh-Jones, an anthrax expert at Louisiana State University.

“Developing an anthrax vaccine is a popular area of research,” said Hugh-Jones. “Give me a name of an institute and they’re working on it,” he added.

The exposure incident at Children’s Hospital Oakland Research Institute, in which researchers were exposed a live anthrax they thought was a dead version of the virus, highlights insufficient regulation of the booming biological defense industry, said Richard Ebright, a microbiology professor at Rutgers University in New Jersey.

“This is a gap in regulation,” Ebright said. “This incident shows that material that is purportedly inactivated can have viable, recoverable agent. And because there are no regulations, no paper trail, this is a gap through which malicious organizations could obtain select agents without a paper trail and perhaps with serious safety incidents,” he added.

After Sept. 11, 2001, Congress and the Centers for Disease Control and Prevention tightened rules on the handling of select agents, the three categories of microorganisms believed to pose the greatest threat of use in bioterrorism. However, the federal health agency has since removed inactivated agent and avirulent or vaccine strains from the list, effectively exempting them from all regulation. Inactivated anthrax bacteria are not subject to the registration, security, shipping or biological safety rules of select agents, according to the Times.

Thomas Voss, a vice president at Southern Research Institute of Frederick, Md. — the organization that provided the Oakland laboratory with the live strains — said a review of the mistake is focused on the neutralization procedure used on the bacteria. Oakland researchers requested the bacteria be killed by heat treatment in boiling water, Voss said.

Some experts said hot water would not kill all the anthrax spores.

“If it is what it appears to be, it represents an institutional and a regulatory failure,” said a veteran anthrax researcher. “I would expect SRI to catch an incredible amount of heat and perhaps be closed down for a while,” the researcher added.

The CDC is launching a full investigation into Southern Research, according to the Times (Vesely/Hoffman, San Mateo County Times, June 12).

June 10, 2004

Researchers in Oakland accidentally exposed to live anthrax

By Paul Elias

SAN FRANCISCO – At least five workers developing an anthrax vaccine at a children's hospital research lab in Oakland were accidentally exposed to the deadly bacterium because of a shipping foul up, officials reported Thursday.

Officials with the Children's Hospital Oakland Research Institute said none of the researchers has shown symptoms of infection since the first exposure perhaps two weeks ago, but each is being treated with precautionary antibiotics.

The researchers believed they were working with syringes full of a dead version of anthrax, hospital spokeswoman Bev Mikalonis said. Instead, according to Mikalonis, they were shipped live anthrax by a lab of the Southern Research Institute in the Frederick, Md.

Anthrax produces severe flu-like symptoms in most of its victims. If inhaled, ingested or otherwise introduced into the body, it can kill.

Other workers may also have been exposed while the researchers handled the live anthrax, Mikalonis said, a possibility that federal, state and local officials – including the FBI – are investigating.

Though the five workers were exposed, state health officials and the hospital don't believe anyone was infected because researchers took proper safety precautions.

The exposure doesn't pose a threat to patients because the Oakland lab is located about one mile from the hospital, according to officials.

"We do not see a threat or a danger to anyone in the community," said Dr. Richard Jackson, the California public health officer. "This really has been very well controlled."

The researchers are working with dead bacteria to develop an anthrax vaccine for children. Mail-borne anthrax attacks killed five people and sickened 17 others in 2001. While no one has ever been arrested for those killings, the attacks spurred research into better vaccines and treatments.

Mikalonis said the Oakland researchers received and stored the shipment from the Southern Research Institute, also known as SRI, about three months ago.

The researchers first used the tainted batch May 28 on lab mice which died soon after, hospital officials said at a news conference Thursday afternoon. But hospital officials said the head of the lab wasn't notified.

Then, last week, the researchers injected the anthrax into more mice. On Monday, those mice were found dead.

The researchers started their own investigation, and on Wednesday night, California state health officials confirmed their worst fears – live anthrax was in the syringes. Agents with the FBI's bioterrorism unit removed the samples from the lab Wednesday, according to a hospital new release.

"The facility here has handled it extremely well," said hospital researcher Amy Morgan. "Our concern is what went wrong at SRI."

Southern Research Institute's Thomas Voss, who is in charge of homeland security and emerging infectious disease, said the Birmingham, Ala.-based nonprofit company is investigating. Voss said it's still unclear whether the institute did ship live anthrax to Oakland.

"We aren't totally sure of the sequence of events," Voss said.

The Southern Research Institute has two highly secure "hot labs" that store some of the world's deadliest diseases. Labs and researchers from around the country that need data about those nasty diseases but don't – or can't – handle them contract SRI to do that work.

Voss said the institute's labs in Frederick and Birmingham handle just about every "select agent" listed with the Centers for Disease Control and Prevention. The institute is one of 350 entities registered with the CDC to handle live anthrax. It employs 600 people nationwide and has about $75 million in revenue a year, Voss said.

While the institute receives many shipments of live diseases, some from the government, it rarely ships them out, Voss said.

"On our end, we ship very infrequently," Voss said. "I can't even recall shipping live agents."

The mishap will likely be seized on by critics of the government's effort to combat biological terrorism by paying for the construction or expansion of 18 high-containment labs nationwide. Supporters of the building boom said the additional lab space is needed to combat emerging global threats, but critics said such expansion increases the likelihood of accidents such as this one.

"This is exactly the kind of thing that a lot groups that oppose this spate of construction fear," said Edward Hammond of the Sunshine Project, a chemical and biological weapons watchdog group. "This is the type of accident that has concerned them a lot."

June 9, 2004

Bioshield Project Moving Forward Without Law

By Joe Fiorill
Global Security Newswire

BALTIMORE — A top U.S. vaccine development official today expressed hope that President George W. Bush would sign the Project Bioshield initiative into law by month’s end but called the absence of such a law unimportant to the project’s progress (see GSN, May 20).

Bioshield is designed to guarantee a government market for vaccines that drug makers otherwise would see as unprofitable and be reluctant to produce.

The Senate and House of Representatives have passed separate versions of legislation to enact Project Bioshield, but no step has yet been taken to reconcile the chambers’ approaches and allow passage by the full Congress. Bush, who first proposed the project early last year, would be expected to quickly sign the bill if congressional passage occurred.

Despite Bioshield’s statutory nonexistence, Congress has appropriated funds for the project, a fact stressed today by top Health and Human Services Department vaccine adviser Philip Russell during a question-and-answer period after a speech he delivered at the University of Maryland Law School.

“The latest rumor was that Congress would probably act and the president would sign it at the end of this month. I hope so,” said the former head of the Walter Reed Army Institute of Research and the Army Medical Research and Development Command.

Russell said Health and Human Services could be expected to begin spending appropriated funds within months irrespective of Congress’ progress on the legislation.

“It really isn’t holding us up,” Russell said of the congressional delay. He said proposals already issued would “hopefully” result in the award of a contract for vaccine production by August or September.

Officials have said the first contract likely to be awarded under Bioshield would be for an anthrax vaccine (see GSN, June 8). Russell today placed such a vaccine among top priorities for the project, along with anthrax treatments, a “next-generation” smallpox vaccine, botulinum antitoxin, recombinant plague vaccine and other products.

Russell also underlined the danger of development of dangerous antibiotic-resistant biological agents. “We have about five years to find a first-class solution to that problem,” he said, mentioning mass vaccinations as one such fix.