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How Science Policy Affects Pandemic Pathogen Research

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By: Samuel Porter, PhD

         In 2012, a pair of studies were published in Nature and Science weeks apart igniting one the biggest national debates about science in recent memory. These studies demonstrated that a few mutations in the highly pathogenic H5N1 strain of influenza virus (colloquially known as “bird flu”) could enable it to be transmitted through the air to mammals. At the heart of controversy was the question of whether scientists should be creating more virulent and/or pathogenic strains of deadly viruses in the lab. This controversial research is known as “gain of function” studies.

Critics claimed that the research was too dangerous that the risk of an accidental or deliberate release of these lab strains was far greater than the scientific and public health benefits. In an attempt to respond to the growing concern over their work, the community of researchers working with these pathogens voluntarily agreed to suspend this gain of function research for 60 days to discuss new policies on conducting the research safely.

But that was not enough to satisfy critics of the research, who continued to lobby the Obama administration to take official action. On October 17, 2014 the White House Office of Science and Technology Policy (OSTP), abruptly announced a pause on all U.S. Government funding of gain of function research on influenza, Middle East respiratory syndrome (MERS), and severe acute respiratory syndrome (SARS) coronavirus until the National Science Advisory Board for Biosecurity (NSABB) could make recommendations for policy regulating the research going forward. The NSABB was formed in 2005 (in the wake of the anthrax attacks in 2001), and is composed of scientists from universities around the nation, and administrators from 14 separate agencies in the federal government. The board reports to the Secretary for Health and Human Services (HHS) and is tasked primarily with recommending policies to the relevant government entities on preventing published research in the biological sciences from negatively impacting national security and public health.

The move drew harsh criticism from researchers in the field, many of whom thought that it was too broad. They claimed it would jeopardize their ability to predict, detect, and respond to potentially emerging pandemics. In the private sector, several companies said that the order would prevent them from working on new antiviral drugs and vaccines. Furthermore, many young scientists worried that an inability to do their experiments could jeopardize their careers. In an effort to bring attention to the issue, many scientists (including the two flu researchers whose research triggered the pause) formed the group Scientists for Science, which advocates against blanket bans on research. In addition, researchers were especially upset by the recommendation of the NSABB to censor the publications resulting from the experiments due to fears that this research could have a “dual use” that would threaten national security. However, not all researchers in the field support gain of function research (the opposition group is called Cambridge Working Group) and maintain that the risks of the research outweigh benefits.

The moratorium lasted until January 9th, 2017, when the OSTP released the guidelines for funding this research in the future. The new rules are essentially the same recommendations put forth by the NSABB seven months earlier. The NSABB had concluded that these studies involving “potentially pandemic pathogens” (PPP) do indeed have important benefits to public health, but warranted additional screening prior to funding approval. It directed federal agencies to create a pre-funding review mechanism using eight criteria (including whether the pathogen is likely to cause a naturally occurring pandemic, and if there are alternative methods of answering the scientific question). The results of these reviews must be reported to the White House OSTP. Importantly, the policy was implemented in the final days of the Obama administration rather than leave it to the incoming Trump administration, who, as of this date, has yet to fill nearly any top science positions, and may not have issued guidance for months, if at all.  Researchers welcomed the decision to finally lift the ban, but questioned when the projects would be allowed to resume.

What can we learn from this situation from a science policy perspective? First, we must learn not to overreact to hysteria regarding the risks of this type of research. Indeed, there are risks in performing research on potentially pandemic strains of influenza and other pathogens, as there are with other types of research. But issuing overly broad, sweeping moratoriums halting ground breaking research for years is not the answer, nor is government censorship of academic publication. While in the end, the studies were given the green light to resume, and were published without modification, there is no making up for the lost time. These studies are not machines than can simply be turned on and off on a whim without repercussions. When we delay research into learning how viruses become pandemic, we hurt our ability to detect and respond to naturally occurring outbreaks. Additionally, when American scientists are prevented from doing research that other countries are still pursuing, American leadership in the biomedical sciences is at a competitive disadvantage. (The European Academies Science Advisory Council also recently updated its recommendations for PPP research in 2015, but did not institute a moratorium.) What we learn from these studies could potentially save countless lives. Secondly, the freedom to publish without any government censorship must be valiantly defended in any and all fields, especially with a new administration with an aggressively anti-science and anti-climate stance. Lastly, the scientific community must do a better job educating the public both on the importance of these studies from a public health perspective, and on the precautions put into place to ensure that these studies are conducted safely.

In the future, there will inevitably be debates over the safety or ethics of the latest experiments in a particular field. In attempting to wade through the murky waters of a complex controversy, science policy makers should make decisions that balance public health, safety, and ethics, rather than reactionary policies like censorships and moratoriums.

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April 21, 2017 at 8:47 am

Science Policy Around the Web – July 29, 2016

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By: Eric Cheng, Ph.D.

Photo source: pixabay.com

Clinical Trials

Europe overhauls rules for ‘first-in-human’ trials in wake of French disaster

Following the disastrous clinical study in Rennes, France in January 2016 that resulted in the death of one volunteer and the hospitalization of five more, efforts are being taken by the European Medicines Agency (EMA) to improve identify and reduce risks in human clinical trials. EMA proposed changes to the current guidance on first-in-human clinical trials in a new concept paper which has been released for public comment.

The current guidelines for “first-in-human” (FIH) studies on healthy volunteers date to 2007 after a similar tragedy in London in 2006. Nine volunteers were hospitalized with severe adverse events after receiving a monoclonal antibody named TGN1412 for the first time.

The concept paper states that the role of pharmacology and toxicology data in estimating the therapeutic dose, increases in dosing, and stopping criteria need to be addressed in the revised guideline. Also, other subjects will be addressed which include new instructions for decision-making processes and stopping rules, rolling review of emerging human data during the study, communication to authorities and subjects, and guidance on the type of scientific information to be included in a trial application. The deadline for comments on this concept paper is September 30, after which it will publish a draft revised guideline later this year.

These changes are a direct response to the French clinical trial which has been criticized for its lax design. The trial protocol allowed the study to move to additional phases without external review such as an analysis of pharmacokinetic data of the previous cohort. The prosecutor is still investigating whether involuntary manslaughter charges are warranted in the case. (Hinnerk Feldwisch-Drentrup, ScienceInsider)

Climate Change

Cleaner air may be driving improvements in Chesapeake Bay water quality

A new study suggests that cleaner air may be the main driving force on  the improvement in water quality in the Washington, DC metro area, including the Chesapeake Bay.

The Chesapeake Bay is the nation’s largest estuary. For decades it has suffered from excessive nutrient and low oxygen conditions. Although land-based management practices and improvements to wastewater treatment plants have helped to improve water quality in the Chesapeake Bay, researchers have found that improvement in air quality is the primary driver of improvements in water quality in the area studied – the Upper Potomac River Basin which covers 12,000 square miles in Maryland, Virginia, West Virginia, Pennslvania, and the District of Columbia. It is believed that these region-wide water quality benefits were due to the implementation of the Clean Air Act of 1990.

“The recent water quality successes in the Chesapeake Bay restoration are apparently driven more by air quality regulation rather than by water quality control efforts,” said study author Keith Eshleman, professor at the University of Maryland Center for Environmental Science’s Appalachian Laboratory. “These air quality regulations were intended to address human health issues and acid sensitive streams. No one thought you would have this positive impact on water quality. It was totally unanticipated.”

One cautionary note is that the apparent reversibility of the process means that a relaxation in air quality regulation would lead to a reversal in the direction of watershed water quality across the basin. (Keith N. Eshleman and Robert D. Sabo, Atmospheric Environment)

Science and Society

Turkish academics targeted as government reacts to failed coup

After the failed July 15th coup attempt, the Turkish government has disrupted higher education. As part of a massive political purge, educators across the country have been suspended from their roles. “They are restructuring academia,” says Caghan Kizil, a Turkish molecular biologist based at the Dresden University of Technology in Germany who has been in close communication with colleagues in Turkey. “People are very scared and not hopeful.”

In the span of a few days, more than 45,000 civil servants in the military and judiciary have been fired or suspended. In addition, it appears that some 15,000 staff members of the ministry of education also were fired, with 21,000 teachers losing their professional licenses, and more than 1500 university deans were all but ordered to resign. Turkish academics currently abroad have also been ordered back by the government. “They want to take the universities under their full control,” says Sinem Arslan, a Turk doing a political science Ph.D. at the University of Essex in the United Kingdom. “Academic freedoms will no longer exist. I don’t think that anybody will be able to work on research areas that are considered taboo by the government or write anything that criticizes the government.”

The motives behind this new crackdown is currently not known. However, the truth may emerge from an unexpected source – Wikileaks. This whistleblower site released nearly 300,000 emails allegedly written from Turkish government officials going back as far as 2010. Time will tell if this new information will shed light on the motives behind the new crackdown on education and research in Turkey. (John Bohannon, ScienceInsider)

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July 29, 2016 at 9:00 am

Science Policy Around the Web – December 22, 2015

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By: Allison S. Burrell, MS, MPhil

Photo credit: via pixabay.com

Nuclear Policy and Science Diplomacy

When Scientists Do What Diplomats Can’t

Scientists are playing a role in ongoing nuclear negotiations with Iran’s Atomic Energy Organization and the United States, as well as five other PN+1 countries. An agreement was signed in July 2015, and as of September, new bids by the US Senate have not been able to hinder the deal from moving forward. As this deal is implemented, economic sanctions against Iran currently in place will be slowly lifted in exchange for increased controls on Iran’s nuclear-weapons program. Science diplomats partner with political diplomats to ensure a proper understanding of the scientific details underlying the economic negotiations underway. This type of partnership is essential, and science diplomacy has been integral in international politics related to atomic weapons since the Manhattan Project back in 1945.

Scientists travel the world communicating and sharing their science through topic-specific conferences. This creates an international community of scientists, where borders are blurred and science is the common language. US secretary of Energy’s Ernest Moniz, and Iran’s head of the Atomic Energy Organization, Ali Akbar Salehi, both went to MIT, although at different times. But their common ground in physics and nuclear engineering allowed for a more personal relationship during these heated economic negotiations. It is proposed that the language of science is what brought the Iranian atomic negotiations back on track, accomplishing what political negotiations alone could not. Those who oppose the Iranian deal fundamentally disagree with the politics, yet still praise scientists’ role in negotiations. Scientists alone can’t be expected to understand the intricacies of political negotiations. Science diplomacy is slowly becoming a more popular term. The international editor for Science magazine, Richard Stone, believes that scientists “can come together and bond over a common cause…no matter where they are [from]”, and this is a strength that can be harnessed in the international diplomatic forum. (Audra Wolfe, The Atlantic)

Biosafety, Biosecurity and Risk

A more systematic approach to biological risk

In the past few years there have been worrying events that lay out the question of the status of biosafety and biosecurity in the U.S. Just last year, vials labeled variola, aka smallpox, were found in a freezer at the National Institutes of Health, and later determined to be viable. These pathogens, such as anthrax, smallpox and avian flu, have strict handling and storage protocols, which were not properly followed. In response to these events, as recently as October 2015, the White House laid plans, through a memorandum, to improve U.S. biosecurity and biosafety. Managing biological risk is a top priority, yet not much has changed since the well-known 1975 Asilomar meeting, which discussed the potential guidelines for using recombinant DNA.

Current meetings to address new biotechnology issues are still coming up short. Emerging biosafety and security issues cannot be treated solely as technical issues, but must also be represented from a governance standpoint. The National Institutes of Health, being the largest scientific funding agency in biological research, is currently evaluating a risk-benefit analysis of gain-of-function research, just as the National Academies of Science are evaluating gene editing and gene drives. Without outside governance, the end results run the risk of being biased towards success at any cost. Since the people making the decisions are specialists, they are also often involved in conducting the research, creating a conflict of interest. There is something to the thought, that if you are too close to a problem/project, you can’t see mistakes or alternatives.

There are committees or boards, such as the National Science Advisory Board for Biosecurity (NSABB), or the Presidential Commission for the Study of Bioethical Issues (PCSBI), that help with overseeing guideline creation for new biotechnologies. But these committees lack authority to impose rules that highlight biosecurity and risk. Mechanisms that are effective at regulation lie mostly in blocking or rescinding public funding, or inflicting fines. Transparency, through public reporting, is lacking, and this hinders investigations looking into improving risk strategies.

The advancement of scientific discovery is inevitable, and in order to protect our future, political and scientific realms must meet in a new arena, thus fostering a side-by-side collaboration of political and technical expertise. Science diplomacy, even on a national level, is key to moving forward with biosafety and biosecurity regulations. A new oversight position, as well as a coordinating committee, should be created in the U.S. government; that which focuses on anticipating and managing biotechnological risks, and works closely, through accountability and transparency, with the NIH, other federal agencies, and organizations intimately involved in emerging biotechnologies. (Megan J. Palmer, Francis Fukuyama and David A. Relman, Science Magazine)

Federal Funding for Science

Congress ready to give NIH its biggest increase in 12 years

The National Institutes of Health, a world leader in biomedical research and funding, has experienced budget cuts across the board over the past decade, in line with other federal institutions. Although biomedical research is arguably one of the most important science endeavors to invest in the security of our future health, a budget increase has not been seen in over 12 years. A new federal spending bill is up for vote in Congress, and was introduced on December 16, 2015. If it passes the house, and the Senate, the NIH will receive a $2 billion funding increase. But a bipartisan compromise will be necessary to get this all the way to Obama’s desk to be signed into law.

Some of the hottest research topics receiving new funding with this bill are as follows: $200 million is allocated for a new presidential Precision Medicine Initiative, $350 million for Alzheimer’s research, $85 million for the BRAIN Initiative, $303 million in the effort to combat antibiotic-resistant bacteria, and $91 million towards opioid abuse programs.

NIH released a strategic plan of growth for the agency over a four-year period. How the new funding will be used towards this end is yet to be determined, since it was released before knowledge of the potential funding increase. Amazingly, even with the funding growth, adjusted for inflation, the NIH’s purchasing power is not comparable to its peak in 2003. Republican representative Tom Cole of Oklahoma wants a new goal for the future; to not just increase the budget this year, but in years to come as well.

Policy changes associated with the new spending bill include a hold on the Obamacare medical device tax for two years. The current restrictions preventing the CDC from researching gun violence, in effect for about 20 years, will not be lifted. The new legislation will limit e-cigarettes pre-market reviews. And new policy on genetically engineered salmon dictates that it will not be sold until new labeling guidelines are in place. (David Nather and Dylan Scott, Stat News)

Update: This spending bill passed both the house and the senate, and was signed into law by President Obama.

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December 22, 2015 at 9:00 am

Science Policy Around the Web – September 6, 2014

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By: Tara Burke, Ph.D.

photo credit: Kris Krug via photopin cc

Environment

Time to focus on committed, not current, carbon emissions, study argues – A new study published in Environmental Research Letters argues that instead of focusing on annual carbon emissions, scientists and policy makers should track committed emissions. Committed emissions track how much energy infrastructure we’ve already built and adds up the emissions those infrastructures are projected to produce during their forecasted lifetime. The authors of the study argue that this is a superior method of highlighting the climate challenge Earth faces. The traditional measurement of annual emissions has masked the problematic growth of committed emissions. Adoption of committed emissions will hopefully enable policymakers to recognize the implications of today’s policies on future policies and may help developing countries adopt energy infrastructure of lower carbon intensity.  (Eli Kintisch)

 

Infectious Disease

Ebola now threatens national security in west AfricaThe spread of Ebola has become so entrenched in west Africa that it now poses a real risk to the stability and security in the region. The Ebola virus continues to spread and its outbreak is stressing the infrastructure of many west African countries that must still provide basic health, security and commercial practices despite the outbreak. Fear has also become a huge hindrance to stopping the outbreak. Citizens are fearful of hospitals and risk not being treated for other maladies and health workers are afraid to go to their jobs. CDC director, Tom Frieden, is urging the world to respond quickly. He states that “the window of opportunity really is closing”. The CDC recommends scaling up medical supplies and recruiting more health care management experts to the region. The World Health Organization has asked for $490 million to help with the response.   (Dina Fine Maron)

 

Biosafety

White House orders biosafety review at federal labs – In the wake of three recent U.S. biosafety and biosecurity incidents, the White House is asking federally funded labs studying infectious agents to inventory samples and review safety and security procedures. These steps are not mandatory for extramural labs with federal funding. The memo asks these labs to perform a ‘Safety Stand-Down’ where leaders will review practices and protocols. During this time, laboratories will also develop plans to consistently monitor their inventory. Additionally, labs are also asked to do an ‘immediate sweep’ for select infectious agents and toxins that may potentially cause harm and make sure these samples are either properly registered or destroyed. While some are supportive of this move by the White House to regulate biosafety, some are criticizing it as too weak arguing that most select agent work occurs at academic or nonfederal labs where these procedures are not required. (Jocelyn Kaiser)

 

 

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September 6, 2014 at 12:58 pm

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Science Policy Around the Web – January 3, 2013

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photo credit: USFWS Pacific via photopin cc

photo credit: USFWS Pacific via photopin cc

By: Jennifer Plank

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

Frankenfish on the menu? FDA gives final approval – AquaAdvantage salmon, a genetically modified Atlantic salmon also dubbed “Frankenfish”, has been approved by the FDA.  The AquaAdvantage salmon contain genes from Chinook salmon and an eel-like species called an ocean pout. The addition of these specific genes allows the fish to grow more rapidly. Atlantic salmon normally take 3 years to be large enough for consumption while the AquaAdvantage salmon will be large enough within 18 months. The approval from the FDA will be followed by a 60 day period of public commentary regarding AquaAdvantage salmon. After that time, the AquaAdvantage salmon can be approved for human consumption. (Marc Lallanilla)

BGI clears hurdle in buyout of Complete Genomics – BGI (formerly called the Beijing Genomics Institute) has been an active player in genome wide sequencing including playing an instrumental role in the Human Genome Project. However, BGI has been dependent on sequencing instruments from companies such as Illumina. Recently, BGI has gained approval from the United States to buy the California-based company, Complete Genomics, who has developed their own complete sequencing platform. With the acquisition of Complete Genomics, BGI will be able to sequence individual genomes without being dependent on other companies. (Ryan McBride)

Child support claim rankles sperm donor to lesbian couple – In 2009, William Marotta donated sperm to a lesbian couple wishing to have a child. At the time, the couple and Marotta signed a document stating that he would not be the father of the child nor would he be financially responsible for the child. Since then, the couple has broken up and fallen on hard financial times. One mother of the child applied for Medicare to cover the child’s medical expenses and the state of Kansas deemed the father financially responsible for the expenses. The state of Kansas is suing Marotta for child support and approximately $6000 for the medical care of the child. A hearing about the case will be held on January 8, and at that time, Marotta will ask for the case to be dismissed. (Kevin Murphy)

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January 3, 2013 at 5:05 pm

Science Policy Around the Web – March 14, 2012

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By: Science Policy For All Contributors

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

111 Organizations Call for Synthetic Biology Moratorium – A coalition of environmental, watchdog, and social justice organizations have issued a position paper calling for a complete moratorium on synthetic biology activities.  The link in the article to the report seems misdirected, but the original position paper can be found here.  (by Elizabeth Pennisi via ScienceOnline)

UK medical research in jeopardy due to animal import boycott – Another article on this topic reiterated that only two airlines (which have circuitous routes that extend shipping times and thus animal stress) are now carrying research animals into the UK.  This is particularly bad news for anyone who needs to import a transgenic animal (animal with a particular genetic background of interest in studying certain diseases) that might only be available from a non-UK source.  (by Maria Cheng via the Associated Press)

Why Don’t Americans Elect Scientists? – An excellent question, given the dearth of scientists in Congress.  John Allen Paulos suggests that one reason is “that an abstract, scientific approach to problems and issues often leads to conclusions that are at odds with religious and cultural beliefs and scientists are sometimes tone-deaf to the social environment in which they state their conclusions. A more politically sensitive approach to problems and issues, on the other hand, often leads to positions that simply don’t jibe with the facts, no matter how delicately phrased.”  This article touches on the odd love-hate relationship Americans have with scientists.  (via the New York Times)

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March 14, 2012 at 4:19 pm

Controversial H5N1 Influenza Research

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By Adele Blackler

H5N1, the highly pathogenic and deadly avian flu, has been causing panic since it first appeared in Hong Kong in 1997.  Though the flu has a high mortality rate, it is very rarely transmissible between humans, and thus there has been no widespread epidemic or pandemic resulting from H5N1[i].

However, the announcement last year by two research groups, from the U.S. and the Netherlands, that they had identified key mutations that made the flu highly transmissible among ferrets, caused an outcry among the public and the scientific community.  The U.S. National Science Advisory Board for Biosecurity, NSABB, raised concerns that full publication of the research methods could give potential bioterrorists a new weapon and asked that only redacted methods be published, to make it difficult to duplicate the results[ii].

Recently, a special World Health Organization (WHO) panel convened to discuss the flu research and, after discussion with the research authors and leading scientists in the field, recommended that the current voluntary halt to research should continue until a more thorough analysis of laboratory biosafety could be completed[iii]. However, in the interest of aiding public health efforts and scientific research, the WHO panel recommended that both papers be published with complete methods, meaning that the published methods will be complete enough to be replicated by other labs around the world with access to the starting material.  In response, the NSABB has requested a second look at the manuscripts and research and Congressional Representative Jim Sensenbrenner (R-WI) has questioned why this research was funded by the National Institutes of Health (NIH) in the first place[iv].

In an influenza pandemic, early detection and tracking is essential to being able to slow the spread of the virus and mitigate damage by quickly developing a vaccine.  Understanding what mutations can make the H5N1 flu transmissible could help with early detection of emerging pandemic-causing strains and could make tracking the flu easier. This research could play a key role in understanding how the avian flu can become transmissible among humans, and that could help with early detection.  Ultimately, if the H5N1 flu becomes highly transmissible among humans and turns into a pandemic-causing strain, early detection could save a countless number of lives.

Is the possibility of great public benefit enough to allow the H5N1 research to continue?  Supporters of continuing this line of research point to the 1970s, when a new type of experiments involving altering DNA made headlines.  Recombinant DNA research was also temporarily halted due to safety concerns, yet today DNA recombination experiments are routinely performed with no risk to health and safety[v].

Or is the risk that the deadly virus could escape the lab simply too great to justify continuation of the research? If research continues, what security measures should be in place? Further complicating the current debate is that many scientists in favor of H5N1 research are disagreeing about the biosafety level (BSL) a lab should have in place while working with the virus.  Currently, most infectious disease labs work with the second highest level of biocontainment, BSL3.  This is the same biocontainment level that was used for the current H5N1 research.   Individuals in favor of raising the required BSL to the highest possible level (BSL4) argue that it is the safest way to work with the virus and minimize exposure. However, few labs in the nation are equipped for BSL4, and requiring such a high level of security might unduly restrict who can perform research on H5N1, effectively putting an end to most of the research on the virus[vi].

Currently, it looks like research on the engineered flu strain will resume at the end of the voluntary moratorium, and the results will most likely be published with full, not redacted, methods.  However, the debate on whether or not this research should continue, and if the proposed benefits outweigh the possible risks, will continue for quite some time.


[i]            http://www.sciencemag.org/content/335/6070/802.full

[ii]            http://news.sciencemag.org/scienceinsider/2012/03/nsabb-members-react-to-request.html

[vi]         http://www.eurekalert.org/pub_releases/2012-03/asfm-nhv030112.php

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March 13, 2012 at 7:55 am

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