Developmental Milestones/Developments to Date:
Current Assessment/State of the Field:
Osterholm, Michael T.,”SARS: How effective is the state and local response?” Hearing before the Permanent Subcommittee on Investigations, May 2003, pgs 14-16.
- “There is a critical need for our country to prepare its homeland security against human-made and Mother Nature-made biological attacks.”
- “There is a growing threat of emerging infections and use of biologic agents as a form of terrorism.”
- “Federal agencies such as the Department of Heath and Human Services, and Department of Homeland Security have been responding to such threats.”
- “The United States has fortunately been lucky as compared to places like Toronto, Canada, who has seen the worst of the SARS pandemic.”
- “Their country is experiencing impacts on mortality rates, as well as economic and social impacts.”
- “SARS is a disease transmitted via respiratory route that has now seeded itself in a sufficient number of humans which could make elimination impossible.”
- “It is imperative that we coordinate the roles of Federal, State and local agencies.”
- “We also need to understand the capabilities of our health care delivery systems and the private sector in responding to this problem.”
MacKenzie, Debora, “Experts Fear Escape of 1918 Flu from Lab ,” New Scientist, October 21, 2004. http://www.newscientist.com/article/dn6554-experts-fear-escape-of-1918-flu-from-lab.html
- “‘The potential implications of an infected lab worker – and spread beyond the lab – are terrifying,’ says D. A. Henderson of the University of Pittsburgh, a leading biosecurity expert.”
- “‘All the virologists I have spoken to have concerns,” says Ingegerd Kallings of the Swedish Institute for Infectious Disease Control in Stockholm, who helped set laboratory safety standards for the World Health Organization.’”
- “Kallings and others are calling for international discussions to resolve the issues related to such work. ‘It is time for influenza scientists to find a consensus on containment,’ she says. John MacKenzie of the University of Queensland in Australia, who investigated how the SARS virus escaped from high-level containment labs in east Asia on three occasions after lab workers became infected, agrees. ‘A meeting would be beneficial.’”
- “The team started the work at the highest level of containment, BSL-4, at Canada’s National Microbiology Laboratory in Winnipeg. Then they decided the viruses were safe enough to handle at the next level down, and did the rest of the work across the border in a BSL-3Ag lab in Madison.”
- “The main difference between BSL-4 and BSL-3Ag is that precautions to ensure staff do not get infected are less stringent: while BSL-4 involves wearing fully enclosed body suits, those working at BSL-3Ag labs typically have half-suits.”
- “Kawaoka told New Scientist that the decision to move down to BSL-3Ag was taken only after experiments at BSL-4 showed that giving mice the antiviral drug oseltamivir (Tamiflu) in advance prevented them getting sick. This means, he says, that if all lab workers take oseltamivir ‘they cannot become infected’.”
- “Terrence Tumpey’s team at the US Department of Agriculture’s poultry research lab in Athens, Georgia, got quite different results: they found that mice given oseltamivir still got sick and 1 in 10 died. It is not clear why Kawaoka’s mice fared better.”
- “Yet Kawaoka’s decision does comply with the US National Institutes of Health guidelines for BSL-3 agents: those causing ‘serious or lethal human disease for which preventive or therapeutic interventions may be [its italics] available.’”
- “By contrast, the team in Georgia, the first to experiment with genetically engineered 1918 viruses, did all its work at BSL-3Ag. Meanwhile, Michael Katze at the University of Washington at Seattle is planning to expose monkeys to aerosols of 1918-type viruses at BSL-3, a step down from BSL-3Ag. The recent SARS escapes were from BSL-3 labs.”
- “‘We would have to do any such work at BSL-4,’ says John Wood of the UK’s National Institute for Biological Standards and Control. In the US, the differing standards applied by different groups are due to the fact that experiments on engineered viruses such as the 1918 flu are approved on a case-by-case basis by Institutional Biosafety Committees (IBCs), composed of local scientists and officials. Critics say these are free to interpret the official guidelines in a way that suits them.”
- “‘There is no effective national system to ensure consistency, responsibility and good judgement in such research,’ says Edward Hammond of the Sunshine Project, a biosecurity pressure group in Austin, Texas. In a review of IBCs published this month, he found that many would not provide minutes of recent meetings as required by law.”
- “He [Hammond] says the IBC that approved the planned 1918 flu study at the University of Washington considered only one scenario that could result in workers being exposed to airborne virus – the dropping of samples. Its solution: lab workers ‘will be trained to stop breathing.’”
Altman, Lawrence, K., Santora, Marc, “Risk From Deadly Flu Strain Is Called Low,” NYT, April 14, 2005.
- Lab mistake contaminated specimen with dangerous 1957 strain.
- Mistake in sending out H2N2, Level 2 microbe subject to upgrade.
Editors, “Ebola vials found in car trunk: Ex-Winnipeg scientist arrested at U.S. border,” Toronto Star, A29, May 14, 2009,
- ”Konan Michel Yao, 42, is in U.S. custody charged with smuggling.”
- ”The U.S. Centers for Disease Control, which has possession of the missing vials, has determined some contain small amounts of genetic Ebola material, said Plummer.”
- ”Dr. Frank Plummer, head of the Winnipeg lab, said Yao did not have security clearance to work with high-level pathogens such as the Ebola virus. But he was allowed to work on an Ebola vaccine project in the facility’s special pathogens unit.”
- ”The vials, according to court documents, were in a glove, wrapped in aluminum foil and placed in a plastic bag. They were found in the trunk of the scientist’s car.”
- ”But he [Plummer] added the material poses no risk to public health. ‘It was not infectious,’ Plummer told reporters yesterday. ‘The only thing (Yao) could have done with it would be to make an Ebola vaccine.’”
- “Yao left work in January when his research fellowship ended and he signed a document swearing he had not taken any government property, said Plummer.”
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.”
Pollack, Andrew, “In Vaccine Additive, Benefit and Doubt“, NYT, D1, Sept. 22, 2009.
- “Are Americans obliged to use an unproven vaccine to help protect people in other countries from the flu pandemic? That is the crux of a debate over adjuvants”
- “Early studies suggest that adjuvants (pronounced AD-joo-vants) could allow four times as many people to be immunized against H1N1 pandemic influenza with a given amount of vaccine.”
- “But while Canada and some European nations will use vaccines containing adjuvants, American officials have decided against it for now.”
- “Officials also fear that using an adjuvant would raise public fears about vaccine safety at a time when their challenge might be about to shift from producing enough vaccine to persuading people to use it.”
- “…There’s a concern that people would be reluctant to get vaccinated,’ said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.”
- “Officials say, one reason to use adjuvants is that they can increase a vaccines’s potency against a virus to which it is poorly matched. But the swine flu vaccine is well matched to the virus, which has not mutated.”
McNeill, Donald, G., “Transfers of Surplus Flu Vaccine Are Going Slowly to Countries That Need It,” NYT, A15, February 2, 2010.
- “There is now so much unused swine flu vaccine in the world that rich nations, including the United States, are trying to get rid of their surpluses.”
- “…95 countries that told the World Health Organization last year that tehy had no means of getting flu vaccine…”
- “… countries that can afford vaccines save themselves first and, when the worst has passed, transfer their leftovers to the poor, using the W.H.O. as a clearinghouse. …’it’s a very complex operation.'”
- “Each country must submit a plan proving it can store and refrigerate vaccine, give it to those who need it most, inject it safely and do medical follow-up. It must also sign letters exempting donors from legal liability, and the W.H.O. has to certify the vaccine as safe if the country has no regulatory agency.”
- “Bill Gates … dismissed flu vaccine shipments a ‘a pipe dream.’ ‘It’s not practical; they have no infrastructure to deliver it.’
- “At first , there was deep skepticism; 80 percent of French residents polled said they would refuse. But after a few deaths were reported, such huge lines formed that, in Lyon, the riot police were called.”
- “The chairman of the Swiss pharmaceutical company Novartis, Daniel Vasella, recently warrned governments breaking their contracts might not be be first in line in the next pandemic. ‘Reliable partners will be treated preferentially,’ Mr. Vasella said.”
- “Canada recently lent Mexico five million doses because Mexico’s first shipments were not due to arrive until this month. Similar bilateral deals took place between Western and Eastern Europe, a W.H.O. spokesman said.”
- “The [U.S.] cancellation of 22 million doses out of 36 million ordered from CSL Ltd., an Australian manufacturer that fell behind on orders anyway…”
- “The [US] country also promised 25 million doses to the W.H.O. [and the rest will be stockpiled in bulk antigen form, i.e. a portion of which will not placed in viles.] an extra step that involves a seperate payment.”
McNeill, Donald, G., “Flu Shots in Children Can Help All Ages, Study Says,” NYT p. A16, March 10, 2010.
- “Although previous studies have demonstrated what scientists call ‘herd immunity,’ none have been so incontrovertable, because they were done in less isolated places with more sources of flu passing through.”
- “Dr. Anthony Fauci … added that its results validated the American government’s decision to vaccinate children first during the recent swine flu epidemic.”
- “In 25 of the colonies that joined, all children ages 3 to 15 received flu shots in late 2008; in 24 others, they received hepatitus A vaccine instead.”
- “There was a 60 percent ‘protective effect’ for the whole community, the study concluded.”
- “It implies, Dr. Bridges said, that giving flu shots only to school children would protect the elderly just as well as giving flu shots to the elderly themselves.”
Palmer, Randall, “Canada Firms to Capitalize on Nuclear Trade with India”, November 6, 2012, Reuters, U.S. Edition, http://www.reuters.com/article/2012/11/06/us-india-canada-idUSBRE8A50M520121106 Last checked February 14, 2013.
- ”Canadian firms will be able to export uranium and nuclear reactors to India for the first time in almost four decades under an agreement between the two nations, their prime ministers said, but more work is needed to implement the deal.”
- ”Once implemented, the agreement will end a ban on nuclear cooperation Canada imposed in 1976 after India secretly exploded its first nuclear bomb in 1974, commonly called the “Smiling Buddha”, using material from a Canadian-built reactor in India.”
- ”India aims to lift its nuclear capacity to 63,000 MW in the next 20 years by adding nearly 30 reactors. The country currently operates 20 mostly small reactors at six sites with a capacity of 4,780 MW, or 2 percent of its total power capacity, according to the Nuclear Power Corporation of India Limited.”
- ”However, the CNSC official said India would now be required to notify Canada of any transfers to a third country and trade could only go to facilities that are safeguarded by the IAEA.”
Fouchier, Ron, García-Sastre, Adolfo, Kawaoka, Yoshihiro et al., “Transmission Studies Resumefor Avian Flu,” Science Express – Letters, January 23, 2013 http://www.sciencemag.org/content/early/2013/01/22/science.1235140.full.pdf last checked January 24, 2013.
- ”In January 2012, influenza virus researchers from around the world announced a voluntary pause of 60 days on any research involving highly pathogenic avian influenza H5N1 viruses leading to the generation of viruses that are more transmissible in mammals. We declared a pause to this important research to provide time to explain the public-health benefits of this work, to describe the measures in place to minimize possible risks, and to enable organizations and governments around the world to review their policies (for example on biosafety, biosecurity, oversight, and communication) regarding these experiments.”
- ”The World Health Organization has released recommendations on laboratory biosafety for those conducting this research, and relevant authorities in several countries have reviewed the biosafety, biosecurity, and funding conditions under which further research would be conducted on the laboratory-modified H5N1 viruses. Thus, acknowledging that the aims of the voluntary moratorium have been met in some countries and are close to being met in others, we declare an end to the voluntary moratorium on avian flu transmission studies.”
- ”The controversy surrounding H5N1 virus transmission research has high-lighted the need for a global approach to dealing with dual-use research of concern.”
- ”Because H5N1 virus transmission studies are essential for pandemic preparedness and understanding the adaptation of influenza viruses to mammals, re-searchers who have approval from their governments and institutions to conduct this research safely, under appropriate biosafety and biosecurity conditions, have a public-health responsibility to resume this important work.”
- ”Scientists should not restart their work in countries where, as yet, no decision has been reached on the conditions for H5N1 virus transmission research. At this time, this includes the United States and U.S.-funded research conducted in other countries.”
- ”Scientists should never conduct this type of research without the appropriate facilities, oversight, and all necessary approvals. We consider biosafety level 3 conditions with the considerable enhancements (BSL-3+) outlined in the referenced publications as appropriate for this type of work, but recognize that some countries may require BSL-4 conditions in accordance with applicable standards (such as Canada).”
- ”We fully acknowledge that this research—as with any work on infectious agents—is not without risks. However, because the risk exists in nature that an H5N1 virus capable of transmission in mammals may emerge, the benefits of this work outweigh the risks.”