CHAPTER EIGHT(BIO)TERRORISM

A. INTRODUCTION

To many Americans time is divided by September 11, 2001; there is a world before September 11 and a different world after September 11. September 11 may not have “changed everything,” but it has certainly changed a lot—including major changes in public health funding, laws, and structure. It has caused us to be concerned, even obsessed, with a disease the eradication of which has been seen as public health’s greatest triumph: smallpox. It has refocused public health funding, led to new public health laws, and created an entirely new field, emergency and “public health preparedness.” How should public health and public health lawyers react to the threat of terrorist attacks, including the possible use of a biological agent as a weapon, so-called “bioterrorism?”

This concluding chapter on a post-9/11 terrorism challenge to public health is designed as a case study to encourage students to apply the law highlighted in the preceding chapters to determine the most effective, efficient and civil-liberties friendly responses. Because compulsory measures related to contagious disease epidemics, like quarantine, are often discussed in the context of preparedness planning, the materials in chapter 3 will often be of particular relevance. Among the questions that are posed throughout are: Can public health funding really be “dual use” so that we need not sacrifice traditional public health activities for new ones, or will have to develop new priorities? Does our current “all-hazards” approach to disaster planning make sense given our experience with it in failing to prepare for and respond effectively to Hurricane Katrina? What does “preparedness” mean, and how do we apply public health principles to preventing a bioterrorist attack? Should we expand public health surveillance over medical care in emergency departments and physician offices? Should we develop new rules restricting access to bacteria and viruses that can be used as weapons? Should we shift legal power from states and localities to the federal government, or even to multinational or global organizations? How can the trust of the public in public health be maintained and fostered? Is public health the ultimate global public good? Should public health encourage international cooperation and respect international law? And, ultimately, have we over-reacted to 9/11, and if so, in what areas can or should we return to the pre-9/11 public health?

The materials begin with summaries and recommendations from the 9/11 Commission in Section B; Section C is devoted to the anthrax attacks that occurred just after 9/11; Section D details and explores the smallpox vaccination program initiated in the run-up to the Iraq war; Section E is devoted to the new and rapidly growing area of bioterror preparedness and research and its impact on public health and risk perception; Section F is on federal preparedness, and Section G is on global health., including the emerging field of (public) “health and human rights.”

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B. 9/11

CRAIG R. WHITNEY, INTRODUCTION TO THE 9/11 INVESTIGATIONS xx-xxi, xxxiii (STEVEN STRASSER ED., 2004)

Until the cold war unraveled after the collapse of the Berlin Wall in 1989, the administrations of presidents Ronald Reagan and George H.W. Bush paid comparatively little attention to terrorism, despite the Hezbollah attack that killed 241 marines in Lebanon in October of 1983 and the Libyan sabotage of Pan American Flight 103 that killed 270 people over Lockerbie, Scotland in 1988. Before the first terrorist attack on the World Trade Center in New York City in 1993—and the later discovery of a related plot to blow up the city’s river tunnels and the United Nations building—terrorism had been considered only a marginal threat to the United States itself. It took time for the implications to sink in.

Not until 1995 did President Bill Clinton establish a working level “Counterterrorism Security Group” inside the White House, chaired by Richard A. Clarke. It was not until 1996, Clarke wrote in a controversial book published on the eve of his public testimony before the 9/11 commission, that the government figured out that it was up against an Islamic terrorist network of global dimensions led by a renegade from a wealthy Saudi Arabian family, Osama bin Laden. And only after terrorist suicide truck bombers destroyed the American embassies in Tanzania and Kenya in August 1998, killing 257 (including 12 Americans) and wounding 5,000 people in Nairobi, did President Clinton order the first direct response against al Qaeda, a cruise missile attack on its training grounds in Afghanistan.

Spending on U.S. defensive actions against terrorism increased in 1999 and 2000, but President Clinton was distracted by the Monica Lewinsky affair. Even after suicide bombers used a boat full of explosives to blow up the U.S.S. Cole in Aden on October 12, 2000, killing seventeen sailors and injuring thirty-nine, the Clinton administration did not retaliate against al Qaeda, unsure that it had carried out the attack. Clarke and other officials were left to try to persuade the incoming administration of President George W. Bush that the threat of terrorist strikes on American soil posed an urgent danger. President Bush’s first national security briefings, Clarke said, were not about terrorism but about two issues that seemed more important to the president then—Iraq, where his father’s administration had left Saddam Hussein in power after Operation Desert Storm, and missile defense.

Then came September 11. . .September 11 was a warning, but also an opportunity to set in place defenses against new and even more terrible terrorist attacks. With the Arab world in turmoil over the war in Iraq and the Bush administration’s unconditional backing of Israel in its showdown with the Palestinian Authority, al Qaeda metastasized rapidly despite losing its sanctuary in Afghanistan. After attacks in Indonesia, Thailand, the Philippines, and then Madrid in the spring of 2004, the threat of terrorism to the United States and its Middle Eastern and European allies seemed even greater than it had been in 2001. The worst scenario would be an attack using nuclear, biological, or chemical weapons, and al Qaeda and its spawn were known to have tried to acquire them.

* * *

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NATIONAL COMMISSION ON TERRORIST ATTACKS UPON THE U.S., 9/11 COMMISSION REPORT 361-398 (2004).

Three years after 9/11, Americans are still thinking and talking about how to protect our nation in this new era. The national debate continues. Countering terrorism has become, beyond any doubt, the top national security priority for the United States. This shift has occurred with the full support of the Congress, both major political parties, the media, and the American people.

The nation has committed enormous resources to national security and to countering terrorism. Between fiscal year 2001, the last budget adopted before 9/11, and the present fiscal year 2004, total federal spending on defense (including expenditures on both Iraq and Afghanistan), homeland security, and international affairs rose more than 50 percent, from $354 billion to about $547 billion. The United States has not experienced such a rapid surge in national security spending since the Korean War.

This pattern has occurred before in American history. The United States faces a sudden crisis and summons a tremendous exertion of national energy. Then, as that surge transforms the landscape, comes a time for reflection and reevaluation. Some programs and even agencies are discarded; others are invented or redesigned. Private firms and engaged citizens redefine their relationships with government, working through the processes of the American republic. Now is the time for that reflection and reevaluation. The United States should consider what to do—the shape and objectives of a strategy. Americans should also consider how to do it—organizing their government in a different way.

Defining the Threat

In the post-9/11 world, threats are defined more by the fault lines within societies than by the territorial boundaries between them. From terrorism to global disease or environmental degradation, the challenges have become transnational rather than international. That is the defining quality of world politics in the twenty-first century.

National security used to be considered by studying foreign frontiers, weighing opposing groups of states, and measuring industrial might. To be dangerous, an enemy had to muster large armies. Threats emerged slowly, often visibly, as weapons were forged, armies conscripted, and units trained and moved into place. Because large states were more powerful, they also had more to lose. They could be deterred.

Now threats can emerge quickly. An organization like al Qaeda, headquartered in a country on the other side of the earth, in a region so poor that electricity or telephones were scarce, could nonetheless scheme to wield weapons of unprecedented destructive power in the largest cities of the United States. In this sense, 9/11 has taught us that terrorism against American interests “over there” should be regarded just as we regard terrorism against America “over here.” In this same sense, the American homeland is the planet.

But the enemy is not just “terrorism,” some generic evil. This vagueness blurs the strategy. The catastrophic threat at this moment in history is more specific. It is the threat posed by Islamist terrorism—especially the al Qaeda network, its affiliates, and its ideology.

* * *

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Our enemy is twofold: al Qaeda, a stateless network of terrorists that struck us on 9/11; and a radical ideological movement in the Islamic world, inspired in part by al Qaeda, which has spawned terrorist groups and violence across the globe. The first enemy is weakened, but continues to pose a grave threat. The second enemy is gathering, and will menace Americans and American interests long after Usama Bin Ladin and his cohorts are killed or captured. Thus our strategy must match our means to two ends: dismantling the al Qaeda network and prevailing in the longer term over the ideology that gives rise to Islamist terrorism.

* * *Islam is not the enemy. It is not synonymous with terror. Nor does Islam

teach terror. American and its friends oppose a perversion of Islam, not the great world faith itself. …

* * *The present transnational danger is Islamist terrorism. What is needed

is a broad political-military strategy that rests on a firm tripod of policies to

Attack terrorists and their organizations; Prevent the continued growth of Islamist terrorism; and Protect against and prepare for terrorist attacks.

More than a War on Terrorism

Terrorism is a tactic used by individuals and organizations to kill and destroy Our efforts should be directed at those individuals and organizations. Calling this struggle a war accurately describes the use of American and allied armed forces to find and destroy terrorist groups and their allies in the field, notably in Afghanistan. The language of war also evokes the mobilization for a national effort. Yet the strategy should be balanced.

The first phase of our post-9/11 efforts rightly included military action to topple the Taliban and pursue al Qaeda. This work continues. But long-term success demands the use of all elements of national power: diplomacy, intelligence, covert action, law enforcement, economic policy, foreign aid, public diplomacy, and homeland defense. If we favor one tool while neglecting others, we leave ourselves vulnerable and weaken our national effort.

Certainly the strategy should include offensive operations to counter terrorism. Terrorists should no longer find safe haven where their organizations can grow and flourish. America’s strategy should be a coalition strategy, that includes Muslim nations as partners in its development and implementation. Our effort should be accompanied by a preventive strategy that is as much, or more, political as it is military. The strategy must focus clearly on the Arab and Muslim world, in all its variety.

Our strategy should also include defenses. America can be attacked in many ways and has many vulnerabilities. No defenses are perfect. But risks must be calculated; hard choices must be made about allocating resources. Responsibilities for America’s defense should be clearly defined. Planning does make a difference, identifying where a little money might have a large effect. Defenses also complicate the plans of attackers, increasing their risks of discovery and failure. Finally, the nation must prepare to deal with attacks that are not stopped.

Measuring Success

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What should Americans expect from their government in the struggle against Islamist terrorism? The goals seem unlimited: Defeat terrorism anywhere in the world. But Americans have also been told to expect the worst: An attack is probably coming; it may be terrible.

With such benchmarks, the justifications for action and spending seem limitless. Goals are good. Yet effective public policies also need concrete objectives. Agencies need to be able to measure success.

* * *We do not believe it is possible to defeat all terrorist attacks against Americans, every time and everywhere. A president should tell the American people:

No president can promise that a catastrophic attack like that of 9/11 will not happen again. History has shown that even the most vigilant and expert agencies cannot always prevent determined, suicidal attackers from reaching a target.

But the American people are entitled to expect their government to do its very best. They should expect that officials will have realistic objectives, clear guidance, and effective organization. They are entitled to see some standards for performance so they can judge, with the help of their elected representatives, whether the objectives are being met.

* * *Recommendation: The U.S. government must define what the message is, what it stands for. We should offer an example of moral leadership in the world, committed to treat people humanely, abide by the rule of law, and be generous and caring to our neighbors. America and Muslim friends can agree on respect for human dignity and opportunity. To Muslim parents, terrorists like Bin Ladin have nothing to offer their children but visions of violence and death. America and its friends have a crucial advantage—we can offer these parents a vision that might give their children a better future. If we heed the views of thoughtful leaders in the Arab and Muslim world, a moderate consensus can be found.

That vision of the future should stress life over death: individual educational and economic opportunity. This vision includes widespread political participation and contempt for indiscriminate violence. It includes respect for the rule of law, openness in discussing differences, and tolerance for opposing points of view.

* * *

Recommendation: The United States should engage its friends to develop a common coalition approach toward the detention and humane treatment of captured terrorists. New principles might draw upon Article 3 of the Geneva Conventions on the law of armed conflict. That article was specifically designed for those cases in which the usual laws of war did not apply. Its minimum standards are generally accepted throughout the world as customary international law.

* * *Recommendation: Our report shows that al Qaeda has tried to acquire or make weapons of mass destruction for at least ten years. There is no doubt the United States would be a prime target. Preventing the proliferation of these weapons warrants a maximum effort—by strengthening counterproliferation

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efforts, expanding the Proliferation Security Initiative, and supporting the Cooperative Threat Reduction program.

* * *Recommendation: At this time of increased and consolidated government authority, there should be a board within the executive branch to oversee adherence to the guidelines we recommend and the commitment the government makes to defend our civil liberties.

We must find ways of reconciling security with liberty, since the success of one helps protect the other. The choice between security and liberty is a false choice, as nothing is more likely to endanger America’s liberties than the success of a terrorist attack at home. Our history has shown us that insecurity threatens liberty. Yet, if our liberties are curtailed, we lose the values that we are struggling to defend.

* * *Recommendation: Homeland security assistance should be based strictly on an assessment of risks and vulnerabilities. Now, in 2004, Washington, D.C., and New York City are certainly at the top of any such list. We understand the contention that every state and city needs to have some minimum infrastructure for emergency response. But federal homeland security assistance should not remain a program for general revenue sharing. It should supplement state and local resources based on the risks or vulnerabilities that merit additional support. Congress should not use this money as a pork barrel.

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Notes and Questions

1. The 9/11 Commission (officially known as “the National Commission on Terrorist Attacks Upon the U.S.”) made 41 specific recommendations. Their final report was issued in July, 2004 and is available in its entirety on a frozen website that is maintained by the National Archives at www.9-11commission-gov/report/index.htm (last visited Aug. 2006). In December 2005 the Commission issued a report card on its recommendations, giving the government failing grades on many of its most important recommendations, including a “D” on developing critical infrastructure; and “F” on airline passenger pre-screening; a “D” on checked bag and cargo screening, a “D” on international collaboration on borders and document security, a “privacy and civil liberties oversight board, and on developing guidelines for sharing of personal information, and an “F” on “coalition detention standards” Dan Eggen, U.S. Issued Failing Grades by 9/11 Panel, WASHINGTON POST, Dec. 6, 2005, at A1.

Perhaps most strikingly, Congress continues to fund preparedness based on congressional districts rather than giving more funds to areas that are the most vulnerable. Editorial, Hokum on Homeland Security, N.Y. TIMES, Aug. 20, 2006, at WK9. For the inside story of the Commission by its co-chairs, see THOMAS H. KEAN & LEE H. HAMILTON, WITHOUT PRECEDENT: THE INSIDE STORY OF THE 9/11 COMMISSION (2006). Not everyone was enthusiastic about the Commission’s recommendations. Richard Clarke, for example, thought that the quest for bipartisan unanimity led to the commission failing to “admit the obvious: we are less capable of defeating the jihadists because of the Iraq war. Unanimity has its value, but so do debate and dissent in a democracy facing a crisis. To fully realize the potential of the commission’s report, we must see it not as the end of the discussion but as a partial blueprint for victory.” Richard A. Clarke, Honorable Commission, Toothless Report, N.Y.TIMES, July 25, 2004, A11. See also, RICHARD A. CLARKE, AGAINST ALL ENEMIES: INSIDE AMERICA’S WAR ON TERROR (2004).

2. One of the Commission’s most striking findings was that the president had received a briefing on Bin Ladin’s plans on August 6, 200l, raising the question of whether warnings and preparations can do much good. The Presidential Daily Brief Memo is reprinted on pages 261-262 of the final report, and contains with the following observations about reports that Bin Ladin has wanted to hijack US aircraft since 1998:

“FBI information since [1998] indicates patterns of suspicious activity in this country consistent with preparation for hijackings or other types of attacks, including recent surveillance of federal buildings in New York. The FBI is conducting approximately 70 full field investigations throughout the US that it considers Bin Ladin-related. CIA and the FBI are investigating a call to our embassy in the UAE in May saying that a group of Bin Ladin supporters was in the US planning attacks with explosives.”

The Commission concluding that there were no further discussions “before September 11 among the President and his top advisors of the possibility of a threat of an al Qaeda attack on the United States.” NAT’L COMM’N ON TERRORIST ATTACKS, supra, at 262.

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Five years later the lesson seemed to have been learned, as the president said in a September 5, 2006 five-year anniversary speech on the global war on terror, “We know what the terrorists intend to do because they’ve told us—and we need to take their words seriously.” (available at www.whitehouse.gov) On the role of Al Qaeda see generally, LAWRENCE WRIGHT, THE LOOMING TOWER: AL-QAEDA AND THE ROAD TO 9/11 (2006).

3. New York Times columnist Tom Friedman has argued that dating America from September 11 is a major mistake, and that our country should remain the country of the 4th of July. In his view, globalization should continue to be seen as a positive force for the good of all, rather than as a threat to America. See, e.g., THOMAS FRIEDMAN, THE WORLD IS FLAT: A BRIEF HISTORY OF THE TWENTY-FIRST CENTURY (Updated and expanded ed. 2006).

4. It is striking that the 9/11 Commission highlighted the importance of the Geneva Conventions in our response to 9/11. Only a few months after the attacks, the president signed an executive order declaring that the Geneva Conventions did not apply to the Taliban or to prisoners held at Guantanamo Bay Cuba. This was the first time in U.S. history that a president has ever claimed an exception for the U.S. from this international treaty that covers the treatment of prisoners and civilians during wartime. In the summer of 2006 the U.S. Supreme Court got its first opportunity to decide if the president could unilaterally declare international law, specifically the Geneva Conventions, null. In what has been described as the most important case the Court has ever decided on the question of executive powers, the Court ruled that the Conventions must be followed as an integral part of international law. Justice Stevens wrote for the Court:

The [Court of Appeals] accepted the Executive’s assertions that Hamdan was captured in connection with the United States war with a Qaeda and that war is distinct from the war with the Taliban in Afghanistan. It further reasoned that the war with al Qaeda evades the reach of the Geneva Conventions. See 415 F. 3d, at 41-42. We, like Judge Williams, disagree with the latter conclusion.

The conflict with al Qaeda is not, according to the Government, a conflict to which the full protections afforded detainees under the 1949 Geneva Conventions apply because Article 2 of those Conventions (which appears in all four Conventions) renders the full protections applicable only to “all cases of declared war or of any other armed conflict which may arise between two or more of the High Contracting Parties.” 6 U.S.T., at 3318. Since Hamdan was captured and detained incident to the conflict with al Qaeda and not the conflict with the Taliban, and since al Qaeda, unlike Afghanistan, is not a “High Contracting Party”—i.e., a signatory of the Conventions, the protections of those Conventions are not, it is argued, applicable to Hamdan.

We need not decide the merits of this argument because there is at least one provision of the Geneva Conventions that applies here even if the relevant conflict is not one between signatories. Article 3, often referred to as Common Article 3 because, like Article 2, it appears in all four Geneva Conventions, provides that in a “conflict not of an international character occurring in the territory of one of the High Contracting Parties, each Party to the conflict shall

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be bound to apply, as a minimum, certain provisions protecting “[p]ersons taking no active part in the hostilities, including members of armed forces who have laid down their arms and those places hors de combat by…detention.” One such provision prohibits “the passing of sentences and the carrying out of executions without previous judgment pronounced by a regularly constituted court affording all the judicial guarantees which are recognized as indispensable by civilized peoples.”

The Court of Appeals thought, and the Government asserts, that Common Article 3 does not apply to Hamdan because the conflict with al Qaeda, being “‘international in scope,’” does not qualify as a “‘conflict not of an international character.’” 415 F. 3d, at 41. That reasoning is erroneous. The term “conflict not of an international character” is used here in contradistinction to a conflict between nations. So much is demonstrated by the “fundamental logic [of] the Convention’s provisions on its application.” (Williams, J., concurring). Common Article 2 provides that “the present Convention shall apply to all cases of declared war or of any other armed conflict which may arise between two or more of the High Contracting Parties.” High Contracting Parties (signatories) also must abide by all terms of the Conventions vis-à-vis one another even if one party to the conflict is a nonsignatory “Power,” and must so abide vis-à-vis the nonsignatory if “the latter accepts and applies” those terms. Common Article 3, by contrast, affords some minimal protection, falling short of full protection under the Conventions, to individuals associated with neither a signatory nor even a nonsignatory “Power” who are involved in a conflict “in the territory of” a signatory. The latter kind of conflict is distinguishable from the conflict described in Common Article 2 chiefly because it does not involve a clash between nations (whether signatories or not). In context, then, the phrase “not of an international character” bears its literal meaning.

Hamdan v. Rumsfeld, 126 S.Ct. 2749 (2006).

5. The complete text of Common Article 3 of the Geneva Conventions is:

In the case of armed conflict not of an international character occurring in the territory of one of the High Contracting Parties, each Party to the conflict shall be bound to apply, as a minimum, the following provisions:

(1) Persons taking no active part in the hostilities, including members of armed forces who have laid down their arms and those places hors de combat by sickness, wounds, detention, or any other cause, shall in all circumstances be treated humanely, without any adverse distinction founded on race, color, religion or faith, sex, birth or wealth, or any other similar criteria.

To this end, the following acts are and shall remain prohibited at any time and in any place whatsoever with respect to the above-mentioned persons:

(a) violence to life and person, in particular murder of all kinds, mutilation, cruel treatment and torture;

(b) taking of hostages;

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(c) outrages upon personal dignity, in particular, humiliating and degrading treatment;

(d) the passing of sentences and the carrying out of executions without previous judgment pronounced by a regularly constituted court affording all the judicial guarantees which are recognized as indispensable by civilized peoples.

(2) The wounded and sick shall be collected and cared for.An impartial humanitarian body, such as the International Committee of the Red Cross, may offer its services to the Parties to the conflict.The Parties to the conflict should further endeavor to bring into force, by means of special agreements, all or part of the other provisions of the present Convention.The application of the preceding provisions shall not affect the legal status of the Parties to conflict.

6. Taking human rights seriously in this context would have better sustained international support for the U.S. fight against terrorism. Moreover, following a convention-mandated screening process the United States could lawfully have questioned those prisoners (likely a majority) who did not qualify for POW status under the conventions. In short, little was gained, and much was lost, in the administration’s attempt to trash the Geneva Conventions by putting pragmatism over principle.

The administration’s decision to treat the Geneva Conventions as inapplicable helped create a sense that Guantanamo was a legal black hole to which neither U.S. nor international law applied. This attitude in turn helped produce the scandalous abuse and torture of Iraqi prisoners of war at Abu Ghraib prison. The photographs of their humiliating and degrading treatment made it appear that the United States was willing to fight terror with terror. Abu Ghraib negated any American claim of moral superiority in the world and destroyed all human rights rationales for the Iraq war. The “good guys” had become the “evildoers” on prime-time TV for the world to see.

Military physicians performed better and honored both medical ethics and the human rights provisions of Geneva I, which covers wounded prisoners. After the fiercest battle in Afghanistan, (part of Operation Anaconda), for example, the surgeon in command of the U.S. Army field hospital at Bagram Air Base, Lt. Col. Ronald Smith, told reporters who asked him that the Taliban and al Qaeda wounded were being treated side by side with the American wounded at the hospital, noting that “the ethics of combat surgery” require it.

It is also worth noting that the Geneva Conventions themselves affirmatively protect medical ethics. For example, Article 16 of Protocol I (1977) states in relevant part:

1. Under no circumstances shall any person be punished for carrying out medical activities compatible with medical ethics, regardless of the person benefiting therefrom.

2. Persons engaged in medical activities shall not be compelled to perform acts or to carry out work contrary to the rules of medical ethics or to other medical rules designed for the benefit of the wounded and sick or to the provisions of the Conventions or this

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Protocol, or to refrain from performing acts or from carrying out work required by those rules and provisions. (emphasis added)

In short, under international humanitarian law, human rights and medical ethics requirements are symbiotic. See, e.g., GEORGE J. ANNAS, AMERICAN BIOETHICS: CROSSING HUMAN RIGHTS AND HEALTH LAW BOUNDARIES 9-10 (2005); Edmund Pellegrino, Medical Ethics Suborned by Tyranny and War, 291 JAMA 1505 (2004).

7. Of course it is not just terrorism that has been globalized. As discussed in length in chapter 3, diseases know no national boundaries, and pandemics like HIV/AIDS, SARS, and the avian flu are all inherently global diseases that, like the global environment, no country can deal with effectively on its own. See, e.g., LAURIE GARRETT, THE COMING PLAGUE: NEWLY EMERGING DISEASE IN A WORLD OUT OF BALANCE(1994).

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C. THE ANTHRAX ATTACKS

ELIN GURSKY ET AL., ANTHRAX 2001: OBSERVATIONS ON THE MEDICAL AND PUBLIC HEALTH RESPONSE

Biosecurity & Bioterrorism 97 (2003).

The immediate and continuing medical and public health response to the anthrax attacks of 2001 represents a singular episode in the history of public health . . .

The “response” to the anthrax attacks [which infected 22 people and killed 5] was extremely complex, and any analysis that purports to assess the response must account for this complexity. The unprecedented nature of the attacks and the context in which the response occurred are also crucial to understanding what happened and why. The long-standing neglect of federal, state, and local public health agencies, and the highly stressed condition of U.S. medical facilities, which routinely work at the limits of their capacity, are acknowledged by virtually all informed observers. That the medical and public health institutions involved in the response functioned as well as they did is a tribute to the extraordinary efforts of the individuals involved.

Despite the commitment and hard work of the individuals in these professional communities, what was revealed by the anthrax attacks was an unacceptable level of fragility in systems now properly recognized as vital to national defense. Too many citizens, elected leaders, and national security officials still have limited understanding of the degree to which 22 cases of anthrax rocked the public health agencies and hospitals involved in the response to this small bioterrorist attack. Most of the vulnerabilities in the medical and public health systems revealed by this response remain unaddressed. It is not the purpose of this article to praise or criticize individuals who responded to the 2001 anthrax attack. The emphasis here is on how to improve response systems. The article seeks to identify the strategic and organizational successes and shortcomings of the health response to the anthrax attacks so that medical and public health communities as well as elected officials can learn from this crisis….

Chronology of Key Events Following the Attacks

October 2, 2001—An infectious disease physician recognized a possible case of inhalational anthrax in a man hospitalized in Palm Beach County, Florida. This physician contacted the local health officer in Palm Beach County, who immediately began a public health investigation. By October 2, there were already 7 persons with cutaneous anthrax in the northeastern U.S., but none had yet been diagnosed.

October 4—The microbiologic diagnosis of B. anthracis was confirmed by the Florida Department of Health (FDH) and the Centers for Disease Control and Prevention (CDC), and the diagnosis was

October 15—A staff member in the office of Senator Daschle in the Hart Senate Office Building opened a letter (postmarked October 9) which contained a powder and a note identifying the powder as anthrax. The powder tested positive for B. anthracis on October 16. Nasal swab testing of anthrax spores was performed on 340 Senate staff members and visitors to the building who potentially were exposed and to approximately 5,000 other people who self-referred for testing. This testing indicated exposure in 28 persons. Antimicrobial prophylaxis was administered on a broader scale and environmental testing was initiated.

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made public. Epidemiologic and environmental investigations were launched to determine the source of the patient’s anthrax exposure. Evidence of contamination with B. anthracis was found at American Media Inc. (AMI) in Boca Raton, Florida where the first victim worked as a photo editor.

October 5—The first victim of the anthrax attacks died. A second AMI employee, who had been hospitalized for pneumonia on September 30, was diagnosed with inhalational anthrax. He was an employee in the AMI mailroom.

October 6—The Palm Beach County Health Department began to obtain nasal swabs from those who had been in the AMI building in an attempt to define exposure groups. Because nasal swab testing was known to be an insensitive diagnostic test, the health department also recommended prophylactic antibiotics for all those people who had been in the AMI building for at least one hour since August 1 regardless of the results of their nasal swab tests. Environmental samples taken from the mailroom showed evidence of B. anthracis.

October 7—A nasal swab was positive on another employee. A swab from the first victim’s computer screen was positive. The AMI building was closed.

October 9—The New York City Department of Health notified CDC of a woman with a skin lesion consistent with cutaneous anthrax. The woman, an assistant to NBC anchor Tom Brokaw, had handled a powder-containing letter postmarked September 18 at her workplace.

October 13—Another cutaneous case of anthrax was recognized in a 7-month-old infant who had visited his mother’s workplace, the ABC office building on West 66th Street in Manhattan, on September 28.

October 13—Symptoms of cutaneous and inhalational anthrax in New Jersey postal workers began to be observed and reported by physicians to the New York City Health Department. Diagnoses of anthrax are confirmed by the CDC on October 18 and 19.

October 19—CDC linked the four confirmed cases of anthrax to “intentional delivery of B. anthracis spores through mailed letters or packages.”

October 19-22—Four postal workers at the Brentwood Mail Processing and Distribution Center in the District of Columbia were hospitalized with inhalational anthrax. The Brentwood facility was closed on October 21. On October 22 two of these four postal workers died.

October 24—CDC sent an advisory to state health officials via the Health Alert Network recommending antibiotic prophylaxis to prevent anthrax for all people who had been in the non-public mail operations area at the U.S. Postal Service’s Brentwood Road Postal Distribution Center or who had worked in the non-public mail operations areas at postal facilities that had received mail directly from the Brentwood facility since October 11.

October 27—A CDC alert recommended antibiotic prophylaxis for workers in the mail facilities that supplied the CIA, the House office buildings, the Supreme Court, Walter Reed Army Institute of Research, the White House, and the Southwest Postal Station after preliminary environmental sampling revealed B. anthracis contamination in these mailrooms.

October 31—A 61-year-old female hospital stockroom worker in New York City died from inhalational anthrax after she had become ill with malaise and myalgias on October 25. The source of her exposure remains unknown despite extensive epidemiologic investigation.

November 16—A 94-year-old woman residing in Oxford, Connecticut, was hospitalized with fever, cough, and weakness. She died on November 19. Her diagnosis was confirmed as B. anthracis on November 20 by the Connecticut Department of Public Health Laboratory. Subsequent environmental and epidemiological testing indicated exposure from cross-contaminated letters.

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Public health decision-making processes

The 2001 anthrax attacks challenged traditional decision-making processes of federal, state, and local public health authorities. Historically, most outbreaks of naturally occurring disease are first recognized in a limited geographic region; laboratory and clinical methods for accurately diagnosing and treating cases of an unfamiliar illness (e.g., HIV/AIDS, Hanta virus, Legionnaire’s Disease) often evolve over a period of months or even years. Data pertaining to the outbreak and the causes of the illness are collected and analyzed by scientists at CDC and other public health agencies and medical institutions, and these analyses are discussed in the academic public health and medical communities at conferences and in medical journals. With time, a consensus view usually emerges about the causes of a disease, who is at risk, and how the illness can best be diagnosed, treated, and prevented. These scientifically based guidelines often are published by CDC and/or professional medical societies and serve as the basis for state and local public health practice.

In October 2001, at the time of the initial discovery of a person with anthrax infection in Florida, public health officials worked closely with clinicians in Palm Beach County to rapidly confirm the medical diagnosis of anthrax and to initiate the epidemiologic investigation that followed. For many of the decisions and actions that would follow, traditional public health decision-making processes were not adequate to cope with the extent, pace, and complexities of events surrounding the attacks.

This was the first time that CDC had been called on to respond to outbreaks of illness occurring nearly simultaneously in five geographic epicenters. Because sending B. anthracis spores through the mail was clearly an act of terrorism, the FBI was involved, substantially increasing the number of people and organizations that needed to receive and interpret information pertinent to the disease investigation and remain “in the loop.” In addition, because anthrax is virtually unknown in current medical practice, few local or federal public health officials had ever seen or been involved in evaluating a single case of B. anthracis infection, let alone a bioterrorist attack resulting in a series of cases.

Many public health policies—for example, whether to offer needle exchange programs to stem the spread of HIV/AIDS, or the nature and extent of prenatal care programs—routinely differ quite extensively from state to state and reflect variations in resources, expertise, and judgments about local priorities and needs. In the context of the anthrax attacks, however, policies and recommendations that differed between states, and between states and CDC, caused confusion. In some case, inconsistencies in the response were interpreted as evidence of incompetence or inequitable treatment, rather than as nuanced reactions to local situations or principled disagreement about what was the best course of action.

* * *In some instances, state and local public health officials were reluctant to initiate public health actions, such as recommending prophylactic antibiotics, without benefit of specific CDC guidance. Other health departments made decisions prior to receiving CDC guidance, in some instances deciding to act in ways that conflicted with CDC recommendations. Such variations in states’ decisions were especially notable in the context of determining who was at risk for exposure to B. anthracis spores and who should receive prophylactic antibiotics.

Confusion and contention surrounded both CDC’s authority to mandate specific public health actions and state public health officials’ responsibility to act on their own best judgments. Noted one state public health official, “We relied on CDC as a consultant. They gave us guidance and

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knowledge, but we used our own instincts. [We concluded that], if the environment had one spore, you are exposed.” A local public health official expressed the view that although CDC’s scientific expertise was valuable, CDC was “a research-based organization, far removed from how public health is delivered,” and hence was not well placed to make operational decisions on the local level.

* * *On some occasions during the response to the anthrax attacks of 2001,

confusion about who was at risk of developing anthrax and ambiguities about the extent of public health officials’ authority resulted in public health actions being influenced by political pressures. Several of those interviewed reported that in some locations elected officials had directed which groups of people should receive preventive antibiotics. In at least one case, differences among state health departments’ recommendations about who should receive antibiotic prophylaxis caused great concern among elected federal representatives. One public health official noted, “The media would compare our decisions to those made [elsewhere]. It was extremely uncomfortable. Elected officials came down on us regarding fairness. One elected official said, ‘The only fair thing was to give every postal worker [in the state] Cipro’ even though state public health officials believed that the information available warranted a more limited distribution of antibiotics.”…

In a number of areas targeted by the anthrax attacks, several different adjacent or overlapping public health agencies were simultaneously responding. City, county, and state health officials within states and across state borders, in many instances, had difficulty acquiring and sharing information and harmonizing their recommendation.

Medical and public health professionals from the greater Washington, DC, area reported many obstacles to reaching consensus decisions and to working collaboratively across the region. The Washington, DC, metropolitan area encompasses a complicated network of government jurisdictions. Many people who work in DC live in Maryland or Virginia. Three different health departments (Maryland, Virginia, and DC) were involved in the 2001 anthrax investigation and response. Although each was responsible for actions in their respective jurisdictions, the people at risk and the issues at stake often crossed geopolitical boundaries. In some instances, local public health officials working in these different jurisdictions were receiving contradictory recommendations from different sources….

CDC’s usual approach to investigating disease outbreaks—a careful, step-by-step gathering of evidence followed by deliberate scientific analysis—was not feasible in the context of a high-profile attack occurring in multiple epicenters that potentially placed thousands at risk and was causing massive disruption of government, business, and citizens’ routines. The analytical challenges were compounded by the complexities of the investigation. For example, the FBI was in charge of studying the anthrax powder found in the identified envelopes—material that immediately became evidence in a criminal investigation. It is unclear how soon CDC became aware that the anthrax powder found in the letter to Senator Daschle had different physical properties from the anthrax powder in letters sent to ABC, which had been examined earlier. The Daschle material was more refined, “fluffier,” and more likely to remain airborne, thus posing a greater threat of inhalation….

In the days immediately following the discovery of the first case of inhalational anthrax in Florida, CDC scientists had judged that only opened envelopes posed a risk of spore exposure. The investigation to date had revealed that no postal workers were ill in the Florida facility “upstream” of the contaminated letter that was believed to have been the source of the first victim’s exposure. Concerned about the potential side-effects of preventive antibiotics, and lacking information about what risks anthrax spores in sealed

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letters might pose to people working in the U.S. postal system, CDC initially recommended that only those in close proximity to opened anthrax-laden letters receive antibiotic prophylaxis. As the risks posed by sealed B. anthracis-laden envelopes became evident, prophylaxis recommendations were expanded to include mail handlers and others working in contaminated sites….

Postal workers also questioned the reliability of some of the CDC guidance. A representative of the postal workers noted, “The information [from CDC] changed every day. Nobody knew what was going on. I started a web page, but I would put something out and it would change. They said you need 10,000 spores to be ill, but we asked, ‘Can’t some people get sick with less?’ They said, ‘No. You have a better chance of getting hit by a bicycle.’ We had a party [to celebrate] the end of 60 days [of Cipro] and then they came back [a few weeks later] and said there were spores still living in us. They held a lot of meetings. I sat in on each one. Every doctor and every story was different. They said the stuff [vaccine] was safe but we would have to sign all these papers and maybe we could lose our rights under workers comp. Then they said the military people used to get six shots but we were going to get less. Even that doctor said she had the six. If six was good for her, why not for us?”

The confusion caused by these scientific uncertainties was compounded by the poor communication among public health officials and the media and the public. As the investigation first evolved and CDC learned more about the nature of the anthrax powder, the risk posed by unopened envelopes working their way through post office sorting machines, and other technical issues that bore on who was at risk and the nature of the public health response, the public heard little from top federal health officials. The lack of a consistent, credible message emanating from CDC in the early days after the anthrax attacks has yet to be fully explained.

CDC thus faced daunting challenges. The world expected CDC to provide detailed, authoritative information about a disease with which it was not familiar, in the context of a deliberate attack during a criminal investigation, the scope of which was larger than anything CDC had ever handled. Key aspects of the investigation were not under CDC’s control, and it is unclear to what extent CDC officials were free to speak to the public or the media.

* * *Faced with either poor access to public health officials or inadequate

information, reporters scanned websites, downloaded articles, and attempted to identify experts. Without information from the public health authorities, one journalist noted that they had to assemble pieces of the anthrax puzzle from a variety of what they hoped would be credible sources. One reporter noted, “It was extremely difficult to get information [out of public health]. If I did not have a several-year relationship with officials, it would have been impossible. I have been in the business 25 years, but this was the fastest unfolding story. There was information, rumors, powders, and people on edge. It would have been useful to have a single person, point of contact, or continually updated website. Everyone was having meetings and things were hush-hush. They didn’t know what was safe to say. The press relied on back channel contacts. We wanted to make sure we did not embellish. This took effort. The job of good reporting is a function of the reliability of data. There were many agencies involved that had conflicting information. You don’t want reporters making scientific judgments.”

The anthrax attacks of 2001 placed heavy and novel demands on a public health system that long has been recognized to lack resources commensurate with its responsibilities. Although some public health officials reported that experience with previous communicable disease outbreaks had helped to prepare them to respond to the anthrax attacks, most believed that the demands placed

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on public health authorities by the anthrax crisis made this different from past public health events. One state public health official noted, “Public health planning for West Nile Virus, Y2K and even 9/11 facilitated the development of systems and strategies, but we were underprepared for the surge in demand [caused by the anthrax attacks].” A number of concerns were common across affected communities.

Communications technology was inadequate. Equipment widely requested on an emergency basis by public health officials during the attacks included computers, software applications, conference call capability, wireless email, broadcast fax, and cell phones….

Systems for emergency procurement of critical resources were lacking. Few public health departments had emergency procurement systems….

Public health laboratories were stretched. State public health laboratories across the country were highly stressed by the quantity of potentially contaminated items brought in for testing….

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Notes and Questions

1. The authors of this study/description of the public health reaction to the anthrax letter attacks drew five conclusions: (1) Expectations about federal, state and local public health responsibilities require clarification; (2) Medical preparedness requires better communications among physicians and between medical and public health communities; (3) Public and medicine must recognize that response to bioterror attacks will evolve based on changing circumstances and new information; (4) Health officials must prepare to handle the media storm; and (5) Public health resources are barely adequate for a small-scale bioterror attack. Gursky, Inglesby & O’Toole supra, at 107-109. The report stressed the need for more funding for public health and noted that “The smallpox immunization plan announced by the administration in December 2002 [see infra] has added great stress to public health agencies around the country.” Id. at 109.

It is worth noting that this report identified no legal obstacles to public health response and recommended not changes in local, state, or federal law to enhance public health preparedness. Was this omission a mistake? Could specific legal changes have improved the quality of public health response to the anthrax mailings? If so, what changes would you recommend? Of course, the most critical pieces of information were scientific facts, such as how anthrax is spread. On the other hand, in an emergency, there will never be time to obtain all the scientific facts before acting.

The authors conclude:

It will take considerable vision and leadership—and sustained funding—to build the medical and public health systems needed to appreciably improve the nation’s capacity to mitigate the consequences of bioterrorist attacks. The anthrax attacks of 2001 demonstrated the feasibility of the use of biological weapons upon civilian populations. The SARS outbreak has again demonstrated the great responsibilities and challenges that the medical and public health systems bear in confronting disease epidemics, even when the overall number of cases remains relatively modest. Assessments of the response to the 2001 anthrax attacks and to other disease outbreaks such as SARS are critical to making wise decisions and strategic investments at the local, state, and federal levels concerning bioterrorism preparedness and response. Establishing the policy priorities, resources, and institutional capabilities to practice public health at a level of sophistication consistent with 21st century science and technology and commensurate with the threat posed by catastrophic bioterrorism is the task before us. Id. at 110.

2. Anthrax vaccine has been approved for use to prevent cutaneous anthrax and was mandatorily given to the troops in the Gulf War on the basis that it was an approved agent that could be given for an unapproved but

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closely-related use (inhalation anthrax). This vaccine was developed in 1970. After the Gulf War, DOD signed a sole source contract with a new company, Bioport, to produce anthrax vaccine. In 1998 Secretary of Defense William Cohen ordered that all active duty troops be given the anthrax vaccine, which was to be delivered in a series of six injections over an 18 month period. Some soldiers refused, and challenged the orders, arguing that the vaccine was experimental and thus could not be given without informed consent. Many of them were court-martialed. Anthrax vaccination was halted in 2001 when supplies ran out and the sole-source company was shut down by the FDA for failure to maintain proper manufacturing standards. Production and military vaccination resumed in 2002. There is no evidence of any military personnel or installation ever being attacked by anthrax anywhere in the world.

The bioterrorist anthrax attacks in the U.S. were on civilians, none of whom has been vaccinated. The recommended course of treatment for exposure to anthrax is 60 days of antibiotics, and antibiotics were made available to the 10,000 people potentially exposed. The anthrax vaccine was not available to civilians in October or November. In late December 2001, however, DOD agreed to supply sufficient vaccine to vaccinate the 10,000 exposed civilians. Of the 10,000 people eligible for the vaccine, only 152 eventually took it. Since the anthrax vaccine was an investigational drug when used for post-exposure inhalation anthrax, it could only be used in the context of a clinical trial, and then only with the informed consent of the subjects.

The FDA and CDC designed a consent form, together with a counseling process, for use in obtaining the consent of the exposed civilians to participate in the research project. Unlike the case of the military in the Gulf War, or even the peacetime military with the anthrax vaccine, in which the government required soldiers to be vaccinated, the choice was left entirely to individuals. Government officials did not even make a recommendation as to what they thought any individual should do. D.A. Henderson, the chief bioterrorist adviser to the Secretary of Health and Human Services (HHS), justified this failure to recommend for or against taking the anthrax vaccine by saying that there was insufficient information available to make a recommendation. But on what basis could individuals make a decision if those with the most experience with the anthrax vaccine refused even to advise them about what action was medically reasonable?

Although no survey of the exposed civilians has been conducted, it seems likely that the potential subjects mostly decided for themselves that their 60 days (or less) of antibiotics was sufficient protection. It is also unlikely that anyone who actually read and understood the information in the consent forms provided (for adults, adolescents, and children) would have chosen to take the vaccine. Specifically, the consent forms (which are essentially identical) are five-page, single-spaced documents. Designed for a clinical research trial, the forms are nonetheless captioned “Anthrax Vaccine and Drugs Availability Program for Persons Possibly Exposed to Inhaled Spores.” Most of the form is in regular typeface, but the following information is in bold:

Before you decide to take part in this program, there are several important things that you should know…

Anthrax vaccine has not been shown to prevent infection when given to people after exposure to anthrax spores…

The vaccine that you will receive in this program has not been approved by the Food and Drug Administration (FDA) for this use and is considered investigational…

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FDA has not approved this lot of vaccine (Lot FAV-063) because the company’s license to produce the vaccine is under review…

You should not consider the vaccine as a treatment for anthrax. The vaccine given in this program not been shown to give long term protection against anthrax.

You may have undesirable side effects from taking this vaccine. …DHHS is not making any recommendation whether you should or should not

take this vaccine. DHHS is making the vaccine available to you to allow you to decide whether or not you wish to use the vaccine.

* * *The FDA does seem to have learned from its experience in the Gulf War, and

did seem to understand that there could be no justification for waiving informed consent for competent adults, even in the face of a bioterrorist attack and uncertainty about the usefulness of the anthrax vaccine. Informed consent for research on competent adults is always feasible and is always ethically required. Informed consent is also required for treating competent adult civilians—only military personnel agree to accept reasonable and necessary approved medical procedures without specific consent. That is only one reason why it is dangerous to civilians to argue that after 9/11 “we are all soldiers now.” George J. Annas, Blinded by Bioterrorism: Public Health and Liberty in the 21st Century, 13 HEALTH MATRIX 33, 38-41 (2003). See also, George J. Annas, Protecting Soldiers from Friendly Fire: The Consent Requirement for Using Investigational Drugs and Vaccines in Combat, 24 AM. J. LAW & MED. 245 (1996); D. G. McNeil, Drug Tested in Gulf War is Approved for Troops, N.Y. TIMES, Feb. 6, 2003, at A19, and Michael E. Frisina, Medical Ethics in Military Biomedical Research, in MILITARY MEDICAL ETHICS, VOL. 2 533-63 (Thomas E. Beam & Linette R. Sparacino eds., 2003). Lawsuits related to the military’s anthrax vaccination program continue, as do production and safety questions.

3. It is worth noting that the first the first “bioterrorist” attack in the U.S. is generally credited to a small religious sect in Oregon who followed Bhagwan Shree Rajneesh who lived on a ranch about a two hour drive from The Dalles, Oregon. The “attack” took place on September 9, 1984, when members of the sect used agents ordered from the American Type Culture Collection, including Salmonella typhimurium, Francisella tularensis, Enterobacter cloacae, Neisseria gonorrhoeae, and Shigella dysenteriae to poison a salad bars at various restaurants in The Dallas to make people sick and prevent them from voting in an election that could have been detrimental to their sect. The attack is described in JUDITH MILLER, STEPHEN ENGELBERG, WILLIAM BROAD, BIOLOGICAL WEAPONS AND AMERICA’S SECRET WAR: GERMS (2001), 15-33.

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THE SMALLPOX VACCINATION PROGRAM

INSTITUTE OF MEDICINE, COMMITTEE ON SMALLPAX VACCIONATION PROGRAM IMPLEMENTATION, THE SMALLPOX VACCINATION PROGRAM: PUBLIC HEALTH

IN AN AGE OF TERRORISM, 123-161 (2005).

The last case of smallpox in the United States occurred in 1949. General vaccination against smallpox—accomplished with cutaneous administration of a closely related virus, vaccinia virus—ceased in the United States in 1972, when the threat of smallpox disease disappeared due to eradication efforts, which were declared complete by the World Health Organization on May 8, 1980. Only two official stocks of smallpox (variola) virus remained—under the auspices of the governments of the United States and the Soviet Union. It has often been rumored and suggested that some of the virus possessed by the Soviet Union could have been given illegally to people attempting to use the virus as a biological weapon, though factual evidence to support this concern has not been made public. The events of September and October 2001 increased U.S. concerns about all types of possible terrorism, including the potential for biological terrorism. Thus, attention turned to considerations of initiating vaccination against smallpox. CDC has been concurrently developing “post-event” vaccination plans (mass vaccinations after a smallpox release) and—the focus of this committee—“pre-event” plans (precautionary vaccination of smallpox response teams, first responders, and the general public).

On December 13, 2002, President Bush announced his policy on pre-event vaccination against smallpox. Vaccination of select military personnel, including the president in his role as Commander-in-Chief, began immediately thereafter. At the time of this writing, voluntary vaccination of state-based teams of public health disease investigators and of hospital-based teams of health care workers (who would respond to the first case of smallpox, should it ever appear) is scheduled to begin in late January 2003. The president has asked that this round of vaccinations be completed as quickly as possible and that a broader vaccination effort commence thereafter. As currently understood, the subsequent vaccinations will encompass the voluntary vaccination of all health care workers and those commonly defined as first responders, such as firefighters, police, and emergency medical personnel. Vaccination of the general public is specifically not recommended, but the president also announced the intent to provide vaccinations to those members of the public who request the intervention. The IOM’s Committee on Smallpox Vaccination Program Implementation met for the first time December 18-20, 2002, to begin addressing their charge, stated most succinctly as providing advice on how best to implement the policy as announced by President Bush.

The committee has not been asked to, and will not, comment on the president’s policy decision to recommend voluntary smallpox vaccination to health care, public health, and emergency personnel under a precautionary program, and to allow but not recommend access to the vaccine by people not included within those groups. The extensive expertise the committee brings to this issue will focus on program implementation.

The committee realizes that this is an atypical vaccination campaign, and that it is neither a research study nor an ideal public health program. Rather, it is a public health component of bioterrorism preparedness….

* * *

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For practical reasons, the committee uses the term “phase I” to describe the planned vaccination of 500,000 public health and health care workers who volunteer to be part of smallpox response teams, and “phase II” to refer to the subsequent vaccination of 10 million health care and public health workers and other emergency responders. However, it is unclear what the rounds of vaccination are being called by CDC (“phases” seems most frequently used) and clarification also is needed about the target population for later vaccination efforts.

…Before addressing the specific items in its charge, the committee summarizes its key messages and then addresses some general considerations.

The committee urges CDC to:

1. Highlight the unique nature of the smallpox vaccination program as a public health component of a national bioterrorism preparedness policy, focusing on the delivery of clear, consistent, science-based information.

2. Proceed cautiously, allowing continuous opportunity for adequate and thoughtful deliberation, analysis, and evaluation. Embark on phase II only after adequate evaluation of phase I has occurred.

3. Use a wide range of methods for proactive communication, training, and education, and customize it to reach diverse audiences, including potential vaccines, all health care providers, and the general public.

4. Designate one credible, trusted scientist as key national spokesperson for the campaign, and sharpen and expand communication plans and strategies to ensure rapid, transparent, and sustained contact with the media throughout implementation.

* * *

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Smallpox Vaccination Program Timeline

Date Event

June 2001 “Dark Winter,” a war game for senior-level officials, is conducted….Exercise included a smallpox outbreak spreading to 25 states and 15 countries….

[SEE CHAPTER 3]

September 2001 Terrorist attacks in New York, Arlington (Virginia), and Pennsylvania

October 2001 Letters containing anthrax spores delivered through U.S. mail

February 2002 CDC asks ACIP to review its recommendations on smallpox vaccination

June 2002 ACIP meets and drafts supplemental recommendations on smallpox vaccination (vaccinate up to 20,000 health

care and public health workers) (ACIP, 2002). Public Health Security and Bioterrorism Preparedness and Response Act of 2002 signed into law…

October 2002 ACIP meets again and updates recommendations on smallpox vaccination. ACIP also recommends offering

vaccine to up to 500,000 health care and public health personnel.

November 2002 President signs Homeland Security ActDesignated CDC staff members receive smallpox

vaccination(epidemiologic investigation teams)Mass media report that Bush administration

intelligence review has concluded that four nations (Iraq, North Korea, Russia, and France) may

possess covert and illegal stocks of smallpox virus

December 2002 States submit to CDC smallpox response plans and smallpox pre-event vaccination plans

President announces smallpox vaccination programHHS telebriefing on smallpox policy; initial goal: vaccinate 500,000 workers in 30 days

January 2003 Letter to White House issued by minority members of Senate calling for smallpox vaccine injury

compensation.CDC begins shipping smallpox vaccine to states.Department of Homeland Security established.DHHS secretary authorizes civilian smallpox

vaccinations.Civilian smallpox vaccination begins.

February 2003 Media reports cite lack of a compensation plan as a barrier to smallpox vaccination

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DHHS announces contracts to develop safer smallpox vaccines

DoD has vaccinated over 100,000 against smallpoxMorbidity and Mortality Weekly Report (MMWR) notifies

of one case of angina 4 days after smallpox vaccination

DoD reports first cases of myocarditis among personnel recently immunized with smallpox vaccine

March 2003 First civilian instances of myo/pericarditis identified, later classified as suspected and

probableDHHS proposes smallpox vaccination compensation planSurgeon general, CDC director, and others are

vaccinated against smallpoxWar with Iraq begins on March 19, 2003CDC accepts ACIP’s exclusion criteria and revises

fact sheets, screening materials, and informed consent form

April 2003 GAO report Smallpox Vaccination: Implementation of National Program Faces Challenges finds that 6% of

target population has been vaccinated by week 10 of program; data are insufficient to assess safety

On April 30, 2003, president signs into law Smallpox Emergency Personnel Protection Act of 2003, which

establishes no-fault Smallpox Vaccine Injury Compensation Program

May 2003 President declares end of major combat operations in Iraq

Media reports that in April and May, some states have begun offering smallpox vaccine to first responders

June 2003 ACIP recommends against expansion of smallpox vaccination program beyond “first phase”

December 2003 Federal government issues interim final rule for Smallpox Emergency Personnel Protection Act of 2003

(SEPPA), plan for smallpox vaccine injury compensation

January 2004 HHS secretary’s declaration regarding administration of smallpox countermeasures extended until and

including January 23, 2005

February 2004 DoD reports that 581,183 service members received smallpox shots from December 13, 2002, to February

11, 2004. Seventy-two vaccinees, or about 1 in 8,072, suffered myopericarditis, and there were 30 cases of vaccinia infection in contacts of vaccinees.

June 2004 DoD announces anthrax and smallpox vaccinations for all personnel deployed by Central Command and select

units in Pacific Command. Since December 2002,

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625,000 troops have been vaccinated against smallpox.

July 2004 The Senate Select Committee on Intelligence issues report which describes evidence on Iraq’s possession

of smallpox as weak

October 2004 CIA…concludes that, although Iraq had capability to work with smallpox virus, there is “no direct

evidence that Iraq either retained or acquired smallpox virus isolates or proceeded with

any follow- up smallpox related research”

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Notes and Questions

1. In its final report, which also contains complete copies of the above “letter report” and its five subsequent reports, the Committee labels the smallpox vaccination program “a case study at the intersection of public health and national security, two fields brought together by the threat of bioterrorism.” It notes that the campaign involved federal agencies that usually do not work together, and problems, such as classified information, that are not encountered in “typical public health programs.” Most centrally, it emphasized that “Bioterrorist attacks epitomize ‘low-likelihood, high-consequence’ events” for which planning is especially problematic and difficult. INSTITUTE OF MEDICINE, supra, at 5. Its two recommendations:

Based on the lessons learned from the smallpox vaccination program, the committee concludes that a policy strategy and a mechanism are needed to balance the need for scientific evidence and public health analysis with the imperatives of national security, ensuring in the process that the authoritative voice of CDC, the nation’s public health leader, will be preserved. The committee recommends that, in collaboration with its state and local partners and in the context of broad bioterrorism preparedness, CDC defines smallpox preparedness; set goals that reflect the best available scientific and public health reasoning; conduct regular, comprehensive assessments of preparedness at the national level and by state; and communicate to the public about the status of preparedness efforts. Id. at 6.

2. The military vaccination program was mandatory. The civilian one, however, was completely voluntary and relied on a combination of public trust and informed consent. In its first report, in January 2003, the committee noted specific problems that needed to be addressed, writing that the program was not a “typical public health program” but rather “a matter of national public health preparedness against a national security threat.” There was no real way of quantifying the actual threat and the benefit of the vaccine was unknown—the question was how to communicate this. The committee specifically recommended: “all consent documents include a statement that the risks of smallpox vaccine, which are very low, are predictably higher than the risks associated with most other vaccines, but that the benefit is at present unknown—possibly very low (absent exposure to smallpox) or very high (in the event of exposure). The committee further recommends that informed consent forms included explicit notification of the availability, or lack thereof, of compensation for adverse reactions.” Id. at 136-138.

3. The major reason [for the failure of the smallpox vaccination program] is that the administration failed to persuade physicians and nurses that the known risks of serious side effects with the vaccine were justified given the fact that there is no evidence that Iraq (or anyone else) has both smallpox virus and the wish to use it in a terrorist attack. The information provided on this issue to the physicians and nurses was in the same spirit as the Iraq nuclear threat information, except that it

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contained no facts at all, not even misleading or phony ones. The Director of the Centers for Disease Control and Prevention (CDC), and the person in charge of the smallpox vaccination program, for example, told a U.S. Senate Appropriations Subcommittee on January 29, 2003, about a month after the smallpox vaccination campaign began,

I can’t discuss all of the details because some of the information is, of course, classified. However, I think our reading of the intelligence that we share with the intelligence community is that there is a real possibility of a smallpox attack either from nations that are likely to be harboring the virus or from individual entities, such as terrorist cells that could have access to the virus. Therefore, we know it is not zero. And, I think that’s really what we can say with absolute certainty that there is not a zero risk of a smallpox attack.

This is wonderful doubletalk that proves nothing except that the CDC’s director does not seem to know much about the risk of a smallpox attack. Most importantly, however, if the U.S. government knows that an individual, group, or nation has smallpox and is working to make it into a weapon, this information should be made public. It is the terrorists who want to keep their methods and intentions secret; the best defense from a potential target is to make this information public. George J. Annas, The Statue of Security: Human Rights and Post-9/11 Epidemics, 38 J.HEALTH LAW 319. 330-31 (2005).

Gerberding’s approach seems to have been guided by what has become known as the post-9/11 Cheney “One-Percent Doctrine.” As described by author Ron Suskind, when asked how to respond to report that Pakistani scientists may be helping al Qaeda to build a nuclear weapon Cheney responded, “If there’s a one percent chance that Pakistani scientists are helping al Qaeda build or develop a nuclear weapon, we have to treat it as a certainty in terms of response. It’s not about our analysis, or finding a preponderance of evidence. It’s about our response.” In Suskind’s words,

This doctrine—the one percent solution—divided what had largelyBeen indivisible in the conduct of American foreign policy; analysisAnd action. Justified or not, fact-based or not, ‘our response’ is What matters. As to ‘evidence,” the bar was set so low that the wordItself almost didn’t apply.

RON SUSKIND, THE ONE PERCENT DOCTRINE: DEEP INSIDE AMERICA’S PURSUIT OF ITS ENEMIES SINCE 9/11 62 (2006). Marc Siegel applies the numbers to try to make sense of post-9/11 alarms regarding public health in his FALSE ALARM: THE TRUTH ABOUT THE EPIDEMIC OF FEAR (2005).

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E. BIOTERROR PREPAREDNESS AND RESEARCH

HILLEL COHEN ET AL., THE PITFALLS OF BIOTERRORISM PREPAREDNESS: THE ANTHRAX AND SMALLPOX EXPERIENCES

94 Am. J. Public Health 1667 (2004).

Recent Bioterrorism preparedness programs that illustrate irrational and dysfunctional responses to inadequately characterized risks should be of urgent concern to all members of the public health community….

* * *Efforts by the United States to prepare for the use of biological agents in war based on flawed evaluations of risks have had serious health consequences for military personnel and have led to significant weakening of international agreements against the use of biological agents. Massive campaigns focusing on “bioterrorism preparedness” have had adverse health consequences and have resulted in the diversion of essential public health personnel, facilities, and other resources from urgent, real public health needs. Preparedness proponents argued that allocating major resources to what were admittedly low-probability events would not represent wastefulness and would instead heighten public awareness and promote “dual use” funding that would serve other public health needs. Public health resources are woefully inadequate, and the notion that bioterrorism funding would bolster public health capability seemed plausible to many, even though we and others have argued that the “dual use” rationale is illusory. An evaluation of recent experience concerning anthrax and smallpox can help illuminate these issues.

Anthrax

Despite extensive work on the possible weaponization of anthrax, there has been no example of effective use of anthrax as a weapon of indiscriminant map destruction. In 2001, shortly after the events of September 11, weapons-grade anthrax spores were mailed to several addressees, but none of the intended targets were injured. Of 11 people who developed inhalation anthrax, 5 died. Of the 12 who had cutaneous infections, all recovered after administration of antibiotics. Thousands of people in potentially exposed areas such as postal sorting centers were advised to use antibiotics prophylactically. Millions of people were terrified, and many thousands in areas where there was no possible risk of exposure also took antibiotics. Congress was closed for days, mail service was disrupted for months, and state and county public health laboratories were inundated with white powder samples that ranged from explicit anthrax hoaxes to spilled powdered sweeteners.

Despite early speculation linking the anthrax release to “foreign terrorists,” evidence led investigators to suspect an individual who had been working in a US military facility that may have been in violation of the Biologic and Toxin Weapons Convention. Whether or not that specific individual was involved, it appears likely that the perpetrator or perpetrators were associated in some way with a US military program, that the motive for the extremely limited release was political, and that, without the existence of a US military laboratory, the material for the release would not have been available.

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This experience supports the view that, as a consequence of the inherent difficulties in obtaining and handling such material, mass purposeful infection is highly improbable and the likely impact on morbidity and mortality limited. However, the nature of US “biodefense” programs may modify this prognosis; such programs may result in dangerous materials being more readily available, thus undermining the Biologic and Toxin Weapons Convention. Despite an absence of evidence of anthrax weapon stocks posing a threat to US military personnel, and despite problematic experiences of the military anthrax vaccination program, the US government announced plans to spend as much as $1.4 billion for millions of doses of an experimental anthrax vaccine that has not been proven safe or effective and the need for which has not been opened to public debate.

Smallpox

The 2002-2003 campaign to promote smallpox as an imminent danger coincided with the Bush administration’s preparations for war on Iraq and the now discredited claims that Iraq had amassed weapons of mass destruction and could launch a biological or chemical attack in “as little as 45 minutes.” A media campaign describing the dangers of smallpox coincided with the buildup for war. An unprecedented campaign advocating “preevent” mass smallpox vaccinations, to be carried out in 2 phases—involving half a million members of the armed forces and half a million health workers in phase 1 and as many as 10 million emergency responders in phase 2—was announced in December 2002.

Before then, the debate on smallpox had been whether the stocks of stored stand-by vaccine were adequate or whether they should be increased. The World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and virtually every public health official took the position that the vaccine involved too many adverse events—was too dangerous—to warrant mass vaccination when no case of smallpox existed or had existed for more than 20 years. When the Bush administration announced support for mass vaccinations, WHO did not change its position, but the CDC and other US public health officials and organizations, including the American Public Health Association (APHA), decided to acquiesce.

The coincidence of the Bush war calendar and the smallpox vaccination calendar, while not conclusive, is nonetheless consistent with an inference that the war agenda was the driving force behind the smallpox vaccination campaign. Since the invasion, evidence has emerged that allegations regarding Iraqi weapons of mass destruction were deliberate exaggerations or lies. The evidence is highly suggestive that the smallpox vaccination program was launched primarily for public relations rather than public health reasons.

The vaccination campaign did not proceed as planned. Opposition arose on both safety and political grounds, and most front-line health professionals simply did not volunteer to participate. Of the 500,000 health professionals who were targeted for inoculations in phase 1, fewer than 8% participated. Despite efforts to avoid vaccination of those who might be at elevated risk, the CDC reported that there were 145 serious adverse events (resulting in hospitalization, permanent disability, life-threatening illness, or death) associated with smallpox vaccinations among civilians. Of these cases, at least 3 were deaths.

Three deaths resulting from thousands of inoculations would have been justifiable in preparation for a real threat of smallpox or in the midst of a smallpox outbreak, when vaccination could have saved many more lives. However,

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in the absence of any smallpox cases worldwide or any scientific basis for expecting an outbreak, these deaths and other serious adverse events are inexcusable….

* * *The smallpox vaccinations harmed others beyond those who suffered side effects. Considerable public health resources were used in the campaign. In a climate of state and local budget crises coinciding with the war and occupation, a downturn in employment, and a tax cut for the wealthy, public health services have been cut or are at serious risk. Funding for bioterrorism programs is not correcting the deficit, because such funds have been for the most part specifically earmarked for preparedness efforts and cannot be transferred to other public health programs. In general, federal increases in public health funding are much less extensive than state or local cuts. During the height of the smallpox vaccination effort, a number of state health officials complained that important work, including tuberculosis screening and standard children’s inoculations, had to be scaled back. The siren song of dual use—that bioterrorism funding would strengthen public health infrastructure—has shown itself to be an empty promise, as preparedness priorities have weakened rather than strengthened public health.

Broader Problems

Even worse, bioterrorism “preparedness” programs now under way include the development of a number of new secret research facilities that will store and handle dangerous materials, thus increasing the risk of accidental release or purposeful diversion. Reports of accidental leaks and improper disposal of hazardous wastes at the US Army facility at Fort Detrick serve as future warnings, as do revelations of mishandling of biological agents at the Plum Island, New York, facility that studies potential bioweapons that affect animals.

Most important, the proposed development of “biodefense” programs at sites, such as national nuclear weapons laboratories, that are traditionally secretive in their operations also provides an impetus for a potential global “biodefense race” that would likely spur proliferation of offensive biowarfare capabilities. Accidents or purposeful diversions from these facilities seem at least as likely as terrorist events, and perhaps more so, since the deadly materials are already present. The Patriot Act has greatly expanded the clock of secrecy that shields these facilities from public awareness and oversight.

In short, bioterrorism preparedness programs have been a disaster for public health. Instead of leading to more resources for dealing with natural disease as had been promised, there are now fewer such resources. Worse, in response to bioterrorism preparedness, public health institutions and procedures are being reorganized along a military or police model that subverts the relationships between public health providers and the communities they serve.

* * *

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U.S. v. BUTLER

429 F.3d 140 (5th Cir. 2005), cert. denied 126 S. Ct. 2049 (2006)

Before Wiener, DeMoss, and Prado, Circuit Judges.

PER CURIAM

Appellant Dr. Thomas Butler was convicted on 47 of 69 counts of various criminal activity relating to work he performed as a medical researcher at the Texas Tech University Health Sciences Center ("HSC"). Of these 47 counts, Butler was convicted of 44 counts of contract-related crimes, including theft, fraud, embezzlement, mail fraud, and wire fraud, (collectively, the "Contract Counts"). Butler was also convicted of three counts relating to the transportation of human plague bacteria ("Yersinia pestis" or "YP"), including the illegal exportation of YP to Tanzania, the illegal transportation of hazardous materials, and making a false statement on the waybill accompanying the YP vials shipped to Tanzania, (collectively, the "Plague Counts"). The district court sentenced Butler to 24 months' imprisonment followed by 3 years' supervised release, a $ 15,000 fine, and ordered him to pay restitution to HSC in the amount of $ 38,675. Butler timely filed the instant appeal. For the reasons discussed below, we affirm.

Butler was a professor and Chief of Infectious Diseases in HSC's Internal Medicine Department since 1987. As part of Butler's pay structure, a percentage of his income was provided by the State of Texas while the remainder came from the Medical Practice Income Plan ("MPIP"). Under MPIP, a doctor earned money by seeing patients, receiving research grants, or conducting clinical studies under the auspices of HSC. The monies received from the patients a doctor treated and the funds paid out for the research/studies was remitted to HSC. Part of these monies paid for HSC's overhead costs and other expenses while another part was paid out as the non-state portion of the doctor's income. Any remaining funds from a clinical study was transferred to a developmental account for the researcher's department or division. The money in this account was earmarked for expenses such as professional dues and business travel, none of which was related to any particular project.

When a researcher at HSC was in a position to obtain a research grant or conduct a clinical study, it was required that the accompanying documentation be submitted to the institution for approval. Moreover, any monies paid out as a result of the research grant or clinical study were required to be paid directly to the institution. Consulting contracts, however, received different treatment from research grants or clinical studies. Specifically, a consulting contract was viewed by HSC as a means for a doctor to sell his or her expertise or advice directly to a third party, such as in designing a drug study. The consulting would not involve patient care or patient safety issues, and the consultant would not be using HSC's resources such as labs and personnel. Because of these considerations, consulting contracts were permissible without HSC's financial involvement or approval, unlike contracts covering clinical studies.

Between 1998 and 2001, Butler entered into several clinical study contracts with two different pharmaceutical companies, Pharmacia and Chiron. The first contract entered into with Pharmacia occurred in March 1998. Under this contract, Pharmacia agreed to pay HSC $ 2,400 for each patient enrolled in the clinical study. Apparently unbeknownst to HSC, however, Pharmacia and

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Butler entered into another "shadow" or "split" contract that provided Butler with an additional $ 2,400 per patient enrolled in the same study. A similar contract was entered into between Pharmacia and Butler in the spring of 2000 and again in the fall of 2000.

With respect to the contract in the fall of 2000, there was another HSC researcher, Dr. Casner, who was working on the same study as Butler. Dr. Casner's contract with Pharmacia was not split, and therefore it appeared that he had a budget twice the size of Butler's. A representative with HSC who was aware of Dr. Casner's contract, contacted Butler to inform him that she could get Butler a bigger budget. Butler allegedly refused the offer and informed the HSC representative that he would remain in charge of negotiating his own contracts. Butler had also negotiated two similar contracts with Chiron (another pharmaceutical company), using the contracts with Pharmacia as a template. The contracts with Chiron involved drug studies that were conducted in February 1999 and March 2000. Butler received payments under the contracts with Pharmacia and Chiron until August 2001.

The existence of the shadow contracts first came to the attention of HSC in July 2002, when an HSC representative learned from a Pharmacia representative that Butler was getting one-half of the money from the Pharmacia studies, while HSC received the other half. HSC initiated a preliminary investigation into the split contracts that continued until January 9, 2003, when HSC informed Butler by letter that an additional investigation by authorities charged with compliance issues was to begin. In the letter, HSC sought a response from Butler by no later than January 21, 2003. For the reasons discussed below, HSC never received the requested response.

In addition to his work at HSC in Texas, Butler conducted plague research in Tanzania in 2001.1 Then, in April 2002, Butler returned to Tanzania where, for approximately 10 days, he worked on research of plague in human patients at clinics there. Part of his research involved personally culturing and subculturing specimens that he planned to bring back to the United States for additional studies.

Having returned to the United States with the Yersinia pestis cultures, Butler continued his research. Then, on January 13, 2003, four days after receiving the letter from HSC auditors warning of the impending investigation into the alleged shadow contracts, Butler reported that 30 vials of the Yersinia pestis were missing from his HSC laboratory in Lubbock. The FBI was immediately notified and within hours descended upon Lubbock, where Butler was questioned. Eventually, Butler revealed that the Yersinia pestis was not actually missing, but that he had destroyed the vials accidentally.

In April 2003, a grand jury returned a 15-count indictment charging Butler with various crimes relating to his transporting of Yersinia pestis, the providing of false statements to FBI agents regarding Yersinia pestis, and a tax crime. A superceding indictment was returned by the grand jury in August 2003, in which Butler was charged with 54 additional criminal counts, including mail fraud, wire fraud, and embezzlement that arose out of Butler's agreements with the pharmaceutical companies and the Food and Drug Administration (the "FDA"). Butler filed a motion seeking to sever the Contract and Plague Counts, which the district court denied. After a three-week trial in November 2003, the jury returned a mixed-verdict against Butler, finding him guilty on most of the Contract Counts and not guilty on most of

1 This work was reportedly encouraged by the Food and Drug Administration (the "FDA"), the Center for Disease Control and Prevention ("CDC"), and the United States Army.

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the Plague Counts and the tax count. On March 10, 2004, the district court sentenced Butler to 24 months' imprisonment, three years' supervised release, $ 15,000 in fines, and a $ 4,700 special assessment. Butler was also ordered to pay HSC restitution in the amount of $ 38,675. Butler timely filed the instant appeal.

DISCUSSION

I. Whether the district court erred by not severing the Contract Counts and the Plague Counts.

On appeal, Butler argues the Federal Rules of Criminal Procedure and this Circuit's case law prohibit the joinder of unrelated criminal categories charged; here, the Contract Counts and the Plague Counts. Butler contends that trying all the counts together caused him prejudice. Conversely, the Government maintains that joinder was proper because the charges in the superceding indictment were linked as transactions within a common scheme or plan.

The indictment specifically outlines Butler's research into non-plague-related diseases for Pharmacia and Chiron and his plague-related research for the FDA. The indictment's description of Butler's scheme to defraud explained how he failed to disclose material facts to HSC regarding not only the Pharmacia and Chiron contracts, but also the plague-related contracts with the FDA.

The introduction to the superseding indictment details how the FDA offered research opportunities to medical professionals regarding "the development and review of medications for the prevention and treatment of illness that could be caused by terrorists using biological agents." The FDA subsequently purchased Butler's professional service, and specifically, according to the indictment, "for the results of experimental research regarding the post-antibiotic effect of drugs on the microorganism Yersinia pestis," and later "to provide experimental results from [Butler]'s laboratory about the] post-antibiotic effect of drugs on various strains of Yersinia pestis isolated from plague patients in Tanzania."

Meanwhile, the actual FDA fraud counts charged Butler with attempting to conceal the existence of his FDA contracts from HSC's administrative review and approval process. Butler was alleged to have subsequently obtained payments from the FDA without distributing any monies therefrom to HSC in accordance with HSC's relevant policies for doing so.

The superceding indictment clearly sets forth an alleged common scheme that connects both Butler's plague research and the Pharmacia/Chiron pharmaceutical contracts to the FDA fraud counts. In doing so, the superseding indictment, on its face, creates an overlap that logically intertwines the Contract Counts with the Plague Counts.

* * *

V. Whether the Government presented sufficient evidence as to the Contract and Plague Counts.

. . . Butler maintains there was insufficient evidence to support the jury's finding that he willfully: (1) exported Yersinia pestis to Tanzania without a license; (2) described in a misleading manner the Yersinia pestis as

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"laboratory materials" on the FedEx waybill; and (3) violated federal hazardous material regulations when he shipped the Yersinia pestis to Tanzania.

As to the first sub-issue, the Government points this panel to evidence introduced at trial that Butler certified on the FedEx waybill that the samples were being "exported . . . in accordance with Export Administration Regulations," when in fact they were not. The Government notes that Butler had in his office a document downloaded from the Center for Disease Control website that clearly indicated a Department of Commerce permit was required to export Yersinia pestis. As further evidence of Butler's knowledge of export requirements, the Government observes that Butler previously signed four waybills shipping hazardous materials to Canada and checked the box indicating a Shipper's Export Declaration was not needed (which it is not in those circumstances). Moreover, the Government introduced evidence that during the 1990s, Butler properly shipped infectious substances and other dangerous goods more than 30 times. Based on this evidence, Butler's argument here must fail.

With regard to Butler's conviction for making a false statement by labeling the Yersinia pestis as "laboratory materials," he contends that because he did not intend to deceive anyone, he cannot be found to have acted willfully. The Government responds by noting that Butler also certified on that same label that he was not shipping dangerous goods. According to the Government, a reasonable person certainly could conclude that an accomplished researcher, who was the Chief of Infectious Diseases at HSC and had spent considerable time studying plague abroad, would have known that plague was a dangerous good requiring the proper identification thereof. Accordingly, Butler's sufficiency of the evidence argument on this sub-issue is also without merit.

Finally, Butler contends his conviction for violating hazardous material regulations required the Government to prove that his infraction could not have been due to a good faith mistake or misunderstanding of the law. The Government responds with an argument identical to its reason why there was sufficient evidence establishing Butler's unlawful export of Yersinia pestis to Tanzania without a license: Butler had successfully and legally shipped hazardous materials at least 30 times before making this particular shipment. Importantly, Butler comes forward with no specific evidence of his own on appeal refuting the Government's evidence, or establishing what about his actions warranted a finding that he made a good faith mistake or misunderstood the law. Without more, a reasonable trier of fact could have found that the evidence established guilt beyond a reasonable doubt.

Having carefully reviewed the entire record of this case, and having fully considered the parties' respective briefing and arguments, we conclude the district court did not commit reversible error by refusing to sever the Contract Counts from the Plague Counts. Moreover, the district court made appropriate discovery and evidentiary rulings. Also, there was sufficient evidence supporting Butler's convictions under the Contract Counts and the Plague Counts…. Accordingly, we AFFIRM Butler's conviction and sentence.

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Notes and Questions

1. On January 2, 2006, Butler completed his two-year sentence and was released. A scientific article detailing his plague research in Tanzania, completed while he was in prison, was published shortly thereafter. See William Mwengee, Thomas Butler, et al., Treatment of Plague with Gentamicin or Doxycycline in a Randomized Clinical Trial in Tanzania, 40 CLINICAL INFECTIOUS DISEASE 614 (2006).

2. The case of physician-researcher Thomas Butler has been the subject of many commentaries—most arguing that his prosecution represents a gross overreaction on the part of federal authorities. Nonetheless, in an article in Science, Margaret A. Somerville and Ronald M. Atlas argued that Butler’s prosecution “sent a clear signal to the research community, especially scientists and university researchers, that all ethical and legal requirements must be respected when undertaking research.” The continued, “Biosafety regulations are not merely legal technicalities. They constitute some of the terms of the pact between science and the public that establishes public trust.” Ethics: A Weapon to Counter Bioterrorism, 307 SCIENCE 1881 (2005).

Ethical guidelines for life sciences research that could be related to bioterrorism do seem critical, and the scientific community should be actively engaged in setting the standards for such research. As the National Research Council of the National Academy of Sciences has states, “biological scientists have an affirmative moral duty to avoid contributing to the advancement of biowarfare or bioterrorism.” It is reasonable for society to expect that scientists will adopt the equivalent of the physician’s “do no harm” principle. Arguing for such an oath well before September 11, literary scholar Roger Shattuck noted that it could “help scientists scrutinize the proliferation of research in dubious areas” as well as “renew the confidence of ordinary citizens” in what is a potentially revolutionary endeavor. (Forbidden Knowledge, New York: St. Martin’s Press, 1996 at 224)

But can an ethical code be effective? What should it say? Who should write it? Consider, for example, the National Research Council’s seven classes of microbial experiments that should require special review:

The experiments would:Demonstrate how to render a vaccine ineffective;Confer resistance to therapeutically useful antibiotics or antiviral agents;Enhance the virulence of a pathogen or render a nonpathogen virulentIncrease transmissibility of a pathogen;Alter the host range of a pathogen;Enable the evasion of diagnostic and detection methods;Enable the weaponization of a biologic agent or toxin.

3. The major approach the administration has taken toward potential bioterrorism since 9/11 has been to categorize biological agents according to their risks of being used as a terrorist weapon. The current scheme has three categories, and the fact that plague is in category A goes a long way to explaining why the FBI acted so strongly against Butler.

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Category A:

Anthrax, botulism, plague, smallpox, tularemia, viral hemorrhagic fevers.

Category B:

Brucellosis, food safety threats, glanders, melioidosis, psittacosis, Q fever, ricin toxin, staphyloccococcal enterotoxin B, typhus fever, viral encephalitis, water safety threats.

Category A, or “high priority agents…pose a risk to national security because they can be easily disseminated or transmitted from person to person; result in high mortality rates and have the potential for majorpublic healthy impact; might cause public panic and social disruption; and, require special action for public health preparedness.

Category B agents “include those that are moderately easy to disseminate; result in moderate morbidity rates and low mortality rates; and require specific enhancements of CDC’s diagnostic capacity and enhanced disease surveillance.

There is also a Category C for those agents “that could be engineered for mass dissemination in the future because of availability; ease of production and dissemination; and potential for high morbidity and mortality rates and major health impact.” CDC, BIOTERRORISM AGENTS/DISEASES, available at (http://www.bt.ced.gov/agent/agentlist-category.asp)

An Institute of Medicine committee has suggested that making such lists is not a useful way to counter bioterrorism because it takes no account of the future of science. In the Committee’s words:

First, the future is now. Even in the short time since the creation of the committee, we have seen the phenomenon of RNAInterference capture the collective consciousness of the lifesciences community, providing entirely new insights into howhuman genes are normally regulated and how this regulation might be disrupted for malevolent purposes by those intent on doing harm.Similarly, ‘synthetic biology,’ an approach embraced and discussed by few at the time the Committee was formed, has now been redefined and promoted on the cover of one of the most widely read scientificjournals. Neither of these developments could have been foretold evera few years back, pointing to the futility of trying to predict withaccuracy what will come in the next few years [the committee concluded, among other things, that we need a new threat reduction paradigm for the biological sciences].

INSTITUTE OF MEDICINE, COMMITTEE ON ADVANCES IN TECHNOLOGY AND THE PREVENTION OF THEIR APPLICATION TO NEXT GENERATION BIOWARFARE THREATS: GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES viii (2006). On the risks to public health from concentrating too much on preparedness see TERRORISM AND PUBLIC HEALTH: A BALANCED APPROACH TO STRENGTHENING SYSTEMS AND PROTECTING PEOPLE (BARRY S. LEVY & VICTOR W. SIDEL, eds. 2003)

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4. There are other examples of an arguably overly aggressive FBI that seems to see bioterrorism in activities, including art, that it would not have seen them pre-9/11, and wastes time, effort, and resources that could almost certainly be better spent in trying to identify real bioterrorist threats:

Shortly after Butler’s trial, in another part of the country—Buffalo, New York—FBI agents were called in to investigate a suspected act of bioterrorism in the home of Steve Kurtz, a professor and artist at the State University of New York at Buffalo. Kurtz awoke on May 11, 2004, to find his wife dead beside him. Kurtz and his wife previously had cofounded the Critical Art Ensemble, an artists’ collective “dedicated to exploring the intersections between art, technology, radical politics and critical theory.” Kurtz liked to distinguish what he did from the emerging field of “bioart,” which is perhaps best known to the public because of the notoriety of Alba, a rabbit that glowed green because of the insertion of a jellyfish gene. Kurtz thinks of bioart as consisting of stunts and his own art as an exploration of “the political economy of biotechnology.” He had previously argued against the introduction of genetically modified food, and he had encouraged activists to oppose it by means of “fuzzy biological sabotage”—for instance, by releasing genetically mutated and deformed flies at restaurants to stir up paranoia.

The day after his wife’s death, the FBI raided his home in full biohazard gear. Kurtz had been studying the history of germ warfare for a new project. In connection with this project, he was growing bacterial cultures that he was planning to use to simulate attacks with anthrax and plague. He had obtained the bacteria samples (Serratia marcescens and Bacillus atrophaeus) from a colleague, Professor Robert Ferrell, a geneticist at the University of Pittsburgh Medical Center, who had ordered them for him from the American Type Culture Collection. Kurtz and Ferrell were suspected almost immediately of being involved in a bioterror ring and were thoroughly investigated. Once the New York department of Health determined that the bacteria were harmless and that Kurtz’s wife had died of natural causes, the bioterrorism investigation was dropped. The Justice Department nonetheless charged both Ferrell and Kurtz with four counts of wire fraud and mail fraud. The allegation was that Ferrell, at Kurtz’s request, defrauded the University of Pittsburgh and the American Type Culture Collection by representing that the bacteria samples he ordered would be used in his University of Pittsburgh laboratoy. [As of September 2006]neither case has yet gone to trial.

Exactly what Kurtz was planning to do with the bacteria is unclear, but serratia, which is known for its ability to form bright red colonies, has been used in biowarfare simulations in the past. Perhaps its most well-known use was a 1950 simulation in which an offshore naval vessel blanketed a 50-square-mile section of San Francisco with an aerosol spray containing serratia to determine what dose could be delivered effectively to the population. Whether using a similar

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technique as an art exhibit would constitute bioart, biotechnology, or biohazard (or even bioterrorism) may be in the eye of the beholder even more than in the eye of the artist or scientist.

Bioart is not bioterrorism, but the two are related politically. As bioart curator and commentator Jens Hauser has staid, bioart aims “at the heart of our fears” and is meant to “disturb.” He notes, “these artists expose the gulf between the apologetic official discourse about technoscience on the one hand, and paranoia on the other.” Like defensive and offensive bioweapons research, bioart and biotechnology may be impossible to distinguish by anything other than the researcher’s or creator’s intent. Thus, Alba, the bunny with the inserted jellyfish gene, is considered to be and is accepted as a creation of bioart, at least in the contemporary art community; whereas ANDi, the monkey with the inserted jellyfish gene, is considered to be a creation of science, at least in the biotechnology community. Hauser was referring to paranoia in the face of the “rapid acceleration of technical prowess.” On the basis of the reaction of federal law enforcement to the actions of Thomas Butler and Steve Kurtz, however, although the advances of biotechnology that have potential applications to bioterrorism and biowarfare are scary, even scarier are the responses—in the name of preventing bioterrorism—of law-enforcement agencies to legitimate scientists and artists whose actions pose no threat to the public.

Butler’s arrest came about one year after a simulated bioterrorism event in Lubbock, Texas; this simulation involved the use of aerosolized plague at a civic center. Simulations have been a centerpiece of efforts to prepare for acts of bioterrorism. As we should have learned from our obsession with building bomb shelters during the cold war, however, simulations promote fear of worst-case scenarios and make them look much more likely. Bioterrorism simulations such as Dark Winter (smallpox) and Top Officials (TOPOFF) involve more art than science and are likely to provoke a response based more on fear than logic. They should probably be classified as bioart in the sense of performance art, and they should have their most socially useful outlet not in federal law-enforcement agencies or biosafety laboratories but in television dramas like 24.

George J. Annas, Bioterror and “Bioart” – A Plague o’ Both Your Houses, 354 NEW ENG. J. MED. 25 (2006).

Do you agree? Are law enforcement agencies overreacting or underreacting to the threat of bioterrorism?

Annas concludes:

One reasonable response to the dispute between Butler and the Justice Department and the dispute between Kurtz and the Justice Department could be Mercutio’s retort in Romeo and

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Juliet: “A plague o’ both your houses.” This is because the public is currently more victim and bystander than participant and seems much more likely to be harmed than helped by much of the research. Members of the public recognize this probability, and their skepticism of federal authorities, of the effectiveness of countermeasures, of the existence of weapons of mass destruction in Iraq, and of the entire bioterrorism scare is well illustrated by the few people who took drugs to treat anthrax that were offered after the anthrax attacks. This same skepticism, combined with the lack of evidence of stockpiles of smallpox in Iraq and the certainty of side effects from the drugs, also explains the small number of health professionals who volunteered to take the smallpox vaccine immediately before and shortly after the commencement of the war in Iraq. Id. at 2719.

5. At least some over-reactions can be traced to books highlighting the dangers of a bioterrorist attack. President Bill Clinton, for example, said he first became focused on this risk when he read Richard Preston’s novel, THE COBRA EVENT (1997) in 1997. Preston later wrote a nonfiction book on the dangers of a smallpox attack, THE DEMON IN THE FREEZER: A TRUE STORY (2002). Perhaps more frightening to public health officials were the books by the former Soviet head of bioweapons development, KEN ALIBEK (BIOHAZARD: THE CHILLING TRUE STORY OF THE LARGEST COVERT BIOLOGICAAL WEAPONS PROGRAM IN THE World—Told FROM INSIDE BY THE MAN WHO RAN IT (1999), and by Minnesota epidemiologist MICHAEL OSTERHOLM (with John Schwartz), LIVING TERRORS: WHAT AMERICANS NEEDS TO KNOW TO SURVIVE THE COMING BIOTERRORIST CATASTROPHE (2000). All of these books portray what might be described as worse case scenarios, and the value of concentrating on worse cases (instead of likely cases) is debatable. Of course the nuclear arms race provided the background for over-reaction, complete with its “mutually assured destruction” scenarios, home fallout shelters, and “duck and cover” grade school exercises. See, e.g., HERMAN KAHN, ON THERMONUCLEAR WAR (2d ed, 1961), and SHARON GHAMARI-TABIZI, THE WORLDS OF HERMAN KAHN: THE INTUITIVE SCIENCE OF THERMONUCLEAR WAR (2005).

“Worst case scenarios” are not only popular in emergency preparedness training exercises, but also in more mundane public health problems such as deciding if a particular site for a new post-9/11 research laboratory is safe for the public. Controversy continues, for example, over Boston University’s plan to build a post-9/11 BSL-4 laboratory on the Boston Medical Center campus in the city of Boston. The following is from a Superior Court decision examining the adequacy of an environmental impact report prepared for the laboratory. The report was required by the Massachusetts Environmental Policy Act (G.L. c. 30, secs.61-62H).

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TEN RESIDENTS OF BOSTON v. BOSTON REDEVELOPMENT AUTHORITY Suffolk Sup. Ct., 05-0109-BLS2 (July 31, 2006)

Gants, J.

. . . The Secretary specifically directed that the Final EIR [Environmental Impact Report] address only four issues: (1) “discuss the design features that the biocontainment building will employ to enhance safety,” (2) “document how the facility would meet any applicable state and federal regulations regarding safety of the facility,” (3) “evaluate a ‘worst case’ safety event involving the loss of the physical integrity of the containment systems,” and (4) “address safety considerations related to any transport of potentially hazardous biological agents to and from the Biocontainment facility.” In providing this guidance, the Secretary failed to focus on the difference in risk posed by pathogens which can be spread through the air and may be fatal if inhaled but are not contagious (such as anthrax or, more precisely, its infectious agent—bacillus anthracis), versus those pathogens which are infectious and can be spread through person-to-person contact, such as:

Smallpox, which can be spread by “direct and fairly prolonged face-to-face contact” or “direct contact with infected bodily fluids or contaminated objects, such as bedding or clothing,”

Severe Acute Respiratory Syndrome, known as SARS, which can be spread “through respiratory droplets,”

Ebola hemorrhagic fever, which can be spread “through direct contact with infected blood secretions, organs or semen.”

Since the “worst case safety event” was limited to “the loss of the physical integrity of the containment systems,” University Associates reasonably understood that the focus should be on pathogens that can be spread by airborne inhalation if the ventilation containment system at the BSL-4 laboratory were to fail, and therefore provided the scenario involving the dropped vial of purified anthrax inside the laboratory.

There were two substantial failures in the risk assessment that arose from limiting the “worst case safety event” to a failure of the ventilation containment system. First, no “worst case safety event” was analyzed regarding any release of a contagious disease from the laboratory, even though such a release potentially may occur, not from a complete failure of the ventilation containment system, but simply from a laboratory staff member becoming infected with the infectious pathogen. The risk of such an infection, while small, cannot be characterized as nonexistent.

Appendix 4 of the Final EIR contains two reports prepared by Karl M. Johnson, M.D. on October 15, 2003. The first, entitled “Biosafety at National Institute of Allergy and Infectious Disease: 1982-2003,” examines the number of accidental exposures to infectious agents during this period at BSL-2 and BSL-3 laboratories operated by the National Institute in three locations—Bethesda and Rockville, Maryland, and Hamilton, Montana. Dr. Johnson found one clinical infection, four silent infections, and 24 other

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accidents which did not lead to infections in more than three million hours of working with these organisms. While Dr. Johnson justly concludes that the safety record for these laboratories is “outstanding” and specifically notes that “[n]o agent has escaped from any laboratory to cause infection in adjacent civilian communities,” his report demonstrates that there is a small, but significant, risk of infections and accidental exposures over the life of these facilities. Dr. Johnson’s second report, entitled “Biosafety at BSL-4: More than 20 Years Experience at Three Major Facilities,” examined the number of laboratory accidents at three BSL-4 laboratories—Fort Detrick, Maryland, the CDC laboratory in Atlanta, and a laboratory in Johannesburg, South Africa operated by the South African National Institute for Communicable Diseases. Dr. Johnson found that, at Fort Detrick, in the early years of the laboratory, an unspecified number of “invasive accidents resulted in treatment with human plasma containing specific antibodies to virus in question, as well as confinement in an isolation suite in one building….” Two invasive accidents were of the greatest concern, one in which a staff member’s finger was accidentally punctured with a needle on a syringe loaded with the Lassa virus and another in which a bone fragment of a monkey infected with the Junin virus punctured a staff member’s finger. Fortunately, no infection occurred in either incident. At the CDC facility, various laboratory accidents were identified, none of which resulted in an infection. Among these accidents were: a rodent infected with Hantavirus bit a staff member; a needle pricked a worker who was setting up an inoculation with a mouse-adapted Ebola virus; and “multiple events over the years of outer gloves or suits developing tears or holes detected during work.” At the Johannesburg laboratory, Dr. Johnson learned of a bat bite through double gloves, which did not produce an infection, and “multiple other accidents,” during which “[t]hose exposed are monitored closely for 21 days, during which time they are not permitted to leave town—as are all employees after their last day of work inside BSL-4 space.” No infections were reported from these accidents. Here, too, Dr. Johnson could justly conclude that no clinical infections had occurred at these facilities despite nearly half a million hours of working with these organisms, and that no infectious agent had escaped into a neighboring community. However, Dr. Johnson does not negate the possibility of infection to either laboratory workers or the outside community. Rather, he states, “The zero numerator of infections in these three laboratories and the huge denominator of exposure hours make it impossible to provide a number for ‘risk of infection’ to either laboratory workers or outside communities. Nevertheless, that number must be small.”

Dr. Johnson did not identify any instance of intentional infection by a laboratory employee, such as a laboratory worker who intended to infect himself or a co-worker, or of the intentional removal of a pathogen from the laboratory to commit extortion or provide to a terrorist organization. This risk, too, is surely small but, equally surely, the risk must be recognized to exist. To be sure, the Final EIR observes that background and security checks will be conducted on all employees before being assigned to the Biolab. However, all CIA and FBI agents are subject to background and security checks as well, perhaps more intensive than any contemplated by NIH, but there are at least two documented instances in the past two decades of a CIA agent (Aldrich Ames) and FBI agent (Robert Hanssen) each with compartmentalized top secret clearances, providing classified secrets to the then-Soviet Union that risked (and probably cost) the lives of various confidential informants. If the CIA and FBI, with their expertise in background checks, cannot ensure that none of

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their carefully selected agents will betray their trust, there is no good reason to assume that University Associates need not fear this risk.

* * *

In short, the Final EIR demonstrated that there was a small, but significant, risk of a laboratory accident that could result in the infection of a laboratory worker with a contagious disease, but the Final EIR did not contain any “worst case” scenario that explored the potential consequences of such an accident. Nor did it contain any “worst case” scenario that explored the potential consequences of the release of a contagious pathogen arising from a suicidal, criminal, or terrorist act.

* * *

. . .Any reasonable evaluation of a risk requires an understanding of the probability of the risk occurring over the life of the Project and the magnitude of harm that could arise if it were to occur. From the Final EIR, the agencies could evaluate the probability of an accidental or malevolent release of a contagious pathogen and recognize it to be small, but the Final EIR did not provide any guidance as to the magnitude of harm that could result if that small risk were sadly to occur. Since, as noted earlier, “[a]ny finding required by [Section 61] shall be limited to those matters which are within the scope of the environmental impact report,” G.L. c. 30 §62A, the absence of this information regarding the potential environmental impact meant that it could not be addressed in the Section 61 finding. Even worse, the Final EIR permitted the agencies to act upon the belief that even the “worst case safety event” posed only a negligible risk of public harm. Therefore, the absence of any “worst case” scenario involving the accidental or malevolent release of a contagious disease-causing organism meant that the Final EIR failed to inform the relevant public agencies making financial and permitting decisions regarding the Project of the potential for catastrophic harm posed by the Project. To be sure, the small risk of even catastrophic harm does not suggest that any public agency should kill the Project, especially when, as here, the Project itself will conduct research designed to combat bioterrorism. But it is necessary that a public agency considering such a Project come to grips with the true risks posed by the Project and not be lulled by the Final EIR into ignoring the small possibility of enormous public harm.

* * *

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F. FEDERAL PREPAREDNESS

PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002, Pub. L. No. 107-188.

Title I—NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES

Subtitle A—National Preparedness and Response Planning, Coordinating, and Reporting

“Sec. 2801. NATIONAL PREPAREDNESS PLAN.

“(a) In General.—

“(1) Preparedness and response regarding public health emergencies.—The Secretary shall further develop and implement a coordinated strategy, building upon the core public health capabilities established pursuant to section 319A, for carrying out health-related activities to prepare for and respond effectively to bioterrorism and other public health emergencies, including the preparation of a plan under this section. The Secretary shall periodically thereafter review and, as appropriate, revise the plan.

“(2) National approach.—In carrying out paragraph (1), the Secretary shall collaborate with the States toward the goal of ensuring that the activities of the Secretary regarding bioterrorism and other public health emergencies are coordinated with activities of the States, including local governments.

“(3) Evaluation of progress.—The plan under paragraph (1) shall provide for specific benchmarks and outcome measures for evaluating the progress of the Secretary and the States, including local governments, with respect to the plan under paragraph (1), including progress toward achieving the goals specified in subsection (b).

“(b) Preparedness Goals.—The plan under subsection (a) should include provisions in furtherance of the following:

“(1) Providing effective assistance to State and local governments in the event of bioterrorism or other public health emergency.

“(2) Ensuring that State and local governments have appropriate capacity to detect and respond effectively to such emergencies, including capacities for the following:

“(A) Effective public health surveillance and reporting mechanisms at the State and local levels.

“(B) Appropriate laboratory readiness.

“(C) Properly trained and equipped emergency response, public health, and medical personnel.

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“(D) Health and safety protection of workers responding to such an emergency.

“(E) Public health agencies that are prepared to coordinate health services (including mental health services) during and after such emergencies.

“(F) Participation in communications networks that can effectively disseminate relevant information in a timely and secure manner to appropriate public and private entities and to the public.

“(3) Developing and maintaining medical countermeasures (such as drugs, vaccines and other biological products, medical devices, and other supplies) against biological agents and toxins that may be involved in such emergencies.

“(4) Ensuring coordination and minimizing duplication of Federal, State, and local planning, preparedness, and response activities, including during the investigation of a suspicious disease outbreak or other potential public health emergency.

“(5) Enhancing the readiness of hospitals and other health care facilities to respond effectively to such emergencies.

* * *

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DEPARTMENT OF HOMELAND SECURITY, NATIONAL RESPONSE PLAN (December 2004)

Introduction

The Nation’s domestic incident management landscape changed dramatically following the terrorist attacks of September 11, 2001. Today’s threat environment includes not only the traditional spectrum of manmade and natural hazards—wildland and urban fires, floods, oil spills, hazardous materials releases, transportation accidents, earthquakes, hurricanes, tornadoes, pandemics, and disruptions to the Nation’s energy and information technology infrastructure—but also the deadly and devastating terrorist arsenal of chemical, biological, radiological, nuclear, and high-yield explosive weapons.

These complex and emerging 21st century threats and hazards demand a unified and coordinated national approach to domestic incident management. The National Strategy for Homeland Security; Homeland Security Act of 2002; and Homeland Security Presidential Directive-5 (HSPD-5), Management of Domestic Incidents, establish clear objectives for a concerted national effort to prevent terrorist attacks within the United States; reduce America’s vulnerability to terrorism, major disasters, and other emergencies; and minimize the damage and recover from attacks, major disasters, and other emergencies that occur.

Development and Implementation of a National Response Plan

Achieving these homeland security objectives is a challenge requiring bold steps and adjustments to established structures, processes, and protocols. An important initiative called for in the above documents is the development and implementation of a National Response Plan (NRP), predicated on a new National Incident Management System (NIMS), that aligns the patchwork of Federal special-purpose incident management and emergency response plans into an effective and efficient structure. Together, the NRP and the NIMS integrate the capabilities and resources of various governmental jurisdictions, incident management and emergency response disciplines, nongovernmental organizations (NGOs), and the private sector into a cohesive, coordinated, and seamless national framework for domestic incident management.

The NRP, using the NIMS, is an all-hazards plan that provides the structure and mechanisms for national-level policy and operational coordination for domestic incident management….

* * *Purpose

The purpose of the NRP is to establish a comprehensive, national, all-hazards approach to domestic incident management across a spectrum of activities including prevention, preparedness, response, and recovery.

The NRP incorporates best practices and procedures from various incident management disciplines—homeland security, emergency management, law enforcement, firefighting, hazardous materials response, public works, public health, emergency medical services, and responder and recovery worker health and safety—and integrates them into a unified coordinating structure.

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The NRP provides the framework for Federal interaction with State, local, and tribal governments; the private sector; and NGOs in the context of domestic incident prevention, preparedness, response, and recovery activities. It describes capabilities and resources and establishes responsibilities, operational processes, and protocols to help protect the Nation from terrorist attacks and other natural and manmade hazards; save lives; protect public health, safety, property, and the environment; and reduce adverse psychological consequences and disruptions….

* * *Incidents of National Significance

As the principal Federal official for domestic incident management, the Secretary of Homeland Security declares Incidents of National Significance…and provides coordination for Federal operations and/or resources, establishes reporting requirements, and conducts ongoing communications with Federal, State, local, tribal, private-sector, and nongovernmental organizations to maintain situational awareness, analyze threats, assess national implications of threat and operational response activities, and coordinate threat or incident response activities.

Incident Management Activities

…Examples of incident management actions from a national perspective include:

Increasing nationwide public awareness;

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The NRP bases the definition of Incidents of National Significance on situations related to the following four criteria…:

1. A Federal department or agency acting under its own authority has requested the assistance of the Secretary of Homeland Security.

2. The resources of State and local authorities are overwhelmed and Federal assistance has been requested by the appropriate State and local authorities. Examples include:

Major disasters or emergencies as defined under the Stafford Act; and

Catastrophic incidents3. More than one Federal department or agency has become

substantially involved in responding to an incident. Examples include:

Credible threats, indications or warnings of imminent terrorist attack, or acts of terrorism directed domestically against the people, property, environment, or political or legal institutions of the United States or its territories or possessions; and

Threats or incidents related to high-profile, large-scale events that present high-probability targets such as National Special Security Events (NSSEs) and other special events as determined by the Secretary of Homeland Security, in coordination with other Federal departments and agencies.

4. The Secretary of Homeland Security has been directed to assume responsibility for managing a domestic incident by the President.

Assessing trends that point to potential terrorist activity; Elevating the national Homeland Security Advisory System (HSAS) alert

condition and coordinating protective measures across jurisdictions; Increasing countermeasures such as inspections, surveillance, security,

counterintelligence, and infrastructure protection; Conducting public health surveillance and assessment processes and,

where appropriate, conducting a wide range of prevention measures to include, but not be limited to, immunizations;

Providing immediate and long-term public health and medical response assets;

Coordinating Federal support to State, local, and tribal authorities in the aftermath of an incident;

Providing strategies for coordination of Federal resources required to handle subsequent events;

Restoring public confidence after a terrorist attack; and Enabling immediate recovery activities, as well as addressing long-term

consequences in the impacted area.

GEORGE J. ANNAS,THE STATUE OF SECURITY: HUMAN RIGHTS AND POST-9/11 EPIDEMICS

38 J. Health Law 319 (2005)

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Our enemies are innovative and resourceful, and so are we. They never stop thinking about new ways to harm our country and our people, and neither do we.

President George W. Bush on signing the Defense Appropriations Act, August 5, 2004

Immediately after 9/11 the U.S. government closed the Statue of Liberty to the public. It took almost three years to reopen Liberty Island, just in time for the Republican National Convention. The public can again visit, but little is the same. Those wishing to take the ferry to the island, for example, must submit to airport-like screening, as well as bag checks, including bomb-sniffing dogs, upon arrival. And on the boat trip, the National Park Service has a new recorded “welcome” which asserts that although historically the Statue of Liberty symbolized freedom, it is now “a symbol of America’s freedom, safety, and security.” Similar screening is also required to view the Liberty Bell in Philadelphia. We have not yet renamed the Statue of Liberty, the “Statue of Security”; or the Liberty Bell, the “Safety Bell,” but safety and security have been consistently promoted as at least as important as liberty, and often more important, since 9/11.

The next stop after Liberty Island is Ellis Island, the site of screening for more than 2 million immigrants to America in the early 20th century. The most rigorous part of screening immigrants involved federal uniformed public health service physicians whose main duty was to prevent immigrants with contagious diseases from entering the country. Few federal public health officials other than the Surgeon General any longer where military uniforms, and most public health activities now are done under state or local jurisdiction. But 9/11 has affected public health as well, as public health has been called upon to prepare the nation for a “bioterrorist attack” utilizing lethal disease agents, like smallpox or anthrax. Many public health officials hope that public health can take advantage of the new funding available for terrorism preparedness, and not only do its part in national security, but also make “dual use” of the funding to help it fulfill its core missions of protecting the publics’ health and preparing for “natural” epidemics.

September 11 was an event, not an epidemic, but the U.S. reacted to it as if it portends an actual epidemic of terrorist attacks against us. In this way, September 11 has been viewed by many in the public health community as a signal of a coming pandemic: akin to the rise of SARS in China, or a novel form of bird flu in Asia. (1) And public health has been asked to prepare for both natural and terrorist-induced epidemics simultaneously. Does 9/11 mean we must make fundamental changes in public health practice regarding epidemic control and revert to 19th century Ellis Island-type quarantine and forced treatment? Must we trade off human rights and civil liberties for increased safety and security? These are important and complex questions. In this article I argue that the answer to both of these questions is no, and that the movement in public health toward the adoption of a modern health and human rights ethical framework begun before 9/11 should continue.

Osama bin Laden and his homicidal Qaeda followers present a real danger to Americans, and the US should bring them to justice for their crimes. The U.S. is more vulnerable to terrorist attacks than we had believed; and we should strengthen our defenses. But we should not undermine our lives and our values by overreacting to the threat of terrorism. Preserving a human rights framework in the war on terrorists both preserves core American values, and

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makes it more likely that we will prevail in the long run. Ignoring or marginalizing human and constitutional rights, and treating Americans themselves as suspects or actual enemies is counterproductive and dangerous in itself—a conclusion I will support in this article with specific post-9/ll examples, such as public health preparedness plans for mass smallpox vaccination, the experiences of public health in the SARS epidemic, the enactment of new state public health vaccination and quarantine laws, and the use of torture on terrorist suspects and prisoners of war. Public health professionals are the “good guys” and rightly want to protect the publics’ health. But the world has changed since the early 19th century, and reliance on coercion rather than education is no longer either legally justifiable or likely to be effective. In this regard, what might be labeled “public health fundamentalism,” is as dangerous to the health and safety of Americans as Islamic religious fundamentalism.

The language of human rights also has the great advantage of being universal and thus global. Neither the fight against terrorists, nor the fight against epidemics, can be successfully waged on a local, state, or even national level alone: both can easily cross national boundaries and both can only be effectively confronted by a global, cooperative, strategy. “Safety first” is a good thought, as is the Hippocratic injunction, “first, do no harm”; but neither safety nor inaction are ends in themselves, but only means to promote health and human rights. Sacrificing human rights for safety is almost never necessary and almost always counterproductive in a free society. Benjamin Franklin went further in expressing an American thought from “the land of the free and the home of the brave,” saying, “Those who would give up an essential liberty to purchase temporary security deserve neither liberty nor security.” ***

Bioterrorism

In the immediate aftermath of 9/11 it was easy for human rights advocates and civil libertarians to despair. Congress almost immediately passed the Orwellian-named USA Patriot Act, and authorized an international (and 1984-like perpetual) global war on terror, and the Bush Administration also announced that it would disregard not only the United Nations but also fundamental international human rights and humanitarian law as expressed in the Geneva Conventions.

More recently, however, the tide seems to be changing, and many governmental actions are now met with considerable skepticism and even active resistance. The color-coded terrorist warning system has been all but abandoned as too vague to do any more than scare the public. A proposal to enlist mail carriers and TV repair persons as “tipsters” (the so-called “tips” program) has been abandoned. Duct tape and plastic sheeting remain punch lines in jokes about personal protection from chemical and biological agents.

We continue to be bombarded with bioterrrorism doomsday scenarios, although the major terrorist threats are not from biological agents. Rather they are from conventional weapons (e.g., firearms and bombs—including “dirty bombs,” conventional explosives containing radioactive material), delivered either in trucks or by individual suicide bombers, as evidenced by terrorist activities in Israel for decades, by insurgent attacks in Iraq, and by terrorists worldwide. These create panic, but the most dangerous weapons are not chemical or biological, but nuclear. Our government knows this. Although there were many inconsistent rationales given for going to war with Iraq, no one suggested it was because they possessed chemical or biological weapons: we have known about these weapons for more than two decades, and Iraq has actually used their chemical weapons on both civilian and military

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targets. It was the future prospect of possessing nuclear weapons that ultimately moved us to war.

Bioterrorism, nonetheless, continues to be hyped beyond all scientific or historic reality, even in the public health community which should know better. A leading public health lawyer, for example, has asserted that “a single gram of crystalline botulinum toxin, evenly disperse and inhaled, could kill more than 1 million people.” But, when looking at actual data, that same lawyer admits that in fact, when Aum Shinrikyo, the Japanese terrorist cult, actually “attempted to disperse aerosolized botulinum toxin both in Tokyo and at several military installations in Japan” the result was not millions dead, or even thousands or hundreds: rather all of these attacks “failed to kill anyone.” Likewise, it has been asserted that the release of 100 kilograms of aerosolized anthrax over Washington, D.C. could kill up to three million people. The real anthrax attacks through the U.S. mails were highly effective in sowing terror in the populations, but resulted in only 5 deaths (the number killed in American hospitals by negligence every 30 minutes, or on our nation’s highways every hour).

The scariest scenario involves smallpox because, unlike botulinum or anthrax, smallpox can be transmitted from one person to another. This is why the Bush administration used the threat of a smallpox attack from Iraq as one reason for us to fear Iraq, and as the almost sole justification for its massive three-phase smallpox vaccination program. That now-abandoned program was a public policy and public relations disaster, vaccinating only about 4,000 of the initially-proposed 500,000 health care workers the government planned to have vaccinated with the smallpox vaccine during phase one (phase two would have encompassed up to 10 million first responders and public safety personnel, and phase three would have included all willing civilians). I think the major reason is that the administration failed to persuade physicians and nurses that the known risks of serious side effects with the vaccine were justified given the fact that there is no evidence that Iraq (or anyone else) has both smallpox virus and the wish to use it in a terrorist attack. The information provided on this issue to the physicians and nurses was in the same spirit as the Iraq nuclear threat information, except that it contained no facts at all, not even misleading or phony ones. ***

Bioterrorism and Epidemics

But what about a “real” epidemic, such as a new, worldwide pandemic? A repeat of the 1918 flu epidemic is likely at some point, and could prove devastating. We can and should produce vaccines against the annual flu epidemics. Our new emphasis on bioterrorism, however, has actually drained public health resources away from this effective vaccine. As the World Health Organization warned in late-2004, we need much better planning, and international cooperation, to prepare for an influenza pandemic. Instead we are diverting funds away from this traditional public health concern which involves tens of thousands of deaths a year in the U.S. alone, and a predictable worldwide pandemic at some point, to trying to protect against an extremely unlikely bioterrorist attack. And it is here that we can determine whether or not “dual use” is a reality or just a marketing slogan. I agree with those who say that public health infrastructure generally must be improved for the sake of the nation’s health. But where I disagree is on what effect bioterrorism preparation will actually have on public health infrastructure.

I wrongly and naively (it turns out) expected the federal government to provide increased funding for public health in the wake of 9/11. There has been some funding for bioterrorism, but mostly public health departments have

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been struggling with more unfunded federal mandates and suggestions, and have had to actually divert funds from public health programs we know work to save lives and improve health, to bioterrorism preparation which has little or no public health payoff.

My own state of Massachusetts, for example, always a national leader in public health, has made major cuts in tobacco control, domestic violence prevention, and immunizations against pneumonia and hepatitis A and B. Public health dollars have shrunken $30 million in two years, during which time Massachusetts has received $21 million for bioterrorism-related activities, some of which could be categorized as “dual-use.” Public health expert David Ozonoff of the Boston University School of Public Health accurately describes what is happening: “The whole bioterrorism initiative and what it’s doing to public health is a cancer, it’s hollowing out public health from within…This is a catastrophe for American public health.” This was dramatically demonstrated nationally in the fall of 2004 when the U.S. experienced a shortage of flu vaccine and was forced to ration it to Americans most at risk of death and hospitalization from the flu. Cartoonist Matt Davies caught the irony in his cartoon picturing a citizen coming to the door of the “Homeland Security Bio-Terror Readiness Unit” only to be greeted by a note pinned to the door reading, “Out with the Flu.”

Other public health experts have put the weakening of public health in even most disturbing terms, noting “Worse, in response to bioterrorism preparedness, public health institutions are being reorganized along a military or police model that subverts the relationships between public health providers and the communities they serve.” To the extent that these experts are correct, and I think they are, exaggerated fear of bioterrorism is resulting in overreaction that is already counterproductive in that it is harming both public health’s effectiveness and its relationship with the communities public health serves.

Exaggerated risks produce extreme responses that are based more on fear than facts, so it is not surprisingly that they have unintended consequences. Public health planning should be based on science not free-floating anxiety and fear. Instead of using the tools of public health, especially epidemiology to gather data and risk-assessment, to identify most likely risks and work on them, our government seems to have adopted the bizarre notion that all threats are equal and that all states and localities should equally prepare for all of them. This philosophy has produced two interrelated epidemics in the U.S. today: an epidemic of fear, and an epidemic of security screening.

In the midst of concern over bioterrorism, but after the SARS epidemic, the New York Academy of Medicine did a survey of the American public asking how they would respond to two types of terrorist attacks: smallpox and a dirty bomb. Published in September 2004, the surveys results support two lessons that were apparent on 9/11: (1) the primary concern Americans have in a crisis is the safety of their family members; and (2) the most important predictor of whether they will follow the advice of public officials is if they trust them to be telling the truth and to be guided by their welfare. Specifically, the survey found that only 40% of Americans would go to a vaccination site in a smallpox outbreak if told to do so, and only 60% would shelter in place for as long as they were told to in the event of a dirty bomb explosion.

The reasons given for not following advice are instructive. In the smallpox scenario, 60% had worries about the safety of the vaccine itself—twice as many who worried about getting smallpox themselves. The respondents also suggested ways to make them more likely to cooperate. For smallpox, overwhelming majorities (94% and 88%) wanted to speak with someone who knew a lot about smallpox and who they trusted to want what was best for them. A

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physician not working for the government would fit the bill. In the dirty bomb case, the primary concern respondents had was the safety of their family members. 75% of those who would not shelter in place said they would do so if they could communicate with people they care about or if they knew they were safe. Overall the study concluded that “people are more likely to follow official instructions when they have a lot of trust in what officials tell them to do and are confident that their community is prepared to meet their needs if a terrorist attack occurs.”

These survey results are consistent with past bioterrorist exercises as well. As Senator Sam Nunn, who played the part of the president in the smallpox exercise, Dark Winter, in which mass quarantine failed: “There is no force on earth that can make Americans do something that they do not believe is in their own best interests and that of their families.”

Given the data from real world events, public opinion surveys, and mock exercises, it is quite remarkable that some public health officials are still at home with draconian 19th century quarantine and compulsory treatment methods. This is likely because public health officials, who believe all their actions are designed to protect the public, are much more concerned with false positives (failing to treat of detain someone who actually has a communicable disease) than with false negatives (detaining someone who actually does not have a communicable disease), and believe that brute force can effectively control the behavior of Americans in an epidemic or bioterrorist attack. To the extent this faith in coercion remains alive in the public health community, it is predictable that public health officials with the power to arbitrarily quarantine large numbers of people in an emergency will use it immediately, whether it is warranted or not. From their perspective, protecting public health is more important than protecting liberty, and as public health officials they may really believe they have nothing to lose. But abuse of power will predictably destroy public trust and instill panic. Even totalitarian dictatorships like China cannot control their populations in epidemics by fear alone in the 21st century.

It cannot be emphasized enough that the primary goal and purpose of public health is prevention of disease in the first place. In the case of bioterrorism, this means prevention of the attack is much more important (to public health) than responding to it after the fact. And contemporary public health prevention of epidemics and bioterrorism is not primarily a local or state issue at all, but is fundamentally a global security issue that must be dealt with by the community of nations working together. National laws and treaties, with realistic inspection and sanctions, devoted to preventing the development and production of biological weapons are the most important tool in the prevention of bioterrorism. We are also right to want to modernize the World Health Organization’s International Health Regulations: but, as WHO recognizes, to be effective revised regulations must be founded on respecting and protecting human rights, not trampling them.

State laws, no matter what they say, and no matter what the CDC says, simply cannot prevent or control bioterrorism. Moreover, by seeming to grant unconstitutional power over citizens lives and liberty, bad state public health emergency laws undermine public trust and are thus a danger to public health itself. Florida’s crude summary of CDC’s-sponsored “model act” which seeks to trade off human rights for safety and security, provides the country’s starkest example, and thus helps illustrate why honoring rather than destroying human rights is essential to effective public health action in the 21st century. *** [for material from this article on the U.S. reaction to SARS, and the Florida statute based on the model act, see Chapter 3]

Conclusion

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At the outset of the 21st century bioterrorism, although only one threat to public health, can be the catalyst to effectively federalize and integrate much of what is now uncoordinated and piecemeal state and local public health programs. This should include a renewed effort for national health insurance, national licensure for physicians, nurses, and allied health professionals, and national patient safety standards. Federal public health leadership will also encourage us to look outward, and to recognize that prevention of future bioterrorist attacks and even ordinary epidemics will require international cooperation. As the SARS epidemic illustrates, it is time to not only federalize public health, but to globalize it as well. And universal human rights is the proper foundation for a global public health ethic. Our new kind of war against bioterrorism should be built on a goal of protecting liberty, not depriving Americans of it. There is a knee jerk tendency in times of war and national emergencies to restrict civil liberties as the most effective way to counteract the threat. But history has taught us that such restrictions are almost always useless and often counterproductive, and we usually wind up with deep regrets for our action. The tendency to return to the days before liberty and informed consent were taken seriously has been evident both in the immediate aftermath of 9/1l. Arbitrary and unlawful responses have not, however, helped make Americans safer or more secure, instead they threaten the very liberties that make our country worth protecting. It is wrong and dangerous for our government to treat its citizens either as enemies to be controlled by force or children to be pacified with platitudes. America is strong because its people are free, and to be both moral and effective public planning for war and public health emergencies must be based on respecting freedom and trusting our fellow citizens. The United States should lead the world in proclaiming a new, global public health, based on transparency, trust, and science, and most importantly, based on respect for human rights. We don’t need a new Statue of Security: the Statue of Liberty is just fine.

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Notes and Questions

1. The National Plan has defined roles for state and local officials as well:

Police, fire, public health and medical, emergency management, public works, environmental response, and other personnel are often the first to arrive and the last to leave an incident site. In some instances, a Federal agency in the local area may act as a first responder, and the local assets of Federal agencies may be used to advise or assist local officials in accordance with agency authorities and procedures. Mutual aid agreements provide mechanisms to mobilize and employ resources from neighboring jurisdictions to support the incident command.

When State resources and capabilities are overwhelmed, Governors may request Federal assistance under a Presidential disaster or emergency declaration. Summarized below are the responsibilities of the Governor, Local Chief Executive Officer, and Tribal Chief Executive Officer.

Governor

As a State’s chief executive, the Governor is responsible for the public safety and welfare of the people of that State or territory. The Governor:

Is responsible for coordinating State resources to address the full spectrum of actions to prevent, prepare for, respond to, and recover from incidents in an all-hazards context to include terrorism, natural disasters, accidents, and other contingencies;

Under certain emergency conditions, typically has police powers to make, amend, and rescind orders and regulations;

Provides leadership and plays a key role in communicating to the public and in helping people, businesses, and organizations cope with the consequences of any type of declared emergency within State jurisdiction;

Encourages participation in mutual aid and implements authorities for the State to enter into mutual agreements with other States, tribes, and territories to facilitate resource-sharing;

Is the Commander-in-Chief of State military forces...; and Requests Federal assistance when it becomes clear that State or tribal

capabilities will be insufficient or have been exceeded or exhausted.

Local Chief Executive Officer

A mayor or city or county manager, as a jurisdiction’s chief executive, is responsible for the public safety and welfare of the people of that jurisdiction. The Local Chief Executive Officer:

Is responsible for coordinating local resources to address the full spectrum of actions to prevent, prepare for, respond to, and recover from incidents involving all hazards including terrorism, natural disasters, accidents, and other contingencies;

Dependent upon State and local law, has extraordinary powers to suspend local laws and ordinances, such as to establish a curfew, direct evacuations, and, in coordination with the local health authority, to order a quarantine;

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Provides leadership and plays a key role in communicating to the public, and in helping people, businesses, and organizations cope with the consequences of any type of domestic incident within the jurisdiction;

Negotiates and enters into mutual aid agreements with other jurisdictions to facilitate resource-sharing; and

Requests State and, if necessary, Federal assistance through the Governor of the State when the jurisdiction’s capabilities have been exceeded or exhausted.

2. The post-9/11 approach has been an “all-hazards” one. What are the pros and cons to this type of “one-size fits all” planning? Is it really true, as President Bush has said, that planning for a pandemic flu will build our capacity to respond to a chemical attack?

3. President Eisenhower, when he was commanding general in Europe, is credited with observing before the D-Day invasion: “It’s not the plan, it’s the planning.” Explain. In March, 1942, Winston Churchill observed, “One cannot always provide against the worse assumptions, and to try to do so prevents the best disposition of limited resources.” What did these leaders mean and are these observations from World War II relevant today?

4. The most notorious example of a complete failure of the national preparedness plan was the response to Hurricane Katrina. This despite the fact that only a year earlier the agencies responsible for responding to a hurricane/flood in New Orleans had participated in a simulation of just such a catastrophe, called “Hurricane Pam.” Under new rules that existed at the time, the Department of Homeland Security was to be the lead agency, but it did not get involved until days after the flooding. On the day the levees broke, Secretary Chertoff traveled to Atlanta to take part in exercises designed to get the country ready for an avian flu pandemic. Almost a year later Chertoff announced the Department’s new plan, which was that:

People should be prepared to sustain themselves for up to72 hours after a disaster—because first responders mightnot be able to reach every single person within the first day.that means individuals—especially those in the Gulf states—need to have an emergency plan and an emergency kit with adequate supplied of food, water, and other essential like a flashlight, first-aid, and medicine.

In the words of Christopher Cooper and Robert Block, who quote this speech from Chertoff to conclude their study of Katrina, DISASTER: HURRICANE KATRINA AND THE FAILURE OF HOMELAND SECURITY (2006), “In the end Chertoff unwittingly defined the most important lesson of all to emerge from Hurricane Katrina: When disaster strikes, we are all on our own.” Id. at 306. On the actual response of local, state and federal officials during the week after Katrina struck see DOUGLAS BRINKLEY, THE GREAT DELUGE: HURRICANE KATRINA, NEW ORLEANS, AND THE MISSISSIPPI GULF COAST (2006).

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RICHARD HORTON, PUBLIC HEALTH: A NEGLECTED COUNTERTERRORIST MEASURE

358 Lancet 1112 (2001)

The war against terrorism, announced by President Bush and endorsed by western political leaders in the immediate aftermath of the Sept. 11 assault on America, will fail. No matter how much international collaboration is achieved between governments, intelligence services, and police networks, terrorists will never be wholly eradicated from society. Such is the nature of terrorism. A declaration of war, deemed necessary to reassure an anxious public, has raised false expectations of victory. The western response will not only come to be discredited but also may foster the very terrorist activity it is designed to prevent.

Paul Pillar, a former counterterrorism policymaker at the US Central Intelligence Agency, has studied American covert and foreign-policy approaches to terrorist threats. …He argues that war metaphors…drive “a tendency toward absolute solutions and a rejection of accommodation and finesse.” He views traditional counterterrorist policies—diplomatic, legal, military, and economic—as ineffective and counterproductive. The best home we have, he concludes, is not triumph, but containment. Terrorism is a problem managed, never solved.

In response to the present crisis there has been a curious failure to discuss the root causes of terrorism, except for some rather blunt criticism of America itself. Action so far has been confined to three fronts. First, the capabilities of terrorist groups have been targeted. Their organization is being disrupted, their members sought. Second, the intentions of terrorists have been scrutinized. A capability to attack might well be available, but what makes the terrorist decide to act? Encouraging terrorists not to attack involves deterrence and diplomacy. The third front is occupying most political airtime right now—namely, defence. Airport and aircraft security, homeland protection, and military force are all important defensive instruments. None of these efforts gets close to the cause of the problem.

* * *No single counterterrorist measure will succeed alone. But the existing

narrow range of options could be broadened to find ways of engaging and helping rather than punishing populations at risk.

* * *Afghanistan has been the victim of two decades of savage exploitation by

several of those countries now urging a war against terrorism. The hypocrisy of these governments is breathtaking, the consequences predictable and tragic.

In addition to the welcome promises of aid by western powers, there must be three longer-term revisions of policy. First, foreign-policy goals should incorporate health, development, and human rights as key strategic objectives. Too often, foreign policy is reduced to little more than short-term alliances for political or military advantage. These limited goals sow the seeds for later terrorist—and humanitarian—crises.

Second, the application of sanctions must be judged more wisely. In Afghanistan, UN sanctions were aimed at forcing the Taliban government to hand over Osama bin Laden. The health effects have been crushing, while the political objective has failed entirely. Third, western powers must recommit

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themselves to international agencies, such as the UN, and to international treaties, such as those on criminal justice and the environment. . .

The discipline of public health therefore adds fresh perspectives on foreign policy and counterterrorism measures. Principles of harm reduction are more realistic and practicable than false notions of a war on terrorism. Attacking hunger, disease, poverty, and social exclusion might do more good than air marshals, asylum restrictions, and identity cards. Global security will be achieved only by building stable and strong societies. Health is an undervalued measure of our global security.

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Notes and Questions

1. Horton makes a strong case in his editorial. Is he correct about the importance of public health to combat terrorism? Former UN Commissioner for Human Rights, Mary Robinson, has argued that our world is continually becoming less secure because of the increase in global public health problems. She quotes from the 2004 HUMAN DEVELOPMENT REPORT from the United Nations:

More than 800 million people suffer from undernourish-ment. Some 100 million children who should be in schoolare not, 60 million of them girls. More than a billionpeople survive on less than one dollar a day.. And about 900 million people belong to ethnic, religious, racialor linguistic groups that face discrimination... Anunprecedented number of countries saw development slide backwards in the 1990s. In 46 countries people are poorer today than in 1990. In 25 countries more people go hungry today than a decade ago. Id. at 129.

Robinson goes on to note that in the last six year approximately 25,000 people have died from terrorist attacks. During that same time period, approximately 25,000 people die each day from hunger, malaria, and other preventable diseases. Mary Robinson, Connecting Human Rights, Human Development, and Human Security, in HUMAN RIGHTS AND THE ‘WAR ON TERROR’ 311 (Richard Ashly Wilson, ed., 2005).

2. Economist Amartya Sen, cited by Robinson, has also directly linked health, especially public health, to freedom and economic development. For example, in his DEVELOPMENT AS FREEDOM 4(1999) he writes:

Sometimes the lack of substantive freedoms relatesdirectly to economic poverty, which robs people of the freedom to satisfy hunger, or to achieve sufficientnutrition, or to obtain remedies for treatableillnesses, or the opportunity to be adequatelyclothed and sheltered, or to enjoy clean water orsanitary facilities. In other cases, the unfreedomlinks closely to the lack of public facilities and social care, such as the absence of epidemiologicalprograms, or of organized arrangements for healthcare or educational facilities.. .

See also on the relationship between health and development, THE WORLD BANK, WORLD DEVELOPMENT REPORT 1993: INVESTING IN HEALTH (1993).

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G. GLOBAL HEALTH

SOFIA GRUSKIN & DANIEL TARANTOLA, HEALTH AND HUMAN RIGHTS, PERSPECTIVES ON HEALTH AND HUMAN RIGHTS

(Gruskin et al., eds., 2004) 3-57.

Since the creation of the United Nations over 50 years ago, international responsibility for health and for human rights has been increasingly acknowledged. Yet the actual links between health and human rights had not been recognized even a decade ago. Generally thought to be fundamentally antagonistic, these two worlds had evolved along parallel but distinctly separate tracks until a number of recent events helped to bring them together.

Conceptually one can point to the HIV/AIDS pandemic, to women’s health issues, including violence, and to the blatant violations of human rights which occurred in such places as the Balkans and the Great Lakes region in Africa as having brought attention to the intrinsic connections that exist between health and human rights. Each of these issues helped to illustrate distinct, but linked, pieces of the health and human rights paradigm. While the relationship between health and human rights with respect to these and similar issues may always have made sense intuitively, the development of a ‘health and human rights’ language in the last few years has allowed for the connections between health and human rights to be explicitly named, and therefore for conceptual, analytical, policy, and programmatic work to begin to bridge these disparate disciplines and to move forward. In the last few years human rights have increasingly been at the centre of analysis and action in regard to health and development issues. The level of institutional and state political commitment to health and human rights has, in fact, never been higher. This is true within the work of the United Nations system but, even more importantly, can also be seen in the work of governments and non-governmental organizations at both the national and international level.

The importance of the HIV/AIDS pandemic as a catalyst for beginning to define some of the structural connections between health and human rights cannot be overemphasized. The first time that human rights were explicitly named in a public health strategy was only in the late 1980s, when the call for human rights and for compassion and solidarity with people living with HIV/AIDS was embodied in the first World Health Organization (WHO) global response to AIDS. This approach was motivated by moral outrage but also, even more importantly, by the recognition that protecting the human rights of people living with HIV/AIDS was a necessary element of the worldwide public health response to the emerging epidemics. The implications of this call were far reaching. Framing this public health strategy in human rights terms—although initially focused on the rights of people living with HIV/AIDS rather than on the broad array of human rights influencing people’s vulnerability to the epidemic—allowed it to become anchored in international law, thereby making governments and intergovernmental organizations publicly accountable for their actions towards people living with HIV/AIDS. The groundbreaking contribution of this era lies in the recognition of the applicability of international law to HIV/AIDS issues and in the attention this approach then generated to the links between other health issues and human rights—and

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therefore to the ultimate responsibility and accountability of the state under international law for issues relating to health and well being.

* * *While human rights thinking and practice has a long history, the

importance of human rights for governmental action and accountability was first widely recognized only after the Second World War. Agreement between nation-states that all people are ‘born free and equal in dignity and rights’ was reached in 1945 when the promotion of human rights was identified as a principal purpose of the newly created United Nations. The United Nations Charter established general obligations that apply to all its member states, including respect for human rights and dignity. Then, in 1948, the Universal Declaration of Human Rights was adopted as a common standard of achievement for all peoples and nations. The basic characteristics of human rights are that they are the rights of individuals, which inhere in individuals because they are human, that they apply to people everywhere in the world, and that they are principally concerned with the relationship between the individual and the state. In practical terms, international human rights law is about defining what governments can do to us, cannot do to us, and should do for us. For example, governments obviously should not do things like torture people, imprison them arbitrarily, or invade their privacy. Governments should ensure that all people in a society have shelter, food, medical care, and basic education.

The Universal Declaration of Human Rights can well be understood to be the cornerstone of the modern human rights movement. The preamble to the Universal Declaration of Human Rights proposes that human rights and dignity are self-evident, the ‘highest aspiration of the common people,’ and the ‘foundation of freedom, justice and peace.’ ‘Social progress and better standards of life’ including the ‘prevention of barbarous acts which have outraged the conscience of mankind,’ and, broadly speaking, individual and collective well being, are understood to depend on the ‘promotion of universal respect for and observance of human rights.’ Although the Universal Declaration of Human Rights is not a legally binding document, nations have endowed it with a tremendous legitimacy through their actions, including invoking it legally and politically at the national and international levels. Portions of the Universal Declaration of Human Rights are cited in the majority of national and international levels. Portions of the Universal Declaration of the Human Rights are cited in the majority of national constitutions drafted since it came into being, and governments often cite the Universal Declaration of Human Rights in their negotiations with other governments, as well as in their accusations against each other of violating human rights. Under the auspices of the United Nations, more than 20 multilateral human rights treaties have been formulated since the adoption of the Universal Declaration of Human Rights. These treaties create legally binding obligations on the nations that have ratified them, thereby giving them the status and power of international law. …The rights that form the corpus of human rights law are found in the international human rights documents. While it is possible to identify different categories of rights, it is also critical to rights discourse and action to recognize that all rights are interdependent and interrelated, and that individuals rarely suffer neglect or violation of a particular right in isolation. …

* * *

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Health and government responsibility for health is codified in these documents in several ways. The right to the highest attainable standard of health appears in one form or another in most of them. More importantly, nearly every article of every document can be understood to have clear implications for health. While the rights to information, education, housing, and safe working conditions, and social security, for example, are particularly relevant to the health and human rights relationship, specific reference must be made to three rights: the right to non-discrimination, the right to the benefits of scientific progress, and the right to health.

* * *

Governments are responsible not only for not directly violating rights, but also for ensuring the conditions which enable individuals to realize their rights as fully as possible. This is understood as an obligation to respect, protect, and fulfill rights, and governments are legally responsible for complying with this range of obligations for every right in every human rights document they have ratified.

Governmental obligations towards ensuring the right to health are summarized below as an illustration of the range of issues relevant to respecting, protecting, and fulfilling human rights.

1. Respecting the right means that a state cannot violate the right directly. A government violates its responsibility to respect the right to health when it is immediately responsible for providing medical care to certain populations, such as prisoners or the military, and it arbitrarily decides to withhold that care.

2. Protecting the right means that a state has to prevent violations of rights by non-state actors and offer some sort of redress that people know about and can access if a violation occurs. This means that the state would be responsible for making it illegal to deny insurance or health care to people on the basis of a health condition, and that they would be responsible for ensuring safety nets and some system of redress that people know about and can access if a violation does occur.

3. Fulfilling the right means that a state has to take all appropriate measures—including but not limited to legislative, administrative, budgetary, and judicial—toward fulfillment of the right, including to promote the right in question. A state could be found to be in violation of the right to health if it failed to allocate sufficient resources incrementally to meet the public health needs of all the communities within its borders.

In all countries, resource and other constraints can make it impossible for a government to fulfill all rights immediately and completely. The human rights machinery recognizes this and acknowledges that, in practical terms, a commitment to the right to health requires more than just passing a law. It will require financial resources, trained personnel, facilities, and, more than anything else, a sustainable infrastructure. Therefore, realization of rights is generally understood to be a matter of progressive realization of making steady progress toward a goal. The principle of ‘progressive realization’ is fundamental to the achievement of human rights. This is critical for resource-poor countries that are responsible for striving towards human rights goals to the maximum extent possible. It is also of relevance to wealthier countries in that they are responsible for respecting, protecting, and fulfilling human rights not only within their own borders, but through their engagement in international assistance and cooperation.

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* * *In spite of the importance attached to human rights, there are

situations where it is considered legitimate to restrict rights in order to achieve a broader public good. As described in the International Covenant on Civil and Political Rights, the public good can take precedence to ‘secure due recognition and respect for the rights and freedoms of others; meet the just requirements of morality, public order, and the general welfare; and in times of emergency, when there are threats to the vital interests of the nation’ (ICCPR Article 4). Public health is one such recognized public good. (The specific power of the state to restrict rights in the name of public health can be understood to be derived from Article 12(c) of the ICESCR, which gives governments the right to take the steps they deem necessary for the ‘prevention, treatment, and control of epidemic, endemic, occupational, and other diseases.’) Traditional public health measures have generally focused on curbing the spread of disease by imposing restrictions on the rights of those already infected or thought to be most vulnerable to becoming infected. In fact, coercion, compulsion, and restriction have historically been significant components of public health measures. Although the restrictions on rights that have occurred in the context of public health have generally had as their first concern protection of the public’s health, it is also true that the measures taken have often been excessive. Interference with freedom of movement when instituting quarantine or isolation for a serious communicable disease—for example, Ebola fever, syphilis, typhoid, or untreated tuberculosis—is an example of a restriction on rights that may in certain circumstances be necessary for the public good and therefore could be considered legitimate under international human rights law. Conversely, arbitrary measures taken by public health authorities that fail to consider other valid alternatives may be found to be abusive of both human rights principles and public health ‘best practice.’ In recent times, measures taken around the world in response to HIV/AIDS provides some examples of this type of abuse.

Certain rights are absolute, which means that restrictions may never be placed on them, even if justified as necessary for the public good. These include such rights as the right to be free from torture, slavery, or servitude, the right to a fair trial, and the right to freedom of thought. (See, for example, Article for of the ICCPR, which states that ‘[n]o derogation from articles 6, 7, 8 (paragraphs 1 and 2), 11, 15, 16, 18 may be made under this provision.’) Paradoxically, the right to life, which might at first glance appear to be inalienable, is not absolute; what is forbidden is the arbitrary deprivation of life. Interference with most rights can be legitimately justified as necessary under narrowly defined circumstances in many situations relevant to public health. (See, for example, Article 4 of the ICCPR, which states that ‘[I]n time of public emergency which threatens the life of the nation and the existence of which is officially proclaimed, the States Parties to the present Covenant may take measures derogating from their obligations under the present Covenant to the extent strictly required by the exigencies of the situation, provided that such measures are not inconsistent with their other obligations under international law and do not involve discrimination solely on the ground of race, color, sex, language, religion, or social origin.’)

Limitations on rights, however, are considered a serious issue under international human rights law, regardless of the apparent importance of the public good involved. When a government limits the exercise or enjoyment of a right, this action must be taken as a last resort and will only be considered legitimate if the following criteria are met.

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1. The restriction is provided for and carried out in accordance with the law;

2. The restriction is in the Interest of a legitimate objective of general interest;

3. The restriction is strictly necessary in a democratic society to achieve the objective;

4. There are no less intrusive and restrictive means available to reach the same goal; and

5. The restriction is not imposed arbitrarily, i.e., in an unreasonable or otherwise discriminatory manner.

This approach, often called the Siracusa Principles because they were conceptualized at a meeting in Siracusa, Italy, has long been recognized by those concerned with human rights monitoring and implementation as relevant to analyzing a government’s actions, and it has also recently begun to be considered a useful tool by those responsible within government for health-related policies and programs. This framework, although still rudimentary, may be helpful in identifying public health actions that are abusive, whether intentionally or unintentionally.

At the outset of the twenty-first century, the translation of the right to health into guidelines and other tools useful to national and international monitoring of governmental and intergovernmental obligations is still in its infancy. The ICESCR General Comment on the Right to the Highest Attainable Standard of Health, which was adopted in 2000, may help to provide some useful guidelines. In parallel, as described below, the WHO is developing a new set of tools and recommendations aimed at redirecting the attention given to monitoring global health indicators from disease-specific morbidity and mortality trends towards others that are more reflective of the degree to which health and human rights principles are respected, protected, and fulfilled. How and to what extent these instruments will be put to use and how effective they will be in advancing the health and human rights agenda has yet to be seen, but there are several factors that, even at this early stage, allow for guarded optimism. First, the treaty bodies and international organizations concerned with health are doing this work based on open dialogue and a degree of collaboration that greatly exceeds the level and quality if interagency collaboration traditionally observed within the United Nations machinery. This is exemplified by the sharing of goals and the collective technical co-operation that has prevailed in the current processes of defining obligations and monitoring methods and standards relevant to health and human rights in the process of operationalizing both the international treaties and the recommendations promulgated at the international conferences. Potentially, this work will help not only to monitor what governments are doing, but also to build their capacity to incorporate health and human rights principles into their policies and programs.

In several countries, including Brazil, Thailand, and South Africa, human rights principles relevant to health have recently found their way into national legislation and new constitutions, thereby ensuring citizens the right to seek fulfillment of their right to care, for example, through national juridical means.

* * *

Over 50 years ago, the Constitution of the WHO projected a vision of health as a state of complete physical, mental, and social well being—a

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definition of health that is more relevant today than ever. It recognized that the enjoyment of the highest attainable standard of health was one of the fundamental rights of every human being and that governments have a responsibility for the health of their peoples, which can be fulfilled only through the provision of adequate health and social measures. The 1978 Alma-Ata Declaration called on nations to endure the availability of the essentials of primary health care, including:

Education concerning health problems and the methods for preventing and controlling them

Promotion of food supply and proper nutrition An adequate supply of safe water and basic sanitation Maternal and child health care, including family planning Immunization against major infectious diseases Prevention and control of locally endemic diseases Appropriate treatment of common disease and injuries Provision of essential drugs.

In 1998, the World Health Assembly reaffirmed the commitment of nations to strive towards these goals in a World Health Declaration that stressed the ‘will to promote health by addressing the basic determinants and prerequisites for health’ and the urgent priority ‘to pay the greatest attention to those most in need, burdened by ill health, receiving inadequate services for health or affected by poverty.’…

WHO [has attempted] to measure health on the national or international level selectively [using] morbidity, mortality, and disability indicators. This exercise was severely constrained by incomplete national data, differences in measurement methods across countries, and, even more importantly, an inability to relate health outcomes to the performance of health systems. Furthermore, most of these indicators were applied at a national aggregate level with insufficient attempts to disaggregate the data collected to reveal the disparities that exist within nations. It has been understood that measurement indicators and benchmarks that focus on the aggregate (national) level may not reveal important differentials that may be associated with a variety of human rights violations—in particular, discrimination.

In order to improve the knowledge and understanding of health status and trends, and to relate these trends to health system performance, the WHO…developed the following five global indicators [in 2000].

1. Healthy life expectancy: a composite indicator incorporating mortality, morbidity, and disability in a disability-adjusted life years measure. This indicator will reflect time spent in a state of less than full health.

2. Health inequalities: the degree of disparity in healthy life expectancy within the population.

3. Responsiveness of health systems: a composite indicator reflecting the protection of dignity and confidentiality in and by health systems, and people’s autonomy (that is, their individual capacity to effect informed choice in health matters).

4. Responsiveness inequality: the disparity in responsiveness within health systems, bringing out issues of low efficiency, neglect, and discrimination.

5. Fairness in financing: measured by the level of health financing contribution of households.

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The WHO has stated that it will collect this data through built-in health information systems, demographic and health surveys conducted periodically within countries, and other survey instruments. Data will thus be analyzable by sex, age, race/birth (if warranted under national law), population groups (for example, indigenous populations), educational achievement, and other variables.

The WHO has also expressed its commitment to working with countries toward increasing their capacity to collect this information and also to determine additional data and targets that may be specifically suited to country-specific situations and needs. The WHO and other institutions concerned with health have stated their desire to use thee data to assess trends in the performance of national health systems, inform national and international policies and programs, make comparisons across countries, and monitor global health.

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Who Is WHO?

The World Health Organization (WHO) was established in 1948 under the auspices of the United Nations. The United Nations Charter and the WHO Constitution grant WHO the authority to monitor world health. The WHO Constitution allows WHO to address various public health issues by adopting conventions, agreements, and regulations through its supreme decision-making body, the World Health Assembly (Health Assembly). Any member of the United Nations may become a member of WHO by accepting its Constitution. Membership is available to other countries by application, if approval is given by a majority vote of the Health Assembly. There are currently 192 WHO member countries. Each WHO member sends a delegation to meetings of the Health Assembly, typically held in Geneva in May of each year. A 32-member Executive Board meets in January to set the agenda for the upcoming meeting. The Secretariat of WHO is responsible for implementation. The Secretariat has a staff of approximately 3500 at its Geneva headquarters, in six regional offices, and in specific countries. Its head is the Director-General, who is appointed by the Health Assembly on the nomination of the Executive Board.

Articles 19-22 of the WHO Constitution delineate the specific areas of authority of the Health Assembly. Article 21 empowers the Health Assembly to adopt regulations in areas including sanitary and quarantine requirements and other procedures designed to prevent the international spread of disease; nomenclature with respect to diseases; causes of death and public health practices; and standards for diagnostic procedures. After notice of adoption is given, regulations come into force for all member countries, with the caveat that the notice of adoption will specify a period for members to reject or register reservations with the Director-General. The member countries are bound by a set of regulations, and any reservations are typically listed in annexes to the official text.

The control of infectious diseases is one of the areas in which international law has been developed and implemented by WHO. These efforts have culminated in the body of regulations referred to as the International Health Regulations (IHRs). The precursors of today's IHRs were adopted in 1951 as the International Sanitary Regulations . . . and were given their current name in 1969. The IHRs have been modified twice since their enactment, in 1973 and in 1981. The IHRs are intended to maximize security against the global spread of disease while minimizing interference with global movement.

The IHRs require member countries to notify WHO of all cases of certain infectious diseases in humans. Currently [as of 2003], the list of notifiable diseases is limited to cholera, plague, and yellow fever. The IHRs also provide health-related rules for travel and commerce; require health documentation of those traveling from infected to non-infected places; require other travel documentation, such as maritime declaration of health; and establish guidelines for de-ratting, disinfecting, and adopting other hygiene measures related to travel and commerce. The IHRs not only mandate certain public health activities, they also set limits on the measures member countries may take to protect public health, especially if these impede international traffic For example, with respect to quarantine, the IHRs allow for surveillance or isolation of infected persons only for the duration of the incubation period based on the date of last exposure or arrival.

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For many years, there has been debate on the need to revise and strengthen the IHRs to reflect the current concerns about the rapidity with which infectious disease can spread under contemporary social conditions as well as the emergence of new and dormant infections. The SARS outbreak has given a new impetus to the effort needed to update provisions and standards related to reporting and controlling infectious disease on a global level.. .

The Department of Communicable Disease Surveillance and Response (CSR) at WHO houses its global alert and response activities. The mission of CSR is to provide support for global health security and epidemic alert and response. . . . The IHRs provide the basic framework for CSR and are the only set of binding. international legal rules on infectious disease control. . . .

The Global Outbreak Alert and Response Network (GOARN) was established by WHO in 2000 with the assistance of the Canadian government. GOARN is a collaboration of institutions and networks around the world that provides coordination and logistical support in the form of standardized protocols, agreed standards, procedures for alert and verifications process, communications, coordination of response, specialist equipment, medical supplies, emergency evacuation, research, evaluation, and relations with media. It is supported administratively by the office of Alert and Response Operations within CSR. Through GOARN, WHO and partners aim to enhance the coordinated delivery of international assistance in support of local efforts; strengthen local infrastructure and capacity to reduce illness, death, and prevent disease spread. . . .

. . . GOARN functions under guiding principles developed through international consensus with the IHRs as the overarching framework. . . . Although GOARN has played a central role in keeping the global community informed and updated as to changes and progress regarding SARS, its effectiveness has been limited by the voluntary nature of countries reporting beyond the three notifiable diseases under the IHRs. . . .

WHO maintains a number of specific mechanisms that assist member countries in detecting, responding to, and sharing information about disease outbreaks. The Global Public Health Intelligence Network is an electronic system that continuously searches websites, newswires and media sites, public health e-mail services, national government websites, public health institutions, non-governmental organizations, and specialized discussion groups to identify information regarding epidemic threats and rumors. . . . Support for effective response to threats comes from Global Alert and Response Teams, which draw on the expertise of personnel from WHO country offices, WHO regional response teams, alert and response operation center teams, and disease specialists. . . . The Outbreak Verification List is a weekly electronic report of confirmed and unconfirmed reports of outbreaks of international public health importance. . . . The Disease Outbreak News is a web-based system providing public information about officially confirmed outbreaks of international importance.

From MARK A. ROTHSTEIN, et al., QUARANTINE AND ISOLATION: LESSONS LEARNED FROM SARS 27-32 (2003).

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UNIVERSAL DECLARATION OF HUMAN RIGHTS (1948)

Whereas recognition of the inherent dignity and of the equal and inalienable rights of all members of the human family is the foundation of freedom, justice and peace in the world,

Whereas disregard and contempt for human rights have resulted in barbarous acts which have outraged the conscience of mankind, and the advent of a world in which human beings shall enjoy freedom of speech and belief and freedom from fear and want has been proclaimed as the highest aspiration of the common people,

Whereas it is essential, if man is not to be compelled to have recourse, as a last resort, to rebellion against tyranny and oppression, that human rights should be protected by the rule of law,

Whereas it is essential to promote the development of friendly relations between nations, Whereas the peoples of the United Nations have in the Charter reaffirmed their faith in fundamental human rights, in the dignity and worth of the human person and in the equal rights of men and women and have determined to promote social progress and better standards of life in larger freedom,

Whereas Member States have pledged themselves to achieve, in co-operation with the United Nations, the promotion of universal respect for and observance of human rights and fundamental freedoms,

Whereas a common understanding of these rights and freedoms is of the greatest importance for the full realization of this pledge,

Now, Therefore THE GENERAL ASSEMBLY proclaims THIS UNIVERSAL DECLARATION OF HUMAN RIGHTS as a common standard of achievement for all peoples and all nations, to the end that every individual and every organ of society, keeping this Declaration constantly in mind, shall strive by teaching and education to promote respect for these rights and freedoms and by progressive measures, national and international, to secure their universal and effective recognition and observance, both among the peoples of Member States themselves and among the peoples of territories under their jurisdiction.

Article 1.

All human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood.

Article 2.

Everyone is entitled to all the rights and freedoms set forth in this Declaration, without distinction of any kind, such as race, colour, sex, language, religion, political or other opinion, national or social origin,

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property, birth or other status. Furthermore, no distinction shall be made on the basis of the political, jurisdictional or international status of the country or territory to which a person belongs, whether it be independent, trust, non-self-governing or under any other limitation of sovereignty.

Article 3.

Everyone has the right to life, liberty and security of person.

Article 4.

No one shall be held in slavery or servitude; slavery and the slave trade shall be prohibited in all their forms.

Article 5.

No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment.

Article 6.

Everyone has the right to recognition everywhere as a person before the law.

Article 7.

All are equal before the law and are entitled without any discrimination to equal protection of the law. All are entitled to equal protection against any discrimination in violation of this Declaration and against any incitement to such discrimination.

Article 8.

Everyone has the right to an effective remedy by the competent national tribunals for acts violating the fundamental rights granted him by the constitution or by law.

Article 9.

No one shall be subjected to arbitrary arrest, detention or exile.

Article 10.

Everyone is entitled in full equality to a fair and public hearing by an independent and impartial tribunal, in the determination of his rights and obligations and of any criminal charge against him.

Article 11.

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(1) Everyone charged with a penal offence has the right to be presumed innocent until proved guilty according to law in a public trial at which he has had all the guarantees necessary for his defense.

(2) No one shall be held guilty of any penal offence on account of any act or omission which did not constitute a penal offence, under national or international law, at the time when it was committed. Nor shall a heavier penalty be imposed than the one that was applicable at the time the penal offence was committed.

Article 12.

No one shall be subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honour and reputation. Everyone has the right to the protection of the law against such interference or attacks.

Article 13.

(1) Everyone has the right to freedom of movement and residence within the borders of each state.

(2) Everyone has the right to leave any country, including his own, and to return to his country.

Article 14.

(1) Everyone has the right to seek and to enjoy in other countries asylum from persecution.

(2) This right may not be invoked in the case of prosecutions genuinely arising from non-political crimes or from acts contrary to the purposes and principles of the United Nations.

Article 15.

(1) Everyone has the right to a nationality.

(2) No one shall be arbitrarily deprived of his nationality nor denied the right to change his nationality.

Article 16.

(1) Men and women of full age, without any limitation due to race, nationality or religion, have the right to marry and to found a family. They are entitled to equal rights as to marriage, during marriage and at its dissolution.

(2) Marriage shall be entered into only with the free and full consent of the intending spouses.

(3) The family is the natural and fundamental group unit of society and is entitled to protection by society and the State.

Article 17.

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(1) Everyone has the right to own property alone as well as in association with others.

(2) No one shall be arbitrarily deprived of his property.

Article 18.

Everyone has the right to freedom of thought, conscience and religion; this right includes freedom to change his religion or belief, and freedom, either alone or in community with others and in public or private, to manifest his religion or belief in teaching, practice, worship and observance.

Article 19.

Everyone has the right to freedom of opinion and expression; this right includes freedom to hold opinions without interference and to seek, receive and impart information and ideas through any media and regardless of frontiers.

Article 20.

(1) Everyone has the right to freedom of peaceful assembly and association.

(2) No one may be compelled to belong to an association.

Article 21.

(1) Everyone has the right to take part in the government of his country, directly or through freely chosen representatives.

(2) Everyone has the right of equal access to public service in his country.

(3) The will of the people shall be the basis of the authority of government; this will shall be expressed in periodic and genuine elections which shall be by universal and equal suffrage and shall be held by secret vote or by equivalent free voting procedures.

Article 22.

Everyone, as a member of society, has the right to social security and is entitled to realization, through national effort and international co-operation and in accordance with the organization and resources of each State, of the economic, social and cultural rights indispensable for his dignity and the free development of his personality.

Article 23.

(1) Everyone has the right to work, to free choice of employment, to just and favorable conditions of work and to protection against unemployment.

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(2) Everyone, without any discrimination, has the right to equal pay for equal work.

(3) Everyone who works has the right to just and favorable remuneration ensuring for himself and his family an existence worthy of human dignity, and supplemented, if necessary, by other means of social protection.

(4) Everyone has the right to form and to join trade unions for the protection of his interests.

Article 24.

Everyone has the right to rest and leisure, including reasonable limitation of working hours and periodic holidays with pay.

Article 25.

(1) Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.

(2) Motherhood and childhood are entitled to special care and assistance. All children, whether born in or out of wedlock, shall enjoy the same social protection.

Article 26.

(1) Everyone has the right to education. Education shall be free, at least in the elementary and fundamental stages. Elementary education shall be compulsory. Technical and professional education shall be made generally available and higher education shall be equally accessible to all on the basis of merit.

(2) Education shall be directed to the full development of the human personality and to the strengthening of respect for human rights and fundamental freedoms. It shall promote understanding, tolerance and friendship among all nations, racial or religious groups, and shall further the activities of the United Nations for the maintenance of peace.

(3) Parents have a prior right to choose the kind of education that shall be given to their children.

Article 27.

(1) Everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits.

(2) Everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.

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Article 28.

Everyone is entitled to a social and international order in which the rights and freedoms set forth in this Declaration can be fully realized.

Article 29.

(1) Everyone has duties to the community in which alone the free and full development of his personality is possible.

(2) In the exercise of his rights and freedoms, everyone shall be subject only to such limitations as are determined by law solely for the purpose of securing due recognition and respect for the rights and freedoms of others and of meeting the just requirements of morality, public order and the general welfare in a democratic society.

(3) These rights and freedoms may in no case be exercised contrary to the purposes and principles of the United Nations.

Article 30.

Nothing in this Declaration may be interpreted as implying for any State, group or person any right to engage in any activity or to perform any act aimed at the destruction of any of the rights and freedoms set forth herein.

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INTERNATIONAL COVENANT ON CIVIL AND POLITICAL RIGHTS (1966)

Article 1:

1. All peoples have the right of self-determination. . .

Article 4:

1. In time of public emergency which threatens the life of the nation and the existence of which is officially proclaimed, the States Parties to the present Covenant may take measures derogating from their obligations under the present Covenant to the extent strictly required by the exigencies of the situation, provided that such measures are not inconsistent with their other obligations under international law and do not involve discrimination solely on the ground of race, colour, sex, language, religion or social origin.

2. No derogation from articles 6, 7, 8 (paragraphs 1 and 2), 11, 15, 16 and 18 may be made under this provision.

3. Any State Party to the present Covenant availing itself of the right of derogation shall immediately inform the other States Parties to the present Covenant, through the intermediary of the Secretary-General of the United Nations, of the provisions from which it has derogated and of the reasons by which it was actuated. . .

Article 6:

1. Every human being has the inherent right to life. This right shall be protected by law. No one shall be arbitrarily deprived of his life. . .

Article 7:

No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation.

Article 8:

1. No one shall be held in slavery; slavery and the slave-trade in all their forms shall be prohibited.

2. No one shall be held in servitude. . .

Article 11:

No one shall be imprisoned merely on the ground of inability to fulfill a contractual obligation.

Article 15:

No one shall be held guilty of any criminal offence on account of any act or omission which did not constitute a criminal offence, under national or international law, at the time when it was committed. . .

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Article 16:

Everyone shall have the right to recognition everywhere as a person before the law.

Article 18:

Everyone shall have the right to freedom of thought, conscience, and religion. . .

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INTERNATIONAL COVENANT ON ECONOMIC, SOCIAL, AND CULTURAL RIGHTS (1966)

Article 2:

1. Each State Party to the present Covenant undertakes to take steps, individually and through international assistance and co-operation, especially economic and technical, to the maximum of its available resources, with a view to achieving progressively the full realization of the rights recognized in the present Covenant by all appropriate means, including particularly the adoption of legislative measures. . .

Article 11:

1. The States Parties to the present Covenant recognize the right of everyone to an adequate standard of living for himself and his family, including adequate food, clothing and housing, and to the continuous improvement of living conditions. . .

Article 12:

1. The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

2. The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for:

(a) The provision for the reduction of the stillbirth-rate and of infant mortality and for the healthy development of the child;

(b) The improvement of all aspects of environmental and industrial hygiene;

(c) The prevention, treatment and control of epidemic, endemic, occupational and other diseases;

(d) The creation of conditions which would assure to all medical service and medical attention in the event of sickness.

Article 13:

1. The States Parties to the present Covenant recognize the right of everyone to education. . .

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Notes and Questions

1. The United Nations was formed at the end of World War II as a permanent peace-keeping organization. The charter of the United Nations, signed by the 50 original member nations in San Francisco on June 26, 1945, spells out the organization’s goals. The first two goals are “to save succeeding generations from the scourge of war…and to reaffirm faith in fundamental human rights, in the dignity and worth of the human person, in the equal rights of men and women and of nations large and small. After the charter was signed, the adoption of an international bill of rights with legal authority proceeded in three steps: a declaration, a treaty-based covenant, and implementation measures.

2. The Universal Declaration of Human Rights was adopted by the United Nations General Assembly in 1948, with 48 member states voting in favor of adoption and 8 (Saudi Arabia, South Africa, and the Soviet Union together with 5 other countries whose votes it controlled) abstaining. The declaration was adopted as a “common standard for all people and nations.” As Steiner notes, “No other document has so caught the historical moment, achieved the same moral and rhetorical force, or exerted so much influence on the human rights movement as a whole.” The rights enumerated in the declaration “stem from the cardinal axiom that all human beings are born free and equal, in dignity and rights, and are endowed with reason and conscience. All the rights and freedoms belong to everybody.” These points are spelled out in Articles 1 and 2. Nondiscrimination is the overarching principle. Article 7, for example, is explicit: “All are equal before the law and are entitled without any discrimination to equal protection of the law.” Other articles prohibit slavery, torture, and arbitrary detention and protect freedom of expression, assembly, and religion, the right to own property, and the right to work and receive an education. Of special importance to health care professionals is Article 25, which states, in part, “Everyone has the right to a standard of living adequate for the health and well-being of himself and his family, including food, clothing, housing, and medical care and necessary social services.”

Human rights are primarily rights individuals have in relation to governments. Human rights require governments to refrain from doing certain things, such as torturing persons or limiting freedom of religion, and also require that they take actions to make people’s lives better, such as providing education and nutrition programs. The United Nations adopted the Universal Declaration of Human Rights as a statement of aspirations. The legal obligations of governments were to derive from formal treaties that member nations would individually sign and incorporate into domestic law. On the development of the UDHR see MARY ANN GLENDON, A WORLD MADE NEW: ELEANOR ROOSEVELT AND THE UNIVERSAL DECLARATION OF HUMAN RIGHTS (2002).

2. Because of the cold war, with its conflicting ideologies, it took almost 20 years to reach an agreement on the texts of the two human-rights treaties. On December 16, 1966, both the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social, and Cultural Rights were adopted by the General Assembly and offered for signature and ratification by the member nations. The United States ratified the International Covenant on Civil and Political Rights in 1992, but not surprisingly, given our capitalist economic system with its emphasis on

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private property, we have yet to act on the International Covenant on Economic, Social, and Cultural Rights. The division of human rights into two separate treaties illustrates the tension between liberal states founded on civil and political rights and socialist and communist welfare states founded on solidarity and the government’s obligation to meet basic economic and social needs.

The rights spelled out in the International Covenant on Civil and Political Rights include equality, the right to liberty and security of person, and freedom of movement, religion, expression, and association. The International Covenant on Economic, Social, and Cultural Rights focuses on well-being, including the right to work, the right to receive fair wages, the right to make a decent living, the right to work under safe and healthy conditions, the right to be free from hunger, the right to education, and “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.”

Given the horrors of poverty, disease, and civil wars over the past 50 years, it is easy to dismiss the rights enunciated in these documents as empty gestures. Indeed, Amnesty International, in marking the 50th anniversary of the Universal Declaration of Human Rights, labeled the rights it articulates “little more than a paper promise” for most people in the world. It is certainly true that unadulterated celebration is not in order, but as Kunz noted almost 60 years ago in writing about the birth of the declaration, “In the field of human rights as in other actual problems of international law it is necessary to avoid the Scylla of a pessimistic cynicism and the Charybdis of mere wishful thinking and superficial optimism.” Joseph L. Kunz, The United Nations Declaration of Human Rights, 43 AM. J. INT. LAW 316, 321 (1949).

3. The right to health has been given more precise definition in a report of the Committee on Economic, Social, and Cultural Rights, the treaty entity formed to help implement the International Covenant on Economic, Social, and Cultural Rights. The document is known as General Comment No. 14 and was issued in 2000. Among its most important provisions are the following:

Health is a fundamental human right indispensable for the exercise of other human rights…

4. ...the right to health embraces a wide range of socio-economic factors that promote conditions in which people can lead a healthy life, and extends to the underlying determinants of health, such as food and nutrition, housing, access to safe and potable water and adequate sanitation, safe and healthy working conditions, and a healthy environment.

8. The right to health is not to be understood as a right to be healthy. The right to health contains both freedoms and entitlements. The freedoms include the right to control one's health and body, including sexual and reproductive freedom, and the right to be free from interference, such as the right to be free from torture, non-consensual medical treatment and experimentation. By contrast, the entitlements include the right to a system of health protection which provides equality of opportunity for people to enjoy the highest attainable level of health.

11. …the right to health…[is] an inclusive right extending not only to timely and appropriate health care but also to the underlying

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determinants of health, such as access to safe and potable water and adequate sanitation, an adequate supply of safe food, nutrition and housing, healthy occupational and environmental conditions, and access to health-related education and information, including on sexual and reproductive health…

12. The right to health in all its forms and at all levels contains the following interrelated and essential elements, the precise application of which will depend on the conditions prevailing in a particular State party:

(a) Availability. Functioning public health and health-care facilities, goods and services, as well as programs, have to be available…

(b) Accessibility. Health facilities, goods and services have to be accessible to everyone without discrimination…physical accessibility…economic accessibility (affordability)…information accessibility…

(c) Acceptability… All health facilities, goods and services must

be respectful of medical ethics and culturally appropriate…

(d) Quality… must also be scientifically and medically appropriate and of good quality. This requires, inter alia, skilled medical personnel, scientifically approved and unexpired drugs and hospital equipment, safe and potable water, and adequate sanitation.

17. The right to health facilities…[includes] the provision of…equal and timely access to basic preventive, curative, rehabilitative health services and health education; regular screening programs; appropriate treatment of prevalent diseases, illnesses, injuries and disabilities, preferably at community level; the provision of essential drugs; and appropriate mental health treatment and care…

33. The right to health, like all human rights, imposes three types or levels of obligations on States parties: the obligations to respect, protect and fulfill.

34. States are under the obligation to respect the right to health by, inter alia, refraining from denying or limiting equal access for all persons, including prisoners or detainees, minorities, asylum seekers and illegal immigrants, to preventive, curative and palliative health services; abstaining from enforcing discriminatory practices as a State policy; and abstaining from imposing discriminatory practices relating to women's health status and needs…

35. Obligations to protect include, inter alia, the duties of States to adopt legislation or to take other measures ensuring equal access to health care and health-related services provided by third parties; to ensure that privatization of the health sector does not constitute a threat to the availability, accessibility, acceptability and quality of health facilities, goods and services; to control the marketing of medical equipment and medicines by third parties; and to ensure that medical practitioners and other health professionals meet appropriate standards of education, skill and ethical codes of conduct…

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36. The obligation to fulfill requires States parties, inter alia, to give sufficient recognition to the right to health in the national political and legal systems, preferably by way of legislative implementation, and to adopt a national health policy with a detailed plan for realizing the right to health. States must ensure provision of health care, including immunization programs against the major infectious diseases, and ensure equal access for all to the underlying determinants of health, such as nutritiously safe food and potable drinking water, basic sanitation and adequate housing and living conditions. Public health infrastructures should provide for sexual and reproductive health services, including safe motherhood, particularly in rural areas…

43. . . .core obligations [minimum essential level of the right] include at least the following obligations:

(a) To ensure the right of access to health facilities, goods and services on a nondiscriminatory basis, especially for vulnerable or marginalized groups;

(b) To ensure access to the minimum essential food which is nutritionally adequate and safe, to ensure freedom from hunger to everyone;

(c) To ensure access to basic shelter, housing, and sanitation, and an adequate supply of safe and potable water;

(d) To provide essential drugs, as from time to time defined under the WHO Action Program on Essential Drugs;

(e) To ensure equitable distribution of all health facilities, goods and services;

(f) To adopt and implement a national public health strategy and plan of action, on the basis of epidemiological evidence, addressing the health concerns of the whole population; the strategy and plan of action shall be devised, and periodically reviewed, on the basis of a participatory and transparent process; they shall include methods, such as right to health indicators and benchmarks, by which progress can be closely monitored; the process by which the strategy and plan of action are devised, as well as their content, shall give particular attention to all vulnerable or marginalized groups.

47. . . .a State party cannot, under any circumstances whatsoever, justify its noncompliance with the core obligations set out in paragraph 43, which are non-derogable.

4. World War II, arguably the first truly global war, led many nations to acknowledge the universality of human rights and the responsibility of governments to promote them. Jonathan Mann perceptively noted that the AIDS epidemic can be viewed as the first global epidemic, because it is taking place at a time when all countries are linked both electronically and by easy transportation. Like World War II, this tragedy requires us to think in new ways and to develop effective methods to prevent and treat disease

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on a global level. Globalization is a mercantile and ecologic fact; it is also a reality in health care. The challenge facing medicine and health care is to develop a global language and strategy to improve the health of all the world’s citizens.

Clinical medicine is practiced one patient at a time. The language of medical ethics is the language of self-determination and beneficence: doing what is in the best interests of the patient with the patient’s informed consent. This language is powerful, but often has little application in countries where physicians are scarce and medical resources very limited.

Public health deals with populations and prevention of disease—the necessary frame of reference in the global context. In the context of clinical practice, the treatment of human immunodeficiency virus infection with a combination of antiviral medicines makes sense. In the context of worldwide public health, however, such treatment may be available to less than 5 percent of people with AIDS. To control AIDS, it has become necessary to deal directly with discrimination, immigration status, and access to health care. It is clear that population-based prevention is required to address the AIDS epidemic effectively on a global level (as well as, for example, tuberculosis, malaria, and tobacco-related illness). Nonetheless, it has been much harder to articulate a global public health ethic. The field of public health itself has had an extraordinarily difficult time developing its own ethical language. This problem of language has two basic causes: the incredibly large array of factors that influence health at the population level, and the emphasis by contemporary public health professionals on individualism and market forces rather than on the collective responsibility for social welfare. Because of its universality and its emphasis on equality and dignity, the language of human rights is well suited to public health.

On the 50th anniversary of the Universal Declaration of Human Rights, George Annas, following the lead of Jonathan Mann, the father of the “health and human rights” field, suggested that the declaration itself sets forth the ethics of public health, since its goal is to provide the conditions under which people can flourish. This is also the goal of public health. The unification of public health and human-rights efforts throughout the world could be a powerful force to improve the lives of every person. George J. Annas, The Universal Declaration of Human Rights at 50, 339 NEW ENG. J. MED 1778-1781 (1998).

5. The “Siracusa Principles” describe the conditions under which emergency powers can be used by the state to limit human rights. U.N., ECONOMIC AND SOCIAL COUNCIL, SUB-COMMISSION ON PREVENTION OF DISCRIMINATION AND PROTECTION OF MINORITIES, SIRACUSA PRINCIPLES ON THE LIMITATION AND DEROGATION OF PROVISIONS IN THE INTERNATIONAL COVENANT ON CIVIL AND POLITICAL RIGHTS, U.N. Doc. E/CN4/1984/4, Annex (1984):

LIMITATION CLAUSES

A.  General Interpretative Principles Relating to the Justification of Limitations

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1. No limitations or grounds for applying them to rights guaranteed by the Covenant are permitted other than those contained in the terms of the Covenant itself.

2. The scope of a limitation referred to in the Covenant shall not be interpreted so as to jeopardize the essence of the right concerned.

3. All limitation clauses shall be interpreted strictly and in favor of the rights at issue.

All limitations shall be interpreted in the light and context of the particular right concerned.

* * *

9.      No limitation on a right recognized by the Covenant shall discriminate contrary to Article 2, paragraph 1.

10.  Whenever a limitation is required in the terms of the Covenant to be "necessary," this term implies that the limitation:

(a)    is based on one of the grounds justifying limitations recognized by the relevant article of the Covenant,

(b)   responds to a pressing public or social need,

(c)    pursues a legitimate aim, and

(d)   is proportionate to that aim.

Any assessment as to the necessity of a limitation shall be made on objective considerations.

11.  In applying a limitation, a state shall use no more restrictive means than are required for the achievement of the purpose of the limitation.

12.  The burden of justifying a limitation upon a right guaranteed under the Covenant lies with the state.

B. Interpretative Principles Relating to Specific Limitation Clauses…

iv. “public health”

25.  Public health may be invoked as a ground for limiting certain rights in order to allow a state to take measures dealing with a serious threat to the health of the population or individual members of the population. These measures must be specifically aimed at preventing disease or injury or providing care for the sick and injured.

26.  Due regard shall be had to the international health regulations of the World Health Organization.

6. International Health Regulations, promulgated by the WHO, have always been problematic because the WHO itself is founded on the theory that each state party retains its complete sovereignty. As noted in chapter 3 in the discussion on SARS, this can be a major problem if a country wants to prevent an investigation of an outbreak by WHO because it is worried about things like trade and tourism. After the SARS epidemic, the International Health Regulations were amended in 2005, and take effect June 15, 2007. WORLD HEALTH ORG., APPLICATION OF THE INTERNATIONAL HEALTH

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REGULATIONS (2005), http://www.who.int/gb/ebwha/pdf_files/WHA59_2-en.pdf (last visited Aug. 2006). See, e.g., Lawrence Gostin, International Infectious Disease Law: Revision of the World Health Organization’s International Health Regulations, 291 JAMA 2623 (2004) The new regulations are designed, among other things, to encourage the development of more effective public health surveillance methods and to encourage information sharing, especially for “potential public health emergencies of international concern” defined as “an extraordinary event which is determined, as provided in these regulations, (i) to constitute a public health threat to other States through the international spread of disease, and (ii) to potentially require a coordinated response.” Other provisions include:

Article 5, Surveillance

Each State Party shall develop, strengthen and maintain, as soon as possible but not later than five years from the entry into force of these Regulations for that State Party, the capacity to detect, assess, notify and report events in accordance with these Regulations, as specified in Annex 1 [of the regulations].

Article 6, Notification

1. Each State Party shall assess events occurring within its territory by using the decision instrument in Annex 2. Each State Party shall notify WHO, by the most efficient means of communication available, by way of the National IHR Focal Point, and within 24 hours of assessment of public health information, of all events which may constitute a public health emergency of international concern, within its territory in accordance with the decision instrument, as well as any health measure implemented in response to those events. ..

2. Following a notification, a State Party shall continue to communicate to WHO timely, accurate and sufficiently detailed public health information available to it on the notified event, where possible including case definitions, laboratory results, source and type of the risk, number of cases and deaths, conditions affecting the spread of the disease and the health measures employed; and report, when necessary, the difficulties faced and support needed in responding to the potential public health emergency of international concern.

7. There are also treaties that apply directly to bioterrorism and biowarfare, the most important of which is the 1972 Biological and Toxin Weapons Convention. Article I sets forth its basic operative language:

Each State Party to this Convention undertakes never in anycircumstance to develop, produce, stockpile or otherwise acquireor retain:

(1) Microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic,Protective or other peaceful purposes;

(2) Weapons, equipment or means of delivery designed to use

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such agents or toxins for hostile purposes or in armed conflict.

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MINISTER OF HEALTH v. TREATMENT ACTION CAMPAIGN South Africa Constitutional Court,

2002(10) BCLR 1033(CC)

The HIV/AIDS pandemic in South Africa has been described as "an

incomprehensible calamity" and "the most important challenge facing South Africa since the birth of our new democracy" and government's fight against "this scourge" as "a top priority". It "has claimed millions of lives, inflicting pain and grief, causing fear and uncertainty, and threatening the economy". These are not the words of alarmists but are taken from a Department of Health publication in 2000 and a ministerial foreword to an earlier departmental publication.

This appeal is directed at reversing orders made in a High Court against government because of perceived shortcomings in its response to an aspect of the HIV/AIDS challenge. The court found that government had not reasonably addressed the need to reduce the risk of HIV-positive mothers transmitting the disease to their babies at birth. More specifically the finding was that government had acted unreasonably in (a) refusing to make an antiretroviral drug called Nevirapine available in the public health sector where the attending doctor considered it medically indicated, and (b) not setting out a timeframe for a national program to prevent mother-to-child transmission of HIV.

The case started as an application in the High Court in Pretoria on 21 August 2001. The applicants were a number of associations and members of civil society concerned with the treatment of people with HIV/AIDS and with the prevention of new infections. In this judgment they are referred to collectively as "the applicants". The principal actor among them was the Treatment Action Campaign (TAC). The respondents were the national Minister of Health and the respective members of the executive councils (MECs) responsible for health in all provinces save the Western Cape. They are referred to collectively as "the government" or "government".

Government, as part of a formidable array of responses to the pandemic, devised a program to deal with mother-to-child transmission of HIV at birth and identified Nevirapine as its drug of choice for this purpose. The program imposes restrictions on the availability of Nevirapine in the public health sector. This is where the first of two main issues in the case arose. The applicants contended that these restrictions are unreasonable when measured against the Constitution, which commands the State and all its organs to give effect to the rights guaranteed by the Bill of Rights. This duty is put thus by sections 7(2) and 8(1) of the Constitution respectively: "7(2)The State must respect, protect, promote and fulfill the rights in the Bill of Rights.. . . 8(1)The Bill of Rights applies to all law, and binds the legislature, the executive, the judiciary and all organs of State." At issue here is the right given to everyone to have access to public health care services and the right of children to be afforded special protection. These rights are expressed in the following terms in the Bill of Rights:

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"27(1)Everyone has the right to have access to - (a)health care services, including reproductive health care;. . . (2)The State must take reasonable legislative and other measures, within its available resources, to achieve the progressive realization of each of these rights. . . 28(1) Every child has the right -. . . (c) to basic nutrition, shelter, basic health care services and social services."

The second main issue also arises out of the provisions of sections 27 and 28 of the Constitution. It is whether government is constitutionally obliged and had to be ordered forthwith to plan and implement an effective, comprehensive and progressive program for the prevention of mother-to-child transmission of HIV throughout the country. ***

The State is obliged to take reasonable measures progressively to eliminate or reduce the large areas of severe deprivation that afflict our society. The courts will guarantee that the democratic processes are protected so as to ensure accountability, responsiveness and openness, as the Constitution requires in section 1. As the Bill of Rights indicates, their function in respect of socio-economic rights is directed towards ensuring that legislative and other measures taken by the State are reasonable. As this Court said in Grootboom, "[i]t is necessary to recognize that a wide range of possible measures could be adopted by the State to meet its obligations …” As was said in Soobramoney: "The State has to manage its limited resources in order to address all these claims. There will be times when this requires it to adopt a holistic approach to the larger needs of society rather than to focus on the specific needs of particular individuals within society."

Courts are ill-suited to adjudicate upon issues where court orders could have multiple social and economic consequences for the community. The Constitution contemplates rather a restrained and focused role for the courts, namely, to require the State to take measures to meet its constitutional obligations and to subject the reasonableness of these measures to evaluation. Such determinations of reasonableness may in fact have budgetary implications, but are not in themselves directed at rearranging budgets. In this way the judicial, legislative and executive functions achieve appropriate constitutional balance.

We therefore conclude that section 27(1) of the Constitution does not give rise to a self-standing and independent positive right enforceable irrespective of the considerations mentioned in section 27(2). Sections 27(1) and 27(2) must be read together as defining the scope of the positive rights that everyone has and the corresponding obligations on the State to "respect, protect, promote and fulfill" such rights. The rights conferred by sections 26(1) and 27(1) are to have "access" to the services that the State is obliged to provide in terms of sections 26(2) and 27(2).***

It is the applicants' case that the measures adopted by government to provide access to health care services to HIV-positive pregnant women were deficient in two material respects: first, because they prohibited the administration of Nevirapine at public hospitals and clinics outside the

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research and training sites; and second, because they failed to implement a comprehensive program for the prevention of mother-to-child transmission of HIV.*** The applicants' contentions raise two questions, namely, is the policy of confining the supply of Nevirapine reasonable in the circumstances; and does government have a comprehensive policy for the prevention of mother-to-child transmission of HIV.

In deciding on the policy to confine Nevirapine to the research and

training sites, the cost of the drug itself was not a factor*** In substance four reasons were advanced in the affidavits for confining the administration of Nevirapine to the research and training sites. First, concern was expressed about the efficacy of Nevirapine where the "comprehensive package" is not available. *** Secondly, there was a concern that the administration of Nevirapine to the mother and her child might lead to the development of resistance to the efficacy of Nevirapine and related antiretrovirals in later years. Thirdly, there was a perceived safety issue. Nevirapine is a potent drug and it is not known what hazards may attach to its use. Finally, there was the question whether the public health system has the capacity to provide the package. It was contended on behalf of government that Nevirapine should be administered only with the "full package" and that it was not reasonably possible to do this on a comprehensive basis because of the lack of trained counselors and counseling facilities and also budgetary constraints which precluded such a comprehensive scheme being implemented.

We deal with each of these issues in turn. First, the concern about efficacy. It is clear from the evidence that the provision of Nevirapine will save the lives of a significant number of infants even if it is administered without the full package and support services that are available at the research and training sites. Mother-to-child transmission of HIV can take place during pregnancy, at birth and as a result of breastfeeding.*** the wealth of scientific material produced by both sides makes plain that sero-conversion of HIV takes place in some, but not all, cases and that Nevirapine thus remains to some extent efficacious in combating mother-to-child transmission even if the mother breastfeeds her baby. As far as resistance is concerned, the only relevance is the possible need to treat the mother and/or the child at some time in the future. Although resistant strains of HIV might exist after a single dose of Nevirapine, this mutation is likely to be transient. At most there is a possibility of such resistance persisting, and although this possibility cannot be excluded, its weight is small in comparison with the potential benefit of providing a single tablet of Nevirapine to the mother and a few drops to her baby at the time of birth. The prospects of the child surviving if infected are so slim and the nature of the suffering so grave that the risk of some resistance manifesting at some time in the future is well worth running.

The evidence shows that safety is no more than a hypothetical issue. The only evidence of potential harm concerns risks attaching to the administration of Nevirapine as a chronic medication on an ongoing basis for the treatment of HIV-positive persons. There is, however, no evidence to suggest that a dose of Nevirapine to both mother and child at the time of birth will result in any harm to either of them. *** The policy of confining Nevirapine to research and training sites fails to address the needs of mothers and their newborn children who do not have access to these sites. It fails to distinguish between the evaluation of programs for reducing mother-to-child transmission

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and the need to provide access to health care services required by those who do not have access to the sites. In Grootboom (supra) this Court held that: "[t]o be reasonable, measures cannot leave out of account the degree and extent of the denial of the right they endeavor to realize. Those whose needs are the most urgent and whose ability to enjoy all rights therefore is most in peril, must not be ignored by the measures aimed at achieving realization of the right. ***

In evaluating government's policy, regard must be had to the fact that this case is concerned with newborn babies whose lives might be saved by the administration of Nevirapine to mother and child at the time of birth.***the provision of a single dose of Nevirapine to mother and child where medically indicated is a simple, cheap and potentially lifesaving medical intervention. Children's rights There is another consideration that is material. This case is concerned with newborn children. Sections 28(1)(b) and (c) of the Constitution provide that "[e]very child has the right -

(b)to family care or parental care, or to appropriate alternative care when removed from the family environment; (c)to basic nutrition, shelter, basic health care services and social services."

The provision of a single dose of Nevirapine to mother and child for the purpose of protecting the child against the transmission of HIV is, as far as the children are concerned, essential. Their needs are "most urgent" and their inability to have access to Nevirapine profoundly affects their ability to enjoy all rights to which they are entitled. Their rights are "most in peril" as a result of the policy that has been adopted and are most affected by a rigid and inflexible policy that excludes them from having access to Nevirapine.

The State is obliged to ensure that children are accorded the protection contemplated by section 28 that arises when the implementation of the right to parental or family care is lacking. Here we are concerned with children born in public hospitals and clinics to mothers who are for the most part indigent and unable to gain access to private medical treatment which is beyond their means. They and their children are in the main dependent upon the State to make health care services available to them.***

We are also conscious of the daunting problems confronting government as a result of the pandemic. And besides the pandemic, the State faces huge demands in relation to access to education, land, housing, health care, food, water and social security. These are the socio-economic rights entrenched in the Constitution, and the State is obliged to take reasonable legislative and other measures within its available resources to achieve the progressive realization of each of them. In the light of our history this is an extraordinarily difficult task. Nonetheless it is an obligation imposed on the State by the Constitution.***

South African courts have a wide range of powers at their disposal to ensure that the Constitution is upheld. These include mandatory and structural

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interdicts. How they should exercise those powers depends on the circumstances of each particular case. Here due regard must be paid to the roles of the legislature and the executive in a democracy. What must be made clear, however, is that when it is appropriate to do so, courts may - and if need be must - use their wide powers to make orders that affect policy as well as legislation.*** In the present case we have identified aspects of government policy that are inconsistent with the Constitution. The decision not to make Nevirapine available at hospitals and clinics other than the research and training sites is central to the entire policy. Once that restriction is removed, government will be able to devise and implement a more comprehensive policy that will give access to health care services to HIV-positive mothers and their newborn children, and will include the administration of Nevirapine where that is appropriate. The policy as reformulated must meet the constitutional requirement of providing reasonable measures within available resources for the progressive realization of the rights of such women and newborn children. This may also require, where that is necessary, that counselors at places other than at the research and training sites be trained in counseling for the use of Nevirapine. We will formulate a declaration to address these issues.***

It is essential that there be a concerted national effort to combat the HIV/AIDS pandemic. The government has committed itself to such an effort. We have held that its policy fails to meet constitutional standards because it excludes those who could reasonably be included where such treatment is medically indicated to combat mother-to-child transmission of HIV. ***We consider it important that all sectors of the community, in particular civil society, should co-operate in the steps taken to achieve this goal. In our view that will be facilitated by spelling out the steps necessary to comply with the Constitution. We will do this on the basis of the policy that government has adopted as the best means of combating mother-to-child transmission of HIV, which is to make use of Nevirapine for this purpose. Government must retain the right to adapt the policy, consistent with its constitutional obligations, should it consider it appropriate to do so. The order that we make has regard to this. ***We accordingly make the following orders: 1. The orders made by the High Court are set aside and the following orders are substituted. 2. It is declared that: (a)Sections 27(1) and (2) of the Constitution require the government to devise and implement within its available resources a comprehensive and co-ordinated program to realize progressively the rights of pregnant women and their newborn children to have access to health services to combat mother-to-child transmission of HIV. (b)The program to be realized progressively within available resources must include reasonable measures for counseling and testing pregnant women for HIV, counseling HIV-positive pregnant women on the options open to them to reduce the risk of mother-to-child transmission of HIV, and making appropriate treatment available to them for such purposes. (c)The policy for reducing the risk of mother-to-child transmission of HIV as formulated and implemented by government fell short of compliance with the requirements in subparagraphs (a) and (b) in that:

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(i)Doctors at public hospitals and clinics other than the research and training sites were not enabled to prescribe Nevirapine to reduce the risk of mother-to-child transmission of HIV even where it was medically indicated and adequate facilities existed for the testing and counseling of the pregnant women concerned. (ii)The policy failed to make provision for counselors at hospitals and clinics other than at research and training sites to be trained in counseling for the use of Nevirapine as a means of reducing the risk of mother-to-child transmission of HIV. 3. Government is ordered without delay to: (a)Remove the restrictions that prevent Nevirapine from being made available for the purpose of reducing the risk of mother-to-child transmission of HIV at public hospitals and clinics that are not research and training sites. (b)Permit and facilitate the use of Nevirapine for the purpose of reducing the risk of mother-to-child transmission of HIV and to make it available for this purpose at hospitals and clinics when in the judgment of the attending medical practitioner acting in consultation with the medical superintendent of the facility concerned this is medically indicated, which shall if necessary include that the mother concerned has been appropriately tested and counseled. (c)Make provision if necessary for counselors based at public hospitals and clinics other than the research and training sites to be trained for the counseling necessary for the use of Nevirapine to reduce the risk of mother-to-child transmission of HIV. (d)Take reasonable measures to extend the testing and counseling facilities at hospitals and clinics throughout the public health sector to facilitate and expedite the use of Nevirapine for the purpose of reducing the risk of mother-to-child transmission of HIV. 4.The orders made in paragraph 3 do not preclude government from adapting its policy in a manner consistent with the Constitution if equally appropriate or better methods become available to it for the prevention of mother-to-child transmission of HIV.***

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Notes and Questions

1. The provisions in the South African constitution discussed in this case are modeled on those in the International Covenant on Economic, Social and Cultural Rights—and placing the provisions of this international treaty in legislation and constitutional provisions of individual states is an especially effective way of making international law integral to national law. Note that article 12 of the Covenant includes not only appropriate health care, but also the underlying determinants of health, including clean water, sanitation, safe food, housing, and health-related education. In addition, South Africa’s constitution adopts specific provisions in the Convention on the Rights of the Child, which, of course, have special application in this case.

2. The decision in the nevirapine case illustrates both the strength and

the weakness of relying on courts to determine specific applications of the right to health. The strength is that the right to health is a legal right, and since there can be no legal right without a remedy, courts will provide a remedy for violations of the right to health. In this regard, it is worth noting not only that the right to health and access to health care articulated in the Universal Declaration of Human Rights has been given more specific meaning in the International Covenant on Economic, Social, and Cultural Rights and other internationally binding documents on human rights, but also that these rights have been written into the constitutions of many countries, including South Africa. The widespread failure of governments to take the right to health seriously, however, means that we are still a long way from the realization of this right. Nonetheless, the activism of many nongovernmental organization, such as the Treatment Action Campaign, in the area of health rights, provides some ground for optimism that government inaction will not go unchallenged.

The weakness of relying on courts is that the subject matter of the right to health in a courtroom struggle is likely to be narrow, involving interventions such as kidney dialysis or nevirapine therapy. The HIV epidemic demands a comprehensive strategy of treatment, care, and prevention, including education, adequate nutrition, clean water, and nondiscrimination. The government of South Africa has so far been unwilling to designate the HIV epidemic as a national emergency or to take steps to make the prevention and treatment of HIV infection its highest health priority.

3. This was the third case in which the Constitutional Court had been asked to enforce a socioeconomic right under the South African constitution. The first, Soobramoney v. Minister of Health, was also a right-to-health case, 1997 (12) BCLR 1696 (CC). It involved a 41-year-old man with chronic renal failure and a history of stroke, heart disease, and diabetes, who was not eligible for a kidney transplant and therefore required lifelong dialysis to survive. The renal-dialysis unit in the region where he lived, which had 20 dialysis machines—not nearly enough to provide dialysis for everyone who required it—had a policy of accepting only patients with acute renal failure. The health department argued that this policy met the government’s duty to provide emergency care under the constitution. Patients with chronic renal failure, like the petitioner, did not automatically qualify.

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In considering whether the constitution required the health department to provide a sufficient number of machines to offer dialysis to everyone whose life could be saved by it, the court observed that under the constitution, the state’s obligation to provide health care services was qualified by its “available resources.” The court noted that offering extremely expensive medical treatments to everyone would make “substantial inroads into the health budget…to the prejudice of the other needs which the state has to meet.” The Constitutional Court ultimately decided that the administrators of provincial health services, not the courts, should set budgetary priorities and that the courts should not interfere with decisions that are rational and made “in good faith by those political organs and medical authorities whose responsibility it is to deal with such matters.”

Likewise, in South Africa v. Grootboom, 2000 (11) BCLR 1169 (CC), a case involving the right to housing, the Constitutional Court determined that although the state is obligated to act positively to ameliorate the conditions of the homeless, it “is not obligated to go beyond available resources or to realize these rights immediately.” The constitutional requirement is that the right to housing be “progressively realized.” Nonetheless, the court noted, there is “at the very least, a negative obligation placed upon the state and all other entities and persons to desist from preventing or impairing the right of access to adequate housing.”

Applying the rulings in these two cases to the nevirapine case, the Constitutional Court reasonably concluded that the right to health care services “does not give rise to a self-standing and independent fulfillment right” that is enforceable irrespective of available resources. Nonetheless, the government’s obligation to respect rights, as articulated in the housing case, applies equally to the right to health care services. See George J. Annas, The Right to Health and the Nevirapine Case in South Africa, 348 NEW ENGL. J. MED. 750 (2003). For a discussion of a similar case from Venezuela see, Mary Ann Torres, The Human Right to Health, National Courts, and Access to HIV/AIDS Treatment: A Case Study from Venezuela, 3 CHICAGO J. INTERNATIONAL LAW 1 (2002).

4. Jonathan Mann was the first to observe that “health and human rights are inextricably linked,” Jonathan M. Mann, Human Rights and AIDS: The Future of the Pandemic, in HEALTH AND HUMAN RIGHTS: A READER 216-26 (Jonathan M. Mann et al., eds., 1999), and Paul Farmer has argued that “the most important question facing modern medicine involves human rights.” Farmer noted that many poor people have no access to modern medicine and concluded, “The more effective the treatment, the greater the injustice meted out to those who do not have access to care.” Paul Farmer, The Major Infectious Diseases in the World—To Treat or Not to Treat? 345 N. ENGL. J MED. 208 (2001). See also, PAUL FARMER, INFECTIONS AND INEQUALITIES: THE MODERN PLAGUES (Updated ed. 1999), AMARTYA SEN, DEVELOPMENT AS FREEDOM (1999), and LAURIE WERMUTH, GLOBAL INEQUALITY AND HUMAN NEEDS: HEALTH AND ILLNESS IN AN INCREASINGLY UNEQUAL WORLD (2003).

5. Access to treatment for infection with the human immunodeficiency virus (HIV) and AIDS has been problematic in most countries, but especially in South Africa, where almost 5 million people are infected with HIV and the government’s attitude toward the epidemic has been described as pseudoscientific and dangerous. M.W. Makgoba, HIV/AIDS: The Peril of

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Pseudoscience. 288 SCIENCE 1171 (2000) Political resistance by the South African government to outside funders who want to set the country’s health care agenda is, of course, understandable in the context of racism and colonialism. But even understandable politics cannot excuse the government’s failure to act more decisively in the face of an unprecedented epidemic.

6. A major concern, of course, is that the entire human rights movement could fall victim to the “war on terror.” As Richard Falk has expressed it:

By highlighting ‘terrorism’ there is an almost unavoidable tendency to perceive Issues through the lens of the September 1l attacks, and to downplay such other issues as are associated with the inequities arising from the operation of the world economy or with the practices that produce environmental decay. In these respects from the perspective of human rights’ priorities, the highlighting of the security agenda inevitably leads to a downplaying of economic and social rights, the right of self-determination, health issues, and rights associated with environmental protection. It is to be expected that academic discussions of security would take different forms in other parts of the world, that the American context of discussion is in this respect rather the exception than the rule.

Richard Falk, Human Rights: A Descending Spiral, in HUMAN RIGHTS IN THE ‘WAR ON TERROR’ 229 (Richard Ashby Wilson ed., 2005).

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JIM KIM & PAUL FARMERAIDS IN 2006—MOVING TOWARD ONE WORLD, ONE HOPE?

355 New Engl J Med 645 (2006)

For the past two decades, AIDS experts—clinicians, epidemiologists, policymakers, activists, and scientists—have gathered every two years to confer about what is now the world’s leading infectious cause of death among young adults. This year, the International AIDS Society is hosting the meeting in Toronto from August 13 through 18. The last time the conference was held in Canada, in 1996, its theme was “One World, One Hope.” But it was evident to conferees from the poorer reaches of the world that the price tag of the era’s great hope—combination antiretroviral therapy—rendered it out of their reach. Indeed, some African participants that year made a banner reading, “One World, No Hope.”

Today, the global picture is quite different. The claims that have been made for the efficacy of antiretroviral therapy have proved to be well founded: in the United States, such therapy has prolonged life by an estimated 13 years—a success rate that would compare favorably with that of almost any treatment for cancer or complications of coronary artery disease. In addition, a number of lessons, with implications for policy and action, have emerged from efforts that are well under way in the developing world .During the past decade, we have gleaned these lessons from our work in setting global AIDS policies at the World Health Organization in Geneva and in implementing integrated programs for AIDS prevention and care in places such as rural Haiti and Rwanda. As vastly different as these places may be, they are part of one world, and we believe that ambitious policy goals, adequate funding, and knowledge about implementation can move us toward the elusive goal of shared hope.

The first lesson is that charging for AIDS prevention and care will pose insurmountable problems for people living in poverty, since there will always be those unable to pay even modest amounts for services or medications, whether generic or branded. Like efforts to battle airborne tuberculosis, such services should be seen as a public good for public health. Policymakers and public health officials, especially in heavily burdened regions, should adopt universal access plans and waive fees for HIV care. Initially, this approach will require sustained donor contributions, but many African countries have recently set targets for increased national investments in health, a pledge that could render ambitious programs sustainable in the long run.

As local investments increase, the price of AIDS care is decreasing. The development of generic medications means that antiretroviral therapy can now cost less than 50 cents per day, and costs continue to decrease to affordable levels for public health officials in developing countries. All antiretroviral medications—first-line, second-line, and third-line—must be made available at such prices. Manufacturers of generic drugs in China, India, and other developing countries stand ready to provide the full range of drugs. Whether through negotiated agreements or use of the Agreement on Trade-Related Aspects of Intellectual Property Rights, full access to all available antiretroviral drugs must quickly become the standard in all countries.

Second, the effective scale-up of pilot projects will require the strengthening and even rebuilding of health care systems, including those charged with delivering primary care. In the past, the lack of a health care

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infrastructure has been a barrier to antiretroviral therapy; we must now marshal AIDS resources, which are at last considerable, to rebuild public health systems in sub-Saharan Africa and other HIV-burdened regions….Only the public sector, not nongovernmental organizations, can offer health care as a right.

Third, a lack of trained health care personnel, most notably doctors, is invoked as a reason for the failure to treat AIDS in poor countries. The lack is real, and the brain drain continues. But one reason doctors flee Africa is that they lack the tools of their trade. AIDS funding offers us a chance not only to recruit physicians and nurses to underserved regions, but also to train community health care workers to supervise care, for AIDS and many other diseases within their home villages and neighborhoods….

Fourth, extreme poverty makes it difficult for many patients to comply with antiretroviral therapy. Indeed, poverty is far and away the greatest barrier to the scale-up of treatment and prevention programs. Our experience in Haiti and Rwanda has shown us that it is possible to remove many of the social and economic barriers to adherence but only with what are sometimes termed “wrap-around services”: food supplements for the hungry, help with transportation to clinics, child care and housing. In many rural regions of Africa, hunger is the major coexisting condition with AIDS or tuberculosis, and these consumptive diseases cannot be treated effectively without food supplementation….

* * *

Fifth, investments in efforts to combat the global epidemics of AIDS and tuberculosis are much more generous than they were five years ago, but funding must be increased and sustained if we are to slow these increasingly complex epidemics. . .

The unglamorous and difficult process of increasing access to prevention and care needs to be our primary focus if we are to move toward the lofty goal of equitably distributed medical services in a world riven by inequality. Without such goals, the slogan “One World, One Hope” will remain nothing more than a dream.

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Notes and Questions

1. Kim and Farmer approach the HIV/AIDS pandemic from the perspective they would describe as “social justice.” How does this perspective differ from a “health and human rights” perspective? Jonathan Mann, the founder of the health and human rights field, has observed that most of the problems of health are problems of poverty—nonetheless he also noted that framing them as poverty problems makes them seem insurmountable and intractable. Better, he thought, to focus on the basic human rights which most people support and whose recognition can dramatically improve health status.

2. Kim and Farmer (and the World Health Organization generally) have argued that we must make treatment available to all who are infected with HIV as soon as possible. This is a reasonable goal, but how can it be achieved? Most recently, for example, WHO failed in its attempt, labeled “3x5” to enroll 3 million new HIV patients in treatment programs by the end of 2005. It seems reasonable to note that in this same period of time more than 5 million new HIV infections occurred. The point needs to be emphasized: treatment is critical, but from a public health perspective, prevention is overwhelmingly vital. Consider how treatment and prevention go hand in hand. Assuming that not everyone can get access to treatment immediately, how should public health officials prioritize who should get access first? Do we need an explicit rationing scheme that puts parents, workers, children, or some other group at the top of the priority list? How should such a list be constructed and who should construct it? Would it be an inherent violation of the nondiscrimination basis of the human rights movement?

Of course, these same issues will be faced in the event of an epidemic or bioterrorist attack—who should be treated first with available drugs and vaccines? In this regard, the CDC has suggested priorities for flu vaccinations, both in the yearly flu (when supplies are short) and in the event of an avian pandemic, when vaccine will not be immediately available to anyone. Who should be at the top of the distribution list and why? See, e.g., Alfred I. Tauber, Medicine, Public Health, and the Ethics of Rationing, 45 PERSPECTIVES IN BIOLOGY & MED. 16 (2002), and Ezekiel Emanuel & Alan Wertheimer, Who Should Get Influenza Vaccine When Not All Can?, 312 SCIENCE 854 (2006).

3. The editor of the Lancet, Richard Horton, was far less impressed by the August 2006 International AIDS meeting in Toronto than others. The meeting, for example, committed to a goal of “universal access to comprehensive prevention programs, treatment, care and support by 2010.”

Unfortunately, as Horton notes,

. . . the opportunity to produce a roadmap to reach the 2010Target of universal access was squandered. Rarely has thereBeen a meeting that felt so disengaged from a globalPredicament of such historic proportions. The agenda in Toronto was unfocused, giving prime air time to celebrities,Such as Bill Gates and Bill Clinton, while largely ignoring

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Africa [even though] Africa bears the greatest burden of AIDSToday—24.5 million of 38.6 million people with HIV.

Horton went on to raise ten specific questions that he believes need answers now, including: 1. Why do we refuse to admit that there is still no genuine global commitment to scale up our response to AIDS?; 2. Why are the wider health, economic, social and cultural contexts of AIDS still being ignored?; 6. Why do health agencies and programs still base their prevention messages on the outdated and scientifically corrupt idea of abstinence?, and 7. Why are civil society and NGOs still not being given the credit they deserve as vital levers in the global AIDS response?

The next International AIDS meeting will be in Mexico in 2008. In Horton’s view, “The litmus test for Mexico’s success will be the degree to which the conference can be transformed from a scientific meeting and global beacon for AIDS, to a coordinating mechanism to drive advances in prevention, treatment, and care at the country level. Talking is easy. Doing will demand a revolution.” Richard Horton, A Prescription for AIDS 2006-10, 368 LANCET 726-28 (2006). Horton’s essay echoes the much more generalized arguments of LAURIE GARRETT, BETRAYAL OF TRUST: THE COLLAPSE OF GLOBAL PUBLIC HEALTH (2000), a critical pre-9/11 look at global public health dedicated to Jonathan Mann.

4. As Horton notes, the stars of the 2006 AIDS meeting were Bill Gates and Bill Clinton, based largely on their recent work in donating and raising private funds for AIDS research and treatment. Their activities and status raise some disturbing questions for public health advocates. Why do governments fail to adequately fund public health programs? And what is the role of the private sector in public health? Are public-private partnerships the future of public health?

Of course, global public health problems demand global approaches. And even the Wall Street Journal has taken note that these issues have yet to be resolved, and that what decisions are made in late 2006 to fill the now vacant positions of Director-General of WHO, Executive Director of the Global Fund to Combat AIDS, Tuberculosis, and Malaria, and the Senior VP for Health Development of the World Bank “will help determine the world’s strategy for confronting health threats ranging from AIDS to pandemic flu for years to come.” Betsy McKay, Three Top Jobs in Global Health Face Vacancies, WALL ST. J., September 5, 2006, A16.

Bill Gates has recently concluded that his foundation will put most of its resources into global health initiatives, especially HIV/AIDS, because he believes that this is the area in which you can get the most return on your investment in terms of lives saved. Warren Buffet, the second richest man in the US after Gates, has announced that he will leave most of his fortune to the Gates Foundation because he believes they have the right approach and his own foundation could not do it better. Private charity is to be admired and foundations funding is almost always welcome. But what does this say about public health to note that the Gates Foundation annually provides more funding for public health initiatives than the entire budget of the World Health Organization? Gates has said that he got most of his philanthropic investment ideas from reading a report by the World Bank, which is still

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well worth reading. WORLD BANK, WORLD DEVELOPMENT REPORT 1993: INVESTING IN HEALTH (1993).

The Bill and Melinda Gates Foundation has so far been primarily interested in developing an AIDS vaccine, although the foundation has branched out more recently. Vaccines are, of course, the most basic of successful public health interventions, in that they can prevent disease in populations. Nonetheless, even the limited quest to provide already existing and effective vaccines to the world’s children has been consistently overwhelmed by politics. See, e.g., WILLIAM MURASKIN, THE POLITICS OF INTERNATIONAL HEALTH: THE CHILDREN’S VACCINE INITIATIVE AND THE STRUGGLE TO DEVELOP VACCINES FOR THE THIRD WORLD (1998).

5. One of the major legal issues involving world health of the past decade has been the debate around pharmaceutical patenting and profits. Although almost everyone now realizes that just providing drugs, without a public health infrastructure to deliver them and care for patients is not feasible, nonetheless the cost of drugs remains a critical issue to providing decent care, especially for HIV/AIDS, in many countries. An excellent introduction to this subject is contained in a symposium issue of the AMERICAN JOURNAL OF LAW AND MEDICINE, vol. 32, numbers 2 and 3, 2006: Globalization of Pharmaceuticals: International Regulatory Issues. See also, Ellen ‘t Hoen, TRIPS, Pharmaceuticals Patents, and Access to Essential Medicines: A Long Way from Seattle to Doha, 3 CHICAGO J. INTERNATIONAL LAW 27 (2002).

6. Norman Daniels has argued persuasively that bioethics should move to broaden its agenda from the doctor-patient relationship to broader public health and population problems, and should do so based on a social justice rather than a human rights perspective. The last three items he urges bioethicists to add to their agenda are to:

10) assess the implications of the obligation not to harmfor reducing health inequalities internationally;

11) develop an account of justice for the evolving internationalinstitutions and rule-making bodies that have an impact oninternational health inequalities; and

12) examine Promethean challenges from the perspective of their impact on international health inequalities and obligationsof justice regarding them.

Norman Daniels, Equity and Population Health: Toward a Broader Bioethics Agenda, 36(4) HASTINGS CENTER REPORT 22, 33 (2006).

7. Other commentators prefer to keep bioethics at some distance from public health. Jonathan Mann, for example, has written that he believes bioethics is the correct language for medicine, but that human rights is the proper language for public health. See, e.g., Jonathan Mann, Medicine and Public Health, Ethics and Human Rights, 27(3) HASTINGS CENTER REPORT 6 (1997). Ron Bayer and Amy Fairchild would go much further, arguing that modern bioethics has no place in public health ethics. In their words, “Bioethics cannot serve as a basis for thinking about the

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balances required in the defense of the public’s health. As we commence the process of shaping an ethics of public health, it is clear that bioethics is the wrong place to start.” Ronald Bayer & Amy L. Fairchild, The Genesis of Public Health Ethics, 18 BIOETHICS 473, 492 (2004). Of course, the real answer may be that when medicine and public health work together (usually the case) public health must take account of bioethics (sometimes called simply “medical ethics”), and that in real life there are no sharp borders between health law, bioethics, and human rights in public health practice. See, e.g., GEORGE J. ANNAS, AMERICAN BIOETHICS: CROSSING HUMAN RIGHTS AND HEALTH LAW BOUNDARIES(2005), BRITISH MEDICAL ASSOCIATION, THE MEDICAL PROFESSION AND HUMAN RIGHTS: HANDBOOK FOR A CHANGING AGENDA (2001), and DAVID J. ROTHMAN & SHELIA M. ROTHMAN, TRUST IS NOT ENOUGH: BRINGING HUMAN RIGHTS TO MEDICINE (2006)

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