TRANSCRIPT, Meeting 9, Distinguished Speaker

Date

May 17, 2012

Location

Washington, DC

Presenters

The Honorable Kathleen Sebelius
Secretary of the Department of Health and Human Services

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Transcript

DISTINGUISHED SPEAKER

DR. GUTMANN:  So it is my honor and privilege and pleasure to welcome the 21st Secretary of Health and Human Services, the Honorable Kathleen Sebelius.  I want to say a few words about the Secretary before she says a few words to us.

In each phase of her career, Kathleen Sebelius has embodied the motto of the Sunflower State, leading Americans to the stars through difficulties.  The difficulties have been tremendously numerous and diverse.  Time and again she's triumphed to benefit citizens across this country.

Since assuming office in 2009, Secretary Sebelius has presided over momentous changes at HHS.  The passage of the Affordable Care Act has lead to a new focus on wellness and prevention, increased access to primary care health providers and a more efficient medical records system to the benefit of millions of Americans.

Public officials from both parties have praised her as an expert collaborator and as a consensus builder.  I needn't tell members of our Commission how important that is and members of the American public recognize how important those talents put to work for the public good are.

In her two terms as Governor of the State of Kansas, Secretary Sebelius boosted state education spending, fought to create jobs and increased affordable health care.  In 2005, Time Magazine called her "One of the nation's five best governors."

Prior to that, Secretary Sebelius served eight years as Kansas Insurance Commissioner earning a reputation for standing up for consumers and proposing visionary changes to the health care system.

In recognition of her many accomplishments, Governing Magazine selected her as its public official of the year for 2000.

Secretary Sebelius leads the nation's emergency health response to crises and natural disasters, including the Haiti earthquake, the Gulf oil spill and the Joplin, Missouri tornado.  She is no stranger to how to respond effectively to the nation's greatest crises.  It is in this role that Secretary Sebelius has asked us, the Presidential Commission for the Study of Bioethical Issues, for ethical advice on the development of medical countermeasures for children.

We're honored, Madame Secretary, to have you in our presence and to be entrusted with such a task.  Welcome on all our behalves.

(Applause)

SECRETARY SEBELIUS:  Well, thank you so much to Amy Gutmann, not only for that very kind introduction ‑‑ my mother would be very proud ‑‑ but for your leadership on this really important endeavor.  I want to also thank the Commission members and recognize my old friend, Barbara Atkinson, who comes from the Sunflower State and has done great work.  But the job that you're doing is just incredibly important and it's one of the reasons I wanted to spend a little time with you today.

I know that we have Dr. Skip Nelson here from the FDA, Major General Parker with the National Biodefense Science Board, Lisa Kaplowitz is here from ASPR.  I want to recognize the great, new Executive Director of the Commission, Dr. Lisa Lee, who spent over a decade at CDC and now is here.  I can tell you that Amy lost no time in saying, "We have to get her on board quickly, move quickly, we need Lisa," so we're delighted that you're here doing this important work.

I really do recognize that all of you have busy lives and lots to do, but the work of this Commission is critical.  It's critical to us at the Department and it's critical to the President.  I think that you have volunteered your time and effort to make sure that we get these very important issues right.

The work that you did looking at the public health service experiments in Guatemala was critical to get us through a situation that could have provoked, really, international crises and yet you helped us navigate that difficult terrain.  Assessing the rules that protect human subjects and research today are really important framework going forward and clearly need that kind of balanced look.

I think that the effort to bring transparent deliberations to some of the most difficult issues also serves a real role in educating the public about what has to be regarded as important and brings that dialogue forward.

So I think there's serious ethical issues around the development of medical countermeasures for children.  We are very concerned that as we look at our responsibility to protect the health and safety of the American public, we have the responsibility at HHS for developing and stock piling safe and effective medical countermeasures to protect the nation from bioterror attacks or naturally occurring issues.  The work that is done in our various departments on this issue is ongoing; continually assessing what's out there trying to be informed by the newer science looking at what's available.

One of the things that I did ‑‑ because many of you might know I was sworn in in the midst of the first pandemic in 70 years in this country.  I had done a lot of things in Kansas, but we'd never had a pandemic ‑‑ thank God.  But I learned very quickly about some of the challenging issues around medical countermeasures; what we knew and what we didn't know, how long it might take to develop effective responses.

So one of the after action items in that situation was to have a review of our entire medical countermeasure system.  The President asked us to conduct that and I was pleased to do it.  It was clear, among other things, that we needed to improve our capacity to produce medical countermeasures more rapidly in the face of any attack or threat.  We were in a situation in the United States, and that is being changed over time, but that we really could only produce less than a third of whatever was needed.

So we relied on contracts; international contracts, that might or might not have been fulfilled.  We have little control.  It was a situation which we have identified as one that we need to fix.

So we've made some progress toward goals for adults.  We know that the development of appropriate countermeasures for children is really slower, but critically important.  It's due in part to the challenges of collecting appropriate scientific information about pediatric populations.  We know we've got to address that problem.  You can't just assume that what we have for adults works for children, but we have to do it thoughtfully and carefully and with children's safety as the highest priority.

We know that the best science has to be available but that's really only part of the job.  We have to look at all of the costs and benefits, risks and opportunity and then proceed in a way that really reflects our best values as a nation as we go down this path.

So we are relying on you at the Department from the Office of the President, because we know that the work that you have done delivers rational, independent evidence‑based advice on a wide variety of issues.  I can think of no issue really more important, and really more urgent, then helping us develop a pathway to figure out how to keep our children safe and secure in the event that something occurs.

So I just wanted to come and say, thank you.  Thank you for the work you have done.  We seem to have no lack of work for you to do.  I wish we would run out of issues to bring your way, but I don't think that's likely to happen any time soon, but your work is critically important and to the 300 million people or so who can't be in the room today, I want to say, thank you, on their behalf because the problems that you're helping to solve and sort through are really affecting the lives of a lot of Americans, whether they know it or not.  So thank you very, very much, and thank you, again, Dr. Gutmann, for your leadership and your willingness to take on these challenges.

(Applause)

DR. GUTMANN:  I think you'll all recognize, so I would normally apologize, but I think no apologies are necessary for this particular interruption, right?  We all know how busy the Secretary's schedule is, so really I have to say personally, and I know Jim feels the same way, it's really very good of her to take the time.  I have no doubt of her sincerity in how important it is for us to continue the deliberations from where your board left off.

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