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…
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.
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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 Healthand Liberty in the 21st Century, 13 Health Matrix 33, 38-41 (2003). See also, George J. Annas, Protecting Soldiers from Friendly Fire: The Consent Requirementfor 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.
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:
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.
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.
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.
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
DateEvent 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 Act
Designated 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 program
HHS 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.
DHHS proposes smallpox vaccination compensation plan
Surgeon general, CDC director, and others are vaccinated against smallpox
War with Iraq begins on March 19, 2003
CDC 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, 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”
Notes and Questions
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.
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.
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 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 largely
Been indivisible in the conduct of American foreign policy; analysis
And action. Justified or not, fact-based or not, ‘our response’ is
What matters. As to ‘evidence,” the bar was set so low that the word
Itself 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).
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….
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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.
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, 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….
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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.