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Germ research gets urgent

- The Washington Times - Sunday, June 8, 2003

Second of two parts

Continuing bioterrorism scares are breathing new life into obscure scientific projects as the nation gropes for a way to defend itself from deadly microbes.

The sudden interest in microbiology is fueled by revelations such as the discovery of a mobile bioterrorism laboratory that traveled Iraqi highways.

A few thousand miles away, a South African court is revealing details of an apartheid-era contingency plan to use anthrax on black communities.

The U.S. government is waging an uphill battle against the tiny and nearly untraceable microbes of bioterrorism.

"If you can brew beer, you can make a bug," FBI spokesman Bill Carter said, recalling a warning from an FBI scientist on manufactured viruses.

The elusiveness of the bacteria spores and microscopic viruses is turning bioterrorism research into big business. Companies that focused on cures for cancer and Alzheimer's disease are finding bigger profits in vaccines, antidotes and other bug-fighting tools.

But the bioterrorism scare also is creating new fears for researchers, both in terms of safety and criminal liability.

Good for business

Concerns about bioterrorism are resulting in the kind of device Army scientists demonstrated at a recent biodefense conference in Baltimore.

The handheld "microarray" system tests white blood cells to detect viruses within 36 hours of exposure, sometimes even before victims know they are sick.

The device is supposed to be an early warning system against biological bombs. It was developed by the Walter Reed Army Institute of Research for the malaria soldiers might encounter in other countries.

"In many cases the products of that research apply to public health," said Chuck Dasey, spokesman for the U.S. Army Medical Research and Materiel Command.

The Army plans to refine the system to detect anthrax, smallpox and other diseases.

Before the September 11 terrorist attacks, the Silver Spring researchers worked largely in isolation to develop cures for malaria, hepatitis, dengue fever and common battle injuries.

The terrorist attacks, anthrax in letters a month later and the risks of a biochemical war unleashed on the United States refocused their attention.

Now, the military and its private contractors in the biotechnology industry have decided that what's good for business is good for the country.

"It appears that private investments in bioterrorism research are believed to be more likely to bring near-term payback," said Sau Lan Tang Staats, chief executive officer of Phoenix Science & Technology Inc.

The Elkton, Md., company produces disposable equipment for biotechnology research.

Before the attacks, the company had difficulty finding financial backers and customers. Now its equipment is being tested by the Army's Aberdeen Proving Ground, which houses a biochemical defense laboratory in Northeast Maryland.

In addition, the Maryland Technology Development Corp., a public-private venture that encourages technology business in Maryland, is interested in investing $50,000 in the company.

Gaithersburg biotech company GenVec Inc. is using malaria vaccine technology it developed with the Navy to work on a SARS vaccine. SARS, or severe acute respiratory syndrome, is a virus that started in China in November and has been spreading around the world.

Chief Executive Paul Fischer said similar technology could be a safeguard against bioterrorism.

"The core technology is essentially the same," Mr. Fischer said. "That same kind of technology could be available in the future for these unknown events."

Cell Works Inc. in Baltimore wants to develop a blood test for anthrax, similar to a system for cancer cells it produces.

"It's something that companies like ours can incorporate into our diagnostic technology," Vice President Peter Rheinstein said.

Biodefense projects "create new technologies, the spin-offs of which can be commercialized into some pretty good things," he said.

Biotech companies along the Interstate-270 corridor in Montgomery and Frederick counties also have turned their attention toward defense projects:

• Human Genome Sciences Inc. of Rockville is developing a drug that may prevent and fight anthrax by bolstering the body's defenses against the germ. It says it expects to begin clinical trials later this year.

• The Department of Defense has hired DynPort Vaccine Co. of Frederick to research as many as 17 vaccines, including a next-generation version for anthrax.

• Igen International of Gaithersburg makes five field diagnostic tests for biological agents. The company's biodefense-related sales jumped to about $2 million in the final quarter of 2002, after the Army Medical Research Institute for Infectious Diseases at Fort Detrick asked Igen to custom-make the tests.

• It's just a matter of time before the Institute of Genomic Research, a Rockville research firm, makes a contribution to bioterrorism defense. The company already has published its research to read the anthrax genome. Understanding the genome was a first step toward new drugs and vaccines.

However, other companies are having trouble cashing in on bioterrorism.

One of them is Columbia-based Cylex Inc., which has won FDA approval for its test to screen immune-system function for organ transplants. It wants the government to buy the system to screen out immune-compromised people likely to be sickened by a smallpox vaccine. So far, the government has not expressed an interest.

BioShield ups the ante

A debate in Congress over President Bush's proposed Project BioShield is ensuring that more companies will vie for government money.

Mr. Bush proposed the huge project to protect the nation from bioterrorism during his State of the Union address.

The House and Senate agree BioShield is needed, but not on the amount to spend.

Mr. Bush wants no cap on funding, preferring instead to spend whatever is needed for specific projects. The House and Senate proposals run between $5 billion and $5.6 billion over the next 10 years.

With such large sums available, the direction microbiology research companies will follow for the next decade is clear.

"They tend to follow what can be funded," said Steve Fritz, president of the Maryland Technology Development Corp. "What would have been done instead, I can't say."

Needless to say, BioShield is popular with microbiologists.

"I think the BioShield legislation is clearly an effort to streamline the process of acquisition for getting the drugs and vaccines we are going to need," said Tom Inglesby, deputy director of the Johns Hopkins University Center for Civilian Biodefense Strategies. "I think the administration should be commended for this."

BioShield is merely an addition to the biodefense effort already operating in overdrive since the anthrax letters started circulating in October 2001.

The National Institutes of Health's bioterrorism budget increased 500 percent this year to $1.3 billion.

"I don't believe there was bioterrorism in the NIH budget prior to 9-11," spokesman Don Rabolvsky said.

Some scientists say the new bioterrorism research adds to other advances in biology rather than diverting from more traditional projects.

"A rising tide raises all ships," said Gillian Woollett, vice president of science and regulatory affairs at the Biotechnology Industry Organization trade group.

Opportunity beckons

The bigger budgets are lifting hopes for scientific breakthroughs.

"Most scientists who work in the area of infectious disease feel that the new funding will not only benefit the needs of the Homeland Security Department but also basic science in better understanding host-pathogen relationships, expedite much-needed new human and animal therapies and delivery systems for vaccines," said Jennie Hunter-Cevera, president of the University of Maryland Biotechnology Institute.

Bioterrorism threats are making projects possible that would have been ludicrous only a few years ago.

For example, a crop duster released a mixture of grain alcohol, clay dust and water and polyethylene glycol over central Oklahoma March 24. The Army and the Environmental Protection Agency were testing whether radar could detect a bioterrorist attack.

Ultimately, they hope to develop computer technology for a nationwide bioterrorism detection program. The EPA has done similar tests in Maryland, Utah and Florida since 2001.

At least three sophisticated national laboratories will be built with federal money.

The most dangerous research is done at government Biosafety Level 4 labs, also known as BSL-4. NIH operates one of them in Bethesda, and another at the U.S. Army's Medical Research Institute on Infectious Disease at Fort Detrick, Md.

Much of NIH's budget increase for this year will be spent to build more BSL-4 labs.

Scientists wearing airtight suits will use them to handle the world's deadliest germs.

Therein lies the risk.

Scared of new rules

Congress responded to the October 2001 anthrax scare by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, known as the Biopreparedness Act.

Anthrax-laced letters shut down the Hart Senate Office Building and killed postal workers at the Brentwood mail distribution center. Other anthrax letters arrived at media organizations and private homes in New York, Florida and Connecticut.

The Biopreparedness Act created new restrictions on who can handle dangerous microbes, which ones they can handle and how and where they can be used. In addition, industry must follow stricter procedures to prevent contamination of food and water supplies.

Businesses and academia are confused and upset by the government intervention, which is common for many new regulations.

The Food and Drug Administration used the Bioterrorism Act to require the $500 billion food-processing industry to register facilities and give prior notice of any imports companies accept. The agency also increased its inspections of foods that could be contaminated with anthrax or other toxins.

The new regulations "would pose a significant burden to industry in terms of both cost and operational facilities," the National Food Processors Association said.

Other provisions of the Biopreparedness Act impose criminal penalties on unauthorized handling of organisms and chemicals, some of which are commonly used in academic research.

"There certainly is fear in the microbiology community," said Ronald Atlas, president of the American Society of Microbiology.

The FBI is checking the backgrounds of researchers, while potential criminal penalties for mishandling microbes are having a "chilling impact on life-science research," Mr. Atlas said.

In addition, foreign scholars are excluded from some projects.

"A significant number of visa applications have been declined," Mr. Atlas said.

Cures from deadly sources

He has testified to Congress that medical treatments depend on access to potentially deadly cultures. Natural disease creates more risk than bioterrorism.

Among the prohibited items are viruses for Ebola, yellow fever and Marburg, the anthrax virus, and toxins for botulinum and ricin.

All of the agents can cause serious illness. Until now, thousands of laboratories used them for research.

"So many university labs in the past have worked with these agents and never reported them since it was not really required, nor did federal agencies such as CDC or the USDA have enough staff to actually go out and do checks on a regular basis," said Mrs. Hunter-Cevera of the University of Maryland Biotechnology Institute.

"Industry has organized central culture depositories where everything is inventoried, monitored and documented. Academia will now have to catch up to industry standards."

However, biologists warn that the legal restrictions limit the experimentation that could result in new drugs or chemicals.

Botulism, for example, would be a deadly scourge if it spread unaltered through food and water supplies. With chemical modifications, it is used as a key ingredient in botox, the material used in cosmetic surgery to eliminate wrinkles.

E-coli, an organism sometimes found in rancid meat or contaminated water, is being studied as a cure for cancer.

A University of Connecticut graduate student was charged with violating the Patriot Act after FBI agents found anthrax vials stored in his laboratory freezer. A professor verified the student obtained the specimens from a malfunctioning storage freezer, which he was cleaning out.

The Patriot Act

The Patriot Act, which Congress passed overwhelmingly a month after the September 11 attacks, consolidated federal law-enforcement authority to investigate and detain persons with suspected terrorist links.

Although the Connecticut graduate student said he did not realize he was doing anything illegal, he accepted a plea bargain that will require community service and visits to a probation officer.

In another incident, infectious disease researcher Thomas Butler at Texas Tech University was arrested in January. He had lied to cover up the fact he failed to properly document destruction of vials of plague bacteria.

• Part I: Medical Alert