Can Science Be Trusted Without Government Regulaltion ???

Taking Sides: Clashing Views in Science, Technology, and Society Thomas Easton McGraw-Hill Education Unit 1 1.3 Can Science Be Trusted Without Government Regulation? Page 63 Critical Thinking and Reflection 3. Does publishing the full methods and results of the Fouchier and Kawaoka H5N1 studies seem likely to increase our ability to protect public health from future H5N1 pandemic?


nature International weekly journal of science


The risks and benefits of publishing mutant flu studies


Research describing two mutant strains of H5N1 avian influenza that spread between mammals is likely to be published in its entirety. Nature examines the controversial decision.


Ed Yong


March 2, 2012


Two teams of scientists, led by Ron Fouchier of Erasmus Medical Center in Rotterdam, the Netherlands, and Yoshihiro Kawaoka of the University of Wisconsin-Madison, have created mutant strains of H5N1 avian influenza. These laboratory strains could be passed between mammals more easily than wild strains of the virus.




Research into mutant strains of avian influenza (white) aims to reveal more about flu transmission mechanisms.


News of the research sparked an intense debate about whether the two teams’ work should be published in full to aid pandemic preparedness or redacted to prevent misuse by terrorists. A meeting convened by the World Health Organization two weeks ago in Geneva, Switzerland, concluded that the papers should be published in full, despite recommendations to the contrary from a US government advisory board. Nature takes a look at the debate and the science.



University of Wisconsin Madison


Influenza researcher Yoshihiro Kawaoka wins Breakthrough Award


October 7, 2014


Kelly April Tyrrell


The University of Wisconsin–Madison’s Yoshihiro Kawaoka has been recognized as a 2014 Popular Mechanics Breakthrough Award recipient for his efforts to understand and prevent pandemic influenza.


In recent years, Kawaoka has found himself at the center of controversy surrounding research on highly pathogenic influenza and other sensitive pathogens known as select agents. His studies to understand, monitor, treat and potentially prevent pandemic influenza have often been misrepresented and misunderstood.


However, according to Popular Mechanics — a science and technology-focused magazine published by Hearst Magazines — Kawaoka was chosen despite the controversy because his work studying mutations in viruses that are currently found in nature and carry pandemic potential could “help protect humanity.”


– See more at:


Popular Mechanics


Mike Magnuson


October 7, 2014




WHO Yoshihiro Kawaoka University of Wisconsin–Madison


FIELD Virology


ACHIEVEMENT Flu pandemic prevention research.


The virus sits in 2-milliliter vials inside a freezer kept at minus 80 degrees Celsius. At that temperature, in that deep of a deep freeze, the virus is preserved as if in amber, lying in wait. Under a microscope it looks something like a medieval battle weapon, a spherical object stabbed with dozens of little spikes, like the actual virus it was engineered to replicate: the 1918 strain of H1N1, otherwise known as the Spanish flu, a pandemic estimated to have killed more than 40 million people.


The freezer is locked and sealed inside a room made of concrete walls set within a lab surrounded by another set of walls—those outer walls made of 18 inches of concrete, every inch of it reinforced by steel rebar. A box within a box, as it’s known in the research world. Entry is through a series of rooms starting with air-locked, submarine-type doors, and the place is rigged with extensive alarms—more than 500 of them in all, spread throughout the building and attached to various pieces of equipment, ready to alert safety personnel and the campus police who monitor the facility around the clock if someone who doesn’t belong there tries to get in.


The freezers, the air-locked doors, the alarms—they must all operate perfectly, because perfection is the minimum requirement at the $12.5-million Influenza Research Institute. The facility sits on the outskirts of the University of Wisconsin-Madison, home of the Badgers, whose basketball team went to the Final Four this year. But the building seems a thousand miles from all that.


Assuming they pass the FBI background check necessary even for the administrative assistants who work there, employees entering the lab are required to remove all their street clothes, including undergarments. Once they put on dedicated scrubs, with shoe covers both inside and outside a pair of dedicated garden clogs, they access an anteroom outside the lab. To go into the laboratory, they need a different pair of clogs and shoe covers specific to that space, and must pull on a Tyvek jumpsuit, a hooded respirator outfitted with an air filter, and two pairs of disposable Tyvek gloves. Upon leaving, they take all that off in a specific order, then take a 5-minute shower with soap and water during which they are required to wash all orifices and blow their noses.


The suite that houses the virus is a BSL-3-Ag facility—essentially the most secure building of its kind in existence, give or take one or two features. (The building also houses research on the Ebola virus.) Not one particle of anything is allowed to escape.


The institute was built in 2008 largely to advance the efforts of one man, Yoshihiro Kawaoka, a professor of virology who several months ago published a study detailing his successful bid to build the virus—a strain of influenza that’s almost identical to the Spanish flu—from contemporary flu genes. For the study he infected ferrets with the virus and mutated the strain to make it more easily transmissible through respiratory droplets—in other words, from sneezing mammal to sneezing mammal.


Outside the concentric, secure rings of his research facility , and outside the comforts of Madison—the university, and officials in the state of Wisconsin itself, have been unwavering in their support of Kawaoka, to the point of constructing the $12.5 million building in order to fight off other suitors—that question has been debated by hordes of people with varying degrees of credibility.


His study of the H5N1 virus, because it detailed so precisely his methods for rebuilding the virus, was so controversial that a National Institutes of Health advisory panel recommended parts of the research be kept from the public when it was scheduled to appear in 2012 in the journal Nature.


nature International weekly journal of science


Mutant-flu paper published


Controversial study shows how dangerous forms of avian influenza could evolve in the wild.


Ed Yong


May 2, 2012


The first hints of Kawaoka’s work emerged last year, along with details of similar experiments led by Ron Fouchier at the Erasmus Medical Center in Rotterdam, the Netherlands. The news sparked intense discussion about whether the benefits of knowing about these potentially dangerous mutations outweighed the risks of publishing them openly. The US National Science Advisory Board for Biosecurity (NSABB) — an independent government advisory board — recommended in December 2011 that both papers should be censored before publication, citing concerns that the strains could be used by bioterrorists, or that untrammelled proliferation of the work would raise the risk of an accidental release from a lab.


But after a meeting that included international flu experts and health-agency representatives, the NSABB decided in March that revised versions of the two papers should be published in full (see ). The board was swayed by plans to tighten the oversight of such work, as well as by fresh information about the potential benefits to surveillance. It also acknowledged the difficulties in restricting access to the research. Fouchier has just received an export licence from the Dutch government, which has allowed him to submit his paper to Science (see ).

A mutant flu virus became more transmissible as it passed between lab ferrets, raising fears that mutations in the wild could create a human pandemic strain.


nature International weekly journal of science


Second mutant-flu paper published


Just five mutations allow H5N1 to spread between ferrets.


Ed Yong


June 21, 2012


The H5N1 ‘bird flu’ virus could evolve to spread through the air between ferrets by picking up as few as five mutations, according to a long-awaited study from Ron Fouchier from the Erasmus Medical Centre in Rotterdam, the Netherlands1. The paper is published today in Science after months of debate about whether the benefits of publishing the research outweighed the risks.


H5N1 can cause lethal infections in humans but it cannot spread effectively from person to person. Fouchier’s paper is the second of two publications describing how the virus could evolve this ability. The first, from Yoshihiro Kawaoka at the University of Wisconsin–Madison, involved a hybrid virus with genes from both H5N1 and the H1N1 strain behind the 2009 pandemic2 (see ). Fouchier’s mutant contains only H5N1 genes.

RE: Can Science Be Trusted Without Government Regulaltion?


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United States Department of Health and Human Services

United States Government Policy for Institutional Oversight of Life Sciences DURC 

On September 24, 2014, the United States Government released the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern . The policy addresses institutional oversight of DURC, which includes policies, practices, and procedures to ensure DURC is identified and risk mitigation measures are implemented, where applicable. Institutional oversight of DURC is the critical component of a comprehensive oversight system because institutions are most familiar with the life sciences research conducted in their facilities and are in the best position to promote and strengthen the responsible conduct and communication

This Policy and the March 2012 DURC Policy are complementary and emphasize a culture of responsibility by reminding all involved parties of the shared duty to uphold the integrity of science and prevent its misuse. Like the March 2012 DURC Policy, the scope of this Policy is limited to a well-defined subset of life sciences research that involves 15 agents and toxins and seven categories of experiments. The U.S. Government will solicit feedback on the experience of institutions in implementing the Policy; evaluate the impact of DURC oversight on the life sciences research enterprise; assess the benefits and risks of expanding the scope of the Policy to encompass additional agents and toxins and/or categories of experiments; and update the Policy as warranted.

Research institutions are encouraged to be mindful that research outside of the scope articulated in this Policy may also constitute DURC. Institutions have the discretion to consider other categories of research for DURC potential and may expand their internal oversight to other types of life sciences research as they deem appropriate, but such expansion would not be subject to oversight as articulated in this Policy.

The Federal Register Notice Response to Comments and Notice of Final Action Regarding the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern was published on September 25, 2014.

Bottom of Form

RE: Can Science Be Trusted Without Government Regulaltion?


Top of Form

Close to home for those of us who live in southern Ohio, as referenced by David R. Franz, from “The Dual Use Dilemma: Crying Out for Leadership”, Saint Louis University Journal of Health Law & Policy (2013).

The New York Times

Tests Indicate Seized Material Is Nonlethal Form of Anthrax

Todd S. Purdum

February 22, 1998

But extensive tests at a military laboratory at Fort Detrick, Md., have determined that the substance in fact contained only harmless traces of anthrax that could not be used to make a biological weapon, Bobby Siller, the special agent in charge of the Las Vegas office of the Federal Bureau of Investigation, said today at a news conference there.

Mr. Siller said Larry Wayne Harris , one of the two men in Las Vegas who were charged with possession of biological toxins for use as a weapon, would remain in custody at the Clark County Detention Center in Las Vegas pending further investigation and a hearing on Monday.

Mr. Harris , a former member of the Aryan Nations white supremacist group, is on probation from a Federal conviction last year on charges of illegally obtaining bubonic plague bacteria from a mail-order laboratory in 1995. One of the conditions of his probation was that he not handle dangerous toxins.

Mr. Siller said he believed that testing on other material, seized from Mr. Harris’s houses in Ohio, had not been completed.

In fact, the Government’s official complaint later made clear, Mr. Harris had boasted in the past about how easy such an attack would be, though officials said they had no indication of any plans to use the material.

In fact, officials had some reason to be worried. Mr. Harris , a freelance water tester and microbiologist from Lancaster, Ohio, has published a book, ”Bacteriological Warfare: A Major Threat to North America,” that he describes as a guide for surviving a germ attack, but that also details how such an attack could be carried out.

Mr. Harris has said he grew anthrax cultures from material taken from a burial ground of cows that died in an outbreak in the 1950’s, and law-enforcement officials and experts on right-wing groups say he has traveled the country addressing anti-Government groups on the dangers of germ warfare, and inoculating people against biological agents.

But Mr. Leavitt, of Logandale, Nev., had no criminal record, and friends described him as a pillar of his local Mormon church who owned a fire safety business and had a passion for alternative medical research in a quest for cures for AIDS and other diseases. His lawyers said he had asked Mr. Harris to help him test an electronic machine that he had been told could kill bacteria.

Mr. Leavitt had been negotiating with Ronald G. Rockwell, a local researcher who claimed to have developed such a machine, but Mr. Leavitt’s lawyers said the two could not agree on a price. This week, when Mr. Harris and Mr. Leavitt told Mr. Rockwell that they had anthrax they wanted tested, Mr. Rockwell had said ”it scared me so bad” that he called the authorities, who moved in to arrest the suspects as they met Mr. Rockwell at a clinic in Henderson, Nev., on Wednesday night.

In any event, Mr. Leavitt and Mr. Rockwell made no secret of their testing plans, discussing them on a radio talk show on KNXT-AM in Las Vegas just last week, and saying that Mr. Harris would help them.

”Larry Harris has been a consultant to our Government for some time, and he will be participating in some very specific tests as far as to the efficacy of the technology, in regard to some of the bacteriologic agents,” Mr. Leavitt told the radio host, according to a transcript published today in The Las Vegas Review-Journal/Las Vegas Sun.

In the past, Mr. Harris has claimed that he worked for the Central Intelligence Agency in the 1980’s. But a C.I.A. spokesman, Mark Mansfield, said that Mr. Harris had never been employed by the agency.

FRONTLINE 1706 “Plague War”

Air date: October 13, 1998

Plague War

Produced by Peter Molloy, Jim Gilmore

Reported by Tom Mangold

Clive Syddal, Executive Producer

Written by Tom Mangold and Jim Gilmore

LARRY WAYNE HARRIS : My view of the future is that we are facing now a biological apocalypse. It is coming. The Bible says that it is coming.

NARRATOR: Larry Wayne Harris , a member of the white supremacist group Aryan Nation, has been in constant trouble with the law for his attempts to obtain plague bacteria and anthrax through the mail. Harris has written a manual for do-it-yourself biological warfare, and he claims it is easy to acquire these deadly agents.

INTERVIEWER: How would you obtain samples of anthrax?

LARRY WAYNE HARRIS : Anthrax? Go out where cows have died of anthrax. Dig down to where the bodies are. Get a sample of the culture. Grow it up.

INTERVIEWER: How would you obtain a sample of plague?

LARRY WAYNE HARRIS : The rats the plague usually inhabits- rats would like to be above 5,000-foot altitude. Go out in California, get above the 5,000-foot mark. Catch you some rats, get some blood samples. Bingo, you got your plague.

INTERVIEWER: Could you personally use biological organisms offensively, if you had to?

LARRY WAYNE HARRIS : Most definitely. I- I hope I never have- we never have to, but most definitely.

INTERVIEWER: Do you believe, looking into the future, that you may have to?

LARRY WAYNE HARRIS : I hope and pray that I never have to.

INTERVIEWER: That’s not the question, Mr. Harris .


Larry Wayne Harris

Lauren Harrison, Jacqueline E. Miller

Published Online: July 15, 2011

DOI: 10.1002/0471686786.ebd0168.pub2

Copyright © 2005 John Wiley & Sons, Inc.

Book Title

Encyclopedia of Bioterrorism Defense


Larry Wayne Harris , a trained microbiological technician from Lancaster, Ohio has been implicated in two cases of possession of biological materials that are of particular concern in weapons. In 1995, he was charged with misrepresenting himself while ordering three vials of the causative agent of plague. He was also arrested on suspected possession of the causative agent of anthrax. This substance was later found to be a harmless veterinary strain. He is thought to be a lone actor and not maintaining ties with any terrorist groups or states. He did have, at one time, ties with Aryan Nations and other neo-Nazi groups. He renounced his racist views in mid-1990s.


Larry Wayne Harris ; anthrax; plague; motivation factors; legislation; CDC clearance

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