http://www.terrorismlibrary.com/bioterrorism.htm

 
Source: Foreign Affairs, Jan-Feb 2001 v80 i1 p76.

Title: The Nightmare of Bioterrorism.
Author: Laurie Garrett

Full Text COPYRIGHT 2001 Council on Foreign Relations, Inc.

TOOLS IN HAND

As the twenty-first century begins, the following nations possess biological weapons: Iraq, Iran, Syria, Libya, China, North Korea, Russia, Israel, Taiwan, and possibly Sudan, India, Pakistan, and Kazakhstan. The list cuts across lines of ideology, politics, and geography. In addition, according to intelligence sources in Europe and the United States, militant political groups across the globe are now developing or seeking to purchase biological weapons for terrorist use.

Meanwhile, the sophistication of biological weaponry has improved by leaps and bounds. Until 1985, all of the world's biological-weapons makers were stuck with the same list of pathogens and toxins that could kill thousands of enemies and be delivered with missiles or large-scale aerosol systems. Each nation knew the list and stocked antidotes and vaccines. It was a standoff.

But biology in the last decade has been what physics was in the 1940s and 1950s: a field of exponential discovery. What seemed impossible in 1980 was accomplished by 1990 and, by 2000, had become ho-hum fodder for high school biology classes. By the late 1990s, a massive pool of bioengineers, equipped with genetic blueprints to guide their efforts, had emerged. Determining the genetic sequence of a virus, such as Ebola, was no longer much of a feat. In 1998, scientists at the Frederick Cancer Research Center in Maryland determined, at the genetic level, exactly how anthrax kills human cells.

In response to such advances, Western militaries hardened their defenses against biological warfare as they vaccinated troops, stockpiled antitoxins, stored appropriate antibiotics, purchased protective suits and masks, practiced war-game drills involving biological weapons, and supported research on potential microbe- detecting devices. But no one had a master plan for dealing with the collateral impact of biological weapons on civilians located around the combat zone -- or the deliberate impact of bioterrorist damage inflicted on an unsuspecting community. Were a terrorist to disperse the smallpox virus, for example, populations that were once universally vaccinated would now be horribly vulnerable. Today the U.S. government stows only about 15.4 million doses of the smallpox vaccine -- enough for less than seven percent of the American population. The World Health Organization (WHO) keeps another 500,000 doses in the Netherlands, and other national stockpiles total about 60 million more doses of varying quality and potency. If the smallpox virus were released today, the majority of the world's population would be defenseless, and given the virus' 30 percent kill rate, nearly two billion people could die.

The picture worsened in 1999, when scientists discovered that the U.S. samples of the smallpox vaccine had severely deteriorated. Originally made in the 1970s by the Wyeth pharmaceutical company, the samples were stored at the Centers for Disease Control and Prevention (CDC) in Atlanta in the form of freeze-dried crystals parceled out in 100-dose quantities inside vacuum-sealed glass tubes. The tubes were further sealed with rubber stoppers secured by metal clamps. To their dismay, CDC investigators discovered condensation in many of the glass tubes, indicating that the rubber stoppers had decayed and vacuum pressure had been lost. Such vaccine supplies can no longer be considered safe for human use. Although the rest of the world's vaccine reserves have not undergone similar scrutiny, experts do not have much confidence in those either. Furthermore, the world's supplies of bifurcated needles - - uniquely designed for scratch-administering the smallpox vaccine on human skin -- have been depleted, and companies are no longer interested in manufacturing such specialized devices.

The world is thus completely vulnerable to a smallpox attack. The last time a mass emergency vaccination took place in the United States was 1947, when a traveler from Mexico spread smallpox to New York City. Vaccines were then readily available, and 6.35 million New Yorkers were immunized in less than four weeks. In 1961, a similar vaccination campaign was administered following a smallpox outbreak in England: 5.5 million people were immunized in a month's time. A decade later, smallpox cases in Yugoslavia prompted the rapid vaccination of 20 million people in that country. Were a smallpox crisis to emerge today, none of these efforts could be repeated.

LETHAL LAG TIME

Even if large stockpiles of the smallpox vaccine could be collected immediately, they would be of limited value for two reasons: only several days after infection would individuals develop recognizable symptoms, by which time thousands -- even millions -- would have been exposed; and only several days or weeks after vaccination would individuals develop sufficient antibodies to stave off infection.

For other diseases preventable by vaccine, such as anthrax, the lag time between inoculation and the development of powerful antibodies could be far longer -- up to a year, even with boosters. And of course, immunization efforts would be useless against vaccine-resistant pathogens, such as those created by Soviet scientists working on anthrax weapons. Furthermore, a determined bioterrorist could simply try a succession of microbial weapons -- or use a cocktail at the outset -- defying even the best-organized vaccination programs.

The cost of a delayed response to an anthrax attack would be staggering, explains CDC economist Martin Meltzer: in a model city of 100,000 people, the number of "deaths is 5,000 if you start [a vaccination program] on day one [after the attack], versus 35,000 on day six." Cities large and small, then, should start stockpiling relevant antibiotics, vaccines, and general medical supplies.

But even if cities were well equipped for a bioterrorist attack, they would still have a difficult time recognizing that such an attack had occurred. Local authorities "probably aren't going to be able to recognize it has happened ... until the incubation period is over," says Clark Staten, executive director of the Emergency Response and Research Institute in Chicago. "And by then, you've got it spread over a wide area. And it may take longer to recognize there's a pattern going on."

Once an outbreak is recognized, an epidemiologist would be dispatched to identify the cause. If the pathogen were fairly common, like Clostridium botulinum (the bacterium that causes botulism, a fatal food poisoning), local hospital laboratories could probably identify the culprit first. But if the microbe were rare, like those that cause anthrax, Q fever, Ebola, smallpox, or plague, local facilities would probably be unable to diagnose the problem. With precious time passing, people dying, and disease possibly spreading, local officials would then await word from the diagnostic labs at the CDC. If the suspected pathogen were highly deadly, like the smallpox virus, the analysis would be handled in the CDC's Special Pathogens laboratory, which is normally staffed by fewer than a dozen highly specialized scientists. And during a crisis, it would be difficult to find qualified supplementary staff to scale up operations. During the 1995 Ebola outbreak in Zaire, forexample, the lab was staffed by a mere six scientists WHO toiled around the clock trying to identify the presence of the lethal virus in some 30,000 tissue, blood, plant, insect, and animal samples. In the case of a bioterrorist attack, valuable time -- and lives -- might be lost during such an arduous process.

In a large urban center, the true costs of a bioterrorist attack might be the consequences of panic, such as a stock market collapse in New York or a commodities market crash in Chicago. At a 1998 Senate hearing on bioterrorism, then Minnesota State Epidemiologist Michael Osterholm warned against underestimating the degree of panic such an event would provoke:

[A] single case of meningitis in a local high school causes enough fear and panic to bring down a whole community. ... Now imagine you're telling people, "This is going to unfold for eight weeks, and I can't tell you if you're going to die." And with every symptom ... real or imagined, [people are] going to think, "I've got it! I'm going to die!"

A TELLING SCENARIO

In February 1999, the Johns Hopkins Center for Civilian Defense Studies enacted an elaborate bioterrorist scenario in Crystal City, Virginia. The details played out over a tense eight-hour period in a room packed with public health, military, and law enforcement personnel. Under the scenario, the vice president of the United States makes a speech at a prestigious university located in a fictional town dubbed Northeast. It's April 1. Eleven days later, a 20-year-old student who attended the vice president's speech shows up in the university hospital's emergency room with flu-like symptoms: high fever, muscle aches, fatigue, headache. She is sent home with aspirin and the old maxim: get some rest and drink plenty of fluids.

Two days later, the young woman returns to the hospital, now fighting for her life. And a janitor who cleaned up after the vice president's speech turns up with the same symptoms. By six o'clock that night, April 13, the hospital's infectious disease expert gingerly voices an outrageous conclusion: both patients have smallpox.

Since smallpox was officially eradicated in 1977, and remaining samples of the virus exist only in Atlanta and Siberia under lock and key, there can be but one conclusion: someone has stolen laboratory samples of the virus and deliberately released them in a bioterrorist attack aimed at the vice president of the United States.

Under this scenario, more than 15,000 people die of smallpox worldwide within two months, and epidemics rage out of control in 14 nations. All global supplies of the smallpox vaccine are depleted, and it will take years to manufacture enough to save humanity. The global economy teeters on the brink of collapse as nations close their borders and sink into isolation, barring all Americans from entering their countries. In the city of Northeast, utter chaos reigns, and the National Guard enforces martial law over the city's two million residents. Similarly, government authority either breaks down or reverts to military-style control in cities all over the world as smallpox claims lives and pits terrified citizens against one another. Meanwhile, back in Northeast, a top smallpox expert scribbles projections on the back of an envelope and gently slides it in front of the state governor: within 12 months 80 million people worldwide will be dead.

"We blew it," declared California's top public health scientist, Michael Ascher, commenting on the fictional scenario. "It clearly got out of control. Whatever planning we had ... didn't work. I think this is the harsh reality [of] what would happen."

BUDDING BIOTERRORISTS

Although most people remain ignorant of the issues raised in that scenario, handfuls of Internet-hooked extremists, right-wing militia members, psychologically imbalanced belligerents, and postmodern fascists are well versed in the fine points of bioterrorism. Recipes for producing botulinum and anthrax are posted on the Web. Books describing biological-warfare assassination techniques are readily available. Some private militia groups train to use biological weapons.

Indeed, law enforcement leaders claim that religious cults and militant political groups are likely to engage in biological terrorism. After all, they argue, the first bioterrorist attack in America was carried out by members of an Oregon-based religious cult led by Bagwan Shree Rajneesh. The cult members, hoping to disrupt an upcoming county election, contaminated local salad bars with salmonella, infecting hundreds of Oregonians.

Perhaps it is the tone of some militants' rhetoric that sparks the most concern. In The Poisoner's Handbook, for example, Maxwell Hutchkinson suggests that readers poison or kill Internal Revenue Service workers by filling out phony tax-return forms and lacing them with a mixture of ricin (a poisonous protein) and dimethylsulfoxide (DMSO) -- a concoction Hutchkinson claims is 100 percent lethal. "The purpose of all this is to disrupt the operations" of the IRS, Hutchkinson writes. "If done on a large enough scale, it would serve two purposes -- it would make it more difficult for the IRS to operate efficiently, thus helping tax cheats and tax protesters. It might also awaken the politicians to the depth of resentment felt by the taxpaying public."

Fortunately, Hutchkinson is a lousy chemist: only simple chemicals -- not proteins such as ricin -- can dissolve in DMSO. But the depth of Hutchkinson's antagonism is unmistakable: he suggests that readers kill Catholics by soaking their rosary beads in Phytotoxin abrin, a toxin derived from a rare bean; he writes that botulinum is "fun and easy to make"; and he urges survivalists around the world to hone their skills, readying themselves for biological warfare in the coming Armageddon.

RAISING THE BAR

In response to such threats, Congress has passed a number of laws aimed at making it harder for anyone -- domestic or foreign -- to attack America with biological weapons. In 1989, Congress passed the Biological Weapons Act, outlawing the possession, trade, sale, or manufacture of a biological substance "for use as a weapon." In 1991, it enacted an embargo, soon enforced against Iraq, barring U.S. companies from trading with countries believed to be developing biological weapons. After the 1995 Oklahoma City bombing, Congress passed the Anti-Terrorism Act of 1996, allowing federal authorities to arrest anyone WHO even "threatens" to develop or use biological weapons. And the following year, by order of Congress, the CDC named 24 infectious organisms and 12 toxins as "restricted agents," the use or possession of which requires a federal permit. Although these measures now provide legal instruments for federal law enforcement officials, it is impossible to judge how effectively they have, or have not, deterred biological terrorism.

The Clinton administration hoped to stave off the worst threats by training the National Guard and local hazardous-material defense teams to rapidly respond to bioterrorist attacks. But the teams, comprising elite local police squads and fire department personnel, handled chemical and biological threats as if they were roughly synonymous -- a fatal mistake, according to biologists. Having been trained in classical techniques for limiting the spread of lethal chemicals, the defense teams assumed that a visible source of contamination could be identified, that exposed individuals could be isolated, and that a toxin could be swiftly cleared out of the environment with water or neutralizing chemicals. None of these assumptions holds true for lethal microbes, biologists argue, because their long incubation periods in potentially contagious human beings render it nearly impossible to identify and contain a source. Furthermore, "washing" an area contaminated with pathogens might only spread them.

Congress has sought technological solutions as well, allocating money for Department of Defense (DOD) research on devices that might sniff out bugs and sanitize contaminated areas. First in line was the Navy's TagMan, a sophisticated gene scanner that could, in less than half an hour, determine whether a liquid sample contained any of several known pathogens. But the system had significant limitations: weighing 300 pounds, it was hardly portable. And it could not detect pathogens of high "biohazard levels" -- precisely the most worrisome microbes. Most significant, the device could not analyze air samples.

In 1998, Congress also gave the DOD's Defense Advanced Research Projects Agency (DARPA) $2 billion to sponsor wild and crazy science projects -- ideas so far-out that standard civilian funding sources would not consider them. These projects included $61.6 million of bioweapons defense efforts, the foremost of which was the development of a fast, cheap, safe, and portable way to sample air for the presence of nasty pathogens. Most of the research focused on unique genetic attributes of bacteria and viruses.

One project involved trying to grow human nerve cells on microscopic chips that would change color or light up if they detected a neurotoxin, such as botulinum. Several laboratories -- notably the Argonne National Laboratory in Chicago -- tried to develop chips lined with thousands of pieces of bacterial DNA to serve as probes. Argonne's goal was to build a bacteria detector small enough to be handheld, akin to a police radar gun. But research director Eli Huberman said such a device "is years away from mass production or for widespread use." Furthermore, neither Argonne nor any other research group envisioned sampling the air for viruses. Even DARPA's wild thinkers could not imagine how that could be done.

Even the simplest technological defense against biological weapons has proven to be too much for DOD contractors. In the spring of 2000, DOD officials revealed that the protective suits U.S. troops had relied on during the Persian Gulf War (and that still form the basis of soldiers' defense against deadly microbes) were defective. At least five percent of the 900,000 suits the DOD had purchased during the 1990s were useless, and the reliability of the entire inventory was suspect.

It seems unlikely, then, that a technological quick fix will soon be found. The three immediate American responses to bioterrorism -- military defense, hazardous-material defense teams, and high-technology sensors -- appear to be seriously flawed.

WHO'S IN CHARGE?

Consider this hypothetical scenario: the Red Army terrorist group successfully releases drug-resistant anthrax spores in the Bourse station of the Paris Metro at 8:00 am on a warm Wednesday in June. What would be the role of the French military, Surete (the French intelligence service), the Paris police, or any number of high-tech sensory devices? None.

The most important responders would not be the military or law enforcement officials. They would be the doctors, epidemiologists, ambulance drivers, nurses, and bureaucrats of the Paris public health system. It is they who would note -- days after the actual attack -- that large numbers of Parisians appeared to be ill, suffering similar symptoms. With further questioning they would perhaps realize that all the ailing individuals routinely took the same Metro train or stopped at the same station. Whether or not anyone would ever discover that terrorists had sprayed a lethal biological mist in the Bourse Metro station, it would be the public health workers who would track down and treat the patients, dispense appropriate drugs, determine whether the outbreak was spreading from the Bourse source, and analyze the microorganism for any special attributes.

Yet military-like responses have dominated Western government thinking, sparking recent outcries among defenders of civil liberties. During role-playing episodes in 1998-99, the DOD claimed the right to seize command during a bioterrorist attack -- a constitutionally shaky move. And on February 1, 1999, Defense Secretary William Cohen announced the creation of a special command within the DOD designed to coordinate responses to domestic bioterrorist attacks. Cohen's plans echoed the popular 1995 movie Outbreak, in which the U.S. Army declared martial law and took full control of an American city to limit the spread of an airborne form of the Ebola virus. Civil-liberties advocates responded to Cohen's announcement with indignation: Such a clear violation of the Constitution might be OK for Hollywood, they cried, but not for the real world.

President Clinton had tried to obviate such worries in his January 22, 1998, speech to the National Academy of Sciences. "We will be aggressive," he said, referring to his administration's response to the bioterrorist threat. "At the same time ... we will remain committed to uphold privacy rights and other constitutional protections, as well as the proprietary rights of American businesses. It is essential that we do not undermine liberty in the name of liberty." That day Clinton requested congressional approval of a $10 billion antiterrorism program, including $86 million for improving public health surveillance, $43 million for research on vaccines for anthrax, smallpox, and other potential bioweapons agents, and $300 million for stockpiles of essential drugs and vaccines. The proposed expenditures doubled the previous year's bioterrorism budget.

The job of building the nation's drug and vaccine warehouse fell to Margaret Hamburg, assistant secretary for the U.S. Department of Health and Human Services. She had to race to catch up with the DOD and the FBI. Public health was a late entrant to the bioterrorism field, she said, and significant dangers lurked in the developing antiterrorist infrastructure. Beyond the civil liberties issues that had already been voiced, Hamburg warned, "we don't want public health to be identified with the CIA and FBI activities. ... We in public health need to have public trust and confidence."

Already, local public health departments were having a hard time responding to fake bioterrorist attacks. Claiming to have dropped off or shipped an anthrax-containing device suddenly became chic at the turn of the millennium. Terrorism expert Jessica Stern counted 47 such hoaxes in the United States since 1992. In all 47 cases, local fire and police authorities reacted seriously, decontaminating thousands of people and appearing on the scenes dressed in full-body protection suits. And Stern's list was by no means comprehensive.

Secretary of the Navy Richard Danzig warned that panic, in and of itself, is becoming the new terrorist tool. "Only through a new union of our public health, police, and military resources," he said, "can we hope to deal with this dangerous threat." But Hamburg worried that the police and FBI responses actually encourage such false alarms. It seems that bioterrorist hoaxes attract the type of individuals WHO enjoy watching fire departments douse buildings they have set afire. "When an envelope comes in saying 'This is anthrax,' we don't need the fire department in full protective gear on site," Hamburg insists. "What we need is to discreetly move the envelope to a public health laboratory for proper analysis. Mass decontamination and quarantine only [add] fuel to the fire of the hoax perpetrators, and it's totally unnecessary in terms of public health."

DIFFERENT DRUMMERS

It is obvious that public health, law enforcement, and defense officials have very different priorities in the event of a bioterrorist attack. For public health workers, the paramount concerns are limiting the spread of infection, identifying the cause of the disease, and if possible, treating and vaccinating the public. Law enforcement agents, however, are in the business of stopping and solving crimes -- and the scene of any bioterrorist incident is, first and foremost, a source of evidence. Managing a response to an outbreak thus poses a conflict of interest, since the police and the FBI would, by mandate, focus on detaining witnesses and obtaining evidence, even if those efforts ran counter to public health needs.

Even within the military itself, priorities blur when it comes to bioterrorism. The DOD's primary mission is to protect the United States against military foes. A secondary concern is to defend the health of American troops. How those priorities square with intervening -- and indeed, commanding -- responses to domestic bioterrorist attacks is not at all clear.

What is even less clear is how a public health system can respond to bioterrorism without destroying the basis of its credibility. When a public health system needs to intrude on individuals' lives to protect the larger community, it does so in limited ways and usually under the hard-and-fast promise of confidentiality. During an epidemic, for example, individuals may be asked to submit to blood tests and medical exams, and their medical charts may be scrutinized -- but all under the promise of confidentiality. In the long term, a public health system protects the community by monitoring disease trends, which requires tracking who has which diseases. Again, this information is generally stored under confidential or anonymous terms. On a global level, the WHO and a variety of other groups keep count of nations' diseases, monitoring for the emergence of new epidemics. After the 1995 Ebola outbreak in Zaire, for example, the WHO sought to create a more rigorous surveillance system and pushed countries to be more open about epidemics in their populations.

All of these functions, in all tiers of public health systems, require the maintenance of a crucial social contract: the individual or country agrees to openly disclose information for the sake of the larger community's health. In return, public health authorities promise never to abuse this trust, maintaining discretion and protecting patient privacy.

But the fear of bioterrorism threatens to destroy that vital social contract, which is not shared by law enforcement and defense officials. The closer a public health system draws to the other two systems, the greater the danger that it will lose credibility in the eyes of the public. Indeed, suspicions already run high in many American minority communities, prompting widespread belief that such microbes as the aids virus were created by the U.S. Public Health Service, the National Institutes of Health, or the CIA with the intention of obliterating key minority populations.

Some public health advocates are convinced that no marriage between their profession and law enforcement could ever work and have denounced all efforts to heighten concerns about bioterrorism. One prestigious group argues that "bioterrorist initiative programs are strongly reminiscent of the civil defense programs promoted by the U.S. government during the Cold War ... [that fostered] the delusion that nuclear war was survivable."

For many older public health leaders, the bioterrorism scare evokes nasty memories of Cold War cover-ups and censorship. By adopting thebioterrorism issue, they warn, public health officials are buying into a similar framework of paranoid thinking. Indeed, in 1999, biologists working in national laboratories found, for the first time, their work facing censorship in the wake of allegations of Chinese espionage at the Los Alamos National Laboratory. The Department of Energy (DOE), which oversees the national labs, clamped down so hard in 1999 that the National Academy of Sciences warned that the future of U.S. scientific enterprise could be imperiled. Although the DOE's primary concern was computer and nuclear secrecy, the threat of bioterrorism prompted the agency to broaden its new security restrictions to embrace basic biology research as well.

Many advocates argue that the public health system's role in the fight against bioterrorism can be comfortable only if it is an equal partner of the law enforcement and defense communities. One of the loudest voices speaking on behalf of public health in this regard is Michael Osterholm. In his new book, Living Terrors, Osterholm argues that "the overuse of the term 'weapons of mass destruction' (WMD) has done a great deal to stunt the necessary attention to the looming threat of biological terrorism." The WMD terminology places defense against bioterrorism in the hands of the military and the police, Osterholm insists. And that means, he says, "our priorities are really screwed up."

Osterholm's proposed solutions go to the heart of a larger public health agenda: to enhance the readiness and capacities of local, state, and federal health departments for responding to both natural and deliberately created epidemics. After all, Osterholm argues, it is impossible to tell at its outset whether an epidemic is a natural or ghoulishly unnatural event.

The new administration must work out these tensions among public health, law enforcement, and military authorities. The Clinton administration offered a broader definition of national security, bringing emerging infectious diseases and the aids pandemic under the security umbrella. That allowed agencies more traditionally concerned with terrorism, such as the National Security Council, the CIA, and the FBI, into the public health arena. A new administration may seek to redefine national security in more classic nation-state terms, or to sharpen the public health focus on diseases that directly affect terrorism and warfare. The future balance of authority and influence in the fight against bioterrorism will undoubtedly hinge on a new administration's larger view of national security.

Public health's role in the bioterrorism issue will also be better defined when its leaders come up with a clear consensus on what exactly they want. The issue is so new to most public health officials and raises so many uncomfortable questions that the profession is currently unable to speak with a clear, united voice. In contrast, the law enforcement and military communities appear comparatively determined and direct in their views of the bioterrorism threat and their desired responses to it.

In a historic speech in Atlanta during the winter of 1998, D. A. Henderson, head of Johns Hopkins University's Working Group on Civilian Biodefense, beckoned public health officials to jump on board a train already in motion, conducted by the law enforcement and defense communities. Less than a year later, public health had boarded the train, but only as a passenger. The train was fueled by an $8.4 billion budget in fiscal year 2000, yet public health was allotted a mere 3.7 percent of those funds, according to a recent study by the Stimson Center in Washington, D.C. With such comparatively paltry funding, it is no wonder that public health found itself sitting at the back of the train, watching the scenery race by as other government players steered the locomotive's course. Unless this changes, the train is going to crash.

Laurie Garrett is a Pulitzer Prize-winning science and medical writer for Newsday. This article is adapted from her new book, Betrayal of Trust: The Collapse of Global Public Health. Copyright (c) 2000 by Laurie Garrett. Published by Hyperion.
 

 
Arms Control Today May 2001
Back to Normal

An Essential First Step

James F. Leonard
For the past five years, discussions and negotiations have been held in Geneva aimed at developing what is sometimes called a verification protocol for the 1972 Biological Weapons Convention (BWC). The original treaty effectively contained no provisions to ensure its parties' compliance, a reflection of the clear fact that, despite the consensus that biological weapons should be outlawed, verification is very difficult in the biological weapons field.

These extended negotiations have now reached a decision point, with the presentation of a "chairman's text" on March 30 to the protocol's negotiating body, the Ad Hoc Group. Following the successful example of the chairmen of the Chemical Weapons Convention and Comprehensive Test Ban Treaty negotiations, Ambassador Tibor Tóth, chairman of the Ad Hoc Group, has in one fell swoop reduced the hundreds of brackets in the so-called rolling text to present a balanced document that attempts to find a common ground for all participants. His text consists of more than 200 pages of complex provisions for declarations, visits, and investigations and for the establishment of an implementing organization to manage the operation of the protocol.

The conclusion of the BWC 30 years ago was in some ways an almost miraculous event. It was preceded by a U.S. decision to destroy unilaterally its rather large stockpile of biological weapons. The United States then set out to persuade the rest of the world to follow its example. At first only the United Kingdom—which earlier had originated the proposal for an unverified treaty—took part in the U.S. effort, but in time most other significant governments joined. Today the BWC has 143 parties.

The convention, however, turned out to be less successful than it first seemed. The Soviet Union, we learned later, had been totally dishonest in its endorsement of the treaty, choosing the period of the negotiations to enlarge its secret offensive biological weapons program vastly while violently denouncing any allegations that it might be cheating. Only in 1992 did President Boris Yeltsin admit the violation and declare the program halted.

The Middle East has also been a problem area for the BWC. Iraq, a treaty party, secretly developed biological weapons on a large scale, a fact that was only uncovered after the Persian Gulf War by the United Nations Special Commission (UNSCOM). Moreover, neither Israel nor a number of Arab states, including Egypt, have become parties to the BWC.

For some observers, these problems make the whole effort to develop a protocol to the BWC an exercise in futility. At best, they assert, it will tell us that the good guys are being good. It will not help us at all to ascertain which of the bad guys are being bad and in which specific ways.

For others, including this author, things are not so simple. Russia today is not the Soviet Union of 1972. It seeks international respectability and assures us that it has terminated its offensive biological weapons program. Yet suspicions linger. A protocol could help to dispel these suspicions or, in the worst case, could help mobilize pressure on Russia to clean up its act. Something similar could take place with regard to one or more of the "rogue states" that regularly appear on the CIA's list of governments developing biological weapons. It is true that the protocol would have little utility for the problem of Iraq, but fortunately there are very few Saddam Husseins.

Iran is quite a different case. One can reasonably hope that a future Iranian government, moving back into a normal relationship with the international community, would find the projected protocol machinery helpful in building confidence that it is observing the BWC in good faith.

These three cases—Russia, Iraq, and Iran—illustrate an important point about any verification (or confidence-building) apparatus. It will almost always be heavily dependent on the sincere desire of a government to demonstrate that it is not cheating on an agreement. Even in a relatively open society, a government has considerable powers of concealment. The United States, for example, has successfully concealed large, "black" weapons programs, and India denied having chemical weapons stockpiles for years before finally acknowledging them. A tyrannical regime like Iraq therefore has almost total ability to defeat on-site inspection systems.

An arrangement for a field as difficult as biological weapons is thus inherently a rather optimistic wager by the international community that the hard cases like Iraq or North Korea will over time diminish in number and importance. That is a good bet and a step forward toward the remote but foreseeable goal of a complex, multifaceted structure to deter or prevent harmful, even catastrophic, abuses of the astonishing advances being made in the life sciences. Much more than intergovernmental agreements and treaties will eventually be needed if disasters are to be avoided—domestic legislation must be developed and the scientific community must elaborate its own rules and procedures—but the protocol is an essential first step.

The importance of this enterprise should be beyond dispute. The death toll from a single infectious disease, HIV-AIDS, is now mounting into the tens of millions. And there is no malicious human intelligence behind this threat—only good old Mother Nature. Many knowledgeable experts believe that a well-executed ballistic missile or terrorist attack against an urban area using existing biological weapons agents could result in casualties comparable to an attack with a nuclear weapon. Moreover, looking to the future, if a small group of highly trained microbiologists were to set their minds on creating even more virulent biological agents, for which medical science has no adequate response, there is at least some possibility that they could create a new Black Death, with global consequences.

Would a BWC protocol exclude these frightening possibilities? Obviously not. Would it contribute to lessening their likelihood? In the view of most of the small group of scholars and officials that have studied the matter, it clearly would help.

That was the conclusion that the Clinton administration reached early and pursued consistently, despite considerable misgivings within the Washington bureaucracy and substantial problems in the Geneva negotiations. It does not appear to be the conclusion of the Bush administration. The new administration has quite rightly been conducting a review of the whole protocol project. What conclusions it has reached have not been made public, but there are indications it would prefer that the concept either be radically reshaped or simply allowed to wither away.

Certainly, there is much to criticize in the chairman's text. For most non-governmental observers, the verification provisions are not as strong as they would like. For the U.S. pharmaceutical industry, the verification measures are too intrusive. But for most of our good friends and allies, the chairman's text is the best available compromise—a whole bundle of compromises—and far better than nothing. They will, it appears, be quite upset if they find themselves faced with yet another example of American unilateralism.

A review conference for the BWC itself is scheduled for November. Without strong, positive American leadership, agreement this year on a consensus text for the protocol is extremely unlikely, and that sort of leadership does not appear to be in the cards. Working by consensus is difficult in the best of circumstances, and if the major powers—Russia, China, and especially the United States—hang back, then a stalemate can go on for years.

Because of Washington's lack of interest in leading and the hesitance of Russia and China, the Europeans have become the driving force in protocol negotiations, and they now face difficult choices. One option is simply to abandon the whole effort to produce a protocol. That might be quietly welcomed by the United States, but it would leave our allies very bitter indeed. They have invested years in the development of the text that is now before the Ad Hoc Group. They are not likely to give up quickly or easily.

A second possibility would be for the Europeans to try to go forward without the United States, as happened with the Ottawa convention on landmines and the International Criminal Court. That option is also unattractive. If the United States were pressing strongly for a protocol text, whether the present chairman's text or some other, then there would be a good chance of bringing along Russia, China, and almost all the non-aligned countries. Without U.S. leadership, the particular reservations or objections that various delegations will have are more likely to be maintained. And a treaty accepted only by the Europeans would be rather meaningless. Europe is not where the danger from biological weapons is particularly strong. That dubious honor goes to Russia because of the hangover from its massive biological weapons program in the 1970s and 1980s. If there were "leakage" from that program into the Middle East, for example, the consequences could be horrific.

The most likely response of the allies to a negative U.S. posture will thus be a third option: to play for time, trying to maintain some modest forward momentum while working on the United States to rethink its position.

If our friends are patient, there is some chance that they will succeed, but they will need to find a way to exert more pressure on Washington. To that end, the American scientific community could be their most effective ally. The dangers of misuse of science, especially in the area of genetics, are widely discussed here, and the scientific community is well aware that these dangers could best be met by procedures developed and implemented by scientists, not by diplomats, bureaucrats, or members of Congress. If U.S. scientists can agree among themselves on what they need to do, what codes and rules they need to elaborate, and if they can generalize these understandings among scientists abroad, then at the right moment they can tell the administration what sort of rules and procedures need to be established among governments. These rules and procedures could well be very close to those outlined in the chairman's text and help give the protocol to the BWC the push that it needs.
------------------------------------------------------------------------
James F. Leonard, a former U.S. ambassador to the UN Conference on Disarmament, served as the lead U.S. negotiator for the BWC.

 
pecial Issue

The Threat of Biological Attack: Why Concern Now?

David W. Siegrist
Potomac Institute for Policy Studies, Arlington, Virginia, USA

For a biological attack to occur, three elements must be in place: a vulnerable target, a person or group with the capability to attack, and the intent (by the perpetrator) to carry out such an attack. Much of what can be done to limit the capability and the intent of potential attackers is already on its way to being accomplished. The most work, and the highest return on investment, involve reducing the vulnerability of the United States to both intentional and unintentional pathogen releases.

Vulnerability to Biological Attack

Among weapons of mass destruction, biological weapons are more destructive than chemical weapons, including nerve gas. In certain circumstances, biological weapons can be as devastating as nuclear ones—a few kilograms of anthrax can kill as many people as a Hiroshima-size nuclear weapon (Figure).
  

 Figure.  Effects of a nuclear and biological weapons release.


The United States is unprepared to deal with a biological attack. Over the past several years, preparedness strides have been made, especially in the largest cities. However, much of the needed equipment is not available. Pathogen sensors are not in place to detect that a biological attack has taken place. New medicines are needed. In combating terrorist attacks, treatment is a more practical approach than prevention; yet many biological agents are extremely difficult to treat with existing medicines once the symptoms appear. In addition, many of the most important prophylactic drugs have limited shelf lives and cannot be stockpiled. Moreover, their effectiveness could be compromised by a sophisticated attacker.

Local emergency medical response capability is limited. A number of localities define a "mass casualty event" as one with more than a dozen casualties, far fewer than an intentional biological release could cause. Emergency room capacity in major cities can be overwhelmed all too quickly by more common emergencies. Much emergency medical capability is also located in downtown areas that may be targeted for attack.

The National Disaster Medical System has voluntary access to approximately 100,000 hospital beds across the country to cope with a large-scale medical emergency. However, not all of those beds have the specialized means for patient respiration and supportive therapy that may be needed in a crisis. Such equipment is not available in large numbers (>5,000), even from deployable field hospital Department of Defense war stocks (1). Further, current federal plans favor not evacuating injured people from the affected area but may relocate patients who were already in hospitals to free up local bed space (2). This indicates that localities need to increase their own capabilities. The federal government will augment local efforts, not supersede them.

Steps are being taken to decrease U.S. vulnerability to biological attack. Technical research is being supported, needed medicines and vaccines will be acquired, and emergency response templates are being developed. One of the reforms was setting up the Office of State and Local Domestic Preparedness Support within the Department of Justice. The office has developed a set of objective criteria that measure domestic readiness to deal with an attack by a weapon of mass destruction. No locality has yet qualified for the top ranking—being prepared for such a crisis (3).

Perpetrator Capability

Biological weapons can range in lethality from salmonella used to temporarily incapacitate to super bubonic plague engineered for mass casualities. Biological weapons include ricin, which an extremist may use to assassinate a single local official, as well as pathogens with high transmissibility and broad potential impact. Biological agents may be used to kill or disable humans or to attack plants or animals to harm a nation's economy. Given that broad scope, biological attacks have already taken place and continue to be a distinct probability for the foreseeable future (4). However, of greatest concern is the capability to deliver a sizable lethal attack against a population center.

Technical Capability

Making reliable biological weapons requires art as well as science. Such weapons are not readily adaptable to "cookbook" type recipes that can be implemented by novices. Nevertheless, technical expertise and sophistication about biological processes have become much more widespread. Moreover, even though technical expertise is required to produce high-quality, military-grade biological weapons and reliable means of dissemination, terrorist applications are less demanding.

Making biological weapons requires sample cultures; the means to grow, purify, and stabilize them; and the means to reliably disseminate them. All these tasks pose substantial but not insurmountable challenges. More than 1,500 biological culture libraries worldwide, as well as numerous research institutions and natural sources, maintain sample cultures (5). Growth media and fermenters to multiply the sample cultures are widely available. Purifying, concentrating, and stabilizing agents is demanding and dangerous but not a great technical challenge. Freeze-drying the product and milling it into particles of a uniform respirable size requires even more technical capabilities. A state sponsor may be needed to do it, although companies and institutes regularly spray dry and mill commercial microbes. Moreover, a respirable aerosol of germs can be achieved through other high-pressure devices.

Biological production and weapon-producing facilities can be small, inexpensive, and inconspicuous. Equipment to develop biological arms may have legitimate commercial and research purposes, as well as nefarious ones. Unlike nuclear weapons, biological weapons do not require unique ingredients that are ready objects of arms control.

Institutional Capability

Depending on their sophistication, terrorist groups may or may not have the capability to build broad-impact biological weapons. However, most nations have the capability to make biological weapons. Some 18 nations are believed to have done so, including the former Soviet Union and several nations the State Department lists as supporting terrorism.

Intention to Use Biological Weapons

Why would anyone wish to use biological weapons? A leading entity with a motive to perpetrate a biological attack could be a rogue state as an act of clandestine warfare. The very strength of a superpower may provide an incentive to adversaries to challenge this strength unconventionally.

If a rogue regime were to mount such an unconventional asymmetric attack, they might choose biological weapons because their extreme destructive potential is concentrated in a relatively small and unremarkable package with virtually no detectable sensor signature. Because of the agent's incubation period, the perpetrators might be gone before anyone knew that an attack had been made. Finally, biological agents, unlike ballistic missiles, lend themselves to clandestine dissemination.

Warfare itself may be becoming more total and losing much of its political character in some situations. Biological weapons, which kill people but leave infrastructure intact, could become the "poor man's neutron bomb."

In the past, the essence of terrorism was to make a political statement through violence. It was a political act designed to influence an audience. Levels of violence were carefully calculated so as to draw attention but not to be so high as to alienate supporters or trigger overwhelming response from authorities. That continues to be a main theme of conventional terrorism. However, in so-called postmodern or superterrorism, the aim is to maximize the number of casualties (6). This reflects a shift in the goal of the terrorists, from trying to make a political statement through violence to maximizing damage to the target as an end in itself. Such terrorists may be motivated by ethnic or religious considerations, among others (7).

Even conventional terrorism tends to escalate levels of violence to keep garnering attention. The threat of biological weapons imparts high levels of fear that may make them desirable to perpetrators who wish to terrorize, even more than to kill. Threats have to become increasingly credible after the initial shock of specious threats has diminished. Even a minor biological attack, made to demonstrate credibility, could have a disproportionate impact. Thus, a certain subset of terrorists may be motivated to commit mass casualty terrorism, including biological terrorism.

Nonintentional Pathogen Releases

Certain kinds of biological assaults can be predicted with even higher confidence than bioterrorist attacks. Stephen Morse, Defense Advanced Research Projects Agency, has said that Mother Nature is the greatest terrorist. Since infectious diseases were widely dismissed as a world health threat some 30 years ago, nature has loosed some 30 new or reemerging infectious diseases on the world (Table) (8). An influenza pandemic was averted 2 years ago by the alert and energetic actions of epidemiologists in Hong Kong and around the world. Slower reactions might have permitted the pathogen's genes to shuffle among human and avian infections to make the flu strain readily transmissible from person to person. Multidrug-resistant tuberculosis is increasing rapidly in Russia in part because of lack of adequate antibiotics (9). More health challenges are almost certainly in store. Causes contributing to emerging disease outbreaks (overcrowding, deforestation, airline travel) will likely continue (9).

Health security and national security needs overlap. If the United States prepares to confront and defeat intentional human releases of pathogens, we will be better prepared for the unpredictable but robust threats likely to occur from nature. For emergency medical response, patients need rapid and efficacious treatment, whether the source of an outbreak of disease is intentional or natural. Medical research needs drugs that treat disease after symptoms become apparent. Such drugs might target common features of disease (10), e.g., inflammation cascade and toxic shock. Aerosol challenge is also typical of both military threats and other airborne pathogens; vaccines that enhance mucosal immunity may mitigate them. Expression of specific genes that may be critical and unique to a number of pathogens might one day be inhibited by medicine.

Effective and safe multipurpose and specific drug treatments would help in the battle against both naturally occurring and intentional releases of infectious disease. Through advanced biotechnology, we could begin to reverse the offense-defense mismatch that now greatly favors disease over cure.

Conclusions

Vulnerability and capability, two prerequisites of bioterrorism, are in place. Enhancing emergency medical preparedness and supporting advanced pharmaceutical research for multivalent drugs, among other measures, will help us deter and defeat deliberate and naturally occurring pathogen releases, as well as increase the general health and well-being of the population. The intention of potential attackers is difficult to manage. Therefore, limiting our vulnerability is the most promising way to prevent or mitigate biological attacks on the United States.
Table. New and reemerging viruses (8)

------------------------------------------------------------------------

Viruses
Date
Family
Comments
------------------------------------------------------------------------

New



  Human herpesvirus 6 (HHV-6)
1986
Herpesvirus

  Human herpesvirus 7 (HHV-7)
1990
Herpesvirus

  GS viruses (hepatitis)
1994
Flavivirus

  Human herpesvirus 8 (HHV-8)
1995
Herpesvirus

Reemerging



  Cocoa swollen shoot

Badnavirus
Destroyed 200 million cocoa trees in West Africa.
  Dengue

Flavivirus

  Ebola

Filovirus

  Equine morbillivirus
1994
Morbillivirus
Emerged in Brisbane Australia. Causes acute respiratory disease with high mortality in horses. Believed to cause a fatal encephalitis in humans.
  Hantaan group

Bunyaviruses

  Phocine distemper
1987
Morbillivirus
Caused death rates in seals in the Baltic and North Sea. Similar viruses subsequently recognized as responsible for porpoise and dolphin deaths in the Irish Sea and the Mediterranean.
Rabbit calicivirus disease /Viral hemorrhagic disease
1985
Calicivirus
Emerged in China  spread naturally through UK and Europe. Introduced toWardang Island off the coast of South Australia to test potential for rabbit population control  accidentally spread to mainland decimating rabbit populations.
Rift Valley fever

Bunyaviruses

Tomato spotted wilt

Bunyavirus

Whitefly-transmitted  geminiviruses (group III geminiviruses)

Geminivirus

------------------------------------------------------------------------

      Mr. Siegrist is research fellow at the Potomac Institute for Policy Studies and is director of Studies for Countering Biological Terrorism. He is also an adjunct faculty member at Georgetown University, where he was National Strategy Public Policy Fellow and where he teaches classes on national security. He is the project leader of Countering Biological Terrorism in the U.S., from Oceana Press (May 1999).

      Address for correspondence: David W. Siegrist, Potomac Institute for Policy Studies, 1600 Wilson Boulevard, Suite 1200, Arlington, VA 22209, USA; fax: 703-525-0299; e-mail: siegrist@potomacinstitute.com.

References

1. Army Reserve National Guard. Stakeholders III Conference Medical Panel. National Guard Bureau, Arlington, VA, December 1998.
2. Tonat K. Office of Emergency Preparedness, U.S. Department of Health and Human Services. Panel discussion at conference "Integrating Medical and Emergency Response," Washington, DC, March 10, 1999.
3. Mitchel A. Office of State and Local Domestic Preparedness Support, U.S. Department of Justice. Panel discussion at conference "Integrating Medical and Emergency Response," Washington, DC, March 10, 1999.
4. Carus S. Bioterrorism and biocrimes: the illicit use of biological agents in the 20th Century. Washington: Center for Counterproliferation Research, National Defense University; 1998.
5. Broad W, Miller J. The threat of germ weapons is rising. Fear, too. The New York Times, December 27, 1998.
6. Laqueur W. Postmodern terrorism. Foreign Affairs; Sep/Oct 1996.
7. Ikle F. Waiting for the next Lenin. The National Interest; spring 1997.
8. Cann AJ. Principles of molecular virology. 2d ed. San Diego: Harcourt Brace & Co. Academic Press; 1997. p. 230.
9. Lee C. US can't ignore implications of TB plaguing Russia. USA Today, February 8, 1999, p. 16A and 232.
10. Committee on R&D Needs for Improving Civilian Medical Response to Chemical and Biological Terrorism Incidents, Chemical and Biological Terrorism: Research and Development to Improve Civilian Medical Response, Institute of Medicine, National Research Council, National Academy Press, Washington: 1999; pp. 129-32.


Note: On 3/11/02, corrections were made to the Table: the families of Dengue and Ebola were changed to Flavivirus and Filovirus, respectively.

 
[7/2/2002 5:47:50 PM | Mike Meredith] ---that is teh #5 on page 71

 
http://sml.nlc.org/nc061900.txt

#4 is you search for it on PAge 71

 
http://www.heritage.org/library/backgrounder/bg1522.html

there's #3 Page 71

 
http://www.apha.org/legislative/testimonies/2003_budget.htm

that's #2 Page 71

 
http://nationaljournal.qpass.com/about/njweekly/stories/2002/0419nj1.htm

that is teh page 71 (1) article

 
THE FOLLOWING POSTS WILL BE LINKS

 


Search Terms: thank the congress

Document 3 of 4.

Copyright 2002 eMediaMillWorks, Inc.
(f/k/a Federal Document Clearing House, Inc.)
FDCH Political Transcripts
May 2, 2002 Thursday

TYPE: COMMITTEE HEARING

LENGTH: 24837 words

COMMITTEE: HHS, AND EDUCATION SUBCOMMITTEE, HOUSE APPROPRIATIONS COMMITTEE

SUBCOMMITTEE: LABOR

HEADLINE: U.S. REPRESENTATIVE RALPH REGULAR (R-OH) HOLDS HEARING ON FY '03 APPROPRIATIONS

SPEAKER:
U.S. REPRESENTATIVE RALPH REGULAR (R-OH), CHAIRMAN

LOCATION: WASHINGTON, D.C.

WITNESSES:

U.S. REPRESENTATIVE DAVID VITTER (R-LA), U.S. REPRESENTATIVE JOHN D. DINGELL (D-MI)
DR. PAUL HARCH, PRESIDENT, INTERNATIONAL HYPERBARIC MEDICAL ASSOCIATION
DR. PHILIP O. ALDERSON, COLUMBIA UNIVERSITY
JIM ABRAHAMS, DIRECTOR, CHARLIE FOUNDATION TO HELP CURE PEDIATRIC EPILEPSY
DR. MICHAEL D. JENSEN, PRESIDENT, NORTH AMERICAN ASSOCIATION FOR THE STUDY OF OBESITY
DR. WILLIAM F. CROWLEY JR., MASSACHUSETTS GENERAL HOSPITAL
DR. ROBERT R. RICH, PRESIDENT FEDERAL, AMERICAN SOCIETIES FOR EXPERIMENTAL BIOLOGY
KAREN STUDWELL, FRIENDS OF NATIONAL INSTITUTE OF CHILD HEALTH AND, HUMAN DEVELOPMENT COALITION
WALTRAUD E. PRECHTER, PRESIDENT, HEINZ C. PRECHTER FUND FOR MANIC DEPRESSION
DR. ALLAN JENSEN, AMERICAN ACADEMY OF OPHTHALMOLOGY
DR. JOUNI UITTO, PRESIDENT, SOCIETY FOR INVESTIGATIVE DERMATOLOGY
DR. VICKY WHITTEMORE, SOCIETY FOR INVESTIGATIVE DERMATOLOGY
DR. SHEILA K. WEST, PRESIDENT, ASSOCIATION FOR RESEARCH IN VISION AND OPHTHALMOLOGY
DR. STEPHANIE O'MALLEY, YALE UNIVERSITY SCHOOL OF MEDICINE
DR. DAVID A. D'ALESSIO, AMERICAN FEDERATION FOR MEDICAL RESEARCH
DR. CELIA J. MAXWELL, HOWARD UNIVERSITY, WOMEN'S HEALTH RESEARCH COALITION
DR. NOEL K. MACLAREN, CORNELL UNIVERSITY
JUDI LUND PERSON, PRESIDENT AND CEO, THE CAROLINAS CENTER FOR HOSPICE AND END OF LIFE CARE
K. KIMBERLY KENNEY, PRESIDENT AND CEO, CHRONIC FATIGUE AND IMMUNE DYSFUNCTION SYNDROME
PAULA KIM, PANCREATIC CANCER ACTION
DR. PATRICIA G. ARCHBOLD, SCHOOL OF NURSING, OREGON HEALTH AND SCIENCES UNIVERSITY
HARRY TETER, AMERICAN TRAUMA SOCIETY
NANCY J. NORTON, PRESIDENT, INTERNATIONAL FOUNDATION FOR, FUNCTIONAL GASTROINTESTINAL DISORDERS
DR. NANCY CREAGHEAD, UNIVERSITY OF CINCINNATI
DR. MOHAMMED AKHTER, EXECUTIVE DIRECTOR, AMERICAN PUBLIC HEALTH ASSOCIATION

BODY:


HOUSE COMMITTEE ON APPROPRIATIONS: SUBCOMMITTEE ON LABOR,
HEALTH AND HUMAN SERVICES, AND EDUCATION HOLDS A HEARING ON
FY '03 APPROPRIATIONS FOR PROGRAMS UNDER ITS JURISDICTION

MAY 2, 2002

SPEAKERS:
U.S. REPRESENTATIVE RALPH REGULA (R-OH)
CHAIRMAN
U.S. REPRESENTATIVE C.W. BILL YOUNG (R-FL)
U.S. REPRESENTATIVE ERNEST J. ISTOOK JR. (R-OK)
U.S. REPRESENTATIVE DAN MILLER (R-FL)
U.S. REPRESENTATIVE ROGER F. WICKER (R-MS)
U.S. REPRESENTATIVE ANNE M. NORTHUP (R-KY)
U.S. REPRESENTATIVE RANDY "DUKE" CUNNINGHAM (R-CA)
U.S. REPRESENTATIVE KAY GRANGER (R-TX)
U.S. REPRESENTATIVE JOHN E. PETERSON (R-PA)
U.S. REPRESENTATIVE DON SHERWOOD (R-PA)

U.S. REPRESENTATIVE DAVID OBEY (D-WI)
RANKING MEMBER
U.S. REPRESENTATIVE STENY H. HOYER (D-MD)
U.S. REPRESENTATIVE NANCY PELOSI (D-CA)
U.S. REPRESENTATIVE NITA M. LOWEY (D-NY)
U.S. REPRESENTATIVE ROSA L. DELAURO (D-CT)
U.S. REPRESENTATIVE JESSE L. JACKSON JR. (D-IL)
U.S. REPRESENTATIVE PATRICK J. KENNEDY (D-RI)


*

REGULA: OK. We'll get started because we have a long list today, and we'll probably get some interruptions for votes.
And happy to welcome all of you. These are important issues. I just came from the office of an office full of people on diabetes. And they're convinced, and maybe so, that another couple of dollars and there'll be a cure. And I'm sure most of you feel the same way about whatever you're dealing with.
The United States has done a remarkable job in research. I was impressed the other day. The NIH people testified that every five years life expectancy goes up a year. So in 50 years, that's 10 years. And that's thanks to the research that's done and a lot of what's happening, good diet and a lot of things that are pluses.
So we want to get started, because we want to get everybody an opportunity. Our first witness will be introduced by David Vitter from the great state of Louisiana.
VITTER: Thank you very much, Mr. Chairman.
I'm pinch-hitting today for Ernest Istook. But I'm very, very happy and honored to introduce Dr. Paul Harch from Louisiana. He's an emergency and hyperbaric medicine physician, who graduated magna cum laude and Phi Beta Kappa from the University of the University of California, Irvine in 1976 with a Bachelors Degree in biology and subsequently from Johns Hopkins Medical School in 1980. He completed two years of general surgery training at the University of Colorado, one year of radiology at the LSU School of Medicine, has worked 17 years in hospital-based emergency medicine and 15 years in hyperbaric and diving medicine. His primary interest have been brain decompression sickness and hyperbaric oxygen therapy, base (ph) spec (ph) brain imaging index, neuro-rehabilitation.
He's going to obviously talk more about his work. It has been very, very promising, having treated over 180 children in 320 adults. And he's now recognized as one of the foremost authorities in the U.S. on hyperbaric oxygen therapy. In that capacity he's been elected as the first president of the newly formed International Hyperbaric Medical Association.
And with that, I'm very pleased to present Dr. Harch.
REGULA: Dr. Harch, thank you for coming.
Let me say to all of you, because we have 25 witnesses today, we have to limit you to five minutes. I'm sorry, but there just any other choice. And there's a little box on the desk that gives you a warning when the time's about to expire. If I ask questions, that's on my time.
HARCH: OK. Thank you.
REGULA: OK.
HARCH: Chairman Regula and members of the committee, I, first, want to thank you for the opportunity to testify today.
My name is Paul Harch, and as Mr. Vitter said, I am an emergency and hyperbaric medicine physician, who is here representing the International Hyperbaric Medical Association and brain-injured Americans. And I'm not here to ask for money. I'm here to show you how we can save money and improve the health, welfare and outcomes of brain-injured Americans.
What I'd like to say is that simply we have a treatment for brain injury that is...
REGULA: What types of brain injury?
HARCH: Almost all types.
We have looked at this now in over 500 patients over the last 12 years, and 50 different brain-based neurological conditions. And this is a generic treatment for brain injury with, I believe, the capacity to revolutionize treatment of brain injury in the world.
And amongst these 500 patients have been 180 children. The first five brain-injured children in the United States treated with hyperbaric oxygen therapy were treated by me in New Orleans. Many of these children have cerebral palsy, autism, near drowning, a variety of neurological disorders. And many of them include IDEA children, who, as you know, the federal and statement is now spending $55 billion a year to attempt to educate when they don't have the capacity to learn, often from organic brain injury. This treatment, as we have shown in a number of these children, can give them the capacity to learn. And the cost is roughly about a year to a year and a half of the education support money.
What I wanted to show you today was that this can be applied in a variety of conditions. And after presenting this in 1992 through '95 to scientific meetings and experiencing a fair amount of criticism, it went to an animal model. And we have now done this and replicated this in animals and have the first-ever demonstration of improvement of chronic brain injury in animals.
What I wanted to show you today and just mention quickly about diabetes, this is actually the only modality that can prevent major amputations in diabetics with foot wounds, which, as you know, was a major failed target of the Healthy People 2000 initiative.
What I'm going to show you here today are a few examples of what can be done. And the patient here, whose brain scans are on the poster, are one of Mr. Istook's constituents. This is the first Alzheimer's patient in the United States, and possibly the world, treated with hyperbaric oxygen therapy for his Alzheimer's. He was a 58-year-old architect who, of course, had lost his job and now needs 24-hour supervision and accompaniment by his wife. And after a lecture I gave at the University of Oklahoma Health Science Center, the neurology group referred him as a test case.
What you're looking at here are brain blood flow scans. And the way brain blood flow and the brain works is similar to a gasoline engine: more gasoline, more blood flow, more RPMs to the engine, better metabolism to the brain.
And if you look at these pictures, these are three-dimensional reconstructions of the human brain blood flow. On top here is the brain scan before treatment, and this is the face view. We're looking right at the patient. The eyes would sit here -- excuse my tremor; a little caffeine and nervousness -- and wherever there are holes in the brain are significant reductions in blood flow. This is the right side view and this is the left side view and here is the top view. The three major arteries in the brain on each side come together is right here on each side. And that's the most vulnerable area for brain injury. It's the area primarily injured in Alzheimer's. And after three and a half months of treatment, 89 hyperbaric treatments, you see how all of these damaged areas of the brain have begun to fill in.
Simultaneously, he was tested by the neuropsychologists at the University of Oklahoma.
REGULA: We got about a minute left. Tell me what the process is.
HARCH: It is putting a patient in an enclosed chamber, increasing the pressure and giving them pure oxygen. It dissolves in the blood. And you're able to put the oxygen in the liquid portion of the blood, above and beyond what is bound to hemoglobin in our red blood cells, which is, you and now have, 100 percent saturation.
It's been delivered to injured areas in the body. And by repetitive exposure you grow new blood vessels, you stimulate damaged cells to begin repair.
REGULA: Plus there's a more intense flow of oxygen...
HARCH: Yes.
REGULA: ... to the injured, or in this case, the brain area.
HARCH: Exactly. Exactly. And it's an ability to restore not dead but damaged tissue that is not functioning.
REGULA: OK. You've developed a process. Is it being used or is it still in the experimental stage?
HARCH: It is being used for a variety of other indications, and increasingly so for this at a number of centers in the United States.
REGULA: Has NIH done any experimentation with this?
HARCH: No. Well, there has been some in the past on senility and some other neurological disorders.
REGULA: Well, thank you very much. We'll read your paper. And I know the staff will be interested. It's a challenging idea, because we deal with a lot of Alzheimer's, a lot brain injuries; could revolutionize the treatment.
HARCH: Thank you.
REGULA: Thank you for coming.
VITTER: Thank you, Doctor.
REGULA: Thank you, David.
Our next witness is Dr. Philip Alderson, chairman of the Department of Radiology at Columbia University, president of the Academy of Radiology Research.
Welcome, Dr. Alderson.
ALDERSON: Thank you, Mr. Chairman.
I represent the Academy of Radiology Research, which represents more than 30,000 radiologists, imaging scientists and allied professionals, as well as over 90,000 imaging technologists. And Mr. Chairman, I appreciate the opportunity to speak on the fiscal year '03 budget for the National Institute of Biomedical Imaging and Bioengineering.
NIBIB will support research in both biomedical engineering and in imaging. The two fields are closely related scientifically and we are working closely with our engineering colleagues to take full advantage of the synergies.
In the recent words of NIH Director-nominee Elias Zerhouni, "We need to encourage cross-cutting initiatives." And also the recent words of Acting Director Ruth Kirschstein, "A cross-cutting institute, such as NIBIB, is truly a reflection of where science is today and where it will take us tomorrow." Well, I strongly agree with both Dr. Zerhouni and Kirschstein: A cross-cutting technology has had and will continue to have an enormous positive impact on clinical care and advanced biomedical research.
Imaging science is already revolutionized medical care, and the second revolution is already under way; a revolution in which imaging will allow us not only to visualize diseases, but to see and measure those diseases and find out how they actually work. Witness the display from our first witness today.
Techniques for imaging biological activity at the cellular and molecular levels could produce images of genetic or molecular activity that signal disease processes much earlier than we can now; a multitude of infectious, degenerative, immunological diseases or even cancer. So as a result, physicians could begin disease treatment earlier, for example, breast cancer or prostate cancer, and then do much better for their patients.
Basic cross-cutting research in molecular imaging, supported by NIBIB, could make broadly applicable new diagnostic tools available more quickly than would be possible if disease-specific research in the other institutes were the only way to accomplish these goals at the NIH. And new techniques developed in NIBIB could be applied to studies in all the other institutes.
The NIBIB is planning a number of promising initiatives that are likely to result in breakthroughs in both imaging science and biomedical engineering. Unfortunately, there's a large gap between the science to be done and the funds available. The budget requested for '03 includes only a $9 million increase for NIBIB, a level that will severely reduce its capability to fund the research to develop new bio-sensors, to build new and better imaging systems, to develop image-guided surgical approaches, just to name only a few of the many, many great potential initiatives that NIBIB is exploring. Unless something is done to change the current budget plan, scientific opportunities will be lost.
According to NIBIB budget documents, the institute will fund 100 new competing research grants in the current fiscal year, but only 49 in '03 if the budget request is enacted. We cannot build a new institute on a shrinking research program, especially when we begin with what is the smallest institute at the NIH.
Moreover, it's anticipated that NIBIB will be able to fund only 14 percent of the research proposals it receives for '03, whereas it is currently able to fund 30 percent, which is in line with the other institutes. If that rate is only 14 percent next year, there surely will be widespread and severe discouragement among researchers.
Stifling the growth of the NIBIB at this early stage would be especially tragic because of its potential to attract new investigators: scientists who have not been previously been supported by NIH to biomedical research. In particular, the NIBIB provides a research home at NIH for physical, in addition to biological, science. Investments in NIBIB will create opportunities for closer collaborations between the physical and biological scientists and will unquestionably benefit both areas.
This potential expansion of the scientific talent focused on biomedical questions will not happen, however, unless NIBIB has sufficient resources to meet the demand created by the many high quality research proposals.
The imaging and biomedical engineering communities believe that an increase of $100 million for NIBIB in fiscal '03 over and above the results of the current review of imaging and bioengineering grants at the NIH is needed. Such an increase could be managed effectively by the NIBIB staff, would allow the institute to begin to explore current scientific opportunities and would provide a foundation for appropriate growth in the future.
I'm pleased to answer your questions.
REGULA: Thank you for coming today, and we will discuss this with the NIH folks. I'm not sure why the reduction, but maybe they have a reason. In any event, we'll check with them.
Thank you.
ALDERSON: Thanks very much.
REGULA: Our next witness, Waltraud Prechter, will be introduced by our good friend, John Dingell.
DINGELL: Mr. Chairman, thank you for your courtesy to me and to my dear friend, Mr. Waltraud Prechter.
I thank you for the courtesy. I will be brief in my introduction. First of all, thank you.
I am proud to introduce a very good personal friend of mine, Wally Prechter. She and her late husband have been community leaders in southeast Michigan for over 20 years. The family founded the World Heritage Foundation, a major philanthropic entity dedicated to helping make a difference in areas of health, education, welfare, arts, culture and the community. The foundation also fosters innovative public and private sector partnership, entrepreneurial development and German-American relations.
DINGELL: Ms. Prechter has been the president of the World Heritage Foundation since 1985, when it was conceived. She has been a positive force in our community and a model citizen. She serves in numerous leadership positions, including the University of Michigan Health Care Advisory Group, Wayne State University's Detroit Medical Center's Women's Clinical Services Board, the Detroit Symphony Orchestra and the Downriver Council for the Arts.
She's a bright light in our community and our country, and it's a privilege to present her to the committee this morning. She will speak on an issue that has had great impact on families and communities across the country. I'm proud to introduce Wally Prechter.
PRECHTER: Thank you, Mr. Dingell.
Chairman Regula, members of the committee, my name is Wally Prechter, Waltraud Prechter. I thank the committee and also wish to thank Representatives Dingell and Rogers for making this possible.
I'm president of a foundation my children and I established last year in my husband's memory, the Heinz C. Prechter Fund for Manic Depression. I greatly appreciate the opportunity to speak to you today as a wife, a mother, an individual whose life has been touched by the insidious illness called manic depression.
I will never forget July 6, 2001. Heinz, my husband for 24 years, seemed to feel far better than he had in months. After struggling with his third bout of manic depression in over three decades, the hopelessness that immobilized him seemed to have lifted. He rose early for a workout, and I was relieved and elated.
However, my feelings of joy were short lived. Only minutes later, I discovered Heinz in the guest house. He had taken his life. He left without a word. There were no goodbyes for our twin children, Paul (ph) and Stephanie (ph), and there was no goodbye for me. He was 59 years old.
He embodied the American dream. I have tried to do justice to his life in the full testimony as submitted to the committee. Let me just say here that he came to this country with only $11 in his pocket, but he went on to introduce the sun roof to America and build a premier global supplier of specialty vehicles and open-air systems.
He also was a philanthropist and he felt a deep obligation to give back to his community and his new country. He became a citizen and believed deeply in the American dream.
At the height of his career, my husband fell victim to suicide. Heinz was one of 30,000 fellow Americans who took their lives last year. That, Mr. Chairman, represents one person taking his or her life every 17 minutes.
Many of those individuals suffering from manic depression or bipolar experience extreme changes in mood, thought, energy, behavior and productivity. It affects an estimates 2.7 million adult Americans.
As debilitating as blindness or paraplegia, manic depression destroys the ability to reason, motivate, communicate, share ideas and foster productive relationships. Thereby, manic depression erodes the very foundation of America's information economy, an economy of mental performance.
Bipolar disorder contributes to billions of dollars in economic loss due to lost productivity, absenteeism and premature death. Mr. Chairman, it's an illness that our great country can no longer afford.
In order to prevent others from going through what our family went through, we established the Heinz C. Prechter Fund for Manic Depression in his memory. The fund will engage the brightest and best researchers to advance medical research to find cures for bipolar disorder.
But we and other similar organizations cannot do this alone. While the federal government has begun to address this problem, much more needs to be done. And that is why I'm here today. My request to this committee is threefold.
First, I wish to thank the Congress for increasing funding for research at the National Institutes of Health. While this is a significant accomplishment, research funding at the National Institute of Mental Health is lagging behind. I would respectfully ask this committee to ensure that funding at the NIMH increases on a par with other institutes.
Secondly, I would ask the committee to encourage NIMH to provide bipolar disorder with its proportionate share of funding increases for mental research. Even more importantly, I would suggest for NIMH to focus its bipolar research on unlocking the underlying genetic causes of this insidious hereditary disease, as well as developing effective and safe treatment options. As in the case of cancer or AIDS, we as a nation should commit ourselves to finding cures for this condition that affects millions of Americans.
Lastly, I would ask you to urge the Department of Health and Human Services to convene a national symposium to create a research road map for finding cures for bipolar disorder. As I noted in my written testimony, a national strategy for suicide prevention was successfully developed as a result of such a conference. That 1998 conference brought together the best and brightest researchers and clinicians, mental health advocacy groups and affected individuals. Since bipolar disorder is a significant factor in many suicides, this type of national approach is certainly warranted.
I appreciate the committee's consideration of these requests. I'm humbled and deeply honored to share my story with you. Mine is just one story of thousands of untold stories all over America. It is my hope that starting today we will jointly embark on a journey in pursuit of a new frontier: to battle the illness that robs us of our loved ones and to find cures for manic depression. I urge you, Mr. Chairman, and distinguished members of the committee to do whatever is in your power to support our endeavor, which will lead to a healthier, happier and more productive America.
Thank you.
REGULA: Well, thank you for coming. I knew your husband well, was a wonderful man.

 
PRECHTER: Yes.
REGULA: Served, particularly I'm on the board at the Smithsonian, and he was on the board of advisers there...
PRECHTER: Correct.
REGULA: ... and was just a good citizen in a lot of different ways. And obviously this is something we should address. The numbers are much greater than I would have thought...
PRECHTER: That's correct.
REGULA: ... from listening to your testimony.
PRECHTER: That's correct.
REGULA: And I know when I heard about Heinz it was a real shock to me, because he was such a dynamic personality.
PRECHTER: Yes.
REGULA: It's something that's impossible to understand.
PRECHTER: Thank you very much.
PRECHTER: Thank you for coming. Thank you.
DINGELL: Mr. Chairman, thank you for your courtesy.
REGULA: Our next witness is Dr. Michael Jensen, president, North American Association for the Study of Obesity.
Thank you for coming.
JENSEN: Thank you. Chairman Regula, members of the subcommittee, thank you of the opportunity to testify before you on behalf of NAASO, the North American Association for the Study of Obesity.
I am Dr. Michael Jensen, the president of NAASO, and NAASO is America's leading obesity organization. Our membership is comprised of the leading scientists and clinicians in this field.
JENSEN: And I'm here to testify as to the importance of federally funded programs that support obesity research and prevention. The scientific advances we've made in the last 10 years could not have happened without the support expressed by this committee.
Obesity is quickly becoming the leading health care problem in the United States. It is a complex disease that involve genetic, metabolic, behavioral and environmental factors. The increased prevalence and causal relationship with serious medical complications has considerable health and economic consequences for our country.
For example, the prevalence of obesity has doubled in the last 20 years. Approximately 60 percent of adults and 15 percent of children are now overweight or obese. It is the number-two preventable cause of death in the United States, resulting in more than 300,000 lost lives each year and more than $61 billion in obesity-related health care expenses. And we are now seeing children with adult-type obesity diseases such as Type II diabetes. In short, obesity is an expensive, growing epidemic that has the potential to bankrupt our health care system.
We believe that increased research for understanding, preventing and treating obesity will decrease the prevalence of costly obesity- related diseases, like diabetes, high blood pressure, coronary disease, and could ultimately result in considerable financial savings.
Research funding supported by this committee has lead to some remarkable advances in our understanding of obesity. It's revolutionized how we understand how the brain regulates food intake. We've determined the amount of physical activity required to prevent weight regain and what properties of food promote overeating. We've demonstrated that behavioral and lifestyle changes that result in only a 6 percent weight loss can result in a 58 percent decrease in the risk of developing diabetes.
I think it's important to build on these accomplishments. Future research should be directed at developing more effective prevention strategies, improving obesity treatment and improving our understanding of how excess fat impairs health.
Regarding prevention, the current obesity epidemic can be attributed in large part to an environment that discourages physical activity and encourages overeating. This is particularly true in children. To be successful, prevention efforts are going to need to target the environment.
In the past, we thought that educating people to eat less and exercise more would solve the problem. Thanks to research, we have learned why this is not true, and we can now develop sound, scientific approaches for treatment and prevention. The efforts in the CDC in obesity prevention should be fully supported.
Regarding treatment, much of the information gained on weight- management strategies has not been effectively translated into treatment. Additional research is needed to identify the means to sustain long-term changes in eating and physical activity behavior.
I think the most exciting new development in obesity therapy will probably be derived from research that improves our understanding of how our body regulates fat. This may lead to development of new and effective treatments that safely mimic the body's natural defenses against obesity.
In addition, if we can understand the links between excess fat and other diseases, we should be able to prevent the organ and tissue damage that relates to excess body fat. If we can learn more about how the brain regulates energy intake, physical activity and how it controls body fat, we may be able to make the kind of rapid progress in prevention and treatment that has been accomplished in other areas such as high blood pressure and high cholesterol. These scientific advances could result in savings of billions of dollars in health care costs.
The NIH has a great track record of successfully addressing health problems and could do the same for obesity. But the NIH currently plans on allocating 1 percent of its total budget to obesity research. NAASO feels strongly that this is inconsistent with the scope of the problem.
We urge this committee to double the amount spent on obesity research. Two percent of the NIH budget for the number two health problem is not too much to ask. Thank you.
REGULA: You're really trying to change, to some degree, people's lifestyle. Isn't that a factor?
JENSEN: And allowing the change to be made in such a way that people can do it. We just haven't been able to do that yet.
REGULA: You need one of those things like smokers get then -- you put a patch on that discourages it.
JENSEN: If we understood what regulated that, that would be a great approach.
REGULA: Need to come up with a patch. OK. Thank you for coming.
JENSEN: Thank you.
REGULA: It is a problem, and it's one of the factors that we have such a wide range of foods available in our country, and plenty of it. I know it's not an easy answer.
Our next witness is Dr. Stephanie O'Malley, director of Division of Substance Abuse Research, Department of Psychiatry at Yale University.
Welcome.
O'MALLEY: Good morning. Mr. Chairman and members of the subcommittee, thank you for the opportunity to speak today.
In addition to the credentials you mentioned, I'm here as the president of the Research Society on Alcoholism to present testimony on behalf of the society. The Research Society on Alcoholism is a professional society of over 1,400 members who are committed to understanding and intervening in the negative consequences of alcohol use through basic research, clinical protocols and epidemiological studies.
I'm sure I don't need to tell you this, but the costs of alcohol abuse and alcohol dependence in this country are staggering, and on individual lives and families. In this country, one out of four families has an immediate family member who has an alcohol problem. The economic cost to the nation is estimated to be approximately $185 billion annually.
What's surprising is a recently released report on college drinking, sponsored by the National Institute on Alcohol Abuse and Alcoholism, revealed that 1,400 college students between the ages of 18 to 24 die each year from unintended alcohol-related injuries, and 500,000 other students are unintentionally injured as a result of alcohol use.
Equally disturbing is the increasing trend of alcohol consumption among children ages 9 to 15. A report issued last year by the Robert Wood Johnson Foundation states that by eighth grade, 52 percent of adolescents have consumed alcohol. And the Leadership to Keep Children Alcohol-Free, which is a multi-year, national initiative founded by the NIAAA, the Robert Wood Johnson Foundation and other federal agencies, reports that almost one-third of eighth graders and half of tenth graders have been drunk at least once, and one-fifth of ninth graders report binge drinking, that is five or more drinks in a row, in the past month.
We'll only be able to intervene in these kinds of problems with evidence-based research for policies and prevention programs.
In addition, for some sub-groups, such as American Indians, the costs associated with alcoholism are disproportionately high and may be directly linked to some of the major health problems such as diabetes and hypertension. The Indian Health Service, for example, estimates that the age-adjusted alcoholism mortality rate for American Indians is 63 percent higher than for all other races in the U.S.
Despite this, or perhaps because of the widespread impact and effects of alcohol, it's been impossible to identify a single cause or solution. But because of this subcommittee's support for biomedical research, and specifically for the NIAAA, the alcohol research community has been making important strides in clarifying many of the factors, which we now know contribute to alcoholism and the consequences of drinking.
We've seen significant advances in disentangling the role of genetics and environmental influences. We've begun to identify some critical components of effective treatment and to develop new treatments. And we've begun to explore integrated approaches for those with the most severe illness.
While recognizing these advances, however, the federal investment in alcohol research has been modest, given the magnitude of the problem. There must be a strong national commitment to alcohol research and treatment if we hope to reverse these current trends.
I would like to just mention a few examples of promising opportunities in the field of alcohol research, which, if adequately supported, will move the field significantly forward.
One area is the NIAAA's funded research, which has successfully identified molecular targets of alcohol in the brain, and the characterization of these targets may lead to the discovery of compounds that block specific effects of alcohol. These discoveries have already identified -- led to the prevention of alcohol-related birth defects in mice, and so we need to have future research to translate these findings.
We also have had sponsored research on medications development that have proved to be effective but not for everyone. And additional funding is needed to aggressively pursue the range of activities, from basic to clinical research, to make sure that we have new ways of treating this disorder.
We also know, as I mentioned, that there is an increased risk for alcoholism in certain minority groups, and we don't really understand why this risk exists and whether or not the risk applies to all members.
O'MALLEY: Initial studies have begun to identify specific strengths and vulnerabilities which are important to explore if we are to address the needs of all Americans.
Because I'm running out of time, I want to sum up, but I do also want to mention that I've been talking about some of the science today. But I also want to encourage you just to read the newspapers, which I know everyone here does. And you can see from that that this country's still dealing with the aftermath of September the 11th, and many people are increasing their alcohol consumption in response to the events. And then I would predict that many of these problems associated with alcohol could increase in magnitude in the near future.
As a result, the RSA requests a budget of $475 million for the NIAAA in fiscal year 2003. This request represents the professional judgment of the alcohol research community and is justified based on the historic underfunding of NIAAA and the promise of the opportunity in the present.
Thank you.
REGULA: Thank you for coming and bringing your message.
Our next witness is Dr. Robert Rich, president federal of American Societies for Experimental Biology.
Dr. Rich, welcome.
RICH: Thank you, Mr. Chairman. It's my privilege today, on behalf of the Federation of American Societies for Experimental Biology and the biomedical research community, to thank you and the members of this subcommittee for your past leadership and your continuing commitment to fund the historic five-year campaign to double the budget of the National Institutes of Health, certainly the world's leading biomedical research organization.
FASEB is very grateful too to President Bush for requesting $27.3 billion for NIH in fiscal 2003 and to the full House's endorsement of this request. This amount represents the fifth and final installment in that doubling effort. However, Mr. Chairman, while we are very pleased with the president's overall budget, we do have three concerns about the details of the president's budget that I would like to raise with the subcommittee.
The first issue that I'd like to discuss with you is that for the first time in NIH's history, the president's budget requests appropriations language for a specific disease; that is to say, cancer.
Mr. Chairman, if this recommendation is adopted, I predict a host of other patient and other disease advocacy groups coming before this subcommittee next year requesting their specific research earmarks. Let me be clear, Mr. Chairman, FASEB is not concerned about the amount of money recommended for cancer research in the president's budget, but we're very concerned about a specific earmark setting such a precedent.
Second, while the president's fiscal 2003 budget requests $27.3 billion for NIH, it's important to note that this recommendation includes almost $500 million in procurements for non-research activities and for tax and transfers to other agencies. Additionally, the president's budget proposal allows the secretary of HHS to tap the budget of NIH by up to 3 percent. This could be as much as $820 million, undercutting this subcommittee's specific decisions regarding NIH spending.
Collectively, up to $1.3 billion could thus be subtracted directly from the bottom line of funds available for biomedical discovery. We believe this proposal should be rejected.
Mr. Chairman, for the past half-century, our investment in people who do research has been the secret to NIH's spectacular advances. My third concern is therefore with two specific proposals in the president's budget that threaten to reduce our supply of scientists at two critical points in the research career continuum: young investigators and senior researchers.
We're currently facing a shortage of qualified young scientists because of high debt burdens and low salaries. The president's budget would exacerbate this crisis by shortchanging stipends for pre- doctoral and post-doctoral fellows under National Research Service awards.
Last spring, NIH recommended increasing stipends by 10 to 12 percent per year over the next several years, but the president's '03 budget calls for only a 4 percent increase. FASEB believes that Congress should increase stipends by at least 10 percent, a level that would be consistent with last year's appropriation.
Regarding researchers at the peak of their productivity, the administration has again proposed reducing the maximum salary available for performing NIH-funded research and our nation's universities below the level for scientists working directly for the government. We wish to thank you for rejecting this same proposal last year, and we urge you to do so again.
Maintaining the higher rate will retain for university scientists the maximum salary available to senior researchers at NIH's Bethesda campus and will help to ensure that the best clinical scientists continue to be able to do NIH-funded research.
Finally, Mr. Chairman, I'd like to thank you and the members of this subcommittee once again for making those really difficult choices that have been needed to support NIH. Allow me to conclude simply by observing that it is not too early for us to begin discussions about funding in the post-doubling era. Thank you very much.

 
REGULA: Thank you, and there's no question that stipends make a difference and likewise that salaries impact the supply. And something of concern that you can't research without researchers.
RICH: That's right. Thank you very much.
REGULA: Doctor -- rather Jim Abrahams, co-founder, director of the Charlie Foundation to help cure pediatric epilepsy.
ABRAHAMS: Thank you for allowing me to appear before you today. Frankly, I was asked by some other parents of children with epilepsy to speak today, because I've had a career in the movie business, and it was the hope of those who in the past have seen these rooms overflow with elected officials and media to hear testimony of celebrities and then be virtually evacuated for others less well known, that perhaps my appearance would bring just one more congressman or one more journalist to hear our plea.
Because in fact there are many parents of children with epilepsy who have lived with the horror and agony of this God-forsaken disease longer than I, and who would be better qualified to testify before you about its devastating effects on their children and families, and point out the frustratingly paltry sums our government has appropriated to try to understand it.
I say this because my son, Charlie, is perhaps what you would consider a best-case scenario with regard to his epilepsy. You see, Charlie does not number among the 400,000 Americans who died of epilepsy-related causes since his first seizure 10 years ago, a number by the way which is equivalent to those who have been killed by breast cancer.
Also, because his seizures are currently controlled by a rigorous high fat, ketogenic diet, Charlie no longer has to deal with anti- seizure drugs and their mind- and body-altering side effects, such as insomnia, diarrhea, high blood pressure, rashes, nausea, lethargy, constipation, gum growth, suppressed appetite, depression, and on and on.
Women, for instance, using Dilantin, among the most highly prescribed of these drugs, are told not to have babies, not because they can't conceive, but because their doctors are afraid of what they would conceive.
But because Charlie might be considered a best-case scenario, I don't want to leave the impression his chances for a normal, independent life haven't been severely damaged by epilepsy, nor do I want you to think he doesn't use up his share of the $12.5 billion annual cost that epilepsy reaps on our nation.
He's mainstreamed through the public school system and his adaptive occupational physical therapy one-on-one tutors, social interactive groups, special reading groups and public school resource programs designed to help him make up the physical and intellectual delays his seizures, drugs and brain surgery caused him are all subsidized by public tax dollars. And, of course, none of us can guess how Charlie and millions like him may have contributed to society had their young brains not been ravaged so horribly.
This chart behind me displays the dollar amounts allotted by you to epilepsy research versus other diseases. I'll not burn my time by repeating the inequity you can clearly see. However, I will comment on it by saying that if you've seen your only child's eyes go dead, fall back in his head as he drops to the ground, until you've watched your child slowly fade into retardation, one painstaking day at a time, until you've seen your own child decay from a drug reaction or you've buried your own child after she drowned in her bathtub during a seizure you can't possibly appreciate the cruelty of this disparity.
More Americans have epilepsy than muscular dystrophy, cerebral palsy, multiple sclerosis and Parkinson's disease combined.
ABRAHAMS: Of the 181,000 new cases diagnosed this year, 75 percent will be children.
And tragically, the research budget of the national government nowhere near reflects that. As a matter of fact, in the last five years, you've increased funding 3 percent per year on average. I personally have sat through many meetings with bright, intrigued, willing, dedicated scientists who have been unable to pursue potentially invaluable avenues of epilepsy research literally due to an inability to pay for technicians, lab rats or even counter space.
I do not take lightly the honor of speaking for and attempting to express the frustration of the 2.5 million Americans and their families whose lives have been damaged or destroyed by the hell of epilepsy. And I appreciate that until this moment, you, like many Americans, may have been unaware of the devastation epilepsy causes and the relative lack of attention it gets from the federal government.
For years now, parents like myself have come before you hat in hand, sharing their grief and imploring you to help, but, as this chart so clearly points out, to very little avail.
It's difficult to tightrope walk the line between expressing outrage on one hand and alienating the very people from whom we are asking help on the other, so I hope you'll understand my opting for candor over diplomacy. For this government to continue along its path of underfunding epilepsy research, when it is clear that with modern science it is merely a function of dollars until we can understand and cure this centuries-old agony, it is more than a mere shame. I can't help but feel it is both callous and disheartening.
You have the power to act to save lives and spare other children and their families the tragedy so many of us have known. Please do so.
REGULA: Thank you for bringing this to our attention. I don't know on what basis NIH makes its judgments on as far as what will be funded by way of research. I think your statement is that it's not adequate in relationship to other...
ABRAHAMS: The NIH budget was increased 15 percent this year, and epilepsy got a 3 percent increase.
REGULA: Well, thanks for coming.
Dr. Mohammed Akhter, executive director, American Public Health Association; Dr. Akhter?
AKHTER: Thank you, Mr. Chairman. Good morning. My name is Mohammed Akhter. I'm the executive director of the American Public Health Association, the largest association of public health professionals in the world. We are very pleased to have this opportunity to appear before you this morning to speak about the budget.
Mr. Chairman, we're grateful to you and the members of your committee and the Congress for your support of bioterrorism preparedness. We're really doing wonderful work all across this country, getting our nation prepared to deal with any future attacks by the terrorists.
And this has helped a great deal for us to prepare, not only for the bioterrorism situation but also other public health problems: building public health infrastructure in the country. And this has been a tremendous credit to you, the members of your committee and the members of Congress, and we're grateful.
We're also very pleased with the president's budget that further supported bioterrorism preparedness. And we request of you that preparedness must continue. We must continue to invest, to make sure that we are as prepared as we can.
REGULA: We had a panel yesterday from HHS, the top people, and they definitely are on the move on trying to get ready for whatever future crisis might occur.
AKHTER: Thank you, Mr. Chairman. We appreciate the support that you have shown for this particular effort.
Our membership is also concerned about the other areas that affect the health of the American people. You already heard about the obesity, chronic diseases. Obesity is a major cause of many chronic diseases, especially the top four leading causes of death among the six are related to overweightness and obesity. And we need to have a program nationwide that starts to deal with what we know, so that American people could change their lifestyles, change their eating habits, and start to do exercise a little bit more, and we can get a lot of mileage out of it.
We have a very tiny program at CDC right now, and we request very much that you increase that program funding to $60 million this year, so that we could have a program at least in half of the states to provide information and education to the public.
One of the areas where we need to really pay attention is the children. You earlier heard that 15 percent of our children are obese. Over 60 percent of those obese children have high blood cholesterol and already have early signs of heart disease. And this is not very good news.
And the best way to reach these people is through the media. CDC again has a media campaign, and we'd very much appreciate it if you would fund the media campaign to $175 million level that it was originally intended to do.
And finally, Mr. Chairman, there are 50,000 deaths in this country that are called "violent death." And I am very grateful to you for putting some money in to set up a reporting system so that we can know, what are the causes of suicide, who is committing suicide, what are the causes of other violent deaths among our society. Once we know who these people are, once we know what the causes are, then we can develop adequate preventive strategies. Mr. Chairman, we request that you put $10 million into that effort, so that we have adequate data, on the basis of which our scientists could develop adequate programs.
Health Services and Resources Administration is one of our nation's wonderful agencies that provide access to many treatment programs. Mr. Chairman, one of the areas that we need help is the professional training. We need to have people -- you already heard of our researchers, and I talk to you about other professionals that we need to deliver public health services, to provide support to the local health agencies. A new look, a revisit, on the health professional training program will be very helpful.
And finally, within HRSA is a program that supports abstinence education only. Mr. Chairman, that's a wonderful program. We would very much like to see, as Secretary Powell has said and as previous Surgeon General David Satcher has indicated, for those who are not sexually active, abstinence is a great thing. And we must support that.
But for those who are sexually active, we must have another choice, of having condoms, so that they could not have sexually transmitted diseases and not have hepatitis B and things like that.
And so, Mr. Chairman, providing the flexibility to the states, so the states could develop a comprehensive program, would go a long way in having a wonderful program for our children.
The Agency for Health Care Research and Quality, Mr. Chairman, this is the agency that looks at the quality of care, particularly the medical errors. And we believe this agency needs to be funded at full levels, so they can fulfill your congressional mandates, have adequate resources to do that.
And in conclusion, Mr. Chairman, substance abuse, alcohol, is an immediate problem among our society. And to really have good prevention programs are a must. And we suggest that the Substance Abuse and Mental Health Services Administration be funded at $3.65 billion this year, so that they can have adequate programs.
In summary, Mr. Chairman, we appreciate your support of bioterrorism (sic). But we should have a balanced approach, so that we should look at the long-term consequences of some of our programs. Thank you very much for this opportunity.
REGULA: Thank you.
Dr. Allan Jensen, ophthalmologist, Baltimore, Maryland, member of the board of trustees, American Academy of Ophthalmology?
JENSEN: Thank you, Mr. Chairman. Thanks for the opportunity to appear before you today in support of appropriations for the National Eye Institute. My name is Allan Jensen. I'm a practicing ophthalmologist in Baltimore, an assistant professor of ophthalmology at Johns Hopkins, and presently serve as a member of the board of trustees of the American Academy of Ophthalmology. The academy is the world's largest organization of eye physicians and surgeons, with over 27,000 members.
The academy first wants to thank you for the support that you and your colleagues have demonstrated for the NIH and the National Eye Institute in the past. As a result of your commitment, the NIH budget is on track to be doubled over the five-year period that ends with this budget cycle.
Of particular note, in fiscal year 2002 the NEI budget saw growth that for the first time in recent memory outpaced the budget growth of most other NIH institutes. The National Eye Institute congressional appropriation represented an increase of 13.9 percent, for a total budget of $581 million.
While the NEI has received many welcome and useful budget increases over the years, historically it's fallen behind in comparison to budget increases for other NIH institutes. The American Academy of Ophthalmology is concerned that the tremendous research opportunities made possible by the fiscal year 2002 appropriation will be jeopardized by the president's proposed 8.4 percent budget increase for this year.
The academy believes it is essential that the commitment to funding the National Eye Institute be maintained so that vital research can be continued. Polls have shown that Americans fear blindness more than any other condition except cancer, and the public deserves to have these fears met with sound research that can preserve sight.
To allow the National Eye Institute to continue to pursue research opportunities in areas that show great promise, including genomics, neuroscience, bioengineering and other clinical research, we ask that Congress appropriate $692 million for fiscal year 2003.
With your support, we've made many advances in relieving the pain and suffering from many blinding disorders. Examples of investments in research that have significant potential to save sight include gene therapy studies, which will provide essential information on many types of vision disorders, including retinitis pigmentosa, an inherited now incurable form of blindness.
NEI-supported research has led to the development of prosthetic devices that can be surgically implanted in the brain or retina to partially restore sight. NEI-sponsored research has led to the development of new drugs effective in the treatment of glaucoma, the leading cause of irreversible blindness among African-Americans.
JENSEN: For macular degeneration, NEI-supported research has led to the development of a drug to inhibit the growth of abnormal vessels that leak and bleed to cause blindness in this disorder. And as you know, macular degeneration is the leading cause of vision loss in older Americans, affecting more than 10 percent of Americans over age 65.
NEI-supported studies have documented important information about how the herpes simplex virus spreads and how physicians can better treat it.
Diabetes is the number one cause of blindness of working-age adults. And NEI-supported studies have demonstrated that blindness from diabetes can be prevented in most patients by laser therapy. Something in my career, which is over two decades, when I first entered practice, there was really nothing available and we really have seen a miracle. Those at greatest risk from diabetes are Native Americans and African-Americans.
The American Academy strongly recommends that $692 million be directed to research conducted by the NEI on eye and vision disorders. As the baby boomers age, it is critical that research is targeted toward finding effective treatments and cures for diseases such as glaucoma and macular degeneration, but also on the prevention of other blinding and disabling eye diseases. Missed opportunities in eye and vision research will translate into increased government dependence and a decreased quality of life for many of our citizens.
I appreciate the opportunity to speak to you this morning and glad to take any questions.
REGULA: Thank you.
I think it was Helen Keller said that she'd rather give up hearing than eyesight. I can understand that.
Thank you very much.
Our next witness is Jouni Uitto, president, Society for Investigative Dermatology, accompanied by Dr. Vicky Whittemore, co- chair, Coalition of Patient Advocacy for Skin Disease Research.
Welcome, Dr. Uitto.
UITTO: Mr. Chairman and members of the committee, let me first thank you for the opportunity to testify here today on behalf of the Society for Investigative Dermatology, which has as its mission the support of research in skin diseases. Our 2,000 members include researchers and physician-scientists from universities, hospitals and industry committed to the science of dermatology.
My specific purpose in being here today is to personally emphasize the need for increased funding for the programs of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, or NIAMS. And this position is also supported by the American Academy of Dermatology.
I'm here with Dr. Vicki Whittemore, co-chair of the Coalition of Patient Advocates for Skin Disease Research. And she will speak for one minute after my comments.
Mr. Chairman, before I describe some of the recent advances in skin research, let me first thank you personally for three specific matters. First, for taking time to meet in your district office with Dr. Jake Clema (ph), a dermatologist constituent of yours, together with Dr. Kevin Cooper, who is the chair of dermatology at Case Western Research University and with Ms. Angela Welsh (ph), who is our administrative director. We certainly know how busy you are, Mr. Chairman and the more we appreciate your courtesy.
Secondly, we would like to thank you for the language that you and the subcommittee provided for the bill report calling for a workshop at the NIAMS to determine economic and social costs of skin disease in the United States. And as you know, this analysis has not been updated since 1979. I am happy to report that the workshop will be held in September. And the Society of Investigative Dermatology is very pleased at the positive way that NIAMS is developing plans for it.
Finally, we thank you for the large increase in funding you provided last year for the NIAMS and NIH in general. We also appreciate the administration's proposal this year to increase NIH overall funding to provide for the final funds required to double the NIH budget. We recommend to you that the Congress agrees with that proposal.
At the same time, we do recognize that the concerns about bioterrorism overshadow other matters. But we would prefer that the same 16.5 percent increase for NIH overall include a similar percentage increase for NIAMS.
There are more than 3,000 different diseases affecting the skin, hair and nails, with an average each year about 60 million Americans being affected by these conditions. With the advent of technologies in molecular and cell biology in general, there has been an increased sophistication of our understanding of the mechanisms underlying many of these disorders affecting the skin. Important new advances in dermatology and cutaneous biology have certainly been made over the past year, and in the interest of time I will refer to the full text of my testimony for those details.
Mr. Chairman, thank you for this opportunity to discuss with you the science of dermatology. Everyone in the field of medical research certainly understands that it was this committee, your committee, which initiated the move to double the NIH research budget over the five years. And we congratulate you and thank you for your leadership.
I'll be happy to answer any questions. But please allow Dr. Whittemore to say a few words.
WHITTEMORE: Thank you, Dr. Uitto and Mr. Chairman. I am Vicky Whittemore, the co-chair of the Coalition of Patient Advocates for Skin Disease Research. And we -- I represent 25 different organizations who in turn advocate on behalf of the over 60 million Americans with skin disease, including common skin diseases like acne, psoriasis and excema, but also the less common skin diseases like tubersclerosis, which affects my nephew. He has benign tumors that cover his face that bleed excessively and that the insurance will not pay for their removal because they say its cosmetic. And these tumors would regrow if they were removed with laser treatments. But he does not have this treatment, because he also suffers from epilepsy and autism and could not undergo the procedure.
But there is no cure for tubersclerosis and there -- the skin disease part of it or the other aspects of the disease, or for any of the skin disease for that matter. And so together with the Society of Investigative Dermatology, the coalition also advocates and thanks you for the increase for the NIH and a similar increase for the National Institutes of Arthritis and Musculoskeletal and Skin Diseases.
Thank you.
REGULA: Do you include in the skin diseases the effects of cancerous growths?
WHITTEMORE: Absolutely.
UITTO: Absolutely, sir. Skin cancer, as you know, is an epidemic in this country, which is increasing tremendously. And that is part of the...
REGULA: Too much sun, I guess, is part of the problem.
WHITTEMORE: Yes.
REGULA: But that's included in all your research applications?
UITTO: Absolutely.
REGULA: Well, thank you very much.
WHITTEMORE: Thank you.
UITTO: Thank you.
REGULA: Dr. Sheila West, president of the Association for Research in Vision and Ophthalmology; Dr. West?
WEST: Mr. Chairman, good morning.
REGULA: Morning.
WEST: I am testifying as president of the American Association for Research in Vision and Ophthalmology. It's the largest organization of vision scientists in America. But specifically, though, I am speaking as one of the researchers in academia who has devoted a career to the prevention and treatment of blinding disorders in our population.
Your support for the increase in the FY 2002 budget for the National Institutes of Health and specifically for NEI is greatly appreciated. Today I am adding the research community's voice in support of the citizens' budget request for FY 2003 of $692 million for the National Eye Institute. This amount almost completes the fulfillment of the bipartisan goal for doubling the NEI budget since 1999.
You might question the need for increasing eye research at this time. The answer lies in the fiscal as well as the social responsibility to invest now against what is certain to be a sizable increase in numbers and in the cost of visual impairment in the United States.
As you heard, most of the blindness and visual impairment in this country is age-related eye diseases like cataracts, macular degeneration, glaucoma.
WEST: At present, we estimate there are more than 1 million blind people in the U.S. and an additional 2.4 million with severe visual impairment. If nothing were to change in our ability to take care of these eye diseases, in another 30 years those numbers would double, due entirely just to the aging of the U.S. population.
The growth of the age group 85-plus is of special concern. They are the fastest growing among the elderly population, and their rate of eye disease is especially high. One in seven Caucasians will have AMD. One in 10 Hispanics and African-Americans will have glaucoma.
These 4.2 million Americans age 85 and over now include our parents. In 30 years time, that number's going to swell to 8.9 million, and God willing, that's going to be you and that's going to be me. The cost of the American people with visual loss is high. Each year over 1.5 million cataract surgeries are performed, and despite significant declines in reimbursement, cataract surgery alone now accounts for 12 percent of the Medicare budget.
The annual cost to Medicare for just cataract surgery is $3.4 billion. It's over five times the amount we request for vision research at NEI for all of the eye diseases. And the cost is not just to Medicare; you heard Dr. Jensen earlier talk about the treatment for diabetic retinopathy. It's cost-effective; it saves society up to an estimated $975 per person with diabetes.
However, recent research in the Hispanic community suggests that of the one in five people with diabetes in that community, 15 percent are unaware of their disease, and a quarter of them already have eye disease. So in that community, diabetic retinopathy is the leading cause of visual loss in the working age population. That's the 40 to 64 years old. That's going to pull them out of the working group in their most productive years.
Well, you also heard from Al Jensen that the news from the research community in eye disease is both exciting and hopeful. In my research in particular, I'm convinced of the need to prevent or delay the onset of worldwide cataract.
More people are now visually impaired from cataract worldwide, between 40 million and 80 million people, than are currently living with HIV/AIDS. Research that we're doing in Maryland suggests that there are both genetic and environmental factors that are important: specifically, smoking, ocular exposure to sunlight are risk factors. And if we can understand the interplay of those, we have hope for enabling further specific research on anti-cataract agents.
So, we as investigators feel the urgency for the continuation of enhanced support for vision research at this crucial junction of exciting discovery and progress but at the time of an imminent explosion in the magnitude of blindness and visual loss for the United States and worldwide, and we look to our political leaders for the foresight to invest now the $692 million for the protection of sight for all Americans.
I'd be pleased to respond to any questions at this time. Thank you, Mr. Chairman.
REGULA: Thank you. Is there any single cause that represents the greatest volume of cause of vision problems?
WEST: Because macular degeneration is so common in the Caucasian population, in the United States, that's the single leading cause. But I think it's important to look within groups. Clearly, glaucoma is absolutely critical.
REGULA: Macular degeneration, the degeneration of the nerve of the -- nerve ending?
WEST: Of the retina. Once you have macular degeneration, you lose central reading vision.
REGULA: What can you do to prevent it?
WEST: The National Eye Institute has just published a trial suggesting that people with early signs of this disease taking a vitamin supplement may delay the onset of visual loss, but that's expected to be effective in about 20 percent of people.
REGULA: But part of it's just the aging process.
WEST: We think it's tied to the aging process, but we also think that there are other ways that we can intervene. Thank you.
REGULA: Thank you very much.
WEST: Dr. William Crowley, director of clinical research, Massachusetts General Hospital; Dr. Crowley?
CROWLEY: Thank you, Chairman Regula, for the opportunity to participate in these hearings. I'm a physician scientist, a professor of medicine at Harvard Medical School, and director of clinical research at the Mass General Hospital.
My own personal research is all NIH-funded, and it's allowed me to take from the conceptual level to the FDA approval process the ability to treat children with precocious puberty and disease and infertility in women. These therapies that I pioneered are now being used for men with prostate cancer, women with painful emdometriosis and uterine fibroids.
But I'm not here to talk about my own research. I'm actually here representing a group called the Academic Health Center Clinical Research Forum. The Academic Health Center is -- the top 24 or so of these centers are all involved in a consortium to focus on clinical research and to drive clinical research. Arguably, many of the people who are here asking for more funding actually are asking for more clinical applications on that funding, and that's what clinical research does.
So my first mission is to thank you for your vision and leadership in doubling the NIH budget. It's led to the improved life expectancies that you talked about, the decreased mortalities from heart attacks of 30 percent, now some improvements in cancer survival, and certainly infections which were preventable or treatable that couldn't have been done without this doubling of the NIH budget.