Born - May 3, 1951 ..

Father -

Mother - Jeanne (Whalen) O'Toole

https://www.govinfo.gov/content/pkg/CHRG-111shrg51784/html/CHRG-111shrg51784.htm

https://ota.fas.org/reports/9320.pdf

http://www.allgov.com/officials/otoole-tara?officialid=29250

http://s3.amazonaws.com/propublica/assets/financial_disclosures/otoole_tara_dhs.pdf

https://www.hsgac.senate.gov//imo/media/doc/061009Otoole.pdf?attempt=2

https://www.centerforhealthsecurity.org/our-people/otoole/

ASSOCIATIONS

• Dr. Peter Daszak (born 1965) - [HG00CE][GDrive] ( 2016 - National Academies - Workshop : "Rapid Medical Countermeasure Response to Infectious Diseases : Enabling Sustainable Capabilities Through Ongoing Public- and Private-Sector Partnerships")

• Dr. Richard Jones Hatchett IV (born 1968) - [HG00CE][GDrive] ( 2016 - National Academies - Workshop : "Rapid Medical Countermeasure Response to Infectious Diseases : Enabling Sustainable Capabilities Through Ongoing Public- and Private-Sector Partnerships")

• Thomas Vincent Inglesby, Jr. (born 1957) - [HG00CE][GDrive] ( 2016 - National Academies - Workshop : "Rapid Medical Countermeasure Response to Infectious Diseases : Enabling Sustainable Capabilities Through Ongoing Public- and Private-Sector Partnerships")

• Donna Edna Shalala (born 1941) - ( ... )

• [....]

Tara O'Toole, MD, MPH - Professional Biography (from 2006 Infectious Diseases Conference)

Source - [HI000E][GDrive]

Wired Magazine, 2009 : DHS' New Chief Geek is a Bioterror 'Disaster,' Critics Charge

Source - [HP002B][GDrive] -

About Dark Winter :

https://en.wikipedia.org/wiki/Operation_Dark_Winter

"Dark Winter revealed that the lack of sufficient vaccine or drugs to prevent the spread of disease severely limited management options"

"or example, state leaders wanted control of decisions regarding the imposition of disease-containment measures (e.g., mandatory vs. voluntary isolation and vaccination)"

"Dark Winter revealed that information management and communication (e.g., dealing with the press effectively, communication with citizens, maintaining the information flows necessary for command and control at all institutional levels) will be a critical element in crisis/consequence management. For example, participants worried that it would not be possible to forcibly impose vaccination or travel restrictions on large groups of the population without their general cooperation.^[6] To gain that cooperation, the President and other leaders in Dark Winter recognized the importance of persuading their constituents that there was fairness in the distribution of vaccine and other scarce resources,^[6] that the disease-containment measures were for the general good of society,^[6] that all possible measures were being taken to prevent the further spread of the disease,^[6] and that the government remained firmly in control despite the expanding epidemic"

https://www.centerforhealthsecurity.org/our-work/events-archive/2001_dark-winter/Dark%20Winter%20Script.pdf

Wikipedia - Tara O'Toole

Saved wiki - [HK001K][GDrive]

1993 (Sep 15) - US Senate Hearing: "O'Toole and Hakes Nominations: Hearing Before the Committee on Energy and Natural Resources, United States Senate, One Hundred Third Congress, First Session, on the Nominations of Tara O'Toole to be Assistant Secretary, Environment, Safety, and Health, and Jay E. Hakes to be Administrator, Energy Information Administration, Department of Energy"

First source (Missing a few pages!!!) - U.S. Government Printing Office, 1993 - Government publications - 155 pages - Full PDF : [HG00CH][GDrive] / PDF with OCR: [HG00CI][GDrive]

Second source (more complete) - [HG00CU][GDrive] / PDF with our OCR performed : [HG00CV][GDrive]

2002 science

https://sci-hub.se/10.1126/science.295.5560.1624a

2002-enserink.pdf

2009

https://www.govinfo.gov/content/pkg/CRECB-2009-pt20/html/CRECB-2009-pt20-Pg26672.htm

Congressional Record (Bound Edition), Volume 155 (2009), Part 20]

[Senate]

[Pages 26672-26675]

[From the U.S. Government Publishing Office, www.gpo.gov]

EXECUTIVE SESSION

______

NOMINATION OF TARA JEANNE O'TOOLE TO BE UNDER SECRETARY FOR SCIENCE AND

TECHNOLOGY

The PRESIDING OFFICER. Under the previous order, the Senate will

proceed to executive session to consider the following nomination,

which the clerk will report.

The legislative clerk read the nomination of Tara Jeanne O'Toole, of

Maryland, to be Under Secretary for Science and Technology, Department

of Homeland Security.

Mr. McCAIN. Mr. President, I understand the Senate is proceeding to

the consideration of the nomination of Dr. Tara O'Toole to serve as

Under Secretary for the Science and Technology Directorate at the

Department of Homeland Security. This nomination has not been available

for consideration until now because I was waiting for Dr. O'Toole to

answer the nearly two dozen questions I submitted to her during the

past month. As of Monday, she has answered each question.

While I continue to have concerns about this nominee failing to

disclose her activities as strategic director for the Alliance for

Biosecurity, I will not hold up consideration of her nomination. A

September 8, 2009 article in the Washington Times referred to the

Alliance as a ``lobbying group funded by the pharmaceutical industry.''

Specifically, the article stated, ``The alliance has spent more than

$500,000 lobbying Congress and federal agencies--including Homeland

Security--since 2005, congressional records show. However, Homeland

Security officials said Dr. O'Toole need not disclose her ties to the

group on her government ethics form because the alliance is not

incorporated . . . Analysts say the lack of disclosure reflects a

potential loophole in the policies for the Obama administration, which

has boasted about

[[Page 26673]]

its efforts to make government more transparent.''

The article continued:

They also question lobbying laws that allow such a group to

spend hundreds of thousands of dollars without the public

knowing exactly how much money each of the companies that

belongs to the group contributes, though such arrangements

are permitted under the law . . . Ethics rules require

nominees to report any paid or unpaid positions held outside

of government, including but not limited to those of

``officer, trustee, general partner, representative, employee

or any consultant of any corporation, firm, partnership or

other business enterprise.'' Dr. O'Toole signed a letter on

behalf of the group sent to the White House as recently as

March.

I put forward numerous questions to Dr. O'Toole about her ``stealth

lobbying'' on behalf of the Alliance. She repeatedly answered that her

``activities did not constitute lobbying.''' I also asked numerous

questions about her involvement in securing an earmark for the Center

for BioSecurity at the University of Pittsburgh Medical Center. She

provided answers to the questions and stated that although she provided

a statement for the media in support of the earmark, she did not

provide any assistance in lobbying Congress for the earmark.

Elections have consequences, and while she would not have been the

nominee I would have chosen for this position, she is the President's

choice.

I ask unanimous consent that the September 8, 2009, Washington Times

article be printed in the Record.

There being no objection, the material was ordered to be printed in

the Record, as follows:

[From the Washington Times, Sept. 8, 2009]

Obama Nominee Omitted Ties to Biotech

(By Jim McElhatton)

President Obama's nominee at the Department of Homeland

Security overseeing bioterrorism defense has served as a key

adviser for a lobbying group funded by the pharmaceutical

industry that has asked the government to spend more money

for anthrax vaccines and biodefense research.

But Dr. Tara O'Toole, whose confirmation as undersecretary

of science and technology is pending, never reported her

involvement with the lobbying group called the Alliance for

Biosecurity in a recent government ethics filing.

The alliance has spent more than $500,000 lobbying Congress

and federal agencies--including Homeland Security--since

2005, congressional records show.

However, Homeland Security officials said Dr. O'Toole need

not disclose her ties to the group on her government ethics

form because the alliance is not incorporated: ``There's no

legal existence so she wouldn't have to disclose it,'' said

Robert Coyle, an ethics official for the Department of

Homeland Security.

Analysts say the lack of disclosure reflects a potential

loophole in the policies for the Obama administration, which

has boasted about its efforts to make government more

transparent. They also question lobbying laws that allow such

a group to spend hundreds of thousands of dollars without the

public knowing exactly how much money each of the companies

that belongs to the group contributes, though such

arrangements are permitted under the law.

``You're not allowing the public to know the full

background of this nominee,'' said Judy Nadler, a senior

fellow at the Markkula Center for Applied Ethics at Santa

Clara University in California. ``It shouldn't matter whether

it's incorporated or not.''

Craig Holman, legislative director of the nonpartisan

watchdog group Public Citizen, said the lack of disclosure

``definitely and clearly runs counter to the intent of the

law.''

Ethics rules require nominees to report any paid or unpaid

positions held outside of government, including but not

limited to those of ``officer, trustee, general partner,

representative, employee or any consultant of any

corporation, firm, partnership or other business enterprise.

. . .'' Dr. O'Toole signed a letter on behalf of the group

sent to the White House as recently as March.

Dr. O'Toole declined to comment for this article. Her

office referred questions to Mr. Coyle at Homeland Security

and to officials for the Alliance for Biosecurity, who said

the group is in ``full compliance'' with lobbying rules and

noted that there were no financial ties between the Center

for Biosecurity, where Dr. O'Toole is chief executive, and

the lobbying group she help found.

In written testimony to Congress, Dr. O'Toole said the

alliance was ``created to protect the Center for

Biosecurity's status as an honest broker between the

biopharma companies and the U.S. government.''

As undersecretary of science and technology, one of Dr.

O'Toole's responsibilities would involve overseeing the

department's chemical and biological division, which is in

charge of making sure the nation is prepared to defend itself

against chemical and biological attacks.

Dr. O'Toole was nominated less than four years after the

alliance was formed in 2005. She has served as the group's

unpaid strategic director and has signed her name on more

than a dozen letters sent to Congress and federal agencies.

The group's letters to policymakers often seek more money

for research and vaccines. She signed the letters as the

group's strategic director, in addition to listing her full-

time paid job as director of the Center for Biosecurity,

which is affiliated with the University of Pittsburgh.

The letters, including one that Dr. O'Toole sent to House

Speaker Nancy Pelosi, California Democrat, last fall,

describe the Alliance for Biosecurity as a ``collaboration''

among the Center for Biosecurity of the University of

Pittsburgh Medical Center, pharmaceutical companies and

biotechnology companies ``working to develop vaccines,

medicines and other medical countermeasures for the nation's

Strategic National Stockpile.''

Members include companies such as Pfizer Inc., Sig

Technologies and PharmAthene Inc. The group discloses the

letters and list of members on a Web site.

But for all its lobbying and letters to Congress, the

alliance isn't incorporated, it doesn't have a bank account

and its day-to-day operations are overseen by the K Street

lobbying arm of Drinker Biddle & Reath LLP, which also

lobbies on behalf of the alliance, according to records and

interviews.

The alliance's legal counsel, Anita Cicero, is also a

Drinker Biddle lawyer who serves as a lobbyist for the group.

In an e-mail response to questions about the alliance, Ms.

Cicero said the group was formed to work ``in the public

interest to improve prevention and treatment of severe

infectious diseases--particularly those diseases that present

global security challenges in the 21st century.''

Ms. Cicero described the lobbying activities as focusing on

broad issues. ``The overarching advocacy issues we address

run across the industry, and we do not conduct lobbying

activities to advance the commercial interests of any

individual member company,'' she said.

Still, a review of the group's correspondence to federal

lawmakers along with member companies' public disclosures to

investors show that the lines between advocacy and commercial

interests aren't always clear.

In an Oct. 31 letter to Mrs. Pelosi signed by Dr. O'Toole

and two other alliance officials, the group called on

Congress to include more than $900 million for the ``advanced

development of medical countermeasures'' to be administered

by the Biomedical Advanced Research and Development

Authority.

The letter also was signed by the chief executive officer

of member company PharmAthene, David Wright, who was one of

the two first co-chairmen for the alliance after its creation

in 2005.

Mr. Wright's company has a big financial interest in

securing work from the authority, according to investor

filings. A Securities and Exchange Commission filing last

summer disclosed that PharmAthene has been trying to win a

contract administered by the authority to supply 25 million

doses of an anthrax vaccine to the national stockpile, which

is overseen by the Department of Health and Human Services.

As undersecretary, Dr. O'Toole wouldn't be directly

responsible for decisions on which vaccines to develop or

buy. Still, she would oversee the government's threat

assessments on the risks of bioagents.

Dr. O'Toole has told the Senate in written testimony that

she would adhere to all ethics rule on conflicts of

interests, but that because she has no financial interest in

PharmAthene, she's not aware of any recusal requirements if

she were to become involved in decisions concerning

government funding for anthrax vaccine development.

Ethics groups say the alliance's setup is an example of

what critics call ``stealth lobbying,'' in which like-minded

companies form a loosely knit compact and spend lots of money

lobbying the government. The arrangement is legal, but it

exposes loopholes that prevent the public from finding out

how much money each company pays and whether one business

exerts more control over the others.

Ms. Cicero said the group is complying with all applicable

federal laws and that the alliance discloses on a Web site

its membership list and correspondence to the White House,

Congress and federal agencies. She said the companies pay a

``pro rata'' share to the Drinker Biddle & Reath firm.

``The alliance does not generate income, does not have a

bank account and does not owe taxes,'' she said.

Ms. Cicero said the law firm ``regularly convenes consortia

of biopharma companies that share common goals or interests

and provides secretarial and legal support for the groups.''

She said the alliance was formed so companies, academic

institutions and the government could work together to

``accelerate the development of therapeutic and vaccine

countermeasures.''

Ms. Cicero said Dr. O'Toole no longer has an active role as

the strategic director for the alliance.

[[Page 26674]]

Another lobbying client of the firm, the International

Pharmaceutical Aerosol Consortium, appears structured

similarly. There are no records of any incorporation papers

for that group, either. The group has a Web site listing

several pharmaceutical companies as members, and Senate

records show it has paid more than $250,000 to Drinker,

Biddle & Reath since 2007.

Government watchdog groups acknowledge that the arrangement

is legal but say it seems at odds with lobbying reform laws

that were intended to shed more light on who bankrolls and

controls special interest groups.

``At the end of the day, companies that form coalitions

like this are being able to get around having to disclose the

full breadth of who they are and what they're doing,'' said

Dave Levinthal, a spokesman for the nonpartisan Center for

Responsive Politics. ``Does that cut against an open and

transparent government? It appears that it does.

``Stealth lobbying has been taking place for years and

despite the focus on the influence of lobbying, what's

happening is that organizations are finding, if not

loopholes, then ways around the spirit of the law,'' he said.

``Companies that are lobbying Congress are not necessarily

disclosing the full strength of their lobbying.''

Mr. LEVIN. Mr. President, I cannot support the nomination of Dr. Tara

O'Toole to be the Under Secretary for Science and Technology at the

Department of Homeland Security.

By its nature, this position requires a disinterested scientific

approach to issues affecting homeland security. It is a position which

the Department of Homeland Security and its policymakers must rely on

for objective advice and counsel.

Dr. O'Toole fell short of the strict adherence to scientific

principles when she was the director of the Johns Hopkins Center for

Civilian Biodefense Strategies. Dr. O'Toole was one of the principal

designers and authors of the June 2001 Dark Winter exercise that

simulated a covert attack on the United States by bioterrorists.

The Dark Winter exercise had a deadly serious purpose: to assess the

vulnerability of the United States to a biological weapons attack and

our ability to deal with such an attack.

But many top scientists have said that the Dark Winter exercise was

based on faulty and exaggerated assumptions about the transmission rate

of smallpox.

Dr. James Koopman of the Department of Epidemiology at the University

of Michigan, an expert at modeling the transmission rates of infectious

diseases who participated in the smallpox eradication program, has said

that Dr. O'Toole ``has not sought balanced scientific input in her

thinking, that she shows a lack of analytic orientation to scientific

issues, and that she has generated hype about bioterrorism that she

will feel obligated to defend rather than pursue a balanced approach.''

Dr. Anthony Fauci, the Director of the National Institute of Allergy

and Infectious Diseases, told me that the conclusions of the Dark

Winter exercise were ``dramatically affected'' by the assumptions that

were used, and that these assumptions were ``much, much worse than

would have been the case'' in real life.

Dr. Michael Lane, the former Director of the Centers For Disease

Control Smallpox Eradication Program--who has had extensive and first-

hand experience with the disease--found the assumptions about smallpox

transmission rates in the Dark Winter exercise ``improbable'' and even

``absurd.''

The transmission rate of smallpox was not the only area where Dr.

O'Toole exaggerated the facts. On February 19, 2002, she wrote that

``Many experts believe that the smallpox virus is not confined to these

2 official repositories [1 in the United States and 1 in Russia] and

may be in the possession of states or subnational groups pursuing

active biological weapons programs.'' This statement referenced a New

York Times article of June 13, 1999, for support of that very startling

statement about ``subnational groups.'' But the article she cited made

no reference to any subnational or terrorist or nonstate group

possessing active biological weapons programs.

Bioterrorism poses a serious threat to our national security. But it

is one of many threats we face. All threats to our security must be

addressed objectively and scientifically so that we spend our resources

in the most effective way possible to address the most likely and most

dangerous threats. Exaggerations for the purpose of influencing policy

makers do a disservice and result in the misallocation of limited

resources that must be utilized wisely and objectively in order to

enhance our security.

Mr. LIEBERMAN. Mr. President, I rise today to urge my colleagues to

take up and approve the nomination of Dr. Tara O'Toole to be Under

Secretary of Science and Technology at the Department of Homeland

Security.

When the Homeland Security and Governmental Affairs Committee held

its confirmation hearing on Dr. O'Toole's nomination I said I believed

it was an ``inspired choice.''

My judgment remains unchanged and I would note that her nomination

was reported out of committee favorably on a bipartisan basis with just

one dissenting Democratic vote.

I would also note that DHS Secretary Janet Napolitano has been

pleading with the Senate to confirm Dr. O'Toole. Secretary Napolitano

has said that Dr. O'Toole's biosecurity and epidemiology expertise are

critical to DHS and to her, personally. The Secretary's urgency is

heightened because of the critical roles Dr. O'Toole will play in both

defending our Nation against bioterrorism and in the continuing

preparations for the H1N1 flu pandemic.

Let's consider the tough job Dr. O'Toole has been asked to take on

and then consider the qualifications she brings to it.

The Science and Technology Directorate is charged with managing our

Nation's investments in homeland security research and development

projects with the goal of providing its customers within and without

the DHS the kinds of state-of-the-art technologies they need to achieve

their missions.

The S&T Directorate got off to a rocky start and struggled in its

early years to clarify and execute its primary mission. Former Under

Secretary Jay M. Cohen resolved to build a leaner and more tightly

managed organization that focused on better serving its customers and

being transparent with Congress. He implemented internal controls to

monitor S&T finances and track the progress of S&T investments. He

established a structured strategic planning process that is designed to

produce specific objectives and annual performance measures.

But despite this progress, big challenges await the new

undersecretary, including expanding investments in innovative R&D for

homeland security--like the advanced spectroscopic portal, ASP, and the

secure border initiative--and insuring the reliability of the a testing

and evaluation that DHS relies on for large acquisition programs.

Programs like these can be force multipliers for DHS's customers

within and without the department.

Now let's consider the resume Dr. O'Toole brings to the job--both as

a medical professional and as a manager.

Let's start with Dr. O'Toole's solid and impressive educational

background: a bachelor's degree from Vassar College, a medical degree

from George Washington University, and a master of public health degree

from Johns Hopkins University.

Now let's consider her management skills: From 1989 to 1993 she

served as a senior analyst and project director with the Congressional

Office of Technology Assessment; from 1993 to 1997, she served as the

Assistant Secretary for Environment, Safety and Health at the

Department of Energy.

From 1999 to 2003, she managed the Johns Hopkins Center for Civilian

Biodefense Strategies. For the last 6 years, she has served as the

Director and Chief Executive Officer of the Center for Biosecurity at

the University of Pittsburgh.

On top of all this, Dr. O'Toole is also an accomplished author.

She has published her research on anthrax, smallpox, the plague,

biological attacks, containment of contagious disease epidemics,

biodefense, and hospital preparedness. She is coeditor in chief of the

Journal of Biosecurity and Bioterrorism.

And she took all this knowledge she has gained over these many years

and

[[Page 26675]]

used it to help create the 2001 bio-terror attack simulation known as

``Operation Dark Winter'' that helped open our eyes to our many

vulnerabilities.

Dr. O'Toole is also a former chair of the board of the Federation of

American Scientists and she has participated in major studies or

advisory panels at the request of the National Science Foundation, the

Department of Defense, the Department of Health and Human Services and

the Department of Homeland Security.

Besides these many qualifications, another important measure of her

fitness for this post is the bipartisan respect she has earned across

the government and scientific communities that monitor homeland

security and bioterrorism challenges.

Among her many supporters are: Former Senators Bob Graham and Jim

Talent, Chairman and Cochairman of the Commission on the Prevention of

WMD Proliferation and Terrorism; former DHS Secretary Tom Ridge; former

Senator and defense expert Sam Nunn; former National Security Adviser

to Presidents Gerald Ford and George H.W. Bush, Brent Scowcroft, as

well as Dr. Robert P. Kadlec, former Special Assistant for Biodefense

Policy at the Homeland Security Council under President Bush; Dr. D.A.

Henderson, who led the World Health Organization's efforts to rid the

world of smallpox, and the Federation of American Scientists.

Dr. O'Toole brings a remarkable breadth of experience to this job

that is so crucial to our nation's security and I say again she is an

inspired choice and I urge my 3 colleagues to take up her nomination

and confirm her to this position where our nation so desperately needs

her talents.

The PRESIDING OFFICER. The question is, Will the Senate advise and

consent to the nomination of Tara Jeanne O'Toole, of Maryland, to be

Under Secretary for Science and Technology, Department of Homeland

Security?

The nomination was confirmed.

The PRESIDING OFFICER. Under the previous order, the motion to

reconsider is laid upon the table, and the President will be

immediately notified of the Senate's action.

____________________

1993 (Dec 7)

https://www.c-span.org/video/?52772-1/nuclear-testing-humans

Nuclear Testing on Humans

Energy Secretary Hazel O’Leary briefed reporters and department employees on the reasons for declassifying nuclear weapons information accumulated since the mid-1940s. She stated that environmental concerns helped to bring about this decision. The secretary suggested that over 20% of the nuclear tests came without warning because of national security reasons. Included in her report was the disclosure that 18 individuals were used in experiments on the effects of plutonium. Throughout the briefing, Secretary O’Leary used an overhead projector to describe the information. Following her presentation, she took questions from reporters

• Hazel R. O'Leary :Secretary , Department of Energy

• Tara O'Toole M.D. : Assistant Secretary, Department of Energy->Environment, Safety and Healt

1994 (Jan 18)

https://www.c-span.org/video/?53871-1/radiation-experiments

Radiation Experiments

The House Energy and Commerce Subcommittee on Energy and Power held a hearing on documents released earlier in the week by the Department of Energy that revealed experiments with radiation on human subjects in the 1940s and 1950s. Witnesses who included Energy Secretary Hazel O’Leary testified on the Department of Defense testing and whether compensation is due any of the subjects.

PEOPLE IN THIS VIDEO

• Patricia Durbin : Professor, Lawrence Berkeley Natl. Laboratory->Life Sciences Division

• Kenneth Mossman : President, Arizona State University->Health Physics Society

• Gerald Mousso : Resident, Rochester, NY

• Hazel R. O'Leary : Secretary , Department of Energy

• Tara O'Toole M.D. : Assistant Secretary , Department of Energy->Environment, Safety and Health

• Leroy Walters : Researcher , Georgetown University->Center for Bioethics

• Eileen Welsome : Writer , Albuquerque Tribune

• Elemerine Whitfield : Resident , Dallas, TX

1997 (Jan 15)

https://www.c-span.org/video/?77978-1/nuclear-information-storage

Nuclear Information and Storage

Secretary Hazel O’Leary of other Department of Energy officials released a report on nuclear waste storage problems and classification for public comment. It contains several previously classified items, including 6500 films of early above ground nuclear tests, that 3 pounds of plutonium were left in Vietnam in 1975 and that several U.S. nuclear facilities pose a health hazard to workers, and some even to the surrounding population.

PEOPLE IN THIS VIDEO

• Hazel R. O'Leary : Secretary , Department of Energy

• Tara O'Toole M.D. : Assistant Secretary , Department of Energy->Environment, Safety and Health

• Harold Smith : Assistant Secretary , Department of Defense->Atomic Energy

• Linton Wells : Deputy Undersecretary , Department of Defense

1997 (March 28)

https://www.c-span.org/video/?80065-1/radiation-exposure-compensation

Radiation Exposure Compensation

Government officials told reporters that the last of many claims had been settled with families of civilians who were injected with plutonium or uranium as part of secret experiments in the 1940s. They also said they would ask Congress to expand compensation programs to uranium miners.

• John Dwyer :Associate Attorney General (Acting) . Department of Justice

• Tara O'Toole M.D. : Assistant Secretary , Department of Energy->Environment, Safety and Health

• Federico F. Pena : Secretary , Department of Energy

2011 (Oct 04) - Event : "Charting the Future of Biosecurity: Ten Years after the Anthrax Attacks"

Also there - Dr. Thomas Vincent Inglesby, Jr. (born 1957) / Dr. Tara Jeanne O'Toole (born 1951) / Andrew Charles Weber (born 1960) /

PDF of event webpage : [HI0035][GDrive] / PNG screenshot of full page : [HI0036][GDrive]

2016 (Feb 12)

https://www.c-span.org/video/?404636-1/hearing-biodefense-preparedness

FEBRUARY 12, 2016

Biological Threat Preparedness

Witnesses, including members of the Blue Ribbon Study Panel on Biodefense, testified at a hearing on how to prepare and respond to biological threats. The hearing came following the release of 33 recommendations from the Blue Ribbon Study Panel on Biodefense. The witnesses stressed the importance of developing a comprehensive strategy to improve the nation’s biodefense. One of the key recommendations from the panel called for a centralized leadership position within the Vice President’s offic

2016-02-16-cspan-org-hearing-biological-threat-preparedness-img-1.jpg

2016-02-16-cspan-org-hearing-biological-threat-preparedness-img-1-dialogue.txt

• Donna Edna Shalala (born 1941) ( ... )

• Tara O'Toole

• Jim Greenwood

• Dr. Gerland W. Parker

• [...]

• Tara O'Toole M.D.

• MINUTES. MS. OY TOOLE: THANK YOU, MR. CHAIRMAN, RANKING MEMBER DEGETTE. NAUNG, MR. CHAIRMAN. -- THANK YOU, MR. CHAIRMAN. I'M HAPPY TO BE HERE TODAY TO DISCUSS THIS TOPIC, WHICH HAS BEEN A PREOCCUPATION OF MINE FOR MOST OF MY PROFESSIONAL CAREER. I WANT TO THANK YOU FOR YOUR KIND INTRODUCTION AND EMPHASIZE THE VIEWS I EXPRESS ARE MY OWN, NOT THOSE OF IN-Q-TEL. I WANT TO COMMEND THE PANEL ON THEIR REPORT WHICH I HOPE WILL BE HIGHLY INFLUENTIAL. I SHARE THEIR SENSE OF URGENCY ABOUT REPAIRING THE COUNTRY'S VULNERABILITY TO HIGHLY CONSEQUENTIAL BIO EVENTS. I WANT TO EMPHASIZE THE NATURE AND SIGNIFICANCE OF BIOLOGICAL WEAPONS THREATS AND EXPLAIN WHY IT'S A FIRST TIER NATIONAL SECURITY PROBLEM. SECOND, I WANT TO DESCRIBE WHY NATURALLY OCCURRING EPIDEMICS ALMOST CERTAINLY WILL INCREASE IN FREQUENCY AND IMPACT IN THE COMING YEARS. NATURAL EPIDEMICS, IT IS IMPORTANT TO UNDERSTAND, ARE DIFFERENT FROM DELIBERATE BIOATTACKS. THE LATTER WOULD BE FASTER, FIERCER AND IT MAY BE THAT MANY VICTIMS ARE BEYOND RESCUE. BUT IF WE CANNOT HANDLE NATURAL OUTBREAKS MORE EFFECTIVELY AND EFFICIENCY TISSUE EFFICIENTLY, WE HAVE NO DEFENSE AGAINST BIOLOGICAL WEAPONS. THIRDLY, THERE'S A MAJOR REVOLUTION IN OUR UNDERSTANDING OF HOW THE BIOLOGICAL WORLD WORKS AND OUR ABILITY TO MANIPULATE IT. THE ADVANCES IN BIOSCIENCE AND BIOTECHNOLOGIES SHOULD BE PART OF THE FOUNDATION OF U.S. BIODEFENSE AGAINST BOTH NATURAL AND DELIBERATE EPIDEMICS. THESE ADVANCES ARE GOING TO BE EXTREMELY BENEFICIAL TO HUMAN KIND ACROSS MANY DIFFERENT FIELDS THAT GO BEYOND BIOMEDICINE. BUT IT ALSO MEANS THAT WE NOW HAVE CREATED A WORLD IN WHICH THERE IS WIDE ACCESS TO ADVANCED BIOLOGICAL KNOWLEDGE AND THE MATERIALS NEEDED TO BUILD AND DISSEMINATE BIOLOGICAL WEAPONS. AS THE DEFENSE SCIENCE BOARD SAID , IN 2001, AN AGE AGO IN TERMS OF SCIENTIFIC ADVANCES, THERE WERE NO TECHNICAL BARRIERS TO NONSTATE ACTORS INCLUDING TERRORIST GROUPS AND LONE WOLVES CARRYING OUT DEVASTATING BIOATTACKS THAT COULD KILL MILLIONS AND COST BILLIONS. BUT, THESE ADVANCES IN SCIENCE AND IN BIOTECHNOLOGY ALSO FOR THE FIRST TIME GIVE US POWERFUL TOOLS THAT COULD ALLOW US TO PREVENT AND TO RAPIDLY DETECT AND QUENCH EPIDEMICS, WHATEVER THEIR CAUSE. I'M GOING TO GIVE YOU SOME EXAMPLES OF CRITICAL TECHNOLOGIES WHICH MIGHT HELP REALIZE THE PANEL'S ASSERTION THAT INNOVATION IS A KEY INGREDIENT AND THAT DRAMATIC IMPROVEMENTS IN BIODEFENSE ARE WITHIN REACH. FIRST OF ALL, THE POTENTIAL DESTRUCTIVE POWER OF BIOLOGICAL WEAPONS IS AKIN TO THAT OF NUCLEAR WEAPONS. IN 1993, THE CONGRESSIONAL OFFICE OF TECHNOLOGY ASSESSMENT ESTIMATED THAT A KILOGRAM OF ANTHRAX DROPPED ON WASHINGTON, D.C. IN IDEAL WEATHER CONDITIONS WOULD RESULT IN ONE MILLION TO THREE MILLION DEATHS. THAT'S ABOUT THE SAME TOTAL AS A ONE MEGA TON HYDROGEN BOMB. THESE STATEMENTS ARE NOT BASED ON SPECULATION BUT DECADES OF DEVELOPMENT AND FIELD TESTING BY THE U.S. MILITARY IN THE OFFENSIVE BIOLOGICAL WEAPONS PROGRAM OF THE UNITED STATES WHICH WAS ENDED BY PRESIDENT NIXON IN 1969. WE ALSO KNOW THAT THE USSR HAS A MASSIVE PROGRAM CREATED AFTER THEY SIGNED THE BIOLOGICAL WEAPONS CONVENTION IN 19 2. THESE WERE BOTH AMBITIOUS AND THERE'S IN THE CASE OF THE U.S. HIGHLY SUCCESSFUL PROGRAMS. DURING THE COLD WAR THE U.S. FIELD TESTED MANY DIFFERENT BIOWEAPONS IN REALISTIC CONDITIONS, INCLUDING RELEASES FROM AIR, BOATS, SHIP AND SUBWAYS. DECLASSIFIED U.S. DOCUMENTS FROM THE 1960'S CLEARLY RECOGNIZE THE STRATEGIC POWER OF BIOWEAPONS. WE DO NOT NOW KNOW THE FATE OF THE SOVIET EFFORT. IN THE HALF CENTURY SINCE THE U.S. ENDED ITS OFFENSIVE B.W. PROGRAM THERE'S BEEN A REVOLUTION IN BIOSCIENCE. ADVANCES IN MANY FIELDS INCLUDING PHARMACOLOGY AND AIR SOL BIOLOGY AND OUR ABILITY TO READ, WRITE AND EDIT D.N.A. , THE CODE OF LIFE, HAVE RESULTED IN TREMENDOUS BENEFICIAL ACHIEVEMENTS, BUT THESE ADVANCES HAVE ALSO MEANT THE GLOBAL SPREAD OF BIOLODGE AND ACCESS TO SOPHISTICATED BIOTECHNOLOGIES. THE MATERIALS AND KNOW HOW NEEDED TO BUILD A BIOWEAPON HAVE MANY LEGITIMATE USES. THESE ARE DUEL-USE TECH -- DUAL USE TECHNOLOGIES AND THIS MAKES THE TASK OF COLLECTING INTELLIGENCE ABOUT COVERT BIOWEAPONS PROGRAMS EXCEEDINGLY DIFFICULT. WE ARE GOING TO SEE AN INCREASE IN THE TEMPO OF NATURALLY OCCURRING EPIDEMICS WHICH WE CAN TALK ABOUT IN THE DISCUSSION. I WANT TO END BY SAYING THAT THERE ARE TWO CRITICAL TECHNOLOGIES THAT HAVE NOT GOTTEN SUFFICIENT ATTENTION IN OUR BIODEFENSE PROGRAM. THE FIRST IS RAPID DIAGNOSTICS UPON WHICH WE SPENT VERY LITTLE MONEY AND FOR WHICH THERE IS A VERY BIG MARKET PROBLEM THAT MAKES IT DIFFICULT FOR PRIVATE COMPANIES TO PURSUE DIAGNOSTICS, AND THE SECOND IS VACCINES. I SEE THAT I'M OUT OF TIME, MR. CHAIRMAN, SO I'LL AWAIT YOUR QUESTIONS. MR. MURPHY: THANK YOU. I RECOGNIZE DR. PARKER FOR FIVE MINUTES.

• [...]

• Tim Murphy

• MURPHY: THIS IS PRETTY SOBERING TESTIMONY. SO LET ME START OFF AND RECOGNIZE -- FIRST DR. O'TOOLE, THIS IS THE FIRST TIER NATIONAL SECURITY PROBLEM AND BIOATTACKS ARE FASTER AND FIERCER. IT SEEMS LIKE THESE NATURAL OUTBREAKS, THESE ARE TEST RUNS HOW WE HANDLE EBOLA AND ZIKA AND GIVES AN OPPORTUNITY TO RESPOND. BUT I DON'T THINK WE ARE WHERE WE NEED TO BE. ARE WE MORE CONCERNED OR LESS CONCERNED ABOUT THE THREATS OF

• Tara O'Toole M.D. [ 00:41:52 ]

• BIOTERRORISM? >> IT SHOULD BE SEEN AS TEST RUNS. EVERYONE HERE AS LIVED THROUGH A LOT OF NATURAL AND WE CAN CONTEMPLATE THE STRATEGY OF CREATING A FOUNDATION SUCH THAT WE COULD RAPIDLY DESIGN AND BUILD, FOR EXAMPLE, A VACCINE SUITABLE FOR A PARTICULAR THREAT AND A MUCH SHORTER TIME THAN IS NOW THE CASE. AND WE DO HAVE TO PREPARE FOR A WHOLE ARRAY OF THREATS WHICH WE AREN'T GOING TO BE ABLE TO PREDICT. THE OTHER ISSUE THAT DR. SHALALA MENTIONED IS THAT A LOT OF OUR RESPONSE DEPENDS ON THE STATE AND LOCAL PUBLIC HEALTH DEPARTMENTS. THEY HAVE LOST ALMOST 50,000 PEOPLE SINCE 2008. AND SO ONE COULD ARGUE THAT OUR CAPACITY TO RESPOND TO AN EPIDEMIC HAS DIMINISHED COMPARED TO THEY THEN AND THAT IS A PROBLEM. MR. MURPHY: WOULD IT BE FAIR TO SAY THAT BIPARTISAN PANELS, GENERAL CONCERN IS THAT BIOLOGICAL THREATS ARE INCREASING WHILE IMPORTANT AS PEBTS OF THE BIODEFENSE PREPAREDNESS ARE DELING OR INADEQUATE.

• Donna E. Shalala

• IS THAT A CONCLAUGS? HONORABLE SHALALA: THAT IS FAIR. OUR INFRASTRUCTURE FOR DEALING WITH THESE HAS GOTTEN WEAKER, STARTING WITH THE STATE AND LOCAL RESPONSE. ONE OF THE THINGS WE FORGOT IN THE EBOLA DISCUSSION, THE STATES ARE OUR FIRST LINE OF DEFENSE. WE HAVE BEEN BUILDING THE PUBLIC HEALTH INFRASTRUCTURE FOR YEARS WITH BLOCK GRANTS FROM THE C.D.C. AND THOSE HAVE BEEN WEAKEND AND IF YOU DON'T HAVE A STATE AND LOCAL RESPONSE, THINK ABOUT THE OUTBREAK OF DISEASES CAUSED BY FOOD POISONING. THAT IS THE FIRST LINE OF DEFENSE FOR THESE -- FOR THESE BIOLOGICAL ISSUES THAT WE'RE TALKING ABOUT. IF WE DON'T HAVE A STRONG STATE ROLE WITH THEIR LABORATORIES AND TRACKING SYSTEMS THAT IT IS DIFFICULT FOR US TO PICK UP SOMETHING THAT'S GOING TO REOCCUR OVER A LONG PERIOD OF TIME. THAT'S WHY WE TALK ABOUT THE VICE PRESIDENT, BECAUSE IT'S VERY DIFFICULT FOR ANYONE ELSE TO PULL IN ALL THE ACTORS, THE PRIVATE SECTOR ACTORS.

• MR. MURPHY: CHAIRMAN GREENWOOD, AS WE HAVE INCREASING NUMBER OF THESE NATURALLY OCCURRING BIOATTACKS, IS OUR DIMINISHED CAPACITIES BECAUSE WE HAVE CONSTRAINED OR LOST GROUND OVERALL?

• Jim Greenwood [ 00:45:02 ]

• HONORABLE GREENWOOD: ABSOLUTELY YES. IF YOU THINK ABOUT ISIS AND WHAT THEY HAVE BEEN ABLE TO DO WITH RIFLES AND ASSAULT WEAPONS AND SO FORTH. IT'S CLEAR THAT THEIR INTENTION IS TO KILL AS MANY AS THEY POSSIBLY CAN AND DO A LOT OF THAT USING CHEMICAL AND BIOLOGICAL WEAPONS. THEY WANT TO DO THAT. AND THERE IS EVIDENCE THAT THEY ARE TRYING TO FIGURE OUT HOW TO USE BUE BONNIC PLAGUE. AND HAVE A PLAN TO POISON THE TURKISH WATER SYSTEM. WHILE THAT IS HAPPENING, THE SAME TECHNOLOGY, SYNTHETIC BIOLOGY, GENE -- COMPANIES DEVELOPING NEW DRUGS AND NEW PRODUCTS IS MAKING IT EASIER TO FORMULATE THESE NEW WEAPONS. THE THREAT IS GROWING AND TO SEE THAT IN THE FACE OF ALL OF THAT. THE FEDERAL GOVERNMENT'S FUNDING IS DIMINISHING AND IT'S FRIGHTENING. THE HEARING YOU DON'T WANT TO HAVE IS THE ONE THAT HAPPENS AFTER TENS OF THOUSANDS OF PEOPLE HAVE LOST THEIR LIVES AND YOU ARE SITTING HERE ASKING YOURSELVES WHY WE WEREN'T READY.

• [ ... ]

• Gerald W. Parker [ 00:53:00 ]

• DR. PARKER: IMPLEMENTATION PLAN. THIS IS THE CLOSEST EXAMPLE THAT HAS HAPPENED TO DATE THAT KIND OF REFLECTS THE CENTRALIZED LEADERSHIP ON STRATEGY THAT WE ACTUALLY DID THAT ACCOMPANIED AN APPROPRIATION THAT REALLY COVERED ALMOST ALL OF THE DEPARTMENT AGENCIES, STATE, LOCAL, PRIVATE SECTOR THAT WERE INVOLVED IN PREPAREDNESS BACK AT THAT TIME. THIS IMPLEMENTATION PLAN CONTAINED OVER 300 ACTION ITEMS. IT IDENTIFIED LEAD DEPARTMENT AGENCIES AND SUPPORTING DEPARTMENT AGENCIES. IT WAS VERY DETAILED. IN MY OWN DEPARTMENT AT THE TIME, H.H.S., THERE WAS A LOT OF COMPLAINTS THAT IT WAS MICRO MANAGING AND MAYBE SUPERSEDING DEPARTMENT AUTHORITIES. MAYBE IT WAS. BUT WE GOT STUFF DONE. IT ALLOWED US TO ACCOMPLISH THINGS THINGS THAT WE WOULDN'T HAVE BEEN ABLE TO DO. I OFFER THAT AS AN EXAMPLE OF SOMETHING THAT WE HAVE ALREADY DONE -- LET ME ALSO ADD THAT WE HAD TO -- WE WERE VERY RESPONSIBLE FOR MEETING OUR MILESTONES AND METRICS THAT WERE PART OF THIS IMPLEMENTATION PLAN, BOTH IN THE EXECUTIVE BRANCH AND TO CONGRESS, BECAUSE ALL CONGRESSIONAL COMMITTEES THAT HAD THE APPROPRIATE OVERSIGHT FOR THE DEPARTMENT AGENCIES WERE REGULARLY BEING UPDATED. HEARINGS WERE HAPPENING ON PROGRESS OF THAT PLAN. I JUST OFFER THAT UP AS AN EXAMPLE IN THE PAST THAT I THINK IS IN THE SPIRIT OF WHAT THE PANEL HAS RECOMMENDED THAT WOULD DRIVE US A LONG WAY FORWARD DOING WHAT WE NEED TO DO IN THAT EPIDEMIC PERIOD AND BEFORE AN ATTACK OCCURS. >> I CONGRATULATE YOU.

• SFLORS FLORES DR. O'TOOLE, THE POTENTIAL IMPACT OF SYNTHETIC BIOLOGY ON SMALLPOX PREPAREDNESS AND CONTROL AND THE WHO SCIENTIFIC GROUP FOUND THAT THE EMERGENS AND HOW TO CREATE THE SMALLPOX VIRUS. THE BRSP FOCUSED HEAVILY ON THE THREATS WE FACE TODAY. CAN YOU TELL ME WHAT'S POSSIBLE GIVEN THE RAPID ADVANCES IN SYNTHETIC BIOLOGY AND HOW HAVE THESE ADVANCES ESCALATED THE THREAT?

• Tara O'Toole M.D. [ 00:56:38 ]

• HONORABLE O'TOOLE: SMALLPOX IS A HUGE VIRUS. A FUNCTIONAL SMALLPOX VIRUS. THERE ARE MANY OTHER CHOICES AVAILABLE. WE KNOW THAT THE SOVIETS CREATED A VACCINE. NEW GENE EDITING TECHNIQUES MAKE THAT KIND OF CREATION OF RESISTANT VIRUS USES QUITE FORWARD AND NONRESISTANT CAN DO A GREAT DEAL OF DAMAGE. I'M NOT SURE IT CAN GO THROUGH THE TROUBLE OF MAKING IT. BUT WHAT WE ARE MISSING IS THE OPPORTUNITIES ON THE UPSIDE THAT ADVANCES ALLOW. I MEAN, WE ARE IN A REVOLUTIONARY ELL BIOLOGICAL SCIENCE AND NONE OF THIS IS BEING LEVERAGED AGAINST OUR BIODEFENSE NEEDS. WE NEED MORE CONTRACTING PROCEDURES IN BARTA AND WE NEED A COMMITMENT. SAME THING WITH DIAGNOSE NO, SIR PARTICULARS. WE CAN DO THAT AND SHIFT IT BUT WE CAN'T DO IT WITH INCREMENTAL TWEAKS ON THE PROGRAMS WE HAVE NOW IN MY OPINION. WE NEED A MUCH MORE INVESTMENT.

• [..]

• MR. TONKO: DR. O'TOOLE, IN YOUR TESTIMONY, YOU SPEAK OF THE NEED TO TAKE ADVANTAGE OF RECENT DEVELOPMENTS IN BIOSCIENCE TO RAPIDLY TESTS AND MANUFACTURE VACCINES AGAINST INFECTIOUS DISEASES. CAN YOU SPEAK TO THE ROLE THAT TECHNOLOGY PLAYS IN THIS PROCESS AND IS THIS PROGRAM INDICATIVE OF THE PUBLIC-PRIVATE PARTNERSHIPS THAT WE SHOULD BE PURSUING? THE CENTERS FOR INNOVATION AND TECHNOLOGY.

• Tara O'Toole M.D. [ 00:58:44 ]

• HONORABLE O'TOOLE: THEY CAN PLAY A CRITICAL ROLE. NEW DIAGNOSE NO, SIR PARTICULARS HAVE A DIFFICULT TIME GETTING PAID FOR. THAT DISCOURGES COMPANY FROM MAKING THEM. IMAGINE THE TEST AND WE COULD VERY CLEARLY SAY YOU ARE INFECTED, WHAT IS THE OUTCOME OF YOUR PREGNANCY OR YOU ARE NOT INFECTED. SAME THING FOR EBOLA AND WE COULD TELL SOMEONE IS INFECTED. THE TECHNOLOGIES FOR A WHOLE HOST OF NEW DIAGNOSE GNOSTICS ARE OUT THERE. THE PATH OUT THERE IS VERY TROUBLED FROM A REGULATORY POINT OF THROUGH. AND THE RETURN ON INVESTMENT IS NOT NEARLY AS GREAT AND ALSO FROM THE PAYMENT MECHANISMS. THE CENTER HAS A TREMENDOUS ROLE TO PLAY. MR. TONKO: HOW DOES THE FIRST RECOMMENDATION THAT YOU SHARED WITH US TODAY GET OFF THE GROUND SHOULD THERE BE A CONGRESSIONAL MANDATE TO HAVE THE EXECUTIVE BRANCH EXPLORE AND IMPLEMENT IF EXPERTS AGREE IT'S NEEDED? WHAT ARE THE NEXT STEPS TO TAKE US FORWARD?

• [..]

• HONORABLE GREENWOOD: WE ARE NOT ORGANIZED AS A GOVERNMENT TO EFFECTIVELY AND QUICKLY RESPOND TO EITHER PANDEMICS OR BIOTERROR BECAUSE OF THE AUTHORITIES ARE DIFFUSED. DON'T ALWAYS TALK TO ONE ANOTHER AND THAT IS WHY A CENTRAL UNIFIED PLAN, A CENTRAL BUDGET AND GIVING THE AUTHORITY TO THE VICE PRESIDENT MAKES THE SENSE. MRS. BROOKS: CITIZENS KNOW AND BELIEVE WE HAVE THESE STOCKPILES AND THEY ARE ADEQUATELY -- THAT THEY ARE ADD EQUAL FILLED WITH THE TYPES OF VACCINES. WOULD ANYONE LIKE TO COMMENT, DR. O'TOOLE?

• Tara O'Toole M.D. [ 01:08:18 ]

• HONORABLE O'TOOLE: I'M THE CHAIR OF THE NATIONAL COMMITTEE ON THE STRATEGIC NATIONAL STOCK BILE RIGHT NOW AND THEY HAVE MADE TREMENDOUS PROGRESS. THE PROBLEM WITH THE STOCKPILE, THE NEW DRUGS GOING INTO IT ARE LARGELY BIOLOGICAL AND EXPENSIVE AND EXPIRE IN TWO, THREE YEARS. SO THERE IS A PIPELINE OF NEW COUNTERMEASURES COMING IN THAT INCREASES THE COST OF THE STOCKPILE AND EVERYBODY'S BUDGET IS STAYING FLAT. SO THE LIMITATIONS ON THE COUNTERMEASURES WE HAVE IN THE STOCKPILE, FIRST OF ALL ARE BUDGETARY LIMITATIONS. THIS IS AN EXPENSIVE PROPOSITION. IT HOLDS $7 BILLION AND HAVING TO COVER MULTIPLE CITIES WITH THE VERY EXPENSIVE DRUGS AND VACCINES AND WE NEED A CHEAPER WAY TO DO IT. THEY WILL NEVER CREATE A STOCKPILE THAT HAS EVERYTHING YOU WANT IN IT. WE HAVE TO MOVE TO A STRATEGY TO QUICKLY DESIGN AND MANUFACTURE ITS SCALE, WHAT WE NEED. MRS. BROOKS: I YIELD BACK. MR. MURPHY: I RECOGNIZE MR. MULLEN FOR FIVE MINUTES.

• [..]

• HON. O'TOOLE: LET ME KNOW THE PROBLEM DOWN TO TESTS THAT WE NEED FOR INFECTIOUS DISEASE, AND PARTICULARLY, DURING EPIDEMICS. WE NEED A VARIETY OF DIFFERENT KINDS OF TESTS. AS YOU KNOW, YOU WANT A VERY SENSITIVE TEST WHEN YOU HAVE A LOW PREVALENCE, BUT YOU DO NOT WANT THAT SAME TEST WHEN YOU'RE IN THE MIDDLE OF AN EPIDEMIC. SO, IT GETS TRICKY. HOWEVER, HERE'S THE PROBLEM. IT IS VERY DIFFICULT TO VALIDATE A NEW DIAGNOSTIC AGAINST EBOLA OR EVEN ZIKA, IF YOU DO NOT HAVE CURATED SAMPLES OF THOSE DISEASES. MY VIEW, THE GOVERNMENT, YOU CAN PUT THIS IN DOD OR HHS, YOU CAN PUT IN FDA, BUT THE GOVERNMENT SHOULD DEVELOP A CURATED BANK OF DISEASES ABOUT WHICH WE ARE WORRIED. SO THAT, COMPANIES, ESPECIALLY THE SMALL, AGILE, FRAGILE COMPANIES CAN COME AND TEST THEIR DIAGNOSTICS AGAINST THEM, SO THAT THEY CAN MUCH MORE RAPIDLY GIVE FDA USEFUL DATA. ON HOW WELL THEIR TEST WORKS. THAT IS WONDERING SECONDLY, I THINK THAT JUST AS FDA HAS EMERGENCY USE ROLES, FOR MEDICAL COUNTERMEASURES, DURING PUBLIC HEALTH EMERGENCIES, WE ARE TO THINK ABOUT EMERGENCY USE TOOLS FOR DIAGNOSTICS, WHICH I THINK WE CAN ACTUALLY CREATE, RATHER RAPIDLY, AND MANUFACTURE QUICKLY. >> I WOULD JUST SAY LAST YOUR 18 MONTHS GO-GO, DURING THE BECAUSE EBOLA OUTBREAK AM I WENT TO A HEARING IN THE FOREIGN AFFAIRS COMMITTEE WHERE WE HEARD THAT THE FDA HAD ACTUALLY PUT A CLINICAL HOLD ON A DRUG COLUMN -- DRUG CALLED OK EBOLA WHICH WAS IN USE AT THE TIME. I WANT TO HEAR ABOUT CRITICAL TRIALS. IT REALLY DID SEEM LIKE THEY WERE AN OBSTACLE, FACE WAS WORLDWIDE SCORCH. I NEED TO ASK A QUICK QUESTION. I WOULD APPRECIATE YOUR LISTENING TO THE RECOMMENDATIONS OF THE BLUE RIBBON TASK FORCE. IN MY POLITICAL TRAINING, WHICH GRANTED, WAS A STREET LEVEL COURSE, I WAS SORT OF TALK THAT YOU ONLY DO THREE THINGS, YOU PRODUCE A LIST OF 33 THINGS. I DID READ THROUGH YOUR LIST, AND IT IS A GOOD LIST. IT IS EXHAUSTED. I HOPE IT IS NOT STATIC, BECAUSE, ONE OF THE THINGS THAT WE HAVE WORKED ON ON THE 24TH CENTURY CURES BILL, IS THE WHOLE ISSUE OF INTEROPERABILITY OF ELECTRONIC HEALTH RECORDS, AND IF WE DO NOT ADDRESS THAT FACT IN THIS RECOMMENDATIONS THAT YOU HAVE, I THINK THAT WAS ACTUALLY STYMIE THE ABILITY FOR RESEARCHERS AND CLINICIANS TO COMMITTEE RAPIDLY, IDENTIFYING DATA TO BE SURE, RESPECTING PATIENT PRIVACY RIGHTS, BUT AT THE SAME TIME, WE NEED THE ABILITY FOR RAPID LEARNING WITHIN A SYSTEM, WHATEVER DEVELOPS.

• [..]

• MR. GRIFFITHS: THANKS FOR BEING HERE. DR. UNTIL, DURING EBOLA OUTBREAK, THEIR WEAKNESSES IDENTIFIED IN OUR SYSTEM THAT WE ARE NOW WITNESSING AGAIN WITH THE CUT. SURVEILLANCE AT SECTION, DIAGNOSTICS, OVERALL, HOW WOULD IMPROVE SURVEILLANCE OF ANIMAL DISEASE OUTBREAK STRENGTHEN OUR SURVEILLANCE OF HUMAN DISEASE OUTBREAKS AND BE BETTER PREPARED FOR DEALING WITH EPIDEMICS?

• Tara O'Toole M.D. [ 01:50:40 ]

• HON. O'TOOLE: THE MAJORITY OF EMERGING INFECTIOUS DISEASES COME FROM ANIMALS. THERE ARE DISEASES THAT AFFECT BOTH HUMANS AND ANIMALS. WE DEFINITELY NEED TO DO A BETTER JOB LOOKING AT THOSE HOTSPOTS WHERE WE ARE LIKELY TO SEE SPILLOVER FROM ONE SPECIES TO HUMANS. MOST OF THOSE HOTSPOTS ARE IN TROPICAL ZONES. IN THE JUNGLES OF SOUTH AMERICA, AND ASIA, AND AFRICA. MOST OF OUR SURVEILLANCE IS INTEMPERATE SENSE. FOR STARTERS. WE ARE NOW BEGINNING TO HAVE TOOLS SUCH AS HIGH SEQUENCING GENOMICS, HIGH-SPEED ECONOMIC, THAT ACTUALLY GIVE US A MUCH BETTER HANDLE OF WHAT DISEASES MIGHT BE ABOUT TO SPILL. WE OUGHT TO THINK ABOUT FUNDING FIELD SURVEILLANCE OF THESE HOTSPOT ECOSYSTEMS. FOR STARTERS. SECONDLY, WE HAD TO FUND MUCH MORE RIGOROUSLY THE USDA'S EXISTING PROGRAM FOR LOOKING AT AGRICULTURAL ANIMALS. BECAUSE, MODERN METHODS OF AGRICULTURE THAT SOMETIMES TENS OF THOUSANDS OF ANIMALS TOGETHER , CREATING OUR OWN INDUSTRIAL HOTSPOTS. FOR SPILLOVER, AND WE HAVE SEEN THAT WITH THE FLU. AND THE LOSS OF TURKEYS AND CHICKENS IN THE PAST YEARS. THIRDLY, FOR HUMANS, WE HAVE TO HAVE A MUCH MORE STRATEGIC APPROACH TO SURVEILLANCE. WE HAVE SPENT BILLIONS, LITERALLY BILLIONS, ON SURVEILLANCE IN THE PAST 15 YEARS. SOME THINGS HAVE WORKED, SOMETHING CAP NOT. WE HAVE DONE A TERRIBLE JOB AT LESSONS LEARNED. WE OUGHT TO GO BACK AND FIGURE OUT WHAT REALLY HAS MADE A DIFFERENCE. PART OF THAT IS, AGAIN, WE SUMMIT BROKEN RECORDS, FUNDING STATE HEALTH DEPARTMENTS. BECAUSE THAT IS WHERE THE RUBBER MEETS THE ROAD, BUT WE HAVE TO HELP STATE HEALTH DEPARTMENTS TO A BETTER JOB. DIAGNOSTICS, AGAIN, CRITICAL, CRITICAL, CRITICAL. CLINICAL DISEASES, IT IS VERY VAGUE. IF YOU DO NOT HAVE A DIAGNOSTIC TO SAY, THIS IS ZIKA VIRUS, YOU ARE GOING TO HAVE A HARD TIME GOING OUT WHAT IS GOING ON AT THE BEGINNING, AND AT THE MIDDLE OF AN EPIDEMIC. I WOULD BE VERY CAREFUL ABOUT INVESTING LARGE AMOUNTS OF MONEY , IN PARTICULAR SURVEILLANCE PROGRAMS, UNLESS YOU KNOW EXACTLY WHAT THEY ARE SUPPOSED TO DO, WHETHER THEY WERE, AND WAS GOING TO USE THAT INFORMATION. >> MY NEXT QUESTION WAS GOING TO BE, ARE WE DOING AN ADEQUATE JOB OF INTEGRATING HUMAN-ANIMAL AND IN BY MENTAL HEALTH AND I THINK YOU ALREADY ANSWERED THAT, AND I WOULD SAY NO, WE ARE NOT IN A GREAT JOB. HOW CAN WE IMPROVE INTEGRATING THOSE THREE COMPONENTS TO DEVELOP A MORE COVERAGE OF STRATEGY TO ENSURE THAT WE ARE PREPARED FOR WHATEVER IS NEXT?

• [...]

• Tara O'Toole M.D. [ 01:54:20 ]

• HON. O'TOOLE: I UNDERSTAND THE DEEP CONCERN THAT THE ZIKA VIRUS HAS RAISE. WHENEVER CHILDREN ARE AFFECTED, GROWN-UPS GET DEEPLY WORRIED. THAT IS WHAT IS HAPPENING HERE. I WILL SAY THAT THERE ARE DOZENS OF VERY DANGEROUS MOSQUITOES AND EVEN TICK-BORNE DISEASES THAT HAVE BEEN WITH US FOR MILLENNIA. YOU CAN, TO SOME EXTENT, PROTECT YOURSELF FROM MOSQUITO BITES BY USING DEET AND DRESSING WELL AND SLEEPING IN PLACES WITH SCREENS AND SO FORTH, BUT THAT IS NOT A PERFECT PROTECTION. IT IS NOT A ZERO RISK. WE HAVE TO WAIT AND SEE UNTIL WE HAVE MORE INFORMATION ABOUT WHAT IS REALLY GOING ON, WE HAVE KNOWN THAT THERE HAVE BEEN MORE OR LESS AN EPIDEMIC OF GAIN THE --. IT IS A SERIOUS DISEASE. IN SOUTH AMERICA, FOR A FEW YEARS, THAT IS NOT STOP PEOPLE FROM GOING DOWN THERE. I THINK WE HAVE TO WAIT UNTIL THERE IS MORE SCIENTIFIC DATA ABOUT THE ZIKA VIRUS. I KNOW NIH'S WORKING ON A VACCINE, I WISH WE HAD ONE. BUT, I THINK IF I WERE A YOUNG WOMAN WHO IS PREGNANT, OR GETTING PREGNANT, I WOULD THINK TWICE ABOUT GOING TO SOUTH AMERICA RIGHT NOW. BUT, I THINK FOR MOST PEOPLE, THERE ARE WAYS TO AT LEAST MITIGATE THE RISKS. >> WOULD YOU INDULGE ME FOR 30 SECONDS ON THIS ZIKA VIRUS QUESTION? THANK YOU. I WANTED TO POINT OUT THAT ASIDE FROM MEDICAL COUNTERMEASURES, I'M ZIKA VIRUS, THERE IS A WHOLE FIELD OF LOOKING AT HOW TO BIOENGINEER MOSQUITOES, WHICH WE ALREADY KNOW HOW TO DO.

• Jim Greenwood [ 01:56:11 ]

• SO THAT THERE ACTUALLY -- THEY ARE ALL MILLS, THEY DO NOT BITE. AND THEY MATE WITH THE FEMALES, AND THE PROGENY'S DO NOT SURVIVE. I THINK THAT IS A FASCINATING NEW TECHNOLOGY THAT MAY BE PART OF THE SOLUTION TO THIS PROBLEM. >> THANK YOU. I KNOW WE HAVE VOTES IN A FEW MINUTES, BUT IF YOU HAVE A QUICK FOLLOW UP QUESTION. >>

• Susan W. Brooks [ 01:56:44 ]

• [...]

2016 (March 26, 27) - National Academies - Workshop : "Rapid Medical Countermeasure Response to Infectious Diseases : Enabling Sustainable Capabilities Through Ongoing Public- and Private-Sector Partnerships"

Also there : Thomas Vincent Inglesby, Jr. (born 1957) / Dr. Tara Jeanne O'Toole (born 1951) / Dr. Peter Daszak (born 1965) / Dr. Richard Jones Hatchett IV (born 1968)

Workshop summary Document : [HG00CE][GDrive]

Father - Harold J. O’Toole

Mar 3, 1999 - Cape Cod Times : "Harold J. O’Toole, 74 : Award-winning insurance agent WWII veteran"

Source = [HN01GV][GDrive]