Developmental Milestones/Developments to Date:
Current Assessment/State of the Field:
Glass, Thomas A. and Monica Schoch-Spana, “Bioterrorism and the People: How To Vaccinate a City against Panic,” Clinical Infectious Diseases, 34:217-23 (Jan 15, 2002)
- Glass and Schoch-Spana propose a five point model for community participation in response bioterror attacks, especially epidemics: 1. “treat the public as a capable ally,” 2. “enlist civic organizations,” 3. “anticipate the need for home-based patient care and infection control,” 4. “invest in public outreach and communication strategies,” and 5. “ensure that planning reflects the values and priorities of affected populations.”
- The public has generally been discounted as an effective means of defense against bioterrorism; this attitude is not based on experience, as the authors claims “natural and technological disasters and disease outbreaks indicate a pattern of generally effective and adaptive collective actions.”
- “Collective behavior changes over time and in relation to external events. This suggests that, in times of disaster, panic may be ‘iatrogenic’: that is, the actions of emergency managers may determine the extent and duration of he panic, to the extent that it exists.”
Emergency Response, Public Health, Prophylaxis, Anthrax, Ethics
Lubchenco, Jane, Rosswall, Warren +, “Scientific freedom: new strategies are needed: threats to the flow of knowledge may come from small groups as well as governments,” NATURE correspondence v. 421, 20 feb 2003.
- ”boycott of Israeli scientists for actions/policies of their government is criticized.
Victoria Sutton, “A Multidisciplinary Approach to an Ethic of Biodefense and Bioterrorism” Journal of Law, Medicine and Ethics, 1 June 2005.
- “Biodefense research is a double-edged sword. Research in the area of biodefense can be used for altruistic purposes, or the same research could be used for the destruction of humankind.”
- “Bioethics comprise a large scope of activities within the rubric of biodefense, but may be examined first in the context of human subjects in experimentation.”
- “Areas for consideration in bioethics in biodefense from a federal government perspective involve three sets of issues: (l) the bioethical considerations for the citizens of the United States, and; (2) the bioethical considerations for the governments and individuals outside of the United States; and (3) the bioethical considerations for the environment that affect all individuals in the world.”
Morton, Oliver, “Biology’s New Forbidden Fruit” NYT op ed, Feb. 11, 2005, p. A25
- generalizations about biologists, compares to physicists, argues for more Ethics and history training.
Ethics, Codes of Conduct
Enemark, Christian, “United States biodefense, international law, and the problem of intent,” Politics and the Life Sciences, July 19, 2006, vol. 24, no. 1-2, p. 32.
- Transparency, Ethics, Policy, Biodefense having paradoxical effect of increasing likelihood of attack, BWC
BWC, Law, Ethics, Biodefense
Atlas, Ronald, “Securing Life Sciences Research in an Age of Terrorism,” ISSUES IN SCIENCE AND TECHNOLOGY ONLINE, Fall 2006. http://www.issues.org/23.1/atlas.html
Tucker, Jonathan, “Preventing the Misuse of Biology,” International Security, Vol. 31, No. 2, 2006, pp. 116-150
- “Science will kill, heal, build and destroy.”
- “Dual-use first attracted attention in 2001 when Australian scientists reported that while developing a vaccine to control rodent populations, they created a virus that was highly lethal in mice.”
- “The most troubling example of dual-use was the recreation of the Spanish influenza virus that Jeffrey Taubenberger created in 2005.”
- “Critics claimed that this was irresponsible because of the risk that the lethal virus might escape from the laboratory.”
- “The accelerating pace of discovery in the life sciences is generating potential threats to international security that warrant a coherent policy response.”
- “In the 1970’s U.S. molecular biologists imposed a voluntary moratorium on certain areas of research until the risks were better understood.”
- “In 1975 the Asilomar conference formulated some proposed guidelines that included the use of weakened strains of bacteria that would not be able to survive outside the laboratory.”
- “This conferences lead the U.S. National Institutes of Health to issue the ”NIH Guidelines for Research Involving Recombinant DNA Molecules”, 1976.”
- “NIH-funded research must establish institutional biosafety committees (IBCs) that assess the risks of experiments.”
- “In 2003 Gerald Fink published ”Biotechnology Research in an Age of Terrorism” which stated that life science could be misused for hostile purposes.”
- “Fink committee identified seven types of experiments of concern:”
1. demonstrate how to render a vaccine ineffective
2. confer resistance to a therapeutically useful antibiotic or antiviral drug
3. enhance the virulence of a pathogen
4. increase the transmissibility of a pathogen
5. alter the range of hosts that a pathogen can infect
6. enable the evasion of a diagnostic or detection methods
7. facilitate the weaponization of a biological agent or toxin
- “In 2004 under George W Bush the National Science Advisory Board for Biosecurity (NSABB) recommends strategies for the efficient and effective oversight of dual-use research supported or conducted by the U.S. government.”
Zimmerman, Richard, “Rationing of influenza vaccine during a pandemic: Ethical analyses“, Vaccine, 25, 2007, pg. 2019–2026.
- “Rationing of scarce vaccine supplies will likely be required when the next pandemic occurs, raising the questions about how to ration and upon what principles.”
- “Since influenza pandemics have differing mortality patterns, such as the 1918 pandemic’s “W” shaped curve that effected healthy young adults, the particular pattern should inform rationing.”
- “ethical principles for vaccine rationing can be utilitarianism and egalitarianism.”
- “A framework that uses multiple principles to address influenza vaccine rationing in light of a shortage is recommended.”
Vaccination, Ethics, 1918 Flu, Flu, Pandemic
Garoon, Joshua P., Duggan, Patrick S., “Discourses of disease, discourses of disadvantage: A critical analysis of National Pandemic Influenza Preparedness Plans,” Social Science & Medicine, 67, 2008 1133–1142.
- “The threat of pandemic influenza to global health has led to increased emphasis on pandemic influenza preparedness planning. Previous analysis of national pandemic preparedness plans has revealed that those plans paid scant attention to the needs and interests of the disadvantaged. This paper investigates those findings via critical discourse analysis of the same plans as well as World Health Organization guidance documents. The analysis reveals that the texts operate within and as parts of an ordered universe of discourse.Unless the plans recognize their discursive construction,implementation of the policies and practices they prescribe runs the risk of further disadvantaging those very populations most likely to require protection.
Verweij, Marcel, “Health Inequities In Times Of A Pandemic“, PUBLIC HEALTH ETHICS, Volume 2, Issue 3, pgs 207-209, 2009. http://phe.oxfordjournals.org/content/2/3/207.extract
- people in low-income countries may have no access to vaccination despite being more vulnerable to the significant negative effects of H1N1
- “Australia, Canada, and the Netherlands expect to have sufficient vaccines to immunise the whole population”
Ethics, Flu, Pandemic, Vaccination, Public Health, Developing Countries
Somerville, Margaret, “A world of competing sorrows; There’s a flu pandemic and health-care resources are scarce. How do we decide who lives and who dies?” The Globe and Mail (Canada), Pg. A17, July 16, 2009.
- “H1N1 flu presents us with what we call in ethics “a world of competing sorrows” – that is, one in which there is no response that does only good and not also harm.”
- “How do we decide who gets a chance to live and who dies, when those outcomes depend on who gets access to or is denied scarce health-care resources? Who should decide? On what basis? Using which processes? The H1N1 influenza pandemic raises a large cluster of such ethical issues.”
Flu, Vaccination, Canada, Pandemic, Ethics
Yamada, Tadataka, “Poverty, Wealth, and Access to Pandemic Influenza Vaccines“, THE NEW ENGLAND JOURNAL OF MEDICINE. September 17, 2009. Volume 361, Number 12, pgs. 1129-1131., http://content.nejm.org/cgi/content/full/NEJMp0906972?query=TOC
- do developing countries have the manufacturing capacity, cost, and delivery systems and resources available to get vaccines?
- only a few countries in the world have plants for manufacturing influenza vaccine and 3 companies account for most of the world’s manufacturing capacity: GlaxoKlineSmith, Sanofi-Aventis, and Novartis.
- problem- “much if not most of the manufacturing capacity is already spoken for through purchasing contracts held by many of the world’s wealthy countries.”
- steps to ensure global community has vaccinations: identify strategies and mechanisms to make vaccines more accessible
Flu, Pandemic, Vaccination, Public Health, Ethics, Developing Countries
Editors, “Swine Flu Pandemic Will Reveal 21st Century’s Poverty Pandemic“, GLOBAL HEALTH POLICY AT NYU-WAGNER, Sept 27, 2009. http://globalhealthpolicynyu.wordpress.com/2009/09/27/swine-flu-pandemic-will-reveal-21st-century%E2%80%99s-poverty-pandemic/
- historically influenza not an “equal opportunity” disease
- “people with coexisting conditions are more susceptible to poor health outcomes” and “most developng countries have high incidence of malnourished children and adults with many coexisting medical conditions.”
- socioeconomic factors- “poor resources for clean water and sanitation, no health care system or inadequate resources to seek medical attention”
Flu, Pandemic, Vaccination, Public Health, Ethics, Developing Countries
Pollack, Andrew, “Biotech Company Fires Chief and Others Over Handling of Data,” NYT, Sept. 29, 2009, B2.
- “A biotech company developing what was expected to be a groundbreaking blood test for [detecting] Down Syndrome fired its chief executive, a top research official and three other employees Monday after an investigation into ‘mishandling’ of test data and results.”
- “its investigation concluded that the company had ‘failed to put in place adequate protocols and controls’ for studies… [as reported in a regulatory filing citing] ‘inadequately substantiated claims, inconsistencies and errors’ about the Down syndrome test [that] had been disclosed to investors.”
- ”Sequennom’s announcement left many questions unanswered, in particular how exactly the data was ‘mishandled’ and whether what happened was mere sloppiness or outright fraud.”
- “the company could not say more because it was under investigation by the Securities and Excahnge Commission and had been sued by shareholders.”
- “The company’s work drew widespread attention from Wall Street, the medical community and the news media, especially after it reported that in early trial runs the test was virtually perfect in detecting Down syndrome, with no false positives or false negatives.”
Committee on Laboratory Security and Personnel Reliability Assurance Systems for Laboratories Conducting Research on Biological Select Agents and Toxins, National Research Council of The National Academies, Report Released September 30, 2009. http://www.nap.edu/catalog.php?record_id=12774
- “The Committee was asked to consider the appropriate framework of laboratory security and personnel reliability measures that will optimize benefits, minimize risk, and facilitate the productivity of research.”
- ”Recommendation” 1: “…personnel with access to select agents and toxins should receive training in scientific ethics and dual-use research.”
- ”Recommendation” 2: “… a Biological Select Agents and Toxins Advisory Committee (BSATAC) should be established. … [to]… Promulgate guidance of the Select Agent Program; … Promote harmonization of regulatory policies and practices.”
- ”Recommendation” 3: “The list of select agents and toxins should be stratified in risk groups according to the potential use of the agent as a biothreat agent, …mechanisms for the timely inclusion or removal of an agent or toxin from the list are necessary and should be developed.”
- ”Recommendation” 4: “Because biological agents have an ability to replicate, accountability is best achieved by controlling access to archived stocks and working materials. …[as opposed to] counting the number of vials.”
- ”Recommendation” 5: The appeals process for Security Risk Assessments should be broadened beyond mere checks for factual errors.
- ”Recommendation” 6: “… define minimum cross-agency physical security needs.”
- ”Recommendation” 7: Dedicated funding should support an independent evaluation of the Select agent Program to assess benefits and consequences of the program.
- ”Recommendation” 8: “Inspectors of select agent laboratories should have scientific and laboratory knowledge and experience, as well as appropriate training in conducting inspections specific to BSAT research. Inspector training and practice should be harmonized across federal, state, local, and other agencies.”
- ”Recommendation” 9: A separate category of support should be allocated for BSAT research due to the costs of security.
Ethics, Dual Use, Misconduct, Law Enforcement, Lab Security, Law
Baccini, Michela, et al., “Multiple Imputation in the Anthrax Vaccine Research Program,” http://www.springerlink.com/content/1q54165h36533m48/, CHANCE, Number 1, Volume 23, March, 2010.
- “Since 2000, the CDC has been planning and conducting a clinical trial, the Anthrax Vaccine Research Program (AVRP), to evaluate a reduced AVA schedule and a change in the route of administration in humans.”
- “The AVA trial is a 43-month prospective, randomized, double-blind, placebo-controlled trial for the comparison of immunogenicity (i.e., immunity) and reactogenicity (i.e., side effect) elicited by AVA given by different routes of administration and dosing regimens.”
- “Administration is subcutaneous (SQ) versus intramuscular(IM).”
- “The AVA study has been significant because, as a result of the interim analysis, the FDA approved the change in the routeof AVA administration from SQ to IM. However, as with other complex experimental and observational data, the AVRP data creates various challenges for statistical evaluation.”
- “During the last two decades, multiple imputation (MI) has become a standard statistical technique for dealing with missing
- “A practically more important task is to address missing measurements not intended to be obtained in this study— these values are the survival status of the human subjects if, after the vaccination, they had been exposed to anthrax.”
- “For predicting this survival, there is little information from the human study alone because exposing humans to lethal anthrax doses is not ethical, given the risks of such exposure. For this reason, in parallel to the study with humans, CDC has been conducting a study with macaques.”
Carey, Benedict, “Studies Halted at Brain Lab Over Impure Injections,” NYT, July 16, 2010, http://www.nytimes.com/2010/07/17/health/17columbia.html?_r=1&hp Checked July 17, 2010.
- “Columbia University has quietly suspended research at a nationally prominent brain-imaging center and reassigned its top managers after federal investigators found that it had routinely injected mental patients with drugs that contained potentially dangerous impurities.”
- “The investigations found that the center — regarded by experts as the nation’s leader in the use of positron emission tomography, or PET, for psychiatric research — repeatedly violated Food and Drug Administration regulations over a four-year period.”
- “F.D.A. investigators returned in January 2010 and found that many of the center’s lab’s practices had not changed, and cited a long list of specific violations, including one instance in which the staff hid impurities from auditors by falsifying documents.”
- “‘They raided the place like it was a crime scene, seizing hard drives,’ said one former lab worker, who requested anonymity because he feared reprisals from the university.”
- “The office under fire, the Kreitchman PET Center, on West 168th Street in Manhattan, has attracted millions of dollars in research funds from the federal government and pharmaceutical companies to study drug actions and the biology of brain disorders, among other things.”
- “The agency regulates the allowable radiation levels and the purity of the drugs. If a drug contains too many impurities — unknown chemicals that may or may not be related to the tracer itself — then its effects in the body are unpredictable.”
- “‘There could be a patient safety issue, for one,” said Dr. Barry Siegel, chairman of the radioactive drug research committee at Washington University in St. Louis. “And there could be a scientific validity issue. If you’re exposing people to radiation and getting garbage data, then that becomes an ethical problem.'”
- “The report highlighted an equation that the lab routinely used, resulting in injections that exceeded the limit for acceptable impurities. The lab did not adequately check ‘the identity, strength and purity of each active ingredient prior to release’ for injection into patients, the report said. Agency investigators also found a forged document, a hard copy record that had been altered to hide a drug impurity that showed up clearly in the computer records.”
- “Former employees, speaking on the condition of anonymity because they worked in the imaging field or hoped to, said those practices were not only commonplace but also condoned. They described a center under such pressure to produce studies that it papered over and hid impurities in drugs to stretch its resources and went ahead with business as usual despite F.D.A. warnings.”
Misconduct, Ethics, Personnel Reliability, Oversight, Law Enforcement
Wade, Nicholas, “Harvard Researcher May Have Fabricated Data,” NYT, August 27, 2010. http://www.nytimes.com/2010/08/28/science/28harvard.html?ref=science Checked Sept. 1, 2010.
- “Harvard authorities have made available information suggesting that Marc Hauser, a star researcher who was put on leave this month, may have fabricated data in a 2002 paper.”
- “‘Given the published design of the experiment, my conclusion is that the control condition was fabricated,’ said Gerry Altmann, the editor of the journal Cognition, in which the experiment was published.”
- “Some forms of scientific error, like poor record keeping or even mistaken results, are forgivable, but fabrication of data, if such a charge were to be proved against Dr. Hauser, is usually followed by expulsion from the scientific community.”
- “‘There is a difference between breaking the rules and breaking the most sacred of all rules,” said Jonathan Haidt, a moral psychologist at the University of Virginia. The failure to have performed a reported control experiment would be “a very serious and perhaps unforgivable offense,’ Dr. Haidt said.”
- “Last week, Dr. Smith, the Harvard dean, wrote in a letter to the faculty that he had found Dr. Hauser responsible for eight counts of scientific misconduct. He described these in general terms but did not specify fabrication.”
Purlain, Ted, “Expert decries potential burning of anthrax vaccine,” Bioprepwatch.com, October 22, 2010. http://www.bioprepwatch.com/news/218325-expert-decries-potential-burning-of-anthrax-vaccine, Last Checked October 27, 2010.
- “Colonel Randall Larsen, USAF (Ret.), a bioterrorism expert, has decried potential plans by the federal government to burn a large stockpile of the anthrax vaccine.”
- “Larsen, in an opinion posted on BioSecurityBlog.com, says that the government intends to destroy 6.9 million doses of the life-saving vaccine, or $150 million worth. He compared the action to turn-of-the- century robber barons using $100 dollar bills to light their cigars.”
- “Larsen asserted that because anthrax is one of the likeliest agents to be used in a bioterrorism attack, the destruction of the vaccine doses will reduce America’s capability to respond, making the country less secure.”
- “Larsen was the executive director of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism and the former chairman of the Department of Military Strategy and Operations at the National War College He is currently the CEO of the Weapons of Mass Destruction Center.”
McNeill, Robert, G., Jr., “Response of W.H.O. to Swine Flu Is Criticized,” NYT March 10, 2011, http://www.nytimes.com/2011/03/11/health/policy/11flu.html?ref=health Last checked March 14, 2011.
- “A panel of independent experts has harshly reviewed the World Health Organization’s handling of the 2009 epidemic of H1N1 swine flu, though it found no evidence supporting the most outlandish accusation made against the agency: that it exaggerated the alarm to help vaccine companies get rich.”
- “The world is still unprepared to handle a severe pandemic, and if a more dangerous virus emerges, ‘tens of millions would be at risk of dying,’ the panel said in its draft report, which was posted on an obscure corner of the W.H.O.’s Web site on Thursday.”
- “Although millions of doses of vaccine ultimately went unused, the panel found ‘no evidence of malfeasance.’”
- “Later, when rich nations donated 78 million doses for use in poor ones, the health agency could not deploy them because it was bogged down in negotiations with vaccine companies over liability and costs.”
- “The panel, which has experts from 24 countries and is led by Dr. Harvey V. Fineberg, president of the Institute of Medicine, criticized the agency’s “needlessly complex” definition of a pandemic, which had six levels of alert, based on the virus’s geographical spread, not its severity.”
- “Nonetheless, it concluded, ‘no critic of W.H.O. has produced any direct evidence of commercial influence on decision-making.’Communications were also clumsy. Ceasing routine news conferences after the disease was elevated to pandemic status was ‘ill advised,’ the report said, and the agency responded ‘with insufficient vigor’ when its integrity was questioned.”
- “Countries that needed technical help could not obtain it in enough languages…”
- “Asking countries to submit counts of laboratory-confirmed cases created confusion, the report said, adding that knowing hospitalization and death rates would have been better.”
- “Although the W.H.O. excels at sending small teams to focused outbreaks like a village overwhelmed by Ebola, it fumbled even simple aspects of a prolonged effort, like food, lodging and child care for its staff.”
- “With help from national health agencies like those of the United States and Canada, the W.H.O. identified the virus quickly and got seed strains to vaccine makers. It also sent experts to countries that asked for help.”
- “Vaccine companies use slow 60-year-old technology, diagnostic tests are cumbersome, and virologists know too little about which mutations are the most dangerous.”
- “The panel urged the creation of a ‘global reserve corps’ of experts for emergencies, and a $100 million fund for their use. It urged vaccine makers to reserve 10 percent of their production for poor countries. It also criticized some international rules. For example, there is no way to punish nations that needlessly close borders or curtail trade. In 2009, many countries banned pork imports in the mistaken belief that a human flu with some swinish genes could be spread by bacon. Others closed borders or forcibly quarantined visitors with fevers.”
WHO, Flu, Pandemic, Public Health, Vaccination, Pharma, Misconduct, Ethics
Rowe, Aaron, “Molecules To Protect The Brain From Nerve Gas“, 6 January 2012, cen.acs.org, http://cen.acs.org/articles/90/web/2012/01/Molecules-Protect-Brain-Nerve-Gas.html, Last Checked 16 January 2012.
- “A new family of oxime compounds can cross the blood-brain barrier in mice and protect the animals from nerve gas poisoning. The researchers who developed them hope the molecules could serve as antidotes for exposure to the gases or certain pesticides.”
- “One of the most common antidotes for nerve gas exposure is pralidoxime. (Soldiers carry syringes filled with the compound in case of a chemical weapons attack.) It reactivates cholinesterases when the molecule’s oxime group breaks the bond formed between the organophosphate and the enzyme.”
- “But pralidoxime has a problem: It contains a positively charged quaternary amine, which prevents it from slipping through the blood-brain barrier. So although pralidoxime can undo paralysis in respiratory tissue, it can’t alleviate problems within the central nervous system.”
- “To overcome this problem, John Cashman and his team at the Human BioMolecular Research Institute, a nonprofit organization in San Diego, designed a set of oximes that replace the quaternary amine with an amidine. This group can be neutral in charge, allowing the molecule to pass into the brain.”
- “In a test of the new molecules’ efficacies, several of them protected mice from a lethal dose of a sarin mimic when researchers injected the compounds into the animals. None of the treated mice succumbed to the poison, but half of the mice that received no treatment died. The researchers found high levels of the amidine-oximes in the treated animals’ brains. Next Cashman and his colleagues want to test their compounds to see if they can protect the brain from pesticide poisoning.”